REGULATORY NEWS

EU's new chemicals strategy: A watershed moment

Date: 15 December 2020

With the publication of the Chemicals Strategy for Sustainability on October 14th, the European Commission sets out their new long-term vision for the EU`s chemical policy: a toxic-free environment. The strategy outlines a pathway how these goals can be achieved. This article focuses on the most important actions to be completed by the European Commission in the next years and which might have a big impact on your daily regulatory compliance.

Reducing exposure towards the most harmful chemicals shall be reached by restricting chemicals in consumer products that cause cancers, gene mutations, affect the reproductive or the endocrine system, or are persistent and bioaccumulative. While restriction is only a transitional measure the “generic approach to risk assessment” will become the default option to ensure that consumers, vulnerable groups and the natural environment are most consistently protected. This approach is intended to be extended to further harmful chemicals including those affecting the immune, neurological or respiratory systems and chemicals toxic to a specific organ. Substances exhibiting such properties will be grouped instead of regulating them one-by-one. The first tangible impacts of the strategy can already be found in several updates of regulations and related guidance documents focussing more strongly on the identification of genotoxic substances, e.g. food contact materials and food additives.
Another big topic to be prioritised in 2021 will be the identification of endocrine disrupting chemicals (EDCs) based on the definition of the WHO, and to ensure that they are banned in consumer products as soon as they are identified, allowing their use only where it is proven to be essential for society. Since the EU regulatory system on EDCs is overall fragmented and limited, it needs to be consolidated and simplified across all relevant legislations. Moreover, screening and test methods must be further developed and established in order to generate information on EDCs. Updates of the REACH requirements to allow identification of EDCs are already underway. By taking an international leadership role the European Commission will further promote the introduction of new criteria and hazard classes in UN GHS, i.e. for EDCs but also for terrestrial toxicity and persistency and mobility.

Particular attention will be paid on the protection of the natural environment in general and the use of PFAS in particular, which are to be phased out in the EU unless they are proven essential for society.
People and other living organisms are daily exposed to a wide mix of chemicals originating from various sources. To adequately address the combination effect of chemical mixtures, the Commission will assess how to best introduce ‘mixture assessment factors’ in REACH and introduce or reinforce provisions to take account of the combination effects in other relevant legislation, e.g. food additives and food contact materials, toys and cosmetics.

Industry will face increasing data requirements under REACH, e.g. registration of polymers of concern, assessment of the overall environmental footprint, identification of substances with critical properties including effects on the nervous and immune system as well as carcinogenic substances irrespective of the volume. At the same time a ‘zero tolerance’ approach to non-compliance will be pursued by the Commission and measures to strengthen the enforcement of chemicals legislation could be put in place.

Taken together, new chemicals and materials must be inherently safe and sustainable, from production to end of life, while new production processes and technologies must be deployed to allow the chemical industry’s transition to climate neutrality. The European chemicals strategy for sustainability will affect not just companies that already have a footprint in the bloc of 27 countries, but also those that sell or are looking to sell their products on the EU market. If a company wants to sell something in Europe, it will have to follow the requirements that flow from the new EU strategy, thereby being a big market driver.