Conditions to ensure safety for functional foods

Conditions to ensure safety for functional foods plays an important role in protecting consumer health, preventing the risk of poisoning and side effects. Compliance with standards on raw material origin, production processes, storage and labeling helps ensure product quality. Fully meeting safety conditions not only helps businesses comply with the law but also enhances reputation and creates trust for customers.

What are functional foods?

According to the provisions of Clause 23, Article 2 of the Law on Food Safety 2010, “Functional foods are foods used to support the functions of the human body, create a comfortable state for the body, increase resistance, reduce the risk of disease, including dietary supplements, health protection foods, and medical nutritional foods”.

According to Clause 1, Article 2, Circular 43/2014/TT-BYT, “Supplemented Food is a regular food supplemented with micronutrients and health-beneficial elements such as vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, prebiotics and other biologically active substances”.

Before November 9, 2023, the concept of health protection foods and medical nutritional foods is specified in Clause 2 and 3 of Circular 43/2014/TT-BYT as follows:

1. Health Supplement, Food Supplement, Dietary Supplement is a product processed in the form of capsules, tablets, tablets, paste, granules, powder, liquid and other processed forms containing one or a mixture of the following substances:

• Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other biologically active substances;
• Biologically active ingredients are naturally derived from animals, minerals and plant sources in forms such as extraction, isolation, concentration and metabolism.

2. Medical nutritional food, also known as nutritional food for special medical purposes (Food for Special Medical Purposes, Medical Food), is a type of food that can be eaten by mouth or by inhaler, designated to adjust the patient’s diet and used only under the supervision of medical staff.

However, currently, these two concepts have been abolished by Point đ, Clause 2, Article 7 of Circular 17/2023/TT-BYT, effective from November 9, 2023.

Conditions to ensure safety for functional foods today

Pursuant to Article 14 of the Law on Food Safety 2010, guided by Chapter IX of Decree 15/2018/ND-CP, conditions to ensure safety for functional foods are prescribed as follows:

1. Comply with the general conditions for ensuring food safety specified in Article 10 of the Law on Food Safety 2010, specifically:

• Meet corresponding technical regulations, comply with regulations on limits of pathogenic microorganisms, pesticide residues, veterinary drug residues, heavy metals, pollutants and other substances in food that can be harmful to human health and life.
• Depending on the type of food, food must also meet a number of other regulations such as: Regulations on the use of food additives and processing aids in food production and business; Regulations on food packaging and labeling; Regulations on food preservation.

2. There is information and scientific documents proving the effects of the ingredients that create the announced functions.
3. Functional foods that are put on the market for the first time must have an effective test report on the product’s uses.
4. The Minister of Health specifically regulates the management of functional foods (currently, the management of functional foods is implemented according to Circular 43/2014/TT-BYT, amended and supplemented by Circular 17/2023/TT-BYT).

Conditions for ensuring food safety in the production of health protection foods

Health protection food is a form of functional food. Conditions for ensuring food safety in the production of health protection foods are specified in Article 28 of Decree 15/2018/ND-CP as follows:

1. Health protection food production facilities must meet general conditions for ensuring food safety specified in Clause 1, Article 19, Clause 1, Article 20, Clause 1, Article 21 of the Law on Food Safety and the following regulations:

