Submission to Object to Terms Proposed by the European Union for Protection As Geographical Indications in Australia

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SUBMISSION TO OBJECT TO TERMS PROPOSED BY THE EUROPEAN UNION FOR PROTECTION AS GEOGRAPHICAL INDICATIONS IN AUSTRALIA

Submitter’s contact information

Name: Shawna Morris Company represented, including ACN or ABN, if any: Consortium for Common Food Names (CCFN) Other representative: E-mail address: [email protected]

Mailing address: 2107 Wilson Blvd., Suite 600, Arlington, VA, 22201, United States of America Phone number: +1 (703) 528-4818

EU GI name you are objecting to (please use a new form for each term objected to)

GRUYERE

Ground(s) of objection to the protection of the EU GI name (please tick all the grounds that apply) 1. The EU GI name is used in Australia as the common name for the relevant good. X (See details below regarding grounds for our objection based on this element.)

2. The EU GI name is used in Australia as the name of a plant variety or an animal breed. (Please provide any relevant information that shows the name is also a plant variety or animal breed, such as studies, articles, copies of websites or any other relevant information)

3. The EU GI name is identical to, or likely to cause confusion with a trade mark or geographical indication that is registered or the subject of a pending application in Australia. (Please include the details of the GI or the trade mark including the trade mark number)

4. The EU GI name is identical, or likely to cause confusion with, an unregistered trade mark or geographical indication that has acquired rights through use in Australia. (Please identify the trade mark or GI and provide information that demonstrates how it is being used in the Australian marketplace.)

5. The EU GI name contains or consists of scandalous matter. (Please identify examples of how the name could be used in an offensive manner and who it would be offensive to.)

Information or evidence supporting objection

1. The Opponent, the Consortium for Common Food Names (“CCFN”), is an independent, international non-profit alliance whose goal is to work with leaders in agriculture, trade, and intellectual property rights to foster the adoption of high standards and model geographical indication guidelines throughout the world. It is committed to working closely with all stakeholders as well as policymakers in the world to assist in amongst others, developing a clear and reasonable scope of protection for geographical indications as well as to foster adoption of a high-standard and model geographical indication guidelines worldwide.

2. Gruyere is the name of a town in Victoria, Australia, postcode 3770: https://en.wikipedia.org/wiki/Gruyere,_Victoria. The town's post office was named as Gruyere at least as early as 1950, which is well before "gruyere" was established as a Swiss AOP in 2001 (https://en.m.wikipedia.org/wiki/Gruy%C3%A8re_cheese). The area is agricultural and has a history of dairy production. Protection of the EU GI would prevent local producers from Gruyere, Victoria from labelling their goods with their Australian place of origin and accordingly should be refused.

3. The word “gruyere” is a common name, describing a particular style of cheese. This cheese is dense, smooth and a bit waxy, with occasional pea-sized holes. In support of ground number 1 above (the EU GI name is used in Australia as the common name for the relevant good), CCFN presents the following evidence and information in support:

• In Australia “gruyere” has been produced and has won prizes like the “Heidi Farm Gruyere”, made at Lion’s factory The Heritage at Burnie, which earned the prestigious Grand Champion Cheese award in 2016, beating entries from across the country. https://www.themercury.com.au/lifestyle/heidi-farm-gruyere-earns- grand-champion-cheese-award/news- story/101e835ad48dd38e6d06b985e3026dcf

• Other Australian producers of "gruyere" include Beston Global Food Company Ltd, producer of Edwards Crossing "gruyere":

(https://bestonglobalfoods.com.au/products/dairy/bestons-edwards-crossing/) • "Gruyere" is claimed as a good in several current or former trade mark registrations in Australia, the details of which are set out in Annexure A. The earliest registration dates from 1979. The registrants include Australian registrants and other registrants from outside the EU PDO "gruyere" region in Switzerland, including Dodoni S.A. - Agricultural Dairy Industry Of Epirus, which is from Epirus in the EU PDO "fetta" region of Greece (see eg registration 481584 which dates from 1988, and which covers "gruyere (kefalograviera)"). These indicate that at least as early as 1979, the term was regarded as a common name for a style of cheese in Australia by Australian and European producers alike.

• "Gruyere" is the name of a category for the Sydney Royal Cheese & Dairy Produce Show, the 2019 winners of which included Beston's Edwards Crossing Gruyere from South Australia:

• Major New Zealand producers including Fonterra produce "gruyere" cheese, including under the MAINLAND and KAPITI brands:

(https://www.mainland.co.nz/products/cheese/gruyere-style/mainland-gruyere- style-cheese-block.html). New Zealand is a leading trade partner of Australia in the dairy industry, with Australia importing 56,000 tonnes of New Zealand cheese as at 2017/8: https://www.dairyaustralia.com.au/industry/production-and- sales/cheese. Fonterra's MAINLAND range is readily available in Australian supermarket channels: https://shop.coles.com.au/a/a- national/everything/search/mainland%20cheese?pageNumber=1. The Fonterra MAINLAND "gruyere" cheese above has also been advertised for sale via Australian online stores: https://www.pleaseshopforme.com.au/index.php?main_page=product_info&cPath =73_76&products_id=1917.

