Which documents to request when buying bulk extracts in the EU

Before an extract enters production, your quality team needs documents that show what it is, that it meets EU rules and that each lot was tested. This checklist covers what to ask for, and why.

Certificate of analysis, for every lot

The certificate of analysis (CoA) reports test results for the specific lot you receive. Check that its lot number matches the labels on the drums. A useful CoA includes:

• Assay of the marker compound, stating the method (HPLC, UV or other).
• Identity of the plant material.
• Heavy metals: lead, cadmium, mercury and arsenic.
• Microbiology: total plate count, yeasts and moulds, E. coli and Salmonella.
• Physical data such as loss on drying and particle size.

Specification sheet

The specification sheet sets the agreed limits for every parameter. Compare each CoA against it: a result inside the CoA but outside your specification is still a deviation.

Contaminants and residues

• Pesticide residues, assessed against Regulation (EC) No 396/2005.
• Contaminants covered by Regulation (EU) 2023/915, where they apply to the material.
• Residual solvents, when solvents other than water were used.
• Ethylene oxide: many EU buyers now request a statement or test result, following the recalls linked to it in 2020 and 2021.

Product statements

• Allergen statement covering the 14 allergens listed in Regulation (EU) No 1169/2011.
• GMO status and irradiation status.
• Country of origin of the plant material.
• Organic certificate, only if you buy and label the product as organic.

Regulatory status

Check whether the ingredient, and the plant part used, needs authorisation as a novel food under Regulation (EU) 2015/2283. The Novel Food Catalogue of the European Commission is the usual starting point. Claims on finished products follow Regulation (EC) No 1924/2006.

On our product pages you can see which documents are available for each specification, for example milk thistle extract or grape seed extract. You can also request a sample with its documents before placing an order.