24.7.2018 EN Official Journal of the European Union L 187/1

II (Non-legislative acts)

REGULATIONS

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods (Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 ( 1), and in particular Article 8 thereof,

Whereas:

(1) Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission is to establish, by 1 January 2018, the Union list of novel foods authorised or notified under Regulation (EC) No 258/97 of the European Parliament and of the Council ( 2 ).

(2) The Union list of novel foods authorised or notified under Regulation (EC) No 258/97 was established by Commission Implementing Regulation (EU) 2017/2470 ( 3).

(3) Pursuant to Article 36 of Regulation (EU) 2015/2283, the new novel food Regulation applies from 1 January 2018. A number of products were authorised or notified under Regulation (EC) No 258/97 during the period between the Standing Committee vote on the Union list on 6 December 2017 and the date of application of Regulation (EU) 2015/2283 on 1 January 2018. These products should therefore be included in the Union list established through Implementing Regulation (EU) 2017/2470.

(4) On 19 December 2017, the company Demethra Biotech S.r.l. notified the Commission that it placed the novel food ‘Echinacea purpurea extract from cell cultures’ on the Union market pursuant to Article 5 of Regulation (EC) No 258/97. This novel food was not included in the Union list. Therefore, a new entry should be added to Tables 1 and 2 of the Annex to Implementing Regulation (EU) 2017/2470.

(5) On 21 and 22 December 2017, two companies, DuPont Nutrition & Biosciences ApS and FrieslandCampina Nederland BV, notified the Commission that they placed the novel food ‘2'-Fucosyllactose (microbial source)’ on the Union market pursuant to Article 5 of Regulation (EC) No 258/97. ‘2'-Fucosyllactose (microbial source)’ was already included in the Annex to Implementing Regulation (EU) 2017/2470. Those new notifications modify the numerical values of several parameters listed in the specifications of this novel food and therefore, the entry ‘2'-Fucosyllactose (microbial source)’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 should be corrected accordingly.

( 1 ) OJ L 327, 11.12.2015, p. 1. ( 2 ) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1). ( 3 ) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72). L 187/2 EN Official Journal of the European Union 24.7.2018

(6) On 20 December 2017, the company c-LEcta GmbH notified the Commission that it placed the novel food ‘Trehalose’ on the Union market pursuant to Article 5 of Regulation (EC) No 258/97. ‘Trehalose’ was included in the Annex to Implementing Regulation (EU) 2017/2470. That new notification concerns a new source of trehalose, sucrose. Therefore, the specifications of the entry ‘Trehalose’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 should be corrected accordingly.

(7) After the publication of Implementing Regulation (EU) 2017/2470, a number of errors or omissions were noted concerning the specifications or the conditions of use of a number of authorised novel foods. Therefore, the Union list established in the Annex to Implementing Regulation (EU) 2017/2470 should be corrected.

(8) The novel food ‘L-Alanyl-L-Glutamine’ was authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The category ‘Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen’ was erroneously omitted. Therefore, a correction adding ‘Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen’ as allowed food category in the entry ‘L-Alanyl-L- Glutamine’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(9) The novel food ‘Glucosamine HCl’ was authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The food category ‘Milk-based drinks and similar products intended for young children’ was added erroneously and should be deleted from this entry. A correction in the entry ‘Glucosamine HCl’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is therefore necessary.

(10) The novel food ‘Lacto-N-neotetraose’ was authorised under certain conditions of use and maximum levels by Commission Implementing Decision (EU) 2016/375 ( 1). The wording ‘at concentrations up to 1,2 g/l’ was added erroneously and should be removed from the food category ‘Milk-based drinks and similar products intended for young children’ for this novel food. Therefore, a correction of the entry ‘Lacto-N-neotetraose’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(11) The novel food ‘Spermidine-rich wheat germ extract (Triticum aestivum)’ was authorised under certain conditions of use for ‘adult population excluding pregnant and lactating women’ pursuant to Article 5 of Regulation (EC) No 258/97. However, the exclusion of pregnant and lactating women erroneously did not feature in the Union list. In consequence, the correction of the entry ‘Spermidine-rich wheat germ extract (Triticum aestivum)’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(12) The novel food ‘Antarctic Krill oil from Euphausia superba’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 erroneously omitted the following requirement, which should be added: ‘Oxidative stability: all food products containing Antarctic Krill oil from Euphausia superba should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC)’. Therefore, a correction of this entry in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(13) The novel food ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’ was authorised under certain conditions of use by the Finnish competent authorities ( 2 ). The specifications erroneously added the following requirement: ‘Oxidative stability: all food products containing Antarctic Krill oil rich in phospholipids from Euphausia superba should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC)’. This requirement should be removed. Therefore, a correction of the entry ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(14) The novel food ‘Chia seeds (Salvia hispanica)’ was initially authorised under certain conditions of use by Commission Decision 2009/827/EC ( 3 ). The specifications erroneously added the following requirement: ‘(EU: carbohydrates are available = sugar + starch)’. This requirement should be removed. Therefore, a correction of the entry ‘Chia seeds (Salvia hispanica)’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

( 1 ) Commission Implementing Decision (EU) 2016/375 of 11 March 2016 authorising the placing on the market of lacto-N-neotetraose as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 70, 16.3.2016, p. 22). ( 2 ) Letter of 8 May 2015 (https://ec.europa.eu/food/sites/food/files/safety/docs/novel-food_authorisation_2015_auth-letter_krill-oil_en.pdf) ( 3 ) Commission Decision 2009/827/EC of 13 October 2009 authorising the placing on the market of Chia seed (Salvia hispanica) as novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 294, 11.11.2009, p. 14). 24.7.2018 EN Official Journal of the European Union L 187/3

(15) The novel food ‘Chitosan extract from fungi (Agaricus bisporus; Aspergillus niger)’ was initially authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The specifications erroneously added the following requirement: ‘Fat binding capacity 800 x 9 w/wet weight): pass’. This requirement should be replaced by ‘Fat binding capacity 800 x (w/w wet weight): pass’. Therefore, a correction of the entry ‘Chitosan extract from fungi (Agaricus bisporus; Aspergillus niger)’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(16) The novel food ‘Citicoline’ was authorised under certain conditions of use by Commission Implementing Decision 2014/423/EU ( 1 ). In Table 2 of the Annex to Implementing Regulation (EU) 2017/2470, the specifications of the novel food ‘Citicoline’ refer to citicoline produced via either a synthetic or a microbial process. After the publication of that Regulation, it became clear that microbial process for the production of citicoline, also involved synthetic process. Thus, the specifications concerning ‘Citicoline’ in Table 2 of the Annex to Imple­ menting Regulation (EU) 2017/2470 should be corrected to include only the microbial production process.

(17) The novel food ‘Echinacea angustifolia extract from cell cultures’ was initially authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The specifications erroneously omitted the wording ‘description/definition’. Therefore, a correction of the entry ‘Echinacea angustifolia extract from cell cultures’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(18) The novel food ‘Galacto-oligosaccharide’ is included in the Union list established by Implementing Regulation (EU) 2017/2470. The following microbial sources Pichia pastoris, Kluyveromyces lactis, Sporobolomyces singularis and Papi­ liotrema terrestris of the enzyme ‘β-galactosidase’ were erroneously omitted in the specifications. Therefore, these sources of β-galactosidase should be added to the entry ‘Galacto-oligosaccharide’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470.

(19) The novel food ‘Vitamin K2 (menaquinone)’ was initially authorised under certain conditions of use by Commission 2 Decision 2009/345/EC ( ). The chemical definition of Vitamin K2 was added to ‘specifications of microbiologically produced vitamin K2 (menaquinone-7)’ but erroneously not added to ‘specifications of synthetic vitamin K2 (menaquinone-7)’. Therefore, a correction of the entry ‘Vitamin K2 (menaquinone)’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(20) The novel food ‘Yeast beta-glucans’ was authorised under certain conditions of use by Commission Implementing Decision 2011/762/EU ( 3 ). In the specifications, ‘Microbiological data’ and ‘heavy metals’ erroneously refer to the three forms of Yeast beta-glucans instead of to the form ‘Insoluble in water but dispersible in many liquid matrices’. Therefore, a correction of the entry ‘Yeast beta-glucans’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(21) The novel food ‘Phytosterols/phytostanols’ was authorised under certain conditions of use by Commission Decision 2004/333/EC ( 4). On 14 April 2016, the company BASF SE Human Nutrition, ENS/HR notified the Commission that it placed the novel food ‘Phytosterols/phytostanols’ on the Union market in the category ‘Food supplement’ pursuant to Article 5 of Regulation (EC) No 258/97. The category ‘Food supplement’ was erroneously omitted. Therefore, a correction adding ‘Food supplement’ as allowed food category in the entry ‘Phytosterols/phytostanols’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(22) The novel food ‘Arachidonic acid-rich oil from the fungus Mortierella alpina’ was authorised under certain conditions of use by Commission Decision 2008/968/EC ( 5 ). The following non-genetically modified strain ‘CBS 210.32’ of the fungus Mortierella alpina was erroneously not included in the specifications. Therefore, this strain should be added to the entry ‘Arachidonic acid-rich oil from the fungus Mortierella alpina’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470.

( 1 ) Commission Implementing Decision 2014/423/EU of 1 July 2014 authorising the placing on the market of citicoline as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 196, 3.7.2014, p. 24). 2 ( ) Commission Decision 2009/345/EC of 22 April 2009 authorising the placing on the market of Vitamin K2 (menaquinone) from Bacillus subtilis natto as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 105, 25.4.2009, p. 16). ( 3 ) Commission Implementing Decision 2011/762/EU of 24 November 2011 authorising the placing on the market of yeast beta- glucans as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 313, 26.11.2011, p. 41). ( 4 ) Commission Decision 2004/333/EC of 31 March 2004 authorising the placing on the market of yellow fat spreads, salad dressings, milk type products, fermented milk type products, soya drinks and cheese type products with added phytosterols/phytostanols as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 105, 14.4.2004, p. 40). ( 5 ) Commission Decision 2008/968/EC of 12 December 2008 authorising the placing on the market of arachidonic acid-rich oil from Mortierella alpina as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 344, 20.12.2008, p. 123). L 187/4 EN Official Journal of the European Union 24.7.2018

(23) The novel food ‘Epigallocatechin gallate as a purified extract from green tea leaves (Camellia sinensis)’ was initially authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The food category ‘Foods fortified in accordance with Regulation (EC) No 1925/2006’ was added erroneously and should be deleted from this entry. Furthermore, a correction adding ‘Foods’ to ‘food supplements as defined in Directive 2002/46/EC’ as the allowed food category in the entry ‘Epigallocatechin gallate as a purified extract from green tea leaves (Camellia sinensis)’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(24) The novel food ‘Lycopene from tomatoes’ was authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The food category ‘Food supplement’ was omitted erroneously and should be added to this entry. Therefore, a correction adding ‘Food supplement’ as allowed food category in the entry ‘Lycopene from tomatoes’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

(25) In addition, after the publication of Implementing Regulation (EU) 2017/2470, several typographical errors have been identified in the Annex. While such typographic errors are usually corrected by a corrigendum, for the sake of clarity for economic operators and enforcement authorities, the correction of those typographical errors should be included in this correcting act.

(26) Given the number of corrections, it is appropriate to replace the whole Annex to Implementing Regulation (EU) 2017/2470.

(27) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1 The Annex to Implementing Regulation (EU) 2017/2470 is replaced by the Annex to this Regulation.

Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 23 July 2018.

For the Commission The President Jean-Claude JUNCKER ______

24.7.2018 EN Official Journal of the European Union L 187/5

ANNEX

UNION LIST OF NOVEL FOODS Content of the list 1. The Union list shall consist of Tables 1 and 2. 2. Table 1 includes the authorised novel foods and contains the following information: Column 1: Authorised novel food Column 2: Conditions under which the novel food may be used. This column is further subdivided into two: Specified food category and Maximum levels Column 3: Additional specific labelling requirements Column 4: Other requirements 3. Table 2 includes the specifications on novel foods and contains the following information: Column 1: Authorised novel food Column 2: Specifications L 187/6 EN Official Journal of the European Union 24.7.2018

­ Other requirements Other -acetyl- -acetyl-D- N N

-acetyl-D-neur N the labelling of the foodstuffs containing it be shall ‘ aminic acid’ Food supplements containing D-neuraminic acid shall bear a statement that the food supplement should not be given to infants, young children and children under 10 years of age where they consume breast milk or other foods with added neuraminic acid within the same twenty four hour period.

The designation of the novel food on food novel the of designation The

Additional specific labelling requirements labelling specific Additional

0,05 g/L of reconstituted formula 1,25 g/kg 0,05 g/kg for solid foods with the particular In accordance of the nutritional requirements for infants and young children whom the products are intended but than the not higher in any case for the specified maximum levels category mentioned in the table corresponding to the products. 0,2 g/L (drinks) 1,7 g/kg (bars) 0,05 g/L

­ ­ Maximum levels Maximum

) ) 1 2 Unflavoured pasteurised and sterilised Unflavoured pasteurised (including UHT) milk-based products Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013 Foods bearing statements on the absence or reduced presence of with the gluten in accordance requirements of Commission Imple (EU) No 828/ menting Regulation 2014 ( Foods for special medical purposes Foods for special as for infants and young children defined by (EU) Regulation No 609/2013 Infant and follow-on formulae as Infant and follow-on formulae (EU) No defined by Regulation 609/ 2013 ( foods for Total diet replacement weight control as defined by Regu lation (EU) No 609/2013

Specified food category food Specified Conditions under which the novel food may be used be may food novel the which under Conditions Authorised novel food -Acetyl-D-neuraminic acid Table 1: Authorised novel foods Table 1: Authorised N 24.7.2018 EN Official Journal of the European Union L 187/7

Other requirements Other the labelling of the foodstuffs be ‘Baobab fruit containing it shall pulp’ Additional specific labelling requirements labelling specific Additional

0,05 g/L (beverages) 0,25 g/kg (solids) 0,05 g/L (beverages) 0,4 g/kg (solids) 300 mg/day for general older than 10 years population 55 mg/day for infants 130 mg/day for young children 250 mg/day for children between 3 to of age 10 years 0,2 g/kg ­ 0,05 g/L 0,05

) 3 8,3 g/kg 8,3 0,05 g/L 0,05 The designation of the novel food on food novel the of designation The 0,5 g/kg 0,5

Not specified Flavoured drinks Speciality coffee, tea, herbal and fruit tea, herbal and infusions, chicory; fruit infusions and extracts; chicory tea, plant, fruit and cereal preparations for infusions Dairy analogues, including beverage whiteners Table top sweeteners Fruit and vegetable-based drinks as defined in Food Supplements ( Directive 2002/46/EC Cereal bars Unflavoured fermented milk-based products, heat treated after fermen tation, flavoured fermented milk products including heat-treated products Conditions under which the novel food may be used be may food novel the which under Conditions (Baobab)

Authorised novel food Adansonia digitata dried fruit pulp L 187/8 EN Official Journal of the European Union 24.7.2018

Other requirements Other seed

Allanblackia ’ Ulkenia sp.

the labelling of the foodstuffs be containing it shall ‘Oil from the micro-algae the labelling of the foodstuffs be ‘ containing it shall oil’ The designation of the novel food on food novel the of designation The Ajuga on food novel the of designation The Additional specific labelling requirements labelling specific Additional

20 g/100 g 200 mg/100 g In line with normal use in food normal use In line with of supplements of a similar extract parts of the flowering aerial reptans 60 mg/100 ml

Maximum levels Maximum levels DHA Maximum of levels Maximum levels Maximum

500 mg/100 g mg/100 500 Specified food category Specified food category

Foods for special medical purposes as purposes medical Foods for special defined in (EU) Regulation No 609/ infants for foods 2013 excluding and young children Drinks intended to meet the expenditure of intense muscular for sportsmen effort especially Cereal bars (including Non-alcoholic beverages milk based beverages) Food Supplements as defined in Food Supplements Directive 2002/46/EC as defined in Food Supplements Directive 2002/46/EC Yellow fat spreads and Yellow fat spreads cream based spreads Bakery products (breads, rolls and sweet biscuits)

Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Specified food category food Specified extract from cell extract seed oil seed

sp. Authorised novel food Allanblackia L-Alanyl-L-Glutamine Algal oil from the microalgae Ulkenia Ajuga reptans cultures 24.7.2018 EN Official Journal of the European Union L 187/9

Other requirements Other

)’ Euphausia superba The designation of the novel food on the labelling of the foodstuffs be extract ‘Lipid containing it shall Krill Antarctic from the crustacean ( ­

Additional specific labelling requirements labelling specific Additional (L.) Burm.

EPA

from Aloe vera 200 mg/100 g or for cheese products 600 mg/100 g g mg/100 cheese products 600 with the particular In accordance of the nutritional requirements persons for whom the products are intended 200 mg/100 g 80 mg/100 ml In line with normal use in food normal use In line with supplements of the similar gel derived 3 000 mg/day for the general lation popu 450 mg/day lactating women for pregnant and 200 mg/100 g or for analogues to analogues for or g mg/100 200 Maximum levels of combined DHA and DHA levels combined of Maximum levels Maximum 600 mg/100 g mg/100 600 500 mg/100 g mg/100 500

500 mg/100 g mg/100 500

360 mg/100 ml mg/100 360 Specified food category Specified food category

Dairy analogues except drinks Cooking fats Bakery products (breads, rolls and sweet biscuits) bars Nutrition bars/cereal as defined in Food Supplements Directive 2002/46/EC Foods for special medical purposes as purposes medical Foods for special defined in (EU) Regulation No 609/ 2013 Food Supplements as defined in Food Supplements Directive 2002/46/EC Breakfast cereals Spreadable fat and dressings Dairy products except milk-based Dairy products except drinks Non-alcoholic beverages Milk-based drinks Dairy analogue drinks Conditions under which the novel food may be used be may food novel the which under Conditions

Baker leaf Authorised novel food

Antarctic Krill oil from Antarctic Krill oil Euphausia superba Aloe macroclada extract L 187/10 EN Official Journal of the European Union 24.7.2018

Other requirements Other

)’ Euphausia superba The designation of the novel food on the labelling of the foodstuffs be extract ‘Lipid containing it shall Krill Antarctic from the crustacean (

Additional specific labelling requirements labelling specific Additional

EPA

200 mg/100 g or for cheese products 600 mg/100 g g mg/100 cheese products 600 200 mg/100 ml 80 mg/100 ml 250 mg/meal ­

200 mg/100 g or for analogues to analogues for or g mg/100 200 Maximum levels of combined DHA and DHA combined of levels Maximum 600 mg/100 g mg/100 600

500 mg/100 g mg/100 500

360 mg/100 ml mg/100 360 Specified food category

Foods bearing statements on the absence or reduced presence of with the gluten in accordance requirements of Commission Imple (EU) No 828/ menting Regulation 2014 Processed cereal-based food and baby food intended for infants and young children covered by Regulation (EU) No 609/2013 Dairy analogues except drinks Cooking fats Foods intended to meet the expenditure of intense muscular for sportsmen effort, especially Breakfast cereals Spreadable fat and dressings Dairy products except milk-based Dairy products except drinks Non-alcoholic beverages Milk-based drinks Dairy analogue drinks Total diet replacement for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 replacements and meal control for weight Conditions under which the novel food may be used be may food novel the which under Conditions Euphausia

Authorised novel food Antarctic Krill oil rich in Antarctic Krill oil phospholipids from superba 24.7.2018 EN Official Journal of the European Union L 187/11

Other requirements Other Mortierella alpina ’ or ‘ ’ or

the labelling of the foodstuffs containing it be shall ‘Oil from Mortierella alpina oil’ ­ The designation of the novel food on food novel the of designation The Additional specific labelling requirements labelling specific Additional

In accordance with the particular In accordance of the nutritional requirements persons for whom the products are intended (EU) Regulation with In accordance No 609/2013 200 mg/100 g 200 mg/100 ml 3 000 mg/day for the general lation popu 450 mg/day lactating women for pregnant and 250 mg/meal ­

Maximum levels Maximum 500 mg/100 g mg/100 500

Specified food category

Foods bearing statements on the absence or reduced presence of with the gluten in accordance requirements of Commission Imple (EU) No 828/ menting Regulation 2014 Nutrition bars/cereal bars Nutrition bars/cereal as defined in Food Supplements Directive 2002/46/EC Processed cereal-based food and baby food intended for infants and young children covered by Regulation (EU) No 609/2013 Foods for special medical purposes as purposes medical Foods for special defined in (EU) Regulation No 609/ 2013 Foods intended to meet the expenditure of intense muscular for sportsmen effort, especially Total diet replacement for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 replacements and meal control for weight Infant formula and follow-on formula Infant formula as defined in Regulation (EU) No 609/ 2013 Bakery products (breads, rolls and sweet biscuits)

Conditions under which the novel food may be used be may food novel the which under Conditions Mortierella alpina Mortierella Authorised novel food Arachidonic acid-rich oil from the fungus L 187/12 EN Official Journal of the European Union 24.7.2018

Other requirements Other

the labelling of the foodstuffs containing it shall be ‘Argan oil’ and if used as seasoning ‘Vegetable oil only for seasoning’ shall be mentioned label on the the labelling of the foodstuffs containing it shall be ‘Astaxanthin’ the labelling of the foodstuffs be ‘Fermented black containing it shall Soya or ‘Fermented bean (Soya) extract’’ extract’ the labelling of the foodstuffs containing it shall be from ‘Lactoferrin milk’ cows’ ­

The designation of the novel food on food on novel food the novel of on the designation food on of The novel food designation the novel The of the designation of The designation The

) Additional specific labelling requirements labelling specific Additional

Ocimum basilicum 8 mg astaxanthin per day per astaxanthin mg 8 ≤ In accordance with Regulation (EU) Regulation with In accordance No 609/2013 3 g/200 ml for addition of whole basil seeds ( 100 mg/100 ml Depending on needs of the indi the g/day vidual up to 3 In line with normal food use of normal food use In line with vegetable oils 40-80 mg/day of oleoresin, resulting in 4,5 g/day 200 mg/100 g

Maximum levels Maximum levels levels Maximum levels Maximum levels Maximum Maximum 670 mg/100 g mg/100 670

Not specified Not

Specified food category Processed cereal food (solid) as purposes medical Foods for special (EU) defined in Regulation No 609/2013 Food Supplements as defined in Food Supplements Directive 2002/46/EC Fruit juice and blend fruit/vegetable beverages intended Foods on basis for dairy to (ready eat/drink) young children As seasonings Food Supplements as defined in Food Supplements Directive 2002/46/EC Infant formula and follow-on formula Infant formula as defined in Regulation (EU) No 609/2013 to drink) (ready Foods for special medical purposes Foods for special infants as defined in for premature Regulation (EU) No 609/2013 Food Supplements as defined in Food Supplements Directive 2002/46/EC Specified food category food Specified Specified food category food Specified ) Specified food category food Specified

Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Argania spinosa Ocimum basilicum Authorised novel food Haematococcus pluvialis

Astaxanthin-rich oleoresin from algae Bovine lactoferrin Fermented black bean extract Argan oil from Basil seeds ( 24.7.2018 EN Official Journal of the European Union L 187/13

­ Other requirements Other Buglos

oil’ the labelling of the foodstuffs be containing it shall ‘Refined soides The designation of the novel food on food novel the of designation The

Additional specific labelling requirements labelling specific Additional

500 mg/day 330 mg/100 g 750 mg/100 g 50 mg/100 g 75 mg/100 g for drinks 250 mg/100 g mg/100 250 Maximum levels of stearidonic acid (STA) acid stearidonic of levels Maximum 750 mg/100 g mg/100 750 80 mg/100 g mg/100 80

2 000 mg/100 g mg/100 000 2 200 mg/100 g mg/100 200 120 mg/100 g mg/100 120 1 000 mg/100 g mg/100 000 1 625 mg/100 g mg/100 625

3 000 mg/100 g mg/100 000 3 130 mg/100 g mg/100 130 750 mg/100 g mg/100 750 Powdered drink mixes based on milk (ready to drink) Beverages based on fermented milk (including yoghurt drinks) Products based on yoghurt Cakes and pastries Chewing gum and other fat oil emulsions Butter including spreads (not for cooking or frying purposes) Breakfast cereals defined in as Food supplements Directive 2002/46/EC, excluding infants and for food supplements young children Ice cream Candies Cheese and products cheese Non-alcoholic drinks Products based on cheese Dairy products and analogues Beverages based on milk Specified food category food Specified Conditions under which the novel food may be used be may food novel the which under Conditions seed oil seed Authorised novel food Buglossoides arvensis L 187/14 EN Official Journal of the European Union 24.7.2018

Other requirements Other Salvia

Calanus

(crustacean)’

)’ the labelling of the foodstuffs be containing it shall ‘oil from finmarchicus the labelling of the foodstuffs containing it shall be ‘Gum base (including 1,3-butadiene, 2-methyl- homopolymer, maleated, esters with polyethylene glycol mono-Me ether)’ or ‘Gum base (including CAS No: 1246080-53-4)’ the labelling of the foodstuffs containing it shall be ‘Gum base (including methyl vinyl ether-maleic anhydride copolymer)’ or ‘Gum base (including CAS No 9011-16-9)’ the labelling of the foodstuffs containing it shall be ‘Chia oil ( hispanica The designation of the novel food on food on novel food the novel on of the food designation on of novel The food designation the novel The of the designation of The designation The Additional specific labelling requirements labelling specific Additional

In accordance with the particular In accordance of the nutritional requirements persons for whom the products are intended 2,3 g/day 2 g/day 250 mg/meal Maximum levels levels Maximum Maximum levels Maximum levels Maximum

8 % 8 % 2 2 g/day 2 10 % 10 Specified food category Specified food category Food Supplements as defined in Food Supplements Directive 2002/46/EC Pure chia oil Total diet replacement for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 replacements and meal control for weight Fats and oils Food supplements as defined in as Food supplements Directive 2002/46/EC Chewing gum Chewing gum Foods for special medical purposes as purposes medical Foods for special defined in (EU) Regulation No 609/ special for foods 2013, excluding medical purposes intended for infants and young children Specified food category food Specified Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified oil Salvia hispanica

Authorised novel food

Chewing gum base (Methyl anhydride vinyl ether-maleic copolymer) Chia oil from Chewing gum base (monomethoxypolyethylene glycol) Calanus finmarchicus 24.7.2018 EN Official Journal of the European Union L 187/15

) Other requirements Other

’ ’ or ‘Chitosan ’ or Salvia hispanica

’

’ )’ Aspergillus niger Aspergillus Aspergillus niger Aspergillus fomentarius Fomes bisporus Agaricus Salvia hispanica seeds shall carry additional labelling seeds shall carry the that consumer the to inform g. is no more than 15 intake daily on the labelling of foodstuffs seeds be ‘Chia containing it shall ( 2. Pre-packaged Chia ( the labelling of the foodstuffs containing it be shall ‘Chitin-glucan from the labelling of the foodstuffs containing it be shall ‘Chitin-glucan from the labelling of the foodstuffs be ‘Chitosan extract containing it shall from extract from ­

1. The designation of the novel food novel the of designation The 1. on food on novel food on the novel food of the novel designation of the The designation of The designation The

Additional specific labelling requirements labelling specific Additional

5 % whole chia seeds 15 g/day for seeds mashed or ground chia addition of whole, yoghurt or 4,3 g whole chia seeds per yoghurt or 4,3 330 g of yoghurt (portion) 5 g/day 5 g/day in food normal use In line with supplements of chitosan from crusta ceans 15 g/day whole chia seeds chia whole g/day 15 Maximum levels Maximum levels levels Maximum levels Maximum Maximum 10 % whole chia seeds chia whole % 10

10 % whole chia seeds chia whole % 10 10 % whole chia seeds chia whole % 10 5 % (whole or ground chia seeds) chia ground or (whole % 5

1 % whole chia seeds chia whole % 1

Specified food category Specified food category Specified food category g of 100 seeds per chia g whole 1,3 Breakfast cereals Fruit, nut and seed mixes Fruit juice and blend fruit/vegetable beverages based on to eat meals ready Sterilised grains cereal grains, pseudocereals and/or pulses Baked products Yoghurt Fruit spreads as defined in Food Supplements Directive 2002/46/EC Pre-packaged Chia seed as such Bread products as defined in Food Supplements Directive 2002/46/EC Food Supplements as defined in Food Supplements Directive 2002/46/EC Specified food category food Specified

) Conditions under which the novel food may be used be may food novel the which under Conditions Aspergillus Aspergillus

; Salvia hispanica Authorised novel food

) Agaricus bisporus Chitin-glucan complex from Fomes fomentarius Chitosan extract from fungi ( niger Chitin-glucan from niger Chia seeds ( L 187/16 EN Official Journal of the European Union 24.7.2018

­ Other requirements Other L.

