Download England - Food Standards Agency

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)