On April 3rd, 2024, the China National Institutes for Food and Drug Control (NIFDC) issued two announcements, further clarifying matters related to changes in special cosmetics.
Q1: How do we apply for changes when there are alterations in the suppliers of ingredients used in special cosmetics?
According to the requirements of the "Regulations on the Management of Registration and Filing Materials for Cosmetics"(hereinafter refer as Regulations), applicants of registered or filed products should update and maintain the commodity name, manufacturer information, submission code, and safety information attachments of the ingredients through the registration and filing information platform if there are alterations in the suppliers of ingredients or modifications to the quality specifications of the ingredients, and yet the content of the ingredients in the formula as well as the specific types and proportions of the ingredients remain unchanged. If changes in ingredient safety information lead to modifications in product labels or safety assessment data, applications for changes should be promptly submitted by the regulations.
Q2: When applying for the registration of special cosmetics, if all packaging specifications actually produced are not fully filled in the label sample, is it necessary to apply for changes when adding or changing product packaging specifications?
According to the Regulations, when adding or changing the product packaging specifications, it is not necessary to apply for changing the net content of the product label sample; enterprises can provide remarks and explanations when uploading sales packaging.
Regarding the second announcement, ZMUni Compliance Centre provides a further explanation for your understanding:
After the registration of special cosmetics, if there is a need to increase packaging specifications (such as changing the net content of the product from 50ml to 100ml) or to change the sales specifications filled in during the initial submission, enterprises only need to provide remarks and explanations when uploading sales packaging, no need to apply for label changes in the "Cosmetic Intelligent Reporting and Review" system. It will significantly shorten the market launch cycle for special products with new packaging specifications, eliminating the need to undergo a 90-working-day technical review period.
Actually, regarding the application for special product label changes, the Regulations stipulates that if there are multiple sales packaging, label images for all sales packaging should be submitted. If any of the following circumstances apply, only one of the sales packaging label images needs to be submitted:
a) Only the net content specifications differ;
b) Only additional annotations such as sales channels, promotions, holiday specials, or gifts are added to the already uploaded sales packaging;
c) Only the color of the sales packaging differs;
d) Products registered or filed are sold in sets, gift boxes, etc., where the packaging process does not involve contact with the product contents. Apart from adding the name of the combined packaging product, other annotations do not exceed the content of each product label;
e) Differences from the already uploaded sales packaging can be clearly reflected through textual description and have been noted accordingly.
