As the authoritative voice of the natural health industry, the HFMA supports the interests of its members with legislators and regulators; promotes industry best practice for product quality and safety; and provides responsible information for consumers.
Probiotics - Best Practice Standard
PROBIOTIC FOOD SUPPLEMENTS
Summary
Owing to previous unsubstantiated claims on Probiotic food supplement products, an HFMA working Group has produced the following specification applying to Probiotic Food Supplement products wishing to achieve the HFMA standard.
This standard applies to the manufacture, packing, labelling and distribution of Probiotic finished product presented for sale to consumers. It may be necessary to advise separate storage conditions for different stages of the supply chain to ensure the final product standards are met (eg refrigeration at the manufacturing premises and wholesaler).
Product
The product should be manufactured and packed in line with HFMA’s guidelines on Good Manufacturing Practice (GMP).The pack size and materials of the container must be appropriate for the stated shelf life.
The product and/or the strains that it contains should have demonstrated beneficial effects in humans or appropriate animal models, and should be supported by scientific studies
Labelling
The product should be identified as a “Probiotic” and labelled according to the requirements of the Food Supplements (England) Regulations (SI 2003/1387). The product should be marked with its “Best before date” indicating the end of its shelf-life for the claimed level of active organisms.
The product should be marked with the storage conditions necessary to achieve the claimed level of active organisms until the “Best before date” on the product. The product should be clearly marked with the strain(s) of organisms that it contains.
The product should be marked with the quantity of organisms, in total, that are available in the product until the end of shelf-life. Labels should indicate quantities of organisms as 10x (eg 10 7= 10,000,000).Total labelled organisms should not be less than 10 7 in total per unit/daily dose.Individual levels of labelled organisms should not be less than 10 4 per unit/daily dose.
The product should be suitably marked with the conditions for use (eg with food, on an empty stomach, time of day for dosage, with water) if this affects the viability of the product during gastro-intestinal transit. [It is normal to recommend taking the product with food/meals unless the dosage form is treated to protect it from stomach acidity (enteric coating)]
Strains
All strains included in products conforming with this specification should:
• be listed and identified with international depository numbers for each strain.
• have been obtained from a supplier from clearly identified, listed strains confirmed by a laboratory with UKAS accreditation or appropriate experience for micro-organism strain identification and measurement.
not have demonstrated any toxicity nor have any pathogenic variants, potentially harmful metabolites .
Identification & Measurement of Organisms
The organisms contained in the Probiotic product should have been identified against an authenticated sample by the supplier or Probiotic product manufacturer before input.
The organisms (contained in the Probiotic product) should have confirmed viability under the storage conditions stated for the period of the shelf life of the product (up to “Best before date”) and measured by an UKAS accredited or suitably experienced laboratory. These viability tests should be carried out on organisms in the product or where this is impractical (e.g. for multi-strain products) on the individual strains under similar conditions.
Records of identification and measurement of the active organisms used in Probiotic products should be retained for the same period as the product batch records.
August 2006
