Chemical Regulation

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Significant English Supreme Court decision overturns High Court and Appeal Court ruling on personal injury compensation.

By Paul A. Davies and Michael D. Green

Three former employees of a chemical company appealed against the decisions of the High Court and the Court of Appeal that held they could not claim against their employer for damages for personal injury.

Johnson Matthey, the respondent employer, allegedly failed to properly clean the areas in which three of its employees worked and, as a result, they developed a sensitivity to platinum salts whilst working on the production of catalytic converters. Two of the men were dismissed on medical grounds and the other was given a lesser paid position as a result. The sensitivity was discovered after a routine skin prick test was carried out.

By Richard P. Bress, Philip J. Perry, Andrew D. Prins, Ryan Baasch and Alexandra Shechtel

On February 26, for the first time ever, a federal district court has enjoined a California Proposition 65 warning requirement on First Amendment grounds. Under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 — colloquially known as “Proposition 65” — the State listed the herbicide glyphosate, the most widely used herbicide in the world, as a chemical “known” to the…

By Michael Green and Paul Davies

A coalition of medical and environmental groups has called upon the European Commission (EC) to propose specific legislation that will address pollution, in particular, by active pharmaceutical ingredients (APIs). This political development highlights the complex debate currently taking place over how to identify and address the effects of APIs.

An API is the biologically active component of a pharmaceutical drug. Other ingredients, known as “excipients”, are the inert substances present in a pharmaceutical drug. For example, if a product is in syrup form, the excipient is the liquid being used.

The coalition has raised the concern that APIs make their way into groundwater, rivers, lakes, oceans, and even drinking water after being disposed, with potentially harmful effects on the environment and human health. APIs are specifically designed to trigger a biological process (unlike most other chemical pollutants). As such, if APIs are present at significant-enough levels, biological processes in humans and/or animals may be unintentionally activated with potentially harmful effects. For example, some evidence suggests that the environmental presence of antibiotics contributes to developing antibiotic-resistant strains of bacteria, and that synthetic hormones found in contraceptive pills cause infertility in fish. Moreover, the effects on humans of inadvertent long-term exposure to low levels of APIs in drinking water, particularly given the potential for the presence and interaction of multiple APIs, are relatively unknown.

By Paul Davies and Michael Green

A new European Parliament briefing highlights the benefits of, and difficulties associated with, transitioning the chemicals industry to a circular economy.

The traditional economy typically involves purchasing and using a product, and then disposing that product when it no longer has utility (i.e. the “take-make-dispose” approach to resources). Conversely, a circular economy seeks to extend the life cycle of products by aiming to both extract and retain the maximum value of their component materials.

A greater emphasis on product re-use and mechanical recycling in the chemicals industry requires developing new solutions and manufacturing products intentionally designed for re-use. This presents a growth opportunity and a new source of competitiveness for European operators compared with raw material-rich regions, whilst providing the more obvious benefits of preserving increasingly scarce resources and injecting renewed value into waste products.

By Paul Davies and Michael Green

On 16 June 2017, the Member State Committee (MSC) of the ECHA unanimously agreed to identify BPA as a substance of very high concern (SVHC) under the REACH regime. BPA is common in a variety of household products, typically used in the manufacture of plastics and resins found in insulation, reusable containers and bottles, kettles, and DVDs. This identification follows the 2011 EU ban on BPA as an ingredient in babies’ bottles.

At the end of 2015, the European Commission (EC) proposed a roadmap — Proposal for a new measure on bisphenol A (BPA) in food contact materials — to harmonise BPA classification. Further, the British Plastics Federation (BPF) contributed to the Joint Value Chain Input to DG Health & Food Safety in support of option 3 of the roadmap, which proposed a decrease in the migration limit from 0.6mg/kg to 0.05mg/kg. This new Specific Migration Limit (SML) came into force in March 2016, and is applicable to plastics, coatings, and varnishes for metals and other food contact sources of BPA. In addition, in October 2016, the European Food Standards Agency (EFSA) published a review of two 2014 studies, concluding that “New data confirm EFSA’s previous conclusion that BPA might affect the immune system in animals but the evidence is too limited to draw any conclusions for human health.” As a result, EFSA stands by its original position of January 2015 that there is “no consumer health risk from BPA exposure at current exposure levels.” Some argue that, as BPA is one of the most researched chemicals in the industry, and as there are safety measures such as the new SML in place, both the public and the environment are adequately protected. The risk of BPA has also been extensively assessed within the areas of consumer, worker, and environmental safety to ensure that there is no health risk at current exposure levels.

