DH Interested Parties Letter, 27 January 2012
The Commission had arranged this working group meeting to discuss questions of interpretation of the nutrition and health claims regulation raised by Member States in recent months.
1. What is a health [care] professional (HCP) within the scope of Regulation (EC) 1924/2006 on nutrition and health claims (NHCR)?
Member States (MS) take a wide interpretation beyond medicine and nursing to encompass nutritionists and dietitians; some MS also include anyone with a professional business who represents themselves as having expertise in nutrition and health, or speaks for such experts including personal trainers.
2. Do communications on the health benefit of a product to an HCP fall within scope of the NHCR?
The NHCR applies to claims made in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer (Article 1(2)). In discussing whether claims (as defined in the NHCR) in communications to HCPs fall within the scope of the Regulation MS considered the definition of commercial communication and whether it was that or the food that was to be delivered to the final consumer.
On what constitutes a commercial communication, MS were reminded of the definition in Directive 2006/123: ‘any form of communication designed to promote, directly or indirectly, the goods, services or image of an undertaking, organization or person engaged in commercial, industrial or craft activity or practicing a regulated profession’ and that, in some language versions of the NHCR, it is clear that ‘to be delivered as such to the final consumer’ applies to foods. Several MS therefore regard communications to HCPs about the health benefits of foods as within scope; others think it should be considered on a case-by-case basis.
The Commission asked whether claims about substances (e.g. beta-glucans, calcium) should be treated the same as claims about foods. It was suggested that if the substances are not destined for the final consumer then they would be out of scope; it was noted that how the information was presented was important and if it were put on the web and available to consumers then claims would be within scope. It would be important to consider whether claims about ingredients could be linked, either directly or by implication, to a food destined for the final consumer.
3. Do communications on the health benefit of a product from an HCP fall within the scope of Regulation 1924/2006?
Several MS said that the Regulation does not cover non-commercial communications such as independent advice given by HCPs to patients. However, if HCPs talk about the health benefits of a product in a commercial communication they must avoid contravening the prohibition in Article 12(c) NHCR.
4. Are summaries of scientific studies containing claims on commercial webpages seen as claims within the scope of the NHCR?
Some MS were clear that such claims would be within the scope while others took a view on a case-by-case basis, noting that it would be important to consider if the information were visible to consumers and how it might be understood by them. With regard to claims about ingredients on food business websites ostensibly targeted at HCPs but easily accessible to consumers, the general view was that these were within scope of the Regulation.
5. Is business to business (b2b) communication within scope?
Several MS consider that communication about a product destined for the final consumer (e.g. communication between a food manufacturer and a retailer) is within scope. Others consider that, while the NHCR applies to claims made in commercial communication it does not control claims made in b2b communication provided the recipients are acting within the scope of their professional activities and are not being addressed as final consumers of the foods. However, they also consider that if that information were ever conveyed to final consumers, within a commercial context, any claims would have to comply with the Regulation.
6. Are recommendations of, or endorsements by, health-related organisations other than national bodies (e.g. World Health Foundation) prohibited since Article 11 of the NHCR only refers to national associations?
Some MS consider anything not permitted by Article 11 to be prohibited by Article 12(c); therefore recommendations and endorsements by organisations other than national bodies are prohibited. However, it was suggested that it would be within the spirit of the Regulation to consider world bodies in the same way as national ones. Some MS said that association and charity logos (e.g. heart logos) could be considered Art 10(3) claims depending upon the context and, in that case, they would need to be accompanied by a relevant, authorised health claim.
7. What is meant by Article 5(3) “ready for consumption in accordance with the manufacturer’s instructions”?
We considered two examples: (1) a powdered chocolate drink or a dried soup which is clearly intended to be consumed after reconstitution and whose packaging carries clear instructions for making up with milk or water and (2) meat or flour which could be cooked or used in a number of different ways. Several MS said that, in general, nutrition claims should apply to the food as sold except in the case of foods in the first example where they should apply to the food reconstituted in accordance with the manufacturers’ instructions. The reasoning was that for many foods (e.g. meat sold raw) it was impossible to always account for its composition after cooking. Others considered that nutrition claims should apply to the food as used by the consumer. In any case, food business operators must be able to justify claims (Article 6 NHCR) and labelling should make it clear to consumers whether a nutrition claim refers to the food as sold or as used if that is different.
8. How to regard “contains bifidus”, “contains Coenzyme 10”, “contains lycopene”?
Most delegates that spoke considered these to be “contains” claims. Some would consider it misleading to use “Contains X substance / micro-organism” claims with respect to ingredients for which EFSA had issued only negative health claim opinions. However, it was not clear what evidence would be needed to justify such claims or who should assess it.
We considered whether the statement “Glucosamine is a structural component of joint cartilage and is, in part, responsible for its resistance to compression” on a food supplement could be construed as a health claim. Most MS that spoke considered it to be an implied health claim; however, it was noted that context and presentation would need to be taken into account.
There was no agreement on whether the terms “unsalted butter” and “unsalted peanuts” were general descriptors or nutrition claims.
9. Definition of children’s claims
The Commission reminded MS that rules on Article 14(1)(b) claims were introduced into the NHCR due to European Parliament concerns about claims on FOF and weaning foods; the intention was that only Article 14(1)(b) claims should be allowed on those products.
We discussed whether Article 13(1) claims could be made on products advertised for children aged 3-18 years of age or whether claims on products targeted at this age group had to fall under Article 14(1)(b) of the NHCR. The Commission pointed out that there is specific legislation on infant formula (IF), follow-on formula (FOF) and cereal-based baby food and there are specific rules for claims made on infant formula. Claims on FOF and cereal-based baby foods will be subject to the NHCR (i.e. Art 14(1)(b) process). However, for products such as growing up milks, food supplements for children and products advertised for children aged 3-18 years (as well as for the general population), could Article 13(1) claims be placed on such foods if the evidence substantiating the claim covered all life stages?
Some MS consider that health claims used on products intended for children aged 3-18 years must be Article 14(1)(b) claims; other think that Article 13(1) claims may be made if the evidence substantiating the claim covers that group of the population. It was agreed that EFSA should be asked to confirm whether or not it had included young children as part of the general population when assessing Article 13(1) claims.
10. “Reduced / increased (name of nutrient)”
MS discussed whether a “reduced cholesterol” claim is permissible. Article 2 of 1924/2006 provides a definition of a nutrient; if cholesterol is considered a component of a defined nutrient then a “reduced cholesterol” claim would be permissible. However, it was suggested that the claim could be misleading since on grounds that it may not indicate a beneficial nutritional property of a food.
11. Comparative nutrition claims
Article 9.2 of the Nutrition and Health Claims Regulation states “Comparative nutrition claims shall compare the composition of the food in question with a range of foods of the same category, which do not have a composition which allows them to bear a claim, including foods of other brands”. We discussed what is meant by “a claim”.
There seemed to be agreement that the comparison required by Article 9 should be with a range of foods which do not have a composition which allows them to bear the comparative claim in question however, if they bore nonrelated, authorised nutrition claims this would not exclude them from the comparator range. So for example, a soft drink bearing a “reduced – 30% less sugar” claim could be compared with a range of standard soft drink products which do not have a composition which allows them to bear the “reduced – 30% less sugar” claim or e.g. “low in sugars”. However, they could have a composition which allowed them to bear a non-related nutrition claim e.g. “low salt”.
The Commission is considering how to disseminate the outcomes of the discussion.
Next working group meeting
The date of the next meeting is provisionally set for 9 March.