All the flavouring substances used in the European Union (EU) market are approved by the EU
Regulation (EC) No 2232/96 of the European Parliament and of the Council lays down a Community procedure for flavouring substances used or intended for use in or on foodstuffs.
It also lays down a procedure for the establishment of an EU-wide list of flavouring substances (i.e. “the Union List”).
The first step in this procedure was the establishment of a register of the substances used in Member States. Commission Decision 1999/217 of 23 February 1999 established the register, which has been amended several times and which has meanwhile been repealed since the application of the Union List on 24 April 2013.
Following the establishment of this register, Commission Regulation (EC) No 1565/2000 of 18 July 2000, stipulated the measures necessary for the adoption of the evaluation program in application of Regulation (EC) No 2232/96.
As far as the fully evaluated flavouring substances are concerned (as listed in the Union List Part A), regulation (EC) No 2232/96 has been repealed since 22 April 2013.
However, Articles 1 and 2, Article 3(1) and (2), and Article 4(1) and (2) of Regulation (EC) No 2232/96 and the Annex thereto shall continue to apply to flavouring substances under evaluation pending their inclusion as evaluated substances in Part A of the Union list or their removal from that list.
Regulation (EC) No 1565/2000 has been repealed since 22 April 2013. However it shall continue to apply to flavouring substances under evaluation.
Regulation (EC) No 1331/2008 establishes a common authorisation procedure for food additives, food enzymes and food flavourings. It was published on 31 December 2008 along with the other three Regulations constituting the so-called “FIAP” (Food Improvement Agents Package), namely the Enzymes, Additives and Flavourings Regulation.
This Regulation lays down a common procedure for the assessment and authorisation (i.e. “the Common Authorisation Procedure” or “CAP”) of food additives, food enzymes and food flavourings. The latter also includes source materials of food flavourings and of food ingredients with flavouring properties used or intended for use in or on foodstuffs.
The common procedure lays down the procedural arrangements for updating the lists of substances the marketing of which is authorised in the Community, namely:
The regulation provides for the general rules and procedure how each Community List shall be updated after substances have been authorised after the Authority (European Food Safety Authority, EFSA) has given its opinion. It also foresees the time lines by when the Authority has to give its opinion.
However, the criteria according to which the substances can be included in the resp. Community Lists are laid down in each sectorial food law: in particular the criteria according to which flavourings can be included in the Union List of flavourings and source materials are laid down in the Flavouring Regulation.
The implementation of this regulation (CAP) is foreseen through the “Implementing Regulation”, Regulation (EU) No 234/2011. The Implementing Regulation provides for the general rules for applications, namely the content, drafting and presentation of an application.
Apart from general provisions on data required for risk assessment, the Implementing Regulation lays down the specific data required for risk assessment and data required for risk assessment of food additives, food enzymes and flavourings.
It further describes the arrangements for checking the validity of an application and the information that has to be included in the opinion of the Authority (EFSA).
The Implementing Regulation also provides Model letters that should accompy an application (either for food additives, food enzymers or flavourings).
However the specific data required for the risk assessment of flavourings and consequently the data that should be included in / covered by an application (dossier) are not described in any of the Commission Regulations, but are described by EFSA.
For that purpose EFSA has published a Guidance on the data required for the risk assessment of flavourings to be used in or on food.
In addition EFSA has also published a Proposed template to be used in drafting scientific opinion on flavouring substances.
The proposed template is expected to facilitate the drafting and the harmonization of scientific
opinions on flavouring substances. This document provides explanatory examples.
As the EFSA Guidance Document is rather technical, the Commission has also elaborated a Practical guidance for applicants on the submission of applications on food additives, food enzymes and flavourings which is updated on a very regular basis.
The objective of this guidance is to provide applicants with practical information which aims at facilitating the preparation and submission of applications for establishing or updating (adding, removing or changing conditions, specifications or restrictions) the Union lists falling under the sectoral food Regulations (i.e. food additives, food enzymes and flavourings).
This guidance further clarifies the type of requested information and data that are to be included in an application file (referred to as "dossier") and it lists a number of documents (EU legislation, EFSA guidance, etc.) which have to be followed when preparing the dossier. It provides also a brief description of the various stages of the authorisation procedure.
EFSA: Data requirements for evaluation of new food flavourings applications
EFSA: Proposed template to be used in drafting scientific opinion on flavouring substances (explanatory notes for guidance included)
For more information:
EFSA - Food ingredient applications: overview and procedure: