View - Kobo Products Inc.

Transcription

www.koboproducts.com
k b
d
k b
d
SFDA was established in 1998
> a regulatory agency directly under the State Council,
> supervises food, health care products, cosmetics safety management
and competent drug.
drug
> responsible
ibl ffor th
the administrative
d i i t ti and
d ttechnical
h i l supervision
i i off th
the
research, production, circulation and the use of pharmaceutical
p
product;
> responsible for the supervision and coordination,
coordination and organizations of
food health care products,
food,
products cosmetics safety management and for
investigation of the major accidents in accordance with the law
> responsible for the approval of the health care products
k b
d
General office
Deputy
Commissioners
Dept of Policy & Regulation
Wu Zhen
Dept of Health Food & Cosmetics
ใ 䳏
Commissioner
Mr. Li Yin
ዣജ
Bian Zhenjia
Bi
Zh ji
㤈஡‫ظ‬
Dept off Food
d SSafety
f
Supervision
S
Sun Xianzhe
䪘ভ䳊
Dept of Medical Device Supervision
Jiao Jong
g
Dept
p of Drug
g Registration
g
G
General
l office
ffi
Division 1
Health Food
Division 2
Cosmetics
Division off
manufacturing and
Distribution
Supervision
ὶ 任
Dept of Drug Safety & Inspection
Chief of
Discipline
p
Inspection
Group
Yu Xiancheng
g
੓凙‫ګ‬
Bureau of Investigation &
E f
Enforcement
t
Dept of personnel
Dept
p of International Cooperation
p
Four other administrative Dept
k b
d
• 9/26/1989
– issued Cosmetics Hygiene
yg
Supervision
p
Ordinance
• 3/27/1991
– issued Cosmetics Hygiene Supervision Ordinance
Implementation Rules
• 5/20/2005
– issues amended rules
• 1999,
1999 2002
2002, 2007
– issued Hygienic Standard for Cosmetics
• 2008
– passed tthe
e aut
authority
o ty to SSFDA
k b
d
Promulgated
by:
P
lg t d b
Date of enactment:
Implementation date:
Document No.:
No :
Chapter
h
Chapter
Chapter
p
Chapter
Chapter
Chapter
I
II
III
VI
V
VI
Ministry
Health
Mi i t off H
lth
November 13, 1989
January 1, 1990
Ministry of Health Order No.
No 3
Overview
Supervision of cosmetics production hygiene
Hygiene
yg
supervision
p
of cosmetics business
Cosmetic hygiene supervision agencies and their responsibilities
Penalty
Supplementary
Cosmetics Hygiene Supervision Regulations Implementing Rules
Documentt N
D
No.:
Implementation
p
date:
Ministry
Mi
i t off H
Health
lth O
Order
d N
No. 13
March 27,, 1991
k b
d
Production of cosmetics, new cosmetic raw materials must be approved
by the State Council administrative department of health.
health
New cosmetic raw materials is the natural or synthetic
y
materials used in
the manufacture of cosmetics for the first time in China .
k b
d
--- Regulations Concerning Hygiene Supervision over Cosmetics
Chapter V
Penalty
1.
Having
g their g
good and illegal
g earnings
g confiscated
2
2.
A fine 3 to 5 times their illegal profits
3.
Giving a warning or even publicizing the violation through media
MOH – cosmetic business is a new area in 1990s.
1990s
FDA - local
l
l SFDA offices
ffi
were asked
k d to
t supervise
i since
i
2004,
2004
but had no executive p
power until recent yyears
k b
d
• Issued by:
• Date of enactment:
Ministry of Health
Januaryy 2007
General Principle
Methods of Toxicological Test
Methods of Hygienic Chemical Test
Methods of Microbiological Test
Methods of Safetyy and Efficacyy Evaluation in Human
k b
d
• 4/27/2003 Minster of Heath issued a “List of In-use Cosmetic
Ingredient” based on all approved formulas in China by 2000.
Ingredient
* This has become the onlyy official
list off approved
ingredients
up
ff
pp
g
p to
now.
