The REACH Registration process generated knowledge for nearly 22,000 substances in over 90,000 registration dossiers by the third registration deadline on 31 May 2018. With this impressive amount of data, REACH has the potential of becoming an advanced, global model and it has great potential in achieving its main goal of protecting human health and the environment from the exposure of chemicals.
REACH consists of four processes: Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). In this report the achievements of the REACH Evaluation process are reviewed. The two steps of Evaluation under REACH are Dos- sier evaluation and Substance evaluation. Dossier evaluation is performed by the European Chemicals Agency (ECHA), while Substance evaluation is executed by the Member States.
Dossier evaluation checks whether the information provided by industry in the registration dossiers is compliant with the legal information required by REACH. ECHA performed Dossier evaluations on over 2,000 dossiers covering 700 substances. Dossier evaluation revealed that 70% of the dossiers is not compliant with the legal information requirements of REACH.
The aim of Substance evaluation is to clarify whether a substance is of concern for human health or the environment and if so, recommend risk management measures to properly address these concerns. In this report the results obtained underSubstance evaluation are analysed and factors contributing to the slow pace of evaluation are discussed together with recommendations to improve evaluation under REACH.
Under REACH, 352 substances were prioritised for Substance evaluation in CoRAP (Community Rolling Action Plan) by the end of 2018. 94 substance evaluations were completed by the end of 2018. Member States concluded that for almost half of the substances with completed Substance evaluation the use today on the EU market is not safe for EU citizens and/or the environment. Risk management has been initiated for only twelve substances to control the risks as follow-up of the Substance evaluation programme since the entry into force of REACH. It includes one restriction (included in Annex XVII), one substance identified as a substance of very high concern (SVHC) and added to the Candidate List and ten proposals for harmonised Classification & Labelling (C&L). For 74% of substances (34 out of 46), concerns were demonstrated, but no actual regulatory follow-up has been initiated to control the risks. These substances are allowed on the EU market today, while it is known that their use is not safe for EU citizens and/or the environment.
In addition, Member States concluded that 64% of the substances under evaluation (126 out of 196) lacked the information to demonstrate the safety of the chemicals marketed in Europe. Further information was required from industry before the concerns could be clarified, extending the evaluation procedure to 7 – 9 years, during which expo- sure of people and environment continues.
The results achieved by Evaluation under REACH demonstrate the need to speed-up evaluation and make the process more effective. Suggestions for improvement are included in this report. Registration dossiers do not comply with the information required by law and do not contain sufficient information to ensure a safe use for EU citizens and the environment. This shifts back the burden of proof to authorities and it delays the implementation of risk management measures (restriction, authorisation and classification & labelling). The results also demonstrate the need to improve the interface between Evaluation and follow-up risk manage- ment. If a concern is identified, risk management should be initiated without delay.
The results obtained under Evaluation after 10 years of REACH demonstrate the need to streamline and simplify the Evaluation process.