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Overview of Recent Commission Implementing Regulations
Commission Implementing Regulation (EU) 2024/2652
This regulation modifies the existing Implementing Regulation (EU) 2020/761, focusing on the management of specific tariff quotas in the rice sector, adjustments to cheese export tariff quotas for the United States, and updates to the technical specifications for IMA1 certificates for importing dairy products from New Zealand. It establishes reference quantities for rice tariff quotas to manage over-demand, corrects discrepancies in cheese export quotas due to the UK’s withdrawal from the EU, and mandates updated IMA1 certificate templates to align with recent regulations. A transitional period for adapting to the new certificate formats is also introduced, along with a timeline for implementing reference quantity requirements.
Commission Implementing Regulation (EU) 2024/2651
This regulation grants Union authorization for the biocidal product family known as ‘Taski-Room Care-Suma Family based on Lactic Acid’, covering various product types according to Regulation (EU) No 528/2012. It specifies that the product family contains lactic acid as an active substance and outlines the assessment process that led to the authorization. The regulation includes detailed product characteristics, safety measures, and general use directions. This authorization is valid until 2034, reflecting the EU’s commitment to ensuring the safe use of biocidal products.
Commission Implementing Regulation (EU) 2024/2649
This regulation serves to correct the Swedish language version of Commission Implementing Regulation (EU) 2023/1773, which pertains to the carbon border adjustment mechanism (CBAM). It addresses an incorrect term used in the previous regulation’s annexes, ensuring consistency and accuracy in legal terms. This regulation emphasizes the importance of precise language in EU regulations and is binding across all Member States, reinforcing compliance obligations for the CBAM.
Commission Delegated Regulation (EU) 2024/2684
This regulation amends Delegated Regulation (EU) 2016/127 to update protein-related requirements for infant and follow-on formulas made from protein hydrolysates. It introduces specific protein content requirements, processing methods, and amino acid compositions, allowing for greater flexibility in product formulations. The regulation facilitates the introduction of new protein hydrolysates into the market following positive evaluations by the European Food Safety Authority (EFSA) and aims to maintain high safety and nutritional standards for infants. Immediate implementation is designed to avoid delays in the availability of compliant formulas.
Review of each of legal acts published today:
Commission Implementing Regulation (EU) 2024/2652 of 10 October 2024 amending Implementing Regulation (EU) 2020/761 with regard to the management of certain tariff quotas in the rice sector, the adjustment of cheese export tariff quotas for the United States and an update of the technical specifications for the IMA1 certificates for the import of dairy products from New Zealand
Commission Implementing Regulation (EU) 2024/2652 Overview
This regulation modifies the existing Implementing Regulation (EU) 2020/761, focusing on the management of specific tariff quotas in the rice sector, cheese export tariff quotas for the United States, and updates to the technical specifications for IMA1 certificates for importing dairy products from New Zealand.
Key Provisions
Amendments to Rice Tariff Quotas
The regulation addresses the over-demand of several rice tariff quotas (order numbers 09.4112, 09.4117, 09.4118, 09.4119, 09.4130, 09.4154, 09.4166, and 09.4168) by establishing a reference quantity for applications. This adjustment aims to enhance the management of these quotas, as required by Article 9 of Commission Delegated Regulation (EU) 2020/760.
Adjustment of Cheese Export Tariff Quotas
Following the UK’s withdrawal from the EU, discrepancies arose in the allocation of cheese export quotas to the United States. The regulation corrects these discrepancies by amending Annex XIV.5 of Implementing Regulation (EU) 2020/761 to ensure clarity and accuracy in quota distributions.
Updates to IMA1 Certificates for Dairy Products
For dairy imports from New Zealand, the regulation mandates that IMA1 certificates must conform to new templates aligned with recent regulations (EU) 2023/608, 2024/1173, and 2024/1178. The templates for certificates related to cheese and butter imports from New Zealand are updated to reflect these changes, ensuring compliance with EU standards.
Transitional Provisions
A transitional period until 30 June 2025 is established, during which customs authorities may accept both the old and new IMA1 certificate formats. Furthermore, the requirement for reference quantities will take effect from 23 November 2026, giving operators sufficient time to adapt to the new regulations.
Implementation and Binding Nature
This regulation will enter into force on the seventh day following its publication in the Official Journal of the European Union. It is binding in its entirety and directly applicable in all Member States, ensuring uniform enforcement across the EU.
