relative file path for layout
Skip to main content  Skip to search  Skip to main menu
Trade and Industry Department The Government of the Hong Kong Special Administrative Region
Brand Hong Kong - Asia world city
MY COLOUR

Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 230/2/12

27 January 2010

Dear Sirs,

Commercial Information Circular No. 46/2010

European Union (EU)* : Regulation on Cosmetic Products

The European Parliament and the Council of European Union have adopted a Regulation on cosmetic products. Details are set out in Regulation (EC) No. 1223/2009 of the European Parliament and of the Council (the Regulation), which can be accessed through the following link : http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:EN:PDF

DETAILS

  1. To ensure a high level protection of human health, the Regulation has established rules to be complied with for cosmetic products, which is defined as any substance or mixture intended to be placed in contact with the external parts of human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view to clean them, perfume them, change their appearance, protect them, keep them in good condition, or correct body odours.

  1. Under the Regulation, only cosmetic products of a designated "responsible person" (manufacturer, importer or distributor) can be placed on the market, and the responsible person shall ensure the cosmetic products complies with the relevant obligations of the Regulation. Particular obligations of the responsible person include :

  1. ensuring that the cosmetic products is safe for human health when used under normal and reasonably foreseeable conditions, taking into account of :-

    - presentation, including conformity with Directive 87/357/EEC (concerning general product safety);
    - labelling;
    - instructions for use and disposal; and
    - indication or information provided.

  1. upon request, responsible person shall identify the distributor(s) or other responsible person(s) whom supplied them with the product, and to whom they have supplied the product. This information shall be available for a period of 3 years after the batch of the cosmetic product was made available to the distributor;

  1. the manufacture of cosmetic products shall comply with good manufacturing practice to ensure compliance;

  1. prior to placing a cosmetic product on the market, carry out a safety assessment based on the relevant information and set up a cosmetic safety report. Details of the report are set out in Annex I of the Regulation;

  1. when a cosmetic product is placed on the market, the responsible person shall keep a product information file for a period of 10 years after the last batch of the cosmetic product was placed on the market. The product information file should be readily accessible and contain the following information :-

    - a description of the cosmetic product which enables the product information file to be attributed to the relevant product;
    - the cosmetic product safety report;
    - a description of the method of manufacturing and a statement on compliance with good manufacturing practice;
    - proof of the effect claimed for the cosmetic product, where justified by the nature or the effect of the product;
    - data on any animal testing performed relating to the development or safety assessment of the product or its ingredients;

  1. sampling and analysis of cosmetic products shall be performed in a reliable and reproducible manner, preferably using the relevant harmonised standards;

  1. prior to placing a cosmetic product on the market, responsible person has to submit information to the Commission by electronic means regarding the product. When there is any change in the information, the responsible person shall also provide an update without delay;

  1. cosmetic products shall not contain prohibited substances listed in Annex II of the Regulation. Certain substances are also subject to restrictions set out in Annex III. Colorants, preservatives, and UV-filters other than those listed in Annexes IV, V, and VI respectively (with conditions of use) are also prohibited;

  1. substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) shall be prohibited to use in cosmetic products, except under certain strict conditions;

  1. for the use of nanomaterials in cosmetic products, responsible persons have to notify the Commission by electronic means 6 months prior to placing the cosmetic product in the market. For cosmetic products placed on the market before 11 January 2013, they should notify to the Commission during the period 11 January 2013 - 11 July 2013;

  1. animal testing of the cosmetic products shall be prohibited, except under certain conditions, such as there are no alternatives yet under consideration;

  1. the container and packaging of the cosmetic products placed in the market should bear relevant product information in indelible, easily legible and visible lettering. Such information includes the name and address of the responsible person, country of origin, nominal content of the product in weight or volume, date of minimum durability, precautions to be observed, batch number or any reference for identify the cosmetic product, function and ingredients of the product, etc. The labelling of the product also shall not mislead consumers; and

  1. in case of serious undesirable effects, responsible persons shall immediately notify the competent authority on all serious undesirable effects known, the product concerned and the corrective measures taken, if any.

  1. In case of any non-compliance, the responsible person will be required to take all appropriate measures, which include corrective actions bringing the cosmetic product into conformity, withdrawal of the product from the market, or recall within a time limit, commensurate with the nature of the risk.

  1. To allow sufficient time for manufacturers and traders to adapt to the requirements of the Regulation, except for certain provisions, the Regulation shall apply from 11 July 2013.

ENQUIRIES

  1. For enquiries concerning the content of this circular, please contact the undersigned at telephone number 2398 5556.

Yours faithfully,

 

(Miss Peggy LEUNG)
for Director-General of Trade and Industry

* The EU includes Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.




Note ：

  • (1) While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.
  • (2)The biweekly newsletter "Business Alert - EU" of the Hong Kong Trade Development Council provides up-to-date information on the latest developments in EU trade policy and trade regulations. The newsletter is available for free e-subscription and can be accessed through
    http://www.tdctrade.com/alert/eualert.htm.