• Today, “gruyere” cheese is produced in various countries, including the United States, Argentina, Brazil, Uruguay and New Zealand, among others, attached as Exhibit 1. Due to this long-standing and widespread production in other countries, including Australia, the term “gruyere” has become the generic name for a certain type of cheese. Attached as Exhibit 1 is a non-exhaustive list of companies from outside Australia, that offer cheeses under the generic term “gruyere”. Pages from each of the websites showing use of the generic terms is also attached as part of Exhibit 3. It is important to note that each of these websites can be accessed by the Australian consumer and that the MAINLAND product is advertised directly for sale in Australia as noted above. In addition to the EU, New Zealand and the USA form the three major exporters of cheese products to Australia: https://www.dairyaustralia.com.au/industry/production-and-sales/cheese, so protection would present an obstacle to the legitimate export activities of major trading partners.

• In one of Australia’s free trade agreement partners, the United States Food and Drug Administration has established what are known as standards of identity

(SOIs). SOIs establish the common name for a food and define the basic nature of that food and its ingredients. The US Code of Federal Regulations Title 21-- FOOD AND DRUGS, CHAPTER I--FOOD AND DRUG ADMINISTRATION, SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION establishes the production process of “gruyere” cheese. A copy of the relevant section of the code is attached as Exhibit 2. This SOI, in addition to establishing “gruyere” as the product name for this type of cheese for production in the United States, would also apply to any “gruyere” cheese imported from non-United States countries, including Australia. Given that Australia is a significant exporter of cheese to the United States, Australian exporters of cheese to the United States would be familiar with the fact that “gruyere” is considered a generic term for a type of cheese and not a cheese from a specific geographic location. See Exhibit 3 showing cheese exports to the United States from Australia.

• In the Harmonized Tariff Schedule of the United States (HTSUS), also referred to as the Harmonized Tariff Schedule of the United States Annotated (HTSA), the primary resource for determining tariff (customs duties) classifications for goods imported into the United States, “gruyere” is listed, implicating that this type of cheese can be produce anywhere in the world. The codes under which “gruyere” can be imported to the U.S. are 04061064, 04062081, 04063081, and 04069090. As noted above, this is information Australian cheese exporters would have available and be aware of. The US tariff schedule can be found in Exhibit 4.

• Even the European Union has a documented record of previously treating “gruyere” as a generic term for a type of cheese as evidenced by the fact that “gruyere” is listed in the EU tariff schedule. The Integrated Tariff of the European Community (“TARIC”) applies to all members of the EU and contains more than 14,000 codes for goods. TARIC designates the tax rate for each code of imported goods, other fees payable upon import, and licenses/special licenses (if requested) for importing goods into the EU from countries all around the world, including from Australia. ‘Gruyere” cheese is listed in TARIC under codes 04069015 and 0406301020 and can be found in Exhibit 4. If “gruyere” was not a type of cheese and could only be produced under the EU geographical indication for “gruyere”, there would be no need to include the term in the tariff schedule.

• The United States and Australia brought a World Trademark Organization dispute resolution procedure (DS174; DS290) against the EU’s geographical indication protection regime (the predecessor to the current EU protection regime). The EU

defended its protection of geographical indications even when those protections would be in conflict with prior trademark rights. The EU was successful in defending its geographical indication regime based solely on the grounds that use of the geographical indications registered pursuant to that regime would be considered a “fair use” under Article 17 of the TRIPS Agreement. It is striking that the EU now tries to deny the “fair use” of generic terms based on those same geographical indications. Specifically, the EU stated: “Moreover, Article 17 [of the TRIPS Agreement] mentions expressly as an example of "limited exception" the "fair use of descriptive terms". Geographical indications are "descriptive terms"…. The use of a geographical indication in order to indicate the true origin of the goods and the characteristic associated to that origin is certainly a "fair" use of that descriptive term.”

WT/DS174/R/Add.2 Annex B-2, page B-81, ¶318

174RA2-01.pdf

This bad faith action on the part of the EU clearly indicates that its efforts to protect “Gruyere” as a geographical indication in Australia is nothing more than an attempt to monopolize generic terms for the benefit of its producers and to the detriment of other producers from around the world and to the detriment of Australian supply chain purchasers and consumers who would be denied greater competition and more choices of cheese products.

