Europe Regulatory News

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 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. 

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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On 23 September 2024, the European Commission adopted a Regulation amending the Test Methods Regulation (Regulation (EC) No 440/2008). The aim of the update is to adapt the test methods to recent tech...

On 23 September 2024, the European Commission adopted a Regulation amending the Test Methods Regulation (Regulation (EC) No 440/2008). The aim of the update is to adapt the test methods to recent technical progress, thereby improving the accuracy of the evaluation of chemical substance evaluations under the REACH Regulation (Regulation (EC) No 1907/2006), while at the same time promoting more humane scientific practices by limiting the need for animal testing.

Alignment with OECD Guidelines

The amendment includes seven new and revised test methods in line with the Organisation for Economic Cooperation and Development (OECD) guidelines. These methods are designed to assess the physicochemical, toxicological and ecotoxicological properties of substances, aligning the EU with globally accepted testing standards.

Focus on Reducing Animal Testing

The amended Regulation prioritises reducing the use of animals in scientific experiments, as set out in Directive 2010/63/EU. New in vitro methods for immunotoxicity and skin sensitisation are now included, along with updated ecotoxicity tests. These improvements ensure a more ethical and accurate evaluation of the impact of chemicals on human health and the environment.

Entry into Force

The amended Regulation will enter into force 20 days after its publication in the Official Journal of the European Union and will become binding in all EU Member States.

On 25 September 2024, the European Union notified the World Trade Organization (WTO) about a Draft Commission Delegated Regulation amending Regulation (EC) No 1272/2008 on classification, labelling, a...

On 25 September 2024, the European Union notified the World Trade Organization (WTO) about a Draft Commission Delegated Regulation amending Regulation (EC) No 1272/2008 on classification, labelling, and packaging (CLP) of hazardous substances and mixtures. The Regulation updates Table 3 of Part 3 of Annex VI to the CLP Regulation by introducing and revising the harmonised classification and labelling (CLH) of 32 substances or groups of substances.

Updated Substances

These updates are based on scientific opinions from the European Chemicals Agency’s (ECHA) Committee for Risk Assessment (RAC), which reviewed data on several chemicals. The substances are listed in the table below.

The list of updates with details about hazard classes can be found here. The substances were flagged for potential hazards, such as carcinogenicity, environmental toxicity, or serious health risks, which require stricter regulation in the EU.

Consultation Process 

The proposed changes were informed by public consultations managed by ECHA, where Member States and stakeholders provided feedback. Comments were taken into account in the final RAC opinions. Additionally, expert input was sought through the CARACAL group, which brings together Member States competent authorities responsible for REACH and CLP, as well as industry and regulatory stakeholders.

Main Objectives and Rationale 

The main objectives of the amendments are:

• To ensure the protection of human health and safety.

• Strengthen the protection of the environment by tightening regulations on hazardous substances.

• To facilitate the free movement of substances and mixtures in the EU by harmonising classifications at EU level.

Timeline for Adoption and Application 

The Regulation is expected to be adopted in the fourth quarter of 2024. It will enter into force 20 days after its publication in the Official Journal of the EU, probably in early 2025. A transition period of 18 months is included to allow companies time to adapt their labelling and packaging to the new requirements. However, suppliers will be able to voluntarily apply the new classifications once the regulation enters into force.

Next Steps and Stakeholder Involvement 

Stakeholders are invited to submit comments on the draft Regulation within 60 days of its notification. The final regulation will be shaped by the feedback received during this consultation period to ensure that the amendments address industry concerns while maintaining high safety standards.

Further Resources 

The full text of the Draft Commission Delegated Regulation is available here and the full list of substances is available here.

In a recent plenary session on 18 September 2024, the European Parliament blocked two European Commission decisions that would have allowed residues of pesticides currently banned in the EU in importe...

In a recent plenary session on 18 September 2024, the European Parliament blocked two European Commission decisions that would have allowed residues of pesticides currently banned in the EU in imported food products.

Details of the Blocked Decisions

The decisions concerned maximum residue levels (MRLs) for pesticides such as cyproconazole and spirodiclofen in cereals, seeds and meat products, as well as benomyl, carbendazim and thiophanate-methyl in citrus fruits and okra. These pesticides are highly toxic and are banned in the EU due to their serious health and environmental risks. Carbendazim, thiophanate-methyl and cyproconazole are classified as mutagenic, reprotoxic and endocrine disruptors, with the potential to harm human health and aquatic life. MEPs argued that allowing residues of these pesticides in imports would endanger public health and create unfair competition for EU farmers.

MEPs Call for Equal Standards

The resolutions stressed that products imported from non-EU countries should meet the same safety standards as those produced in the EU, to ensure a level playing field. The objection to the Commission’s decision on cyproconazole and spirodiclofen was supported by 522 MEPs, while 516 MEPs voted against the use of benomyl, carbendazim and thiophanate-methyl.

Next steps

The Commission must now withdraw its proposals and come forward with new draft that lower the MRLs to the limit of detection or set a default value of 0.01 mg/kg.