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www.food.gov.uk To: Heads of Environmental Health Services (England) Directors of Trading Standards (England) Chief Port Health Officers (England) cc: LACORS, TSI, CIEH, APHA, APA 17 December 2009 Reference: ENF/E/09/053 Dear Colleagues, The Food Supplements (England) and Addition of Vitamins, Minerals and Other Substances (England) (Amendment) Regulations 2009 The Food Standards Agency (FSA) wrote to enforcement colleagues on 2 April and 28 July 2009 to provide updates on the status of vitamins, minerals and their sources permitted for use in food supplements under the derogation provided by Article 4(6) of the Food Supplements Directive 2002/46/EC which expires on 31 December 2009. The draft European Commission Regulation referenced in our letter of 28 July has been enacted as Commission Regulation (EC) No. 1170/2009 and can be found on the European Union website at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:314:0036:0042:EN:PDF Food Supplements Regulation 1170/2009 amends the Food Supplements Directive to add 2 minerals and 67 vitamin and mineral sources currently permitted for use under the terms of the derogation to those already listed in the Annexes to the Directive, following favourable opinions on these sources from the European Food Safety Authority (EFSA). Annexes I and II to Regulation 1170/2009 reflect all the vitamins, minerals and their sources which will be permitted for use in food supplements from 1 January 2010. These annexes will respectively replace Annexes I and II to the Food Supplements Directive, harmonising this area across the European Union for the first time. The amendments Regulation 1170/2009 will make to the Food Supplements Directive are being implemented in England by the Food Supplements (England) and Addition of Vitamins, Minerals and Other Substances (England) (Amendment) ___________________________________________________ Room 6B, Aviation House, 125 Kingsway, London WC2B 6NH Tel: 020 7276 8566 Fax: 020 7276 8568 E-mail: [email protected] Regulations 2009 (SI 2009/3251) (‘the national regulations’) which come into force on 1 January 2010, as will separate, parallel, legislation in Scotland, Wales and Northern Ireland. The national regulations can be found on the Office of Public Sector Information (OPSI) website at http://www.opsi.gov.uk/si/si2009/pdf/uksi_20093251_en.pdf. They will make amendments to the Food Supplements (England) Regulations 2003 which: Remove Schedules 1 and 2 which list the vitamins, minerals and their sources permitted for use in food supplements. Replace the references to the Schedules in Regulation 5 with direct, ‘ambulatory’, references to the Annexes to the Food Supplements Directive, in so doing giving automatic effect in national law to any future amendments to the Directive with regard to permitted vitamins, minerals and their sources. Update the reference to Directive 2001/83/EC on the Community code relating to medicinal products for human use in Regulation 3(2) (definition of ‘medicinal products’), to which there have been further amendments; Update the reference, in Regulation 6(3)(e) (recommended daily allowance (RDA) percentage labelling), to the Annex to Council Directive 90/496/EEC of on nutrition labelling for foodstuffs as regards recommended daily allowances, energy conversion factors and definitions which was amended by Commission Directive 2008/100/EC. Insert a new Regulation 12 to provide for the transitional period provided by Commission Directive 2008/100/EC which expires on 31 October 2012. Addition of Vitamins and Minerals to Foods Commission Regulation 1170/2009 also adds 1 mineral and 10 vitamin and mineral sources to those permitted for addition to food under Regulation (EC) No. 1925/2006 on the addition of vitamins and minerals and certain other substances to food, following favourable opinions from EFSA on these sources. The national Regulations will amend the Addition of Vitamins, Minerals and Other Substances (England) Regulations 2007 in order to give domestic legal effect to Regulation (EC) No. 1925/2006, as amended by Regulation 1170/2009. Additional Minerals and Vitamin and Mineral Sources A list of the vitamins, minerals and their sources being added to those already present in the Annexes to the Food Supplements Directive and Regulation 1925/2006 can be found in the annex to this letter. Enforcement Approach Enforcement authorities should ensure that account is taken of the above during, and when planning, food law enforcement activities and that enforcement action is in line with the principles of proportionality and consistency set out in the Food Law Code of Practice. Further Information / Assistance Should you require any further information or clarification on these issues please contact Colin Clifford who can be reached by telephone on 020 7276 8568, by fax on 020 7276 8564 or via e-mail at [email protected]. Yours sincerely, Dr Clair Baynton Head of Nutrition Division ANNEX MINERALS AND VITAMIN AND MINERAL SOURCES BEING ADDED TO THOSE CURRENTLY LISTED IN THE ANNEXES TO DIRECTIVE 2002/46/EC AND REGULATION (EC) NO. 1925/2006 Directive 2002/46/EC (Food Supplements) Annex I – Permitted Vitamins and Minerals Minerals to be added: Boron Silicon Annex II – Permitted Vitamin and Mineral Sources Vitamin Sources to be added: Vitamin B1 thiamine monophosphate chloride thiamine pyrophosphate chloride Vitamin B12 5'-deoxyadenosylcobalamin methylcobalamin Niacin inositol hexanicotinate (inositol hexaniacinate) Vitamin C magnesium L-ascorbate zinc L-ascorbate Pantothenic Acid pantethine Vitamin E mixed tocopherols* tocotrienol tocopherol* Vitamin B6 pyridoxal 5'-phosphate Vitamin K menaquinone* Mineral Sources to be added: boric acid calcium acetate calcium L-ascorbate calcium bisglycinate calcium citrate malate calcium fluoride calcium L-lysinate calcium L-pidolate calcium L-threonate calcium malate calcium pyruvate calcium succinate calcium sulphate choline-stabilised orthosilicic acid chromium (III) lactate trihydrate chromium nitrate chromium picolinate copper (II) oxide copper L-aspartate copper bisglycinate ferrous L-pidolate ferrous phosphate iron (II) taurate L-selenomethionine magnesium acetyl taurate magnesium L-ascorbate magnesium bisglycinate magnesium L-lysinate magnesium L-pidolate magnesium malate magnesium potassium citrate magnesium pyruvate magnesium succinate magnesium taurate manganese ascorbate manganese bisglycinate manganese L-aspartate manganese pidolate potassium L-pidolate potassium malate potassium molybdate (Molybdenum (VI)) selenious acid * selenium enriched yeast silicic acid gel* silicon dioxide sodium borate sodium monofluorophosphate zinc L-ascorbate zinc L-aspartate zinc bisglycinate zinc L-lysinate zinc L-pidolate zinc malate zinc mono-L-methionine sulphate zinc picolinate * With conditions of use (See Annex II to Regulation (EC) No. 1170/2009) Regulation (EC) No 1925/2006 (Addition of Vitamins and Minerals to Foods) Annex I – Permitted Vitamins and Minerals Minerals to be added: Boron Annex II – Permitted Vitamin and Mineral Sources Vitamin Sources to be added: Vitamin K Menaquinone* Folic Acid calcium-L-methylfolate Mineral Sources to be added: boric acid calcium citrate malate calcium malate ferrous bisglycinate magnesium potassium citrate selenium enriched yeast* sodium borate zinc bisglycinate * With conditions of use (See Annex III to Regulation (EC) No. 1170/2009)