Opportunities & Headwinds in Global Ingredient Regulations

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1 Decernis LLC (USA) 1250 Connecticut Ave. N.W. #200 Washington DC USA Decernis GmbH (Europe) Johann-Strauss-Str Kelkheim/Ts. Germany Opportunities & Headwinds in Global Ingredient Regulations Carolyn Fisher 2014 Protein Trends & Technologies Seminar April 8-9, 2014 Arlington Heights, IL, USA

2 DECERNIS Food & Consumer Products 78,000 Regulations, 180 Countries, 16 Economic Areas 22 languages, 5 million synonyms & identifiers PRODUCTS: Regulatory Encyclopedia Formulation Compliance Analysis Red light/green Light News & Issue Management Questionnaire & Certification Automation 8 April Protein Trends & Technologies Seminar 2

3 National Good News? Harmonization Harmonization 8 April Protein Trends & Technologies Seminar 3

4 Established 1963 (FAO & WHO) Today: 184 Member countries + 1 Int. Org (EU) 211 Codex Observers 48 IGOs 147 NGOs 16 UN Primary Goal: Develop harmonised international food standards, guidelines and codes of practice 8 April Protein Trends & Technologies Seminar 4

5 General Subject Committees Acronym Codex Committee Id Doc Ref Host Country CCCF Contaminants in Foods CX-735 CX/CF NL CCFA Committee on Food Additives CX-711 CX/FA CN CCFH Food Hygiene CX-712 CX/FH US CCFICS Food Import and Export CX-733 CX/FICS AU Certification and Inspection Systems CCFL Food Labelling CX-714 CX/FL CA CCGP General Principles CX-716 CX/GP FR CCMAS Methods of Analysis and CX-715 CX/MAS HU Sampling CCNFSDU Nutrition and Foods for CX-720 CX/NFSDU DE Special Dietary Uses CCPR Pesticide Residues CX-718 CX/PR CN CCRVDF Residues of Veterinary Drugs CX-730 CX/RVDF US in Foods 8 April Protein Trends & Technologies Seminar 5

6 Countries which directly follow Codex Additives (CCFA): Azerbaijan Haiti Pakistan Bahamas Iran Panama Bangladesh Ivory Coast Peru Barbados Jamaica Rwanda Beliz Jordan Senegal Bolivia Laos Sierra Leone Burundi Maldives St. Lucia Cayman Islands Mali Tanzania Curacao Mozambique Tajikistan Dominican Republic Myanmar Trinidad/Tobago Ethopia Namibia Turkmenistan Georgia Nepal Uganda Ghana Nigeria Zimbabwe = 39 Countries 8 April Protein Trends & Technologies Seminar 6

7 If no local regulation for individual substance, follow Codex Additives Argentina: Article 2 of Decree 2092 states: "... all foods, condiments, beverages, or their raw material and food additives which are manufactured, fractioned, preserved, transported, sold, or exposed, must comply with the CAA requirements. GOA also considers products from countries which have food controls comparable to those of Argentina, or when they use the Codex Alimentarius (FAO/OMS) standards, to be in compliance with Argentine standards." Algeria Indonesia South Africa Argentina Kazakhstan St. Kitts CARICOM Jordan Thailand Chile Kenya Turkey Colombia Peru Ukraine Cuba Philippines Uzbekistan Ecuador Serbia Venezuela Fiji Singapore Vietnam + 32 Countries 8 April Protein Trends & Technologies Seminar 7

8 Advantages Brings everybody to the table Transparency: Freely, electronically available Arabic, Chinese, English, French, Spanish, Russian Makes it possible for less advanced countries to catch up in a hurry Disadvantages Glaciers sometimes move faster Purely voluntary US, EU will never agree to drop 50 years of legislation 8 April Protein Trends & Technologies Seminar 8

9 Eurasian Countries 8 April Protein Trends & Technologies Seminar 9

10 EU 28 EU + other countries + Associate Member Turkey + EEA Members Iceland Lichtenstein Norway + Under the influence EU: Albania, Bosnia/Herzegovina, Croatia, Egypt (94/36/EC as amended), Kosovo, Montenegro, Serbia, Israel, Syria NL: Aruba, Curaçao and Sint Maarten Croatia 1 July 2013 FR: French Polynesia, French Guiana, Guadeloupe, Martinique, Mayotte, Reunion 48 Countries and territories under 8 April 2014 EU influence 10

