REACH out and touch base—revaluating the EU legislative framework for chemicals

Nov 21, 2016 | Purpose Built (LexisNexis)

39499782 - chemistry laboratory concept. laboratory chemical test tubes and objects on the table with chemistry draw on whiteboard.The European Commission is conducting an evaluation of Regulation (EC) 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), ie the main EU law on chemicals. How will the European Commission’s Regulatory Fitness and Performance Programme (REFIT) revaluation impact on the chemicals regime in the EU?
 Caroline May, head of safety and environment and Emilia Richards, associate, at Norton Rose, explain the background, and say the 2017 REACH review and the chemicals fitness check will assess the relevance, coherence, effectiveness and efficiency of the EU legislative framework on chemicals.

What is the background to the review?

REACH came into force in June 2007, consolidating in excess of 40 regulations which previously formed the EU chemicals regime. REACH places obligations on Member States, manufacturers, importers, suppliers and downstream users to ensure that only
safe chemical substances are marketed in the EU.The REACH REFIT Evaluation 2017 (the 2017 Review) is being carried out as part of the European Commission’s obligation under REACH, art 117(4) to report on the functioning of REACH every five
years. The 2017 Review must cover the following compulsory evaluation criteria:
  • effectiveness
  • efficiency
  • relevance
  • coherence, and
  • EU added value

What were the findings of the first REACH Review in 2013, and what key developments have there been since then?

The findings of the first REACH Review in 2013 (the 2013 Review) were largely positive. The review noted that ‘five years after the entry into force of REACH, it is still too early to quantify the benefits’. However, overall, the Commission
concluded that REACH was functioning well and was delivering ‘on all objectives that at present can be assessed’. Although there were some ‘needs for adjustment’ identified, the Commission concluded that it was not necessary
to enact any changes to the terms of REACH.These ‘needs for adjustment’ were as follows:

 

  • the European Chemical Agency (ECHA) reported that a high number of registration dossiers were non-compliant, particularly regarding substance identity
  • ECHA also reported that insufficient assessments of certain substances (in particular, those with persistent, bioaccumulative and toxic and very persistent and very bioaccumulative properties) were being carried out by registrants, and
  • issues surrounding the content and form of extended safety data sheets, as reported by industry

A number of issues have emerged since the 2013 Review, which will be examined as part of the 2017 Review. These include:

  • the impact of REACH on small and medium-sized enterprises (SMEs)—this will be addressed and any residual unnecessary administrative burdens identified
  • since 2013, the knowledge base on chemicals has evolved significantly—the 2017 Review will assess whether REACH is fit to tackle new chemical issues such as nanomaterials, cumulative effects andendocrine disruptors
  • the 2017 Review will also consider the need (if any) to register types of polymers, and
  • concerns regarding the implementation of requirements set out in the extended safety data sheets

What sources will be drawn on for the review?

According to the European Commission, a ‘broad range of information sources’ will be used for the 2017 Review, in particular reports and studies prepared by Member States, ECHA, the Commission and external consultants. There will also
be a stakeholder consultation (see below).Some of the reports and studies that will be used are set out in the European Commission’s REACH REFIT 2017 Roadmap. These include (but are not limited to) the following:

 

  • the report prepared following the first REACH Review in 2013
  • a report prepared by ECHA regarding the use of non-animal testing methods for the purposes of REACH
  • reports prepared by Member States and ECHA regarding the operation of REACH, in particular its evaluation and enforcement
  • reports prepared in relation to a range of technical matters including substances of very high concern (SVHCs), registration requirements for low tonnage and registration requirements for polymers
  • studies prepared in relation to enforcement, and
  • reports prepared in relation to the impact of REACH and other chemicals legislation on human health, the environment and occupational health and safety

What consultation is planned as part of the review?

In terms of process, a public consultation is now running from 28 October 2016 to 28 January 2017. In particular, the consultation focusses on the effectiveness of REACH (ie the extent to which its objectives are being met), the efficiency of REACH
(the costs and benefits of implementing REACH), the extent to which REACH is consistent with current needs, and its coherence.

 

How does the review tie in with the fitness check on the most relevant chemicals legislation, excluding REACH which is happening in parallel?

As noted above, some of the studies that will be taken into account as part of the REACH Review 2017 are related to the current review of chemicals legislation (the chemicals fitness check). The chemicals fitness check will be participated in by the
Directorate-General for the Environment, the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. As with the REACH Review 2017, the chemicals fitness check will assess the relevance, coherence, effectiveness, efficiency
and EU added value of the EU legislative framework on chemicals. A public consultation was also carried out in earlier 2016 (which was open until 27 May 2016).Interviewed by Nicola Laver. The views expressed by our Legal Analysis interviewees are not necessarily those of the proprietor.

 

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Source: LexisNexis Purpose Built
REACH out and touch base—revaluating the EU legislative framework for chemicals