• The pursuit of protection for this EU GI despite clear evidence of the common name status of “gruyere” is imposing costly burdens on companies by forcing businesses (directly or via associations) to object to this GI to avoid negative impacts. Registration of the GI would compound this harm, resulting in heavy burdens on Australian food manufacturers/suppliers/importers, as well as on companies in Australia’s trade partners, who are simply trying to continue to sell their products and maintain market access opportunities already established by Australia, whether domestically or via market access rights granted under prior FTAs such as the U.S.-Australia FTA. Granting protection for the term “Gruyere” as a GI would be highly disruptive in terms of their continued sales and maintenance of future sales opportunities for this product type.

• Protection of EU GIs will give GI holders effectively “permanent” protection as a result of the typical nature of GI protection as well as wide ranging enforcement

rights against the use of common names as ingredients (which extends beyond the usual scope of trademark rights), as well as the ability to enforce protected GIs against what the EU asserts to be “deceptively similar” names, which could capture additional common names, names that include only part of the GI or part of the English translation of the foreign name. EU trademark owners can already obtain protection for their specific registered marks in Australia and should be required to pursue the exact same process open to all other mark applicants already. It is entirely inappropriate for Australia to contemplate granting EU producers special privileges that they could not win through use of the trademark system on the independent merits of their own applications.

4. For the foregoing reasons, we respectfully request that the term GRUYERE be denied protection as a geographical indication in Australia.

Annexure A – Current and expired Australian trade mark registrations for goods including "gruyere"

Australia

Mark Number Owner Filing Date Classes/Goods and Services Status

JALNA 334580 Jalna Dairy Foods 26 JUN 1979 Class: 29 Dairy products, cultured and otherwise, including Registered Pty Ltd cheese, cream cheese, dessert cheese, dessert gruyere cheese, hard cheese, soft cheese, cheese paste, Polish (Renewal Due cheese, non-fat and low-fat quarg, sour cream, buttermilk, Date 26 JUN leben, natural and flavoured yoghurt; and all other dairy 2020) products as are included in this class

481584 DODONI S.A. - 16 FEB 1988 Class: 29 All goods in this class; pasteurized milk, sour milk, Registered AGRICULTURAL sheep Feta cheese, gruyere cheese (kefalograviera), sheep DAIRY INDUSTRY gruyere, pecorino cheese, goat cheese, wheycheese, cream (Renewal Due Date 16 FEB OF EPIRUS cheese, whey, cow yoghurt, strained yoghurt, kefalotyri. 2029)

481585 DODONI S.A. - 16 FEB 1988 Class: 29 All goods in this class; pasteurized milk, sour milk, Registered AGRICULTURAL sheep Feta cheese, gruyere cheese (kefalograviera), sheep DAIRY INDUSTRY gruyere, pecorino cheese, goat cheese, wheycheese, cream (Renewal Due OF EPIRUS cheese, whey, cow yoghurt, strained yoghurt, kefalotyri. Date 16 FEB 2029)

DODONI 484062 DODONI S.A. - 24 MAR 1988 Class: 29 Pasteurized milk, sour milk, sheep's feta cheese, Registered AGRICULTURAL (Priority Date: hard gruyere, hard cheese, sheep's gruyere, pecorino cheese, DAIRY INDUSTRY 16 NOV 1987) goat cheese, cream cheese, anthotiri, galotiri, cow's yoghurt, (Renewal Due OF EPIRUS sheep's yoghurt, whey cheese, whey and strained yoghurt Date 24 MAR 2029)

515985 Jalna Dairy Foods 01 AUG 1989 Class: 29 Dairy products, cultured and otherwise, cheese, fetta Removed - Pty Ltd cheese, skim milk cheese, milk and milk preparations and Not renewed: products, including butter, cream cheese, farm cheese, dessert Renewal fee cheese, dessert gruyere cheese, hard cheese, soft cheese, not paid cheese paste, Polish cheese, non-fat and low-fat quarg, sour

Australia

Mark Number Owner Filing Date Classes/Goods and Services Status

cream, buttermilk, leben, natural and flavoured yoghurt; and all other dairy products as are included in this class

618539 Jalna Dairy Foods 15 DEC 1993 Class: 29 Dairy products, cultured and otherwise, as are Removed - Pty Ltd included in this class, including: cheeses of all types, including Not renewed: fetta cheese, skim milk cheese, cream cheese, farm cheese, Renewal fee dessert cheese, dessert gruyere cheese, hard cheese, soft not paid cheese, cheese paste, Polish cheese; milk and milk preparations; non-fat and low fat quarg; sour cream; buttermilk; leben; natural and flavoured yoghurt; butter; butter cream; cream