Clostridium

Cistus incanus (CBM 588)’

MIYAIRI 588 (CBM 588)’ or

on the labelling of foodstuffs be ‘Citicoline’ containing it shall citicoline shall bear a statement that the product is not intended to be consumed by children Clostridium butyricum the labelling of the foodstuffs be ‘Chondroitin containing it shall sulphate derived from microbial fermentation and sulphation’ the labelling of the foodstuffs be containing it shall ‘ Pandalis herb’ 2. The labelling of foods containing the labelling of the foodstuffs be ‘ containing it shall butyricum ‘ the labelling of the foodstuffs containing it shall be ‘Chromium Picoli nate’

The designation of the novel food on food novel the of designation The The designation of the novel food on food novel the of on designation food food The novel novel the the of on of designation food designation The novel The the 1. of designation The Additional specific labelling requirements labelling specific Additional

CFU/day

8 g/day μ (2 cups/day) serving and a maximum mg per 250 mg 000 daily consumption level of 1 250 1 200 mg/day 500 mg/day 1,35 × 10 ­

) 4 Maximum levels of total chromium levels total of Maximum levels Maximum levels levels Maximum Maximum levels Maximum

Intended daily intake: 3 g herbs/day g 3 intake: daily Intended

Foods fortified in with accordance ( Regulation (EC) No 1925/2006 Foods for special medical purposes as purposes medical Foods for special defined in (EU) Regulation No 609/ 2013 Herbal infusions Foods covered by Regulation (EU) No 609/2013 Food supplements as defined in as Food supplements Directive 2002/46/EC for adult popu lation, excluding pregnant and lactating women as defined in Food Supplements Directive 2002/46/EC Food Supplements as defined in Food Supplements Directive 2002/46/EC Specified food category food Specified Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Specified food category food Specified Specified food category food Specified L. Pandalis herb L. Pandalis Specified food category food Specified Authorised novel food Cistus incanus Chromium Picolinate Citicoline Clostridium butyricum Chondroitin sulphate 24.7.2018 EN Official Journal of the European Union L 187/17

­ ­ ­ Other requirements Other Crataegus pinna

-cyclodextrin’ α dried fruit’

the labelling of the foodstuffs containing it shall be ‘Alpha-cyclo or ‘ dextrin’ consume more than 600 mg poly consume more than 600 g of to phenols corresponding 1,1 extract of defatted cocoa powder per day mg of cocoa consume more than 600 flavanols per day the labelling of the foodstuffs be containing it shall ‘Coriander seed oil’ the labelling of the foodstuffs containing it be shall ‘ tifida

Consumers shall be instructed not to not instructed be to on shall not food Consumers on instructed novel food be the novel shall of the Consumers designation of The designation The Additional specific labelling requirements labelling specific Additional

Crataegus laevigata corresponding to not more than of defatted cocoa mg of extract 550 powder in one portion of food (or food supplement) 600 mg/day 730 mg per 1,2 g/day serving and around

Maximum levels Maximum levels levels Maximum levels Maximum Maximum

) 5

In line with normal food use of use food normal with line In 1 g/day and 300 mg polyphenols mg 300 and g/day 1 The designation of the novel food on food novel the of designation The

Specified food category Specified food category Specified food category Any other foods Any other (including food supplements as defined in Directive become have 2002/46/EC) which for established vehicles functional ingredients and are typically which positioned for consumption by health conscious adults Compotes Milk based beverages Jams and jellies in with accordance ( Directive 2001/113/EC Food Supplements as defined in Food Supplements Directive 2002/46/EC Nutrition bars Foods including food as supplements 2002/46/EC defined in Directive Herbal infusions Conditions under which the novel food may be used be may food novel the which under Conditions

Specified food category food Specified dried

Not specified Not

Authorised novel food

-cyclodextrin α Low fat cocoa extract Low fat Coriander seed oil from oil Coriander seed Coriandrum sativum Crataegus pinnatifida fruit Extract of defatted cocoa Extract of defatted powder L 187/18 EN Official Journal of the European Union 24.7.2018

­ Other requirements Other

-Cyclodextrin’ γ

on the labelling of foodstuffs be ‘Dihydrocap containing it shall siate’ will be synthetic dihydrocapsiate labelled as ‘not intended for children up to 4.5 years’ the labelling of the foodstuffs be ‘Gamma- containing it shall or ‘ Cyclodextrin’ the labelling of the foodstuffs containing it shall be ‘Dextran’ the labelling of the foodstuffs containing it shall be ‘Diacylglycerol % oil of plant origin (at least 80 diacylglycerols)’ 2. Food supplements containing The designation of the novel food on food on novel food the novel of the designation of food The designation novel The the of designation The 1. Additional specific labelling requirements labelling specific Additional

1,5 mg/100 ml 9 mg/100 g mg/100 9 Maximum levels levels Maximum Maximum levels Maximum

12 mg/100 g mg/100 12 2 mg/100 ml mg/100 2 5 % 5

The designation of the novel food on food novel the of designation The

9 mg/100 g mg/100 9

Specified food category Specified food category Bakery products Mayonnaise Salad dressings Meal replacement for weight control (as drinks) Fat spreads Yoghurt type products Biscuits, cookies and crackers Rice based snacks Vegetable drinks Carbonated drinks, dilutable drinks, Carbonated drinks, dilutable based fruit juice beverages Cereal bars Cooking oils Bakery products

Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Not specified Not Authorised novel food

Leuconostoc mesenteroides Leuconostoc -cyclodextrin Dihydrocapsiate (DHC) Diacylglycerol oil of plant origin Dextran preparation produced Dextran preparation by γ 24.7.2018 EN Official Journal of the European Union L 187/19

Other requirements Other Additional specific labelling requirements labelling specific Additional

1 mg/100 ml 1,5 mg/100 ml mg/100 1,5 3 mg/meal 3 2 mg/100 g mg/100 2 2 mg/100 g mg/100 2 2,5 mg/100 g mg/100 2,5 4 mg/100 g mg/100 4 7,5 mg/100 g mg/100 7,5 1 mg/100 ml mg/100 1 1,1 mg/100 g mg/100 1,1 3 mg/meal 3 40 mg/100 g mg/100 40 5 mg/100 g mg/100 5 115 mg/100 g mg/100 115 16 mg/100 g mg/100 16 4,5 mg/100 g mg/100 4,5 27 mg/100 g mg/100 27 200 mg/100 g mg/100 200

Other cereals desserts dairy Ice cream, Hard candy Salad dressing Pudding mixes (ready to Pudding mixes (ready eat) Products based on yoghurt Chocolate confectionery Whitener/creamer to Soup (ready eat) to eat meals Ready Meal replacements for Meal replacements weight control Meal replacement for weight control (as drinks) Flavoured water — still Precooked oatmeal cereal Sugar-free gum Sweeteners Vegetable protein Coffee based drinks, tea based drinks based drinks, Coffee Conditions under which the novel food may be used be may food novel the which under Conditions Authorised novel food L 187/20 EN Official Journal of the European Union 24.7.2018

Other requirements Other from cell cultures from cell cultures

Vb’ Vb’

® ®

the labelling of the foodstuffs of containing it be shall ‘dried extract Lippia citriodora HTN the labelling of the foodstuffs of containing it be shall ‘dried extract Echinacea purpurea HTN the labelling of the foodstuffs containing it shall be ‘Refined echium oil’

The designation of the novel food on food novel the of designation The

The designation of the novel food on food novel the on of food designation novel The the of designation The Additional specific labelling requirements labelling specific Additional

Lippia citriodora Lippia Echinacea angustifolia Echinacea

Echinacea purpurea Echinacea 3 mg/single intake 9 mg/day in food normal use In line with supplements of a similar extract of from the leaves in food normal use In line with supplements of a similar extract from the root of in food normal use In line with supplements of a similar extract head the flower within from florets of 250 mg/100 g; drinks 75 mg/100 g for 500 mg/day 100 ml 14,5 mg/kg equivalent to 1,5 mg/ mg/kg to equivalent 1,5 14,5 Maximum levels levels Maximum (STA) levels Maximum acid stearidonic Maximum of levels Maximum 750 mg/100 g mg/100 750

750 mg/100 g mg/100 750 625 mg/100 g mg/100 625

Specified food category Specified food category Specified food category Cheese preparations Non-alcoholic powdered drink mixes Non-alcoholic powdered Spreadable fat and dressings Breakfast cereals defined in as Food supplements Directive 2002/46/EC Food Supplements as defined in Food Supplements Directive 2002/46/EC Milk-based products and drinkable Milk-based products yoghurt products delivered in a single dose Food Supplements as defined in Food Supplements Directive 2002/46/EC as defined in Food Supplements Directive 2002/46/EC Food Supplements as defined in Food Supplements Directive 2002/46/EC

Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified extract oil extract

Lippia from cell cultures Authorised novel food Echium plantagineum Dried extract of citriodora Echinacea angustifolia from cell cultures Echinacea purpurea from cell cultures 24.7.2018 EN Official Journal of the European Union L 187/21

Other requirements Other

consumers should not consume more per day mg of extract than 300 the labelling of the foodstuffs be ‘L-ergothioneine’ containing it shall The designation of the novel food on the labelling of the foodstuffs Sodium be ‘Ferric containing it shall EDTA’ The labelling shall bear a statement that statement on a food bear novel shall the labelling of The designation The

Additional specific labelling requirements labelling specific Additional

EDTA)

In accordance with the particular In accordance of the nutritional requirements persons for whom the products are intended 12 mg/100 g 30 mg/day for (excluding pregnant and lactating general population women) 20 mg/day for children 3 years older than 18 mg/day for children 75 mg/day for adults 250 mg/meal 150 mg of extract in one portion food supplement food or of

Maximum levels levels Maximum anhydrous as Maximum (expressed levels Maximum

Specified food category

Total diet replacement for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 replacements and meal control for weight Foods fortified in with accordance Regulation (EC) No 1925/2006 Food supplements as defined in as Food supplements Directive 2002/46/EC Foods covered by Regulation (EU) No 609/2013 Foods including food as supplements 2002/46/EC defined in Directive Foods for special medical purposes as purposes medical Foods for special defined in (EU) Regulation No 609/ 2013 defined in as Food supplements Directive 2002/46/EC Conditions under which the novel food may be used be may food novel the which under Conditions

) Specified food category food Specified Specified food category food Specified Camellia sinensis Authorised novel food Ferric Sodium EDTA Ferric Sodium Epigallocatechin gallate as a purified extract from green tea leaves ( L-ergothioneine L 187/22 EN Official Journal of the European Union 24.7.2018

Beverages containing flavonoids shall be presented to the final consumer as single portions. ­ Other requirements Other Sardinops ’

Glycyrrhiza glabra L. glabra Glycyrrhiza consumed by pregnant and breast feeding women, children and and young adolescents; should only consume the product under medical super vision; ) peptides’ on the labelling of foodstuffs be ‘Flavonoidscontaining it shall from product was added as a novel food a statement bear ingredient shall that: (a) the product should not be drugs prescription taking (b) people the labelling of the foodstuffs containing it be shall ‘Ferrous ammonium phosphate’ 1. The designation of the novel food the where foods the of labelling 2. The the labelling of the foodstuffs containing it be ( shall ‘Fish sagax The designation of the novel food on food novel the of designation The

The designation of the novel food on food novel the of designation The

Additional specific labelling requirements labelling specific Additional

Glycyrrhiza glabra

0,3 g/100 g (ready to drink) 120 mg/day 120 mg/day To be used in compliance with To be used in compliance Directive 2002/46/EC, Regulation Regulation (EU) No 609/2013 and/or (EC) No 1925/2006 120 mg/day 0,48 g/100 g (ready to eat/drink)

0,3 g/100 g (ready to eat) to (ready g g/100 0,3

Maximum levels product peptide Maximum fish from levels Maximum flavonoids of levels Maximum

120 mg/day 120

2 g/100 g g/100 2

Specified food category Specified food category

Foods fortified in with accordance Regulation (EC) No 1925/2006 Soups, stews and soup powders Beverages based on fruit or vegetables Food Supplements as defined in Food Supplements Directive 2002/46/EC Breakfast cereals Foods covered by Regulation (EU) No 609/2013 Foods based on yoghurt yoghurt, drinks, fermented milk and products, powdered milk Beverages based on yoghurt for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 as purposes medical Foods for special defined in (EU) Regulation No 609/ 2013 Flavoured water, and vegetable-based drinks Food supplements as defined in as Food supplements Directive 2002/46/EC Beverages based on milk Specified food category food Specified Conditions under which the novel food may be used be may food novel the which under Conditions Sardinops Glycyrrhiza Authorised novel food

Fish peptides from Fish peptides sagax Flavonoids from glabra Ferrous ammonium phosphate Ferrous ammonium 24.7.2018 EN Official Journal of the European Union L 187/23

­ ­ Other requirements Other

-fucosyl

′ ’. -fucosyllac

′ -fucosyllactose ′ -fucosyllactose shall ′ -fucosyllactose are ′ Fucus vesiculosus flavonoids per day should be consumed. on the labelling of foodstuffs be ‘2 containing it shall tose’. containing 2 statement that the bear a supplements should not be used if added 2 other foods with lactose are consumed the same day. containing 2 shall children intended for young statement that the bear a supplements should not be used if breast milk or other foods with added 2 day. same consumed the final food shall be indicated on be indicated the final food shall labelling of the food containing it. (c) a maximum of mg 120 of the labelling of the foodstuffs extract be ‘Fucoidan containing it shall from seaweed the labelling of the foodstuffs extract be ‘Fucoidan containing it shall Undaria pinnatifida’ from seaweed 2. The labelling of food supplements 3. The labelling of food supplements 3. The amount of flavonoids in the The designation of the novel food on food on novel food food the novel novel of the the designation of of The designation designation The The 1. Additional specific labelling requirements labelling specific Additional

1,2 g/l beverages 1,2 g/l beverages 1,2 g/l beverages 1,2 g/l 250 mg/day 250 mg/day 400 g/kg for whitener 19,2 g/kg beverages products other than 19,2 g/kg beverages products other than 12 g/kg for beverages products other than

Maximum levels levels Maximum levels Maximum Maximum

Specified food category Specified food category

Unflavoured fermented milk-based products Flavoured fermented milk-based products including heat-treated products Dairy analogues, including beverage whiteners Unflavoured pasteurised and sterilised Unflavoured pasteurised (including UHT) milk-based products Foods including food as supplements 2002/46/EC defined in Directive for population the general Foods including food as supplements 2002/46/EC defined in Directive for population the general

Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Undaria pinnatifida Fucus vesiculosus Authorised novel food -Fucosyllactose ′ Fucoidan extract from the seaweed 2 Fucoidan extract from the seaweed L 187/24 EN Official Journal of the European Union 24.7.2018

Other requirements Other

-neotetraose at -neotetraose at Additional specific labelling requirements labelling specific Additional N N

-neotetraose, at a ratio of 2:1 in the at a ratio -neotetraose, 12 g/kg for beverages products other than with the particular In accordance of the nutritional requirements persons for whom the products are intended 1,2 g/l alone or in combination g/l of lacto- with up to 0,6 of 2:1 in a ratio the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 1,2 g/l alone or in combination g/l of lacto- with up to 0,6 of 2:1 in a ratio the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 4,8 g/l for drinks 40 g/kg for bars 1,2 g/l for liquid food ready for use, food ready g/l for liquid 1,2 marketed as such or reconstituted as instructed by the manufacturer 1,2 g/l for similar products added alone or in milk-based drinks lacto- g/l to 0,6 up combination with and N final product ready for use, marketed or reconstituted as instructed as such by the manufacturer

200 g/kg 200

12 g/kg 12

Table-top sweeteners Follow-on formula as defined in Follow-on formula Regulation (EU) No 609/2013 Processed cereal-based food and baby infants and young children food for as defined in Regulation (EU) No 609/ 2013 Milk-based drinks and similar products intended for young children for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 Infant formula as defined in as Infant formula Regulation (EU) No 609/2013 Foods for special medical purposes as purposes medical Foods for special defined in (EU) Regulation No 609/ 2013 Cereal bars Conditions under which the novel food may be used be may food novel the which under Conditions Authorised novel food 24.7.2018 EN Official Journal of the European Union L 187/25

Other requirements Other

Additional specific labelling requirements labelling specific Additional

galacto-oligosaccharide/kg final food) 9,6 g/l — the maximum level refers to ready to use the products 0,020 60 g/kg 3,0 g/day for general population 0,333 1,2 g/day for young children ­ Maximum levels (expressed as ratio kg ratio as (expressed levels Maximum

0,020

1,2 g/l 1,2

0,030

0,033 0,020 Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products Milk Milk drinks Meal replacement for weight control (as drinks) Dairy analogue drinks Yoghurt Flavoured drinks Food supplements as defined in as Food supplements Directive 2002/46/EC, excluding infants for food supplements Food Supplements as defined in Food Supplements Directive 2002/46/EC Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regu lation (EU) No 828/2014 Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Authorised novel food Galacto-oligosaccharide L 187/26 EN Official Journal of the European Union 24.7.2018

Other requirements Other Additional specific labelling requirements labelling specific Additional

0,008 0,013 0,012 0,021

0,043 0,043 0,024 0,125 0,059 0,027 0,027 0,143 0,025 0,125

0,021 0,125 Frozen dairy deserts Frozen dairy Fruit drinks and energy drinks drinks replacement Infant meal Baby juice Baby yogurt drink Baby desert Baby snack Baby cereals Drinks intended to meet the expenditure of intense muscular for sportsmen effort especially Juice Fruit pie fillings Fruit preparations Bars Cereals and follow-on formula Infant formula as defined in Regulation (EU) No 609/ 2013 Dairy based deserts Conditions under which the novel food may be used be may food novel the which under Conditions Authorised novel food 24.7.2018 EN Official Journal of the European Union L 187/27

Other requirements Other

on the labelling of foodstuffs Gum’. be ‘Guar containing it shall discomfort linked risks of digestive aged of children exposure to the under 8 gum must be to guar visible on the label of any foodstuffs containing it. 2. A specific mention of the possible ­ ­ ­ food novel the of designation The 1. Additional specific labelling requirements labelling specific Additional

10 g/100 g in the cereals dairy accompanying None in the product In line with normal food use of gluco normal food use In line with samine from shell fish of gluco normal food use In line with samine from shell fish of gluco normal food use In line with samine from shell fish 1,8 g/100 g 1,5 g/100 g

­ ­ 3,25 g/100 g g/100 3,25

Maximum levels Maximum levels levels Maximum levels Maximum Maximum

Meal replacement for Meal replacement weight control Foods bearing statements on the absence or reduced presence of with the gluten in accordance requirements of Commission Imple (EU) No 828/ menting Regulation 2014 Fruit or vegetable-based liquid food stuffs (of the ‘smoothie’ variety) Fruit or vegetable-based compotes Food Supplements as defined in Food Supplements Directive 2002/46/EC Foods covered by Regulation (EU) No 609/2013 as defined in Food Supplements Directive 2002/46/EC as defined in Food Supplements Directive 2002/46/EC Cereals accompanied by a dairy product, in packaging containing two compartments Foods intended to meet the expenditure of intense muscular for sportsmen effort, especially Fresh dairy products such as yogurts, and fermented milks, fresh cheeses desserts. other dairy-based Specified food category food Specified Specified food category food Specified Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Specified food category food Specified Authorised novel food Glucosamine sulphate KCl Glucosamine sulphate Glucosamine sulphate NaCl Glucosamine sulphate Guar Gum Glucosamine HCl L 187/28 EN Official Journal of the European Union 24.7.2018

Other requirements Other

consumed by children under the consumed by children pregnant age of three years, women; women, and lactating used for cooking, baking or frying’ For example, ‘Excessive consumption ‘Excessive For example, cause may products of these for especially digestive discomfort, children under 8 of years age’. and compartments containing dairy the cereal products respectively, instructions for use must clearly specify the need to mix the cereal before product and the dairy consumption, in order to take into of account the potential risk gastro- intestinal obstruction. the labelling of the food products be ‘hydroxytyrosol’. containing it shall The labelling of the food products bear shall containing hydroxytyrosol the following statements: should not be food product (a) This (b) This food product should not be the labelling of the foodstuffs containing it shall be ‘Ice Structuring Protein’ 3. In the case of products with two The designation of the novel food on food novel the on of food designation novel The the of designation The Additional specific labelling requirements labelling specific Additional

0,215 g/kg 0,175 g/kg 1 g/100 g in the product when ready to eat ­

)), 6

Maximum levels levels Maximum Maximum levels Maximum

0,01 % 0,01 Specified food category Specified food category

placed as such on the market Fermented milk products (in Fermented milk products liquid, semi-liquid and spray-dried powder forms) Spreadable fats as defined in Part VII (EU) of Annex VII Regulation on such as No 1308/2013, placed the market Edible ices Fish and vegetable oils, (except olive oils and olive pomace oils as defined in Part VIII of Annex VII of Regu ( lation (EU) No 1308/2013 Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Bacteroides

Authorised novel food Hydroxytyrosol Heat-treated milk products fermented with xylanisolvens Ice Structuring Protein type III Protein type Ice Structuring HPLC 12 24.7.2018 EN Official Journal of the European Union L 187/29

­ Other requirements Other

’ Ilex guayusa Ilex on the labelling of foodstuffs be ‘Isomaltoolicontaining it shall gosaccharide’. ingredient must be labelled as ‘a source of glucose’. the labelling of the foodstuffs of dried be containing it ‘Extracts shall leaves of 2. Foods containing the novel The designation of the novel food on food food novel novel the the of of designation designation The The 1. Additional specific labelling requirements labelling specific Additional

Ilex paraguariensis Ilex infusions and food supplements of a similar aqueous extract of dried leaves of 20 % 5 % 6,5 % Maximum levels Maximum levels Maximum 6,5 % 6,5 25 % 25

25 % 25 5 % 5 20 % 20 In line with normal use in herbal in use normal with line In 5,0 % 5,0 97 % 97 10 % 10 5 % 5 Specified food category

Cookies, Biscuits Breakfast Cereal Bars Hard Candies Bars Soft Candies/Chocolate Meal replacement for weight control (as bars or milk based) Food Supplements as defined in Food Supplements Directive 2002/46/EC Energy Drinks Foods intended to meet the expenditure of intense muscular for efforts, especially sportsmen (including isotonic drinks) Fruit Juices Processed Vegetables and Vegetable Juices Other Soft Drinks Cereals Bars Herbal infusions Energy-Reduced Soft Drinks Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified

Ilex guayusa Ilex Authorised novel food Isomalto-oligosaccharide Aqueous extracts of dried leaves of L 187/30 EN Official Journal of the European Union 24.7.2018

­ - - ­ Other requirements Other N N

-neotetraose N -neotetraose shall -neotetraose are N N

on the labelling of foodstuffs be ‘Isomaltulose’. containing it shall be accom shall labelling on the panied by indication that the ‘Isom altulose is a source of glucose and fructose’. on the labelling of foodstuffs be ‘lacto- containing it shall neotetraose’. containing lacto- statement that the bear a supplements should not be used if other foods with added lacto- consumed the same neotetraose are day. containing lacto- shall children intended for young statement that the bear a supplements should not be used if breast milk or other foods with added lacto- day. same consumed the 2. The designation of the novel food the labelling of food supplements containing it shall be ‘Lactitol’ 2. The labelling of food supplements 3. The labelling of food supplements The designation of the novel food on food food novel novel the the of of designation designation The The 1. Additional specific labelling requirements labelling specific Additional

0,6 g/l for beverages 6 g/kg for beverages products other 200 g/kg for whitener than 20 g/day 0,6 g/l for beverages 9,6 g/kg for beverages products other than 0,6 g/l for beverages 9,6 g/kg for beverages products other than 0,6 g/l

­ Maximum levels Maximum levels Maximum 100 g/kg 100 1. The designation of the novel food novel the of designation The 1. 6 g/kg 6

Unflavoured fermented milk-based products Table-top sweeteners Flavoured fermented milk-based products including heat-treated products Dairy analogues, including beverage whiteners Cereal bars Unflavoured pasteurised and sterilised Unflavoured pasteurised (including UHT) milk-based products Food Supplements as defined in Food Supplements Directive 2002/46/EC (capsules or tablets) intended for the adult popu lation Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Not specified Not -neotetraose Specified food category food Specified Authorised novel food N Lacto- Lactitol Isomaltulose 24.7.2018 EN Official Journal of the European Union L 187/31

Other requirements Other

-fucosyllactose, Additional specific labelling requirements labelling specific Additional ′

-fucosyllactose at a ratio -fucosyllactose at a ratio ′ ′

In accordance with the particular In accordance of the nutritional requirements persons for whom the products are intended 0,6 g/l in combination 1,2 g/l with of 2 up to for ready final product of 1:2 in the use, marketed as such or reconstituted by as instructed the manufacturer 0,6 g/l in combination 1,2 g/l with of 2 up to for ready final product of 1:2 in the use, marketed as such or reconstituted by as instructed the manufacturer 6 g/kg for beverages products for use, food ready g/l for liquid other 0,6 than marketed as such or reconstituted as instructed by the manufacturer 2,4 g/l for drinks 20 g/kg for bars 30 g/kg 0,6 g/l for similar products added alone or in milk-based drinks 2 combination with and final product of 1:2 in the a ratio at ready for use, marketed as such or reconstituted as instructed by the manufacturer

­ ­

Milk-based drinks and similar products intended for young children as purposes medical Foods for special defined in (EU) Regulation No 609/ 2013 for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regu lation (EU) No 828/2014 Follow-on formula as defined in Follow-on formula Regulation (EU) No 609/2013 Processed cereal-based food and baby infants and young children food for as defined in Regulation (EU) No 609/2013 Infant formula as defined in Regu Infant formula as lation (EU) No 609/2013 Conditions under which the novel food may be used be may food novel the which under Conditions Authorised novel food L 187/32 EN Official Journal of the European Union 24.7.2018

Other requirements Other

) protein’ or ‘Alfalfa ) protein’ ) protein’. Medicago sativa Medicago sativa ( the labelling of the foodstuffs be ‘Lucerne containing it shall ( the labelling of the foodstuffs containing it shall be ‘Lycopene’

The designation of the novel food on food on novel food the novel of the designation of The designation The

Additional specific labelling requirements labelling specific Additional

4,8 g/l — the maximum level refers to ready to use the products 1,5 g/day for general population 0,6 g/day for young children 10 g/day 2,5 mg/100 g 8 mg/meal 2,5 mg/100 g 1 mg/100 g mg/100 1 3 mg/100 g mg/100 3

Maximum levels levels Maximum Maximum

10 mg/100 g mg/100 10 0,6 g/l 0,6 5 mg/100 g mg/100 5

Specified food category Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products Drinks intended to meet the expenditure of intense muscular for sportsmen effort especially for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 replacements and meal control for weight Fats and dressings breads) Bread (including crispy Breakfast cereals Soups other than tomato soups Food supplements as defined in as Food supplements Directive 2002/46/EC, excluding infants for food supplements Food supplements as defined in as Food supplements Directive 2002/46/EC Fruit/vegetable juice-based drinks (including concentrates) Flavoured drinks

Conditions under which the novel food may be used be may food novel the which under Conditions

Specified food category food Specified Authorised novel food Lycopene Lucerne leaf extract from Medicago sativa 24.7.2018 EN Official Journal of the European Union L 187/33

Other requirements Other

the labelling of the foodstuffs containing it shall be ‘Lycopene’ The designation of the novel food on food novel the of designation The Additional specific labelling requirements labelling specific Additional

In accordance with the particular In accordance of the nutritional requirements persons for whom the products are intended In accordance with the particular In accordance of the nutritional requirements persons for whom the products are intended 15 mg/day 15 mg/day 2,5 mg/100 g 8 mg/meal 2,5 mg/100 g 1 mg/100 g mg/100 1 3 mg/100 g mg/100 3

Maximum levels Maximum

10 mg/100 g mg/100 10 5 mg/100 g mg/100 5

Specified food category

Drinks intended to meet the expenditure of intense muscular for sportsmen effort especially for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 replacements and meal control for weight Fats and dressings breads) Bread (including crispy as purposes medical Foods for special defined in (EU) Regulation No 609/ 2013 Breakfast cereals Food supplements as defined in as Food supplements Directive 2002/46/EC defined in as Food supplements Directive 2002/46/EC Soups other than tomato soups Fruit/vegetable juice-based drinks (including concentrates) Foods for special medical purposes as purposes medical Foods for special defined in Regulation (EU) No 609/2013 Conditions under which the novel food may be used be may food novel the which under Conditions Blakeslea

Authorised novel food Lycopene from trispora L 187/34 EN Official Journal of the European Union 24.7.2018

Other requirements Other

the labelling of the foodstuffs containing it shall be ‘Lycopene’ the labelling of the foodstuffs be containing it shall ‘Lycopene oleoresin from tomatoes’ The designation of the novel food on food novel the of designation The The designation of the novel food on food novel the of designation The Additional specific labelling requirements labelling specific Additional

In accordance with the particular In accordance of the nutritional requirements persons for whom the products are intended 15 mg/day 2,5 mg/100 g 8 mg/meal 2,5 mg/100 g 2,5 mg/100 g 2,5 mg/100 g 1 mg/100 g mg/100 1 3 mg/100 g mg/100 3

Maximum levels Maximum lycopene of levels Maximum

10 mg/100 g mg/100 10 5 mg/100 g mg/100 5 Specified food category

Drinks intended to meet the expenditure of intense muscular for sportsmen effort especially for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 replacements and meal control for weight Drinks intended to meet the expenditure of intense muscular for sportsmen effort especially Fats and dressings breads) Bread (including crispy as purposes medical Foods for special defined in (EU) Regulation No 609/ 2013 Breakfast cereals Food supplements as defined in as Food supplements Directive 2002/46/EC Soups other than tomato soups Fruit/vegetable juice-based drinks (including concentrates) Fruit/vegetable juice-based drinks (including concentrates) Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified

Authorised novel food Lycopene oleoresin from tomatoes Lycopene from tomatoes 24.7.2018 EN Official Journal of the European Union L 187/35

Other requirements Other

the labelling of the foodstuffs be ‘Magnesium containing it shall citrate malate’ the labelling of the foodstuffs containing it be shall ‘Magnolia Bark Extract’ the labelling of the foodstuffs containing it shall be ‘Maize-germ oil extract’ ­ The designation of the novel food on food on novel food the novel on of the food designation of novel The designation the The of designation The Additional specific labelling requirements labelling specific Additional

In accordance with the particular In accordance of the nutritional requirements persons for whom the products are intended 2 g/day 8 mg/meal Based on a 0,2 % maximum incor Based on a 0,2 poration level and a maximum each g each, gum/mint size of 1,5 gum or mint will contain no serving mg of magnolia bark more than 3 extract. 1 mg/100 g mg/100 1 3 mg/100 g mg/100 3 0,2 % for breath freshening purposes. freshening breath for % 0,2 Maximum levels levels Maximum Maximum levels Maximum

10 mg/100 g mg/100 10 5 mg/100 g mg/100 5 % 2 Specified food category

Chewing gum Fats and dressings breads) Bread (including crispy as purposes medical Foods for special defined in (EU) Regulation No 609/ 2013 Breakfast cereals Soups other than tomato soups Chewing gum Food Supplements as defined in Food Supplements Directive 2002/46/EC Food Supplements as defined in Food Supplements Directive 2002/46/EC Mints (confectionary products) Mints (confectionary Total diet replacement for weight Total diet replacement (EU) by Regulation control covered No 609/2013 replacements and meal control for weight Specified food category food Specified Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified

Authorised novel food Maize-germ oil high in Maize-germ oil high unsaponifiable matter Magnolia Bark Extract Magnesium citrate malate L 187/36 EN Official Journal of the European Union 24.7.2018

