Evaluation

Dossier evaluation

Dossier evaluation is a compliance check of the registration dossier, based on scientific judgement. It assesses whether the information needed for the registration is present in the dossier and is adequate to meet the requirements under REACH. In fact, ECHA and the European Commission published a REACH Evaluation Joint Action Plan to address the lack of compliance of the information in the registration dossiers.

ECHA may examine any registration dossier for each tonnage band. Attention is focused on dossiers for substances listed in the “CoRAP” (Community Rolling Action Plan) as well as those from companies opting out of joint submission of shared classification and labelling or (robust) study summaries. However, the prioritisation is not exclusive; data-rich dossiers may be chosen to ensure the information is sufficient and adequate, and dossiers containing waivers used to adapt the standard information requirements may be scrutinised to ensure the waivers are adequately justified.

Following dossier evaluation companies may be required to submit further information to support their registration.

Substance evaluation

Substance evaluation is carried out by Member States. It assesses whether the risk to human health or the environment of a given substance is such that additional controls, for example Authorisation or Restriction, or other actions outside the scope of REACH such as harmonised classification are required.

Risk-based criteria are used to prioritise substances for evaluation, which are then listed by ECHA in the “CoRAP”. Each CoRAP substance has a designated Member State responsible for its evaluation. The Member State takes into account the information submitted in all registration dossiers for the substance or group of substances and considers combined exposure and aggregated tonnages of production.

Member States have 12 months to evaluate the substances starting from the date of publication of the first CoRAP. Where necessary they will prepare a draft decision for requesting further information from registrants to clarify the suspected risks. The information requested may go beyond the standard requirements in Annexes VII to X to REACH and may consider the substance exposure or its intrinsic properties to help the authorities decide if further EU-wide controls are necessary to manage the risks.

Following evaluation of a substance the designated Member State may propose further controls such as; harmonised classification and labelling for carcinogenic, mutagenic or toxic to reproduction, respiratory sensitiser or other effects, restriction, EU-wide occupational exposure limits, or Candidate List inclusion.

Examination of testing proposals

Companies registering substances at 100 tonnes or more per year should submit testing proposals in their IUCLID dossiers for each “missing” Annex IX and X endpoint (according to Article 40 of REACH regulation). ECHA examines each testing proposal to ascertain whether testing is necessary to complete the registration, and whether the conditions of the test are acceptable. If testing is deemed necessary ECHA will draft a decision setting out the timescale and details of the testing required. In the case of a proposal for a test involving vertebrates a 45-day public consultation takes place via the ECHA website prior to ECHA’s draft decision.

Priority is given to testing proposals for substances which are, or may be, CMRs, PBTs, vPvBs, or sensitisers, as well as those registered above 100 tonnes per year with widespread and diffuse exposure during use.

Where more than one company has submitted proposals for the same test on a given substance only one such company will carry out the test. However, cost sharing and data sharing rights must still be respected.