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REGULATIONS CONCERNING THE HYGIENE SUPERVISION OVER COSMETICS

Category  PUBLIC HEALTH AND MEDICINE Organ of Promulgation  The State Council Status of Effect  In Force
Date of Promulgation  1989-11-13 Effective Date  1990-01-01  

Regulations Concerning the Hygiene Supervision Over Cosmetics



Chapter I  General Provisions
Chapter II  Hygiene Supervision over the Production of Cosmetics
Chapter III  Hygiene Supervision over Cosmetics Sales
Chapter IV  The Organ for Hygiene Supervision over Cosmetics and Its
Chapter V  Penalty Provisions
Chapter VI  Supplementary Provisions

(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 appearence.

    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 govermnent 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 Govemment) 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 departrnent 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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