Free-from claims: appropriate use of free- from claims in relation to food and overview of European regulation and future change

May 8th 2019 Anne-Claire Thiboult [email protected]

Produits de Stratégie Expertise scientifique, Expertise Information Classification:& de Santé General Règlementaire médicale et toxicologique à l’international Introduction

Information Classification: General Introduction

▪ What is a free from claim? Free – Communication on the absence from gluten of some Free Free from from ingredients/constituents that lactose TFA are considered as : “bad for Free from health” / “bad for claims Free Free environment” / “bad for from from specific groups” / “not useful”/ Palm oil GMOs Free “controversial”… from E171 – Part of the Clean label

3 Information Classification: General Summary

▪ Overview of the evolution of regulations on food allergens and specific foods for people with food – 2 main regulations: • Food information to consumer • Foods for specific groups ▪ Reviewing rules for making a free-from claim – General free from claims – Particular case of gluten – Other free from allergen claims including lactose ▪ Discussion of future legislation on allergens and global overview of free-from allergen claims regulation outside Europe

4 Information Classification: General Overview of the evolution of regulations on food allergens and specific foods for people with food allergies

Information Classification: General Changes in the legislation

▪ LABELLING : ALLERGENS

▪ The regulations regarding consumer information on food allergens have changed over the past 15 years.

▪ Since 2003 and the Directive 2003/89/EC : allergens shall be indicated on the labelling

– List of 12 allergens Enable consumers to make informed choices – Shall be indicated on the labelling : “contains”+ the name of the ingredient(s) concerned. – indication not necessary when the ingredient is already included under its specific name in the list of ingredients or in the name under which the food is sold

▪ In 2007 Commission Directive 2007/68/EC : gives an update of the list – list of 14 allergens – and exclusions of ingredients or substances derived from those listed ingredients which are not likely to cause adverse reactions in susceptible individuals

6 Information Classification: General Changes in the legislation

▪ LABELLING : ALLERGENS Current legislation

▪ More recently, the rules regarding the labelling of substances or products causing allergies or intolerances have been strengthened by the regulation n° 1169/2011 of 25 October 2011 on the provision of food information to consumers.

▪ Which ingredients are concerned? – All the ingredients including food additives, processing aids and other substances or products with a scientifically proven allergenic or intolerance effect listed in Annex II or derived from a substance or product listed in Annex II used in the manufacture or preparation of a food and still present in the finished product, even if in an altered form.

7 Information Classification: General Changes in the legislation

▪ LABELLING : NEW PRESENTATION OF THE ALLERGENS

– They shall be indicated in the list of ingredients emphasis by font, style or background colour – In the absence of a list of ingredients, they shall comprise the word ‘contains’ followed by the name of the substance – The information shall be clear for each ingredient or concerned. – The indication (…) shall not be required in cases where the name of the food clearly refers to the substance or product concerned. + Article 44 : Mandatory allergen information for non-prepacked food, including in restaurants and cafes Still 14 allergens in Annexe II 8 Information Classification: General Changes in the legislation

▪ Accidental contamination - labelling – The Commission is working on an implementing act regarding requirements for voluntary food information on the possible and unintentional presence in food of substances or products causing allergies or intolerances according to article 36. • No delay

– Some Member States/associations already issued Guidance →In general, what is required is to avoid cross contamination by quality management (GMP + allergen management practices). Only the contamination that cannot be avoided should be mentioned in the labelling : “may contain traces of…”. The industrial shall prove that everything has been put in place to avoid the presence of the allergens. → Free from claims excluded

9 Information Classification: General Changes in the legislation

▪ On 13 July 2017, the Commission adopted a Notice on the provision of information on substances or products causing allergies or intolerances – to assist consumers, businesses and national authorities in understanding the new requirements of Regulation (EU) No 1169/2011 related to the indication of the presence of certain substances or products causing allergies or intolerances. – This Notice was drafted in collaboration with EU countries and was subject to Public Consultation.

▪ For example: – Where gluten is added as such, as an ingredient, the type of the cereal the gluten is coming from has to be indicated. • gluten (), wheat gluten or gluten (from wheat) • dextrin (wheat) or (wheat gluten); dextrin (contains wheat) or (contains wheat gluten). – When a product containing one of the cereals mentioned in Annex II (e.g. oats) meets the relevant requirements of Commission Implementing Regulation (EU) No 828/2014, then the statement ‘gluten-free’ or ‘very low gluten’ can be used on the product. However, the cereal mentioned in Annex II has to still be indicated and emphasised in the list of ingredients in accordance with Articles 9 and 21 of the Regulation.