BIO-GUARD, 719875 Jalna Dairy Foods 17 OCT 1996 Class: 29 Dairy products, cultured and/or otherwise, as are Removed - BIOGUARD Pty Ltd included in this class, including: cheeses of all types, including Not renewed: fetta cheese, skim milk cheese, cream cheese, farm cheese, Renewal fee dessert cheese, dessert gruyere cheese, hard cheese, soft not paid cheese, cheese paste, Polish cheese, milk and milk preparations; non-fat and low-fat quarg; sour cream; buttermilk; leben; natural and flavoured yoghurt; butter; butter cream; cream

1106791 Jalna Dairy Foods 31 MAR 2006 Class: 29 Dairy products, cultured and/or otherwise, including: Removed - Pty. Ltd. natural and flavoured yoghurt, yoghurt with additives; cheeses Not renewed: of all types, including fetta cheese, skim milk cheese, cream Renewal fee cheese, farm cheese, dessert cheese, dessert gruyere cheese, not paid hard cheese, soft cheese, cheese paste, Polish cheese; milk and milk preparations; sour cream; buttermilk; butter; butter cream; cream; milk beverages, including fruit flavoured cultured milk drinks and cultured milk fruit drinks; dietary supplements as are included in this class including milk or milk

Australia

Mark Number Owner Filing Date Classes/Goods and Services Status

products (cultured and/or otherwise); skim milk; processed milk and processed milk products

GOOD THINGS 1314902 New Zealand Milk 13 AUG 2009 Class: 29 Cheese and cheese products including soft and hard Registered TAKE TIME Brands Limited (Priority Date: cheeses, blue cheese, brie, camembert, parmesan, feta, 17 JUL 2009) havarti, gruyere, mozzarella, gouda, edam and colby cheese; (Renewal Due flavoured cheeses including flavoured camembert, cracked Date 13 AUG pepper cheese and herb triple cream cheese; cheddar cheese 2029) including mild, tasty, strong, organic and vegetarian cheddar

1688385 DODONI S.A. - 20 APR 2015 Class: 29 Milk and milk products, pasteurized milk, sour milk, Registered AGRICULTURAL sheep milk, goat milk, cow milk, cheese and cheese products, DAIRY INDUSTRY sheep feta cheese, hard gruyere, gruyere cheese (Renewal Due OF EPIRUS (kefalograviera), kefalotyri, sheep gruyere, pecorino cheese, Date 20 APR goat cheese, whey cheese, cream cheese, anthotyri, galotyri, 2025) whey, cow yogurt, sheep yogurt, strained yogurt, processed cheese, ripened cheese, white cheese, soft cheese, jellies, jams, compotes

1688386 DODONI S.A. - 20 APR 2015 Class: 29 Milk and milk products, pasteurized milk, sour milk, Registered

AGRICULTURAL sheep milk, goat milk, cow milk, cheese and cheese products, DAIRY INDUSTRY sheep feta cheese, hard gruyere, gruyere cheese (Renewal Due OF EPIRUS (kefalograviera), kefalotyri, sheep gruyere, pecorino cheese, Date 20 APR goat cheese, whey cheese, cream cheese, anthotyri, galotyri, 2025) whey, cow yogurt, sheep yogurt, strained yogurt, processed cheese, ripened cheese, white cheese, soft cheese, jellies, jams, compotes

Australia

Mark Number Owner Filing Date Classes/Goods and Services Status

1750031 NEW ZEALAND 07 MAY 2015 Class: 5 Dietetic foods; dietetic beverages; dietetic substances Cancelled (IR MILK BRANDS (Priority Date: adapted for medical use; dietary supplements intended to No.12853 LIMITED 04 MAY 2015) supplement a normal diet or to have health benefits; health 14) food supplements; food for babies; milk powder for babies; food for infants; milk powder for infants; nutritional additives for foodstuffs; nutritional supplements; nutritional cultures; food supplements for medical purposes; mineral supplements for foodstuffs; casein dietary supplements; vitamins for human consumption; vitamin formulations for human consumption; pharmaceutical preparations in the nature of foodstuffs for humans; pharmaceutical preparations in the nature of food ingredients for humans; bacteriological cultures; probiotic cultures; bacteriological preparations; probiotic preparations; bacteriological substances; probiotic substances; cultures of micro-organisms; dietary supplements incorporating probiotic cultures, substances or preparations; dietary supplements incorporating bacteriological cultures, substances or preparations Class: 29 Dairy products in this class; dairy foods in this class; dairy based beverages; dairy based powders; milk; milk based products; ultra high temperature (UHT) milk; extended shelf life (ESL) milk; milk concentrate; milk protein; milk powder; dried milk; flavoured milk powders; milk substitutes in this class; milk beverages; flavoured milk beverages (milk predominating); fortified milk beverages (milk predominating); cream; butter; edible oils namely margarine and edible oil based spreads; edible fats; margarine; blends of margarine; blends of butter; products included in this class consisting wholly or principally of edible oils for use in creaming coffee and like drinks; products included in this class consisting wholly or principally

