FSA Interested parties Letter (CPD/0016), 16 September 2008
The Commission Working Group on Nutrition and Health claims met on 5 September. The agenda comprised of nutrient profiles, the Article 13 health claims process and the EFSA opinions on Article 13(5) and Article 14 claims.
EFSA presented its revised food database for nutrient profiles. This was made up of available data from a limited number of member states, supplemented by data submitted by two or three others, and industry data where this fit the format of the database. Licensing problems meant that the whole database of some 20,000 entries cannot be made public, but a limited shared database of some 3,000 entries will be made public, of which 1,000 – 1,500 foods will make up the ‘test basket' to help develop models.
Foods are grouped under categories taken from Eurofir, with sub-categories devised for the operation of exemptions, if necessary. Some adaptation was necessary, such as placing soy drinks with dairy products, based on consumption pattern, and member states will be asked to comment on this before it is finalised.
The Commission has updated its spreadsheet tool, which comprises the test basket, and allows the different models to be tested. This was subsequently circulated to Member States and should be available to stakeholders through the European trade bodies, but I have also attached a copy to this e-mail [see links below].
The intention is that the Commission will update the Working Document it circulated in June for detailed discussion at the next meeting. Member States were asked to consider the key questions – structure, nutrients, base, exemptions, threshold levels, definition of category, etc – and to undertake their own testing of these aspects using the spreadsheet tool.
There was discussion of interpretation of the derogations available in Article 4 – use of a ‘reduced' claim, and one nutrient disclosure – with a divergence of view about whether these apply together or exclusively. The Commission did not seek a conclusion, but reminded Member States that any interpretation they take can be tested in the European Courts of Justice.
Article 13 process
The Commission explained the consolidation of the list after the last round of consultation and the response to the published database. It noted that Member States continued to insist that some claims were missing and it would look at these again; however, EFSA was concerned about the size of the list and some means of managing this was required. The Commission thought that many of these “missing” claims might be there, but presented slightly differently and asked Member States to bear this in mind. There was continued concern about non-measurable components of claims, in particular conditions of use, but also health relationships or in a few cases, substances. This was particularly the case with many botanical claims, where the condition of use given was “traditional use” or something similar, or where lack of specification of the substance would not allow EFSA to give an opinion. The Commission said it planned to hold a discussion with stakeholders here. Lack of specification of the substance was also a problem in probiotic claims, which (with the possibility of some limited exception) would need a specific strain to be identified.
EFSA introduced the recently published opinions on applications for claims under Article 13(5) (proprietary data) and Article 14 (disease risk reduction or claims referring to children's development and health). Member States welcomed the standard of EFSA's rigour in these assessments. The Commission said that the procedure was that it must now propose decisions on these applications, for discussion at 13 October Standing Committee. The Commission also stated that it had had enquiries about withdrawing applications for authorisation and said that once EFSA has published an opinion, the Regulation requires a decision by Standing Committee, so any withdrawals must be before an EFSA opinion.
Validating claims applications
The Commission had presented a paper interpreting Article 15 to say that Member States were responsible to ensure Article 14 claims were valid before passing to EFSA for an assessment. Most Member States did not fully accept the Commission's interpretation; nevertheless, they were equally concerned to ensure only valid claims go to EFSA to lighten their workload and aid stakeholders. The Commission suggested an ad hoc working group meet to discuss a procedural solution.
Date of next meeting: 15 October, to be confirmed.