opportunities & headwinds in global ingredient regulations

Decernis LLC (USA) 1250 Connecticut Ave. N.W. #200 Washington DC 20036 USA +1 240-428-1800 Decernis GmbH (Europe) Johann-Strauss-Str. 35 65779 Kelkheim/Ts. Germany +49 6195 3709 www.decernis.com [email protected]

Opportunities &

Headwinds in Global Ingredient

Regulations

Carolyn Fisher

2014 Protein Trends &

Technologies Seminar

April 8-9, 2014 • Arlington

Heights, IL, USA

http://www.decernis.com/

mailto:[email protected]

http://globalfoodforums.com/proteinseminar

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

2014 Protein Trends & Technologies Seminar 8 April 2014 2

Good News? Harmonization

Nati

on

al

Harmonization


• 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


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

2014 Protein Trends & Technologies Seminar 8 April 2014

5

Countries which directly follow Codex Additives (CCFA):

2014 Protein Trends & Technologies Seminar

= 39 Countries

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

8 April 2014 6

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 2014 7

• 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


Eurasian Countries


EU + other countries

• EU 28

• + 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

– FR: French Polynesia, French Guiana, Guadeloupe, Martinique, Mayotte, Reunion

48 Countries and territories “under

EU influence” 8 April 2014 10

Croatia – 1 July 2013

Eurasian Economic Community Customs Union


Chapter II, section 22: Requirements for Food Additives and Flavourings

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

Customs Union’s document prevails over national regulations of Customs Union’s Member States

Eurasian Economic Community

Customs Union


Middle East & African Countries


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 2014 14

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


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


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

Latin America and Caribbean


MERCOSUR


MERCOSUR

Brazil198,361,000

Argentina 41,119,000

Venezuela 29,891,000

Paraguay 6,683,000

Uruguay 3,391,000

CountryUN Population Est.

1 July 2012Flag

Admittance of Venezuela as a

full member: 31 July 2012


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 16.2.2: 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

– 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)


+5 Countries

8 April 2014 21

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


http://www.sieca.int/site/Enlaces.aspx?ID=030001003003001


Countries:

Costa Rica

El Salvador

Guatemala

Honduras

Nicaragua

+

Panama

29 June 2012


+6 Countries

COMEICO: RTCA

8 April 2014 23


RTCA 67.04.54:10 [Processed Foods and Beverages. Food Additives]

– Entered into force November 2012

– 405 pages

COMEICO: RTCA

8 April 2014 24

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 1999

2. Bermuda - 2 July 2003

3. British Virgin Islands - 2 July 1991

4. Cayman Islands - 15 May 2002

5. Turks and Caicos Islands - 2 July 1991


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 2014 26

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):

Using Codex Food Additives as ‘benchmark standards’


+10 Countries

8 April 2014 27

Individual Country Influence: USA & Japan

Also:

Japan as major

influence for Food

Additives in Asia

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

+10 Countries


Formulation Compliance Analysis


Protein Drink

8 April 2014 2014 Protein Trends & Technologies Seminar 30

Additives in Protein Drink


Maximum Limits for Red 40


Protein Bar


Additives in Protein Bar


Summary

• 180 Countries covered

• 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)


Thank you!

Kevin C. Kenny, J.D., LL.M

Chief Operating Officer

Decernis

1250 Connecticut Avenue NW #200

Washington, DC 20036

Tel +1 240-428-1810

US Mobile: +1 301-535-2234

Int Mobile: +49 163-435-2234

E-Mail: [email protected]

Carolyn Fisher, Ph.D.

Senior Scientist

Decernis

2101 Gaither Road, Suite 150

Rockville, MD 20850

Tel. +1 240-428-1805

Mobile +1 443-890-4560

E-Mail: [email protected]




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