Q&As

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REACH

Authorisation

Applications for Authorisation - a) Scope and procedure

Does the exemption for the use of Annex XIV substances in scientific research and development under Article 56(3) REACH also apply to analytical activities such as monitoring and quality control?

Yes, it does. Under Article 3(23) of REACH, scientific research and development means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year. Thus, the use of an Annex XIV substance in analysis is exempted from authorisation under Article 56(3) if the substance is used, on its own or in a mixture, in analytical activities such as monitoring and quality control where these activities are carried out under controlled conditions and in a volume not exceeding one tonne per year and per legal entity. The exemption applies to the use of an Annex XIV substance when it is required as part of an analytical method for the measurement of another substance or property (e.g. used as an extraction solvent or reagent) and the analysis of the Annex XIV substance itself (e.g. for quality or process control). Where these conditions are met, there is no need to apply for an authorisation for this use or to include this task as a working contributing scenario (i.e. PROC 15) in an application for authorisation. This exemption applies irrespective of where the analysis is performed i.e. on-site or off-site facilities. However, this exemption does not cover sampling activities (see Q&A  1153).

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