The 36th Session of the CCFL was held in Ottawa, Canada from April 28 to May 2, 2008. The Session was attended by 273 delegates representing 72 member countries, one member organization, and 27 international organizations. The United States Delegation was headed by Dr. Barbara Schneeman of the U.S. Food and Drug Administration, with support provided by Dr. Heejong Latimer (alternate U.S. Delegate) of the USDA Food Safety and Inspection Service, 12 government advisors, and 6 non-government advisors.

The Session discussed numerous complex issues and made significant progress on most agenda items. The U.S. is particularly pleased that the Committee agreed to undertake new work related to the implementation of the WHO Global Strategy on Diet, Physical Activity and Health. The Committee also successfully resolved two agenda items related to quantitative ingredient declaration and a definition of advertising and advanced the documents to Step 8 for adoption by the Commission.

Specifically, the Committee:

• Agreed, in response to the WHO Global Strategy on Diet, Physical Activity and Health, to undertake new work on proposed amendments to the Codex Guidelines on Nutrition Labelling with respect to: 1) reviewing and revising the list of nutrients that are required to be declared and 2) developing general criteria for the legibility and readability of nutrient declaration. The Committee agreed to forward a project document on these two items to the Commission for approval as new work. Three electronic working groups will further consider these two items and a third item related to labelling dealing with food ingredients identified in the Global Strategy. A physical Working Group will convene immediately prior to the next Session to further consider these issues. The United States will be a member of these Working Groups.

• Endorsed the labelling provisions of various Codex Standards. The country of origin labelling provision within the Draft Standard for Ginseng Products was revised to be consistent with section 4.5.1 of the Codex General Standard for the Labelling of Prepackaged Foods.

• Continued consideration of the subject of the labelling of foods derived from modern biotechnology, eliminating the long-standing Guidelines at Step 4 and replacing that text with a new "Concepts" text at Step 3, and retaining the Definitions at Step 7. The Background Paper on how existing Codex texts could be used to address the labelling of foods derived from modern biotechnology, which was prepared by the U.S., Canada, and Nigeria, was well-received and countries noted the usefulness of the document. Concepts that were derived from this Background Paper and modified by the Ghana Working Group will be considered at Step 3 by the next CCFL Session.

• Decided, with respect to the Codex Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods:

• To discontinue work on the inclusion of sodium nitrite, potassium nitrate, ascorbate salts and certain phosphate salts into table 3 of Annex 2.
• To advance to Step 8 for adoption by the Commission the addition of ethylene and to return other possible uses of ethylene to Step 6.
• To undertake new work regarding the deletion of rotenone from Annex 2 and forwarded the project document to the Commission for approval as new work.

• Recommended for adoption at Step 8 revisions to the Quantitative Declaration of Ingredients provisions of the Codex General Standard for the Labelling of Prepackaged Foods.

• Recommended for adoption at Step 8 the definition of advertising as it relates to nutrition and health claims that was agreed to at the 35th CCFL Session, with the recommendation to include it as a footnote to the term "advertising" with section 1.1, Scope of the Codex Guidelines for Use of Nutrition and Health Claims.

• Agreed to continue work of the electronic working group to consider the development of principles related to the use of modified standardized common names. The United States will continue to be a member of the electronic Working Group.

A full report of the meeting, ALINORM 08/31/22, can be found on the Web site of the Codex Alimentarius Commission: www.codexalimentarius.net. The following is a brief summary of the Committee's substantive discussion on the various agenda items.

Draft Action Plan for Implementation of the Global Strategy on Diet, Physical Activity and Health

At the 35th Session of the CCFL, the Committee had agreed to establish a physical working group to be held immediately prior to the 36th Session to further consider various proposed actions outlined in the WHO Draft Action Plan for Implementation of the Global Strategy on Diet, Physical Activity and Health. The physical working group held on April 26, 2008, considered the following items:

• Proposed Action 1.2: Amend the Guidelines on Nutrition Labelling to require that nutrient declaration be mandatory on the labels of all prepackaged foods.
• Proposed Action 1.3: Expand the list of nutrients that are always declared to include energy, protein, available carbohydrate, sugars, fat, saturated fat, trans fatty acids, and sodium.
• Proposed Action 1.4: Develop additional criteria for the presentation of the nutrient declaration to enhance legibility.
• Proposed Action 1.5: Develop nutrient reference values (NRVs) for nutrients that are associated with both increased and decreased risks of NCDs.
• Proposed Action 3.1: Quantitative declaration of ingredients (QUID)

