Arguments and Positions
Arguments and Positions
With the entry into force of the chemicals regulation REACH, the European chemicals policy was restructured and harmonised in 2007. The complex requirements are to be implemented stepwise by 2020 and beyond. Building blocks of REACH are the registration, evaluation, authorisation and restriction of chemicals as well as the communication along the supply chain on the safe use of substances and mixtures.
Build-up work performed and important milestones of REACH achieved
Implementing REACH, the chemical companies did much build-up work in the initial two registration phases to end November 2010 and May 2013. They submitted their substance registrations in due course to the European Chemicals Agency (ECHA). From the start in June 2008 to mid-September 2017, ECHA received ca. 53,000 registration dossiers for roughly 11,600 substances. In many cases, German companies had a lead role.
3rd registration phase to 31 May 2018
REACH still gives no pause to chemical companies. Now the companies are working on their registrations for the 3rd phase; by 31 May 2018 they need to register with ECHA the substances manufactured or imported in volumes from 1 to 100 tonnes per year. Frequently, these are cost-sensitive substances and specialty chemicals.
Preserve competitiveness under REACH
REACH registrations have improved the data situation for many substances. Already now, studies show the positive effects on the protection of humans and environment. Considerable registration costs and personnel expenses have arisen for the companies; they might be faced with additional costs, inter alia, through furthergoing information requirements within the evaluation procedure. It is too early to assess whether the competitiveness and the innovation capability of the chemical and pharma industry still can be preserved or will be impaired under REACH. This can only be evaluated after the end of the 3rd registration phase, from mid-2018 at the earliest.
Prevent uncertainties and burdens because of the REACH authorisation procedure
The authorities are identifying more and more substances important to the chemical industry (e.g. solvents and catalysts) as candidates for the authorisation procedure. The authorisation requirement brings increases in costs and competitive disadvantages for products manufactured in the EU. The review of granted authorisations impairs the legal and planning certainty for investments. This can cause a withdrawal of substances and impact entire value chains.
- Support SMEs in REACH registrations and in supply chain communication
Small and medium-sized chemical enterprises need to have direct contact persons at ECHA. Moreover, simplified forms of support and dossier submission options – tailored to their needs – are called for, in particular for registrations. The requirements for the preparation of safety data sheets must be such that they can be implemented by the users of the chemicals.
- No changes to the text of the Regulation - benefit from lessons learned
With a view to increasing the efficiency of REACH processes, lessons should be learned from the gained experiences. Therefore, the Commission's conclusion from 2013 continues to fully apply that industry and public authorities primarily need a stable regulatory environment for further REACH implementation. Industry is doing whatever it can to meet its obligations under REACH in due course. This must not be rendered even more difficult by new, additional requirements to content and formal framework.
- Before including substances in the candidate list: check alternatives together with industry
According to the roadmap for identifying substances of very high concern (SVHCs), authorities are to include by 2020 all relevant SVHCs in the candidate list for the authorisation procedure. Strict scientific criteria should apply in this process. For each individual substance an analysis of the most suitable risk management options should be mandatory for the authorities, involving the impacted industry.
As intended under REACH, exemptions should be granted for already specifically regulated uses. Authorisation applications should be simplified overall and i.a. for small volumes. Deadlines for reviews by the authorities should adequately take into account the investment cycles.