Updates from EU Working Group on Health Claims (20th June 2016)

Here below some updates for all the real claims “geek” reading this blog (a lot…). Of extreme interest, in my opinion, particularly the note about probiotics.

Discussion on a health claim related to glycaemic carbohydrates and cognitive function Article 13(5) of Regulation (EC) No 1924/2006

Reference was made to a recent EU General Court case brought about by Dextro Energy. The EGC ruling found that the Commission did not err in rejecting a number of health claims relating to glucose and energy metabolism on the basis that they encouraged the consumption of sugar, which is incompatible with generally accepted principles of nutrition and health. The ruling means that a number of health claims relating to glucose cannot be authorised. In light of the ruling it was proposed that the health claim relating to carbohydrates and cognitive function should be rejected (as the claim could not be used on glucose it would be unfair to the applicant if it was authorised for use on non-glucose carbohydrates). The health claim will be presented for an opinion at Standing Committee under the Article 18.4 procedure by consultation.

Discussion on a draft Commission Regulation authorising a health claim related to lactitol and maintenance of normal defecation Article 13(5) of Regulation (EC) No 1924/2006

The wording of the health claim has been revised in the latest draft Regulation to “Lactitol contributes to normal bowel function by increasing stool frequency”. The conditions of use were revised to: “The claim may be used only for food which contains 10 g of lactitol in a single quantified portion. In order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained by consuming 10 g of lactitol daily and that the daily dose of 10 g lactitol should not be exceeded. Information shall also be given to the consumer that the excessive consumption of lactitol may produce laxative effects”. Some Member States raised concerns regarding the safety of lactitol and were advised to direct their concerns to the Working Group on Novel Foods, as it was currently considering an application for lactitol as a food ingredient. The discussions at the Working Group on Novel Foods would inform further discussion/a decision on the health claim.

Discussion on a draft Commission Regulation authorising a health claim made on foods related to creatine in combination with resistance training and improvement in muscle strength Article 13(5) of Regulation (EC) No 1924/2006

EFSA gave a positive opinion on the health claim. A few Member States raised concerns about the highly technical conditions of use and whether consumers would understand the meaning of resistance training being performed at an intensity of at least 65%-75% of one repetition maximum. One Member State suggested that a footnote explaining that “repetition maximum is the maximum weight or force an individual can exert in a single lift” could be helpful. The health claim will be presented for an opinion at Standing Committee under the Article 18.4 procedure by consultation.

Discussion on a draft Commission Regulation authorising a health claim made on foods and referring to the reduction of disease risk, related to Monacolin K and maintenance of normal blood LDL-cholesterol concentrations Article 14(1)(a) of Regulation (EC) No 1924/2006

Regarding the health claim relating to a high intake of Monacolin K claim (10 mg), a procedural issue in relation to adoption would prevent the replacement of the authorised health claim with a new entry, revised to include additional warning statements in the conditions of use. The Commission therefore proposed launching Article 8 of Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods, and thereby requested EFSA to make an assessment of the safety of Monacolin K. The intention is to proceed with the health claim relating to the lower 2 mg concentration of Monacolin K. A few Member States raised concerns that the latest draft of the Regulation had the warning statements removed. In order to come to an informed view on the need for safety warnings on the health claim, Member States were asked to submit information on the use of safety warnings on Monacolin K food supplements on their market.

Exchange of views with Member States on health claim made on foods and referring to children‘s development and health – Follow-up discussion on point B.06 of the agenda of Standing Committee meeting of 12 April 2016 Article 14(1)(b) of Regulation (EC) No 1924/2006

There was discussion on what constitutes the age group “children” in light of the approval at the PAFF Committee held on 12 April 2016 to authorise the health claim for “Vitamin D contributes to the normal function of the immune system in children” where the targeted age group is children from 3 to 18 years of age. There was discussion on the twenty health claims targeted at children, which received positive opinions from EFSA, but have been pending due to developments relating to Regulation 609/2013 on Foods for Specific Groups (FSG) and the Delegated Act on Infant formulae and follow-on formulae which has now been adopted. A decision would have to be made on how to deal with the health claims, but there were some reservations regarding the potential for the claims to be used on follow-on formulae. The Commission will send Member States a list of questions covering the different categories of food (e.g. follow-on formulae, baby foods) in order to seek views on how to treat health claims for these food categories.

