Europe Regulatory News

On 1 March 2024, the European Chemicals Agency (ECHA) published a call for comments on proposals to identify two substances as Substances of Very High Concern (SVHC). The deadline for subtmitting com...

On 1 March 2024, the European Chemicals Agency (ECHA) published a call for comments on proposals to identify two substances as Substances of Very High Concern (SVHC). The deadline for subtmitting comments is 15 April 2024. Comments are particularly welcome on the identity of the substance and on PBT or vPvB properties or properties of similar concern. Furthermore, ECHA welcomes comments and further information on uses, tonnage per use, exposure, alternatives, and risks of the chemicals, which will help to decide whether the substance should be recommended for inclusion in the Authorisation List at a later stage.

Substances of Very High Concern

SVHCs are substances that may cause serious and often irreversible effects on human health and the environment. A substance identified as an SVHC will be added to the Candidate List for possible addition to the Authorisation List. As of January 2024, the Candidate List has 240 entries, some of which are groups of chemicals, so the total number of chemicals concerned is higher. The Authorisation List contains 59 entries. If a substance is on the Authorisation List, its use is prohibited unless the European Commission grants an authorisation for continued use.

Substance 1: Bis(α,α-dimethylbenzyl)peroxide

The first substance in the consultation submitted by Norway is bis(α,α-dimethylbenzyl peroxide (CAS No 80-43-3) which is proposed to be identified as a substance meeting the criteria of Article 57 (c) of the REACH Regulation as it is classified as toxic for reproduction category 1B (H360D: may damage the unborn child).

Bis(α,α-dimethylbenzyl peroxide is mainly used in the polymer industry. Between 10,000 and 100,000 tonnes are manufactured or imported each year in the European Economic Area (EEA).

Substance 2: Triphenyl phosphate

The second substance submitted by France is triphenyl phosphate (TPhP) (CAS No 115-86-6), which is proposed to be identified as a substance meeting the criteria of Article 57 (f) of the REACH Regulation because it is an endocrine disrupting substance for which there is scientific evidence of probable serious effects to the environment.

TPhP is used as a flame retardant and plasticiser in polymer formulations, adhesives and sealants, cosmetics and personal care products. TPhP is used by consumers, in articles, by professionals (widespread use), in formulation or repackaging, at industrial sites and in manufacturing. TPhP is found as an impurity in many other organophoshate flame retardants or as a component of this family of compounds. It is manufactured and imported in the EEA in the range 100 to 1000 tonnes per year.

Future process

The substances will be added directly to the Candidate List if ECHA receives no comments challenging the identification. If the consultation comments provide new information that challenges the basis for SVHC identification, the comments and the proposal will be referred to ECHA’s Member State Committee (MSC).

At a meeting of the European Commission’s REACH Committee on 29 February 2024, EU Member States voted in favour of a Commission Regulation restricting perfluorohexanoic acid (PFHxA), its salts and r...

At a meeting of the European Commission’s REACH Committee on 29 February 2024, EU Member States voted in favour of a Commission Regulation restricting perfluorohexanoic acid (PFHxA), its salts and related substances. The proposal, originally submitted by the German authorities in 2020 and endorsed by ECHA's Scientific Committees in late 2021, will now undergo a three-month review by the European Parliament and the Council before possible adoption by the Commission.

Perfluorohexanoic acid

PFHxA, its salts and related substances are a subgroup of PFAS (per- and polyfluorinated substances). They are used in large quantities in sectors such as clothing, textiles and paper and cardboard food packaging, to provide water, oil and stain repellency. Concerns about PFHxA and other PFAS stem from the resistance of these compounds to hydrolysis, photolysis, and biodegradation, which leads to their persistence in the environment.

Amendment to Annex XVII of the REACH Regulation

The Regulation prohibits the placing on the market or use of PFHxA and its salts and PFHxA-related substances, in various products. The amendments will be added to Annex XVII of the REACH Regulation. The concentration limits are set at 25 parts per billion (ppb) for PFHxA and its salts, and 1000 ppb for PFHxA-related substances, measured in homogeneous material. The restrictions will enter into force 24 months after the entry into force of the Regulation and will apply to

• Textiles, leather, furs and hides in clothing and related accessories for the general public.

• Footwear for the general public. 

