Dr Reach: Tougher product safety laws demand holistic thinking

Meeting product-based regulation increasingly requires knowledge and control of manufacturing processes, even if production occurs outside the EU. This level of information may need to be known to companies operating in the EU in order to demonstrate compliance with chemical safety legislation.

Responsibility for compliance and safety is being placed on companies supplying products in the EU. For instance, the ‘brander’ of a toy is deemed as a ‘manufacturer’ under the new Toy Safety Directive.

With the new Cosmetics Regulation, a similar line of responsibility may fall on various actors in the supply chain. The General Product Safety Directive underpins some of these obligations and brings the potential for product recalls for non-compliant goods.

In some cases, the final product can be tested to determine the chemical composition and assess compliance, but without knowing the actual manufacturing process involved, it can prove more challenging. Recycled materials in particular face an unprecedented challenge.

Take for instance, the forthcoming restriction on polyaromatic hydrocarbons in tyres. Demonstrating (or checking) compliance can be achieved in two ways. One can test the extender oil or the final tyre.

NMR spectroscopy is needed to test the tyre, which requires cutting a tyre into each component part. In comparison, testing, control and documentation of oils used in manufacture offers a cheaper solution.

Further examples of legislation requiring knowledge and/or control of manufacturing:

• REACH registration requirements of monomers and other reactants in imported polymers
• impurity assessments in cosmetics or medical devices
• material and additive identification for food contact

The focus on control of manufacture tends to be to ensure that the final product is produced to sufficiently high quality standards. For instance, Good Manufacturing Practice is now often referenced in legislation. Documentation is proving critical for example, to record if a supplier changes its material source.

Manufacturing a product within the EU may remove importer burden; it may facilitate compliance checks, making it easier for customers to perform on-site audits of suppliers. Some companies have already moved to reduce REACH non-compliance risk by preferentially sourcing raw materials in the EU.

But of course, manufacturing and sourcing of goods still often occurs outside the EU. Such is the importance for product safety, the European Commission has even published an official version of the Toy Safety Directive in Chinese! The Commission’s consumer protection Directorate also announced in November that it plans to sign a product safety agreement with the USA to give regulators in both countries better access to the information they need to protect consumers (CW 10 November 2009).

Legislation tends to focus on hazardous substances, usually with reference to cut-off values for classification requirements. This helps to make compliance more feasible, while helping to safeguard confidential information on applications in some cases. But these cut-off levels can vary according to hazard categories, even for specific substances, and can change when substances are used in mixtures.

For example, a substance may have a skin irritation classification of 1%, but its presence in a mixture may need to be above 10% to trigger classification of the mixture. This depends on whether there are other skin corrosive/irritant substances in the mixture.

As substance classification can have a knock-on effect for compliance with other legislation, data generated under REACH, the EU classification, labelling and packaging Regulation and other initiatives needs to be carefully managed. Changes to classifications need to be anticipated and companies need to ensure that consequential reformulations or alterations to production triggered by legislative restrictions do not compromise the safety of products in other areas, such as material strength.

In some cases, requirements are set on broad categories of substances, such as volatile organic compounds. This offers possibilities for management strategies.

In my opinion, companies should ensure that their systems can manage:

• changes to classification and/or formulation
• grouping of chemicals (eg according to hazard categories)
• systems to track applicable product-specific legislation

Full material declarations are sometimes being sought but these may be disproportionate, beyond any regulatory requirement and administratively burdensome especially considering the need to update information in the event of changes in suppliers or formulations. Typically, product communication and declaration systems will target certain substances and product types, or focus on safety data sheets.

Product-based legislation tends not to take a holistic approach considering all health and environmental impacts coherently, for instance, including climate change challenges. There is some way to go before these laws can be said to integrate the concept of sustainability into standard-setting and decision-making.

So while increasing attention is being placed on products and the processes needed to attain chemical specifications, society needs to launch into a wider debate on material selection, production methods, recycling and the environmental impact associated with attaining certain product standards.