China Consults on New Dosage Forms for Health Food Filing

On Aug 28th, China SAMR consulted on two new dosage forms for health food filing, i.e., gelatinized confections and powder. Four supportive draft documents were released for public comments as written below:

1. List of Auxiliary Materials for Health Food Filing and Terms of Use (2020)

2. Dosage Forms and Manufacturing Techniques for Health Food Filing (2020)

3. Technical Requirements for Gelatinized Confections (2020)

4. Technical Requirements for Powder (2020).

Main contents of the supportive documents are:

1. Auxiliary materials for health food filing and terms of use

Auxiliary materials listed in the List of Auxiliary Materials for Health Food Filing and Terms of Use (2019) (now on referred to as the List) are permitted for health food filing of all dosage forms. Since gelatinized confection and powder are forms of ordinary food, according to the List, auxiliary materials for health food products of ordinary-food form should also comply with GB 2760 National Food Safety Standard for Uses of Food Additives.

For gelatinized confections

Unpermitted auxiliary materials

Among 196 auxiliary materials in the List, 152 are applicable for gelatinized confections. Note, there are 25 auxiliary materials applicable for gelatinized confections that belong to both food and medicinal standards. In this case, they should follow their food standards only (not their medicinal standard). 

Auxiliary materials not permitted for gelatinized confections include:

• Medicinal materials: For the 24 auxiliary materials only with medicinal standards mentioned in the List (excluding "purified water") e.g. monosaccharide syrup are not permitted for gelatinized confections.

• Food additives: according to GB 2760, 18 auxiliary materials are not allowed to be used in gelatinized confections. For example, in GB 2760, butylated hydroxyanisole (BHA) can be used in many food categories such as biscuits, buffed food, and gum-based candies, etc., but since gelatinized confection doesn’t belong to gum-based candies BHA cannot be used in gelatinized confections.

• Two ordinary food ingredients: maltodextrin, isomalt.

Maximum limits

For maximum limits of permitted auxiliary materials, 26 materials have maximum limits listed both in GB 2760 and the List. Among the 26 materials, maximum limits of 16 materials are lower in GB 2760 than in the List. Following the principle of strict management, these 16 materials should comply with maximum standards in GB 2760.

Coating agent

Coating agent used to produce gelatinized confections follows the regulation of coating premixes for tablets.

For powder

As with gelatinized confections, medicinal standard for any auxiliary material doesn’t apply to powder either. An exception is purified water, which can be used in powder although it only has  medicine standard in the List. Silicon dioxide, talc, sodium carboxy methyl cellulose and maltodextrin are not permitted for powder forms either.

Other auxiliary materials

• Standard for olive oil changes from mandatory standard GB 23347 Olive oils and olive pomace oils to recommended standard GB/T 23347 Olive oils and olive pomace oils.

• Empty capsule in the List of Auxiliary Materials is divided into gelatin empty capsule and hydroxypropyl starch empty capsule. Relevant standards and maximum limits of the two follow that of previous empty capsule.

2. Technical Requirements for gelatinized confections and powder

The draft Technical Requirements for Gelatinized Confections (2020) and Technical Requirements for Powder (2020) stipulate the definition, instruction content, technical requirements and product name requirements for the two new dosage forms. Instruction content includes which groups of people it is suitable for and unsuitable for, amount and method of consumption, specification, and shelf life. Technical requirement includes sensory requirements, physical and chemical index, microbiological index, net content and the allowed negative deviation index.

By now the approved dosage forms for health food filing include tablets, hard capsules, soft capsules, granules, pills, oral liquid and drops. The new forms gelatinized confections and powder in this draft are for vitamin and mineral products only. With the development of health food raw materials, health food products subject to filing may not be limited to vitamin and mineral supplements in the future. For example, on Aug 12th, SAMR consulted on technical requirements of filing health food using coenzyme Q10 and other four substances as raw materials. Permitted dosage forms for such new materials may be announced together with Health Food Raw Materials Directory in the future.