11 Eurasian Economic Community Customs Union 8 April Protein Trends & Technologies Seminar 11

12 Eurasian Economic Community Customs Union Customs Union (Russia, Belarus, Kazakhstan) Customs Union Committee Decision No. 299, 28 May 2010 (cons. 9 Dec 2011): Uniform Sanitary-Epidemiological and Hygienic Requirements for Goods Subject to Sanitary and Epidemiological Supervision entered into force 1 July 2010 = 1,025 pages Chapter II, section 22: Requirements for Food Additives and Flavourings Customs Union s document prevails over national regulations of Customs Union s Member States 8 April Protein Trends & Technologies Seminar 12

13 Middle East & African Countries 8 April Protein Trends & Technologies Seminar 13

14 GCC Gulf Cooperation Council (GCC) مجلس التعاون الخليجي Founded 25 April 1981 Economic cooperation Coordination on Standards Dominated by Saudi Arabia Yemen is not a member but: In 2002, Yemeni PM issued a decree to adopt and enforce all food-related standards. - All GCC Members are Codex Members +6 Countries 8 April Protein Trends & Technologies Seminar 14

15 GCC GSO Standards: 19/2000 Permitted Food Additives in Edible Oils and Fats 23/1998 Colouring Matter Used in Foodstuffs 172/1994 Benzoic Acid, Sodium Benzoate and Potassium Benzoate used in Preservation of Foodstuffs 175/1994 Salts of Sulphurous Acid Used in Preservation of Foodstuffs 356/1994 Preservatives Permitted for use in Food Products 357/1994 Antioxidants Permitted in Foodstuffs 381/1994 Emulsifiers, Stabilizers and Thickeners Permitted for use in Food Products 707/1997 Flavourings Permitted for Use in Foodstuffs 995/1998 Sweeteners Permitted for Use in Food Products 1059/2002 Maximum Limits of Antioxidants Permitted for use in Food Products 8 April Protein Trends & Technologies Seminar 15

16 GCC National Derogations Growing trend toward national authorities overriding permissions in GS 28/1998 Dubai in UAE has a banned list containing items on GSO permitted list 8 April Protein Trends & Technologies Seminar 16

17 East African Community (EAC) Burundi Kenya Rwanda Tanzania Uganda Customs Union 1500 East African Standards, goal: regional harmonization Food and agriculture Standards Technical Committee (UNBS/TC 2) Accepts Codex Additives + 5 Countries 17

18 Latin America and Caribbean 8 April Protein Trends & Technologies Seminar 18

19 MERCOSUR 8 April Protein Trends & Technologies Seminar 19

20 MERCOSUR Flag Country Brazil UN Population Est. 1 July ,361,000 Argentina 41,119,000 Venezuela 29,891,000 Paraguay 6,683,000 Uruguay 3,391,000 Admittance of Venezuela as a full member: 31 July April Protein Trends & Technologies Seminar 20

21 MERCOSUR Requires implementation in national legislation GMC/RES No 50/97 : Asignación de Aditivos y su Concentración Máxima para la Categoría de Alimentos 7: Productos de Panificación y Galletería GMC/RES No 73/97 : Asignación de Aditivos y sus Límites a las siguientes Categorías de Alimentos Categoría 8: Carnes y Productos Cárnicos GMC/RES No 53/98 : Aditivos para la Categoría de Alimentos 5 (caramelos, pastillas, confites, chicles, turrones, productos de cacao y productos con cacao, chocolates, bombones, baños rellenos y otros productos similares) GMC/RES No 54/98 : Asignación de Aditivos y sus Concentraciones Máximas para la Categoría de Alimentos 19 : Postres GMC/RES No 16/00 : Aditivos y sus Concentraciones Máximas para la Categoría de Alimentos 12 GMC/RES Nº 141/96: Modificación: GMC/RES Nº 07/06, Anexo I (Aditivos y sus Concentraciones Máximas para la Categoría de Alimentos 3: Helados Comestibles) GMC/RES Nº 09/06 : Asignación de Aditivos y su Concentración Máxima para la Categoría de Alimentos 16.2: Bebidas No Alcohólicas, Subcategoría : Bebidas No Alcohólicas Gasificadas y No Gasificadas GMC/RES Nº 11/06: Reglamento Técnico MERCOSUR sobre Lista General Armonizada de Aditivos Alimentarios y sus Clases Funcionales +5 Countries GMC/RES Nº 02/08: Aditivos y sus Concentraciones Máximas para la Categoría de Alimentos 18. Productos para copetín (Snacks) GMC/RES. Nº 34/10: Aditivos alimentarios autorizados para ser utilizados según las Buenas Prácticas de Fabricación (BPF) 8 April Protein Trends & Technologies Seminar 21

