Regulatory Developments

EC Opens Survey for Industry on Potential REACH Amendments Concerning the Generic Risk Management Approach and Authorization and Restriction

May 11, 2022

The European Commission (EC) recently opened a survey focused only on potential reforms to the authorisation and restriction provisions of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation (No. 1907/2006), as well as the extension of the Generic Risk management Approach (GRA). The EC is revising REACH to reflect the goals in its ambitious Chemicals Strategy for Sustainability (CSS). The survey supports the EC’s impact assessment for the REACH revision and is intended only for industry stakeholders. Responses are due June 1, 2022.

Although the survey focuses only on potential reforms to the authorisation and restriction provisions and the extension of GRA, the survey captures other related changes to REACH processes that are currently being considered, such as the possible implementation of the concept of essential use, where they are relevant to specific questions. As reported in our February 2, 2022, memorandum, the EC held a wider public consultation on all the measures it is considering for the REACH revision that ended on April 15, 2022.

The survey addresses four options that the EC is considering:

  • Option 1: Keep authorisation (with clarifications and simplifications) and restriction processes separate;
     
  • Option 2: Merge the authorisation and restriction processes;
     
  • Option 2A (variation of option 2): Keep titles for substances of very high concern (SVHC) and restriction separate, but introduce the possibility for derogation requests; and
     
  • Option 3: Remove the authorisation title from REACH.
     

At this stage, the EC has not decided which, if any, of these potential options may be adopted, but it may combine elements from different options. The survey notes that two possibilities for granting authorisations and/or derogations from restrictions will also apply to the options being considered:

  • The “essential use” concept (being developed under another study), where derogations from restrictions and/or authorisations are granted only if the use is proven necessary for health and/or safety or critical for the functioning of society, and if there are no suitable alternatives that are acceptable from the standpoint of environment and health; and
     
  • The “minimal exposure” route for uses of substances in articles and for industrial uses of substances in mixtures, where in exceptional cases, a derogation and/or authorisation may be granted if industry proves that the exposure/emissions throughout the whole life cycle of the substance are absent or minimal and there are no suitable alternatives that are acceptable from the standpoint of environment and health.
     

Through the survey, the EC seeks views on the effectiveness and efficiency of both the current REACH processes and how this may change under the options discussed in more detail in the section Options for the revision of authorisation and restriction processes. These options seek a balance among five aims, and the survey asks questions on whether and how the options might achieve them:

  • Reduce the administrative burden on companies and authorities;
     
  • Free authority resources to tackle a wider range of chemical risks;
     
  • Make the authorisation processes more efficient and effective;
     
  • Achieve a higher level of protection of human health and the environment from the risks of the most harmful substances; and
     
  • Give clearer market signals and greater planning security for companies.
     

The survey is structured in two main parts, the first one dedicated to the extension of the use of the GRA and the second one dedicated to the revision of authorisation and restrictions processes. Industry stakeholders may select which part(s) of the questionnaire to complete to reduce the length of time required to complete it.

Commentary

Industry stakeholders are encouraged to take advantage of this opportunity to share their views with the EC by participation in this survey. Consideration by the EC of potential reforms to the authorisation and restriction provisions of REACH is the first proposal for significant revision of foundational provisions of REACH since its entry into force in 2007. Participation in this survey provides industry stakeholders an opportunity to share their views with the EC and to ensure that the EC takes them into consideration. The scope of the current survey is limited to the extension of the use of the GRA and the revision of the authorisation and restrictions processes. The authorisation and restriction processes, in particular, affect a wide variety of stakeholders, substances, and uses. This survey provides a valuable opportunity for industry stakeholders to share their experiences and express their preferences regarding whether they would prefer to maintain the current REACH process or whether they would welcome changes to the process according to the proposed options. The information that the EC receives from industry stakeholder responses to this survey will inform revisions of REACH that will likely apply for another 15 years before such an extensive revision of the regulation is considered again.


 
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