Methylcellulose is not to specially in foods be used prepared for young children ­

Other requirements Other ’ or ‘extract

Lentinula edodes the labelling of the foodstuffs containing it shall be ‘Methylcellulose’ the labelling of the foodstuffs be ‘(6S)-5-methyltet containing it shall rahydrofolic acid, glucosamine salt’ or ‘5MTHF-glucosamine’ the labelling of the foodstuffs from the be containing it shall ‘extract mushroom mushroom’ from Shiitake the labelling of food supplements be silicon containing it shall ‘Organic (monomethylsilanetriol)’ The designation of the novel food on food novel the of designation The The designation of the novel food on food novel the of on designation food The novel the on of food designation novel The the of designation The Additional specific labelling requirements labelling specific Additional

10,40 mg/day ­ Maximum levels Maximum levels silicon of Maximum levels levels Maximum Maximum

2,5 ml per meal per ml 2,5

2 ml/100 g ml/100 2

0,5 ml/100 ml ml/100 0,5 2 % 2

Specified food category Specified food category Specified food category

Soups and broths Fruit preparations (pulps, purees or compotes) Soft drinks Cold desserts (dairy, fat, fruit, cereal, fruit, fat, (dairy, Cold desserts egg-based products) Flavoured or unflavoured fermented milk products Ready prepared meals Ready prepared Flavoured drinks Food Supplements as defined in Food Supplements Directive 2002/46/EC as a source of folate Bread products Food Supplements as defined in Food Supplements Directive 2002/46/EC for adult popu form) lation (in liquid Edible ices

) Conditions under which the novel food may be used be may food novel the which under Conditions

Specified food category food Specified Lentinula edodes Authorised novel food (6S)-5-methyltetrahydrofolic salt acid, glucosamine Monomethylsilanetriol (Organic Silicon) Mycelial extract from Shiitake mushroom ( Methylcellulose 24.7.2018 EN Official Journal of the European Union L 187/37

Other requirements Other Morinda

’

fruit concentrate’ or fruit puree’ or ‘Noni Morinda citrifolia Morinda

’ Morinda citrifolia Morinda citrifolia The designation of the novel food on the labelling of the foodstuffs be containing it shall ‘Noni juice of powder or ‘Juice powder’ citrifolia the labelling of the foodstuffs be ‘Nonior containing it shall juice’ ‘Juice of the labelling of the foodstuffs containing it shall be: For fruit puree: ‘ fruit puree’ For fruit concentrate: ‘ concentrate’ ‘Noni fruit The designation of the novel food on food novel the on of food designation novel The the of designation The

Additional specific labelling requirements labelling specific Additional

Fruit puree

30 ml with one serving (up to 100 % noni juice) or 20 ml twice a day, 40 ml per day not more than 53 g/100 g 2,5 ml per day dose 6,6 g/day (equivalent to 30 ml of noni juice) Maximum levels Maximum levels Maximum 1,5 ml/100 ml ml/100 1,5 53 g/100 g g/100 53

11 g/100 g g/100 11 45 g/100 g g/100 45 31 g/100 g g/100 31 53 g/100 g g/100 53 Specified food category Specified food category 12 g/100 g g/100 12 53 g/100 g g/100 53

Food supplements as defined in as Food supplements Directive 2002/46/EC Food supplements as defined in as Food supplements Directive 2002/46/EC Cereal bars Powdered nutritional drink mixes (dry weight) Carbonated beverages Ice cream & sorbet Yoghurt Biscuits Buns, cakes and pastries Candy/confectionery Pasteurised fruit and fruit nectar based Pasteurised drinks Foods based on yoghurt

) Conditions under which the novel food may be used be may food novel the which under Conditions

) Morinda Morinda citrifolia

) Authorised novel food Morinda citrifolia Noni fruit juice ( juice Noni fruit citrifolia Noni fruit juice powder juice Noni fruit ( Noni fruit puree and puree Noni fruit concentrate ( L 187/38 EN Official Journal of the European Union 24.7.2018

Other requirements Other

Additional specific labelling requirements labelling specific Additional

Fruit concentrate

12 g/100 g 133 g/100 g 133 g/100 Based on quantity to pre-processing g product produce final 100 88 g/100 g 26 g/day 30 g/100 g 31 g/100 g g/100 31 g g/100 7 88 g/100 g g/100 88 g g/100 20 12 g/100 g g/100 12

3 g/100 g g/100 3 10 g/100 g g/100 10 7 g/100 g g/100 7

12 g/100 g g/100 12 3 g/100 g g/100 3 12 g/100 g g/100 12

Ice cream & sorbet Yoghurt Biscuits Candy/Confectionery Jams and jellies in with accordance Directive 2001/113/EC gravies and Savoury sauces, pickles, condiments as defined in Food Supplements Directive 2002/46/EC Cereal bars Powdered nutritional drink mixes (dry weight) Carbonated beverages Buns, cakes and pastries Breakfast cereals (wholegrain) Jams and jellies in with accordance Directive 2001/113/EC fillings and icings Sweet spreads, Sweet spreads, fillings and icings Sweet spreads, Breakfast cereals (wholegrain) Conditions under which the novel food may be used be may food novel the which under Conditions Authorised novel food 24.7.2018 EN Official Journal of the European Union L 187/39

Other requirements Other

’. Odontella aurita

Morinda citrifolia Morinda

on the labelling of foodstuffs be ‘Noni leaves’ shall containing it of or ‘leaves of consumer that a infusion cup should not with more be prepared leaves and roasted g of dried than 1 citrifolia. of Morinda 2. Instructions shall be given to the the labelling of the foodstuffs containing it shall be ‘Morinda citrifolia fruit powder’ or ‘Noni fruit powder’ the labelling of the foodstuffs be ‘ containing it shall microalgae’ 1. The designation of the novel food novel the on of food designation on novel The food the 1. novel of the designation of The designation The Additional specific labelling requirements labelling specific Additional

Morinda citrifolia shall not be with prepared more g of dried and leaves roasted than 1 of 20 g/100 g 6 g/day 2,4 g per/day A cup of infusion to be consumed be to infusion of cup A Maximum levels Maximum levels levels Maximum Maximum

1,5 % 1,5 1 % 1 1,5 % 1,5 0,5 % 0,5

1 % 1 Specified food category 1,5 % 1,5 Food Supplements as defined in Food Supplements Directive 2002/46/EC Fish soups Marine terrines Broth preparations Crackers Frozen breaded fish For the preparation of For the preparation infusions as defined in Food Supplements Directive 2002/46/EC Flavoured pasta Savoury sauces, pickles, gravies and Savoury sauces, pickles, condiments Specified food category food Specified ) Specified food category food Specified Conditions under which the novel food may be used be may food novel the which under Conditions Morinda microalgae Morinda citrifolia

) Authorised novel food Noni leaves ( Noni leaves Odontella aurita Noni fruit powder ( powder Noni fruit citrifolia L 187/40 EN Official Journal of the European Union 24.7.2018

Other requirements Other

In accordance with Annex III.5 to In accordance Regulation (EU) No 1169/2011 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’. ­ ­

Additional specific labelling requirements labelling specific Additional

combined

phytostanols food ingredient shall be presented shall food ingredient be can they that manner a in such easily divided into portions that g maximum of 3 a contain either or day) per of one portion (in case of three g (in case a maximum of 1 phytos day) of added portions per terols/phytostanols. of container to a tostanols added g. beverages shall not exceed 3 shall be spicy sauces packed as single portions. cheese products 600 mg/100 g mg/100 cheese products 600 200 mg/100 g or for cheese products 600 mg/100 g 200 mg/100 g 1. The products containing the novel the containing products 1. The 2. The amount of phytosterols/phy 3. Salad dressings, mayonnaise and

200 mg/100 g or for analogues to analogues for or g mg/100 200 Maximum levels of phytosterols/ of levels Maximum EPA and DHA of levels Maximum 600 mg/100 g mg/100 600

12 g per g 12 ≤ 500 mg/100 g mg/100 500

Specified food category

Salad dressings, mayonnaise and spicy Salad dressings, sauces Dairy analogues except drinks Breakfast cereals Bakery products (breads and bread rolls) Milk based products, such as Milk based products products, based on semi-skimmed and skimmed the with possibly milk products, cereals, addition of fruits and/or products based on fermented milk such as yoghurt and cheese based products (fat content the milk fat possibly g), where 100 has been and reduced the fat or protein has been or fully partly replaced by vegetable fat or protein Soya drinks Spreadable fat and dressings Dairy products except milk-based Dairy products except beverages Spreadable fats as defined in Annex VII, Part VII and Appendix II, points (EU) No B and C of Regulation cooking excluding 1308/2013, and based on and spreads and frying fats butter or other animal fat Specified food category food Specified

Conditions under which the novel food may be used be may food novel the which under Conditions Authorised novel food Oil extracted from squids Oil enriched with phytosterols/phytostanols 24.7.2018 EN Official Journal of the European Union L 187/41

­ Other requirements Other

pressure treatment’ pressure treatment’ shall be displayed next to the name of the fruit preparations as such and in any product in which it is used the labelling of the foodstuffs containing it shall be ‘Phosphated maize starch’ the labelling of the foodstuffs containing it be shall ‘Fish phosphati dylserine’ The designation of the novel food on food novel the of designation The The designation of the novel food on high- food by novel ‘pasteurised the wording The of designation The Additional specific labelling requirements labelling specific Additional

In accordance with the particular In accordance of the nutritional requirements persons for whom the products intended 60 mg/100 ml 3 000 mg/day for general population 450 mg/day lactating women for pregnant and 200 mg/meal 40 mg/100 ml ready to drink) ­ 3 500 mg/100 g (equivalent to (equivalent g mg/100 500 3 Maximum levels Maximum levels phosphatidylserine Maximum of levels Maximum 50 mg/100 ml mg/100 50

15 % 15

500 mg/100 g mg/100 500

Specified food category Specified food category

Breakfast cereals Non-alcoholic beverages (including Non-alcoholic beverages milk-based beverages) Cereal bars Foods for special medical purposes as purposes medical Foods for special defined in Regulation (EU) No 609/2013 Pasta Total diet replacement for weight Total diet replacement control defined in (EU) Regulation No 609/2013 replacements and meal control for weight Food Supplements as defined in Food Supplements Directive 2002/46/EC Powders based on milk powders Beverages based on yoghurt Types of fruit: apple, apricot, banana, blackberry, blueberry, cherry, coconut, fig, grape, grapefruit, mandarin, mango, melon, peach, pear, pineapple, prune, rasp berry, rhubarb, strawberry Baked bakery products Cereal bars Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified

Authorised novel food Phosphatidylserine from fish phospholipids Pasteurised fruit-based using preparations produced high-pressure treatment Phosphated maize starch L 187/42 EN Official Journal of the European Union 24.7.2018

The product is not intended to be marketed breast- or to pregnant feeding women ­ ­ Other requirements Other

the labelling of the foodstuffs be containing it shall ‘Soya phosphati dylserine’ the labelling of the foodstuffs be ‘Soy phosphati containing shall dylserine and acid’ phosphatidic The designation of the novel food on food novel the of designation The on food novel the of designation The

Additional specific labelling requirements labelling specific Additional

In compliance with Regulation (EU) with Regulation In compliance No 609/2013 (EU) with Regulation In compliance No 609/2013 40 mg/100 ml ready to drink) 300 mg/day 3,5 g/100 g (equivalent to (equivalent g g/100 3,5 80 mg/100 g mg/100 80 200 mg/100 g mg/100 200 g mg/100 200 Maximum levels of phosphatidylserine of levels Maximum phosphatidylserine of levels Maximum 50 mg/100 ml mg/100 50 80 mg/100 g mg/100 80 g mg/100 80 80 mg/100 g mg/100 80

80 mg/100 g mg/100 80 350 mg/100 g mg/100 350 g mg/100 g 350 mg/100 350

Specified food category Specified food category Chocolate based confectionary as purposes medical Foods for special defined in Regulation (EU) No 609/2013 Chocolate based confectionary as purposes medical Foods for special defined in Regulation (EU) No 609/2013 Foods based on yogurt Food supplements as defined in as Food supplements Directive 2002/46/EC Cereal bars Foods based on yoghurt Cereal bars Cereal bars products Soy-based yogurt-like Powders based on milk powder Beverages based on yoghurt Breakfast cereals Foods based on yoghurt Conditions under which the novel food may be used be may food novel the which under Conditions

Authorised novel food Phosphatidylserine from soya phospholipids Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid 24.7.2018 EN Official Journal of the European Union L 187/43

Other requirements Other

the labelling of the foodstuffs containing it shall be ‘Phytoglycogen’ Regulation (EU) No 1169/2011 ­

The designation of the novel food on food novel of the III.5 of Annex designation with The accordance In Additional specific labelling requirements labelling specific Additional

manner that they can be easily they manner that divided into portions that contain g (in case either a maximum of 3 maximum a or of 1 portion/day) of 3 portions/day) g (in case of 1 phytosterols/phytostanols. of added The amount of phytosterols/phy of container to a tostanols added g. beverages shall not exceed 3 and mayonnaise Salad dressings, shall be spicy sauces packed as single portions In compliance with Regulation (EU) with Regulation In compliance No 609/2013 40 mg/100 ml ready-to drink) 800 mg/day 3,5 g/100 g (equivalent to (equivalent g g/100 3,5 Maximum levels levels Maximum levels Maximum Maximum 50 mg/100 g mg/100 50

50 mg/100 g mg/100 50 30 % wheat; and wheat; % 30 ≤ 25 % 25

1. They shall be presented in such a such in presented be shall They 1.

4 % added sugar but no fat no but sugar added % 4

≤ 50 % rye (wholemeal flour, 50 with added. Salad dressings, mayonnaise and spicy Salad dressings, sauces. Soya drink Not specified Rye bread with flour containing ≥ whole or rye kernels and cracked rye flakes) and Soy-based yogurt-like drinks Soy-based yogurt-like Powders based on milk powder Food Supplements as defined in Food Supplements Directive 2002/46/EC as purposes medical Foods for special defined in Regulation (EU) No 609/2013 Processed foods Yogurt based-drinks Rice drinks Specified food category food Specified Specified food category food Specified Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Authorised novel food Phytoglycogen Phytosterols/phytostanols Phospholipides from egg yolk L 187/44 EN Official Journal of the European Union 24.7.2018

Other requirements Other the labelling of the foodstuffs containing it shall be ‘Potato protein’

Additional specific labelling requirements labelling specific Additional

3 g/day vegetable oils Maximum levels Maximum In line with normal food use of use food normal with line In

The designation of the novel food on food novel the of designation The

Not specified Products based on fermented milk such as yoghurt and cheese type % per products (fat content < 12 the milk fat possibly g), where 100 has been or reduced, where milk fat and/or protein has been or partly fully replaced by vegetable fat and/or protein Spreadable fats as defined in Annex VII, Part VII and Appendix II, points (EU) No B and C of Regulation cooking excluding 1308/2013, and based on and spreads and frying fats butter or other animal fat. Food Supplements as defined in Food Supplements Directive 2002/46/EC For frying and as seasoning Milk type products, such as semi- such products, Milk type skimmed and milk type products, possibly with the addition where of fruits and/or cereals, the milk possibly fat has been reduced, or where milk fat and/or protein has been or fully partly replaced by vegetable fat and/or protein. Conditions under which the novel food may be used be may food novel the which under Conditions

Specified food category food Specified Authorised novel food Potato proteins (coagulated) Potato proteins and hydrolysates thereof Plum kernel oil Plum kernel 24.7.2018 EN Official Journal of the European Union L 187/45

­ Other requirements Other

on the labelling of foodstuffs be ‘Rapeseed containing it shall protein’. statement that a bear shall protein’ this ingredient may cause allergic reaction to consumers who are allergic to mustard and products thereof. Where this relevant, in close appear statement shall proximity to the list of ingredients. 1. The designation of the novel food 2. Any foodstuff containing ‘rapeseed the labelling of the foodstuffs containing it shall be oligopepti ‘Prolyl dase’ the labelling of the foodstuffs containing it be shall ‘Rapeseed oil extract’

PPI/day) The designation of the novel food on food novel the of designation on The food novel the of designation The

6 Additional specific labelling requirements labelling specific Additional

120 PPU/day (2,7 g of enzyme of g (2,7 120 PPU/day preparation/day) (2 × 10 PPU – Prolyl Peptidase Units or Peptidase Prolyl PPU – Units Proline Protease Picomole International PPI – Protease mg 12,6 equalizing 3 capsules/day; a day pig kidney extract (DAO) content: Diamine oxidase 0,9 mg/day (3 mg/capsule) content of DAO 0,3 capsules with a 1,5 g per portion recommended daily consumption for Maximum levels Maximum levels Maximum levels Maximum

Specified food category Specified food category Specified food category

except in infant formula and follow- on formula Food Supplements as defined in Food Supplements Directive 2002/46/EC Food for special medical purposes as purposes medical Food for special defined in (EU) Regulation No 609/ 2013 as defined in Food Supplements Directive 2002/46/EC Food Supplements as defined in Food Supplements Directive 2002/46/EC for general adult population Conditions under which the novel food may be used be may food novel the which under Conditions

As a vegetable protein source in foods in source protein vegetable a As

Authorised novel food Rapeseed oil high in unsaponifiable matter Protein extract from pig kidneys Rapeseed Protein Prolyl oligopeptidase (enzyme Prolyl oligopeptidase preparation) L 187/46 EN Official Journal of the European Union 24.7.2018

Other requirements Other

-resveratrol’. -resveratrol’. -resveratrol’. Trans Trans containing trans-resveratrol shall containing trans-resveratrol using people statement that bear a medicines should only consume the product under medical supervision. shall containing trans-resveratrol using people statement that bear a medicines should only consume the product under medical supervision. on the labelling of the food the of labelling on the supplements containing it shall be ‘ food the of labelling on the supplements containing it shall be ‘ 2. The labelling of food supplements 2. The labelling of food supplements the labelling of the foodstuffs be ‘Rooster comb containing it shall comb extract’ or ‘Cockerel extract’ the labelling of the foodstuffs oil be inchi ‘Sacha containing it shall (Plukenetia volubilis)’ Fallopia

1. The designation of the novel food novel the food of novel designation the The on of 1. food designation novel The the on 1. of food designation novel The the of designation The Additional specific labelling requirements labelling specific Additional

) In line with normal use in food normal use In line with supplements of extracted resveratrol knotweed ( from Japanese japonica linseed oil 150 mg/day ­

Maximum levels Maximum levels Maximum levels Maximum levels Maximum 80 mg/100 g or mg/100 ml 65 mg/100 g or mg/100 ml

40 mg/100 g or mg/100 ml In line with normal food use of use food normal with line In 110 mg/100 g or mg/100 ml Specified food category Specified food category Milk based fermented drinks Yoghurt-type products Fromage frais Food Supplements as defined in Food Supplements Directive 2002/46/EC for adult popu or tablet form) lation (capsule defined in as Food supplements Directive 2002/46/EC Milk-based drinks As for linseed oil Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Plukenetia Specified food category food Specified

Authorised novel food Trans-resveratrol (microbial source) Rooster comb extract Sacha inchi oil from oil Sacha inchi volubilis Trans-resveratrol 24.7.2018 EN Official Journal of the European Union L 187/47

­ Other requirements Other Schizo

sp.’ on the labelling of foodstuffs be ‘reduced containing it shall energy fat (salatrims)’. excessive consumption may lead to gastro-intestinal disturbance. products are not intended for use by children. The designation of the novel food on the labelling of the foodstuffs be ‘DHA and containing it shall EPA- rich oil from the microalgae chytrium 2. There shall be a statement that the that statement a be shall 3. There 1. The designation of the novel food novel the of designation The 1.

Additional specific labelling requirements labelling specific Additional : combined

In accordance with the particular In accordance of the nutritional requirements persons for whom the products are intended 3 000 mg/day 450 mg/day 250 mg/meal 200 mg/100 g

­

Maximum levels of DHA and EPA levels and DHA Maximum of levels Maximum

Specified food category

Food Supplements as defined in Food Supplements Directive 2002/46/EC for pregnant women and lactating Milk-based drinks and similar products intended for young children Processed cereal based food and baby infants and young children food for as defined in Regulation (EU) No 609/2013 Total diet replacement for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 replacements and meal control for weight Foods for special medical purposes as purposes medical Foods for special defined in (EU) Regulation No 609/ 2013 Bakery products and confectionary Food Supplements as defined in Food Supplements Directive 2002/46/EC for adult popu lation excluding pregnant and lactating women Conditions under which the novel food may be used be may food novel the which under Conditions oil rich in

Specified food category food Specified Authorised novel food Schizochytrium sp. EPA DHA and Salatrims L 187/48 EN Official Journal of the European Union 24.7.2018

Other requirements Other

Additional specific labelling requirements labelling specific Additional

600 mg/100 g 200 mg/100 g for (including milk, fromage frais and for milk yoghurt products; excluding drinks) products cheese; 200 mg/100 g 200 mg/100 g for soy and imitation drinks) (excluding milk products 80 mg/100 g

­

600 mg/100 g for cheese; for g mg/100 600 600 mg/100 g mg/100 600 500 mg/100 g mg/100 500 500 mg/100 g mg/100 500

360 mg/100 g mg/100 360

Bakery Products (Breads, Rolls and Sweet Biscuits) Foods bearing statements on the absence or reduced presence of with the gluten in accordance requirements of Commission Imple (EU) No 828/ menting Regulation 2014 Breakfast Cereals Cooking Fats Dairy Analogues except drinks Spreadable Fats and Dressings Cereal/Nutrition Bars Dairy Products except milk-based drinks Non-alcoholic Beverages (including Non-alcoholic Beverages dairy analogue and milk-based drinks) Foods intended to meet the expenditure of intense muscular for sportsmen effort, especially Conditions under which the novel food may be used be may food novel the which under Conditions Authorised novel food 24.7.2018 EN Official Journal of the European Union L 187/49

Other requirements Other sp. (ATCC

Schizochytrium the labelling of the foodstuffs be containing it shall ‘Oil from the microalgae PTA-9695)’ ­

The designation of the novel food on food novel the of designation The Additional specific labelling requirements labelling specific Additional

200 mg/100 g or for cheese products 600 mg/100 g g mg/100 cheese products 600 250 mg DHA/day for general lation popu 450 mg DHA/day for pregnant lactating women and 250 mg/meal 200 mg/100 g

­

200 mg/100 g or for analogues to analogues for or g mg/100 200 600 mg/100 g mg/100 600 Maximum levels of DHA of levels Maximum

500 mg/100 g mg/100 500 Specified food category

Foods bearing statements on the absence or reduced presence of with the gluten in accordance requirements of Commission Imple (EU) No menting Regulation 828/2014 Dairy analogues except drinks Breakfast cereals as defined in Food Supplements Directive 2002/46/EC Milk-based drinks and similar products intended for young children Foods intended to meet the expenditure of intense muscular for sportsmen effort, especially Total diet replacement for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 replacements and meal control for weight Spreadable fats and dressings Dairy products except milk-based Dairy products except drinks Conditions under which the novel food may be used be may food novel the which under Conditions sp. (ATCC PTA-

Authorised novel food Schizochytrium 9695) oil L 187/50 EN Official Journal of the European Union 24.7.2018

Other requirements Other

sp.’ Schizochytrium the labelling of the foodstuffs be containing it shall ‘Oil from the microalgae

The designation of the novel food on food novel the of designation The Additional specific labelling requirements labelling specific Additional

In accordance with the particular In accordance of the nutritional requirements persons for whom the products are intended 200 mg/100 g or for cheese products 600 mg/100 g g mg/100 cheese products 600 200 mg/100 g In accordance with Regulation (EU) Regulation with In accordance No 609/2013 200 mg/100 g 80 mg/100 ml

200 mg/100 g or for analogues to analogues for or g mg/100 200 600 mg/100 g mg/100 600 Maximum levels of DHA of levels Maximum 500 mg/100 g mg/100 500

360 mg/100 g mg/100 360 500 mg/100 g mg/100 500

Cereal bars Cooking fats (including Non-alcoholic beverages dairy analogue and milk-based drinks) Dairy analogues except drinks Breakfast cereals Bakery products (breads,rolls, and, Bakery products (breads,rolls, sweet biscuits) Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 Infant formula and follow-on formula Infant formula as defined in Regulation (EU) No 609/2013 Spreadable fats and dressings Dairy products except milk-based Dairy products except drinks Foods for special medical purposes as purposes medical Foods for special defined in (EU) Regulation No 609/ 2013 Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified sp. oil Authorised novel food Schizochytrium 24.7.2018 EN Official Journal of the European Union L 187/51

Other requirements Other ­ Additional specific labelling requirements labelling specific Additional

In accordance with the particular In accordance of the nutritional requirements persons for whom the products are intended 200 mg/100 g 250 mg DHA/day for general lation popu 450 mg DHA/day for pregnant lactating women and 250 mg/meal 200 mg/100 g

­

360 mg/100 g mg/100 360 500 mg/100 g mg/100 500

Foods for special medical purposes as purposes medical Foods for special defined in (EU) Regulation No 609/ 2013 Foods intended to meet the expenditure of intense muscular for sportsmen effort, especially Foods bearing statements on the absence or reduced presence of with the gluten in accordance requirements of Commission Imple (EU) No 828/ menting Regulation 2014 Milk-based drinks and similar products intended for young children Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 Cereal bars Cooking fats Total diet replacement for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 replacements and meal control for weight Bakery products (breads, rolls and sweet biscuits) Food Supplements as defined in Food Supplements Directive 2002/46/EC Conditions under which the novel food may be used be may food novel the which under Conditions Authorised novel food L 187/52 EN Official Journal of the European Union 24.7.2018

Other requirements Other

sp.’ Schizochytrium the labelling of the foodstuffs be containing it shall ‘Oil from the microalgae ­

The designation of the novel food on food novel the of designation The Additional specific labelling requirements labelling specific Additional

200 mg/100 g or for cheese products 600 mg/100 g g mg/100 cheese products 600 250 mg DHA/day for general lation popu 450 mg DHA/day for pregnant lactating women and 250 mg/meal 200 mg/100 g 80 mg/100 ml

­

200 mg/100 g or for analogues to analogues for or g mg/100 200 600 mg/100 g mg/100 600 Maximum levels of DHA of levels Maximum

500 mg/100 g mg/100 500

Foods bearing statements on the absence or reduced presence of with the gluten in accordance requirements of Commission Imple (EU) No 828/ menting Regulation 2014 Dairy analogues except drinks Breakfast cereals as defined in Food Supplements Directive 2002/46/EC Milk-based drinks and similar products intended for young children Foods intended to meet the expenditure of intense muscular for sportsmen effort, especially Total diet replacement for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 replacements and meal control for weight Spreadable fats and dressings Dairy products except milk-based Dairy products except drinks Non-alcoholic beverages (including Non-alcoholic beverages dairy analogue and milk-based drinks) Specified food category food Specified Conditions under which the novel food may be used be may food novel the which under Conditions sp. (T18) oil Authorised novel food Schizochytrium 24.7.2018 EN Official Journal of the European Union L 187/53

Other requirements Other

on the labelling of foodstuffs be ‘Fermented shall containing it soybean extract’. containing fermented soybean extract shall bear a statement that persons taking medication should under product only consume the medical supervision. 2. The labelling of food supplements the labelling of food supplements containing it shall be ‘spermidine-rich wheat germ extract’ ­ 1. The designation of the novel food novel the on of food designation novel The the 1. of designation The Additional specific labelling requirements labelling specific Additional

In accordance with the particular In accordance of the nutritional requirements persons for whom the products are intended 200 mg/100 g In accordance with Regulation (EU) Regulation with In accordance No 609/2013 200 mg/100 g 80 mg/100 ml 100 mg/day mg/day sper Equivalent of max. 6 midine

Maximum levels Maximum levels Maximum

360 mg/100 g mg/100 360 500 mg/100 g mg/100 500 Specified food category

Cereal bars Cooking fats (including Non-alcoholic beverages dairy analogue and milk-based drinks) Bakery products (breads, rolls and, sweet biscuits) Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 Infant formula and follow-on formula Infant formula as defined in Regulation (EU) No 609/2013 Food Supplements as defined in Food Supplements Directive 2002/46/EC (capsules, tablets or powder form) intended for excluding the adult population, women pregnant and lactating Food Supplements as defined in Food Supplements Directive 2002/46/EC intended for excluding the adult population, women pregnant and lactating Foods for special medical purposes as purposes medical Foods for special defined in (EU) Regulation No 609/ 2013 Specified food category food Specified

) Conditions under which the novel food may be used be may food novel the which under Conditions Triticum aestivum Authorised novel food Spermidine-rich wheat germ extract ( Fermented soybean extract L 187/54 EN Official Journal of the European Union 24.7.2018

­ Other requirements Other

shall bear ’ or ‘Dried microalgae ’ or ‘Dried

Tetraselmis chuii Tetraselmis ’

on the labelling of foodstuffs be ‘Sucromalt’. containing it shall be accom shall labelling on the panied by indication that the product is a source of glucose and fructose. 2. The designation of the novel food the labelling of the foodstuffs containing it shall be ‘Sunflower oil extract’ the labelling of the foodstuffs containing it be shall ‘Dried microalgae Tetraselmis chuii T. chuii containing dried Food supplements microalgae the following statement: ‘Contains negligible amounts of iodine’ 1. The designation of the novel food novel the of designation The 1. on food on novel food the novel of the designation of The designation The Additional specific labelling requirements labelling specific Additional

1,1 g/day 250 mg/day Maximum levels Maximum levels Maximum levels levels Maximum Maximum 3 % 3 3 % 3

5 % 5 2 % 2 5 % 5

1 % 1 250 mg/day 250 5 % 5 Specified food category 20 % or 250mg/day % or % 2 20 8 % 8 Bread Special salts Bakery goods Meat and muscle products Seasonings and spices Grated cheeses Special diet foods Sauces Beverages Condiment Food Supplements as defined in Food Supplements Directive 2002/46/EC as defined in Food Supplements Directive 2002/46/EC Not specified Sauces Conditions under which the novel food may be used be may food novel the which under Conditions

Specified food category food Specified Specified food category food Specified

Specified food category food Specified Authorised novel food Tetraselmis chuii Tetraselmis Sunflower oil extract Sugar cane fibre Dried microalgae Sucromalt 24.7.2018 EN Official Journal of the European Union L 187/55

­ ­ ­ Other requirements Other

on the labelling of foodstuffs be ‘D-Tagatose’. containing it shall g 15 exceeds of D-Tagatose the level % per serving and all beverages than 1 containing greater D-Tagatose (as consumed) shall bear a statement ‘excessive laxative produce consumption may effects’. on the labelling of foodstuffs be ‘Trehalose’ containing it shall on the be displayed and shall or as such labelling of the product of food ingredients of list in the stuffs containing it. be accom shall labelling on the the ‘Tre panied by indication that halose is a source of glucose’. 2. The labelling of any product where product any of labelling 2. The the labelling of the foodstuffs containing it be shall ‘taxifolin-rich extract’. 2. The designation of the novel food 1. The designation of the novel food novel the of on designation food The novel food 1. the novel of the designation of The designation The 1. Additional specific labelling requirements labelling specific Additional

100 mg/day

Maximum levels Maximum levels Maximum levels Maximum

culinary fish products and dishes, including cooked, raw, smoked and baked raw, cooked, including and dishes, products fish culinary fish products Not specified Food Supplements as defined in Food Supplements Directive 2002/46/EC intended for excluding population, the general infants, young children and children, adolescents younger than 14 years Not specified Conditions under which the novel food may be used be may food novel the which under Conditions of Intended to that of use identical the salmon, namely preparation Specified food category food Specified /Scortum Specified food category food Specified Specified food category food Specified Authorised novel food D-Tagatose Taxifolin-rich extract Trehalose Therapon barcoo L 187/56 EN Official Journal of the European Union 24.7.2018

­ ­ ­ ­ ­ ­ Other requirements Other

Agaricus bispo yeast’

2

levels’.

