DH Letter, 15 November 2010
Article 14(1) claims related to docosahexaenoic acid (DHA): EFSA Questions 2008-690, 691, 212, 666, 675, 773, 211, 688, 689
Discussion focused on a draft Regulation that would authorise four claims and reject three and which will be tabled for a vote at the 6 December meeting of the Standing Committee on the Food Chain and Animal Health (SCOFCAH).
'ALA contributes to the brain development of children'
Several delegates reiterated concerns that this claim might be misleading given the low conversion rate of α-linolenic acid (ALA) to DHA. The Commission confirmed that the target population is children 0-18 years of age, citing EFSA advice.
'DHA has a structural and functional role in the retina and DHA intake contributes to the visual development of infants up to 12 months of age'
The conditions of use (COU) would allow the claim on other foods as well as follow-on formula. There was discussion about how to amend COU in order to make the target populations clear. In response to a question about whether the claim could be used on foods for special medical purposes (FSMPs) the Commission said that the intention of the legislation (i.e. the nutrition and health claims regulation and the infant formula directive read together) was that where an FSMP was used in place of an infant formula then the claim could not be used. One member state (MS) suggested that this should be explicit in the COU but the Commission was against this as it was not normal practice.
'DHA has a structural and functional role in the retina and maternal DHA intake contributes to the normal development of the eye of the foetus and breastfed infants' and 'DHA has a structural and functional role in the brain and maternal DHA intake contributes to the normal brain development of the foetus and breastfed infants'.
The only significant discussion was on technical points about the drafting of the Regulation.
‘DHA and ARA contribute to the optimal brain development of infants and young children’; ‘Lipil® contributes to optimal brain development of infants and young children’; ‘Enfamil® contributes to optimal brain development of infants’
These claims are included in the Annex of rejected health claims in the draft Regulation.
Negative EFSA opinion Q-2010-00137 on Lactobacillus casei strain Shirota and maintenance of upper respiratory tract defence against pathogens (Article 13.5)
The Commission has received comments from stakeholders but not yet from the applicant (deadline 18 November) therefore this claim will be discussed in Working Group after EFSA has responded to comments.
Exchange of views on health claims with positive opinions in the third series of EFSA opinions
There were few comments as MS had not yet had time to consider all the opinions. There will more discussion about this in future Concerns were expressed about :
- claims for 'X...contributes to normal psychological functions' which might mislead consumers into thinking that foods could cure depression; and
- the different conditions of use for 'plant stanols / sterols help maintain normal blood cholesterol concentrations' compared with the disease risk reduction claim ‘plant sterols and plant stanol esters have been shown to lower/reduce blood cholesterol.’ .
EFSA will correct its opinion on live yogurt cultures and improved lactose digestion so that the COU relate to 'per g culture’ rather than 'per serving'.
In response to questions the Commission agreed that, in principle, the seven claims in this batch where the EFSA opinion said that the evidence was insufficient to substantiate the claim could be added to the list of claims that may be accorded a ‘further assessment’ even though this ‘grey list’ will not be established soon. However, it was also agreed that food business operators could submit Article 13.5 applications for claims that were candidates for this list before the list was established.
Discussion on the setting of conditions of use for Article 13.1 claims
The Commission's working document on the principles of setting COU for Article 13.1 claims was welcomed by many MS. The Commission will amend the document in light of MS' few comments and it will be discussed again.
Draft Commission guidance on MS’ validity checks of health claim applications
The Commission will consider making minor amendments in response to a few comments from MS then the document will go to SCOFCAH in the new year.
There was a brief discussion about whether 'beauty' claims e.g. ‘this food contains X which reduces skin wrinkles’ are within the scope of the nutrition and health claims regulation (NHCR). Some participants were of the view that such claims need to be considered on a case-by-case basis to see if they fall within scope – if they are linked to a function of the body then they may do. The Commission is considering how to deal with beauty claims if they are linked to a claimed psychological benefit; this will be discussed in future in relation to specific claim applications.
In response to a question about whether claims on restaurant menus would fall within the scope of the NHCR the Commission referred to Article 1.2 NHCR which states that the Regulation applies to nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered to the final consumer.
The next Commission Working Group meeting on health claims will take place on 10 December 2010.