On November 7, 2022, the State Administration for Market Regulation issued the Guidance for the Labeling of Food for Special Medical Purpose (Draft for Comments) for public opinions. The deadline for feedback is November 25, 2022. Below we briefly introduce the basic requirements and content requirements of the draft for reference of enterprises.
Basic requirements
The labelling of food for special medical purpose shall comply with relevant laws, regulations, rules and national food safety standards, and the contents of the registration certificate of food for special medical purpose shall be consistent with the registration certificate. Labels and instructions shall be true, standardized, scientific, accurate, easy to understand, clear and legible, and shall not contain false, exaggerated or absolute words.
Content requirements
Product name
The product name consists of the trade name and the generic name. Each product can only have one product name, and the trade name shall not be the same as that of the approved food for special medical purpose, health food or drug. Imported products may also be marked with English names, which shall correspond to Chinese names.
The size of trade name shall be smaller than that of generic name, and the font and color of trade name shall not be more prominent than that of generic name. In terms of the area of a single word, the total area of the font of the trade name shall not be more than one half of that of the font used for the generic name. The trade name may be a trademark name registered according to laws.
If a registered trademark other than the trade name is used, the total area of the trademark (measured by rectangle method) shall not be greater than one fourth of the font area of the generic name, and shall be less than the area of the trade name, and shall not be used with the product name. The font size of the trademark shall not be larger than that of the trade name.
Generic name shall be prominent and shall not be marked separately. For details, please refer to the Announcement of the State Administration for Market Regulation on Adjustment of the Generic Name of Food for Special Medical Purpose [No. 26 of 2019].
Product category
The product category (classification) shall be marked according to the National Food Safety Standard General Principles for Food for Special Medical Purpose (GB 29922) and the National Food Safety Standard General Principles for Infant Formula Food for Special Medical Purpose (GB 25596).
Ingredients list
The names of various ingredients in the ingredients list shall be marked with specific names in accordance with relevant standards and regulations. Food additives in compound ingredients that play a technological role in the final product shall be marked.
Nutrition information
The nutrition information shows the amount of energy (kJ), nutrients and optional nutrients per 100g / 100mL and per 100kJ of the product in the form of a "box table"; the amount of product per 100kcal can also be indicated at the same time. When marked with serving, the quantity per serving shall be indicated.
Formula characteristics/nutritional characteristics
The relevant description of the product formula characteristics and nutritional characteristics shall have sufficient basis. The objective description or explanation shall be made in combination with the product formula characteristics, process characteristics and nutritional characteristics (such as energy, energy supply ratio, nutrient absorption and utilization), including the explanation of the product and the disease or medical condition of the suitable people.
Clinical trial
The label and instruction for specific whole nutrient formula food shall provide a general description of the clinical trial conducted. The objective description of research purpose, design scheme, observation people, sample size, observation period, control samples, primary/secondary observation indicators, observation results and other contents of clinical trial can be made.
Organization status
The description shall conform to the corresponding characteristics of the product, such as powder and liquid.
Suitable people
The suitable people shall be marked in accordance with the provisions of GB 29922 and GB 25596, as well as the suitable people of the product development, special medical status, etc., and the age range and/or special medical status of the suitable people shall be accurate and described in details.
Consumption method and dosage
"Consumption method and dosage shall be determined according to the age, weight and medical condition of the suitable people under the guidance of a doctor or clinical nutritionist" or similar statements shall be indicated; according to the actual demand of the product, based on the characteristics of the product and the suitable people, the intake route (for example, oral or gavage), preparing method and preparing amount shall be indicated. The contents such as temperature maintained by the product, consumption speed and storage method of the product after preparing can be described optionally.
Net content and specification
Single pre-quantified prepackaged food shall mark net content; if a prepackaged food contains multiple single pre-quantified packaged foods, the specification shall be marked along with the net content.
Production date and shelf life
Production date and shelf life shall be clearly marked in order of year, month and day. Date marking shall not be separated from packaging materials and container, and shall not be post affixed, reprinted or tampered with.
Storage condition
The storage conditions of products shall be indicated, such as temperature and humidity requirements, cool storage, and room temperature storage. If necessary, indicate storage conditions after opening and the best before consumption. If the unsealed product is not easy to be stored or shall not be stored in the original packaging container, the consumers shall be specially reminded. For products with special storage requirements, special indication shall be made.
Warning notes and cautions
It shall be marked in a prominent position that "Please use under the guidance of a doctor or clinical nutritionist", "not suitable for non-target consumer", "this product is prohibited for parenteral nutrition support and intravenous injection"; warnings such as "Improper preparation and improper use may cause harm to XX" and "Strictly prohibited use by XX people or people under XX disease condition" shall also be selectively marked according to actual needs. And "The product may cause intolerance (discomfort) after consumption", "Consumed by XX people may cause health hazards", "can be consumed as a single nutritional source" or "cannot be consumed as a single nutritional source, shall be combined with XX food", "avoid bacterial contamination during consumption", "gavage system shall be used correctly", "the packaging cannot be heated by microwave" and other cautions. The title column of "warning notes and cautions" shall be bold, and the font shall be no smaller than the other contents on the non-principal display panel of the label.
Next week, we will introduce the requirements for principal display panel, prohibitive requirements, and other requirements of the draft. If you are interested, please follow us!
Source: SAMR
Note: This article is compiled by Antion, please indicate our source if reprint it.