Taiwan Infant Formula Regulation
Sep 16, 2019
Echo Cao
Tags : Taiwan, China
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CONTENTS

1. Introduction


In Taiwan, infant and follow-up formulas are classified as special nutritional foods which are subject to examination and registration by Taiwan Food and Drug Administration.

2. Definitions


Infant and follow-up formulas in Taiwan are classified into 3 types:

  • Infant Formula: It refers to the specially-made food substitute for breast milk, and can be used for feeding alone before infants begin eating supplementary food as it satisfies the nutritional needs of infants of 0-6 months.

  • Follow-up Infant Formula: It refers to the food for infants of 6-12 months, and serves as the weaning formula for feeding in conjunction with complementary foods; however, it is not fit for feeding alone for infants who are under six months of age.

  • Infant Formula for Special Medical Purposes: It refers to the food substitute for breast milk or infant formula and satisfies the special nutritional needs of infants suffering from nutritional disorder or diseases or having health conditions. After growing older, infants may begin eating proper supplementary food.

3. Main regulations


4. Competent authorities


Ministry of Health and Welfare (MoHW)

Taiwan Food and Drug Administration (TFDA) under MoHW, responsible for matters including:

  • formulating food safety policies, laws and regulations;

  • examining, registering and licensing food products, including infant formula and follow-up formula; 

  • testing, inspecting and examining imported food;

  • laboratory accreditation and risk assessment; and

  • post-market surveillance and implementing consumer protection measures.

5. Registration documents


  • Application form (go to http://www.fda.gov.tw to download);

  • Ingredients list and their contents, product specification and nutritional ingredients analysis table;

  • Free sale certificate in foreign countries or relevant product trial report;

  • Key points of production procedure;

  • Production license issued by country of origin within the last 2 years (for imported products);

  • Product labels, outer-packaging, instructions for use, Chinese labels;

  • Business license of the applicant;

  • Samples of products

If the product is approved by TFDA after submitting these materials, TDFA will issue a license to the applicant, which will be valid for 5 years. The applicant should apply for extension of the license within 3 months before it expires. The applicant can also apply for modification of the license if the ingredients or their contents are not amended.

6. Registration fee


On May 26, 2015, Taiwan FDA issued a notice on fee standards for the inspections, registrations and licenses for foods, food additives and health foods. The new regulation has taken effect on July 1, 2015. According to it, the inspection and registration of special nutritional food is NT$3,000. (click here to see the original sources in Chinese)

7. Number of TFDA-approved infant and follow-up formula


TFDA has created an online database that enables the public to look up whether a baby formula is approved by TFDA. As of Aug 19, 2015, 180 types of baby formula had been approved by TFDA, most of which are imported and manufactured by foreign manufacturers. The exporting countries include Ireland, Australia, Belgium, Poland, Denmark, German, French, Korea, Holland, Canada, America, New Zealand, Japan, Switzerland, Spain and Singapore.

8. Labelling of infant and follow-up formula


According to the article 22 of the Act Governing Food Safety and Sanitation, the container or external packaging of food shall conspicuously indicate in Chinese and common symbols the following information:

  1. product name;

  2. name of the ingredients; those that contain two or more ingredients shall indicate the respective ingredients in descending order of proportion; 

  3. net weight, volume or quantity; 

  4. name of food additives; in the case of a mixture of two or more food additives which are named according to its function it is necessary to indicate the name of each additive separately;

  5. name, telephone number and address of the manufacturer or that of the responsible domestic company. Traceability documentation on the domestic certified agricultural products; and the production systems prescribed by the central agricultural competent authority in a public announcement;

  6. country of origin;

  7. expiry date;

  8. nutrition label;

  9. genetically modified food raw materials (if any);

  10. other matters designated by the central competent authority in a public announcement.

Labeling of the ingredients shall indicate the percentage of the main ingredient. The labeling of food items, main ingredient, labeling content, labeling method, and the implementation date of each product shall be prescribed by the central competent authority. 

The labelling, promotion or advertisement of foods shall not be false, exaggerated or misleading and state any medical efficacy.

9. Nutritional labelling


The Nutritional Labelling Requirements for Infant and Follow-up Formula and Formula Foods for Special Medical Purposes stipulate the nutrition information that need to be labeled, their units, format, and permitted labelling error range. According to it, the format of nutritional label is displayed below:

Nutrition Labelling

                                                                                Per 100g                                                                 Per 100 ml

(or per 100 kcal)

Calory

kcal

kcal

protein

g

g

Fat

saturated fat

trans fat

linoleic acid

α-gamma linolenic Acid

g

g

g

g or mg

g or mg

g

g

g

g or mg

g or mg

Carbohydrate

             sugar

g

g

g

g

Sodium

mg

mg

Water

g

g

Vitamin

mg or μg

mg or μg

Dietary fiber

mg

mg

Inositol

mg

mg

L-carnitine

mg

mg

Ash

g

g

minerals (excluding Na) and microelements

mg or μg

mg or μg

Other nutrients contents labelled by companies voluntarily

g, mg or μg

g, mg or μg

α-gamma linolenic acid, dietary fiber, inositol, L-carnitine and ash are non-mandatory labeling items for follow-up formula.

