Takehome:
- In the newly revised draft of the Implementation Rules of the Food Safety Law, infant formula has been earmarked for intensified management including infant formula standards, production and trading process control, infant formula importation, and labeling, etc.
Over the last decade China has attached special emphasis on ensuring the safety and quality of infant formula. Infant formula is considered a special food in China together with health food and foods for special medical purpose (FSMP), all of which are subject to special measures taken to guarantee their safety. Recently, the secondly revised draft of Implementation Rules of Food Safety Law was released (see CL news report on Oct. 21, 2016) in which infant formula is again given special treatment.
Infant formula standards:
No local food safety standard shall be formulated for infant formula. In cases where an infant formula manufacturer formulates its own individual enterprise standard for infant formula, it shall be published to the public. In cases where this individual enterprise standard impacts on the final product formulation or production technique requirements, the filing of the enterprise standard is deemed unnecessary based on prior filing in line with other mandatory requirements and standards.
Process control for infant formula production and trading:
Under the implementation rules the establishment of mandatory infant formula traceability systems should be accelerated by infant formula manufacturers and trading enterprises.
The registration certificate for infant formula will be verified to check if it is consistent with the information in product label and user’s directions.
Infant formula supervision and management:
Infant formula can only be sold on the market after the raw materials, food additives, product formula and product label are filed with relevant competent authority.
Infant formula should be sold in special areas of shops, and shall not be sold together with other conventional foods and drugs. Sale of Infant formula should not be regionally restricted and single formulation or product lines should not be customized for distributors or sale agents.
Infant formula manufacturers can only market “3 product lines (3 stages per product line)” in China. There must be significant difference between recipes for the same stage applied by the same manufacturer, supported by solid scientific evidence.
Infant formula importation:
AQSIQ will conduct full-item inspection on imported infant formula batch by batch. Meanwhile, the enterprise quality management system and implementation of good manufacturing practice will be examined by CFDA on site.
Requirements for infant formula labeling and user’s directions:
The infant formula label and user’s directions shall not contain any misleading information or any information regarding product efficacy. No content claim or function claim should be made either in product label or in the advertisement.
For the optional substances permitted to be added in infant formula as specified, they should not be indicated in the product name. Substances that may cause allergic reaction should be indicated in the ingredients list.
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