FSA Letter, 26 March 2009
The letter provides an update on discussions in the Commission Working Group held on 20 March. The agenda focused on the Nutrient Profile proposal, feedback on the list of Article 13 claims, EFSA opinions and draft decisions, and amendment to Regulation 353/2008 on implementing rules.
Nutrient profiles
The Commission explained that this issue had attracted political interest from within the Commission at a high level which had prompted a reappraisal as to how to meet the statutory obligation to establish nutrient profiles, while taking into account the role of certain foods in the diet for which reformulation is not possible or which are eaten in smaller quantities and contribute little to the diet. The result of this is a proposal to increase the list of exempt food categories to include meat and edible meat offal, fish and crustaceans, molluscs, other aquatic invertebrates, milk, eggs, bread with a minimum of 3g/100g fibre content, cough drops, chewing gum and dextrose tablets, honey, table top sweeteners and salt containing iodine/fluorine.
In addition to these exemptions, the Commission said it was considering new sub-categories for soya products and for fine bakery, and revised threshold levels. Suggested revisions included:
fats and oils - 500mg/100g sodium, 30g/100g limit for saturated fat;
meat and fish- 800mg/100g sodium, 8g/100g saturated fat (10g/100g for fish);
dairy - 2.6g/100g saturated fat;
cheese - 900mg/100g for sodium, 20g/100g saturated fat;
biscuits - 500mg/100g sodium, 8g/100g saturated fat, 25g/100g sugar
Soya - 3-10% soya protein - same thresholds as dairy
- 10+% soya protein - same thresholds as meat plus 10g/100g for sugars
(The Commission commented that these alternatives to meat and dairy products could be defined; other alternatives would need equally to be defined or would default to the “other” food category).
It is proposed to redefine the fruit and vegetable category to include nectars and the dairy category to have a minimum dairy content of 40g/100g.
Article 13 update
This section includes detailed feedback in response to queries raised by the Agency following stakeholder questions.
Claims requiring clarification that were submitted by more than one Member State (MS) had been divided up, with one MS appointed as lead. The UK is to lead on 124 claims, will have sole responsibility for 373 and contribute to 226 claims where other MS lead. The Commission said that comments and clarification on the Article 13 list must be sent via the relevant MS as direct requests from industry cannot be considered. MS must agree on one clarified claim as the Commission will not consider different suggestions, unless agreement cannot be reached. EFSA has indicated that it may be possible to include more than one health relationship within a claim if they refer to different health effects (e.g. “healthy skin and hair” would be split into two claims).
The Commission said that where MS had identified claims as missing from the list or incorrectly assigned to main entries, but considered them similar to main entries already on the list, they had been re-assigned to those main entries. We have updated the spreadsheet that lists the UK claims that EFSA identified as requiring clarification to reflect this, and this is attached. [See: UK Clarifiaction Spreadsheet] The Commission is still considering how to deal with those missing/misplaced claims that cannot be assigned to a main entry.
The Commission reiterated that health relationships must be measurable to be assessed and EFSA said it would be helpful to have information on the health effect endpoints, as backed up by the scientific evidence, for example the endpoint for mental activity could be memory or concentration etc. EFSA underlined that it was crucial that there is evidence in support of any proposed clarified health relationships. EFSA indicated that claims allocated screening code 0 should not be amended as it is already able to assess these.
The Commission acknowledged that the assessment exercise by EFSA may extend beyond the January 2010 deadline in which case the solution could be that transition periods continue until the final list is adopted. In response to concerns about competitive issues arising if some claims are authorised before others, the Commission agreed that equality of treatment was important and it would consider this for the list of authorised claims. However, it did not foresee any legal implications of the EFSA opinions being issued in phases as this is only one step of the authorisation process.
There is no facility to amend the example wording as the focus is on the health relationship where EFSA require something measurable. The Commission acknowledged that to provide a measurable effect for some claims complex technical or medical language may be necessary, but this will not determine how claims should be phrased – the Commission agreed that translating the scientific advice into understandable wording will be dealt with at a later stage in the authorisation process. However, it also noted that if all the evidence is based on a medicinal effect, it may not be possible to translate this into a non-medicinal claim.
The Commission said that industry would not be under time pressure as claims will remain as “requiring clarification” until the necessary information is provided. Although it acknowledged the legal deadline in the Regulation the Commission said it could not push MS into providing clarification within set timescales. One MS estimated they would need 3-6 months to provide the necessary clarification. The Commission said it would rather allow this time than have to return to this exercise later. The Commission will write to MS with their deadline, and the Agency will inform submitters of this as soon as possible. The Commission does not want MS comments on a piecemeal basis, so the Agency plans to collect comments, including from other MS and send only one return. Please note: the 20 March deadline we set previously is not a final date and we will continue to accept clarifications from submitters until we are able to confirm a new deadline.
EFSA's approach to the Article 13 list and its terms of reference were raised by two MS with the concern that too narrow an interpretation may mean that some evidence is wrongly excluded, such as epidemiological evidence that does not have specific measurable outcomes. However, the Commission limited discussion to the clarification exercise only.
Article 13(5) and 14 claims
The Commission said that the new list of claims being proposed for adoption (three Article 13(5) claims for rejection, two Article 14 claims for adoption and 13 for rejection) would be on the agenda of April's Standing Committee as required in the Regulation, for a vote if possible (depending on any comments received). The draft proposals are attached. [See: Commission Proposal (1) and Commission Proposal (2)]
There was concern that the proposed risk factor for the xylitol and dental caries claim was not based on transparent science. One MS thought that a claim should not be ruled out where only an end point effect and no risk factor has been identified, and nor should inappropriate risk factors be substituted. EFSA said that where there is sufficient evidence of an end point it may be possible to treat a non-validated intermediate factor as a risk factor. The Commission is awaiting scientific advice from EFSA which will be circulated to MS.
Amendment to 353/2008
The Commission introduced a proposed amendment to the implementing rules for applications under Article 13(5) and 14, which prohibits the withdrawal of claims at late stages of the authorisation process. It also makes explicit MS responsibility in judging claims valid or not for assessment. There was some concern over this aspect of the proposal and MS were asked to comment in writing. The draft proposal is attached [See: Commission Proposal (3)]
Guidance on admissibility check
The Commission introduced its first draft of guidance to MS on the process they should follow after application for an authorisation. This linked to the previous agenda item. This was thought potentially useful, and MS were asked to comment further in writing.
Nutrition Claims
On progress amending the nutrition claims Annex, the Commission said there would not be time to consider all 41 amendments proposed by the food industry European umbrella organisation before the January 2010 deadline and prioritisation was required. Those claims on the market before the Regulation came into force should be dealt with first.