Europe Regulatory News

On September 6, 2024, the European Chemicals Agency (ECHA) launched a consultation for IPBC (3-iodo-2-propynylbutylcarbamate) under Article 10(1)(e) of the Biocidal Products Regulation (Regulation (EU...

On September 6, 2024, the European Chemicals Agency (ECHA) launched a consultation for IPBC (3-iodo-2-propynylbutylcarbamate) under Article 10(1)(e) of the Biocidal Products Regulation (Regulation (EU) No 528/2012). The consultation focuses on concerns related to IPBC’s critical effects.  

Importance of IPBC in Wood Preservation 

This biocidal substance is widely used in the EU for wood preservation, protecting against fungal degradation that can affect the appearance and structural integrity of wood. Its uses range from the temporary protection of freshly-sawn timber to the preservation of outdoor structures such as fences and furniture.  

Endocrine Disruption Concerns and the Search for Alternatives 

Due to concerns about the potential of IPBC for endocrine disruption, alternative substances are being assessed. However, although several approved substances have been identified as potential substitutes, the analysis concluded that none are viable replacements for IPBC in its various applications, primarily due to concerns about efficacy, risk, and availability. 

Use of IPBC in the EU 

IPBC is registered under the REACH Regulation, with annual production or import volumes between 10 and 100 tonnes in the European Economic Area (EEA). It has biocidal approvals for several applications, including product preservation, wood preservation, and working/cutting fluids. It is also under review for additional uses in the preservation of films, fibres, and construction materials. Industrially, IPBC is used in formulation of mixtures and manufacturing processes. 

Role in Wood Preservation 

As a biocidal agent, IPBC is used in wood preservatives to combat fungal degradation and enhance the appearance and structural integrity of wood. It is utilized throughout the wood lifecycle, often in combination with other fungicides to broaden effectiveness and reduce resistance. Approximately 713 PT8 biocidal products contain IPBC,280 of which use it as the sole active ingredient. 

Health and Environmental Concerns 

IPBC has been classified as hazardous in the European Union's harmonized classification and labeling (ATP06) has identified. It poses serious health risks, being toxic when inhaled and harmful if ingested. Prolonged exposure can damage organs, and it is highly toxic to aquatic life, with long-lasting effects. Additionally, it can cause severe eye injuries and may trigger allergic skin reactions. 

Consultation Deadline 

The consultation for IPBC will end on November 6, 2024. 

On September 6, 2024, the European Chemicals Agency (ECHA) launched a consultation for medetomidine in accordance with Articles 10 and 5 of Regulation (EU) No 528/2012 (the Biocidal Products Regulatio...

On September 6, 2024, the European Chemicals Agency (ECHA) launched a consultation for medetomidine in accordance with Articles 10 and 5 of Regulation (EU) No 528/2012 (the Biocidal Products Regulation, BPR). The Biocidal Products Committee (BPC) has determined that medetomidine does not meet the renewal criteria for product type 21 set out in Article 5(1)(d) of the BPR. As a result, the approval for medetomidine will not be renewed unless it meets one of the exceptions specified in Article 5(2). 

Overview of Medetomidine 

Medetomidine is a synthetic compound used as an anaesthetic and analgesic in veterinary medicine and as a sedative in human medicine. It consists of two stereoisomers, of which dexmedetomidine exhibits significant biocidal activity as an antifouling agent. Dexmedetomidine selectively activates α2 adrenoceptors, reducing norepinephrine release and decreasing central nervous system excitation, which contributes to its sedative effects and potential toxicity. In antifouling applications, medetomidine binds to octopamine receptors on marine larvae, increasing their motility and preventing settling.  

Safety Assessment 

The BPC has concluded that medetomidine is not mutagenic, carcinogenic, or a reproductive toxicant. However, it does exhibit endocrine-disrupting properties that  affect and related biological pathways. Although there are no standardized methods for assessing these effects, medetomidine is categorized as an endocrine disruptor under EU regulations. Traditional exposure assessment revealed no significant risks, except for young children who may come into contact with freshly treated surfaces. However, a definitive conclusion regarding the overall risk to human health remains elusive. 

Substitution 

Medetomidine has been determined to meet the exclusion criteria specified in Article 5(1)(d) of the BPR, making it eligible for substitution under Article 10. This classification is due to its identification as a persistent, bio-accumulative, and toxic (PBT) substance containing a significant amount of non-active isomers. The assessment was carried out in accordance with guidelines established during recent meetings of Member State Competent Authorities, focusing on the relevant exclusion and substitution criteria in the BPR. 

Consultation Deadline 

The consultation for medetomidine will close on November 6, 2024. 

UPDATE: The new CLP Regulation (Regulation (EU) 2024/2865) was published in the Official Journal of the European Union on 20 November 2024 and will enter into force on 10 December 2024. The full text ...

UPDATE: The new CLP Regulation (Regulation (EU) 2024/2865) was published in the Official Journal of the European Union on 20 November 2024 and will enter into force on 10 December 2024. The full text can be found here. In addition, ECHA published its updated guidance on the application of CLP criteria on 13 November 2024, to reflect these regulatory changes and provide enhanced support for compliance.

