AHPA updates GACP-GMP guidance to include new appendix on prevention of pyrrolizidine alkaloid contamination
Update replaces the 2017 version of the document
May 25, 2021
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The American Herbal Products Association (AHPA) has updated its guidance document “Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials” (AHPA GACP-GMP) to include a new appendix addressing prevention of pyrrolizidine alkaloid contamination. The new appendix provides information and identifies resources to support specific actions that can be taken by crop growers, botanical material suppliers, and finished product manufacturers to prevent the inadvertent presence of pyrrolizidine alkaloids in botanical crops intended for use in human food and dietary supplements.
Pyrrolizidine alkaloids (PAs) are a group of naturally-occurring compounds that are common in several plant families, and more than 600 PA and PA oxide compounds have been identified in over 6,000 plant species. The plant families most commonly containing PAs include Asteraceae, Fabaceae, and Boraginaceae, and PA containing species can also be found in the Orchidaceae, Convolvulaceae, and Lamiaceae families. Many of these plants are noxious, invasive weeds that are widespread in agricultural areas, pastures, and along roadsides, etc.
In December 2020, the European Commission adopted a regulation containing specific maximum levels for the occurrence of PAs in a variety of botanical foodstuffs, including food supplements and teas. This regulation is intended to address the inadvertent presence of PAs in botanical products through the co-harvesting of PA-containing weeds. Compliance will be based on analysis for 35 PAs specified in the regulation and the sum of detected levels as compared to the maximum level of PA content for the defined food category. The implementation date for this regulation is July 1, 2022.
The AHPA GACP-GMP guidance document is a resource for growers, collectors, and processors of botanical crops. It helps ensure that the herbal raw materials used in consumer products are accurately identified, are not adulterated with contaminants that may present a public health risk, and are in full conformity with all of the quality characteristics for which they are represented. The AHPA GACP-GMP has relevance to the growing, collecting, and processing of botanical crops for a wide variety of purposes, including use as foods, drugs, cosmetics, perfumes, propagative material, etc., but with particular focus on use for food and supplement ingredients. First issued in 2006 to address good agricultural and collection practices, AHPA expanded the scope in 2017 to include good manufacturing practices for botanical materials. A series of self-assessment tools based on the AHPA GACP-GMP are also available to support implementation of the agricultural and manufacturing practices contained in the guidance document.