This Regulation lays down rules for the implementation of Article 20 of Regulation (EU) 2015/2283 as regards the administrative and scientific requirements concerning traditional foods from third countries and transitional measures referred to in Article 35(3) of that Regulation.
Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance. )
Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance. )
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001(1), and in particular Article 20 and Article 35(3) thereof,
Whereas:
Regulation (EU) 2015/2283 lays down rules for the placing on the market and use of novel foods in the Union.
Pursuant to Article 20 of Regulation (EU) 2015/2283 the Commission has to adopt implementing acts laying down administrative and scientific requirements concerning traditional foods from third countries.
Without prejudice to Articles 5, 15 and 16 of Regulation (EU) 2015/2283, the Commission should verify whether the notification falls within the scope of that Regulation and the validity of the notification or the application.
Notifications referred to in Article 14 of Regulation (EU) 2015/2283 should contain sufficient information and scientific documentation to allow the Commission to verify the validity and enable Member States and the Authority to evaluate the history of safe use of the traditional food from a third country.
Applications referred to in Article 16 of Regulation (EU) 2015/2283 should contain sufficient information and scientific documentation to allow the Commission to verify the validity and enable the Authority to conduct comprehensive risk assessments.
Where the applicant submits a notification or an application to add, remove or change the conditions of use, the specifications, additional specific labelling requirements or post-market monitoring requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required for the safety assessment where the applicant provides adequate verifiable justification.
The exchange of information between the Commission, the Member States and the Authority should allow that duly reasoned safety objections are submitted to the Commission where necessary.
The opinion of the Authority should provide sufficient information to ascertain whether the proposed use of the traditional food from a third country is safe for consumers.
Pursuant to Article 35(3) of Regulation (EU) 2015/2283 the Commission has to adopt implementing acts laying down the requirements referred to in Article 20 of that Regulation.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1 Scope and subject matter
It applies to notifications and applications as referred to in Articles 14 and 16 of Regulation (EU) 2015/2283.
Article 2 Definitions
In addition to the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council(2) and Regulation (EU) 2015/2283, the following definitions shall apply:
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‘notification’ means a stand-alone dossier containing the information and the scientific data submitted in accordance with Article 14 of Regulation (EU) 2015/2283.
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‘application’ means a stand-alone dossier containing the information and the scientific data submitted in accordance with Article 16 of Regulation (EU) 2015/2283.
Article 3 Structure, content and presentation of a notification
A notification shall be submitted electronically to the Commission and shall consist of the following:
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a cover letter;
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a technical dossier;
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a summary of the dossier.
The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex I.
The technical dossier referred to in paragraph 1(b) shall contain:
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the administrative data as provided for in Article 5;
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the scientific data as provided for in Article 6.
Where the applicant submits a notification to modify the conditions of use, the specifications, specific labelling requirements or post-market monitoring requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required under Article 6 where the applicant provides verifiable justification explaining that the proposed changes do not affect the results of the existing safety assessment.
The summary of the dossier referred to in paragraph 1(c) shall provide evidence that the use of a traditional food from a third country complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283.
Article 4 Structure, content and presentation of an application
An application shall be submitted electronically to the Commission and shall consist of the following:
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a cover letter;
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a technical dossier;
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a summary of the dossier;
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duly reasoned safety objections referred to in Article 15(2) of Regulation (EU) 2015/2283;
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the applicant's response to duly reasoned safety objections.
The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex II.
The technical dossier referred to in paragraph 1(b) shall contain:
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the administrative data as provided for in Article 5;
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the scientific data as provided for in Article 6.
Where the applicant submits an application to modify the conditions of use, the specifications, specific labelling requirements or post-market monitoring requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required under Article 6 where the applicant provides verifiable justification explaining that the proposed changes not affect the results of the existing safety assessment.
The summary of the dossier referred to in paragraph 1(c) shall provide evidence that the use of a traditional food from a third country complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283.