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Updated ECHA Q&A document on the restriction of Cr(VI) substances is available

Of particular interest is the question of what impact the entry into force of the restriction will have on existing authorizations. As things stand at present, the restrictions are set to come into force in 2027, with existing authorizations losing their validity after 18 months at the latest. Authorization applications that have already been submitted would receive a correspondingly shorter authorization period.

Against this background, ECHA will give priority to applications for authorization of other substances over authorization applications and review reports for Cr(VI) substances in the period before the restriction comes into force. Furthermore, applications for authorization from new users will take priority over review reports for Cr(VI) substances. It is therefore unlikely that the process will be completed before the restriction comes into force, particularly for the submission of review reports.

In view of the emerging developments, it is all the more important that the industry takes advantage of the opportunity to comment on the Annex XV dossier prepared by ECHA and addresses the emerging issues. This must be done by September 18, 2025. Comment on ECHA website

Download the recent Q&A document via CIRCABC: European Commission updates Q&As on Chromium(VI) compounds

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Classification of titanium dioxide revoked

The European Court of Justice (EuGH) has revoked the classification of titanium dioxide (TiO2). Since 2021, TiO2 powder containing particles with an aerodynamic diameter of ≤ 10 μm had to be classified as “probably carcinogenic when inhaled” (Carc. 2) and labelled accordingly.

Shortly after the classification decision was made, the industry spoke out against this classification, as TiO2 is indispensable as a colour pigment. In 2022, a lawsuit was filed with the EuGH against the classification, and an appeal was lodged against an initial ruling.

In August, the ruling that the classification of TiO2 should be revoked was confirmed. The classification was based on flawed studies. The next step is to repeal the 14th ATP by means of an implementing regulation.

The judgment can be viewed here: https://curia.europa.eu/jcms/upload/docs/application/pdf/2025-08/cp250099de.pdf

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New REACH Enforce project (REF-15) introduced

In 2027, inspections will be carried out in companies that

  • handle substances of very high concern (SVHC)
  • have a valid authorization for Annex XIV substances.

The aim is to check restrictions on use in accordance with Annex XIV (authorization) and Annex XVII (restriction), REACH. The inspections are carried out by the national/municipal authorities. These are announced in advance.

The REF project aims to improve worker safety and strengthen enforcement by improving cooperation between the enforcement authorities responsible for REACH and the authorities responsible for occupational health and safety regulations. The evaluation is expected in 2028.

ECHA Enforcement Forum: https://echa.europa.eu/about-us/who-we-are/enforcement-forum

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Pharma Deutschland warns against reclassification of ethanol

In the course of the evaluation of ethanol as a biocidal active substance, Greece is currently examining the classification of ethanol as a CMR substance. The associations of the German healthcare industry are looking with great concern at ECHA’s classification procedure.

Ethanol is used in particular in disinfectants and in the manufacture of medical products and medicines. It is indispensable in the healthcare sector as its antimicrobial properties are effective against bacteria and viruses. During the pandemic, ethanol-based disinfectants ensured that chains of infection were broken.

We, ACA-pharma concept GmbH, support the associations of the German healthcare industry and are participating in the ECHA’s call for consultation.

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8% of registration dossiers audited still in breach of the update rule

From 2021 to 2023, ECHA conducted two campaigns on the update obligation of REACH registration dossiers under Article 22, REACH, as part of the REACH-En-Force projects. The first campaign examined 148 registrations of substances listed on Annex XIV, REACH. Only if the use of the downstream users is indicated in the registration dossier, they are allowed to use the substance.

The second campaign evaluated the correct indication of the harmonised classification according to the CLP Regulation in 541 registration dossiers.

A total of 57 registration dossiers were found to be deficient and even after requests from the auditors these deficiencies were not corrected in a timely manner. The companies concerned are reminded by the national authorities of the member states. If necessary, the registrants’ registration will be withdrawn and they will be ordered to pay an administrative fee.

The (planned) REACH En-Force projects can be viewed on the ECHA website.

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Comments on PFAS closed

On 25.09.2023 the comment period on the Annex XV Report on the restriction of PFASs in the EU closed. 5600 comments were submitted, the majority of which are against a general restriction of PFASs.

The public comments can be viewed on ECHA’s site.

RAC and SEAC are evaluating the proposed restriction and take the relevant information received during the consultation into account. The Committees prepare their independent scientific opinions, which are expected in 2024 and will be published on the ECHA website.

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REACH Enforce 13: Online trade

With the new REACH-Enforce Project No. 13, online trade in particular will be scrutinised more closely. State and federal authorities have reminded online traders of the labelling obligations of their products, and only in extreme cases have penalties been issued for non-compliance with Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP).

In 2025, inspectors will check online articles and mixtures for compliance with the REACH and CLP Regulations, as well as for compliance with RoHS II and POPs Guideline. The evaluation and a comprehensive report are expected in 2026.

For more information on the REACH-Enforce projects, please visit ECHA’s website.

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Communication of hazardous substances (SVHC) in products needs improvement

A pilot enforcement project in 15 participating countries has found that 12 % of inspected products contain substances of very high concern (SVHCs). ECHA informs, that the majority (88 %) of suppliers of these products are failing to communicate sufficient information to their customers about SVHCs in products they supply.

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