CHAPTER II

CONTENT, DRAFTING AND PRESENTATION OF AN APPLICATION

General provisions on data required for risk assessment
Article 5
1
The dossier submitted in support of an application for the safety evaluation of a substance shall enable a comprehensive risk assessment of the substance and shall permit verification that the substance does not pose a safety concern to consumers within the meaning of Article 6(a) of Regulation (EC) No 1332/2008, Article 6(1)(a) of Regulation (EC) No 1333/2008 and Article 4(a) of Regulation (EC) No 1334/2008.
2
The application dossier shall include all the available data relevant for the purpose of the risk assessment (i.e. full published papers of all references cited or full copies of the original unpublished studies).
3
The applicant shall take into account the latest guidance documents adopted or endorsed by the Authority available at the time of the submission of the application ....
4
The documentation on the procedure followed when gathering the data shall be provided, including the literature search strategies (assumptions made, key words used, databases used, time period covered, limitation criteria, etc.) and a comprehensive outcome of such search.
5
The safety evaluation strategy and the corresponding testing strategy shall be described and justified with rationales for inclusion and exclusion of specific studies and/or information.
6
The individual raw data of the unpublished studies and, where possible, of the published studies as well as the individual results of examinations shall be made available on request from the Authority.
7
For each biological or toxicological study, it shall be clarified whether the test material conforms to the proposed or existing specification. Where the test material differs from that specification, the applicant shall demonstrate the relevance of those data to the substance under consideration.
Toxicological studies shall be conducted in facilities which comply with the requirements of Directive 2004/10/EC of the European Parliament and of the Council or, if they are carried out outside the territory of the United Kingdom, they shall follow ‘the OECD Principles of Good Laboratory Practice’ (GLP). The applicant shall provide evidence to demonstrate that those requirements are complied with. For studies not conducted according to standard protocols, data interpretation, as well as a justification on their appropriateness for the risk assessment, shall be provided.
8
The applicant shall propose an overall conclusion on the safety of the proposed uses of the substance. The overall evaluation of potential risk to human health shall be made in the context of known or likely human exposure.
Words in Art. 5(3) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 142(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 5(7) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 142(b); 2020 c. 1, Sch. 5 para. 1(1)