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COSMETICS REGISTRATION IN CHINA
Introduction – Administration Bodies – Definition: Cosmetics – Cosmetics Categories– Regulations & Standards
Two Different Approval Systems – Registration vs. Filing (opportunities and challenges)– Choice of NMPA Responsible Person– Special cosmetics: Registration – Non-special cosmetics: NEW Filing – Document Checklist– Chinese Label– Safety Limits– Test Duration and Costs– Do’s and Don’ts: Samples– Change & Renewal Application
.
Hot Topics – Animal Tests– Latest regulatory updates
(Microbeads and Overseas Inspection)
.
NMPA (National Medical Product Adminstration)Changed* Registration of pharma, cosmetics and medical devices;
supervision and management after registration
China Food and Drug Administration (CFDA)
2013 - New* Food safety 2017 - New* Infant formulas & food registration for medical purposes
State Food and Drug Administration (SFDA)
New* Administration and registration of foods, medical devices, health foods and cosmetics
State Drug Administration (SDA)
Administration and registration of pharma products
Evolution of NMPAHistory of NMPA
3
2003
2013 - 2017
2018
1998
4
Health Food
Food for Special Medical
Purposes
Infant Formula CFE
In-vitro Diagnostic
Medical Devices
CosmeticPharma Products
CFDA
NMPA
NMPA Categories
DEFINITION: COSMETICS
COSMETICS
Product property
Chemical products
Application
On external parts of human body
Application method
Spread Spray Other methods
Intended Effects
Cleanse the body
Eliminate unpleasant
odorProtect
skinImprove
appearance and beauty
COSMETICS CATEGORIESNon-special cosmetics
Non-special
cosmetics
Hair care
Skin care
FragrancesMake-up
Nail cosmetics
COSMETICS CATEGORIESSpecial cosmetics
Special cosmetics
Hair growth restoration
Breast enhancement
Deodorants
Spot removing
Sun screenprotection
Hair dyeing colorants
Hair perming
Depilatories
Body slimming
REGULATIONS & STANDARDS
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Type Regulation & StandardOverarching Cosmetics Hygiene Supervision Regulation (CHSR) 1989Hygiene Standard Cosmetics Safety and Technical Standards 2015
Approval
Detailed Rules for the Implementation of CHSR 1991
Health Administrative Approval Procedures for Health-Related Products
Provisions for the Application & Acceptance of Cosmetics Administrative Approval
Guidelines for Registration Review and Approval of Imported Special Use Cosmetic Products
Guidance on Application and Review of New Cosmetic Ingredient
Guidance on Application and Review of Children’s Cosmetics
REGULATIONS & STANDARDS
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Type Regulation & Standard
Testing Requirements for Cosmetic Administrative Licensing Testing 2010;Safety and Technical Standards for Cosmetics 2015
LabelingAdministrative Measures on Cosmetics Labeling
GB 5296.3-2008 General Labeling for Cosmetics
Naming Standard Chinese Name Directory for International Cosmetic Raw Materials 2010Standard Chinese Name Directory for International Cosmetic Raw Material (draft for comment) 2018
Ingredients Green List Inventory of Existing Cosmetic Ingredients in China (IECIC) 2007Inventory of Existing Cosmetic Ingredients in China (IECIC) 2015
New Filing System For Imported Non-Special Purpose Cosmetics
Source: 09.11.2018 NMPA Announcement No. 88-2018
As of 10 November 2018, foreign manufacturers have no choice anymore:
All imported non-special purpose cosmetics are subject to the
Special purpose cosmetics continue - as before - with the
New National UnifiedFiling Management
Registration in Beijing
Registration VS Filing
Filing ManagementRegistration
Type of cosmetic Special purpose cosmetics Non-special purpose cosmetics
Application location Beijing NMPA - Beijing NMPA(*)- Local MPA in 11 Free Trade Zones
Duration of approval(starting with type tests)
9-12 months 4-5 months
Certificate type Hard-copy Electronic
Certificate validity 4 years Unlimited(*)
Responsibility of Responsible Person
Registration Filing, import, operation, post-market safety
Residence of Responsible Person
No limitation - No limitation(*)- 11 New Trade Zones
Import All ports - All ports(*)- 11 New Trade Zones (unless info of new import ports and consignee is submitted to filing system)
(*) Only for imported cosmetics
Tianjin, Liaoning, Shanghai, Zhejiang,
Fujian, Henan, Hubei, Guangdong,
Chongqing, Sichuan, Shaanxi provinces
NM
PA
Res
pons
ible
Pe
rson
Legal entity in China
Authorized by applicant
Responsible for the registration (special) / filing (non-special)
Stamps and signs the application documents
Ensures that all submitted registration documents shall be truthful and in line with requirements
Bears the corresponding legal responsibility and all the consequences arising therefrom, if there are any inaccuracies
Non-special cosmetics:Responsible for the import, marketing, product safety
- Have an actual office address- The registered address must be in the filing port- Domestic Responsible Person’s business license must cover cosmetic business- One overseas cosmetic manufacturer can appoint several Domestic Responsible Persons but one product can only have one Domestic Responsible Person.
