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Information on chemicals still has to improve


ECHA’s annual progress report on evaluation under REACH includes this time also a 10 years overview: safety information on chemicals is improving, but more still needs to be done.

Helsinki, 28 February 2018 - Since 2008, ECHA has checked the compliance of 1 952 registrations, most of them with suspected data gaps. In the vast majority of cases, important safety information on chemicals was missing – mostly related to pre-natal developmental toxicity, mutagenicity or genotoxicity, reproduction toxicity and long-term aquatic toxicity. Overall, ECHA has issued 2 586 information requests to registrants.

In 2017, ECHA checked the compliance of 222 registrations, most of them on substances of potential concern. In 151 cases, the Agency requested further information that is essential for demonstrating the safe use of the substance.

Bjorn Hansen, ECHA’s Executive Director says: “Evaluation activities play an important role in improving the safety of chemicals in Europe. We will continue our efforts to ensure that industry has the data they need to safely use their substances. This also improves safety for consumers. Industry needs to keep updating their dossiers, taking into account new information related to tonnages, uses, exposure and hazard information.”

Currently, ECHA carries out 300-350 follow-up evaluations each year to see whether registrants have provided the data required in the Agency’s decisions. By focusing on substances of potential concern, ECHA also considers the need for further risk management measures. Since 2013, based on dossier evaluation, ECHA has flagged 73 substances for potential harmonised classification.

Between 2012 and 2017, Member State authorities have evaluated 221 substances to clarify suspected concerns. For 159 substances, further information was requested from registrants. Overall, 74 substance evaluations have been concluded. In 43 % of the concluded cases, the national authorities considered further measures to manage the substances’ risks.

Besides the 10-year overview and the 2017 progress in evaluation activities, the report gives recommendations to registrants on how to improve and update their registration dossiers.

Key recommendations:

  • Update your dossier with relevant new information.
  • Justify and document your weight-of-evidence approach.
  • Provide robust grouping and read-across arguments.

Background information

Evaluation and ECHA’s integrated regulatory strategy

ECHA’s Integrated Regulatory Strategy was developed to meet the United Nations chemicals management goals set by the World Summit on Sustainable Development. The strategy brings all the REACH and CLP processes coherently together.

Dossier evaluation forms an essential part of the strategy. Under compliance check, priority is given to full registrations of chemicals produced in volumes over 100 tonnes per year and to substances with potential concern. In addition, a number of other measures support the compliance check and improve the overall quality of registration dossiers.

Member States and ECHA have developed a common screening process, which aims to identify the substances that have the greatest potential for negative impact on human health and the environment. Such substances are screened to see whether they should be subject to regulatory measures or whether substance evaluation would be effective to clarify the concerns.