Thursday, April 21, 2016

Singapore - Health Products (Cosmetic Products — Asean Cosmetic Directive) Regulations – Part II

PART II
SUPPLY OF COSMETIC PRODUCTS
Duty to notify Authority of supply of cosmetic products
4.
—(1)  Subject to regulation 5, a person responsible for placing a cosmetic product in the market shall not —
(a)
where no prior notification has been submitted for that cosmetic product —
(i)
begin to supply that cosmetic product, or cause that cosmetic product to be supplied on his behalf, in Singapore; or
(ii)
continue to supply that cosmetic product, or cause that cosmetic product to be supplied on his behalf, in Singapore,
unless he has notified the Authority of his intention to do so; or
(b)
where a prior notification has been submitted for that cosmetic product, continue to supply that cosmetic product, or cause that cosmetic product to be supplied on his behalf, in Singapore after the expiry of one year beginning from the most recent notification made under this paragraph in respect of that cosmetic product, unless he has submitted a further notification under this paragraph to the Authority of his intention to continue doing so.
(2)  A notification for the purposes of paragraph (1) shall be submitted to the Authority in such form and manner as the Authority may require and shall be accompanied by —
(a)
such particulars, information, documents and samples of the cosmetic product as the Authority may require;
(b)
if required by the Authority, a statutory declaration by the applicant verifying any information contained in or related to the notification; and
(c)
the appropriate fee specified in the First Schedule.
(3)  Any person who contravenes paragraph (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
(4)  Any person who, in submitting a notification for the purposes of paragraph (1) —
(a)
makes any statement or furnishes any document which he knows to be false or does not believe to be true; or
(b)
by the intentional suppression of any material fact, furnishes information which is misleading,
shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
(5)  This regulation shall not apply to —
(a)
a cosmetic product that is supplied solely as a sample in connection with any advertising, sponsorship or promotional activity;
(b)
a cosmetic product that is supplied solely for testing or trial use in connection with any research or development of that product; or
(c)
a cosmetic product that is manufactured by or in accordance with the specifications of a medical practitioner, and supplied solely by that medical practitioner for the use of patients under his care.
Application of regulation 4 in relation to existing cosmetic products
5.  Regulation 4 —
(a)
shall not apply to an existing cosmetic product in respect of which there is in force immediately before 1st January 2008 a product licence granted under the Medicines Act (Cap. 176), until such time the product licence expires; and
(b)
shall only apply to an existing cosmetic product of a type listed in the Second Schedule with effect from the date specified opposite thereto.
Contents of cosmetic products
6.
—(1)  A new cosmetic product shall not contain any substance that is listed in Part I of the Third Schedule unless the presence of such substance —
(a)
is in trace amount;
(b)
is technically unavoidable in good manufacturing practice; or
(c)
where applicable, is in compliance with the conditions specified in that Part of that Schedule.
(2)  A new cosmetic product shall not contain any substance that is listed in the second column of Part II of the Third Schedule unless —
(a)
the cosmetic product is of a type listed in the third column of that Part of that Schedule;
(b)
the substance as contained in the cosmetic product does not exceed the appropriate limit as specified in the fourth column of that Part of that Schedule; and
(c)
the cosmetic product complies with the other relevant requirements as specified in the fifth column of that Part of that Schedule.
(3)  A new cosmetic product, other than a cosmetic product intended solely to colour hair, shall not contain any colouring agent unless the colouring agent —
(a)
is listed in Part III of the Third Schedule; and
(b)
is contained in the cosmetic product in accordance with the requirements as specified in that Part of that Schedule.
(4)  A new cosmetic product shall not contain any preservative unless —
(a)
the preservative is listed in the second column of Part IV of the Third Schedule;
(b)
the preservative as contained in the cosmetic product does not exceed the appropriate limit as specified in the third column of that Part of that Schedule; and
(c)
the cosmetic product complies with the other relevant requirements as specified in the fourth column of that Part of that Schedule.
(5)  A new cosmetic product shall not contain any ultraviolet filter unless —
(a)
the ultraviolet filter is listed in the second column of Part V of the Third Schedule;
(b)
the ultraviolet filter as contained in the cosmetic product does not exceed the appropriate limit as specified in the third column of that Part of that Schedule; and
(c)
the cosmetic product complies with the other relevant requirements as specified in the fourth column of that Part of that Schedule.
(6)  An existing cosmetic product —
(a)
shall not contain any substance that is listed in Part VI of the Third Schedule;
(b)
shall not contain any substance that is listed in the second column of Part VII of the Third Schedule if the cosmetic product is of a type listed in the third column of that Part of that Schedule; and
(c)
