LCQ16: Regulation of cosmetics, skin care products and slimming health food
Quite a number of members of the public have complained to me about the inadequate regulation of the sale of various types of cosmetics, skin care products and slimming health food by the Government at present, which has, from time to time, led to cases of the health of members of the public being affected as a result of using or taking these products. In this connection, will the Government inform this Council:
(1) of the number of complaints received by the Department of Health and the relevant institutions in the past three years about members of the public suffering from skin allergies or feeling unwell allegedly caused by using or taking the aforesaid products, together with a breakdown by the contents of the complaints and type of the products involved;
(2) whether it will review the existing mechanism and entrust a single government department to be responsible for the prosecutions, inspections, sampling tests and handling of complaints concerning the aforesaid products, so as to avoid confusion that may be caused by the lack of coordination among several departments; if so, of the details; if not, the reasons for that;
(3) of the measures in place to ensure that the aforesaid products, imported or made in Hong Kong, comply with the safety standards concerned;
(4) whether it proactively conducts, at present, sample laboratory tests on the safeness of cosmetics and skin care products; if so, of the mechanism concerned; if not, whether it plans to conduct such tests on a regular basis;
(5) given that online shopping is becoming more prevalent, how the Government combats the illegal sale on the Internet of slimming health food containing unregistered pharmaceutical substances, or cosmetics and skin care products not in compliance with the safety standards in Hong Kong; how the Government regulates the sale of such products by overseas websites to Hong Kong residents; and
(6) whether it will consider requiring composition labelling on the packaging of cosmetics and skin care products, so as to further protect consumers; if so, of the details; if not, the reasons for that?
The safety of consumer goods which are ordinarily supplied for local consumption, including cosmetics and skin care products, if not covered by specific legislation, is subject to the regulation of the Consumer Goods Safety Ordinance (Cap 456) (CGSO) and its subsidiary legislation, Consumer Goods Safety Regulation (Cap 456A).
Products which fall within the definition of "pharmaceutical product" under the Pharmacy and Poisons Ordinance (Cap 138) are regulated by the Pharmacy and Poisons Ordinance. Products which fall within the definition of "proprietary Chinese medicine" (pCm) under the Chinese Medicine Ordinance (Cap 549) are subject to the control of the Chinese Medicine Ordinance.
Having consulted the Food and Health Bureau, my consolidated reply to the six parts of the question is as follows :
(1) From 2014 to 2016, the Drug Office of the Department of Health (DH) received a total of 369 complaints related to unregistered pharmaceutical products. During the same period, it handled a total of 138 cases convicted of sale or possession of unregistered pharmaceutical products, 23 of which involved Internet sellers. Detailed figures are as follows:
|Year||No. of complaints related to unregistered pharmaceutical products received by the Drug Office of the DH||No. of cases convicted of sale or possession of unregistered pharmaceutical products||No. of cases convicted of sale or possession of unregistered pharmaceutical products by Internet sellers|
From 2014 to 2016, the Chinese Medicine Division of the DH received a total of 143 complaints related to unregistered pCms. During the same period, it handled a total of 16 cases convicted of sale or possession of unregistered pCms, none of which involved Internet sellers. Detailed figures are as follows:
|Year||No. of complaints related to unregistered pCms received by the Chinese Medicine Division of the DH||No. of cases convicted of sale or possession of unregistered pCms||No. of cases convicted of sale or possession of unregistered pCms by Internet sellers|
For the above figures, the DH does not maintain breakdowns by cosmetics, skin care products and slimming health food.
The Customs and Excise Department (C&ED) received a total of 37 complaints related to the safety of cosmetic and skin care products in the past three years: 16 in 2014, 11 in 2015 and 10 in 2016.
(2) to (5) Due to their different risk profile and nature, consumer goods and drugs are subject to different regulatory mechanisms administered by relevant professional departments.
Products which fall within the definition of "pharmaceutical product" under the Pharmacy and Poisons Ordinance must meet the requirements specified therein as regards their safety, quality and efficacy, and be registered with the Pharmacy and Poisons Board before they can be sold in Hong Kong. On the other hand, products which fall within the definition of pCm under the Chinese Medicine Ordinance (Cap 549) must fulfill the requirements set by the Chinese Medicine Council of Hong Kong (CMCHK) in terms of safety, quality and efficacy, and be registered with the Chinese Medicines Board under the CMCHK before they can be imported, locally manufactured and sold.