10 Information Classification: General Changes in the legislation

▪ DIETETIC FOODS

In Europe, the status of food products specifically processed for consumers suffering from a food or intolerance has never been clearly defined :

▪ At the beginning, these products have been considered as dietetic foodstuffs because the population consuming these products was considered as a “specific” population – Directive 2009/39/EC ▪ But, a specific European Directive has only been published in 2009 for consumers intolerant to gluten (Regulation 41/2009/EC) ▪ For other allergens, no specific European regulation, the products could either be considered as “other categories” dietetic foodstuffs or as common foodstuffs by the member states.

With the new European Regulation n°609/2013 of 12 June 2013 on dietetic foodstuffs, the status of the food products for intolerant people has changed. This population is no longer considered as a specific group according to this regulation. All the new legislations on allergens will be part of the FIC regulation (1169/2011) including “free from claims”.

11 Information Classification: General Reviewing rules for making a free-from claim

Information Classification: General Free from claims – several legislations

▪ Regulation shall be checked before making a free from claim – Lots of different legislations depending on the type of claim that is made

Free from GMO

•Authorized under condition •Regulations 1829/2003 and 1830/2003 for GMOs •National laws for the use of free from claims (ie.: French decree n° 2012-128)

Free from additives

•No EU regulation •In general: Not authorized if it is considered as denigrating or refers to non-authorized additives (Ex: free from ) / Authorized if it concerns the absence of a category of additives (“Free from colors”) except if this category is forbidden in the application (fruit juices)

Free from palm oil

•Depends if it is considered as a nutrition claim (Reg 1924/2006 : exhaustive positive list of claim including claims on FA → forbidden) or as an environmental claim (ok if you can prove the change has been done to answer sustainability issues) 13 Information Classification: General “Free from allergens” claims

▪ “Free-from allergens” foods: – There is a trend toward special ranges of foods made without common allergenic foods

– Is there a specific legislation applicable for this communication today?

14 Information Classification: General Current legislation : Gluten

▪ European legislation – Only one regulation for “free from allergens” claims : Case of gluten • Harmonised thresholds in the COMMISSION IMPLEMENTING REGULATION (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food : applicable from 20 July 2016

15 Information Classification: General Current legislation : Gluten

▪ With the new regulation on gluten free products (Regulation n°828/2014), information may be accompanied by the statements : ✓ ‘suitable for people intolerant to gluten’ or ‘suitable for coeliacs’.

✓ ‘specifically formulated for people intolerant to gluten’ or ‘specifically formulated for coeliacs’ if the food is specially manufactured to: ✓ reduce the gluten content of one or more gluten-containing ingredients; ✓ substitute the gluten-containing ingredients with other ingredients naturally free of gluten. The new regulation aims to ensure that people who are intolerant to gluten are adequately informed of the difference between a food that is specially manufactured in order to reduce the gluten content of the food and other food that is made exclusively from ingredients naturally free of gluten. ▪ It is misleading to suggest that a food possesses special characteristics when in fact all similar foods possess such characteristics. Therefore you should not claim “gluten-free” on and similar products. 16 Information Classification: General Current legislation : other allergens

▪ European legislation – Other allergens do not have specific harmonised rules for “free from allergens” claims • General food law applies (Regulation 178/2002) – You shall ensure the safety of your product • Regulation on FIC applies (Regulation 1169/2011) – You shall not mislead the consumer by suggesting that the food possesses special characteristics when in fact all similar foods possess such characteristics – In case of new regulation for products for intolerant people (new free from claims), it should be included to the Regulation FIC 1169/2011 (FSG regulation 609/2013 does not include this category anymore) • Specific guidelines are set for some allergens (lactose free) • Case by case assessment is done by the authorities • Quality management is under industrial responsibility (GMP / allergen management practices (eventually including tests according to recognized methods)

17 Information Classification: General Current legislation : other allergens

▪ Specific case of lactose – Labelling and compositional rules indicating the absence or reduced presence of lactose in food will be determined through the Regulation (EC) 1169/2011 (amending act) (recital 42 and article 36 of the Regulation (UE) N°609/2013) → NO DELAY – EFSA Scientific opinion on lactose thresholds 2010 concludes that no general thresholds can be set for general population.

