Actualités

Past articles

Past events : where we were

Articles 2013

EFSA - Health claims

EFSA has published a series of positive opinions in October.

Several health claims received a favourable opinion from the EFSA in October:

• 2 children health claims (article 14 dossiers, submitted by Specialised Nutrition Europe (formerly IDACE¹)) :
  • Pantothenic acid and contribution to normal energy-yielding metabolism;
  • Riboflavin (vitamin B2) and contribution to normal energy-yielding metabolism.
• 2 health claims based on newly developed scientific evidence (article 13.5 dossiers):
  • Hydroxyanthracene derivatives and improvement of bowel function; however the proprietary nature of the claim was not acknowledged by the panel on the basis that there was no evidence that any of the other food constituents in Transitech® besides the hydroxyanthracene derivatives exert an effect on bowel function. The Panel stated that they could have reached its conclusions on the basis of the published literature on hydroxyanthracene derivatives, without the human intervention study claimed as proprietary by the applicant (dossier submitted by Vivatech);
  • Glycaemic carbohydrates and recovery of normal muscle function (contraction) after strenuous exercise (dossier submitted by Aptonia).

Those claims now have to appear on the EU Register of health claims and be formally authorized within the EU.

¹ European Dietetic Food Industry Association

http://www.efsa.europa.eu/en/efsajournal/pub/3411.htm?utm_source=ejtoc&utm_medium=email&utm_campaign=2013/10
http://www.efsa.europa.eu/en/efsajournal/pub/3410.htm?utm_source=ejtoc&utm_medium=email&utm_campaign=2013/10
http://www.efsa.europa.eu/en/efsajournal/pub/3412.htm?utm_source=ejtoc&utm_medium=email&utm_campaign=2013/10
http://www.efsa.europa.eu/en/efsajournal/pub/3409.htm?utm_source=ejtoc&utm_medium=email&utm_campaign=2013/10

Author: A. Chanson-Rolle. December 2013.

EFSA published Dietary Reference Values for intake of vitamin C and manganese

As part of its ongoing work on Dietary Reference Values (DRVs), the EFSA has published early November two scientific opinions on the DRVs for intake of vitamin C and manganese.

The two opinions were finalised by the NDA Panel after public consultations performed this summer, ensuring that EFSA benefits from the widest range of information, data and views from the scientific community, stakeholders and other interested parties.

Please remind that DRVs comprise a set of reference values such as average requirements, population reference intakes, adequate intakes, lower threshold intakes and tolerable upper intake levels. Scientific advice on DRVs is an important basis for the policy decisions of the European Union in the field of nutrition.

The two scientific opinions can be consulted at the following links:

http://www.efsa.europa.eu/fr/efsajournal/pub/3418.htm
http://www.efsa.europa.eu/fr/efsajournal/pub/3419.htm

Author: A Chanson-Rolle. November 2013.
 

EFSA : Technical meeting on the reporting of human studies included in health claim dossiers

The scientific team of VAB-nutrition attended this meeting, in Parma on November 20th, 2013.

Approximately 200 people attended the meeting, from various private companies (food and beverage industries, consulting companies and CROs), universities and research centers. The main information collected during this meeting are as follow:

• Results from clinical studies included in health claim applications must be presented in a way which is appropriate and coherent regarding the EFSA requirements. This actually has not been the case for many received applications.
• Several guidance documents do exist to help improving the quality of reporting of clinical studies. Those are for instance the “Consort” statement for randomized trials, the “Strobe” statement for observational studies, the “Prisma” statement for systematic reviews and meta-analyses of randomized controlled trials, and the “Moose” statement, for systematic reviews and meta-analyses of observational studies. Those documents are the results of a collaborative and international work, and are often updated.
• The EFSA will publish in April 2014 a draft guidance related to the reporting of studies to be included in EFSA dossiers (relevant for all kinds of applications). This document will in particular detail issues related to the reporting of statistics and study results. It will be open to discussion and the final version is planned to be published in October 2014.
• Discussions focused in particular on the interest of meta-analyses for health claim applications, extrapolation of results obtained in particular populations, and possibilities of one to one interactions between EFSA & applicants before or during the health claim evaluation process.

For more information or to obtain detailed minutes of this meeting, please do not hesitate to contact us.

Author: A. Chanson-Rolle. November 2013.
 

New European regulation UE 907/2013 on generic descriptors

The new text, published on September 20th 2013, sets the rules for applications concerning the use of generic descriptors and their exemption from the EU regulation on health claims (1924/2006).

