The chemicals industry and society are being damaged by the “very high level of uncertainty” brought about by REACH processes, the American Chamber of Commerce in Brussels (AmCham EU) says.
In its submission to the European Commission’s second REACH review, the organisation says despite efforts made by the EU executive, Echa and member states, the implementation of REACH processes “remains somewhat chaotic”. And, it adds, this can lead to inconsistencies or contradictions.
AmCham EU is one of several industry groups, NGOs and public sector bodies, to submit comments to the consultation. The review’s findings are due to be completed later this year.
“Given the number of different REACH processes and the plurality of actors involved in their implementation, it is sometimes difficult to understand which substances are targeted under which process and why,” AmCham EU says.
It is “particularly difficult”, it goes on, to see why the same substance would be targeted by different processes led by different member states. “We would encourage the Commission and Echa to clarify everyone’s obligations and rights.”
It adds that “significant improvements” are needed in predictability to support investment in existing and new substances.
And in its general comments on the REACH review, the American Chemistry Council (ACC) also calls for simplified and improved implementation. It notes that “a perceived lack” of robust evaluation of hazard data – rather than risk – leads to substances essential for health, such as Vitamin D, being identified as hazards.
AmCham EU says there is no mechanism to prevent two member states from running two risk management option analyses (RMOA) in parallel and reaching different conclusions. It recommends formalising the RMOA process through the use of guidance, or by developing a new REACH annex.
Both US bodies want improvements to guidance documents. The ACC says “more transparency” is needed and stakeholders should be given multiple opportunities to provide input into documents. AmCham EU says it is not clear whether industry comments are even considered in the final decisions.
The Commission and Echa should take on a more “”central role”in implementing REACH by consulting with registrants and other stakeholders for major substances, AmCham EU says.
It adds that it “deplores” significant regulations being advanced outside of REACH that “jeopardise the legitimacy of the entire REACH framework”, citing developments to the occupational safety and health (Osh) directive and Classification, Labelling and Packaging (CLP) Regulation.
Overlaps between REACH and other EU legislation, ACC says, often lead to “inconsistencies and deadlocks”, such as those between REACH and Osh. One example, AmCham EU says, is where Echa’s risk assessment committee (Rac) and DG Employment’s Scientific Committee on Occupational Exposure Limits (Scoel) “continuously apply different limit values” as their methodologies differ on the reprotoxic solvent 1-methyl-2-pyrrolidone (NMP).
Eye on enforcement
Compliance checks sometimes lead to “multi-year processes with no predictability of compliance”, AmCham EU says. REACH restrictions, if not enforced, are a “de facto competitive advantage” for non-compliant European and third-country industries, it adds.
For example, the restriction on polycyclic aromatic hydrocarbons (PAHs) has meant that tyre companies manufacturing in Europe, including US ones, have spent more than €100m on research, development and testing for compliance and alternatives assessment, it says.
Competent authorities must be constantly updated on the most recent interpretation of the Regulation and apply guidelines agreed at EU level, AmCham EU says. And better training of enforcement officials and greater coordination between different departments of national competent authorities is needed.