The list contains:
General ingredients
g
- 2156
Generally
G
ll restricted
i d iingredients
di
Preservatives -152
152
Sunscreen actives -24
Colorants -151
151
Natural ingredients - 563
k b
d
• Table 2 (1) - prohibited synthetic ingredients -1028
1028
• Table 2 (2) - prohibited natural ingredient -78
78 and their extract
T bl 3 - Restricted
R t i t d cosmetic
ti iingredients
di t 73 ( lik
Ti l
• Table
like Triclosan,
ZPT)
• Table
T bl 4 - Restricted
R
i d preservatives
i
iin cosmetic
i iingredients
di
-56
56
• Table 5 - Restricted sunscreen actives -28
• Table 6 - Restricted colorants -156
• Table 7 - temporarily allowed hair dyes -93
93
k b
d
࿖呄֏㣜঴଺ற䰬଱խ֮‫ټ‬㲯‫ؾ‬㨯
stt
㧔
nd
㧔
㧕
k b
d
k b
d
•
1st Set SFDA Health Food/Cosmetic Doc [2012] No.198
No 198
P bli h d 12/6/11 and
d revised
i d on 4/27/12
> Published
> 1210 ingredients
g
• 2nd Set – SFDA Health Food/Cosmetic Doc [[2012]] No.298
> Published 6/28/12
di
> 637 iingredients
• 3rd Set – SFDA Health Food/Cosmetic Doc [2012] No.298
No 298
> Published 6/28/12
> 1356 ingredients
For ingredients with use level limits, the limits are set the
same as in Hygienic Standard for Cosmetics issued in 2007
k b
d
k b
d
ൻ㣜঴ᄅ଺ற‫ع‬㦅ᩓ䪢兖ਐত
-SFDA
SFDA Health Food/Cosmetic Doc [2011] No.207
No 207
Issued: 5/12/11
Effective: 7/1/11
-- defined as a natural or artificial ingredient used in the
f t
ti in
i Chi
manufacture
off cosmetics
China ffor th
the fi
firstt ti
time.
k b
d
* With the
th d
development
l
t off scientific
i tifi research,
h SFDA may re-exam
ap
previouslyy approved
pp
ingredient
g
k b
d
k b
d
Name,, source,, relative molecular mass,, molecular formula,,
chemical structure, physical and chemical properties
background process and related technological info
Research background,
General
the application
G
l iinfo
f about
b t th
li ti iin fforeign
i countries
ti
Intended application,
pp
, application
pp
scope,
p , use limits and restriction
- Specification, test method and supporting documents
k b
d

the copy
py of authorization letter to a business unit in China

a copy off b
business
license off th
the party
China responsible
i
li
t iin Chi
ibl ffor
registration with the official seal.
seal
7.
k b
d
1.
2
2.
3.
4.
The acute oral and acute dermal toxicity
Skin and acute eye irritation / corrosion
Skin allergy
Skin phototoxicity and light sensitivity (for those having UV
absorption)
5
5.
M t
Mutagenicity
i it (at
( t least
l t one gene mutation
t ti test
t t and
d a chromosomal
h
l
aberration test)
6. Subchronic oral and dermal toxicity
7
7.
Teratogenicity
8. Chronic toxicity / carcinogenicity binding assays
9. Toxicokinetics and dynamic tests
10. Other test may be required according to the characteristics and uses
10
th raw material.
t i l If th
t i lh
i il
off the
the new raw material
has th
the similar
chemical
h
l structure and
d characteristics
h
as an approved
d ingredient,
d
some tests can be waived.
k b
d
݇Ѣᕕ∖ǉ
ǉ࣪ཚક⫼࣪ᄺॳ᭭ԧ໪7Ё
Ёᗻ㑶ᨘপ‫↦ܝ‬ᗻ䆩偠ᮍ⊩
˄ᕕ∖ᛣ㾕〓˅
˅Ǌᛣ㾕ⱘߑ
k b
d
k b
d
k b
d
݇Ѣॄথǉ
ǉ೑ᆊ亳ક㥃કⲥⴷㅵ⧚ሔֱ‫ع‬亳ક࣪ཚકᣛᅮᅲ偠ᅸㅵ⧚ࡲ⊩Ǌ
Ǌⱘ䗮ⶹ
-SFDA Health Food/Cosmetic Doc [2012] No.149;
No 149; Issued: 6/11/12
Designated Laboratory of 㨄㨄,
㨄 State Food and Drug Administration
k b
d
‫࣪ޝ‬ཚકᅵ䆘ϧᆊㅵ⧚ࡲ⊩‫ޞ‬
‫ޞ‬
-SFDA
SFDA Health Food/Cosmetic Doc [2010] No.301; Issued: 7/29/10
Experts
E
t iin th
the fi
field
ld off cosmetic
ti raw materials,
t i l fformulations
l ti
,h
health,
lth
microbiology,
gy, toxicology,
gy, skin science and oversight
g management
g
12 + members)
b )
- new application
- renewal of approval
- application
li ti ffor a review
i
3 + members)
b )
- supplementary information
- changes to the approved product
k b
d
Product
registration
g
Labeling Record
New
ingredient
registration
Time (appox.)
