Europe Regulatory News

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/.

The European Chemicals Agency (ECHA) has received a mandate from the European Commission to prepare a restriction proposal in accordance with the requirements of Annex XV of the REACH Regulation targe...

The European Chemicals Agency (ECHA) has received a mandate from the European Commission to prepare a restriction proposal in accordance with the requirements of Annex XV of the REACH Regulation targeting at least two Chromium (VI) substances. The proposal is expected to be submitted by 4 October 2024. The full text of the request can be found here.

Chromium (VI) substances

Within the EU-REACH Authorisation list (Annex XIV), there are 11 entries for Cr (VI) substances (entries 16-22 and 28-31). These substances are classified as carcinogenic (1A or 1B) and exposure to them poses a risk to both workers and the general population when exposed via the environment.

The proposed restriction will cover at least the following two Cr(VI) substances:

• Chromium trioxide (CrO3) - Annex XIV entry 16

This particular Cr(VI) substance is responsible for the majority of applications for authorisation.

• Chromic acid (H2Cr2O4) - Annex XIV entry 17

This is a group of acids produced from chromium trioxide and therefore needs to be included in the scope of the restriction proposal.

One of the main applications of these substances is in electroplating, a common surface finishing process for coating materials.

Background

The European Commission has received a substantial number of applications for authorisation of the use of the Cr(VI) substances listed in Annex XIV. This has stretched the capacity of the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) and has affected their ability to regulate other hazardous substances.

The situation also undermines one of the objectives of the authorisation provisions which is the gradual substitution of this type of substance by economically and technically viable alternative substances or technologies.

The Commission’s Mandate

As part of the restriction proposal the Commission has requested that ECHA carries out a short analysis of the availability of alternatives. ECHA should also assess whether there is a potential risk of substitution of other chromium (VI) substances. If this is the case an extension of the mandate is possible.

The preparation of the restriction proposal and its evaluation by the RAC and SEAC will follow the standard REACH restriction process. In preparing the proposal, ECHA will take into account the knowledge and experience gained from handling applications for authorisation for these substances during the preparation of the proposal.

Once the Commission adopts the restriction, the substances within the scope will be removed from the Authorisation List. This action would be a historic first under EU-REACH.

Timeline

In the best case scenario, the Commission expects that a restriction could be adopted approximately 3 years after the receipt of the mandate by ECHA.

Help for companies

The Commission has published a Q&A document to clarify the situation for affected companies. This document also addresses the main issues related to the judgment of the European Court of Justice annulling the authorisation of a consortium comprising many downstream users of chromium trioxide.

  On 4 October 2023, the European Commission notified its ‘Proposal for a Regulation of the European Parliament and of the Council on the Safety of Toys and Repealing Directive 2009/48/EC’ to ...

On 4 October 2023, the European Commission notified its ‘Proposal for a Regulation of the European Parliament and of the Council on the Safety of Toys and Repealing Directive 2009/48/EC’ to the World Trade Organization (WTO). The proposed Regulation will introduce general bans on the most harmful chemicals in toys and will require that a product passport for toys, including information on compliance. Comments will be accepted for 90 days from the date of notification.

Background

In the EU toys are currently regulated by Directive 2009/48/EC on the safety of toys. This Directive sets out the safety requirements that toys must meet in order to be placed on the EU market, whether they are manufactured in the EU or in third countries. This facilitates the free movement of toys within the Single Market.

However it has been found that there is a need for a higher level of protection against possible risks in toys, in particular those posed by harmful chemicals. In addition, the EU’s Chemicals Strategy for Sustainability (CSS) called for better protection of consumers and vulnerable groups from the most harmful chemicals. As a result, the European Commission is proposing new rules to ensure that only safe toys are sold in the EU.

Key points of the proposed Toy Safety Regulation

The new proposed Toy Safety Regulation will build on the existing legislation and update the safety requirements that toys must meet to be marketed in the EU, whether they are manufactured in the EU or elsewhere.

The proposed Regulation will mainly focus on increasing the protection from harmful chemicals but will also strengthen enforcement measures by introducing a Digital Product Passport. Details of the two measures are set out below.

1. Strengthening protection against harmful chemicals: The proposed Regulation will not only maintain the current ban on substances that are carcinogenic, mutagenic or toxic for reproduction (CMRs), but will also ban the use of other harmful chemicals in toys. It targets chemicals that are particularly harmful for children such as endocrine disrupters, or substances toxic to a specific organ including the immune, neurological or respiratory systems. Specifically, the Regulation prohibits the use in toys of substances or mixtures classified in any of the following categories:

• Carcinogenicity, germ cell mutagenicity or reproductive toxicity (CMR): Category 1A, 1B or 2

• Endocrine disruption: Category 1 or 2

• Specific target organ toxicity: Category 1 (either in single exposure or in repeated exposure)

• Respiratory sensitisation: Category 1

Substances within these hazard classes are automatically banned in toys without the need to assess the specific risk they pose to children. 

