Evaluation report 2015: checking for key data gaps on substances of potential concern
In 2015, ECHA focused its dossier evaluation activities on substances that matter the most for human health and the environment. In the majority of the cases, data on one or more key endpoints was missing to conclude whether the substance is of concern or not. ECHA encourages registrants to read and follow the recommendations of its report to improve their dossiers.
In 2015, ECHA followed its new compliance check strategy to prioritise and select substances that raise potential concern. The focus was on checking high-tonnage registration dossiers with human health and environmental data gaps and with a high potential for worker, consumer or environmental exposure.
Dossiers of 107 such substances were assessed, covering 853 (eco)toxicology endpoints. In 88 cases, relevant data was missing mostly due to poorly justified waiving of standard tests. For these, ECHA issued draft decisions requesting the registrants to provide the standard information or an adaptation complying with the requirements. Most of the requests were related to pre-natal developmental toxicity and mutagenicity endpoints.
Altogether, ECHA concluded 183 compliance check evaluations and took 144 compliance check decisions. To encourage registrants to update their dossiers in advance, the Agency started publishing a list of substances potentially subject to compliance check.
ECHA's Executive Director Geert Dancet says: "Our compliance check strategy targets the substances with the greatest impact on people and the environment. The checks have shown that crucial data is missing in many of the registrations we targeted. I encourage industry associations to motivate their members to fill the knowledge gaps in order not to delay the conclusion on whether their substances are of concern or not."
Regarding testing proposals, ECHA concluded the examination of 184 cases and took 194 decisions. To promote the use of alternative methods, ECHA started requesting and publishing the registrant's considerations on alternatives to their proposed vertebrate testing. This information is published as part of the public consultation on testing proposals.
A large majority of registrants comply with ECHA's decisions on compliance checks and testing proposals. The Agency conducted 300 follow-up evaluations in 2015, examining whether the registrants had provided the information requested in ECHA's decisions. In 86 % of the cases, the registrant had complied. In 44 cases, ECHA informed the Member State authorities to enable national enforcement actions.
In substance evaluation, Member States evaluated 50 substances in 2014 and concluded that 39 required further information from the registrants to clarify the suspected concerns. ECHA took 29 decisions based on earlier rounds of substance evaluation.
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 topics:
- Testing on animals must only be undertaken as a last resort.
- Familiarity with the read-across assessment framework (RAAF) is essential for building a successful read-across case.
- Maintain efficient communication and planning throughout the substance evaluation process.
- Accurate substance identification is vital.
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