Cefic statement on the revision of REACH

The REACH revision is an opportunity to continue reducing exposure to the most harmful substances and continue building a predictable regulatory system that enables industry and authorities to focus resources where it matters the most, including development of safe and sustainable alternatives, where needed, and simplifying administrative processes.

Today more than ever Europe needs a robust domestic chemical industry to reduce strategic dependency on other regions. The role of REACH is therefore to keep the industry’s engine of growth and innovation running at full speed whilst raising the bar on safety.

The chemical industry will go through a ‘double twin’ transition (climate neutrality, Chemicals Strategy for Sustainability, circularity and digitalisation). Prioritising regulatory actions that bring the most benefits to health and environment, keeping the regulatory framework as stable as possible, and maintaining coherence of REACH with all other pieces of EU legislation should be the guiding principles of the revision. Last but not least, advances in risk assessment methods, human and environmental monitoring, predictive toxicology and alternatives to animal testing need to be reflected in this revision.

In particular, we call on the European Commission to focus its attention on the following key aspects when developing legislative proposals :

• This is a landmark opportunity to accelerate development, validation and regulatory acceptance of human-relevant animal-free approaches to assess safety of chemicals. By making every effort to identify where animal-based testing can reliably be replaced by non-animal methodologies and reflect latest advances in science, we will create a triple win for the industry, regulators and animal welfare. This requires a paradigm shift in safety assessment towards Next Generation safety assessment, similar to moves seen in the area of cosmetics or pharmaceuticals.

• On generic approach to risk management (GRA), we recommend prioritising consumer uses with a high likelihood of exposure to the most severe hazardous chemicals. Yet we call for a more nuanced approach to protect professional users of chemicals that may have to handle high-performance hazardous chemicals to perform their jobs . Identifying occupations where the risks are the greatest and introducing tailored protective action such as mandatory training and certification schemes will secure safe handling of hazardous chemicals in this group.

• Beyond the GRA, the reform of Restriction and Authorisation needs to provide a clear long-term vision on how to regulate chemicals more effectively and efficiently. Clear priorities for action must be set, distinguishing different categories of users and types of exposure, making optimal use of the full regulatory toolbox without overlaps, minimising policy by derogation and ensuring adequate resourcing.

• There is a high risk that the concept of “essential use”, simple at first sight,would turn the current system upside down and result in the chemicals regulation being driven by judgement instead of scientific evidence. It is close to impossible to judge which uses are essential for society. A Committee with a political mandate and accountability would need to be set up to make choices as to what should be considered essential or not.  The application of this concept would lead to a barrage of new derogation requests instead of getting to faster decision making, with prolonged discussions consuming time and resources of national authorities and agencies.  At best, essential use might become a supplementary tool for assessing case by case whether or not to continue the use of a substance subject to authorisation or restriction.

• Polymers are the backbone of the materials needed to achieve ambitious future goals. They are the focus of innovation work. They are also unique. This means that the current substance registration scheme cannot be reapplied to polymers. We need a different, workable and proportionate scheme for polymers that targets only those which have properties associated with a higher likelihood of hazard in line with a globally accepted approach. Polymers recognised globally as Polymers of Low Concern (PLC) based on the experience of other non-EU agencies should be excluded from registration. ECHA resources will have to be ramped up to manage thousands of polymer registrations.

• Available evidence supports a targeted implementation of the Mixture Assessment Factor (MAF) for environmental risk assessments. A broad-brush approach such as one generic MAF applied to all chemicals would penalise safe chemicals, with substantial impact on supply chains and risk of more animal testing. Having analysed all available evidence, Cefic has developed a decision tree to help decide when the application of MAF is justified.