Infant and Children Cosmetics Face Stricter Supervision in China

Since Jan. 2021, the regulatory authorities in more than 20 regions in China, such as Beijing and Zhejiang, have issued the Special Inspection Work Plan for Children Cosmetics. Most of the work plans are similar, carrying out special rectification work on children cosmetics from Mar. 1 to Sep 30. ¹

Key Points of the Special Inspection Work Plan

1. Key Inspection Products

Cosmetics illegally added hormones and anti-infective drugs;
Counterfeit and substandard cosmetics;
Cosmetics without certificates;
Cosmetics claiming "medicated cosmetics," "medical skincare products,";
Homemade cosmetics without production licenses.

2. Major Inspection Items

Inspection Targets		Inspection Items
Manufacture	Manufacturers of infant and children cosmetics, the registrants and notifiers of entrusted products	Ingredient source; Labels and claims; Whether the product is manufactured in accordance with the registered or notified formula.
Notification	Post-notification inspection of notified infant and children cosmetics	Labels. Whether the production date and shelf life (or batch number and expiration date), domestic manufacturer's name, address and production license No. (for domestic cosmetics), country of origin, domestic responsible person's name and address (for imported cosmetics) are labeled; Claims. Whether there are illegal claims of "medicated cosmetics," "medical skincare products," claims expressing or indicating attending functions, indications, therapeutic functions or medicinal effects, etc.; Formula. Whether the product formula meets the safety requirements.
Operation	Infant and children cosmetics operators such as supermarkets, maternal and infant products specialty stores, children barber shops, infant bath centers, and cosmetics centralized trading markets	Whether the product qualification is compliant; Whether the purchase and sale channels are legal; Whether the purchase inspection and record and sales record are true and complete; Whether there are illegal claims such as “treat diseases”; Whether the transportation and storage conditions meet the requirements on the labels and instructions; Whether there are self-made cosmetics (without production licenses).
Sampling and Testing	Leave-on infant and children cosmetics	Microorganisms, hormones, anti-infective drugs, and fluconazole.
Investigation and Punishment		For infant and children cosmetics illegally added substances that may be harmful to human health, or the labels indicating or implying medical effects, heavier penalties shall be imposed; For cosmetic registrants, notifiers, entrusted production enterprises who illegally add substances that may harm human health, heavy penalties shall be imposed if the circumstances are serious, and the legal representative or the main responsible person, the person who is directly in charge and other directly responsible persons shall be investigated for legal responsibility; For suspected crimes, promptly transfer to the public security organs. The products involved should be inspected and verified.

The special inspections on children cosmetics will last for 7 months, cover a wide range of inspection targets and impose heavy penalties for non-compliance. Children cosmetics are now ushering more stringent surveillance in China. While strengthening post-market surveillance of children cosmetics, China also put forward special requirements for children cosmetics’ registration, notification and production.

Special Requirements for Children Cosmetics under the New Regulations

Compared with adult cosmetics, Safety and Technical Standards for Cosmetics 2015 and Guidance on Application and Review of Children Cosmetics have already imposed stricter requirements on children cosmetics’ ingredients, formulas, production processes, labels, use methods, and quality control. Three CSAR subsidiary regulations, Provisions for Management of Cosmetic Registration and Notification Dossiers, Cosmetic Classification Rules and Catalog (Draft) and Good Manufacturing Practices for Cosmetics (Draft), will further tighten the registration, notification and production requirements for children cosmetics.

If infant cosmetics (under 3 years old) claim to have efficacies other than cleansing, moistening, moisturizing, relieving, and body refreshing, they shall be managed as special cosmetics;
If children cosmetics (3-12 years old) claim to have efficacies other than cleansing, makeup removing, moistening, moisturizing, beautifying and embellishing, hair styling, fragrant, hair care, repairing, relieving, oil-control, exfoliating, body refreshing, and hair break prevention, they shall be managed as special cosmetics;
Although China will exempt general cosmetics from submitting toxicological testing reports, infant and children cosmetics are not in the exemption scope. They are required to submit toxicological testing report and safety assessment report during registration and notification, meaning that animal testing is still mandatory for infant and children cosmetics;
Strict environmental index requirements are put forward for the cleaning work area and quasi-cleaning work area of children cosmetics production.

Infant and Children Cosmetics Face Stricter Supervision in China

Key Points of the Special Inspection Work Plan

Special Requirements for Children Cosmetics under the New Regulations

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