Hazardous Substances Evaluation report 2015: checking for key data gaps on substances of potential concern

In 2015, the European Chemicals Agency (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.

More info - Source: European Chemicals Agency