A project funded by the European Union WELCOME TO THE EU SME CENTRE WEBINAR SERIES
A project funded by the European Union
WELCOME TO THE EU SME CENTRE WEBINAR SERIES
www.eusmecentre.org.cn [email protected]
Please continue to submit your text questions and comments using the Questions Panel
Purpose
• The EU SME Centre in Beijing is a project funded by the European Union
• To assist European SMEs to export to China and establish, develop and maintain commercial activities in the Chinese market
• Free, confidential information and advice, and practical support services
BD
S&C
HR & Training
Legal
Information and advice • Documentation
• Enquiries
• Trainings
• Webinars
Support services • Hot desks
• Receiving delegations
• Matchmaking and networking
• Databases
Services
Are you ready for China?
www.eusmecentre.org.cn/quiz
How to Successfully Import Cosmetics onto the Chinese Market
22 Aug 2013
Bio of Speaker
Dr Michael Chang, PhD in Chemistry, USTC R&D Department Manager Chemical Inspection and Regulation Service(CIRS) China 7 years chemical regulatory consultancy experience Safety assessment and registration of new substances and cosmetics in China; Managing a 18-staff team who are responsible for dossier preparation and communications with authorities.
Contents
Overview of the Chinese Cosmetics Market录内容1 1
2 Overview of the Chinese Cosmetics Regulations and Main Differences with EU Regulation
3 General Progress of Exporting Cosmetics to China目录内容4
4 Relevant Chinese Organizations & Resources
I. “Overview of the Chinese Cosmetics Market”
Import Cosmetics onto Chinese Market How
80%
20%
Annual growth rate greater than 16%
Foreign companies dominate market
Per capital spending is at a low level
The third-largest cosmetics market
General situation
2007 2008 2009 2010 2011 2012
134
110.3
88.9 74
59.7 48.8
Yearly growth (%) 2008 2009 2010 2011 2012
Cosmetics 22.1 16.9 16.6 18.7 17.0
Retail value of cosmetics by wholesale and retail enterprises
Source: National Bureau of Statistics of China (NBS) Unit: (billion RMB)
Fast growth
> 80% domestic companies
< 20% market share
In total: 3245
Guangdong Prov.: 1467
Zhejiang Prov.: 300
Jiangsu Prov.: 250
Shanghai: 225
Fujian Prov.: 101
…
Distribution of cosmetic companies in China(2010)
Great demand for imported cosmetics/Strong competition
2011
2013
2012 51.0 %
25.8 % Imported ordinary
use cosmetics Imported special
use cosmetics
2011 7145 1073
2012 11423 990
2013 (Jan to May)
5559 524
2012 (Jan. to May) 4381 528
No. of imported cosmetic products approved by CFDA(2011-2013)
+51.0 %
+25.8 %
II. “Overview of the Chinese Cosmetic Regulations and Main Differences
with EU Regulation”
Import Cosmetics onto Chinese Market How
Regulations on the Hygiene Supervision Over Cosmetics (Order.3 MOH)
Detailed Rules for the Implementation of the Regulation on the Hygiene Supervision over Cosmetics (Order.13 MOH)
Hygienic Standard for Cosmetics 2007 (MOH)
Regulations on the Management of Cosmetics Labels (Order.100 AQSIQ)
The Measures for the Administration of Hygiene License for Cosmetics (SFDA)
Guidelines for the Registration and Evaluation of New Cosmetic Ingredient (SFDA)
Major cosmetic regulations in China
Definition
Cosmetic product dossier
Nanomaterial and animal testing
Labelling requirements
Competent authorities
Obligations of responsible person
Comparison with EU COSMETICS REGULATION
(EC 1223/2009)
Ingredient requirements
D efinition EU: Cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body or with with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.
the teeth and the mucous membranes of the oral cavity
China: The teeth and the mucous membranes of the oral cavity are excluded.
Comparison with EU regulation: Definition
European parliament and the council
European Commission
Member States
SCCS
Annual report on animal testing and nanomatetials
Safety assessment
Notification
CFDA: Pre-market approval
CIQ: Manufacturing management
SAIC: Market surveillance
Comparison with EU regulation: Competent Authorities
Comparison with EU regulation: Obligations of Responsible Person
Responsible for product registration only Preparation of dossier Name will not appear on product label
Taking legal responsibility for product safety Keeping of cosmetic product dossier for inspection Name needs to appear on product label.
Comparison with EU regulation: Cosmetic Product Dossier
Product Information File Cosmetic Registration Dossier
Technical product description (including packaging and labeling information) Detailed product composition Single ingredients data, including information on additives and any relevant contaminants Manufacturing information (GMP) Product safety assessment (safety report) Product stability data and PAO justification Scientific claim support Post-marketing surveillance of health-related undesirable effects
Application form for license; Product formula(different from EU); Manufacturing process and diagram; Product quality standard; Testing report from a cosmetics testing institution approved by the CFDA and related materials; Product package (sales package & product label); Certified document for production and sales in the manufacturing country (region); Statement on related problems of ‘Mad Cow Disease’; Power of attorney in case of a responsible person; Safety assessment of risk substances; Evidence of use for some product types; Some other documents that may be helpful(GMP).
