New Edition of the EDQM Guide on Metals and Alloys
Recommendation

19/20 May 2026
All relevant GMP/GACP aspects for Medical Cannabis
The EDQM Technical Guide on Metals and Alloys describes chemical elements that constitute metallic materials and articles or may be present as impurities and sets out the Specific Release Limits (SRLs) for those elements. Moreover, the guide includes a chapter regarding release testing which provides up-to-date instructions for sampling, measuring and calculating results.
Updates of the Second Edition
The 2nd edition represents a significant update over the initial 2013 edition. The guide takes into account regulatory developments and recent risk assessments plus scientific opinions of the European Food Safety Authority (EFSA). The 2nd edition was open for public consultation in April 2022.
According to th EDQM, the review of safety data has resulted in changes to SLRs for chromium, manganese and thallium. Furthermore, a new section on zirconium has been added. "Enforcement officers may apply the SRLs and test procedures directly and national policy makers can rely on the guide’s harmonized provisions when adopting legislative and other measures designed to reduce health risks arising from exposure to certain metals".
More information is available on the EDQM website in Metals and alloys used in food contact materials and articles.
Related GMP News
22.04.2026Roadmap for the Introduction of the Electronic Package Leaflet
15.04.2026Revision of Ph. Eur. Chapter on Extractables in Plastic Materials
08.04.2026What are the GMP Requirements for Pharmaceutical Packaging Materials?
26.03.2026ICH Q3E: EMA publishes Comments Received
11.03.2026Revised USP Chapter <382> Elastomeric Component Functional Suitability
04.03.2026Revised USP Chapter <661> Plastic Packaging Systems and Their Materials of Construction


