2021.05.31

A limited revision of REACH is needed to increase transparency and improve chemical safety

The European Commission suggests a revision of the EU REACH regulation to improve the present legislation. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals, and it entered into force on 1 June 2007. It was adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry.

Text: Marie Löf & Marlene Ågerstrand

Even though REACH has been termed the best existing chemicals legislation, there are weaknesses in the present legislation that need to be improved. 

We welcome a careful and limited revision of the EU REACH regulation to improve the protection of humans and the environment against hazardous chemicals and promote a sustainable use of chemicals. It is key, however, that a revision does not lead to a weakened chemicals regulation, in any aspect, which could be a risk when opening a legislation for revision. Thus, a targeted opening of the REACH legislation is therefore needed.

The Commission lists several problems that a revision aims to tackle, these are in short:

  • REACH is the most advanced knowledge base globally but there are still gaps in knowledge of many substances. 
  • The registrants’ safety assessments do not take combination effects of chemicals into account. 
  • The communication in the supply chains is inefficient. 
  • The evaluation of registration dossiers and substances is too complex and insufficient. 
  • The authorisation procedure is too heavy and inflexible. 
  • The current restriction process is too slow to sufficiently protect consumers and professional users against risks from the most hazardous substances. 
  • The control and enforcement is not equally effective in all Member States. 

In general, we agree with the identification of the problems described in the roadmap, which the initiative aims to tackle. However, under the point ‘The evaluation of registration dossiers and substances is too complex and insufficient’ we find the phrasing ’too complex’ somewhat worrying. It is very important that rationalisations and simplifications of the registration process, incl. the compliance check and substance evaluation, does not lead to a deterioration in the quality of the registration dossiers, or their control, as their completeness and accuracy is a fundament for the risk assessment. 

To improve the REACH regulation, provide protection of health and the environment, while preserving the internal market, the commission suggests the following options, in short:

  • Revision of the registration requirements 
  • Introduction of a Mixtures Assessment Factor (MAF) 
  • Simplifying communication in the supply chains 
  • Revision of the provisions for dossier and substance evaluation 
  • Reforming the authorisation process 
  • Reforming the restriction process 
  • Revision of provisions for control and enforcement 

In our reply to the Commission, we have identified and suggested complementary measures that should be included to improve risk assessment of chemicals:

  • Increasing the transparency of data: Full transparency should be the general rule for the whole chain of events from generation of information, via reporting of data, to hazard and risk assessment. The current developments in the food law are very welcome and should be expanded to all chemicals.

In a system where manufacturers are responsible for assessing their own products sufficient resources to control the quality of this work must be secured. The overall aim must be full legal compliance. 

  • Making use of academic studies: change the requirements to also include academic studies, if available, in hazard and risk assessment, as a complement to the toxicity studies commissioned by the chemical industry. Increasing the use of academic studies is also expressed in the Chemicals Strategy for Sustainability. 

Under the present heading Reforming the authorisation process’ we also suggest to supplement the current wording with the bold text, as it is important to align the concept of essential use of the most hazardous substances already in the authorisation process:

  • Reforming the authorisation process: Options include clarifications and simplifications of the current provisions, national authorisation for smaller applications, removing the authorisation title from REACH, integrating the REACH authorisation and restriction systems into one and improving the interface with other pieces of legislation (complementing actions under the one-substance one-assessment action under the Chemicals Strategy), ‘and the concept of essential use should be aligned with the authorisation process’.

Finally, we strongly support the ambition in the Chemicals Strategy for Sustainability to ’introduce endocrine disruptors, persistent, mobile and toxic and very persistent and very mobile substances as categories of substances of very high concern’ within REACH restriction processes.

For more information about the need for grouping and mixture risk assessment in European chemicals legislation, please read: Policy Brief: Time for smarter and safer chemical management and: Future chemical risk management - Accounting for combination effects and assessing chemicals in groups, SOU 2019:45.

For more information about the need for increased transparency in REACH, please read: Policy Brief: European chemicals regulation needs more transparency 

Read the full consultation reply here.