TFDA also requires companies of approved infant formulas to print a logo on the package in order to encourage breastfeeding, which contains the following two sentences:

  • Breastfeeding is healthier for infants; and

  • The Ministry of Health and Welfare cares about you.

The word size should be at least 8 and the color of the logo should be GreenY100c60 and OrangeY100M60. The minimum size of the logo should be no smaller than 3cm*3cm.

pic 3 logo-taiwan-infant-formula-1.pngPlease click here to see the official notice.

10. Advertisement and sales promotion of infant and follow-up formula


The infant and follow-up formula shall be prohibited from advertisement. 

It is prohibited to state, expressly or implicitly, that the nutrition contained in the infant and follow-up formula is commensurate with or better than that of breast milk.

No sales promotion shall be conducted for the infant and follow-up formula by giving out samples, giveaways or coupons, giving discount or promotional price with opened products, selling with other products, or special display.

11. Sanitary requirements and pesticide residue limits


The Standards for Sanitation and Pesticides Residue Limits in Infant Foods applies to powdered or liquid formula for infants not more than 12 months of age as well as follow-up infant formula manufactured primarily from the edible components of cereals and legumes which should constitute at least 25% of the final mixture on a dry basis.

The maximum level of microorganism:

Microorganism

Sampling plan (1)

Limits (2)

Remark

n

c

m

M

Coliform

(MPN/g)

5

2

(3)<3

10

The detected results allowable between m and M from ≤c sample quantity. Unacceptable ≥M.

Enterobacter sakazakii (Cronobacter species)

10

0

-

Apply to powered infant formula

Salmonella

10

0

-


Listeria monocytogenes

10

0

-


(1) n= number of units comprising the sample.

c= maximum allowable number of sample units yielding results between m and M (marginally acceptable)

(2) m=a microbiological limit that separates good quality from marginally acceptable quality.

M=a microbiological limit above which sampling results are unacceptable or detective.

        (3)m= “<3” is the MPNs per gram that refer to the methods of test for Coliform bacteria

The tolerance of mycotoxins in infant foods:

Mycotoxins

Food category

Limit (ppb)

Aflatoxin B1

Cereal-based foods for infant

0.1

Infant formula for special medical purposes

0.1

Aflatoxin M1

Infant formula and follow-up infant formula

0.025

Infant formula for special medical purposes

0.025

Ochratoxin A

Cereal-based foods for infant

0.50

Zearalenone

Cereal-based foods for infant

20

Deoxynivalenol

Cereal-based foods for infant

200

Fumonisins B1+B2

Cereal-based foods for infant

200

The tolerance of heavy metals in infant foods:

Heavy metal

Limit (ppm)

Lead

0.02

Tin

50

The maximum level of pesticide residue in infant foods is 0.01 ppm.

12. Traceability of infant and follow-up formula


Infant and follow-up formulas have been listed in the category of foods that require implementation of traceability systems in Taiwan since 31 Jul 2015. The requirement will be fully implemented from 1 Jan 2016 for imported products (click here to see the category and effective date for different food types). 

According to the Regulations Governing Traceability of Foods and Relevant Products, food business that engaged in the import of infant formula shall establish traceability system include at least the following items:

1. Product Information:
(1) Chinese and English (foreign) product name;
(2) main and minor raw materials;
(3) food additives;
(4) packaging containers;
(5) storage conditions;
(6) applicant of inspection;
(7) net weight, volume, quantity or measurement;
(8) expiry date or manufacture date;
(9) notice number of foods and relevant products import admitted.
2. Identification: including any unique mark, lot number, text or picture that is identifiable on raw materials, semi-finished products or finished products.
3. Supplier Information:
(1) exporter and manufacturer (slaughterer) (name/code of enterprise or company, address, contact person, telephone number etc.);
(2) product name;
(3) net weight, volume, quantity or measurement;
(4) lot number;
(5) expiry date or manufacture date;
(6) receiving date;
(7) the products shall be labelled the country of origin of raw materials designated by the central competent authority in a public announcement; the country of origin of raw materials must be included.
4. Product Flow Information:
(1) distributor and recipient (enterprise or company name, address, contact person, telephone number etc.);
(2) product name;
(3) net weight, volume, quantity or measurement;
(4) lot number;
(5) expiry date or manufacture date;
(6) delivery date.
5. Other information of internal traceability related to the products.

13. Import inspection


Similar to China mainland, foods exported to Taiwan also need to be inspected. The importer or a representative should file an application for inspection to local FDA at the port of entry within 15 days prior to the entry date of goods and submit required information stated in Regulations of Inspection of Imported Foods and Related Products. Only infant formulas that are approved by TFDA will are permitted for import in Taiwan. 

Tags : Taiwan, China