Conclusion
The amendments introduced by this regulation are aimed at refining the management of tariff quotas in the agricultural sector, particularly concerning rice and cheese, while also updating the import certification process for dairy products from New Zealand. These changes reflect the EU’s ongoing commitment to ensuring the integrity and effectiveness of its agricultural market regulations.
Consequences:
Description of Commission Implementing Regulation (EU) 2024/2652
The Commission Implementing Regulation (EU) 2024/2652 introduces changes to the management of agricultural tariff quotas in the European Union, specifically in the rice and dairy sectors. This regulation includes the establishment of reference quantities for certain rice tariff quotas, aimed at addressing over-demand and creating a more balanced market.
In conjunction with these changes, the regulation adjusts cheese export tariff quotas to the United States, a move that reflects the evolving trade landscape post-Brexit and seeks to maintain the competitiveness of EU dairy products in the American market.
The regulation also updates the technical specifications for IMA1 certificates, facilitating the importation of dairy products from New Zealand and ensuring compliance with EU standards. A transitional period is provided to allow traders to adapt to the new certificate formats, which is expected to minimize disruption in trade operations.
However, the introduction of reference quantity requirements could create challenges for smaller market operators who may lack the necessary import history, potentially leading to market concentration. Additionally, the allocation process for tariff quotas could introduce inconsistencies, causing confusion among exporters and customs authorities, which may result in trade disruptions.
The transitional phase for the outdated IMA1 certificates may create a dual compliance system, risking delays in customs processing. Furthermore, the extended timeline for the implementation of new reference quantity rules may create uncertainty for market operators, affecting their operational strategies and investment decisions.
Overall, while the regulation aims to streamline the management of agricultural tariff quotas and enhance market responsiveness, it also poses certain challenges that could impact trade efficiency and competitive equity within the EU agricultural sector.
Commission Implementing Regulation (EU) 2024/2651 of 10 October 2024 granting a Union authorisation for the biocidal product family Taski-Room Care-Suma Family based on Lactic Acid in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2024/2651 Overview
The Commission Implementing Regulation (EU) 2024/2651, adopted on 10 October 2024, grants a Union authorization for the biocidal product family known as ‘Taski-Room Care-Suma Family based on Lactic Acid’. This authorization is in accordance with Regulation (EU) No 528/2012, which governs the availability and use of biocidal products within the European Union.
Key Provisions
Application and Approval Process
The regulation outlines that Diversey Europe Operations B.V. submitted an application on 16 April 2019 for the Union authorization of the ‘Taski-Room Care-Suma Family based on Lactic Acid’, covering product-types 2, 3, and 4, as defined in Annex V of Regulation (EU) No 528/2012. The competent authority of Latvia agreed to evaluate the application. The application was registered under case number BC-FV051273-25.
Active Substance
The product family contains L-(+)-Lactic acid, which is listed as an approved active substance in the Union list referenced in Article 9(2) of Regulation (EU) No 528/2012 specifically for product-types 2 (Disinfectants and algaecides not intended for direct application to humans or animals), 3 (Veterinary hygiene), and 4 (Food and feed area).
Assessment and Opinion
On 28 February 2023, the evaluating competent authority submitted an assessment report and conclusions to the European Chemicals Agency (ECHA). Subsequently, on 2 October 2023, ECHA provided its opinion on the Union authorization, confirming that the product family meets the conditions set out in Article 19(1) and (6) of the Regulation, subject to compliance with the draft summary of product characteristics (SPC).
Authorization Details
Article 1 of the regulation states that a Union authorization, numbered EU-0031644-0000, is granted to Diversey Europe Operations B.V. for the marketing and use of the biocidal product family. This authorization is valid from 31 October 2024 until 30 September 2034.
Annex – Summary of Product Characteristics
The annex includes detailed information regarding the product types, formulation, authorized uses, hazard statements, and precautionary measures. The product is classified under multiple product types and outlines specific applications for disinfecting various surfaces in different environments, including food processing areas and veterinary settings.
Safety and Compliance
The regulation emphasizes the importance of adhering to safety measures during the handling of the product. Risk mitigation measures are specified, including the use of personal protective equipment (PPE) to ensure safe handling and application.
General Directions for Use
General directions for use of the product are provided, including instructions for dilution, application methods, and contact times required for effective disinfection. The regulation also highlights the importance of compliance with local regulations for the disposal of the product and its packaging.
Final Notes
This regulation is binding in its entirety and directly applicable in all Member States, reflecting the EU’s commitment to ensuring the safe use of biocidal products across the Union.
