2012: A Recap of Cosmetic Regulatory Development in China

The State Food and Drug Administration (SFDA) which is responsible for cosmetic management in China was busy reforming the legislation and regulations governing areas of the cosmetics industry involving existing and new ingredients, labelling, children's cosmetics, alternative to animal testing etc. This article addresses the following topics:

Contents

• Update of Vital Regulations

• Cosmetic Ingredient

• Cosmetic Labelling

• Children's Cosmetics

• Classifications Management on Non-Special Use Cosmetics

• Testing Institutions for Registration of Cosmetics

• Import and Export of Cosmetics

• Alternative to Animal Testing

Tabel 1: Main Regulatory Development for Cosmetics in 2012

Update of Vital Regulations

The overriding Regulations concerning the Hygiene Supervision over Cosmetics, published by the Ministry of Health (MoH) in 1989, has been implemented for more than 20 years but never been amended since, essentially rendering it incompatible with the lower-level cosmetic regulations. The SFDA is revising it at present which may take two or three years before  finally being enacted. The pre-market registration of cosmetics is expected to be relaxed but the post-market supervision is expected to be intensified. However, little is known about whether the future amendments would be huge or trivial.  

The Hygienic Standard for Cosmetics 2007, released by the MoH, acts as an indispensable standard for all cosmetic products in China. It contains lists of prohibited and restricted substances in cosmetics and the testing and evaluation methods.

The last five years saw the rapid development of the cosmetic industry, during which the Chinese government realized that only supervising the quality of cosmetic products but neglecting the safety of raw materials is far from enough. Besides, many testing methods have been improved or innovated. In an effort to incorporate these recent updates in cosmetic industry, the SFDA made the revision and re-named it as the "Technical Safety Standard for Cosmetics". The main changes are summarized as follows:

• Highlight the safety of ingredients by putting general and technical requirements on them;

• Update lists of prohibited and restricted substances and improve the test methods; 

• Reduce the limits of Pb/As in cosmetics from 40 and 10 to 10 and 4 (mg/kg), respectively. 

See the Table below for comparisons between the structures of the old and new standards:

Go Top

Cosmetic Ingredient

Existing Ingredient

Ingredients to be included in the Inventory of Existing Cosmetic Ingredients in China (IECIC) are exempt from registration. Based on the IECIC 2003 issued by the MoH, the SFDA released the revised IECIC in three batches for public comments in 2012.

The Picture below shows how many ingredients each batch contains: 

It is noted that the new inventory not only lists the Chinese names and the INCI names of existing cosmetic ingredients but also specifies the limit for ingredients restricted to be used in cosmetics.

New Cosmetic Ingredient

PM-Lysine (CAS No. 543700-70-5), Nivitol (CAS No. 869743-37-3) and Phenylethyl Resorcinol (CAS No. 85-27-8) are three new cosmetic ingredients (NCI) approved by the SFDA in 2012. According to the overriding Regulations concerning the Hygiene Supervision over Cosmetics, before a new ingredient is used to make cosmetics, an application must be made to the SFDA for approval. However, due to the lack of risk assessment guidelines, since 2004, only 9 NCIs were announced to be registered successfully. Nevertheless, the SFDA is dedicated to fill the regulatory blank by enacting the guidance for risk assessment of substances with potential risks in cosmetics and the guidance for the registration of NCIs. Furthermore, the Institute of Environmental Health and Related Product Safety under China CDC has also drafted the guideline to assess the cosmetic raw materials, which is not effective yet.

Go Top

Cosmetic Labelling

Regulations for cosmetics label instructions together with its guidance were notified by the China SFDA to the WTO. Compared with the well-known GB 5296.3-2008, no big changes yet slight differences exist between the new regulation and the old national standard. For instance, cosmetics with net quantity equal to or less than 15/g or 15/ml are now required to label the approval license number if there is one.

Children's Cosmetics

The SFDA issued the Guidance on Application and Review of Children's Cosmetics to regulate products made for children from the age 0-12. Higher requirements on the ingredients for children's products have been raised. Producers shall adopt minimum varieties of ingredients and avoid the use of ingredients with special functions of whitening, freckle-removing, acne treatment, depilation, deodorization, hair nourishing, hair dyeing, hair perming, slimming, etc. As long as the effectiveness can be maintained, it is recommended to use less or no fragrance, colorants, preservatives and surfactant in cosmetics. what's more, the ingredients selected should have a certain period of safe use. Those that are manufactured through genetic and nano technology are not encouraged.

Classifications Management on Non-Special Use Cosmetics

Based on the concept of risk management, the SFDA has consulted on opinions on classification management of non-special use cosmetics, among which products that are acknowledged to present relatively high risk (like cosmetics for skin whitening and acne treatment) will be incorporated into the special-use cosmetics, which means it will be tougher to have them registered and they will receive stricter surveillance.

Go Top

Testing Institutions for Registration of Cosmetics

To meet the rising demand of cosmetic testing, another 4 testing institutions (marked in Orange in the table below) are designated by the SFDA to carry out microbiological, hygienic chemical and toxicological tests on cosmetics. In China, only testing reports issued by the SFDA-approved testing units are valid for the registration of cosmetics. By the end of 2012, the SFDA has approved 27 cosmetic testing institutions in total. Every test unit has its own number.

Go Top

Import and Export of Cosmetics

On 1 Feb 2012, China General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) bought into force the Measures for the Administration of Imported and Exported Cosmetics Inspection and Quarantine Supervision. Cosmetics included in the Catalogue of Entry-Exit Commodities Inspected and Quarantined by the Competent Entry-Exit Inspection and Quarantine Authority are subject to application. Later on 30 July, the AQSIQ released the Announcement of 110 to further specify the documents required for inspection and quarantine and highlight the cosmetic products' safety information.

Alternatives to Animal Testing

Very different from the animal testing ban in the European Union, non-animal tests are not officially accepted by the Chinese government to be used for assessment of cosmetic products and ingredients. Only testing reports based on animal tests are valid for cosmetics registration, which has caused tremendous dissatisfaction among companies and animal protection organizations. Nevertheless, China has made continued efforts in recent years to adopt the very first alternative method, the 3T3 Neutral Red Uptake Phototoxicity Assay, for cosmetic ingredients. This has been notified to the WTO last year and will be the milestone of alternative toxicological method development in China once it is adopted by China.

Go Top

Reference Links

Regulations concerning the Hygiene Supervision over Cosmetics

Hygienic Standard for Cosmetics 2007

Technical Safety Standard for Cosmetics

Inventory of Existing Cosmetic Ingredients in China (IECIC)

Regulations for cosmetics label instructions

Guidance for cosmetics label instructions

Guidance on Application and Review of Children's Cosmetics

Opinions on classification management of non-special use cosmetics

Measures for the Administration of Imported and Exported Cosmetics Inspection and Quarantine Supervision