Those descriptors are those which have traditionally been used to indicate a particularity of a class of foods or beverages which could imply an effect on health, such as terms like « probiotics », « prebiotics », « digestive biscuits »…

The text specifies that applications for exemption from EU regulation 1924/2006 should be submitted by the industrial using the generic descriptor, or a trade association acting on behalf of industrials using the generic descriptor, to a national competent authority of a Member State. Operators may choose the Member State to which to submit their application among those Member States where the generic descriptor is used.

The application should present a detailed description highlighting the particularity and the elements that distinguish the class of foods or beverages marketed under the generic descriptor, for which the application is made, from other products falling within the same class of foods or beverages. The application should also contain data proving the presence on the market of the class of foods or beverages with the generic descriptor, over at least a 20-year period, in the Member State(s), prior to the date of entry into force of this Regulation. Member States may also require additional data from the applicant, where they consider it necessary for the assessment of the application. Such additional information may be related to consumer understanding and perception of the effects that could be implied by the generic descriptor or to the demonstration that the consumer links the generic descriptor with the specific class of foods or beverages mentioned in the application.

The recipient Member State and other concerned Member State(s) shall provide their opinion to the Commission stating whether the generic descriptor fulfills the conditions for obtaining the exemption and whether it is supported by the above described elements.

Therefore, this new text paves the way for a new possibility for industrials to communicate on the health properties of their products, out of the use of authorized health claims. However, this will concern only those industrials which can prove the use of the generic descriptors for at least 20 years in at least one Member State. One expected difficulty will probably relate on the way the additional information on consumers’ perception and understanding will be handled. Let see how Member States and the European Commission will consider those applications in the coming months.

Source: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:251:0007:0009:EN:PDF
Author: A. Chanson-Rolle. October 2013.

The European Commission authorizes three new health claims with protection of proprietary data

The list of the new authorized health claims has been published on September 4^th 2013 within the Commission Regulation (EU) No 851/2013. These three claims are:

• Consumption of products high in slowly digestible starch (SDS) raises blood glucose concentration less after a meal compared to products low in SDS (Mondelez International).
• Replacing sugar-containing, acidic drinks, such as soft drinks (typically 8-12 g sugars/100 ml), with reformulated acidic drinks contributes to the maintenance of tooth mineralization. In order to bear the claim, reformulated acidic drinks shall comply with the following description: less than 1 g fermentable carbohydrate per 100 ml (sugars and other carbohydrates except polyols), calcium in a range from 0,3 to 0,8 mol per mol acidulant, pH between 3,7-4,0 (GlaxoSmithKline).   
• Cocoa flavanols help maintain the elasticity of blood vessels, which contributes to normal blood flow (Barry Callebaut).

Those health claims are restricted to the use of their applicants, i.e.: Mondelez International, GlaxoSmithKline, and Barry-Callebaut, respectively. This is because the EFSA has recognized in its scientific opinions that the scientific data claimed as proprietary by the applicants were needed to substantiate the claims. The restriction of use will expire in September 2018.

The three health claims have been added to the EU register of authorized health claims, making to four the total number of claims for which protection of proprietary data has been granted (the other one being a health claim on a tomato extract and platelet aggregation / healthy blood flow, granted to Provexis in 2009).

Author: A. Chanson-Rolle. September 2013.
Read more: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:235:0003:0007:EN:PDF and http://ec.europa.eu/nuhclaims/?event=getListOfPropClaims

The EFSA has published on July 25^th a draft of the first part of its scientific Opinion
on the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs,
which is about exposure assessment

This is the Authority’s first review of exposure to BPA since 2006 and the first to cover both dietary and non-dietary sources. Occurrence data from scientific literature and available in the public domain have been collected and considered in this exposure assessment. Diet was found to be the main source of exposure to BPA in all population groups, but exposure estimates were much lower than those reported in the 2006 EFSA opinion. Thermal paper appears as the second source of exposure in all population groups above 3 years of age. This draft opinion is open to discussion and comments until 15 September 2013.

Author: A. Chanson-Rolle. September 2013.
Read more: http://www.efsa.europa.eu/fr/consultations/call/130725.htm

EFSA has published a draft scientific opinion on dietary reference values (DRV) for manganese

This opinion follows other recent scientific opinions on the DRV for vitamin C, fluoride and molybdenum. It proposes dietary reference values for manganese for adults, infants and children, pregnant and lactating women.  This opinion is currently open to discussion and comments can be sent to the EFSA until September 13^th. Opinions on DRV for other micronutrients will be published in the coming months.

