David Ettinger and Yin Dai Quoted in Chemical Watch Article on Chemical Regulation in China in 2023

Keller and Heckman Partner David Ettinger and Associate Yin Dai were quoted in the Chemical Watch article, “What’s next for chemicals regulation in India and China?” The article examines key major developments in chemical regulations expected in India and China over the next 12 months. David and Yin specifically touch on the cosmetics sector in China. 

Commenting on the increased data requirements and scrutiny of chemical ingredients, particularly with regards to cosmetics, Yin stated, “Pursuant to the [Cosmetics Supervision and Administration Regulation] CSAR and its supporting documents, companies could face temporary import or distribution bans, or even severe penalties if they fail to meet the new ingredient reporting requirement in time.”

Yin brought up an example regarding a domestic cosmetic manufacturer being fined by the Medical Product Administration (MPA) of Tianjin “for failing to upload the cosmetic efficacy evaluation summary by a 1 May deadline.” Such instances “remind the industry that Chinese authorities watch closely to ensure the deadlines they set are respected in practice. Companies are advised to carry out thorough due diligence and to strictly follow deadlines established under the CSAR,” said Yin. She added, “Foreign companies that wish to succeed in China must keep its unique regulatory requirements in mind from day one of their product design: from formulation creation to post-market surveillance, from efficacy substantiation to marketing restrictions. Rarely will there be a one-size-fits-all approach if a company wishes to include the Chinese market to its global footprint. It is imperative to know your products well and understand their corresponding compliance requirements in practice.”

David and Yin also discussed key challenges for the cosmetics sector, including what is required of applicants: “From 1 January, applicants are required to elaborate on ingredient safety in addition to the safety of the final product, and to upload a summary of their product efficacy evaluation to a publicly accessible online platform by a certain deadline – different deadlines applying to different types of applicants. In the past, the impact of the safety information submission was limited. Information was not mandated on all ingredients but only substances considered ‘risky’. In addition, risky substances already subject to restrictions in China were exempted from the safety review. Commonly, a guarantee statement for safety was made by the cosmetic applicant in their application. However, under CSAR, safety information of almost all ingredients must be incorporated in the application dossier, including a brief overview of the ingredient’s manufacturing process, quality control measures, use restrictions and safety evaluation.”

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