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Report: ECHA’s scrutiny has a profound impact on authorisation decisions

ECHA/PR/17/16

According to ECHA’s report the requirements for authorisation have introduced stricter controls of use and have therefore reduced risks from harmful chemicals to workers and the population at large. They have often led to early substitution to safer alternatives. Where applicants made a convincing case that substitution was not possible the recommended authorisations permit them to continue using substances of very high concern and to avoid substantial costs to society. 

Helsinki, 18 September 2017 - The authorisation system has entailed costs to applicants and regulatory authorities, but the benefits outweigh the remaining risks, based on ECHA’s analysis of the first 100 applications for authorisation submitted and evaluated by the end of 2016.

The authorisation requirements as well as the reputational issues of continued use of substances of very high concern (SVHCs) have driven companies to substitute hazardous substances with safer alternatives as witnessed by the non-receipt of applications for seven substances on the Authorisation list.

Substitution of substances on the REACH Authorisation List is taking place. No applications were received for seven substances and several applications contained planned substitution activities.   

Three findings stand out: 

  • Whilst the remaining risks associated with the continued use of SVHCs are important, the risk reductions brought about by the authorisation system have reduced the exposure to harmful chemicals of workers and the population at large. Thereby, the authorisation system has helped to lower the burden of occupational and other diseases in the EU.
  • The aggregate benefit of authorisations (i.e. the costs that applicants, their clients and society as a whole would have to bear if the authorisations had not been granted) were estimated to outweigh the remaining monetised risks to human health and the environment by on average a factor of 15 to 1. This ratio varied a lot from one application to another.
  • While ECHA’s scientific committees recommended to the European Commission that all the authorisations be granted, they suggested additional conditions and/or monitoring requirements in two-thirds of the uses. Furthermore, they recommended that the review periods be – on average – 2.5 years shorter than proposed by the applicants. Thus, the scientific scrutiny of the applications manifests itself in the opinion-making process.

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