REACH registration dossiers still lack quality

26th May 2016

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Clare McMahon

A ignificant proportion' of registration dossiers provided by companies to meet European legislation on chemicals do not provide sufficiently detailed information, according to the body set up to regulate the regime.

The European Chemicals Agency (ECHA) published its second evaluation of the effectiveness of rules governing the use of chemicals in Europe today. Overall, it concluded that the REACH and the Classification, Labelling and Packaging (CLP) regulations have improved knowledge of chemical properties, leading to better management, safer products and to the phasing out of the most dangerous substances.

However, further progress is required, particularly concerning the quality of registration and classification data on chemicals submitted by companies, the ECHA said. The main weaknesses highlighted by the agency were: a lack of clarity about the identity of complex substances; poor justifications for using alternatives to animal testing; insufficient detailed information on the uses of and potential exposure of people to substances; and poor risk management (or mitigation) measures for each use.

One of the main aims of the regulations is to place the burden of proof that a substance is safe on the manufacturer rather than national authorities. However, the poor quality of some of the data from companies is undermining this aim, leaving it to authorities to show that a firm has not taken its responsibility to describe a substance and its effects clearly enough, the agency said.

When notified of the need to improve data to ensure compliance, the vast majority of companies do so, the ECHA noted. It said good quality data was necessary to ensure the safe use of chemicals by all firms in the supply chain, and that poor information made it difficult to choose safe substances.

Poor quality data also wastes the time and effort of the agency, member states and companies, since registration documents have to be examined and sent back for improvement.

The ECHA is concerned about the low level of awareness of REACH among smaller companies, which need to register substances sold in low volumes by 2018. The agency said it is working with member states to raise awareness among SMEs and provide tools to help them prepare dossiers.

The ECHA has asked the European Commission to clarify requirements on nanomaterials. At the moment, there is no explicit information in REACH about nanomaterials and many companies are holding back on providing data, it said.

The agency recommends a review of the CLP after noting that companies have been providing contradictory classifications for substances. It wants a requirement introduced to force companies to share data and agree on the classification to avoid confusing information being released.

Although the agency does not believe a review of the REACH is necessary, it says the regulation should be better integrated with the CLP, for example by making more use of the data generated to comply with other EU chemicals legislation. This would reduce unnecessary burdens on businesses and provide more clarity for consumers, the agency said.

It also wants to see a review of the legal requirements for substances of very high concern. The current rules are not working well, it said.

ECHA executive director Geert Dancet said that REACH and CLP are unequivocally leading to a safer Europe: ‘The recommendations [in the report] encourage all other actors in the process – industry associations, member states, the commission – to do their share so that we’ll have comprehensive and reliable data to identify chemicals of serious concern and adopt the most appropriate risk management measures.’


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