Chemical safety: uncovering challenges for manufacturers and downstream users

A quick look at the chemical safety regulatory landscape within the EU

The chemicals market is global with complex supply chains across different regulatory jurisdictions and has never been more strictly regulated than now. Chemicals can only be regulated when their inherent properties are communicated to supply chain actors, authorities and the public.

Within the EU, the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation stands at the forefront of chemical safety regulations. It dictates the communication requirements between actors in the chemicals supply chain and seeks to ensure that all actors from manufactures to consumers are protected and well-informed about chemical hazards and risks. Other key EU chemical regulations include the Regulation on classification, labelling and packaging of substances and mixtures (CLP).

Despite all the best intentions behind regulatory initiatives, each information exchange between supply chain actors still poses the risk of information gaps and misinformation spreading through the remaining parts of the supply chain.

Chemical safety challenges faced by manufactures

Manufacturers of chemical substances play a pivotal role in the chemical supply chain by ensuring quality, safety and regulatory compliance. However, they encounter several challenges that complicate their responsibilities.

Effective communication between manufacturers and DUs regarding chemical uses and safe handling is a significant challenge. Complex supply chains mean manufacturers often rely on DUs for detailed use information. When this information is lacking, manufacturers must make assumptions, leading to generic use details that may not cover actual conditions or in some cases, certain uses being excluded from assessments.

Navigating multiple regulations and differing substance hazard information is yet another challenge for manufacturers. Chemical substances may be subject to various legislation based on their use, necessitating multiple risk and hazard assessments which can lead to conflicting conclusions, complicating comprehensive safety assessments.

Chemical safety challenges faced by DUs – and what they can do about it

DUs, including re-fillers, formulators and article produces, play a pivotal role in the chemical supply chain by utilising and placing substances or mixtures on the market. Despite their critical function, they face numerous challenges in ensuring chemical safety.

Under the REACH Regulation, DUs are required to provide information up the supply chain, which often turns out to be a significant challenge. DUs are often part of complex supply chains involving multiple regional and international suppliers; tracing the origin of chemicals can therefore be a difficult and time-consuming task.

Furthermore, formulators, producers of articles, and DUs that supply directly to end-users all face unique challenges. Formulators for instance face unique challenges because they are producing mixtures. Most regulations focus on single substances and ignore combined effects. Under EU REACH, formulators must pass safe use information down the supply chain, but compiling data from individual substances often leads to irrelevant and differing operational conditions (OCs) and risk management measures (RMMs).

Producers of articles face specific challenges in chemical safety due to their use of regulated substances in product manufacturing. When substances are incorporated into articles, the regulatory focus shifts from chemical regulations like REACH to product-specific regulations, such as for electronics, toys, textiles, and medical devices. Despite this shift, producers must still register or notify authorities about certain substances and inform customers, which can be overwhelming.

Finally, DUs supplying to end-users face challenges in transparency and traceability of chemicals in mixtures and articles. They rely on supplier information to comply with regulations and assess risks, but there's no obligation for full chemical disclosure. Formulators are reluctant to share detailed data due to competitive concerns, while public and customer demands for transparency grow. Despite regulatory and customer pressure, many DUs receive incomplete data, complicating compliance and safety efforts.

How Ramboll can help you comply with REACH regulation

The EU is collaborating intensely with relevant partners to address the challenges faced by various actors in the chemical supply chain, aiming to improve overall chemical safety and ultimately safeguard public health and the environment.

Ramboll’s chemical experts closely monitor regulatory developments within the EU, assisting chemical manufacturers and DUs in tackling challenges related to quality, safety, and regulatory compliance. Our experts work globally, helping clients navigate and comply with REACH regulations. Offering services from strategic advice and planning to technical analysis, support, and troubleshooting, they provide comprehensive REACH regulation compliance solutions tailored to meet clients’ specific needs.