2

)’. )’. novel food as such or of the food or of the such novel food as stuffs containing be it shall accom panied by indication that a ‘con used to trolled light treatment was increase vitamin D or levels’ ‘UV to increase used treatment was vitamin D novel food as such or of the food or of the such novel food as stuffs containing be it shall ‘UV- treated mushrooms ( rus novel food shall be ‘UV-treated’. novel food shall is D that vitamin amount of considered significant in accordance with Point 2 of Part A of Annex XIII (EU) No 1169/2011 to Regulation and of Parliament European of the the Council, designation for by be accompanied labelling shall ‘contains vitamin D by produced ‘milk containing UV-treatment’ or from UV-treat vitamin D resulting ment’. 2. The designation on the label of 1. The designation on the label of The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Vitamin D D ‘Vitamin or yeast’ The designation on the label of the by novel food shall be accompanied by ‘contains vitamin D UV- produced treatment’ 1. The designation on the label of an contains milk UV-treated 2. Where

2 2 2 3

/100 g fresh

2

Additional specific labelling requirements labelling specific Additional

/100 g /100 g /day

2 2 2

/100 g 2

g/kg for general population g/kg for general population

μ μ g of vitamin D g of vitamin μ g vitamin D g of vitamin D g of vitamin D g of vitamin D μ μ μ μ 3 5 5-32 excluding infants weight 1-15 excluding infants 5 5

10 ) Maximum levels of vitamin D vitamin of levels D Maximum vitamin D of D vitamin levels vitamin of Maximum of levels levels Maximum Maximum

Agaricus bisporus Specified food category Specified food category Mushrooms ( Pasteurised whole milk as defined in Regulation (EU) No 1308/2013 to be consumed as such Pasteurised semi-skimmed milk as defined in (EU) Regulation No 1308/ such as be consumed 2013 to Yeast-leavened fine bakery wares as defined in Food Supplements Directive 2002/46/EC Yeast leavened bread and rolls Yeast leavened (without toppings) Yeast-leavened breads and rolls Conditions under which the novel food may be used be may food novel the which under Conditions

)

) Specified food category food Specified Specified food category food Specified Authorised novel food Saccharomyces cerevisiae Agaricus bisporus UV-treated milk UV-treated bread UV-treated baker’s yeast UV-treated baker’s ( UV-treated mushrooms ( 24.7.2018 EN Official Journal of the European Union L 187/57

The ‘Wheat Bran Extract’ The ‘Wheat Bran Extract’ may not be introduced a as market onto the food or food supplement supplement ingredient. to be added it Nor may infant formula. Other requirements Other

) beta-glucans’

’

2

Saccharomyces cerevisiae The designation of the novel food on the labelling of the foodstuffs be ‘Menaquinone’ containing it shall or ‘Vitamin K the labelling of the foodstuffs be ‘Wheat bran containing it shall extract’ The designation of the novel food on the labelling of the foodstuffs be ‘Yeast containing it shall (

The designation of the novel food on food novel the of designation The Additional specific labelling requirements labelling specific Additional

from yeast (Saccharomyces cervisiae) from yeast (Saccharomyces 1,275 g/day for children population adult older and general 12 years than 0,675 g/day for children younger than 12 years 1,275 g/day 1,275 g/day 1,3 g/kg Maximum levels beta-glucans Maximum pure of levels Maximum

0,6 g/100 g g/100 0,6

9 g/100 g g/100 9 0,4 g/100 g g/100 0,4 2 g/100 g g/100 2

2,4 g/100 g g/100 2,4

0,6 g/100 g g/100 0,6 609/2013 and/or Regulation (EC) No 1925/2006 No (EC) Regulation 609/2013 and/or Ready to eat cereals Ready Fruit and vegetable juices Soft drinks Meat preparations Total diet replacement for weight Total diet replacement defined in (EU) control as Regulation No 609/2013 Dairy products Food for special medical purposes as purposes medical Food for special defined in (EU) Regulation No 609/ special for food 2013, excluding medical purposes intended for infants and young children Beverages based on fruit and/or including concentrate vegetable juices juices and dehydrated Food supplements as defined in as Food supplements Directive 2002/46/EC, excluding infants and for food supplements young children Beer and substitutes To be used in compliance with Directive 2002/46/EC, Regulation (EU) No (EU) Regulation 2002/46/EC, Directive with compliance in used be To Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Specified food category food Specified (menaquinone)

2

Authorised novel food Yeast beta-glucans Wheat bran extract Vitamin K L 187/58 EN Official Journal of the European Union 24.7.2018

Other requirements Other

Additional specific labelling requirements labelling specific Additional

11,3 g/kg 1,5 g/kg 7 g/kg (powder) 1,8 g/kg (condensed) 6,3 g/kg (powder) 38,3 g/kg (powder) g/kg 38,3 4 g/kg 4 19,1 g/kg 19,1 3,8 g/kg 3,8 25,5 g/kg 25,5 3,8 g/kg 3,8 to eat) g/kg (ready 0,9 0,8 g/kg 0,8 3,8 g/kg 3,8 6,7 g/kg 6,7 6,7 g/kg 6,7 15,3 g/kg 15,3

to drink) g/kg (ready 0,8 6 g/kg 6

Breakfast cereals Protein bars and powders Cereal bars Wholegrain and high fibre instant hot breakfast cereals Soups and soup mixes Jam, marmalade and other fruit spreads Chocolate and confectionery Cocoa beverages preparation powder Cocoa beverages preparation Cookie-type biscuits Cracker-type biscuits Milk based beverages Fermented milk products Milk product analogues Dried milk/milk powder Other beverages Fruit-flavoured drinks Conditions under which the novel food may be used be may food novel the which under Conditions Authorised novel food 24.7.2018 EN Official Journal of the European Union L 187/59

­ Other requirements Other d minerals and of certain other substances to foods (OJ L substances other and of certain d minerals 404, onsumers on the absence or reduced presence of gluten in food of gluten presence or reduced on the absence onsumers tion of the markets in agricultural products and repealing Council and products repealing tion of the markets in agricultural intended for human consumption (OJ L 10, 12.1.2002, p. 67). 41/EC, Directive 2009/39/EC of the European Parliament and of the Parliament 2009/39/EC of the European 41/EC, Directive

mber States relating to food supplements (OJ L (OJ to food supplements relating mber States 183, 12.7.2002, p. 51). ung children, food for special medical purposes, and total diet replacement purposes, medical food for special ung children, the labelling of the foodstuffs zeaxan be ‘synthetic containing it shall thin’ the labelling of the foodstuffs be containing it shall ‘Zinc L-pidolate’ The designation of the novel food on food on novel food the novel of the designation of The designation The Additional specific labelling requirements labelling specific Additional

3 g/day 2 mg/day

­

Maximum levels levels Maximum Maximum

Food Supplements as defined in Food Supplements Directive 2002/46/EC Food bearing statement on the absence or reduced presence of with the gluten in accordance requirements of Commission Imple (EU) No 828/ menting Regulation 2014 Milk based drinks and similar products intended for young children Meal replacement for Meal replacement weight control Foods intended to meet the expenditure of intense muscular for sportsmen effort, especially Food Supplements as defined in Food Supplements Directive 2002/46/EC Foods covered by Regulation (EU) No 609/2013 Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Specified food category food Specified Authorised novel food Regulation (EEC) No 922/72, 234/79, (EC) 1037/2001 Regulation and (EC) 1234/2007 L (OJ 347, 20.12.2013, p. 671). for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC 92/52/EEC, Commission Directives and 2006/1 Council Directive and control repealing for weight L 953/2009 (OJ (EC) No 41/2009 (EC) No and Regulations Commission and Council 29.6.2013, p. 181, 35). (OJ L 228, 31.7.2014, p. 5). 30.12.2006, p. 26). ) of 12 the Council and of (EU) Parliament No 609/2013 Regulation European of the 2013 infants and yo on food intended for June ) Commission Implementing Regulation (EU) No 828/2014 of 30 2014 July on for the provision of the requirements information to c ) Council of 10 and of the 2002/46/EC Parliament of the European Directive Me of the laws of the 2002 June on the approximation ) (EC) Regulation No 1925/2006 Parliament and of of the Council 20 the European December 2006 on the addition of vitamins an organisa common 2001/113/EC Council Directive of 20 ) a 17 establishing of 2013 purée Council and sweetened chestnut and marmalades December jellies December 2001 jams, to relating fruit the of and Parliament European the of 1308/2013 No (EU) ) Regulation

1 2 3 4 5 6 ( ( ( ( ( ( Zinc L-pidolate Zeaxanthin L 187/60 EN Official Journal of the European Union 24.7.2018

Specifications

12,5 % (w/w) % 12,5 ≤

O) (dihydrate) 2

* 2H

9

NO

19 H

11

(C

(acid)

9 11

NO NO

19 23 H H -Acetyl-D-neuraminic acid is a white to off-white crystalline powder -Acetyl-D-neuraminic acid (dihydrate) -Acetyl-D-neuraminic acid (dihydrate): > % 97,0

11 11 N Definition: Chemical name: IUPAC names: N 5-Acetamido-3,5-dideoxy-D-glycero-D-galacto-non-2-ulopyranosonic acid (dihydrate) Synonyms: Sialic acid (dihydrate) Chemical formula: C C Molecular mass: 309,3 Da (acid) 345,3 (309,3 + 36,0) (dihydrate) CAS No.: acid) 131-48-6 (free 50795-27-2 (dihydrate) Specifications: Description: white to off-white crystalline powder % solution): 1,7 – 2,5 °C, 5 pH (20 N %): to 10,4 calculates Water (dihydrate < Ash, sulphated: % (w/w) 0,2 Acetic acid (as free acid and/or sodium < acetate): % (w/w) 0,5 Heavy Metals: Iron: < mg/kg 20,0 Lead: < mg/kg 0,1 Residual proteins: < % (w/w) 0,01 Description:

Authorised Novel Food -Acetyl-D-neuraminic acid Table 2: Specifications N 24.7.2018 EN Official Journal of the European Union L 187/61

) and then packaged. μ

Specifications

Absence in 10 g Absence in 10 ) fruits are harvested from trees. The hard shells are cracked open and the pulp is separated from the seeds and is separated open and the pulp cracked hard shells are The from trees. harvested are ) fruits

Absence in 25 g Absence in 25

< 50 CFU/g Adansonia digitata Absence in 25 g Absence in 25 shell. This is milled, separated into coarse and fine lots (particle size 3 to 600 and fine lots (particle into coarse is milled, separated This shell. components: Typical nutritional g): 4,5-13,7 Moisture (loss on drying) (g/100 g): 1,8-9,3 Protein (g/100 g): 0-1,6 Fat (g/100 g): 76,3-89,5 (g/100 Total carbohydrate Total sugars (as glucose): 15,2-36,5 g): 0,1-25,2 Sodium (mg/100 Analytical specifications: % Foreign matter: Not more than 0,2 g): 4,5-13,7 Moisture (loss on drying) (g/100 g): 3,8-6,6 Ash (g/100 Description/Definition: The Baobab ( Residual solvents: 2-Propanol: < % (w/w) 0,1 Acetone: < % (w/w) 0,1 Ethyl acetate: < % (w/w) 0,1 Microbiological criteria: Salmonella: total Aerobic mesophilic count:< 500 CFU/g g Enterobacteriaceae: Absence in 10 Cronobacter (Enterobacter) sakazakii: Listeria monocytogenes: Bacillus cereus: Yeasts: < 10 CFU/g Moulds: < 10 CFU/g Residual endotoxins: < 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units.

(Baobab)

Authorised Novel Food Adansonia digitata dried fruit pulp L 187/62 EN Official Journal of the European Union 24.7.2018

Ajuga reptans Ajuga . . During the fermentation process, the . During the fermentation process, Escherichia coli Escherichia

Specifications L. tissue cultures which is substantially equivalent to equivalent extracts from parts of which is substantially L. tissue cultures flowering aerial sp.

o Ajuga reptans Ajuga 0,2 % 0,2

≤

Ulkenia

0,05 % 0,05

≤ 0,1 % 0,1 5,0 meq/kg oil meq/kg 5,0 0,020 % 0,020 ≤ ≤ ≤ 1,0 % 1,0 4,5 % 4,5 ): 0,5 % 0,5 ≤ 0,020 % 0,020 4

≤ ≤ 32 % 32 ≤ 0,020 % 0,020 ≥ ≤ ): : Absence/g 0,5 mg KOH/g mg 0,5 4

O): 5,0-6,0 ≤

2 L-Alanyl-L-Glutamine is produced by fermentation with a modified genetically strain of Description/Definition: Oil from the micro-algae Description/Definition: Hydroalcoholic extract from cultures. obtained by traditional Chloride (Cl): Sulphate (SO ingredient is secreted into the growth medium from which it is subsequently separated and purified to a concentration of > to a concentration and purified separated is subsequently it medium from which into the growth % is secreted ingredient 98 Appearance: White crystalline powder Purity: > % 98 Conformity with ref. standard Infrared spectroscopy: Appearance of solution: Colourless and clear % Assay (dry basis): 98-102 Related substances (each): Residue on ignition: Loss on drying: Optical rotation: +9,0 - +11,0 Microbiological criteria: Escherichia coli Acid value: Peroxide value (PV): Moisture and volatiles: Unsaponifiables: Trans-fatty acids: DHA content: Ammonium (NH pH (1 %; H pH (1

Description/Definition: extract from cell extract

sp. Authorised Novel Food Algal oil from the microalgae Ulkenia L-Alanyl-L-Glutamine Ajuga reptans cultures 24.7.2018 EN Official Journal of the European Union L 187/63 (L.)

Aloe vera A. stuhlmannii. A. ) and A. parviflora (synonymous with

A. floribunda Specifications Baker which is substantially equivalent to the same gel derived from Aloe macroclada

seed oil is obtained from species: the seeds of the allanblackia -Linolenic acid (C18:3): < -Linolenic acid % 1,0 Composition of fatty acids: Composition of fatty Lauric acid (C12:0): < % 1,0 Myristic acid (C14:0): < % 1,0 Palmitic acid (C16:0): < % 2,0 Palmitoleic acid (C16:1): < % 1,0 % Stearic acid (C18:0): 45-58 % Oleic acid (C18:1): 40-51 Linoleic acid (C18:2): < % 1,0 γ Arachidic acid (C20:0): < % 1,0 % Free fatty acids: max 0,1 Characteristics: % max Trans fatty 0,5 acids: meq/kg Peroxide value (PV): max 0,8 g < Iodine value: g/100 46 % Unsaponifiable matter: max 1,0 mg KOH/g 185-198 Saponification value: Allanblackia Description/Definition: Powdered gel derived from extract the leaves of Burm.f. leaves. % Ash: 25 % Dietary fibres: 28,6 % Fat: 2,7 % Moisture: 4,7 % Polysaccharides: 9,5 % Protein: 1,63 % Glucose: 8,9

Description/Definition: Baker leaf

Authorised Novel Food Aloe macroclada extract Allanblackia seed oil Allanblackia seed L 187/64 EN Official Journal of the European Union 24.7.2018 JRK-MA01 and CBS tration. The extraction should demonstrate oxidative stability by and appropriate

) by repeated solvent washings with an approved solvent (under Directive an approved with solvent washings ) by repeated Euphausia superba Euphausia Specifications ) krill or deep-frozen crushed dried krill meal is subjected to with an lipid extraction Euphausia superba Euphausia superba using a suitable liquid. The oil is then extracted from oil the biomass and purified. is then extracted The liquid. using a suitable

/kg oil /kg oil 2

2 5 % 5 5 % 5 9 % 9 9 % 9 ≥ ≥ ≥ ≥ 3 % or 0,6 expressed as water activity at 25 °C 25 at activity water as expressed 0,6 or % 3 3 % or 0,6 expressed as water activity at 25 °C 25 at activity water as expressed 0,6 or % 3 1,5 % 1,5

≤ ≤ ≤ 230 mg KOH/g mg 230 230 mg KOH/g mg 230 3 meq O meq 3 3 meq O meq 3 Mortierella alpina Mortierella ≤ ≤ ≤ ≤ 40 % by weight of the total fatty acid content acid fatty total the of weight by % 40 0,5 % of the total fatty acid content acid fatty total the of % 0,5 1 % 1 1 % 1 ≥ ≤ 0,45 % of the total fatty acid content acid fatty total the of % 0,45 ≤ ≤ ≤ 60 % 60 ≥ Description/Definition: ( Krill from Antarctic extract lipid To produce approved extraction solvent (under Directive 2009/32/EC). Proteins and krill material are removed from the lipid extract by fil solvents and residual water are removed by evaporation. Saponification value: Peroxide value (PV): Description/Definition: IS-4, I49-N18, modified strains oil is obtained by fermentation of the non-genetically F acid-rich arachidonic yellow clear The fungus the 210.32 of Arachidonic acid: Free fatty acids: Trans fatty acids: Unsaponifiable matter: Description/Definition: Oil rich in is phospholipids produced from Antarctic krill ( content Solvents are removed from the final product by evaporation. of 2009/32/EC) the oil. phospholipid to increase Saponification value: Peroxide value (PV): Moisture and volatiles: Phospholipids: Trans-fatty acids: acid): EPA (eicosapentaenoic acid): DHA (docosahexaenoic Oxidative stability: All food products containing Antarctic Krill oil from recognised national/international test methodology (e.g. AOAC). Moisture and volatiles: % Phospholipids: 35-50 Trans-fatty acids: acid): EPA (eicosapentaenoic acid): DHA (docosahexaenoic

Euphausia

Mortierella alpina Mortierella

Authorised Novel Food Antarctic Krill oil rich in Antarctic Krill oil phospholipids from superba Arachidonic acid-rich oil from the fungus Antarctic Krill oil from Antarctic Krill oil Euphausia superba 24.7.2018 EN Official Journal of the European Union L 187/65 harvested and harvested dried; the

(L.) Skeels. Kernels may be roasted prior to Argania spinosa Argania

Specifications algae. Production methods for the growth of the algae are variable; using either closed using either Production methods for the growth of variable; algae. the algae are or a solvent (ethyl acetate). The Astaxanthin is diluted and standardized to 2,5 %, 5,0 %, 7,0 %,

2

Haematococcus pluvialis Haematococcus

/kg

2

5 meq/kg 5 ≤

20 ≤

1,0 KOH/g 1,0 ≤ 0,5 % 0,5 ≤ Argan oil is the oil obtained by cold pressing of the almond like kernels of the fruits of but with no pressing, direct contact with a flame. Composition: % Palmitic acid (C16:0): 12-15 % Stearic acid (C18:0): 5-7 % Oleic acid (C18:1): 43-50 % Linoleic acid (C18:2): 29-36 % Unsaponifiable matter: 0,3-2 g mg/100 100-500 Total sterols: g mg/100 16-90 Total tocopherols: % 0,2-1,5 Oleic acidity: Peroxide value (PV): < meq O 10 Description/Definition: Astaxanthin is a carotenoid produced by open ponds may be alternatively exposed to The algal cells are systems used. controlled illuminated light; sunlight or strictly CO critical using either super oleoresin is extracted 10 %, 15 % or 20 % using olive oil, safflower oil, Sunflower oil or Oleoresin: Composition of the MCT (Medium Chain Triglycerides). % Fat: 42,2- 99 % Protein: 0,3-4,4 % Carbohydrate: 0-52,8 Fibre: < % 1,0 % Ash: 0,0-4,2 Specification of Carotenoids w/w% % 2,9-11,1 Total Astaxanthins: Peroxide value (PV): Anisidin value: Acid value: Moisture: Description/Definition:

Argania spinosa Authorised Novel Food Haematococcus pluvialis

Argan oil from Astaxanthin-rich oleoresin from algae L 187/66 EN Official Journal of the European Union 24.7.2018 Glycine max oybeans ( , mechanical). Production , mechanical). L.) includes seed pre-hydration and pasteurisation

Ocimum basilicum

-glucosidase inhibitor. α Specifications ’ within the order ‘Lamiales’. Post-harvest the seeds are cleaned mechanically. Flowers, cleaned mechanically. are the seeds Post-harvest ‘Lamiales’. order ’ within the Lamiaceae . The extract contains an . The extract Aspergillus oryzae Aspergillus

L.) belongs to the family ‘

: Negative

: Negative 55 % 55 ) fermented with ≥ Ocimum basilicum : Negative 1,0 % 1,0 ≤ -Carotene: 0,01-0,3 % -Carotene: 0,01-0,3 Basil ( Fermented black bean extract (Touchi extract) is a fine light-brown protein-rich powder obtained by water extraction of extraction small s powder obtained by water is a fine light-brown protein-rich extract) (Touchi Fermented black bean extract (L.) Merr. Characteristics: Fat: Protein: leaves and other parts of the plant are removed. Highest level of purity of Basil seeds has to be ensured by filtering (optical by filtering to be ensured has seeds of Basil of purity level Highest removed. are plant of the parts and other leaves process of fruit juice and blend fruit/vegetable beverages containing Basil seeds ( steps. Microbiological controls and monitoring systems are in place. % 94,1 Dry Matter: % Protein: 20,7 % Fat: 24,4 % Carbohydrate: 1,7 % (Method: AOAC 958,29) Dietary Fibre: 40,5 % Ash: 6,78 9-cis-astaxanthin: 0,3-17,3 % 9-cis-astaxanthin: 0,3-17,3 % 13-cis-astaxanthin: 0,2-7,0 % Astaxanthin monoesters: 79,8-91,5 % Astaxanthin diesters: 0,16-19,0 Β % Lutein: 0-1,8 % Canthaxanthin: 0-1,30 Microbiological criteria: < Total aerobic bacteria: 000 CFU/g 3 Yeast and Moulds: < 100 CFU/g Coliforms: < 10 CFU/g E. coli Salmonella Staphylococcus Description/Definition: ) Description/Definition:

Ocimum basilicum Authorised Novel Food Fermented black bean extract Basil seeds ( 24.7.2018 EN Official Journal of the European Union L 187/67 ation steps. Finally, it ation steps. Finally,

. and consists of a single

(L.) I.M.Johnst g/kg μ Specifications Buglossoides arvensis Buglossoides

g/ml μ /kg 2

10 ≤

2,0 % 2,0

≤ 35 % w/w of total fatty acids fatty total of w/w % 35 5,0 meq O meq 5,0 ≥ ≤ 2,0 % w/w of total fatty acids fatty total of w/w % 2,0 15 % w/w of total fatty acids fatty total of w/w % 15 ≤ 0,3 g/100 g g/100 0,3 ≥ 20 % 20 ≤ 8,0 % w/w of total fatty acids fatty total of w/w % 8,0 ≥ ≥ 0,6 mg KOH/g mg 0,6 ≤ 7,0 % 7,0 ≤ 10 % 10 ≤ -glucosidase inhibitory activity: IC50 min 0,025 mg/ml -glucosidase inhibitory IC50 activity: min 0,025 Refined Buglossoides oil is extracted from the seeds of oil is extracted Refined Buglossoides Alpha-linolenic acid: Stearidonic acid: Linoleic acid: Trans fatty acids: Acid value: Peroxide value (PV): Pyrrolizidine alkaloids: Not Pyrrolizidine alkaloids: detectable with a detection limit of 4,0 Bovine lactoferrin is a protein that occurs naturally in cows’ milk. It is an iron-binding glycoprotein of approximately 77 kDa of approximately It is an iron-binding glycoprotein in cows’ milk. naturally that occurs protein is a lactoferrin Bovine polypeptide chain of 689 amino acids. ultra-filtr and subsequent ion exchange via whey from skimmed milk or cheese is isolated lactoferrin Bovine process: Production light pinkish powder odourless, sieved out. It are is a virtually and the large particles is dried by freeze drying or spraying Physical-Chemical properties of Bovine lactoferrin: Moisture: < % 4,5 Ash: < % 1,5 Arsenic: < mg/kg 2,0 Iron: < mg/kg 350 Protein: > % 93 > bovine lactoferrin: of which % 95 < other proteins: of which % 5,0 °C): 5,2-7,2 % solution, 20 pH (2 °C): complete % solution, 20 Solubility (2 Unsaponifiable content: Protein content (total nitrogen): Water: Ash: Carbohydrate: α Soy isoflavone: Description/Definition:

seed oil seed Description/Definition: Authorised Novel Food Buglossoides arvensis Bovine lactoferrin L 187/68 EN Official Journal of the European Union 24.7.2018 Calanus olyethylene

ankton)

Specifications

/kg 2

mol/g μ

. The ingredient consists primarily of esters (> wax primarily . The ingredient consists %) and other neutral lipids. with minor amounts of triglycerides 85 Description/Definition: (Patent number WO2006016179). of monomethoxyp polymer polymers synthetic of branched a is It consists novel food ingredient The % by weight). glycol (MPEG) anhydride (PIP-g-MA), grafted onto and polyisoprene-graft-maleic unreacted MPEG (less than 35 White to off-white colour. CAS No.: 1246080-53-4 Characteristics: Moisture: < % 5,0 Aluminium: < mg/kg 3,0 Lithium: < mg/kg 0,5 Nickel: < mg/kg 0,5 < Residual anhydride: 15 Polydispersity index: < 1,4 Isoprene: < mg/kg 0,05 Ethylene oxide: < mg/kg 0,2 Free maleic anhydride: < % 0,1 The novel food is ruby coloured, slightly viscous oil with a slight shellfish odour extracted from the crustacean (marine zoopl from the crustacean odour extracted slight shellfish a oil with viscous slightly novel food is ruby coloured, The finmarchicus Specifications: Water: < % 1,0 > Wax esters: % 85 > Total fatty acids: % 46 Eicosapentaenoic acid (EPA): > % 3,0 Docosahexaenoic acid (DHA): > % 4,0 > Total fatty alcohols: % 28 > alcohol: C20:1 n-9 fatty % 9,0 > alcohol: C22:1 n-11 fatty % 12 < Trans fatty acids: % 1,0 Astaxanthinesters: < % 0,1 Peroxide value (PV): < meq. O 3,0

Description/Definition: oil

Authorised Novel Food Chewing gum base (monomethoxypolyethylene glycol) Calanus finmarchicus 24.7.2018 EN Official Journal of the European Union L 187/69

Specifications 50 mg/kg 50 ≤

150 ppm 150 ≤ 250 ppm 250 500 CFU/g 500

≤

≤

: Negative to test 10 ppm 10 15 ppm 15

≤ Negative to test ≤ 500 ppm 500 500 CFU/g 500 ≤ : Negative to test ≤ 500 ppm 500 ≤ : Negative to : Negative test

Microbiological criteria: Total aerobic plate count: Mould/yeast: Escherichia coli Salmonella Staphylococcus aureus: Pseudomonas aeruginosa Description/Definition: Methyl vinyl ether-maleic anhydride copolymer is an anhydrous copolymer of methyl vinyl ether and maleic anhydride. Free-flowing, white to white-off powder CAS No: 9011-16-9 Purity: % in dry matter At Assay value: least 99,5 % MEK): 2-10 Specific viscosity (1 Residual methyl vinyl ether: Residual maleic anhydride: Acetaldehyde: Methanol: Dilauroyl peroxide: metals: Total heavy Total oligomeres (less than 1 000 Dalton): Total oligomeres (less than 1 Ethylene glycol: < mg/kg 200 Diethylene glycol: < mg/kg 30 Monoethylene glycol methyl ether: < mg/kg 3,0 Diethylene glycol methyl ether: < mg/kg 4,0 Triethylene glycol methyl ether: < mg/kg 7,0 1,4-Dioxane: < mg/kg 2,0 Formaldehyde: < mg/kg 10

Authorised Novel Food Chewing gum base (Methyl anhydride vinyl ether-maleic copolymer) L 187/70 EN Official Journal of the European Union 24.7.2018

.

2 teurisation steps. cal CO s employed to remove family. Post-harvest the seeds are cleaned mechanically.

