European Ombudsman: Delays in decisions on chemical substances a health threat

European Ombudsman: Delays in decisions on chemical substances a health threat
Credit: European Ombudsman

The European Commission should comply with the statutory deadline of three months for preparing authorisation decisions concerning dangerous chemical substances under the REACH Regulation, according to an own-initiative inquiry published on Monday by the European Ombudsman.

REACH stands for the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals.

The Ombudsman found that the European Commission’s failure to meet the legal deadlines for preparing authorization and other decisions to be maladministration. It takes the Commission on average 14.5 months to prepare draft decisions although the deadline for doing so is three months. In certain cases, it takes several years.

While the decision-making process is ongoing, companies that have submitted the applications can continue using the substances that may represent a threat to human health and the environment. These substances may be carcinogenic, mutagenic, toxic for reproduction, or have endocrine disrupting properties.

The inquiry was opened in May 2023 following a public consultation in 2022 on transparency and participation in EU environmental decision-making. One of the issues brought to the Ombudsman’s attention concerned delays and limited transparency in the risk management of dangerous chemical substances by the Commission.

Emily O’Reilly, the Ombudsman, writes in her recommendation to the Commission that she is very concerned about the delays. In its reply, dated 26 August 2024, the Commission explained that the three-month time limit is unrealistic to attain in practice because of different factors in the administrative process, including the shared responsibility of two Directorates-General.

The Ombudsman, however, was not convinced by the Commission’s reply that it cannot comply with the statutory time limit of three months to draft a decision. The Commission cannot justify non-compliance with mandatory statutory time limits by reference to its internal organisation or the need to hold lengthy internal discussions, she wrote.

“The delays in the Commission’s process defy the main purpose of the REACH Regulation, which is the protection of human health and the environment.”

The Ombudsman also found maladministration in the Commission’s failure to ensure that the decision-making process for authorisation was sufficiently transparent.

In particular, she criticized the lack of information concerning the REACH Committee’s deliberations, with summary records of its meetings not fully capturing the state of play of individual files or the reasons for delays, such as disagreements among the Member States.

The Commission has now three months, until 17 January 2025, to review its internal procedures and ensure compliance with the deadline of three months for preparing authorisation decisions concerning dangerous chemical substances.

It should also be up to applicant companies to demonstrate that they have satisfied the legal conditions for obtaining the authorisation by providing sufficient information. If not, the applications should be promptly dismissed and the companies should no longer be able to use the dangerous substances in the EU.

In its previous reply, the Commission wrote that REACH is the most advanced and comprehensive chemical legislation in the world and that many other jurisdictions have followed the EU’s lead in regulating chemicals. Accordingly, the Commission takes human health and the protection of the environment extremely seriously.

Asked at the Commission press conference on Monday to comment on the Ombudsman’s recommendation, a Commission spokesperson replied that it had taken note of it but could not say if it could meet the deadline in the Regulation. The Commission continues to stick to its opinion given in its previous reply and would need the full three-months deadline to reconsider it.

M. Apelblat

The Brussels Times


Copyright © 2026 The Brussels Times. All Rights Reserved.