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Environment for Europeans
29 augustus 2019 | Directoraat-generaal Milieu

Fit for purpose – the EU chemical legislation framework



Directorate-General for Environment

With one of the most comprehensive chemicals legislation frameworks in the world, the European Union (EU) offers a global benchmark for chemical risk management. A recent Fitness Check confirms that the existing legislation provide EU citizens with a high level of protection from dangerous chemicals and is supportive of the Single Market. It also identifies some challenges, gaps and weaknesses.

The EU’s chemicals legislation framework has evolved and expanded significantly since the first chemicals-related Directive in the late 1960s. The European Commission now has 50 years of chemicals policy in place, including horizontal  legislation and sector- and product-specific legislation with strong provisions on chemicals.

Now it’s time to reflect on the findings and implications for the future of chemicals.

The purpose of the EU chemicals acquis is to protect human health and the environment from the adverse effects of hazardous chemicals, while supporting and enhancing the efficient functioning of the Single Market. With the global market for chemicals set to double by 2030, it is important to ensure that the legislation remains fit to protect citizens and ecosystems and continues to enhance and support the competitiveness and innovativeness of EU industry and business.

Fitness Check

On 25 June 2019, the Commission published a review of the EU chemicals legislative framework which covers the 40 most relevant pieces of EU chemicals legislation (other than REACH (the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation). The review was extensive and complex and had a strong focus on risk assessment and risk management. It was the second of the Commission’s recent evaluations of the EU’s chemicals policy, and was designed to complement the review of the EU’s REACH Regulation published in March 2018.

A high-level conference, ‘EU Chemicals Policy 2030: building on the past, moving to the future’, organised by the Commission and the Ministry of Environment and Food of Denmark, was held to discuss the outcomes of the recent evaluations, including the Fitness Check, and possible future developments for EU chemicals policy in line with the Sustainable Development Goals and the New Strategic Agenda 2019–2024.

A broad assessment

The purpose of the Fitness Check was to see which elements of the EU chemicals legislation that was assessed work well and which need to be improved, both in terms of meeting the policy objectives and reducing the regulatory burden. Unlike most evaluations, the Fitness Check did not focus only on one law. It assessed more than 40 different pieces of legislation on chemical hazard identification, assessment classification and labelling, risk assessment, and risk management, worker safety, transport, and environmental protection, as well as related aspects of legislation applied to downstream industries.

The Classification, Labelling and Packaging Regulation, the Plant Protection Products Regulation, and the Cosmetics Products Regulation are just some of the pieces of legislation addressed.

The Fitness Check mapped out how hazard identification and risk assessment relate to risk management in downstream legislation. It examined the overall effectiveness, efficiency, relevance, coherence, and EU added value of the different risk management approaches. The interface between waste, products and chemicals legislation as set out in the Circular Economy Action Plan, was also taken into account.


‘The headline finding is reassuring,’ said Environment, Maritime Affairs and Fisheries Commissioner Karmenu Vella, speaking at the conference.

The Fitness Check confirmed that the legislation has succeeded in significantly reducing citizens’ exposure to harmful chemicals by banning or restricting the use of certain substances, and is continuously looking to limit the risk posed by harmful chemicals. Contamination by Polychlorinated Biphenyls (PCBs), for example, has been dramatically cut since 1971. The legislation has also reduced exposure to other problematic substances, such as lead, mercury, benzene and asbestos.

According to the Fitness Check, EU chemicals legislation has also been instrumental in ensuring the free circulation of substances, mixtures and articles through the harmonisation of standards and requirements.

Worrying trends

While the results show that there is a comprehensive framework in place, they have also exposed certain challenges and gaps in the legislation. Concerns remain over exposure to hazardous chemicals and require further attention. ‘Nature is suffering’, said Commissioner Vella, ‘with populations of insects and birds in dramatic decline. And humans are suffering, with male fertility decreasing at an alarming rate, and cancers and neurological diseases on the rise. There are multiple causes and chemicals are one of them.’

There are also certain knowledge gaps about the impact of chemicals on biodiversity and human health. A broader dissemination of research and knowledge would allow decision-makers to better address the emerging risks.

The report also identifies areas for improvement in the implementation and application of the rules, including the need for the simplification and streamlining of hazard and risk assessment processes, and the advantages of providing better consumer information.

One of the most important potential gaps is the lack of an overarching approach to the protection of vulnerable groups. There are considerable variations in capacity among the Member States, leading to inconsistencies in the application of EU law. The Commissioner has called for more support for Member State implementation of the legislation, adding, ‘All EU citizens deserve the same protection’.

‘Now it’s time to reflect on the findings and implications for the future of chemicals,’ Commissioner Vella continued. In light of the results of the Fitness Check, he recommended a simplification of the legislative framework, with a more streamlined approach for assessing and managing risk. He also suggested that: ‘Doing more to support “green chemistry” would improve the sustainability of the industry, protecting its future competitiveness.’