Labiatae

Specifications ; it is a slightly yellow, odourless, free-flowing powder. It has a dry matter It content of has a dry powder. free-flowing odourless, yellow, it is a slightly ;

L.) seeds (99,9 % pure) by cold pressing. No solvents are used and, once pressed, the oil is held in No used and, once % solvents are pressed, pure) by cold pressing. L.) seeds (99,9 Aspergillus niger Aspergillus 2,0 % 2,0 Salvia hispanica ≤

60 % 60 0,05 % 0,05

10 meq/kg 10 ≥

≤ L.) is a summer annual herbaceous plant belonging to the ≤

Salvia hispanica (*) Carbohydrates include the fibre value fibre the include (*) Carbohydrates Description/Definition: is obtained from the mycelium of Chitin-glucan Chia oil is produced from Chia ( decantation tanks and a filtration process employed to It can also be remove impurities. produced by extraction with supercriti (**) (**) pentosans and of lignin Crude fibre is the part fibre made mainly of indigestible cellulose, Chia ( Flowers, leaves and other parts of the plant are removed. % Dry matter: 90-97 % Protein: 15-26 % Fat: 18-39 % Carbohydrate (*): 18-43 % 18-43 Crude Fibre(**): % Ash: 3-7 90 % or more. Chitin-glucan is composed largely of two polysaccharides: — (CAS No: 1398-61-4), of N-acetyl-D-glucosamine units of repeating composed chitin, — (CAS No: 9041-22-9). units of D-glucose of repeating composed beta (1, 3)-glucan, Production process: Production process of and blends containing fruit juices fruit juice and beverages, Chia seeds, includes seed pre-hydration pas Microbiological controls and monitoring systems are in place. Production process: Produced by No cold pressing. solvents the are used and, once oil is pressed, held in decantation tanks and a filtration proces impurities. Acidity expressed as oleic acid: Peroxide value (PV): Insoluble impurities: Alpha linolenic acid: % Linoleic acid: 15-20 Description/Definition: Description/Definition: )

Aspergillus Salvia hispanica Salvia hispanica Authorised Novel Food

Chia seeds ( Chitin-glucan from niger Chia oil from 24.7.2018 EN Official Journal of the European Union L 187/71 eating in an alkaline . It consists primarily of two polysaccharides: . It primarily consists Fomes fomentarius

Specifications

0,1 % 0,1 ≤

1,00 ≤ 10 % 10

0,03 0,20 ≤ ≤ 90 % 90 90 % 90 ≤

≥ ≥ 1,00 ≤

8,3 % 8,3 15 % 15 2,0 % 2,0 6,0 % 6,0 ≤ ≤ ≤ ≤ 1,0 % 1,0 1,0 % 1,0 ≤ ≤

3,0 % 3,0 3,0 % 3,0 ≤ ≤ Description/Definition: bodies is obtained of complex from the cell walls of fruit the fungus Chitin-glucan 9041-22-9). No: — (CAS (CAS No: 1398-61-4); of N-acetyl-D-glucosamine units of repeating composed Chitin, D-glucose of units repeating of composed — Beta-(1,3)(1,6)-D-glucan, in size and softening reduction and grinding, cleaning, in water h including: steps, consists of several process The production during the production process. No is applied drying. hydrolysis solution, washing, Appearance: Powder, odourless, flavourless, brown Purity: Moisture: Ash: Chitin-glucan: Ratio of chitin to 70:20 glucan: excluding glucans: Total carbohydrates, Proteins: Lipids: Melanins: Additives: None pH: 6,7-7,5 Heavy metals: Lead (ppm): Cadmium (ppm): Mercury (ppm): Arsenic (ppm): Loss on drying: Chitin-glucan: 30:70 to 60:40 to glucan: of chitin Ratio Ash: Lipids: Proteins:

Authorised Novel Food Chitin-glucan complex from Fomes fomentarius L 187/72 EN Official Journal of the European Union 24.7.2018 . Aspergillus niger Aspergillus ium, solubilisation in ium, solubilisation

Agaricus bisporus Agaricus or from the mycelium of Agaricus bisporus Agaricus

Specifications

85 15 10 ≥ ≤ ≤ /g

3

2,0 n

≤ ) 4

10 3,0 /g ≤ ≤ /g 3 NO

3

11 ): 0,7-1,0

H 10 3

6 10 ≤ ≤

and other pathogenic bacteria: Absence/25 g and Absence/25 bacteria: other pathogenic 10/g ≤

: Description/Definition: is obtained from stems of (containing mainly poly(D-glucosamine)) extract chitosan The The patented production process consists and of steps, including: extraction (hydrolysis) in deacetylation several alkaline med and drying. in medium, washing alkaline medium, precipitation acidic Synonym: Poly(D-glucosamine) Chitosan CAS number: 9012-76-4 Chitosan formula: (C Ash (% w/w dry weight): Proteins (% w/w dry weight): Particle size: > nm 100 Tapped density (g/cm Coliforms at 30 °C: Coliforms at 30 E. coli Appearance: fine free-flowing powder Aspect: Off –white to slightly brownish Odour: Odourless Purity: Chitosan content (% w/w dry weight): Glucan content (% w/w dry weight): Loss on drying (% w/w dry weight): % acetic acid): 1-15 % in 1 Viscosity (1 Degree of (in acetylation % mol/wet weight): 0-30 % acetic acid) (mPa.s): 1-14 % in for 1 chitosan from Aspergillus niger; 12-25 Viscosity (1 for chitin from Salmonella Fat binding 800 capacity × (w/w wet weight): pass Yeast and moulds: Microbiological criteria: bacteria: Total mesophilic

Aspergillus ; Authorised Novel Food

) Agaricus bisporus Chitosan extract from fungi ( niger 24.7.2018 EN Official Journal of the European Union L 187/73 nic solvents. fermentation by the

Specifications 10,0 ≤

3 50 10

85 ≤

≤ ≤

3 10 ≤

10 10

O5:K4:H4 strain U1-41 (ATCC 23502). ≤

0,5 ≤ 0,7 100 ≤ ≤ Di-6S) (%): ≤ : Absence/25g Δ ): 0,5 ≤ 0,1 1,0

0,05 ≤ ≤

1,0 /w (CFU/g):

h ≤ : Absence/25g Escherichia coli Escherichia Loss on drying (%) (105 °C to constant weight): Loss on drying (%) (105 Residue on ignition (% dry basis): 20-30 Protein (% dry basis): Endotoxins (EU/mg): (mg/kg): Total organic impurities at slightly soluble in pH 7. The salt is also soluble in water free-flowing powder, is a polar orga Chromium picolinate reddish acid chromium(III) salt or 2-pyridinecarboxylic Chemical name: tris(2pyridinecarboxylato-N,O)chromium(III) CAS No.: 14639-25-9 Chondroitin sulphate (sodium salt) is a biosynthetic product. It is obtained by chemical sulphation of chondroitin derived from of derived chondroitin sulphation It is obtained by chemical (sodium salt) is a biosynthetic product. Chondroitin sulphate bacterium (sodium salt) (% 95-105 Chondroitin sulphate dry basis): (kDa): 5-12 avg.) MWw (weight 4-11 (kDa): avg.) MWn (number Dispersity (w Escherichia coli Enterobacteriaceae (CFU/g): Salmonella Listeria monocytogenes Yeast and mould count (CFU/g): Sulphation pattern ( Heavy metals: Mercury (ppm): Lead (ppm): Arsenic (ppm): Cadmium (ppm): Microbiological criteria: Aerobic count (CFU/g):

Description/Definition: Description/Definition: Authorised Novel Food Chondroitin sulphate Chromium Picolinate L 187/74 EN Official Journal of the European Union 24.7.2018

Specifications family and native to the Mediterranean region, Chalkidiki Peninsula. Cistaceae

3

) 2

NO

4 H 95 % 95 6

≥ g g g μ μ μ

L. Pandalis herb; species belonging L. Pandalis herb; species to the : 3,0 : 30 : 54 1 2 6

4,0 % 4,0 ≤ Sodium: 0,18 g Sodium: 0,18 g Potassium: 0,75 g Magnesium: 0,24 g Calcium: 1,0 mg Iron: 65 Cistus incanus Composition: g herbs g/100 Moisture: 9–10 g herbs g/100 Protein: 6,1 g herbs g/100 Fat: 1,6 g herbs g/100 Carbohydrates: 50,1 g herbs g/100 Fiber: 27,1 g herbs g/100 Minerals: 4,4 Vitamin B Vitamin B Chemical characteristics: Chromium Picolinate: % Chromium (III): 12-13 Chromium (VI): not detected Water: Vitamin B mg Vitamin C: 28 mg Vitamin A: less than 0,1 mg Vitamin E: 40–50 mg Alpha-Tocopherol: 20–50 mg 2–15 Beta and Gamma-Tocopherols: mg Delta-Tocopherol: 0,1–2 Chemical formula: Cr(C Description:

L. Pandalis herb L. Pandalis Authorised Novel Food Cistus incanus 24.7.2018 EN Official Journal of the European Union L 187/75

Specifications -(trihydrogen diphosphate) P’-[2-(trimethylammonio)ethyl]ester inner salt P’-[2-(trimethylammonio)ethyl]ester -(trihydrogen diphosphate) ′

5,0 % 5,0 ≤

-pyrophosphate, Cytidine 5

CFU/g ′

2

3

P

11

10 O 4

≤ CFU/g CFU/g N

2 0,1 % 0,1

3

26 ≤ H 10

14 (CBM-588) is a Gram-positive, spore-forming, obligate anaerobic, non-pathogenic, non-genetically modified bacterium. 10 ≤ 1,0 % 1,0 ≤ ≤ 0,05 % 0,05 98 % of dry matter dry of % 98 : Absence in 1 g : Absence in 1 : Not detected in 1 g : Not detected in 1 ≤ ≥

-Cytidylic acid: ′ Citicoline is produced by a microbial process. and choline. pyrophosphate Citicoline is composed of ribose, cytosine, powder White crystalline Chemical name: Choline cytidine 5 Clostridium butyricum Depository number FERM BP-2789 Microbiological criteria: count: Total viable aerobic Yeast and moulds: Chemical formula: C Molecular weight: 488,32 g/mol Molecular weight: 488,32 CAS No.: 987-78-0 %): 2,5-3,5 pH (sample solution of 1 Purity: Assay value: °C for 4 hours): Loss on drying (100 Ammonium: ppm Arsenic: Not more than 2 Free phosphoric acids: 5 Microbiological criteria: Total plate count: Escherichia coli Escherichia coli

Description/Definition: Description/Definition: Authorised Novel Food Clostridium butyricum Citicoline L 187/76 EN Official Journal of the European Union 24.7.2018 L. Coriandrum sativum Coriandrum

Specifications

L.) extract

3

CFU/g

2

L.) Extract : Not detected in 1 g : Not detected in 1 10 : Not detected in 1 g : Not detected in 1 ≤ Theobroma cacao Theobroma cacao Cocoa ( Appearance: Dark brown powder free of visible impurities Physical and chemical properties: % GAE Polyphenol content: Min 55,0 % 10,0 Theobromine content: Max % Ash content: Max 5,0 % Moisture content: Max 8,0 g/cm Bulk density: 0,40-0,55 Description/Definition: plant seeds of the coriander from the that is produced acids of fatty oil is an containing glycerides seed Coriander Appearance: Dark red to purple powder % Min 99 concentrate: Cocoa extract, % Silicon dioxide (technological aid): Max 1,0 mg/g Min. 300 Cocoa flavanols: mg/g 45 Min. — Epicatechin: % Loss on 5,0 drying: Max. Slight yellow colour, bland Slight yellow colour, taste CAS No.: 8008-52-4 acids: Composition of fatty % Palmitic acid (C16:0): 2-5 Stearic acid (C18:0): < % 1,5 % Petroselinic acid (cis-C18:1(n-12)): 60-75 % Oleic acid (cis-C18:1 (n-9)): 8-15 pH: 5,0-6,5 ppm Residual solvent: Max 500 Staphylococcus aureus Pseudomonas aeruginosa Yeast and moulds:

Low fat Cocoa ( Cocoa fat Low

Authorised Novel Food Coriander seed oil from oil Coriander seed Coriandrum sativum Extract of defatted cocoa Extract of defatted powder Low fat cocoa extract Low fat 24.7.2018 EN Official Journal of the European Union L 187/77 cription: , sieved or not, without

-cycloamylase α -cyclodextrin may be carried out using one of the following procedures: α family and family native to north China and Korea. Specifications Rosaceae -1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase of cyclodextrin the action by units produced -1,4-linked D-glucopyranosyl α -cyclodextrin from the solution; or chromatography with ion-exchange or gel filtration followed by crystallisation or gel filtration ion-exchange with solution; or chromatography from the -cyclodextrin species belonging to the species α

-cyclodextrin with 1-decanol, dissolution in water at steam-stripping elevated temperature and of the re-precipitation, α -dextrin, cyclohexaamylose, cyclomaltohexaose, -dextrin, cyclohexaamylose, α

15 g/kg 15

≤ 5,0 meq/kg 5,0 ≤ 1,0 % 1,0 ≤ Crataegus pinnatifida Crataegus

2,5 mg KOH/g mg 2,5 -cyclodextrin, ≤ α

-cyclodextrin from the purified mother liquor; or membrane separation methods such as ultra-filtration and reverse osmosis: Des osmosis: and reverse as ultra-filtration methods such or membrane separation mother liquor; from the purified -cyclodextrin α -Linolenic acid (C18:3): < -Linolenic acid % 1,0 Description/Definition: Dried fruits of Composition: % Dry matter: 80 g/kg fresh weight Carbohydrates: 55 g g/100 Fructose: 26,5–29,3 g g/100 Glucose: 25,5–28,1 g weight fresh mg/100 Vitamin C: 29,1 g fresh weight g/100 Sodium: 2,9 Compotes are products obtained by of thermal processing the edible part of one of whole or or several species fruits, in pieces significant concentration. Sugars, water, cider, spices and lemon juice may be used. A non-reducing cyclic saccharide consisting of six saccharide A non-reducing cyclic (CGTase, EC 2.4.1.19) on hydrolyzed starch. Recovery and of purification precipitation of a complex of complexant, and of crystallisation of Virtually odourless, white or almost white crystalline solid. Synonyms: Chemical name: Cyclohexaamylose Linoleic acid (C18:2): 12-19 % Linoleic acid (C18:2): 12-19 α Trans fatty acids: Purity: °C): 1,466-1,474 Refractive index (20 Acid value: Peroxide value (PV): 88-110 Iodine value: units mg KOH/g 186-200 Saponification value: Unsaponifiable matter:

dried Description/Definition: Authorised Novel Food

-cyclodextrin Crataegus pinnatifida fruit α L 187/78 EN Official Journal of the European Union 24.7.2018 ssolve the sample -cyclodextrin in a α 0,45-micrometer filter , Germany) or similar

Specifications Consortium für Elektrochemische Industrie GmbH, München, Germany or Wacker Biochem Group, Biochem Wacker GmbH, München, or Germany Industrie Elektrochemische für Consortium -cyclodextrin into a 10 ml volumetric flask and add 8 ml of deionised water. Dissolve the Dissolve ml of deionised water. flask and add 8 ml volumetric into a 10 -cyclodextrin α (1 % solution)

Macherey & Nagel Co. Düren o m) ( μ (10 and +151

2

o

6

-cyclodextrin (available from -cyclodextrin (available ) α 5

O

10 : Between +145

20 mg/kg 20 0,5 % (as glucose) (as % 0,5 l H ≤ μ ≤ 25 6

D ]

α

) using the conditions described in METHOD OF ASSAY 0,1 % 0,1 ≤

11 % (Karl Fischer Method) Fischer (Karl % 11 98 % (dry basis) (dry % 98 ≤ 0,5 mg/kg 0,5 ≥

≤ Length: 250 mm Length: 250 mm Diameter: 4 °C Temperature: 40 (67/33, v/v) acetonitrile/water Mobile phase: ml/min 2,0 Flow rate: Injection volume: 10 Formula weight: 972,85 Assay: Identification: °C Decomposes above 278 Melting range: Solubility: Freely soluble in water; very slightly soluble in ethanol Specific rotation: [ Chromatography: The retention time for the major peak in a liquid chromatogram of the sample corresponds to that for chromatogram of reference Adrian, MI, USA CAS No.: 10016-20-3 Chemical formula: (C Purity: Water: Residual complexant: (1-decanol) Reducing substances: Sulphated ash: Lead: Method of assay: using the following conditions: chromatography Determine by liquid Di ml of deionised water. and add 8 flask ml volumetric 10 into a mg of test sample about 100 Weigh accurately solution: Sample completely using an ultra-sonification bath (10-15 min) and dilute to the mark with purified deionised water. Filter through a mg of Reference solution: Weigh about accurately 100 sample completely using an bath ultra-sonification and dilute to the mark with purified deionised water. Chromatography: Liquid chromatograph equipped with a refractive index detector and an integrating recorder. Nucleosil-100-NH packing: Column and

Authorised Novel Food 24.7.2018 EN Official Journal of the European Union L 187/79

hase and recovery -CD peak. Calculate the Calculate -CD peak. α

-cyclodextrin may be carried out by of precipitation a complex of γ -cycloamylase γ

-cyclodextrin, respectively, after -cyclodextrin, respectively, correcting for water content. α Specifications (1 % solution) 4 mg/kg 4

≤ o -1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase of cyclodextrin action by the units produced -1,4-linked D-glucopyranosyl ) S

α /W R

-cyclodextrin for the sample solution and reference solution, respectively. α ) (W and + 180

R

o /A

S

6mg/kg 8

) ≤ -dextrin, cyclooctaamylose, cyclomaltooctaose, -dextrin, cyclooctaamylose, 5

γ

O

10

: between + 174

0,5 % (as glucose) (as % 0,5 H ≤ 25 6

D ] α 0,1 % 0,1 -cyclodextrin in the test sample as follows: ≤

α are the weights (mg) of the test sample and reference -cyclodextrin,

are the areas of the peaks due to of the peaks are the areas γ R

R 11 % 11 98 % (dry basis) (dry % 98 ≤ ≥

and W -cyclodextrin (dry basis) = 100 × (A -cyclodextrin (dry basis) = 100 and A

Carbohydrates: 60 % with: (Dextran: 50 %, Mannitol: 0,5 %, Fructose: 0,3 %, Leucrose: %) 9,2 % Protein: 6,5 % Lipid: 0,5 α

S

Powdered form: Powdered

S -cyclodextrin with 8-cyclohexadecen-1-one, dissolution of of and the with 8-cyclohexadecen-1-one, complex with water n-decane, steam-stripping the aqueous p -cyclodextrin Chemical name: Cyclooctaamylose CAS number: 17465-86-0 Chemical formula: (C A non-reducing cyclic saccharide consisting of eight saccharide A non-reducing cyclic (CGTase, EC 2.4.1.19) on hydrolysed starch. Recovery and of purification γ of gamma-CD from the solution by crystallisation. Virtually odourless, white or almost white crystalline solid Synonyms: 1. where A Assay: Identification: °C Decomposes above 285 Melting range: Solubility: Freely soluble in water; very slightly soluble in ethanol Specific rotation: [ W Purity: Water: Residual complexant (8-cyclohexadecen-1-one (CHDC)): Residual solvent (n-decane): Reducing substances: Sulphated ash: Procedure: Inject the sample solution into the chromatograph, record the chromatogram, and measure the area of and the area the measure record the chromatogram, Inject the sample solution into the chromatograph, Procedure: percentage of %

Description/Definition: Authorised Novel Food Leuconostoc mesenteroides Leuconostoc -cyclodextrin Dextran preparation produced Dextran preparation by γ L 187/80 EN Official Journal of the European Union 24.7.2018 Brassica ) or rapeseed oil ( oil ) or rapeseed Glycine max

Specifications

50 % 50 ≥

5,0 % 5,0

≤ 15 % 15 20 % 20 80 % 80

0,1 % 0,1 ) using a specific enzyme. specific a ) using ≤ ≤ ≥ 10 % 10 ≤ 1,0 meq/kg 1,0 ≤ ≤ 2,0 % 2,0

1,0 % 1,0 ≤

≤ 0,5 mg KOH/g mg 0,5 ≤

Lactic acid: 10 %Ethanol: traces Lactic acid: 10 % Ash: 13 % Moisture: 10 Carbohydrates: 12 % with: (Dextran: 6,9 %, Mannitol: %, 1,1 Fructose: 1,9 %, Leucrose: %) 2,2 % Protein: 2,0 % Lipid: 0,1 % Lactic acid: 2,0 % Ethanol: 0,5 % Ash: 3,4 % Moisture: 80 Liquid form: Liquid Description/Definition: ( soybean oil from in particular oils, vegetable from edible derived acids and fatty from glycerol Manufactured campestris, Brassica napus Acylglycerol Distribution: Diacylglycerols (DAG): 1,3-Diacylglycerols (1,3-DAG): Triacylglycerols (TAG): Monoacylglycerols (MAG): Fatty Acid Composition (MAG, DAG, TAG): % Oleic acid (C18:1): 20-65 % Linoleic acid (C18:2): 15-65 (C18:3): Linolenic acid Saturated fatty acids: Others: Acid value: Moisture and volatile: Peroxide value (PV): Unsaponifiables: Trans fatty acids triacylglycerols = TAG = diacylglycerols, DAG = monoacylglycerols, MAG 2.

Authorised Novel Food

Diacylglycerol oil of plant origin 24.7.2018 EN Official Journal of the European Union L 187/81 ­ Echinacea 10 % w/w of w/w % 10 ≥ esterification dihydro L. Stearidonic acid: Echium plantagineum Echium

Vb.

® Specifications g/kg

μ

Vb ® obtained from plant tissue culture which is to substantially equivalent a root extract from

g/ml μ /kg 2

from cell cultures HTN 20 ≤ (Palau) Kunth from cell cultures HTN

4 O

2,0 % 2,0

28

≤ H

Echinacea angustifolia Echinacea

5,0 meq O meq 5,0 ≤

18 2,0 % (w/w of total fatty acids) fatty total of (w/w % 2,0 ≤ Echinacea purpurea Echinacea Lippia citriodora Lippia 0,6 mg KOH/g mg 0,6 ≤ obtained % in echinacoside. ethanol-water titrated to 4 total fatty acids Trans fatty acids: Acid value: Peroxide value (PV): angustifolia Echium oil is the pale yellow product obtained by refining oil extracted from the seeds of Description/Definition: Extract of the roots of Description/Definition: Dried extract of Pyrrolizidine alkaloids: Not Pyrrolizidine alkaloids: detectable with a detection limit 4,0 Description/Definition: Dried extract of Dihydrocapsiate is synthesised by enzyme-catalysed esterification of vanillyl alcohol and 8-methylnonanoic acid. Following the capsiate is extracted with n-hexane. liquid to yellow to colourless Viscous Chemical formula: C CAS No: 205687-03-2 Physical-chemical properties: Dihydrocapsiate: > % 94 < 8-Methylnonanoic acid: % 6,0 Vanillyl acohol: < % 1,0 < Other synthesis related substances: % 2,0 Unsaponifiable content: Protein content (total nitrogen):

Description/Definition: Description/Definition: extract oil extract

Lippia from cell cultures Authorised Novel Food Dried extract of citriodora Echium plantagineum Echinacea purpurea from cell cultures Echinacea angustifolia from cell cultures Dihydrocapsiate (DHC) L 187/82 EN Official Journal of the European Union 24.7.2018

HPLC [Eur. Ph. 2,2.29] Ph. HPLC [Eur. 1H-NMR Polarimetry

) in the form of a fine, off-white to pale pink powder. It is composed pink powder. to pale ) in off-white the form of a fine,

a) Specifications O)

2 Method -imidazol-4-yl)-2-(trimethylammonio)-Propanoate H Visual Camellia sinensis (L.) Kuntze

(+) 122° (c = 1, H = 1, (+) 122° (c ≥

D ] 99,5 % 99,5 % 99,0 α ≥ ≥ S 2

O

3

N

15 Specification H

9

[

Parameter White powder White

Chemical name (IUPAC): (2S)-3-(2-thioxo-2,3-dihydro-1 Chemical formula: C Description/Definition: A highly purified extract from the leaves of green tea ( °C 210 gallate (EGCG), and has a melting point between and 215 % approx. epigallo-catechin of a minimum of 90 Appearance: off-white to pale pink powder Chemical name: polyphenol (-) epigallocatechin-3-gallate (EGCG) gallate Synonyms: epigallocatechin CAS No.: 989-51-5 gallate epigallocatechin INCI name: g/mol Molecular mass: 458,4 % Loss on drying: max 5,0 Heavy metals: ppm Arsenic: max 3,0 ppm Lead: max 5,0 Assay: % EGCG (on dry material) Min. 94 % caffeine max. 0,1 Solubility: EGCG is fairly soluble in water, ethanol, methanol and acetone Molecular mass: 229,3 Da CAS No.: 497-30-3 Chemical purity Optical rotation Appearance

) Definition Camellia sinensis Authorised Novel Food L-ergothioneine Epigallocatechin gallate as a purified extract from green tea leaves ( 24.7.2018 EN Official Journal of the European Union L 187/83 gel

1H-NMR Elemental analysis Gas chromatography [Eur. Ph. 01/2008:20424]

Specifications [Eur. Ph. 01/2008:20232] Ph. [Eur.

[Eur. Ph. 01/2011:50104] Ph. [Eur.

CFU/g CFU/g Atomic fluorescence (Hg) Cd) fluorescence ICP/AES (Pb, Atomic

3 2 HPLC/GPC or 1H-NMR or HPLC/GPC 1 x 10 1 x 10 [Eur. Ph. 01/2008:50400] < 1 000 ppm C: 47,14 ± % C: 47,14 0,4 ± % H: 6,59 0,4 ± % N: 18,32 0,4 ≤ ≤

O)

2

b) (c = 1, H 1, (c =

o

Internal standard < 0,5 % 0,5 < standard Internal b) c) Absence in 1 g 1 in Absence Compliant with the structure the with Compliant = (+) 126,6

< 0,8 % 0,8 <

D < 1,0 ppm 1,0 < ] < 0,1 ppm 0,1 < α

< 3,0 ppm 3,0 < Lead Total viable aerobic count (TVAC) Total viable aerobic Eur. Ph.: European Pharmacopoeia; 1H-NMR: GPC: proton Eur. Ph.: European Pharmacopoeia; nuclear magnetic liquid chromatography; resonance; HPLC: high-performance coupled plasma atomic emission spectroscopy; ICP/AES: Inductively permeation chromatography; CFU: colony-forming units. [ a) Lit. b) Analyses conducted on each batch each on conducted b) Analyses 1881/2006 No (EC) Regulation with accordance in levels c) Maximum Escherichia coli Identification Total residual solvents Total residual isopropanol, acetate, (methanol, ethyl ethanol) Mercury Loss on drying Impurities Cadmium Total yeast and mould count (TYMC) Heavy metals Microbiological specifications

Authorised Novel Food L 187/84 EN Official Journal of the European Union 24.7.2018 ) muscle, y of more than Sardinops sagax

Specifications O 2

* 3H

8

NaO

2

4 FeN 0,1 % 0,1 PO

4 ≤

12 H 0,1 % 0,1 ≤

10

28 % 28 ≥ 7,0 % (w/w) % 7,0 ≤ 3,0 % 3,0 ≤ Ferric Sodium EDTA (ethylenediaminetetraacetic acid) is an yellow to Sodium odourless free-flowing, brown EDTA Ferric purit (ethylenediaminetetraacetic powder with a chemical 99 % (w/w). It is freely soluble in water. Chemical formula: C Description/Definition: of fish ( hydrolysis protease-catalysed is obtained by an alkaline which mixture, novel food ingredient is a The peptide subsequent isolation of the peptide fraction by concentration under column vacuum and chromatography, spray drying. Yellowish white powder Ferrous ammonium Ferrous phosphate is insoluble a grey/green fine in powder, practically water and soluble in dilute mineral acids. CAS No.: 10101-60-7 Chemical formula: FeNH Chemical characteristics: % suspension in water: 6,8-7,8 pH of 5 Iron (total): Chemical characteristics: % solution: 3,5-5,5 pH of 1 % Iron: 12,5-13,5 % Sodium: 5,5 % Water: 12,8 % Organic matter (CHNO): 68,4 % EDTA: 65,5-70,5 Water insoluble matter: Nitrilo-triacetic acid: Iron (II): 22-30 % (w/w) Iron (II): 22-30 Iron (III): % (w/w) Ammonia: 5-9 Water: Description/Definition:

Description/Definition: Sardinops Authorised Novel Food

Fish peptides from Fish peptides sagax Ferrous ammonium phosphate Ferrous ammonium Ferric Sodium EDTA Ferric Sodium 24.7.2018 EN Official Journal of the European Union L 187/85 85 g/100 gVal-Tyr (dipeptide): 0,1- (dipeptide): gVal-Tyr g/100 85 ≥

L. are extracted with ethanol followed by further extraction of this ethanolic Specifications Glycyrrhiza glabra Glycyrrhiza

99 % 99 is extracted using aqueous extraction in acidic solution and filtration processes without the use of organic processes solution and filtration in acidic extraction using aqueous is extracted ≥

Fucus vesiculosus

8 g/100 g g/100 8 than 2 kDa): of less weight molecular a with and tripeptides dipeptides peptides, chain ) (short ≤ 1 10 g/100 g g/100 10 ≤ ) Kjeldahl method ) Kjeldahl

1 0,16 g/100 g Ash: Moisture: Description/Definition: Flavonoids derived from the roots or rootstock of % of glabridin. % extract with to medium-chain It 3,5 triglycerides. is a dark-brown coloured liquid, containing 2,5 Moisture: < % 0,5 Ash: < % 0,1 Peroxide value (PV): < meq/kg 0,5 % of fat Glabridin: 2,5-3,5 Glycyrrhizinic acid: < % 0,005 Fat including substances: polyphenol-type Protein: < % 0,1 Carbohydrates: not detectable ( Description/Definition: Fucoidan from the seaweed with the following specifications: is concentrated and dried to the fucoidan extract The resulting extract yield solvents. Off-white to brown powder and taste Bland odour and Taste: Odour Moisture: < °C for 2 hours) % (105 10 °C) % suspension at 25 pH value: 4,0-7,0 (1 Heavy metals: Arsenic (inorganic): < ppm 1,0 Cadmium: < ppm 3,0 Lead: < ppm 2,0 Mercury: < ppm 1,0 Peptides (

Glycyrrhiza Fucus vesiculosus Authorised Novel Food

Flavonoids from glabra Fucoidan extract from the seaweed L 187/86 EN Official Journal of the European Union 24.7.2018

Specifications is extracted using aqueous extraction in acidic solution and filtration processes without the use of organic

