The General Manager at REACH24H Consulting Group is hosting a workshop at the in-cosmetics event next month in Barcelona, and tells CosmeticsDesign-Europe.com that there have been several significant changes within the revised Cosmetic Management Regulation in China.
A particular area of note to brands outside of China is the added regulatory requirements on imported cosmetics.
“The responsibility on safety for imported cosmetics is firstly specified, and the local agent should shoulder responsibility for it, which is similar to the ‘responsible person’ concept,” says Kong.
“The Safety Assessor is specified within Article 20, and can be either in-house member of staff or third party. Pre-market burdens will be replaced by post-market compliance, such as adverse effect monitoring, product traceability, and labeling re-design for the Chinese market.”
The current pre-market application for imported ordinary cosmetics will be removed, instead of the notification carried out by the local responsible agent within the provisional level, meaning it will be treated the same as ordinary made-in-China cosmetics under Art 11 and Art 12.
Article 11: Cosmetic products will be classified as special use and ordinary use, and CFDA will issue and adjust the list of special use cosmetics
Article 12: Ordinary cosmetics are subject to the notification in the provisional level FDA, and special one should be registered in CFDA, who have the authority to hand down the review authority to provisional FDA
For finished product manufactures who intend to export cosmetics into China, Kong says the notification prior to market activities is still required, however, the related required information for notification and review process will be treated the same as that for made-in-China products, which means the whole process will be simplified.
“Regarding the raw material suppliers, the new cosmetic ingredient registration still remains in the revised regulatory proposal, but the review principles will be now be risk-based, which means some functional ingredients for emulsifying or viscosity adjustment will be much easier to go through the registration,” he adds.
For imported cosmetic products, pre-market application is still required under the current regulatory scheme, and the new cosmetic ingredient registration process is still challenging for raw material suppliers to go through it.
“Furthermore, companies looking at launching in the Chinese market need to find a qualified, local agent to cooperate with them for the registration work preparation,” advises Kong.
“The local agent can be a subsidiary of an overseas company or the other independent third legal entity, which should have views on current and future changes on the regulatory environment and then ensure the compliance for intended products.”
The regulatory changes happening in China will not impact other Asian countries, as different Asian countries, such as Japan, South Korea and ASEAN, have their own cosmetic regulatory system, which is not quite the same as China’s, meaning the changes will have a limited impact on other Asian markets.
When it comes to the scope of a cosmetic product, Dr Kong explains that it is Article 3 that is related to the Definition of Cosmetic Products, and specifies that the application area of teeth and oral mucous membrane is suitable for cosmetics, which means that toothpaste could be regarded as a cosmetic in the future.
The new cosmetic ingredient registration system will also remain, says the REACH24H GM, but some important registration principles are specified in Article 9 (List of Regulated Ingredient (Positive and Negative list, IECIC and approved NCIs), Article 10 (New Cosmetic Ingredient Registration) and Article 83 (Definition on New Cosmetic Ingredient).
“The CFDA will adjust the review principles based on the ingredient category and set up a 4-year investigative period for IECIC inclusion,” he tells CosmeticsDesign-Europe.com.
Dr Tommy Kong will take a workshop on pan-Asian regulations on Wednesday 15 April, 2015 at the in-cosmetics event in Barcelona.