REGULATIONS CONCERNING THE HYGIENE SUPERVISION OVER COSMETICS
REGULATIONS CONCERNING THE HYGIENE SUPERVISION OVER COSMETICS
Important Notice:
This English document is coming from the "LAWS AND REGULATIONS OF THE
PEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)
which is compiled by the Brueau of Legislative Affairs of the State
Council of the People's Republic of China, and is published by the China
Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.
Whole Document
REGULATIONS CONCERNING THE HYGIENE SUPERVISION OVER COSMETICS
(Approved by the State Council on September 26, 1989, and issued
by Decree No. 3 of the Ministry of Public Health on November 13, 1989)
Chapter I General Provisions
Article 1
These Regulations are formulated to strengthen hygiene supervision over
cosmetics so as to ensure hygiene quality and safety use of cosmetics and
to safeguard the consumers' health.
Article 2
The term "Cosmetics" referred to in these Regulations means those daily
used chemical products applied on the surface of any part of the human
body (such as skin, hair, nails and lips) by way of smearing, spraying or
other similar methods to keep the body clean, to get rid of undesirable
smell, to protect the skin, to make up the face and to increase the beauty
of the appearance.
Article 3
The State shall enforce hygiene supervision over cosmetics. The health
administrative department under the State Council is in charge of the
nationwide hygiene supervisory work on cosmetics while the health
administration departments at or above county government level are in
charge of the hygiene supervisory work on cosmetics within their
respective jurisdiction.
Article 4
All units or persons who are engaged in the production and business of
cosmetics must abide by these Regulations.
Chapter II Hygiene Supervision over the Production of Cosmetics
Article 5
The State shall exercise hygiene supervision over the enterprises engaged
in the production of cosmetics by means of Hygiene License system. Hygiene
License for the Production Enterprise of Cosmetics shall be approved and
issued by the hygiene administration department at the provincial,
autonomous regional or municipal (directly under the Central Government)
level.
The term of validity of a Hygiene License for the Production Enterprise of
Cosmetics is four years and it must be verified after two years.
No enterprise shall be allowed to engage in the production of cosmetics
without a Hygiene License.
Article 6
A production enterprise of cosmetics must meet the following hygiene
requirements:
(1) it must be built in a clean area and away from areas contaminated with
poisonous or other harmful matters at a certain distance as required by
the relevant hygiene regulations;
(2) the production building must be strong and clean. The ceiling, walls
and floors inside the workshop must be built with smooth and glazed
material. The workshop must be well-lit and have necessary facilities and
equipment to kill rats and insects and to prevent them from causing harm
to the products and from multiplying;
(3) it must have adequate depository for materials and finished products
and workshops of appropriate capacity for processing and packing purposes;
(4) the workshops must be equipped with the necessary facilities to meet
the specific requirements of the products, and the technological process
must meet the hygiene standard;
(5) it must have testing instruments and qualified technical personnel to
carry out microbiological test on its cosmetic products.
Article 7
The staff and workers directly involved in the production of cosmetics are
required to have a physical check-up every year. Only those who hold a
health certificate shall be allowed to engage in the production.
Any worker who suffers from ringworm of fingers, ringworm of finger-nails,
hand eczema, hand scale, effusive dermatosis, dysentery, typhoid, virus
hepatitis, and active tuberculosis shall not allowed to be directly
engaged in the production of cosmetics.
Article 8
The materials and additives needed in the making of cosmetics and the
immediate containers and packing materials of cosmetics must meet the
State hygiene standards.
Article 9
Before a new kind of material is used to make cosmetics, an application
must be made to the health administrative department under the State
Council for approval. "New kind of material" refers to natural or
synthetic materials that are used to make cosmetics for the first time in
China.
Article 10
The production of special cosmetics must be approved by the health
administrative department under the State Council. Only after an approval
document is obtained from this department can the factory start the
production.
"Special Cosmetics" refer to those substance used for hair nourishment,
hair-dye, hair perm, hair removing, breast massage, deodorant, fading
cream and antisunburn lotion.
