latest update of cosmetic approval in china and cosmetic … · 2018-11-06 · moh aqsiq...
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Enabling Chemical Compliance for A Safer World
Latest Update of Cosmetic Approval in China and Cosmetic Regulations
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目录CONTENTS
Latest Status of Cosmetic Approval in China
Latest Update of Cosmetic Regulations in China
Change of Cosmetic Management System
FAQs about CFDA Reform
1
6
7
9
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Review Status of Imported Non Special Use Cosmetics
0 200 400 600 800 1000 1200 1400 1600
Jan
Feb
Mar
Apr
May
Jun
Registration
Renewal
Re-check
Amendment
6436 products for registration 789 products for renewal 230 products for re-check 37 products for amendment
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Review Status of Imported Special Use Cosmetics
717 products for registration 240 products for renewal 8 products for re-check 373 products for amendment
0 50 100 150 200 250 300 350
Jan
Feb
Mar
Apr
May
Jun
Registration
Renewal
Re-check
Amendment
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Review Status of Domestic Special Use Cosmetics
629 products for registration 483 products for renewal 23 products for re-check 847 products for amendment
0 100 200 300 400 500
Jan
Feb
Mar
Apr
May
Jun
Registration
Renewal
Re-check
Amendment
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Registration Status of Cosmetic Products
6436 imported non special use cosmetics 717 imported special use cosmetics 629 domestic special use cosmetics
0
200
400
600
800
1000
1200
1400
1600
1800
Jan Feb Mar Apr May Jun
Domestic special use cosmetics
Imported special use cosmetics
Imported non special use cosmetics Imported non special use cosmetics
Domestic special use cosmetics
Imported special use cosmetics
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Review Status of New Cosmetic Ingredient
5 imported ingredients for registration 14 imported ingredients and 1 domestic ingredient for amendment 5 imported ingredients for re-check
0 5 10 15
Jan
Feb
Mar
Apr
May
Jun
Registration
Amendment
Re-check
Imported new cosmetic ingredient Domestic new cosmetic ingredient
0 0.2 0.4 0.6 0.8 1
Jan
Feb
Mar
Apr
May
Jun
Registration
Amendment
Re-check
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Latest Update of Cosmetic Regulations in China
30/11/2012
07/2/2013
The first finalized batch of IECIC 2012 issued
01/02/2013
Guideline on the Baby Care Cosmetics Registration and Assessment came into force.
Technical Safety Standard for Cosmetics (draft 2012) will replace the Hygienic Standard for Cosmetics 2007.
10/5/2013
The second finalized batch of IECIC 2012 issued
28/6/2013
CFDA to approve 1 New Cosmetic Ingredient” Elaeagnus mollis diel Oil”
15/5/2013
CFDA reform
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SFDA
REGULATIONS CONCERNING THE HYGIENE SUPERVISION OVER COSMETICS. Detailed Rules for the Implementation of the Regulation on the Hygiene Supervision over Cosmetics Hygienic Standard for Cosmetics 2007
Record-keeping of imported non special use cosmetics Hygiene license of special use cosmetics Approval of new cosmetic ingredient
Production license of cosmetics Sanitary permit of cosmetic production enterprises QS mark application Radom inspection to cosmetics production enterprises.
Administrative
Permit of Cosmetics Drafting-Laws
Supervision of
Cosmetics Production
Old Cosmetic Management System in China
MOH AQSIQ
1/9/2008-15/5/2013
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CFDA
Hygiene license of special use cosmetics Approval of new cosmetic ingredient
Combining the production license and sanitary permit of cosmetic production enterprises into one license.
Administrative
Permit of Cosmetics Drafting Laws
Supervision of
Cosmetics Production
New Cosmetic Management System in China
15/5/2013~
Provision of Acceptance for Cosmetics Administrative Permit Application Guideline on the Application and Assessment of New Cosmetic Ingredient
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Main Differences(Old vs New)
Item Old System New System
Name & Level SFDA, Semi-ministerial body
CFDA, Ministerial body
Imported ordinary use cosmetics
Approved by SFDA in Beijing
Approved by Food & Drug Administration Authority at Provincial Level
Production license for cosmetics & compulsory inspection
Authority: General Administration of Supervision, Inspection and Quarantine of the PRC (AQSIQ)
Authority: CFDA
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When will provincial FDA take over the administrative license of imported non special use cosmetics?
Q1
R1 It is not clear yet. CFDA launched the project for revising the Measures on Management of Cosmetics Registration on 11th Jul 2013. The rules might be published at the end of this year.
Q2 Have the dossier requirements of registering imported non special use cosmetics changed if they are now approved by provincial FDAs?
R2 No.
Q3 When will the remaining batches of IECIC be issued?
R3 We do not have detailed time yet. However, CFDA will not publish IECIC in separate batches afterwards. We could expect a single and final version of IECIC.
FAQs about CFDA Reform
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When will the CFDA publish the revised Measures on the Management of Cosmetics Registration?
Q4
R4 It is estimated that the Measures will be issued near the end of 2013
Q5 Is it possible to approve special use cosmetics as pharmaceutical in the future?
R5 No.
Q6 Whether the CFDA will cancel the registration of new cosmetic ingredient in the future?
R6 No.
FAQs about CFDA Reform
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Thank You!
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