Conditions for production of functional foods - State regulations

With the current rapid growth scale, functional foods are one of the potential industries for anyone who intends to do business. The large demand requires sufficient supply. For that reason, many factories producing this product line in Vietnam are being built. Currently, the state also has very strict regulations on the conditions for producing functional foods!

In this article, let's learn more about the regulations and conditions for businesses to be able to produce this special product line!

I. Conditions for production of functional foods - Legal basis

The competent authorities have specific regulations on the conditions for producing functional foods at:

→ Clause 2, Article 14 of Circular 43/2014/TT-BYT regulating the management of functional foods
→ Article 11, 28 of Decree 15/2018/ND-CP detailing the implementation of a number of articles of the Law on Food Safety
→ Clause 1, Article 34 of the Food Safety Law 2010
→ Section 1 Chapter IV Food Safety Law 2010

To be able to produce functional foods, businesses and factories must fully meet the above regulations of the State.

II. Update: Specific conditions for the production of functional foods

Businesses must meet two major conditions to be able to produce dietary supplements, which are:

• Conditions on production facilities
• Complete legal documents

Let's find out more details!

1. Conditions for production of functional foods on production facilities

About infrastructure

a. Environmental location

The production location and environment must have enough space to accommodate the food production area. Auxiliary and convenient areas for production and storage activities must be ensured.

Production area must be clean, dry, not flooded or stagnant.

In particular, the products must be regularly cleaned and not affected by animals, insects or harmful microorganisms.

The facility must ensure that it does not affect the surrounding environment.

Unaffected by areas polluted with dust, toxic chemicals and other sources of pollution.

NanoFrance GMP-certified dietary supplement factory

b. Factory design

The production workshop must be designed and built according to a suitable model, with enough space to arrange the equipment of the food production line and suitable for the design function of the facility.

The production process of functional foods ensures proper standards from the first step of selecting raw materials to the final product.

There are departments and areas from warehouse, production room, raw material warehouse, finished product warehouse; food preparation, processing, packaging area; hygiene area... each area must be separated.

There is a system of internal roads, toilets, and sewers to ensure a closed and clean system.

Wastewater collection area outside the factory ensures hygiene and does not pollute the surrounding environment.

c. Factory structure

The factory structure is sturdy, suitable for the scale and technological process of food production.

All materials in direct contact with food must have smooth, waterproof surfaces, not release toxic substances into food, be less susceptible to corrosion caused by detergents and disinfectants, and be easy to clean and disinfect.

Factory walls must be clean, flat, free of mold, cracks, dirt and easy to clean.

The floor is flat, smooth, well-drained, impermeable and easy to clean.

d. Lighting system

Lighting must be sufficient to meet production requirements and control product quality. Light bulbs must be fitted with safety covers to avoid breakage.

f. Water supply system

Ensure adequate clean water for food production and hygiene needs. Ensure adequate water supply for daily life, cleaning of tools and users during production and compliance with technical standards for food quality.

g. Steam and compressed air

Must be safe, clean and disease-free. Water systems must have separate pipelines. Never connect water systems used for food production to water systems used for steam production, refrigeration, fire prevention, fire fighting or other purposes.

h. Waste treatment system

There are enough tools to handle waste according to standards, with distinguishing symbols for each type according to regulations of environmental protection law. The waste treatment system must be operated regularly. Waste is treated to meet environmental hygiene standards.

i. Toilets, protective gear

Toilets must be separated from the finished product production area and have ventilation. Avoid ventilation from toilets to production areas, and have separate rooms for changing protective clothing.

Specific regulations for production tools

Equipment and tools used directly must be designed to meet the requirements of production technology. They must be safe, not contaminate food, easy to use, easy to clean, disinfect and maintain. Equipment and tools must be durable, strong, easy to move, easy to disassemble and clean.

Adequate hand washing and sanitizing facilities, soap or disinfectant, boots, shoes and slippers must be available before entering food production areas, and disposable paper towels or hand dryers must be provided.

Food production equipment and tools must be complete and suitable, and can be made of non-toxic, non-abrasive, rust-free, durable materials. They must be easy to clean and not contaminate food with lubricating grease or metal debris.

Prevent insects and pests with effective equipment. Do not use drugs or animals to kill rats, insects and pests in the production area.

Modern and safe monitoring, measuring and instrumentation equipment. There is equipment to monitor quality and food safety and is regularly tested. The equipment used ensures absolute accuracy and is individually tested.

The use of cleaning and disinfecting agents must be in easily identifiable and approved packaging. Instructions for use must be provided and must not be kept in food production areas for each type.

2. Complete legal documents

Full legal documents – SUFFICIENT conditions for producing functional foods

A production facility is only a necessary condition. To produce functional foods, businesses need to complete all legal documents and records. To apply for a certificate of eligibility to produce functional foods, the application must include:

→ Have a business registration certificate with food business line

→ Have a certificate of facility meeting food hygiene and safety conditions as prescribed in Circular No. 26/2012/TT – BYT

→ Functional products must be granted a certificate of conformity to food safety regulations according to the provisions of Decree 38/2012/ND-CP detailing the implementation of the food safety law.

According to the latest regulations: To be able to produce dietary supplements, facilities are required to receive a Good Manufacturing Practice (GMP) certificate.

In case the enterprise has been granted GMP, it may be exempted from the Food Safety Certificate.

After having the Certificate of Eligibility, the enterprise needs to complete the application to apply for a license to produce and trade dietary supplements.

Which state agency should I go to to apply for a license to produce dietary supplements?

Normally, to be licensed to produce functional foods, the Food Safety Department (VFA) will issue a license. Accordingly, the legal documents for production activities must include all of the following:

• Declaration of compliance with food safety regulations
• Detailed product information (with seal of organization or individual)
• Product testing results within 12 months, including product quality indicators and safety indicators
• Periodic monitoring plan and must be confirmed by the organization or individual
• Complete product sample for comparison when submitting application
• Business registration certificate according to standards issued by the Ministry of Health
• Certificate of facility qualified to produce products, ensuring food safety for importing facilities.
• Certificate of conformity to HACCP or ISO: 22000 standards (or equivalent).

Above are the conditions for producing functional foods that any business wishing to join the industry needs to know. Remember to regularly follow the NanoFrance Website to update more information, industry knowledge, and the latest medical knowledge!