Some MS defined maximum levels :

Belgium follows the maximum limits for infant formula: Max 2,5 mg of lactose per 100 kJ (or 10 mg/100 kcal). CASE BY CASE ASSESSMENT 18 Information Classification:HAS TO General BE DONE Current legislation : other allergens

▪ Common position for other allergens: – “Free from” labelling should only be used where an absolute guarantee of the absence of allergens can be given with the exception of allergens where limits are set by legislation (ex : ). It means: • Absence in the formula (via RM / Technological aids) • No cross-contamination or unintentionally presence • HACCP and quality control of products – Regulation 852/2004 + specific guidances for allergens – EFSA Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes (2014) includes methods for the detection of allergens and allergenic foods

19 Information Classification: General Current legislation : other allergens

▪ Considerations for making a free from claim (BRC and FDF guidance : decision tree) Guidance to manufacturers and caterers on the appropriate use of “free-from” claims in relation to food allergens. November 2015.

20 Information Classification: General Discussion of future legislation on allergens and global overview of free-from allergen claims regulation outside Europe

Information Classification: General What about future?

▪ At the european level, – We are still waiting for… Lactose free regulation No timeline

Regulation for Common European position on cross- level “free from contamination allergen claims”

Update of the list of allergens

22 Information Classification: General What about future?

▪ At the national level – Researches on the list of allergens for an eventual update of the European list • France : – Réseau d’Allergo Vigilance® (RAV) emerging allergens: , milk of small ruminants (goat and sheep), kiwi, pine nut, α-galactose (present in mammalian ), peas and lentils. – These allergens present a risk of , that is to say serious allergic reactions, sometimes higher than certain allergens of mandatory mention, listed in Appendix II of the European regulation n ° 1169/2011. – Update of the thresholds for some « free from claims » waiting for an harmonized legislation.

23 Information Classification: General What about future?

▪ At the international level – Codex is working on a code of practice on food allergen management for food business operators (to avoid cross-contamination)

24 Information Classification: General What about other countries outside EU?

▪ Some examples of other legislations for allergens are summarized below Switzerland USA Brasil Ordinance 817.022.16 FALCPA: Lei nº 10.674 du 16 Mai • Allergens shall be put in relief • Different list: milk, eggs, fish (e.g., bass, flounder, cod), Crustacean 2003 • Specific thresholds for each allergen in shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, walnuts, • Allergens shall be put case of cross-contamination (Per kg or l of pecans), peanuts, wheat, and soybeans. in relief ready to eat food): • List by the common or usual name in the ingredients list OR in a “contains” • Mandatory to specify ✓ Sulfites: <10 mg SO2 statement immediately after or adjacent to the ingredients list the presence or ✓ Gluten: <200mg • Font size must be no smaller than the font size used for the ingredients list absence of gluten in ✓ : <10g FDA gluten-free labeling rule : the label : ("contém ✓ Lactose: <1g the food either is inherently gluten free; or does not contain an ingredient that Glúten" or "não ✓ Other: <1g is: 1) a gluten-containing grain 2) derived from a gluten-containing grain that contém Glúten“) has not been processed to remove gluten or 3) derived from a gluten-containing ✓ Gluten free: equivalent definition as in EU grain that has been processed to remove gluten, if the use of that ingredient ✓ « lactose free » (<0,1g/100g or 100ml) results in the presence of 20 parts per million (ppm) or more gluten in the food. ✓ « low in lactose » (-50% similar products + Also, any unavoidable presence of gluten in the food must be less than 20 ppm. max 2g per 100g dried matter Can be used for all the ingredients respecting this rule (including water) ▪ Important: – Always check if the list of ingredients considered as allergens is the same in the country of origin and in the country of destination for the labelling – Check the way you should mention them in the labelling – Search for specific rules to communicate on “free from allergens” claims 25 Information Classification: General Conclusion

Information Classification: General Conclusion

▪ Gluten-free – Well regulated in Europe – Specific thresholds

▪ Free from other allergens – Advice: proof the absence in the product • From the formula including all the raw materials, solvents and technological aids • From the manufacturing facility (accidental contamination) • By accepted methods of control

▪ Main challenges: – Every EU MS can set up his own rules for “free from claims” waiting for an harmonized legislation – At the international level, it is necessary to adapt the labelling to be compliant with the local legislation (other allergens / other rules for the labelling of allergens - for free from claims) – Update in the future: • List of allergens should change in the future based on new scientific researches • New thresholds could be set up

27 Information Classification: General Thanks for your attention

Produits de Nutrition Stratégie Expertise scientifique, Expertise Information Classification:& de Santé General Règlementaire médicale et toxicologique à l’international