Latest Regulatory Developments in Nutrition & Health Claims in the EU

The Regulation Harmonised rules for the use of nutrition and health claims Claims made should be: - Clear - Accurate - Substantiated Nutrition and health claims made on foods: REG (EC) No.1924/2006 of the European Parliament and Council Aims to ensure - Fair competition - Promote and protect innovation 3 Intertek 2015, All Rights Reserved

What is a Claim? A claim means any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics. Source: 4 Intertek 2015, All Rights Reserved

Controlling Nutrition and Health Claims Aims to protect consumers from being misled, by controlling nutrition and health claims. A positive list of permitted health claims has been established: http://ec.europa.eu/nuhclaims/ Specific guidance for registering a new claim Permitted list of nutritional claims in the regulation s annex 6 Intertek 2015, All Rights Reserved

Setting up of a Positive List of Health Claims Ensure any consumers claims on foods, are based on high quality science evaluated by European Food Safety Authority (EFSA) 2008 the food industry was invited to propose, via EU Member States, food claims already supported by good science (Article 13.1 using Generally Accepted Science) Over 44,000 proposals were received of which only 229 were accepted. 7 Intertek 2015, All Rights Reserved

Approved Claims Article 13.1 General function claims under Article 13.1 of the EC Regulation on nutrition and health claims refer to the role of a nutrient or substance in growth, development and body functions; psychological and behavioural functions; slimming and weight control, satiety or reduction of available energy from the diet. These claims do not include those related to child development or health or disease risk reduction. Article 13.5 new science "New function health claims under Article 13.5. Claims under article 13/5 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. Source: European Food Safety Authority (efsa) 8 Intertek 2015, All Rights Reserved

Approved Claims Article 14(1)a reduction of disease risk and Article 14(1)b 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. In August 2008 EFSA has adopted its first series of opinions on health claims under Article 14. Source: European Food Safety Authority (efsa) 9 Intertek 2015, All Rights Reserved

Example on Non-Authorised Claims Claim type Nutrient, substance, food or food category Claim Conditions of use of the claim / Restrictions of use / Reasons for nonauthorisation Health relationship EFSA opinion reference Commission Regulation Status Entry Id Art.13(1) Lactobacillus paracasei subsp. paracasei LPC 00(LMG P-21380)+ Lactobacillus rhamnosus LR 04(DSM 16605)+Bifidobacterium breve BR 03 (DSM 16604) - produces riboflavin;- promotes the wellbeing of the intestine;- supports the maintenance of intestinal homeostasis.- assists autochthonous intestinal flora in controlling episodes of diarrhoea;- rebalances the intestinal motility function, especiall Non-compliance with the Regulation because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. not validated 2010;8(2):1470 Nonauthorised 2954 Art.13(1) Lactobacillus paracasei subsp. paracasei LPC 00(LMG P- 21380)+Lactobacillus rhamnosus LR 04(DSM 16605)+Bifidobacterium breve BR 03 (DSM 16604) - produces riboflavin;- promotes the wellbeing of the intestine;- supports the maintenance of intestinal homeostasis.- rebalances the composition of microflora after treatment with antibiotics;- contributes to the rebalancing of intestinal microflora;- i Non-compliance with the Regulation because on the basis of the scientific evidence assessed, this food is not sufficiently characterised for a scientific assessment of this claimed effect and the claim could not therefore be substantiated. not validated 2010;8(2):1470 Nonauthorised 616 Art.13(1) Bifidobacterium adolescentis EI-15 -ALB 1 (DSM 18351) Non-compliance with the Regulation because on the basis of the scientific - promotes the wellbeing of the intestine;- contributes to restoring evidence assessed, this food is not sufficiently intestinal bacterial flora;- contributes characterised for a scientific to the rebalancing of intestinal assessment of this claimed microflora;- improves the metabolic effect and the claim could not activity of intestinal microflora. therefore be substantiated. not validated 2010;8(2):1470 Nonauthorised 616 Source: European Food Safety Authority (efsa) 11 Intertek 2015, All Rights Reserved

Nutrient Profiling By January 2009 Under Article 4 EU should have established specific nutrient profiles Foods must comply in order to bear nutrition and health claims The nutrient profiles are based on the scientific opinion of EFSA Within 24 months, the Commission presented proposals for nutrient profiles to member state experts Once adopted by the Commission they will be used as a condition for making claims 12 Intertek 2015, All Rights Reserved

What is Nutrition Profiling? The term nutrient profile refers to the nutrient composition of a food or diet. Nutrient profiling is the classification of foods for specific purposes based on their nutrient composition. Source: European Food Safety Authority (efsa) 13 Intertek 2015, All Rights Reserved

Reason for Nutrient Profiling Claims can generate incorrect consumer perceptions Nutrient profiling avoids misleading consumers EFSA 2008 scientific paper on setting nutrient profiles 14 Intertek 2015, All Rights Reserved

Progress in Nutrient Profiling In 2008, FSA developed a nutrient profile to differentiate foods on nutritional composition for television advertising of foods for children Manufacturers and retailers are in the process of developing their own model No model in the EC is yet available for nutrition and health claims The EC plans to readdress the issue of nutrient profiles by 2019, a decade later than initially planned. 15 Intertek 2015, All Rights Reserved

