REACH AUTHORISATION PROCESS

Cefic claims that polymeric materials, reaction intermediates and substances used for R D should not be subject to the REACH evaluation and authorisation process being proposed by the European Commission in its White Paper on future chemicals policy, it is briefly reported. On specific issues, Cefic wants a risk-based approach to chemicals assessment and regulation realistic deadlines for the REACH process and exemption from REACH of finished articles, so that it applies only to substances marketed as substances or as constituents of a preparation. 

A wide range of stakeholders can contribute to the authorisation decision-making process by submitting comments to the European Chemicals Agency. Other than stating that substitution must be technically and economically feasible and reduce overall risks to human health and the environment, the text of REACH does not specify the details of how the authorisation process will work or what a substitution plan should contain such details have been left to the RIPs and the functioning of the Agency that must still be completed or formed, respectively. 

The research further concludes that chemical uses should be subject to a permitting mechanism at Member State rather than EU level when a political response to control occupational exposure in industrial settings is necessary at a national level. This follows the evidence from the interviews that indicate that serious political pressure at national levels may arise if certain chemicals are not included in an authorisation process (Section 5.3 - Box 5.1). Making these uses subject to Member State permitting-based schemes therefore enables national authorities to set the appropriate level of occupational health protection. While implementing measures relating to Article 138 of the EC Treaty is outside the immediate scope of REACH, it will ultimately affect decision-making. 

The chemical industry is facing a crisis in terms of its sustainability. Public trust in the industry needs to be restored in many EU countries and economic growth in the sector needs to be uncoupled from increased production volumes. REACH only begins to address these two issues. While REACH will generate information on chemical risks and will reset the frame of reference on what constitutes sufficient toxicological data for carrying out hazard assessments, it does not address how to control exposure levels. Apart from the authorisation process, REACH does not even propose specific mechanisms to control the increasing concentrations of synthetic chemicals in human blood and environmental media. 

Articles are only subject to limited requirements under REACH. In particular, registration requirements apply only if there is an intentional release of a substance from an article (such as a fragrance). The authorisation process also does not apply to articles. 

By comparison, according to the REACH legal text, proposals for substances subject to restrictions or authorisations would undergo separate processes and not include any specific mechanism to co-ordinate decision-making with other legislative frameworks. 

Information from socio-economic analyses can serve not only to select between alternative risk management measures in the decision-making matrix but can identify the relevant timelines for implementation (e.g., resulting from process change, product reformulation or instillation of pollution abatement technology). In the case of authorisation, REACH specifies that socio-economic data will form a key variable in the identification of suitable alternatives and the period for granting an authorisation before it needs to be reviewed. 

If, as a result of this process, an SVHC is included in the Authorisation List (and thus in Annex XIV of REACH), it cannot be placed on the market or used unless that use is exempted or the manufacturer or user applies for and receives authorisation for a specific use. As described in Article 55 of REACH ... 

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