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How to Comply with Food Contact Regulations in Korea

By Little Pro on 2017-09-04 Views:  Update:2017-11-20

In Korea, there is no official positive list of substances or additives that are permitted for use in manufacturing food contact materials or articles. However, the Ministry of Food and Drug Safety (MFDS) has established standards and specifications for various food contact materials and their raw materials. Some hazardous substances are restricted or banned depending on the type of food contact materials and intended applications. In this article, we will show you how to comply with those food contact safety standards and specifications and how to access them.

Overview of Food Contact Regulations in Korea

The Article 8 of Korean Food Sanitation Act prohibits the manufacture, import, or sale of food-related apparatus, containers or packages that contain poisonous or harmful materials that are likely to cause harm to humans. The Act also authorizes MFDS to enforce the law and establish regulations, standards and specifications for food-related products such as food additives, food packaging materials and food containers. 

The most important standard for food contact materials is Standards and Specifications for Food Utensils, Containers and Packages.  The standard consists of 3 main parts:

  • common standards and specifications
  • specifications for individual materials
  • testing methods.

 More info can be found below:

Category Description

 

Common standards and specifications

 

  • General requirements for apparatus, food containers and packaging, and their materials. Some main requirements are listed below:
  • Tin plating used in food contact surface of utensils, containers and packages shall not contain more than 0.1% of lead.
  • Food contact surface shall not be printed in the manufacture of utensils, containers and packages.
  • Utensils, containers and packages of synthetic resin products, cellophane products, rubber products, paper products, and starch products shall not contain more than 100 mg/kg(as sum) of lead, cadmium, mercury and hexavalent chromium.
  • Di-(2-ethylhexyl)phthalate(DEHP) shall not be used in the manufacture of utensils, containers and packages except that migration into food can be excluded.
  • Di-n-butylphthalate(DBP), benzyl-n-butylphthalate(BBP) and bisphenol A(BPA) shall not be used in the manufacture of feeding bottles(including nipples).
  • Colorant for manufacturing of utensils, containers and packages shall not use other than permitted as food additives, except the case that colorant are melted glaze, glass, enamel, or there is no possibility that colorant migrates into foods.
  • Substances used for lubrication of food machines and utensils can be food, food additives and substances registered on Code of Federal Regulation (CFR) of the United States for lubrication purpose.

 

Specifications for individual materials

  • Specifications include limit on residue content, hazardous substance migration and testing methods that can be used to demonstrate compliance. 
  • Available for 38 types of synthetic resins such as PE, PPE, PVC, PET, etc; and
  • Other materials: cellophane, rubber, paper or processed pape, metal, wood, glass, ceramic, porcelain enamel and pottery, and starch.

Testing methods

 

  • Those testing methods are aimed at ensuring that finished food contact materials meet various specifications, e.g., heavy metal content, migration of hazardous substances and total non-volatile extractives.
  • The solvents and time/temperature conditions used in the testing are based on the intended applications of the packaging material.

Note: To access the complete standard and specification (in English), please click here.

Example: Specifications for PVC

We will use PVC as example to show what specifications look like for individual food contact materials. The specifications below apply to polyvinyl chloride (PVC) containing more than 50% of vinyl chloride. 

Specification Description

Residue specification (mg/kg)

  • Vinyl chloride : not more than 1;
  • Dibutyltin compound : not more than 50(as dibutyltin dichloride);
  • Cresol esters of phosphoric acid : not more than 1,000

 

Migration specification (mg/L)

 

  •  Lead : not more than 1;
  • Consumption of potassium permanganate : not more than 10
  • Overall migration : not more than 30(However, not more than 150 if n-heptane is used as the food simulant) ;
  • Di-butylphthalate : not more than 0.3;
  • Benzyl-n-butylphthalate : not more than 30;
  • Di-(2-ethylhexyl)phthalate : not more than 1.5;
  • Di-n-octylphthalate : not more than 5;
  • Diisononylphthalate and Diisodecylphthalate : not more than 9(as sum);
  • Di-(2-ethylhexyl)adipate : not more than 18 

 

Testing methods

 

  • IV. 2. 2-16 Vinyl chloride test method a. residue test
  • IV. 2. 2-17 Dibutyltin compound test method
  • IV. 2. 2-18 Cresol esters of phosphoric acid test method
  • IV. 2. 2-1 Lead test method b. migrant test
  • IV. 2. 2-7 Consumption of potassium permanganate test method
  • IV. 2. 2-8 Overall migration test method
  • IV. 2. 2-19 Phthalate test method

Note: If you could not find a material-specific standard for your material or product, you will need to submit your product info to the MFDS to develop a new standard.

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References

 

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