• Paper and cardboard used as food contact materials (FCMs) within the scope of Regulation (EC) No 1935/2004.

• Mixtures for the general public.

• Cosmetic products as defined in Article 2(1), point (a), of Regulation (EC) No 1223/2009.

In addition, for non-clothing textiles, leather, fur and hides (other than in clothing and related accessories for the general public), the restrictions will apply 36 months after the entry into force of the Regulation.

On 14 February 2024, the European Chemicals Agency (ECHA) published a comprehensive guidance document (Guidance on the assessment of risks to bees from the use of biocides) aimed at improving the prot...

On 14 February 2024, the European Chemicals Agency (ECHA) published a comprehensive guidance document (Guidance on the assessment of risks to bees from the use of biocides) aimed at improving the protection of bees from the adverse effects of biocidal active substances and products. In line with broader European Union initiatives to reverse the decline of pollinators by 2030 and to promote biodiversity, the guidance provides a strategic approach to assessing risks to honey bees, bumble bees, and solitary bees based on the latest scientific evidence.

Addressing Bee-Specific Risks in Biocides

The guidance specifically addresses the use of products such as insecticides and acaricides (product type 18), recognising that substances in these products can negatively impact the nervous and immune systems of bees. This can make bees more susceptible to disease and contribute to the decline of pollinator populations.

Guiding Companies and Authorities in Biocide Assessments

Companies seeking active substance approvals or product authorisations under the EU’s Biocidal Products Regulation (BPR) will find the guidance instrumental in conducting rigorous risk assessments for their applications. In addition, the document provides guidance principles to authorities to help them assess applications and determine whether a biocidal product complies with the authorisation conditions.

Peter van der Zandt, ECHA’s Director for Risk Management, emphasised the importance of the guidance in addressing the decline in pollinator populations: “This guidance will take companies and authorities one step closer to better protecting bees, that are essential for people and the planet.”

The European Commission and EU Member States are expected to decide at a later stage on the timeline for the application of the guidance in the assessment of biocides.

Background

ECHA developed this guidance in response to a request from the European Commission in 2019, as part of actions under the EU Biodiversity Strategy for 2030 and the Pollinators Initiative. The guidance, which focuses on bees due to data limitations for non-bee pollinators, was developed in collaboration with experts from different Member States and was supported by stakeholder organisations. It is in line with the European Food Safety Authority's (EFSA) guidance on the risk assessment of plant protection products on bees, published in May 2023.

The full text of the ‘Guidance on the assessment of risks to bees from the use of biocides’ is available here.

On 9 February 2024, the European Commission announced a four-week consultation on a draft regulation aimed at strengthening the restriction of bisphenol A (BPA) in food contact materials (FCMs) and ar...

On 9 February 2024, the European Commission announced a four-week consultation on a draft regulation aimed at strengthening the restriction of bisphenol A (BPA) in food contact materials (FCMs) and articles. The proposed legislation also covers other bisphenols and bisphenol derivatives, with provisions for derogations and transition periods for businesses. Stakeholders and the public are invited to submit their comments on the proposed regulations by 8 March 2024.

Bisphenol A

The substance 4,4'-isopropylidenediphenol, commonly known as bisphenol A (BPA) (CAS number 80-05-7), is used in the production of certain food contact materials and articles. Its main applications include the manufacture of epoxy resins for varnishes and coatings on metal food packaging such as cans, tins, and jar lids. BPA is also found in certain types of plastic used in food storage and processing equipment. Its versatile chemical properties can extend its use to materials such as printing inks, adhesives, ion exchange resins, and rubbers in finished food contact articles. Concerns arise because BPA can migrate from the materials or articles it comes into contact with into food, exposing consumers to this substance.

The use of bisphenol A (BPA) in plastic food contact materials is authorised by EU Regulation 10/2011, with a specific migration limit of 0.05 mg/kg of food set by Regulation (EU) 2018/213. This limit is based on the opinion of the European Food Safety Authority (EFSA). The regulation also bans BPA in polycarbonate drinking cups or bottles for babies and young children. In addition, there is a ban on its use in varnishes or coatings for materials intended to come into contact with certain childcare articles, reinforcing the existing ban in Commission Regulation (EU) No 321/2011 on polycarbonate feeding bottles and cups for young children.