The DH has put in place an established system under which samples of registered pharmaceutical products and registered pCms, as well as products which claim or are suspected to be pharmaceutical products or pCms being sold in the market, are collected from the market for surveillance testing regardless of whether they are being sold over-the-counter or online. The DH has also established a mechanism for reporting adverse incidents relating to drugs so as to conduct risk assessment, management and reporting. If substandard pharmaceutical products or pCms are found, the DH may take actions such as requesting the traders concerned to recall the products, prosecuting the traders concerned and referring the cases to the relevant regulatory body for follow-up actions, and issuing relevant press statements. If the products sold are found to be in contravention of the Pharmacy and Poisons Ordinance or the Chinese Medicine Ordinance (including illegal sale or possession of unregistered pharmaceutical products or pCms), the DH will commence investigation immediately and where necessary, conduct joint operation with the Police. Any irregularities found will be handled in accordance with the law. If irregularities found involve auction websites, the webmasters concerned will be required to delete the relevant product information from their websites. The DH will also continue to monitor the situation and review the measures in place.
From 2014 to 2016, apart from registered pharmaceutical products, the Drug Office of the DH tested the ingredients (including undeclared western drugs) of a total of 2 804 product samples taken from the market. Among the aforementioned products tested, there were 216 samples and 673 samples that were skin care products and slimming products respectively. The test results showed that 142 samples were adulterated with western drugs, including four skin care product samples and 75 slimming product samples. Detailed figures are as follows:
|Year||No. of samples tested||No. of skin care product samples||No. of slimming product samples|
|2014||817 (68)||28 (2)||252 (35)|
|2015||1 011 (37)||83 (0)||207 (22)|
|2016||976 (37)||105 (2)||214 (18)|
|Total||2 804 (142)||216 (4)||673 (75)|
* Figures in brackets denote the number of samples adulterated with western drugs. The Drug Office of the DH does not maintain a breakdown of the figures on cosmetics.
The Chinese Medicine Division of the DH collects samples of pCms being sold in the market for testing, in which no cosmetics and skin care products are involved.
Cosmetic and skin care products without Chinese or western drug ingredients are subject to the CGSO enforced by C&ED. In accordance with the CGSO, consumer goods generally supplied in Hong Kong have to comply with the "general safety requirement", which imposes a duty on manufacturers, importers and suppliers to ensure that the consumer goods they supply are reasonably safe, having regard to all the circumstances. When determining whether a product is reasonably safe, C&ED will conduct tests on products of different categories in accordance with the applicable international safety standards or specifications.
In order to ensure the safety of consumer goods, apart from investigating complaints, C&ED also conducts risk and intelligence assessment, and initiates spot checks, test purchases and sample testing for various consumer products as and when necessary. In the past three years, C&ED conducted 440 spot checks of cosmetic and skin care products in the local market and arranged testing for 76 samples (including two samples purchased online). Nine cases resulted in convictions with fines (ranging from $2,000 to $28,300) and community service order (160 hours).
CGSO is equally applicable to goods sold online and in physical stores. As online shopping becomes increasingly common, C&ED will increase the number of online test purchases and safety testing to protect consumers. Members of the public can report to C&ED any suspected contravention of the CGSO through various channels. Regarding online shopping from overseas websites, due to limits of jurisdiction, transactions conducted outside the jurisdiction of Hong Kong may carry risks. Consumers are reminded to be vigilant so as to avoid buying problematic products. C&ED would maintain close liaison with goods safety organisations outside Hong Kong in order to stop the sale of unsafe consumer goods in the market.
There is a case referral mechanism between the departments. If C&ED suspects that a product subject to a complaint may contain pharmaceutical ingredients, poisons (Part 1 Poisons or Part 2 Poisons), antibiotics or Chinese medicine, C&ED would, with the consent of the complainant, refer the case and personal information to DH for follow-up. If the complainant disagrees with the disclosure of personal information, C&ED would refer the case to DH after deleting all the personal information. DH also adopts the same referral mechanism.
(6) Any products which fulfill the definition of pharmaceutical products or that of pCms are already subject to the regulation, including the labelling requirement regarding active ingredients, of the Pharmacy and Poisons Ordinance and Chinese Medicine Ordinance respectively. All registered pharmaceutical products should carry a Hong Kong registration number on the package in the format of "HK-XXXXX". The public may check the details of the registered pharmaceutical products, such as whether a product is registered in Hong Kong and its sales requirements, by using the "Search Drug Database" function on the Drug Office of DH's website and entering the English name of the product or its Hong Kong registration number. Registered pCms are required to carry a Hong Kong pCm registration number on the package in the format of "HKC-XXXXX" or "HKP-XXXXX" and their details are also available on the website of the CMCHK for public reference.
As regards other cosmetic and skin care products, although CGSO does not mandate labels on consumer goods, when determining whether a consumer good is reasonably safe, one must have regard to all of the circumstances, including the use of any mark in relation to the consumer goods and instructions or warnings given for the keeping, use or consumption of the consumer goods. In addition, the bilingual safety labelling requirement under the Consumer Goods Safety Regulation specifies that warning labels on consumer goods must be in both the English and the Chinese languages.
Ends/Wednesday, February 22, 2017
Issued at HKT 14:30
Issued at HKT 14:30