Europe Regulatory News

On 17 October 2024, the European Ombudsman published a recommendation calling on the European Commission to address delays in the authorisation of dangerous chemical substances under the REACH Regulat...

On 17 October 2024, the European Ombudsman published a recommendation calling on the European Commission to address delays in the authorisation of dangerous chemical substances under the REACH Regulation. These delays, which average 14.5 months instead of the statutory three months, allow companies to continue using harmful chemicals, including carcinogens and endocrine disruptors, while decisions are pending. The Ombudsman’s inquiry found that the Commission’s internal procedures and incomplete applications by companies significantly slow down the process, sometimes extending decisions by years.

The REACH Regulation and its Objectives

The REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation aims to protect public health and the environment by regulating substances of very high concern (SVHCs). Companies applying for authorisation must demonstrate that the risks posed by the chemical are adequately controlled or that there are no suitable alternatives, often requiring extensive technical reviews. However, the Commission has struggled to meet deadlines, undermining the effectiveness of the Regulation in controlling hazardous chemicals in the EU.

Concerns about Transparency in Decision-Making

In addition to delays, the Ombudsman identified transparency issues, criticising the Commission for insufficient public access to the details of its decision-making. The Ombudsman recommended that the Commission publish more comprehensive reports of REACH Committee meetings and ensure that they are available before the next meeting. Greater transparency, the report suggests, will help the public to hold relevant stakeholders accountable for the prolonged decision-making process.

Recommendations for Improvement

To address these systemic issues, the Ombudsman recommends that the Commission streamline its internal procedures, enforce stricter data submission requirements on companies, and ensure greater transparency in the decision-making process. This would uphold the REACH Regulation's objectives of protecting human health and the environment from hazardous chemicals while ensuring timely action.

The European Commission has launched a public consultation to gather feedback on a new draft delegated decision to revise the European List of Waste. This update focuses on incorporating changes relat...

The European Commission has launched a public consultation to gather feedback on a new draft delegated decision to revise the European List of Waste. This update focuses on incorporating changes related to new battery chemistries and rapidly evolving manufacturing and recycling processes. The feedback period runs from 11 October 2024 until 8 November 2024.

Aim of the Revision

The European List of Waste serves as a common terminology for waste classification across EU Member States and provides an essential framework for the management and tracking of waste, including hazardous materials. The proposed revision aims to enhance the identification, monitoring and traceability of different waste streams, in particular in the light of recent technological advances in battery production. The aim is to ensure better alignment between environmental legislation and waste management processes, such as the handling of lithium-based batteries, which are increasingly considered hazardous under the ADR agreement.

CLP Classification and Reclassification of Battery Waste

The proposed delegated decision introduces important updates to waste classification under the Classification, Labelling, and Packaging (CLP) Regulation (EC No 1272/2008). New hazardous waste codes have been introduced for battery-related waste streams, in particular for "black masses", which are intermediate fractions from battery treatment. These codes are supported by updated hazard classifications to ensure better alignment with waste shipment requirements under the Waste Shipment Regulation.

Another significant change is the reclassification of alkaline batteries. Previously classified as non-hazardous, alkaline batteries are now considered hazardous due to updated scientific evidence on the concentration of hazardous substances in these batteries. In addition, a new waste code has been introduced for lithium-based batteries, which pose specific hazards such as fire and explosion risks. This aims to improve the safe management and recycling of lithium-based batteries.

Key Considerations for Stakeholders

The Commission is seeking input on how best to adapt the waste classification system to reflect modern battery chemistries and improve waste management practices. Stakeholders are invited to provide feedback on whether the proposed changes will sufficiently address the challenges posed by the rapid development of new battery technologies and whether the classification of certain waste streams should be redefined as hazardous or non-hazardous.

Next Steps

Following the consultation period, the European Commission will review the feedback and refine the draft delegated decision before adopting it. All feedback will be published on the European Commission’s website and where appropriate, incorporated into the final text of the legislation.

This consultation is an important opportunity for industry stakeholders, environmental groups and EU citizens to shape the future of waste management in Europe, particularly in the context of the growing use of advanced battery technologies.

On 30 September 2024, the European Commission published the 22nd Adaptation to Technical Progress (ATP) under Regulation (EC) No 1272/2008 (CLP). The 22nd ATP was adopted on 19 June 2024 and published...

On 30 September 2024, the European Commission published the 22nd Adaptation to Technical Progress (ATP) under Regulation (EC) No 1272/2008 (CLP). The 22nd ATP was adopted on 19 June 2024 and published in the Official Journal of the European Union and amend Table 3 of Part 3 of Annex VI to the Classification, Labelling and Packaging (CLP) Regulation by introducing 27 new harmonised classifications, modifying 16 preexisting entries and deleting 7 harmonised classifications. The amendments will come into effect on 1 May 2026.

Compliance Deadlines for 22nd ATP

The new classifications enter into force on 20 October 2024 and will apply from 1 May 2026, giving suppliers sufficient time to adjust their labelling and packaging in line with the new rules. However, suppliers may voluntarily adopt the updated classifications before this date to ensure compliance and to better protect public health and the environment.

New Harmonised Classifications in 22nd ATP

The table below lists the 27 new harmonised classifications added to Part 3, Table 3 of Annex VI to the CLP Regulation. The 16 modified entries can be found here.

For full access to the regulation, visit https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202402564

Deadline for 21^st Adaptation to Technical Progress

The previous ATP (21st ATP) was published in the Official Journal of the European Union on 5 January 2024 and will apply from 1 September 2025. It, however, entered into force on 25 January 2024 and therefore suppliers may already now classify label and package substances and mixtures in accordance with the CLP regulation as amended by the 21st ATP.

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. 

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. 

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.