EPA/DHA omega-3 health claims update

Further to the recent negative EFSA opinion for Equazen eye q, GOED reviews the current health claims landscape for omega-3s in Europe

In October, the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) determined that there was insufficient evidence to warrant a positive opinion for a cause and effect relationship between the consumption of Equazen eye q, a product containing EPA and DHA, as well as gamma-linolenic acid (GLA) and improving reading ability in children.

As research in this area is still emerging, the negative opinion came as no surprise, given EFSA’s very strict interpretation of science related to health claims. In light of this most recent opinion, GOED thought it was time to review the health claims landscape for omega-3s in the EU. The reality is that EPA and DHA, more than any other nutrient, have received positive opinions. Given the strict regulatory regime under which the evaluations are conducted, this is testament to the well-established benefits associated with long-chain omega-3s.

In the EU, health claims are classified as either Article 13(a) (health claims other than those referring to the reduction of disease risk and to children's development and health) or Article 14 (reduction of disease risk claims [1][a] and claims referring to children's development and health [1][b]). To date, nine health claims, including six Article 13(1)s and three Article 14(1)(b)s have been authorised for use. An additional Article 14(1)(b) health claim for DHA has received a positive opinion from EFSA and an Article 13.5 health claim petition has been submitted and is pending review.

Article 13(1) health claims authorized for use

Claim: DHA contributes to the maintenance of normal brain function.

Conditions of Use: The claim may only be used for food that contains at least 40mg of DHA per 100g and per 100kcal. To bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 250mg of DHA.

Claim: DHA contributes to the maintenance of normal vision.

Conditions of Use: The claim may only be used for food that contains at least 40mg of DHA per 100g and per 100kcal. To bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 250mg of DHA.

Claim: EPA and DHA contribute to the normal function of the heart.

Conditions of Use: The claim may only be used for food that is at least a source of EPA and DHA as referred to in the claim: 'Source of Omega-3 Fatty Acids.' To bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 250mg of EPA and DHA.

Claim: DHA contributes to the maintenance of normal blood triglyceride levels.

Conditions of Use: The claim may only be used for food that provides a daily intake of 2g of DHA and which contains DHA in combination with eicosapentaenoic acid (EPA). To bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 2g of DHA. When the claim is used on food supplements and/or fortified foods, information shall also be given to consumers not to exceed a supplemental daily intake of 5g of EPA and DHA combined. The claim shall not be used for foods targeting children.

Claim: DHA and EPA contribute to the maintenance of normal blood pressure.

Conditions of Use: The claim may only be used for food that provides a daily intake of 3g of EPA and DHA. To bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 3g of EPA and DHA. When the claim is used on food supplements and/or fortified foods, information shall also be given to consumers not to exceed a supplemental daily intake of 5g of EPA and DHA combined. The claim shall not be used for foods targeting children.

Claim: DHA and EPA contribute to the maintenance of normal blood triglyceride levels.

Conditions of Use: The claim may only be used for food that provides a daily intake of 2g of EPA and DHA. To bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 2g of EPA and DHA. When the claim is used on food supplements and/or fortified foods, information shall also be given to consumers not to exceed a supplemental daily intake of 5g of EPA and DHA combined. The claim shall not be used for foods targeting children.

Article 14(1)(b) health claims authorized for use

Claim: Docosahexaenoic acid (DHA) maternal intake contributes to the normal brain development of the foetus and breastfed infants.

Conditions of Use: Information shall be given to pregnant and lactating women that the beneficial effect is obtained with a daily intake of 200 mg of DHA in addition to the recommended daily intake for omega-3 fatty acids for adults (250mg of DHA and EPA). The claim can only be used for food that provides a daily intake of at least 200mg of DHA.

Claim: Docosahexaenoic acid (DHA) intake contributes to the normal visual development of infants up to 12 months of age.

Conditions of Use: Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 100mg of DHA. When the claim is used on follow-on formula, the food shall contain at least 0.3% of the total fatty acids as DHA.

Claim: Docosahexaenoic acid (DHA) maternal intake contributes to the normal development of the eye of the foetus and breastfed infants.

Conditions of Use: Information shall be given to pregnant and lactating women that the beneficial effect is obtained with a daily intake of 200 mg of DHA in addition to the recommended daily intake for omega-3 fatty acids for adults (250mg of DHA and eicosapentaenoic acid [EPA]). The claim can only be used for food that provides a daily intake of at least 200mg of DHA.

Health claims not yet authorised

In October 2014, EFSA delivered a positive opinion on the scientific substantiation for a health claim pursuant to Article 14(1)(b) for 'DHA contributes to normal brain development.' According to the opinion, to bear the claim, foods for children aged 6–24 months should provide a daily intake of 100mg of DHA in one or more servings, whereas foods for children from 2–18 years should provide a daily intake of 250mg of DHA in one or more servings.

If the Panel’s opinion carries through for adoption, as is, by the European Commission, the claim would stress the importance of DHA for children. This is significant. It would be the first recognition of the importance of DHA in children’s brain development beyond infancy, and also an important recognition that our brains continue to develop until adulthood.

On 24 July 2015, DSM Nutritional Products submitted a dossier for an Article 13.5 health claim for 'DHA contributes to improved memory function.' The claim is currently under consideration by EFSA. The outcome of this claim will be interesting to watch, particularly as the Federal Trade Commission (FTC) in the US disagreed with the data supporting this claim. In a rather narrow interpretation, the FTC said that memory claims were only supported if you could demonstrate a benefit in every single domain of memory. As the FTC is not a scientific body, it will be noteworthy to see how EFSA evaluates and interprets this evidence from a more rigorous scientific perspective.

Overall, the track record for EPA and DHA claims is very strong. More claims have been approved for use in Europe for EPA and DHA than most other nutrients. However, one of the key issues we see in the development of new functional foods, and to some extent in dietary supplements, is that less expensive ingredients have also received cardiovascular and brain health claims.

This means that EPA and DHA now compete with other ingredients for incorporation in new products, which was not a factor prior to the health claims regulations. However, these two new claims, if approved, could provide some competitive insulation for omega-3s by opening up a new target consumer that other nutrients cannot reach and/or in a new area where no claims exist for other nutrients. These should be considered to be positive developments for the omega-3 market.

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