Europe Regulatory News

On September 5, 2024, a significant new rule went into effect in Poland concerning the application of several provisions of the Act governing "fertilisers and fertilisation". The Minister of Agricultu...

On September 5, 2024, a significant new rule went into effect in Poland concerning the application of several provisions of the Act governing "fertilisers and fertilisation". The Minister of Agriculture and Rural Development has released a rule that provides detailed instructions and outlines specific guidelines for evaluating fertilisers and plant growth enhancers that promote plant development.

Here are the key updates to the new regulation:

• Permissible Pollutants: The Regulation specifies the maximum permitted concentrations of several contaminants in fertilisers and plant growth enhancers, such as chromium, cadmium, arsenic, lead, mercury, nickel, and others.

• Testing and Authorization: The Regulation lists the companies that are authorised to test fertilisers and other plant cultivation tools used in plant culture, and the specific tests required to ensure that quality criteria are met.

• Animal By-Products: The Regulation also specifies requirements for the inclusion of animal by-products in fertilisers and regulates their use.

• Labelling Requirements: It mandates certain information, such as the manufacturing process, use guidelines, and quality standards, to be published on fertiliser labels.

• Impact Assessments: The regulation also demands studies of the potential effects of fertilizers on human, animal, and environmental health.

The Polish fertilizer regulations aim to ensure the safe and effective use of fertilizers while protecting health and the environment.

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On 10 September 2024, the European Chemicals Agency (ECHA) published a reminder to small and medium-sized enterprises (SMEs) to check their reported company size in the REACH-IT registration system. T...

On 10 September 2024, the European Chemicals Agency (ECHA) published a reminder to small and medium-sized enterprises (SMEs) to check their reported company size in the REACH-IT registration system. This is part of ECHA’s ongoing efforts to ensure accurate reporting and compliance in the registration of chemical substances.

Key Message for SMEs

ECHA emphasised that if a company’s size has been incorrectly reported during registration, it must inform the ECHA Helpdesk immediately to avoid extra charges. Companies that update their size information before the Agency starts its verification process will only be required to pay the difference in the registration fee, instead of an administrative fee of up to EUR 19,900.

Steps to Update Company Size

ECHA encourages SMEs to visit its website for detailed guidance on how to determine their correct company size and compile the necessary documentation. In addition, SMEs should upload relevant supporting documents, regularly check their REACH-IT accounts for updates and ensure that their registration and contact details are accurate.

The European Commission has that two substances, N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP), will be added to the Authorisation List (Annex XVII) of the REACH Regulation (Regulatio...

The European Commission has that two substances, N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP), will be added to the Authorisation List (Annex XVII) of the REACH Regulation (Regulation (EC) No 1907/2006) by a new Commission Regulation which will impose significant restrictions on their use. These measures aim to protect the health of workers by addressing the risks associated with exposure to these chemicals.

This Commission Regulation was notified to the World Trade Organization (WTO) on 30 July 2024 and the notification is open for comments for 60 days.

About the Substances

DMAC (CAS No 127-19-5) and NEP (CAS No 2687-91-4) are widely used solvents with various industrial applications, including the production of man-made fibres, films, coatings and chemicals. Both chemicals are classified as toxic to reproduction, based on developmental toxicity studies, making their exposure a particular concern for workers in industries where they are used. NEP is also widely used in cleaning agents, oil field operations and polymer processing.

Proposed Restrictions

The new Regulation imposes strict restrictions on the market availability and use of DMAC and NEP. Specifically, these substances cannot be placed on the market or used in concentrations equal to or greater than 0.3 % unless manufacturers update safety reports and ensure compliance with Derived No-Effect Levels (DNELs). The DNELs for DMAC have been set at 13 mg/m³ for long-term inhalation exposure and 1.8 mg/kg body weight per day for long-term dermal exposure. For NEP, the long-term inhalation DNEL is 4.0 mg/m³ and the dermal DNEL is 2.4 mg/kg body weight per day.

Exposure to DMAC and NEP above these DNELs poses significant risks to the health of workers due to their reprotoxic properties. Prolonged exposure may cause adverse developmental effects, particularly in relation to reproductive health.

Timeline for Compliance

To give industry sufficient time to implement these changes, the Regulation includes a transitional period. For most sectors, the restrictions will come into force 18 months after the Regulation is published in the Official Journal of the EU. However, for the man-made fibres sector, where DMAC is heavily used, the application of the restriction will be postponed for 48 months.

Reasons for the Regulation

The Regulation follows an extensive review process carried out by the European Chemicals Agency (ECHA). Both the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC) concluded that current measures are not sufficient to reduce the health risks posed by DMAC and NEP. The RAC recommended the proposed DNELs, while the SEAC emphasised the socio-economic benefits of implementing the restriction. The European Commission’s decision also reflects these findings, ensuring that industry prioritises worker safety while adapting to the new requirements.

Conclusion

The inclusion of DMAC and NEP in the REACH Authorisation List is a significant step forward in protecting workers from exposure to harmful chemicals. The transitional periods built into the Regulation will give industry time to comply with the new safety standards, ultimately reducing health risks and ensuring safer working conditions across the EU. The proposed regulation is expected to be adopted in the first quarter of 2025, with the restrictions taking full effect in the following 18 to 48 months.

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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