FSA Interested Parties Note, 15 March 2010
Revision of the nutrition claims annex to 1924/2006 is still on hold pending intra-Commission discussion.
The Commission is considering the potential impact of a “now contains X% less” claim and has requested that Member States provide any information (economic or public health) to inform discussions e.g. if it’s been used already have dietary intakes changed? If X were 15% rather than 10% what impact would this have on reformulation activity?
HEALTH CLAIMS APPLICATIONS, EFSA OPINIONS AND DRAFT DECISIONS
DHA and ALA Article 14 health claims
There was a short, inconclusive discussion about the proposed wordings and conditions of use for these claims trying to take into account the various pieces of advice received from EFSA; the scope of the various health claim applications being considered (including the evidence within them); and the need to provide claim wording that would not convey the wrong message to consumers. There may be further discussion at the next CWG meeting.
Proprietary data – interpretation of Article 21 of 1924/2006
One Member State disputed the Commission’s interpretation of Article 21 of 1924/2006 on proprietary data i.e. that, for health claim applications, data could not be claimed as proprietary if they had been published before the health claim application was submitted. The Commission reiterated that its view would stand until it saw good reason to change it and invited anyone to make proposals.
The Commission has sent the ‘addendum’ of outstanding Article 13(1) claims to EFSA for assessment. No more claims can be submitted under the Article 13(3) procedure. EFSA will update its database as soon as possible.
LIST OF ARTICLE 13 HEALTH CLAIMS
Exchange of views on working document outlining the envisaged decision flow chart on Article 13 claims assessed by EFSA
The Commission introduced the flow chart attached to this note [See: Flow Chart] as a proposed way of completing the assessment of those claims for which EFSA had said that the evidence was insufficient for substantiation (approximately 20/523 applications in EFSA’s first batch) and those where microorganisms (probiotics) had not been sufficiently characterised.
The Commission’s proposed process and timeline are as follows: the aim is that the first part of the Article 13 positive list of authorised health claims will be voted on at Standing Committee on 26 April and, following scrutiny, could be adopted in September. From the time of adoption, food business operators (FBOs) would have 3 months to submit new information to justify going back to EFSA. Three months was considered a reasonable time to allow for this since FBOs had told the Commission / EFSA that they already have the information they think EFSA would require. The Commission stressed that the new information must be relevant to the claim, should not have been assessed already and must be judged likely to make a difference to EFSA’s opinion; for example, it might include information that was not available in January 2008. Since the new information will be submitted via Member States then they must take a view on whether new information put forward by FBOs was likely to be useful to EFSA in looking again at applications. In this context, the Commission said that it did not expect to see any cases of new information being offered for claims where EFSA had clearly said that they were ‘not substantiated’.
The Commission suggested that new information might be submitted either through the Article 13(4) route or the Article 13(5) route via the Article 18 procedure. It suggested that the Article 13(5) route would be better for the following reasons: it would avoid the problems that had occurred in the Article 13(3) process; EFSA would have a clear timeline to work to; EFSA could communicate directly with FBOs; the procedure is clearly set out in 1924/2006.
When the positive list is adopted the legal measure will forsee, but not include, a list of rejected claims, in order to allow for the re-assessment of some claims. At that time the Commission will list, on its website, those claims for which new information can be submitted (i.e. those with ‘insufficient’ information for substantiation and the probiotics where the microorganism was not characterised.) Claims for which new information is not then submitted within the three-month period would subsequently be placed on the list of rejected claims.
EFSA commented that, in order to reassess the applications under discussion, it would need all of the information for each application, not just the new information.
The Commission said that it would put all of this in a paper so that its proposal would be clear for all stakeholders.
The Commission asked for views on whether the Article 18 procedure was the appropriate one for submitting the new information envisaged and whether giving FBOs three months to do this was reasonable.
Evidence of ‘traditional use’ for botanicals and evidence from sick people
The Commission used the flowchart to initiate a discussion about the role of evidence of traditional use in the substantiation of health claims on botanicals and about the role of evidence from sick people in the substantiation of health claims aimed at the normal population.
Many Member States thought that it could be reasonable to use evidence of traditional use as part of the evidence submitted in support of a health claim for a botanical claim and that it could be weighed, by EFSA, during the assessment process. The relevance of that information would have to be considered on a case-by-case basis. EFSA responded that it would look at all the evidence but if this evidence did not include scientific conclusions then it cannot be taken into account.
On the question of whether evidence from sick people could be used in substantiating a claim aimed at the normal population a number of Member States considered that this needed to be considered on a case-by-case basis.
Health claims in the first batch of EFSA opinions for which EFSA concluded there is sufficient evidence for substantiation
There was no time for discussion.
Health claims in the second batch of EFSA opinions
There was no time for discussion.
Next meeting: 12 April 2010.