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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.

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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.

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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.

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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.

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5 substances added to SVHC candidate list

ECHA has added 5 substances to the SVHC candidate list. The list now comprises 240 entries. The entry for dibutyl phthalate (CAS 84-74-2) has also been updated.

The list of newly added substances can be found here.

The current SVHC candidate list can be viewed on the ECHA homepage.

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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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ECHA: updated upload system

On 6 June 2023, ECHA will introduce the new system for the upload of regulatory notifications (REACH: Inquiry, Registration Dossiers, Authorisation Applications, etc.; CLP: PCN notifications, etc.; BPR: Application for Active Substance Authorisation, BP Authorisation Dossiers, etc.). This will bundle the different regulatory applications (REACH-IT, PCNP, R4BP3) in one place so that users can fulfil their obligations of the different regulations in one place.

You can join the webinar on the 6 June 2023 at 10 am (CEST) on the ECHA webpage.

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First comments on PFAS restriction published

You have the opportunity to comment on the application for restriction/authorisation for PFAS (per- and polyfluoroalkyl substances) until 25 September 2023. At regular intervals, the newly submitted public comments will be summarised in a document and made available for download.

ECHA and the national authorities of the Member States that proposed the restriction will respond to the comments, regularly.

You can view and comment on the PFAS restriction application here.

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