Australia

Mark Number Owner Filing Date Classes/Goods and Services Status

of edible fats for use in creaming coffee and like drinks; proteins for human consumption; protein products for human consumption; cheese; brie cheese; cheddar cheese; colby cheese; cream cheese; edam cheese; emmental cheese; feta cheese; gouda cheese; gruyere cheese; haloumi cheese; havarti cheese; mozzarella cheese; parmesan cheese; romano cheese; swiss cheese; cultured dairy products; dairy products incorporating yoghurt; yoghurt; yoghurt preparations; probiotic products in this class; drinking yoghurt; non-alcoholic drinks containing yoghurt; non-alcoholic drinks containing probiotic substances, preparations or cultures; non-alcoholic drinks containing bacteriological substances, preparations or cultures; dairy-based dessert in this class; dairy snacks (milk and dairy products predominating); whey; dairy based food spreads; dairy-based food preserves in this class; custard in this class; dairy based dips; cheese dips; cheese in the form of dips

1771812 Jalna Dairy Foods 19 MAY 2016 Class: 5 Dietary supplements as are included in this class Registered Pty. Ltd. including milk or milk products (cultured and/or otherwise) (Renewal Due Class: 29 Dairy products, cultured and/or otherwise, including: Date 19 MAY natural and flavoured yoghurt, yoghurt with additives; cheeses 2026) of all types, including fetta cheese, skim milk cheese, cream cheese, farm cheese, dessert cheese, dessert gruyere cheese, hard cheese, soft cheese, cheese paste, Polish cheese; milk and milk preparations; sour cream; buttermilk; butter; butter cream; cream; milk beverages, including fruit flavoured cultured milk drinks and cultured milk fruit drinks; skim milk; processed milk and processed milk products

Australia

Mark Number Owner Filing Date Classes/Goods and Services Status

1890147 NEW ZEALAND 07 MAY 2015 Class: 5 Dietetic foods; dietetic beverages; dietetic substances Registered (IR MILK BRANDS (Priority Date: adapted for medical use; dietary supplements intended to No.12853 LIMITED 04 MAY 2015) supplement a normal diet or to have health benefits; health (Renewal Due 14) food supplements; food for babies; milk powder for babies; food Date 07 MAY for infants; milk powder for infants; nutritional additives for 2025) foodstuffs; nutritional supplements; nutritional cultures; food supplements for medical purposes; mineral supplements for foodstuffs; casein dietary supplements; vitamins for human consumption; vitamin formulations for human consumption; pharmaceutical preparations in the nature of foodstuffs for humans; pharmaceutical preparations in the nature of food ingredients for humans; bacteriological cultures; probiotic cultures; bacteriological preparations; probiotic preparations; bacteriological substances; probiotic substances; cultures of micro-organisms; dietary supplements incorporating probiotic cultures, substances or preparations; dietary supplements incorporating bacteriological cultures, substances or preparations Class: 29 Dairy products in this class; dairy foods in this class; dairy based beverages; dairy based powders; milk; milk based products; ultra high temperature (UHT) milk; extended shelf life (ESL) milk; milk concentrate; milk protein; milk powder; dried milk; flavoured milk powders; milk substitutes in this class; milk beverages; flavoured milk beverages (milk predominating); fortified milk beverages (milk predominating); cream; butter; edible oils; edible fats; margarine; food spreads; blends of margarine; blends of butter; blends of other edible oils; products included in this class consisting wholly or principally of edible oils for use in creaming coffee and like drinks; products included in this class consisting wholly or principally

Australia

Mark Number Owner Filing Date Classes/Goods and Services Status

of edible fats for use in creaming coffee and like drinks; proteins for human consumption for use as food additives; soy, whey or dairy based protein products for human consumption; cheese; brie cheese; cheddar cheese; colby cheese; cream cheese; edam cheese; emmental cheese; feta cheese; gouda cheese; gruyere cheese; haloumi cheese; havarti cheese; mozzarella cheese; parmesan cheese; romano cheese; swiss cheese; cultured dairy products; dairy products incorporating yoghurt; yoghurt; yoghurt preparations; dairy based probiotic products in this class; drinking yoghurt; yoghurt based non-alcoholic drinks; non-alcoholic dairy based drinks containing probiotic substances, preparations or cultures; non-alcoholic dairy based drinks containing bacteriological substances, preparations or cultures; dessert products in this class (dairy products predominating); dairy snacks (milk and dairy products predominating); whey; food spreads consisting principally of dairy products; jellies for food; custard in this class; dairy based dips; cheese dips; cheese in the form of dips

