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Substance Evaluation for the Clarification of Open Questions

How we close data gaps in accordance with the REACH Regulation

The EU Member States can fill data gaps by performing a substance evaluation. For this purpose, they require registrants of a substance to submit specific information. We assess substances when we have good reasons to assume the substance could pose a risk.

Contribution of the REACH Assessment Unit OSH

The aim of substance evaluation is to identify and close data gaps regarding the risk assessment of a particular substance. In this process, the Assessment Unit OSH selects substances that may pose a risk to workers . Before the assessment, the substances are included in the Community Rolling Action Plan (CoRAP).

Key aspects

Harmful effects

  • Suspected CMR properties (Cat. 2)
  • STOT RE and inhalation exposure
  • Sensitisation of the respiratory tract
  • Implausible read-across

Exposure and measures

  • Exposure in professional settings
  • Missing/implausible information on risk reduction measures
  • Failure to comply with hierarchy of measures according to OSH legislation

General aspects

  • Specific problem assessment from practical experience
  • Potential substitutes
  • Innovative materials

In this respect, substances used in large quantities are to be evaluated preferentially.

Procedure of the process

The reason for the inclusion of a substance in the CoRAP is documented and forms the basis for the one-year evaluation. The data basis of the substance evaluation are the registrations and other information on toxicology and exposure situation.

At the start of the substance evaluation, the Assessment Unit formulates questions which can be discussed at a meeting with the affected companies and/or associations. This provides companies with the opportunity to rapidly resolve lack of clarity by providing further details. If data gaps remain after this discussion and after further examination, the Assessment Unit compiles a draft decision. This contains specific requirements regarding which information is to be submitted by industry within a certain defined period.

The draft decision can be commented by the affected companies part of ECHA, takes the final decision. After the requested data is submitted, the Assessment Unit carries out another evaluation. If necessary, information may also be requested on a second occasion.

Extended data basis for the decision on regulatory measures

Based on the extended data basis, the Assessment Unit draws conclusions concerning the need for further measures, such as an authorisation obligation or a restriction. The substance evaluation is conducted without preconceived views as to the outcome. Also exoneration of a substance is a possible result.

Other tasks

Further Information

REACH

Registration, evaluation, authorisation and restriction of chemicals.

Find out more : The REACH Regulation …