Registration of New Cosmetic Ingredients

Despite the global economic downturn, China's consumer cosmetics market has continued to develop and prosper. China has become the 3rd largest cosmetic market in the world after US and Japan.

In China, the State Food and Drug Administration (SFDA) is in charge of the supervision and management of cosmetics. Generally, the obligations for registration cosmetics in China depend on two categories:

1. Cosmetic products--- special-use cosmetic products and non-special-use cosmetic products;

2. Cosmetic raw materials---only new cosmetic ingredients used for the first time in China need to be registered before use in a cosmetic product.

Regarding cosmetics products, the SFDA concentrates on the pre-market registration of cosmetics. Meanwhile, other government authorities, such as the AQSIQ, QTS and the CIQ, are also involved in the supervision of cosmetic products following their registration.

Nevertheless, not even a single new cosmetic ingredient has been approved by the SFDA since the power of management transferred from MOH to SFDA in 2008. One reason for this situation could be due to unspecific regulations as well as the difficulty in identifying "new" cosmetic ingredients in China.

On one hand, according to the Hygienic Standard for Cosmetics (2007), the toxicity evaluation of a new cosmetic ingredient requires at least 9 kinds of data. These include a sub chronic toxicity study, mutation study, teratogenicity study in addition to chronic toxicity/carcinogenicity and toxic kinetics data which can be burdensome for cosmetic enterprises to carry out.

On the other hand, the process of identifying new cosmetic ingredients is vague. There has been a draft inventory issued by the MOH in 2003 listing all approved existing cosmetic ingredients. This has been the only basis in determining whether a substance is a new cosmetic ingredient.

In order to provide clarity in the registration procedure of new cosmetic ingredients for industry, the SFDA recently released a guidance document on the safety assessment of new cosmetic ingredients.

In the guidance document, the SFDA defines 6 special cases where the data requirements for the safety evaluation of new cosmetic ingredients can be greatly reduced:

1. If it is a preservative, sunscreen agent, colorant, dye or other substance that is not listed as restricted substance in the "Hygiene Standards for Cosmetics";

2. If the extract of another part of the same plant has already been approved for use as a cosmetic ingredient1;

3. If it has a record of safe use in food products, or if it has been approved for safe use in cosmetic or food products by competent authorities overseas, If it also has been approved for use as a cosmetic ingredient by competent authorities overseas;

4. If it is a polymer2 with average molecular weight >1000;

5. If it has no potentially carcinogenic, mutagenic composition and the systemic exposure dose(SED) < 1.5ug/kg/day;

6. If it is chemically inert3 or a volatile ingredient (The boiling point < 100 ℃, or it is between 50~260 ℃ and saturated vapor pressure at room temperature>133.322Pa);

7. International companies could be exempt from part of the data requirements for new cosmetic ingredient testing by providing sufficient proof that the substance has been used in cosmetic products or food outside of China thereby satisfying the requirements of title c above. Thus, the registration of new cosmetic ingredient could turn out to be faster, practical and more cost-effective.

Remarks:

1. If the whole plant is approved as cosmetic ingredient, then it is not necessary to apply for each part of that plant;

2. The definition of a polymer: includes at least 3 monomers, and at least 1 monomer or other reactant connected by covalent bond;

3. E.g. chemicals without reaction active group, inorganic, alkanes, etc.

In order to further simplify the registration of new cosmetic ingredients, there are still two barriers which may need consideration. The first one, as mentioned above is that the list of existing cosmetic ingredients (2003) IECIC is out of date and has not been updated and finalized. The good news is that the SFDA is working on updating the list, and it is hoped that it will be published early next year.

Another issue for international enterprises, especially to those based in the EU and US, is that of alternatives to Animal Testing. The US and European countries have gradually begun to outlaw animal testing of cosmetics and raw materials. Due to concerns over both animal welfare and the rapid development of toxicology testing, however, they do not enjoy popular support in China. The SFDA has not recognized the validity of alternative testing which means foreign companies in possession of test data obtained by alternative methods may need to perform the animal testing again and SFDA approved testing authorities in China are their best choice since they have sufficient experience on cosmetics.

Updated information:

This expert article was written according to the information in Guidance on Safety Evaluation of New Cosmetic Raw Materials, which is a draft released by SFDA on November 29, 2010 for public consultation. While after half-a-year revision, on May 12, 2011, SFDA officially published Guidance on Application and Review of New Cosmetic Raw Materials, in which special cases where the data requirements for the safety evaluation of new cosmetic ingredients can be greatly reduced are different.

There are only five special cases allowed to reduce toxicological test data:

• 1) if raw materials do not function as preservatives, sunscreen agents, colorants and do not need to be included in "Hygiene Standards for Cosmetics" as restricted substances from a safety point of view;

Updated 

The 1st and 2nd batch of IECIC 2012 (draft) have been published.