Food Law News - EU - 2009

FSA Letter, 26 February 2009

CLAIMS - Commission Working Group, 12 January 2009: Nutrient profiles, Article 13 health claims update and authorisation of claims under Article 13(5) and 14

The following provide a report on the recent Commission Working Group meeting on nutrition and health claims, and noting the result of the votes on the authorisation of Article 13(5) and 14 claims which took place at the Standing Committee meeting on 20 February.

1. Nutrient Profiles

The Commission were keen to press ahead and is aiming for a vote at the Standing Committee meeting scheduled for 27 March. Nutrient profiles will be discussed again at the next Commission Working Group meeting on 20 March but it is unlikely that many changes will be made at that stage as the document for Standing Committee will already have been issued – this will be a revision of the 13 February draft proposal taking into account Member States' comments and amendments resulting from the ongoing intra-service clearance procedure.


Some Member States did not consider the proposed extended transition period for salt in bread to be a suitable solution, although one Member State commented that it was an interesting approach that could be applied to other categories where high sodium thresholds have been set, such as meat and fish.

A number of Member States were in favour of adding biscuits to the breakfast cereals category and reducing the sugar threshold to 20g, which the Commission said they would consider.


A number of Member States felt the sodium and saturated fat thresholds for cheese should be raised, and the Commission noted that most would not be against raising the saturated fat threshold to 12 or 12.5g.

Spreadable fats and oils

The Commission noted that the 30kcal/100g threshold proposed for saturated fat in oils and spreadable fat was an error and should read 30kcal/100kcal. A number of Member States spoke in favour of this change but others requested time for further consideration, citing concerns that this would prohibit claims on light butter but allow claims on oils with a higher total fat content.

Non-alcoholic beverages

The new wider definition for the non-alcoholic beverages category appears to include gravies and sauces as “liquid foods”, and a number of Member States were concerned that a threshold for all nutrients had not been set. The Commission questioned whether Member States wanted to extend the scope of the non-alcoholic beverages category as EFSA had only intended this to cover soft drinks, but there was little reaction from Member States on this point.


A number of Member States asked for eggs to be included in the meat and meat products category as they are an important source of protein and the Commission agreed to consider this.

One Member State expressed concern that the nutrient profiles would be difficult to enforce as labels often don't give information about the proportions of ingredients, and group 2 nutrition labelling is not always required but would be necessary to obtain information about saturated fat, sodium and sugars. Requiring this labelling on all foods is being considered under the Food Information Regulation proposal so thought should be given to converging implementation with this. The Commission indicated it would aim to make the text as clear as possible and also look at clarifying whether the profiles apply to foods on an as sold or as consumed basis.

Food database

EFSA presented a report on building and testing the food composition database, which the Commission said would also be useful in future for testing the effect of the profiles on consumption. The Commission said it was relying on industry to flag any problems as there was no way of checking how well the Eurofir classification system that EFSA used correlated with the classification criteria in the EU nutrient profile model.

2. Article 13 Health Claims

The Commission explained that a number of Member State claims in the EFSA database had been incorrectly assigned to main entries. EFSA has identified a number of these and, where possible, proposed where the claim should be re-assigned – Member States were asked to check whether or not they agree with these proposals and identify any other incorrectly assigned claims by 27 February on a spreadsheet provided by the Commission. We have this in hand. Where there is no suitable entry to re-assign the claim, Member States were asked to indicate this on the spreadsheet, so it can be considered as a new claim. EFSA explained that prompt action is essential as it is already assessing claims and will therefore need all references to be able to do this, although for vitamin and mineral claims it can rely more on textbook knowledge.

Of the 2000-odd claims EFSA has asked for clarification on, the Commission had identified 517 claims that were submitted by more than one Member State , and requested those Member States to communicate with one another as soon as possible to clarify EFSA's questions. The Commission will check revised claims before forwarding them to EFSA for assessment and may go back to Member States if further information is required. Decisions may need to be made at this stage about eligibility of claims and if outside the scope of Article 13 no further action will be possible, and claims should be weeded out.

On the EFSA screening, Member States queried why some claims had been highlighted as vague (screening classification 3), but apparently identical claims had not. EFSA clarified that there needed to be a clear and measurable health effect in order for them to be able to assess claims; in some cases it had established a measurable effect (e.g. digestive health by “stimulating the growth of Bifidobacteria in the colon”), but in others not (e.g. digestive health by “contributing to the normal function of the intestinal tract”). EFSA had checked both the health relationship and example wording for the main entry claim to establish measurable cause and effect relationships and only requested clarification where it could find nothing – but it had not looked at claims behind the main claim entry. If a claim mentions several health effects but only one is measurable then EFSA will only assess that, but if more than one effect is measurable they will assess all (and subdivide into different claims). We will write out to those who submitted Article 13 claims to the UK list shortly about clarifying claims that EFSA have queried.

3. Article 13(5) and Article 14 Health Claims

There was further discussion about the proposed Regulations on Article 13(5) and Article 14 claims, and a vote took place at Standing Committee on 20 February. The proposed Regulations were adopted by a qualified majority.

For the vote the Commission wanted to solve the issue of flexible or fixed wording. Member States were divided on this but several thought flexibility possible with guidance to help enforcement authorities establish the limits of flexibility, particularly where a certain wording while appearing to represent the listed claim might actually mislead consumers, for example by suggesting that only the food bearing the claim could have the health benefit whereas other foods would deliver the same benefit. The Commission said that it was happy to develop guidance to clarify these issues and asked Member States to help.

The xylitol chewing gum/dental caries claim was discussed again, as the Commission and EFSA wanted to establish a risk factor. EFSA said that in general there were very few validated, modifiable risk factors (such as cholesterol and heart disease). The Commission said it is important for these claims that there is evidence that a risk factor has been significantly reduced, but it is not clear how strong the link between the risk factor and disease needs to be. Dental experts consider there to be two possible risk factors for this claim:

Member States did not comment on which approach they preferred.

The Commission explained that a specific claim for cheese containing protein, calcium, vitamin D and phosphorous will not be authorised as the claimed effect on bones is as a result of these individual nutrients rather than cheese itself. Instead, they proposed claims for phosphorous, vitamin D, calcium and protein which would be available for foods containing those nutrients and meeting the conditions of use. EFSA stated that it always considers whether a claimed effect is product-specific or arises as a result of ingredients within the food.

The Commission said that EFSA had recently received further applications for sterols and stanols and lowering cholesterol, and asked whether Member States considered it necessary for EFSA to assess this claim as the sterol and stanol claims already being considered for authorisation are generic rather than product specific. In response to a question about data protection, the Commission explained that both these claims could be substantiated without needing to take proprietary evidence into account. The key issue here is that different levels of sterols/stanols have been proposed, but EFSA said the evidence shows that the response does not alter much over a range of 1.5-2.4g per day – the conditions of use for the claims currently being considered for approval had slightly different levels. Since any company meeting the conditions of use for an authorised claim can use it, alternative conditions of use might need to be considered. The Commission said that they would keep this under review and would be prepared to revise conditions of use on generic claims in the light of new evidence.

Date of next meeting: 20 March

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