Europe Regulatory News

IUCLID 6 has been upgraded version 8.0.2 by the European Chemicals Agency (ECHA). This update, which follows the larger version 8 release at the end of  April, focuses on minor corrections and impro...

IUCLID 6 has been upgraded version 8.0.2 by the European Chemicals Agency (ECHA). This update, which follows the larger version 8 release at the end of  April, focuses on minor corrections and improvements.

 
Update

Users who have not yet updated to IUCLID 6 version 8 are the main target group for this version. It is not necessary to install this new version for current users who have already finished the upgrade procedure, unless they encounter specific problems that are described in detail in the release notes.
 

The specific fixes included in this update are:

• IUCLID Migrator: This tool, used to migrate data from older versions of IUCLID, was failing in some cases due to a "Definition not found" error. This issue has been resolved.

• REACH Messages: The validation assistant, which helps to ensure that data submitted to ECHA complies with REACH regulations, has received updated messages.

• EU BPR Translations: New and updated translations have been added to the Summary of Product Characteristics (SPC) section for use in the context of the EU Biocidal Products Regulation (BPR).

• EU BPR Active Substances: The configuration of active substances under the EU BPR has been updated, including messages for the validation assistant.

• Chesar IUCLID Plug-in: The Chesar IUCLID plug-in, used for hazard assessment has been updated.

• User Synchronization: The process for synchronizing users for ECHA IUCLID instances has been updated.

Enhance Your IUCLID Experience with Powerful Add-on Tools

IUCLID provides a complete set of tools for organising chemical data. But did you know that its functionality can be further enhanced with other tools? With these downloadable tools, you can easily extend your current IUCLID installation and achieve new levels of productivity and data management:

Text Analytics: Perform a thorough search of all IUCLID data fields, including the textual content of any attached documents. Find the information you need quickly and easily.
Data Extractor: Need to extract specific information from your IUCLID dossiers? This user-friendly application makes it easy. Define your extraction criteria and easily extract the necessary data.
Knife Plug-In for Uploading Data: Simplify the procedure for adding external chemical data to your IUCLID database. By converting data from several sources into the IUCLID format, this plug-in helps you save a significant amount of time and work.

By using these add-on technologies you can optimise your chemical information workflows, make data more accessible and significantly improve your IUCLID experience.

Source

Attention seed suppliers! Proper labelling of seeds treated with plant protection products (PPP) is crucial. It ensures transparency and safety for both sellers and users. The government of the Republ...

Attention seed suppliers! Proper labelling of seeds treated with plant protection products (PPP) is crucial. It ensures transparency and safety for both sellers and users. The government of the Republic of Lithuania has released an important update for seed suppliers.

Here are some key points to consider:

• Only Registered PPP: Seeds must be treated with PPPs registered in the EU. It is absolutely forbidden to supply seed treated with unlicensed products.

• Labelling Responsibility: It is the responsibility of the seed to ensure that treated seeds comply with EU legislation, in particular Regulation (EC) No. 1107/2009.

• Labelling Requirements: The seed label or accompanying documents must clearly state:

  • Name of the plant protection product used for treatment.

  • Name(s) of the active ingredient(s) in the PPP.

  • Safety precautions for using the treated seeds.

  • Potential risks to human and animal health associated with the treatment.

• Reliable Sources: It is not permitted to sell seed treated with unregistered PPP or different from registered products.

Important points to remember:

• To obtain a list of PPPs that have been registered, always check the State Crop Production Service's VATIS information system.

• Adhere closely to the distribution, storage, and use policies specified for registered PPPs.

• Make sure you have read and understood all instructions before using treated seeds.

By following these instructions, ‘seed suppliers’ can ensure the safe and responsible use of treated seed, protecting both consumers and the environment.

Source

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.