Update | Taiwan Revises the Review and Registration Requirements for Infant Formula, Formula for Certain Disease, and Food Additives

Updates

On November 30, 2023, Taiwan Food and Drug Administration (TFDA) published the amendment to the Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products. The amendment takes into effect immediately, except for a one-year grace period granted to provisions related to the original hygiene analysis report.

On September 22, 2022, Taiwan Food and Drug Administration (TFDA) announced the proposed amendment to the Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products. The revision mainly involves application details for infant formula and follow-up formula, formula for certain disease, and food additives. The draft is available for public opinion within 60 days from September 22, 2022.

Revisions to infant formula and follow up formula, and formula for certain disease 

1. Food business operators shall submit their applications online. The scanned version of documents and attachments should be uploaded, while the original copies should be kept on hand.

2. The original hygiene analysis report shall be submitted along with the original nutrient analysis report in the following circumstances.

   1) Applicants apply for the review and registration of infant formula and follow-up infant formula.

   2) Applicants seek to extend a permit document for infant formula and follow-up infant formula.

   3) Applicants intend to re-pack the infant formula and follow-up infant formula product in new containers for sale in Taiwan.

   4) Applicants apply for the review and registration of formula for certain disease.

   5) Applicants seek to extend a permit document for formula for certain disease.

3. TFDA modifies the documents required for the change of Chinese label, box packaging, and user instruction of the product.

4. Applications for the change of Chinese label, box packaging and user instruction of the product are exempted in the following circumstances:

   1) Change of patterns or colors.

   2) Proportionate reduction or enlargement of the approved images and texts.

   3) Movement of the position of the approved images and texts.

   4) Change of the fonts of the approved text.

   5) Changes of marks not subject to the Regulations.

5. The authority stipulates the documents required for the change of product specifications with no change in product ingredients and content.

6. The authority makes major revisions as regards the extension of a permit document.

   1) Applicants shall submit additional documents compared to the current regulations. For instance, they shall provide original hygiene and nutrient analysis reports of the latest production batch issued by the original manufacturer or a food testing institution accredited by the central competent authority.

   2) Regarding the description of product usage, applicants shall follow the revised requirements for infant formula and follow-up infant formula. In addition, for formula for certain disease, the authority allows some exemptions to the clinical study report requirement. The two points are detailed in the later part of this article separately.

Revision to infant formula and follow-up infant formula only

1. Infant formula and follow-up infant formula products shall meet the specifications for energy and nutrients in Schedule 1 (illustrated in the draft amendment). If the product contains nutrients other than those in Schedule 1, scientific evidence or other references shall be provided.

2. Applicants seeking to extend a permit document for infant formula and follow-up infant formula shall follow the updated requirements as regards the description of product usage.

   1) Applicants shall submit a report issued or signed by the original manufacturer describing the situations of consumer usage of the product in Taiwan, China and overseas countries in the last five years.

   2) The report shall at least include: 

   i. the sales situations,

   ⅱadverse reactions reported in Taiwan, China and overseas countries, and

   ⅲ the latest results of inspection imposed on the original manufacturer by the competent authorities.

   3) In case the applicant is not able to provide the report within one year after the amendment and promulgation of the new Regulations, it is allowed to use the original substantiating document specified in the current regulations as a substitute.

Revisions to formula for certain disease only

1. TFDA modifies Schedule 2 with the new title “Nutritional Value for a Nutritionally Complete Food with Balanced Formula”.

   1) In the current schedule, the nutrient requirement is based on “1,500kcal”. It is modified to “per 100 Kcal” and “suggested daily intake” to support management practices. Accordingly, the value of the lower limit is changed.

   2) This schedule applies to nutritionally complete food and nutrition supplement formula food within the scope of formula for certain disease.

2. Applicants seeking to extend a permit document for formula for certain disease are exempted from clinical study report in the following cases:

• It belongs to applications for nutritionally complete food with balanced formula.

• The product is attached with clinical study report already.

Revisions on food additives

1. The “Regulation for Registration of Food Additives” is repealed and incorporated into this draft amendment.

2. The amendment stipulates the requirements for the review and registration, the extension, re-issuance and ownership transfer of registered permit document and modified registered items for food additives.