REGULATION & COMPLIANCE
UK, pushing back and slowing the process down so that the hazards can be scrutinised appropriately and the relevant scientific data gathered. So far, no other country has chosen to follow the EU in this regard, instead stating that they will wait and take guidance from the GHS once a consensus is reached.
Industry has also been sceptical of the move, as the current test methodology for detecting some of these substances is technically challenging and less robust than for existing hazards. There is also some debate as to whether EDs are not already suitably covered by hazards already present that are easier to quantify, such as reproductive toxin and carcinogenicity. On top of this additional testing to prove the new endpoints will also come with associated costs.
REFIT reassessment
In September 2024, the EU commissioned the Draghi Report, which concluded that“ overregulation is seen by more than 60 % of EU companies as an obstacle to investment, with 55 % of SMEs naming regulatory obstacles and the administrative burden as their greatest challenge”. Given the already difficult economic climate in Europe, this represents a significant cost being paid by industry.
The report triggered the Regulatory Fitness & Performance Programme
( REFIT), which is assessing various aspects of CLP, the Cosmetics Regulation and the Fertiliser Regulation. The focus of these assessments is to identify areas where the regulations could benefit from streamlining and modernisation, making them more efficient and cost-effective for industry while still ensuring a high level of protection for human and environmental health.
Many of the proposed changes to CLP centre around the legislation released in November 2024( 2024 / 2865), which introduced, amongst other provisions, new labelling and advertising requirements. These updates include rules regarding font size, line spacing and other typographic criteria based on packaging volume, as well as additional requirements for advertisement wording and digital labels.
Whilst certain areas of the regulation, particularly those concerning the introduction of new hazard classes, are to remain in place, many provisions within this update were identified as areas of concern by industry during the REFIT programme. Therefore, Omnibus VI has proposed two new regulations: an initial‘ stop the clock’ measure that delays the implementation of the labelling provisions by two years to January 2028, and a second, more detailed regulation to remove some of the more cost-prohibitive requirements.
Outlook
Until recently, the EU was seen as the gold standard in chemical legislation. Many countries adopted REACHlike systems to monitor substances used and placed on the market, and the EU led the way in the global implementation of GHS revisions. However, cracks in the system are beginning to show.
With growing economic pressures, the cost of extensive regulation is forcing both industry and other global players to rethink their position. Whether through challenges to existing legislation or countries refusing to blindly adopt whatever the EU deems correct, ECHA and the EC are no longer enjoying the free rein they once had.
Whilst their goals of maintaining high levels of human and environmental health by monitoring, classifying and restricting chemicals remain commendable, their ability to achieve this while ensuring economic viability is increasingly under question. With industry struggling more than ever, regulators must now strike an even finer balance before there is no chemical industry left to regulate. ●
Eleanor Grimes
REGULATORY AFFAIRS SPECIALIST
LISAM SYSTEMS k J j eleanor. grimes @ lisam. com www. lisam. com Pics: ad hoc, no captions
54 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981