DEVELOPMENT OF A PROPOSED DRAFT DEFINITION FOR BIOFORTIFICATION
(Chaired by Zimbabwe and South Africa)
First Consultation Paper
March 2016
Please respond by 29TH April 2016To: , , , and copied to ,
1. INTRODUCTION
At the 37th session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), The Committee agreed to re-establish the eWG, led by Zimbabwe and South Africa, working in English, to further develop the proposed draft definition of biofortification at step 4.
The terms of reference for electronic working group
· consider the replies to the request for comments at Step 3 on the proposed draft definition and the comments made at the session;
· consider the request from CAC38 on how the definition would be used and where it would be best placed; and
· Propose a draft definition for further consideration by the next session of the Committee.
Nominations to participate in the eWG were received from 19 Codex Members, and 10 Codex Observers. The list of Members and Observers is attached as Annexure 2.
PROGRAMME OF WORK
Consultation Paper 1
The focus of the first consultation paper will be to:
1. Develop a draft definition for biofortification based on the agreed nine criteria identified as the source of the proposed definition. The draft document will also provide an opportunity for eWG members to comment on other additional issues that should be taken into consideration during the development of a draft definition for biofortification.
2. To consider on how the definition would be used and where it would be best placed.
The Chairs will be requesting the eWG to provide information and evidence that will provide information on these two aspects.
Consultation Paper 2
The focus of the second consultation paper will be finalisation of the draft definition for biofortification based on the identified criteria, and how the definition would be used and where it would be best placed. The chairs of the eWG will also take into consideration the eWG comments to the first consultation paper. This paper will also highlight key areas that still need further discussion or agreement by members. The Chairs of the eWG will be requesting that the eWG provide additional information on gaps and issues identified to inform the development of the definition for biofortification.
TIMELINE FOR THE DEVELOPMENT OF A PROPOSED DRAFT DEFINITION FOR BIOFORTIFICATION
TIMELINES / ACTIVITIES29thth March – 29th April / 5 week consultation period for the 1st Consultation Paper, which will include:
· Summarise decisions and key issues to be covered as agreed at CCNFSDU37
· Summarised criteria identified as the source of the proposed definition for biofortification. The criteria will be used to develop a definition for biofortification.
· Draft proposals on how the definition would be used and where it would be best placed.
20th May – 17th June / 4 week consultation period for the 2nd Consultation Paper, which will include:
· Proposed draft definition for biofortification based on comments from the 1st Consultation Paper
· Proposals on how the definition would be used and where it would be placed
· Explore issues for further consideration by CCNFSDU38 on the proposed draft definition for biofortification based on comments received from eWG.
1st July / Submission of a draft to the Secretariat
August to October / Circulation of Agenda Paper with request for comments due late October
November / Distribution of compiled comments by the Secretariat translated into English, French and Spanish
5th – 9th December / 38th Session of CCNFSDU
2. BACKGROUND
The 36th session of the CCNFSDU agreed to initiate new work on a definition for biofortification and agreed to establish an electronic working group, led by Zimbabwe and South Africa. The CCEXEC70 recommended that CAC38 approve the development of a Codex definition and/or Biofortified foods as new work. Zimbabwe and South Africa were tasked to lead an electronic working group to develop definitions of Biofortification and Biofortified foods and to indicate where the definition will be used.
At CCNFSDU37 the delegations of Zimbabwe and South Africa, as co-Chairs of the eWG, introduced the paper and summarised the nine criteria identified as the source of the proposed definition and presented four options for a definition. The Committee agreed on the following issues:
2.1 The Committee agreed not to discuss the proposed definitions at this time and considered whether the criteria contained in the working document were suitable in general to guide the further work of the eWG.
2.2 The Committee agreed that, in line with the project document, the definition should be as broad as possible to include all possible types of agricultural processes and organisms which would improve the nutritional quality of the product. The Committee noted that the term biofortification did not always translate easily, as “bio” had different meanings in different regions of the world and so the working group could also explore defining a better term.
2.3 The Committee discussed, inconclusively, whether foods enhanced through recombinant-DNA technology should be included in the definition. The Committee noted that for the safety of such foods relevant Codex texts existed (CAC/GL 45-2003, Annex 2).
2.4 The Committee, however, noted that should recombinant DNA technology be included in criteria 1, then consideration could be given to some explanatory text that “competent national and/or regional authorities may decide which agricultural practices they would consider”.
2.5 The Committee considered that the definition should be further developed before entering into considerations of labelling and claims of health benefits. The Committee agreed that the effects of the enhancement should be measurable against objective criteria such as nutrient reference values and not just as an increase as compared to non-fortified products.
2.6 The Committee agreed that anti-nutrients should be further discussed, as decreasing anti-nutrients could increase the availability of nutrients.
2.7 The Committee agreed to establish an eWG co-chaired by Zimbabwe and South Africa and working in English to:
o consider the replies to the request for comments at Step 3 on the proposed draft definition and the comments made at the session;
o consider the request from CAC38 on how the definition would be used and where it would be best placed; and
o Propose a draft definition for further consideration by the next session of the Committee.
· The Committee agreed to return the Proposed Draft Definition for Biofortification to Step 2/3, for consideration at the next session of the Committee.
