Europe Regulatory News

On 25 September 2023, the European Commission adopted new rules under EU-REACH to restrict microplastics intentionally added to products. The amendment, Commission Regulation (EU) 2023/2055, to Annex ...

On 25 September 2023, the European Commission adopted new rules under EU-REACH to restrict microplastics intentionally added to products. The amendment, Commission Regulation (EU) 2023/2055, to Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was published in the Official Journal of the European Union on 27 September 2023 and will enter into force on 17 October 2023.

The new rules prohibit the sale of microplastics as such and of products to which microplastics have been intentionally added and that release those microplastics when used. The restrictions are expected to prevent the release of about half a million tonnes of microplastics to the environment over the next 20 years.

Why are restrictions for microplastics needed?

Microplastics are a concern because once they are released into the environment, microplastics do not undergo biodegradation and are virtually impossible to eliminate. They accumulate in animals, including fish and shellfish, ultimately leading to their ingestion by humans when these animals become part of the food chain.

Microplastics have been detected in marine, freshwater, and terrestrial ecosystems, as well as in food and drinking water supplies Their continued release contributes to permanent pollution of our ecosystems and food chains.  Laboratory studies have established a connection between exposure to microplastics and a variety of adverse ecological and toxicological effects on living organisms.

A significant part of microplastic pollution arises unintentionally, from processes such as the breakdown of larger pieces of plastic waste, wear and tear of tires and road markings, or the washing of synthetic textiles. Nevertheless, minuscule particles of synthetic or chemically altered natural polymers are also intentionally produced for direct use or inclusion in various products.

Definition of microplastics

In the adopted restriction the definition of microplastics covers all synthetic polymer particles smaller than 5 millimetres that are organic, insoluble and resist degradation as well as fibre-like particles below 15 mm in length. However, particles smaller than 0,1 μm (0,3 μm in length for fibre-like particles) will not be taken into account.

Affected products

The following are some common products that will be affected by the restriction:

• The granular infill material used on artificial sport surfaces which represents the largest source of intentional microplastics in the environment.

• Cosmetic products where microplastics are added for purposes such as exfoliation (microbeads) or to obtain specific textures, fragrances, or colours.

• Detergents and fabric softeners

• Glitter

• Fertilisers

• Plant protection products

• Toys

• Medicines and medical devices

Derogated products

The following products can continue to be sold as they are derogated from the sale ban:

• Products used at industrial sites.

• Products that contain microplastic but do not release them during use, e.g. construction materials.

• Products already such as medicinal products, food and feed that are already regulated by other EU legislation.

Manufacturers of such products will be required to provide instructions on how to use and dispose of the product to prevent microplastics emissions. Additionally, they must report the estimated microplastics emissions annually.

Products in which microplastics are not intentionally added but are inadvertently present, such as in sludge or compost, are not in the scope of the restriction.

Transitional periods

The first measures will come into effect on 15 October 2023, such as a ban on the sale of cosmetics containing microbeads, as their use is already being phased out, as well as loose plastic glitter. As for other cosmetics products, a transitional period ranging from 4 to 12 years will apply. The specific duration of the transitional period will depend on factors such as the complexity of the product, the need for reformulation, and the availability of suitable alternatives.

The ban on infill material for sport pitches will come into effect after 8 years. This timeframe offers pitch owners and managers enough time to transition to alternative materials and allowing most existing sports pitches to naturally complete their lifespan.

The complete Commission Regulation (EU) 2023/2055 that amends the REACH regulation as regards synthetic polymer particles can be found here.

On 12 September 2023, the European Commission notified the World Trade Organization (WTO) of decisions concerning two biocidal products. The disinfectant trihydrogen pentapotassium di(peroxomonosulfat...

On 12 September 2023, the European Commission notified the World Trade Organization (WTO) of decisions concerning two biocidal products. The disinfectant trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate) (KPMS) was approved as an existing active substance while Willaertia magna c2c maky was rejected. The final day for comments is 60 days from notification.

Trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate)

The notified document is a Draft Commission Implementing Regulation approving trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate), in accordance with Regulation (EU) No 528/2012

of the European Parliament and of the Council (Biocidal Products Regulation (BPR)), as an existing active substance for use in biocidal products of of the product-types (PTs) 2, 3, 4, and 5 as follows:

• PT 2: For professional and non-professional users to disinfect swimming pool water. For professional users to disinfect equipment and hard surfaces. KMPS is applied onto surfaces by spraying, mopping, and wiping.

• PT 3: For professional users in the veterinary hygiene for foot dips and for terminal disinfection of animal houses with a low-pressure sprayer.

• PT 4: For professional users for surface disinfection of food and feeding areas.

• PT 5: For professional users for continuous disinfection of animal drinking water by manual dosing of the header tank or through a dosing system.

For all product-types (2-5), KMPS shows a broad spectrum of antimicrobial activity and functions as a bactericide, yeasticide, fungicide, and virucide. The Biocidal Products Committee (BPC) supported the approval of this active substance for product-types 2, 3, 4 and 5 by consensus in June 2023.

The proposed date of adoption of the regulation is January 2024 and it will enter into force 20 days from publication in the Official Journal of the EU.

Willaertia magna c2c maky

In the second notification the notified document is a Draft Commission Implementing Decision not approving Willaertia magna c2c maky as an active substance for use in biocidal products of product-type 11 in accordance with the BPR .

Willaertia magna C2c Maky is a new active substance, and it is intended to be used by professionals to prevent the growth of Legionella pneumophila in industrial processing water systems (product-type 11). The BPC supported the non-approval of this active substance since the mode of action was not sufficiently investigated.

Thermally treated garlic juice

On 4 September 2023, the European Commission also notified the approval of thermally treated garlic juice as an existing active substance for use in biocidal products of product-type 19 (repellents and attractants). Biocidal products with this active substance are used in outdoor gardens to deter cats from defecating in treated areas such as lawns and flowerbeds.

The European Commission issued three solicitations for feedback on August 23, 2023: on the WEEE Directive, on the new end-of-life vehicle regulations, and on eco-design standards and labelling of elec...

The European Commission issued three solicitations for feedback on August 23, 2023: on the WEEE Directive, on the new end-of-life vehicle regulations, and on eco-design standards and labelling of electronic displays. The European Commission's commitment to participatory policymaking in sectors essential to sustainability, such as electronics, waste management, and vehicle manufacture, is reflected in these requests for public feedback. Participants are urged to participate through the official website of the European Commission. 

The WEEE directive 

The purpose of this consultation is to ascertain how much the directive supports a circular economy and Waste from Electrical and Electronic Equipment (WEEE) management that is environmentally responsible. 

The WEEE Directive has been implemented, and the Commission has recently opened a public consultation to solicit information and opinions from a variety of stakeholders who have contributed to and/or are otherwise involved in its goals and objectives, including individuals. 

The consultation is open for feedback until 22 September 2023 and contributions can be made by filling in a questionnaire which can be found here. 

Eco-design standards and labelling of electronic displays 

In order to evaluate whether the regulations have been successful in achieving or making progress toward their goals (lowering consumers' energy bills, enhancing the security of supply in the EU, and assisting in the reduction of greenhouse gas emissions), the European Commission is soliciting opinions on its review of the eco-design and energy labelling requirements for electronic displays.  

By September 21, 2023, interested parties are encouraged to offer their opinions. Feedback can be made here and here. 

End-of-life vehicle regulation 

The third consultation regards the proposal for a regulation on circularity requirements for vehicle design and on the management of end-of-life vehicles. 

As part of the European Green Deal, the proposed legislation aims to improve the collection, handling, and recycling of end-of-life vehicles (ELVs).  

The public is invited to participate in this conversation until November 2, 2023. Feedback can be given here (scroll down) 

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”)