4 – 11 M
1 – 1.5 M
12 – 18 M
Sample
p q
quantity(pcs)
y(p )
14 – 56
6–8
1 or more
48 M
Life time
Lif
ti
off
record
I fi it
Infinite
SFDA
IInspection
ti and
d
Q
Quarantine
i
Bureau
Validity
A
Agency
SFDA
-- Chemical Inspection and Regulation Service Limited
k b
d
k b
d
12/30/09
Cosmetic Ingredient (except natural ingredients)
- domestically
d
ti ll made
d or iimported
t d iis regulated
l t d
Finished cosmetic products,
products
– Exempted as they are regulated by MOH (SFDA)
k b
d
k b
d
ਃ ㄆၮචੑ≇ᔧ 䰦឴Ꭸ⢪
SFDA
EPA
Inventory
Listing
2003 List of In-use Ingredients
Y
2004 CTFA Dictionary
Y
2010 List of In-use Ingredients (Draft)
Y
2009 Inventoryy of Existing
g Chemical
Substances
N
k b
d
Revlon (㔺
㔺䦀䳚) Super Lustrous Lipstick ᚑಽ | CosDNA
> ൻ㣜঴...
ൻ㣜঴ Trioctyldodecyl
T i t ld d
l citrate
it t ਃਙㄆၮචੑ≇ᔧ䰦឴Ꭸ⢪,
ਃਙㄆၮචੑ≇ᔧ䰦឴Ꭸ⢪ ... ᨵ㚂咆㧧ԫ‫ګ‬ٝ਷兴
㧧 ‫ګ‬ٝ਷兴 ో
ᚑઝಽᨆ ൻ㣜঴ჼ䪯 ේᢱᚑಽ䢸䦁兌䨫 CosDNA䳦䥒
C DNA䳦䥒 Ozokerite...
O k it
www.cosdna.com/chs/cosmetic_492e759...
d
/ h /
ti 492 759 2012-11-15
2012 11 15 - ⊖ᐲᔟᾖ
LelanVital᳓
᳓Ẏ⋇
᳓
Ẏ⋇䳦
䳦୏ፏ儻൞ऱ㡧୏ծ䳦䪅ኊࢤტ冃Գ ਄
਄ᶏൻ
ᶏൻ㣜
㣜঴ ...
⠽ક㉏ൟ:࣪ཚક ѻકᷛㅒ:࣪ཚક ⠽કᔶᗕ:Ѡ᠟ ⠽ક᠔ሲ:ϾҎ ...
ϝϾ䕯෎कѠ⛋䝛ᶴ₀䝌䝃ǃ䕯෎-ᇍ-⬆⇻෎㙝Ḗ䝌䝃ǃ᳜Ḗ䝌ϝ䝌⫬⊍䝃ǃ...
Ͼ䕯෎कѠ⛋䝛ᶴ₀䝌䝃䕯෎ ᇍ ⬆⇻෎㙝Ḗ䝌䝃 ᳜Ḗ䝌ϝ䝌⫬⊍䝃
shanghai jinti com/huazhuangpin/4201 2012-11-7
shanghai.jinti.com/huazhuangpin/4201...
2012 11 7 - ⊖ᐲᔟᾖ
EsteeLauder/㓷
㓷兩䤣ឝ 㵕ࢤ仟㨕੒咭ਫ㪕ඡញ
࣪ཚક ᳡㺙䵟ᄤ ࣙࣙ 䜡佄 ᆊሙ ݈䍷⽣߽∛ ક⠠ ϧᆊᙼ೼䖭䞠䙺ક∛ ϝϾ䕯෎कѠ⛋䝛ᶴ₀䝌䝃
Ͼ䕯෎कѠ⛋䝛ᶴ₀䝌䝃㙠䝌
㙠䝌㓈Ҫੑ&⻋䝌⇼Ⲥ䞢⫳໻䈚݁㚰㚑ಯ
㓈Ҫੑ&⻋䝌⇼Ⲥ 䞢⫳໻䈚 ݁㚰㚑 ಯѠ
Ѡ
pin.abang.com/product/mianshuang/lau...
p
g
p
g
2012-11-4 - ⊖ᐲᔟᾖ
k b
d
k b
d
k b
d