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CFDA released Administrative Measures on Product Formula Registration of Infant Formula Milk Powder

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On 6 June 2016, China Food and Drug Administration (CFDA) published Administrative Measures on Product Formula Registration of Infant Formula Milk Powder in order to further supervise enterprise designing formula scientifically and enhance R&D, production as well as testing capacity of manufacturers to ensure high quality of infant formula milk powder. The Measures will take into force on 1 October 2016.

The Measures will regulate formula registration of infant formula milk powder through following 4 elements:

1. Add registration requirements and improve production requirements. Refer to medicine management, domestic and import infant formula milk powder shall be administrated via registration formation and qualification of applicant shall be limited strictly. Only the infant formula milk powder manufacturers who meet below requirements can apply for product formula registration:

a). have qualified R&D, production, testing capacities;

b). meet the good manufacturing practises (GMP) requirements for infant formula powder food;

c). conduct hazard analysis and critical control point (HACCP) system;

d). conduct lot by lot inspection on infant formula milk powder before they are out of factory on the basis of relevant law and national food safety standard.

2. Restrict quantities of formula. Some domestic enterprises always promoting several different “new formula” brands with very similar formula. In order to solve this problem, the Measures regulated that each enterprise cannot exceed 3 formula series with 9 product formula in principle.

3. Regulate label and symbol to settle publicity chaos. The Measures require applicants to submit label and specification samples, explanations and certification materials of claim in the specification when they apply for formula registration. Meanwhile, the description of product label and specification is regulated by the Measures in detail. Some examples are showed as below:

a). The source of lactogenesis or raw milk powder should be indicated clearly and practically in the claim. Unclear information (such as “imported milk collection”, “from overseas pasture”, ”ecologic pasture”, ”imported raw materials”, etc..) is forbidden.

b). “Promoting intelligence, disease resistance/ immunity and protecting intestine” cannot be implied or demonstrated in product specification and label.

c). Label and specification cannot emphasize that product doesn’t use/ contain the substance which is banned to add into infant formula milk powder on the basis of food safety standards.

d). False, exaggerated, unreasonable and absolutized information cannot be indicated on the label and specification.

e). The claims on product label and specification must be in accordance with formula registration information.

4. Determine supervision requirements and legal responsibility for applicant. The Measures describe the procedures and penalties of refusing deferred registration, revoking registration, cancelling registration and some other situations.

The implementation of Administratiive Measures on Product Formula Registration of Infant Formula Milk Powder will enhance the requirements for product entering market and settle the brand/formula chaos. Detailed regulation can be found here

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