DH Letter, 26 April 2011
1) Article 8 of Regulation (EC) No 1925/2006 - Discussion on drafting of implementing rules – copy of draft working document attached.
[see Commission Working Document]
The draft regulation circulated to Member States (MS) on 7 April outlines the process for requesting that a substance, which has been identified as a possible risk to consumers, be put forward for assessment by the European Food Safety Authority (EFSA). The rules set out initial criteria to be met before MS submit a ‘request’ (defined in the regulation). When a request is accepted by the Commission, it will then be submitted to EFSA for an initial opinion and based on the outcome, there will be a decision to add the substance to list A (prohibited), list B (restricted) or list C (under community scrutiny) in Annex III to Regulation 1925/2006. Further rules outline the scrutiny process for a decision to be made within 4 years to add the substance to list A or B. If there is insufficient evidence to justify a prohibition or restriction, then the substance will appear on a community list indicating that the substance had completed community scrutiny and is permitted in foods.
The Commission confirmed that national legislation is permitted where areas are not harmonised and that it is not the Commission’s intention to produce a total list, but it should be restricted to only those substances that pose a risk to consumers.
Article 3 of the draft regulation - the MS that spoke did not support the use of a threshold of ‘three times’ the normal consumption as a definition of ‘greatly exceeding the normal diet’, as an indication of potential harm and that a case by case approach should apply.
The regulation outlines a definition of ‘a balanced and varied diet’, which excludes food supplements and fortified foods to be used as the baseline for defining excessive consumption. MS expressed a range of views. Some disagreed with the definition because food supplements and fortified foods are widely consumed as part of the normal diet and it is difficult to identify fortified foods as a distinct category in survey data. Several MS agreed with the definition as drafted, such that food supplements and fortified foods should not be considered as part of the definition of ‘a balanced and varied diet’. Some MS indicated that fortified foods are used by most people but that their survey methodology would allow removal of fortified food data for calculations and that food supplements could be more easily identified.
The Commission asked MS to consider that if food supplements and fortified foods were included in the base diet:
1. How would a baseline comparator be defined?
2. How would these foods be included and how would an assessment be made? Real circumstances and not a hypothetical situation need to be considered
Article 4 of the draft Regulation – comments indicated that the information to be submitted could be wider than ‘scientific’ data; that and/or wording is required between 4 (2)ii and 4(2)iii.
The Commission explained that a deadline for an opinion by EFSA for the initial stage of the process would be agreed when the request was made, but not within these implementing rules. The Commission also indicated that transparency for the stages of the process was very important and that when a request is sent to EFSA, MS will be notified and there will be a discussion at the Standing Committee on the Food Chain and Animal Health (SCoFCAH).
Additional rules will not be inserted in this regulation.
The Commission asked MS to send comments on the draft proposal as soon as possible. It will review the draft and consider whether another Working Group meeting discussion is needed, before taking the draft to SCoFCAH in July.
2) Article 16 of Regulation (EC) No 1925/2006 - implementing rules.
The Commission reminded MS of the purpose of Article 16 and requested MS to provide information, by the end of May, on whether they will be able to provide any data in July 2012, on the evolution of the market and consumption data for fortified foods for both vitamins and minerals and other substances.
There was no discussion of this item.
A question was raised about whether a modification of the notification process was possible to include information of where the product will be placed on the market to allow effective enforcement.
Other MS raised problems in enforcing control of food supplements, particularly those sold via the internet.
The Commission indicated that there was a similar discussion at SCoFCAH last year and that there has been further discussion with RASFF (rapid alert system) network colleagues. Food supplements sold on websites should be covered by the RASFF system and an update is planned so that it is possible to indicate if the product is sold within a MS or from a website based outside of the EU.
Finally, there was no indication of when discussions would restart on setting maximum levels for vitamins and minerals in food supplements and fortified foods.