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General conditions for use of flavourings or food ingredients with flavouring properties
Only flavourings or food ingredients with flavouring properties which meet the following conditions may be used in or on foods: (a) they do not, on the basis of the scientific evidence available, pose a safety risk to the health of the consumer; and (b) their use does not mislead the consumer.
Prohibition of non-compliant flavourings and/or non-compliant food
No person shall place on the market a flavouring or any food in which such a flavouring and/or food ingredients with flavouring properties are present if their use does not comply with this Regulation.
Presence of certain substances
1. Substances listed in Part A of Annex III shall not be added as such to food. 2. Without prejudice to Regulation (EC) No 110/2008, maximum levels of certain substances, naturally present in flavourings and/or food ingredients with flavouring properties, in the compound foods listed in Part B of Annex III shall not be exceeded as a result of the use of flavourings and/or food ingredients with flavouring properties in and on those foods. The maximum levels of the substances set out in Annex III shall apply to foods as marketed, unless otherwise stated. By way of derogation from this principle, for dried and/or concentrated foods which need to be reconstituted, the maximum levels shall apply to the food as reconstituted according to the instructions on the label, taking into account the minimum dilution factor. 3. Detailed rules for the implementation of paragraph 2 may be adopted in accordance with the regulatory procedure referred to in Article 21(2), following the opinion of the European Food Safety Authority (hereinafter referred to as the ‘Authority’), where necessary.
Use of certain source materials
1. Source materials listed in Part A of Annex IV shall not be used for the production of flavourings and/or food ingredients with flavouring properties. 2. Flavourings and/or food ingredients with flavouring properties produced from source materials listed in Part B of Annex IV may be used only under the conditions indicated in that Annex.
Flavourings and food ingredients with flavouring properties for which evaluation and approval are not required
1. The following flavourings and food ingredients with flavouring properties may be used in or on foods without an evaluation and approval under this Regulation, provided that they comply with Article 4: (a) flavouring preparations referred to in Article 3(2)(d)(i); (b) thermal process flavourings referred to in Article 3(2)(e)(i) which comply with the conditions for the production of thermal process flavourings and maximum levels for certain substances in thermal process flavourings set out in Annex V; (c) flavour precursors referred to in Article 3(2)(g)(i); (d) food ingredients with flavouring properties. 2. Notwithstanding paragraph 1, if the Commission, a Member State or the Authority expresses doubts concerning the safety of a flavouring or food ingredient with flavouring properties referred to in paragraph 1, a risk assessment of such flavouring or food ingredient with flavouring properties shall be carried out by the Authority. Articles 4, 5 and 6 of Regulation (EC) No 1331/2008 shall then apply mutatis mutandis . If necessary, the Commission shall adopt measures, following the opinion of the Authority, which are designed to amend non-essential elements of this Regulation, inter alia , by supplementing it, in accordance with the regulatory procedure with scrutiny referred to in Article 21(3). Such measures shall be laid down in Annexes III, IV and/or V where appropriate. On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 21(4).
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