Europe Regulatory News

On 24 May 2024, the European Chemicals Agency (ECHA) launched consultations on eleven active substances identified as potential candidates for substitution under the Biocidal Products Regulation (BPR)...

On 24 May 2024, the European Chemicals Agency (ECHA) launched consultations on eleven active substances identified as potential candidates for substitution under the Biocidal Products Regulation (BPR). These substances meet specific criteria set out in Article 10(1) of the BPR, triggering a consultation process to gather information on potential alternatives. The consultations will end on 23 July 2024.

Exclusion Criteria

In addition, some of these substances meet exclusion criteria listed in Article 5(1) of the BPR, such as being classified as carcinogenic, mutagenic, reprotoxic substances (CMR), endocrine disrupting, or persistent, bioaccumulative and toxic (PBT). Substances meeting these criteria will normally not be authorised unless they qualify for derogations as specified in Article 5(2).

Conditions for Derogations

Derogations may be granted if:

• The risk to humans, animals, or the environment is negligible under realistic worst-case scenarios.

• The substance is essential to prevent serious risks to human health or the environment.

• Non-approval would have disproportionatly negative impact on society.

Substances Included in the Consultations

Below is the list of substances included in the current consultations. The consultation for epsilon-metofluthrin only concerns substitution candidates and not derogations from the exclusion criteria.

Details of the substances can be found here.

Consultation Process

ECHA's consultations aim to gather third-party information on the availability of alternatives and the justification for derogations to ensure a thorough evaluation of these substances. If a derogation is granted, the authorisation is limited to a maximum of five years and to specific uses. Member States can only authorise biocidal products if these conditions are met locally.

The consultations aim to strike a balance between public health, environmental safety and societal impacts, while assessing the viability of alternatives and the need for derogations for the substances in question.

On 17 May 2024, the European Commission published Regulation (EU) 2024/1328, which significantly amends Annex XVII (the list of restricted substances) of the REACH Regulation. This new regulation impo...

On 17 May 2024, the European Commission published Regulation (EU) 2024/1328, which significantly amends Annex XVII (the list of restricted substances) of the REACH Regulation. This new regulation imposes restrictions on the use and placing on the market of octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) due to their recognised harmful effects on the environment.

The regulation targets the presence of the three substances in various consumer and professional products, including leave-on cosmetic products, medical devices, and dry cleaning solvents, which contribute to the release of these hazardous substances into the environment.

D4, D5 and D6 Classification

The European Chemicals Agency (ECHA) classifies D4, D5 and D6 as Substances of Very High Concern (SVHC) due to their very persistent and very bioaccumulative (vPvB) properties. D4 has also been identified as persistent, bioaccumulative and toxic (PBT). In addition, D5 and D6 are classified as PBT if they contain 0.1 % or more by weight of D4.

Phased Implementation and Specific Exemptions

The restriction will apply from 6 June 2026 and will prohibit the use or placing on the market of D4, D5 and D6 as substances on their own, as constituents of other substances or in mixtures in a concentration equal to or greater than 0.1% by weight of the respective substance. 

However, the Regulation provides for a phased approach to the restrictions, with different deferral periods for certain uses to give industry time to adapt. For example, the use of these substances in leave-on cosmetic products will be prohibited from 6 June 2027, while medical devices and veterinary products will be deferred until 6 June 2031. The regulation also includes exemptions for certain professional uses, such as the cleaning or restoration of art and antiques, and for products such silicone insoles for horses and high-performance 3D printing applications. These exemptions are carefully defined to balance environmental protection with practical industrial needs.

The use of D4 and D5 in wash-off cosmetic products have already been restricted since 31 January 2020.

Full details of the restrictions can be found in Regulation 2024/1328 here.