The United States supported the Committee's consideration of the above proposed action items as appropriate within the context of Codex mandate and priorities and in coordination with the Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). The United States elaborated on its experience with the implementation of mandatory nutrition labelling and noted the need for exemptions and special labelling provisions under certain circumstances. The U.S. also stated that cost/benefit analyses conducted in the U.S. clearly demonstrate the considerable benefits of this approach in terms of public health. With respect to criteria for presentation of nutrient declaration, the United States stated that general criteria or principles may be developed at the international level to ensure legibility and readability of nutrition information, but recommended that any criteria developed by CCFL should incorporate sufficient flexibility to permit national governments to determine the appropriate presentation of nutrient information based on the needs of their consumers. With respect to NRVs, the U.S. noted the ongoing work of CCNFSDU and suggested that CCNFSDU may consider additional nutrients with priority given to nutrients that are identified to be among the list of mandatory nutrients.

The Committee recognized that there was sufficient support to undertake new work with respect to proposed action item 1.3 (list of mandatory nutrients) and item 1.4 (general criteria for presentation of nutrient information). With respect to proposed action item 1.2 (mandatory nutrition labelling) the Committee agreed to develop a discussion paper outlining the issues and concerns that were raised at the Session. With respect to item 3.1 (QUID), the Committee agreed that this issue would be more appropriately addressed outside of the QUID provisions of the General Standard and within other guidelines related to claims. The Committee decided to establish three electronic working groups: 1) an electronic working group chaired by New Zealand, Australia, and Canada to develop a paper to examine the list of mandatory nutrients and to prepare a discussion paper outlining issues related to mandatory nutrition labelling; 2) an electronic working group chaired by the U.S. to develop general criteria or principles for the legibility and readability of nutrition labelling; and 3) an electronic working group chaired by Norway to develop a discussion paper on labelling dealing with food ingredients identified in the WHO Global Strategy.

The Committee agreed to convene a physical Working Group prior to the next Session of CCFL to further consider these issues and the results of the electronic working groups. The Working Group is mandated to 1) consider papers developed by the electronic working groups regarding (i) revision of Guidelines on Nutrition Labelling concerning the list of mandatory nutrients and a discussion of issues related to mandatory nutrition labelling; (ii) development of criteria/principles for legibility and readability of nutrition labelling; and (iii) labelling dealing with food ingredients identified in the WHO Global Strategy and 2) provide the 37th CCFL Session with recommendations to progress work in these three areas. The Committee agreed that the Working Group will be co-chaired by New Zealand, Norway, and the United States.

The Committee agreed to forward a project document on the list of mandatory nutrients and the legibility and readability of nutrition labelling to the Commission for approval as new work.

Endorsement of the Labelling Provisions of Draft Codex Standards

The Committee endorsed the labelling provisions in the:

• Draft standard for Gochujang;
• Draft Standard for Ginseng Products, with a revision to the country of origin declaration consistent with section 4.5.1 of the Codex General Standard for the Labelling of Prepackaged Foods;
• Draft Revised Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten;
• Draft Standard for Live and Raw Bivalve Molluscs; and
• Draft Code of Practice for Fish and Fishery Products; and
• Proposed Draft Amendment of the Codex Standard for Natural Mineral Waters.

The Committee did not endorse the labelling provisions of the Draft Standard for Bitter Cassava because of concerns of delegations that the safety of the product had not been adequately addressed in the Preparation Instructions included in the draft standard.

Labelling of Foods and Food Ingredients Obtained through Certain Techniques of Genetic Modification/Genetic Engineering

CCFL, at its 35th (2007) Session, elected to continue consideration of this subject and agreed to continue a Working Group co-chaired by Norway, Ghana and Argentina. The Committee also asked the United States, Canada and Nigeria to undertake an analysis of current Codex texts, particularly Codex labelling texts, to evaluate whether or not these texts supply sufficient guidance on the labelling of foods derived from genetic modification/genetic engineering. This Paper (CL 2007/38-FL), termed the Background Paper, became the focus of discussion at the 2008 meeting of the Working Group held in Accra, Ghana. The Working Group utilized portions of information presented in the Background Paper, along with other language, to prepare a new draft document, subsequently termed a "Concepts Paper" and contained in Appendix III of the Report of the Ghana Working Group.