Undaria pinnatifida Undaria : Absence/g

: Absence/g : Absence/10 g : Absence/10

Description/Definition: Fucoidan from seaweed with the following specifications: is concentrated and dried to the fucoidan extract The resulting extract yield solvents. Off-white to brown powder and taste Bland odour and Taste: Odour Microbiological criteria: Total aerobic microbial count: < 000 CFU/g 10 Yeast and mould count: < 100 CFU/g count: Absence/g Total enterobacteria Escherichia coli Salmonella Staphylococcus aureus of fucoidan: on level based the of extracts, types two permitted of the Composition Extract 1: % Fucoidan: 75-95 % Alginate: 2,0-5,5 % Polyphloroglucinol: 0,5-15 % Mannitol: 1-5 % 0,5-2,5 Minerals: Natural salts/Free % 0,5-1,0 Other carbohydrates: % Protein: 2,0-2,5 Extract 2: % Fucoidan: 60-65 % Alginate: 3,0-6,0 % Polyphloroglucinol: 20-30 Mannitol: < % 1,0 % 0,5-2,0 Minerals: Natural salts/Free % 0,5-2,0 Other carbohydrates: % Protein: 2,0-2,5

Undaria pinnatifida Authorised Novel Food Fucoidan extract from the seaweed 24.7.2018 EN Official Journal of the European Union L 187/87

Specifications

: Absence/g

: Absence/g : Absence/10 g : Absence/10

Moisture: < °C for 2 hours) % (105 10 °C) % suspension at 25 pH value: 4,0-7,0 (1 Heavy metals: Arsenic (inorganic): < ppm 1,0 Cadmium: < ppm 3,0 Lead: < ppm 2,0 Mercury: < ppm 1,0 Microbiology: Total aerobic microbial count: < 000 CFU/g 10 Yeast and mould count: < 100 CFU/g count: Absence/g Total enterobacteria Escherichia coli Salmonella Staphylococcus aureus of fucoidan: on level based the of extracts, types two permitted of the Composition Extract 1: % Fucoidan: 75-95 % Alginate: 2,0-6,5 % Polyphloroglucinol: 0,5-3,0 % Mannitol: 1-10 % 0,5-1,0 Minerals: Natural salts/Free % 0,5-2,0 Other carbohydrates: % Protein: 2,0-2,5 Extract 2: % Fucoidan: 50-55 % Alginate: 2,0-4,0 % Polyphloroglucinol: 1,0-3,0 % Mannitol: 25-35 % 8-10 Minerals: Natural salts/Free % 0,5-2,0 Other carbohydrates: % Protein: 1,0-1,5

Authorised Novel Food L 187/88 EN Official Journal of the European Union 24.7.2018

200,0 mg/kg in combination in mg/kg 200,0 ≤

4)- D-glucopyranose 50,0 mg/kg singly, mg/kg 50,0 Specifications ≤ → -D-galactopyranosyl-(1 β 500 CFU/g 500 ≤ 2)- →

1,0 w/w % w/w 1,0

≤

15

O 0,6 w/w % w/w 0,6

32 ≤ 10 EU/mg 10 H 10 CFU/g 10 ≤

18

≤ 0,01 % 0,01 95 % 95 ≤ -L-Fucopyranosyl-(1 ≥ 0,2 % 0,2 α ≤

0,3 % 0,3

9,0 % 9,0 1,0 w/w % w/w 1,0 ≤ 0,1 mg/kg 0,1

≤ 1,0 w/w % w/w 1,0 ≤ ≤ ≤ 3,0 mg/kg 3,0 ≤

-fucosyllactose is a white to off-white powder that is produced by a chemical synthesis process. -Fucosyl- D-lactulose: ′ ′ Definition: Chemical name: Chemical formula: C Heavy Metals: Palladium: Nickel: Microbiological criteria: total bacteria count: Aerobic mesophilic Yeasts and Moulds: Residual endotoxins: CAS No: 41263-94-9 g/mol Molecular weight: 488,44 Description: 2 Purity: 2'-Fucosyllactose: D-Lactose: L-Fucose: Difucosyl- D-lactose isomers: 2 % solution): 3,2-7,0 °C, 5 pH (20 Water (%): Ash, sulphated: Acetic acid: Residual solvents (methanol, 2-propanol, methyl acetate, acetone): Residual proteins:

Authorised Novel Food -Fucosyllactose ′ 2 (synthetic) 24.7.2018 EN Official Journal of the European Union L 187/89

BL21

Escherichia coli Escherichia 0,01 % (powder and liquid) and (powder % 0,01 90 % 90 3,0 % 3,0 5,0 % 5,0 5,0 % 5,0 ≤ ≥ ≤ 0,5 % (powder and liquid) and (powder % 0,5 ≤ ≤ ≤

3,0 % 3,0 ≤ 3,0 % 3,0 5,0 % 5,0 3,0 % 3,0 ≤ 9,0 % (powder) % 9,0 ≤ ≤

≤

-Fucosyllactose is a -Fucosyllactose white to off white powder and the liquid ′ Description: 2 % concentrate (45 ± % w/v) aqueous solution is a colourless 5 is 2'-Fucosyllactose solution. aqueous clear yellow to slight produced by a microbiological process. Purity: 2'-Fucosyllactose: Lactose: Fucose: 3-Fucosyllactose: Fucosylgalactose: Difucosyllactose: Glucose: Galactose: Water: Ash, sulphated: Residual proteins: Source: Genetically modified strain of

4)-D-glucopyranose Specifications →

K-12 -D-galactopyranosyl-(1 β 3 000 CFU/g 000 3 ≤ 2)- →

Escherichia coli Escherichia

15

O

1,0 % 1,0

32 ≤ H 2,0 % 2,0

18 ≤ 0,01 % 0,01 90 % 90 ≤ -L-Fucopyranosyl-(1

≥ α 2,0 % 2,0 ≤ 10 EU/mg 10 1,0 % 1,0

≤ 3,0 % 3,0 ≤

2,0 ≤ 100 CFU/g 100 ≤ 100 CFU/g 100 9,0 % 9,0 ≤

≤ ≤

-Fucosyllactose is a white to off-white powder that is produced by a to powder that is produced is a white off-white -Fucosyllactose -Fucosyl-D-lactulose: ′ ′ Definition: Chemical name: Chemical formula: C Source: Genetically modified strain of CAS No: 41263-94-9 g/mol Molecular weight: 488,44 Description: 2 microbial process. Purity: 2'-Fucosyllactose: D-Lactose: L-Fucose: Difucosyl-D-lactose: 2 % solution): 3,0-7,5 °C, 5 pH (20 Water: Sulphated ash: Microbiological criteria: total bacteria count: Aerobic mesophilic Yeasts: Moulds: Endotoxins: Acetic acid: Residual proteins:

Authorised Novel Food 2'-Fucosyllactose (microbial source) L 187/90 EN Official Journal of the European Union 24.7.2018

, .

terrestris

50 CFU/g (liquid) CFU/g 50 ≤ Aspergillus oryzae Aspergillus 5 000 CFU/g (liquid) CFU/g 000 5 ≤

100 EU/ml (liquid) EU/ml 100 ≤ CFU/g (powder),

g/kg (powder and liquid)

4 μ -galactosidases from 100 CFU/g (powder); CFU/g 100 β ≤ 10 ≤ 0,025

≤ 100 EU/g (powder), EU/g 100 ≤ 0,1 mg/kg (powder and liquid) and (powder mg/kg 0,1 ≤ 0,5 mg/kg (powder and liquid) and (powder mg/kg 0,5 : negative/100 g (powder), negative/200 ml (liquid) 0,2 mg/kg (powder and liquid) and (powder mg/kg 0,2 : negative/100 g (powder), negative/200 ml (liquid) ≤ ≤ 0,02 mg/kg (powder and liquid); and (powder mg/kg 0,02 ≤ Microbiological criteria: Total plate count: Heavy Metals: Lead: Arsenic: Cadmium: Mercury: Yeasts and Moulds: Enterobacteriaceae/Coliforms: absence in 11g (powder and liquid) Salmonella Aflatoxin M1: Cronobacter Endotoxins:

Specifications o HCl ·

5

- + 73,0

NO o

13 H

6 White crystalline odourless powder odourless White crystalline Molecular formula: C Galacto-oligosaccharide is produced from milk lactose Galacto-oligosaccharide is by an enzymatic process produced from milk using Bifidobacterium bifidum, Pichia pastoris, Sporobolomyces singularis, Kluyveromyces lactis, Bacillus circulans, and Papiliotrema Relative molecular mass: 215,63 g/mol Relative molecular mass: 215,63 % of reference standard (HPLC) D-Glucosamine HCl 98,0-102,0 Specific rotation + 70,0 GOS: min 46 % Dry Matter (DM) GOS: min 46 % DM Lactose: max 40 % DM Glucose: max 27 % DM Galactose: min 0,8 % DM Ash: max 4,0 % DM Protein: max 4,5 mg/kg Nitrite: max. 2 E.

Description/Definition: and

Authorised Novel Food K-12 Glucosamine HCl from Aspergillus niger genetically modified strain of coli Galacto-oligosaccharide 24.7.2018 EN Official Journal of the European Union L 187/91 linkages, II and III to to contamination family). It consists of a Leguminosae L. Taub. (

) & by Commission Implementing Regulation (EU) 2015/175 ) & by Commission Implementing Regulation of 1

Cyamopsis tetragonolobus Cyamopsis Specifications

). 2

o m 2KCl 2NaCl · · μ

4 4

o SO SO - +54 2 2

) ) o 5 5

NO NO to +52,0

14 14

o H H

6 6

Native guar gum is the ground endosperm of seeds from natural strains of guar composed and of primarily mannopyranose units galactopyranose combined high molecular weight polysaccharide, through glycosidic %). as a galactomannan (galactomannan content not chemically may be described less than 75 which Appearance: White to yellowish powder 000 Daltons 000 8 000 – 50 Between weight: Molecular CAS number: 9000-30-0 Einecs Number: 232-536-8 in Annexes listed for food additives (EU) No 231/2012 by Commission Regulation down specifications specified laying As Purity: Regulation (EC) ( No 1333/2008 of the European Parliament and of the Council White crystalline odourless powder odourless White crystalline Molecular formula: (C powder odourless White crystalline Molecular formula: (C Moisture: Max 15 % Moisture: Max 15 Viscosity * at 1 hour — Relative molecular mass: 605,52 g/mol Relative molecular mass: 605,52 % of reference standard (HPLC) D-Glucosamine Sulphate 2KCl 98,0-102,0 Specific Rotation +50,0 g/mol Relative molecular mass: 573,31 % of reference standard (HPLC) D-Glucosamine HCl: 98-102 Specific Optical Rotation: +52 Physico-chemical properties: Powder Shelf-life: 2 years Colour: White Odour: Light Average diameter of 60-70 particles: 5 due in or consigned from India gum originating of guar to the import conditions applicable 2015 down special laying February ( risks by pentachlorophenol and dioxins E. E.

and and Description/Definition:

Authorised Novel Food Aspergillus niger Aspergillus Aspergillus niger Aspergillus K-12 K-12 genetically modified strain of coli Glucosamine sulphate NaCl Glucosamine sulphate from genetically modified strain of coli Guar Gum Glucosamine sulphate KCl Glucosamine sulphate from L 187/92 EN Official Journal of the European Union 24.7.2018

starting the starting

).

1 (DSM 23964)(

Bacteroides xylanisolvens Bacteroides (DSM 23964) as starter culture.

Specifications Bacteroides xylanisolvens Bacteroides (DSM 23964). The resulting fermented milk product is homogenised and then heat-treated to inactivate

3 O

10 H (DSM 23964). The final product does not contain viable cells of

8 Bacteroides xylanisolvens Bacteroides 0,4 % 0,4 ≤

) Modified DIN EN ISO 21528-2. ISO EN DIN ) Modified

1 Hydroxytyrosol is a pale yellow viscous liquid obtained by chemical synthesis Molecular formula: C Description/Definition: fermented Heat-treated milk products are produced with before ultra-heat-treated or pasteurised is less) or % fat (0,5 milk skimmed or % fat) % and 1,8 (between 1,5 Semi-skimmed milk fermentation with Bacteroides xylanisolvens (*) The measurements of viscosity are carried out under the following conditions: 1 %, 25 °C, 20 rpm %, 25 (*) conditions: 1 out under the following carried are of viscosity measurements The ( Molecular weight: 154,6 g/mol Molecular weight: 154,6 CAS No: 10597-60-1 Moisture Odour: Characteristic Viscosity * at 2 hours: Min 3 600 Viscosity * mPa.s at 2 hours: Min 3 000 Viscosity * mPa.s at 24 hours: Min 4 Solubility: Soluble in hot and cold water °C - 6-7,5 pH for 10g/L, at 25 Flakes 1 year Useful life: Colour: White/off white with absence or minimal presence of black spots Odour: Light mm Average diameter of 1-10 particles: % Moisture: Max 15 000 Viscosity * mPa.s at 1 hour: Min 3 Viscosity * at 2 hours — Viscosity * at 24 hours — Solubility — Soluble in hot and cold water °C - 5-7,5 pH for 10g/L, at 25

Description/Definition: Bacteroides

Authorised Novel Food Hydroxytyrosol Heat-treated milk products fermented with xylanisolvens 24.7.2018 EN Official Journal of the European Union L 187/93 lised with 10 mM ied strain of food- ltration. As a result, the ve ISP, glycosylated ISP ve ISP, glycosylated

0,3 % 0,3 ≤

Specifications Ilex guayusa. Ilex ) in which a synthetic gene for the ISP has been inserted into the genome. yeast’s The protein is expressed

0,3 % 0,3

≤

Saccharomyces cerevisiae

0,01 mg/kg 0,01 99 % 99 ≤ ≥ 25,0 mg/kg 25,0 2,50 mg/kg 2,50

≤ 0,4 % 0,4 ≤ ≤ 0,01 mg/kg 0,01 2,00 mg/kg 2,00 ≤ 0,01 mg/kg 0,01 ≤ ≤ 5 g/l active ISP active g/l 5 0,03 mg/kg 0,03 ≥

2,0 % 2,0 ≤ ≤ Description/Definition: by submerged fermentation of a genetically-modif produced is a light-brown liquid Protein (ISP) Ice Structuring preparation The grade baker’s yeast ( and concentrated by ultra-fi by micro-filtration cells from the yeast it is separated into the growth medium where and secreted consists of nati ISP preparation form. The or under an altered as such into the ISP preparation not transferred are cells yeast stabi is concentrate The commonly found in food. and salts acids as well as and sugars the yeast from and peptides proteins and citric acid buffer. Assay: pH: 2,5-3,5 Ash: DNA: Not detectable Description/Definition: Dark brown Aqueous extracts of liquid. dried leaves of Taste: Slightly bitter Miscible with water Solubility (water): pH: 3,5-4,5 Refractive Index: 1,571-1,575 Purity: Hydroxytyrosol: Acetic acid: Hydroxytyrosol acetate: Sum of homovanillic acid, iso-homovanilic and 3-methoxy-4hydroxyphenylglycol: Heavy Metals Lead: Cadmium: Mercury: Residual Solvents Ethyl acetate: Isopropanol: Methanol: Tetrahydrofuran:

Authorised Novel Food Ilex guayusa Ilex Ice Structuring Protein type III Protein type Ice Structuring HPLC 12 Aqueous extract of dried leaves Aqueous extract of dried of L 187/94 EN Official Journal of the European Union 24.7.2018 s with a sweet taste ined from sucrose by ined from sucrose

Specifications 90 90 ≥ ≥

0,3 0,3

5,0 5,0 ≤ ≤

≤ ≤ 0,5 0,5 ≤ ≤ 0,5 0,5 4,0

≤ ≤

≤

Heavy metals: Lead (mg/kg): Arsenic (mg/kg): Syrup: g): > Dried solids (g/100 75 Glucose (% dry basis): Isomaltose + basis): DP9 (% dry DP3 to pH: 4 - 6 g): Sulphated ash(g/100 Heavy metals: Lead (mg/kg): Arsenic (mg/kg): A reducing disaccharide that consists of one glucose and one fructose moiety linked by an alpha-1,6-glycosidic bond. It is obta bond. It is linked by an alpha-1,6-glycosidic moiety and one fructose of one glucose consists that disaccharide A reducing white or odourless, an almost The Virtually enzymatic commercial product is white crystal process. the monohydrate. Appearance: Solubility (water) (%): > 99 Glucose (% dry basis): Isomaltose + basis): DP9 (% dry DP3 to Moisture (%): g): Sulphated ash(g/100 Composition: ml Protein: < g/100 0,1 Fat: < ml g/100 0,1 ml g/100 Carbohydrate: 0,2–0,3 ml < Total sugars: g/100 0,2 ml mg/100 Caffeine: 19,8–57,7 ml mg/100 Theobromine: 0,14–2,0 mg/100ml Chlorogenic acids: 9,9–72,4

Powder: Description/Definition: Authorised Novel Food Isomaltulose Isomalto-oligosaccharide 24.7.2018 EN Official Journal of the European Union L 187/95 ample preparation hydrous, monohydrate n tests, test n tests, test solutions and other reference

), ‘Instrumental methods’

1 Specifications

O

2 H ·

11 11

O O

22 24 -D-glucopyranosyl-D-fructofuranose, monohydrateCAS No.: 13718-94-0 H H -D-Galactopyranosyl-D-glucitol β α

12 12

6,5 % (60 °C, 5 hours) 5 °C, (60 % 6,5 ≤

98 % on the dry basis dry the on % 98 0,1 mg/kg 0,1 ≥

≤ materials (JECFA), 1991, 322 English, ISBN pp., 92-5-102991-1. ) identificatio techniques, analytical general notices, general for to specifications 2 — Guide 5 Rev. and Nutrition Paper Food

1 ( Formula weight: 360,3 Formula weight: (monohydrate) Purity: Assay: Loss on drying: Heavy metals: Lead: size and method of s of sample selection The level. specified to the appropriate technique using an atomic absorption Determine in FNP 5( of the method described be on the principles may based Crystalline powder or colourless solution hydrogenation of manufactured via catalytic lactose. Crystalline products occur in an a catalyst. forms. Nickel is used as and dihydrate Chemical name: 4-O- Chemical formula: C Structural formula g/mol Molecular weight: 344,31 CAS No: 585-86-4 Chemical name: 6-O- Chemical formula: C

Description/Definition: Authorised Novel Food Lactitol L 187/96 EN Official Journal of the European Union 24.7.2018

4)- D-glucopyranose → -D-galactopyranosyl-(1 β 3)- →

-D-glucopyranosyl-(1 Specifications β

4)-2-acetamido-2-deoxy- o → 0,6 % 0,6 ≤ to + 16

o 21

NO

45 = + 13

H 20

26 96 % 96 D

≥ ] 0,3 % 0,3 0,2 % d.b % 0,2 -D-Galactopyranosyl-(1 α ≤ ≤ 0,4 % 0,4 β 0,1 % d.b % 0,1 2,5 % d.b % 2,5 ≤ ≤ ≤ 0,3 % 0,3

1,0 % 1,0 ≤ 200 mg/kg d.b mg/kg 200 100 mg/kg d.b mg/kg 100

≤ ≤ ≤ 3,0 mg/kg d.b mg/kg 3,0 2,0 mg/kg d.b mg/kg 2,0 ≤ 10,5 % 10,5 9,0 % 9,0 95 % d.b (d.b — expressed on the dry weight basis) weight dry the on expressed — (d.b d.b % 95 -neotetraose is a white to off-white powder. Produced by a chemical synthesis process and is isolated by crystallisation. process synthesis Produced by a chemical -neotetraose is a white to off-white powder. ≤ ≤ ≤ 1,0 mg/kg d.b mg/kg 1,0 ≥

N ≤ Chemical formula: C Definition: Chemical name: CAS No: 13007-32-4 g/mol Molecular weight: 707,63 Description: Lacto- Assay: Water: Other polyols: Reducing sugars: Purity: Solubility (in soluble in water): Very water Specific rotation [ Purity: Assay (water free): D-Lactose: Lacto-N-triose II: isomer: Lacto-N-neotetraose fructose % solution): 5,0-7,0 °C, 5 pH (20 Water: Ash, sulphated: Acetic acid: Chlorides: Sulphates: Sulphated ash: Nickel: Arsenic: Lead:

-neotetraose Authorised Novel Food N Lacto- (synthetic) 24.7.2018 EN Official Journal of the European Union L 187/97

4)-D-glucopyranose → -neotetraose is isolated by crystallisation. N -D-galactopyranosyl-(1 β 3)- → 200 mg/kg in combination in mg/kg 200 ≤

-D-glucopyranosyl-(1 50 mg/kg singly, mg/kg 50 Specifications β ≤

K-12 4)-2-acetamido-2-deoxy- 500 CFU/g 500 ≤ → 1,0 % 1,0 ≤

100 mg/kg 100 ≤ 21

Escherichia coli Escherichia 3,0 % 3,0 NO

≤

45 10 EU/mg 10 H ≤

26 92 % 92

0,01 % 0,01 0,01 % 0,01 ≥ 3,0 % 3,0 ≤ ≤ -D-Galactopyranosyl-(1 ≤ 0,4 % 0,4 β ≤

3,0 % 3,0 0,1 mg/kg 0,1

≤ ≤ 10 CFU/g 10 3,0 mg/kg 3,0 10 CFU/g 10 9,0 % 9,0 ≤

-neotetraose is a white to off-white powder that is produced by a microbiological process. Lacto- process. by a microbiological that is produced to off-white powder a white -neotetraose is ≤ ≤ ≤

N -Lacto-N-neohexaose: Chemical formula: C Definition: Chemical name: CAS No: 13007-32-4 g/mol Molecular weight: 707,63 Source: Genetically modified strain of Description: Lacto- Purity: Assay (water free): D-Lactose: Lacto-N-triose II: para isomer: Lacto-N-neotetraose fructose % solution): 4,0-7,0 °C, 5 pH (20 Water: Ash, sulphated: Residual solvents (methanol): Residual proteins: Residual solvents (methanol, 2-propanol, methyl acetate, acetone): Residual proteins: Palladium: Nickel: Microbiological criteria: total bacteria count: Aerobic mesophilic Yeasts: Moulds: Residual endotoxins:

-neotetraose Authorised Novel Food N Lacto- (microbial source) L 187/98 EN Official Journal of the European Union 24.7.2018 arotenoids used in ured. centrate is granulated ude protein. The press d chlorophyll pigments. d chlorophyll

Specifications

500 CFU/g 500 ≤ 96 % lycopene and minor quantities of other related carotenoid components. Lycopene is presented either as a as either presented is Lycopene components. carotenoid related other of quantities minor and lycopene % 96 ≥

L.) is processed within 2 hours after harvest. It is chopped and crushed. By passing through an oleaginous-type press, the an press, By passing through It and L.) is processed within 2 oleaginous-type is chopped harvest. crushed. hours after

56 -trans lycopene) 10 EU/mg 10 H all ≤

40 4,5 mg/kg 4,5

≤ 100 mg/kg 100 350 mg/kg 350 Medicago sativa ≤ ≤ 1,4 % 1,4 200 mg/kg 200 ≤ 10 CFU/g 10 ≤ 10 CFU/g 10 ≤ ≤ Description/Definition: ( The Lucerne % of cr 35 contains about juice matter of this dry The matter). % of dry (10 juice and press residue a fibrous provides Lucerne with carotenoid an of proteins associated allows coagulation injection and (pH 5,8-6,2) Preheating vapour juice is neutralised. protein con acid the Lucerne After adding ascorbic dried. and thereafter by centrifugation is separated protein precipitate The or in cold storage. in inert gas and stored Composition: % Protein: 45-60 % Fat: 9-11 % Free carbohydrates (soluble fibre): 1-2 % Polysaccharides (insoluble fibre): 11-15 % 2-3 including cellulose: % Minerals: 8-13 Saponins: Isoflavones: Coumestrol: Phytates: L-canavanine: by the Wittig lycopene is produced Synthetic condensation commonly of intermediates used in synthetic the production of other c food. Synthetic lycopene consists of to be ass has protection Antioxidative or red-violet. dark red is colour The dispersion. or an oily matrix suitable in a powder Chemical name: Lycopene CAS No.: 502-65-8 ( Chemical formula: C Formula weight: 536,85 Da Microbiological criteria: total bacteria count: Aerobic mesophilic Yeasts: Moulds: Residual endotoxins:

Description/Definition: Authorised Novel Food Lycopene Lucerne leaf extract from Medicago sativa 24.7.2018 EN Official Journal of the European Union L 187/99 sured. ) with subsequent removal of the removal subsequent ) with 5 % other carotenoids. It is presented either as a as either presented is It carotenoids. other % 5 ≤ Lycopersicon esculentum Mill.

in as a powder a suitable It % either is presented other carotenoids. 5 ≤ 95 % lycopene and lycopene % 95 ≥ Specifications L.) consists of 95 % lycopene and lycopene % 95 ≥ consists of Lycopersicon esculantum

Blakeslea trispora Blakeslea

56 56 -carotene): (0,5-0,75/0,4-0,65/0,2-0,35 %) -carotene): (0,5-0,75/0,4-0,65/0,2-0,35 0,5 % 0,5 H H β ≤

40 40 Description/Definition: The purified lycopene from Description/Definition: tomatoes ( of ripe obtained by solvent extraction from tomatoes is oleoresin Lycopene solvent. It is a red liquid. to dark clear brown viscous, % 5-15 Total lycopene: % 90-95 Thereof trans-lycopene: % 6,5-16,5 as lycopene): Total carotenoids (calculated % 1,75 Other carotenoids: (Phytoene/phytofluene/ % 1,5-3,0 Total tocopherols: % Unsaponifiable matter: 13-20 % 60-75 Total fatty acids: Water (Karl Fischer): Magnesium citrate malate amorphous powder. is a Magnesium citrate white to yellowish-white, The purified lycopene from The purified tomatoes ( to be has as protection Anti-oxidative or red-violet. dark red is colour The dispersion. or an oily matrix suitable in a powder Chemical name: Lycopene CAS No.: 502-65-8 (all trans lycopene) Chemical formula: C matrix or an The colour is oily dispersion. dark red or Anti-oxidative protection has to red-violet. be assured. Chemical name: Lycopene CAS No.: 502-65-8 (all trans lycopene) Chemical formula: C Formula weight: 536,85 Da Formula weight: 536,85 Da

Description/Definition: Description/Definition: Blakeslea

Authorised Novel Food Lycopene from tomatoes Lycopene oleoresin from tomatoes Magnesium citrate malate Lycopene from trispora L 187/100 EN Official Journal of the European Union 24.7.2018 dissolved in medical-

L. and produced with supercritical carbon dioxide. The bark is washed Specifications Magnolia officinalis Magnolia

2

)

5

O

4 H

4

15 % 15 ≤ (C 2

) 7

O

5 H 6

94 % 94

≥ (C

5

2 % 2 ≤ 1 ppm 1 0,5 % 0,5 85,2 % 85,2

0,05 % 0,05 0,05 % 0,05 ≤ 0,1 ppm 0,1 ≥ ≥ 3,0 ppm 3,0 ≤ ≤ ≤ ≤ 2,0 ppm 2,0

≤ Magnolia bark extract is obtained from the bark of the plant is obtained from the bark extract Magnolia is The extract carbon dioxide. and oven with supercritical moisture content dried to and before being reduce extracted crushed grade ethanol and to yield re-crystallised magnolia bark extract. is mainly composed of Magnolia bark extract two phenolic compounds, magnolol and honokiol. Appearance: Light brownish powder Purity: Magnolol: Honokiol: Magnolol & Honokiol: Total Eudesmol: % Moisture: 0,50 Chemical name: Pentamagnesium di-(2-hydroxybutanedioate)-di-(2- hydroxypropane-1,2,3-tricarboxylate) CAS No.: 1259381-40-2 Molecular weight: 763,99 Daltons (anhydrous) ml) g in 100 Solubility: Freely soluble in water (about 20 Description of the physical state: Amorphous powder % Assay magnesium: 12,0-15,0 °C/4 hours): Loss on drying (120 Colour (solid): White to yellowish-white % solution): Colourless to aqueous yellowish Colour (20 % aqueous solution): Clear solution Appearance (20 % 6,0 aqueous solution): Approx. pH (20 Impurities: Chloride: Sulphate: Arsenic: Lead: Cadmium: Mercury: Chemical formula: Mg

Description/Definition: Authorised Novel Food Magnolia Bark Extract 24.7.2018 EN Official Journal of the European Union L 187/101 on of ‘maize-germ in the concentration in the

Specifications g/kg μ

/kg 2

10

100 ≤ 2,0 ≤ g/kg 10 mEq O mEq 10 ≤ μ ≤ g/kg μ 0,5 ≤

1,3 g/100 g g/100 1,3 0,5 ≥ 6,0 mg KOH/g mg 6,0 ≤ ≤

-tocopherol (%): 10-25 % -tocopherol (%): 10-25 -tocopherol (%): < % 3,0 -tocopherol (%): < % 7,0 -tocopherol (%): 68-89 % -tocopherol (%): 68-89 Description/Definition: distillation and it is different from matter is produced by vacuum Maize-germ oil high in refined maize-germ oil unsaponifiable g matter’). in in ‘maize-germ unsaponifiable oil high g in refined maize-germ oil and 10 (1,2 fraction of the unsaponifiable Purity: g Unsaponifiable matter: > g/100 9,0 Tocopherols: α β γ δ methylsterols: > Sterols, triterpenic alcohols, g g/100 6,5 Fatty acids in triglycerides: % palmitic acid: 10,0-20,0 stearic acid: < % 3,3 % oleic acid: 20,0-42,2 % 34,0-65,6 linoleic acid: < linolenic acid: % 2,0 Acid value: Peroxide value (PV): Impurities: Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: < 2 (PAH) aromatic hydrocarbons are not to carbon enriched in the ensure that polycyclic Treatment with active is required producti matter’ in unsaponifiable oil high Heavy metals: < Iron (Fe): 500 1 Copper (Cu): < 100 Heavy metals: Arsenic (ppm): Lead (ppm): Methyl eugenol (ppm): Tubocurarine (ppm): Total Alkaloid (ppm):