Aiming for Environmental Protection

ECHA and its Committees have made extensive assessments and recommendations to ensure that the proposed restrictions effectively minimise the environmental risks associated with D4, D5 and D6. The Regulation emphasises that controlling the emissions of these substances is essential to reduce their long-term impact on both aquatic and atmospheric compartments. By implementing these measures, the European Commission aims to achieve a higher level of environmental protection, reflecting a commitment to the sustainable and safe use of chemicals within the EU.

On 17 May 2024, the European Chemicals Agency (ECHA) announced a new streamlined process for third party consultations on biocidal active substances. This initiative aims to gather comprehensive infor...

On 17 May 2024, the European Chemicals Agency (ECHA) announced a new streamlined process for third party consultations on biocidal active substances. This initiative aims to gather comprehensive information on alternatives to hazardous substances and their societal impacts, thus facilitating a more thorough technical assessment for the approval of these substances in the EU.

From the end of May, interested parties will be able to submit information on alternatives to biocidal active substances identified as candidates for substitution. This data is crucial for the comparative assessment required for the authorisation of biocidal products containing these substances.

Consultation Details and Process

When a national authority identifies an active substance as being very hazardous and meeting the exclusion criteria under the Biocidal Products Regulation (BPR), the consultation also seeks information on whether the substance can meet the criteria for  a derogation. The BPR allows derogations for up to five years if the substance is essential for public health and there are no alternatives. It is therefore important to collect detailed information on potential alternatives and justifications for each supported use of the active substance.

These consultations will be integrated into the evaluation process for active substances, providing the national authority with additional information beyond the initial application. This will improve the assessment of alternatives and the applicability of derogation conditions. The feedback received will also inform the applicant and the Biocidal Products Committee will take this comprehensive data into account when preparing its scientific opinion on the substance.

Background and Criteria

An active substance may be considered as a candidate for substitution if it

• Meets at least one exclusion criterion but could be approved under derogation.

• Is classified as a respiratory sensitizer.

• Has significantly lower toxicological reference values compared to most approved substances of the same type.

• Meets two of the criteria for being a persistent, bioaccumulative, and toxic (PBT) substance.

• Cause concern despite stringent risk management measures.

• Contains a significant amount of non-active isomers or impurities.

Active substances meeting the exclusion criteria are:

• Substances classified as carcinogenic, mutagenic or reprotoxic under the Classification, Labelling and Packaging (CLP) Regulation

• Endocrine disruptors,

• Persistent, Bioaccumulative and Toxic (PBT) substances

• Very persistent and very bioaccumulative (vPvB) substances.

Additional Information

For more details on the approval of active substances and the working procedure for the approval and renewal  of active substance, please consult the official ECHA documentation here.

On 17 May 2024, the European Parliament adopted ambitious plans to boost the production of net-zero technologies. A Delegated Directive 2024/1405 was issued, adding the raw materials for the productio...

On 17 May 2024, the European Parliament adopted ambitious plans to boost the production of net-zero technologies. A Delegated Directive 2024/1405 was issued, adding the raw materials for the production of biofuels and biogas and amending Annex IX to Directive (EU) 2018/2001.  

These initiatives aim to strengthen the EU’s leadership in green energy, reduce carbon emissions, and stimulate economic growth.  

Key Highlights 

The newly adopted regulations set clear objectives and provide the necessary support framework to achieve these goals as follows: 

1. Strategic Objectives:  

• Increase EU manufacturing capacity for net-zero technologies.  

• Ensure that at least 40% of the demand for net-zero technologies needs are met by domestic production by 2030. 

2. Innovation and Investment:  

• Promote research and development in renewable energy technologies.  

• Facilitate public and private investment through financial incentives and regulatory support. 

3. Sustainability and Competitiveness:  

• Emphasize sustainable practices in technology production.  

• Enhance the global competitiveness of EU -produced technologies. 

Policy Measures 

In order to achieve these strategic objectives, the following policy measures have been put in place to support innovation, investment, and sustainability in the production of net-zero technology. 

