Revision of the REACH regulation - BusinessEurope contribution to the public consultation

Key messages

• Chemicals are key components of materials used in every-day life, from the food we eat to the medicines we take, from the cosmetics we apply to the devices we use or the clothes we wear. They are present in all industrial ecosystems and are as such crucial to the green and digital transformations of the EU’s economy.
• The envisaged revision of REACH represents a paradigm shift, away from a proven risk-based approach towards an unproven hazard-based approach. The impact assessment must therefore thoroughly assess the cost-benefits of this reform, as manufacturers and users of chemicals along the whole value chain would be significantly impacted.
• For volumes below 10 tonnes per year, information requirements for registration must remain proportionate and targeted, otherwise important substances could disappear from the market due to disproportionate costs.
• The report by the European Commission according to art. 138(2) of REACH is necessary to give a framework to assess whether certain polymers should become subject to registration.
• The generic introduction of a Mixture Assessment Factor (MAF) would massively curtail substances and uses even without relevant combination effects. Any further requirements should target the cases of substances and uses where a combined exposure has been identified.
• The extended use of the generic approach to risk management (GRA) must be based on a stepwise and transparent process, with upfront data collection, and ensure targeted and proportionate regulatory action without restricting substances for which safe use is secured. Given the different framework conditions, an equalisation of GRA for professional use and consumer use would not be justified.
• On the ‘authorisation and restriction’ reform, a combination of the different options should be considered. In principle, some positive aspects of the authorisation procedure should be maintained and not replaced completely by a generic restriction process. Advantages of the two procedures must be maintained, in particular when combined with the GRA and the ‘Essential Use’ concept.
• It is important to keep REACH and OSH legislation separate, giving OSH legislation precedence when it comes to worker protection, whilst acknowledging that REACH can provide complementary measures in specific cases. Decisions on which is the most appropriate framework should be based on a binding list of criteria.
• The mere presence of a hazardous substance in a process or product is not a sufficient reason to apply the “essentiality” assessment. The ‘Essential Use’ concept (EUC) could therefore be a valid solution only if applied in a targeted manner, i.e., in case of proven risks to the health and environment, difficulties in managing these risks and if no acceptable alternatives or substitutes exist.