Europe Regulatory News

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.

On 16 October 2023, the European Commission presented a proposal for a Regulation on the prevention of pellet losses to reduce microplastic pollution. The aim of the proposal is to ensure that all ope...

On 16 October 2023, the European Commission presented a proposal for a Regulation on the prevention of pellet losses to reduce microplastic pollution. The aim of the proposal is to ensure that all operators handling plastic pellets in the EU take the necessary precautionary measures. This is expected to reduce pellet release by up to 74 % contributing to plastic-free rivers and oceans, cleaner ecosystems, and a reduction in potential risks to human health.

Background on Plastic Pellets

Plastic pellets, also known as nurdles, nibs, and resin pellets, are the primary raw material used in the production of all plastics. The majority of these pellets are considered microplastics, measuring up to 5mm in size, although a small proportion may be slightly larger. Plastic pellets represent one of the largest sources of unintentional microplastic pollution.

Current practices for handling plastic pellets result in losses at all stages of the supply chain, in particular during production, processing, transport and waste management operations. Once released into the environment, these small particles do not biodegrade and cannot be removed. Microplastics accumulate in animals including fish and shellfish, and eventually end up in human food. The continued release of microplastics contributes to persistent contamination of our ecosystems and food chains.

Proposed Measures

The measures proposed by the European Commission are as follows:

• Best handling practices for operators: Depending on the size of the facility or transport activity, operators will be required to follow certain best handling practices.

• Mandatory certification and self-declaration: To assist national competent authorities in verifying compliance, larger operators will be required to obtain a certificate from an independent third party, while smaller operators will be required to self-declare their compliance.

• A harmonised methodology to estimate losses: To help operators monitor their losses and fill some of the remaining data gaps, a harmonised methodology will be developed by standardisation bodies. This methodology is expected to increase accountability by increasing awareness of the environmental and human health impacts of different practices. 

• Reduced requirements for SMEs: Given the large share of small and medium-sized enterprises (SMEs) in the pellet supply chain, reduced requirements will apply in particular to micro and small operators.

Who is affected by the proposal?

The proposal sets minimum requirements for all operators, with additional conditions for medium and large companies handling more than 1,000 tonnes of plastic pellets per year. For SMEs and for medium and large companies handling less than 1,000 tonnes of plastic pellets per year the following less stringent requirements will apply:

• No obligation to carry out an internal assessment.

• No requirement for certification but of self-declaration of compliance.

• No obligation of reviewing at formal management meetings certain compliance information.

• No requirement to establish an awareness and training programme. 

• No requirement to establish procedures for informing drivers, suppliers and subcontractors of the relevant procedures to prevent, contain and clean up spills and losses.

Medium-sized companies handling more than 1,000 tonnes of plastic pellets per year will have a longer transition period compared to larger companies (36 months instead of 24 months) and a longer validity of the certificate (four years instead of three). There will also be specific requirements for transporters of plastic pellets.

Other EU Action on Microplastics Pollution

The European Union has taken a number of regulatory initiatives to address the pollution caused by plastic products that ultimately degrade into microplastics in the environment. These initiatives, including the Single-Use Plastics Directive and the proposal for a new EU Packaging Regulation, play a significant role in reducing the production of plastic waste, improving its collection and recycling, and promoting the incorporation of recycled materials in new products.

In addition, the EU adopted restrictions on intentionally added microplastics on 25 September 2023. These restrictions together with the newly proposed measures are the first EU instruments specifically designed to tackle microplastic pollution at the source and contribute to the Zero Pollution Action Plan’s target of reducing microplastic releases into the environment by 30 % by 2030.

The full text of the proposed Regulation on preventing pellet losses to reduce microplastic pollution can be found here.

  Importers and downstream users of industrial-use-only mixtures need to be aware of the upcoming second poison centre compliance date. From 1 January 2024, all newly submitted poison centre notif...

Importers and downstream users of industrial-use-only mixtures need to be aware of the upcoming second poison centre compliance date. From 1 January 2024, all newly submitted poison centre notifications (PCNs) will have to comply with the harmonised information requirements set out in Annex VIII of the Classification, Labelling and Packaging (CLP) Regulation. 

Industrial-use-only mixtures

Industrial-use-only mixtures are used exclusively within industrial premises and remain inaccessible to both consumers and professionals, whether in their final product form or through any dilution achieved by reformulation, such as mixtures within mixtures (MiM). An example of an industrial-use-only mixture (as a final product) could be an automotive paint that is only used on an industrial site and is only available to industrial end-users.

Transitional period

There will be a one-year transitional period. Notifications for industrial-use-only mixtures that are on the market and notified before 1 January 2024 will remain valid until 1 January 2025. This means that after this date, all notifications, regardless of the use type, will have to be submitted in the harmonised format.

If changes are made to the product during the transitional period (e.g. changes to the mixture composition, toxicological properties, or product identifiers), a notification in the harmonised format must be submitted before the modified mixture can be placed on the market.

Information requirements

According to Annex VIII of the CLP Regulation, the harmonised information requirements include:

• The full chemical composition

• The toxicological information

• Product information

• The unique formula identifier (UFI)

However, for industrial use mixtures, there is an option to make a "limited submission" where compositional information from the Safety Data Sheet can be used. If this option is used, the notification must include a contact person who can quickly access the full compositional details 24 hours per day in case of an incident.

PCNs can be prepared and submitted to the European Chemicals Agency (ECHA) using the International Uniform Chemical Information Database (IUCLID). More information is available on the ECHA Poison Centre Website: https://poisoncentres.echa.europa.eu/.