Exhibit 1: Non-exhaustive List of Companies Producing Cheese containing the term "gruyere" as a generic name outside Australia

Company Country Website

Finlandia Argentina http://www.finlandia.com.ar/queso-finlandia/finlandia- light-gruyere.html

Adler Argentina https://www.adler.com.ar/#productos

Tio Pujio Argentina http://lacteostiopujio.com.ar/gruyere-en-bloque/

Polenguhi Brazil https://polenghi.com.br/queijos-especiais#

Quata Brazil http://quataalimentos.com.br/produtos/queijo-tipo- gruyere/

Company Country Website

Finlandia Finland http://finlandiacheese.com/deli-cheeses-and- butter/gruyere/

Mainland New Zealand https://www.mainland.co.nz/products/cheese/gruyere- style/mainland-gruyere-style-cheese-block.html

Boar's Head United States https://boarshead.com/products/cheese/974-pre-cut- gruyere-cheese

Wegmans United States https://www.wegmans.com/products/cheese- shop/swiss-cheese/swiss-type-cheese/aged-4-6- months-gruyere-cheese--mild.html

Conaprole Uruguay https://www.conaprole.com.uy/producto/producto- quesos-pastadura-gruyere/

Exhibit 2: U.S. Code of Federal Regulations – “gruyere”

CFR - Code of Federal Regulations Title 21 11/5/19, 4:47 PM

FDA Home3 Medical Devices4 Databases5 CFR - Code of Federal Regulations Title 21 The information on this page is current as of April 1 2019. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).6

New Search Help7 | More About 21CFR 8 [Code of Federal Regulations] [Title 21, Volume 2] [Revised as of April 1, 2019] [CITE: 21CFR133.149]

TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION PART 133 -- CHEESES AND RELATED CHEESE PRODUCTS Subpart B--Requirements for Specific Standardized Cheese and Related Products Sec. 133.149 Gruyere cheese.

(a) Description. (1) Gruyere cheese is the food prepared by the procedure set forth in paragraph (a)(3) of this section or by any other procedure which produces a finished cheese having the same physical and chemical properties. It contains small holes or eyes. It has a mild flavor, due in part to the growth of surface-curing agents. The minimum milkfat content is 45 percent by weight of the solids and the maximum moisture content is 39 percent by weight, as determined by the methods described in 133.5. The dairy ingredients used may be pasteurized. The cheese is at least 90 days old. (2) If pasteurized dairy ingredients are used, the phenol equivalent value of 0.25 gram of gruyere cheese is not more than 3 micrograms as determined by the method described in 133.5. (3) One or more of the dairy ingredients specified in paragraph (b)(1) of this section may be warmed and is subjected to the action of lactic acid- producing and propionic acid-producing bacterial cultures. One or more of the clotting enzymes specified in paragraph (b)(2) of this section is added to set the dairy ingredients to a semisolid mass. The mass is cut into particles similar in size to wheat kernels. For about 30 minutes the particles are alternately stirred and allowed to settle. The temperature is raised to about 126 deg. F. Stirring is continued until the curd becomes firm. The curd is transferred to hoops or forms, and pressed until the

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CFR - Code of Federal Regulations Title 21 11/5/19, 4:47 PM

desired shape and firmness are obtained. The cheese is surface-salted while held at a temperature of 48deg. to 54 deg. F for a few days. It is soaked for 1 day in a saturated salt solution. It is then held for 3 weeks in a salting cellar and wiped every 2 days with brine cloth to insure growth of biological curing agents on the rind. It is then removed to a heating room and held at progressively higher temperatures, finally reaching 65 deg. F with a relative humidity of 85 to 90 percent, for several weeks, during which time small holes, or so-called eyes, form. The cheese is then stored at a lower temperature for further curing. One or more of the other optional ingredients specified in paragraph (b)(3) of this section may be added during the procedure. (b) Optional ingredients. The following safe and suitable ingredients may be used: (1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in 133.3, used alone or in combination. (2) Clotting enzymes. Rennet and/or other clotting enzymes of animal, plant, or microbial origin. (3) Other optional ingredients. (i) Calcium chloride in an amount not more than 0.02 percent (calculated as anhydrous calcium chloride) of the weight of the dairy ingredients, used as a coagulation aid. (ii) Enzymes of animal, plant, or microbial origin, used in curing or flavor development. (iii) Antimycotic agents, applied to the surface of slices or cuts in consumer-sized packages. (c) Nomenclature. The name of the food is "gruyere cheese". (d) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter, except that: (1) Enzymes of animal, plant, or microbial origin may be declared as "enzymes"; and (2) The dairy ingredients may be declared, in descending order of predominance, by the use of the terms "milkfat and nonfat milk" or "nonfat milk and milkfat", as appropriate. [48 FR 2744, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983, as amended at 58 FR 2893, Jan. 6, 1993]

