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||Applications for authorisations
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:
(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.