EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations provide for the execution and enforcement of Commission Regulation (EC) No. 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten (“the Commission Regulation”) as read with Article 10(2) of Directive 2009/39/EC of the European Parliament and of the Council on foodstuffs intended for particular nutritional uses (O.J. No. L 124, 20.5.2009, p.21). That Directive consolidated Council Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (O.J. No. L 186, 30.6.1989, p.27).

The Commission Regulation imposes requirements on the composition and labelling of foodstuffs for people intolerant to gluten and other foodstuffs suitable for people intolerant to gluten, in particular as regards the use of the terms “very low gluten” and “gluten-free”.

These Regulations—

(a)provide that a person who contravenes specified provisions of the Commission Regulation is guilty of an offence (regulation 3(1));

(b)provide penalties for offences (regulation 3(2));

(c)specify the enforcement authority (regulation 3(3));

(d)provide that these Regulations apply in relation to foodstuffs for people intolerant to gluten that are placed on the retail market irrespective of whether they are in pre-packaged form as provided for in Article 10(2) of Directive 2009/39/EC (regulation 4); and

(e)provide for the application, with modifications, of specified provisions of the Food Safety Act 1990 for the purposes of these Regulations (regulation 5).

A full Business and Regulatory Impact Assessment, which includes a compliance cost assessment of the effect that these Regulations will have on the costs of business and the voluntary sector, has been prepared 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.