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NGO scrutinises REACH substance evaluation failures

Organisation - EEB

Three quarters of the substances found to pose a serious risk to human health or environment under REACH are allowed on the European market without any regulatory action, according to a major NGO report.

Reviewing data from community rolling action plan (Corap) on substance evaluation, the report by the European Environmental Bureau (EEB) says concerns have been "demonstrated" for 34 substances on the list "but no actual regulatory follow-up has been initiated to control the risks".

In ten years of REACH, further risk management measures have been initiated for just 12 substances on the list, the EEB says. These include:

  • one restriction;
  • one SVHC identification; and
  • ten proposals for harmonised classification and labelling.

REACH substance evaluation is performed by member states and the Corap list currently features 352 chemicals they have prioritised for evaluation.

Once a substance is added to the list, however, it takes many years to conclude whether the risks are sufficiently controlled with existing measures or if further regulatory action is necessary, such as restriction or SVHC identification.

Evaluations have been completed for only 94 chemicals on the list, the EEB says, and for 46 of those the risks have been found not adequately controlled.

The report's other findings include:

  • 67 substances are still awaiting evaluation decision;
  • 126 out of 196 substances under evaluation (64%) lack the information needed to demonstrate safety; and
  • 102 substances for which evaluation has started are awaiting further information and follow-up evaluation.

The results also demonstrate the need to improve the interface between evaluation and follow-up risk management, the EEB adds.

Hélène Loonen, the report's main author, urged officials to "raise their game" on chemicals of concern. Protection, not assessment alone, is the main goal of REACH, she said, and "if a chemical substance is found to be unsafe, governments should act without delay".

Long process

The report also queries the long delays in the evaluation process, which leave potential concerns unresolved for many years.

It takes up to between seven and nine years, and sometimes even more, before a suspected concern is clarified under Corap, the EEB says. Add to that the development and implementation of risk management measures, and "it may take 12 to 16 years to regulate chemicals of concern".

Half of all scheduled evaluations were postponed over the last few years, and substances sometimes linger on the list for many years before evaluation can even begin, the report says. It makes several recommendations to accelerate the process, including:

  • avoid delays in Corap. Consider how to implement an integrated approach to accelerate evaluation and how Echa's proposal can be developed to integrate compliance check and substance evaluation;
  • respect legal timeframes stipulated by REACH. Ensure preparation of draft decision or conclusion of evaluation is completed within 12 months of publication of Corap. Start follow-up evaluation if requested information is not provided by legal deadline;
  • avoid delays in reaching conclusions due to requests for further testing. Ensure that all available information is used. It is important to use all weight of evidence and apply the precautionary principle; and
  • optimise the interplay between expert groups and the Member State Committee (MSC). Organise a workshop to align principles and optimise use of expert groups on persistent, bioaccumulative and toxic (PBT) chemicals and endocrine effects.

Improvement to evaluation procedures is one of the actions the European Commission has set out in its second REACH review.

The EEB report also reviews dossier evaluation under REACH, after Echa revealed last year that 70% of dossiers checked in the past ten years were non-compliant. The NGO calls for improved transparency on dossier registrations and decisions, and an increase in Echa's compliance check rate, which is currently set at 5%.

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