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)

FVO Report – Italy deficiencies of official controls on milk and milk products

The following FVO report stress several and persistent profiles of non compliance of the Italian official controls system on milk and milk products: the recommendations made in 2010, 2012 and 2013 were not properly addressed.

The audit took place in Italy from 9 to 20 March 2015 in order to evaluate the official controls related to production and storage of milk and milk products, and the follow-up action taken by the competent authorities (CAs) in response to the relevant recommendations made in the previous audit reports.

Three Regions (Abruzzo, Puglia and Piemonte) were visited. Official controls are carried out frequently according to control plans, are risk based and well documented. However, the establishment reports contain very little relevant information and many deficiencies are overlooked. In addition, there is very little effective follow-up. Communication within local CA units remains poor. In the eight establishments visited, among the deficiencies found by the Food and Veterinary Office audit team, only a few had been identified and documented by the CA.

Audits (Article 4.6 of Regulation (EC) No 882/2004) are carried out by central and Regional levels. The reports of these audits contain findings on non-compliances and systemic problems. Of the seven establishments visited (milk collection centre not included) in three Regions (six provinces) from the point of view of structure, maintenance, equipment, cleanliness and hygiene of operations, – four were satisfactory (with different levels of remarks and deficiencies) and three were unsatisfactory. There was no immediate public health risk. Serious deficiencies in official controls were observed on dairy holdings visited.

Raw milk quality standards (Section IX Annex III to Regulation (EC) No 853/2004): National derogations notified to the Commission for 2008 -2013 for all milk are still in place for sheep and goat milk. Food business operators (FBOs) take samples but these are not always analysed and laboratory performance is not always reliable. The CAs are not always notified of non-compliant results and there is no system in place to ensure notification – CA does take action when informed. There is no national system for official monitoring of FBO own checks related to raw milk parameters.

Residues: There were procedures in place for inhibitor controls in all establishments visited. However, out-of-date kits were in use in three establishments. The requirement to maintain records of treatment with veterinary medicines on milk production holdings is not enforced.

A number of recommendations have been made to the CA with a view of addressing the deficiencies identified during this audit. At least five of these or very similar recommendations have already been made in the Audit Report DG(SANCO)2010-8502, 2012-6333 and 2013-6875 but have not been properly addressed or implemented.