been updated. The proposals also introduce the need for polymer notification and endocrine disruptor data.
There are strong indications of a shift towards increased use of broad restrictions to actively manage the risks associated with chemical use too, prioritising action based on non-essential use. For instance, REACH is widely expected to include tighter restrictions on per- and polyfluoroalkyl substances( PFAS). The second draft of the PFAS restriction proposal may provide important signals in that respect.
So, what do these proposals mean for fine and speciality chemicals? And how can companies that manufacture or import them anticipate and manage the risks and opportunities, and get ahead of the curve?
Ten-year registration expiry
Companies already have a legal obligation to ensure REACH registration dossiers filed with ECHA are complete, accurate and kept updated. For example, a registration must be updated if the annual volume of a chemical substance manufactured or imported crosses into a higher tonnage band. The same is true for other changes in status, such as modification of substance composition or new uses, risks or classification.
Under the proposals, ECHA will be able to revoke a company’ s registration if no updates have been made after ten years, or if the dossier fails an ad hoc technical completeness check( TCC). This would not change existing obligations for the registration of chemicals. However, it would function as a soft enforcement mechanism with hard consequences, pushing companies towards more proactive, continuous dossier management.
Companies that have not updated dossiers since registration will find themselves in hot water if this comes into effect. While the finer details of the draft legislation may include some exclusions or a phased entry, it is a good idea to take stock and review existing dossiers submitted to ECHA now. As well as updating any changes in status, check that information meets ECHA’ s current requirements for a successful submission, which are frequently amended.
Take substance use as an example. Registrants must include every use supported in their supply chain within a registration. During the first wave of REACH registrations in 2010, companies often erred on the side of caution. Many indicated a broad set of uses, which may no longer be supported as originally described and could possibly alert regulatory action.
Now, the concept of use and the way it is described in registrations is much more refined and accuracy is expected. It is important to consider use categories carefully and provide detailed, accurate and relevant use descriptions drawing on the use maps and scenarios developed by and for specific industry sectors. It may be advantageous to clearly indicate‘ advised against’ uses too.
Risk assessment methods have also evolved since 2010. So, chemical safety reports that have not been updated for some time probably need an overhaul.
Figure 2 – Shifting balance of responsibility in REACH revisions
Industry
Workload: Moderate and often challenging
Compliance with ongoing obligations and requests, managing new regulatory risk management measures
Workload: increased and expanded
New obligations, regular updates, pre-empting and adapting to new and updated obligations quickly, policy development
Before REACH revision After REACH revision
ECHA / Commission
Workload: Moderate but overwhelmed
Evaluation, detailed restrictions, processing applications for authorisations
Workload: Moderate but shifted
Rapid implementation of new, broad obligations, more frequent updates
36 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981