Article 11
Before putting its cosmetic products onto the market, the producer is
required to conduct hygiene quality examination in accordance with the
Hygiene Standard for Cosmetics formulated by the State and mark the
qualified products. The products that are not examined or are not up to
the required hygiene standard are not allowed to be shipped out of the
factory.
Article 12
On the label of a cosmetic product, the name of the product, the name of
the producer and the serial number of the hygiene license for the
production enterprise must be clearly stated; on the smaller package or
the specification sheet, the date of production and expiry must be stated.
In the case of special cosmetic products, the approval document number
must also be printed. In the case of cosmetics that may cause undesirable
reactions, warnings and instructions on the use of the product must be
stated in the specification sheet. No indications, curative effect and
medical terms are allowed to be written on the label, on the inner packing
or on the specification sheet of cosmetic products.
Chapter III Hygiene Supervision over Cosmetics Sales
Article 13
No unit or person in the cosmetics business shall be allowed to sell
cosmetics of the following kinds:
(1) the cosmetics produced by an enterprise without a Hygiene License for
the Production Enterprise of Cosmetics;
(2) the cosmetics without a quality tag;
(3) the cosmetics of which the label, the smaller package or the
specification sheet does not conform to the rules stipulated in Article 12
of these Regulations;
(4) the special cosmetics without an approval document;
(5) the cosmetics that has expired.
Article 14
The following content shall not be allowed to be included in cosmetic
advertising:
(1) exaggerating the effectiveness of the cosmetic product through its
chosen name and the description of its production method, its properties
and efficacy;
(2) giving a guarantee in the name of other people or giving a hint to
lure consumers into misunderstanding the efficacy of the product;
(3) advertising the medical efficacy of the cosmetic product.
Article 15
When a cosmetic product is imported for the first time, the importing unit
is required to submit to the health administrative department under the
State Council the relevant information such as the specifications, the
quality standard, and the method of testing, and a sample of that
cosmetics together with a production license issued by the official
department of the exporting country (or region). Only after an approval by
the health administrative department under the State Council is obtained
can the importing unit sign the import contract.
Article 16
All imported cosmetics are subject to inspection by the State Bureau of
Import and Export Commodities Inspection. Only those qualified cosmetics
are allowed to be imported. Cosmetics imported in small quantity for
personal use shall follow the import formalities in accordance with
Customs regulations.
Chapter IV The Organ for Hygiene Supervision over Cosmetics and Its Duties
Article 17
The health administration departments at all government levels shall
exercise hygiene supervision over cosmetics. They shall entrust an
inspection organ to carry out the specific hygiene supervisory work within
their jurisdiction.
Article 18
The health administrative department under the State Council shall invite
research specialists and experts from medical units, production
enterprises and health administration organs to form an appraisal group
for the safety of cosmetics. They shall make appraisal of the safety of
imported cosmetics, special cosmetics and the new ingredients of
cosmetics. Besides, they make technical investigation in the hazardous
results of cosmetics of poor quality.
Article 19
The health administration departments at all levels shall appoint cosmetic
hygiene supervisors to exercise hygiene supervision over cosmetics.
Cosmetics hygiene supervisors shall be selected by the health
administrative department under the State Council, at the provincial,
autonomous regional or municipal (directly under the Central Government)
level from among qualified hygiene personnel and shall be issued with
badges and identity cards.
Article 20
When carrying out their duties, the cosmetic hygiene supervisors are
required to wear their badges and show their identity cards. They must
keep confidential the technical data presented by the production
enterprises.
Article 21
Cosmetic hygiene supervisors are vested with the right to conduct sample
testing of the cosmetics of any production or business unit. They may ask
for information of cosmetic safety that is related to their hygiene
supervisory work. No unit shall refuse to provide or withhold the facts,
or to present false material.
Article 22
The health administration departments, the cosmetic hygiene supervisors or
the hygiene supervision and inspection organs at all levels are not
allowed to have a hand in the production, sale or supervision of the
making of cosmetics in the form of technical consultancy, technical
service and under any other pretences.
Article 23
If any medical treatment unit finds out any cases who suffer from
undesirable effect after using a certain cosmetics, it is required to make
a report to the local health administration department.
