CHAPTER IGENERAL PRINCIPLES

Article 1Subject matter and scope

1.

This Regulation lays down a common procedure for the assessment and authorisation (hereinafter referred to as the common procedure) of food additives, food enzymes, food flavourings and source materials of food flavourings and of food ingredients with flavouring properties used or intended for use in or on foodstuffs (hereinafter referred to as the substances), which contributes to the free movement of food F1... and to a high level of protection of human health and to a high level of consumer protection, including the protection of consumer interests. This Regulation shall not apply to smoke flavourings falling within the scope of Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods10.

2.

The common procedure shall lay down the procedural arrangements for F2determining the authorisation status of substances F3for the purposes of Regulation (EC) No 1333/2008 [on food additives], Regulation (EC) No 1332/2008 [on food enzymes] and Regulation (EC) No 1334/2008 [on flavourings and certain food ingredients with flavouring properties for use in and on foods] (hereinafter referred to as the sectoral food laws).

3.

The criteria according to which substances can be F4authorised and, where applicable, the transitional provisions concerning ongoing procedures are laid down in each sectoral food law.

Article 2F5Definitions

F61.

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F62.

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F7(3.

“Authority” means—

(a)

as regards England and Wales, the Food Standards Agency;

(b)

as regards Scotland, Food Standards Scotland;

(4.

“prescribe”, means prescribe by regulations;

(5.

“appropriate authority” means—

(a)

in relation to England, the Secretary of State;

(b)

in relation to Wales, the Welsh Ministers;

(c)

in relation to Scotland, the Scottish Ministers;

(6.

“Regulation 234/2011” means Commission Implementing Regulation (EU) No. 234/2011 implementing Regulation (EC) No. 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings;

F8(7.

‘Substance’ includes a flavouring substance under evaluation, within the meaning given in Regulation (EC) No 1334/2008.

F9Article 2ARequirement for appropriate authority to determine authorisation status

The appropriate authority must determine the authorisation status of substances in accordance with the sectoral food law concerned and this Regulation.

Article 2BDetermination of authorisation status

(1.

For the purposes of this Regulation, determining the authorisation status of a substance is to consist of the appropriate authority determining whether or not to:

(a)

authorise the placing on the market, or the use in or on food, of a substance;

(b)

modify the authorisation of a substance, including modifying any conditions, restrictions or specifications associated with the authorisation concerned;

(c)

revoke or suspend the authorisation of a substance.

(2.

For the purposes of paragraph 1, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which—

(a)

existing stocks of the substance concerned, and any products derived from it or containing it, may be placed on the market or used;

(b)

the substance concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;

(c)

the labelling of the substance concerned, and any products derived from it or containing it, may continue to be applied.

(3.

The appropriate authority may prescribe other transitional measures not falling within paragraph 2 in relation to the modification, suspension or revocation of an authorisation under the sectoral food law concerned and this Regulation.

(4.

In this Article, “authorisation” includes the permission for a substance to be placed on the market or used in or on food under the sectoral food law concerned, and for this purpose includes food enzymes for which an application for initial authorisation has been entered in the Register under Regulation (EC) No 1332/2008 and flavouring substances under evaluation under Regulation (EC) No 1334/2008; and related terms are to be construed accordingly.

Article 2CDomestic list of substances

(1.

The Authority must establish and maintain a list (the “domestic list”) of substances, the placing on the market, or the use in or on food, of which is permitted in accordance with the sectoral food law concerned and this Regulation.

(2.

The Authority must make the domestic list available to the public.