Europe Regulatory News

On 7 December 2023, the European Commission proposed changes in EU Directive on restriction of hazardous substances (RoHS) in electrical and electronic equipment (EEE). The aim is to reduce hazardous ...

On 7 December 2023, the European Commission proposed changes in EU Directive on restriction of hazardous substances (RoHS) in electrical and electronic equipment (EEE). The aim is to reduce hazardous compounds in EEE to protect public health and the environment, as well as to facilitate environmentally responsible recovery and disposal of waste.  

The amount of, for example, the heavy metals and flame retardants involved would certainly pose a risk to health and the environment, especially if processed under sub-optimal conditions. This is particularly true even in cases when waste EEE is collected separately and sent for recycling. By harmonising Member State laws, the Directive also aims to guarantee functioning of the internal market. 

Background 

The RoHS Directive has contributed to the EU's efforts to minimise hazardous substances in electrical and electronic equipment (EEE) and to protect the environment and public health at various points along the value chain. 

Despite the shortcomings highlighted, the review concluded that the RoHS Directive is working well. In addition to allowing for appropriate exemptions, the Directive imposes basic restrictions on the inclusion of hazardous chemicals in EEE and, consequently in the waste of electrical and electronic equipment (WEEE). The Directive has also helped to harmonise and maintain the efficiency of the internal market by providing a level playing field for manufacturers of electrical and electronic equipment. The same level of harmonisation would not have been possible without the RoHS Directive. In addition, the RoHS Directive has gained international recognition as a standard for reducing hazardous substances in EEE, which might have a major positive impact on global health and the environment. 

Proposed changes to methodology and procedure: 

1. The Commission suggests that the European Chemicals Agency (ECHA) be given new authority for the technical assessment of time-limited exemptions and the revision process of the list of prohibited compounds in order to address concerns about transparency and promote overall consistency. 

2. The substantial conditions that serve as the foundation for the adoption of substance restrictions or related exemptions would remain unaffected by the reassignment of the assessment activities to ECHA. 

3. Such reassignment would result in more efficient procedures and enhance the "one substance - one assessment" idea that was created within the scope of the Chemicals Strategy for Sustainability. 

Suggestions for a subsequent modification 

It is possible to update and improve the provisions, so they are appropriate for the future.  

This begins with upgrading the scope (e.g., examining solar panels) and proceeds to the elimination of several transitory clauses that were pertinent when the open scope was introduced but are now superfluous. Annexes III and IV could be used to reduce the specified administrative costs associated with various EEE categories as well as the expired exemptions. 

Another possible course of action is to consider whether costs should be added to the time-limited exemption system for applications involving banned hazardous chemicals is. 

As hazardous compounds in EEE continue to be a significant topic in the context of the circular economy and zero-pollution goals, the RoHS Directive could be enhanced improved. 

The interaction with other legal instruments currently under reviewed and the possibility of changes to the RoHS Directive (e.g., the REACH Regulation) will make a future amendment necessary as well.  

To read the full proposal click here https://environment.ec.europa.eu/system/files/2023-12/COM_2023_760_1_EN_ACT_part1_v4.pdf 

On 4 December 2023, the European Commission published a draft delegated regulation aimed at revising a number of provisions concerning perfluorooctane sulfonic acid (PFOS) and its derivatives under Re...

On 4 December 2023, the European Commission published a draft delegated regulation aimed at revising a number of provisions concerning perfluorooctane sulfonic acid (PFOS) and its derivatives under Regulation (EU) 2019/1021 on persistent organic pollutants, commonly referred to as the POPs Regulation.

PFOS under the POPs Regulation

PFOS and its derivatives are listed in Annex I of the POPs Regulation. The Annex I listing includes Unintentional Trace Contaminant (UTC) limits in substances, mixtures and articles.

PFOS was the first per- and polyfluoroalkyl compound (PFAS) to be regulated in the EU, and the UTC values were set a long time ago. It is therefore considered unlikely that PFOS is still present in substances and mixtures at the current UTC level of 10 mg/kg.

As regards the UTC for articles, the uses of PFOS (e.g textiles and leather coating, use in semiconductors, etc.) are very similar to those of perfluorooctanoic acid (PFOA), another PFAS regulated under the POPs Regulation. There is no evidence that a different limit value than for PFOA is needed.

