|
THE
MINISTRY OF PUBLIC HEALTH
-------
|
SOCIALIST
REPUBLIC OF VIET NAM
Independence
- Freedom - Happiness
----------
|
|
No:
35/2006/QD-BYT
|
Hanoi,
November 10, 2006
|
DECISION
PROMULGATING THE REGULATION ON MANAGEMENT OF COSMETICS
THE MINISTER OF HEALTH
Pursuant to December 24, 1999 Ordinance No.
18/1999/PL-UBTVQH10 on Goods Quality;
Pursuant to the Government's Decree No. 179/2004/ND-CP of October 21, 2004,
stipulating the state management of goods quality;
Pursuant to the Government's Decree No. 49/2003/ND-CP of May 15, 2003, defining
the functions, tasks, powers and organizational structure of the Ministry of
Health;
At the proposal of the Director of the Vietnam
Drug Administration,
DECIDES:
Article 1.- To
promulgate together with this Decision the Regulation on management of
cosmetic.
Article 2.- This
Regulation takes effect 15 days after its publication in "CONG BAO"
and repeals the Health Minister's Decision No. 3629/1998/QD-BYT of December 19,
1998, promulgating the list of cosmetics subject to quality registration at the
Ministry of Health, Decision No. 19/2001/QD-QLD of April 27, 2001, of the
director of the Vietnam Drug Administration, promulgating the Provisional
Regulation on registration for distribution of imported cosmetics directly
affecting human health and Official Letter No. 3716/QLD of July 3, 2001, of the
Vietnam Drug Administration, promulgating quality standards of cosmetics.
Article 3.- The director
of the Office, the chief inspector of the Ministry of Health, the director of
the Vietnam Drug Administration, heads of units attached to the Ministry,
directors of provincial/municipal Health Services, and heads of branch-based
health agencies shall implement this Decision.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
MINISTER
OF HEALTH
Tran Thi Trung Chien
REGULATION
ON MANAGEMENT OF COSMETICS
(Promulgated together with the Health Minister's Decision No. 35/2006/QD-BYT
of November 10, 2006, promulgating the Regulation on management of cosmetics)
Chapter I
GENERAL PROVISIONS
Article 1.- Scope of
regulation and subjects of application
This Regulation provides the management of
cosmetics that are manufactured and distributed in the country and cosmetics
that are manufactured abroad and imported for distribution in Vietnam.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Article 2.- Interpretation
of terms
In this Regulation, the terms below are
construed as follows:
1. Cosmetics are substances or preparations
which are used in contact with external parts of the human body or with the
teeth, gums or mucous membranes of the oral cavity for exclusively or mainly
cleaning them, perfuming them, changing their appearance or the body odor and/or
protecting or preserving them in good conditions.
2. Substances which are not regarded as cosmetic
ingredients:
a/ Impurities in raw materials used in the
manufacture of cosmetics.
b/ Raw materials and additives used in the
process of preparation but not present in final products.
c/ Raw materials used in necessary minimal
quantities such as solvents or carriers for aromatic ingredients.
3. Cosmetic stability is the quality stability
capability of a cosmetic which is preserved in given conditions to maintain its
inherent physical, chemical, microbiological characteristics, safety, etc.,
within the prescribed limits.
4. Cosmetic shelf life is the use duration set
for a cosmetics after the expiration of which the cosmetic may not be used.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Cosmetic information and advertisement shall
comply with the Health Ministry's Regulation on information on and
advertisement of drugs and cosmetics currently in force.
Chapter II
REGULATIONS ON
REGISTRATION FOR DISTRIBUTION AND ANNOUNCEMENT OF QUALITY STANDARDS OF
COSMETICS
Article 4.- Requirements
on registration for distribution of cosmetics, announcement of quality
standards
1. Foreign cosmetics imported into Vietnam
for distribution must be registered for distribution under the provisions of
Chapter III of this Regulation. The fee for registration for distribution of
cosmetics shall be paid according to current regulations on charges and fees.
2. For cosmetics manufactured in the country for
distribution, their quality standards must be announced under the provisions of
Chapter III of this Regulation.
3. The list of cosmetic products subject to
announcement of quality standards and registration for distribution is included
in Appendix 1 to this Regulation.
