FSA Letter, 4 February 2009
The letter contained two documents.
Update on Article 13 List of Health Claims
As you were informed in our letter of 19 January, EFSA recently published the consolidated list of Article 13 health claims submitted to them for authorisation. This is available as an Access database on their website at:
This database contains a main list of claims and behind each entry are all the similar “linked” claims submitted by Member States. This allows EFSA to consider all the conditions of use, references and example wordings submitted when assessing each claim. If you do not have Access software, there is a summarised version of the list on EFSA's Register of Questions but please be aware that this version of the list does not contain the same level of detail. Although you will be able to see the main entry on the list you cannot see the linked claims or details of EFSA's screening comments.
Approximately 1800 of the claims on the consolidated list were submitted by the UK, and EFSA have asked for clarification on around 700 of these following their initial screening exercise. You may already have noticed that the database contains a column titled “EFSA comments” in which a number or combination of numbers from 0-6 has been entered alongside each claim. Claims that have been allocated a “0” have passed EFSA's screening and are currently undergoing assessment so there is no need for further action to be taken. Claims that have been allocated a number from 1-6 are those that EFSA require further clarification on before they can be assessed. Each number corresponds to a different screening criterion, and details of these criteria can be found by clicking on the “criteria for the initial screening of Article 13(3) health claims” button at the top of the database. Although it is likely that submitters of claims that require clarification will need to be involved in supplying EFSA with the additional information necessary, there is no need to take any action at present. The Commission have said that they will not accept comments until they have discussed how best to supply this information to EFSA with Member States at the next working group meeting on 16 February. In particular, consideration needs to be given to how to proceed where claims being queried by EFSA were submitted by more than one Member State – this accounts for almost half of the 700 UK claims requiring clarification. We will write to those submitters affected with full instructions once we know more.
At first sight, it appears that there is some inconsistency in how these screening criteria have been applied and in a number of cases it is unclear to us why claims have been queried by EFSA. The Commission have indicated that Member States will be given a more detailed explanation of the screening process on 16 February so we hope to be in a position to provide you with further information after then. Meanwhile, we will continue to look at the list with the intention of identifying specific issues on which to request clarification in the meeting.
You will also notice that claims on the list published by EFSA have been given different deadlines for assessment, and full details of the reason for this can be found on EFSA's website at the web address above. At the last working group meeting we asked the Commission what arrangements would be made if claims are not assessed in time to be considered for inclusion on the Community list when it is adopted in January 2010. The Commission did not consider this would be a problem and indicated that EFSA may be able to complete assessment of claims in less time than the 12 months agreed. If it emerges that this will not be possible we will continue to press the Commission for adequate transitional periods for claims that have not been assessed.
We have also notified the Commission of a couple of other issues with the published list. Firstly, we have noticed that a number of claims submitted by the UK appear to be missing from the list without clear reason. As we explained in previous update letters, the Commission have intentionally deleted claims without clear conditions of use as EFSA will not be able to assess these. Secondly, there are some mistakes with how linked claims have been assigned to main entries on the list, as claims for different food components and/or entirely different health relationships sometimes appear as linked claims. We have provided the Commission with some examples of where this has occurred but it is difficult to determine the extent of the problem at this stage. We have recommended that these claims are either re-assigned to the correct corresponding main entries on the list or, where there is not already a matching claim, added to the list as new entries.
Please note that, due to the number of UK submitters and claims, it is difficult for us to respond to individual enquiries about the status of the Article 13 list or specific claims. This letter serves as a general update and we will write to submitters again as soon as we have further information.