Europe Regulatory News

On 30 August 2024, the European Chemicals Agency (ECHA) launched a public consultation on proposals to identify six new chemicals as Substances of Very High Concern (SVHCs). The consultation is open u...

On 30 August 2024, the European Chemicals Agency (ECHA) launched a public consultation on proposals to identify six new chemicals as Substances of Very High Concern (SVHCs). The consultation is open until 14 October 2024 and stakeholders are invited to submit comments in particular on the identity of the substances, their use, potential alternatives, exposure risks and hazardous properties. This input will help ECHA determine whether these substances should be included in the Candidate List for possible inclusion in the Authorisation List.

Substances of Very High Concern

SVHCs are chemicals that cause serious and often irreversible effects on human health and the environment. Once identified, these substances are included the Candidate List, where they are evaluated for possible inclusion in the Authorisation List. Chemicals on the Authorisation List cannot be used without prior approval from the European Commission. As of June 2024, the Candidate List contains 241 entries, while the Authorisation List contains 59.

Proposed Substances for Inclusion in the Candidate List

The six substances proposed for inclusion in the Candidate List are persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), toxic for reproduction or endocrine disruptors. The substances are listed in the table below and further details can be found here.

Next Steps

If no significant objections or new information are raised during the consultation, these substances will be added directly to the Candidate List. However, if the comments reveal new information that challenges their identification as SVHCs, the proposals will be referred to ECHA’s Member State Committee (MSC) for further consideration.

The deadline for submitting comments is 14 October 2024. Stakeholders can contribute by providing data on the uses of the substances, exposure levels, alternatives and the risks they pose.

In a decisive step towards sustainable agriculture, the Spanish Council of Ministers has adopted a new Royal Decree to rationalise crop fertilisation. This initiative, proposed by the Ministry of Agri...

In a decisive step towards sustainable agriculture, the Spanish Council of Ministers has adopted a new Royal Decree to rationalise crop fertilisation. This initiative, proposed by the Ministry of Agriculture, Fisheries, and Food, is in line with the European ‘From Farm to Table’ plan. which emphasises both production and environmental sustainability.

The new regulations, which are included in the 43 measures to support the agricultural sector, aim to facilitate sustainable soil nutrition.

Their main objective is to improve agricultural soil productivity while minimizing the environmental impact of fertilizers and other nutrients. This is in line with the wider European strategy to ensure sustainable food systems. To make some technical procedures easier for farmers to implement, the legislation simplifies them. They ensure consistency with other relevant legislation, such as that on waste and contaminated soil.              

Key changes in the new regulations include:

• Incentives for digital notebooks: Farmers will not be forced to use digital notebooks but will be offered incentives to encourage their use.

• Detailed information in fertilization plans: Required information in fertilisation plans will be provided, including the determination of the dosage.

• Reduced ammonia emissions: Regulation includes measures to reduce ammonia emissions from fertiliser application.

• Flexibility in the use of manure and organic material: The obligations for the use of manure, fertilisers, and other organic materials will be made more flexible, with additional wastes added to the permitted list and requirements modified.

• Extended stacking and burying periods: The period for stacking and burying manure and organic products will be extended, giving farmers more flexibility in their operations.

These measures are part of the Government's efforts to promote and support the agricultural industry and improve the livelihoods of farmers and ranchers. The Government's aim in promoting sustainable soil nutrition is to improve the environmental performance of agriculture while ensuring efficiency and profitability. This regulation is a key step towards achieving these twin goals.

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An EU initiative will ban the use of Bisphenol A (BPA) in food contact materials in 2024. The EU is set to ban BPA in food contact materials such as packaging and kitchenware. The decision follows a s...

An EU initiative will ban the use of Bisphenol A (BPA) in food contact materials in 2024. The EU is set to ban BPA in food contact materials such as packaging and kitchenware. The decision follows a scientific assessment by the European Food Safety Authority (EFSA), which identified potential harmful effects of BPA on the immune system.  

The ban, which was endorsed by Member States after public consultation and discussions, will phase out BPA in items such as coatings of metal cans and reusable plastic bottles. There will be limited exemptions for cases with no safe alternatives, allowing the industry time to adjust and minimizing disruptions.  

European Food Safety Authority on BPA 

Bisphenol A (BPA) is a chemical commonly used in plastics and resins, such as polycarbonate plastics for water dispensers and epoxy resins for can linings. BPA can migrate into food and drink, prompting regular safety reviews by EFSA.  

