The EU Regulation for the Determination of Quality of Botanical Ingredients
The EU Regulation for the Determination of Quality of Botanical Ingredients
The quality of botanical nutraceuticals is subject to regulatory controls in the EU. The European Pharmacopoeia (Ph. Eur.) sets standards for the identity, purity, and strength of botanicals, including herbal medicines and herbal substances used in food supplements. The EU has also established good manufacturing practice (GMP) guidelines for producing food supplements, including those containing botanicals. These guidelines include personnel, premises, equipment, documentation, and quality control requirements.
- It emphasises on good agricultural and cultural practices, ensuring identification and traceability.
- The provider of the botanical raw material should offer sufficient details about the cultivation/collection, harvest, storage, and, where applicable, processing of the botanical.
- The EU Regulation on General Food Law specifies the traceability requirements that must be met by all botanicals used in dietary supplements and foods.
- The shelf life of the extract and/or product plus one year must be taken into consideration when determining how long to keep all traceability information on file.
- In addition to these general regulations, the EU has established specific rules for certain botanicals that are considered to be high-risk, such as those that contain toxic or carcinogenic compounds. These rules may include limits on the levels of these compounds allowed in the product, as well as requirements for safety testing and labelling [1].
The EU regulatory framework for botanical nutraceuticals aims to ensure that these products are safe, effective, and high-quality. By establishing standards and guidelines for production and product labelling, the EU helps protect consumers and ensure they have access to reliable and effective botanical nutraceuticals.