By Paul Davies, Elisabetta Righini and Rosa Espin

Shiny transparent capsule filled with colorful spheresOn 28 April 2017, the European Commission (the EC) published a “roadmap” on the strategic approach to pharmaceuticals in the environment, particularly in the aquatic environment.

Concurrently, the EC launched a 12-week open public consultation to address the environmental pollution caused by human and veterinarian pharmaceutical substances.

Under the title “Strategic approach to pharmaceuticals in the environment”, the EC aims to implement Article 8c of Directive 2008/105/EC, as amended by Directive 2013/39/EU, according to which the strategic approach shall include proposals to improve the procedure for placing medicinal products on the market more effectively to reduce the environmental impacts of medicines. In addition, by September 2017, the EC shall propose measures at the EU and/or Member State level recommending the reduction of discharges, emissions, and losses of such substances into the aquatic environment.

This initiative aims to:

  • Identify remaining knowledge gaps and uncertainties, and present possible solutions for filling them
  • Explore how to address the challenge of protecting the environment (and human health via the environment), while safeguarding access to effective and appropriate pharmaceutical treatments for human patients and animals, considering inter alia opportunities for innovation

By Paul Davies, Julia Hatcher and Alice Gunn

Barack Obama signed the bipartisan Frank R. Lautenberg Chemical Safety for the 21st Century Act on 22 June of this year. This Act, which came into immediate effect, amends the core provisions of the Toxic Substances Control Act (TSCA), the primary federal law governing chemicals for the first time in 40 years.

The amendments mandate potentially significant actions by the US Environmental Protection Agency (EPA), including: risk screening to identify “high-priority” chemicals; risk evaluation of those chemicals; and promulgation of restrictions (including a possible ban) on any chemical deemed to “present an unreasonable risk”. The amendments not only allow states and localities to continue enforcement of their existing chemicals laws, but also grant states some latitude – and, in the event of EPA inaction, wide latitude – to enact new laws.

The TSCA amendments establish a series of ambitious deadlines to implement the measures. Within the first six months, EPA must begin risk evaluations on 10 “high priority” substances. Within the first year, EPA is required to complete several formal rulemakings, including to establish processes for prioritisation of additional chemicals as “high priority”, for risk evaluation and for “resetting” the inventory of chemicals in commerce. Within the following six months, the EPA must work on additional guidance documents, policies and activities, including with respect to the protection of confidential business information (CBI).

By Paul Davies and Alice Gunn

The European Commission published two evaluation and fitness check roadmaps in May this year. These roadmaps will assist the Commission in assessing whether the current legislative framework for chemicals, including REACH, is fit-for-purpose and delivers as expected.

Together with the ongoing evaluation of 24 EU Directives in the area of health and safety at work, the roadmaps will not only serve as evidence for the chemicals stock-taking report referenced in the 2014 Regulatory Fitness and Performance Programme (REFIT) but, more generally, for developing the non-toxic environment strategy as required by the 7th Environment Action Programme by 2018.

Fitness check of chemicals legislation

The first roadmap concerns a fitness check of current chemicals legislation, as well as related aspects of legislation applied to downstream industries. It does not cover REACH, except for the criteria for identifying a phase-out substance.

By Paul Davies, Andrew Westgate and Alice Gunn

China’s Ministry of Industry and Information Technology (MIIT) has recently announced a revised version of the Restriction of Hazardous Substances (RoHS 1), which will come into effect on July 1, 2016.

The revised legislation (RoHS 2) has significant implications for domestic and international companies manufacturing electrical and electronic products in China (including component parts), or those importing such products into China.

By Michael Green and Glen Jeffries

The recent judgment by the European Court of Justice (ECJ) clarified the definition of “article” under the REACH Regulation 2006 ((EC) No 1907/2006).

REACH is a regulation that concerns the registration, evaluation, authorisation and restriction of chemicals in the EU and REACH ensures that chemical manufacturers and suppliers that are producing and distributing “articles” categorised as “substances of very high concern” (SVHC), are obliged to notify the European Chemicals Agency (ECHA) and provide recipients with sufficient product safety guidance.

REACH defines an article as: “an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition”. Both the European Commission and the ECHA confirmed their position that the concentration of a SVHC had to exceed 0.1 percent in the entire article for obligations to apply. Therefore, it was the Commission and the ECHA’s view that the obligations applied only to a complete product and not the constituent parts of that completed product.

The recent ECJ decision, in relation to the disputed definition of an “article”, has essentially lowered the threshold at which the relevant obligations kick in, reversing the position held by the ECHA.