Difficulties in Setting Nutrient Profiles 1 2 3 4 5 Broad agreement is required on what a healthy diet is Based on per 100g or per portion or by energy density (kcal/g)? Across the board or per category? Further restrictions on making claims Use existing profiles? 16 Intertek 2015, All Rights Reserved

Flexibility in Health Claims Experts met in June 2012 from 17 member states to discuss a common approach about flexibility of wording for health claims Recommendations were agreed in December 2012 Regulation 432/2012 states: One of the objectives of Regulation (EC) No 1924/2006 is to ensure that health claims are truthful, clear, reliable and useful to the consumer. 17 Intertek 2015, All Rights Reserved

Conditions for Flexibility EFSA recommends that food businesses should stick as closely as possible to the authorised wording of health claims. The terms and conditions of the EU Register of nutrition and health claims made on foods ( the Register ) explain that some flexibility of wording is possible provided that its aim is to help consumer understanding, taking into account factors such as linguistic and cultural variations and the target population. The same principles should be respected whenever authorised claims are used in commercial communications whether in labelling, presentation or advertising and in whatever medium including on websites, radio and television. 18 Intertek 2015, All Rights Reserved

Use of Words that Were too Flexible In 2014, ASA (Advertising Standard Authority) criticised PepsiCo s advertising campaign on its Naked juice drinks PepsiCo made claims on Vitamin C The official claim reads Vitamin C contributes to the protection of cells from oxidative stress The ASA ruled that these strayed too far from the approved wording Juice Smoothies loaded with nature's elite fighting force to defend your body against free radicals (those nasty little molecules that attack your cells and could have an impact on your overall health). 19 Intertek 2015, All Rights Reserved

The Advertiser Challenge The advertiser argued that the EFSA scientific report that led to the vitamin C claim being approved had used the word antioxidant several times. The ASA pointed out that the Department of Health guidelines warned against picking sentences or phrases from an EFSA opinion when adapting the wording of an authorised claim, because this could increase the risk of changing the meaning of the claim. 20 Intertek 2015, All Rights Reserved

New Developments in Health Claims New health claims have to be approved by EFSA before use Proposed health claims being processed can be reviewed at : http://ec.europa.eu/nuhclaims/?event=claimsbeingprocessed e.g. Latest claim: BSAF SE Stepan Lipid Nutrition Germany: Scientific Opinion on the substantiation of a health claim related to an equimolar mixture of the CLA isomers c9,t11 and t10,c12 (marketed as Clarinol and Tonalin ) and contributes to a reduction in body fat mass pursuant to Article 13(5) of Regulation (EC) No 1924/20061 21 Intertek 2015, All Rights Reserved

Completed Scientific Assessments of Claims These can be found at: - http://www.efsa.europa.eu/en/topics/topic/article13.htm This site supplies: general guidance on how EFSA evaluates a claim Information on the claims listed on their database General guidance on how to make a claim 23 Intertek 2015, All Rights Reserved

New Developments in Health Claims COMMISSION REGULATION (EU) 2015/8 of 6 January 2015 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health Rejected 5 health claims regarding the contribution to an energy yielding metabolism The claims were approved by EFSA but concerns were raised by the commission regarding the message it presents on sugar consumption. The German company Dextro Energy are to take the Commission to the European Court of Justice 24 Intertek 2015, All Rights Reserved

Use of the Claim Probiotic EFSA s had rejected probiotics claims due to insufficient strain characterisation. Reason that probiotic strains differed in efficacy and hence claims must be strain-specific. There was an over-reliance on generic literature that did not test the specific strains. Since December 2012 the name has been banned It has been reported that 300+ applications but none have been approved Latest in sept 2014 on Lactobacillus plantarum TENSIA in the semi-hard Edam-type heart cheese of Harmony and maintenance of normal blood pressure pursuant to Article 13(5) of Regulation (EC) No 1924/2006 Concluded that there was no link 25 Intertek 2015, All Rights Reserved

Caffeine Scientific Opinions There are a number of health claims on caffeine approved by the EFSA but on hold due to public health issues The Report by EFSA on the safety of Caffeine released in May Report confirms consumption of 200mg in a single sitting or 400mg (equivalent to 5 cups of coffee) had no adverse effects Question mark hangs over energy drinks drank by children Some are calling for the ban of health claims to ensure that caffeine is kept within safe limits 26 Intertek 2015, All Rights Reserved

A Unapproved and an Approved claim (Jan 2015) A company in the Netherlands claimed that the use of a equimolar mixture of two isomers of linoleic acid Trade as Clarinol and Tonalin will help to reduce body fat mass EFSA concluded that there was not an established link with the supplement and the physiological effect Opinion on a health claim related to native chicory inulin and maintenance of normal defecation by increasing stool frequency. The food constituent that is a subject of a claim is native chicory inulin. The Panel concludes that a cause and effect relationship had been established The following wording : Chicory inulin contributes to maintenance of normal defecation by increasing stool frequency. In order to obtain the claimed effect, 12 g of native chicory inulin should be consumed daily. 27 Intertek 2015, All Rights Reserved

In Conclusion Over the years the Nutrition and Health claim regulations has certainly reduced the number of claims and cut out the confusing and misleading claims However, it is complicated and difficult to make a new claim Problem for smaller business when even claims made by bigger companies are not approved However, EFSA is generating more guidance to help. Nutrient profiles still in debate and now the EU may not make a decision until 2019 28 Intertek 2015, All Rights Reserved