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China CNCA Clarifies Registration Renewal Requirements for Overseas Infant Formula Manufacturers

CNCA has underscored the importance of infant formula enterprises meeting all basic technical and safety requirements to be eligible for registration extension in addition to prioritizing development and/or adequate maintenance of adverse food safety event prevention and response mechanisms.

On Mar. 14, 2018, China CNCA announced the details of registration renewal for overseas infant formula manufacturers. Registration is valid for 4 years, and enterprises shall apply for renewal and submit materials to CNCA (Certification and Accreditation Administration of the People’s Republic of China) one year before the expiry date.

The announcement clarified that for overseas infant formula manufacturers granted approval before the end of 2014, the deadline for renewal application is the end of 2018.

Documents required

  1. The latest inspection report issued by competent authority of country/region where the enterprise located in

  2. Statement for recommendation and regulatory compliance issued by competent authority of country/region where the enterprise located in (please refer to attachment 1)

  3. Renewal application form (please refer to attachment 1), and enterprises shall update the information at http://cifer.cnca.cn 

  4. Self-evaluation report

  5. Supporting documents for regulatory compliance

  6. Supporting documents for food traceability

  7. Supporting document like authentication certificate is required if the imported product has been organic certified.

CNCA is responsible for materials review. The self-evaluation report should highlight:

  • During the validity period, whether any sanitary conditions in the manufacturing plant have been adjusted

  • If pathogenic bacterium were detected in products and any associated rectification methods

  • Details of safety incident reported to competent authority or publicized and an analysis on underlying cause

Important food safety issues in 2017 include Lactalis' salmonella contamination issue (read CL news here), which have prompted CNCA to extend its focus beyond prioritization of food safety response but also to require enterprises to develop infrastructure and mechanisms to prevent such occurrences from happening in the first place and also development of more efficient response protocols and procedures.

Inspection result

If all the above registration renewal materials are compliant, then the registration validity will be extended by CNCA; otherwise, the enterprises' import accreditation will be suspended. If a manufacturer does not apply for registration renewal within the deadline, their accreditation will also be canceled.

On May 1st, 2014, China CNCA released the first batch of approved overseas infant formula manufacturers. Up to now, 96 overseas manufacturers have been granted approval to export infant formula to China (3 of them were suspended). Please check the detail in our F-list.

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