FSA Interested Parties Letter (CPD/0093), 5 February 2010
This letter mentions 3 annexes. They are available on this site. See Annex 1 (xls file), Annex 2 (pdf file) and Annex 3 (xls file)
This letter provides an update on the status of a number of claims that were submitted by the UK under Article 13 of Regulation (EC) 1924/2006 and have not yet undergone assessment by the European Food Safety Authority (EFSA). This is likely to be of most interest to those who submitted claims to the UK list but it is being copied for information to all stakeholders who have asked to receive updates on claims legislation.
Claims falling outside the scope of Article 13 and product specific claims
As we informed you in our update letter following the Commission Working Group meeting on claims on 14 December 2009, 37 claims on the list of Article 13 claims awaiting assessment by EFSA had been identified as falling outside the scope of Article 13 of the Regulation. Member States were asked to provide justification to the Commission by 31 December 2009 if they considered these claims should remain in the Article 13 process, otherwise they would be withdrawn.
Annex 1 of this letter lists those claims identified as out of scope and, for those claims that were submitted by the UK, column G indicates the reason for this conclusion. All UK-submitted claims in Annex 1 will be withdrawn.
A further 226 claims had been identified as falling outside the scope of Article 13 of the Regulation because they were product specific. As the Article 13 list is intended to be generic, product specific claims should be submitted under Article 13(5) of the Regulation, following the procedure laid down in Article 18.
Claims identified as product specific were those where:
(a) the food component is clearly product specific i.e. there is a reference to brand name/trade mark; or
(b) the wording solely refers to a specific product or brand name/trade mark; or
(c) the scientific studies refer to a specific product and there is not evidence to support a generic claim.
Member States were asked to provide justification to the Commission by 31 December 2009 if they considered the claims on this list were not product specific and therefore should remain in the Article 13 process, otherwise they would be withdrawn. The Commission did not afford Member States the opportunity to amend claims to remove reference to specific products.
At the Commission Working Group meeting on 15 January, some Member States queried whether it was appropriate to reject claims that referred to a specific product or brand name/trade mark if full information on the food component was also given in addition to this. On 25 January the Commission clarified that such claims could remain on the Article 13 list, providing the scientific studies support a generic claim. However, claims where the sole reference is to the specific product or brand name/trade mark will be withdrawn.
Annex 2 to this letter lists those claims identified as product specific. The Agency checked the claims and found that a number of those identified are not truly product specific as neither the food component nor the health relationship refer solely to a specific product and either all the references or the majority of the references refer to a generic food component and not a specific product. We have indicated these claims with “YES” in column L of the spreadsheet and notified the Commission that they should remain on the Article 13 list. Those claims with “NO” in column L are product specific and will be withdrawn. The Agency has only checked the claims that were submitted by the UK.
Comparative claims
In August 2009 we informed submitters that EFSA had experienced difficulties in assessing claims about a health effect that, rather than referring to a direct relationship between consumption of a particular food and health, results only when the food is eaten instead of another product which has not been clearly defined (“comparative claims”) e.g. “keeps you feeling fuller for longer”, “kinder to your teeth”. Member States and the Commission discussed comparative claims at subsequent Commission Working Group meetings and decided that such claims should remain on the Article 13 list and EFSA will proceed with evaluation of these claims. This position is confirmed in EFSA’s briefing document on Article 13 claims . However, Member States have been unable to submit further clarification in support of these claims so the additional information submitters sent to the Agency in 2009 to define the comparator for these claims has not been passed to EFSA. EFSA will assess these claims based on the information in the original application.
Addendum of missing claims
Our letter of 19 January highlighted that the Commission recently produced an addendum of Article 13 claims that were notified as missing from the list published on EFSA’s website in January 2009. Member States were asked to provide justification to the Commission by 31 December 2009 if they considered these claims should remain in the Article 13 process, otherwise they would be withdrawn. In deciding whether these claims were eligible for assessment by EFSA, the Agency checked them against EFSA’s six screening criteria and took into account EFSA’s briefing document on Article 13 claims.
The Agency gave submitters an opportunity to clarify these claims in December. We received very few responses providing additional information and, of those that we did receive, the majority did not sufficiently clarify the claims to make them eligible for assessment by EFSA. Many claims were deemed ineligible because the proposed health effect was too vague. When checking this, we looked first at the health relationship and, if the claimed effect was not clear, then the example wording, in line with EFSA’s approach. Where no well-defined and measurable health effect had been proposed, or where a number of different health effects had been proposed and it was not possible to determine which one to put forward to EFSA, the claim was deemed ineligible.
Annex 3 of this letter lists the UK-submitted claims on the addendum and column H indicates whether the claim is considered eligible for assessment by EFSA and, if not, the reason for this conclusion. Those claims with “YES” in column H of the spreadsheet are those that the Agency has notified the Commission should remain on the Article 13 list because we considered they have a well-characterised generic food component, clear conditions of use and that either the health relationship or example wording provides a single clear and measurable health relationship. All other claims in Annex 3 will be withdrawn. We have not updated Annex 3 to show the additional information provided by submitters in December unless we considered this was sufficient to clarify the claims.
Claims for which submitters provided further information in response to the clarification exercise following EFSA’s initial screening of claims
Member States were asked to send this information to the Commission by 31 May 2009 (for claims where only one Member State was involved) or 30 June 2009 (for claims where more than one Member State was involved). The Agency passed the information provided by submitters to the Commission or, where relevant, the Member State responsible for compiling comments for that claim in advance of these deadlines. The Commission has passed this clarification to EFSA but the list of claims on EFSA’s website has not yet been updated to reflect this. EFSA has informed Member States that it hopes to update the list as soon as possible, but we do not yet know exactly when this will be.
We will continue to keep you informed about developments with the Article 13 process via our usual update letters as discussions in Commission Working Group progress.
If your claim has been identified as being withdrawn from the Article 13 list and you want to continue to use it in future you will need to consider submitting a dossier application. If you intend to submit a dossier application under Article 13(5) or 14, you should refer to EFSA’s technical guidance on compiling and presenting dossiers, which should be followed as closely as possible . EFSA has also recently published a frequently asked questions document which addresses key issues in the assessment of scientific dossiers which should help when preparing applications. You should also refer to EFSA’s pre-submission guidance which addresses a number of administrative and procedural issues.
The Commission has indicated that it intends to produce guidance on submitting claims under Article 13(4) of the Regulation in the near future. The information required and format for presenting this is likely to be similar to that required for dossier applications under Article 13(5) and 14.