About the Annual Evaluation and Joint Evaluation Action Plan

ECHA and Member State Authorities conduct evaluations to ensure that industry actors comply with legal obligations and include the necessary data in their registration dossiers. These evaluations help identify gaps in ensuring chemical safety, and when necessary, lead to new regulatory measures for certain substances.

The Evaluation Joint Action Plan (REACH Evaluation Action Plan) was established by ECHA and the European Commission in 2019. The objective of this action plan was to improve the legal compliance of REACH registrations. However, the activities of this plan ended in 2024, and ECHA will now only monitor the implementation of the recommendations made during this period.

Current Status of Evaluation Statistics

According to the latest announcement published on ECHA’s website, the annual evaluation statistics have been updated. The latest data are as follows:

Between 2009 and 2024, the compliance of 15,500 registrations has been checked. This represents 23% of all submitted registration dossiers, covering 3,200 substances.
34% of high-volume chemicals registered at 100 tonnes or more per year have been evaluated.

In 2024, ECHA:

Conducted 251 full compliance checks (CCH), covering 1,705 dossiers and 234 different substances. These primarily focused on high-tonnage substances or groups of substances with potential concerns, addressing higher-level hazard endpoints.
Performed 62 targeted compliance checks, covering 2,000 registration dossiers and 272 unique substances.
Reviewed 161 testing proposals (TPE) and issued 92 decisions to companies.
Checked the compliance of dossiers where registrants opted out of joint submissions and submitted data separately. This review covered 19 dossiers for 12 substances, and all assessed dossiers were found to be non-compliant.
Verified whether additional information provided by registrants was compliant with REACH requirements. In 2024, this assessment was completed for 241 substances. In approximately 70% of cases, companies provided the requested data to ECHA, while the remaining 30% were referred to Member States for further action.
Issued 300 decisions, including 208 related to full and targeted compliance checks and 92 concerning testing proposal evaluations.

What Are the Most Common Deficiencies Identified by ECHA?

ECHA has shared an Excel file on its website listing the evaluated substances and requests made. A review of this file highlights the most frequently requested data:

Long-term toxicity testing on fish (Annex IX, Section 9.1.6.; test method: EU C.47/OECD TG 210)
Long-term toxicity testing on aquatic invertebrates (Annex IX, Section 9.1.5.; test method: EU C.20/OECD TG 211)
Pre-natal developmental toxicity study by oral route in one species (rat or rabbit) (Annex IX, Section 8.7.2.; test method: OECD TG 414)
Growth inhibition study on aquatic plants (Annex VII, Section 9.1.2.; test method: EU C.3/OECD TG 201)
Long-term toxicity testing on aquatic invertebrates (triggered by Annex VII, Section 9.1.1., Column 2) (test method: EU C.20/OECD TG 211)
Only if a negative result in Annex VII, Section 8.4.1. and Annex VIII, Section 8.4.2. is obtained, in vitro gene mutation study in mammalian cells (Annex VIII, Section 8.4.3.; test method: EU B.17./OECD TG 476 or EU B.67./OECD TG 490)
Sub-chronic toxicity study (90 days), oral route (Annex IX, Section 8.6.2.; test method: OECD TG 408) in rats
Skin sensitisation (Annex VII, Section 8.3)
Screening study for reproductive/developmental toxicity (Annex VIII, Section 8.7.1.; test method: EU B.63/OECD TG 421 or EU B.64/OECD TG 422) by oral route, in rats
In vitro gene mutation study in bacteria (Annex VII, Section 8.4.1.; test method: Bacterial reverse mutation test, OECD TG 471)

Through these evaluations, ECHA aims to support chemical safety by ensuring access to reliable hazard data on chemicals.

Companies are advised to avoid missing information in their REACH dossier submissions to prevent future compliance issues. Seeking expert assistance during this process can help achieve a successful REACH registration.

For detailed information on evaluations, click here.

This article was originated from ECHA.