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Infant formula/milk powder recipe registration implemented has been implemented in China since October 1st 2016. China has already released 13 batches of approved registered infant formula recipe as of September 30th, 2017, including 65 enterprises and 378 formulas (see the News). Many of the domestic registered infant formula enterprise have already released their new product packaging/labeling. In this article we will analyze regulatory requirements for infant formula labels in China and use practical examples to highlight how industry is dealing with new compliance requirements.
Changes in the labeling of registered infant formulas
Example 1 Beingmate Love Plus Stage 2
Registered manufacturer: Hangzhou Beingmate Maternal and Child Nutrition Co., Ltd.
Recipe registration: approved
Changes in labeling front side:
Item | Regulatory basis |
Delete the words of “金装” in product name | Exaggerated and superlative terminology in the product name are prohibited. |
Change the symbol “+” to Chinese word “加” in product name | Product name shall use standardized Chinese characters. |
Applicable age and stage included in the generic name and marked in the middle | Generic name shall be “Infant formula milk powder (0-6 month, Stage 1)”, “Older infant formula milk powder (6-12 month, Stage 2)”, and “Young children milk powder (12-36 month, Stage 3)” based on suitable month age of products; The generic name shall be conspicuous and striking, and shall not be separately labeled. |
Registration No., marked
| Product information of infant formula milk powder includes registration number; Registration number refers to the one stated in “Certificate for product formula registration of infants and young children milk powder”, e.g., 国食注字YP20170003 |
Delete the words of 100% imported ingredients | Vague claims such as “Imported milk source”, “Originated from foreign pasture”, “Ecologic pasture”, “Imported raw material”, “Original ecological milk source” and “Pollution-free milk source”, etc. to describe the source of raw materials are not allowed. |
Delete the content claims for nucleotide, DHA, choline and folic acid | The label shall not include: Disease prevention and treatment function expressions; Explicitly expressing or implying the healthcare function; Functional expressions explicitly expressing or implying functions |
Delete the words relating to mental health formula and LF immune factors |
Example 2 Junlebao Lebo Stage 3
Registered manufacturer: Hebei Junlebao Junyuan Dairy Co.,Ltd.
Recipe registration: approved
Changes in labeling front side:
Item | Regulatory basis |
Delete the words of “白金装LM” of the product name
| The same as the Beingmate example above |
Reduce the typeface of trade name and indicate it on the corner of label | The typeface (as area of individual character) of trade name shall not be greater than a half of the area of typeface used for generic name, and the font size of trade name shall be smaller than that of generic name. |
Applicable age and stage included in the generic name and marked in the middle | The same as the Beingmate example above |
Delete the ingredient source (pasture milk powder) | The same as the Beingmate example above |
Delete the Chinese words relating to lactation | Images of infants and women, and “Humanized”, “Humanisation” or similar terms for expression are prohibited. |
Delete the claim of parental protection, pro-intellectual nutrition and absorption; | The label shall not be indicated with: Explicitly expressing or implying the healthcare function; Functional expressions explicitly expressing or implying the functions |
Strict regulatory requirements on infant formula labelling in China
On Dec. 9, 2016, infant formula manufacturers were required to conduct self-inspection of infant formula labels within 3 months from the date of the release of “Notice for Infant Formula Labeling Standardization and Inspection”. Then on May 25, 2017, China CFDA released the finalized version of “Technical Guidance for Labeling of Infant Formula Recipe Registration” to better regulate infant formula labels. Most of the current labels are pared-down versions of the previous labels.
In this labeling regulation, the product/trade name on the labeling must not contain the following terminology or infer any of the following concepts:
Definition | Example |
a. False, exaggerated and superlative terminology, and those in violation of scientific principle. |
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b. Words involving prevention, treatment and healthcare functions |
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c. Functional expressions explicitly expressing or implying alteration of normal physiological functions including “help the intellectual development”, “enhance the resistance or immunity” and “protect the intestinal function”, etc.; |
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d. Vulgar or excessive opinion |
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e. Words associated with human anatomy |
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f. Other words misleading customers, e.g. homophonic words or homographic words that can lead to customers’ misunderstanding |
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Prohibitive statements/claims/representations include:
Involving disease prevention and treatment function;
Explicitly expressing or implying a healthcare function;
Functional expressions explicitly expressing or implying the functions including “help intellectual development”, “enhance the resistance or immunity” and “protect the intestinal function”, etc.;
Negative content claims i.e. emphasizing that the product doesn’t use or does not contain a substance which under Chinese regulations and laws cannot be contained in the product. Use of words like “Not added”, “Contains no” and “Zero-added”, etc.
