Europe Regulatory News

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 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 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.

On 22 April 2024, the European Commission adopted criteria outlining what constitutes ‘essential uses’ of the most harmful chemicals (‘Guiding Criteria and Principles for the Essential Use Conce...

On 22 April 2024, the European Commission adopted criteria outlining what constitutes ‘essential uses’ of the most harmful chemicals (‘Guiding Criteria and Principles for the Essential Use Concept in EU Legislation Dealing with Chemicals’). This move aims to improve health and environmental protection by accelerating the phase-out of non-essential uses while allowing time for substitution in essential cases.

What is an essential use

In the Communication published on 22 April, the Commission defines that a use of a most harmful substance is essential only if both of the following two criteria are met:

1. Its use is necessary for health or safety or is critical for the functioning of society.

2. There are no acceptable alternatives.

The concept of essential use will only have legal effect if it is included in specific legislation which is currently not the case in the EU.

Most harmful chemicals

A most harmful substance has one or more of the following hazard properties:

• Carcinogenicity Category 1A and 1B.

• Germ cell mutagenicity Category 1A and 1B.

• Reproductive/developmental toxicity Category 1A and 1B.

• Endocrine disruption Category 1 (human health).

• Endocrine disruption Category 1 (environment).

• Respiratory sensitisation Category 1.

• Specific target organ toxicity – repeated exposure (STOT-RE) Category 1, including immunotoxicity and neurotoxicity.

• Persistent, bioaccumulative and toxic/very persistent and very bioaccumulative (PBT/vPvB).

• Persistent, mobile and toxic/very persistent and mobile (PMT/vPvM).

• Hazardous to the ozone layer Category 1.

Use necessary for health and safety

The use of a most harmful substance is necessary for health or safety if the use and the technical function of the substance in that use are necessary in order to:

• Prevent, monitor or treat disease and similar health conditions.

• Maintain essential conditions for human or animal life and health.

• Manage health crises and emergencies.

• Ensure personal safety.

• Ensure public safety.

These elements are described in the Annex to the Communication (Table 2).

Uses critical for the functioning of society

The use of a most harmful substance is critical for the functioning of society if the use and the technical function of the substance in that use are critical in order to:

• Provide resources or services that need to be maintained for society to function (e.g. ensure the supply of energy and critical raw materials or resilience to supply disruptions).

• Manage societal risks and impacts of natural crises and disasters.

• Protect and restore the natural environment.

• Undertake scientific research and development.

• Protect cultural heritage.

These elements are described in the Annex to the Communication (Table 3).

Definition of ‘use’

In the context of the essential use concept, 'use' applies to substances in various forms, including mixtures, articles, products or processes. It covers activities such as processing, formulation, consumption, storage, treatment and production. The assessment of essentiality takes into account both the technical function of the substance and the context of its use. A substance may be essential for one product, but not for another.

Integrating essential use into legislation

The Communication outlines the guiding principles and criteria for the concept of essential use, with the aim of incorporating it into EU legislation in a harmonised way. The legal effect of the concept will only be achieved through its inclusion in legislation, a process which depends on impact assessments.

At present, the essential use concept is not part of the REACH regulation and therefore does not influence initiatives such as the restriction of PFAS. Nevertheless, the Communication reaffirms the Commission's commitment to phasing out harmful substances while recognising their essential societal role, particularly in the green and digital transition.

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.

On 23 April 2024, the European Parliament endorsed the "Right to Repair" initiative. This initiative aims to make repairs more accessible and appealing to consumers across the EU.  Background:  ...

On 23 April 2024, the European Parliament endorsed the "Right to Repair" initiative. This initiative aims to make repairs more accessible and appealing to consumers across the EU. 

Background: 

With the proliferation of electronic devices and appliances, the issue of electronic waste has become increasingly pressing. The "Right to Repair" initiative addresses this challenge by encouraging manufacturers to design products that are easier to repair and maintain. By extending the life of products, this initiative aims to reduce electronic waste and promote a circular economy. 

Key Points: 

Access to Spare Parts: The new rules proposed by the EU Parliament would require manufacturers to provide access to spare parts and repair information for their products. This would enable consumers to repair their devices rather than throw it away when it breaks down. 

Improved Reparability: Manufacturers would be required to design products with repairability in mind, ensuring that components are easily accessible and replaceable. This would not only benefit consumers but also encourage innovation in product design and engineering. 

Consumer Rights: The "Right to Repair" initiative emphasizes consumer rights and gives individuals more control over the products they purchase. By empowering consumers to repair their devices, this initiative promotes sustainability and reduces reliance on disposable products. 

Environmental Impact: By reducing electronic waste and encouraging sustainable consumption habits, the "Right to Repair" initiative contributes to environmental protection efforts. It is in line with the EU's wider objectives of combating climate change and promoting a greener economy. 

Next Steps: 

The proposed rules for the "Right to Repair" initiative will now be subject to further deliberation and negotiation within the EU legislative process. If adopted, these rules have the potential to transform the way products are designed, manufactured, and consumed across the European Union. 

Conclusion: 

The "Right to Repair" initiative is an important step towards creating a more sustainable and consumer-friendly economy. By promoting repairability and empowering consumers, the EU Parliament is paving the way for a future where products are built to last, and electronic waste is minimized.