Introduction on the Lists of Regulated Cosmetic Ingredients in China The document aims to explain in simple terms the types of lists for regulated cosmetic ingredients, especially the related background, involved entries and current progress, whichh will be useful for your well understanding and compliance assurance with cosmetic regulation in China.
Legal Notice This document contains guidance on introduction of regulated cosmetic ingredients in China, including the identities of related lists, the involved entries and updated. However, users are reminded that official government regulation Regulation concerning Hygiene Supervision over Cosmetics and related official documents are the only authentic legal reference. The information in this document does not constitute legal advice. REACH24H Consulting Group does not accept any liability with regard to the contents of this document. If you have questions or comments in relation to this document please do not hesitate to contact us Contact Person Tommy Kong Email: tommy.kong@reach24h.com T: 86 0571 8700 7517 F: 86 0571 8700 7566. Reproduction is authorized provided the source is fully acknowledged in the form "Source: REACH24H Consulting Group, www.reach24h.com", and provided written notification is given to us (info@reach24h.com). Latest updated: 14 May 2013 2 / 8
Table of Contents Background History... 4 Lists of Regulated Ingredients... 4 Inventory of Existing Cosmetic Ingredients in China (IECIC)... 4 List of Standardized Chinese INCI Name... 5 List of Substances Prohibited in Cosmetic Products... 5 List of Substances Restricted in Cosmetic Products... 5 List of Colorants Allowed in Cosmetic Products... 5 List of Preservatives Allowed in Cosmetic Products... 6 List of UV Filters Allowed in Cosmetic Products... 6 List of Hair Colorants Allowed in Cosmetic Products... 6 List of Approved New Cosmetic Ingredients... 6 3 / 8
Background History China established the current cosmetic regulatory scheme through the implementation of Regulation on Hygienic Supervision over Cosmetic Products (Cosmetic Regulation), which came into effect in 1989, and then promulgating and updating related lists of regulated ingredients, such as preservative or UV filters, have been regarded as the useful instrument for regulatory purpose, and the outcome of adoption of international regulatory progress, such as the 2003 amendments on EU Cosmetic Directive, result in more restricted substances listed. Lists of Regulated Ingredients This document intends to present all the nine lists of regulated ingredients (hereafter referred as 9 Regulated Lists), and the table below shows the related name and firstly published, more detailed please refer to the corresponding parts of the guidance. List Name First Publication Current Version Inventory of Existing Cosmetic Ingredients in China 2003 2013 List of Standardized Chinese INCI Name 2007 2010 List of Substances Prohibited in Cosmetic Products 1987 2007 List of Substances Restricted in Cosmetic Products 1987 2007 List of Colorants Allowed in Cosmetic Products 1987 2007 List of Preservatives Allowed in Cosmetic Products 1987 2007 List of UV Filters Allowed in Cosmetic Products 1987 2007 List of Hair Colorants Allowed in Cosmetic Products 2007 2007 List of Approved New Cosmetic Ingredients 2004 2012 Inventory of Existing Cosmetic Ingredients in China (IECIC) Prior to the first publication of the IECIC in 2003, China regulated the cosmetic ingredients based on the Hygienic Standards of Cosmetics issued in 1987, which covered the regulated ingredients of prohibited substances (359 entries), restricted substances (57 entries), preservatives (66 entries), UV Filters (36 entries) and Skin Colorants (67 entries), and till the issuance of 2003 IECIC, the new ingredients can be figured out as substances without inclusion and must be approved by the authority for fist application according to Article 8 of the Cosmetic Regulation. While here is no clearly stated rule on updating of the IECIC, China still try to reform this inventory to make it more comprehensive with the cosmetic technological progress and publish two parts of latest version in 7 Feb and 10 May in2013, separately, more detailed present as below. 2003 IECIC 2013 IECIC Entries 2824 2085 (confirmed), 1582 (in review) 4 / 8
List of Standardized Chinese INCI Name With the aim at standardizing the translation of INCI Name and regulate the labeling on cosmetics marketed in China (the industry must label the cosmetics using the standard Chinese name), Ministry of Health (the former regulator) firstly published the List of Standardized Chinese INCI Name in 2007 (12,072 entries), based on the INCI Handbook (2004 Version), and then issued the latest version in 2010 by CFDA to adopt the newly added entries of 2008 INCI Handbook (15,649 entries). Pleased be well aware of that the ingredients with standardized Chinese INCI Names will not be regarded as the allowable substance automatically, the companies should carefully look into the IECIC to check the status of concerned ingredient as new or existing, more detailed please refer to the Guidance on Pre Market of New Cosmetic Ingredients in China. List of Substances Prohibited in Cosmetic Products China introduced the negative list system by drafting the Hygienic Standard of Cosmetics in 1987, and then revised it at three times to come up with the latest version in 2007, regarding the changes on the entries, please refer to the following table. Entries 359 494 496 1286 Not clear List of Substances Restricted in Cosmetic Products The list for ingredients subject to restricted condition was adopted as the Table 3 of Hygienic Standard of Cosmetics in 1987, and has been updated three times, more detailed present in the following table. Entries 57 67 67 73 Not clear List of Colorants Allowed in Cosmetic Products Allowed colorants were listed in Table 6 of Hygienic Standards of Cosmetics in 1987, more detailed on the updated and changes on the entries as below, Entries 67 157 157 156 Not clear 5 / 8
List of Preservatives Allowed in Cosmetic Products Table 4 of the Hygienic Standards of Cosmetics (1987 version) firstly determine the allowed preservative, more detailed on the updated and changes on the entries as below, Entries 66 55 55 56 Not clear List of UV Filters Allowed in Cosmetic Products The list of allowed UV filter was firstly established in 1987, and several entries were deleted by the revision, more detailed as below, Entries 36 22 24 28 Not clear List of Hair Colorants Allowed in Cosmetic Products The hair colorants was firstly listed for allowable use in cosmetics within the Hygienic Standards in 2007, which covered 93 entries mainly based on the outcome of safety assessment of EU Scientific Committee of Consumers Safety List of Approved New Cosmetic Ingredients Till the end of 2012, here are nine ingredients in total being approved for cosmetic application by CFDA till the end of and the previous competent authority, Ministry of Health (MoH), the related INCI name, supplier name and approved year present below for reference. INCI Name Function Applicants Approved Year Alkyl (C12 C22) trimethyl Non preservative Not disclosed Jun 2004 (MoH) ammonium, bromide and chloride Potassium Methoxysalicylate Brightener Shisheido Apr 2007 (MoH) Methylisothiazolinone Preservative Rohm Haas May 2007 (MoH) Carnitine Tartrate Active ingredient Not disclosed Jun 2008 (MoH) Lathyrus odoratus flower extract Skin conditioning Not disclosed Aug 2008 (MoH) Fructooligosaccharides Humectant Not disclosed Aug 2008 (MoH) Dimethoxytolyl Propylresorcinol Skin conditioning Unigen Mar 2012 (CFDA) Polymethacryloyl Lysine Humectant Not disclosed Mar 2012 (CFDA) Phenylethyl Resorcinol Brightener Symrise Dem 2012 (CFDA) 6 / 8
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