Lets talk SAMR, page-5

I have found this on SAMR - It looks involved, time consuming and expensive. Maybe this is why BUB has the Chinese element on board, for without it will be a long road. (see below).

Infant Formula Milk PowderRegistration in China

27 March 2018original article from CIRS

Food

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Infant formula milkpowder has been highly concerned by government and society, and the qualitycontrol and supervision by Chinese government become stricter in recent years.The Food Safety Law of China (2015 version) stipulates that the formula ofinfant milk powder should be registered under CFDA.

Since January 12018, all infant formula milk powder products produced in China or imported toChina shall get the registration certificate with CFDA, and indicate theregistration number on the label and instruction book (Products that producedbefore January 1, 2018 can still be on market till expire date).

Classification of Infant Formula Milk Powder

The infant formula milk powder refers to the powder product that mainlymade from milk, milk powder, milk protein products, etc., added withappropriate vitamins, minerals, etc., produced by physical method, and suitablefor normal infants. There are 3 classifications of infant formula milk powderin China, namely,

·Infant formula milkpowder (0-6 months, stage 1)

·Older infantformula milk powder (6-12 months, stage 2)

·Young childrenformula milk powder (13-36 months, stage 3)

Laws, Regulations and National Standards

	Laws and Regulations	Issued Date	Implemented Date
1	Food Safety Law of The People’s Republic of China (2015 version)	2015.04.24	2015.10.01
2	Administrative Measure on Product Formula Registration of Infant Formula Milk Powder	2016.06.08	2016.10.01
3	Dossier and Requirements of Infant Formula Milk Powder Formula Registration (trial) (2017 revision)	2017.05.23	2017.05.23
4	Technical Guidelines on Labelling of Infant Formula Milk Powder Formula Registration (trial)	2017.05.24	2017.05.24
5	On-site Inspection Key Points and Judgment Principles on Infant Formula Milk Powder Formula Registration (trial)	2016.11.16	2016.11.16
6	GB 13432-2013 General Rules for Labeling of Prepackaged Food for Special Dietary Uses	2013.12.26	2015.07.01
7	GB 10765-2010 Infant Formula	2010.03.26	2011.04.01
8	GB 10767-2010 Older Infants and Young Children Formula	2010.03.26	2011.04.01
9	(………………….)	-	-

Applicant Qualification

No matter for domestic or imported infant formula milk powder products,the applicants shall be actual manufacturers who have productioncapacity

Note: The overseas applicants shall get the overseas manufacturerregistration under Certification and Accreditation Administration of China(CNCA) as well, before importing the products to China.

Registration Quantities for One Company

·
There are at most 3series and 9 kinds of formulas for one company in principle (a series offormulas include infant formula for stage 1, infant formula for stage 2, andinfant formula for stage 3);

·There should besignificant differences among three formulas for the same stage;

·One wholly-ownedsubsidiary who has got the formula registration license and production licenseis allowed to produce the registered product from another wholly-owned subsidiaryin the same group company.

Registration Procedures
Dossier Requirements

·Application form

·Subjectqualification certifications of the applicant

·Raw materialquality and safety standards

·Product formula

·Product formulaR&D report

·Production processdescription

·Product testreports

·Evidentiarymaterials on production capacity, R&D capacity and inspection capacity

·Samples of labeland specification and related certificates

Test Items

	Test items	Batch amount	Sample requirement
1	Tests of all items listed in GB 10765 or 10767 and relevant laws and regulations	3 batches (at least one batch from commercial production line)	Finished product
2	Other tests if necessary	-	-

RelevantInfo.Refresh

·CFDA Tender Notice on SubjectResearch on Health Food Raw Material Directory and Health Function Directory

·CIRS Free Webinar: How to Get NewFood Contact Substance Notification (FCN) in China

·SAMR Issued the Draft on HealthFood Raw Material Directory of 5 Active Ingredients

·China Great News on Cross-borderE-commerce (CBEC) Published on November 21st, 2018

·Summary and Analysis of FoodAdditives Permitted to be Used in FSMP