1. Regulatory Framework:  

• Simplify administrative procedures for technology deployment.  

• Strengthen intellectual property rights to protect innovations. 

2. Financial Support:  

• Allocate funding for technology start-ups and small enterprises.  

• Establish a dedicated fund to support large-scale projects. 

3. International Cooperation:   

• Foster partnerships with non-EU countries to expand market access.  

• Promote EU standards in global markets. 

Annex Details 

The Directive 2024/1405 amends Annex IX of Directive (EU) 2018/2001 by incorporating new feedstocks for biofuel and biogas production. Issued on 17 May, it emphasizes that sustainable biofuels and biogases are crucial for increasing the use of renewable energy in sectors likely to be dependent on liquid fuels in the long term. 

Member States must implement the new rules by 14 September 2025. They need to inform the Commission of the adopted measures and their compliance. 

Impact on the EU Economy 

Job Creation: Thousands of jobs will be created in the green energy sector. 

Economic Growth: Contribute significantly to the EU's Gross Domestic Product (GDP). 

Environmental Benefits: Drastically reduce greenhouse gas emissions and dependence on fossil fuels. 

The European Parliament’s new regulations mark a decisive step towards a sustainable and competitive green economy. By setting robust targets and supporting innovation, the EU aims to lead the global transition to net-zero technologies. 

For more details, visit the Delegated directive here.

On April 23, 2024, the European Parliament took a significant step towards a greener future by adopting the ‘Net-Zero Industry Act’ aimed at enhancing the production of net-zero technologies in Eu...

On April 23, 2024, the European Parliament took a significant step towards a greener future by adopting the ‘Net-Zero Industry Act’ aimed at enhancing the production of net-zero technologies in Europe. This decision is part of the broader EU strategy to achieve climate neutrality by 2050 and strengthen the continent's industrial base. 

Background and Importance: 

Europe's commitment to climate neutrality by 2050 requires a rapid and sustained increase in the production and deployment of net-zero technologies. The global market for these technologies is expanding, and Europe's proactive stance aims to position the continent as a leader in this critical sector. By adopting these measures, the European Parliament is not only addressing climate change, but also promoting economic growth, job creation and global technological leadership. 

Key Measures Adopted: 

Promotion of Net-Zero Technologies:

The new measures focus on promoting the production of net-zero technologies, including wind turbines, solar panels, batteries and electrolysers. The aim is to increase the EU's share of global production in these sectors, thereby reducing dependence on imports and fostering innovation.

Support for Strategic Projects:

The Parliament's plan includes support for strategic projects that are vital for the development and scaling up of net-zero technologies. This includes financial incentives, streamlined regulatory processes, and increased cooperation between Member States and industry stakeholders.

Boosting Research and Development:

Significant emphasis is placed on boosting research and development in net-zero technologies. This includes increased funding for Research and Development projects, partnerships with academic institutions and the promotion of a collaborative environment for innovation.

Skills and Training:

Recognizing the need for a skilled workforce, the measures include provisions for education and training programs. These programs aim to equip workers with the necessary skills to operate and develop advanced net-zero technologies, ensuring a robust labor market to support the green transition.

Improved Market Conditions:

The measures adopted aim to create favourable market conditions for net-zero technologies. This includes policies to ensure fair competition, support for SMEs in the green tech sector, and initiatives to promote sustainable investment.

Next Steps: 

Following the adoption of these measures by the European Parliament, the focus will shift to their implementation in the Member States. Coordination between national governments, industry stakeholders, and the European Commission will be crucial to achieving the ambitious goals set out in this plan. 

In an effort to strengthen environmental and public health protection, the European Commission has requested the European Chemicals Agency (ECHA) to expand the scope of the REACH restriction proposal ...

In an effort to strengthen environmental and public health protection, the European Commission has requested the European Chemicals Agency (ECHA) to expand the scope of the REACH restriction proposal for chromium (VI) substances. The mandate, received by ECHA on 29 April 2024, now covers a wider range of chromium (VI) substances in order to reduce the potential risks associated with their use.

