On August 1st , 2024, supplementing Council of Europe Resolution CM/Res(2020)9 , the European Directorate for the Quality of Medicines & HealthCare (EDQM) published 2nd Edition of Technical guide for manufacturers and regulators on METALS AND ALLOYS used in food contact materials and articles.
It features modified safety data concerning specific release limits (SRLs) for chromium, manganese, thallium and a new section on zirconium and general recommendations for release testing. The updated methods for the measurement of certain articles facilitate the calculation of specific release for control laboratories.
This guide assists regulators and business operators in applying harmonised technical standards across Europe, in line with the mission of the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, of working towards better health for all.
The revised technical guide contains several important changes when compared to the 1st Edition of 2023.
1. specific release limit (SRL) for metals and alloy components
Element (Symbol) | Technical Guide 2013 1st Edition, SRL (mg/kg food) | Technical Guide 2024 2nd Edition, SRL (mg/kg food) |
---|---|---|
Chromium (Cr) | 0.250 | 1 |
Manganese (Mn) | 1.8 | 0.55 |
Thallium (Tl) | 0.0001 | 0.001 |
Zirconium (Zr) | / | 2 |
2. Updates the guidance on release testing to ensure coherence with the ‘Testing conditions for kitchenware articles in contact with foodstuffs: Plastics, Metals, Silicone & Rubber or its Revisions (Beldi et al., 2021)
3. The chapter on the declaration of compliance in the first edition was omitted from the current edition of Resolution CM/Res(2020)9.
4. FCM and articles within the scope of this Technical Guide shall comply with the SRLs set out below in Tables 1 and 2.
Table 1. SRLs for metals and alloy components
Table 2. SRLs for metals as contaminants and impurities
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