Modifications in the draft regulation for PFOS

For the reasons described above the following modifications for PFOS should be made:

• Align the wording of the substance identification for the entry of PFOS with that for PFOA (i.e. change ‘PFOS and its derivatives’ to ‘PFOS, its salts and PFOS-related compounds’).

• Introduction of a UTC level for PFOS and its salts of 0,025 mg/kg (in line with the one for PFOA)

• Reducing the UTC for PFOS-related substances in substances, mixtures, and articles to 1 mg/kg (in line with the one for PFOA)

• Delete of point 5 (availability of analytical methods).

• Delete a specific exemption for the use of PFOS as a mist suppressant for non-decorative hard chromium plating.

Timeline

The public consultation on the draft regulation is open until 1 January 2024. Feedback can be give here. The European Commission plans to adopt the Regulation in the first quarter of 2024.

On 5 December 2023, the European Parliament and the Council reached a provisional agreement on the revision of the Regulation on the Classification, Labelling and Packaging of Chemicals (CLP). The new...

On 5 December 2023, the European Parliament and the Council reached a provisional agreement on the revision of the Regulation on the Classification, Labelling and Packaging of Chemicals (CLP). The new measures will improve the protection of consumers, workers and the environment, while improving the functioning of the EU market for products containing hazardous chemicals. The revised regulation will improve communication on hazardous chemicals including for chemicals sold online. It will also speed up the identification of hazardous chemicals and mixtures at EU level.

CLP Regulation

The CLP Regulation is the basis for the EU legislation on the risk management of chemicals. It implements the United Nation’s Globally Harmonised System (GHS) for the classification and labelling of chemicals in the EU. Manufacturers and importers are required to classify, label and package their hazardous chemicals in accordance with the CLP Regulation before placing them on the market.

The legislative proposal to revise the CLP Regulation was presented by the European Commission on 19 December 2022. As part of the revision package, the European Commission adopted a Delegated Act adding definitions and criteria for the classification of substances and mixtures with the following properties into established hazard classes:

• Endocrine disrupting

• Persistent, bioaccumulative and toxic

• Very persistent and very bioaccumulative

• Persistent, mobile and toxic

• Very persistent and very mobile

This Delegated Act entered into force on 20 April 2023.

Content of the revision

The key changes introduced by the revision of the CLP Regulation are as follows:

• Clearer labelling of hazardous chemicals: The revision introduces advertising requirements and a minimum font size for labels on hazardous chemicals. The requirements also apply to online sales.

• Digital labelling: Companies will have the option of using fold-out labels and digital labelling. Important information and hazard pictograms must still be displayed on the packaging.

• Online purchases: Websites will have to display the hazardous properties of the products leading to better protection for consumers when buying hazardous chemicals online.

• Complex substances: The rules for classifying complex substances (known as ‘more than one constituent substances’ (MOCS)) have been updated. A specific derogation was agreed upon for plant extracts including essential oils.

• Classification proposals: The Commission will also have the right to develop classification proposals for potentially hazardous substances in addition to Member States and the industry. This will speed up the identification of hazardous substances.

• Refillable chemicals: To support the safe sale of household chemicals in bulk the first rules on refillable chemicals will come into force. The use of refillable chemicals will reduce packaging and therefore packaging waste.

• Poison centres will receive better and faster information for medical emergencies.

Once adopted these changes, together with the new hazard criteria for endocrine disrupters, persistent and toxic chemicals that came into force in April 2023, will ensure better communication and identification of chemical hazards.

Next steps

The new Regulation will now have to be formally adopted by the European Parliament and the Council. Once formally adopted, it will enter into force 20 days after its publication in the Official Journal of the EU.

On 7 December 2023, the European Commission proposed a package of three legislative proposals to reform chemical assessments to make the process faster, simpler and more transparent. The ‘one subst...

On 7 December 2023, the European Commission proposed a package of three legislative proposals to reform chemical assessments to make the process faster, simpler and more transparent. The ‘one substance one assessment’ package aims to streamline the assessments of chemicals across EU legislation, strengthen the knowledge base on chemicals, and ensure early detection and action on emerging chemical risks.

The package involves reallocating tasks between four EU agencies to ensure coherent and transparent assessments of chemicals used in a wide range of products, including medical devices, toys, food, pesticides, and biocides.