Comparison with EU regulation: Nano-materials and Animal Testing
Nano-material is not allowed in Children’s products; No other requirements on nano-materials; Animal test on finished cosmetics mandatory;
Assessment of nano-materials by SCCS; Special labeling requirements for nano-materials; Animal test on finished cosmetics is banned;
Seek a balance between EU animal ban and Chinese market? Customized product formula or name for China
Comparison with EU regulation: Labelling Requirements
Comparison with EU regulation: Ingredient Requirements
Pre-market approval required for NCI; Meet safety requirements and restriction conditions in hygienic standard for cosmetics(2007) – being revised;
Regular new cosmetic ingredients do not require official approval prior to use; Meet safety requirements and restriction conditions in COSMETICS REGULATION (EC 1223/2009)
New Cosmetic Ingredient(NCI): A cosmetic ingredient that is not listed on Inventory of Existing Cosmetic Ingredients in China (IECIC)
III. “General Progress of Exporting Cosmetics to China”
Import Cosmetics onto Chinese Market How
General Progress of Exporting Cosmetics to China
CIQ Inspection and Custom Clearance
Identifying Appropriate Distributors
CFDA Registration of Cosmetics in China
Ready to Sell in China Step 4
Step 3
Step 2
Step 1
Step 1: Identifying Appropriate Distributors
A good distributor is the one that should have close collaborations with the following sales channels.
- Department stores − Supermarkets/hypermarkets − Professional stores/Salons − Specialty stores − Internet retailing
Step 2 CFDA Registration of Cosmetics: Definition and
Required License
Type of Product Required CFDA License
Ordinary cosmetics Record-keeping Certificate
hair care, nail care, skin care, perfumes and make-up
Special use cosmetics
Hygiene License hair growth, hair dye, hair perm, depilation, breast shaping, fitness, deodorizing, anti-freckle and sun block
Foreign company needs to appoint a Chinese responsible agent
Right now all imported cosmetics are approved by CFDA in Beijing.
Appointing a Chinese responsible agent
Application of username and password to access CFDA’s online registration system
Gather relevant technical documents and review
formula and label
Sample testing in CFDA accredited lab
Preparing & submitting product dossier
Completeness Check by CFDA( 5 working days)
Technical review by CFDA (1~3 months) CFDA Issue approval license
Supply more information if required by CFDA
Step 2 CFDA Registration of Cosmetics: Procedure
~1 month
~2-7 months depending on product types
Step 2 CFDA Registration of Cosmetics: CFDA Reform
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
* Principle of formula design and analysis report of product formula shall be provided when registering cosmetics for Children, pregnant and breast-feeding women.
Step 2 CFDA Registration of Cosmetics: Dossier Requirements
for Ordinary Use Cosmetics
Step 2 CFDA Registration of Cosmetics: Dossier Requirements
for Special Use Cosmetics
contents
Product name
Net content
Name of the manufacturer
Address of the manufacturer※
Hygiene license number or record-keeping certificate number※
Country of origin※
Name and address of importer / distributor※
Ingredient list
Date of manufacture and shelf life / batch code and expiration date
Warning statements ※
Instructions for use※
Note: for sun-block cosmetics, SPF value or UVA shall also be mentioned
※ For cosmetics with content less than 15g or 15ml, these label contents do not need to be put on the label. However, they shall be mentioned in a leaflet that comes with the cosmetics
Step 2 CFDA Registration of Cosmetics: Labelling
Requirements
①
②
② ①
③
③
④ ④
⑤
⑤
⑥
⑥
⑦
⑦
* 1EUR: 1RMB=8.2. The cost represents typical cost and it includes both testing and consultancy fee. The specific cost depends on product types.
Type of cosmetics Estimated cost (RMB per product*)
Estimated duration (months)
Imported ordinary cosmetics 12,000~18,000 6-8
Imported special use cosmetics 19,000~80,000 9-14
Step 2 CFDA Registration of Cosmetics: Estimated Cost and
Duration
Step 3 CIQ Inspection and Customs Clearance
CIQ mainly check labels CIQ random carry out heavy metal and micro-biological test for first import at ports; Your distributor or third party logistical provider do customs clearance
Step 3 CIQ Inspection and Customs Clearance: Required Documents
Record Keeping of Buyer/Agent
Record Keeping of products
Custom inspection Qualification certificate issue
Record number of company
issue
Record number of products
issue
IV. “Relevant Chinese Organizations & Resources”
Import Cosmetics onto Chinese Market How
http://www.sda.gov.cn/WS01/CL0001/
http://www.aqsiq.gov.cn/
http://wsb.moh.gov.cn/
http://www.zybh.gov.cn
http://www.cirs-group.com/
http://www.caffci.org/
Organizations
Summary
China is a big and very promising cosmetic market; There are many differences between China and EU’s
cosmetic regulations(animal test ban, etc); Pre-market approval of cosmetics in China can be
time-consuming compared to EU; Registration of imported ordinary cosmetics may
become easier due to CFDA reform;
Available Free Resources Upon Request
Ingredient List
Draft version of the 3 batches of IECIC 2012 (Inventory of Existing Cosmetic Ingredients in China) - EN IECIC(2003) - EN
Label
QB/T 1685-2006 GB 5296.3-2008 GB 23350-2009 In Chinese
Quality & Safety
Hygienic Standard for Cosmetics 2007 In Chinese
www.eusmecentre.org.cn [email protected]