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Commission Consultation, 19 July 2017
The Commission has published a draft Regulation for consultation. The following are the introductory recitals in the document. The full draft Regulation is available on this site as well a document containing draft new Annex. The consultation closes on the 16th August 2017. For more details, see: https://ec.europa.eu/info/law/better-regulation/have-your-say_en
(1) Regulation (EU) 2015/2283 lays down rules for the placing on the market and use of novel foods in the Union.
(2) Pursuant to Article 13 of Regulation (EU) 2015/2283, the Commission has to adopt implementing acts laying down administrative and scientific data requirements for applications referred to in Article 10(1) of that Regulation.
(3) Without prejudice to Articles 5 and 10 of Regulation (EU) 2015/2283, the Commission should verify whether the application falls within the scope of that Regulation and its validity.
(4) Applications referred to in Article 10(1) of Regulation (EU) 2015/2283 should contain sufficient information and scientific documentation to allow the Commission to verify their validity and enable the European Food Safety Authority (the Authority) to conduct comprehensive risk assessments of the novel foods.
(5) The applications should include detailed descriptions of the safety evaluation strategy, the raw data, information on the relevance of the test material used in the toxicological studies, and detection and characterisation test methods for the engineered nanomaterials.
(6) Experience has shown that in certain cases a novel food intended for a particular group of the population may also be consumed by other groups of the population and that the labelling may not be effective in mitigating the potential health risks for those other groups of population. Therefore, sufficient information for the safety assessment of those population groups should be provided in the application.
(7) Where the applicant submits an application to modify the conditions of use, the specifications or additional specific labelling requirements of an authorised novel food, it may not be necessary for the applicant to provide all the data required for the risk assessment, where the applicant provides verifiable justification.
(8) In order to ensure that toxicological tests are performed to a certain standard, they should be carried out in accordance with the rules set out in Directive 2004/10/EC of the European Parliament and of the Council2. Where those tests are carried out outside the territory of the Union, they should follow The OECD Principles of Good Laboratory Practice3.
(9) The opinion of the Authority should provide sufficient information to ascertain whether the authorisation of the proposed use of the novel food is safe for consumers.
(10) In order to benefit from data protection, as laid down in Article 26 of Regulation (EU) 2015/2283, requests for protection of proprietary data should be justified and all data concerned should be kept in a separate part of the application.
(11) Pursuant to Article 35 of Regulation (EU) 2015/2283, it is necessary to lay down transitional measures for the entry into force of that Regulation.
(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed.