Europe Regulatory News

On 6 September 2023, the European Union notified to the World Trade Organization (WTO) a draft Commission Implementing Regulation approving Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (...

On 6 September 2023, the European Union notified to the World Trade Organization (WTO) a draft Commission Implementing Regulation approving Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) as an existing active substance for use in biocidal products of product-type 2 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council.

Alkyl (C12-16) dimethylbenzyl ammonium chloride

Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16); CAS No: 68424-85-1) is a cationic surfactant-type active substance. The physico-chemical properties of the active substance and biocidal products have been evaluated and are considered acceptable for the appropriate use, storage and transport of the active substance and biocidal products.

Similar to other quaternary ammonium compounds, ADBAC/BKC (C12-C16) acts as a membrane-active agent that primarily interacts with the cytoplasmic (inner) membrane of bacteria and the plasma membrane of yeasts and fungi. This interaction results in membrane rupture, subsequent leakage of intracellular components such as K⁺ ions and other cytoplasmic constituents, and ultimately, the precipitation of cell contents, leading to cell death.

Product-type 2 biocidal products

Product-type 2 refers to biocidal products that are used as disinfectants and algaecides and that are not intended for direct application to humans or animals. They are used as follows:

• For the disinfection of surfaces, materials, equipment, and furniture which are not used for direct contact with food or feeding stuffs.

• For disinfection of air, water not used for human or animal consumption, chemical toilets, wastewater, hospital waste and soil.

• As algaecides for treatment of swimming pools, aquariums, and other waters and for remedial treatment of construction materials.

• For incorporation into textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties.

Specific conditions

The authorisation of biocidal products using ADBAC/BKC (C12-C16) as an active substance is subject to the following conditions laid out in the Annex to the Regulation:

• The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.

• The product assessment shall pay particular attention to professional users.

On 6 September 2023, the European Chemicals Agency (ECHA) announced that the OECD eChemPortal has been updated with the latest data from ECHA’s database of REACH registrations. The update means that...

On 6 September 2023, the European Chemicals Agency (ECHA) announced that the OECD eChemPortal has been updated with the latest data from ECHA’s database of REACH registrations. The update means that data on more than 1.3 million endpoints for 27,000 substances registered with ECHA under REACH is now available on the OECD eChemPortal.

Content of the update

The update includes information on 186 new substances from ECHA’s REACH registrations database, bringing the total number to 26 673 substance records. In addition 18207 endpoint data sets have been added across all substances, bringing the total number to 1.35 million. The previous update was in December 2022.

OECD eChemPortal

The eChemPortal of the Organisation for Economic Co-operation and Development (OECD) gives free public access to information on properties of chemicals collected by various worldwide governmental chemical programmes. The portal is hosted by ECHA, and the OECD is responsible for the development and maintenance. The eChemPortal allows users to:

• Search reports and datasets simultaneously by chemical name and number, chemical property, and GHS classification.

• Access direct links to collections of chemical hazard and risk information prepared for national, regional and international governmental chemical programmes.

• Obtain classification results according to national/regional classification schemes or the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), where available.

• Access information on exposure and use of chemicals

The OECD eChemPortal can be accessed here.

On 1 September 2023, the European Chemicals Agency (ECHA) published 6 new proposals to identify Substances of Very High Concern (SVHC). The consultation is open until 16 October 2023.   Substan...

On 1 September 2023, the European Chemicals Agency (ECHA) published 6 new proposals to identify Substances of Very High Concern (SVHC). The consultation is open until 16 October 2023.

Substances of Very High Concern

SVHCs are substances that can have serious and often irreversible effects on human health and the environment. A substance that is identified as an SVHC will be added to the Candidate List for eventual addition to the Authorisation list. As of 14 June 2023, the Candidate list has 235 entries, some are groups of chemicals, so the overall number of impacted chemicals is higher. The Authorisation list has 59 entries. If a substance is on the Authorisation list, its use is prohibited unless the European Commission grants authorisation for continued use.

The proposed SVHCs

The six proposals that the ECHA is looking for comments on are listed in the table below:

Making Comments

The identification of SVHCs is based on the hazard properties of a substance. All interested parties are invited to submit comments during the. Comments are particularly welcome on:

• The identity of the substance (i.e. on the substance name/EC number/CAS number/molecular structure etc.)

• Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) properties and on other properties that give rise to equivalent levels of concern.

Comments for each substance can be made here by following the link to details and choosing making comments.

Comments relevant for the identification of a substance as an SVHC will be forwarded to the Member State Committee (MSC) which will assess whether the substance should be identified as an SVHC.

On 30 August 2023, the European Chemicals Agency (ECHA) published the sixth revised guidance addressing efficacy assessment and evaluation of biocidal products on its web page. The revised guidance co...

On 30 August 2023, the European Chemicals Agency (ECHA) published the sixth revised guidance addressing efficacy assessment and evaluation of biocidal products on its web page. The revised guidance covers the efficacy testing requirements and acceptance criteria for preservatives for liquid cooling and processing systems (product type 11) and slimicides (product type 12).

ECHA’s guidance on the Biocidal Products Regulation

ECHA's guidance on biocides legislation describes how to comply with the information requirements of the Biocidal Products Regulation (Regulation (EU) 528/2012) (BPR) and how to carry out the required evaluations. It also explains the guiding principles for the evaluation of applications to be carried out by the authorities.

Changes in the sixth revised guidance

In the sixth version of the Guidance on the BPR the following sections and appendices have been added:

• PT11 - Section 5.5.11 PT11 Preservatives for liquid-cooling and processing systems

• PT12 - Section 5.5.12 PT12 Slimicides

• Appendix 25 – References to chapters PT11 and PT12

• Appendix 26 – Definitions for PT11 and PT12

• Appendix 8 has been updated by adding the commonly used methods for PT11 and 12

The following corrections have been made, along with some minor editorial corrections relating to spelling.

• Appendix 3 (the Key for Table 42 section has been corrected)

• Appendix 4: PT 3 Teat disinfection (yeasts pre/post-milking - phase 2, step 2 test requirement has been changed from “If claimed” to “Optional”)

On 30 August 2023, the European Chemicals Agency (ECHA) encouraged all registrants of micro, small and medium-sized companies (SMEs) to check if their company size was registered correctly in REACH-IT...

On 30 August 2023, the European Chemicals Agency (ECHA) encouraged all registrants of micro, small and medium-sized companies (SMEs) to check if their company size was registered correctly in REACH-IT when their substance was registered. The deadline for reporting the correct company size is 25 September 2023. By declaring and correcting the company size before the deadline only the difference to the correct registration fee has to be paid.

How to declare company size

If a company size has been reported incorrectly, ECHA must be informed at sme‑verification@echa.europa.eu. Information on how to determine and declare the company size correctly can be found here. Furthermore, documentation supporting the claim must be uploaded in REACH-IT. If the correct company size is declared before ECHA starts a verification only the difference to the correct registration fee has to be paid.

Verification of company sizes

ECHA is continually launching new verifications of the SME company sizes declared when registering with REACH. If it is discovered during such a verification that the company size was declared incorrectly, an administrative charge of up to EUR 19 900 as well as the difference to the correct registration fee must be paid.

Determination of company size category

To determine the company size category for an SME the headcount and financial figures have to be established. Instructions can be found here. The table below gives the ceilings for the headcount and the financial limits that determine if a company can be considered a micro, small or medium-sized enterprise.

The European Chemicals Agency (ECHA) has announced that IUCLID 6 will replace the REACH-IT online dossier preparation functionality. IUCLID 6 is offered via the ECHA Cloud Services (IUCLID Cloud). ...

The European Chemicals Agency (ECHA) has announced that IUCLID 6 will replace the REACH-IT online dossier preparation functionality. IUCLID 6 is offered via the ECHA Cloud Services (IUCLID Cloud).

Changes

In 2024 the following REACH-IT online dossier preparation functionality will be removed:

• Downstream user notification of authorised uses

• Classification and labelling notifcations

Timeline

In January 2024 the initial online dossier preparation will be disabled. It will still be possible to update existing online notifications until April 2024. There is no deadline for the transition from the REACH-IT online dossiers to IUCLID dossiers. An update to an existing online dossier from REACH-IT can be prepared by downloading an old dossier from REACH-IT at any time and converting the dossier file to a dataset in IUCLID.

IUCLID

IUCLID (International Uniform Chemical Information Database) is a software application designed to record, store, maintain and exchange data on the intrinsic and hazard properties of chemical substances or mixtures, their uses of these substances and the associated exposure levels. It is a key software application for both regulatory authorities and the chemical industry where it is used in the implementation of various regulatory programmes.

ECHA develops and maintains the IUCLID software and the underlying format in collaboration with the OECD. This collaboration enables the management of the IUCLID format with the aim of harmonising as much as possible the way in which data on chemicals are collected and exchanged in regulatory settings.

IUCLID 6 on ECHA Cloud Services (https://ecs.echa.europa.eu/cloud/home.html) is free of charge and always up to date.

The European Chemicals Agency (ECHA) has prepared a draft investigation report on carcinogenic, mutagenic and reprotoxic (CMR, cat 1A or 1B) substances that may be present in childcare articles. The p...

The European Chemicals Agency (ECHA) has prepared a draft investigation report on carcinogenic, mutagenic and reprotoxic (CMR, cat 1A or 1B) substances that may be present in childcare articles. The purpose of the current investigation is to support the European Commission in the preparation of a restriction to protect children from exposure to CMR 1A or 1B substances in childcare articles.

The consultation on the draft investigation report has started on 23 August 2023. Interested stakeholders can provide their comments on the report and the appendices until 29 September 2023 (23:59 Helsinki time). Comments can be submitted here.

It is intended for interested parties such as childcare article manufacturers, importers or retailers, industry associations, consumer protection associations, testing laboratories, customs, and enforcement authorities. Both EU/EEA and non-EU stakeholders are encouraged to participate. The information submitted will be used to finalise the investigation report that will be sent to the Commission at the end of October.

The Report and Appendices can be viewed under Related Documents in this link: https://echa.europa.eu/calls-for-comments-and-evidence/-/substance-rev/74151/term

Information can be submitted confidentially and will be treated as such by ECHA. Any statement, figure or information provided via this call for evidence should be supported with a robust justification, and reference and calculation whenever relevant. Where information is submitted in this call for evidence, but no reference to sources or calculations are made to justify such information, it is unlikely that ECHA will be able take the comments into account.

For any clarifications please contact: cmrs-childcare-articles@echa.europa.eu. Information on the background for above news can be found  here.