Consequences:
Neutral Description of Commission Implementing Regulation (EU) 2024/2651
The Commission Implementing Regulation (EU) 2024/2651 authorizes the biocidal product family ‘Taski-Room Care-Suma Family based on Lactic Acid’. This regulation allows for the use of lactic acid-based products, which are intended for disinfection and cleaning purposes across various environments, including food service areas and veterinary settings.
The approval process for this product family involved a comprehensive assessment by the European Chemicals Agency, which evaluated its safety and efficacy. As a result of this regulation, manufacturers can market these products until 2034, providing a stable framework for investment and economic activity within the EU chemical industry.
However, the authorization also raises important considerations. The introduction of these biocidal products could pose risks related to human health and environmental safety. Specific concerns include the potential for harmful effects from exposure to active ingredients and the implications for food safety due to possible chemical residues on food-contact surfaces.
Environmental impacts are also a focal point, as the use of these products may affect local ecosystems if they enter water systems. The regulation does not appear to include extensive risk management strategies, which may leave gaps in ensuring safety for users and the environment.
Overall, while the regulation aims to promote hygiene and offers a new option for biocidal agents, it necessitates careful consideration of the health and environmental effects, as well as the effectiveness of risk mitigation measures to ensure safe use and compliance.
Commission Implementing Regulation (EU) 2024/2649 of 10 October 2024 correcting the Swedish language version of Implementing Regulation (EU) 2023/1773 laying down the rules for the application of Regulation (EU) 2023/956 of the European Parliament and of the Council as regards reporting obligations for the purposes of the carbon border adjustment mechanism during the transitional period
Commission Implementing Regulation (EU) 2024/2649
This regulation, adopted by the European Commission on 10 October 2024, serves to correct the Swedish language version of Commission Implementing Regulation (EU) 2023/1773. The original regulation lays down the rules for the application of Regulation (EU) 2023/956, which pertains to the carbon border adjustment mechanism (CBAM) during the transitional period.
Key Provisions
The regulation identifies an error in the Swedish language version of the earlier Implementing Regulation (EU) 2023/1773. Specifically, it addresses an incorrect term used in Section 1 point 39 of Annex II, which pertains to a defined type of gas. This erroneous term was consistently used throughout Annexes II, III, and IV, thereby affecting the substance of those provisions.
As a result, the regulation mandates that the Swedish language version of Implementing Regulation (EU) 2023/1773 be corrected to ensure consistency and accuracy in the legal text. Importantly, the errors identified do not affect the language versions other than Swedish.
Implementation and Applicability
Article 2 of this regulation stipulates that it will enter into force on the twentieth day following its publication in the Official Journal of the European Union. Furthermore, it establishes that this regulation is binding in its entirety and directly applicable in all Member States, reinforcing the legal obligation for compliance across the EU.
Conclusion
In summary, Commission Implementing Regulation (EU) 2024/2649 is a corrective measure aimed at ensuring the accuracy of the Swedish language version of a previous regulation concerning the carbon border adjustment mechanism. This action underscores the importance of precise legal language in EU regulations and the commitment to maintaining clarity in all official language versions.
Consequences:
Neutral Description of Commission Implementing Regulation (EU) 2024/2649
The Commission Implementing Regulation (EU) 2024/2649 addresses a linguistic error in the Swedish language version of the earlier Implementing Regulation (EU) 2023/1773, specifically concerning the carbon border adjustment mechanism (CBAM). This regulation aims to enhance clarity and consistency in the implementation of CBAM across the European Union member states.
By correcting the specific terminology related to the types of gases, the regulation seeks to improve the coherence of compliance obligations for stakeholders involved in emissions reporting. The amendment is intended to ensure that all member states interpret the regulations uniformly, potentially reducing the risk of ambiguity and fostering a clearer understanding of reporting requirements during the transitional period of the CBAM.
However, the adjustment introduced by this regulation may also lead to legal uncertainty, particularly if discrepancies remain between the various language versions of the regulation. Stakeholders, including businesses and regulatory bodies, might face challenges in aligning their reporting practices with the updated definitions, which could result in additional compliance efforts.
Furthermore, the time required for stakeholders to adapt to the corrected terminology may temporarily impact the overall implementation of the CBAM, potentially delaying some aspects of the EU’s climate policy objectives. These dynamics underscore the importance of precise legislative language to ensure effective enforcement and compliance across the EU.
In conclusion, while Commission Implementing Regulation (EU) 2024/2649 aims to rectify a specific error and promote clarity, its implications for legal certainty, compliance burdens, and implementation timelines warrant careful consideration by all relevant parties.
