Codex Standards – Their role in the international and ...

CRN-I: Nutrition Issues in Codex - Health Claims and Nutrient Reference Values © University of Reading 2011 www.reading.ac.uk

Department of Food and Nutritional Sciences

November 16, 2011

Codex Standards – Their role in the international and national regulatory framework Dr David Jukes, Senior Lecturer in Food Regulation

CRN-I: Nutrition Issues in Codex - Health Claims and Nutrient Reference Values 2

Outline

•  Background •  Codex – purpose, history, structure, procedures,

decisions, output •  Codex and the WTO •  SPS – definitions, harmonisation, assessment of risk •  TBT •  Risk analysis and Codex •  EU – using Codex and WTO •  The reality – EU, global

CRN-I: Nutrition Issues in Codex - Health Claims and Nutrient Reference Values 3

Controversial!

CRN-I: Nutrition Issues in Codex - Health Claims and Nutrient Reference Values

Controversial!

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“Make no mistake about it: those international standards

are moving steadily toward the Codex regime and its

draconian restrictions on health freedom. Pharmaceutical

companies have spent billions of dollars trying to get

Washington to regulate your dietary supplements. So far,

that effort has failed, in part because of a 1994 law called

the Dietary Supplement Health and Education Act. Big

Pharma and the medical establishment hate this Act,

because it allows consumers some measure of freedom

to buy the supplements they want.”

“Although American dietary supplements are currently protected—somewhat—by the Dietary Supplement Health and Education Act

of 1994 (DSHEA), its provisions are threatened by Codex and an interlocking array of emerging regional

and international treaties, agreements, regulatory "handshakes" and other executive arrangements that will "harmonize" our food laws to harsh European standards, thereby relegating DSHEA to the dust bin of

history and suppressing our health freedoms...unless we take immediate action.”


Codex - purpose

The Codex Alimentarius Commission shall … be responsible for making proposals to … the FAO and the WHO on all matters pertaining to implementation of the Joint FAO/WHO Food Standards Programme, the purpose of which is:

•  protecting the health of the consumers and ensuring fair practices in the food trade;

•  promoting coordination of all food standards work undertaken by international governmental and non governmental organizations;

•  finalizing standards and publishing them in a Codex Alimentarius

from Article 1, Codex Statutes

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Codex - history

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•  1st Session: June 1963 •  2nd Session: September

1964 •  …. [1995 – Creation of WTO] •  …. •  25th (Extraordinary) Session:

February 2003 •  …. •  34th Session: July 2011


Codex - structure

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Subject Committees

Commodity Committees

Regional Committees

Executive Committee

Codex Alimentarius Commission

Secretariat (Rome)

Subs

idia

ry B

odie

s


Codex - procedures

Procedural Manual: •  Statutes •  Rules of procedures •  General principles •  Definitions •  Risk analysis

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Codex – adoption procedure

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Step 1 Commission / Subsidiary Body decides to elaborate a standard

Step 2 Proposed Draft Standard

prepared

Step 3 Proposed Draft Standard circulated for comment

Step 4 Comments considered by Subsidiary Body and any

amendments made

Step 5 Commission considers

Proposed Draft Standard and can make it a Proposed

Standard

Step 6 Proposed Standard

circulated for comment

Step 7 Comments considered by Subsidiary Body and any

amendments made

Step 8 Commission considers Proposed Standard and

can make it a Codex Standard

Codex Standard


•  1995: Hormones in beef production – Maximum residue limits (MRLs) adopted by vote

•  1995: Hormones in milk production – Debate on MRLs was adjourned by vote

•  1997: Hormones in milk production – Decision to ask JECFA to re-examine scientific data taken by vote

•  1997: Standard for Natural Mineral Water – Standard adopted by vote despite concern at some aspects

•  2007: Labelling of Emmental cheese – No reference required to Swiss origin of the name taken by vote

•  2011: Hormones in meat production – MRL rejected by vote 10

Rule VIII Voting and Procedures 1. Subject to the provisions of paragraph 3 of this Rule, each Member of the Commission

shall have one vote. An alternate or adviser shall not have the right to vote except where substituting for the representative.

2. Except as otherwise provided in these rules, decisions of the Commission shall be taken by a majority of the votes cast.

Codex – decisions


Codex – decisions

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Consensus The chairpersons should always try to arrive at a consensus and should not ask the Committee to proceed to voting if agreement on the Committee’s decision can be secured by consensus.

MEASURES TO FACILITATE CONSENSUS The Codex Alimentarius Commission, desiring that every effort should be made to reach agreement on the adoption or amendment of standards by consensus, recommends the following measures to facilitate consensus:

•  Refraining from submitting proposals in the step process where the scientific basis is not well established on current data and, where necessary, carry out further studies in order to clarify controversial Issues;

•  Providing for thorough discussions and documentation of the issues at meetings of the committees concerned; …..