Previous Mandate

Previously, the Commission's request in September 2023 focused on initiating restrictions on chromium trioxide and chromic acids (entries 16 and 17 in the REACH Authorisation List). However, recognising the possibility of "regrettable substitution" with other chromium (VI) substances not subject to restrictions, the Commission has now expanded the mandate.

Inclusion of Additional Chromium (VI) Substances

The updated mandate now includes the chromium (VI) substances specified in entries 16 to 22 and 28 to 31 of the REACH Authorisation List. In addition, ECHA is mandated to  consider other chromium (VI) substances, such as barium chromate, which could pose risks if used as substitutes.

To support the preparation of the proposal, ECHA will launch a second call for evidence in June, focusing on alternatives to chromium (VI) substances and their different applications. Stakeholder input from the first call for evidence will be taken into account.

Extended Timeline and Regulatory Commitment

Due to the expanded scope, ECHA will submit the restriction proposal by 11 April 2025 instead of the previously planned date of 4 October 2024. The preparation and evaluation of the proposal will follow to the standard REACH restrictions process. including evaluation by the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC).

The Commission's decision reflects its commitment to stringent regulatory measures to protect human health and the environment from the harmful effects of chromium (VI) substances.

The European Commission is in the process of amending the regulatory frameworks governing plastic materials and articles intended for food contact. A feedback period on a draft regulation ended recent...

The European Commission is in the process of amending the regulatory frameworks governing plastic materials and articles intended for food contact. A feedback period on a draft regulation ended recently and the amendments are planned to be adopted in the fourth quarter of 2024.

Aimed at improving food safety and environmental standards, these amendments will update Regulation (EU) No 10/2011 and Regulation (EC) No 2023/2006 and include provisions for the use of recycled plastics and refinement of quality control measures across the EU.

Key highlights of the draft regulations include:

- Clarification on Plastic Materials: The new regulations will address ambiguities in the current legislation by redefining "plastic layers" to ensure broader coverage of all plastic materials and articles, thereby strengthening safety measures.

- Use of Recycled Plastics: To promote sustainability, the updated rules will specify the conditions under which recycled plastics can be used in food contact materials, ensuring that they meet stringent safety standards to prevent chemical migration into food.

- Purity and Safety: The amendments emphasize the high level of purity required for materials used in food contact articles. This includes detailed purity specifications for natural and synthetic substances to protect consumer health from potential chemical contamination.

- Biocidal Products: The new framework will align with Regulation (EU) No 528/2012 which outlines the use of biocidal products in the manufacture of food contact materials, ensuring that all substances used are authorized and safe for food contact.

- Increased Transparency: Manufacturers will be required to provide detailed documentation of compliance to enforcement authorities, improving traceability and accountability in the manufacturing process.

- Consumer Information: The regulations will also enforce clearer labelling requirements to inform consumers on the safe use of plastic food contact materials, especially those intended for repeated use, to avoid deterioration and potential health risks.

Impact on Manufacturers and Consumers

Manufacturers will need to adapt to these stricter controls which may increase production costs due to higher purity standards and more rigorous testing requirements. However, these changes are expected to benefit consumers by providing greater assurance of the safety and quality of food contact materials in the EU.

Regulatory Transition and Implementation

The amendments will provide a transitional period for manufacturers and businesses to comply with the new standards, allowing products that comply with the previous regulations to be marketed until stocks are exhausted. This phased approach aims to minimize disruption to the supply chain while maintaining a high level of  public health and food safety protection.

Conclusion

This regulatory update underscores the EU's commitment to public health, environmental sustainability and the highest safety standards for food contact materials. By incorporating modernized procedures and stringent controls, the EU continues to lead in comprehensive consumer safety and environmental protection initiatives.