EDQM Publishes the 2024 2nd Edition of Its Technical Guide on Metals and Alloys for Food Contact
09 Dec 2024
Learn About the EDQM's 2024 Update to the Technical Guide on Metals in Food Contact Materials
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has released a revised technical guide on metals and alloys intended for food contact, marking its 2024 2nd Edition. This new guide, which supersedes the 2013 1st Edition, aligns with the Council of Europe Resolution CM/Res(2020)9. The primary objective of this resolution is to establish strict standards for food contact materials (FCMs) not yet covered by specific EU regulations, thus enhancing public health protection by minimizing the migration of potentially harmful substances into food.
Background and Motivation for the Revision
This guide revision addresses the urgent need to strengthen consumer safety in response to evolving scientific knowledge. The EDQM's initiative integrates recent recommendations from leading scientific authorities, including the European Food Safety Authority (EFSA) and Anses (the French Agency for Food, Environmental, and Occupational Health & Safety). This guide provides a harmonized framework for European policymakers to standardize the technical requirements for food contact materials.
Changes to Specific Migration Limits (SML)
The 2nd Edition introduces important updates to specific migration limits (SML) for certain metals, aiming to reduce the migration risk of potentially hazardous substances into food. Key revisions include:
- Chromium (Cr): The migration limit for chromium is now specified solely for chromium (III) and has been increased from 0.250 mg/kg to 1 mg/kg.
- Manganese (Mn): The migration limit has been tightened from 1.8 mg/kg to 0.55 mg/kg.
- Thallium (Tl): The migration limit has been relaxed from 0.0001 mg/kg to 0.001 mg/kg.
- Zirconium (Zr): A new migration limit of 2 mg/kg has been introduced.
Table of Specific Migration Limits (SML) for Metals and Alloys
| Element (Symbol) | 2024 Technical Guide (2nd Edition, SML mg/kg food) | 2013 Technical Guide (1st Edition, SML mg/kg food) |
|---|---|---|
| Aluminum (Al) | 5 | 5 |
| Antimony (Sb) | 0.04 | 0.04 |
| Chromium (Cr) | --- | 0.25 |
| Chromium (Cr) (III) | 1 | --- |
| Cobalt (Co) | 0.02 | 0.02 |
| Copper (Cu) | 4 | 4 |
| Iron (Fe) | 40 | 40 |
| Manganese (Mn) | 0.55 | 1.8 |
| Molybdenum (Mo) | 0.12 | 0.12 |
| Nickel (Ni) | 0.14 | 0.14 |
| Silver (Ag) | 0.08¹ | 0.08 |
| Tin (Sn) | 100² | 100³ |
| Titanium (Ti) | --- | --- |
| Vanadium (V) | 0.01 | 0.01 |
| Zinc (Zn) | 5 | 5 |
| Zirconium (Zr) | 2 | --- |
A reduction factor applies when assessing compliance for silver and silver-plated cutlery. ² Exceptions apply under Regulation (EU) 2023/915. ³ Exceptions apply under the former Regulation (EC) 1881/2006.
Regulatory Framework
The 2024 guide falls within a broader EU regulatory context that includes key regulations:
- Regulation (EC) No 1935/2004: Sets the safety requirements for food contact materials.
- Regulation (EC) No 2023/2006: Establishes good manufacturing practices for FCMs.
- Regulation (EU) 2017/625: Specifies requirements for official controls on food safety.
Key Recommendations and Implementation Strategies
Key recommendations from the revised guide include:
- Legislative Measures: Member states are encouraged to implement regulations aimed at mitigating health risks associated with FCMs.
- Application to Pharmaceutical Packaging: The principles in the guide can also apply to packaging materials used for pharmaceutical products.
- Stricter Standards: Member states are encouraged to adopt more stringent standards than those proposed at the EU level, depending on their specific needs.
- Continuous Updates: The CD-P-MCA (Committee on Medical Products and Materials) will be responsible for regular updates to the guidelines based on new scientific discoveries.
Risk Assessment and Migration Testing Requirements
The 2024 guide reaffirms that food contact materials must meet rigorous standards to prevent the migration of hazardous substances into food. Risk assessments should comply with international scientific standards and take into account potential impurities and degradation products. Additionally, migration testing protocols must simulate actual usage conditions and be representative of production batches to ensure compliance.
Table of Specific Migration Limits (SML) for Metals as Contaminants and Impurities
| Element (Symbol) | 2024 Technical Guide (2nd Edition, SML mg/kg food) | 2013 Technical Guide (1st Edition, SML mg/kg food) |
|---|---|---|
| Arsenic (As) | 0.002 | 0.002 |
| Barium (Ba) | 1.2 | 1.2 |
| Beryllium (Be) | 0.01 | 0.01 |
| Cadmium (Cd) | 0.005 | 0.005 |
| Lead (Pb) | 0.01 | 0.01 |
| Lithium (Li) | 0.048 | 0.048 |
| Mercury (Hg) | 0.003 | 0.003 |
| Thallium (Tl) | 0.001 | 0.0001 |
The revised technical guide takes effect immediately.
