SG 125/24
The EDQM has published the 2024 second edition of its technical guide for food contact metals and alloys. This revised second edition can be considered as effective immediately.
The European Directorate for the Quality of Medicines & Healthcare (EDQM) has recently issued the 2024 2nd Edition of its technical guide for food contact metals and alloys.
The revised technical guide contains several important changes when compared to the 2013 1st Edition. It:
- Supplements and aligns with the guiding principles under Council of Europe Resolution CM/Res(2020)9
- Specifies the main chemical composition of several types of alloy that are often used for food contact applications
- Replaces DIN 10531 with EN 16889:2016 for artificial tap water for aqueous, alcoholic or fatty food
- Replaces the specific release limit (SRL) for chromium with chromium ((III)
- Strengthens SRL for manganese
- Revises the SRL for thallium to become less stringent
- Introduces an SRL for zirconium
- 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)
Comparisons between the element SRLs in the first (2013) and second (2024) editions are summarized in Tables 1 and 2.
| Entry | Element (Symbol) | Technical Guide 2024 2nd Edition, SRL (mg/kg food) | Technical Guide 2013 1st Edition, SRL (mg/kg food) |
| 1 | Aluminum (Al) | 5 | 5 |
| 2 | Antimony (Sb) | 0.04 | 0.04 |
| 3 | Chromium (Cr) | --- | 0.250 |
| 4 | Chromium (Cr) (III) | 1 | --- |
| 5 | Cobalt (Co) | 0.02 | 0.02 |
| 6 | Copper (Cu) | 4 | 4 |
| 7 | Iron (Fe) | 40 | 40 |
| 8 | Magnesium (Mg) | ---¹ | --- |
| 9 | Manganese (Mn) | 0.55 | 1.8 |
| 10 | Molybdenum (Mo) | 0.12 | 0.12 |
| 11 | Nickel (Ni) | 0.14 | 0.14 |
| 12 | Silver (Ag) | 0.08² | 0.08 |
| 13 | Tin (Sn) | 100³ | 100⁴ |
| 14 | Titanium (Ti) | ---¹ | --- |
| 15 | Vanadium (V) | 0.01 | 0.01 |
| 16 | Zinc (Zn) | 5 | 5 |
| 17 | Zirconium (Zr) | 2 | --- |
Table 1. SRL for metals and alloy components
1 Generic SRL of 60 mg/kg food is not applicable
2 Application of a reduction factor when assessing the compliance of cutlery made from silver and silver-plated cutlery
3 Except in the field of application under Regulation (EU) 2023/915
4 Except in the field of application under (former) Regulation (EC) 1881/2006
| Entry | Element (Symbol) | Technical Guide 2024 2nd Edition, SRL (mg/kg food) | Technical Guide 2013 1st Edition, SRL (mg/kg food) |
| 1 | Arsenic (As) | 0.002 | 0.002 |
| 2 | Barium (Ba) | 1.2 | 1.2 |
| 3 | Beryllium (Be) | 0.01 | 0.01 |
| 4 | Cadmium (Cd) | 0.005 | 0.005 |
| 5 | Lead (Pb) | 0.010 | 0.010 |
| 6 | Lithium (Li) | 0.048 | 0.048 |
| 7 | Mercury (Hg) | 0.003 | 0.003 |
| 8 | Thallium (Tl) | 0.001 | 0.0001 |
Table 2. SRL for metals as contaminants and impurities
The revised technical guide can be considered as effective immediately.
SGS has the expertise to help manufacturers and suppliers of FCM achieve compliance with markets around the globe. Our technical experts have extensive experience of testing materials and articles for many markets. We offer the full range of FCM testing, including migration tests, along with expert advice on emerging regulations, compliance issues and documentation review. Our experience can ensure your products meet the appropriate territorial regulations for food contact materials and help pave the way for compliance. Contact us to know more or visit our website. In the end, it’s only trusted because it’s tested.
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