Areas of Dispute within the REACH Proposal
One Substance, One Registration (OSOR)
This proposal, from the UK and Hungarian governments, was extensively debated among member state experts in the Ad Hoc Working Group. It would have the effect of forcing registrants to share all hazard data on their chemicals (not just data from tests on vertebrate animals), and oblige them to agree a core set of hazard data for registration. The goal of this proposal is to avoid multiple registrations of the same substance, thus simplifying the registration process and reducing the cost.
Changes to Prioritization in Registration
Registration was prioritized by tonnage produced or imported and by certain properties - CMRs. There was much discussion on whether it is feasible to further prioritize, while trying to avoid the outcome of rewarding those chemicals with less safety data. A potential option from the Council debate was to accelerate registration for substances with vPvB and PBT properties. The chemical industry (CEFIC and VCI) called for a system that will reduce the amount of data they must submit on registration, though their suggested option has been criticized in analyses by both the German and Swedish Governments. It was also noted (e.g., by WWF, pages 49-50) that the industry proposals tended to result in a substantial reduction in producer responsibility.
Changes to Data Requirements in Registration
The chemical industry pushed for reduced data requirements in registration, in particular for low volume substances. This approach was echoed in a proposal from Malta and Slovenia, but has been strongly criticized by other stakeholders, with NGOs producing a response. In addition, Unions and Environmental NGOs have criticized the REACH proposal for note requiring sufficient safety data for those chemicals produced or imported at 1-10 tpa.
An Increased Role for the Agency in Evaluation
There was some discussion, led by France in Council, on whether the Agency should have a greater role in evaluation. However, it was also clear that Member States wish to retain their expertise on chemicals (not least to be able to enforce the system).
Changes to the Way Chemicals in Articles are Dealt With
Many parties were unhappy with the way substances in articles are dealt with in the REACH system, in particular two issues: (i) The procedure for dealing with unregistered chemicals entering the EU in imported articles; and (ii) Lack of information flow about chemicals in the article supply chain. Options for the former range widely from removing the current procedure to strengthening it. For the latter, there is some focus on labeling of articles containing chemicals of very high concern, and on creating a “Right to Know” within the article supply chain, for example see the Swedish Government proposals.
Increased Focus on Substitution in Authorisation
A number of stakeholders, including NGOs and some governments (see statement produced for Environment Council in June 2004), supported a strengthening of the role of substitution in authorisation. Most NGO groups were calling for a system which would allow the regulator to consider availability of substitutes and socioeconomic justification when considering all applications for authorisation, rather than just those which are not considered ‘adequately controlled.’
More Flexibility in the Scope of Authorisation
Many NGOs wished to remove the requirement for substances of equivalent concern to be “identified as causing serious and irreversible effects to humans or the environment,” arguing that this was too high a burden of proof (e.g., see WWF Policy paper)
More Limited Scope for Authorisation
Other stakeholders, such as the European Chemical Industry Association, CEFIC, were less convinced by Authorisation, and had argued that it was overly bureaucratic, and should be limited to CMRs, and not cover vPvBs and PBTs and substances of equivalent concern.
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