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Amire mahmood
- 1. 8/10/2014 Amire Mahmood Ensuring the right assessment of food supplements and health claims A view from Austria
- 2. Food supplements •‘Means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities (Directive 2002/46/EC) ’ •Accompanied by health claims •List of permitted health claims made on foods established with Regulation (EU) No 432/2012 8/10/2014 Amire Mahmood
- 3. Health Claims – Art. 13 (5) •Claims based on newly developed scientific data and/or which include a request for the protection of proprietary data - Authorised by individual applications - Procedure according to Art. 18 („fast track procedure, only consultation of Member States in case of a positive opinion) - Authorised Claims included in the list of permitted health claims made on foods established with Regulation (EU) No 432/2012 8/10/2014 Amire Mahmood
- 4. Health Claims – Art. 14 (1)(a) •Reduction of disease risk claims - ‘ Any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease ’ - Authorised by individual applications (Art. 15 –17) - Comitology procedure - Claims included in the Union Register (Art. 20) http://ec.europa.eu/nuhclaims/ 8/10/2014 Amire Mahmood
- 5. Health Claims – Art. 14 (1)(b) •Claims referring to children´s development and health - Authorised by individual applications (Art. 15 – 17) - Comitology procedure - Claims included in the Union Register (Art. 20) http://ec.europa.eu/nuhclaims/ 8/10/2014 Amire Mahmood
- 6. Challenges for Member States •Classification of a claim - Health Claim - Medicinal Claim •Classification of a substance - Recital 17 of Regulation (EU) No 432/2012: ‘ Any decision on a health claim … as inclusion in the list of permitted claims referred to in Article 13 (3) thereof does not constitute an authorisation to the marketing of the substance on which the claim is made, a decision on whether the substance can be used in foodstuffs, or a classification of a certain product as a foodstuff. ’ 8/10/2014 Amire Mahmood
- 7. Challenges for Member States •Beauty claims - final approach •Scope of Regulation (EC) No 1924/2006 ‘health claim’ means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health • Functional claims?/Out of the scope? • Case-by-case classification • Not to be misleading (Regulation (EU) No 1169/2011) 8/10/2014 Amire Mahmood
- 8. Challenges for Member States •Pending issues - Health claims for botanicals - Nutrient profiles 8/10/2014 Amire Mahmood
- 9. 8/10/2014 Amire Mahmood Thank you for your attention