22 Central America Secretaría de Integración Economíca Centroamericana (SIECA) Central America Secretariat of Economic Integration Consejo de Ministros de Economía de Centroamérica (COMIECO) Central American Council of Ministers of Economic Integration Reglamento Técnico Centroamericano (RTCA) Central American Technical Regulation 8 April Protein Trends & Technologies Seminar 22

23 COMEICO: RTCA Countries: Costa Rica El Salvador Guatemala Honduras Nicaragua + Panama 29 June Countries 8 April Protein Trends & Technologies Seminar 23

24 COMEICO: RTCA RTCA :10 [Processed Foods and Beverages. Food Additives] Entered into force November pages 8 April

25 CARICOM CARICOM MEMBER STATES 1. Antigua and Barbuda 8. Haiti 2. Bahamas 9. Jamaica 3. Barbados 10. Montserrat 4. Belize 11. Saint Lucia 5. Dominica 12. St. Kitts and Nevis 6. Grenada 13. St. Vincent and the Grenadines 7. Guyana 14. Suriname 15. Trinidad and Tobago CARICOM ASSOCIATE MEMBERS 1. Anguilla - 4 July Bermuda - 2 July British Virgin Islands - 2 July Cayman Islands - 15 May Turks and Caicos Islands - 2 July April Protein Trends & Technologies Seminar 25

26 CARICOM CARICOM Regional Org. for Standards and Quality (CROSQ), Regional standards for: Brewery Products Food Hygiene Fruit and Fruit-based products (many) GMP Rum Labelling of Prepackaged Foods (follows Codex) Etc. Nothing yet for Food Additives +15 Countries 8 April Protein Trends & Technologies Seminar 26

27 SOUTHEAST ASIA Brunei Darussalam Cambodia Indonesia Laos Malaysia Myanmar Philippines Singapore Thailand Vietnam Regional Organization: ASEAN Expert Group on Food Safety (AEGFS) Coming: ASEAN ECONOMIC COMMUNITY in 2015 ASEAN Common Food Control Requirements (ACFCR): +10 Countries Using Codex Food Additives as benchmark standards 8 April Protein Trends & Technologies Seminar 27

28 Individual Country Influence: USA & Japan USA American Samoa Aruba (both US and EU) Bahamas (both US and Codex) Bermuda Cayman Islands Guam Jamaica (both US and Codex) Peru Philippines (US & Japan) US Virgin Islands Also: Japan as major influence for Food Additives in Asia April 2014 Countries 2014 Protein Trends & Technologies Seminar 28

29 Formulation Compliance Analysis 8 April Protein Trends & Technologies Seminar 29

30 Protein Drink 8 April Protein Trends & Technologies Seminar 30

31 Additives in Protein Drink 8 April Protein Trends & Technologies Seminar 31

32 Maximum Limits for Red 40 8 April Protein Trends & Technologies Seminar 32

33 Protein Bar 8 April Protein Trends & Technologies Seminar 33

34 Additives in Protein Bar 8 April Protein Trends & Technologies Seminar 34

35 180 Countries covered Summary Codex/EU/US remain largest groupings Regional groupings growing rapidly Intra-country Harmonization substantial recent food safety overhauls in: China, India Indonesia, Vietnam, others Streamlining of regulatory regimes (China, India) Clearer governmental responsibilities for promulgation, enforcement (India FSSAI) 8 April Protein Trends & Technologies Seminar 35

36 Thank you! Kevin C. Kenny, J.D., LL.M Chief Operating Officer Decernis 1250 Connecticut Avenue NW #200 Washington, DC Tel US Mobile: Int Mobile: Carolyn Fisher, Ph.D. Senior Scientist Decernis 2101 Gaither Road, Suite 150 Rockville, MD Tel Mobile April Protein Trends & Technologies Seminar 36

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