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 far 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.
Important milestones achieved
Implementing REACH, the chemical companies did much build-up work in the three registration phases to end November 2010, May 2013 and May 2018. They submitted their substance registrations in due course to the European Chemicals Agency (ECHA). So far, ECHA has received almost 89,000 registrations for more than 21,000 substances. In many cases, German companies had a lead role. The impacts of the last registration phase on cost-sensitive substances and specialty chemicals are gradually emerging.
Shift in the work focuses
REACH has no expiry date, and the workload remains high. Now, the work focuses in REACH implementation are shifting from registration to dossier updates, evaluation, authorisation/restriction and work on the extended safety data sheet.
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. However, 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. Whether the competitiveness and innovation capability of the chemical and pharma industry can be preserved or will be impaired under REACH can be assessed, at the earliest, in the Commission's next REACH report 2022.
Prevent uncertainties and burdens
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 uncertainties in planning, 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 affect entire value chains.
- No changes to the text of the Regulation - benefit from lessons learned
In its general report on REACH of March 2018, the Commission notes that REACH is and remains well-suited for achieving the protection goals of the REACH Regulation. Therefore, the Commission sees no need to change the enacting terms of REACH. Basically, this creates stable framework conditions that are needed for further implementation. Now, the public authorities and industry should make use of lessons learned and work to enhance reliable planning and efficiency of the REACH processes and also to simplify them.
- Support SMEs in further REACH implementation
Especially small and medium-sized chemical enterprises need simplifications in the evaluation procedure and practice-oriented solutions for the preparation of safety data sheets. Furthermore, direct contact persons at the European Chemicals Agency (ECHA) and simplified forms of support and dossier submission options - tailored to the needs of SMEs - are called for.
- Before including substances in the candidate list: check alternatives together with industry
By 2022, the authorities want to include all relevant SVHCs in the REACH candidate list for the authorisation procedure or in other regulatory procedures. 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. This should be implemented consistently and involve the impacted industry. As intended under REACH, exemptions should be granted for already specifically regulated uses. Authorisation applications should be simplified overall and, inter alia, for small volumes.