11. April 2022 | Position
The European Commission launched a public consultation on options for the revision of the chemicals regulation REACH.
On 20 January 2022 the European Commission launched a public consultation on options for the revision of the chemicals regulation REACH (deadline for submissions: 15 April 2022). This is intended to implement the REACH related measures announced by the Chemicals Strategy of October 2020.
A REACH revision will have major impacts on both the chemical industry and users of chemicals (substances, mixtures and articles).
The chemical-pharmaceutical industry is a key sector that stands at the beginning of many value and supply chains and plays a major role as a driver in achieving the ambitious goals of the Green Deal, e. g. in climate protection, and in further advancing digitalisation and high-quality supplies of medicines.
Thus, regulatory options for achieving ambitious goals must be designed in such a way that value creation continues to take place in the EU. They must go hand in hand with increasing the ability to innovate and improving the international competitiveness of the industry. Planning security in line with a stable and predictable legal framework is crucial.
Shaping of regulatory options should consider the points below:
- Information and data requirements must be proportionate and take into account registration obligations companies must meet in other regions. Where necessary, additional data requirements should be based on a tiered approach considering inter alia, use and exposure.
- More rapid progress in replacing animal testing is possible, if the testing scheme is developed towards a more exposure driven one with gradual uptake of new approach methods and acknowledging that these are not replacing current standards one by one.
- Any registration option for certain polymers must be based on valid technical and scientific criteria considering the specific properties of polymers compared to other substances as well as workability aspects.
- Possible combination effects through exposure to substances should be addressed in a targeted manner, if necessary. Exclusively in the risk assessment of consumer uses mixture assessment factors specific to substances or substance groups might be applied. Supposedly simple regulatory approaches, such as an additional general assessment factor for all substances registered under REACH, do not reflect reality and are not acceptable.
- Supply chain communication can be simplified by drawing on the experience of the writers and users of extended safety data sheets to agree on best digitalising practices. Harmonised electronic formats must be compatible with systems already established in companies and requirements in other regions. Pilots are required before decision making on any harmonized format.
- To improve dossier and substance evaluation, action plans by the European Commission, ECHA and industry are already being implemented and several implementing regulations have been issued.
- For further developing ECHA’s regulatory screening approach, transferring the current candidate list for authorisation into a prioritisation tool is discussed. Options for this should pay specific attention on balancing workload and addressees with data absolutely necessary for focused decisions on regulatory needs.
- Non-REACH options, e.g., under OSH, should be given equal rights compared to REACH measures when assessing regulatory needs. Stakeholders should be involved in assessments of regulatory needs as well as before taking subsequent decisions on potential regulatory options.
- Basically, the authorisation procedure should be maintained for industrial, professional and consumer uses. The scope should focus on cases where non-REACH measures or the ordinary restriction procedure are less suitable. The burden of applications for small quantities and process chemicals should be reduced.
- The regular restriction procedure allows for balanced and informed risk management, e.g., by stakeholder consultations. Therefore, it should not be replaced by the so-called generic risk approach (GRA) without prior consultation and risk assessment.
- Professional uses are subject to occupational health and environmental legislation that has to be implemented by the employer. Thus, in first instance proper implementation and enforcement is key instead of additional regulatory measures. Remaining issues should be addressed outside of the GRA.
- Export restrictions for products manufactured in Europe should be based solely on internationally agreed and harmonised requirements.
- REACH enforcement must be uniform throughout the EU (level playing field, harmonized analytical methods etc.), consider all actors equally and differentiate between intentional infringements and unintentional errors. Involvement of customs is important, should build on smart approaches and may not disrupt the flow of goods.
Please read the full position in the downloads section at the top of this page.
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