Scope:

The fitness check finalised in 2019, included the most relevant chemicals legislation (excluding REACH) as well as related aspects of legislation applied to downstream industries.

The legal scope includes horizontal chemicals legislation, as well as chemicals-related aspects in worker safety, transport environmental protection and product-specific legislation.

Evaluation findings:

The fitness check report presents the EU achievements in chemicals area:

• The EU chemicals legislation is overall fit for purpose with a high EU added value. The more than 40 pieces of legislation that were assessed for the fitness check have evolved into a solid framework that reflects 50 years of continuous efforts and progress.

• The current legislation demonstrates the EU’s commitment to protecting its citizens and the environment and, at the same time, to preserving the internal market which delivers for consumers and where EU business can thrive. EU citizens have much greater confidence in the chemical safety of products manufactured in the EU compared to those imported.

• The EU chemicals legislation has also been instrumental in ensuring free circulation of substances, mixtures and articles through harmonisation of standards and requirements. There is a level playing field in Europe, and chemicals legislation has strengthened the internal market and enhanced the competitiveness of EU industry.

• While the overall regulatory costs of the EU chemicals legislation for the EU industry are estimated to be several billion euro per year, the EU chemicals legislation has also led to significant benefits in terms of avoided health and environmental impacts (e.g. healthcare costs, productivity losses, suffering and premature deaths, remediation costs, and degradation of environmental/eco-system services).

• The EU chemicals legislation has become a benchmark for the development of chemical risk management rules, at the international level as well as in other countries and regions. Where the EU acts on restricting the use of hazardous chemicals, other countries and regions often follow.

The report has also identified areas for further improvements, simplification, burden reduction could or warranting attention:

• Implementation and enforcement of EU chemicals legislation was found to be challenging for authorities due to resource and capacity constraints. On the other hand, understanding their legal obligations and keeping up-to-date with changes is challenging for companies, more so for SMEs compared to larger companies.

• Simplification and streamlining of the hazard and risk assessment processes at the EU level, and increased use of grouping approaches could result in considerable efficiency gains in terms of protecting human health and the environment, accelerating the pace of the hazard and risk assessment processes and cost savings for industry.

• The communication of hazard and safety information to consumers can be improved and simplified, including by using digital tools. Reaping the benefits of the digital age will result in potential burden reduction for SMEs, improved enforcement and compliance, reinforcing cooperation between competent authorities, including customs and market surveillance authorities.

• Globalisation, a strong growth in the production of chemicals in other parts of the world and rapid technological change are the main challenges for the EU chemicals industry.

• Potential gaps in the legal framework were identified for the protection of children and other vulnerable groups. Some inconsistencies have been identified regarding risk management decisions as regards endocrine disruptors, substances that are persistent, bio-accumulative, toxic, substances that are very persistent and very bio-accumulative and substances fulfilling the classification criteria for specific target organ toxicity.

Important knowledge gaps still remain regarding exposure to hazardous chemicals, their use and their impacts on humans and the environment, including on biodiversity and ecosystems’ resilience. The current regulatory framework typically cannot focus on these long term and complex environmental effects.

Which objective(s) does the Commission pursue?

Based on the actions proposed in the Chemicals Strategy for Sustainability and the fitness check, the Commission revised the regulation on classification, labelling and packaging of chemicals (Reg. 1272/2008, “CLP Regulation”), which, together with REACH, is the cornerstone of EU chemicals legislation.

The revision of the CLP Regulation aims at addressing shortcomings identified in the fitness check, such as addressing inconsistencies regarding risk management decisions as regards endocrine disruptors, substances that are persistent, bio-accumulative, toxic, substances that are very persistent and very bio-accumulative and substances fulfilling the classification criteria for specific target organ toxicity.

The impact assessment for the revision of CLP identified three areas where the CLP, in its current version, insufficiently protects humans and the environment from intrinsic hazards of certain chemicals moving freely within the EU’s single market:

1. Hazardous chemicals are not comprehensively identified and classified.

2. Member State Competent Authorities and the European Chemicals Agency (‘ECHA’) operate on the limit of their resources to prepare proposals (in the case of Member State Competent Authorities) and Opinions (in the case of ECHA) for harmonised classification and labelling of substances.

3. The communication on chemical hazards is sub-optimal, which results in a lack of knowledge on hazardous properties of chemicals. There is a high level of non-compliance with the CLP obligations in the context of e-commerce. Information on hazardous mixtures submitted to poison centres for their emergency health response is insufficient in certain cases.

Estimated savings and benefits

The benefits of the preferred option as identified in the impact assessment stem mainly from the improvement of the protection of health and the environment. Savings to public health systems and depollution schemes could amount to more than EUR 300 million per year. Adequate and homogenous hazard classification allows chemicals suppliers, users and public authorities to take adequate measures to manage chemicals risks while preserving the integrity of the single market and levelling the playing field between economic operators.

Improved communication on chemical hazards will allow consumers to make informed choices and avoid unnecessary risks to health or the environment.

Finally, simplified labelling rules will save costs for businesses. Closing legal gaps related to online sales and poison centres will ensure better compliance ultimately leading to better implementation and easier enforcement.

The initiative will entail significant costs for industry actors placing chemicals on the EU market, both administrative annual costs for compliance with the new rules (EUR 28.47 million) and adjustment costs for voluntary substitution down the supply chain for substances which will be covered by the new hazard classes (EUR 26.40 million).