COMPLETE INFORMATION ON FUNCTIONAL FOOD DECLARATION

According to the latest regulations: Functional foods that want to be distributed to the market must be registered and declared according to the provisions of Decree 15/2018/ND-CP.

This article is for those who are interested in the issue of announcing this product group, with information about: Concept of product announcement, steps to make announcement, building a dossier... Don't forget to refer to it right away!

I. What is product declaration? Why is it necessary to declare functional foods?

1. Concept of functional food declaration

Product declaration is the declaration by the enterprise or individual manufacturing organization to the competent authority about the quality of imported or domestically produced products and whether they are allowed to circulate nationwide or not. This is a MANDATORY procedure that must be done before circulating the product on the market.

2. Why do functional foods need to be declared?

Functional foods are included in the list of products that must be declared before being put on the market according to Article 6 of Decree 15/2018/ND-CP. Specific regulations are as follows:

“Article 6. Registration of product declaration

Organizations and individuals producing and trading food must register product declarations for the following products:

Health protection food, medical nutritional food, food for special diets.
Nutritional products for children up to 36 months old.
Mixed food additives with new uses, food additives not on the list of additives permitted for use in food or not for the correct users as prescribed by the Ministry of Health".

The State's regulation requiring the declaration of functional foods not only helps ensure consumer safety but also promotes better business activities. The "guarantee" from product declaration will help increase consumer confidence in the product.

II. What types of functional food declarations are there?

According to regulations, health food declaration is divided into 2 types: Declaration of conformity and Declaration of compliance with regulations. Specifically:

Declaration of conformity

Applicable to functional foods that have technical regulations, must declare conformity and register the declaration of conformity with the Ministry of Health (specifically the Department of Food Safety) before circulating on the market.

Declaration of compliance with regulations

Applicable to functional foods that do not have technical regulations, must be declared in accordance with food safety regulations and registered with the Ministry of Health (specifically the Department of Food Safety) before being circulated on the market.

III. State regulations on functional food declaration

Some lines of functional foods are only allowed to circulate on the market when the competent state management agency has issued a receipt number for the Functional Food Product Declaration Form. Issues related to applying for a license to declare health protection foods are specifically regulated at:

Food Safety Law 2010
Law on product and goods quality 2007
Decree No. 15/2018/ND-CP guiding the Law on Food Safety
Decree No. 34/2017/ND-CP on product labels
Decree 115/2018/ND-CP Stipulating administrative sanctions for violations of food safety
Circular No. 43/2014/TT-BYT regulating the management of functional foods
Circular 18/2019/TT-BYT guiding Good Manufacturing Practice (GMP) in the production and trading of health protection foods.

IV. Full information on functional food declaration procedures

1. Conditions for performing functional food declaration procedures

To carry out the procedures for declaring Health Protection Foods, the entity conducting the declaration must meet the following conditions:

(1) The entity wishing to register for publication must have a business registration and be in the food production and trading industry.

(2) Food supplement manufacturing and trading establishments must have a Certificate of food safety qualified facility that meets Good Manufacturing Practice (GMP) requirements.

(3) Products must be quality tested to ensure compliance with safety standards issued by the Ministry of Health according to risk management principles in accordance with international regulations or safety standards according to corresponding regulations and standards by organizations and individuals in cases where there are no regulations of the Ministry of Health.

Note: For imported products, an Export Certificate or Health Certificate issued by the exporting country's authority is required.

2. Procedure for applying for a license to declare health protection foods

Step 1: Complete the profile

Step 2: Submit application to the Department of Food Safety

Step 3: The Food Safety Department receives and checks the application. Within 30 working days from the date of receipt of a complete and valid application, a Certificate of Acceptance of the Declaration of Compliance with Food Safety Regulations must be issued.

In case of not issuing a certificate of acceptance, a written response must be given stating the reason for not issuing it.

Step 4: Return the certificate of acceptance of food safety compliance to the organization or individual declaring the product.

3. What does the dossier for declaring domestically produced functional foods include?

Components of the dossier for declaring domestically produced health protection foods include: 2 sets of dossiers declaring compliance with food safety regulations and 1 set of general legal dossiers.

DOCUMENT OF CONFORMITY TO REGULATIONS

The Declaration of Conformity dossier includes:

(1) Declaration of compliance with food safety regulations (According to Decree No. 15/2019/ND-CP).

(2) Product information sheet (According to Decree No. 15/2019/ND-CP).

(3) Original or notarized copy of Product Test Result Certificate within 12 months.

(4) Product label sample.

(5) Finished product.

(6) Scientific documents proving the effects of Functional Foods or proving the effects of each ingredient that creates the function need to be published.

(7) Test results on product performance.

(8) Product quality control plan.

(9) Periodic monitoring plan.

GENERAL LEGAL DOCUMENTS

General legal documents include the following:

(1) Business registration certificate with food business line

(2) Certificate of food safety eligibility for importing establishments that are required to be granted a certificate of food safety eligibility according to regulations.

(3) Certificate of compliance with HACCP or ISO 22000 standards or equivalent in case the manufacturing organization or individual has a quality management system certified to comply with HACCP or ISO 22000 standards or equivalent.

Preparing a set of documents is relatively complicated, requiring the subject directly carrying out the declaration to be knowledgeable about the laws and regulations of the State, and have experience in completing documents related to product quality...

With the desire to help you complete your profile ACCURATELY - QUICKLY, NanoFrance has provided functional food declaration services. With the advantage of nearly 10 years of operation in the field of functional food production and having helped businesses produce nearly 1000 product lines, we are confident to provide you with the best quality service!

V. Save time and money with product announcement service at NanoFrance!

1. NanoFrance “makes” the product declaration process simpler than ever!

Instead of directly completing each type of document in the product profile, NanoFrance will support you:

(1) Detailed advice on the latest regulations on functional food declaration in Vietnam.

(2) Check the documents and papers provided by the customer, analyze and advise on adjustments to comply with the published regulations.

(3) Free support for service of building criteria and product testing.

(4) Build and optimize registration dossier

(5) Support businesses in submitting and monitoring the progress of documents at state agencies.

(6) Deliver the registration certificate to the customer.

2. 15-day commitment to "get results"

With a team of professional and experienced staff, NanoFrance will help you complete all procedures related to product declaration and receive the Certificate within 15 days.