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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

21/08/2025 Comments Off on Updated ECHA Q&A document on the restriction of Cr(VI) substances is available Allgemein, Chemicals Like

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

06/08/2025 Comments Off on Classification of titanium dioxide revoked Allgemein, Chemicals Like

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

06/08/2025 Comments Off on New REACH Enforce project (REF-15) introduced Allgemein, Chemicals Like

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.

01/04/2025 Comments Off on Pharma Deutschland warns against reclassification of ethanol Allgemein, Chemicals 1

Consultation: Ethanol as a biocidal active substance

In March 2024, Greece submitted a draft assessment report for ethanol in product groups 1, 2 and 4. This is currently being reviewed by other competent authorities in the EU and Switzerland. A decision on whether ethanol will be approved as a biocidal active substance is expected in the second half of 2025.

Part of the evaluation is also the classification of ethanol according to the CLP Regulation (EC No. 1272/2008). Ethanol is currently harmonized classified as Flammable liquid 2 (Flam. Liq. 2, H 225) according to the CLP regulation. Greece has announced to review the harmonized classification of ethanol and proposes a classification as a carcinogen (category 1A or 1B) and/or toxic for reproduction (category 1A or 1B). This is based on entries from the ECHA classification and labelling inventory. If these properties are confirmed, ethanol may not be used as an active biocidal substance.

On February 25, 2025, the consultation with the ECHA started in order to find possible alternatives for ethanol in biocidal products of PT 1, 2 and 4.

01/04/2025 Comments Off on Consultation: Ethanol as a biocidal active substance Biocides Like

Environmental risk assessment of medicinal products for human use

The marketing of a medicinal product in Europe generally requires authorisation from the competent authorities. An important part of this is the environmental risk assessment (ERA). One of the aims of the PREMIER project is to create a database containing ecotoxicological studies and studies on the fate of active pharmaceutical ingredients in the environment, which will allow data to be made available for the development of models for predicting environmental data.

According to this concept, older active substances that have never undergone an ERA could be prioritised for further (environmental) studies. Similarly, data from the active substances can be used to identify potential environmental risks at an early stage for new active substances that are still in development.

Further information can be found here.

We are happy to support you in the preparation of ERAs and your marketing authorisation: our services.

07/08/2024 Comments Off on Environmental risk assessment of medicinal products for human use Medicine pharma Like

Environmental Risk Assessment

The revised version of the Guideline for the Environmental Risk Assessment (ERA) of medicinal products comes into force on 1 September 2024.

This will result in numerous changes/innovations, e.g. with regard to test strategies to be applied (e.g. antibiotic substances), the assessment of possible secondary poisoning and the methodology. The revised version was a long time coming with initial concepts dating back to 2016.

At the same time, the revision of EU pharmaceutical legislation will result in numerous tightening measures with regard to the assessment of environmental risks posed by medicinal products. The reform of pharmaceutical legislation is intended to support the objectives of the Green Deal, which calls for a transformation of the economy and society towards greater environmental protection and sustainability. The Green Deal calls for a reduction of 50% in plastic waste and 30% in microplastics in the environment, 50% in the use of pesticides and 50% in the use of antibiotics in animals by 2030.

With regard to the risks associated with the use of medicinal products, the proposed Medicinal Products Directive takes into account undesirable effects of the medicinal product on the environment (Art. 4(35)) and the derivation of a risk-benefit ratio of a positive therapeutic effect of the medicinal product in relation to possible environmental risks (Art. 4(41)). This means that environmental aspects can lead to the rejection of an authorisation.

Article 22 also states that other EU legislation relevant to the ERA must be taken into account. Furthermore, the CLP Regulation ((EC) No. 1272/2008) Annex I is to be applied with regard to the classification of the medicinal product, one of its ingredients or other components as PBT, vPvB, PMT or vPvM.

The consequences of the forthcoming revision of the environmental assessment on the authorisation of AMs are not yet foreseeable. The study requirements are becoming more complex, the studies are expensive and lengthy. With the limited number of test facilities, there are probably not enough slots available for conducting them.

ACA-pharma concept GmbH regularly carries out environmental risk assessments and also offers corresponding training seminars.

26/03/2024 Comments Off on Environmental Risk Assessment Medicine pharma 1

Restriction on PFAS – next steps

In the context of the possible restriction of PFAS, ECHA has published new dates regarding the evaluation of the more than 5600 comments on the restriction proposal.

The evaluation by RAC and SEAC is divided into three stages, depending on the use of PFAS in mixtures/products:

March 2024:

Consumer mixtures, cosmetics and ski wax
Hazards of PFAS (RAC only)
General approach (SEAC only)

June 2024:

Metal coating and manufacture of metal products
Further discussions on PFAS hazards (RAC only)

September 2024:

Textiles, upholstery, leather, garments, carpets (TULAC)
Food contact materials and packaging
Petroleum and mining

In parallel, the representatives of the 5 member states are updating their Annex XV dossier with reference to the numerous comments.

You can find the ECHA news article here.

13/03/2024 Comments Off on Restriction on PFAS – next steps Chemicals Like

ECHAChem – ECHA’s new substance databank

ECHA has released ECHChem, their new substance databank. As previously on the ECHA homepage, the dashboard can be used to search for a substance by substance name, CAS number, EC number or structure.

We are happy to help you with the implementation of the REACH and CLP regulations.

14/02/2024 Comments Off on ECHAChem – ECHA’s new substance databank Chemicals Like

28 new and 24 revised entries in Annex VI of the CLP Regulation

Delegation Regulation (EU) 2024/197 adds 28 new entries and revises 24 other entries to Annex VI of the CLP Regulation 1272/2008. The amendments will enter into force on 1 September 2025.

The Delegation Regulation can be found on Eur Lex.

25/01/2024 Comments Off on 28 new and 24 revised entries in Annex VI of the CLP Regulation Chemicals Like

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