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Cosmetic regulations in China

China is a market of nearly 1.4 billion people, with a steadily growing demand for cosmetics. However, entering the Chinese market remains complicated for foreign companies, as numerous standards and regulations apply to cosmetic products.

The end of December saw the publication of two eagerly-awaited new texts, both on the Chinese domestic market and internationally for all players in the cosmetics industry: the new inventory of cosmetic ingredients and the new Chinese cosmetics regulations. Cosmed takes a closer look at these two texts.

As in many countries, cosmetics regulations in China define the substances that may or may not be present in cosmetics.
In China, however, the formula must be verified according to two standards:
- firstly, according to a positive list detailing all known ingredients authorized for use in cosmetic products on the Chinese market. This is the IECIC or Inventory of Existing Chemical Ingredient in China ;
- secondly, the Chinese cosmetics regulations present several lists of substances, with similar wording to the European cosmetics regulations: prohibited substances, regulated substances, colorants, preservatives, UV filters and authorized hair colorants. The publication of the new Chinese cosmetics regulations on Safety and Technical Standard for Cosmeticshas enabled these lists to be renewed.

A new inventory of ingredients

The aim of the IECIC is to list all ingredients approved by the CFDA (China Food and Drug Administration) for use in cosmetics.
Published in 2003, the first IECIC contained 3,265 ingredients.
After an unfinished project in 2012, it wasn't until 2014 that a new IECIC was published: IECIC 2014, containing 8,783 ingredients.
Following errors and duplications in the 2014 version, a new version had been quickly planned. On December 23, 2015, IECIC 2015 was officially published by the CFDA.

The number of ingredients in IECIC 2015 remains unchanged from IECIC 2014, but 153 changes have been made.
Nine new ingredients have been added and nine deleted.
Of these nine ingredients, eight were removed because they were duplicates in the list. Only one ingredient was genuinely withdrawn and is no longer authorized in China. It is poppy seed extract, INCI name, papaver somniferum seed extract.

New ingredients in China

An ingredient is considered new if it does not belong to the IECIC or if it is not present in the IECIC lists. Safety and Technical Standard. It must then be specifically registered and approved by the CFDA before it can be used.
Numerous toxicological tests and data are requested, but the outcome of these requests is very rare. It's understandable, therefore, that the publication of the IECIC and the regulation is eagerly awaited.

The Safety and Technical Standard for Cosmetics Cosmetics regulations in China

The CFDA had long been planning to overhaul China's cosmetics regulations.
A first draft was published in December 2012, but has not yet been officially released. During 2015, two documents were submitted for comment, the first in February 2015 and the second in August 2015. The CFDA announced the official publication of this new text on December 23, 2015.

Repealing the current regulations, i.e. Hygienic Standard for Cosmetics dating from 2007, will come into force on December 1, 2016.

This new regulation is based on the latest international regulations. It allows for the adaptation of the lists of prohibited and authorized substances, which have remained virtually unchanged since the publication of Hygienic Standard for Cosmetics in 2007.
It comprises eight parts: general information, prohibited and restricted ingredients, positive lists of preservatives, colorants, hair colorants and UV filters, physico-chemical test methods, microbiological test methods, toxicological test methods, human safety test methods, test methods for assessing efficacy.

Toothpastes, which have been part of the cosmetics category since December 2013, no longer fall within the scope of this new regulation.

New restrictions on ingredients

The new list of prohibited ingredients contains 1,388 entries, i.e. 82 additional entries, and is closer to that of the European cosmetics regulation.
As far as the positive lists are concerned, there are few changes to those for preservatives, UV filters and colorants. Here again, the aim has been to bring them into line with European regulations.
Hair colorants, on the other hand, are much more restricted, as 47 will be authorized for the application of the Safety and Technical Standard for Cosmeticswhile 72 could be used under Hygienic Standard for Cosmetics.

Important changes in the use of UV filters and preservatives are as follows.
The PABA UV filter previously authorized at 5 % has been removed from the list.
In the new list of curators :
- five curators have been removed: chloroacetamide, methenamine, methyldibromoglutaronitrile, quaternium-15 and sodium iodate ;
- limits of use of iodopropyl butylcarbamate are reduced;
- the following parabens are now banned: isopropylparaben, isobutylparaben, phenylparaben, benzylparaben, pentylparaben ;
- for certain preservatives, the product categories have been restricted: the blend methylisothiazolinone and methylchloroisothiazolinone is limited to rinsed products, the triclosan becomes authorized only in shower gels, soaps, deodorants, make-up powders and nail cleansers;

Expanded regulations with new test methods

All the test methods that will be used to control cosmetics and that will be the reference in China are described in the new Technical and Safety Standard for Cosmetics.
There are 77 physico-chemical methods, 60 more than in the previous year.Hygienic Standard for Cosmetics. Microbiological tests (6 methods) and toxicological tests (17 methods) are identical in number to the previous regulation, but the protocol and structure have been adjusted.

With regard to efficacy measurement methods, the text focuses more specifically on sun protection methods. The normative references are now international, as the methods are in line with ISO 24444:2010 for SPF measurement and ISO 24442:2011 for UVA protection measurement.

Towards future developments?

These changes on the Technical and Safety Standard for Cosmetics show a positive evolution in China and a willingness to adapt to European regulations in the field of cosmetics. Nevertheless, China retains its specific features, notably through the compulsory approval of new ingredients, and despite these changes, the registration process for cosmetics exports to China remains long and complex.

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