False, exaggerated and superlative terminology/contents, and those in violation of scientific principle;
Using the vague claims such as “Imported milk source”, “Originated from foreign pasture”, “Ecologic pasture”, “Imported raw material”, “Original ecological milk source” and “Pollution-free milk source”, etc. to describe the source of raw materials;
Claims inconsistent with the content of product formula registration;
Using images of infants and women, and “Humanized”, “Humanization” or similar terms
Other situations failing to comply with the provisions.
Trends of the infant formula label design in China
Below we have selected 30 infant formula products and found over 83% products have passed recipe registration, over 68% were renamed.
Online selling infant formulas in China in 2017:
SN | Enterprise | Previous Chinese Product Name | Recipe Registered | Registered Product Name (CN) |
1 | Friso | 美素佳儿金装 | Yes | 美素佳儿 |
2 | Wyeth | 惠氏启赋 | Yes | 惠氏®启赋® |
3 | Danone | 爱他美 | Yes | 爱他美 |
4 | Danone | 诺优能 | Yes | 诺优能 |
5 | Wyeth | 惠氏S-26金装爱儿乐 | Yes | 惠氏®爱儿乐™ |
6 | Nestle | 超级能恩 | Yes | 超启能恩 |
7 | MeadJohnson | 安儿宝A+ | Yes | 安儿宝 |
8 | A2 | A2白金 | Yes | 至初® |
9 | Yili | 金领冠 | Yes | 金领冠 |
10 | Nestle | 能恩金装 | Yes | 能恩 |
11 | Danone | 爱他美白金版 | Yes | 爱他美卓萃 |
12 | Beingmate | 贝因美金装爱+ | Yes | 贝因美爱加 |
13 | Abbott | 雅培亲体 | Yes | 雅培经典恩美力 |
14 | Yili | 金领冠珍护 | Yes | 金领冠珍护 |
15 | JUNLEBAO | 君乐宝纯金装 | Yes | 君乐宝乐纯 |
16 | Abbott | 菁智纯净 | Yes | 菁挚纯净 |
17 | BIOSTIME | 合生元金装 | Yes | 贝塔星 |
18 | MeadJohnson | 安婴宝A+ | Yes | 安儿宝 |
19 | Friso | 美素佳儿皇家 | No |
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20 | BIOSTIME | 合生元呵护 | No |
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21 | HiPP | 喜宝益生元 | No |
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22 | FIRMUS | 飞帆 | Yes | 飞帆 |
23 | Yili | 伊利金装 | Yes | 伊利 |
24 | MeadJohnson | 蓝臻 | Yes | 蓝臻 |
25 | Beingmate | 贝因美冠军宝贝 | Yes | 贝因美冠宝 |
26 | Abbott | 菁智有机 | No |
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27 | FIRMUS | 星飞帆 | Yes | 星飞帆 |
28 | BIOSTIME | 合生元超级金装 | Yes | 派星 |
29 | Bellamy | 贝拉米有机 | No | / |
30 | Wondersun | 安力聪 | Yes | 菁美 |
The packaging of infant formula after registration share several common features:
l Trade name and registered trademark are more standardized and less prominent than generic name.
l Product registration number is marked in the middle.
l No claims on the front side of the packaging. Claims like "imported milk", "free range" and other functional claims like “brain cognitive capacity increases, enhances immunity, protection of the intestine and other functional statements" have been removed.
The new technical requirements will force manufacturers to make great changes to infant formula label and packaging design. Manufacturers will need to design clean and simple labels and there will be little room to differentiate products based on label alone. Brand reputation and marketing campaigns will become more important than ever before. We have to expect that enterprise with well established brands and recognition amongst Chinese consumers will have a huge advantage under the new policy.
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