These chemicals are particularly harmful for children as they can affect their hormones, their cognitive development or health in general. The introduction of  general bans for the most harmful substances as soon as their hazards have been established under the Classification, Labelling and Packaging (CLP) Regulation will ensure that children are protected more quickly from the possible risks of these substances when they are present in toys.

The proposed Regulation will only allow derogations from these general bans only in limited circumstances where the use of these substances in toys does not pose a risk to children and where  no alternatives are available.

The Appendices of the proposed Regulation list substances for which specific conditions such as migration limits are set. For example, nitrosamines and nitrosable substances are prohibited in toys intended for us by children under 36 months or in other toys intended to be placed in the mouth where the migration of those substances is equal to or higher than 0.01 mg/kg for nitrosamines and 0.1 mg/kg for nitrosable substances. They also set limits for, for example, flame retardants, preservatives in water-based toys, and fragrances and list substances subject to specific labelling requirements.

2. Strengthening enforcement: The proposed Regulation will ensure that only safe toys are sold in the EU. All toys will be required to have a Digital Product Passport, containing information on compliance with the proposed Regulation. Importers will have to submit Digital Product Passports for all toys at the EU borders, including for those sold online. In addition, if there are unsafe toys that pose risks not clearly covered by the Regulation, the proposal ensures that the Commission has the power to require that these toys are withdrawn from the market.

The full text of the proposed Regulation can be found here.

Timeline

The proposed Regulation will have to be adopted by the European Parliament and the Council under the ordinary legislative procedure. No precise timetable has yet been set.

On 8 September 2023, the Risk Assessment Committee (RAC) of the European Chemical Agency (ECHA) adopted its opinion supporting France’ proposal to restrict the placing on the market, reuse of wood t...

On 8 September 2023, the Risk Assessment Committee (RAC) of the European Chemical Agency (ECHA) adopted its opinion supporting France’ proposal to restrict the placing on the market, reuse of wood treated with creosote and related substances and banning the secondary use of such wood. The Committee for Socio-Economic Analysis (SEAC) also lends support to the proposed restriction in their draft opinion. The SEAC draft opinion is open for comments until 7 November 2023.

Understanding creosote

Creosote is a brownish-black oily liquid and is a distillation product of coal tars which themselves are by-products of the high temperature carbonization of bituminous coal. It is a complex mixture of hundreds of distinct substances, including bi- and polycyclic aromatic hydrocarbons (PAH), phenols as well as heterocyclic, oxygen-, sulphur- and nitrogen-containing substances. On average 35-43 % of creosote remains unidentified.

Creosote is classified as a Category 1B carcinogen under the Classification, Labelling and Packaging (CLP) Regulation. In addition, the Biocidal Products Committee (BPC) has identified certain components of creosote as carcinogenic, persistent, bioaccumulative and toxic (PBT) as well as very persistent and very bioaccumulative (vPvB).

Creosote is approved under the Biocidal Products Regulation (BPR) as an active substance for product-type 8 as a fungicide and insecticide against wood rotting fungi. It has been used to treat e.g. railway sleepers, agricultural fencing, and utility poles.

Current regulations for creosote

In October 2022 the approval of creosote as an active biocidal substance was renewed under the BPR for a maximum of seven years subject to several specific conditions. This approval, effective from 30 April 2023, allows creosote-based biocidal products for railway sleepers and utility poles only. Currently, the EU-REACH regulation permits some reuses and secondary uses of creosote-treated products, a provision challenged by France's proposal.

France’s proposal

The French restriction proposal targets reducing risks to health (in particular to the general public) and the environment associated with the reuse and secondary use of wood treated with creosote and creosote-related substances by amending entry 31 of Annex XVII of the REACH Regulation. As defined by the Dossier Submitter, reuse means the use for the same purpose as the original use (e.g. railway sleepers reused as railway sleepers), secondary use means the use for other purposes than the original use (e.g. railway sleepers used for agricultural fencing, residential landscaping, etc.).

Committee opinions

The RAC concluded in its opinion, that an EU-wide restriction is necessary to minimise environmental emissions and public exposure, as creosote and related substances are carcinogenic, persistent, bioaccumulative and toxic and can cause harm at very low levels of exposure.

The committee supports the ban on all secondary uses as safer alternatives are available. It aligns with SEAC’s opinion to allow reuse of creosote-treated railway sleepers and utility poles by all professionals in the same country rather than limiting it to the ‘same original user’ as proposed by France. This approach is expected to lead to greater environmental benefits compared to the purchasing of new creosote-treated wood, which is the most likely alternative. Newly treated wood is expected to leach more than older treated wood.

Additionally, the RAC considers wood creosote, one of the nine substances in France's proposal, as potentially exempt due to different hazardous properties.

Timeline

As mentioned above, the 60-day consultation of the SEAC draft opinion is open until 7 November 2023. It is expected that the committee will adopts its opinion in December 2023.