In 2023, the EFSA published an updated opinion on BPA, identifying adverse effects, including effects on the immune system, based on new scientific data.

Content of the draft regulation

Highlights of the draft regulation include:

If the draft Regulation is implemented the following transitional provisions will apply for final food contact articles:

1. Final food contact articles made of plastics, varnishes, coatings, inks, adhesives, ion exchange resins, and rubbers complying with pre-existing rules can be placed on the market until 18 months after the entry into force.

2. Certain articles (single-use for certain food types, varnished metal surface articles, and repeat-use articles in professional food production equipment) complying with pre-existing rules can be marketed until 36 months after entry into force.

Timeline

The Regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union. Upon entry into force Regulation (EU) 2018/213 will be repealed.

On 20 February 2024, negotiators from both the Parliament and the Council reached a preliminary political agreement focused on ensuring cleaner air within the EU. The overall objective is ambitious ye...

On 20 February 2024, negotiators from both the Parliament and the Council reached a preliminary political agreement focused on ensuring cleaner air within the EU. The overall objective is ambitious yet vital: complete elimination of air pollution by 2050, protecting human health, preserving natural ecosystems, and promoting biodiversity. 

Background: A Call for Change 

Air pollution remains the primary environmental factor contributing to premature deaths in the EU, claiming approximately 300,000 lives each year. In an urgent response, the Commission proposed a revision of the EU’s air quality rules in October 2022, setting more robust targets for 2030 with the ultimate aim of achieving zero pollution by 2050, aligning with the Zero Pollution Action Plan. 

Stricter Guidelines for Cleaner Air 

The recently introduced rules set significantly stricter limits and target values for 2030, surpassing existing regulations. Notably, key pollutants such as particulate matter (PM2.5, PM10), NO2 (nitrogen dioxide), and SO2 (sulphur dioxide) will face tighter controls. For PM2.5 and NO2, the annual limit values will be more than halved. Regular reviews of air quality standards are incorporated to ensure that they are kept in line with the latest scientific discoveries. 

Flexibility and Accountability for Member States  

Acknowledging the challenges of meeting air quality limit values, Member States will be able to request an extension of up to ten years under specific conditions. The agreement strives for transparency by standardizing air quality indices, making them clear and accessible across the EU. Furthermore, it gives citizens and environmental NGOs the right to challenge the implementation of the directive, fostering accountability. Citizens will also be entitled to compensation if their health is adversely affected due to violations of the new national rules. 

Citizen Protection: Access to Justice and Compensation 

In a noteworthy development, affected citizens and environmental NGOs will now have the right to access justice to contest the directive's implementation.  

Roadmaps to Cleaner Air 

In addition to air quality plans for nations surpassing limits, every Member State commits to developing air quality roadmaps by 31 December 2028. These roadmaps will outline both short- and long-term measures to meet the new 2030 limit values, emphasizing a holistic strategy for cleaner air. 

What's Next? 

While this agreement is a significant step forward, it still needs final adoption by the Parliament and Council. Once ratified, the new law will be published in the EU Official Journal, taking effect 20 days later. Member States will then have two years to implement these transformative rules. 

The Lithuanian government has taken a significant step towards amending the country's chemical management laws, to strengthen safety and environmental protection measures related to chemicals and chem...

The Lithuanian government has taken a significant step towards amending the country's chemical management laws, to strengthen safety and environmental protection measures related to chemicals and chemical mixtures. In a resolution dated February 14, 2024, the Government approved amendments to several key articles of the Law on Chemical Substances and Chemical Mixtures (No. VIII-1641), which will now be submitted to the Seimas, the Lithuanian Parliament. 

The proposed amendments concern Articles 1, 5, 14, 15, 17, 19, 20, and the Appendix of the existing law and reflect the government's commitment to align national regulations with practical needs and EU standards, in particular the implementation of Article 5(2) of EU Regulation 2019/1021 on persistent organic pollutants (POPs). 

Key Highlights of the Amendments: 

1. Scope clarification: The amendments aim to clarify the application of the law to chemicals used in various sectors, including waste management, cosmetics, and pharmaceuticals, to ensure legal clarity and prevent misinterpretations that could hinder environmental protection efforts. 

