New Limits for Heavy Metals in Food Supplements

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

The European Commission (EC) sets new limits for Cadmium (Cd) and Lead (Pb) in certain foodstuffs and food supplements. Products placed on the market before the entry into force of the new regulations and not complying with the new maximum levels should only be allowed to remain on the market for a short period of time.

Background

Commission Regulation (EC) 1881/2006 sets, amongst others, maximum levels for Cd and Pb in a range of foodstuffs. According to the EC, the dietary exposure to Pb should be reduced within the Union by lowering the existing maximum levels (or setting additional maximum levels) for foodstuffs for which lower Pb-levels are reasonably achievable. In addition, an evaluation of the most recent data gathered after implementation of mitigation measures showed that it is achievable to reduce the presence of Cd in many foodstuffs.

Cadmium

Examples for maximum Cd levels according to the new Commission Regulation (EU) 2021/1323 (in ppm wet weight; not exhaustive list):

• Fresh herbs: max. 0,20 ppm
• Oilseeds (the maximum levels do not apply to nuts or oilseeds for oil refining, provided that the remaining pressed nuts or oilseeds are not placed on the market as food), like:
  - Peanuts and soy beans: max. 0,20 ppm
  - Linseed and sunflower seed: max. 0,50 ppm
• Food supplements: max. 1,0 ppm

Lead

Examples for maximum Pb levels according to the new Commission Regulation (EU) 2021/1317 (in ppm wet weight; not exhaustive list):

• Wild fungi, fresh turmeric and fresh ginger: max. 0,80 ppm
• Food supplements: max. 3,0 ppm
• Honey: max. 0,10 ppm
• Dried spices:
  - Fruit spices: max. 0,60 ppm
  - Root and rhizome spices: max. 1,50 ppm
  - Bark spices: max. 2,0 ppm
  - Bud spices and flower pistil spices: max. 1,0 ppm
  - Seed spices: max. 0,90 ppm

Pharmacopoeial Requirements for Herbal Drugs and Extracts

In the EU, herbal drugs, extracts, essential oils, etc. used in medicinal products must comply with the requirements of the European Pharmacopoeia (Ph. Eur.). The Ph. Eur. monographs "Herbal Drugs" & "Herbal Drug Extracts" provide the following limits for Cd and Pb:

Dried Herbal Drugs:
Heavy metals (Ph. Eur. 2.4.27). Unless otherwise stated in an individual monograph or unless otherwise justified and authorized:

• Cd: max. 1,0 ppm
• Pb: max. 5,0 ppm

Herbal Drug Extracts:
The same Cd / Pb limits as those given for Dried Herbal Drugs (see above) apply (unless otherwise stated in an individual extract monograph or unless otherwise justified and authorized). However, where justified, herbal drugs used for the production of extracts may exceed the limits for heavy metals specified in the Ph. Eur. monograph "Herbal Drugs" provided that the resulting extract satisfies the requirements for heavy metals.

In addition, the USP recently announced to elaborate a new general chapter <2760> on Impurities in Food Supplements.

For more information please see Commission Regulations (EU) 2021/1323 and 2021/1317 amending Regulation (EC) 1881/2006 as regards maximum levels of cadmium and lead in certain foodstuffs.