3. THE PROPOSED DRAFT DEFINITION FOR BIOFORTIFCATION
The Committee discussed the proposed nine criteria extensively and agreed that they would be used to guide the development of a proposed draft definition for Biofortification. The nine criteria are attached as Annexure I. The following definitions were proposed in the previous consultation with members and observer organizations. These definitions are included for reference purposes.
1. Biofortification is the process of addition of one or more essential nutrients to a food crop through plant breeding whether or not it is normally contained in the food crop for the purpose of preventing or correcting a demonstrated deficiency of one or more nutrients in the population or specific population groups. It may involve reduction of anti-micronutrients in foods.
2. Biofortification is the process by which the nutritional quality of food crops is improved through plant breeding, with the aim of making the nutrients bioavailable to the body after ingestion, in order to correct or prevent a demonstrated deficiency and provide a health benefit.
3. Biofortification is the process by which the micronutrient quality of food crops, including essential amino acids and fatty acids, is improved through plant breeding, as well as reducing antinutritional factors in key food crops, with the aim of making the nutrients bioavailable to the body after ingestion, in order to correct or prevent a demonstrated deficiency and provide a health benefit.
4. Definition of biofortification from the WHO: Biofortification is the process by which the nutritional quality of food crops is improved through conventional plant breeding and/or use of biotechnology
Based on the agreed upon criteria, as well as the comments made by the committee, the chairs propose the following definition:
NEW PROPOSED DRAFT DEFINITION
Agro-fortification(concern 2.2) is the process by which the nutritional quality(criteria 2) of agricultural food(criteria 1) produce (e.g. plant crop) and products (e.g. eggs) are increased (criteria 5) through any agricultural practice(criteria 1 and concern 2.3)* without adding the nutrient through normal food processing in a beneficially absorbable form(criteria 3, 4 & 6 and concern 2.6)*, in order to correct or prevent a demonstrated deficiency and provide a health benefit.
Footnotes: * To be determined by the competent National Authority
In line with the agreed upon criteria (Annexure 1) and the comments made by the committee (captured under background), the chairs therefore request eWG members to provide comments on the proposed draft definition for biofortification.
4. HOW THE DEFINITION WOULD BE USED AND WHERE IT WOULD BE BEST PLACED
It was requested by CCEXEC that the e-WG consider, once the definition was agreed, specifically how this definition can be used.
i. It is proposed that the definition can be used in dictionaries, as guidance by researchers, regulatory authorities, food manufacturers, packers, traders, consumers, risk assessors (e.g. scientific bodies) et cetera.
ii. The definition can be used in the development of new breeds, labelling of foods, development of food regulations, acts and policies, in reports of risk assessments, marketing of products, and already existing codex texts such as:
iii. The definition can be used in Codex texts such as:
a) The Procedural Manual;
b) Other Codex texts such as, but not limited to:
§ Principles of addition of micronutrients to foods;
§ Guidelines On Formulated Supplementary Foods For Older Infants And Young Children (CAC/GL 08-19911);
§ Standard for Edible Fats and Oils Not Covered By Individual Standards (CODEX STAN 19-1981);
§ General Standard for The Labelling of Prepackaged Foods (CODEX STAN 1-1985);
§ General Guidelines on Claims (CAC/GL 1-1979);
§ Guidelines for Use Of Nutrition And Health Claims (CAC/GL 23-1997);
§ General Principles for the Addition of Essential Nutrients to Foods (CAC/GL 9-1987)
§ Standard for Processed Cereal-based Foods for Infants and Young Children (CODEX STAN 74-1981).
Once adopted the definition can be used by other subsidiary bodies, such as CCFL, CCGP, etc.
The chairs request eWG members to propose other areas on how the definition will be used5. OTHER ISSUES FOR CONSIDERATION BY THE EWG
5.1 Use of the term Biofortification
The Committee noted that the term biofortification did not always translate easily, as “bio” had different meanings in different regions of the world. The eWG was tasked to explore other ways of defining the term better. The Chairs propose the following terminology/ies that could be used instead of biofortification.
‘Agro-fortification’
Question
1. Are you in support of the proposed terminology?
Yes Yes, with amendments No
2. If you support the proposed terminology, with amendments, please provide the amended terminology
3. If you have other proposals, please provide a suggested draft of the terminology as well as the justification for the proposal.
ANNEXURE 1:
Summary of proposed criteria to be covered by the definition
1 / 2 / 3 / 4 / 5 / 6 / 7 / 8 / 9All potential types of agricultural processes which include all potential organisms (animal and animal feed, plant and plant, fungi, yeasts and fertilizers thereof) that may be involved in biofortification / To allow for all essential nutrients (micro- and macro-nutrients) / Must increase/enhance
levels or absorption of nutrient(s) sufficiently for intended purpose (bioavailability) / Are any changes in increased or enhanced nutrient levels measurable?* / To decrease any anti-nutritional elements / Method of production / Distinguish between a biofortified versus a non-biofortified
Increased level of absorption / Intended purpose or health benefits or improved nutritional quality / Must be specified / No need to specify
ANNEXURE 2:
Codex Members
Argentina
Australia
Brazil
Canada
France
European Union
Greece
India
Ireland
Malaysia
New Zealand
Poland
Republic of Korea
South Africa
Switzerland
Thailand
United States of America
Uruguay
Zimbabwe
Codex Observers
8
World Sugar Research Organization
NHF
FoodDrinkEurope
ILCA
International Dairy Federation
8
IFPRI
INFACT Canada
IFT
IACFO
ICGMA
8
8