EFSA’s recent re-evaluation, which considered over 800 new studies since 2013, found potential health risks from BPA, including effects on the immune system, reproductive health and metabolism. The new assessment significantly lowered the tolerable daily intake (TDI) for BPA from 4 micrograms to 0.2 nanograms per kilogram of body weight, a reduction of about 20,000 times. 

The findings suggest that average and high exposures to BPA exceed the new TDI, indicating potential health concerns. EFSA's advice, based on extensive consultation and collaboration with other scientific bodies, will guide EU lawmakers in setting regulatory measures to protect consumer health,.  

Commission Adoption 

On 12 June 2024, EU Member States agreed on the European Commission’s proposal to ban BPA, based on EFSA’s scientific assessment. The proposal will be formally adopted by the European Parliament and the Council following a scrutiny period and will enter into force at the end of 2024.  

The National Food Chain Safety Office (Nébih) in Hungary has reminded license holders of amended regulations for preparations that are not classified as plant protection agents. With immediate eff...

The National Food Chain Safety Office (Nébih) in Hungary has reminded license holders of amended regulations for preparations that are not classified as plant protection agents.

With immediate effect, these preparations may now include simple substances in their composition. However, this requires a written declaration from the license holder stating that the intended use of the product differs from that outlined in the review report for the corresponding simple substance in the database established by Executive Order 540/2011/EU.

The formulation of treatments that are not classified as plant protection agents can now include simple chemicals. This includes:

• Plant protection products that do not qualify as plant protection agents

• Coating aids

• Protective materials

• Interaction enhancers

• Auxiliary materials

• Effect modifiers

• Plant protection tools.

Key Points:

• Simple Substances Allowed: Preparations may now include basic components such as plant protection products, coating aids, protective materials, interaction enhancers, auxiliary materials, effect modifiers, and plant protection tools.

• Declaration Requirement: License holders must provide a signed and sealed declaration stating that the use of the product differs from the database review report. This declaration is required for all new and ongoing licence applications.

• Prohibited Active Ingredients: Preparations must still exclude active substances that are labelled "approved" or "not approved" in the database.

• Full Composition: The full composition of co-formulants must be submitted for evaluation. Confidential information can be sent directly to the licensing authority.

The review of the composition of already registered preparations will take place during renewals. Nébih encourages license holders to thoroughly assess the composition of their preparations to ensure compliance with the updated regulations.

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On 15 July 2024, the European Commission adopted new biodegradability standards for polymers in fertilising products. These standards cover polymers used as coating agents, water retention agents, mul...

On 15 July 2024, the European Commission adopted new biodegradability standards for polymers in fertilising products. These standards cover polymers used as coating agents, water retention agents, mulch films and other additives and require that the polymers are natural and unmodified or meet biodegradability standards. These measures ensure that these polymers do not persist in the environment, thereby reducing potential pollution and ecosystem damage.

Compliance and Implementation Timeline

Manufacturers will need to demonstrate compliance with these new criteria using standardised test methods such as EN ISO 17556:2019 for soil and EN/ISO 14851:2019 for aquatic environments. The criteria will come into force on 17 October 2028, giving manufacturers plenty of time to adapt their products accordingly.

Biodegradability Criteria Details

The newly adopted standards set specific biodegradability criteria for polymers used in fertilising products. These polymers must achieve at least 90% degradation or mineralisation within 48 months of their functionality period, ensuring that they do not persist in the environment. To verify compliance, accelerated testing methods are permitted, allowing testing at higher temperatures, such as 37°C, to reduce the testing time while maintaining reliability. The criteria are designed to ensure that polymers degrade effectively in both soil and aquatic environments, minimising their impact on ecosystems. In addition, products containing these polymers must be labelled with warnings to prevent their use near water, further reducing potential environmental risks.

Consultation Process

The development of these criteria involved consultations with EU Member States and stakeholders, including non-governmental organisations, industry representatives, and private citizens. The public consultation period ran from 8 March to 5 April 2024.

Environmental and Economic Impact

By implementing these biodegradability standards, the European Commission aims to significantly reduce the environmental impact of fertilising products and support the EU’s Farm to Fork Strategy. This strategy includes a target to reduce nutrient losses by 50% by 2030 while maintaining soil fertility. The standards also promote sustainable water use in agriculture, which is essential for adapting to climate change and protecting water resources.