Chapter V Penalty Provisions
Article 24
If any production enterprise without a Hygiene License for the Production
Enterprise of Cosmetics is found to have made cosmetics without
authorization, it shall be ordered to stop production and its products and
illegal earnings shall be confiscated and a fine 3 to 5 times the illegal
profits shall be imposed on it.
Article 25
If any production enterprise without holding an approval document is found
to have produced special cosmetics or have used prohibited materials or
any new ingredients that had not been previously approved, its products
and illegal earnings shall be confiscated and a fine 3 to 5 times their
illegal profits shall be imposed on it. It may be ordered to stop
production or to have its Hygiene License for the Production Enterprise of
Cosmetics revoked.
Article 26
Those who import or sell imported cosmetics that have not been approved or
examined shall be punished by having their goods and illegal earnings
confiscated and by a fine 3 to 5 times their illegal profits.
As for those enterprises holding an approval document for the production
of special cosmetics, if they violate these provisions and the case is
serious enough, their approval document shall be revoked.
Article 27
Those who produce or sell any cosmetics that are not up to the State
Hygiene Standard for Cosmetics shall be punished by having their products
and illegal earnings confiscated and by a fine 3 to 5 times their illegal
profits.
Article 28
If any production enterprise or business enterprise violates other rules
of these Regulations, they shall be given a warning and be ordered to
correct their wrong doings within a prescribed period of time; if the case
is serious enough, in the case of a production enterprise, it shall be
ordered to stop production or to have its Hygiene License for the
Production Enterprise of Cosmetics revoked; and, in the case of a business
enterprise, it shall be ordered to stop business, have its illegal
earnings confiscated and be punished by a fine 2 to 3 times their illegal
profits.
Article 29
Disciplinary sanctions for violation of these Regulations shall be decided
by the health administration departments at or above the county level.
Disciplinary sanctions for violation of Article 14 of these Regulations
shall be decided by the administration department for industry and
commerce.
The punishment by revocation of the Hygiene License for the Production
Enterprise of Cosmetics shall be decided by the health administration
department at the provincial, autonomous regional or municipal (directly
under the Central Government) level. The punishment by revocation of the
approval document for the production of special cosmetics shall be decided
by the health administrative department under the State Council. The fine
and confiscation shall all be turned over to the State treasury and the
products confiscated shall be disposed under the supervision of the health
administration department.
Article 30
If the party concerned does not accept the disciplinary sanction imposed
by the health administration department, it may appeal to the health
administration department at a higher level for a review of the case
within 15 days after receiving the notification of the sanction. The
higher health administration department is required to give a reply within
30 days. If it is still not satisfied with the decision made by the health
administration at the higher level, it may bring a suit to the people's
court within 15 days after receiving the notification of the
reconsideration, but it must carry out at once the order of the health
administration department about confiscation of their products and
suspension of production. If, upon the expiration of this period, the
party has neither applied for reconsideration nor complied with the
sanction, the health administration department may request the people's
court to take enforcement at law.
Article 31
In the case that the consumer is harmed physically or poisoned as a result
of violation of these Regulations, the production enterprise, the business
enterprise or the persons who are directly responsible for the
consequences must compensate for the loss. If the case has produced
serious consequences, the party responsible shall be prosecuted for
criminal responsibility by the judicial organs in accordance with the law.
Article 32
Any cosmetic hygiene supervisor who abuses his power or engages in
malpractices for personal gains or discloses the technical data provided
by the enterprise shall be subject to disciplinary sanctions; and if the
case is serious enough to constitute a crime, he shall be prosecuted for
criminal responsibility according to law.
Chapter VI Supplementary Provisions
Article 33
Hygiene supervision work over the cosmetics produced and put to sale on
the market by any units in the People's Liberation Army shall be conducted
in accordance with these Regulations.
Article 34
The right to interpret these Regulations resides in the health
administration department under the State Council and the rules for the
implementation of these Regulations shall be formulated by the health
administration department under the State Council.
Article 35
These Regulations shall come into force as of January 1, 1990.
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