Date: 2023-03-20Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/612 of 17 March 2023 amending Implementing Regulation (EU) No 307/2012 as regards certain procedures for the Union assessment of the safety of a substance or group of substances under scrutiny (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Regulation (EU) 2023/612 amends Implementing Regulation (EU) No 307/2012 regarding the safety assessment of substances under scrutiny added to food. It ensures a single, complete safety opinion from the European Food Safety Authority (EFSA) by initiating risk assessment after the 24-month period for submitting scientific data. The regulation came into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
Amendments to Regulation EU No 307/2012:
* Article 6 of Regulation EU No 307/2012 is replaced, concerning the Authority's opinion.
Authority's Assessment and Opinion:
* The Authority must assess the validity of each file within 30 days of receipt.
* The Authority shall give its opinion on valid files within nine months from the end of the 24-month period for file submission.
* The Authority will issue a single opinion for multiple files on the same substance or group of substances.
* The Authority can request additional information within 15 days, extending the deadline once by up to three months, informing all relevant parties and the Commission.
Entry Into Force:
* The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
Food Business Operators and Interested Parties:
Impact: They are subject to a revised timeline for the safety assessment of substances they submit for evaluation.
Action Required: Ensure all scientific data files are submitted within the initial 24-month period, and be prepared to provide additional information if requested by the Authority.
European Food Safety Authority (EFSA):
Impact: EFSA's procedures for assessing the safety of substances are modified.
Action Required: Assess file validity within 30 days of receipt, conduct risk assessments after the 24-month submission period, and issue a single opinion for each substance or group of substances.
European Commission:
Impact: The Commission is informed of any extensions to the assessment timeline and receives additional information provided by food business operators.
Action Required: Monitor the implementation of the regulation and ensure that relevant information is accessible to Member States.
Member States:
Impact: Member States are affected by the harmonised rules for safety assessments.
Action Required: Stay informed about the safety assessments and any additional information provided, ensuring consistent application of the regulation within their jurisdiction.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation (EC) No 1925/2006: Regulation of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods.
Commission Implementing Regulation (EU) No 307/2012: Commission Implementing Regulation establishing implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods.
European Food Safety Authority (Authority): An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Treaty on the Functioning of the European Union: One of the two primary treaties forming the constitutional basis of the European Union (EU).
Standing Committee on Plants, Animals, Food and Feed: A committee that provides opinions on measures proposed by the European Commission related to food safety.
Brussels: The de facto capital city of the European Union, located in Belgium. The location where the regulation was adopted.
20.3.2023 EN Official Journal of the European Union L 80/89
COMMISSION IMPLEMENTING REGULATION (EU) 2023/612
of 17 March 2023
amending Implementing Regulation (EU) No 307/2012 as regards certain procedures for the Union
assessment of the safety of a substance or group of substances under scrutiny
(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 1925/2006 of the European Parliament and of the Council of 20 December 2006on
the addition of vitamins and minerals and of certain other substances to foods(1), and in particular Article 8(6) thereof,
Whereas:
(1) Regulation (EC) No 1925/2006 harmonises the national rules in Member States on the addition of vitamins and
minerals and of certain other substances to foods.
(2) Commission Implementing Regulation (EU) No 307/2012(2) lays down, in particular, implementing rules for the
application of the procedure referred to in Article 8(4) and (5) of Regulation (EC) No 1925/2006 concerning the
safety assessment by the European Food Safety Authority (‘the Authority’) of the substances under scrutiny listed in
Part C of Annex III thereto.
(3) To demonstrate the safety of a particular substance under scrutiny contained in the list in Part C of Annex III to
Regulation (EC) No 1925/2006, food business operators and other interested parties may submit to the Authority
within 24 months from the entry into force of a decision listing the substance in Part C of that Annex, a file
containing the scientific data for evaluation.
(4) Under Article 6(1) of Regulation (EU) No 307/2012, the Authority is to give its opinion on the submitted files within
9 months from the date of receipt of a valid file. Where multiple files are submitted for the evaluation of the same
substance or group of substances, and since each file is assessed independently from the other files, the Authority
may not be able to consider the totality of the safety data submitted for the assessment of that substance or group
of substances placed under scrutiny. The individual assessment of each file may therefore lead to several incomplete
and possibly inconsistent opinions on the same substance or group of substances. In view of the above, it is
necessary to amend Regulation (EU) No 307/2012, to allow the Authority to initiate the risk assessment on a
substance or group of substances listed in Part C of Annex III to Regulation (EC) No 1925/2006 only at the end of
the 24-month period following the entry into force of the decision listing that substance or group of substances in
Part C of that Annex and to issue a single opinion on files submitted as regards the same substance or group of
substances.
(5) Regulation (EU) No 307/2012 should therefore be amended accordingly.
(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
(1) OJ L 404 30.12.2006, p. 26.
(2) Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of
Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals
and of certain other substances to foods (OJ L 102, 12.4.2012, p. 2).L 80/90 EN Official Journal of the European Union 20.3.2023
HAS ADOPTED THIS REGULATION:
Article 1
Amendments to Regulation (EU) No 307/2012
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.’
Article 2
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 March 2023.
For the Commission
The President
Ursula VON DER LEYEN