- Flavouring substances used or intended for use in or on foodstuffs
- Evaluation of Chemically Defined Flavouring Substances and other flavourings and source materials which require an evaluation
- Status of the Substances in the Evaluation Programme
Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 and introducing the same list in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council.
The full list of flavouring substances authorised for use in or on foodstuffs is listed in Annex I of the framework Regulation on flavourings, i.e., Regulation (EC) 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods.
The list of flavouring substances consists of both evaluated substances as well as flavouring substances which are still under evaluation by the European Food Safety Authority (EFSA). Those substances which are still under evaluation are considered safe and are marked with a footnote in the Union list. For the submission of data by the manufacturer, deadlines have been established by Commission Regulation (EC) No 622/2002.
Whilst Regulation (EC) No 2232/96 (NO LONGER IN FORCE) of the European Parliament and of the Council of 28 October 1996 which laid down a Community procedure for flavouring substances used or intended for use in or on foodstuffs is no longer in force, Articles 1 and 2, Article 3(1) and (2), and Article 4(1) and (2) and the Annex thereto will continue to apply to flavouring substances under evaluation pending their inclusion as evaluated substances in Part A of the EU list (Union list) or their removal from that list (i.e. substances marked with a footnote in the Union list). References made in those Articles to the Register of flavouring substances shall be construed as references to Part A of the EU list.
Commission Regulation No 622/2002 (OJ L10, p18, 18/04/2002) of 11 April 2002 establishing deadlines for the submission of information for the evaluation of chemically defined flavouring substances used in or on foodstuffs.
The addition of new flavourings and source materials as well as the procedure for amending the Union list on flavourings has to be done in accordance with the Common Authorisation Procedure also known as CAP. The Common Authorisation Procedure is laid down in Regulation (EC) No. 1331/2008.
The implementing measures for CAP which define the format and content of an application and data required for the risk assessment of the substances concerned have been established and published in Commission Regulation (EU) No 234/2011 implementing Regulation (EC) No 1331/2008.
If an interested business operator needs to update the Union list, an application to the Commission is required.
"Updating the Union list" means:
- adding a substance and/or removing a substance
- adding, removing or changing conditions, specifications or restrictions related to the presence of a substance
The Commission have prepared a practical guide for all applicants on how this can be done. This includes information on the necessary addresses, contact points, and the relevant documents that are required for risk assessment.
Evaluation of Chemically Defined Flavouring Substances and other flavourings and source materials requiring and evaluations
The European Food Safety Authority (EFSA) is responsible for the safety assessment of flavouring substances or any flavourings and source materials covered by Article 9 (b)-(f) of Regulation (EC) 1334/2008.
The process EFSA uses for the safety assessment of flavourings is described in EFSA’s Guidance on the data required for the risk assessment of flavourings to be used in or on foods which was published in 2010. With regards to the assessment of the potential genotoxicity of a substance, EFSA’s scientists follow the Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment.
Following the publication of Regulation (EC) 1334/2008, interested parties were to submit applications for authorisation of flavourings and source materials referred to in Article 9(b) to (f) of Regulation (EC) 1334/2008 placed on the market at the time of entry into force of the Regulation to the Commission in accordance with the Regulation (EC) No 1331/2008 at the latest by 22 October 2015. Up until now, only applications have been submitted for a few examples of "other flavourings". Those “other flavourings” which were authorised are listed under Part E of Annex I of Regulation (EC) 1334/2008. No applications were received by the Commission for the categories of flavourings covered by parts B, C, D and F of Annex I, therefore as the deadline has passed these parts will remain empty.