The European Commission has finally published its long-awaited REACH Review, including a raft of recommendations for improving implementation of the Regulation. While the review says that the use of chemicals in Europe has become safer since REACH came into force, it calls for adjustments and admits that more work is needed to protect human health and the environment. It stops short of proposing any major changes.
REACH “functions well and delivers on all objectives that at present can be assessed,” states the Review. “Some needs for adjustments have been identified, but balanced against the interest of ensuring legislative stability and predictability, the Commission concludes that changes to the enacting terms of REACH will not be proposed.” Instead, there are many opportunities for improving the functioning of REACH by “optimising” its implementation, states the EU executive.
The Review consists of a 13-page report fulfilling the Commission's obligation to assess various aspects of REACH and a 148-page Staff Working Document, split into three parts dealing with:
- the operation of REACH, from its scope and application, to registration, evaluation, authorisation and restrictions, information in the supply chain, downstream users, the role of ECHA and the competent authorities and enforcement;
- achieving REACH objectives, namely human health, and the single market, competitiveness and innovation; and
- CLP enforcement activities.
The need to reduce the administrative burden of REACH on SMEs is emphasised in an annex at the end of the report with the Commission setting out eight recommendations. These include a call for industry and ECHA to work together to provide targeted guidance for SMEs on; “transparency, non-discrimination and fair cost sharing” in Siefs; protecting intellectual property; the Use Descriptor System; and how REACH can be integrated early into R&D and innovation processes. The report also highlights ongoing work on the Fee Regulation (CW 23 January 2013), suggesting “further rebalancing the distribution of fees across various company size classes,” and says that the Commission will continue to monitor the situation for SMEs.
In general though, “industry seems able to absorb the additional costs [of REACH] with… no significant adverse effects on its overall competitiveness and with a general acceptance of the longer-term objectives,” states the report. Moreover, “there is no evidence available at this stage indicating sizeable shifts in terms of both imports and exports of chemicals as a result of REACH”. The Commission will continue to monitor the effect of REACH on innovation, in particular in new technological areas and will report by 1 January 2015.
Low tonnages and polymers
Likewise, the Commission says it currently has “insufficient information on the impact on innovation and competitiveness” to propose changes to the information requirements for substances produced in low tonnages, or to decide if certain types of polymers should be registered. It will “continue to work in these areas in co-operation with member states and other stakeholders and come forward with a proposal, if appropriate, by 1 January 2015”.
Health and environment
"Some progress" is being made in meeting the human health and environment objectives of REACH, says the report, but “a number of key shortcomings” are “hindering” the achievement of these goals. The EU executive therefore calls on industry to improve the quality of dossiers and says that “based on evidence gathered by ECHA relating to the identification of substances and determination of 'sameness', the Commission services will consider options to improve the situation, including legal measures”. Likewise, the report says that the “identification and phasing out of SVHCs as well as restrictions should… be encouraged.” It notes its work with EU member states and ECHA to develop a roadmap to assess and identify substances of very high concern (SVHC) aimed at ensuring that all relevant known SVHCs are placed on the candidate list by 2020 (CW 20 December 2012).
If REACH is to achieve its potential “a strong and harmonised approach towards enforcement… is vital,” insists the Commission, acknowledging that “a harmonised enforcement of REACH" across the EU continues to be a challenge. It calls for “more consistent and comparable data from member states on the implementation of REACH” to allow a “better overview and assessment of the actions to be taken”. Moreover, the Commission says it will develop "enforcement indicators" in liaison with the ECHA Enforcement Forum and will clarify the role of customs authorities in the enforcement of REACH. The report adds that the need for member states to improve their coordination of enforcement is also true for CLP.
As expected, the Commission also rules out any dramatic changes to the regulation of nanomaterials in the EU, simply noting that it will “make an impact assessment of relevant regulatory options, in particular possible amendments of REACH Annexes, to ensure further clarity on how nanomaterials are addressed and safety demonstrated in registration dossiers” (CW 31 January 2013). If appropriate the Commission will come forward with a draft implementing act by December 2013.
The report may now be discussed by Council and the European Parliament, and the EU executive will organise a conference on the REACH Review "in the coming months."