The Committee had a lengthy discussion on this agenda item with the discussion focused on the Background Paper and the Concepts Paper.

The United States pointed out that the Background Paper was intended to address the needs of countries, particularly developing countries, for guidance on the labelling of foods derived from modern biotechnology. The United States noted that, from both the 2007 and 2008 Working Groups, it was clear that countries had developed different approaches to the labelling of foods derived from modern biotechnology due to different legal, regulatory and social frameworks. For this reason, reaching consensus at the international level on a labelling guidance for foods derived from modern biotechnology was not possible. The United States also noted the 1996-97 opinion provided by the Codex Executive Committee that "while consumers may claim the right to know whether or not foods had been prepared by such means, it also noted that the claimed right to know was ill-defined and variable and in this respect could not be used by Codex as the primary basis of decision-making on appropriate labelling." The United States stated that existing Codex texts can be applied to address issues related to the labelling of biotechnology foods and, therefore, recommended that CCFL discontinue its work on this subject and forward the Background Paper to the Commission for use as guidance to governments. Several delegations agreed with this approach.

Many other delegations supported further work on GM/GE food labelling focused on the Appendix III "Concepts Paper" based on the progress they felt had occurred at the Ghana Working Group meeting. Discussion points brought forward included many aspects of prior deliberations on the subject including the aspect of consumer right to know.

Some delegations pointed out that mandatory processed-based labelling would substantially increase the cost of production for food and feed manufacturers and negatively affect the availability of foods, which would especially affect developing countries and low income producers. It was also noted that the priority for governments and for CCFL should be the protection of public health and that there was contradiction in the fact that some member countries objected to mandatory nutrition labelling, which was supported by the WHO Global Strategy for Diet, Physical Activity and Health, but supported mandatory processed-based labelling of foods derived from modern biotechnology which was not related to food safety, nutrition or health.

After extensive discussion, based on the extent of views supporting and those opposing the continuation of work on this subject, the Committee agreed to continue work in this area. The Committee recommended that Appendix III (Concepts Paper) of the Report of the Ghana Working Group (CX/FL 08/36/8) replace the current Step 4 Guidelines on biotechnology labelling and become the working document on this subject; the current Step 4 text will, therefore, no longer remain in the Codex Step Procedure and no longer be considered. The Committee agreed that Appendix III should be considered in conjunction with the Background Paper and further agreed to circulate Appendix III for country comments at Step 3 of the Codex Step Procedure. Appendix III, along with country comments received, will then considered at the next CCFL Session.

No substantive discussion occurred on the current Step 7 document relating to definitions and the existing document was held at Step 7.

Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods (Agenda Items 4 a, b, c)

Draft Revised Annex 2: Table 3
At its last Session, the Committee had agreed to return to Step 6 some substances (sodium nitrite, potassium nitrate, ascorbate salts and certain phosphate salts) in Part 2 of the Table. There was disagreement among delegations on the appropriateness of the use of these substances in organic foods and the inclusion of these substances within the Table. After some discussion, the Committee noted that the list is indicative and that governments could determine whether additional substances could be allowed at the national level and agreed to discontinue work on this agenda item.

Draft Amendment: Addition of Ethylene
Several delegations supported the addition of ethylene, while others expressed the view that ethylene met the criteria for the use of substances in several other fruits in addition to kiwifruit and bananas. After further discussion, the Committee agreed that the required information on the use of ethylene had presently only been provided for the ripening of kiwifruit and bananas, but that further information is needed on possible uses of ethylene in other fruits. Therefore, the Committee agreed to advance to Step 8 for adoption by the Commission the addition of ethylene for ripening of kiwifruit and bananas, and return other possible uses of ethylene to Step 6.

