Medical devices: ECHA clarifies the scope of certain REACH exemptions
Following the presentation of a document entitled “Q&As on the scope of certain authorisation exempting provisions” at the 16th CARACAL meeting of REACH and CLP competent authorities, held on 10-11 November, ECHA has updated also its Q&A website on REACH authorisation.
The updated Q&A addresses some critical points of the REACH authorisation exemptions for certain uses, namely:
1 - The scope of REACH authorisation exemptions:
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ECHA clarifies that the “use” of substances exempted from REACH authorisation (e.g., use in medicinal products; food or feedingstuffs; plant protection products; biocidal products; etc.), under Article 2(5) or 56 of REACH, covers also the incorporation of that substance into the product during the manufacturing process.
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ECHA also explains that the exemptions extend to any previous use of the Annex XIV substances upstream, preceding an exempted end-use. ECHA further explains that this use upstream would be exempted only for “the volumes ending up in the exempted end-use”. As a consequence, by way of example, a use consisting of the formulation of substances to be used in a biocidal product would be exempted from REACH authorisation.
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2 - The procedure for the application for authorisation for substances used in medical devices:
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ECHA has clarified that an authorisation exemption is not needed for the use of Annex XIV substances in medical devices. Articles 62(6) of REACH provides that an application for authorisation “shall not include the risks to human health arising from the use of a substance in a medical device”. In a document dated 4 March 2014, the Belgian authorities interpreted this article concluding that, for use in medical devices “a dossier for authorization has to be submitted, but the dossier doesn’t need to consider the aspects linked to the impact on human health of the use of the device, intended for the final user”. ECHA has now clarified that “Pursuant to Articles 60(2) and 62(6) of REACH, an application for authorisation is not required for a substance used in a medical device”.
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