Author: A. Chanson-Rolle. August 2013.
Read more: http://www.efsa.europa.eu/en/consultations/call/130628.htm

Health claims: EFSA has published a series of positive opinions in July

Several health claims received a favourable opinion from the EFSA in July:

• 3 children health claims (article 14 dossier, submitted by IDACE¹) :
  • magnesium and contribution to normal development of bone
  • iron and contribution to normal cognitive development
  • vitamin A and contribution to normal development and function of the immune system
• 2 health claims referring to disease risk reduction (article 14 dossiers)
  • Limicol®² and reduction of blood LDL-cholesterol concentrations (high LDL-cholesterol is a risk factor in the development of coronary heart disease), with acknowledgement of the proprietary nature (submitted by laboratoire Lescuyer) ;
  • increasing maternal folate status by supplemental folate intake and reduced risk of neural tube defects (submitted by Rank Nutrition Ltd)
• 1 health claim based on newly developed scientific evidence (article 13.5 dossier, submitted by Roquette Frères) related to “non fermentable” carbohydrates and maintenance of tooth mineralisation by decreasing tooth demineralisation.

Those claims now have to appear on the EU Register of health claims and be formally authorized within the EU.

¹ European Dietetic Food Industry Association
² artichoke leaf dry extract, red yeast rice, sugar-cane derived policosanols, OPC from French maritime pine bark extract, garlic dry extract, α-tocopherol, riboflavin and inositol hexanicotinate (vitamin B3).

http://www.efsa.europa.eu/en/efsajournal/pub/3331.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=20130731
http://www.efsa.europa.eu/en/efsajournal/pub/3335.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=20130731
http://www.efsa.europa.eu/en/efsajournal/pub/3334.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=20130731
http://www.efsa.europa.eu/en/efsajournal/pub/3327.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=20130731
http://www.efsa.europa.eu/en/efsajournal/pub/3328.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=20130731
http://www.efsa.europa.eu/en/efsajournal/pub/3329.htm?utm_source=newsletter&utm_medium=email&utm_content=pub&utm_campaign=20130731

Author: A Chanson-Rolle. August 2013.

A new regulation (UE 609/2013) for baby food, food for special medical purposes
and total diet replacement for weight control

This new legislation, published in the OJ of the EU on June 29th, simplifies and clarifies the rules on the labelling and the composition of these types of products and abolishes the concept of dietetic food. It also includes an exclusive list of substances such as vitamins and minerals that can be added to these foods. In addition, the text specifies additional requirements regarding the labelling, presentation and advertising of infant formula and the labelling of follow-on formula. Those must not "include pictures of infants, or other pictures or text which may idealise the use of such formula" in order "not to discourage breast-feeding”. However, graphic representations intended for easy identification of the formula and for illustrating methods of preparation will still be permitted.

The Commission should also deliver a report, after consulting the EFSA, to evaluate the necessity, if any, of special provisions regarding compositional and labelling requirements and, if appropriate, other types of requirements, for growing-up milks and similar products intended for young children and for foods intended for sportspeople. In the report on growing-up milks and similar products, the Commission shall examine whether these products intended for toddlers really have "any nutritional benefits when compared to a normal diet for a child who is being weaned”. Those two reports should be delivered to the European Parliament and to the Council before July 20^th 2015.

Author: A. Chanson-Rolle. July 2013.
Read more: http://www.europarl.europa.eu/news/en/pressroom/content/20130607IPR11385/html/New-rules-for-baby-food-special-diet-food-and-low-calorie-food
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:181:0035:0056:EN:PDF

EFSA has published a draft scientific opinion on dietary reference values (DRV) for vitamin C

This document proposes dietary reference values for vitamin C for adults, infants and children, pregnant and lactating women.  In men and women, a population reference intake (PRI) of 110 and 95 mg/day is proposed, respectively. For infants aged 7-11 months, the EFSA has decided to retain a PRI of 20 mg/day. For children and adolescents, proposed PRIs range from 20 mg/day for 1 to 3 year-old children, to 100 and 90 mg/day for boys and girls aged 15-17 years, respectively. For pregnant and lactating women, vitamin C intakes of 10 mg/day and of 75 mg/day in addition to the PRI of non-pregnant and non-lactating women are proposed. This opinion is currently open to discussion and comments can be sent to the EFSA until August 31st.  

This opinion on the DRV for vitamin C follows two other opinions on the DRV for fluoride and molybdenum which have been published earlier this spring. Opinions on DRV for other micronutrients should be published in the coming months.

Author: A. Chanson-Rolle. July 2013.
Read more: http://www.efsa.europa.eu/en/consultations/call/130628.htm

FDOC is launching a call for proposal

Obese children may be more vulnerable to the effects of food advertising
 

According to results from a recent American study*, when viewing food logos, obese children showed significantly less brain activation than the healthy weight children in regions associated with cognitive control (bilateral middle/inferior prefrontal cortex). This provides initial neuroimaging evidence that obese children may be more vulnerable to the effects of food advertising.

Author : A. Chanson-Rolle. April 2013
*Bruce et al.  J Pediatr. 2013 Apr;162(4):759-764.
 