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5. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm 6. http://www.ecfr.gov/cgi-bin/text-idx? SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl

7. /scripts/cdrh/cfdocs/search/default.cfm?FAQ=true 8. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm135680.htm

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=133.149 Page 3 of 3

Exhibit 3: Cheese export data from Australia to the United States of America

U.S. Cheese Imports from Australia (CY 2018) Values in Thousands of U.S. Dollars 2018 2018 HS Code Product UOM Value Qty 0406.90.0890 CH,CHDDR,QT MT 6,298 1,360.60 0406.90.1200 CH,CHDDR,OQ MT 1,523 337.4 0406.10.9500 CH,F,OT,>.5%F,OQ MT 1,008 117 0406.90.9700 C/SB,IMX,>.5F,OQ MT 371 201.4 0406.10.8800 OTH CHS MT 209 52.8 0406.90.9900 C/SB,IMX,OQ MT 137 4 0406.30.2400 CH,PR,CHDDR,QT MT 78 11.3 0406.30.9100 CH,PR-MX,>.5F,OQ MT 55 36.4 0406.40.7000 CH,B-V,XOL,OQ MT 33 1.6 Grand Total All Cheeses MT 9,711 2,122.40 Source: USDA FAS Database https://apps.fas.usda.gov/gats/ExpressQuery1.aspx

Exhibit 4: US Tariff

[See attachment]

Exhibit 5: European Tariff codes

European Commission : Trade : Export Helpdesk

European Commission Directorate-General for Trade

Product List Chapter List/04/0406

Code Product Description

04 DAIRY PRODUCE; BIRDS' EGGS; NATURAL HONEY; EDIBLE PRODUCTS OF ANIMAL ORIGIN, NOT ELSEWHERE SPECIFIED OR INCLUDED

0406 Cheese and curd

0406 10 - Fresh (unripened or uncured) cheese, including whey cheese, and curd

0406 10 20 -- Of a fat content, by weight, not exceeding 40 %

0406 10 20 10 --- Pizza cheese, frozen, cut into pieces each weighing not more than 1 gram, in containers with a net content of 5kg or more, of a water content, by weight, of 52% or more, and a fat content by weight in the dry matter of 38% or more

0406 10 20 30 --- Skyr

0406 10 20 80 --- Other

0406 10 80 -- Other

0406 10 80 10 --- Pizza cheese, frozen, cut into pieces each weighing not more than 1 gram, in containers with a net content of 5kg or more, or a water content, by weight, of 52% or more, and a fat content by weight in the dry matter of 38% or more

0406 10 80 80 --- Other

0406 20 - Grated or powdered cheese, of all kinds

0406 20 10 -- Glarus herb cheese (known as Schabziger) made from skimmed milk and mixed with finely ground herbs

0406 20 90 -- Other

0406 30 - Processed cheese, not grated or powdered

0406 30 10 -- In the manufacture of which no cheeses other than Emmentaler, Gruyère and Appenzell have been used and which may contain, as an addition, Glarus herb cheese (known as Schabziger); put up for retail sale, of a fat content by weight in the dry matter not exceeding 56 %

0406 30 10 10 --- Processed Emmentaler

0406 30 10 20 --- Processed Gruyère

0406 30 10 90 --- Other

0406 30 31 -- Other

0406 30 31 --- Of a fat content, by weight, not exceeding 36 % and of a fat content, by weight, in the dry matter

0406 30 31 ---- Not exceeding 48 %

0406 30 39 ---- Exceeding 48 %

http://exporthelp.europa.eu/...n§ion=tariff&taricCode=0406000000&prodLine=80&limitLevel=10&simDate=20130627&languageId=en[8/8/2017 11:15:53 AM]

European Commission : Trade : Export Helpdesk

0406 30 90 --- Of a fat content, by weight, exceeding 36 %

0406 40 - Blue-veined cheese and other cheese containing veins produced by Penicillium roqueforti

0406 40 10 -- Roquefort

0406 40 50 -- Gorgonzola

0406 40 90 -- Other

0406 90 - Other cheese

0406 90 01 -- For processing

0406 90 13 -- Other

0406 90 13 --- Emmentaler

0406 90 15 --- Gruyère, Sbrinz

0406 90 17 --- Bergkäse, Appenzell

0406 90 18 --- Fromage fribourgeois, Vacherin Mont d'Or and Tête de Moine

0406 90 19 --- Glarus herb cheese (known as Schabziger) made from skimmed milk and mixed with finely ground herbs

