FSA Interested Parties' Letter 13 May 2008
The Commission Working group on Nutrition and Health claims met on 21 April. The agenda comprised of nutrient profiles and Article 13 health claims process.
The Commission reported that it would soon finalise the “test basket” of more than 600 foods that would be used in testing and fine tuning the model. The basket was a smaller sample of the food database, intended to be representative of foods on the European market, based on available data, and also a manageable size for ease of use. Some Member States expressed concerns that it did not fully represent foods important to their national diets and had either submitted more data or would do so in the next few weeks. The question of relevance to food on the market was raised and the Commission said that the food database included commercial data provided by industry, but this was but one element, most being compositional data. The Commission considered the “test basket” to be representative. Several Member States' expert advisory committees had analysed the database and agreed that it was suitable to test any nutrient profile model.
The next step would be to take the EFSA opinion and devise options for a working profile model. The Commission sought Member States' views on the best way to frame options for testing, but Member States appeared unprepared to discuss specific elements for a model. It was felt that the EFSA opinion was indicative of several ways to achieve the objective of controlling health claims and some Member States felt that each possible option would need to be tested. The Commission wanted decisions at the next meeting on specific options and would try to refine the questions Member States must address. Industry and other stakeholders are to be consulted, but the Commission has not given any indications of the process here. Time is likely to be the critical factor for responses to any indications of how the profile will work and what exemptions might be proposed.
The Commission asked the Working group about possible exemptions to the nutrient profile model, in particular whether exemptions were relevant for food supplements and PARNUTS products. Most Member States thought profiles were probably irrelevant to supplements, since there would be few containing macro-nutrients that would be considered adverse using a profile model. On PARNUTS products the same was not true and a blanket exemption could create a loophole in the controls. There was sympathy however for an exemption for those PARNUTS foods for which statutory compositional standards apply, and this would be considered further.
Article 13 health claims
The Commission reported that most of the coded lists from Member States had been received and that it will finish assembling its database of all claims submitted with these codes in place. However, this is not intended to be the draft list to go to EFSA before the summer. The Commission thinks there are duplications of identical or similar claims on the list and will seek to reduce these to one claim.
Further possibilities of how the Commission might seek to ensure eligibility of claims before confirming them on the draft list were explored. It reported on discussions in the ad hoc working group. Wording of claims considered to be medicinal (e.g. prevents/ treats/ cures/ protects) and wording considered to play on fears or imply that good health was difficult without eating a particular food (e.g. harmful/indispensable/necessary/required), should not be associated with health claims. Member States broadly agreed that these were useful criteria to ensure claims were eligible and complied with the legislation. The Commission and EFSA acknowledged that EFSA could include in its opinion advice on what wording of claims fits with the evidence, and this would help set parameters around what claims were possible. Some wording was considered to be vague or meaningless, and the relevance of Article 10 was raised – whether they should only be allowed with a specific claim to back them up. Some Member States questioned how else some claims could express the proven effect, and argued that some finessing of the wording might be required here, rather than outright rejection. One Member State noted that with more than 2000 claims in different languages (translated to English and then back to the mother tongue) deciding what is vague and requiring more specific language, or what is medicinal or in some other way ineligible can be very subjective; it was important to be able to justify any decisions made.
Discussion then moved onto the borderline between Article 13 and 14 claims, in particular relating to blood pressure and heart health. Member States were split on where these claims best fit, but greater support for claims about blood pressure being Article 14, disease risk claims. One Member State thought the science should inform this, but if this was from people recovering from disease, such claims could be either Article 14 or medicinal claims. Most Member States recalled the Commission guidance on this borderline as the best starting point here.
The Commission then raised the issue of claims presented with no conditions of use. EFSA said it would need to frame claims within relevant conditions, and if none had been submitted, this would be difficult. Some Member States had already taken the decision to delete any claims with no condition of use from their list.
The Working Group also saw a draft of the terms of reference (ToRs) for EFSA's consideration of Article 13 claims. EFSA stated that the ToRs should include a reference to the characterisation of substances, but clarified that submitters would not be expected to characterise the substance (where they had not done so), EFSA would do this based on the science. EFSA also wanted to give advice on the nutritional relevance of intake of nutrients. The Commission thought that reference to significant beneficial effect in the ToRs covered this, but agreed that EFSA could consider the importance of a single nutrient among other dietary factors. Some Member States wanted to know the basis for an EFSA opinion on this aspect. The Commission said this was linked to Article 5 (1) (a); and EFSA noted that these factors were explicit in the PASSCLAIM work on functional foods, which informed their approach.
Under AOB EFSA introduced its note to Member States to clarify valid Article 13(5) claims. The Regulation requires Member States to submit valid claims and once received EFSA must begin its time-limited process, with no possibility (unlike the Article 14 process) to stop the clock to query anything. EFSA agreed that we would learn from experience and be able to consolidate a systematic checking and feedback system.
Date of next meeting: 5 June.