The Post-Market Surveillance in Cosmetics without Animal Test

The CIIE 1st China Cosmetics Safety International Forum, hosted by the UK Department of International Trade, was held in Shanghai on November 6th. The CEO of Knudsen & Co, Mette Knudsen, was invited to attend this seminar. Present at today’s conference are: Dr Judy MacArthur Clark, UK Government International 3Rs Programme Leader; Lexie Morris, Head of Retail & Consumer (China), Department for International Trade; Dame Barbara Woodward, HM Ambassador to China; Xu Jinghe, Vice Minister, National Medical Products Administration; Qi Liubin, Director, National Medical Products Administration.

The guests conducted a heated discussion on the revision and improvement of the China Cosmetics Safety Regulations Supervision and Administration Act.

  1. A Risk-Based Approach to Production Quality Assurance

A range of ways for assuring the quality of the production facility might be considered. Selecting the most appropriate for a given manufacturer might depend on the perceived level of risk of the country and/or company of origin. One or more of the following might be appropriate:

  1. Inspection of the overseas production facility by NMPA inspectors. Large companies may opt to invite such a visit; national trade associations might organise an inspection visit for a group of smaller companies to make this affordable.
  2. Inspection by an agreed third party.
  3. Acceptance of proxy reports from an in-country inspection/licensing system.
  4. Provision to NMPA of the safety assessment report used in the country of origin.
  5. Accreditation of the facility and processes in accordance with a recognized standard, e.g. GLP, ISO.
  6. A reliable Chinese system of notification involving safety assessment.

NMPA has built up experience of such a notification system through the Pu Dong Pilot which has now been extended to 10 further free trade zones. However, the Pu Dong model continues to require animal testing data. A strategy should build on this NMPA experience, and possibly supplement this with further training opportunities for NMPA safety assessors.

  1. A Reliable Chinese system of Post-Market Surveillance

Any serious reactions to cosmetics (domestic and imports) in China are currently reported through the hospital system. In the UK and Europe, most reports are made to companies who have sophisticated systems to enable them to identify trends early and investigate. Regulators (Trading Standards in the UK) become involved in serious cases. A parallel system for China would require training of many Chinese domestic producers.

Several well-developed training programmes exist e.g. material developed by the European Commission and a purpose-designed training programme developed by Cosmetics Europe. In addition, individual companies have a lot of experience to share. To succeed, a system would need to be tailored to China’s needs and culture. There can be no doubt it is in everyone’s best interest to create a reliable system for China.

  1. Supervision and Management of On Sale Cosmetics

The Deputy Bureau of the Food and Drug Administration said that it will strengthen the supervision and management of on sale cosmetics. The random sampling of the post-market will be implemented in accordance with the provisions of the National Standards and Cosmetics Supervision and Administration Regulations. It can be inferred from the testing items and programs listed in the regulations that animal test is out of the range of random sampling.

  1. Cross-Border E-Commerce Regulatory System

The meeting also mentioned that the Ministry of Commerce is discussing the details of the cross-border e-commerce regulatory system and soliciting opinions and suggestions from various ministries. It is still under discussion whether cosmetics imported by cross-border e-commerce will be considered as personal items or regulated by trading surveillance.