DH Letter, 19 April 2011

CLAIMS - Update after the European Commission’s ad hoc Working Group meeting on further assessment of certain Article 13 health claims (e.g. probiotics), 14 April 2011

The Commission called this ad hoc working group meeting to discuss details of the further assessment process that will be open to certain Article 13 health claims. Member states (MS) invited were those that had submitted claims the Commission considers eligible for access to the process.

The Commission proposes allowing further assessment of those Article 13 claims where the European Food Safety Authority (EFSA) has said: (1) that microorganisms were insufficiently characterised or (2) that there was insufficient evidence to conclude whether a cause and effect relationship had been established. The Commission had outlined the proposed process in its email of 30 March (which we circulated to you on 5 April) and documents discussed at this meeting were: a spreadsheet detailing claims the Commission considers eligible (also circulated to you on 5 April); a document setting out the principles of the process; and a format for applications.

Basis for the further assessment process

Commission Legal Services’ advice is that further assessment of claims originally submitted via the process set out in Article 13.2 of Regulation 1924/2006 could only be carried out within the unfinished Article 13.2/13.3 process. The process mentioned in Article 13.4 is for changes to the authorised list and that in Article 13.5 is for additions so neither of these can be used for further assessment.

Scope of the process - eligibility of claims

Insufficiently characterised microorganisms

For claims where EFSA said the food component was insufficiently characterised the Commission proposes limiting the scope to those claims for microorganisms listed in two opinions (EFSA Journal 2009; 7(9):1247 & 2010; 8(2):1470). The Commission’s reasoning is that when EFSA screened the 4,000+ applications it received in December 2008 it said that it would be a scientific judgement as to whether these microorganisms were sufficiently characterised to allow assessment. The claims were then assessed and received negative opinions, yet it’s conceivable that they would not have done had further information been submitted. In contrast, for other certain foods e.g. “breakfast” EFSA said, at the outset, that they were insufficiently characterised and asked MS to provide further information for clarification. There was some discussion as to whether the scope of the further assessment process should be widened to include other claims that had also received negative EFSA opinions due to insufficient characterisation and which had not benefited from EFSA’s early request for clarification. The Commission will reflect.

Data requirements

A claim cannot be submitted for further assessment unless there is new evidence to support it. New evidence means any information not already submitted including, where necessary, that needed to complete characterisation.

Many claims originally submitted for microorganisms (e.g. ‘helps keep your digestive system in balance’) are not well enough defined to be assessed and in many cases several wordings were proposed per claim. For further assessment, a submitter must select one of the original claims and must take care to define it clearly, having regard to the available evidence. EFSA is to publish its guidance on ‘scientific requirements for health claims related to gut and immune function’ soon.

For claims where the evidence was insufficient the proposed claim wordings cannot now be changed, since EFSA had already deemed them assessable, so new evidence must relate to substantiation.

Any claims, for which food business operators fail to provide new evidence and submit applications to MS, will be removed from the process.

Organisation of the further assessment process

Key points from the discussion are as follows:

• The further assessment process will be time-limited and deadlines will be immovable once announced.
• The three-month period for industry to submit applications to MS is likely to be opened in May; however, it may need to be extended to reflect inclusion of the holiday period. At the end of this period, MS will have around two months to screen applications. There was no discussion of how long EFSA would have to do assessments.
• If there are any claims in EFSA’s fifth batch of opinions that are eligible for further assessment, the Commission and MS will need to consider how to handle them at that time.
• The lead MS for a claim will be the MS who has the only, or greatest, interest in a claim (judged by the number of sub-entries in EFSA’s database).
• A lead MS will identify a lead member of industry (trade association (TA) or food business operator (FBO)) for each claim and the FBO or TA will compile the application. This will include working with FBOs/TAs in other MS where necessary.
• When submitting an application to a MS the lead FBO/TA must demonstrate that all interested industry members have been involved in an application and are content with it.
• MS will screen applications before deciding whether to submit them even though this is not overtly required in the 13.2 process.
• At the end of the three-month period for industry to submit applications to MS, MS will inform the Commission which claims will not be taken forward.
• During EFSA’s assessment of applications, there will be no opportunity to provide clarification or further information.

The Commission informed MS that the CIAA (Confederation of the Food & Drink Industries in the EU), ERNA (European Responsible Nutrition Alliance) and EHPM (European federation of Associations of Health Product Manufacturers) have agreed to co-operate with this process and co-ordinate industry work if necessary.

Transition periods

Claims in the further assessment process when the list of authorised Article 13 claims is established will not be included in the ‘rejected’ list. The Commission is aiming to find a mechanism for excluding these claims and [unassessed] botanicals from this list.

If a claim is taken out of the further assessment process and an application submitted via the Article 13.5 process, then whether or not it can stay on the market will depend upon whether it falls within one of the transition provisions in Article 28.5 and 28.6 of Regulation 1924/2006.

Next steps for you

The Commission aims to clarify timings and say which claims will be eligible for further assessment at Standing Committee on 2 May; I will write again then. I am sure that those of you with an interest in the claims listed in the Commission’s spreadsheet circulated on 5 April have been considering what you intend to do since the further assessment process was mentioned early last year. I would therefore ask you inform me, by Monday 9 May, if you have already decided that you would like us to withdraw any of the UK claims from the process. You can, of course, consider this up to the end of the submission period.