Key points of the legislative proposals

The three legislative proposals are part of the Commission’s Chemicals Strategy for Sustainability (CSS) and aim to achieve better prevention through improved chemicals data management. The key points are:

Establishment of a Common Data Platform: The platform will provide access to all data compiled under EU legislation and held by the EU agencies and the Commission. The Common Data Platform will integrate existing platforms such as the Information Platform on Chemical Monitoring (IPCHEM), the Public Activities Coordination Tool (PACT), and the EU Chemicals Legislation Finder (EUCLEF). It will include data on hazards, physico-chemical properties, environmental occurrence, emissions, uses, environmental sustainability of chemicals, and ongoing regulatory processes.

Redistributing tasks and improving of cooperation between EU agencies: To avoid the inefficient use of resources and unnecessary costs of having multiple committees carrying out similar assessments, the aim is to strengthen cooperation and consolidate scientific and technical work on chemicals in the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), the European Environment Agency (EEA), and the European Medicines Agency (EMA). The agencies will be better equipped to coordinate priorities, timelines, processes, and methodologies used for the assessment of chemicals. Moreover, knowledge gained from assessments under one piece of legislation (e.g. biocides) can be re-used for another one (e.g. toys).

Human biomonitoring data collection: A systematic collection of human biomonitoring data (e.g. from blood or breast milk) generated in the EU will be used to estimate the level of exposure of EU citizens to chemicals.

Establishment of a monitoring and outlook framework: Such a framework will allow early detection of chemical risks, such as PFAS, to prevent contamination from becoming widespread. It will facilitate a rapid regulatory response and track the impact of regulatory measures implemented on chemicals. The framework will include an early warning and action system, and a set of indicators,

Enable the European Chemicals Agency (ECHA) to generate data as needed.

Ensure transparency of scientific studies on chemicals, including those commissioned by companies.

The full text of the three proposed regulations can be accessed here, here, and here.

Next steps

The three proposals will now be discussed by the European Parliament and the Council under the ordinary legislative procedure.

On November 28, 2023, the European Commission launched a consultation on a draft Act concerning the persistent organic pollutant (POP) hexabromocyclododecane (HBCDD). The Commission aims to eliminate ...

On November 28, 2023, the European Commission launched a consultation on a draft Act concerning the persistent organic pollutant (POP) hexabromocyclododecane (HBCDD). The Commission aims to eliminate or severely restrict the use and production of POPs, as those terms are defined in the Stockholm Convention, in order to protect both the environment and human health. Comments on the draft Act are welcome for four weeks, until December 26. 

Some background 

A class of organic substances known as persistent organic pollutants (POPs) are hazardous to human health and the environment because they persist in the environment, accumulate in food chains, and have poisonous qualities. Because of their persistence, these compounds may be carried across international borders by migratory animals, air, and water far from their source. POPs include industrial compounds like polychlorinated biphenyls and terphenyls (PCBs/PCTs), insecticides like dichlorodiphenyltrichloroethane (DDT), and unintentional byproducts of industrial processes like dioxins and furans. The EU has developed specific regulations to address some of these chemical waste streams. In order to do this, it will update the concentration limit values for some compounds in annexes IV and V of the POPs regulation (Regulation (EU) 2019/1021 on persistent organic pollutants) and add some substances to annex IV of that regulation. 

Draft Act 

Hexabromocyclododecane (HBCDD), which is listed in Annex I of Regulation (EU) 2019/1021, is the subject of this draft Act. The Act lowers the limit value—which was previously set at 100 mg/kg—for the unintentional trace contaminant HBCDD in chemicals, mixtures, and products. Nonetheless, there is an exception and a restriction of less than 100 mg/kg for the use of recycled polystyrene in the manufacturing of expanded polystyrene (EPS) and extruded polystyrene (XPS) insulation for use in buildings or civil engineering projects. The Commission will analyse and evaluate this by January 1, 2026. 

More details about properties and uses of HBCDD as well as available alternatives to HCBCDD can be found here. 

On 22 November 2023, the European Chemicals Agency (ECHA) published an investigation report on PVC and PVC additives. The investigation was carried out by ECHA at the request of the European Commissio...

On 22 November 2023, the European Chemicals Agency (ECHA) published an investigation report on PVC and PVC additives. The investigation was carried out by ECHA at the request of the European Commission to help the Commission determine how to control potential risks from PVC additives and PVC. The investigation found that some substances such as plasticisers, that are added to polyvinyl chloride (PVC) plastic, can potentially pose risks to human health and the environment. It also concluded that regulatory action is needed to limit the use of such additives and to minimise the release of PVC microparticles.