Article 5.- Composition
of cosmetics
Ingredients in cosmetics must comply with the
provisions in the appendices and annexes to the Agreement on ASEAN Harmonized
Cosmetic Regulatory Scheme on the management of cosmetics.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Quality standards of cosmetics must satisfy the
following minimum requirements:
1. Conditions: The form of preparation,
characteristics, form and appearance must be clearly stated.
2. Limits of acids and alkali: are prescribed by
the manufacturer at appropriate levels to ensure safety for users.
3. Allowable limits of lead and arsenic: are
prescribed by the manufacturer at appropriate levels to ensure safety for
users.
4. Limits of bacteria and fungi: must at least meet
the standards prescribed in the Health Minister's Decision No. 3113/1999/QD-BYT
of October 11, 1999, promulgating the standard limits of bacteria and fungi in
cosmetics and methods of skin allergic reaction tests.
5. Degree of skin allergic reaction: is
prescribed by the manufacturer depending on each kind of product and only
permitted at the following levels:
a/ From inconsiderable allergic reaction to no
allergic reaction for products applied to skin for a long time;
b/ From mild allergic reaction to no allergic
reaction (for products applied shortly to skin, such as shampoo and face
lotions).
The method of skin allergic reaction tests shall
comply with the provisions of the Health Minister's Decision No.
3113/1999/QD-BYT of October 11, 1999.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
1. Provisions on cosmetic stability study.
a/ Cosmetics, once manufactured, must be
preserved under the conditions required by manufacturers on the basis of
stability studies.
b/ Stability study documents must describe in
detail:
+ Preservation conditions (temperature,
humidity)
+ Packing.
+ Method of study.
+ Results of standard tests of at least 3
different product lots.
+ Conclusions on product stability.
c/ Results of cosmetic stability studies
conducted with the accelerated testing method shall only be used for predicting
the shelf life of cosmetics. In the process of distribution of cosmetics,
manufacturers must monitor the stability of products under normal conditions.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
a/ The determination of the shelf life of a
cosmetics must be based on the stability study results.
b/ The prescribed shelf life of a cosmetics must
not be longer than its shelf life already determined through study.
Article 8.- Requirements
on cosmetic labels
1. Organizations and individuals manufacturing,
trading or importing cosmetics must label cosmetic goods as provided for by
current law.
2. The contents and presentation of cosmetic
labels must be compatible with the inherent nature of cosmetic products, must
neither mislead consumers as to nor over-advertise the utility of those
products.
3. Labels and industrial designs of cosmetics
must comply with the law on intellectual property.
Article 9.- Changes
subject to new registration:
When cosmetics which have been granted
distribution registration codes have any of the following changes, they must be
registered as new ones:
1. Change of cosmetic name.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
3. Change of ingredients in formula.
4. Change of quality standards and testing
methods.
5. Change of cosmetic utility.
6. Change of manufacturer.
7. Change of place of manufacture.
Article 10.- Changes
subject to submission of additional dossiers:
When cosmetics which have been granted
distribution registration codes have any of the following changes, additional
dossiers must be submitted:
1. Change of shelf life.
2. Change of name and address of registering
unit.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
4. Change of cosmetic label.
Chapter III
PROVISIONS ON DOSSIERS
OF REGISTRATION FOR DISTRIBUTION OF COSMETICS, DOSSIERS OF ANNOUNCEMENT OF
QUALITY STANDARDS OF COSMETICS
Article 11.- Requirements
on language and presentation in dossiers of registration for distribution of
cosmetics, dossiers of announcement of quality standards of cosmetics
1. Language:
a/ Dossiers of announcement of quality standards
of cosmetics of units manufacturing cosmetics in Vietnam
must be written in Vietnamese.
b/ Dossiers of registration for distribution of
foreign cosmetics in Vietnam
must be written in Vietnamese and/or English.
c/ Documents in dossiers of registration for
distribution mentioned in Clauses 2, 3 and 4, Article 12 of this Regulation
must be consularly legalized. The consular legalization shall be effected in
accordance with the Foreign Affairs Ministry's Circular No. 01/1999/TT-NG of
June 3, 1999, stipulating procedures for legalization of papers and documents.
