2007 No. 78

FOOD

The Food Supplements (Scotland) Amendment Regulations 2007

Made

Laid before the Scottish Parliament

Coming into force

The Scottish Ministers, in exercise of the powers conferred by sections 16(1)(a) and (e) and 17(1) of the Food Safety Act 19901 and of all other powers enabling them in that behalf, having had regard in accordance with section 48(4A)2 of that Act to relevant advice given by the Food Standards Agency and after consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety3, hereby make the following Regulations:

Citation, commencement and extent1

1

These Regulations may be cited as the Food Supplements (Scotland) Amendment Regulations 2007 and come into force on 6th April 2007.

2

These Regulations extend to Scotland only.

Amendment of the Food Supplements (Scotland) Regulations 2003

2

The Food Supplements (Scotland) Regulations 20034 are amended in accordance with regulations 3 to 5.

3

In regulation 2(1) (interpretation), in the definition of “Directive 2002/46”, insert at the end “, as amended by Commission Directive 2006/37/EC5 amending Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards the inclusion of certain substances”.

4

In Schedule 1 (vitamins and minerals which may be used in the manufacture of food supplements), in section 1 (vitamins), for “Folic acid”, substitute “Folate”.

5

In Schedule 2 (form of vitamin and mineral substances which may be used in the manufacture of food supplements)–

a

in section A (vitamins), at item 10, for the heading “FOLIC ACID”, substitute “FOLATE” and under that revised heading, after the entry relating to pteroylmonoglutamic acid, insert “(b) calcium-L-methylfolate”; and

b

in section B (minerals), before “Cupric carbonate”, insert “Ferrous bisglycinate”.

LEWIS MACDONALDAuthorised to sign by the Scottish MinistersSt Andrew’s House,Edinburgh

(This note is not part of the Regulations)

These Regulations amend the Food Supplements (Scotland) Regulations 2003 (“the 2003 Regulations”), which implement in Scotland Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements (O.J. No. L 183, 12.7.2002, p.51). These Regulations implement in Scotland Commission Directive 2006/37/EC amending Annex II to Directive 2002/46/EC as regards the inclusion of certain substances. Commission Directive 2006/37/EC is the first instrument to amend Directive 2002/46/EC.

The 2003 Regulations prohibit the sale of a food supplement in the manufacture of which a vitamin or mineral has been used, unless that vitamin or mineral is listed in Schedule 1 to those Regulations and is in a form listed in Schedule 2 (“the positive lists”). This requirement is subject to a transitional provision (see regulation 5 of, and the Schedules to, the 2003 Regulations).

These Regulations–

a

add another form of the vitamin folate and another form of the mineral iron to the positive list in Schedule 2 to the 2003 Regulations (regulation 5);

b

make a consequential amendment (regulation 4); and

c

update the definition of “Directive 2002/46” in the 2003 Regulations (regulation 3).

A full regulatory impact assessment, which includes a compliance cost assessment of the effect which these Regulations would have on business costs, has been prepared for these Regulations and placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency (Scotland), 6th Floor, St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ.