SAMR Issued Not-Approval Decisions to 3 Brands of Infant and Young Children Formula

by 范皓菲 | Source SAMR | Jun 02,2018

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On May 29, SAMR issued a notice about not-approval decisions for infant and young children formulas. From the official site, it shows 3 brands, 9 products, are rejected for formula registration. This is the first time SAMR publicly issued negative decisions since the registration started.

 

The 9 products are all from the Lactalis owned dairy manufacturer, CELIA-LAITERIE DE CRAON, and applied registration in 2017:

 

No.

Reception No.

Product Names (En/Chn)

Applicants

1

国食注申YP20171185

Stolle Stage 1

赐多利婴儿配方奶粉(0—6月龄,1段)

CELIA-LAITERIE DE CRAON

2

国食注申YP20171186

Stolle Stage 2

赐多利较大婴儿配方奶粉(6—12月龄,2段)

CELIA-LAITERIE DE CRAON

3

国食注申YP20171187

Stolle Stage 3

赐多利幼儿配方奶粉(12—36月龄,3段)

CELIA-LAITERIE DE CRAON

4

国食注申YP20171206

Ofmom Stage 1

Ofmom TM婴儿配方乳粉(0—6月龄,1段)

CELIA-LAITERIE DE CRAON

5

国食注申YP20171207

Ofmom Stage 2

Ofmom TM较大婴儿配方乳粉(6—12月龄,2段)

CELIA-LAITERIE DE CRAON

6

国食注申YP20171208

Ofmom Stage 3

Ofmom TM较大婴儿配方乳粉(12—36月龄,3段)

CELIA-LAITERIE DE CRAON

7

国食注申YP20171218

Celia Stage 1

喜丽雅®婴儿配方奶粉(0—6月龄,1段)

CELIA-LAITERIE DE CRAON

8

国食注申YP20171219

Celia Stage 2

喜丽雅®较大婴儿配方乳粉(6—12月龄,2段)

CELIA-LAITERIE DE CRAON

9

国食注申YP20171220

Celia Stage 3

喜丽雅®幼儿配方乳粉(12—36月龄,3段)

CELIA-LAITERIE DE CRAON

 

In the end of 2017, due to the salmonella contamination, CELIA-LAITERIE DE CRAON was known by the world and suspended its registration by CNCA. So people thought the not-approval decision is possibly associated with the pathogen contamination event. Some industry insiders said the applicants might fail to provide sufficient supportive documents for hazard control.

 

We also noticed that SAMR changed the notice title on May 30 by deleting the “not-approval” word. However, there is still difference with other notices. Usually if the formula acquires the certificate, the notice will says “certificate is available to collect”, not “registration decision is available to collect”.

Visit the official notice website: here.