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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 mixtures ◄ 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.