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16 December 2016

REACH: an unsatisfactory authorisation system

If they are to use substances ‘of very high concern’, for instance because they cause cancer, manufacturers must first obtain authorisations, in accordance with the REACH Regulation on the trade in chemical substances in the European Union. According to Tony Musu, an expert in chemical hazards at the ETUI, some application files for authorisation examined by the European Chemicals Agency (ECHA) do not meet the legislative requirements.

‘There is a real problem in terms of the quality of the data provided by manufacturers, in particular with regard to the scope of the intended use and the current alternatives on the market,’ Mr Musu explained at a trade union meeting on 2 December 2016 in Namur, Belgium.

Notwithstanding the dubious quality of some application files for authorisation, he stated that the European Commission had thus far never refused to grant authorisation. The cost of lodging an application for authorisation with the ECHA was at least EUR 50 000. ‘The Commission doubtlessly feels that, if manufacturers are willing to pay such amounts, then they must absolutely need the substances in question, and so it believes that it must grant them their authorisation,’ Mr Musu explains, adding, however, that where the application file is poor quality, authorisation is granted for a relatively short period only.

Mr Musu, the ETUI’s expert representing the European Trade Union Confederation in various ECHA advisory bodies, nonetheless defends the REACH Regulation, which undoubtedly acts as a deterrent. He points out that ‘Manufacturers have a real fear of one of the substances they use being included in the candidate list for authorisation, as this can damage their image. So, the authorisation stage of REACH absolutely encourages the industry to embark on the path of substituting the most problematic substances with safer alternatives.’

He still considers it necessary to explore new avenues for improving the effectiveness of the REACH authorisation system, inasmuch as he favours increasing the number of substances identified as being ‘of very high concern’ on the candidate list and calls for a ‘culture change’ within the ECHA, an organisation that, to his mind, has become ‘too friendly’ towards the industry.

The crucial issue: access to data

Martin Pigeon, a representative of Corporate Europe Observatory, an NGO which studies the influence that corporate lobby groups bring to bear on the European institutions, also questions the quality of the data supplied by the industry. His organisation demands that civil society be given access to this data in its entirety. The NGO’s position is that the industry can all too easily invoke the confidentiality of industrial information whenever it seeks to avoid disclosing sensitive toxicology data.

In this connection, Mr Pigeon cited the judgment delivered on 23 November 2016 by the Court of Justice of the European Union (CJEU) in which it held that the confidentiality of commercial and industrial information may not be invoked to preclude the disclosure of information relating to emissions into the environment.

The judgment makes clear the concept of ‘emissions into the environment’ set out in a 2003 directive.* The CJEU held that the concept includes the release into the environment of products or substances, such as plant protection products or biocides or active substances contained in those products.

Corporate Europe Observatory will certainly have recourse to that judgment for the purpose of improving public access to information on pesticides and their effects on the environment.

Here the NGO has just scored a new victory by finally obtaining from the European Food Safety Authority (EFSA) the raw data from three major scientific studies used by the authority for its controversial evaluation of November 2015. Contrary to the view adopted by the WHO, the authority concluded in its report that the well-known herbicide glyphosate was ‘unlikely’ to pose a carcinogenic hazard to humans. The NGO sent the data for analysis by scientists entirely unconnected with the competitors of the companies that own the data.

* Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information.

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