FSA Letter, 19 January 2009
The Commission concluded the discussion on its working document dated 16 December, focusing on any additional comments from Member States on the adapted profile for cereals, and those for non-alcoholic beverages, ready meals and other foods. The Commission said it would look at all comments received and revise its 16 December paper which would become a technical Annex to a Regulation that would be tabled for a vote at a future Standing Committee, possibly the 20 February meeting.
Discussion here was about the need for adapted thresholds for different sub-categories within the cereals category, or a change of reference quantity to a per 100kcal base. The Commission said that the reference base may hold the best solution to concerns here and that it would be testing the effect of this.
The effect of the sodium threshold on bread was discussed with mixed reaction to changing the threshold proposed. Switching bread to the breakfast cereals (BC) category, together with some biscuits, also had some support, together with a reduction of the sugar threshold here, and for cereals as a whole. Following this discussion on changes to the BC category, the question of a fibre criterion arose.
The Commission noted some Member States thought 5g per 100 g was sufficient as a threshold for sugar in this category. Some Member States also noted that some products may unexpectedly fall into this category, e.g. some soups (discussed below), and that something would need to be done to avoid this.
The Commission clarified that to qualify for this category a serving size of 200g was required and least two ingredients of a minimum of 30g each. It was suggested that as all criteria related to 100g, it would be clearer if this read 15g per 100g for each ingredient. Some Member States were unsure about the 200g serving size and asked this to be looked at. One Member State thought the sodium threshold should be changed to 300g.
For soups the Commission clarified that if the main ingredient was more than 50g per 100g, the soup could be classed as vegetable, meat or fish whatever this ingredient was. Multi-ingredients (each less than 50g) would bring it to the ready meal category. Some Member States took issue over the water content, which would not allow even some single ingredient soups to meet the 50g per 100g level, and suggested a separate soup category. The Commission said it would look at the test basket again.
The Commission confirmed that the nutrient profile will work by comparing foods with the most appropriate category, e.g. a tomato soup with a high tomato content would qualify for the fruit and vegetable product category over the ready meal category.
Some Member States wanted mayonnaise to be classed as a spreadable fat, but this was opposed by others. Clarification was sought on the status of nuts and ice cream. The Commission confirmed that nuts fell within fruit and vegetables, but it was still considering how to address the high saturated fat content of some varieties (either by exclusion or adapted profile). Ice cream would qualify for the adapted profile that its composition made most appropriate. So creamy ice cream would fall into dairy, but iced fruit and sorbet would fall into fruit and vegetables.
Article 13 List
The Commission informed Member States that EFSA aim to publish the list of claims they have received later this week along with details on the status of claims and how the list was established. EFSA clarified that the list will be published in Access format, which shows full information on all conditions of use, health relationships and example wordings received for the main claims and also similar “linked” claims. However, the references column will not show all references received by EFSA after September last year – this will be noted in a disclaimer. EFSA intend to publish a full list of references shortly. The list of Article 13 claims will also be published in an Excel format, but this will have a limited level of detail, and not show linked claims nor all conditions of use, example wording or references.
The Commission explained that, as EFSA agreed to finalise assessment of claims within one year of receipt, claims with sufficient information for assessment received in July 2008 will be assessed by July 2009 and claims received in November 2008 will be assessed by November 2009. However, claims that EFSA do not have sufficient information to assess will be sent back to the Commission for clarification, and the deadline for assessment of these claims is to be negotiated. The Commission agreed that this could have implications for the transition periods for some claims and would consider what might be done to address this.
The Commission said that where clarification is sought, Member States would have to decide how best to handle this and that where the same claim was submitted by several different Member States, the Commission would coordinate replies. On timing, the Commission asked Member States to give an estimation of how much time they would need to do this by the next Working Group meeting.
Additional note: The European Food Safety Authority has now published on its website its database of Article 13 health claims: See EFSA Claims Database. There are two versions: an Access database with full information on the claims; and if you do not have the software to support this, a simplified version in the Register of Questions. Where EFSA is seeking further clarification, we are looking to see how best to manage input on behalf of the UK and will update you in due course. EFSA will focus on the main claim when doing its assessment and use linked claims for further information to help them, but they would not treat each separately.
Article 13(5) and Article 14 Claims
The Commission said that the first ad hoc working group to agree guidance for conducting a validity check of claim applications would be arranged soon.
The Commission explained that the proposed Regulations containing lists of accepted and rejected claims would be re-drafted in light of discussions at the Standing Committee for the Food Chain and Animal Health (SCFCAH) meeting on 18 December and presented at the next SCFCAH on 20 February. The Commission noted that Member States had agreed that the risk factor should be mentioned where one has been identified, but asked for views on whether claims could be allowed where no risk factor could be identified. There was some support for the view that if an EFSA opinion indicated a claim was valid, but no risk factor could be identified, a claim referring to a non-specific “risk-factor” may suffice. Another option might be a claim along the lines of “a healthy diet rich in substance A may reduce the risk of disease B”.
One Member State pointed out that a consistent approach would be necessary. Another suggested that if this proved so difficult maybe all mention of a risk factor should be dropped. The Commission said it would look at these suggestions and seek a legal opinion.
The Commission said they are also awaiting a legal view on whether wording could be fixed for some/all claims and asked for Member States' views on this. Views were mixed, with some favouring fixed wording for all claims, some for disease risk claims only, and others for no fixed wording anywhere – citing the precedent in the nutrition claims Annex.
The Commission said that the issue of quantitative claims, e.g. quantifying the scale of effect such as increasing bone strength by X%, was raised at the last SCFCAH meeting and Member States were divided on whether these should be allowed – the Commission considered that, if allowed, quantitative claims must be expressed as “on average”. The Commission also said that some Member States were against claims referring to foods being “necessary”, and would prefer “important”, “contributes to” or other similar wording. The Commission said that strong reasoning would be needed for disallowing “necessary” if this wording was requested by the applicant and supported by the EFSA opinion; it would look closely at this.
EFSA provided an update on the status of Article 13(5) application as of 31 December 2008:
Amendments to Nutrition Claims Annex
The Commission presented a paper on nutrition claims relating to omega 3 fatty acids and unsaturated fatty acids (UFA, MUFA and PUFA) and said these claims were a priority. They were also open to consider other amendments to the Annex of nutrition claims if Member States thought there was a need, for example changing the criteria for “reduced” claims from 30% to 25% to align with Codex and adding a “now X% less claim to reflect reformulation efforts, but were concerned about making too many amendments at this time. There was general (but not universal) support for aligning claims to Codex, although it was noted that not all the proposals were compatible with Codex. Many Member States were in favour of a claim to reflect reformulation efforts, but wanted to consider what would best suit this. Some Member States said that industry needed flexibility to allow for other new claims on new products and all proposals should be considered. The Commission said it was developing a paper for a future meeting. The Agency will consult stakeholders on this.