d/ If documents in dossiers of registration for
distribution mentioned in Clauses 2, 3 and 4, Article 12 of this Regulation are
not written in English, in addition to the compliance with the provision of
Point c, Clause 1 of this Article, the Vietnamese translations of these
documents are also required, which must be notarized in accordance with
Vietnamese law.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
2. Presentation:
a/ Names of ingredients in cosmetic formulas
must be original names or international nonproprietary names (INN).
b/ Dossiers must be printed on A4-sized papers
and arranged in the order prescribed in Article 12 of this Regulation. Each
dossier shall be made in three sets, including one original set. Technical documents
on formulas, quality standards, testing methods, technical or clinic data (if
any), label forms and written commitments must be certified by the manufacturer
or owner (with signature and stamp). If cosmetic label forms are glued or
pinned on A4-sized papers in the dossier of registration, an overlapping stamp
must be appended on the label forms.
c/ Each dossier of announcement of quality
standards or registration for distribution shall be required per product.
Cosmetics are regarded as a single product in a
dossier when they share all the following details:
- Cosmetic name.
- Preparation form.
- Ingredients.
- Quality standards.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
- Manufacturer.
- Registering unit.
Cosmetic packages of products sharing the same name
for sale in a single kit (combination products in a single kit) may be
registered under a single dossier. In this case, such a dossier must still
contain technical documents for each component product.
Article 12.- Dossiers
of registration for distribution of foreign cosmetics imported into Vietnam
comprise:
1. An application for distribution of cosmetics
(made according to a set form).
2. Permit for distribution of products in the
host country.
This permit is granted by a competent agency of
the country where products are marketed, which also indicates the country of
manufacture.
3. Operation license of the factory, which
certifies the factory's satisfaction of hygiene, safety and quality
requirements, or the certificate of good manufacturing practice for cosmetics,
which is granted by a competent agency in the country of manufacture.
4. Founding license or certificate of business
registration or investment license of the organization or individual
registering for distribution of cosmetics.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
6. Formula: All ingredients, concentration,
content or ratio of each ingredient must be indicated (according to a set
form).
7. Quality standards and testing methods
(clearly indicating the standard levels and testing protocol).
8. Original testing slip issued by the
manufacturer or testing slip issued by the laboratory accredited in good
laboratory practice.
9. Technical or clinical data to prove special
uses of products (if any).
10. Stability study documents.
11. The manufacturer's or ownerư's commitments
that the product formulas do not contain prohibited substances and they observe
the content limits of restricted substances and that products are manufactured
strictly according to the announced formulas.
12. Label form.
13. Product specimen: 3 packed units.
Article 13.- Dossiers
for re-grant of distribution codes of foreign cosmetics imported into Vietnam
comprise:
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
2. Original distribution permit granted by the
Vietnam Drug Administration.
3. Label forms.
4. Product specimens: 3 smallest packed units.
5. Report on the process of distribution of
products.
Article 14.- Dossiers
of announcement of quality standards of domestically manufactured cosmetics
comprise:
1. Written announcement of quality standards of
cosmetics.
2. Business registration certificate or
investment license of the manufacturer showing the manufacturer's function of
manufacturing cosmetics (a copy notarized or authenticated in Vietnam).
3. Formula: All ingredients, concentration,
content or ratio of each ingredient must be indicated.
4. Quality standards and testing methods.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
6. Stability study documents.
7. The manufacturer's or owner's commitments
that the product formulas do not contain prohibited substances and they observe
the content limits of restricted substances and that products are manufactured
strictly according to the announced formulas.
Chapter IV
PROCEDURES FOR RECEIPT
OF DOSSIERS OF ANNOUNCEMENT OF QUALITY STANDARDS, DOSSIERS OF REGISTRATION FOR
DISTRIBUTION OF COSMETICS
Article 15.- Agency
receiving and processing dossiers of announcement of quality standards of
cosmetics and dossiers of registration for distribution of cosmetics
The Vietnam Drug Administration shall receive
dossiers of announcement of quality standards of cosmetics; and receive and
appraise dossiers of registration for distribution of cosmetics.
