Regarding EU REACH Authorisations for substances of very high concern. Of note are the two recommendations below, which could directly impact applicants requesting authorisation.
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- Applying the rule that it is up to applicants to demonstrate that they have satisfied the legal conditions for obtaining the Authorisation by providing sufficient information,
- Ensuring that applications containing insufficient information are promptly dismissed, so that the companies that have submitted those applications can no longer use the dangerous substances in the EU,
Update from MedTech Europe
To: Chemicals Working Group (IVD & MD)
Dear members,
I hope you are all well.
We would like to share for your information a recommendation from the European Ombudsman concerning the Commission’s delays in adopting REACH Authorisation decisions (link), made available on 21 October.
This report is based on the September 2022 public consultation organized by the European Ombudsman on transparency and participation in EU environmental decision-making. One of the issues raised in the responses was the delays and limited transparency in the risk management of dangerous chemical substances by the European Commission.
Given this, the Ombudsman opened an own-initiative inquiry to examine this issue further and resulted in the Ombudsman’s recommendation report, which was based off 12 Authorisation cases (link), stemming from several DEHP Authorisations, sodium dichromate, ammonium dichromate, diarsenic trioxide, strontium chromate, diglyme, and chromium trioxide. (no mention of OPE/NPE Authorisations). From these Authorisations, it was concluded that while the statutory deadline for a decision is three months, it took the Commission on average 14.5 months and, in some cases, several years to prepare draft decisions for granting or refusing Authorisations.
As part of this report, the Commission was also consulted in which it stipulated that the three-month time limit set out in the REACH Regulation to draft decisions after receiving RAC and SEAC opinions is unrealistic to attain in practice, given the complexity and number of applications it receives. In addition, delays in the Authorisation procedure are caused by the following two factors:
- There are two DGs responsible- DG GROW an ENVI for processing Authorisation requests.
- The Commission must take a broader view on applications than RAC and SEAC, which focus on scientific and technical issues.
The Ombudsman concluded that:
- The systemic failure by the Commission to comply with the statutory three-month time limit to present draft decisions to the REACH Committee constitutes maladministration.
- These delays seem largely due to the manner in which the Commission has organised its internal procedures, how it has allocated the responsibilities to its departments, and that it has not put in place a mechanism for ensuring that it can systematically, and at an early stage, reject applications that contain insufficient information to prove that the legal conditions for Authorisation under the REACH Regulation are satisfied (the burden of proof).
- The Commission does not publish information which would allow the public to understand the causes of the excessive timeframes in the Authorisation procedure, including when these are due to disagreements among the actors involved. In particular, the summary records of the REACH Committee meetings do not currently capture the state of play of individual files and the reasons for possible delays, such as disagreements among Member States.
- The Commission should take the following measures to address the issues found by the Ombudsman to comply with the 3-month statutory requirement in REACH by:
- Reviewing its internal procedures,
- Applying the rule that it is up to applicants to demonstrate that they have satisfied the legal conditions for obtaining the Authorisation by providing sufficient information,
- Ensuring that applications containing insufficient information are promptly dismissed, so that the companies that have submitted those applications can no longer use the dangerous substances in the EU,
- Publishing more substantial summary records of the REACH Committee meetings, so as to allow the public to follow the progress of each Authorisation file, understand outstanding issues and any reasons for delays.
