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Food & Cosmetic Product
EU Food Contact Materials
Food containers and kitchen utensils are closely related to people's daily lives, but in fact, they may contain harmful chemicals to the human body that transfer during contact with food, thereby endangering human health.
At present, many European and American countries have issued strict food hygiene laws and regulations, so products that come into contact with food exported to these countries must strictly comply with the requirements of these regulations. The products involved include mixers, juicers, simple machines, toasters, electric kettles, electric coffee makers, microwave ovens, and so on.
NormalTCI can provide the following food container testing services:
● US Food and Drug Administration Regulation U S. FDA Regulations
● EU Directive 1935/2004/EC (formerly 2002/72/EC)
● German Food and Commodity Law LFGB (formerly known as LMBG)
● Italian Regulation DECREE 21-03-1973
● French regulation DGCCRF 2004-64
● Japan Food Hygiene Regulation
● Chinese National Food Hygiene Standards GB
In addition to the above standard tests, we can also provide personalized product safety and functional testing services upon customer request.
The latest revision of the EU Food Contact (EU) Regulation 2017/752
On April 29, 2017, the Official Journal of the European Union (OJ) published the revised Regulation (EU) 2017/752 on Plastic Products in Contact with Food (EU) 10/2011.
Implementation time and transition period
The migration limit for nickel has been added to Appendix II, which officially came into effect on May 19, 2019.
Revision Summary
Revise and add the list of authorized substances in Appendix I Table 1, delete the annotation "1" regarding compliance verification for substances numbered 142, 168, 202, 387, 462, 467, 481, 502, 662, and 779, and add six authorized substances for use.
For the newly added substance alpha tocopherol acetate with the code 1055, add footnote 24. This substance or its hydrolysis product is allowed to be used as a food additive, and its compliance with the requirements of Article 11, point 3 of the regulation should be verified.
Add the migration limit of nickel (Ni) element in Appendix II. The updated specific migration limits for heavy metals are shown in the following table:
Material elements | (EU)2011/10 (Currently) | (EU)2016/1416 (Effective September 14, 2018) | (EU)2017/752 (Effective May 19, 2019) |
AI | / | 1 | / |
Ba | 1 | / | / |
Co | 0.05 | / | / |
Cu | 5 | / | / |
Ni | / | / | 0.02 |
Fe | 48 | / | / |
Li | 0.6 | / | / |
Mn | 0.6 | / | / |
Zn | 25 | 5 | / |
The fourth point of Appendix III of the original (EU) 2011/10 has been replaced by the following content, and the revised version further clarifies the designated food simulants for the comprehensive migration test of food contact products expected to come into contact with various types of food.
Type of food | Food simulants |
All types of food | 1. Distilled water or equivalent quality water or food simulant A 2. Simulated substance B (3% acetic acid) 3. Simulated substance D2 (vegetable oil) |
All other food categories except acidic foods | 1. Distilled water or equivalent quality water or food simulant A (10% ethanol) 2. Simulated substance D2 (vegetable oil) |
All water-based, alcoholic foods and dairy products | Food simulant D1 (50%) |
All water-based, acidic, alcoholic foods and dairy products | 1. Food simulant D1 (50%) 2. Food simulant B (3% ethanol)) |
All water-based and alcoholic foods (with ethanol content ≤ 20%) | Food simulant C (20% ethanol) |
The conformity declaration in Annex VI of EU 2011/10 should include information on the use of materials or products in Article 8 (iii), replacing "food contact surface area to volume ratio" with "the strictest validated food contact surface area to volume ratio".
The European Union has released the second edition of the EDQM 2024 guidelines for metals and alloys in contact with food
The European Medicines Agency has released the EDQM (Metals and Alloys used in food contact materials and articles) 2024 for Food Contact Materials (FCM), replacing the old version CM/Res (2013) 9. This technical guideline has been widely recognized and used as a reference for the safety and quality of metal materials and products. It should be emphasized that this guideline document is currently an important compliance basis for EU metal and alloy materials in the FCM field!
The entire structure of the new guidelines has undergone significant adjustments compared to the old version, and is a supplement based on the quality and safety guidelines for food contact materials CM/Res (2020) 9. The guidelines include the CM/Res (2020) 9 resolution document and
Chapter 1: Definition, Range, and Specific Release Limits (SRLs) of Metals.
Chapter 2: Security Review and Suggestions.
Chapter 3: Analytical methods for release testing of food contact materials and products made of metals and alloys.
Main updates and changes
1. Chromium (Cr): The migration limit has been adjusted from 0.250 mg/kg to 1 mg/kg.
2. Manganese (Mn): The migration limit has been adjusted from 1.8 mg/kg to 0.55 mg/kg.
3. Thallium (Tl): The migration limit has been adjusted from 0.0001 mg/kg to 0.001 mg/kg.
4. Added information on zirconium (Zr) migration, with a migration limit of 2 mg/kg.
5. The migration testing conditions refer to the JRC guidelines "Test Conditions for Food Contact Kitchen Utensils: Plastic, Metal, Silicone Rubber and Rubber, Paperboard" Fourth Edition 2023 or its revised version.
Compliance Points
1、 Simulated liquid
Food Type | Simulated object |
Waterborne/alcoholic/fatty foods | Artificial tap water |
Acidic food (pH ≤ 4.5) | 0.5% citric acid |
2、Judgment rules
One use product: first migration amount ≤ SRL
Reusable products: The third migration amount is ≤ SRL, and the sum of the first and second migration amounts is ≤ 7 x SRL
3、 Control elements
Element | Migration Limit (SRL) | Element | Migration Limit (SRL) |
Al | 5mg/kg | Ti | --- |
Sb | 0.04mg/kg | V | 0.01mg/kg |
Cr | Adjust 0.250mg/kg to 1mg/kg | Zn | 5mg/kg |
Co | 0.02mg/kg | Zr | 2 mg/kg(new) |
Cu | 4mg/kg | As | 0.002mg/kg |
Fe | 40mg/kg | Ba | 1.2mg/kg |
Mg | --- | Be | 0.01mg/kg |
Mn | Adjust 1.8mg/kg to 0.55mg/kg | Cd | 0.005mg/kg |
Mo | 0.12mg/kg | Pb | 0.010mg/kg |
Ni | 0.14mg/kg | Li | 0.048mg/kg |
Ag | 0.08mg/kg | Hg | 0.003mg/kg |
Sn | 100mg/kg | Tl | Adjust 0.0001mg/kg to 0.001mg/kg |
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