DoH Interested Parties Letter, 4 April 2011
The European Commission has invited member states to meet on 14 April to discuss the further assessment process proposed for certain Article 13(1) health claims. The Commission’s note is attached to this letter [Given below] along with a spreadsheet listing those claims that the Commission considers eligible for the process [See Excel Table].
Note from Commission
We had promised to give you information on the further assessment process as soon as we had confirmed the legal base for this. Many Member States have already asked when they can forward data to EFSA under this process.
We are organising an ad-hoc meeting of those Member States who submitted claims eligible for the further assessment on 14 April here at DG Health and Consumers, (invitation to follow) to discuss the details of this exercise.
As it was explained last year, the further assessment is to be made solely available for Article 13 health claims on micro-organisms which were insufficiently characterised for EFSA to be able to make an assessment of the evidence and for health claims where there was insufficient evidence to allow EFSA to conclude on whether a cause/effect relationship is established.
Procedure
The Regulation does not foresee a further assessment procedure, although it does foresee changes to the list of permitted health claims (Article 13.4) or additions to that list (Article 13.5). However, the authorisation of Article 13 health claims is a process defined in Article 13 paragraphs 2 and 3. This process is not finished until a decision on those claims is adopted. We are therefore still within the process outlined in these paragraphs.
The further assessment of health claims on micro-organisms which were insufficiently characterised and health claims where there was insufficient evidence will be conducted within this process, under the procedure outlined in Article 13.2 and Article 13.3. However, we have already finished the process of submission of health claims, which culminated in the consolidated list which EFSA is currently assessing. It is clear that the need for a further assessment requires an adaptation of the original process to allow EFSA to have the additional information to be able to complete an assessment of these claims.
In order to organise a manageable adapted process, the Commission will discuss with the Member States who originally submitted the claims which qualify for the further assessment at the ad hoc working group planned for 14 April. We are not constrained by past processes and can ensure that this further assessment is managed in such a way as to allow EFSA to complete a full assessment of the claims in question. This will require the adapted process to contain all the elements required and to be organised according to experience of successful submissions. Such submissions are systematically organised, with a contact point to ensure any questions can be quickly answered. Those food business operators who originally presented these claims to you and wish to take full advantage of this further assessment opportunity should make the effort now to cooperate with the responsible Member States in this process. Where several operators in one or more Member State are interested in the same claim, some co-ordination will be necessary, with one operator and/or Member State taking the lead. We will communicate final details of the adapted process after the ad hoc meeting.
Member States have asked about contacting stakeholders about the further assessment. It would be in order to give stakeholders notice as soon as possible of the intention to open the 3 month period for submissions under the further assessment. For your information, please note that the Commission is considering opening this period as early as possible, probably in May, as any further delay will not be justified. Claims in any EFSA opinions after May and eligible for the further assessment will be dealt with in a separate call.
While details of the further assessment will be finalised after the ad-hoc meeting, concerned Member States may already wish to alert food business operators, if this has not already been done, in order that the pertinent data relating to claims in the further assessment is being made ready for when further instructions about how it is to be submitted are communicated by the Commission.
Health claims on micro-organisms
The EFSA opinions on micro-organisms state that a cause and effect relationship has not been established between the consumption of the micro-organisms/combination of microorganisms addressed in the opinions and their claimed effects due to the data available being insufficient to characterise the micro-organisms/combination of micro-organisms.
A systematic submission with all of the pertinent data readily available for each individual claim and with information for EFSA of the necessary linkages to the claimed effect for each will be required. This will entail the bringing together of current and new data for each claim. How best to do this can be discussed and developed in the ad hoc meeting. Stakeholders must supply:
Submitters of the claim can check the data currently available to EFSA in the full list of references at: http://www.efsa.europa.eu/panels/nda/claims/article13.htm.
The relevant EFSA opinions can be found by following these links:
Please find enclosed a table of all the individual health claims for micro-organisms involved in this exercise (MO list) [See MS Excel Table]. It shows the ID of the claim in the consolidated list, the Member States(s) involved in each claim and the unique Member State reference number, the stakeholder coding where it appears in the consolidated list, plus information about the claim and a link to the EFSA opinion.
Insufficient evidence
The same arrangements as those described above will be needed for the submissions of additional evidence for health claims in this category.
The enclosed table (Insufficient evidence claims) of individual health claims for which there is insufficient evidence contains all the information Member States need to alert food business operators, Member States involved and links to the relevant EFSA opinions. It also records stakeholder coding where it appears in the consolidated list. A systematic submission of additional data will also be required for these health claims, together with information for EFSA of the necessary linkages to the claimed effect will be required. The links to the EFSA opinions will allow food business operators to see what evidence is currently available and to build on this for their additional submissions to the Member State. Again, more detail on how these submissions are required will be made available after the ad hoc meeting in April.
We have endeavoured as far as possible to identify eligible claims for the further assessment. If Member States consider there are eligible claims missing from these tables, please inform the claims team in the Commission as soon as possible.