CHAPTER I
GENERAL PROVISIONS
Article 1
Scope
Article 1a
Definitions
CHAPTER II
CONTENT, DRAFTING AND PRESENTATION OF AN APPLICATION
Article 2
Content of an application
Article 3
Drafting and presentation
Article 4
Administrative data
Article 5
General provisions on data required for risk assessment
Article 6
Specific data required for risk assessment of food additives
Article 7
Data required for risk management of food additives
Article 8
Specific data required for risk assessment of food enzymes
Article 9
Data required for risk management of food enzymes
Article 10
Specific data required for risk assessment of flavourings
Article 11
Data required for risk management of flavourings
CHAPTER III
ARRANGEMENTS FOR CHECKING THE VALIDITY OF AN APPLICATION
Article 12
Procedures
CHAPTER IV
OPINION OF THE AUTHORITY
Article 13
Information to be included in the opinion of the Authority
CHAPTER V
FINAL PROVISIONS
Article 14
Entry into force and application
ANNEX
MODEL LETTER ACCOMPANYING AN APPLICATION FOR FOOD ADDITIVES
Application for an authorisation of a new food additive
Application for a modification of the conditions of use of...
Application for a modification of the specifications of an already...
Complete dossier
Public summary of the dossier
Detailed summary of the dossier
List of the parts of the dossier requested to be...
Copy of administrative data of applicant(s)
MODEL LETTER ACCOMPANYING AN APPLICATION FOR FOOD ENZYMES
Application for an authorisation of a new food enzyme
Application for a modification of the conditions of use of...
Application for a modification of the specifications of an already...
Complete dossier
Public summary of the dossier
Detailed summary of the dossier
List of the parts of the dossier requested to be...
Copy of administrative data of applicant(s)
MODEL LETTER ACCOMPANYING AN APPLICATION FOR FLAVOURINGS
Application for an authorisation of a new flavouring substance
Application for an authorisation of a new flavouring preparation
Application for an authorisation of a new flavour precursor
Application for an authorisation of a new thermal process flavouring...
Application for an authorisation of a new other flavouring
Application for an authorisation of a new source material
Application for a modification of the conditions of use of...
Application for a modification of the specifications of an already...
Complete dossier
Public summary of the dossier
Detailed summary of the dossier
List of the parts of the dossier requested to be...
Copy of administrative data of applicant(s)
Commission Regulation (EU) No 234/2011
of 10 March 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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings , and in particular Article 9(1) thereof,
After consulting the European Food Safety Authority pursuant to Article 9(2) of Regulation (EC) No 1331/2008,
Whereas:
(1)
Regulation (EC) No 1331/2008 lays down procedural arrangements for updating the lists of substances the marketing of which is authorised in the Union pursuant to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives , Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and Regulation (EC) No 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 (hereinafter referred to as ‘the sectoral food laws’).
(2)
Pursuant to Article 9 of Regulation (EC) No 1331/2008 it is for the Commission to adopt the implementing measure as regards the content, drafting and presentation of applications to update the Union lists under each sectoral food law, arrangements for checking the validity of applications and the type of information that should be included in the opinion of the European Food Safety Authority (hereinafter referred to as ‘the Authority’).
(3)
In order to update the lists it is necessary to verify that the use of the substance complies with the general and specific conditions of use as provided for in the respective sectoral food laws.
(4)
The Authority adopted a scientific opinion on 9 July 2009 on data requirements for the evaluation of food additive applications . This data should be provided when an application for the use of a new food additive is submitted. In case of an application for a modification of the conditions of use of an already authorised food additive or for a modification of the specifications of an already authorised food additive, the data required for risk assessment may not be required, as long as this is justified by the applicant.
(5)
The Authority adopted a scientific opinion on 23 July 2009 on data requirements for the evaluation of food enzyme applications . This data should be provided when an application for the use of a new food enzyme is submitted. In case of an application for a modification of the conditions of use of an already authorised food enzyme or for a modification of the specifications of an already authorised food enzyme, the data required for risk assessment may not be required, as long as this is justified by the applicant.
(6)
The Authority adopted a scientific opinion on 19 May 2010 on data requirements for the risk assessment of flavourings to be used in or on foods . This data should be provided when an application for the use of a new flavouring is submitted. In case of an application for a modification of the conditions of use of an already authorised flavouring or for a modification of the specifications of an already authorised flavouring, the data required for risk assessment may not be required, as long as this is justified by the applicant.
(7)
It is important that toxicological tests are performed to a certain standard. Therefore Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances should be followed. Where such tests are carried out outside the territory of the Union, they should follow ‘the OECD Principles of Good Laboratory Practice’ (GLP) (OECD, 1998) .
(8)
The use of food additives and food enzymes should always be technologically justified. Applicants should also explain in case of a food additive why the technological effect cannot be achieved by any other economically and technologically practicable means.
(9)
The use of a substance should be authorised if it does not mislead the consumer. Applicants should explain that the requested uses do not mislead the consumer. The advantages and benefits for the consumer should also be explained in case of a food additive.
(10)
Without prejudice to Article 9 of Regulation (EC) No 1332/2008, Article 19 of Regulation (EC) No 1333/2008 and Article 13 of Regulation (EC) No 1334/2008, the Commission should verify the validity of the application and whether it falls within the scope of the respective sectoral food law. An advice from the Authority should be taken into account, where appropriate, on the suitability of the submitted data for risk assessment. Such verification should not delay the assessment of an application.
(11)
The information provided in the opinion of the Authority should be sufficient to ascertain whether the authorisation of the proposed use of the substance is safe for consumers. This includes conclusions on the toxicity of the substance, where appropriate, and possible establishment of an acceptable daily intake (ADI) expressed in a numerical form with details of a dietary exposure assessment for all food categories, including exposure of vulnerable consumer groups.
(12)
The applicant should also take into account detailed guidance concerning the data required for risk assessment established by the Authority (The EFSA Journal ).
(13)
This Regulation takes into account current scientific and technical knowledge. The Commission may revise this Regulation in the light of any developments in this field and the publication of any revised or additional scientific guidance by the Authority.
(14)
Practical arrangements related to an application for the authorisation of food additives, food enzymes and flavourings, such as addresses, persons to contact, transmission of documents, etc., should be made available in a separate communication of the Commission and/or the Authority.
(15)
It is necessary to provide for a time period in order to allow the applicants to comply with the provisions of this Regulation.
(16)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
OJ L 354, 31.12.2008, p. 1.
OJ L 354, 31.12.2008, p. 16.
OJ L 354, 31.12.2008, p. 7.
OJ L 354, 31.12.2008, p. 34.
http://www.efsa.europa.eu/en/scdocs/doc/1188.pdf
http://www.efsa.europa.eu/en/scdocs/doc/1305.pdf
http://www.efsa.europa.eu/en/scdocs/doc/1623.pdf
OJ L 50, 20.2.2004, p. 44.
OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring. Number 1. OECD Principles on Good Laboratory Practice (as revised in 1997) ENV/MC/CHEM(98)17.
http://www.efsa.europa.eu/en/efsajournal.htm