EFSA opinion on endocrine disruptors

Following a 2012 request from the European Commission, EFSA’s Scientific Committee has published on March 20th an opinion that clarifies the scientific criteria for identifying an endocrine disruptor.

This document should help inform the decisions of EU risk managers to protect consumers and the environment from possible risks associated with endocrine disruptors in the food chain.

In particular, the EFSA highlights in this opinion that not all endocrine active substances are endocrine disruptors. This depends on whether there is reasonable evidence that the substance can cause an adverse effect as a result of its interaction or interference with the endocrine system. EFSA also concludes that for risk assessment, an approach which considers both potential adverse effects of endocrine active substances together with the likelihood of exposure makes best use of available information to regulate their use.

Author: A. Chanson-Rolle. March 2013.
To read the opinion: http://www.efsa.europa.eu/en/efsajournal/pub/3132.htm?utm_source=homepage&utm_medium=infocus&utm_campaign=easopinion

Association Between Maternal Use of Folic Acid Supplements and Risk of
Autism Spectrum Disorders in Children

Surén et al. JAMA. 2013 Feb 13;309(6):570-7.

Maternal use of prenatal folic acid supplements is known to reduce the risk of neural tube defects in children (e.g., spina bifida). But the impact of such supplementation on the protection against other neurodevelopmental disorders is unknown.

Results from a large prospective mother-child cohort performed in Norway and including 85 000 children showed that the risk of autistic disorder in children whose mothers took folic acid was 39 % lower than those unexposed to folic acid (adjusted OR = 0.61 [95% CI, 0.41-0.90]). In this study, folic acid supplements were consumed 4 weeks before to 8 weeks after the start of pregnancy. Although these findings cannot demonstrate causality, they support the hypothesis that prenatal folic acid supplementation before and at the beginning of the pregnancy is associated with a lower risk of autistic disorder. This study adds to the large corpus of clinical evidence showing the importance of the maternal folate status for the development of the child’s nervous system. Improvement of folate status in women of childbearing age is of important public health relevance. 

Author: A. Chanson-Rollé. March 2013.
Read more: http://jama.jamanetwork.com/article.aspx?articleid=1570279

FoodDrinkEurope launches Guidance on Food Allergen Management

FoodDrinkEurope has published a guidance on Food Allergen Management on February 4^th 2013. The document sets out general principles to manage specific pre-prepacked foods causing allergy or certain intolerances and provides sound, evidence-based and consistent information on good practice in risk management of allergenic foods for producers.

Author: A. Chanson-Rollé. February 2013.
Read more: http://www.fooddrinkeurope.eu/news/press-release/FoodDrinkEurope-launches-Guidance-on-Food-Allergen-Management/

The French agency Anses has issued a report about the dietary and nutritional status of children and adolescents in relation to their socio-economic level.

This expertise shows that a lower nutritional quality of the diet of children and adolescents of low socio-economic background.  Fruits and vegetable intakes are decreased, while soft drinks intakes are enhanced. However, low socio-economic background children and adolescents eat lesser amounts of some sugary foods (sweets, pastries) and the socio-economic background has no influence on fish consumtion. More than the income, the education level of parents appears as a key feature of diet quality.

Author: V. Braesco. February 2013.
Read more: http://www.anses.fr/Documents/NUT2012sa0085Ra.pdf

Guidelines on the use of general and non-specific health claims:
Commission implementing decision n°2013/63/EU.

The implementing decision n°2013/63/EU, published on 25 January 2013 in the Official Journal of the European Union, describes some guidelines for the use of general and non-specific health claims. Indeed, Article 10(3) of regulation 1924/2006 on health claims allows the use of statements which make reference to general, non-specific benefits of a food for overall good health or health-related well-being, without prior authorization. The new Commission decision specifies that such statements can be made if they are accompanied by a specific health claim from the list of permitted health claims in the Union Register (http://ec.europa.eu/nuhclaims/), which should appear ‘next to’ or ‘following’ the statement.  In addition, the specific, accompanying, permitted health claim should bear some relevance to the general reference, and the demonstration of the link between both is upon the responsibility of food business operators. Of course, as the general reference becomes broader, e.g. ‘for good health’, more specific permitted health claims could be eligible to accompany it. Finally, the document stipulates that claims which are listed as non-authorized in the Union Register of health claims because they were judged as too general and non-specific during their scientific assessment by the EFSA, can still be used if they are accompanied by a specific claim from the list of permitted health claims, in accordance with the conditions described above. Therefore, this new text provides details on the use of a type of health claims which may be particularly attractive to consumers (because more ‘consumer-friendly’), provided that they are not misunderstood or misinterpreted.

Author: A. Chanson-Rolle. February 2013.