Regulatory framework

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Sharleen Marsh
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1 Regulatory framework Status and future changes for sports nutrition Nick Morgan, Performance Director, Glanbia Performance NutritionMember of ESSNA Food Matters Live th November - ExCeL, London

2 About When? 2003, when Europe was planning a new law to tightly regulate sports nutrition products Why? organise the sector to enter into dialogue with legislators and prevent a serious adverse impact upon the market Protect potential for innovation

3 Today pan-european trade-association with 47 members Activities broadened from March 2013 to include: Compliance Communications Regulatory advice Police the market to improve reputation of the sector Protect responsible European sports nutrition businesses Foster engagement with enforcement authorities Consumer protection Improve consumers and legislators perceptions Press turns to first for comments on sports nutrition issues Proactively debunk myths Support members in understanding, applying, and remaining compliant with the law Lobbying activities

4 Today we will update you on: ESSNA s non-compliance campaign Sports nutrition regulatory limbo Health claims status

5 ESSNA s non-compliance campaign

Non-compliance campaign Remove illegal products from the market Increase consumer confidence and safety Improve the reputation of the sector How does it work?

6 Non-compliance campaign Remove illegal products from the market Increase consumer confidence and safety Improve the reputation of the sector How does it work? Members raise alert Mainly against the online sale of products containing illegal and dangerous ingredients, EU-wide ESSNA contacts manufacturers/sellers/advertisers on behalf of members Drawing attention to issues and asking them to comply with the law ESSNA contacts enforcement authorities Drawing attention to persistently non-complying firms and/or those that do not respond to our letters

prohibited substances and products (DMAA), outrageous claims, adherence to previous

7 First eighteen month of activity A total of 50 alerts have been raised and acted upon: 3 on-going 28 resolved informally 19 escalated to an enforcement authority Key issues: prohibited substances and products (DMAA), outrageous claims, adherence to previous official rullings/ enforcement Membership: interest from 7 companies approached; 3 have already joined ESSNA

8 PR campaign Use media to warn of the dangers of sports supplements containing illegal ingredients, supporting the non-compliance campaign

9 Sports nutrition regulatory limbo

10 What is the ESSNA position? Sports nutrition should be regulated solely by general food law, as both market and food law have evolved Fortified Foods Regulation 2006 Nutrition and Health Claims 2006 Food Information Regulation 2011 (e.g. caffeine warning statements) General food safety law 2002 Additives, Flavourings, Enzymes regulations Novel Foods Regulation

until 20 th July 2016 20 th July 2016 2011-2013 Dietetic foods review July 2013 New FSG*

report assessing if specific provisions for sports foods are necessary Entry into force * FSG

11 How are sports foods regulated today? As Dietetic Foods (PARNUTS), under the same framework as foods for infants and medical foods, until 20 th July th July Dietetic foods review July 2013 New FSG* Regulation July 2015 Commission Report on Sports Nutrition expected Commission to present a report assessing if specific provisions for sports foods are necessary Entry into force * FSG Food for Special Groups: Regulation on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control.

and close this 10 years debate ESSNA Engaged with Commission and position papers and provided market

12 The forthcoming Commission Report When July 2015 (delays possible) What A report on the necessity, if any, of provisions concerning food intended for sportsmen Opportunity Address crucial outstanding issues and close this 10 years debate ESSNA Engaged with Commission and position papers and provided market information from members confirming that market is now too diverse and therefore difficult to specifically regulate

13 Health claims status

14 List of authorised claims (Reg. 432/2012) Potential for targeting sports people 28% (62 claims) Specific to sports people 1.8% (4 claims) Potential sports nutrition claims on hold (5 claims) ( claims n=222)

15 Health claims specific to sports people Nutrient, substance, food or food category Carbohydrate-electrolyte solutions Carbohydrate-electrolyte solutions Creatine Vitamin C Glycaemic carbohydrates Claim Maintain endurance performance during prolonged endurance exercise Enhance absorption of water during physical exercise Increases physical performance in successive bursts of short-term, high intensity exercise Normal function of the immune system during and after intense physical activity Recovery of normal muscle function (contraction) after strenuous exercise CoU for the claim = Sports Foods Draft Directive = Sports Foods Draft Directive 3 g/day for adults performing high intensity exercise Only foods which contain at least 200 mg vitamin C (in addition to daily need) 4g/kg body weight from all sources - for adults who have performed highly intensive and/or long lasting physical exercise

16 Potential for targeting sports people Claim Vitamins Minerals Proteins Protein synthesis Muscle mass growth Muscle mass maintenance Magnesium, Zinc Muscle function Vitamin D Calcium*, Magnesium, Potassium Energy-yielding Biotin, Niacin, Pantothenic acid, Riboflavin, Thiamine, Vitamin B12, Vitamin B6, Vitamin C Calcium, Copper, Iodine, Iron, Magnesium, Manganese, Phosphorus Proteins Proteins Macronutrient metabolism Biotin, Choline, Vitamin B6 Chromium, Zinc Electrolyte-balance Immune system Folate, Vitamin A, Vitamin B12, Vitamin B6, Vitamin C, Vitamin D Nervous system Biotin, Niacin, Riboflavin, Thiamine, Vitamin B12, Vitamin B6, Vitamin C Magnesium Copper, Iron, Selenium, Zinc Calcium*, Copper, Iodine, Magnesium, Potassium Protect oxidative stress Riboflavin, Vitamin C, Vitamin E Copper, Manganese, Selenium, Zinc Oxygen transport Acid-base metabolism Iron Zinc

17 Potential sports nutrition claims (incl. on-hold ) Nutrient, substance, food or food category Caffeine Caffeine Claim Reduction in the rate of perceived effort during endurance exercise Increase in endurance capacity and in endurance performance CoU for the claim 4 mg/kg body weight one hour prior to exercise 3 mg/kg body weight one hour prior to exercise Sodium Normal muscle function maintenance No CoU proposed by EFSA Carbohydrates Brain function At least 20 g carbohydrates, low sugars or with no added sugars ; n/a for 100% sugars Glucose (Dextro Energy GmbH) Water * Contribution to energy yielding metabolism (Art. 13.5) Maintenance of normal regulation of the body s temperature Significant source of glucose / 1169/2011 RI for carbohydrates At least 2L of water per day (only on waters - Directives 2009/54/EC and 98/83/EC) * Claim published in Article 13.1 list, however there is concern about its CoU.

18 ESSNA main issues Health Claims adoption process: Fails to recognise sports people as a sub-group of the general population Flexibility to target sports people is limited and exposes the industry to greater risk of exaggerating or extrapolating a claim Nutrient profiles: Essential that the needs of sports people are taken into account to enable communication of particular benefits (e.g. carbohydrates claim) Exemption should be granted for sports foods / claims Internal market: The proper functioning of the internal market is crucial The threat of divergent national rules must be addressed.

19 Take-home The next 7 months are crucial for our sector, in view of the Commission s ongoing report into the possibility of adopting specific regulation for sports nutrition products ESSNA activities clearly show that there is a way forward to cooperate in tackling manufacturers, distributors and retailers of non-compliant products Responsible companies have the opportunity to work with ESSNA to create a transparent, clean and well-functioning sports nutrition market so we can achieve our objectives with legislators

20 Thank you, Nicholas Morgan, ESSNA Member

Official Journal of the European Union

Official Journal of the European Union L 230/8 EN 25.8.2016 COMMISSION REGULATION (EU) 2016/1413 of 24 August 2016 amending Regulation (EU) No 432/2012 establishing a list of permitted health claims made on foods other than those referring