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)

Xylella fastidiosa- France control system not better than Italian one


This report describes the outcome of an audit carried out by the Directorate General Health and Food Safety of the European Commission in France from 3 to 12 February 2016. The objective of the audit was to evaluate the plant health situation and control measures applied for Xylella fastidiosa in the two regions of France where there are outbreaks of the bacterium.

In 2015 France carried out a comprehensive and risk based Xylella fastidiosa survey at country level and ran an intensified awareness raising campaign. The high level of alert and awareness promoted by the French authorities ensured the prompt finding and identification of the outbreaks.

Measures were implemented quickly within and outside the demarcated areas. Additional human and financial resources were mobilised, a network for large-scale sampling and laboratory testing was established and the relevant stakeholders were sufficiently informed and involved.

The demarcation, insect vector treatment, removal and destruction of host and symptomatic plants within the 100m radius of the infected plants were carried out fully in line with the provisions of Commission Decision 2015/789/EU.

However, the intensity of the surveys carried out within the buffer zones is significantly lower than that required by Commission Decision 2015/789/EU. Sampling and testing of specified plants within a radius of 100m around the plants confirmed to be infected is also not in line with the Decision. This does not allow the accurate determination of the spread of Xylella fastidiosa. In the case of outbreaks where the eradication work was completed, the sites were not revisited to remove newly identified host plants which could be infected.

Nurseries located in demarcated areas are allowed to move specified plants outside those areas without fulfilling all requirements of the Decision. It increases the risk of the movement of the pathogen to new areas.

Due to the number of recent outbreaks and the size of the demarcated area the French authorities were still implementing a large part of the measures at the time of the audit.

France has taken a number of measures showing its commitment to eradicating Xylella fastidiosa. However, the non-compliances detected reduce the efficiency and effectiveness of the eradication efforts. The risk of spread with human assistance is mitigated to some extent by that all outbreaks of Xylella fastidiosa to date have been recorded in areas with no large-scale production of plants for planting of the major hosts. The eradication efforts are further compromised by the high number of outbreaks and level of spread, particularly in Corsica. This is compounded by the multitude of identified host plants, the inaccessibility of risky areas and by uncertainties about hosts and the mode of transmission.