15 years of the European Union s Food Supplement Directive

Transcription

1 15 years of the European Union s Food Supplement Directive

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3 Food Supplements Directive (46/2002) Recital 3 An adequate and varied diet could, under normal circumstances, provide all necessary nutrients for normal development and maintenance of a healthy life in quantities which meet those established and recommended by generally acceptable scientific data. However, surveys show that this ideal situation is not being achieved for all nutrients and by all groups of the population across the Community.

4 Food Fortified Food Food supplements Food for Special Groups FSMP THMP OTC Rx otc FOOD LAW MEDICINAL LAW Any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans [ ] Art. 2 Regulation (EC) 178/2002 Any substance or combination of substances presented as having properties for treating or preventing human diseases or administered either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolite action [ ] (Art. 1(2) Directive 2001/83/EC, as amended)

5 Before 2002 Food Dietetic food Health product Medicinal product Registration Notification No procedure Diverse approaches RDA based limits common Barriers to trade EU Harmonisation unavoidable

6 A challenging but successful exercise for the 28 Member States Heavy negotiations on definition and principles Bridging widely divergent national approaches Withstanding the test of time over 15 years of application

7 Major Achievements Establishment of an EU definition Small dosage forms Nutritional & physiological effects Recognition of ingredients Vitamins & Minerals based on scientific risk assessment Other substances with a physiological effect (e.g. botanicals) Recognition of the role of Food Supplements Not only to correct sub-optimal intake But to allow consumers the possibility to supplement their diet should they want to

8 Food supplements General Food Law Reg EC 178/2002 General food safety requirements Manufacturer responsibilities Notification duty / Recall Food Hygiene Reg EC 852/2004 Rules for hygienic production based on the principles of HACCP Microbiological criteria Food Supplements Dir 2002/46/EC Definition Permitted forms and maximum levels (vit/ min) Labeling Fortification Labelling Reg 1169/2011 How to label content, composition, etc Allergen labelling Reg EC 1925/2006 Risk assessment and risk management procedure in case the use of a substance would result in harmful effects Additives Reg EC 1333/2008 Pre-marketing approval procedures Allowed additives Conditions of use Health Claims Reg EC 1924/2006 Pre-marketing approval procedures for nutrition and health claims Novel Foods Reg 2015/2283 Pre-marketing approval procedure for novel ingredients + Pesticide residues Reg EC 396/2005 Maximum residue levels Irradiation Dir 1999/2/EC Permitted ingredients to be irradiated Contaminants Reg EC 1881/2006 Maximum levels of selected contaminants in ingredients that can be used in foods Extraction solvents Dir 2009/32/EC Permitted extraction solvents

9 Major Achievements Scientific Risk Assessment As the basis for setting maximum levels for vitamins and minerals No longer multiples of RDA Example for the Codex Alimentarius Guidelines

10 Major Achievements Proportionate procedures Notification if Member States want to monitor - No longer registration procedures - Powerful tool if used for monitoring Harmonisation Labelling Composition Nutritional substances Principles for setting maximum levels\\\

11 Taking everything into account, how successful do you consider the Food Supplement Directive (2002/46/EC) has been? 80% of the respondents believe that the Food Supplement Directive has been successful Average success:62% Res ul ts, % Nb of r es pond ents FSE survey among its members 2017

12 Do you think that the Food Supplement Directive has made the sector stronger or weaker today than it would have been without it? 80% of the respondents think that the Food Supplement Directive has made the sector stronger St r onger 80.0% Weaker 5.0% No di f ere nc e 15. 0% FSE survey among its members 2017

13 Next step: maximum levels 2005: FSE Risk Management model 2006: Discussion Paper 2007: Orientation paper Based on: EFSA UL Risk characterisation Real intake data Consultation on Fortified Food and Food Supplements Examples of 5 possible models One model retained

14 Work stopped in : More and more Member States develop own maximum levels Trend towards the same principles but maximum levels still different No consumer access to the same products in the EU Harmonisation based on scientific principles and best Member State practice is only workable solution

15 Harmonisation of other substances EC 2008 report Further harmonisation Not feasible - Scientific hurdles to overcome Not necessary - Claims Regulation - Fortification Regulation - Novel Foods Regulation - Mutual Recognition Regulation 2018: No significant contribution to an EU harmonised framework

16 Positive towards the Future Research is accumulating for the recognition for the role of Food Supplements for public health: Bridge nutritional gaps in particular populations Enhance health above and beyond nutritional needs Reduce risk of chronic diseases Cut Healthcare Costs Build resilience during adulthood and maintain active lifestyle with ageing

17 The healthcare costs savings potential of food supplements

18 We have come a long way The sector and its products are well established throughout the EU Maximum levels, botanicals and the recognition of the opportunities food supplements offer for public health being the next and most relevant steps

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