Original text:

On 14 October 2024, the Council of the European Union adopted a new Regulation on the Classification, Labelling, and Packaging (CLP) of Chemical Substances. This update modernises the 2008 CLP Regulation to better reflect evolving chemical hazards and trends in trade and consumer protection.

The adoption marks the final step in the legislative process. Once signed by the President of the European Parliament and the President of the Council, the new CLP Regulation will be published in the Official Journal of the European Union and will enter into force three days later.

CLP Background

The European Commission proposed the CLP revision in December 2022. A provisional agreement was reached between the European Parliament and the Council in December 2023. The adoption concludes the legislative process, aiming to better protect consumers and the environment from chemical hazards.

Key Changes to the CLP Regulation

The newly adopted CLP Regulation focuses on improving chemical safety by:

• Ensuring faster identification and classification of new hazards, including endocrine disruptors.

• Clarifying labelling requirements for both traditional and digital formats.

• Adapting the rules to modern trading practices such as online sales and bulk purchasing.

• Promoting the circular economy through refill stations and more sustainable product handling.

A key feature of the new regulation is the introduction of voluntary digital labelling and specific rules for chemical refill stations. Additionally, the Regulation provides for a five-year grace period for non-modified substances of botanical origin with more than one constituent (MOCS).

Strengthening the Chemicals Strategy for Sustainability

This revision is part of the broader Chemicals Strategy for Sustainability, which supports the European Green Deal. Together with the planned revision of the REACH Regulation, the updated CLP legislation aims to create a more sustainable and toxic-free environment.

On September 18, 2024, the European Chemicals Agency (ECHA) launched a public consultation on 2,2-dibromo-2-cyanoacetamide [DBNPA]. European authorities have determined that DBNPA has endocrine disrup...

On September 18, 2024, the European Chemicals Agency (ECHA) launched a public consultation on 2,2-dibromo-2-cyanoacetamide [DBNPA]. European authorities have determined that DBNPA has endocrine disrupting properties, which means that it meets the exclusion criteria present in Article 5(1)(d) of the Biocidal Products Regulation (EU) No 528/2012.  

Risk Assessment and Approval Considerations for Product Type 12 

Despite its classification, the risk associated with the use of DBNPA in Product Type (PT) 12 applications has been assessed as negligible and manageable. Consequently, in the absence of technically feasible, economically viable, and less hazardous alternatives, approval of DBNPA for PT 12 may be considered under Article 5(2). A key factor in this decision is the availability of suitable alternatives. A confidential Analysis of Alternatives (AoA) was carried out to evaluate potential substitutes for the main uses of DBNPA in PT 12, a summary of which was provided for ECHA's Public Consultation, while the complete AoA remains confidential. 

DBNPA for Product Type 12 

Product Type 12 (PT 12) encompasses biocidal products specifically designed as slimicides, which prevent or control the growth of slime on materials, equipment, and structures in industrial processes. Consequently, the use and handling of DBNPA within this category is limited to industrial settings and trained professionals. 

Applications and Alternatives Assessed in the AoA 

The AoA evaluated specific applications of DBNPA in PT 12, including its use for biofouling and biofilm control in Reverse Osmosis (RO) and Nanofiltration (NF) membrane systems for industrial water production, as well as for microbial control in pulp and paper additives, mixtures, and coating systems. 

Although the technical requirements for these applications are similar, the AoA separately identified and assessed potential alternatives for DBNPA in RO/NF systems and in paper production. This evaluation considered the required technical and functional properties, performance, hazards and risks, as well as the availability and economic viability of the alternatives. 

Health and Environmental Risks of DBNPA 

According to the information provided by ECHA, DBNPA is fatal if inhaled and toxic if ingested. It poses a risk of organ damage with prolonged or repeated exposure and is highly toxic to aquatic life, with long-lasting effects. Additionally, it can cause severe eye damage, skin irritation, and may trigger allergic skin reactions. 

Consultation Deadline  

The consultation on DBNPA will close on November 17, 2024. 

The Health and Safety Executive (HSE), the UK's regulatory body for biocidal goods under the GB Biocidal Product Regulation (GB BPR), is conducting a public survey to gather data on the use of bio...

The Health and Safety Executive (HSE), the UK's regulatory body for biocidal goods under the GB Biocidal Product Regulation (GB BPR), is conducting a public survey to gather data on the use of biocidal agents in the treatment of the deceased.. The Product Type (PT22) of the GB BPR covers 'embalming and taxidermist fluids – products used for the cleaning and preservation of human or animal corpses, or parts thereof'. The survey runs until 8 December 2024.

Understanding how biocides are used in many areas of society helps the HSE to make prompt decisions and establish priorities. Following industry input, the HSE would want to gather more information from professionals and businesses involved in embalming and other related procedures such as the preservation of tissue samples for research and/or educational purposes.

