EU Regulatory Bulletin contents
Fieldfisher wins three EU contracts for the drafting of BPR guidance
ECHA is consulting internally on guidance on Article 95 list of the BPR
Fieldfisher expresses a strong opinion on Article 58 (2) of REACH
ECHA publishes guidance on chemical safety assessment
- ECHA publishes REACH and BPR data-sharing dispute decisions
On 15 September 2014, Chemical Watch published an interview with Partner Claudio Mereu, who was a speaker during the Informa Chemical conference in Barcelona on 9 September. The interview entitled ''ECHA's assessment of regulated substances superficial'' was reported by the media as follows.
''ECHA is not fully assessing the legislation already in place for substances recommended to the authorisation list (Annex XIV), says Claudio Mereu, partner of law firm Field Fisher Waterhouse.
Speaking at last week’s Informa EU chemical regulation conference in Barcelona, Mr Mereu said that based on prior decisions, an agency assessment is currently a "mere, superficial desk check" of the community legislation in place, rather than its actual application in practice. Under Article 58(2) of REACH, the agency is required to consider community legislation relevant to a substance proposed for Annex XIV.
Mr. Mereu called for the issue of ECHA's assessment under Article 58(2) to be raised at a political level. "ECHA has issued some guidelines and they use their discretion to diminish the impact of Article 58(2) thereby placing limits." He added that the agency should not limit that assessment to a “simple superficial verification” of the law.
“They should go into the detail, because how can one judge the appropriateness of those measures from a theoretical piece of paper only? One has to dig deeper and look at the implementation of those community measures in the member states, and the reports that are available,” he said.
The EU lead industry recently spoke out against ECHA's recommendation to add seven lead substances to Annex XIV, due to existing EU legislation already covering workplace exposure. Mr Mereu says that if ECHA carries out a more detailed assessment of the measures in place it would possibly exempt these lead components under Article 58(2). “If this happens, it could be a first precedent on this point,” he said.
In response, ECHA said that before finalising its recommendation to the Commission, it is required to take into account the opinion of the Member State Committee as well as comments from interested parties. In particular, comments on uses of a substance which should be exempt from the authorisation requirement, it added.
The agency said it analyses in detail relevant EU legislation to determine whether the human health and environmental risks relating to the use of a substance is already properly regulated under other EU legislation. It also explained that it is the European Commission's decision whether or not to include a substance in Annex XIV and to specify whether any uses can be exempted from the authorisation requirement pursuant to Article 58(2).
The issue is currently being tested in court, where a large number of chromium trioxide producers are taking legal action against the European Commission, regarding its decision to add the substance to the REACH authorisation list.''
Sign up to our email digest