Reference resistance for omega-3s


Work to establish a Codex nutrient reference value for EPA+DHA is off to a slow start

Last year in Nutraceutical Business Review (Vol. 2/Number 3), GOED optimistically reported on the possibility of having a Nutrient Reference Value–Non-Communicable Disease (NRV-NCD) for EPA and DHA adopted at Step 5/8 at the 39th Session of the Codex Alimentarius Commission in the summer of 2016.

This would basically be the Codex equivalent of a recommended intake being established on the basis of chronic disease risk reduction data.

After participating in the 37th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), GOED can report with confidence that the NRV-NCD will not be established this year. In fact, soon after GOED’s last update on this topic, the issue began to meet with unanticipated resistance.

After the first consultation, all but two countries appeared to be in favour of establishing an NRV for EPA+DHA. By the time the CCNFSDU convened in November, more than a handful of countries were pushing back on the effort.

For an hour and a half, the Committee debated the issue. As recounted in the meeting report, those delegations and observers who supported the recommendation of 250mg/day pointed out that there was sufficient evidence to support the link between the NRV-NCD and a reduction in the risk of coronary heart disease (CHD) mortality.

In fact, when GOED was acknowledged by the Committee chair to speak, it made the following points:

  • intake of EPA/DHA from either oily fish or supplements results in an increase in the omega-3 index — a biomarker of risk for cardiovascular disease; a low omega-3 index is associated with an increased risk of cardiac death
  • there are strong documented cardiovascular benefits associated with both fatty fish consumption and taking EPA/DHA supplements: for example, in 2012, a meta-analysis published by the Agency for Healthcare Research and Quality (AHRQ), a US government funded agency included RCTs of EPA and DHA supplementation and large prospective cohorts quantifying EPA and DHA intake from fish; in RCTs, the risk of cardiovascular mortality (14 trials, 48,500 patients) was reduced by 11%; from seven cohorts (123,122 participants), EPA and DHA intake (up to 0.20g/day ) was associated with a statistically significant (36%) decreased risk of cardiac death.

Those delegations (no observers offered dissent during the meeting) of the opinion that it was premature to establish an NRV-NCD of 250mg/day expressed that the relationship between EPA and DHA and mortality from CHD had not been sufficiently characterised.

In addition, they claimed that the evidence is largely based on the consumption of fish and it is not clear whether it is possible to extrapolate the results to EPA+DHA. There are long-term prospective cohort studies that differentiate between the effects of lean and fatty fish, the fat predominantly being EPA and DHA, but this was largely not discussed in the evidence reports.

Given the lack of consensus about the scientific substantiation, many country delegates recommended a third-party review of the science supporting the cardiovascular benefits. GOED views this as a positive outcome because at least the process would still be alive and deeper reviews of the foundation of omega-3 science are always welcome. The question, then, was whether the review should be directed to the World Health Organization (WHO) Nutrition Guidance Expert Advisory Group (NUGAG) or the Joint FAO/WHO Expert Meetings on Nutrition (JEMNU).1,2

In line with the Nutritional Risk Analysis Principles for the CCNFSDU, which acknowledges FAO and WHO as the primary source of scientific advice, there was significant support for initiating a request to JEMNU and for FAO and WHO to work together to provide scientific advice to CCNFSDU.

Despite this support, it was finally agreed that as NUGAG was already in the process of initiating work on a review on polyunsaturated fatty acids, the Committee could evaluate the NUGAG work as it becomes available. Supposedly, a preliminary report is to be available prior to the next session of the Committee. Given that the work has yet to be scoped, it’s not clear how this is going to happen.

At the end of the discussion, the Committee agreed to re-establish the electronic working group (e-WG), led by Russia and Chile, to further develop the NRV-NCD for EPA and DHA in accordance with the General Principles for Establishing Nutrient Reference Values for the General Population (Annex to the Guidelines on Nutrition Labelling (CAC/GL 2-1985), also taking into account the work of NUGAG.

In addition, the Committee agreed to return the proposed draft NRV-NCD for EPA and DHA to Step 2/3 for consideration by the next session (November 2016). On the surface, this may seem like a setback, but GOED reminds the reader that the proposed draft standard for fish oil, which is being worked on by the Codex Committee on Fats and Oils (CCFO), had a similarly slow start. If everything goes as anticipated that standard should be adopted at the Codex Alimentarius Commission meeting in the summer of 2017.

As for the NRV-NCD process, this means there will be at least a one-year delay in the process, but it will be interesting to see how much resistance the proposal meets once the new scientific review is completed. The concerns raised were mostly cosmetic and GOED does not believe the conclusions of the scientific review will change significantly. So, if all nations’ concerns are addressed in the design of the review and the evidence is still supportive, then resistance to the NRV-NCD may indicate other politics at play.