According to the provisions of “Administrative measures for product formula registration of infants and young children formula milk powder” (Decree No.26 of China Food and Drug Administration, hereinafter referred to as “Measures”), wher
e the label and specification involves product formula of the infants and young children formula milk powder, it shall be co
nsistent with that in the registered product formula. In order to do a good job in the label change, the relevant issues are hereby announced as follows:
I. In case of any of the following circumstances, the label change application shall be conducted
Within the validity period of product formula registration certificate of infants and young children formula milk powder, the applicant shall propose change application for registration towards CFDA according to the legal procedures and submit the following materials where it is necessary to change the following contents in label:
(I) Where the product name changes;
(II) Where the enterprise name and production address change;
(III) Where the list of ingredients and nutrition information list change;
(IV) Where the claims of the content allowed in the national food safety standard changes;
(V) Where the registered trademarks, figure, product standard code and certification projects change;
(VI) Where the contents involved in the consistency of product formula registration.
II. In case of any of the following circumstances, the label change application shall not be conducted
Within the validity period of product formula registration certificate of infants and young children formula milk powder, the applicant can change voluntarily where it is necessary to change the following contents in label and no change application is required:
(I) Where the information of date of manufacture, shelf life, use methods, consumption amount, storage conditions, matters need attention, product traceability, reminder or warning and post-sales service change;
(II) Where the claim of place of origin or country of raw materials of raw milk or raw material powder change;
(III) Where the location of main display layout in addition to trademarks and product names, as well as the location of non-main display layout change;
(IV) Where trademark holder, agent, production license number (registration number of overseas production enterprise), contact information (QR code, telephone, etc.) change;
(V) Where the certification mark and label color change;
(VI) Where the product specification (net content) changes;
(VII) Where the contents involved in the consistency of product formula registration change.
III. Label change application shall not be conducted according to the relevant provisions of Article 26 in “Measures”
IV. The labels for application for change and self-revision shall all comply with the content and form requirements of laws, regulations, rules and the national food safety standards.
V. Where the contents of sample manuscript of specification submitted during the registration of product formula needs to be changed, the applicant can change it voluntarily, no change application is required, but it shall all comply with the content and form requirements of laws, regulations, rules and the national food safety standards.
