The Regulations Workshop
The workshop will provide an opportunity to learn or to refresh one’s knowledge on the regulatory frameworks in Europe, China, ASEAN and Korea. In 2013, the new EU Regulation will replace the European Cosmetic Directive. With it come a number of changes that will affect product development as well as labeling or the documentation required to do business in Europe.
09:30 - 10:15 EU: Preparation For The Regulation Implementation - Annelie Struessmann (Conusbat)
Who better than Annelie Struessmann, from CONUSBAT, could present these? Annelie is a well appreciated speaker of many workshops on the EU regulation topic. She will explain in details the changes, the new requirements and those things that don’t change.
The European Union’s single market allows products to be moved around the 27 Union Member States as freely as it happens within one country. This is achieved on the basis of central EU legislation in force for the various industry sectors. The worldwide manufacturers of cosmetics doing business in Europe are actually affected by a recast of the Union’s regulatory framework for cosmetic products with a final implementation deadline in July 2013. Additionally, compliance with the EU Regulation for Chemicals (REACH), which applies to the product ingredients, has to be assured.
The presentation will focus on the changes introduced with the new Cosmetics Regulation and the prevalent actual implementation activities. Additionally, the interface between the Cosmetics Regulation and REACH will be clarified. Contents are especially targeting the obligations arising for non-European manufacturers of both, products and ingredients. As such, an overview of the necessary preparative steps before import into the EU will be provided as well as options for achieving compliance. Included will be an explanation of the roles of Responsible Person and Only Representative.
10:15 - 11:00 China Focus: What Is New? - Wendell Wei (China Gate)
China is becoming one of the World biggest cosmetic markets, but whoever has tried to register a product in China has faced contradictory information, not always documented on what to submit, how to submit and where to submit thus creating hurdles to enter the market.
Mr. Wendell Wei, from China Gate, will explain these requirements, who the regulatory agencies involved are, with their responsibilities, and what to expect with the changes coming up in 2012.
The presentation will cover the general situation of cosmetics registration and inspection in China. Followed by the procedure of cosmetics registration in China.Documents preparation will then be discussed as well as the cost and time for registration of cosmetics in China. The key technical point while registering a cosmetics product, new ingredient registration and trends for cosmetics registration will also be covered.
11:00 - 11:15 Break
11:15 - 12:00 ASEAN – Korea: Overview Of Changes - Dr Alain Khaiat (Seers Consulting)
ASEAN is a market of 10 countries representing 550 million consumers with one regulation, the ASEAN Cosmetic Directive, setting the requirements. Nevertheless, there are some “country specific” requirements which will be detailed by Dr. Alain Khaiat, from Seers Consulting, the recipient of in-cosmetics Lifetime Achievement Award.
Dr. Khaiat will also present the changes introduced recently by the Korean FDA to the regulations in one of the largest skin care market.
12:00 - 12:45 Ingredient And R&D Regulatory Strategies To Succeed In Asia – Le Chau Giang (Johnson & Johnson)
When suppliers introduce new ingredients to Companies looking for innovative technologies to excite the consumers, speed to market and competitive advantages are vital. In many cases, this can be hindered by the differences in regulatory requirements in various markets. The question is how to introduce the same formulation containing the new ingredient in various markets.
We will review an example of possible regulatory strategies that can be used to address the issues.
12:45 - 13:00 Q&A session