16 6 月 2016 China Food and Drug Administration Imposes Mandatory Prior Registration System for Infant Formulas
On 8 June 2016, the PRC Food and Drug Administration (hereinafter “CFDA”) promulgated the Provision on the Registrations of Infant Formulas (2016) (hereinafter the “Provision”), which will come to effect on 1 October 2016.
The Provision is a specification of the general requirement stipulated in Articles 82 of the PRC Food Safety Law (2015) which came to effect on 1 October 2015.
The Provision imposed a mandatory requirement that all infant formula products manufactured and/or sold in main-land China must have their formulas registered with the CFDA beforehand. Both domestic and foreign manufacturers shall comply with such requirement to register the formulas.
Shortly after the PRC Food Safety Law (2015) came into effect in 1 October 2015, CFDA released its first draft provision on the registration of infant formula. Recently, CFDA officially promulgated the Provision on the Registrations of Infant Formulas (2016), which will come to effect on 1 October 2016.
Before the promulgation of the Provision, there existed 103 infant formula manufacturers in mainland China selling approximately 2,000 different infant formulas. To win the market, it is common for Chinese manufactures to advertise their products by using catchy but vague descriptions like “imported raw materials”, “from organic ranch”, “zero additions”, etc.
CFDA aims to regulate the market and improve the situation by imposing strict prior registration system for all infant formula products to be sold in Chinese market. The Provision stipulates clearly that both domestic and foreign manufactures are required to register the specifics of the formula of the infant formula products they wish to sell in main-land China.
It is noteworthy that in the draft of the Provision published in October 2015, such requirement only applies to Chinese domestic manufacturers. The expansion to foreign manufacturers shows the CFDA’s and/or other PRC governmental authorities’ determination to unify the treatment towards manufacturers from both abroad and domestic. However, it turns out to be more burn for foreigner manufacturers who also need to comply with the Decree No. 145 of the Administration of Quality Supervision, Inspection and Quarantine (hereinafter the “AQSIQ”), according to which foreign-manufacturers are already required to register with the Certification and Accreditation Administration of PRC (hereinafter the “CNCA”).
To apply for the registration under the Provision, applicants are obligated to submit the following documents:
(i) The application form;
(ii) The business registration certificate of the applicant;
(iii) The quality standard that applicable to all ingredients used in the formula;
(iv) The research report of the formula;
(v) Illustrations and specifications of the production process;
(vi) The report of the product quality inspection;
(vii) Documents in support of the manufacturer’s research qualification, production qualification, as well as its quality control qualification;
(viii) Other documents to support that the formula is “scientific”.
The descriptions of documents in the Provision are pretty much the Chinese way. They are of a general and vague nature, which makes it difficult to provide one comprehensive list. It addition, the formalistic requirements on those documents remain undefined without further consultation with relevant departments. For example, it is unclear whether the translations need to be certified, whether original documents need to be notarized and legalized, etc.
2. Three Stages, Nine Formulas
According to Article 9 of the Provision, one company shall not be allowed to apply for the registrations of more than three formulas under each of the three stages (Stage 1 for 0 – 6 months, State 2 for 6 – 12 months, and State 3 for 12 – 36 months).
Once the registration is done by one wholly-owned subsidiary of one entity, the other wholly-owned subsidiaries of this entity may also use such registered formula. However, a report should be sent to CFDA beforehand.
It is theoretically plausible to circumvent the nine formulas limits for large groups who have more than one wholly-owned subsidiaries. Each of its subsidiaries may apply up to 9 formulas and then “cross-licenses” the registrations among its subsidiaries.
3. Administrative Registration Process
Similar like most administrative registrations in China, the registration of formula is also very time consuming. The whole process will easily take three to four months.
Starting from the date that the applicant submits the application with supporting documents, the applicant may receive a notice of handling or refusal after formalistic review within 5 working days.
Within 3 days thereafter, the application will be handed over for substantial review. The substantial review is supposed to be finished within 60 working days, with a possible extension of 30 working days.
In parallel, CFDA may appoint a proxy to conduct on-site inspection with the purpose of confirming the descriptions contained in application materials are true. The on-site inspection shall be concluded within 20 days.
Thereafter, the CFDA will take another 20 working days to decide whether to issue the certificate or not. If yes, the certificate shall be produced within another 10 working days.
All in all, even assuming the applicant is able to duly and properly prepare all documents, it is still a process of almost 98 – 128 working days to receive the certificate.
4. Strict Requirements on Labelling
When applying for the registration, draft samples of the label and specification shall also be submitted. Once the registration is done, the label and specification shall indicate the registration number and be in conformity with the formula registered.
The Provision also re-emphasized the requirement of food labelling in infant formula, and specified the following expressions shall be prohibited on any label:
(1) Expression of “imported milk”, “from foreign ranch”, “organic ranch”, “imported materials” without specifying the state of origin;
(2) Expression of disease preventing or curing function;
(3) Explicitly or implicitly expressions as increasing intelligence, developing immunity to disease, protecting digesting system etc.;
(4) Explicitly mentioning of “no addition”, “zero addition” of certain substances which are already on the negative list of the national standards;
(5) Faked, exaggerated, unscientific or absolute descriptions;
(6) Information that is not in consistent with the formula registered.
5. Difference with Previous Registration Requirement for Foreign Manufacturers
Before the issuance of this Provision, foreign manufacturers wishing to sell their formula products shall proceed with the registration with CNCA in accordance with AQSIQ’s Decree No. 145 (2011).
The two registration scheme are not in conflict with each and shall both be completed for the purpose of importing infant formula products to main-land China market.
It is advised for all relevant companies to prepare for and initiate the registration process with the CFDA as soon as possible considering the time-consuming nature and the abovementioned rules to be implemented on 1 October 2016.
For inquiries regarding further specifics on the registration, please contact us at email@example.com.