Altering Previously Registered Infant Formula Products in China

During the 2018 China Special Food Conference, Long Jihong of the National Health Food Review Committee revealed that 168 infant milk powder enterprise successfully changed information related to a previously registered infant formula product (Now the number is 202 because later on Nov. 5 and Nov. 7, another 13 and 21 products had alterations to registered information approved; the following data is based on the 168 products’ alternations). The information is published in the former CFDA website.

 One of the circulars of altered registration issued by former CFDA

Up to Nov. 1 this year, 26 companies and 168 products, including Abbott, Yashily and Bright Dairy had changed information on previously registered products. Items that are changed (some changed several items) mainly fall into 9 categories:

• Company name

• Legal representative

• Label

• Product name

• Manufacture address

• Registered trade mark

• Graphics

• Generic name

• Production technique*

* Generally if a previously registered infant formula product undergoes a change of production technique it will require an applicant to undertake a new infant formula registration application from scratch, however in China there are two types of dry and wet composite process method and replacing one of them for the other does not require new registration.

The altering of certain information does not require submission of a new registration application and instead only requires the applicant to apply to change information of a previously registered product. The eligibility criteria are stipulated within Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes.

As stipulated in the consultation draft of Technical Guidance on Changing Registration of Infant Milk Powder Products (draft version- still subject to minor alteration) and in CFDA No.150 “Notification About Label Change of Registered Infant Milk Powder Products” there are 2 broad categories of changes applicable to previously registered infant formula

1) Simple change

2) Complicated change

◆ Simple change

Simple change is defined as “change that has no influence on the scientificity and safety of IF formulation”, and usually takes 10 working days for the competent authority to review and draw conclusion. It includes changes in:

1. Product name;

2. Company name, name of manufacturing site, legal representative;

3. Claims of content (approved by National Food Safety Standards) in label and instruction book;

4. Trade mark, graphics, code name of product standard, certified items in label and instruction book;

5. Other changes not affecting scientificity and safety.

Here are some examples î

u Complicated change

Complicated change is defined as “change that might has influence on the scientificity and safety of IF formulation”. This mainly refers to changes of information in registration certificate and its attached files, and some other significant changes happening to equipment or techniques. It takes longer time than simple change due to careful review, check and even sampling. It includes:

1. Changes in variety, form, specification of food raw materials;

2. Changes in variety, form, specification of food additives;

3. Replace mixed ingredients or food additives by separate ingredients or food additives and vice versa;

4. Changes in variety of food raw materials or food additives that do not function as nutrients or process technique in final products (exception: if what you are to alter is not presented in the certificate or its supporting documentation, you do not have to file application for change of registered products according to Mrs. Long);

5. Nutrients change resulted from amending national food safety standard;

6. Changes in concentration of food raw materials or food additives that cause change to the ingredients list order;

7. Significant changes to equipment and technique that influence the relative concentrations of ingredients

8. Change the step of adding food raw materials/ food additives from wet process link to dry process link, and vice versa; (e.g. previously add certain ingredient during wet process, but now add it during dry process)

9. Other changes that might affect scientificity and safety.

u Cases not requiring application for alteration of previously submitted information

Actually several companies filed applications for altering their label sample or product specification (net content), but they are not required to do so. Here are some examples of information which can be changed without permission from the competent authority:

1. Change information of production date, expiration date, usage method, dosage, storage condition, notice, product traceability, alert, after-sales service;

2. Change claims of raw materials and raw milk powder’s country of origin;

3. Change position of contents in the package (excluding trademark and product name);

4. Change trademark holders, agent, production license Number (registration number of overseas manufacturer), contact information (QR code, cell number, etc.);

5. Change color of certification mark label;

6. Change product specification (net content);

7. Others

In these cases, if the conclusion of review and inspection by the authority shows what you change does have an impact on the scientificity and safety of the product, then a new infant formula registration application could be required.