Commission Delegated Regulation (EU) 2024/2684 of 2 February 2024 amending Delegated Regulation (EU) 2016/127 as regards the protein-related requirements for infant and follow-on formula manufactured from protein hydrolysates
Analysis of Commission Delegated Regulation (EU) 2024/2684
Commission Delegated Regulation (EU) 2024/2684, adopted on 2 February 2024, amends Delegated Regulation (EU) 2016/127. This regulation specifically addresses the protein-related requirements for infant and follow-on formulas manufactured from protein hydrolysates. It is relevant to the European Economic Area (EEA) and aims to update existing provisions based on new scientific evaluations.
Key Provisions
1. Amendments to Compositional Requirements
The regulation modifies Annexes I, II, and III of Delegated Regulation (EU) 2016/127. It introduces new protein-related requirements for infant formulas and follow-on formulas derived from protein hydrolysates, ensuring that they meet updated safety and nutritional standards.
2. Protein Content and Sources
The regulation outlines specific protein content requirements for different groups of protein hydrolysates. For instance, it specifies minimum and maximum protein content levels, which vary by group (A, B, C, and D). Each group has defined sources of protein, primarily derived from cow’s milk whey, with particular specifications regarding the composition and processing methods.
Example of Protein Requirements:
- Group A: Minimum 0.44 g/100 kJ; Maximum 0.67 g/100 kJ.
- Group B: Minimum 0.55 g/100 kJ; Maximum 0.67 g/100 kJ.
- Group C: Minimum 0.45 g/100 kJ; Maximum 0.67 g/100 kJ.
- Group D: Minimum 0.57 g/100 kJ; Maximum 0.67 g/100 kJ.
3. Processing Requirements
The regulation specifies processing methods for protein hydrolysates, including two-stage hydrolysis processes and heat-treatment steps. These methods are crucial for ensuring that the protein sources maintain their nutritional integrity and safety for infant consumption.
4. Amino Acid Composition
Infant formulas must provide adequate amounts of indispensable and conditionally indispensable amino acids. The regulation allows for some flexibility in the calculations of amino acid ratios, provided that the suitability for infants is demonstrated. This includes specific requirements for L-carnitine levels as well.
5. Scientific Evaluation and Market Access
The regulation permits the introduction of new protein hydrolysates into the market, following a positive evaluation by the European Food Safety Authority (EFSA). This is significant for manufacturers seeking to diversify their product offerings based on emerging scientific findings.
6. Urgency and Implementation
The regulation is designed to enter into force immediately upon publication to avoid delays in the availability of compliant infant formulas. It asserts that these amendments are necessary to ensure that all infant formulas on the market are safe and nutritionally adequate.
Conclusion
Commission Delegated Regulation (EU) 2024/2684 reflects the European Commission’s commitment to ensuring the safety and nutritional adequacy of infant and follow-on formulas. By updating the compositional and processing requirements, the regulation aims to protect vulnerable populations while accommodating new scientific insights into protein hydrolysates.
Consequences:
Neutral Description of Commission Delegated Regulation (EU) 2024/2684
The Commission Delegated Regulation (EU) 2024/2684 introduces new provisions regarding the formulation of infant and follow-on formulas derived from protein hydrolysates. This regulation aims to provide greater flexibility for manufacturers by allowing the inclusion of new protein hydrolysates that have undergone clinical evaluations for safety and suitability.
As a result of these changes, manufacturers may innovate and develop products tailored to meet specific dietary needs of infants, including those with certain allergies or dietary restrictions. However, the regulation allows for a case-by-case evaluation process, which may lead to variability in safety assessments and quality across different products.
The European Food Safety Authority (EFSA) plays a key role in evaluating the protein hydrolysates permitted in these formulas, ensuring that those approved meet established safety standards. Nonetheless, there are concerns about the potential for less rigorous evaluations for some formulations, which could affect the overall safety and nutritional adequacy of the products available in the market.
The regulation also includes specific protein-related requirements concerning protein content, processing methods, and amino acid profiles aimed at ensuring a minimum nutritional value. However, the flexibility afforded to manufacturers in these areas may result in inconsistencies in product quality, which could pose challenges for consumers and healthcare professionals in making informed choices.
Overall, Regulation (EU) 2024/2684 reflects an effort to adapt to evolving infant nutritional needs while balancing innovation with safety. The implications of these regulatory changes will be closely monitored, especially considering the importance of maintaining high standards for the health and well-being of infants and young children.[:]