Article 16.- Procedures
for receipt and processing of dossiers of announcement of quality standards of
domestically manufactured cosmetics
Within 15 working days after receiving valid
dossiers of announcement of quality standards, if they are proper, the Vietnam
Drug Administration shall issue slips of receipt of written announcements of
quality standards (according to a set form). If a dossier is improper, the
Vietnam Drug Administration shall notify in writing the improper contents to
the applicant for revision and re-announcement.
Article 17.- Procedures
for receipt and processing of dossiers of registration for distribution of
foreign cosmetics imported into Vietnam.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
If dossiers are proper, the Vietnam Drug
Administration shall grant cosmetic distribution permits; when a dossier is
improper, the Vietnam Drug Administration shall notify in writing the improper
contents to the applicant for amendment and supplementation. If the amended and
supplemented dossier is proper, the Vietnam Drug Administration shall grant a
cosmetic distribution permit; if the amended and supplemented dossier remains
improper, the Vietnam Drug Administration shall notify in writing the improper
contents to the applicant for submission of a new dossier and payment of a fee.
2. At the expiration of the period of 60 working
days counting from the date of receipt of the Vietnam Drug Administration's
notice on the contents which need to be amended and supplemented, if the
applicant fails to amend and supplement the dossier, the submitted dossier is
no longer valid.
Chapter V
SUPERVISION AND
INSPECTION OF COSMETIC QUALITY
Article 18.- Legal
grounds for quality supervision
1. Legal provisions on assurance of goods
quality.
2. Written announcements on cosmetic quality
standards and written distribution registrations already received and approved
by the Vietnam Drug Administration.
Article 19.-
Conclusions on cosmetic samples that are quality-tested
1. For cosmetic samples which are taken by state
agencies competent to conduct quality examination and ensure representation for
the whole cosmetic lot, quality conclusions are legally valid for the whole
cosmetic lot.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Article 20.-
State agencies in charge
of examining cosmetic quality
The central drug test institute, the Ho
Chi Minh City drug test institute and drug-cosmetic test
institutes of provinces and centrally run cities are state agencies competent
to conduct quality examination.
The heads of the above cosmetic quality
examination agencies shall take responsibility before law for their cosmetic
quality conclusions.
Article 21.- Recall of
cosmetics
The Vietnam Drug Administration, the Health
Ministry Inspectorate and provincial/municipal Health Services shall supervise
and oversee the recall of cosmetics showing quality violations.
1. The Vietnam
Drug Administration shall issue notices on recall of cosmetics which fail to
satisfy quality standards in the whole country.
2. Provincial/municipal Health Services and
branch-based health agencies shall:
a/ Issue notices on recall of cosmetics within their
management which fail to satisfy quality standards as concluded by local
agencies competent to conduct cosmetic quality examination.
b/ Implement notices of the Vietnam Drug
Administration on recall of cosmetics failing to satisfy quality standards, handle
violations in accordance with law and report thereon to the Vietnam Drug
Administration.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Upon receiving recall notices, cosmetic trading
units shall:
a/ Immediately and thoroughly recall cosmetic lots
that fail to satisfy quality standards.
b/ Send reports on the recall and handling of
cosmetic lots that fail to satisfy quality standards to the Vietnam Drug
Administration and concerned functional agencies.
c/ Remedy consequences caused by cosmetics that
fail to satisfy quality standards.
Article 22.-
State management agencies
in charge of cosmetics performing the function of examining and inspecting
cosmetic quality
1. The Vietnam
Drug Administration shall perform the function of supervising in accordance
with law the observance of regulations on management of cosmetic quality.
2. The Vietnam
Drug Administration and the Health Ministry Inspectorate shall:
a/ Supervise and inspect the observance of the
law on cosmetic quality, propose measures to prevent, handle and stop acts that
violate the law on cosmetic quality.
b/ Consider and settle disputes, complaints and
denunciations related to cosmetic quality.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
3. Provincial/municipal Health Services,
branch-based health agencies and local health inspectorates shall supervise and
inspect cosmetic quality management work and handle acts of violation in their
respective provinces or cities.
