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Food Contact Materials (FCM) Comprehensive Analysis
Food Contact Materials (FCM) Comprehensive Analysis




Food Contact Materials (FCM) refer to materials that come into direct, indirect, or potential contact with food during normal use. As they interact with food, their safety directly affects food safety, which is a critical control point for businesses.

Products related to food contact materials include food packaging, tableware, kitchenware, food processing machinery, kitchen appliances, etc. Food contact materials encompass: plastics, resins, rubber, silicone, metals, alloys, paper, cardboard, glass, ceramics, enamel, colorants, printing inks, etc.


As materials that come into direct or indirect contact with food, during the production, storage, transportation, and other processes of food, food contact materials and articles not only affect the sensory characteristics of food but may also introduce non-food components through the migration of toxic and harmful substances (such as heavy metals, toxic additives), thereby affecting food safety and even endangering human health. Therefore, every country has relatively strict requirements for food contact materials, and the standards and certifications vary from country to country.


China GB4806 Testing


gb


What are the GB4806 test items?

• Evaporation residue in different food simulants

• Potassium permanganate consumption

• Heavy metals (as lead)

• Decolorization test

• Heavy metal leaching test: such as lead, cadmium, arsenic, chromium, nickel, etc.

• Toxic and harmful monomer residues: such as vinyl chloride monomer, acrylonitrile monomer, etc.

• Microbial testing


GB4806 Series Product Testing Standards


Standard No. Standard Name
GB 4806.1-2016 General Safety Requirements for Food Contact Materials and Articles
GB 4806.2-2015 National Food Safety Standard - Pacifiers
GB 4806.3-2016 National Food Safety Standard - Enamel Products
GB 4806.4-2016 National Food Safety Standard - Ceramic Products
GB 4806.5-2016 National Food Safety Standard - Glass Products
GB 4806.6-2016 National Food Safety Standard - Plastic Resins for Food Contact
GB 4806.7-2023 Plastic Materials and Articles for Food Contact
GB 4806.8-2022 National Food Safety Standard - Paper and Paperboard Materials and Articles for Food Contact
GB 4806.9-2023 Metal Materials and Articles for Food Contact
GB 4806.10-2016 National Food Safety Standard - Coatings and Coatings for Food Contact
GB 4806.11-2023 Rubber Materials and Articles for Food Contact
GB 4806.12-2022 National Food Safety Standard - Bamboo and Wood Materials and Articles for Food Contact
GB 4806.13-2023 Composite Materials and Articles for Food Contact
GB 4806.14-2023 Composite Materials and Articles for Food Contact


South Korea Food Grade Testing MFDS


MFDS

MFDS is the Korean government agency responsible for the safety supervision of food, drugs, medical devices, cosmetics, and related materials. All food contact materials (FCM) entering the Korean market, such as plastics, rubber, metals, coatings, ceramics, paper, etc., must comply with MFDS regulations and testing requirements.


MFDS General Standards for Food Grade Testing in South Korea

Item Description
Heavy Metal Limits The total amount of lead (Pb), cadmium (Cd), mercury (Hg), and hexavalent chromium (Cr(VI)) in the contact surfaces of synthetic resins, regenerated cellulose (e.g., cellulose film), rubber, paper, and starch products shall not exceed 100 mg/kg.
Tin Coating Lead Content Lead in tin coating shall not exceed 0.1%.
Material Coloring and Printing Set leaching test conditions (temperature, time, medium) according to different business purposes.
Phthalate (Plasticizer) Restrictions If printing or coloring is only for decoration and does not migrate to food, it can generally be used. However, color materials must be food additives permitted by MFDS, or safe materials such as fused glazes, glass, enamel, etc.
Phthalate (Plasticizer) Restrictions DBP, BBP, BPA shall not be used in the manufacture of baby bottles and nipples.

Japanese Food Contact CE Certification (JFSL370 Directive)


Japanese food contact material testing regulations are managed by the Japanese Ministry of Health, Labour and Welfare under the Japan Food Sanitation Law 370 (JFSL370). JFSL 370's control scope for food-grade materials mainly includes rubber, metal, glass, ceramics, enamel glaze, plastic, paper, organic coatings, and wood materials. Different test materials in Japanese JFSL370 have different testing items.


Common Testing Items for Japanese Food Contact Materials

67Overall Migration Test: Total amount of migratable substances in materials.

67Specific Migration Test: Such as heavy metals like lead, cadmium, mercury, arsenic, or specific chemical additives.

67Solvent Residue and Volatile Substance Detection: Ensuring no harmful residues from production processes.

67Sensory Test: Evaluating if materials affect food odor or taste.


Applicable Materials for Japanese Food Contact

678副本Plastics (containers, films, coatings, etc.)

678副本Metals (cutlery, stainless steel products)

678副本Ceramics, Glass

678副本Rubber, Paper, Coating Materials


German LFGB Testing

lfgb

LFGB is the German Food and Feed Law; products related to food entering the German market must obtain LFGB approval. Food contact material products commercialized in Germany must pass relevant testing requirements and obtain LFGB test reports.


LFGB Testing Applicable Standards


Standard Testing Items
DIN EN 1186
Plastic Overall Migration Test
DIN EN 13130
Plastic Specific Migration Test
DIN 51032
Ceramic Lead and Cadmium Migration Test


The core of LFGB testing is sensory + chemical migration + physical performance testing, ensuring food contact materials do not pose health risks under normal use conditions.


EU Food Contact Material Testing


The EU has issued Regulation (EC) No. 1935/2004 concerning materials and articles intended to come into contact with food. Materials exported to the EU that come into contact with food must comply with relevant standards.


