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

Article 1

Subject matter

This Regulation establishes implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 and in particular:

(a) the conditions for the use of the procedure referred to in paragraphs 1 and 2 of Article 8 of Regulation (EC) No 1925/2006; and

(b) the procedure referred to in paragraphs 4 and 5 of Article 8 of Regulation (EC) No 1925/2006 concerning substances listed in Annex III, Part C thereto.

Article 2

Definitions

For the purpose of this Regulation the following definitions shall apply:

(a) ‘request’ means the submission to the Commission by a Member State of information, including scientific data, for the purpose of initiating the procedure under paragraph 2 of Article 8 of Regulation (EC) No 1925/2006;

(b) ‘file’ means a file as referred to in paragraphs 4 and 5 of Article 8 of Regulation (EC) No 1925/2006 that is submitted by a food business operator or interested party to the Authority;

(c) ‘placing on the market’ as defined by Article 3(8) of Regulation (EC) No 178/2002.

Article 3

Conditions to be met for the request

Member States may submit a request to the Commission when the assessment referred to in paragraph 1 shows at least one of the following:

(a) a potential risk to consumers is associated with the ingestion of amounts of the substance that greatly exceed those reasonably expected under normal conditions of consumption of a balanced and varied diet, due to the conditions under which the substance is added to food or used in the manufacture of food;

(b) a potential risk to consumers is associated with the consumption of this substance by the general adult population or other specified population group for which a potential risk has been identified.

Article 4

Content of the request

The request shall contain the available and relevant generally accepted scientific evidence demonstrating that the conditions specified in Article 8(1) of Regulation (EC) No 1925/2006 are met and shall include:

(a) Evidence demonstrating the addition of the substance to food or use of the substance in the manufacture of food. Such evidence shall include information on the current placing on the market of food products containing the substance as referred to in paragraph 1 of Article 3 of this Regulation.

(b) In cases referred to in Article 3(2)(a), evidence demonstrating that intake of the substance greatly exceeds normal conditions of consumption of a balanced and varied diet, as assessed in accordance with Article 3(3). Such evidence shall include scientific data that represents actual dietary intake of the substance obtained from the most recently available dietary intake surveys or food consumption surveys. The inclusion of foods to which the substance has been added and/or food supplements containing the substance may be taken into account. Member States shall provide justification for the basis of their assessment of ‘normal conditions of consumption of a balanced and varied diet’ when making the request.

(c) Evidence demonstrating a potential risk to consumers from consumption of the substance. This evidence shall consist of relevant scientific data including unpublished validated reports, scientific opinions by a public risk assessment body or independent and peer-reviewed articles. A summary of the scientific data and the list of references of the scientific data shall be provided.

Article 5

Substance listed in Part C of Annex III to Regulation (EC) No 1925/2006

After the adoption of standard data formats, the file shall be presented in accordance with those standard data formats to be considered valid.

Where the Authority considers a file not valid, it shall inform the food business operator or interested party that has submitted the file and the Commission of the reasons why it considers that file not valid.

Article 5a

Pre-submission advice

At the request of a food business operator or any other interested party, the staff of the Authority shall provide advice on the rules applicable to, and the content required for, the submission of a file containing the scientific data aiming to demonstrate the safety of a substance listed in Part C of Annex III to Regulation (EC) No 1925/2006.

Food business operators and other interested parties may request pre-submission advice for a potential submission from the day of the adoption of an opinion by the Authority under Article 8(2) of Regulation (EC) No 1925/2006, which identifies the possibility of harmful effects on health associated with the intake of a substance.

Such pre-submission advice shall be provided in accordance with Article 32a of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.

Article 5b

Notification of studies

Article 5c

Transparency

Where the Authority is to deliver an opinion on a substance under scrutiny listed in Part C of Annex III to Regulation (EC) No 1925/2006, on the basis of a valid file, it shall:

(a) make public the data submitted in that file in accordance with Article 38(1)(c) of Regulation (EC) No 178/2002, which shall apply mutatis mutandis;

(b) consult stakeholders and the public, pursuant to Article 32c(2) of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, on the basis of the non-confidential version of the data submitted in accordance with this Regulation.

Article 5d

Confidentiality

Upon the submission of a file, the food business operator or other interested party may request the treatment as confidential of certain parts of the information or data submitted.

Such a confidentiality request shall be accompanied by a verifiable justification that demonstrates that the disclosure of such information or data significantly harms the interests of the requestor, within the meaning of Article 39(2) and (3) of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.

Article 6

Opinion of the Authority

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.

The Authority shall make the additional information provided in accordance with paragraph 4 available to the Commission and to the Member States.

Article 7

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.