Chapter VI
RESPONSIBILITIES OF
ORGANIZATIONS AND INDIVIDUALS MANUFACTURING, TRADING IN, IMPORTING AND
REGISTERING COSMETICS AND RIGHTS OF COSMETIC CONSUMERS
Article 23.-
Responsibilities of organizations and individuals manufacturing, trading in,
importing and registering cosmetics
1. Organizations and individuals manufacturing,
trading in, importing or registering cosmetics may only distribute cosmetics
that satisfy their announced or registered quality standards, remain in their
shelf life, do not infringe upon intellectual property rights, and comply with
regulations on goods labeling.
2. Organizations and individuals manufacturing,
trading in, importing or registering cosmetics shall ensure truthfulness and
accuracy in the information and advertisement on their cosmetic quality.
3. Organizations and individuals manufacturing,
trading in, importing or registering cosmetics shall monitor, discover and
promptly recall cosmetics that fail to satisfy quality standards; immediately
settle customers' claims about cosmetic quality; and pay compensations in
accordance with law for damage caused to customers.
4. Upon receiving conclusions of the National
Office of Intellectual Property under the Ministry of Science and Technology on
marks or industrial designs that infringe upon intellectual property rights,
organizations or individuals shall cease manufacture, trading or import so as
to change those marks or industrial designs according to regulations, pay
indemnities and remedy consequences (if any).
5. Cosmetic trading organizations and
individuals shall comply with the requests of competent state agencies that
conduct cosmetic quality examination and inspection and may lodge complaints
about the latter's conclusions and forms of handling of violations in
accordance with the law on complaints and denunciations.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Article 24.- Rights of
cosmetic consumers
Consumers are entitled to information on
cosmetic quality, to lodge complaints and denunciations, and to request
cosmetic trading units to pay compensation in accordance with law for damage
caused by manufactured or distributed inferior quality cosmetics.
Chapter VII
HANDLING OF VIOLATIONS
Article 25.- Stoppage
of distribution of cosmetics
Cosmetics shall be stopped from distribution
when one of the following circumstances occurs:
1. Distributed cosmetics fail to meet quality
standards stated in their registration or announcement dossiers.
2. Distributed cosmetics have a formula
different from that stated in their registration or announcement dossiers.
3. Distributed cosmetics have labels
inconsistent with the provisions of Article 8 of this Regulation.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Organizations and individuals violating
regulations on cosmetics shall, depending on the nature and severity of their
violations, be administratively sanctioned or examined for penal liability; if
causing any damage, they shall pay compensation therefor in accordance with
law.
Chapter VIII
IMPLEMENTATION PROVISIONS
Article 27.- The
Vietnam Drug Administration, the Health Ministry Inspectorate,
provincial/municipal Health Services and branch-based health agencies shall
guide and organize the supervision and inspection of the implementation of this
Regulation.
APPENDIX 1
LIST OF COSMETIC PRODUCTS SUBJECT TO QUALITY
REGISTRATION AT THE MINISTRY OF HEALTH
(Promulgated together with the Health Minister’s Decision No. 35/2006/QD-BYT
of November 10, 2006, promulgating the Regulation on management of cosmetics)
1. Creams, emulsions, lotions,
gels and oils for the skin (hands, face, feet).
2. Facial masks (with the
exception of chemical peeling products).
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
4. Make-up powders, after-bath
powders, hygienic powders.
5. Toilet soaps, deodorant
soaps.
6. Perfumes, toilet waters and
eau de Cologne.
7. Bath
and shower preparations (salts, foams, oils. gels).
8. Depilatories.
9. Deodorants and
anti-perspirants.
10. Hair care products.
- Hair tints and bleaches.
- Products for waving, straightening
and fixing,
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
- Cleansing products (lotions,
powders, shampoos),
- Conditioning products
(lotions, creams, oils),
- Hairdressing products
(lotions, lacquers, brilliantines).
11. Shaving products (creams,
foams, lotions).
12. Products for making-up and
removing make-up from the face and the eyes.
13. Products intended for
application to the lips.
14. Products for care of the
teeth and the mouth.
15. Products for nail care and
make-up.
16. Products for external
intimate hygiene.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
18. Products for tanning without
sun.
19. Skin-whitening products.
20. Anti-wrinkle products.