China Consults on Infant Formula Recipe Registration Measures

As revealed by SAMR notification ^[1] on June 26th, SAMR is now soliciting opinions on the revision of Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes (2016) ^[2], fulfilling plans raised in Opinions of the Central Committee of the CPC and the State Council on Deepening the Reform and Strengthening Food Safety ^[3]. 

This administrative measures apply to both domestic and overseas infant formula enterprises. Here are the details.

Main Revisions

• Stricter registration requirements

• Applicants must demonstrate qualified production techniques during the entire production process

• Product recipe shall be submitted to SAMR along with other application materials including a supporting rationale for product development. 

• SAMR will reject applications under the following 7 conditions：

• When applying for the formula registration of other series, enterprises must show distinctive difference in both recipe composition and nutritional features. Scientific studies are also required.

• To enterprises who violate laws severely and are listed in the credit blacklist, their registration approval will be canceled. (provision 37)

• Requirements for labels and instruction manual are further detailed, eg. images of both infants and women shall not be used,  "breast milk" mimetic claims or similar terminology is also forbidden.

• Newly added requirements for alteration application

• Applicants shall also submit a verification report for recipe alteration to SAMR, along with alteration application, etc.

• During the practical production, the amount of ingredients and food additives are allowed to be adjusted rationally, if the content of ingredients table and nutrient component table remains the same. In this case, there's no need for enterprises to apply for the alteration application.

• If recipe adjustment changes the content of ingredient and nutrient component table, then manufacturers will be required to submit a new registration application which will be assessed on a case by case basis. 

• Implementing the principle of "streamlining administration, delegating powers, and improving regulation and services" reform

• Enterprises shall bear the major responsibility. Before submitting a written report to SAMR, the parent company shall fully evaluate the feasibility of using the infant formula recipe from its wholly-owned subsidiaries, or allow the wholly-owned subsidiaries to use its registered recipe, to ensure product safety.

• Alteration of the manufacturer's administrative address (the facility actually didn't move) will be approved when officials confirmed it onsite.

• When enterprises apply for product name alteration, product labels alteration, and alterations that won't influence the infant formula recipe, evaluation authority shall deal with the alteration within 10 working days.

• To validate the function of E-certificate, which will be effective for 5 years.

• The re-examination part was canceled.

• Onsite inspection procedures are clarified

• Onsite inspection procedures are clarified and will become mandatory during registration. (Although the 2016 version also regulated onsite inspection requirements, they are too general and not always carried out during the practical implementation.)

• Inspection authority shall confirm the onsite inspection schedule with applicants within 3 days after receiving the notification from evaluation authority. Applicants shall confirm the onsite inspection date within 30 working days. The officials will review the R&D, production, testing capacity of applicants as well as the consistency between application materials and the actual situation onsite. This inspection will be finished within 20 working days starting from the confirmed inspection date.

• The onsite inspection timeframe to overseas manufacturers depends.

• Competent authority was changed from CFDA to SAMR due to the institutional reform underwent in 2018.

• This measure will come into effect on the release day, replacing the Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes (2016) at the same time.

Feedback Collection

Any comments should be sent to SAMR prior to July 25, 2019, via following channels:

1. Go to China Law Opinion Solicitation System and leave comments under this administrative measures

2. Send emails to [email protected]. Please note "《婴幼儿配方乳粉产品配方注册管理办法（征求意见稿）》公开征集意见" in the subject line, which is translated to “Opinions on Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes (opinion consultation)”

3. Mail letters to SAMR, and note "《婴幼儿配方乳粉产品配方注册管理办法（征求意见稿）》公开征集意见" on the envelope

Editor's Note

On May 23, 2019, the National Development and Reform Commission of China issued the 'The Promotion Action Plan of Domestic Infant Formula Milk Powder' ^[5], which was designed to stimulate an increase in overall production volume of domestic infant formula by enhancing infant formula quality, etc., from all the policies China released these years to help revitalize its dairy industry ^[6], we can see China's determination and endeavor in getting rid of label with "unqualified infant formula".

Given that these administrative measures will come into effect on the release day, enterprises registering products should prepare for onsite inspection in advance. To overseas enterprises that have already registered products, they still need to optimize their products to ensure each product line is clearly differentiated in terms of formula and ingredients. 

For the full version of this administrative measures, please contact [email protected] for translation service.