Amendments to Regulation (EU) No 307/2012
Article 1
Open ↗Article 6 of Regulation (EU) No 307/2012 is replaced by the following: ‘Article 6 Opinion of the Authority 1. The Authority shall assess the validity of each file submitted under Article 5 of this Regulation within 30 days from its receipt. 2. The Authority shall give its opinion on the files it considers valid under Article 5 of this Regulation within nine months from the end of the 24-month period referred to in Article 5(2) of this Regulation. 3. Where multiple files on the same substance or group of substances are submitted in accordance with Article 5 of this Regulation, the Authority shall issue a single opinion on those files. 4. The Authority may request from the food business operator or the interested party to provide additional information to their file within 15 days from the date of receipt of the Authority’s request. Where the Authority requests additional information, including information with regard to the conditions of use of the substance in a food or in a category of foods and the purpose of that use, it may extend the time limit referred to in paragraph 2. The time limit may be extended only once by up to three months. That time limit shall include the time set in the first subparagraph for the food business operator or any interested party to provide the requested information. 5. Where the Authority extends the time limit in accordance with paragraph 4, it shall inform thereof all food business operators or interested parties that have submitted the file with regard to the same substance or group of substances and the Commission. The Authority shall make the additional information provided in accordance with paragraph 4 available to the Commission and to the Member States.’