The annual evaluation report covers the Agency's evaluation activities and the corresponding output. In 2014, the focus of dossier evaluation activities shifted to testing proposals from the 2013 registration deadline. The Agency concluded 239 examinations and took 129 decisions. In 112 cases, ECHA accepted the tests proposed by the registrants and in 16 cases, it modified at least one of the proposed tests. In one case, the testing proposal was rejected.
A total of 283 compliance check evaluations carried over from 2013 or opened during 2014, were concluded. Of these, 111 were concluded with no further action and 172 cases led to a draft decision, requesting more information from registrants. Due to the selection of dossiers with clear indications of potential non-compliance, this proportion is not a reliable indicator of the overall data quality of the whole registration database. Regarding compliance check cases at a decision-making phase, 132 were closed after the draft decision and for 273 dossiers, ECHA took decisions. Most of the information requests in draft or final decisions were related to exposure assessment and risk characterisation, substance identity, pre-natal developmental toxicity studies, sub-chronic toxicity studies and physicochemical properties.
ECHA conducted 282 follow-up evaluations, examining whether registrants had provided the information requested in ECHA's decisions. In 72% of the cases, the evaluation could be completed as the registrant had complied with the decision. The compliance rate has grown from 2013, when 64% of the registrants provided the information requested.
For 17 compliance checks and 27 testing proposal decisions, ECHA concluded that they were not properly implemented; the Member State authorities were invited to start enforcing these evaluation decisions. Therefore, 44 statements of non-compliance (SONC) were sent to registrants. For 30 cases, the information was provided after the involvement of the enforcement authorities in the Member States.
Progress was also made with substance evaluation process: ECHA published the first 26 decisions on substances for which evaluation started in 2012. The Agency also sent out draft decisions to registrants for commenting for 38 substances which had been evaluated by the Member States in 2013.
To achieve high quality of data-rich registration dossiers, ECHA developed a new compliance check strategy in 2014. The Agency focuses on checking the quality of hazard, use and exposure information for those higher-volume substances having the biggest potential impact on human health and the environment.
The report gives specific recommendations for both future registrants for the 2018 deadline and existing registrants who may need to update their dossiers. The recommendations cover the following subjects:
- The correct identity and composition of the substance is crucial;
- Report hazard information clearly;
- Adapt according to REACH rules;
- The chemical safety report should reflect realistic uses and conditions of use;
- Use ECHA's guidance and tools.