A cornerstone of REACH, the European chemicals regulation, is the authorisation of substances of very high concern – a highly complex process. TÜV SÜD helps companies to take timely and appropriate action to minimise their risks.
“The application deadlines for 12 out of 22 substances currently listed as requiring authorisation will expire this year”, warns Dr Daniel Mauder, REACH expert at TÜV SÜD Industrie Service GmbH. “Only companies that receive authorisation within these deadlines may continue to produce or use the substances after the deadlines have expired.” The REACH authorisation process transfers responsibility for chemical substances to their producers, importers and downstream users.
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The regulation focuses on substances of very high concern (SVHCs), which are associated with particularly high risks and include substances that are carcinogenic, mutagenic, toxic for reproduction, bioaccumulative or toxic to humans and the ecosystem. The regulation aims to replace these substances with suitable alternative substances or technologies and to permit only methods of manufacturing and use that involve manageable risks. For this reason, authorisation does not apply to a substance in general, but only to uses of that substance for which approval has been applied for and received – and only for a restricted period of time.
Expiry, deadlines and application periods: strategic and economic aspects
Given the risks associated with SVHCs, authorisation of these substances is strictly regulated. Dr Daniel Mauder explains, “Care is essential when addressing the process, both to minimise risks and to ensure the procedure is aligned to individual requirements.” In the first step, SVHCs are identified as such by the EU member states and the Helsinki-based European Chemicals Agency. The ECHA then publishes a restriction dossier for the substance. After expiry of a public consultation period during which comments can be made, the substance is added to the Candidate List, which currently contains 144 substances. As soon as a substance is included in the Candidate List, an extensive range of duties to inform concerning the substance take effect. In a further step, the ECHA assigns priorities to the substances on the Candidate List, which is regularly updated and published. In a ‘comitology procedure, the EU Commission then decides on inclusion of the substances in Annex XIV of REACH. An expiry deadline is set for the substance, which may be up to four years after its Annex XIV inclusion. The amount of fees payable depends on the size of the company issuing the application, the number of uses of the substance and the number of companies participating in the application. Important factors are therefore the identity of the issuer of the application, and whether the applicant is a single company or a consortium.
TÜV SÜD”s experienced specialists help companies to navigate the authorisation procedure for substances of very high concern, submit their applications within the deadlines and successfully gain authorisation, thus providing them with legal certainty and streamlining the costs of the authorisation process.To find out more about REACH services, visit www.tuev-sued.de/reach.
