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IADSA Annual General Meeting Jakarta, 25 April 2013

Argentina Brasil Colombia Costa Rica Dominican Rep. Ecuador El Salvador Estados Unidos Guatemala Honduras México Nicaragua Paraguay Perú Uruguay Venezuela

Alemania Arabia Saudi Austria Bélgica Bulgaria Croacia Chipre Dinamarca Eslovaquia Eslovenia España Estonia Finlandia Francia Grecia Holanda Hungría Irlanda

Brunei Camboya China Filipinas India Indonesia Japón Korea Laos Malasia Myanmar Nueva Zelanda Singapur Tailandia Vietnam

Israel Italia Letonia Lituania Luxemburgo Malta Noruega Polonia Portugal Reino Unido Rumanía Rep. Checa Rusia Sudáfrica Suecia Turquía

Legislation in development

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Argentina Brasil Colombia Costa Rica Dominican Rep. Ecuador El Salvador Estados Unidos Guatemala Honduras México Nicaragua Paraguay Perú Uruguay Venezuela

Alemania Arabia Saudi Austria Bélgica Bulgaria Croacia Chipre Dinamarca Eslovaquia Eslovenia España Estonia Finlandia Francia Grecia Holanda Hungría Irlanda

Brunei Camboya China Filipinas India Indonesia Japón Korea Laos Malasia Myanmar Nueva Zelanda Singapur Tailandia Vietnam

Israel Italia Letonia Lituania Luxemburgo Malta Noruega Polonia Portugal Reino Unido Rumanía Rep. Checa Rusia Sudáfrica Suecia Turquía

Harmonization EU & ASEAN

Legislation in development

Focus of regulation

•  Classification

•  Definition

•  Benefits and safety of food supplement ingredients.

•  Scientific justification of health claims

•  Quality of food supplements

•  Requirements for market access

•  Monitoring products once they are on the market.

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Codex Alimentarius Codex

Alimentarius Commission

Executive Committee

Codex Secretariat

Commodity Committees

Horizontal Committees

Regional Committees

185 Member Countries + EU Impact:

- Regional - National - Legal force/WTO

Observers

2005 Guidelines for Vitamin and

Mineral Food Supplements

CCNFSDU

Supplements regulated under drug law Supplements regulated as an intermediate category Supplements regulated under food law

Trends in the classification of food/dietary supplements

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RDA based levels Countries moving to safety based levels Safety based levels

Trends on Vitamin & Mineral Maximum Levels

Intermediate scheme based levels

Codex Alimentarius Codex

Alimentarius Commission

Executive Committee

Codex Secretariat

Commodity Committees

Horizontal Committees

Regional Committees

185 Member Countries + EU Impact:

- Regional - National - Legal force/WTO

Observers

Asia

Africa

Europe

N. Am & SWP

LatAm & Caribbean

CCFO: Fish Oils Additives

Labelling

Contaminants CCNFSDU: NRVs

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The revision of the following 28 Nutrient Reference Values (NRVs) is important because the revisions agreed by Codex are implemented by governments worldwide and will have an impact on the labelling of most nutrition claims.

Table 2 Table 3

CCNFSDU: Revision of NRVs

800 μg#

5 μg#

60 mg#

1.4 mg#

1.6 mg#

18 mg#

2 mg#

200 μg#

1 μg#

800 mg#

300 mg#

14 mg#

15 mg#

Guidelines on Nutrition Labelling (1985) – NRVs amended in 1993#

60 μg#

1.2 mg#

1.2 mg#

15 mg#

1.3 mg#

400 μg#

2.4 μg#

5 mg#

30 μg#

150 μg#

1000 mg# Agreed by CCNFSDU#in 2012#

2011: Codex agreed to develop a Codex Standard for Fish Oils.

2013: Discussion of a first proposed draft Standard for Fish Oils at CCFO meeting.

CCFO: Standard for Fish Oils

• Scope: Unnamed fish oils & Named fish oils.

• Named fish oils:

- Focus on those traded internationally in significant volumes.

- Criteria for their identification: Proposed ranges of fatty acid profiles.

• Call for data sent by the Codex Secretariat.

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Table 2 Table 3

Codex General Standard for

Food Additives

The single authoritative reference point for food additives and source of food additives recognized as

suitable for use in foods and whose uses are technologically justified

Magnesium Stearate

Essential for the production of dietary supplement tablets

CCFA meeting

Agreed to include in the priority List for JECFA evaluation

Over 30 key additives for supplements adopted since 2005

Data: Suppliers (CEFIC & IFAC) with

support of Confectionary & Supplements

sectors

Potassium Aluminium Silicate

Technological function as Carrier: Adopted INS 555

Based pearlescent pigments: Decision on INS postponed pending JECFA evaluation

Health Claims should be scientifically substantiated:

▶ Recommendations to assist national authorities in their evaluation of health claims in order to determine their acceptability for use in food products (including food supplements).

▶ Recommendations are based in taking into account the totality of the available relevant scientific data and the weighing of the scientific evidence:

• Health claims should be primarily be based on evidence provided by well- designed human intervention studies.

• Human observational studies may contribute to the totality of evidence.

• Animal model studies, ex vivo or in vitro data may be provided as supporting knowledge base for the relationship between the food or food constituent and the heath effect.

Guidelines for the Use of Nutrition and Health Claims

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• The totality of the evidence, including unpublished data where appropriate, should be identified and reviewed, including: evidence to support the claimed effect; evidence that contradicts the claimed effect; and evidence that is ambiguous or unclear.

• Evidence based on human studies should demonstrate a consistent association between the food or food constituent and the health effect, with little or no evidence to the contrary.

• Although a high quality of scientific evidence should always be maintained, substantiation may take into account specific situations and alternate processes.

• Evidence-based dietary guidelines and authoritative statements prepared or endorsed by a competent authoritative body and meeting the same high scientific standards may also be used.

• By taking into account the totality of the available relevant scientific data and by weighing the evidence, competent national authorities can determine if, and under what circumstances, a claimed relationship is substantiated.

Health Claims should be scientifically substantiated:

Guidelines for the Use of Nutrition and Health Claims