Regulatory Affairs overview: January 2025

Dive into our team's expertise in this Linkedin newsletter on the Biocides and REACH markets.

We are delighted to welcome you to this first 2025 issue of our newsletter. We wish you a happy new year!

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REACH

1. KKDIK news?

The Republic of Turkiye, Ministry of Environment, Urbanization and Climate Change has published the updated?Revolving Fund Unit Price List for 2025?which covers, among others, the?fees for?Registration of substances, intermediates, PPORD (Product and process-oriented R&D notifications) and for updates of the dossiers. Reduced fees are foreseen for SMEs and companies taking part in joint submissions.?

2. Ukraine REACH

On January 26, 2025, six months after its approval, the so-called Ukraine REACH regulation will come into effect, featuring a one-year pre-registration period and the formation of pre-SIEFs. Subsequent deadlines for chemical registration will be established based on tonnage bands and hazard classifications.

3. PCN

Starting from 1st January 2025, the notification requirement to EU national inventories of harmful mixtures? will no longer apply and only PCN notifications will be compliant for all types?of uses. Enforcement activities will begin to ensure that notification dossiers are complete and accurate.

Biocides

1. Revised Emission Scenario Document for Insecticides, Acaricides and products to control other arthropods for household and professional uses (ESD PT18)

Last December a new ESD for the evaluation of the environmental risk assessment for PT18 products for household and professional uses was published.

This document can almost be regarded as a new ESD rather than merely an update of the old OECD ESD No. 18, as it introduces significant changes to the calculation of environmental emissions arising from the use of PT18 products. These changes include adjustments to the extent of the treatments, frequency of use, and cleaning efficiency factors.

Additionally, new scenarios have been defined, such as:

• Outdoor large-scale spraying
• Direct surface and wastewater treatments
• Irrigation water treatment for private gardens
• Applications in sewage systems
• Uses in outdoor waste management facilities

These developments imply significant modifications to the regulatory strategy required for preparing PT18 dossiers. We strongly encourage applicants to familiarize themselves with these updates promptly and to begin applying the new scenarios immediately.

Do not hesitate to contact Aviron-Violet Sophie or José Antonio Fernández López for more information.

2. Change regulation: Elements for consideration for a potential amendment of Commission Implementing Regulation (EU) No 354/2013 on changes of biocidal products.

At the 105th CA meeting, the Commission presented a draft list of elements to consider for a potential amendment to the “Changes Regulation.” The goal is to establish a common understanding of key aspects to address before drafting a concrete proposal for the regulatory text.

The main topics discussed include:

• Classification of changes / Annex: Revise and complement the list of changes in the Annex of the Regulation using the available ECHA opinions on the classification of changes and the experience gained. If the change is not listed in the Annex, applicants need to provide an opinion from ECHA on the classification of the change with the submission of the application.
• Grouping of changes: Modification of Article 4(2)(a) and (d).
• Content of applications: Clarification of what needs to be submitted for each type of change (administrative, minor, major) and type of authorization (national and Union authorization).
• Simplification of the process of notification of administrative changes.
• Possibility to request for additional data during the validation step for minor/major changes.
• Procedure for changes to simplified authorizations. Developing more detailed rules for changes requested for authorization granted under the Art. 26.
• Changes during ongoing renewal, mutual recognition, other on-going changes. To cut off the possibility to request MIC or MAC during a renewal process. The changes must be completed before the RNL process.
• MIC/MAC for mutual recognition. Current practice allows a mutually recognized product to be changed in some but not to all concerned Member States.

It is important to note that these proposed amendments are still under discussion and may not necessarily be implemented.

If you are planning to apply for changes to your BPR authorizations, do not hesitate to contact us for guidance: [email protected]

In need for personalized regulatory advice to meet your specific needs? Whether you need assistance about compliance, product registration or any other regulatory issue, our experts are here to provide support: Aviron-Violet Sophie José Antonio Fernández López Elena Campagnoli

Contact us or visit our website for more information: [email protected]

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