Internal Market, Industry, Entrepreneurship and SMEs

Approach for Evaluation of PBTs Subject to Authorisation and Restriction Procedures in context of Socio-economic analysis

Approach for Evaluation of PBTs Subject to Authorisation and Restriction Procedures in context of Socio-economic analysis
Published on: 13/07/2016 Last update: 19/09/2017
Deadline: 16/09/2016
  • Number: 549/PP/GRO/IMA/16/1131/8911

Persistent, bioaccumulating and toxic (PBT) substances can be subjected to the authorisation or restriction procedures under Regulation (EC) 1907/2006 on REACH. According to REACH Article 60, an authorisation for the use of PBT substances (as well as for non-threshold substances) can only be granted to companies if it is shown that the socio-economic benefits of continued use outweigh the risk to human health or the environment and if there are no suitable alternative substances or technologies available. For restrictions, the socio-economic impacts of the envisaged restricting measure have to be considered.

However, no generally accepted method is currently available to estimate or quantify the adverse impacts from the use of a PBT substance. The study aims to develop such a method in order to support regulators in performing a sound socio-economic assessment of the use of PBT-substances.

A recognised approach will increase applicability, transparency and acceptance of the socio-economic route of the authorisation procedure under REACH for PBT substances. Companies applying for authorisation will profit from a generally accepted approach as it will increase certainty and predictability. Similarly, it will increase transparency and predictability of the restrictions process under REACH. Both are harmonising measures which are contributing to the objective of having a well-functioning and robust Single Market.

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