 Legislative Context and Support

The new criteria are part of an amendment to Regulation (EU) 2019/1009, which was originally adopted on 5 June 2019. This Regulation requires the assessment of biodegradability criteria for polymers used in fertilising products. The legal basis for this delegated act is Article 42(1) of the Regulation.

Conclusion

The European Commission's adoption of new biodegradability criteria for polymers used in fertilising products is an important step towards reducing environmental pollution and promoting sustainable agricultural practices. The new standards are in line with the EU’s wider environmental objective and will ensure

The European Commission is seeking public feedback on a draft delegated regulation amending Regulation (EU) 2019/1021, to include UV-328 in the list of persistent organic pollutants (POPs). The aim of...

The European Commission is seeking public feedback on a draft delegated regulation amending Regulation (EU) 2019/1021, to include UV-328 in the list of persistent organic pollutants (POPs). The aim of the Regulation is to protect human health and the environment by restricting or prohibiting the use of substances listed under the Stockholm Convention on POPs.

The draft Regulation is open for public feedback from 30 July to 27 August 2024. The Commission encourages public feedback, which will be taken into account when finalising the Regulation. Feedback can be submitted via the European Union’s official website.

Decision to Include UV-328

At the eleventh meeting of the Conference of the Parties to the Stockholm Convention (COP11) in May 2023 in Geneva, Switzerland, it was decided to add UV-328 to Annex A of the Convention, with specific exemptions. This amendment requires the inclusion of UV-328 in Annex I of Regulation (EU) 2019/1021. This decision is reflected in the draft Delegated Regulation.

UV-328 is a chemical compound widely used as a UV stabilizer in various plastic and rubber products to prevent degradation from ultraviolet light. Its full chemical name is 2-(2H-Benzotriazol-2-yl)-4,6-di-tert-pentylphenol (CAS No 25973-55-1).

Consultation Process to Date

The Commission consulted with experts from all Member States and relevant stakeholders, including the chemical industry and civil society, at meetings held on 14 June 2023, 29 November 2023 and 7 June 2024. In addition, the European Chemicals Agency (ECHA) conducted a call for information from 31 May to 18 August 2023. Feedback highlighted the need for specific exemptions for articles containing UV-328 imported into the Union.

Proposed Exemptions and Restrictions

The proposed Regulation includes specific exemptions for the use of UV-328 in certain articles, such as mechanical separators in blood collection tubes, polarisers, photographic paper and spare parts for land-based motor vehicles. These exemptions are intended to allow the continued import and use of these articles until suitable alternatives are found. A limit of 1 mg/kg is also proposed for UV-328 as an unintentional trace contaminant in substances, mixtures and articles. Details of the exemptions can be found in the Annex to the draft Delegated Regulation here.

Next Steps

The Regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union and will apply from 26 February 2025.

For more details and to participate in the consultation process, please visit the European Commission's official website here

On 23 July 2024, the European Chemicals Agency (ECHA) announced that it has adopted a new policy on administrative charges for joint authorisation applications involving small and medium-sized enterpr...

On 23 July 2024, the European Chemicals Agency (ECHA) announced that it has adopted a new policy on administrative charges for joint authorisation applications involving small and medium-sized enterprises (SMEs). This update, which has been confirmed by the European Commission, simplifies the charging process for companies with an incorrectly declared size.

Single Charge for Joint SME Applications

Under the new policy, ECHA will now issue only one administrative charge for joint authorisation applications, even if several applicants have wrongly declared their company size. The charge will be based on the size of the largest applicant in the group. The invoice will be sent to the lead applicant. If all applicants have declared their company sizes correctly, no administrative charge will be applied.

Updated Definition of Financial Gain

The definition of ‘financial gain’ has been revised to include the benefit of incorrect size declarations made before the invoice is issued. This change will ensure that the lower charges SMEs might gain as a result of incorrect declarations are properly reflected in the administrative charges.

Charge Levels Remain Unchanged

The levels of administrative charges and other provisions remain the same as previously set. The updated decision, which applies from 22 July 2024, consolidates and simplifies past regulations into a single framework. The fee structure last revised in 2015 will continue to apply.

Background on SME Fees

The REACH Regulation and the REACH Fee Regulation authorise ECHA to levy charges for administrative and technical services. The updated policy integrates previous decisions from 2010, 2013 and 2015 into a single approach and streamlines the fee process for joint authorisation applications involving SMEs.