The European Commission published two evaluation and fitness check roadmaps in May this year. These roadmaps will assist the Commission in assessing whether the current legislative framework for chemicals, including REACH, is fit-for-purpose and delivers as expected.
Together with the ongoing evaluation of 24 EU Directives in the area of health and safety at work, the roadmaps will not only serve as evidence for the chemicals stock-taking report referenced in the 2014 Regulatory Fitness and Performance Programme (REFIT) but, more generally, for developing the non-toxic environment strategy as required by the 7th Environment Action Programme by 2018.
Fitness check of chemicals legislation
The first roadmap concerns a fitness check of current chemicals legislation, as well as related aspects of legislation applied to downstream industries. It does not cover REACH, except for the criteria for identifying a phase-out substance.
The legislative framework for chemicals comprises legislation directly regulating chemical substances and mixtures, as well as legislation regulating conditions under which chemicals are manufactured, treated or used (such as occupational health and safety or environmental legislation), or regulating products in which chemicals are used.
The fitness check will assess the overall effectiveness, efficiency, relevance, coherence, and EU added-value of this legislative framework, and identify possible excessive regulatory burdens, overlaps, inconsistencies, obsolete measures and gaps.
The results of this fitness check, together with the forthcoming 2017 REACH Report and the studies listed in the roadmap, is expected to provide an overall picture of the current standing of EU chemicals legislation.
The fitness check is expected to be completed at the end of 2017 and is supported by a consultation strategy, which includes a public consultation launched in March 2016 (ending 27 May 2016).
The second roadmap concerns the REFIT evaluation, which is being carried out in accordance with Article 117(4) of the REACH Regulation, which stipulates that the Commission is to report on the implementation of REACH by 1 June 2017. Such reports are to be carried out every five years by member states, European Chemicals Agency (ECHA) and the Commission in order to monitor progress in the achievement of the objectives of the REACH regulation.
The REFIT evaluation covers the same evaluation criteria as the fitness check and emphasises the potential for burden reduction and simplification. The evaluation will assess the impact of REACH requirements on stakeholders, in particular SMEs, and seek to identify any unnecessary administrative burdens. The evaluation will also determine whether REACH is fit to tackle evolving issues such as nanomaterials, cumulative effects, endocrine disruptors and other emerging issues.
A public consultation on REACH is planned to take place in Q2/Q3 2016 in order for collaborative conclusions to be presented as part of the 2017 Report.
In addition, ECHA published guidance in May 2016 to assist manufacturers and importers of smaller quantities of substances with simplified registration requirements under the EU REACH chemicals regime. REACH allows manufacturers and importers of smaller quantities (one to ten tonnes per year) to provide less information when they register their substances, if none of the hazard criteria in Annex III of the REACH Regulation apply to the relevant substance(s).
As part of the guidance, ECHA has published an inventory of substances that are likely to fulfil the hazardous criteria. The criteria covers substances that are carcinogenic, mutagenic or toxic to reproduction, persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), or classified as hazardous for human health, or as an environmental hazard under the Classification, Labelling and Packaging Regulation.
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