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Nutrition and Health Claims Regulation (EC/1924/2006)

The Nutrition and Health Claims Regulation for foods has been effective from July 2007. It applies to all nutrition and health claims made in commercial communications (i.e. labelling, presentation or advertising) for a food. It describes how nutrition and health claims should be used, and the procedure to apply for the authorisation of a claim by the European Commission. The aim of this legislation is to put together a list of permitted nutrition and health claims that can be used by manufacturers across the EU. Also it requires specific nutrient profiles to be established that foods or certain groups of foods must respect in order to bear nutrition and health claims. Ultimately, only health claims that are on this list will be permitted for use in the EU, although there are interim measures in place to give manufacturers time to adapt to the new rules. Foods that are likely to be affected include substances commonly referred to as nutraceuticals, novel foods, food supplements, herbal supplements and functional foods. 

What is a nutrition claim? 
A nutrition claim is a statement that suggests that a food has particular beneficial nutritional properties due to the nutrients it does or does not contain. Some examples of nutrition claims are 'low in fat', 'high in fibre' or 'no added sugar'.

What is a health claim? 
A health claim is any claim that states, suggests or implies that a relationship exists between a food category, a food, or one of its constituents and health. This could be a statement that a food can help a particular physiological function, such as calcium in dairy products maintaining bone health or dietary fibre aiding bowel function. Health claims may also be about the reduction of disease risk, such as 'long chain omega 3 fatty acids may help reduce the risk of coronary heart disease'.

Nutrition and Health Claims Regulation - claims under Article 13 
Nutrition and health claims under Article 13 of the EC Regulation on nutrition and health claims refer to general claims for a substnce: - The role of a nutrient/substance in growth, development and the functions of the body; - Psychological and behavioural functions - Slimming and weight control or reduction of hunger, increase of satiety or the reduction of available energy from the diet. - Initial opinions under Article 13.1 were published on 01 October 2009. Many of the opinions were negative due to a lack of substantiated data, vitamins and minerals received the most positive opinions. Very few botanicals or herbals were included snd now these subjects are temporarily outside the sciope of the current regualtion implementation.This pattern has continued. Timeline of publications of EFSA's general function evaluations. Approximately 200 positive opinions have been now finalised: Oct 2009, 521 claims addressed in 94 opinions, Feb 2010, 416 claims covered in 31 opinions, Oct 2010, 808 claims, addressed in 75 opinions, Apr 2011, 442 claims, addressed in 63 opinions, Jun 2011, 536 claims, addressed in 73 opinions and Jul 2011, 35 claims addressed in 5 opinions. efsa.europa.eu/EFSA/efsa_locale-1178620753812_article13.htm

So far, 2,538 of 2,758 general function claims have not been successfully evaluated, amounting to a 92% rejection rate. Many of these evaluations were unsuccessful because insufficient data were provided, meaning that if companies are able to provide more of the right kind of data, further approvals will be issued. It is expected the EP will vote on the register within 90 days. If it passes, six months after that, the 2000 claim rejections will be banned across the EU.

Nutrition and Health Claims Regulation - health claims under Article 14
Health Claims under Article 14 of the EC Regulation on nutrition and health claims refer to the reduction of disease risk or to children's development or health.

The panel initially received 246 applications,some applications have been withdrawn and scientific opinions are now being regularly issued. The first series of opinions on health claims under Article 14 were in August 2008. The opinions published by EFSA provide information on the scientific substantiation of the proposed health claims to the European Commission and Member States, which will now decide officially whether to authorise the recommended claims. Approved claims have included a definition of the claim wording to use. Many claims have been rejected which indicates rigourous assessment criteria.

The NDA Panel has adopted 75 opinions on claims relating to disease risk reduction and child development or health by the end of 2011. http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_article14.htm

Nutrition and Health Claims Regulation - health claims under Article 13.5
Health Claims under Article 13.5 of the EC Regulation on nutrition and health claims are those based on newly developed scientific evidence and/or for which protection of proprietary data is requested. For these health claims authorisation is required on a case-by-case basis, following the submission of a scientific dossier to EFSA for assessment. The NDA Panel has adopted 27 scientific opinions on "new function" by the end of 2011. The only positive opinion from EFSA in 2009 for a tomato extract has taken more than 6 months to have the final claim wording approved by the European Commission. The Commission adapted EFSA's suggested wording for Provexis's Fruitflow tomato extract, so that, "helps maintain normal platelet aggregation" became: "Helps maintain normal platelet aggregation, which contributes to healthy blood flow."

Please contact us directly if you are have concenrs for how to market your product and how it should be advertised and labelled once the Nutrition and Health claims Regulation becomes fully implemented.

EFSA Guidance on Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements

The European Food Safety Authority ( EFSA) have issued a guidance document that suggest a two tier system of considering safety evidence for herbs, traditional data and then emerging data including animal and clinical studies. If an adequate body of knowledge exists no further testing may be needed. i.e. the first tier alone should satisfy EFSA safety assessment. The document can be used as a template for standardising the preparation of data. This guidance was published in September 2009 and there is currently no experience to further share on this proposal. It is not directly related to t he Nutrition and Health claims regulation but is likely to influence any assessments regarding health claims. http://www.efsa.europa.eu/cs/BlobServer/Guidance_of_Panel/sc_op_ej1249_botanicals_en.pdf?ssbinary=true