Authorised Novel Food Maize-germ oil high in Maize-germ oil high unsaponifiable matter L 187/102 EN Official Journal of the European Union 24.7.2018 ucosamine salt thyl groups. loroform. Soluble in glacial ) and not more than 5 % of hydroxyethoxyl groups % of hydroxyethoxyl ) and not than 5 more 3

Specifications

16 O 9

N

51

H

32 10 % (105 °C, 3 hours) 3 °C, (105 % 10 8,0 (1 % colloidal solution) colloidal % (1 8,0 1,5 % determined at 800 ± 25 °C ± 25 800 at determined % 1,5 ≤ ≤ ≤

1,0 mg/kg 1,0 OH)

≤

1,0 mg/kg 1,0

2 3

3,0 mg/kg 3,0 ≤ ≤ or CH 2,0 mg/kg 2,0 CH

2

3 2 ≤ 5,0 and 5,0 ≥ Description/Definition: acid, gl Chemical name: N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic Chemical formula: C Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and etherified with partially me Chemical name: Methyl ether of cellulose units the following general formula: with contain substituted anhydroglucose The polymers formula: Chemical may be one of the following: C6H7O2(OR1)(OR2)(OR3) R1, R2, R3 each where — H — CH — CH Molecular weight: Macromolecules: from about 20 000 (n about 100) up to about 380 000 g/mol (n about 2 000) g/mol (n about 2 000 000 (n about 100) up to about 380 from about 20 Macromolecules: weight: Molecular (-OCH groups methoxyl % of 33 not more than % and 25 than Content not less Assay: Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder. granular and odourless tasteless, or greyish yellowish or slightly white hygroscopic Slightly and ch ether in ethanol, Insoluble solution. colloidal viscous, to opalescent, clear a producing Swelling in water, Solubility: acetic acid. Purity: Loss on drying: Sulphated Ash: pH: Molecular weight: 817,80 g/mol (anhydrous) Molecular weight: 817,80 CAS No.: 1181972-37-1 Appearance: Creamy to light-brown powder Heavy metals: Arsenic: Lead: Mercury: Cadmium: (-OCH

Description/Definition: Authorised Novel Food (6S)-5-methyltetrahydrofolic salt acid, glucosamine Methylcellulose 24.7.2018 EN Official Journal of the European Union L 187/103

Specifications

100 CFU/g 100 ≤

Si

3

O

6 100 CFU/g 100

≤

g/l

μ g/l g/l μ

μ

g/l : Absence in 10g μ 1,0 1,0 ppm 1,0 5,0 mg/kg (residual presence) (residual mg/kg 5,0 ≤ ≤ 1,0 0,1 ppm 0,1 ≤ 3,0 2,0 ppm 2,0

≤ ≤ 10 ppm 10 ≤ ≤ 8,0 % 8,0 ≤ ≤ 1,0 2,0 ppm 2,0

≤ ≤ Arsenic: Solvents: Methanol: Description/Definition: 1-methyl- Chemical name: Silanetriol, Chemical formula: CH Cadmium: Molecular weight: 94,14 g/mol Molecular weight: 94,14 CAS No: 2445-53-6 Purity: Organic Silicon (aqueous solution): (monomethylsilanetriol) preparation Acidity (pH): 6,4-6,8 mg Si/l Silicon: 100-150 Heavy metals: Lead: Mercury: Purity: % of (6S)-5-methyltetrahydrofolic acid Diastereoisomeric purity: At least 99 % in dry basis 34-46 Glucosamine assay: % in 5-Methyltetrahydrofolic acid dry assay: 54-59 basis Water: Heavy metals: Lead: Cadmium: Mercury: Arsenic: Boron: Escherichia coli Microbiological criteria: Total aerobic microbial count: Yeasts and moulds:

Authorised Novel Food Monomethylsilanetriol (Organic Silicon) L 187/104 EN Official Journal of the European Union 24.7.2018 dextrins constant xed with maltodextrins cultivated in a submerged fermentation. It is a in a submerged fermentation. cultivated Daltons, a degree of branching of 2/5 of branching and a triple a degree Daltons,

5 Lentinula edodes Lentinula

: Specifications are separated. The obtained pulp is filtered to separate juice from the flesh. Desiccation of from Desiccation the flesh. juice to The obtained pulp is filtered separate are separated. Lentinula edodes Morinda citrifolia

L.) are pressed. The obtained juice is pasteurised. An optional fermentation step before or after the pressing may are harvested by are harvested hand. Seeds and skin may from be the the separated mechanically pureed fruits. After pasteurisation,

): < mg/ml 10

2

-(1-6)-D-glucan which has a molecular weight of approximately 5 × 10 × 5 approximately of weight molecular a has -(1-6)-D-glucan which β

Morinda citrifolia Morinda

g/kg μ g/kg -(1-3) μ ): < mg/ml 0,1

β 1 Morinda citrifolia 10 ≤ 10 ≤ ) Bradford method ) Bradford method ) Kjeldahl

1 2 Lucidin: Description/Definition: of mycelium obtained from the extract aqueous a sterile is novel food ingredient The turbid liquid. light brown, slightly a Lentinan is Description/Definition: Seeds and skin of the sun-dried fruits in one or occurs two ways: juice the produced and malto rates of inflow is obtained by keeping the the juice this mixture by atomisation using maize maltodextrins, Either and then mi to be initially dried the juice allows process this Or by zeodratation or drying and then mixing with an excipient, (same amount as used in atomisation). Description/Definition: The fruits of puree is packaged in aseptic containers and stored under cold conditions. Description/Definition: of (fruits Noni fruits occur. Rubiadin: Lentinan: 0,8 – 1,2 mg/ml\ Lentinan: 0,8 – 1,2 ( ( N-containing constituents( helical tertiary structure. mycelial extract from Purity/Composition of the % Moisture: 98 % Dry matter: 2 Free glucose: < mg/ml 20 Total protein(

)

)

) Morinda Morinda citrifolia Lentinula edodes

) Authorised Novel Food Morinda citrifolia Noni fruit juice ( juice Noni fruit citrifolia Noni fruit puree and puree Noni fruit concentrate ( Noni fruit juice powder juice Noni fruit ( Mycelial extract from Shiitake mushroom ( 24.7.2018 EN Official Journal of the European Union L 187/105 ­

trate. e juice is collected and is collected e juice imits of 2,5 detection: ng/ml (5,15 dimethyl

Specifications puree by h). treatment Then °C the with pectinolytic for puree enzymes is 1-2 (50– 60 M. citrifolia

g/ml g/ml μ μ 0,254 0,254

≤ ≤ ):

1 concentrate is prepared from

0,4 g/100 g g/100 0,4 ≤ morindol); 50,0 ng/ml (lucidin); 6,3 ng/ml (alizarin) and 62,5 ng/ml (rubiadin). 6,3 ng/ml (alizarin) 50,0 ng/ml (lucidin); morindol); L puree and concentrate. in Morinda citrifolia of anthraquinones By an for the HPLC-UV analysis method developed and validated )

1 ( Morinda citrifolia heated to inactivate the pectinases and then immediately cooled. The is juice separated in a th decanter Afterwards centrifuge. of 6 from a brix to 8 of 49 to a brix to 51 evaporator in the final concen to being in a vacuum concentrated prior pasteurised, Composition: Puree: % Moisture: 89-93 g Protein: < g/100 0,6 Fat: Ash: < g g/100 1,0 g g/100 5-10 Total carbohydrates: g g/100 Fructose: 0,5-3,82 g g/100 Glucose: 0,5-3,14 Dietary fibre: < g g/100 0,5-3 5,15-dimethylmorindol (1): Lucidin (1): Not detectable Alizarin (1): Not detectable Rubiadin (1): Not detectable Concentrate: % Moisture: 48-53 g g/100 Protein: 3-3,5 Fat: < g g/100 0,04 g g/100 Ash: 4,5-5,0 g g/100 37-45 Total carbohydrates: g g/100 Fructose: 9-11 g g/100 Glucose: 9-11 g g/100 Dietary fibre: 1,5-5,0 5,15-dimethylmorindol (

Authorised Novel Food L 187/106 EN Official Journal of the European Union 24.7.2018

detection: 2,5 ng/ml (5,15 dimethylmorindol)

Specifications fruits by freeze-drying. Fruits are pulped and seeds are removed. After freeze-drying are pulped and seeds are removed. fruits by Fruits freeze-drying. Morinda citrifolia L.) Morinda citrifolia are subject to drying and roasting steps. The product has a particle size ranging from broken leaves to

g/ml μ g/kg μ g/kg μ 2,0 ≤ 10 Morinda citrifolia Morinda ≤ 10 ):

≤ 1

of Limits powder. fruit citrifolia in Morinda of anthraquinones for the analysis and validated an By HPLC-UV method developed )

1 Lucidin: non detectable, After cutting, the leaves of coarse powder with fines. It is of greenish brown to brown colour. Purity/Composition: Moisture: < % 5,2 % Protein: 17- 20 % Carbohydrate: 55-65 % Ash: 10-13 % Fat: 4-9 Oxalic acid: < % 0,14 Tannic acid: < % 2,7 5,15-dimethylmorindol: < mg/kg 47 Rubiadin: non detectable, Description/Definition: noni ( pulped made from is powder Noni fruit is removed from noni the remaining noni which water fruits, during pulp is milled to a powder and encapsulated. Purity/Composition % Moisture: 5,3-9 g g/100 Protein: 3,8-4,8 g g/100 Fat: 1-2 g g/100 Ash: 4,6-5,7 g g/100 80-85 Total carbohydrates: g g/100 Fructose: 20,4-22,5 g g/100 Glucose: 22-25 g g/100 Dietary fibre: 15,4-24,5 5,15-dimethylmorindol ( ( Description/Definition: )

Morinda Morinda citrifolia

) Authorised Novel Food Noni fruit powder ( powder Noni fruit citrifolia Noni leaves ( Noni leaves 24.7.2018 EN Official Journal of the European Union L 187/107 , best ensured by a

Specifications

2,0 % 2,0 ≤ /kg oil

2

10 % 10

≤

5,0 % 5,0 25 % 25

0,5 % 0,5 ≤ ≤ 3,0 % 3,0 ≤ 5 meq O meq 5

≤ ≤ 20 3 hours 3 1 % 1 ≤ ≤ ≤ 3,0 % 3,0 5,0 % 5,0 30 % 30 40 % 40 15 % 15 ≤ ≤ 80 % 80 0,5 KOH/g oil KOH/g 0,5 ≤ ≤ ≤ ≤ ≤ 0,1 % (w/w) % 0,1 ≤

-sitosterol: -sitostanol: campesterol: campestanol: stigmasterol: brassicasterol other sterols/stanols: Others: Moisture and volatile: Peroxide value (PV): < meq/kg 5,0 Trans fatty acids: Contamination/Purity (GC-FID or equivalent method) of phytosterols/phytostanols: of to be contaminants free for food have oil suitable than vegetable other from sources extracted and phytostanols Phytosterols %. purity of more than 99 Peroxide value (PV): Description/Definition: is composed of fraction. an oil fraction and a phytosterol with phytosterols/phytostanols Oil enriched Acylglycerol Distribution: Free fatty acids (expressed as oleic acid): Monoacylglycerols (MAG): Diacylglycerols (DAG): Triacylglycerols (TAG): Making up the balance Phytosterol fraction: β β p-Anisidine value: °C: Cold test at 0 Moisture: Unsaponifiable matter: Silicon: 3,3 %Crystalline silica: max 0,1-0,3 % as impurity as % 0,1-0,3 max silica: %Crystalline 3,3 Silicon: Acid value: Acid

microalgae Authorised Novel Food Oil extracted from squids Oil enriched with phytosterols/phytostanols Odontella aurita L 187/108 EN Official Journal of the European Union 24.7.2018

­

rch by combining

cultural and manufacturing practices

Equivalent to storage regimen for conventionally processed product processed conventionally for regimen storage to Equivalent Fruit homogenised and added to other ingredients other to added and homogenised Fruit Fruit harvested and stored in conjunction with good/hygienic agri good/hygienic with conjunction in stored and harvested Fruit Specifications ]y

2 H 3

Comments )PO 5

O

9 H

6

Assured by added sugars added by Assured Assured by added sugars added by Assured H]x [(C

2 PO 2

) Minimum 15 days at – 20 °C – 20 Minimum 15 at days < 0,95 5

O

9 H 6

[(C

0,4 % (as phosphorus) ‘high amylose maize’ as source as maize’ amylose ‘high phosphorus) (as % 0,4

≤ n

) 5

O 20 % 20

10 % 10

10 ≥ ≥ Target H 6

1,0 % 1,0 ≤ 70 % 70 Parameter ≥ at + 5 °C maximum maximum 60 days 40 % to 60 % of thawed fruit 0,8 % 0,8

0,8 % 0,8 ≤ ≤ 7 to 42 to 7 3,2 to 4,2 to 3,2

Brix

w

o Phosphated maize Phosphated phosphate) is starch (phosphated distarch a modified chemically resistant starch derived from high amylose sta chemical treatments to create phosphate cross-links between carbohydrate residues and esterified hydroxyl groups. The novel food ingredient is a white or nearly white powder. CAS No: 11120-02-8 Chemical formula: (C n = number of glucose units; x, y = degrees of substitution of = degrees y x, units; of glucose = number n of distarch phosphate: phosphated The chemical characteristics % Loss on drying: 10-14 pH: 4,5-7,5 Dietary fibre: % Starch: 7-14 Protein: Lipids: Residual bound phosphorus: Trans fatty acids: Docosahexaeonic acid: Eicosapentaenoic acid: Fruit storage before high-pressure treatment a Final storage Fruit added pH

Description/Definition:

Authorised Novel Food Pasteurised fruit-based using preparations produced high-pressure treatment Phosphated maize starch 24.7.2018 EN Official Journal of the European Union L 187/109 bean lecithin with bean lecithin nsphosphorylation it includes significant it includes e via a phosphodiester e via colour. The liquid form colour.

Specifications

/kg 2

)

1

35 % 35 % 61 ≥ ≥ 75 % 75 % 85 % 25 ≥ ≥ ≥

) Tocopherols may be added as antioxidants according to Commission Regulation (EU) No 1129/2011 No (EU) Regulation Commission to according antioxidants as added be may ) Tocopherols

1 Peroxide value (PV): < meq O 5,0 Description/Definition: tra by an enzymatic is obtained from fish phospholipids Phosphatidylserine to brown powder. is yellow food novel ingredient The with the amino acid L-serine. Specification of the product phosphatidylserine manufactured from fish phospholipids: Moisture: < % 5,0 Phospholipids: Phosphatidylserine: Glycerides: < % 4,0 Free L-serine: < % 1,0 Tocopherols: < % ( 0,5 ( Description/Definition: The novel food ingredient in It is off-white to form is liquid light yellow powder. also available with a brown clear to orange due to the fact that of Phosphatidylserine It contains lower levels (MCT) as a carrier. triacylglycerides contains medium chain amounts of oil (MCT). Phosphatidylserine from soya phospholipids is obtained through enzymatic transphosphatidylation of soy high-phosphatidylcholine two with skeleton acids and L-serin fatty conjugated consists of a glycerophosphate the amino L-serine. Phosphatidylserine acid linkage. from soya Characteristics of Phosphatidylserine phospholipids: Powder form: Moisture: < % 2,0 Phospholipids: Phosphatidylserine: Glycerides: < % 2,0 free L-serine: < % 1,0 Tocopherols: < % 0,3 Phytosterols: < % 0,2 Liquid form: Moisture: < % 2,0 Phospholipids:

Authorised Novel Food Phosphatidylserine from soya phospholipids Phosphatidylserine from fish phospholipids L 187/110 EN Official Journal of the European Union 24.7.2018 (1 – 6) (1 – α llow-brown powder

(1 – 4) glycosidic bonds branched every 8 to 12 glucose units by units 8 to 12 glucose every bonds branched 4) glycosidic (1 –

Specifications α

)n with linear linkages of linkages linear )n with

6 O

12 H 6

70 % 70

≥ 20 % 20 20 % 20 20 % 20 ≥ ≥ ≥

1,0 % 1,0

0,3 % 0,3 2,0 % 2,0 ≤ ≤ ≤ White to off-white powder which is an odourless, colourless, flavourless polysaccharide derived from non-GM derived sweet corn using polysaccharide flavourless White to is an odourless, colourless, off-white powder which 1,0 % 1,0 ≤ Glucose polymer (C 2,0 % 2,0 ≤ conventional food techniques processing Definition: Description/Definition: ye concentrated, product is a highly enzymatic conversion of The phospholipid The product is manufactured through soy lecithin. level. at an equal acid and phosphatidic form of phosphatidylserine Specification of the product: Moisture: Total phospholipids: Phosphatidylserine: Phosphatidic acid: Glycerides: Free L-serine: Tocopherols: Phytosterols: % a maximum content of is used with 1,0 Silicon dioxide glycosidic bonds Specifications: % Carbohydrates: 97 % Sugars: 0,5 % Fibre: 0,8 % Fat: 0,2 % Protein: 0,6 Phosphatidylserine: Glycerides: not applicable free L-serine: < % 1,0 Tocopherols: < % 0,3 Phytosterols: < % 0,2 from egg yolk Phospholipides % pure % and 100 85

Description: Authorised Novel Food Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid Phytoglycogen Phospholipides from egg yolk 24.7.2018 EN Official Journal of the European Union L 187/111 , best ensured by a tanols or esterified with tanols or esterified

) kernels.

Prunus domestica

Specifications

(GC-FID or equivalent method): 500 mg/kg 500 150 mg/kg 150

10 mg/kg 10 ≤ ≤ 600 mg/g (dry substance) (dry mg/g 600 ≤ ≥ 800 mg/g 800 ≥

(with GC-FID or equivalent method): GC-FID or equivalent (with 400 mg/g (dry substance) (dry mg/g 400 ≤ -Sitosterol: 80-90 % of total sterols -Sitosterol: 80-90 -sitosterol: < % 81 -sitostanol: < % 35 -Tocopherol:80 % of total tocopherols Plum kernel oil is a vegetable oil Plum kernel oil is obtained a vegetable by cold pressing of plum ( Composition: % Oleic acid (C18:1): 68 % Linoleic acid (C18:2): 23 γ β % of triglycerides Triolein: 40-55 mg/kg oil Cyanhydric acid: maximum 5 Phytosterols and phytostanols are sterols and stanols that are extracted from plants and may be presented as free sterols and s sterols free as and may be presented from plants extracted are and stanols that sterols are and phytostanols Phytosterols acids. fatty food grade Composition β β campesterol: < % 40 campestanol: < % 15 stigmasterol: < % 30 brassicasterol: < % 3,0 < other sterols/stanols: % 3,0 Contamination/Purity of to be contaminants free for food have oil suitable than vegetable other from sources extracted and phytostanols Phytosterols ingredient. phytosterol/phytostanol % of the of more than 99 purity Dry substance: Protein (N * 6,25): Ash: Glycoalkaloid (total): Lysinoalanine (total): Lysinoalanine (free):

Description/Definition:

Description/Definition: Authorised Novel Food Potato proteins (coagulated) Potato proteins and hydrolysates thereof Plum kernel oil Plum kernel Phytosterols/phytostanols L 187/112 EN Official Journal of the European Union 24.7.2018

Specifications

(GEP-44) )/g)

2

Aspergillus niger Aspergillus

CFU/g CFU/g

3 2

30 CFU/g 30

≤ 10

10 ≤ )/g (> 34,8 PPU(

≤

1

: Absence in 10 g : Absence in 10 : Absence in 25 g : Absence in 25 : Absence in 10 g : Absence in 10

: < 10 CFU/g

: Absence in 25 g : Absence in 25 Prolyl oligopeptidase is available as an enzyme preparation containing approximately 30 % maltodextrin. 30 containing approximately as an enzyme preparation is available oligopeptidase Prolyl 0,5 mg/kg 0,5 ≤ 0,1 mg/kg 0,1 1,0 mg/kg 1,0 : Absence in 25 g : Absence in 25 ≤ ≤ 1,0 mg/kg 1,0 ≤ Specification of the enzyme: Systematic name: Prolyl oligopeptidase Synonyms: Prolyl endopeptidase, endoprolylpeptidase endopeptidase, proline-specific Molecular weight: 66 kDa Enzyme Commission number: EC 3.4.21.26 CAS number: 72162-84-6 Source: A genetically modified strain of Description: of prolyl oligopeptidase: enzyme preparation of the Specifications Activity: > 000 PPI( 580 Total yeasts and moulds: Appearance: Microgranulate from batch to may change The colour to orange yellowish. Off-white Colour: > Dry Matter: % 94 Gluten: < ppm 20 Heavy metals: Lead: Arsenic: Cadmium: Mercury: Microbiological criteria: Total aerobic plate count: Sulphite reducing anaerobes: Enterobacteriaceae Salmonella Escherichia coli Staphylococcus aureus Pseudomonas aeruginosa Listeria monocytogenes Absent Antimicrobial activity:

Authorised Novel Food Prolyl oligopeptidase (enzyme Prolyl oligopeptidase preparation) 24.7.2018 EN Official Journal of the European Union L 187/113 g/kg), T-2 μ ugation. The nd is resuspended in nd is resuspended active sites of digestion. g/kg), Ochratoxin A (< g/kg), Ochratoxin 0,20 μ

g/kg) μ g/kg), total Aflatoxins (< 2,0 μ Specifications

CFU/g CFU/g

5 4

g/kg), Fumonisin B1 and B2 (< B1 and Fumonisin g/kg), 2,5 μ

CFU/g

5

: negative (Real Time PCR) : negative : < 100 CFU/g

: < 10 CFU/g g/kg), Zearalenone (< g/kg), Zearalenone 2,5 μ spp.: negative (Real Time PCR) : Absence/10g ) PPI – Protease Picomole International Picomole Protease – Units ) PPI Protease Proline or Units Peptidase Prolyl – ) PPU

1 2 Description/Definition: is obtained from The protein extract homogenised pig kidneys through a combination and of high speed centrif salt precipitation 1.4.3.22) a E.C. (enzyme nomenclature enzyme diamine oxidase % of the 7 with proteins contains essentially obtained precipitate the to coated pellets reach enteric is formulated as encapsulated The obtained buffer system. pig kidney extract a physiologic Basic Product: Specification: pig kidney protein excerpt with natural content of Diamin oxidase (DAO): Physical condition: liquid Colour: brownish Appearance: slightly turbid solution pH value: 6,4-6,8 > Enzymatic activity: 677 kHDU DAO/ml (DAO REA (DAO Radioextractionassay)) 2 Microbiological criteria: Brachyspira Listeria monocytogenes ( ( Staphylococcus aureus Real Time PCR) Transcription Influenza A: negative (Reverse Escherichia coli count: < Total aerobic microbiological 10 Salmonella < Bile salt resistant enterobacteriaceae: 10 Yeasts/moulds count: < 10 Final product: Specification pig kidney protein excerpt with natural content of DAO (E.C. 1.4.3.22) in an enteric coated formulation: Physical condition: solid Colour: yellow gray Mycotoxins: Below limits of detection: Aflatoxin B1, B2, G1, G2 (< 0,25 Toxin (< 5

Authorised Novel Food Protein extract from pig kidneys L 187/114 EN Official Journal of the European Union 24.7.2018 the concentration of the concentration the reduction of triglycerides reduction

Specifications

CFU/g

CFU/g CFU/g 3

4 2 /kg

2

10 mEq O mEq 10 ≤ : < 100 CFU/g

: < 10 CFU/g 6,0 mg KOH/g mg 6,0 ≤ : Absence/10g

-tocopherol (%): 30-50 % -tocopherol (%): 30-50 -tocopherol (%): < % 6,0 -tocopherol (%): 50-70 % -tocopherol (%): 50-70 Description/Definition: Rapeseed oil high in unsaponifiable matter’ is produced by vacuum distillation and it is different from refined rapeseed oil in g in g refined in rapeseed oil unsaponifiable fraction (1 ‘rapeseedand oil high 9 in unsaponifiable matter’). There is a minor fatty acids. containing monounsaturated and polyunsaturated Purity: g Unsaponifiable matter: > g/100 7,0 Tocopherols: > g g/100 0,8 α γ δ methylsterols: > Sterols, triterpenic alcohols, g g/100 5,0 Fatty acids in triglycerides: % palmitic acid: 3-8 % stearic acid: 0,8-2,5 % oleic acid: 50-70 % 15-28 linoleic acid: % 6-14 linolenic acid: erucic acid: < % 2,0 Acid value: Peroxide value (PV): Salmonella < Bile salt resistant enterobacteriaceae: 10 Escherichia coli count: < Total aerobic microbiological 10 Total combined count: < yeasts/moulds 10 Appearance: micropellets 110-220 Enzymatic activity: kHDU DAO/g pellet (DAO REA (DAO Radioextractionassay)) pH Borat 60 min by followed HCl min 0,1M 15 stability Acid > 9,0: = Radioextractionassay)) (DAO REA (DAO pellet DAO/g 68 kHDU Humidity: < % 10 Staphylococcus aureus

Authorised Novel Food Rapeseed oil high in unsaponifiable matter 24.7.2018 EN Official Journal of the European Union L 187/115 Brassica L. and L. on of ‘rapeseed oil Brassica napus Brassica

Specifications g/kg μ

100 CFU/g 100 10 000 CFU/g 000 10

≤ ≤ 10 CFU/g 10 1 mmol/kg 1 g/kg ≤ μ ≤ g/kg μ

85 % 85 7,0 % 7,0 ≥ 1,5 % 1,5 90 % 90 ≤

≤ ≥ Absence in 10 g Absence in 10

7,0 % 7,0 ≤ : Absence in 25 g : Absence in 25 0,5 % 0,5 0,5 mg/kg 0,5

4,0 % 4,0

≤ ≤ 2,0 % 2,0 ≤ ≤ L. Description: dried powder White to spray off-white, Total protein: Soluble protein: Moisture: Carbohydrates: Fat: Ash: Fibre: Total glucosinolates: Rapeseed protein is an aqueous protein-rich extract from rapeseed press cake originating from non-genetically modified rapa Purity: Total phytate: Lead: Microbiological criteria: Yeast and mould count: count: Aerobic bacteria Total coliform count: Escherichia coli: Salmonella Impurities: Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: < 2 carbon aromatic hydrocarbons (PAH) Treatment with active to is required are not ensure that polycyclic enriched in the producti high in unsaponifiable matter. Heavy metals: < Iron (Fe): 000 1 Copper (Cu): < 100

Definition: Authorised Novel Food Rapeseed Protein L 187/116 EN Official Journal of the European Union 24.7.2018 sulphate A and sulphate

Specifications by enzymatic hydrolysis of rooster comb and by subsequent filtration, concentration and concentration comb filtration, and by subsequent of rooster hydrolysis by enzymatic Saccharomyces cerevisiae Saccharomyces 0,5 % 0,5 Gallus gallus ≤ m μ

0,1 % 0,1 ≤

3

5,0 % 5,0 O ≤

12 H

14 50 mg/kg 50

≤ 98 %-99 % %-99 98 0,5 % 0,5 ≥ : A genetically modified strain of : A genetically 0,1 % 0,1 ≤ -resveratrol is off-white to beige crystals. ≤

0,1 ppm 0,1 1,0 ppm 1,0 Trans ≤ ≤ 1,0 ppm 1,0

≤ -resveratrol: Synthetic Chemical name: 5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diol Chemical formula: C Rooster comb extract is obtained from precipitation steps. The principal constituents of rooster comb extract are the glycosaminoglycans hyaluronic acid, chondroitin dermatan sulphate (chondroitin sulphate B). White or almost white powder. hygroscopic % Hyaluronic acid: 60-80 A: Chondroitin sulphate Molecular weight: 228,25 Da CAS No: 501-36-0 Purity: Trans Total by-products (related substances): Any single related substance: Sulphated ash: Loss on drying: Heavy metals: Lead: Mercury: Arsenic: Impurities: Diisopropylamine: Microbial source % w/w (dry Trans-resveratrol content: weight Min. basis) 98 % w/w Ash: Max. 0,5 % w/w Moisture: Max. 3 Appearance: Off-white to slight yellow powder % less than 62,23 Particle size: 100

Description/Definition: Description/Definition: Authorised Novel Food Rooster comb extract Trans-resveratrol 24.7.2018 EN Official Journal of the European Union L 187/117 L. It is a transparent, fluid (liquid) and shiny oil at

Plukenetia volubiis

Specifications

25 % 25 ≤

10 % 10 ≤

CFU/g /kg

2 2

10 ≤

: Absence in 1g : Absence in 1 g : Absence in 1

: Absence in 1 g : Absence in 1 10 mg/kg 10 1,0 mg/kg 1,0 ≤ 1,0 % 1,0

8,0 % 8,0 ≤ 0,1 mg/kg 0,1 ≤ 1,0 mg/kg 1,0 ≤ : Absence in 1 g : Absence in 1 ≤ ≤ 0,5 mg/kg 0,5

≤ Description/Definition: oil obtained from the seeds of vegetable % cold pressed 100 oil is a inchi Sacha flavours. undesirable taste without green vegetable light, a fruity, It has room temperature. Aspect, limpidity, shine, colour: Fluid at room clean, shiny temperature, yellow gold vegetable without non Odour and taste Fruity, or odour acceptable taste: Purity: g < Water and Volatiles: g/100 0,2 Impurities insoluble in hexane: < g g/100 0,05 g < Oleic acidity: g/100 2,0 Peroxide value (PV): < meq O 15 Escherichia coli Salmonella Staphylococcus aureus Pseudomonas aeruginosa g < Trans fatty acids: g/100 1,0 > fatty acids: Total unsaturated % 90 Dermatan sulphate (chondroitin sulphate B): pH: 5,0-8,5 Purity: Chlorides: Nitrogen: °C for 6 hours): Loss on drying: (105 Heavy metals: Mercury: Arsenic: Cadmium: Chromium: Lead: Microbiological criteria: count: Total viable aerobic

Plukenetia

Authorised Novel Food Sacha Inchi oil from oil Sacha Inchi volubilis L 187/118 EN Official Journal of the European Union 24.7.2018 ancid odour. lower oil. Description: by non-enzymatic inter-

Specifications 90 % 90 ≥

0,5 % 0,5 ≤ 10 % 10 ≤ 1,0 % 1,0 ≤

2,0 Meq/Kg 2,0 2,0 % 2,0 ≤ ≤ 1,0 % 1,0 ≤ 10 % 10 ≤ 0,3 % 0,3 ≤ 3,5 Red (Lovibond) Red 3,5 ≤ 0,1 % 0,1 ≤ Salatrim is the internationally recognised Salatrim is the acronym for (short internationally and molecules). Salatrim is prepared long chain acyl triglyceride esterification of triacetin, tripropionin, tributyrin, or their mixtures with hydrogenated canola, soybean, cottonseed, or sunf Clear, slightly amber liquid to a light coloured waxy solid at room matter Free of and temperature. particulate of foreign or r Glycerol ester disribution: Triacylglycerols: > % 87 Diacylglycerols: Monoacylglycerols: Fatty acid composition: % 33-70 MOLE % fatty acids): LCFA (long chain % 30-67 MOLE % acids): SCFA fatty (short chain Saturated long chain fatty acids: < % by weight 70 Trans fatty acids: Free fatty acids as oleic acid: Triacylglycerol profile: Triesters (short/long of 0,5 to 2,0): Triesters (short/long = 0): Unsaponifiable material: Moisture: Ash: Colour: Peroxide value (PV): Omega 3 alpha linolenic acid (ALA): > linolenic acid Omega 3 alpha % 45 Saturated fatty < acids: % 10 (< acids No trans fatty %) 0,5 (< acid No erucic %) 0,2 % of tri-linolenin and di-linolenin-triglycerides More than 50 Phytosterols composition and level g) (< No cholesterol mg/100 5,0

Description/Definition: Authorised Novel Food Salatrims 24.7.2018 EN Official Journal of the European Union L 187/119

Specifications oil rich in DHA and EPA should demonstrate stability by and oxidative appropriate Schizochytrium sp. Schizochytrium 7,5 % 7,5 ≤ 0,05 % 0,05 0,05 % 0,05 0,05 % 0,05

≤ ≤ ≤

5,0 meq/kg oil meq/kg 5,0 5,0 meq/kg oil meq/kg 5,0 5,0 meq/kg oil meq/kg 5,0 5,0 meq/kg oil meq/kg 5,0

≤ ≤ ≤ ≤ 2,0 % 2,0 1 % 1 % 1,0 2,0 % 2,0 3,5 % 3,5 4,5 % 4,5 4,5 % 4,5 3,5 % 3,5 0,4 % 0,4 0,4 % 0,4 ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ 35 % 35 22,5 % 22,5 % 32,0 35 % 35 10 % 10 ≥ ≥ ≥ ≥ ≥ 0,5 mg KOH/g mg 0,5 0,5 mg KOH/g mg 0,5 0,5 mg KOH/g mg 0,5 ≤ ≤ ≤ Peroxide value (PV): Unsaponifiables: Trans-fatty acids: Free fatty acids: Docosapentaenoic acid (DPA) n-6: DHA content: Acid value: Peroxide value (PV): Oxidative stability: All food products containing recognised national/international test methodology (e.g. AOAC) Moisture and volatiles: Unsaponifiables: Trans-fatty acids: DHA content: EPA content: Peroxide value (PV): Moisture and volatiles: Unsaponifiables: Trans-fatty acids: DHA content: Peroxide value (PV): Moisture and volatiles: Unsaponifiables: Trans-fatty acids: Free fatty acids: DHA content: Acid value: Acid

Acid value: Acid oil rich in

sp. (T18) oil sp. oil sp. (ATCC PTA-

Authorised Novel Food Schizochytrium Schizochytrium Schizochytrium 9695) oil Schizochytrium sp. EPA DHA and L 187/120 EN Official Journal of the European Union 24.7.2018 and 70 % and 70 modified soybeans ) by the process of solid-liquid process ) by the is removed during the manufacturing process. the manufacturing during is removed Triticum aestivum

2

Specifications )

1 var. natto.

