In a move aimed at bolstering health protection for infants and young children, the European Commission has amended Regulation (EU) 2023/915 to lower the maximum permissible levels of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters in infant formulae, follow-on formulae, and foods for special medical purposes intended for infants and young children. This amendment, established through Commission Regulation (EU) 2024/1003, will become enforceable on January 1, 2025.
This notification was timely identified and is available to users through the SGS Digicomply Regulatory Agenda. It offers a comprehensive list of regulatory deadlines, including historical and upcoming dates, with detailed insights and analysis. Explore the demo to try this tool in action.
Background and Legislative Context
Commission Regulation (EU) 2024/1003, published on April 4, 2024, reflects a proactive approach to mitigating potential health risks associated with the consumption of 3-MCPD and its fatty acid esters by infants and young children. This regulation is a response to accumulating evidence and updated scientific opinions from the European Food Safety Authority (EFSA), highlighting the necessity of stricter control over these contaminants in food products.
The journey towards this amendment began with the establishment of maximum levels for 3-MCPD and its esters in Regulation (EU) 2020/1322, which were later integrated into Regulation (EU) 2023/915. The EFSA's 2018 assessment flagged the presence of these compounds in certain foods as a significant health concern, particularly for infants and young children. Subsequent data from Member States' controls during 2020-2022 demonstrated that lower contaminant levels could be achieved through good practices, thereby justifying the revision.
Key Provisions of Regulation (EU) 2024/1003
1. Lowered Maximum Levels
The regulation specifies new, reduced maximum levels for the sum of 3-MCPD and 3-MCPD fatty acid esters in relevant infant and young child food products:
- Infant formulae, follow-on formulae, and food for special medical purposes (powder form): Maximum level set at 80 µg/kg.
- Infant formulae, follow-on formulae, and food for special medical purposes (liquid form): Maximum level set at 12 µg/kg.
2. Enforcement Date
The new maximum levels will be enforceable from January 1, 2025. This grace period allows manufacturers and distributors sufficient time to comply with the updated standards.
3. Transitional Provisions
Products lawfully placed on the market before January 1, 2025, may remain on the market until their minimum durability or use-by date, ensuring a smooth transition without immediate disruption to supply chains.
4. Scope of Application
The regulation applies to all infant formulae, follow-on formulae, and food for special medical purposes intended for infants and young children marketed within the EU. This includes both domestically produced and imported products, ensuring a comprehensive approach to health protection.
Implications for Manufacturers and Suppliers
The revised regulation necessitates significant adjustments in the production processes of infant and young child food manufacturers. Companies must adopt enhanced quality control measures and possibly reformulate their products to meet the new, stricter contaminant limits. This may involve:
- Reviewing and optimizing raw material sourcing to ensure lower contaminant levels.
- Implementing advanced processing techniques that minimize the formation of 3-MCPD and its esters during manufacturing.
- Regularly testing finished products to ensure compliance with the new limits.
Failure to comply with the revised standards could lead to significant regulatory and financial repercussions, including product recalls, fines, and reputational damage.
Health and Safety Impact
The primary aim of the new regulation is to enhance the safety of food products consumed by vulnerable populations, particularly infants and young children. 3-MCPD and its fatty acid esters have been associated with potential carcinogenic and genotoxic effects. By lowering the permissible levels of these contaminants, the EU seeks to reduce the risk of adverse health outcomes, thereby contributing to the overall well-being of young consumers.
Conclusion
The amendment of Regulation (EU) 2023/915 through Commission Regulation (EU) 2024/1003 marks a significant advancement in food safety standards within the European Union. By proactively addressing the risks associated with 3-MCPD and its fatty acid esters, the EU reinforces its commitment to protecting the health of its youngest and most vulnerable citizens.
Professionals in the food industry must stay informed about these regulatory changes and take proactive steps to ensure compliance. For detailed insights and updates on this and other regulatory developments, stakeholders can utilize the SGS Digicomply Regulatory Intelligence Hub, a comprehensive platform offering up-to-date information and expert analysis on food safety regulations.
For more detailed inquiries, stakeholders can reach out directly to the European Commission, the regulatory body overseeing this amendment, or utilize the SGS Digicomply platform for comprehensive insights and updates. Feel free to get in touch now to learn about implementing the Regulatory Intelligence Hub for your company. Or explore the demo and try this tool in action.
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