Survey on Embalming and Preservation Products

The HSE is particularly interested in input on the most commonly used chemicals and goods, as well as their availability. The survey's insights will enable the HSE to continue to develop policies that take into account the industries to which they apply. The target audience is professionals and enterprises involved in embalming, taxidermy, and tissue preservation.

The information collected will assist the HSE to make informed decisions and establishing priorities for the regulation of biocidal goods in the UK. Understanding the industry's particular demands and practices will enable the HSE to establish regulations that effectively address the safety and environmental problems associated with these substances.

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On 26 September 2024, the European Chemicals Agency’s (ECHA) Committee for Risk Assessment (RAC) concluded that talc should be classified as a Category 1B carcinogen and STOT RE1 under the Classific...

On 26 September 2024, the European Chemicals Agency’s (ECHA) Committee for Risk Assessment (RAC) concluded that talc should be classified as a Category 1B carcinogen and STOT RE1 under the Classification, Labelling and Packaging (CLP) Regulation. Although a lower classification (Category 2 carcinogen) was proposed by the proposal submitter the Netherlands, RAC opted for the more stringent Category 1B, indicating greater concern about talc’s potential to cause cancer.

Implications of the New Classification

The Category 1B classification means that talc (Mg₃H₂(SiO₃)₄; CAS No 14807-96-6) is suspected of causing cancer in humans, which may lead to its designation as a substance of very high concern (SVHC). This new classification could have a significant impact on industries that rely on talc, particularly in cosmetics, pharmaceuticals and other consumer products.

Evidence Behind the Decision

RAC's decision was based on limited human and animal evidence, a first for the committee, which usually bases its conclusions on sufficient evidence from animal studies. Talc has been linked to lung tumours in female rats following inhalation and ovarian tumours in humans following perineal exposure. The Committee also agreed on a classification for specific target organ toxicity (STOT RE) related to repeated lung exposure.

Industry Reaction and Regulatory Implications

The European talc industry, represented by Eurotalc, strongly opposes this classification, claiming that the evidence does not meet the criteria for carcinogenicity. Nevertheless, tighter regulatory controls on talc-containing products are expected as the new classification addresses all routes of exposure due to insufficient data to exclude other routes, such as oral ingestion.

 Future Regulatory Outlook

RAC’s decision is expected to influence regulatory frameworks across Europe and beyond. As authorities continue to assess the safety of talc, manufacturers will need to prepare for tighter regulations and increased scrutiny of products containing talc.

Other Classification and Labelling Decisions from the RAC Meeting

In addition to the classification of talc, RAC adopted opinions on harmonised classification and labelling (CLH) for twelve other substances including:

• Eugenol (CAS 97-53-0): Widely used in perfumes, cosmetics, and cleaning products. Classified as Acute Toxicity 4, Eye Irritation 2 and Aquatic Chronic 2, but no classification for skin irritation.

• 3,5-Dimethylpyrazole (CAS 67-51-6): Used in the manufacture of polymers and coatings. RAC supported the classifications Acute Toxicity 4 and Reproductive Toxicity 1B proposed by Belgium.

• Borate Minerals Group: RAC supported a Reproductive Toxicity 1B classification potential risks to fertility.

The full list of opinions is available here. These decisions reflect the ongoing work of RAC to ensure the safety of chemicals in the EU. The full opinions will be published on the ECHA website shortly.

Opinions on Chromium Compounds

RAC also adopted opinions on chromium compounds, which are commonly used in metal plating, pigments and corrosion protection. These included opinions on the use of chromium trioxide and other compounds of hexavalent chromium (Cr(VI)), which are known carcinogens. The full list of adopted opinions can be found here.

The Lithuanian State Crop Production Service, part of the Ministry of Agriculture, has issued a strict warning to buckwheat producers that the use of glyphosate-containing herbicides on buckwheat crop...

The Lithuanian State Crop Production Service, part of the Ministry of Agriculture, has issued a strict warning to buckwheat producers that the use of glyphosate-containing herbicides on buckwheat crops before harvest is prohibited by law.

Recent Violations and Penalties

As the buckwheat harvest season begins, the State Crop Production Service has issued a strong warning against the use of glyphosate-containing pesticides in buckwheat fields. The State Crop Production Service of the Ministry of Agriculture has said that no plant protection chemicals are licensed for use on buckwheat before harvest, so glyphosate treatment is completely banned.

Recent incidents of buckwheat producers applying glyphosate on their crops have resulted in administrative penalties and the removal of contaminated production. This approach not only poses a risk to food safety but is also illegal and can result in financial losses for farmers.

Ongoing Inspections and Public Reporting

The State Crop Production Service regularly inspects fields to ensure they are compliant. If cases of unauthorised glyphosate use are reported, full inspections are carried out, and violators are fined. Information on violations and possible contaminated items will be shared with the relevant authorities, such as the State Food and Veterinary Service, the National Payment Agency, and VšĮ "Ekoagros" the organic certification for organic farms.

The public is encouraged to report any suspected violations of plant protection product use, especially during the harvest season.

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