How does REACH, the EU regulation governing chemical substances, work?

Adopted by the European Union in 2006, the REACH regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals) governs the manufacture and use of chemical substances in Europe. Despite its importance, REACH has often been criticised for being slow and complex. These concerns prompted calls for reform as part of the European Green Deal, though the European Commission ultimately postponed the revision. Various NGOs have called for this reform, and in early 2024, the French National Assembly’s European Affairs Committee reignited the conversation, with a resolution currently under review.

Nevertheless, REACH remains an ambitious and indispensable regulation that protects human health and the environment from the hazards posed by chemical substances. While it’s not perfect, it represents progress in comparison with previous regulatory frameworks. One notable success is the ban on bisphenol A (BPA), a controversial chemical previously used in baby bottles.

Understanding the REACH process

REACH is straightforward if you break down its steps:

This graphic illustrates how chemical substances are registered in line with the REACH regulation. Source: France’s formerly titled ministry of ecology, energy, sustainable development and planning

Substance registration: Manufacturers must submit detailed information on the chemical, toxicological and environmental properties of substances they produce or import. If no data exists, they are required to generate it. Unlike previous regulations and directives, REACH places the burden of proof on companies. To comply with the regulation, companies must identify and adequately manage the risks associated with the substances they manufacture and market in the EU. In particular, they must demonstrate how the substances can be used safely and communicate risk management measures to users.

Compliance checks: The European Chemicals Agency (ECHA) ensures that the registration dossiers are complete and meet regulatory requirements. This is known as compliance analysis.

Substance evaluation: If concerns arise, a substance undergoes further evaluation to assess risks to human health and the environment. This procedure is conducted by the member states (with ANSES representing France) and enables the authorities to request additional information from industries.

Member states, including ANSES, carry out these evaluations, focusing on national health priorities. Substances flagged for further assessment are added to the Community Rolling Action Plan (CoRAP), a three-year plan outlining substances to be evaluated by member states.

If additional safety measures are needed, several outcomes are possible:

SVHC identification: Substances of Very High Concern (SVHC) may require authorisation for continued use.

Restrictions: Can limit or ban certain uses of a substance.

Classification: Hazardous substances may be classified as carcinogenic, toxic to reproduction or in other such categories and must be labelled for these hazardous properties.

Bisphenol A: a case study

Bisphenol A (BPA) exemplifies REACH’s impact. In 2017, Germany initiated an evaluation of BPA, resulting in its classification as a reprotoxic substance under the EU’s Classification, Labelling and Packaging (CLP) regulation. BPA was also identified as an SVHC due to its endocrine-disrupting properties, which pose risks to human health and the environment.

Although these various management measures have faced legal challenges from industry, including through appeals, all have been upheld. They have proven effective, as highlighted by a European Environment Agency (EEA) report showing that BPA concentrations in Europeans’ urine are decreasing, in contrast to other bisphenols.

Bisphenol A or BPA is an endocrine disrupter that was particularly found in plastic bottles.
Shutterstock

The role of ANSES

ANSES plays a key role in implementing the EU’s REACH regulation, supporting French authorities in managing chemical risks. Among its responsibilities, ANSES can identify a substance as an SVHC, preparing dossiers that can lead to these substances being added to Annex XIV of REACH. Once listed, the substances are restricted, and their use is only allowed if the European Commission specifically authorises it. Such authorisations are granted when it’s proven that the risks are controlled or the socioeconomic benefits outweigh them.

Before a substance is included in Annex XIV, it must first be identified as an SVHC. This step is aimed at encouraging the gradual replacement of these hazardous chemicals with safer alternatives, protecting both human health and the environment.

ANSES also prepares restriction dossiers, evaluating the socioeconomic impact of limiting or banning substances that pose unacceptable risks. These restrictions can apply to chemicals in their pure form, in mixtures, or within products.

Additionally, ANSES produces harmonised classification dossiers for chemicals like carcinogens, mutagens, and reproductive and respiratory sensitizers, for instance. Once included in Annex VI of the CLP regulation, industries must label their products accordingly, alerting users – especially workers – about potential hazards and ensuring proper precautions are taken.

Room for improvement

Despite improvements, the REACH regulation still faces significant challenges. Many industries, and particularly smaller companies, struggle to comply due to the high cost of registration. In 2018, the German Federal Institute for Risk Assessment (BfR) reported that 31% of chemical substances produced in or imported into the EU in quantities over 1,000 tonnes per year failed to meet REACH requirements.

In response, ECHA has enhanced its chemical data management, but industries remain unsatisfied, accusing ECHA of pushing for classifications or requesting new tests without robust toxicological justifications. These requests often aim to address data gaps in industry-provided dossiers while minimising animal testing.

REACH’s main limitation is its dependence on industry-submitted data to evaluate chemical risks. These data can be incomplete, outdated or missing, forcing regulators to request additional information, which delays risk assessments and decision-making.

Consequently, the evaluation of substances and review of authorisation requests are often slow, delaying the entry of safer, innovative chemicals. Many potentially hazardous substances remain on the market without adequate regulation, a persistent concern from a public health standpoint.

A revision of REACH is expected to streamline processes, improve efficiency and impose stricter penalties on non-compliant industries, potentially revoking their REACH registration numbers. This would prevent the sale of substances without the necessary data.

These changes align with the European Commission’s strategy for a toxic-free environment under the European Green Deal. However, there is concern that lobbying could undermine this vital regulation, a global standard in chemical safety.

Despite its complexities, REACH remains a critical safeguard for European public health and environmental protection.