11.3.2011 Official Journal of the European Union L 64/15 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 (*) (here- inafter 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. () 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. (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 spec- ifications 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 verifi- cation 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) (). 5 ttp://www.efsa.europa.eu/en/scdocs/doc/1188.pdf () h () http://www.efsa.europa.cu/en/scdocs/doc/1305.pdf () http://www.efsa.europa.eufen/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.