Proposal for New Work: Deletion of Rotenone from Annex 2
The Delegation of Japan presented a proposal for new work and a project document concerning the deletion of rotenone as an insecticide from Table 2 of Annex 2. Some delegations supported the deletion of rotenone because of its toxicity to fish. However, other delegations pointed out that restricting its use to preventing it from flowing into waterways was sufficient to manage this risk and, therefore, these delegations did not support the deletion of rotenone. Following further discussion, the Committee agreed to undertake new work on this issue and forward the project document to the Commission for approval as new work.

Draft Amendment to the General Standard for the Labelling of Prepackaged Foods: Quantitative Declaration of Ingredients (QUID)

The Committee recalled that the Draft Amendment had been adopted at Step 5 by the 30th Session of the Commission.

The United States noted the significant progress made by the Committee at the 35th Session during a physical Working Group and the Plenary and recommended adoption of the text. The Committee discussed the text section by section and made a few minor modifications to the requirements relating to the presentation of the QUID information.

The Committee agreed to advance the Draft Amendment to Step 8 for adoption by the Commission.

Proposed Draft Definition of Advertising in Relation to Health and Nutrition Claims

At the previous Session, the Committee had an extensive discussion on this subject and agreed to the text defining the term "advertising" for its use in relation of health and nutrition claims. The Committee recalled that the proposed draft definition had been adopted at Step 5 by the 30th Session of the Commission, which recommended that CCFL clarify in which text this definition should be included when finalized.

The United States reiterated its previous position that advertising is best defined at the national level and noted the extensive discussions on this issue at the 35th Session of CCFL. The United States also recognized the significant compromise reached by that Session on a definition for this term and observed that the agreed-upon definition of advertising is limited in its scope to its relation to health and nutrition claims only and not to a broader definition of advertising. Therefore, the United States recommended that the definition should be included within the Codex Guidelines for Use of Nutrition and Health Claims (CAC/GL 23-1997, Rev. 1-2004) and an appropriate placement of this definition would be as a footnote to the term "advertising," which appears in section 1.1, Scope of the Guidelines. Several countries supported the U.S. suggestion to place the definition as a footnote within the Scope.

Other countries, however, recommended the placement of the definition within the "Definitions" section of the Guidelines. After some discussion and confirmation given by the Codex Secretariat that footnotes were considered as an integral part of Codex texts, several delegations that were in favor of inclusion of the definition under "Definitions" stated that they could accept its inclusion as a footnote within "Scope" of the Guidelines.

The Committee agreed to advance the draft definition as agreed to at the 35th Session to Step 8 for adoption by the Commission. The agreed-upon definition is:

"Advertising means any commercial communication to the public, by any means other than labelling, in order to promote directly or indirectly, the sale or intake of a food through the use of nutrition and health claims in relation to the food and its ingredients."

The Committee agreed that the definition would appear as a footnote to the word "advertising" in paragraph 1.1 of the Guidelines for Use of Nutrition and Health Claims.

Discussion Paper on Modified Standardized Common Names

The Delegation of Canada introduced a discussion paper and project document, based on discussions of the electronic working group, on the issue of naming of standardized foods that are modified to qualify for Codex-defined nutrition claims. The electronic working group identified certain general principles or conditions for the use of modified names of standardized foods that undergo nutritional modifications.

The United States along with other delegations stated that food standards should not impede the development of healthier formulations of a food and supported the development of horizontal guidelines for the naming of nutritionally modified standardized foods. These delegations emphasized the importance of this work in relation to the implementation of the WHO Global Strategy for Diet, Physical Activity and Health and recommended that CCFL undertake the new work stated in the project document.

Some other delegations, however, were concerned about the impact of this work on existing commodity standards and stated that nutritional modification of standardized foods would need to be addressed on a case-by-case basis, not through the development of horizontal principles. The Committee concluded that there was no consensus to move the project document to the Commission to request new work. The Committee, however, decided to continue work in this area and asked the electronic working group to consider in more detail the scope of the new work and its impact on other Codex standards. The United States will continue to be a member of this electronic Working Group.

Date and Place of the Next Session of CCFL

The date and place of the 37th Session was tentatively indicated to be May 4 to 8, 2009, in Calgary, Alberta.

The Committee was informed that, as a result of retiring from government service, Dr. Anne McKenzie was chairing the Committee for the last time and that the next Session would be chaired by Mr. Paul Mayers of the Canadian Food Inspection Agency.