Food Legislation. Janet Worrell July 2014

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1 Food Legislation Janet Worrell July 2014

2 Topics to be covered Food legislation what is a supplement origin of food legislation Making a product from a concept claim development Regulation in transition

3 Towards a Healthier Britain Few people would expect significant numbers of British adults and children to be at risk of nutrient deficiency where food is affordable PAGB 2010

4 What is a Food Supplement? concentrated sources of nutrients or other substances with a nutritional or physiological effect whose purpose is to supplement the normal diet. marketed 'in dose' form i.e. as pills, tablets, capsules, liquids in measured doses etc. intended to supplement the diet; they are not medicines. not licensed in the UK Food law does not permit any food to make any claim to treat, prevent or cure a disease or adverse medical condition.

5 Food Supplements and Food Law Food Supplements are regulated under Food Law Majority of Food Law originates from the EU The primary legislation relating to food supplements is the EC Food Supplements Directive (Directive 2002/46/EC), implemented in the UK in In addition the UK has the Food Safety Act of 1990 under which all national food law is made

6 EU Directive Food Supplements and Food Law Lists Minerals and Vitamins permitted for use in supplements (All have been assessed and approved by European Food Safety Authority (EFSA)) UK uses 2003 safe upper levels and EU Recommended Daily Amount The underpinning principles of all food law are that products have to be safe for consumption and not misleadingly labelled. It is the responsibility of the manufacturer, importer or distributor to comply with the relevant legislation.

7 Who Regulates? European Food Safety Authority - EFSA EFSA has grown quickly since its creation in EFSA s role is to assess and communicate on all risks associated with the food chain. Includes health claims for food supplements Food Standards Authority Trading Standards Office Office for Better Regulation Competitors Consumers

8 Parma, Italy Management Board Communications Science Strategy & Co-ordination Resources & Support Scientific Evaluation of Regulated Products Risk Assessment and Scientific Assistance NUTRITION

9 What is a Claim? Regulation EC1924/2006 Nutritional Claim 'Nutrition claim' means any claim which states, suggests or implies that a food has particular beneficial nutritional properties Health claim Regulation lays down harmonised rules across the European Union for the use of nutrition claims such as low fat, high fibre or health claims such as reducing blood cholesterol. Health claims further divided by General Function Claims Article 13.1 New Function Claims Article 13.5 Risk Reduction Claims Article 14

10 Types of Nutritional Claims Low energy Energy-reduced Energy-free Low fat Fat-free Low saturated fat Saturated fat-free Low sugars With no added sugars Low sodium/salt Very low sodium/salt Sodium-free or salt-free No added sodium/salt Source of fibre High fibre Source of protein High protein Light/lite Naturally/natural Source of omega-3 fatty acids High omega-3 fatty acids High monounsaturated fat High polyunsaturated fat High unsaturated fat

11 Health Claims (1) A health claim is any statement about a relationship between food and health. The Commission authorises different health claims provided they are based on scientific evidence and can be easily understood by consumers. The European Food Safety Authority (EFSA) is responsible for evaluating the scientific evidence supporting health claims. The Commission draws up lists of health claims including the different types of authorised and rejected health claims in the EU.

12 Health Claims (2) General function (Article 13.1) of the 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. New function (Article 13.5) 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.

13 Health Claims (3) Risk reduction (Article 14) reducing a risk factor in the development of a disease e.g. Or "Plant stanol esters have been shown to reduce blood cholesterol. Blood cholesterol is a risk factor in the development of coronary heart disease Health claims referring to children's development ( Article 14(1)(b) claims e.g. "Vitamin D is needed for the normal growth and development of bone in children"

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15 Statistics Article 13.1 General claims Article New Function claims Article 14 disease risk reduction Number of applications Number of withdrawals Number of opinions adopted low success rate Evidence based approach similar to ethical pharmaceuticals 91 additional claims under assessment for micro organisms

16 The Future - Guidance in Transition Food Information for Consumers Regulation (FIR) Regulation (EU) No 1169/2011 Dec 2014 rules apply Dec 2016 nutritional information must be provided Food for Specific Groups (FSG) Regulation (EU) No 609/2013 July 2016 Regulation to set maximum and minimum levels for Vitamins and Minerals in consultation Botanical Food Supplements

17 Food Information for Consumers Regulation (FIR) Mandatory nutrition 'back of pack' information on processed foods; Mandatory Country of origin labelling of unprocessed meat from pigs, sheep, goats & poultry Highlighting allergens e.g. peanuts or milk in the list of ingredients; Better legibility i.e. minimum size of text; Requirements on information on allergens also cover non pre-packed foods including those sold in restaurants and cafés. Date marking: consumers will continue to see 'best before' and 'use by' dates on pre-packed foods, will include a date of first freezing. Drinks with high caffeine content will have to be additionally labelled as not recommended for children or pregnant and breastfeeding women, with the actual caffeine content quoted. The types of vegetable oil used in food, such as palm oil, must be stated. Added water in certain meat and fishery products will need to be shown in the name of the food if it makes up more than 5% of the final product.

18 Regulation on Food for Specific Groups Covers food intended for infants and young children, food for special medical purposes (FSMP) total diet replacement for weight control A recent innovation in FSMPs is Souvenaid, indicated in patients for the dietary management of early Alzheimer's disease. FSMP must be used under medical supervision. Consult with doctor, specialist nurse or pharmacist for advice.

19 Harmonised Regulation & Market Forces Data from 17 Member States indicate that the most commercially important (>50% market share) substances are : Fish oils Probiotics Certain herbal ingredients National variations exist fish oils constitute over 50% of the market of other supplements in Denmark, but under 3% in Spain and in Italy. Probiotics account for 44% of the market in Italy & 0.3% in Denmark. Herbal products (ginkgo, ginseng, St John s Wort, Echinacea and garlic) make up 75% of the market in the Netherlands, 40% in France, and under 5% in Italy these are now medicines.

20 Regulation a Barrier for Innovation? Impact of EFSA regulations improve consumer protection and ultimately safety Level playing field across one market Opportunity exists to further improve consumer health & well being, Diet alone is not the solution