0406 90 21 --- Cheddar

0406 90 21 10 ---- Made from unpasteurized milk, of a minimum fat content of 50% by weight, in the dry matter, matured for at least nine months, of a free-at-frontier value per 100 kg net weight of 334,20 Euro or more in the case of standard whole sizes (cheeses of the conventional flat cylindrical shape of a net weight of not less than 33 kg but not more than 44 kg; cubic block shape or parallelepiped shape, of a net weight of 10 kg or more), 354,83 Euro or more in the case of cheeses of a net weight of 500 g or more and 368,58 Euro or more in the case of cheeses of a net weight of less than 500 g

0406 90 21 20 ---- Whole cheeses (of the conventional flat cylindrical shape of a net weight of not less than 33 kg but not more than 44 kg and cheeses in cubic blocks or in parallelepiped shape, of a net weight of 10 kg or more) of a minimum fat content of 50% by weight, in the dry matter, matured for at least three months

0406 90 21 90 ---- Other

0406 90 23 --- Edam

0406 90 23 10 ---- Norwegian

0406 90 23 90 ---- Other

0406 90 25 --- Tilsit

0406 90 27 --- Butterkäse

0406 90 29 --- Kashkaval

0406 90 32 --- Feta

0406 90 35 --- Kefalo-Tyri

0406 90 37 --- Finlandia

0406 90 39 --- Jarlsberg

0406 90 50 --- Other

0406 90 50 ---- Cheese of sheep's milk or buffalo milk in containers containing brine, or in sheepskin or goatskin bottles

0406 90 61 ---- Other

0406 90 61 ----- Of a fat content, by weight, not exceeding 40 % and a water content, by weight, in the non-fatty matter http://exporthelp.europa.eu/...n§ion=tariff&taricCode=0406000000&prodLine=80&limitLevel=10&simDate=20130627&languageId=en[8/8/2017 11:15:53 AM]

Important information regarding the receipt and handling of your submission We will send a confirmation message to you when we receive your submission. We may also contact you if we need to clarify matters in your objection. DFAT reserves the right to release information publicly and/or to the EU, including any information contained in your submission and supporting evidence, unless: (i) you indicate in your submission the parts of your submission and supporting evidence you do not wish to be made public or provided to the EU (noting the EU will need to be provided with your objection for it to be considered); or (ii) you clearly identify it as commercial-in-confidence information. Consider including commercial-in-confidence information as separate annexures to the submission. You will retain the ownership of any intellectual property rights in your submission. You consent, however, to DFAT using your submission, free of charge, for the purposes outlined above. Before making a submission, please ensure you have read the information on the DFAT webpage applicable to submissions. If your submission contains commercial-in-confidence information, you must clearly identify it. We request you send your submission as a Microsoft Word document or readable PDF (not a scan).

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• contact you about your objections, comments or supporting evidence • consult with other Australian Government agencies, including IP Australia, and ministerial offices, and • inform the Australian Government’s decision about whether to recognise the EU’s terms as GIs under the Australia-EU FTA. DFAT may publicly release any information received as part of this consultation, in part or in full. If you do not consent for some or all of your personal information contained in your submission to be shared with Australian Government agencies or to be disclosed to overseas third party recipients, including the EU or to be used in any other way, you should clearly state this when you make your submission to DFAT. DFAT may disclose your personal information to third parties operating outside Australia. If you consent to this disclosure, you understand that DFAT will not be required to take reasonable steps to ensure that the relevant overseas third party recipients do not breach the Australian Privacy Principles. This means that if an overseas third party recipient handles your personal information in a way that breaches the Australian Privacy Principles, DFAT will not be accountable under the Privacy Act and you will not be able to seek redress under the Privacy Act. By providing your submission to DFAT, you consent to DFAT disclosing your personal information to third parties operating outside Australia, including the EU.

Privacy Policy DFAT’s Privacy Policy contains further information about how you can access your personal information, seek correction of that information, and complain about a breach of the Australian Privacy Principles. DFAT’s Privacy Policy is available at: https://dfat.gov.au/about- us/corporate/privacy/Pages/privacy.aspx. Freedom of Information (FOI) Please note your submission may be subject to a request made under the Freedom of Information Act 1982 (Cth). Further information about DFAT’s FOI Act obligations are available here: https://dfat.gov.au/about-us/corporate/freedom-of-information/Pages/freedom-of-information.aspx Disclaimer The submission of an objection or objections or comments will not determine whether an EU term will or will not be protected as a GI under the Australia-EU FTA and in Australia. This objections process does not guarantee the protection of any of the terms identified as GIs under the Australia-EU FTA or in Australia. The information in this public objections procedure is provided as a guide only and does not constitute legal advice. We encourage any person submitting an objection to contact a qualified legal professional.