Europe Regulatory News

On 15 November 2023, the European Chemicals Agency (ECHA) published a news report that identifies areas where research is needed to protect human health and the environment. The report entitled "Key a...

On 15 November 2023, the European Chemicals Agency (ECHA) published a news report that identifies areas where research is needed to protect human health and the environment. The report entitled "Key areas of regulatory challenges” also highlights areas where new methods are needed to support the move away from animal testing.

Background

The implementation of the Chemicals Strategy for Sustainability (CSS) calls for ECHA to review its advisory role on the issues where it can provide the most valuable input. Therefore ECHA has started to map its Key Areas of Regulatory Challenge (KARC) as part of the European Partnership for the Assessment of Risks from Chemicals (PARC) project.

The PARC project is a seven-year EU-wide research and innovation project that aims to advance research, share knowledge, and improve skills in chemical risk assessment. ECHA’s role in PARC is to ensure that the scientific research funded addresses current challenges in chemical risk assessment and adds value to EU regulatory processes.

Priority areas for research

In order to improve chemical safety in the EU, it is essential that scientific research provides data relevant to the rregulation of chemicals. ECHA has identified the following priority areas for research to improve the regulatory relevance of scientific data.

• Protection against the most harmful chemicals. Hazard identification for critical biological effects for which specific and sensitive test methods are currently lacking, i.e. developmental and adult neurotoxicity, immunotoxicity and endocrine disruption.

• Addressing chemical pollution in the natural environment. Key areas include bioaccumulation, extending biodiversity protection, and exposure assessment.

• Moving away from animal testing. Development of New Approach Methods (NAMs) to facilitate reduction of animal testing for read-across under REACH, move away from fish test to determine fish toxicity, and mechanistic support for toxicology studies e.g. carcinogenicity).

• Improve the availability of chemical data in particular for polymers and nanomaterials.  Development of analytical methods to ensure proper assessment of hazardous substances.

Mike Rasenberg, ECHA’s Director of Hazard Assessment, emphasised the urgency of aligning scientific research with regulatory needs "ECHA believes that to achieve the ambitions of the European Green Deal and the EU’s Chemicals Strategy for Sustainability we need more scientific research with regulatory relevance." He added: "There is a growing need for new test methods that do not rely on animals, and a better understanding of the toxicological mode of action of certain hazardous chemicals. Generating the necessary data without animal testing while protecting health and the environment cannot be achieved without scientific progress."

 The full text of the report is available here.

The European Chemicals Agency (ECHA) published its third report on the operation of the Prior Informed Consent (PIC) Regulation in October 2023. In the report, ECHA recommends more transparency in the...

The European Chemicals Agency (ECHA) published its third report on the operation of the Prior Informed Consent (PIC) Regulation in October 2023. In the report, ECHA recommends more transparency in the trade of hazardous chemicals.

About the PIC Regulation

The PIC Regulation regulates the export and import of hazardous chemicals and pesticides between the European Union (EU) and non-EU countries. Within the EU, the Regulation implements the Rotterdam Convention on the prior informed procedure in international trade and it places obligations primarily on companies exporting these chemicals to non-EU countries.

Findings of ECHA’s Report

ECHA’s report shows that despite a slight decrease in export notifications the workload for implementing the PIC Regulation is still increasing. This increase is attributed to the continuous addition of new chemicals subject to PIC and the growing number of substances that require explicit consent from non-EU importing countries prior toexport.

The report highlights the challenges posed by newly added chemicals, such as substances containing benzene (the first "substance in substance") and neonicotinoids harmful to bees, resulting in numerous notifications and new types of exports. There has also been an increase in public requests for data on the trade of hazardous substances collected under the PIC Regulation.

In response to these findings, ECHA recommends that future revision of the PIC Regulation should include:

• Definition of which parts of export notifications should be made public.

• Clarification of the trade information to be included in the annual reports at EU level.

• Improving the predictability and clarity through amendments to the legal text and implementation practices.

Sharon McGuinness, ECHA’s Executive Director, highlights the growing interest in the export of hazardous chemicals from the EU in recent years. She says "The ongoing evaluation of the regulation offers a good opportunity to improve the impact and transparency of PIC." McGuinness adds, "Our recommendations aim at a more transparent and effective implementation of the regulation, which controls the trade of hazardous chemicals."

The full report is available here.

On November 7, 2023, the European Union's Scientific Committee on Consumer Safety (SCCS) released a preliminary opinion on the use of hydroxypropyl p-phenylenediamine and its dihydrochloride salt ...

On November 7, 2023, the European Union's Scientific Committee on Consumer Safety (SCCS) released a preliminary opinion on the use of hydroxypropyl p-phenylenediamine and its dihydrochloride salt in oxidative hair colourants. Hair colouring cosmetic products contain hydroxypropyl p-phenylenediamine and its dihydrochloride salt. They are currently not covered by the Cosmetics Regulation.