PVC additives

The polymer PVC needs to be combined with specific additives before it can be converted into products. The additives play an important role in determining the flexibility, stability, colour, clarity, and electrical properties of PVC products.

Some additives used in PVC such as stabilisers containing cadmium- and lead and certain phthalates have been found to pose an unacceptable risk to human health and the environment. As a result, these additives are now restricted under REACH. In addition, studies are underway to assess the risks associated with other additives such as medium-chain chlorinated paraffins and flame retardants.

Conclusions

The study focused on 63 PVC additives selected from an initial list of 470 substances. The 63 substances are plasticisers, heat stabilisers and flame retardants (the full lists can be found here). The main findings of the report suggest that regulatory action is needed in the following areas:

• To minimise risks from plasticisers, in particular ortho-phthalates which have already been confirmed to be reprotoxic or endocrine disruptors. Suitable regulatory action is REACH restriction.

• To reduce risks from organo-tin substances (such as DOTE) used as heat stabilisers, which can cause developmental malformations and reproductive problems. Suitable regulatory action is REACH restriction in combination with other measures.

• To ensure that releases of PVC microparticles and prioritised PVC additives are minimised. Technologies to minimise emissions of PVC microparticles at recycling facilities and landfills must be implemented and improved. The microparticles contain the harmful additives so minimising the emissions would consequently reduce emissions of the additives.

• To reduce emissions of flame retardants, which contribute significantly to the emission of the prioritised additives, as proposed in ECHA’s strategy on flame retardants.

The risks posed by PVC resin to workers and the environment are considered to be adequately controlled by the current operating conditions and safety measures implemented by companies. This conclusion follows an analysis of the materials used to produce of PVC resin, the production process itself, waste management practises, and exposure to PVC dust.

The full text of the report can be accessed here.

Next steps

ECHA’s investigation report has now been sent to the European Commission. The Commission will evaluate the report and decide whether there is a need to formally request ECHA to prepare a proposal for a restriction under REACH.

In an effort to achieve net-zero emissions by the middle of the century, the European Commission is planning to propose a system for certifying the removal of carbon dioxide from the environment.  ...

In an effort to achieve net-zero emissions by the middle of the century, the European Commission is planning to propose a system for certifying the removal of carbon dioxide from the environment. 

How does carbon removals work? 

Activities that remove carbon dioxide from the atmosphere and store it permanently are known as carbon removals.  

There are numerous approaches to accomplish this, such as: 

• Removing carbon directly from the air and storing it in a stable state for permanent storage. 

• Carbon farming, or practises that improve carbon sequestration in soil and forest (e.g., wetland and peatland management, forest restoration). 

• Carbon storage in products (for instance, wood-based structures store carbon that is sequestered by trees). 

In addition to increasing carbon reductions, the EU must accelerate its 2050 climate neutrality goal in order to compensate for residual emissions that are anticipated from industries like manufacturing and agriculture. 

Today, the natural carbon cycle is carried out by nature, mostly by forests, soils, and oceans, which absorb CO2. Reforestation and "carbon farming" techniques, which capture CO2 from the atmosphere and store it in soil or plant material, can promote these natural processes. 

EU carbon removal certification scheme 

In November 2022 the European Commission suggested the creation of an EU-wide carbon removal certification programme to promote and accelerate the implementation of efficient, high-quality carbon removal operations. 

Certification would guarantee precise measurement of carbon removal activities, long-term storage of carbon, and support, or at the very least not hinder, other environmental objectives such as biodiversity, zero pollution, and the circular economy. 

A unified certification programme would build confidence and direct funding from public and private sources towards carbon reduction initiatives. 

Members of the European Parliament (MEPs) stressed the need to create an "EU registry" to maintain openness, disseminate information to the public, reduce the possibility of fraud, and prevent duplicate counting of carbon reductions, The system must also comply with international standards. 

Additionally, MEPs believed it is necessary to differentiate between the definitions, quality standards, and regulations for carbon removals, carbon farming, and carbon storage in products, due to their differences and environmental impacts. 

Next decisions 

Now that the Parliament is ready, talks with EU member states can begin.