On April 3, 2025, at the CARACAL-54 meeting of the joint advisory body REACH-CLP, the European Commission officially released the final proposal for the reform of the REACH Regulation. The European Chemical Industry Council (Cefic) pointed out that the digital transformation is expected to increase costs for SMEs by 40%, and that the 10-year review cycle and complex mixed assessment models may slow the development of innovative pharmaceuticals.
The following core issues are directly related to cosmetics companies that are planning to enter or have already entered the EU market:
Registration Validity Period Shortened to Ten Years
Under the REACH Regulation, cosmetic products are defined as mixtures, and each component exported to the EU in quantities exceeding one tonne per year must be registered. If the validity period of registration is shortened to ten years, the entire supply chain for cosmetics exported to the European Union will need to undergo the registration process again, leading to a significant increase in compliance costs, particularly for SMEs.
Registration Numbers May Be Revoked
Even after companies invest heavily to complete registration, if the lead registrant’s dossier fails the completeness check or is not updated in a timely manner, ECHA has the authority to revoke the registration number. In such cases, the registration investment would be entirely lost.
Higher Data Requirements
New safety assessments include additional classifications such as PMT and EDs. To demonstrate that a substance does not fall under these categories, companies may need to conduct costly testing, which could significantly increase registration expenses.
Polymers Will Also Require Registration
Under the current REACH Regulation, polymers are exempted from registration as long as their monomers or other relevant substances are registered. However, in the new proposal, polymers will be subject to classification and registration requirements. In general, polymers that do not meet the criteria for "polymers of low concern" (PLCs) will need to be registered as substances in their own right. Given the widespread use of polymers, this change is expected to affect the majority of companies across various sectors.
Digital Product Passport (DPP)
In the proposed regulation, the Digital Product Passport (DPP) is considered the most effective tool for improving information exchange across the supply chain, particularly for communicating whether a product contains substances of concern. The DPP has already been made mandatory under the new EU Battery Regulation and is expected to be extended to other sectors such as toys, biocides, textiles, and furniture. Similar requirements are anticipated for the cosmetics industry in the near future.
Digitalization of Safety Data Sheets (SDS)
Companies will be required to provide digital Safety Data Sheets (SDS) that are aligned with the product’s Digital Product Passport (DPP). Although finished cosmetic products are exempt from the supply chain communication obligations under Chapter 4 of the REACH Regulation, raw materials exported to the EU still require SDS and the establishment of a DPP. This will increase compliance costs for relevant enterprises.
Customs Enforcement Integration
During enforcement, customs authorities may require importers to provide SDSs in the official language of the Member State. They may also verify the registration number or authorization number of the importer or Only Representative (OR), if applicable. It is planned that within four years after the regulation enters into force, the REACH database will be interconnected with the EU customs system, enabling automated verification of such information.
Distance Sales
Currently, there is a regulatory gap in the REACH framework concerning distance sales from non-EU countries directly to EU consumers, as no responsible entity is designated to ensure compliance. To address this issue, the proposal introduces the requirement for an economic operator to be responsible for REACH compliance in such cases. This imposes stricter obligations on goods sold into the EU via e-commerce platforms.
Other Proposals
Additional proposals include new requirements for nanomaterials and further restrictions on animal testing. These aspects are not elaborated in detail here but represent other important areas of regulatory development.
Next Steps
The public consultation on the European Commission’s proposed revision of the REACH Regulation is open until April 25, 2025. The final legislative text is expected to be published in the fourth quarter of 2025. Relevant stakeholders-particularly manufacturers, importers, and downstream users-are strongly advised to review the proposed registration timelines and data requirements, assess their readiness for supply chain digitalization, and provide feedback on the relevant provisions.
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