DO‘S AND DON‘TSNMPA Responsible Person
New
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DO‘S AND DON‘TSNMPA Responsible Person
Foreign Manufacturers
Own Subsidiary
Distributor
Consulting Firm
Foreign manufacturers require a legal entity in China for the registration of cosmetics:
Intellectual property!Insight into application documentation, including confidential confirmation (e.g. formula, production process).Special purpose cosmetics: Receives certificate!The manufacturer cannot import products into China, change or renew the certificate without the support of the distributor.
Independence!This solution is neutral and preserves full control over NMPA online account, ensures independence for future decisions, including distributor changes or multiple distributors.Resources and knowledge for all regulatory affairs matters -during and after approval.
REGISTRATION PROCESS(Special Purpose Cosmetics)
Collection ofRegistration Files
Preparation & Submission of
Registration Files
Submission for Second Review
NMPAAdministrative Review
Responsible PersonApplication
Packaging & FormulaAnalysis
NMPA AccountOpening
Sample Transport
Sample Testing
Preparation of Supplementary Files
after Receiving Supplementary Notice
NMPA Approval
Customs Clearance & Import
Certificate Issuing
NMPA Technical Review
REGISTRATION CERTIFICATE(Special Purpose Cosmetics)
FILING PROCESS(Non-Special Purpose Cosmetics)
Collection ofRegistration Files
Preparation & Submission of
Registration FilesAdministrative Review
Packaging & Formula Analysis
A) NMPA Approval
NMPA Technical Review(within 3 months)
Responsible PersonApplication
NMPA AccountOpening
Sample Transport
Sample Testing
Customs Clearance & Import
Electronic Certificate
Issuing
B) Submission of Supplementary Files Within 30 Days
C) Import of Distribution of Products Shall Be Suspended
D) Remove and Recall Products From The Market
ELECTRONIC FILING CERTIFICATE(Non-Special Purpose Cosmetics)
Document Checklist(Non-Special Purpose Cosmetics)
1) Power of Attorney & Letter of Authorization between applicant and Domestic Responsible Person
2) Business License of Domestic Responsible Person
3) Application form
4) Chinese product name and nomenclature
5) Product formula containing the INCI name, content and function of each ingredient
6) Packaging layout (including labels and inlet)
7) Chinese label
8) Free Sales Certificate
9) BSE free statement
10)Original ISO/GMP certificate
11)Contract manufacturing agreement (if applicable)
12)Product quality and safety control file
13)Production process (flowchart)
14)Safety test report
15)Risk assessment report of potential risk substances included in formula
16)Technical requirements
Chinese Label
For the import of cosmetics, a Chinese Label shall be applied to the original package.
This Chinese Label must contain the following information:
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Product name
Country of origin
Name and address of the manufacturer
Address of contract manufacturer
Name and address of the Responsible Person
Approval number
Ingredient list
Production date and Shelf life, or Batch number and expiration date
Net content
Cautions
Usage instructions and storage conditions
Application DossierSafety Limits
Product quality and safety control requirementsDepending on the concrete products, the following quality and safety control items shall be followed, where they are applicable.
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Item Limit
Aerobic Bacterial Count (CFU/g or CFU/ml):500 (cosmetics for eyes, lips and
baby)1000 (other cosmetics)
Molds and Yeast Count: (CFU/g or CFU/ml): 100Thermotolerant Coliform Bacteria (g/or ml) Not detection
Staphylococcus Aureus (g/or ml) Not detectionPseudomonas Aeruginosa (g/or ml) Not detection
Lead (Pb) (mg/kg): 10Mercury (Hg) (mg/kg): 1Arsenic (As) (mg/kg): 2
Cadmium (Cd) (mg/kg): 5Dioxane (mg/kg): 30
Methyl alcohol (mg/kg): 2000
Formaldehyde (mg/kg): 200050000 nail hardening
Asbestos (mg/kg): Not detection
TESTING DURATION AND COST*
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Category Subcategory Duration(Month)
Basic testing fee(RMB)
Human body testing fee(RMB)
Testing fee / per type of substance** (RMB)
Non-special cosmetics
3 6,300.00 –8,300.00
N.A. 500.00 – 1,500.00
Special cosmetics
Sun screenprotection
6 12,300.00 ＞10,000.00 500.00 – 1,500.00
Hair dyeing 4 14,500.00 N.A. 500.00 – 1,500.00
Hair perming 4 18,700.00 N.A. 500.00 – 1,500.00 Depilatories 4 5,600.00 6,000.00 500.00 – 1,50.00 Body slimming 8 17,300.00 18,000.00 500.00 – 1,500.00
Hair growing 8 22,300.00 18,000.00 500.00 – 1,500.00 Breast enhancement
8 17,300.00 18,000.00 500.00 – 1,500.00
Deodorants 4 8,500.00 2,700.00 500.00 – 1,500.00
Spot removing 4 12,400.00 2,700.00 500.00 – 1,500.00
*: figures are estimations and are regularly subject to change**: dioxane, phenol, methyl alcohol, formaldehyde, diethylene glycol, pesticide residue etc.
Samples
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Unsealed samples may lead to failure on microorganism testsSamples should not be close to expiration“Dummy“ packaging is insufficient
CHANGE & RENEWAL APPLICATION
Change ApplicationFor example:• Address change of (contract) manufacturer• Change of NMPA Responsible Person• Change of product name in Chinese
Renewal Application – In the Past
• Submit no later than 6 months before expiration date of certificate• In case there are changes of the regulations or technical standards,
timely initiation of the renewal is important to avoid disruption of sales• Cisema reminds clients 1 year in advance
If this concerns non-special cosmetics, which were approved under the old system, change application is impossible.
Instead: filing!
This applies to special purpose cosmetics only!
RENEWAL APPLICATION(Special Purpose Products)
Announcement on Renewal Commitment System to Hygiene Permit of Cosmetics for Special Purpose (NMPA No. 45-2019) – released 29.05.2019
Status Quo: products have been sold in China for the last 4 years
Problem: Previously, NMPA took at least 6 months for renewal verification, therefore many hygiene permits (certificates) expired before a new one could be obtained.
Future Timeline of renewal application :
Start self-checking 6 months before certificate expirationSubmission deadline 30 working days before certificate expiration Certificate renewed at around 15 working days after acceptance New validity starts from previous expiration date
RENEWAL APPLICATION(Special Purpose Products)
Announcement on Renewal Commitment System to Hygiene Permit of Cosmetics for Special Purpose (NMPA No. 45-2019) – released 29.05.2019
Product self-checking report is the key to a successful renewal application• Consistency with documents (e.g. formula) submitted in previous registration• Compliance with current regulation and standard (e.g. without newly prohibited
ingredient)• Records of changes or renewals• Sales records in the past 4 years (full test may be required)• Status of monitoring adverse reaction and the corresponding measures that have
been taken• If applicant is punished due to violation of regulation, applicant should report the
status of rectification, and extra test may be required
Verification Results:Pass Supplementary information shall be submitted (different deadlines) Certificate is revoked
Cosmetics Import
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There are 3 feasible ways for cosmetics importation in China.
Cruelty Free
Animal Tests
Test Item Test Method Date Application scopeSkin phototoxicity In Vitro 3T3 Neutral Red
Uptake Phototoxicity Assay (In Vitro 3T3 NRU PT)
11th Nov, 2016
cosmetic ingredient
Skin corrosion In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER)
21st Aug, 2017
cosmetic ingredient
Skin photoallergy Skin Photoallergy Test 21st Aug, 2017
cosmetic ingredient and cosmetic product
Skin sensitization In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)
22nd Mar, 2019
cosmetic ingredient
Eye irritation or corrosion
Short Time Exposure In Vitro Test Method (STE)
22nd Mar, 2019
cosmetic ingredient
Skin sensitization Skin Sensitization: Local Lymph Node Assay: DA (LLNA:DA)
22nd Mar, 2019
cosmetic ingredient
Skin sensitization Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA (LLNA:BrdU-ELISA)
22nd Mar, 2019
cosmetic ingredient
REGULATORY UPDATES
Date Announcement
10.09.2019
&
12.09.2019
NMPA announced changes to cosmetics sample tests in China (No. 72-2019). Laboratories need to re-apply for their qualification as a testing institutions because the relevant qualification will be automatically suspended on 01.11.2019. Furthermore, cosmetics enterprises and their NMPA Responsible Persons will have to apply for and manage tests online. New mandatory test items for: - Methanol, Phenol, Diethylene glycol, Dioxane, Acrylamide, Anti dandruff agent, Formaldehyde, Asbestos, α-hydroxy acid, Pesticide residues - >0.5% sunscreen agents in non-sunscreen products- human tests: rinse-off products claiming anti-acne, anti-wrinkle, anti-spot- efficacy test: anti-spot (whitening), hair growth
REGULATORY UPDATES
Date Announcement
22.11.2019 NMPA released a draft regulation, which would require foreign manufacturers to undergo overseas inspection of cosmetics production facilities to standardize and optimize the inspection process before foreign manufacturers import cosmetic products to China.
06.11.2019 China’s National Development and Reform Commission announced (No.29-2019) the prohibition of daily chemical articles containing plastic microbeads for production after December 31, 2020, and for sale after December 31, 2022.
Our worldwide locations
Cisema (Hong Kong) Limited7/A, Shun Pont Commercial Building5-11 Thomson Road, Wan ChaiHong Kong
Speaker: Anna KingEmail: [email protected]: www.cisema.com
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