Pre Market Approval of New Cosmetic Ingredients in China

Transcription

1 Pre Market Approval of New Cosmetic Ingredients in China The document aims to explain in simple terms the regulatory requirement on new cosmetic in China, the application procedures and information requirements as well for companies with intentions to manufacture or export concerned cosmetic into China.

2 Legal Notice This document contains guidance on the pre market application of new cosmetic in China, including the legal requirements, definition, application procedure, the required information and the approved list. 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 T: F: Reproduction is authorized provided the source is fully acknowledged in the form "Source: REACH24H Consulting Group, and provided written notification is given to us Last Updated: 30 May / 10

3 Table of Contents Regulatory Requirements... 4 Definition of New Ingredients... 4 Apply for Pre Market Approval... 4 Application Dossier... 5 Safety Criteria and Evaluation... 6 Toxicological Profile... 6 Reduced Requirements... 7 Quality Control... 7 Must Know... 8 Approved New Ingredients / 10

4 Regulatory Requirements Article 8 of the Regulations concerning the Hygiene Supervision over Cosmetics required that any new cosmetic should be approved by the Ministry of Health, currently China Food and Drug Administration (CFDA), prior to firstly being used in cosmetic products for commercial purpose, furthermore, CFDA detailed the approval application procedures and related information requirement. Definition of New Ingredients CFDA defines the new ingredient as the raw material, synthesized or occurring in nature, which is firstly applied in cosmetic products in China, in practice, the applicant can check the status of concerned ingredient through the following way, if listed in Inventory of Existing Cosmetic Ingredient in China (IECIC) or, if has been used in cosmetics for the nine special functions and approved in China or, if it is the extraction of the whole plant that has been listed in IECIC, specially for botanical, An answer of NO for any of the above three questions means it will be a new ingredient in China. Apply for Pre Market Approval The new ingredient manufacturers or cosmetic producers should apply for the pre market approval from the CFDA. The basic application procedures are presented below and for more detailed information requirement, you can refer to the Application Dossier part of this Guidance. Step Item Remarks 1 Check the status of the concerned 2 Confirm the applicant or assign the responsible agent The oversea companies should assign one Chinese responsible agent for application 3 Gap analysis on the information requirements 4 Gap fill in plan and execution 5 Application dossier preparation 6 Submission Application dossier includes 1 original paper and other 4 hardcopies 7 Technical review by the expert panel of CFDA 8 Feedback to any technical review outcome from CFDA 9 Approval granted 4 / 10

5 Application Dossier Currently, CFDA only accept the paper application dossier with the appropriate signature and stamp for approval review, which consists of the following parts, Contents The application dossier R&D Report Description on the manufacturing process Specification and quality control Safety evaluation Responsible agent Testing sample verification reports Analytical method validation reports Sample for marketing Other supportive material Remarks The basic information on the applicants and responsible agent, if applicable, will be covered. The information on the identification (eg. INIC original and Chinese name, IUPAC name and CAS#), source of origin and physicochemical property should be provided, furthermore, the intended function, applicable cosmetic type, recommended concentration in cosmetic products, regulatory status in other countries and warning statement be involved as well. The necessary procedures and process parameters should be reported both in narrative and flow chart way. The Information on the purity and impurity should be specified, moreover, the quantitative/qualitative analytical method for QC submitted as well. The safety on the ingredient and other impurities with risk concern should be evaluated based on the required toxicological profile. The authorization letter and business license on the responsible agent assigned by oversea applicant are required. The verification reports on the testing sample for toxicological studies should be provided by the related testing facilities to demonstrate the consistency, or the statement to prove the new ingredient was employed in the actual toxicological testing be compiled by the applicants. If the analytical method for identification and QC was developed by the applicant itself, not derived from CFDA published testing guidelines, the validation should be carried out by three separate CFDA approved testing institutes in China to meet the requirements. One packed sample for marketing should be provided. Other documents regarding the quality, safety and efficacy can be submitted as well. 5 / 10