About the SCCS opinion

A dossier in favour of the safe use of hydroxypropyl p-phenylenediamine (CAS No. 73793-79-0) and its dihydrochloride salt (CAS No. 1928659-47-5) in cosmetic products was received by the Commission Services in 2018. However, because of the possibility of genotoxicity, the SCCS concluded that the substances should not be used in oxidative hair colouring products. The applicant submitted a second dossier in June 2022, requesting a re-assessment of the safety of p-phenylenediamine and its dihydrochloride salt for use in oxidative hair colouring products up to a concentration of 2% on-head.

Conclusion of the SCCS

Based on the information presented, the SCCS concludes that hydroxypropyl p-phenylenediamine and its dihydrochloride salt are safe when used in oxidative hair colouring products at a maximum concentration of 2% on-head. The possibility that the test substance may cause mild to moderate eye discomfort cannot be ruled out. According to animal studies, hydroxypropyl p-phenylenediamine and its dihydrochloride salt cause moderate cutaneous sensitization.

The opinion is open for public comment until January 8, 2024.

On 9 November 2023, the European Commission notified to the World Trade Organization (WTO) of a proposed regulation to reduce emissions of fluorinated greenhouse gases (Proposal for a Regulation of th...

On 9 November 2023, the European Commission notified to the World Trade Organization (WTO) of a proposed regulation to reduce emissions of fluorinated greenhouse gases (Proposal for a Regulation of the European Parliament and the Council on fluorinated greenhouse gases amending Directive (EU) 2019/1937 and repealing Regulation (EU) No 517/2014). The notification is open for comments for 60 days from the date of notification.

Fluorinated greenhouse gases

Fluorinated greenhouse gases are man-made greenhouse gases (GHG) with a high global warming potential. Examples of fluorinated GHGs are:

• Hydrofluorocarbons (HFCs)

• Perfluorocarbons (PFCs)

• Sulphur hexafluoride

• Nitrogen trifluoride

GHGs are used in common appliances such as refrigerators, air conditioners, heat pumps, fire protection, foams and aerosols. They are covered by the Paris Agreement along with CO₂, methane and nitrous oxide and account for around 2.5% of EU’s greenhouse gas emissions.

Further reductions in emissions of fluorinated gases are required to support the European Union's climate goals and comply with the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer. Earlier this year, the European Parliament and the Council agreed on measures to reduce emissions of ozone-depleting substances.

Proposed Regulation

The European Commission’s proposed regulation include limits on the placing on the market of HCFs. It also lays down conditions for the import, export, placing on the market and further supply and use of fluorinated gases and of certain products and equipment that contain or rely on these gases.

The objective of the proposed Regulation is to implement measures aimed at reducing emissions from fluorinated GHGs that contribute to global warming. These measures are intended to contribute to achieving the objectives of the Paris Agreement, in particular to limit the global average temperature increase to 1.5 °C. At the same time, they aim to meet the EU’s commitment under the Montreal Protocol to phase down HCFs. This initiative is in line with the broader objective of protecting the environment.

The full text of the proposed Regulation is available here.

Timeline

On 5 October 2023, the European Council and the European Parliament reached a provisional agreement on the proposed Regulation, which sets 2050 as the year by which the consumption of HFCs should reach zero and 2036 as the year by which the production of HFCs (in relation to the production rights allocated by the Commission) should be phased down to a minimum (15%).

The proposed Regulation is expected to be adopted by February/March 2024 and enter into force at the same time.

On 31 October 2023, the European Chemicals Agency (ECHA) published an investigation report on the use and presence of CMR 1A or 1B substances in childcare products. The report was prepared to support ...

On 31 October 2023, the European Chemicals Agency (ECHA) published an investigation report on the use and presence of CMR 1A or 1B substances in childcare products. The report was prepared to support the European Commission in preparing an EU-wide restriction under the REACH regulation with the aim to protect children from exposure to CMR substances.

Results of the investigation

The investigation carried out by ECHA gathered data from 48 sources and showed that childcare products may contain substances known to be carcinogenic, mutagenic, or toxic for reproduction (CMR). It focused on substances that have a harmonised classification under the Classification, Labelling and Packaging (CLP) Regulation as a CMRs in category 1A (known human carcinogen, mutagen or reproductive toxicant) or 1B (presumed human carcinogen, mutagen or reproductive toxicant).

The most common CMRs found in these products include metals such as cobalt and lead, as well as phthalates such as di(2-ethylhexyl) phthalate (DEHP). These hazardous substances were commonly found in products such as car seats, bibs, products related to toiletry, bedding, and mattresses.