2. Representation and authority: Environment Minister Simonas Gentvilas, or his deputies if he is unavailable, is authorized to represent the government in the legislative process, ensuring informed and responsive advocacy of the amendments in the Seimas. 

3. Improved management of POPs: Concerning the management of persistent organic pollutants (POPs), the amendments aim to improve the national regulatory framework for reporting and management of POPs stockpiles, thereby enhancing environmental safety and compliance with international obligations under the Stockholm Convention. 

4. Streamlining compliance and monitoring: The proposal includes provisions to harmonize compliance timelines and clarify supervisory roles, thereby facilitating more effective enforcement and reducing the administrative burdens on companies involved in chemicals management. 

5. Legislative and regulatory adjustments: The amendments will be accompanied by the necessary adjustments to the related legal and regulatory framework to ensure coherence and alignment with EU legislation, in particular on concerning the management of hazardous substances. 

Expected Results: 

The adoption of these amendments is anticipated to bring significant positive outcomes, including improved safety and health protection, enhanced environmental sustainability, and alignment with EU standards on chemical management. By clarifying the legal provisions, the amendments aim to eliminate ambiguities, reduce legal disputes, and streamline the management and control of chemicals and chemical mixtures throughout Lithuania. 

Public and Institutional Engagement: 

The drafting process involved consultations with relevant stakeholders, to ensure that the amendments address practical challenges and reflect the needs of both the public and the affected industries. The proposed legislative changes underscore Lithuania's proactive stance on environmental protection and public health, and emphasize the government's dedication to upholding and enhancing standards in chemical management. 

Next Steps: 

Following its submission to the Seimas, the draft law is expected to be discussed during the spring session of Parliament, with potential adoption in March or April 2024. The law is expected to come into effect on November 1, bringing Lithuania's legal framework in line with contemporary environmental and health standards. 

This legislative initiative marks a crucial step forward in Lithuania's environmental governance, reinforcing the country's commitment to sustainable development and the well-being of its citizens. 

EU co-legislators reached a preliminary agreement on 15 February 2024 to update and strengthen fortify EU rules addressing pollution from ships navigating European waters. The agreement emphasizes the...

EU co-legislators reached a preliminary agreement on 15 February 2024 to update and strengthen fortify EU rules addressing pollution from ships navigating European waters. The agreement emphasizes the imposition of fines on offenders perpetrators to ensure a robust response to maritime pollution incidents. 

Background: Maritime Safety Package Unveiled 

This milestone agreement is part of the Maritime Safety Package introduced by the Commission in June 2023. The overall objective is to modernize and strengthen the EU’s maritime regulations, focusing on both safety and pollution prevention. 

Extended Ban on Ship Discharges 

Under the agreement, the existing list of prohibited substances discharged from ships, including oil and noxious liquid substances, will now include sewage, garbage, and residues from scrubbers. This extension represents a strengthened commitment to prevent a wider range of spills and pollutants from impacting European waters. 

MEPs Call for Ongoing Review 

Members of the European Parliament (MEPs) secured a commitment for the EU to reassess the rules five years after their integration into national laws. In particular, the review will evaluate whether penalties should be applied to incidents involving marine plastic litter, loss of containers, and plastic pellet spills from ships. The aim is to ensure a proactive approach to emerging challenges in maritime pollution. 

Improved Verification Mechanisms 

MEPs reinforced communication channels between EU countries and the Commission regarding pollution incidents. A focus on best practices and follow-up measures, triggered by alerts from the European satellite system CleanSeaNet (European satellite-based oil spill and vessel detection service), is central to the agreement. To prevent illegal discharges from going undetected, the text proposes a digital review of all high-confidence CleanSeaNet alerts. There is also a target for at least 25% of these alerts to be verified by competent national authorities. 

Effective Penalties and Criminal Sanctions 

The agreement requires EU countries to establish effective and dissuasive fines for ships violating these regulations. Criminal sanctions which will be dealt with in separate legislation agreed upon by MEPs and EU governments in November, will complement these penalties. Importantly, the preliminary agreement emphasizes that penalties should not be set at a level that is insufficient to ensure their dissuasive nature. 

What's Next? 

While the preliminary deal still needs to be approved by the Council and Parliament, its potential impact is clear. EU countries will have 30 months to transpose the new rules into national law and prepare for their implementation.