Bacillus subtilis Bacillus )/g 3

CFU(

3 g/g μ 10

≤ CFU/g

10 CFU/g 10

≤ 2

10 ≤ 10 % 10 ≤

0,1 mg/kg 0,1 : Absence/25 g : Absence/25 ≤ 30 CFU/g 30 (L.)) with a selected strain of : ≤

2 3,0 mg/kg 3,0 : Absence/25 g : Absence/25 ≤ 5,0 mg/kg 5,0 : Absence/25 g : Absence/25 ≤ ) Assay method as described by Takaoka et al. (2010). al. et Takaoka by described as method ) Assay

Glycine max 1 Fermented soybean extract is an odourless milk-white coloured powder. It is comprised of 30 % powder fermented soybean extract of It is is an 30 comprised odourless milk-white coloured powder. Fermented soybean extract K Vitamin processing. is added during the which from corn-starch, carrier) (as dextrin resistant Escherichia coli Description/Definition: Spermidine-rich wheat germ extract is obtained from non-fermented, non-sprouting wheat germs ( but extraction targeting not specifically, polyamines. exclusively mg/g Spermidine: 0,8-2,4 mg/g Spermine: 0,4-1,2 < Spermidine trichloride 0,1 Heavy metals: Lead: Arsenic: Microbiological criteria: count: Total viable aerobic Yeast and mould: ( Coliforms: Spore-forming bacteria: Salmonella Listeria Nattokinase activity: 20 000 -28 000 Fibrin degradation unit/g( degradation 000 Fibrin 000 -28 20 activity: Nattokinase Identity: Confirmable Condition: No taste or smell offensive Loss on drying: Vitamin K Fermented soybean extract contains by nattokinase isolated from natto, a foodstuff the fermentation Fermented soybean extract produced of non-genetically ( Description/Definition:

)

Triticum aestivum Authorised Novel Food Spermidine-rich wheat germ extract ( Fermented soybean extract 24.7.2018 EN Official Journal of the European Union L 187/121

reaction. In this Leuconostoc citreum lulosic components, rom sugar cane, of the cane, rom sugar . The resulting oligosaccharides are characterised by the presence are characterised . The resulting oligosaccharides

Specifications Bacillus licheniformis Bacillus

g/kg

μ 3 % 3

ах 3) glycosidic compounds. The overall product is syrup, in addition to these oligosaccharides, contains mainly fructose but also fructose mainly contains oligosaccharides, to these in addition syrup, is product overall The compounds. 3) glycosidic Absence/25g g/g → μ -(l α < 10 CFU/g

Absence/25g 6) and → -(1 α the disaccharide leucrose and leucrose other disaccharides. the disaccharide % Total solids: 75-80 % Moisture: 20-25 % Sulphatase: Max 0,05 pH: 3,5-6,0 Conductivity < %) 200 (30 Nitrogen < ppm 10 % d.w. Fructose: 35-45 % d.w. Leucrose: 7-15 M Other disaccharides: % d.w 40-60 Higher saccharides: Sugar Cane Fibre is derived from the dry cell wall or or remaining after fibrous extraction of f expression residue sugar juice Saccharum genotype. It consists primarily of cellulose and hemicellulose. The production process consists of alkaline digestion, removal of several steps, including: chipping, lignins and other non-cel bleaching of fibres, acid washing and purified neutralization. Sucromalt is a complex mixture of saccharides which is produced from sucrose and a starch hydrolysate by means of an and hydrolysate enzymatic from sucrose a starch is produced which of saccharides Sucromalt is a complex mixture by means by the bacterium of an enzyme produced hydrolysate from the starch to saccharides units are attached glucose process, of production organism the or by means of a recombinant strain of Putrescine: < mg/g 0,3 Cadaverine: < 0,1 Mycotoxins: Aflatoxins (total): < 0,4 Microbiological criteria: < Total aerobic bacteria: 000 CFU/g 10 Yeast and moulds: < 100 CFU/g Escherichia coli: Salmonella: Listeria monocytogenes:

Description/Definition: Description/Definition: Authorised Novel Food Sugar cane fibre Sucromalt L 187/122 EN Official Journal of the European Union 24.7.2018 cted from the seeds of family, cultivated in sterile sea water in Chlorodendraceae

, belonging to the Specifications Tetraselmis chuii Tetraselmis 95 % 95 ≥

L.

1 000 1 ≤

: Absence

0,1

≤ 0,1 1,0 ≤ ≤

200

Helianthus Annuus 1,0 ≤ ≤ 7,0 % 7,0 ≤ : Absence

0,3 % 0,3 ≤ The sunflower extract is obtained by a concentration factor of 10 of the unsaponifiable fraction of refined sunflower oil extra of refined sunflower fraction of 10 of the unsaponifiable concentration factor is obtained by a extract sunflower The the sunflower, Composition: % Oleic acid (C18:1): 20 % Linoleic acid (C18:2): 70 % Unsaponifiable matter: 8,0 % Phytosterols: 5,5 % Tocopherols: 1,1 Description/Definition: microalgae is obtained from the marine dried product The insulated from the outside air. closed photobioreactors Moisture: Ash: Total Dietary Fibre (AOAC) dry basis (all insoluble): %) %) (70-75 and cellulose (20-25 Hemicellulose of which: Silica (ppm): % Protein: 0,0 Fat: Trace pH: 4-7 Heavy metals: Mercury (ppm): Lead (ppm): Arsenic (ppm): Cadmium (ppm): Microbiological criteria: Yeast and moulds (CFU/g): Salmonella Listeria monocytogenes

Description/Definition:

Authorised Novel Food Tetraselmis chuii Tetraselmis Dried microalgae Sunflower oil extract 24.7.2018 EN Official Journal of the European Union L 187/123

otechnology

Scortum barcoo Scortum or Therapon

Specifications

is a species of fish in the family Terapontidae. It is an endemic fresh water species from Australia. It is now reared in fish It is now reared from Australia. species water It is an endemic fresh Terapontidae. of fish in the family a species is

7,0 % 7,0 ≤ Therapon barcoo 15 mg/kg 15 ≤ PUFA n-3: 1,2-20,0 PUFA n-6: 0,3-2,0 Composition of fish flesh: Composition of fish Protein (%): 18-25 Moisture (%): 65-75 Ash (%): 0,5-2,0 6000-11500 Energy (KJ/Kg): Carbohydrates (%): 0,0 Fat (%): 5-15 Fatty acids (mg FA/g fillet): Σ Σ PUFA n-3/n-6: 1,5-15,0 Total omega 3 1,6-40,0 acids: Total omega 6 2,6-10,0 acids: Scortum/ farms. > genus: Terapontidae > family: Perciformes > order: Actinopterygii Class: Identification: Taxonomic Purity/Composition: 600 in base pairs) the National Centre for Bi S (sequence analysed no less than 1 Identified by means of nuclear marker rDNA 18 % information (NCBI) Not less than 99,9 database: Humidity: % Proteins: 35-40 % Ashes: 14-16 % Carbohydrates: 30-32 % Fibre: 2-3 % Fat: 5-8 % of total fatty acids Saturated fatty 29-31 acids: % of total fatty acids Monounsaturated fatty acids: 21-24 % of total fatty acids Polyunsaturated fatty acids: 44-49 Iodine:

Description/Definition: /Scortum Authorised Novel Food Therapon barcoo L 187/124 EN Official Journal of the European Union 24.7.2018 e by means of roquercetin] tests, test solutions and other test reference tests, of sample preparation may be based on preparation of sample

(Rupr.) Rupr) is (Rupr.) from a white to hot powder that crystallizes pale-yellow ).

1 Specifications )

1

Larix gmelinii (1 % aqueous solution)(

o

7

6

O O

12 : – 4 to – 5,6

12 H 20 H

D

6 15 ]

α

0,5 % (102 °C, 2 hours) 2 °C, (102 % 0,5 -Hexulose

≤

lyxo

10 % 10 ≤ 98 % on a dry weight basis weight dry a on % 98 1,0 mg/kg(*) 1,0 ≥

≤ the principles of the method described in FNP 5. ‘Instrumental methods’( of the method described in FNP 5. ‘Instrumental the principles materials (JECFA) 1991, 307 – ISBN materials (JECFA) p.; English 92-5-102991-1 ) identification techniques, analytical Food and notices, general nutrition5 general paper Rev 2 for – Guide to specifications

1 Tagatose is produced by isomerization of galactose by means of chemical or enzymatic conversion, or by epimerization of fructos or by epimerization conversion, or enzymatic by means of chemical of galactose isomerization by is produced Tagatose These are single-step conversions. enzymatic conversion. Appearance: White or almost white crystals Chemical name: D-tagatose Synonym: D- CAS number: 87-81-0 Chemical formula: C Taxifolin-rich extract from the wood of Dahurian Larch ( aqueous solutions. Definition: also called (+) trans (2R,3R)- Chemical name: [(2R,3R)-2-(3,4 dihyd dihydroxyphenyl)-3,5,7-trihydroxy-2,3-dihydrochromen-4-one, Chemical formula: C (*) Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method and size sample of selection The level. specified the to appropriate technique absorption atomic an using (*) Determine Molecular mass: 304,25 Da CAS No: 480-18-2 Specifications: Physical parameter Moisture: Formula weight: 180,16 (g/mol) Purity: Assay: Loss on drying: Specific Rotation: [ Melting range: 133– 137 °C 133– Melting range: 137 Heavy metals: Lead: (

Description: Description/Definition: Authorised Novel Food Taxifolin-rich extract D-Tagatose 24.7.2018 EN Official Journal of the European Union L 187/125 llisation in a quantity of 1,5 %. llisation in a quantity of 1,5

Specifications

0,05 mg/kg 0,05 ≤

CFU/g

4

10 ≤

1 – 3 – 1 100 CFU/g 100 : Absence/1 g : Absence/1 ≤ 90,0 % of the dry weight dry the of % 90,0

≥ Content, usual observed range (%) range observed usual Content, 100/g ≤ 2,5 – 3,5 – 2,5 : Absence/1 g : Absence/1 0,5 mg/kg 0,5 0,05 – 0,12 – 0,05 : Absence/1g 0,01 – 0,1 – 0,01 ≤ 0,1 mg/kg 0,1 0,2 – 0,3 – 0,2 0,1 – 0,3 – 0,1 0,02 mg/kg 0,02 : Absence/10 g : Absence/10 0,3 – 0,5 – 0,3 ≤ ≤ 90 – 93 – 90 1,5 0,5 mg/kg 0,5 ≤ Usual range of components of the Taxifolin-rich extract (as per dry substance) Taxifolin-rich of components Usual range of the Pseudomonas Enterobacteria: Yeast and Mould : Escherichia coli Salmonella Staphylococcus aureus (*) of crysta on of the inclusion water results This is a crystal. process the drying form and in during its hydrated Taxifolin Eriodictyol Quercetin Naringenin Kaempferol Water(*) Taxifolin Pinocembrin Unidentified flavonoids Aromadendrin Compound analysis Taxifolin (m/m): Residual solvents Ethanol: < mg/kg 000 5 Microbiological criteria Total Plate Count (TPC): Extract component Heavy Metals, Pesticide Heavy Metals, Lead: Arsenic: Cadmium: Mercury: Dichlorodiphenyltrichloroethane (DDT):

Authorised Novel Food L 187/126 EN Official Journal of the European Union 24.7.2018 ndard trehalose purified, deionised ample preparation er a solution having rystals with a sweet

-1,1-glucosidic bond. It is obtained from liquefied starch or from α

Specifications -D-glucopyranoside, dihydrate α O (dihydrate) 2

2H ·

11

O

22 H l

12 μ

-D-glucopyranosyl- α -trehalose α , α 98 % on the dry basis dry the on % 98 ≥ A non-reducing disaccharide that consists of moieties linkes by an that consists two glucose A non-reducing disaccharide by sucrose a white or odourless, multistep enzymatic The commercial product is almost process. Virtually the white c dihydrate. taste Synonyms: Chemical name: CAS No.: 6138-23-4 (dihydrate) Chemical formula: C Procedure: inject separately equal volumes of the sample solution and standard into equal the chromatograph. separately inject Procedure: peak of the size of the trehalose response and measure the chromatograms Record ml of the sample solution by following formula: in in mg, of 1 trehalose the quantity, Calculate Formula weight: 378,33 (dihydrate) Assay: The selection of sample size and method of s level. to the specified appropriate technique Determine using an atomic absorption of may be the method described in FNP 5 based on the (1), principles ‘Instrumental methods’ Method of assay: containing sta standard to a reference by comparison and quantified chromatography by liquid is identified trehalose Principle: ml of 80 and add about flask ml volumetric 100 into a sample g of dry about 3 accurately weigh solution: of sample Preparation filt a 0,45 micron through Filter water. deionised purified with to mark dilute and dissolution to complete sample Bring water. to obtain in water trehalose reference standard of dry quantities weighed accurately dissolve solution: of standard Preparation ml. per mg of trehalose known concentration of about 30 Apparatus: liquid chromatography equipped with a refractive index detector and integrating recorder Conditions: Column: Shodex Ionpack KS-801 (Showa Denko Co.) or equivalent mm 300 — length: mm 10 — diameter: °C 50 — temperature: water Mobile phase: ml/min 0,4 flow rate: Injection volume: 8

Description/Definition: Authorised Novel Food Trehalose 24.7.2018 EN Official Journal of the European Union L 187/127

2

(ergocalciferol). Vitamin D

2

g/g). μ

(5 % aqueous solution, anhydrous substance)

o Specifications g/100 g fresh weight at the expiration of shelf life μ ) to which UV light treatment is applied to harvested mushrooms. to harvested applied is treatment UV light to which U

) is treated with ultraviolet light to induce the conversion of ergosterol to D light to induce the conversion of ergosterol vitamin ) ultraviolet is treated with (5 % aqueous solution, dihydrate), +199 /W

S

o

) (W

S /R = +179

U

20 Agaricus bisporus Agaricus

D ,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol ]

β α 1,5 % (60 °C, 5h) °C, (60 % 1,5 ≤

Saccharomyces cerevisiae

in the final product: 5-10 in the final product: : 0,05 % 0,05

2

≤ 2

1,0 mg/kg 1,0

≤ = weight of dry sample in mg in sample dry of = weight = weight in mg of trehalose in the standard preparation standard the in trehalose of mg in = weight = peak area of trehalose in the sample preparation sample the in trehalose of area = peak = peak area of trehalose in the standard preparation standard the in trehalose of area = peak

S U

S U Description/Definition: Commercially grown nm. of 200-800 wavelength the within light in ultraviolet of radiation process a UV radiation: Vitamin D Characteristics: Identification: Solubility: Freely soluble in water, very slightly soluble in ethanol Specific rotation: [ W W Description/Definition: ( yeast Baker’s R where R Chemical name: (3 Synonym: Ergocalciferol CAS No: 50-14-6 g/mol Molecular weight: 396,65 Contents: Vitamin D Melting point: 97 °C (dihydrate) Melting point: 97 Purity: Loss on drying: Total ash: Heavy metals: Lead: % trehalose × (R = 100 content in the yeast concentrate varies between 800 000-3 1 500 000 IU vitamin D/100 g (450-875 Tan-coloured, free-flowing granules

)

) Authorised Novel Food Agaricus bisporus Saccharomyces cerevisiae UV treated mushrooms UV treated ( UV-treated baker’s yeast UV-treated baker’s ( L 187/128 EN Official Journal of the European Union 24.7.2018 rgy input of is applied after is applied d after baking in order (cholecalciferol) concentrations by

3

Specifications ) 1 g/100 g( μ

. 3

(ergocalciferol).

2

)

2

/g 3 10/g ≤

. : 2

10 (ergocalciferol) in the final product: 0,75-3 : :

2 2

≤ 2

: Absence in 25g ) EN 12821, 2009, European Standard. European 2009, 12821, ) EN calculation. ) Recipe

1 2 UV-treated milk is cow’s milk (whole and semi-skimmed) to which a treatment with ultraviolet (UV) via turbulent flow radiation ultraviolet UV-treated milk is cow’s a treatment with (whole and semi-skimmed) to which D vitamin in the increase in an results UV radiation milk with pasteurised treatment of the The pasteurisation. Escherichia coli leavened bread and radiation is applie UV-treated bread is yeast rolls (without toppings) a to treatment with ultraviolet which to vitamin D ergosterol to convert Vitamin D ( ( Salmonella ene nm for maximum of 5 seconds with of 240-315 light within the wavelength in ultraviolet of radiation A process UV radiation: 10-50 mJ/cm Chemical name: (5Z,7E,22E)-3S-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol Synonym: Ergocalciferol CAS No.: 50-14-6 g/mol Molecular weight: 396,65 Microbiological criteria for the yeast concentrate: Coliforms: Chemical name: (5Z,7E,22E)-3S-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol Synonym: Ergocalciferol CAS No: 50-14-6 g/mol Molecular weight: 396,65 Contents: Vitamin D g ( g/100 Yeast in dough: 1-5 UV radiation: A process of radiation in ultraviolet light within the wavelength of 200-310 nm with energy input of 1 045 J/l. 045 of 1 input energy nm with of 200-310 wavelength the light within in ultraviolet of radiation A process UV radiation: Vitamin D conversion of 7-dehydrocholesterol to conversion of 7-dehydrocholesterol vitamin D

Description/Definition: Description/Definition: Authorised Novel Food UV-treated bread UV-treated milk 24.7.2018 EN Official Journal of the European Union L 187/129 and

2

O

56 H 41

consists of 5 consists ]ethylidene]-4- r extent MK-6. ommon organisation of the of ommon organisation No 1234/2007 L (OJ 347, , menaquinone-6 (MK-6)(n = 5) being C 2

O

64 (2-methyl-3-all-trans-polyprenyl-1,4-naphthoquinones), or the H

2 46

Specifications . 2

O

40

) H 2 31

g/100 g( )

μ 2

2

O

64 H g/100 g( μ

46 )0,5-3,2

(menaquinones) series with menaquinone-7 (MK-7)(n with (menaquinones) series = 6) being C 1 in the final product: :

3

2 3

markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 (EEC) No 922/72, 234/79, (EC) (EC) and Regulations Council repealing and products agricultural in markets 20.12.2013, p. 671). ) (EU) As defined by Regulation No 1308/2013 and of the Council 17 Parliament of the European December 2013 a c establishing ) HPLC

1 2 ( Whole milk( Semi-skimmed milk(1): 0,1–1,5 ( Chemical name: (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene methylidenecyclohexan-1-ol Synonym: Cholecalciferol CAS No: 67-97-0 g/mol Molecular weight: 384,6377 Contents: Vitamin D g/mol Molecular weight: 649 Chemical Name: (all-E)-2-(3,7,11,15,19,23,27-Heptamethyl-2,6,10,14,18,22,26-octacosaheptaenyl)-3-methyl-1,4-naphtalenedione Chemical Name: (all-E)-2-(3,7,11,15,19,23,27-Heptamethyl-2,6,10,14,18,22,26-octacosaheptaenyl)-3-methyl-1,4-naphtalenedione CAS Number: 2124-57-4 Molecular formula: C Vitamin D menaquinone series, is a group of prenylated naphthoquinone derivatives. The number of isoprene residues, where 1 isoprene unit 1 isoprene where residues, number of isoprene The derivatives. naphthoquinone of prenylated group is a menaquinone series, MK-7 and the to a smalle menaquinone homologues containing primarily is used to characterise carbons comprising the side chain, Vitamin K menaquinone-4 (MK-4)(n = 3) being C This novel food is produced by a synthetic or microbiological process.Vitamin K process.Vitamin microbiological or synthetic a by produced is food novel This

(menaquinone)

2

Authorised Novel Food Vitamin K L 187/130 EN Official Journal of the European Union 24.7.2018

nnoproteins are

L. bran, rich in arabinoxylan oligosaccharides

Specifications Triticum aestivum Triticum (menaquinone-7)

2

(menaquinone-7)

2

Bacillus licheniformis Bacillus

spp. natto spp. natto and : Max 1000/g

: Max 1000/g : Absence in 25g Bacillus subtilis Bacillus Source: powder or oil Appearance: Yellow suspension Appearance: Yellow powder Appearance: Yellow % other impurities max 2,0 % cis-isomer, Purity: Max 6,0 Menaquinone-7) % all-trans 92 least at % Menaquinone-7 (including Content: 97-102 Vitamin produced K Specifications of microbiologically Specification of synthetic Vitamin Specification of K White crystalline powder obtained by enzymatic extraction from obtained powder by enzymatic extraction White crystalline % Dry matter: Min. 94 % of dry matter Min 70 Arabinoxylan oligosaccharides: 3-8 oligosaccharides: of arabinoxylan of polymerisation degree Average % of Ferulic acid (bound dry matter to 1-3 arabinoxylan oligosaccharides): % Min 90 Total poly/oligosaccharides: % of dry matter Protein: Max 2 % of dry matter Ash: Max 2 Microbiological parameters: Mesophilic bacteria – total count: Max 10 000/g Yeasts: Max 100/g Fungi: Max 100/g Salmonella Beta-glucans are complex, high molecular mass (100–200 found kDa) in polysaccharides, the cell wall of many yeasts and cereals. The chemical name for ‘yeast beta-glucans’ is (1-3),(1-6)-ß-D-glucans. and ma chitin by ß-1-6-linkages, branched to which of a backbone that are consist of ß-1-3-linked residues Beta-glucans glucose linked by ß-1-4-bonds. Bacillus cereus Clostridium perfringens

Description/Definition: Description/Definition: Authorised Novel Food Yeast beta-glucans Wheat bran extract 24.7.2018 EN Official Journal of the European Union L 187/131

d matrices.

consists of chains of ß-1,3-linked glucose residues, branched by ß-1,6-linkages, Specifications

) beta-glucans: . Saccharomyces cerevisiae Saccharomyces Saccharomyces cerevisiae Saccharomyces Saccharomyces cerevisiae

12 % 12 ≤ Beta-glucans are isolated from yeast The tertiary structure of the glucan cell wall of structure The tertiary ß-1,4- bonds, ß-1,6-glucans and some mannoproteins. via linked chitin are forming a backbone to which in many liqui but dispersible insoluble and insoluble in water, soluble, forms: in three different novel food is available This Chemical characteristics yeast ( Soluble form: > Total carbohydrates: % 75 Beta-glucans (1,3/1,6): > % 75 Ash: < % 4,0 Moisture: < % 8,0 Protein: < % 3,5 Fat: < % 10 Insoluble form: > Total carbohydrates: % 70 Beta-glucans (1,3/1,6): > % 70 Ash: Moisture: < % 8,0 Protein: < % 10 Fat: < % 20 matrices: in many liquid in water, but dispersible Insoluble (1,3)-(1,6)-ß-D-Glucans: > % 80 Ash: < % 2,0 Moisture: < % 6,0 Protein: < % 4,0 Total fat: < % 3,0 matrices: in many liquid but dispersible in water, insoluble for data Microbiological Total plate count: < 000 CFU/g 1 Enterobacteriaceae: < 100 CFU/g Total coliforms: < 10 CFU/g Yeast: < 25 CFU/g

Authorised Novel Food L 187/132 EN Official Journal of the European Union 24.7.2018 -tocopherol and ascorbyl α

Specifications

-tocopherol. Synthetic zeaxanthin is produced by a multi-step chemical synthesis from smaller α

2

O

56

H

40

: Absence in 1 g : Absence in 1 : Absence in 1 g : Absence in 1 : < 100 CFU/g : Absence in 25 g : Absence in 25 -trans zeaxanthin: > -trans zeaxanthin: % 96 Zinc L-pidolate is a white to off-white powder, with characteristic odour. Zinc L-pidolate is a with white to characteristic off-white powder, Zinc salt name acid, (INN): International non-proprietary L-pyroglutamic Zeaxanthin is a naturally occurring xanthophyll pigment, it is an oxygenated carotenoid. The synthetic zeaxanthin is presented either as a powder of spray-dried gelatin or starch base (‘beadlets’) with added palmitate or as a corn oil suspension with added molecules. powder with little or no Orange-red crystalline odour. Chemical formula: C CAS No: 144-68-3 Molecular weight: 568,9 daltons Physical-chemical properties: Loss on drying: < % 0,2 All Cis-zeaxanthin: < % 2,0 < Other carotenoids: % 1,5 Triphenylphosphine oxid (CAS No 791-28-6): < mg/kg 50 Mould: < 25 CFU/g Salmonella Escherichia coli Bacillus cereus Staphylococcus aureus matrices: liquid in many but dispersible in water, insoluble for metals Heavy Lead: < mg/g 0,2 Arsenic: < mg/g 0,2 Mercury: < mg/g 0,1 Cadmium: < mg/g 0,1

Description/Definition: Description/Definition: Authorised Novel Food Zeaxanthin Zinc L-pidolate 24.7.2018 EN Official Journal of the European Union L 187/133 f guar gum originating in or consigned from India due to contamination III to Regulation (EC) No 1333/2008 of the European Parliament and of and Parliament (EC) No 1333/2008 European to Regulation of the III

Specifications

Zn

2

1 000 CFU/g 000 1 ) ≤ 3

o NO

98 % 98

6

≥ H

- 22,8

o

5 100 CFU/g 100

≤

1,0 ppm 1,0 ≤ 0,1 ppm 0,1 2,0 ppm 2,0 ≤ ≤ 10,0 % 10,0 ≤ 3,0 ppm 3,0

≤ Water: < Glutamic acid: % 2,0 Heavy metals: Lead: Arsenic: Cadmium: Mercury: Microbiological criteria: count: Total viable mesophilic Yeasts and moulds: Pathogen: Absence Relative anhydrous molecular mass: 321,4 Appearance: White to slightly white powder Purity: Zinc L-pidolate (purity): % aqueous sol.): 5,0-6,0 pH (10 Specific rotation: 19,6 Synonyms: Zinc 5-oxoproline, Zinc pyroglutamate, Zinc pyrrolidone carboxylate, Zinc PCA, L-Zinc pidolate Zinc pyrrolidone carboxylate, Synonyms: Zinc 5-oxoproline, Zinc pyroglutamate, CAS No.: 15454-75-8 Molecular formula: (C

Authorised Novel Food the Council (OJ L 83, 22.3.2012, p. 1). and dioxins (OJ L risks by pentachlorophenol 30, 6.2.2015, p. 10). ) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and II Annexes in listed additives food for specifications down laying 2012 9 of March 231/2012 No (EU) o Regulation ) Commission import the to applicable conditions special down laying 2015 5 February of 2015/175 (EU) Regulation Implementing ) Commission

1 2 ( (