shall not contain any substance that is listed in the second column of Part VIII of the Third Schedule unless —
(i)
the cosmetic product is of a type listed in the third column of that Part of that Schedule;
(ii)
the substance as contained in the cosmetic product does not exceed the appropriate limit as specified in the fourth column of that Part of that Schedule; and
(iii)
the cosmetic product complies with the other relevant requirements as specified in the fifth column of that Part of that Schedule.
(7)  For the purposes of section 2 (2)(d)(iv) of the Act, a cosmetic product that does not comply with paragraph (1)(2)(3)(4)(5) or (6) shall be considered to be an unwholesome cosmetic product.
Labelling of cosmetic products
7.
—(1)  For the purposes of section 18(1) of the Act, no person shall supply any cosmetic product unless the cosmetic product has a label that sets out the following information:
(a)
the name of the cosmetic product;
(b)
the function of the cosmetic product, except when it is clear from the presentation of the cosmetic product;
(c)
the instructions on the use of the cosmetic product, except when it is clear from the name or presentation of the cosmetic product;
(d)
the list of all the ingredients in the cosmetic product, with the exception of the following substances:
(i)
impurities in the raw materials used;
(ii)
subsidiary technical materials used in the preparation of the cosmetic product but not present in the final product; or
(iii)
materials used in the manufacture of the cosmetic product in strictly necessary quantities as solvents, or as carriers for perfume and aromatic compositions;
(e)
the weight or volume of the cosmetic product contained in the immediate container or package, expressed in metric system;
(f)
the batch number given by the person who manufactured the cosmetic product to the batch of which it forms a part;
(g)
the name and address in Singapore of the person responsible for placing the cosmetic product in the market;
(h)
the name of the country where the cosmetic product was manufactured;
(i)
any special precautions to be observed when using the cosmetic product, or special precautionary information in accordance with any requirements specified in Parts II,IV and V of the Third Schedule which are relevant to that cosmetic product;
(j)
the date of expiry of the cosmetic product where the cosmetic product has an expected period of durability of less than 30 months between the date of its manufacture and the date of its expiry; and
(k)
the date on which the cosmetic product was manufactured, except when the expiry date of the cosmetic product has been specified on the label.
(2)  Paragraph (1)(h)(i)(j) and (k) shall not apply to an existing cosmetic product.
(3)  The information specified in paragraph (1) shall appear in the following manner:
(a)
where the cosmetic product has an outer packaging, the information shall appear on the outer packaging of the cosmetic product;
(b)
where the cosmetic product does not have an outer packaging, the information shall appear on the immediate container or package of the cosmetic product; and
(c)
where the size, shape or nature of the container or package does not permit all the information specified in that paragraph to be displayed, the information may appear in a leaflet that accompanies the product or on a display panel placed together with the product, provided at least the information specified in paragraph (1)(a) and (f) shall appear on the immediate container or package.
(4)  The list of ingredients specified in paragraph (1)(d) shall appear in the following manner:
(a)
where an ingredient appears in the latest edition of any of the standard references listed in the Fourth Schedule, that ingredient shall be named according to the nomenclature in that standard reference, except for —
(i)
any perfume or aromatic composition, which may be referred to by the term “perfume”, “fragrance”, “aroma” or any other similar term; and
(ii)
any flavouring, which may be referred to by the term “flavour” or any other similar term; and
(b)
the ingredients shall be listed in descending order by weight, except for —
(i)
ingredients, other than colouring agents, present in concentrations of less than 1% (by weight), which may be listed in any order by weight after those ingredients present in concentrations of 1% or more; and
(ii)
colouring agents, which may be listed in any order after the other ingredients.
(5)  All information on the label of a cosmetic product shall be provided in the English language, but nothing in this paragraph shall prevent such information from being provided in any other language as well.
(6)  All numbers, letters and symbols used in providing the information on the label of a cosmetic product shall be printed in such a manner as to be legible, permanent, indelible and prominent.
(7)  If a symbol or code (whether in the form of a colour or otherwise) is used in providing the information on the label of a cosmetic product, an explanation of the symbol or colour shall be provided.
Misleading labelling
8.  For the purposes of section 18(1) of the Act, no person shall supply any cosmetic product with a label which contains any statement, trademark, picture or other sign —
(a)
to the effect, whether directly or indirectly, that the supply or use of the cosmetic product is being promoted or endorsed by the Authority; or
(b)
that is likely to create an erroneous impression regarding the formulation, composition, quality or safety of the cosmetic product.


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