Adopted by Commission in 2003


Codex - output

•  Guidelines •  Recommended Codes of

Practice •  Standards •  Additives (GSFA) •  Veterinary drug residues •  Pesticide residues

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Codex and the WTO

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Member Countries

Codex Alimentarius Commission

Codex Standards

National Laws and Regulations

Member Countries

World Trade Organisation

GATT TBT Agreement SPS Agreement

Dispute Settlement

National Laws and Regulations


SPS - definitions

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Sanitary or phytosanitary measure –

Any measure applied: …. (b) to protect human or animal life or health within the territory of the Member from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs; …. Sanitary or phytosanitary measures include all relevant laws, decrees, regulations, requirements and procedures including, inter alia, end product criteria; processes and production methods; testing, inspection, certification and approval procedures; … provisions on relevant statistical methods, sampling procedures and methods of risk assessment; and packaging and labelling requirements directly related to food safety.

International standards, guidelines and recommendations

(a)  for food safety, the standards, guidelines and recommendations established by the Codex Alimentarius Commission relating to food additives, veterinary drug and pesticide residues, contaminants, methods of analysis and sampling, and codes and guidelines of hygienic practice;

(b)  ….


SPS - harmonisation

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Leve

l of P

rote

ctio

n

Codex Standards

3(2). Sanitary or phytosanitary measures which conform to international standards, guidelines or recommendations shall be deemed to be necessary to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement

National SPS

measure

National SPS

measure

3(3). Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations, if there is a scientific justification, or as a consequence of the level of sanitary or phytosanitary protection a Member determines to be appropriate in accordance with the relevant provisions of paragraphs 1 through 8 of Article 5.

3(1). To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist, except as otherwise provided for in this Agreement, and in particular in paragraph 3.


SPS – assessment of risk

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5(1). Members shall ensure that their sanitary or phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations.

•  Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius. (Adopted in 2003)

•  Definitions of Risk Analysis Terms related to Food Safety. (Adopted in 1997. Amended in 1999, 2003, 2004)

•  Risk Analysis Principles Applied by the Committee on Food Additives and the Committee on Contaminants in Foods. (Adopted in 2005, amended in 2007)

•  Nutritional Risk Analysis Principles and Guidelines for Application to the Work of the Committee on Nutrition and Foods for Special Dietary Uses (Adopted in 2009)

•  Statements of Principle Concerning the Role of Science in the Codex Decision-making Process and the Extent to Which Other Factors are Taken into Account (Adopted in 1995)

•  Statements of Principle Relating to the Role of Food Safety Risk Assessment (Adopted In 1997)

Codex


SPS – assessment of risk

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Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius.

10. When there is evidence that a risk to human health exists but scientific data are insufficient or incomplete, the Codex Alimentarius Commission should not proceed to elaborate a standard but should consider elaborating a related text, such as a code of practice, provided that such a text would be supported by the available scientific evidence.

11. Precaution is an inherent element of risk analysis. Many sources of uncertainty exist in the process of risk assessment and risk management of food related hazards to human health. The degree of uncertainty and variability in the available scientific information should be explicitly considered in the risk analysis.

Codex

5(7). In cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other Members. In such circumstances, Members shall seek to obtain the additional information necessary for a more objective assessment of risk and review the sanitary or phytosanitary measure accordingly within a reasonable period of time.


TBT

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2.4 Where technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for their technical regulations except when such international standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursued, for instance because of fundamental climatic or geographical factors or fundamental technological problems.

Technical regulation Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.

TBT measures

SPS measures


Risk analysis and Codex

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Risk analysis Risk

communication Risk assessment Risk

management

Risk Management The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.

Risk Assessment A scientifically based process consisting of the following steps: (i)  hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization.


Risk analysis

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Risk communication

Risk assessment Risk management

Codex •  Commission •  Subsidiary Bodies

FAO / WHO Expert Committees •  The Joint FAO/WHO Expert Committee on

Food Additives (JECFA) •  Joint FAO/WHO Meetings on Pesticide

Residues (JMPR) •  Joint FAO/WHO Expert Meetings on

Microbiological Risk Assessment (JEMRA) •  Joint FAO/WHO Expert Meetings on Nutrition

(JEMNU) •  WHO Nutrition Guidance Expert Advisory

Group (NUGAG)

Risk analysis and Codex


EU - using Codex and WTO

•  REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 January2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

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•  Appropriate level of protection?

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•  Use of risk analysis?

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•  Insufficient scientific data?

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•  Risk assessment?

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•  Use of international standards?

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The reality - EU

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European Commission

European Parliament

Council (Ministers from

27 Member States)

27 Member States’ Parliaments

Citizens

EFSA


The reality – global

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•  Does the system work? •  Can we do better?



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Risk analysis

Risk assessment Risk management

Risk communication


Risk communication

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?


Trust !

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Governments

Voters

WTO Industry

?


Codex


Thank you!

Dr David Jukes Department of Food and Nutritional Science The University of Reading Whiteknights Reading RG6 6AP United Kingdom

Tel: +44 (0) 118 935 6531 E-mail: [email protected] Web page: http://www.reading.ac.uk/foodlaw/

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