January 15, 2013

Secretariat, Codex Alimentarius Commission, Joint WHO/FAO Food Standards Programme
Malaysian Secretariat for CCFO, Food Safety and Quality Division, Ministry of Health Malaysia

Re: Proposed Draft Standard for Fish Oils

Dear Secretariat, Codex Alimentarius Commission:

The Council for Responsible Nutrition (CRN) submits this letter on behalf of its members to provide comments on the Proposed Draft Standard for Fish Oils. CRN is an international non-governmental organization (NGO) officially recognized by the Codex Alimentarius for more than a decade. CRN has participated as a Codex Observer on the eWG responsible for the development of the Proposed Draft Standard for Fish Oils.

CRN represents the interests of U.S. and international companies involved in the dietary/food supplement industry. CRN staff and representatives commonly participate in several Codex meetings each year, with emphasis on the CAC, CCNFSDU, CCGP, and CCFL. CRN frequently submits written comments on scientific and technical issues, including nutrient risk assessment, nutrient reference values, health claims, and proper uses of precaution.

Summary of recommendations:

Further details on these recommendations are outlined below.

Section 2.5, Concentrated fish oils

The process definitions should be removed because they are too restrictive and limit future innovations in fish oil processing. There is no need to list steps used to concentrate oils for it could be misconstrued that these are the only steps allowed. The art and science of concentrating oils is always evolving and innovation is an important part of fish oil refining. CRN is concerned that a list of specific steps that can be used to concentrate oil may not cover all methods currently in use, and may hamper future innovation.

We recommend that the process steps be removed from section 2.5.

Section 3.1, GLC Ranges of fatty acid composition
CRN is significantly concerned with Table 1 on fatty acid profiles for named fish oils. Table 1 was designed to provide a tool to identify named fish oils as per their fatty acid profiles. However, CRN questions the validity and/or reproducibility of the data provided. We are concerned that the source of data for named fish oils cannot be traced to specific fishing zones and years. We question whether the data listed for each named fish oil in Table 1 are representative of all the major global fisheries. Furthermore, CRN is aware that the data in Table 1 have not been confirmed by a qualified entity or third party.

CRN’s concerns stem from the fact that fatty acid profiles are prone to significant fluctuations. Factors that impact fatty acid profiles include geographical waters, food sources, environmental conditions and variations of seasonal fisheries. The International Alliance of Dietary/Food Supplement Associations (IADSA) has submitted comments on the Codex Proposed Draft Standard for Fish Oils that include Annex I, Scientific Implications of Reliance on Fatty Acid Profiling for Fish Identification. As a member of IADSA, CRN agrees that Annex I provides additional scientific justification for the concern that data in Table 1 may not be representative of global fisheries.

We request a more in-depth review of the data used to develop Table 1 to ensure scientific validity.

Section 3.2, Oxidation parameters
CRN is concerned with the oxidation exemptions for flavored fish oils. Crude fish oils are exempt, which we feel is acceptable. However, flavored oils should not be exempt. CRN is aware that added flavors can skew acid and peroxide values and lead to false positive test results for oxidation. Therefore, for flavored fish oil, standard testing methodology and limits are not fit-for-purpose. However, the Proposed Draft Standard for Fish Oils, as currently written, creates a quality loophole that will allow low-quality fish oils the privilege of not having to meet the standard acid and peroxide values simply by adding flavors.

We recommend incorporating realistic oxidation parameters for flavored fish oils.

Section 4, Food Additives
The Proposed Draft Standard for Fish Oils references the Codex Genearl Standard for Food Additives (Codex Stan 192-1995). Specifically, antioxidants used must be in accordance with Category 02.1.3 Lard, tallow, fish oil and other animal fats. CRN feels this is inappropriate due to the fact that there are critical antioxidants commonly used in fish oils that are absent from Category 02.1.3.

We recommend that this issue be deferred to the Codex Committee on Food Additives. Codex Standard 192-1995 needs to be revised to address this critical omission.

Section 5, Contaminants
As stated in the Proposed Draft Standard for Fish Oils, contaminants shall comply with the maximum levels stated in the Codex General Standard for Contaminants and Toxins in Food and Feed (CODEX STAN 193-1995). There is no mention of contaminants such as PCBs, dioxin and furans that are commonly included in fish oil monographs.

We recommend that this issue be deferred to the Codex Committee on Contaminants in Foods.

Section 8, Methods of Analysis and Sampling
CRN disagrees that only selected test methods are defined as acceptable. There needs to be an acceptance of alternative validated methods such as USP, PhEur, and EPA.

We recommend that this issue be deferred to the Codex Committee on Methods of Analysis and Sampling.

Sincerely yours,

Douglas MacKay, N.D.
Vice President, Scientific & Regulatory Affairs

James C. Griffiths, Ph.D., DABT
Vice President, Scientific & International Affairs