SAMR Ratchets up Enforcement of Infant Formula Registration Policy by Making Onsite Inspection a Prerequisite

According to our technical experts onsite inspection has become a prerequisite for registration approval, and the competent authority has designated an expert panel to Netherlands and Denmark in November this year. SAMR has already corroborated these facts with one official stating “the onsite inspection is the key point for formula registration at present. Due to the different production standards, quality examination, and supervision systems in various countries, it is essential to conduct onsite factory inspection overseas, and we are facilitating the overseas inspection work now”.

Onsite inspection will focus on enterprises’ production, inspection and R&D capacity, authenticity of the materials submitted, and inspection conformity which involve the laboratory, production workshop, personnel and facilities. Additionally, some samples may be taken back to China for further testing. Enterprises can refer to Key Points and Judging Principles for On-Site Verification and Inspection of Registration of Infants and Young Children Milk Powder Formula Recipes (Trial) for more detailed requirements.

Obviously formula registration is much more stringent after the department restructuring, and this trend is likely to continue in the short to medium term. Song Liang, senior dairy analyst, suggested that enterprise already granted registration approval could have their approval revoked if found violating related regulations during post-approval onsite inspection.