DH Interested Parties Letter, 18 October 2010
In summary, there was a brief discussion on the second batch of Article 13 health claims; some progress on Article 14 claims on long chain omega 3 fatty acids; more details on the Commissions review of the progressive adoption of claims and a brief discussion on proposed Article 13(4) process for health claims.
Article 14(1) claims related to DHA
The Commission advised that if conditions of use could not be agreed, claims could not be authorised. Foods with 200mg per portion can include the claim; therefore the claim is not exclusive to food supplements. A statement referring to intake levels for pregnant or lactating women was also agreed.
EFSA advised that claims made on alpha linolenic acid (ALA) are applicable for children of all ages.
EFSA agreed to redefine the target group for claims made on DHA in relation to infant visual development. The Commission suggested the claim could be more widely applied, for example to baby foods. The Commission will develop wording for the claim on baby foods for future discussion. A draft measure will be prepared for the Standing Committee on the Food Chain and Animal Health (SCoFCAH) at the beginning of December. A more formal proposal will be discussed at the next Working Group.
Applications under validation
It was noted that EFSA need to proceed within agreed deadlines and Member States (MS) should therefore inform the Commission if they have no feedback from applicant/s by 29 October. In these cases, the Commission will assume that either application/s are not valid, or proceed to assessment.
Review of the process of progressive adoption of Article 13 health claims
The Commission reiterated that all claims, other than botanicals, will be assessed by June 2011; the modified approach has been adopted to minimise distortion to the market in recognition of concerns raised by MS.
Many botanical claims overlap with the Traditional Herbal Medicinal Products Directive (THMD), therefore, there will be a period of reflection prior to their assessment. Under THMD a different level of evidence is required, with a broader base of evidence taken into consideration. EFSA will continue their work programme and opinions will be reviewed by Working Group as they are published. This will enable problems to be highlighted in good time to allow the drafting of appropriate regulations. The position of botanical claims already assessed must be considered.
Approved generic claims may be applied to any foods for which claims are appropriate. The Commission confirmed a 6-month transition period for rejected claims and advised that claims not yet evaluated may remain on the market. EFSA opinions have no legal force until agreed by MS, and adopted into legislation. Claims not in conformity may continue to be used until the formulation of the list. A negative opinion may require re-examination; this would need to be considered with regard to enforcement. The issue of possible challenges to rejected claims was discussed and concern was expressed that there is currently no listing of the reasons for rejecting claims.
EFSA published the third batch of 75 opinions on 808 claims on 19 October. To date, a total of 1745 claims have been assessed, with 1000 claims outstanding, excluding botanicals. EFSA are discussing workload management with the Commission and MS may be asked not to submit new applications until June 2011.
Although there is no intention to reopen the Nutrition and Health Claims legislation, the legislative picture covering claims, the Food Supplements Directive and the Traditional Herbal Medicinal Products Directive needs to be re-examined to ensure a cohesive approach.
Second series of claims
There was a brief discussion on weight loss claims on a specific product. The Commission asked for MS opinions on whether they considered the claim was a description of the effect of low calorie diets or infracted Regulation 96/8 (on foods intended for energy restricted diets and weight reduction). EFSA advised that the product may not fit with Regulation 96/8 (on foods intended for use in energy-restricted diets for weight reduction) due to the protein content; however the data indicates that the claim is valid.
It was agreed to shorten vitamin D claim 154, removing reference to “healthy inflammatory response” as this could be misleading to consumers.
EFSA indicated that the wording “neuro-muscular function” would be more appropriate for potassium claims 320 and 386; MS were asked to submit suggestions.
The Commission indicated some safety concerns on consumption of guar gum, based on evidence from the USA. It was suggested that a warning to limit the likelihood of over consumption should be put in place, MS were asked to submit further comments.
Process for further assessment of article 13(1) claims
The Commission indicated a need for additional routes for assessment of applications of Article 13(1) claims. It intends to produce a potential procedure for discussion at future WG.
Withdrawal of health claim applications
The Commission set a deadline of 29 October for responses; if no responses are received, the issue will be closed for those entries already received.
Interpretation of claims legislation in line with legislation on promotion campaigns for agricultural products
In many MS the relevant national competent authority for health claims approves claims being made for promotional campaigns.
Guidance documents
A number of last minute comments were received from MS on the guidance for use of health claims; not all have been taken into account. Wider consultation will be undertaken through the Commission advisory group and MS were asked to send the Commission any further comments before the next working group, in particular for examples for healthy ‘organ’ eg healthy heart. The document will be presented one last time at working group before going to SCoFCAH. The Commission clarified that only EFSA is responsible for the assessment of claims, the MS role is to check whether the relevant information is present. The Commission will check the legal deadlines for simultaneous assessment for claims and novel food status.
Views on use of ‘Unsalted’ as a generic descriptor
It was suggested that this be determined on a case by case basis. The overall view was that this would be generally considered to be a generic descriptor. The Commission will consider adding guidelines on interpretation to the guidance document.
The next Commission Working Group meeting on nutrition and health claims will be held on 15 November 2010.