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Updates to the EDQM Technical Guide on Metals and Alloys Used in Food Contact Materials and Articles

Sep. 17 2024

The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published the 2024 2nd Edition of its technical guide concerning metals and alloys used in food contact materials and articles. This revised 2024 edition introduces significant updates compared to the 2013 1st Edition.

The revised 2024 edition technical guide contains several important changes when compared to the 2013 Edition, as listed below and following table.

  • Supplements and aligns with the guiding principles under Council of Europe Resolution CM/Res(2020)9
  • Replaces DIN 10531 with EN 16889:2016 for artificial tap water for aqueous, alcoholic or fatty food
  • Amend the specific release limit (SRL) for chromium with Cr(III)
  • Lowering SRL for manganese (Mn)
  • Revises the SRL for thallium (Tl)
  • New section for zirconium (Zr) is added and set new SRL.
  • 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)

Table 1 illustrate the change of SRL of related element

Element (Symbol)

Practical Guide 2013 1st Edition,
SRL (mg/kg food)

Technical Guide 2024 2nd Edition, (mg/kg food)

Chromium (Cr)

0.250 mg/kg

1 mg/kg

Manganese (Mn)

1.8 mg/kg

0.55 mg/kg

Thallium (Tl)

0.0001 mg/kg

0.001 mg/kg

Zirconium (Zr)

---

2 mg/kg

For more information, see the link below:
https://freepub.edqm.eu/publications/PUBSD-128/detail

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