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CHAPTER-2: Granting of authorisations
ARTICLE 62: Applications for authorisations
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ARTICLE 62: Applications for authorisations
1. An application for an authorisation shall be made to the Agency.
2. Applications for authorisation may be made by the manufacturer(s), importer(s) and/or downstream user(s) of the substance. Applications may be made by one or several persons.
3. Applications may be made for one or several substances, that meet the definition of a group of substances in Section 1.5 of Annex XI, and for one or several uses. Applications may be made for the applicant's own use(s) and/or for uses for which he intends to place the substance on the market.
4. An application for authorisation shall include the following information:
(a) the identity of the substance(s), as referred to in Section 2 of Annex VI;
(b) the name and contact details of the person or persons making the application;
(c) a request for authorisation, specifying for which use(s) the authorisation is sought and covering the use of the substance in preparations and/or the incorporation of the substance in articles, where this is relevant;
(d) unless already submitted as part of the registration, a chemical safety report in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex XIV;
(e) an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution and including, if appropriate information about any relevant research and development activities by the applicant;
(f) where the analysis referred to in point (e) shows that suitable alternatives are available, taking into account the elements in Article 60(5), a substitution plan including a timetable for proposed actions by the applicant.
5. The application may include:
(a) a socio-economic analysis conducted in accordance with Annex XVI;
(b) a justification for not considering risks to human health and the environment arising either from:
(i) emissions of a substance from an installation for which a permit was granted in accordance with Directive 96/61/EC; or
(ii) discharges of a substance from a point source governed by the requirement for prior regulation referred to in Article 11(3)(g) of Directive 2000/60/EC and legislation adopted under Article 16 of that Directive.
6. The application shall not include the risks to human health arising from the use of a substance in a medical device regulated by Directives 90/385/EEC, 93/42/EEC or 98/79/EC.
7. An application for an authorisation shall be accompanied by the fee required in accordance with Title IX.
Referred by:
ARTICLE 60: Granting of authorisations
ARTICLE 61: Review of authorisations
ARTICLE 63: Subsequent applications for authorisation
ARTICLE 64: Procedure for authorisation decisions
ARTICLE 74: Fees and charges