6 Safety Criteria and Evaluation Information on safety evaluation is part of the application dossier. In Nov 2010, CFDA issued the recommended guidance on safety evaluation for new cosmetic, which stated the safety criteria is that the normal, or foreseeable reasonable use of the final cosmetic products containing the new ingredient should not present any harm to human raised by the new one, and the required toxicological profile was specified as well, however, there has no official publication on the safety evaluation methodology available, and the applicant can assess the safety on the based on the SCCS Guidance or other related documents. Toxicological Profile In principle, CFDA require the applicant to submit the following toxicological information to identity the hazard of the new, to minimize the testing activities or avoid the issue on animal testing ban in EU, the applicant can provide the toxicological information in the way of read across (the referred substance must be already used in cosmetics), QSAR, and available clinical or epidemiological data. Required toxicological endpoints Acute toxicity (oral and dermal) Irritation/Corrosion (skin and eye) Skin sensitization Photo induced toxicity Mutagenicity/Genotoxicity Sub chronic toxicity (oral and dermal) Teratogenicity toxicity Chronic toxicity/carcinogenicity Toxicokinetics 6 / 10

7 Reduced Requirements Above required toxicological information can be reduced for some special types of as below, Ingredient Types General Listed general Edible ingredient Polymer Reviewed new Remarks Refer to the ingredient without intention to be listed as restricted substance, preservative, UV Filter, colorant or hair dye. Refer to the above general which have been included in related list of regulated for over 4 years, such as Annexes of EU Cosmetic Regulation. Refer to the ingredient with edible history or approved by Chinese or other national authorities for food Refer to the polymer (n>3) with over 1,000 Da Refer to any new which has been subject to safety evaluation by oversea recognized institutes, such as SCCS or CIR, or approved by the authorities And the related exempted endpoints (marked as X ) present below Endpoints Listed Reviewed General Edible Polymer general new Ingredient ingredient Acute toxicity X X X Irritation/Corrosion X Skin sensitization X X Photo induced toxicity X Mutagenicity/Genotoxicity X X X Sub chronic toxicity X X X Teratogenicity toxicity X X X X X Chronic X X X X X toxicity/carcinogenicity Toxicokinetic X X X X X Quality Control The expert panel of CFDA will carefully look into the impurity, and the specification should fully indicate the impurity identities, contents, expired period and storage condition, furthermore, the quantitative/qualitative and other available physicochemical analytical method for quality control should be provided as well. 7 / 10

8 Must Know Oversea supplier should assign one local responsible agent for pre marketing application New cosmetic ingredient should be approved prior to being used in final products by CFDA New regarded as the new chemicals under China chemical regulation, should be registered and approved by MEP before manufacturing or importing Information on the specification on quality control will be intensively reviewed by the expert panel Recommend having the safety of evaluated by local assessors in China with a good understanding of international principles Be proactive to commission any animal testing for Chinese new cosmetic ingredient application Approved New Ingredients Till the end of 2012, here are nine 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 ApprovedYear 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) Lathyrusodoratus flower extract Skin conditioning Not disclosed Aug 2008 (MoH) Fructooligosaccharides Humectant Not disclosed Aug 2008 (MoH) DimethoxytolylPropylresorcinol Skin conditioning Unigen Mar 2012 (CFDA) Polymethacryloyl Lysine Humectant Not disclosed Mar 2012 (CFDA) Phenylethyl Resorcinol Brightener Symrise Dem 2012 (CFDA) 8 / 10

9 About REACH24H REACH24H Consulting Group, a subsidiary of Centre Testing International Corporation, is a leading service provider of professional regulatory consultancy and cost-effective solution for chemical regulatory compliance to various industries. Since 2009 (business started as early as 2007), over 90 professionals with chemical, toxic, eco-toxic backgrounds have been continuously focusing on deepening research on major chemical regulations such as EU Reach, China NCSN; combining various resources and delivering valued products and services to meet demands from large multinational corporations ( Fortune Global 500 ) or small-and-medium enterprises worldwide. REACH24H has close working relationships with ECHA, US department of Commerce, CEFIC, EPA, CPCIA, also satisfying relationships with China Rubber Industry Association, China national chemicals import and export chamber of commerce, China national chemicals import and export chamber of commerce, Singapore Chemical Industrial Association; Malaysia Chemical Industry Association, South Korea Academy of Science. REACH24H serves key areas : >> Global chemical control legislation consultancy >>Execution of regulation compliance >>Experiment/testing management and report review >>Supply chain communication and compliance >>In-house technical training or workshop >>Chemlinked - the largest regulatory database in China >>IT solutions for global GHS >>Multi-language translation, authoring and auditing Specialties EU REACH regulation, new chemical notification in China, hazardous chemicals management, agrochemicals, cosmetics regulation, GHS / C&L, SDS authoring and auditing, chemical regulations in US, Japan, Korea and more. 9 / 10

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