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)

Plant Harmful organisms in the EU – Annual report 2014

Article 16 (1) and (2) of Directive 2000/29/EC, requires that Member States immediately notify the European Commission and other Member States, of the presence or appearance of harmful organisms found on their territory or part of it, as well as the measures taken to eradicate or avoid the spread of the harmful organism concerned.

This is required whether the harmful organisms are regulated (specifically listed in European Union (EU) legislation) or not. The European Commission analyses and reports on these notifications on a continuous basis and provides monthly reports on notifications received to the Standing Committee on Plants, Animals, Food and Feed, section Plant Health, in order to assist risk management decisions at EU level.

This report provides an overview of the notifications received from Member States in 2014, as well as the main trends in the period 2010 to 2014.

The total number of notifications received annually has remained relatively stable since 2010. In 2014, a total of 220 notifications were received from 27 Member States. Approximately two thirds of these related to regulated harmful organisms. 19 were updates to previous notifications.

Some of the notifications received in 2014 give rise to concern because of the seriousness of the particular harmful organisms and because of their first finding or their spread in the EU territory. Some of these harmful organisms are currently non–regulated in the EU. However, because of the potential risk they present, they are listed in the European and Mediterranean Plant Protection Organisation Alert list, i.e. identified as good candidates for a Pest Risk Analysis.

At EU level, actions have been planned or are being taken with a view to addressing these risks. As in previous years, the number of notifications varies significantly between Member States which could reflect a different interpretation of Member States’ obligations pursuant to Article 16 (1) and (2).

Furthermore, despite some improvement compared to previous year, notifications still present a consistent lack of certain information which hinders the risk management decision process and capacity to have a clear picture of the effectiveness of phytosanitary measures implemented and of the status of the different harmful organisms in the EU. The adoption of Decision 2014/917/EU in December 2014, which sets out detailed rules for the implementation of Article 16 (1) and (2), combined with the development of a web-based notification system (EUROPHYT) and a common protocol for notifications, are expected to foster the harmonisation of practices between Member States. This should help timely decisions at EU level for an increased level of protection of the EU territory against phytosanitary risks.

In 2014, a large proportion of the outbreak notifications (72%) either did not make any reference to the source of the infestation or stated that it was unknown. Out of the 201 outbreak notifications, only 57 provided information on the possible source of the infestation. As regards movements within the EU, infested planting material is often considered as the likely source of the infestation.

Between the new risks identified the well known Xylella fastidiosa in coffee plants was the most dangerous. Xylella fastidiosa, a bacterium listed in Annex IAI, was first found in the EU in 2013, in the province of Lecce in Italy where a sudden decline of olives was observed. This finding was closely followed up by the Commission in consultation with the Standing Committee, and EU emergency measures were adopted in February 2014. In addition, a Commission audit was carried out to the affected area in February 2014, followed by 3 further audits since then to assess the situation and control measures implemented by the Competent Authorities. Amongst other exchanges of information with Italy, three notifications were received in 2014 in which Italy reported new vectors, new host plants and the extent of the infestation in the Lecce region (see also section 4.2.1). Regarding the findings on Coffea plants referred to in section 4.2.1, an import ban on such plants from Costa Rica and Honduras has been introduced with Commission Implementing Decision 2015/789/EU to protect the EU from further introductions from these origins.

For more information see also the EU Commission infographic.