WHAT ARE THE REQUIREMENT ON MANUFACTURING AND TRADING ANTIBACTERIAL FABRIC MASK (NOT MEDICAL MASK)?

In the situation of the epidemic, I have found a source of raw material for producing fabric mask. So, I intend to produce and sell antibacterial fabric face mask (not medical mask). I would like to know if I have to establish a company and the requirements I have to meet to produce and sell this product.

I look forward to hearing from FDVN Law Firm. Thank you and best regards.

FDVN’s opinions:

Thank you for concerning FDVN legal services. Base on your consulting requirements, after studying the legal documents, FDVN Law Firm offers the following opinions:

[1]. Legal provisions on the subjects required to register their business

According to Clause 1, Article 2 of the Decree No. 39/2007/NĐ-CP on individuals doing trade independently and regularly who do not have to register for their businesses:

“1. Individuals doing trade mean individuals who every day themselves conduct one, several or all activities allowed by law on goods purchase and sale, service provision and other activities with the purpose of profitability but do not register their business as prescribed by law on business registration and not be called as “trader” as prescribed by the Commercial Law. Particularly including individuals doing the following trade activities:

a) Street trading (trading in public places) means activities of purchase and sale without a fixed location (purchase on street, sale on street or both purchase and sale on street), includes even the receipt of books, news, magazines, cultural products of traders allowed doing business in these products as prescribed by law, for sale on street;

b) Petty trading means to purchase and sale of small and odd items with or without a fixed location;

c) Petty-food trading means sale of fruits, cakes, candies, drinks (beverage) with or without a fixed location;

d) The consignment trading means the purchase of goods from other places according to each consignment to sell for wholesalers or retailers;

dd) Providing services: Polishing shoes, selling lottery tickets, repairing key, repairing vehicles, safekeeping for vehicles, washing for vehicles, barber, painting, taking photo and other services with or without fixed locations;

e) Other commercial activities done independently and regularly do not have to register for business.”

Besides, according to Article 66 of Decree No. 78/2015/NĐ-CP on enterprise registration, there are the cases not required to register their business:

“1. Business household owned by an individual, a group of individuals being Vietnamese citizens from 18 years of age or older, have full civil capacity, or owned by a household may only register one business location, employs fewer than 10 employees, and take responsibility for the business operation with all of their property.

2. Households engaged in agriculture, forestry, aquaculture, salt productions, street vendors, nomadic businesspeople, and service providers earning low revenues are not required to register, except for conditional business lines. The People’s Committees of provinces shall specify the low revenues applied within their provinces.

3. Any business household that hires 10 employees or more must apply for enterprise registration as prescribed.”

Therefore, notwithstanding that you do business as an individual or set up a business household in the field of manufacturing and trading antibacterial fabric face masks, you have to register your business because you don’t fall into the cases specified in Clause 1, Article 3 of the Decree. No. 39/2007/NĐ-CP and Article 66 of Decree No. 78/2015/NĐ-CP above.

[2]. Regulations on the technical standards for the production of antibacterial fabric face masks (not medical masks)

Pursuant to Decision No. 870/QD-BYT on temporary technical guidelines for fabric anti-droplet and bacteria prevention facemasks:

“3. Technical requirements

3.1. General provisions

- Face masks must not cause any allergic reactions to the wearers;

- Surfaces of face masks must be clean, free of snags, pills and having no visual flaws:

- Ear bands must be firmly structured;

- Shapes and size must be able to completely cover the nose and mouth, edges of face masks must fit the face of the wearer without any gap.

3.2. Structure and requirements for materials

3.2.1. Structure:

- At least 3 layers: the outermost layer must be waterproof, preventing droplets or combined with preventing bacteria; other layers are filter and antibacterial layers (the bacteria prevention layer shall be made from antibacterial fabric, silver nano, activated carbon or equivalent materials);

- Ear bands;

3.2.2. Requirements for materials

3.2.2.1. The outer layers must be smooth, airy, waterproof, and capable of preventing respiratory droplets.

3.2.2.2. The antibacterial layer for preventing bacteria.

3.2.2.3. The filter layer must be layer airy and dust resistant.

3.2.2.4. Ear bands: made of elastic materials, namely rubber bands to aid and guarantee wearing and taking off of face masks.

3.3. Technical requirements of face masks

3.3.1. Droplet resistance: Filtering capacity for aerosol in 30 l/min flow rate must not be lower than 90% (testing method under Section 2.1 of Annex);

3.3.2. Breathing resistance: Breathing resistance in 30 l/min flow rate must not be lower than 9 mm water (testing method under Section 2.1 of Annex);

3.3.3. Antibacterial property:  The antibacterial property of fabric face masks shall be identified according to the declaration of manufacturers (with experiment results attached).

3.3.4. Permissible limit of heavy metal elements in non-woven fabric; Conform to Article 3.5 - TCVN 8389-1 (may accredit equivalent experiment results under Section 2.3 of Annex).

4. Packaging and labeling

4.1. Packaging

According to the declaration of manufacturers, individual packaging is recommended, ensuring sterility of face masks when packaging.

4.2. Labeling

- Comply with applicable regulations and laws on product labeling.

- Based on the technical basis of these Guidelines, organizations and individuals operating in manufacturing and construction shall develop, publicize base standards and comply with product quality requirements according to Law on Quality of Goods and Products and applicable regulations and law.”

Therefore, in order to do business in the field of manufacturing and trading antibacterial fabric masks, you have to register your business and comply with the technical requirements as analyzed above.

This is FDVN Law firm's opinion for your request basing on studying the relevant legal provisions. Hopefully, our advice will be useful for you.

Legal expert: Dinh Thi Thong

FDVN Law Firm

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