Children are at risk of exposure to these harmful substances through skin or oral contact when using these products. They are particularly vulnerable to the harm caused by such chemical substances because their small size, developing physiology, and behaviour make them more susceptible to the effects of these substances.

During the investigation, ECHA carried out two public calls for evidence and held a consultation on the draft report. The Agency contacted 233 different stakeholders to inform them about the work and took their feedback into account.

The full text of the report can be found here.

Next steps

ECHA's report provides key insights to assist the European Commission in the preparation of a possible future restriction. It covers the definition of childcare articles, the possible scope of the restriction, recommended concentration limits, timeframes for implementation and potential derogations. It also includes perspectives from ECHA's Enforcement Forum on the feasibility of such a restriction.

The report will be submitted to the European Commission to enable the preparation of a restriction proposal under Article 68(2) of REACH without direct involvement of ECHA's Scientific Committees.

On 24 October 2023, the MEPs on the EU’s Environment Committee (ENVI) took a stand on a draft regulation that would set standards for the whole life cycle of packaging from raw material to final dis...

On 24 October 2023, the MEPs on the EU’s Environment Committee (ENVI) took a stand on a draft regulation that would set standards for the whole life cycle of packaging from raw material to final disposal. The objective of the regulation is to make packaging easier to reuse and recycle, to minimise excess packaging, and to promote the use of recycled content.  

Background of the draft proposal  

People and civil society organisations throughout the EU are demanding significant action on waste prevention, packaging waste management, and packaging circularity through the increased use of recycled materials, as stated at the Conference on the Future of Europe. 

A circular packaging economy will reduce the EU economy's strategic dependence on a number of materials, help achieve carbon neutrality by 2050, and help decouple economic progress from the use of natural resources. It can also have a positive impact on employment, particularly in the social sector, by creating more ‘green quality jobs, provided the necessary investment in skills is made and takes into account the unique characteristics of the Member States, regions, and types of work. 

The 2018 amendment to Directive 94/62/EC included three review provisions which will be implemented by this project but did not solve all of the implementation issues. 

This project will update the EU's legal framework on packaging and packaging waste, providing enterprises and Member States with the necessary support to achieve waste reduction targets. This support comes in the form of a uniform legislative framework that will be applicable in all EU Member States, encouraging high-quality recycling, decreasing waste, and encouraging investment. 

The proposed rule will support the EU's growth strategy for a modern, resource-efficient, clean, and competitive economy with zero net greenhouse gas emissions by 2050 and decoupled economic growth from resource use as a key component of the European Green Deal and the new EU Ccircular Economy Action Plan. 

Specific actions suggested by ENVI 

• Ban the sale of extremely thin plastic carrier bags (less than 15 microns), except where necessary for hygienic or as the main container for loose food in an effort to reduce food waste. 

• Set specific waste reduction targets for plastic packaging 

• Targets and sustainability standards for bio-based plastics should be proposed by the Commission by the end of 2025. 

• To differentiate and clarify the specifications for refillable or reusable packaging. Reusable packaging must meet certain requirements, such as having a minimum number of reusable uses (to be determined later). In the hotel, restaurant and catering (HORECA) sector, final distributors of beverages and take-away meals should allow customers to bring their own containers. 

• Ban the use of Bisphenol A and other intentionally added per- and polyfluorinated alkyl substances (PFASs), also known as “forever chemicals”, in food contact packaging. These materials have been linked to a number of adverse health effects and are frequently used to make packaging waterproof or fireproof, especially food packaging made of paper and cardboard. 

The Commission will be tasked with adopting criteria to define packaging as "designed for recycling" and "recyclable at scale." Other proposed measures include ensuring that 90% of the materials found in packaging—including plastic, wood, ferrous metals, aluminium, glass, paper, and cardboard—are collected separately by EU member states by 2029. Online service providers will also be subject to the same extended producer responsibility obligations as producers. 

The EU Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (EU-REACH) is the EU’s main legislation to protect human health and the environment from the risks that ...

The EU Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (EU-REACH) is the EU’s main legislation to protect human health and the environment from the risks that chemicals can pose.  

The REACH regulation is due for a revision to promote sustainable chemicals and simplify the regulation. The revision was originally promised in 2020 as part of the European Commission’s Chemicals Strategy for Sustainability, which aims for a toxic-free environment, and was scheduled for adoption at the end of 2022.

The complexity of the REACH regulation, which has not been revised since it came into force, is a major factor contributing to the delay. Parallel efforts to revise the Classification, Labelling, and Packaging (CLP) Regulation have also added to the complexity of the process.

On 17 October 2023, the Commission’s work programme for the period until the European Parliament elections in June 2024 was adopted. The revision of REACH is not included in the work programme ,so it can be assumed that the revision will be postponed until after the elections.