Update of Caffeine claims

The European Parliament (EP) lodged an objection to the caffeine claims which received a favourable opinion by qualified majority vote at Standing Committee on 12 April. The objection was upheld and will be voted on at EP Plenary in early July. The EP objection2 is on the grounds that sugary drinks and energy drinks containing caffeine should not display claims that they can help increase alertness or concentration, as this would encourage high consumption of sugar among adolescents, who are the largest group of energy drink consumers.

Update on use of the term “Probiotic”

The Commission is considering the option of using the term “Probiotic” as a voluntary statement under Regulation 1169/2011 on the provision of food information to consumers, although this is not a fixed position. There is an indication of commitment to resolve the issue.

(Source: UK Department of Health Bulletin)

EU Commission report on food intended for sportspeople

The report, published on 15th June 2016, is intended to meet the obligation set for the Commission by Article 13 of Regulation (EU) No 609/2013 of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control (hereinafter ‘FSG Regulation’). According to this Article, the Commission is required to present to the European Parliament and to the Council, after consulting the European Food Safety Authority (EFSA), a report on the necessity, if any, of provisions for food intended for sportspeople (hereinafter ‘sports food’).

The request for this report is linked to the repeal by the FSG Regulation of the framework on foodstuffs intended for particular nutritional uses, as of 20 July 2016. This framework was established by a Council Directive in 1989 and completed by the recast Directive 2009/39/EC.

Sports food can currently be classified either (1) as ‘foodstuff intended for particular nutritional uses’ under Directive 2009/39/EC or (2) as food for normal consumption governed by relevant horizontal rules of food law. The FSG Regulation does not include sports food within its scope, since it focuses on foods for certain vulnerable groups of consumers.

Thus, since a categorisation as foodstuff intended for particular nutritional uses will no longer be available to sports food, this type of food will be exclusively governed by horizontal rules of food law as from 20 July 2016.

This report reflects on potential consequences of the change of status for sports food.

It builds upon a market study carried out by the Food Chain Evaluation Consortium (FCEC Study) between January 2015 and June 2015. In the context of the preparation of this report, a consultation was carried out with national competent authorities and other interested parties.

The European Commission consulted the European Food Safety Authority (EFSA) which provided scientific and technical assistance regarding sports food. EFSA compiled existing scientific advice in the area of nutrition and health claims and Dietary References Values for adults that are relevant to sportspeople and informed the Commission that its subsequent advice does not differ from the recommendations of the Report of the Scientific Committee on Food (SCF) adopted in 2001 on composition and specification of food intended to meet the expenditure of intense muscular effort, especially for sportsmen.

Here below, the conclusions:

“There are clear indications that sport has become mainstream in the general population. Consequently, people carrying out sports activity can hardly be characterised as a specific vulnerable group of consumers but rather as a target group of the general population who is protected at an appropriate level by horizontal legislation.

In view of the growing completion of the horizontal rules of food law which took place in the last years, an appropriate legislative framework is in place to ensure that sports food classified nowadays as food intended for particular nutritional uses can remain on the market and can operate. The horizontal rules of food law provide the necessary safeguards for these products in terms of food safety, food composition, consumer information and legal certainty. As a result, not only all sports food products will be subject to the same legal requirements but they will have the same level of harmonisation as other foods falling under the horizontal rules of food law. It is expected that, through the simplification and clarification of the legal framework applicable for sports food, legal certainty will be enhanced and the current fragmentation based on the different legal frameworks reduced.

From this analysis, it can be concluded that there is no necessity for specific provisions for food intended for sportspeople. Nevertheless, sports food may include some element of specificity and the analysis in this report shows that this may have to be taken into account by the Commission in the application and implementation of the horizontal rules, so that such specificities can be adequately addressed. The Commission will ensure proper application of horizontal legislation and monitor the developments after 20 July 2016.”

(Source: DG Sante website)