How to de-risk chemical regulations, the smart way

It’s easier to navigate regulatory complexity, maximise resilience, and embrace new commercial opportunities when you have seamless access to specialist expertise.

1. Go beyond ‘checklist compliance’ for deeper insight and assurance

Mandatory requirements for chemical compliance are just the baseline of regulatory management. It’s important to go further than this, considering developments on the horizon and identifying those that may have business repercussions. This helps to future proof your products and maintain a competitive edge.

Emerging regulation and policy are often a focal point for corporate regulatory support. Take the ongoing evolution of EU and UK regulations for Classification, Labelling, and Packaging (CLP) and Registration, Evaluation, and Authorization, and Restriction of Chemicals (REACH). Developments can have major implications for product marketing as well as data and documentation requirements. Regulatory activity can also have consequences for product reputation and market acceptance. Anticipating what forthcoming changes are likely to mean in practice facilitates a well-planned strategic response.

The potential impact of new data requirements and approaches for substance classification, grouping, and risk management under frameworks such as REACH and the US Toxic Substances Control Act (TSCA) is another priority area. These developments increase the risk of regulators taking the most conservative approach for a given substance, with potentially serious implications for business. Partnering with scientists who understand the chemistry of specific substances and the relevant toxicity and eco-toxicity endpoints is highly beneficial here. They can unpick and make sense of complicated data sets, facilitating robust, risk-based outcomes.

2. Navigate regulatory complexity to determine the best way forward

Regulatory requirements for chemicals are not always clear-cut. Ambiguous or grey areas can make it difficult to fully understand obligations. In some cases, it can be hard to determine which regulatory frameworks apply to a given substance, formulation or product, especially when they are used in multiple applications.

A corporate support partner helps navigate this complexity, bringing specialist expertise, insights, and experience to the table. For instance, TSG’s consultants include previous assessors for authorities including the European Chemicals Agency (ECHA) and the UK’s Health and Safety Executive (HSE). This enables them to interpret regulatory documentation and anticipate how authorities around the world might respond in given circumstances. A partner can also liaise with authorities on your behalf – anonymously if required – to clarify specific points.

In situations where a statement of non-compliance or an enforcement notice has been received, corporate support is invaluable. The ability to quickly deploy an expert partner with existing knowledge of the business and deep understanding of its chemical formulations can enable rapid resolution. Firstly, direct engagement with the relevant authority ascertains the nature of the problem. This is followed with rapid development of an effective plan for compliance or corrective actions to prevent escalation and minimise harm to the business. Understanding national and local nuance and processes can help resolve these matters effectively.

3. Access specialist insights to maximise commercial opportunities

When market expansion or business growth is on the cards, early and frequent regulatory guidance is invaluable. Direct access to a corporate support partner facilitates timely insights which accelerate progress, reduce risk, and maximise commercial returns.

Take the global market scaling of a formulated product such as an insect repellent or contact lens cleaner. Premarket assessment may reveal multiple markets with similar stipulations. Understanding the requirements of different markets, and prioritising those with close regulatory alignment, usually results in quicker, more cost-effective international rollout.

Corporate restructuring and expansion initiatives – such as acquisitions, divestitures, and spin-offs – also benefit from upfront regulatory evaluation. While legal entities handle formal transactional elements of these processes, early risk assessment and identification of potential compliance gaps is highly beneficial. Insights and guidance from a corporate support partner can inform decision making, aid negotiations, and avoid obstacles which may otherwise hinder progress.