Europe Regulatory News

On 13 March 2024, the European Chemicals Agency (ECHA) published on its official website the next steps in the evaluation of the proposal to restrict per- and polyfluoroalkyl substances (PFAS).   ...

On 13 March 2024, the European Chemicals Agency (ECHA) published on its official website the next steps in the evaluation of the proposal to restrict per- and polyfluoroalkyl substances (PFAS).

Outcome of the public consultation

Following the public consultation on the PFAS restriction dossier, submitted jointly by Germany, Denmark, the Netherlands, Norway, and Sweden, where a record-breaking 5642 comments were received between March and September 2023. Following a thorough initial review by both the submitting authorities ECHA, the comments will now undergo sector-specific processing by ECHA's Scientific Committees, namely the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC), in addition to review by the dossier submitters. The submitting countries will use the feedback to revise the original restriction report, which will serve as the basis for the Committees' opinion, together with the comments.

Upcoming Committee meetings

The upcoming RAC and SEAC Committee meetings will address the following topics and sectors:

March 2024 Meetings:

• Consumer mixtures, cosmetics, and ski wax

• Hazard properties of PFAS (RAC only)

• General approach (SEAC only)

June 2024 Meetings:

• Metal coating and manufacturing of metal products

• Additional discussion on hazard properties (RAC only)

September 2024 Meetings:

• Textiles, upholstery, leather, apparel, carpets (TULAC)

• Food contact materials and packaging

• Petroleum and mining

ECHA will continue to provide updates on the timetable and planned discussions in the committees as work progresses. Information releases will be timed to coincide with the committee meetings.

Next steps

Once the ECHA Committees have finalised their opinions, the European Commission together with the EU Member States will decide on the restriction.

In a significant step towards environmental protection, the European Union published Regulation (EU) 2024/590 on Substances that Deplete the Ozone Layer in the Official Journal of the European Union o...

In a significant step towards environmental protection, the European Union published Regulation (EU) 2024/590 on Substances that Deplete the Ozone Layer in the Official Journal of the European Union on 20 February 2024. This Regulation which aims to limit emission of substances that deplete the ozone layer, will enter into force on 11 March 2024 and will repeal the existing Regulation (EC) No 1005/2009. The new regulation is a key step in protecting the Earth's stratospheric ozone layer, which is crucial for protecting the planet from harmful UV radiation.

Tackling Twin Threats: Ozone Depletion and Greenhouse Gas Emissions

Ozone-depleting substances (ODS) not only contribute to the formation of the so-called 'hole in the ozone layer', but also play a significant role in increasing greenhouse gas emissions. When these man-made chemicals reach the upper atmosphere they deplete the ozone layer, causing adverse effects on human health, ecosystems, as well as significant financial costs.

Prohibitions and Exemptions

The new Regulation lays down comprehensive rules covering the entire life cycle of ODS. It prohibits the production, import, export, placing on the market, storage, and subsequent supply of the substances listed in Annex I to the Regulation. It also addresses the critical aspects of their use, recovery, recycling, reclamation, and destruction, emphasising responsible practices throughout the supply chain. The legislation also requires detailed reporting of information on ozone-depleting substances.

The Regulation allows exemptions for the following purposes:

• Feedstock i.e. any ozone-depleting substance that undergoes chemical transformation in a process in which it is completely converted from its original composition and whose emissions are insignificant.

• Process agents i.e. any ozone-depleting substance used as chemical process agents in the applications listed in Annex III to the Regulation.

• Essential laboratory and analytical uses

• Critical uses of halons e.g. fire extinguishers on military vehicles.

• Emergency use of methyl bromide when unexpected outbreaks of certain pests or diseases requires it.

A Step Towards a Greener Future: Regulation in Line with European Green Deal

The adopted regulation, part of the Emissions and Pollutants Package, is aligned with the European Green Deal (2019), reflecting the EU's commitment to environmental sustainability.

A thorough Regulatory Fitness and Performance (REFIT) evaluation by the European Commission found that the previous regulation, Regulation (EC) No 1005/2009, was generally fit for purpose, but that improvements were needed to better align it with evolving environmental objectives.

The legislative process involving the European Parliament, the Council of the European Union, and the European Commission, culminated in the adoption of the new Regulation on 7 February 2024, marking a decisive step towards a greener and more sustainable future for the European Union.

The full text of the Regulation can be accessed here.

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 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. 

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.

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.