• Must establish and maintain a quality management system to control the production and distribution process to ensure that all products manufactured by the facility meet quality standards according to published standards and are safe for users until the end of their shelf life;
• Enough employees have professional qualifications appropriate to the assigned job positions and are trained in basic knowledge of GMP, food safety and related professional knowledge. The head of production and the head of quality control must be official personnel, working full-time for the facility and independent of each other. The person in charge of the facility must have a university degree or higher in one of the following majors: Medicine, Pharmacy, Nutrition, Food Safety, Food Technology and must have at least 3 years of working experience in the relevant specialized field;
• The factory system, equipment and auxiliary utilities are designed, built and installed in accordance with the intended use, according to the one-way principle, easy to clean, prevent and minimize the risk of confusion, avoid accumulation of dust, pollution and factors that adversely affect the product and maintain daily cleaning activities;
• Implement and save complete records and documents on production, quality control, circulation and distribution to retrieve the history of all product batches and records of all other activities performed at the facility;
• All production operations must be carried out according to procedures and instructions. Apply inspection and supervision measures during the production process to prevent and avoid the risk of confusion, pollution, and cross-contamination. Record the results immediately when performing the operation or immediately after completing the production step in the records;
• Have a quality control department to ensure products are manufactured under appropriate conditions and processes and meet established standards; The necessary tests have been performed; Raw materials are not approved for export for use, products are not approved for sale without being assessed to meet the required quality; Products must be monitored for stability;
• In case of testing or production under contract, the contract recipient must have enough factories, equipment and personnel to meet the transferor’s requirements and comply with the regulations of the competent management agency on conditions for testing or producing health protection foods;
• There are procedures for resolving complaints, product recalls, and self-inspection activities; Follow the process and record and keep complete records for these activities.

2. The Ministry of Health guides Good Manufacturing Practices (GMP) for health-protecting foods for health-protecting food manufacturers to apply.
3. Since July 1, 2019, health food production facilities must apply Good Manufacturing Practices (GMP) for health protection foods according to instructions from the Ministry of Health.

Frequently asked questions about conditions to ensure safety for functional foods

To help you better understand, here are some answers to our questions about conditions to ensure safety for functional foods, please refer to:

How are functional foods different from drugs?

Functional foods support body functions, increase resistance, reduce the risk of disease; Does not have the same therapeutic effect as medicine.

Is it necessary to prove the effectiveness of functional foods before circulation?

Yes, functional foods that are first circulated need to report on effectiveness testing for their declared uses.

What is GMP and is it mandatory for dietary supplement manufacturers?

GMP (Good Manufacturing Practice) is good manufacturing practice. From July 1, 2019, health food production facilities are required to have GMP.

What requirements do health food production facilities need in terms of personnel?

Need enough professional staff, full-time head of production and quality control, person in charge of expertise with a university degree or higher and 3 years of experience.

What does the factory system of a functional food manufacturing facility need to ensure?

The system needs a one-way design, easy to clean, prevents pollution, avoids dust and factors that adversely affect the product.

What records and documents need to be stored at health food production facilities?

Records and documents on production, quality control, circulation, distribution and other activities at the facility need to be fully archived.

What should the complaint resolution and product recall process be like?

Facilities need to have clearly defined procedures, follow the procedures and keep all relevant records.

How do I know if a functional food has been licensed for circulation?

The product must have full labels, information about the manufacturer, ingredients, uses and license number issued by the Ministry of Health.

What should consumers keep in mind when choosing to buy functional foods?

Choose to buy products with clear origins and reputable brands, carefully check the information on the label and consult experts.

Can dietary supplements completely replace a healthy diet?

No, dietary supplements are only a support, not a complete replacement for a balanced diet and healthy lifestyle.

Full service of applying for a Certificate of eligibility for food safety at Long Phan Consulting Company

Long Phan Consulting Company provides a comprehensive food safety facility application service, supporting businesses to complete procedures quickly and in accordance with regulations. Service scope includes:

• Consulting on licensing conditions: Guiding businesses to meet food hygiene and safety standards according to legal regulations.
• Prepare documents: Prepare complete documents, including license application, business license, environmental inspection contract, and related documents.
• Facility inspection support: Consulting on site layout, production processes, and equipment to meet food safety standards.
• Submit documents and work with authorities: Enterprise representatives process documents at competent authorities and monitor the approval process.
• Support to receive the appraisal team: Guide businesses to best prepare for the actual inspection process from the management agency.
• Receive and hand over the certificate: Ensures quick results, helping businesses start legal operations soon.

With a team of experienced experts, Long Phan Consulting Company is committed to providing professional services, saving time and costs.

Conclude

Conditions to ensure safety for functional foods help control quality, prevent health risks and ensure compliance with legal regulations. Enterprises that fully meet the standards will enhance brand reputation, create trust with consumers and facilitate product circulation. Long Phan Consulting Company supports businesses in completing food safety certification procedures. Contact the hotline 0906735386 for detailed advice.