As the concept of "white is beautiful" and "one white covers all ugliness" is deeply rooted in people's minds, in recent years, spot-removing and whitening cosmetics have become very popular among consumers, and the demand for spot-removing and whitening cosmetics is also increasing. Many companies are also paying attention to the development of blemish whitening cosmetics and their regulatory developments.

In this issue's article, ZOOP will give you a brief introduction to freckle-removal and whitening cosmetics and their regulatory changes.

I. What are freckle-removal and whitening cosmetics?

The Cosmetics Classification Rules and Classification Catalogue defines spot whitening as: helping to reduce or slow down skin pigmentation to achieve skin whitening and whitening effects; achieving skin whitening and whitening effects in the form of physical concealment. freckle-removal and whitening cosmetics also include products that improve the appearance of acne marks due to pigmentation.

Fig. 1 Special certificate for the spot whitening category

Fig. 2 Special certificate of spot whitening (physical masking only)

Tips: The product category on the licence is printed with the words "Spot Whitening (Physical Covering Only)", and the label of such products also needs to be clearly marked "Physical Covering Only" to show the difference.

II. Changes in regulations related to freckle-removal and whitening cosmetics

December 2013

The CFDA issued Announcement No. 10, which included whitening cosmetics into the management of spot-removing cosmetics, and whitening cosmetics attracted the attention of all walks of life.

September 2019

The CFDA issued Notice No. 72, requiring that products claiming to remove spots and whiten hair or prevent hair loss should be tested for efficacy and issued with a test report accordingly. However, the test method has not yet been released.

June 2020

The Regulation on the Supervision and Administration of Cosmetics is issued. Clarifies that cosmetic registrants and filers are responsible for the quality, safety and efficacy claims of cosmetics. Spot-removing and whitening cosmetics are special cosmetics.

March 2021

The State Drug Administration issued Announcement No. 17, incorporating the Test Method for the Efficacy of Cosmetics in Removing Spots and Whitening into the Technical Specification for Cosmetic Safety (2015 Edition)

April 2021

The State Drug Administration issued Notice No. 50, clarifying that cosmetics with spot whitening, sunscreen and hair loss efficacy should be tested by cosmetic registration and filing inspection agencies in accordance with the requirements of mandatory national standards and technical specifications to conduct human efficacy evaluation tests and issue reports. Since then, spot whitening cosmetics have entered the stage of efficacy testing.

III. Trends in the declaration of blemish-removing and whitening cosmetics in recent years

In 2013, many companies applied for special approvals for whitening cosmetics due to the inclusion of whitening cosmetics in the category of blemish removal cosmetics;

Figure 3 Number of batches of imported blemish-removing and whitening cosmetics

Figure 4 Number of batches of domestic spot-removing and whitening cosmetics

From 2021 onwards, there will be a reduction in the number of companies applying, as well as a significant reduction in the number of special certificates approved and a significant increase in the number of disapprovals (a total of 455 cosmetic applications were disapproved from July to October 2022, of which approximately 133 were in the category of blemish removal and whitening), due to the increase in the costs used for testing the efficacy of blemish removal and whitening products, as well as a more detailed and rigorous review and a higher threshold for filing;

In the future, due to the high cost of compliance for special cosmetic products in the whitening and blemish removal category, fewer companies will hold licensed approvals for these products and the whitening and blemish removal category will be a rarer variety of cosmetic products;

National Medical Products Administration is still formulating new requirements for the declaration of spot-removing and whitening products, which will be more difficult to declare at a later stage. It is recommended that companies with the ability to do so should consider declaring such special certificates as soon as possible.

References

SCCS. Safety of alpha-arbutin and beta-arbutin in cosmetic products.

2. National Medical Products Administration. Cosmetics classification rules and classification directory.

3. CFDA. Circular of the CFDA on the Adjustment of the Management of Cosmetics Registration and Filing (No. 10).

4. National Medical Products Administration. Notice of the State Drug Administration on the Issuance and Implementation of the Specification for the Registration and Filing Inspection of Cosmetics (No. 72 of 2019).

5. State Council. Regulations on the supervision and administration of cosmetics.

6. National Medical Products Administration. Notice of the State Drug Administration on the incorporation of seven tests, including the test method for preservatives in cosmetics, into the Technical Specification for Cosmetic Safety (2015 Edition) (No. 17, 2021).

7. National Medical Products Administration. Announcement of the State Drug Administration on the Publication of the Specification for the Evaluation of Cosmetic Efficacy Claims (No. 50 of 2021).

8. NMPA data search website.