EU Food Contact Material Regulations and Testing


Material Regulatory Basis Main Testing Requirements
Plastic (EC) No. 1935/2004 + (EU) No. 10/2011 Overall Migration Test
Ceramics, Glass (EC) No. 1935/2004 + 2005/31/EC Lead and Cadmium Release Test
Silicone Rubber (EC) No. 1935/2004 + AP(2004)5 Overall Migration Test
Melamine Resin (EC) No. 1935/2004 + AP(2004)5 Overall Migration Test; Formaldehyde Release Test
Organic Coating (EC) No. 1935/2004 + AP(2004)1 Overall Migration Test
Rubber (EC) No. 1935/2004 + AP(2004)5 & 93/11/EEC Overall Migration Test; Nitrosamine Content Test; Aromatic Amine Migration
Paper (EC) No. 1935/2004 + AP(2002)1 Pentachlorophenol Test; Antimicrobial Efficacy Test; Heavy Metal Test
Wood (EC) No. 1935/2004 Pentachlorophenol Test; Formaldehyde Release Test
Metal, Alloys, and Electroplating (EC) No. 1935/2004 Heavy Metal Release Test


US FDA Testing

fda

What is FDA Testing?


The US Food and Drug Administration (FDA) manages drugs, food, biological products, cosmetics, veterinary drugs, medical devices, and diagnostic products. FDA defines Food Contact Substances (FCSs): If a substance can be used as a component in food production, packaging, transportation, or support materials without any technical effect on the food, it can be called a food contact substance.


What Products Require FDA Testing?


US FDA testing applies to materials and products that come into contact with food during processing, production, packaging, storage, transportation, and use, including products made of: plastics, metals, ceramics, paper, enamel, plastic, rubber, silicone, glass, wood, bamboo, natural/chemical fibers, organic coating products, etc.


FDA Food Contact Material Corresponding Regulations


Material Category Relevant Regulations (21 CFR) Testing Focus
Coatings and Adhesives 175.300, 175.105 Overall Migration, Specific Monomer and Additive Residue
Paper and Paperboard 176.170 (lipid/water foods), 176.180 (dry foods) Overall Migration Test, Heavy Metals, Plasticizers
Plastics and Polymers 177.1010 (acrylic plastics), 177.1520 (polyolefins), 177.1580 (polyesters), 177.2600 (rubber products) Monomer Residue, Specific Migration, Overall Migration
Sealing Materials/Gaskets 177.1210 Volatiles, Migrants, Specific Chemical Substance Limits
Additives and Auxiliaries 178.2010 (antioxidants), 178.3297 (color masterbatches) Specific Migration Limits (SML), Dissolution Testing


French DGCCRF Testing

DGCCRF testing is the English abbreviation for French food-grade safety regulations. For food contact products sold in France, in addition to complying with EU Regulation (EC) No 1935/2004, they must also comply with local French regulations, including French DGCCRF 2004-64 and French Décret no 92-631. French regulations not only have special requirements for plastic and rubber products in food contact products, but also have special classifications and requirements for metal products. For example, for cookware with organic coatings, in addition to testing the coating surface, there are corresponding requirements for the metal substrate.


Common DGCCRF Test Requirements


Material Category Document Number Common Test Items Limits/Requirements
Plastic, Rubber, Composite Materials DM/4B/COM-003 - Overall migration test (10%/3% acetic acid, 50% ethanol, vegetable oil, etc.)
- Specific migration test: formaldehyde, formamide, VOM (volatile organic compounds)
- Heavy metal detection (lead, cadmium, chromium, etc.)
According to different food simulant migration limit requirements
Metal and Alloy DM/4B/COM-001 - Heavy metal dissolution determination (stainless steel, aluminum alloy, etc.)
- Stainless steel chromium content requirements
- Electroplated parts need to test coating and substrate separately
- Stainless steel should contain Cr ≥ 13%
- Dissolution amount complies with DGCCRF requirements
Ceramic, Glass, Enamel DM/4B/COM-002 - Specific metal migration: aluminum, cobalt, arsenic
- Continuous migration test using 4% acetic acid, take the 3rd migration result
- Al < 1 mg/kg
- Co < 0.02 mg/kg
- As ≤ 0.002 mg/kg
Paper and Paperboard DM/4B/COM-004 - Overall migration limit
- Specific migration test (using different simulants: water, acetic acid, Tenax/MPPO, 50%/95% ethanol, isooctane)
- Coated paperboard ≤ 10 mg/dm²
- Uncoated paperboard ≤ 60 mg/kg


Italian DM Testing


dm


Italian DM 21373 applies to materials in contact with food. The Italian regulation is "Italian Decree No. 777 of 1982", which covers the Ministerial Decree DM 21373 and its subsequent updates as legal requirements for food contact materials.


Italian food-grade requirements for plastic materials align with EU Directive 2002/72/EC. In addition, this decree has some national requirements. For example, rubber, silicone, glass, and stainless steel are outside the scope of EU regulations, but the Italian decree makes specific requirements for them.


Main Italian DM Test Items

67Overall Migration Test (OML): Evaluate the total migration of non-volatile substances from the material, unit mg/dm² or mg/kg.

67Specific Migration Test (SML): Detect the migration of specific harmful substances (such as heavy metals, monomers, plasticizers).

67Sensory Test: Ensure the material does not alter the odor or taste of food.

67Specific Material Testing: For example, rubber requires nitrosamine testing, metals require nickel, lead, cadmium release testing, etc.


National Food-Grade Testing Process:


789Fill out the test application form

789Determine the product material, actual use and conditions, and types of food it may contact

789Provide test samples

789Arrange testing

789Issue test report


Compliance of food contact materials is a necessary threshold for companies to enter the international market. Choosing testing standards that comply with the regulations of the export destination country is key to ensuring smooth customs clearance and market access.

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