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ECHA on Evaluation
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ECHA on Restrictions

Evaluation

Substance evaluation under REACH aims to determine whether the uses of a substance pose a risk to human health or the environment. There are two main evaluation mechanisms under REACH.

 

Testing Proposal Examination.

Substance evaluation is carried out by Member State Competent Authorities (MS-CAs), with ECHA in a coordination role. In the testing proposal examination, ECHA examines testing proposals to check that reliable and adequate data will be produced, and to prevent unnecessary animal testing.

  • ECHA issues draft decisions within specified timeframes that vary for phase-in and non phase-in substances. Registrants and downstream users have the right to comment on the draft decision before it is finalized, and MS-CAs may propose amendments.
  • Possible decisions include accepting or rejecting the testing protocol, or accepting or rejecting it with conditions (e.g., requiring more testing).

 

Compliance Check.

During the compliance check, ECHA checks a registration dossier to ensure that the legal requirements of REACH are fulfilled, the quality of the submitted dossier is sufficient, the safety assessment is suitably documented in a Chemical Safety Report (CSR), the proposed risk management measures are adequate, and that any explanation to opt out from a joint submission of data has basis.

  • If the dossier is found not to comply, EPA prepares a draft decision requiring the registrant to submit any necessary information to bring it into compliance.
  • ECHA performs the compliance check on a sample of the dossiers it receives, with both random-based and criteria-based selection of which dossiers to check.
 

 

Substance evaluation is triggered by risk-based concerns after an evaluation of hazard, exposure, and tonnage data. Substance evaluation involves assessment of information from all registrants of the same substance. ECHA prioritizes substances for evaluation and lists them in a Community Rolling Action Plan (CoRAP).

  • Within 12 months of the publication of the CoRAP, the MS-CA must complete a substance evaluation (unless time is extended because additional information is required).
  • MS-CAs may propose substances to be added to the CoRAP.
  • ECHA plans to submit the first proposal for the CoRAP to the Member States by December 1, 2011. In 2012, 40 substances should be evaluated, increasing to 50 substances per year after that.
 

Substance evaluation is part of an iterative process of data collection and data review, starting with an initial concern and ending with a decision on how to address the concern. The outcome of substance evaluation is a decision on whether sufficient information is available to clarify the risk-based concern, with the possibility of a decision to request further information. If a concern remains, there may be voluntary action by registrants or downstream users to address the concern. Otherwise, the MS-CA may conclude that action should be taken under the authorization, restriction, or classification and labelling procedures in REACH, that information should be passed to other authorities responsible for relevant legislation, or that no further action is needed. Registrants and downstream users have the right to comment on draft decisions before they are finalized.

The evaluation process may trigger restrictions (i.e., conditions for or prohibitions of manufacture, use or placing on the market of a substance), which may be accomplished through an Annex XV dossier prepared by ECHA and/or a MS.

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.