EU REACH Evaluation Compliance Service

The full name of the EU REACH Regulation is Regulation concerning the Registration, Evaluation, Authorization, and Restriction of Chemicals. Since its implementation in 2008, it has had a significant and far-reaching impact on global chemical trade and environmental effects.

After completing REACH registration, enterprises must continue to focus on the evaluation requirements under REACH. Evaluation is covered in Annex VI of the REACH Regulation, primarily conducted by ECHA and member states agencies. REACH evaluation can be divided into two main categories - dossier evaluation and substance evaluation.

Dossier evaluation involves the review of Testing Proposals (TP) submitted under high tonnage registrations for certain data endpoints under Annexes IX and X. Dossier evaluation covers compliance assessment as well, which consists of random reviews and targeted dossier reviews. This means that ECHA reviews submitted dossiers, examining content primarily including substance identification information, spectrographic data, physicochemical information, ecotoxicological information, and information related to the safe use of the substance, such as data quality and sources reliability, justification for exemptions, and the quality of the risk assessment report. After dossier evaluation, the lead registrant may be required to conduct additional testing and update the dossier and risk assessment report, while the joint registrants need to share the related responsibilities and obligations.

In terms of substance evaluation, enterprises should pay close attention to the Community Rolling Action Plan (CoRAP) initiated by ECHA from 2011. CoRAP regularly identifies substances that may pose risks to human health or the environment and conducts further assessments to clarify these risks. Substances in the CoRAP list will be assigned to different EU member states for evaluation. Once a substance is included in the CoRAP list, the responsible member state has at least one year to evaluate the substance and draft a decision. This may involve requesting additional data from the registrants (lead registrants) to determine potential hazards. The draft decision must be reviewed and agreed upon by ECHA and other member states. After revisions, once agreed upon by other member states, ECHA adopts the final decision and notifies the European Commission. The evaluating member state actively communicates with the registrants associated with the substance, requiring companies to gather and submit more information. This facilitates a comprehensive understanding of the evaluated substance, clarifies its risks, and promotes safe management of the substance.

Our Services

• Registration dossier evaluation compliance for lead registrants (review of draft decision/final decision, communication with competent authority, laboratory commissioning and coordination, SIEF agreement drafting and signing, SIEF communication and management, cost sharing dossier/CSR updates, etc.);
• Consortium management (consortium formation, consortium member management, REACH registration and post-registration evaluation compliance);
• Registration dossier evaluation compliance for joint registrants (review of draft decision/final decision, SIEF communication, cost sharing, dossier/CSR updates, etc.);

Further Information

EU REACH Only Representative

SVHC Notification