European Union (EU) Regulation 10/2011, which is the most stringent and important law on food-grade plastic products, has extremely strict and comprehensive requirements on the standard of heavy metal limit for food contact products, and is the wind indicator of international food contact material safety risk control.
New EU Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food was published on 2011
Jan 15.This new regulation starts to effect on 2011 May 1. It repeals Commission Directive 2002/72/EC. There are several
transitional provisions and are summarized in Table 1.
Table 1
Transitional Provisions
Until 2012 Dec. 31
It may accept to place the following on the market
- the food contact materials and articles which have been lawfully placed on the market
FCM supporting documents transitional provisions
before 2011 May 1
Supporting documents shall be based on the basic rules for overall migration and specific migration testing set out in the Annex to Directive 82/711/EEC
From 2013 Jan. 1 to 2015 Dec. 31
Supporting document for materials, articles and substances placed on the market may be based on either the new migration rules stated in Regulation (EU) No. 10/2011 or the rules set out in Annex to Directive 82/711/EEC
From 2016 Jan 1
Supporting documents shall be based on the rules for migration testing set out in Regulation (EU) No. 10/2011
Note: 1. Content of the support document refers to Table 2, D
Table 2
A. Scope.
1. Material and articles and parts thereof consisting exclusively of plastics
2. Plastic multi-layer materials and articles held together by adhesives or by other means
3. Materials and articles referred to in pointed 1 & 2 that are printed and/or covered by a coating
4. Plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closure compose a set of two or more layers of different types of materials
5. Plastic layers in multi-material multi-layer materials and articles
B. Exemption
1. Ion exchange resin
2. Rubber
3. Silicones
C. Substances behind functional barrier and nanoparticles
Substances behind a functional barrier2
1. May be manufactured with substances not listed in the Union list
2. Shall comply with the restriction for vinyl chloride monomer Annex I (SML: Not detected, 1 mg/kg in finish product)
3. Non-authorized substances may be used with a maximum level of 0.01 mg/kg in food
4. Shall not belong to substances that are mutagenic, carcinogenic or toxic to reproduction without previous authorization
5. Shall not belong to nanoform
Nanoparticles::
1. Should be assessed on a case-by-case basis as regards their risk until more information is known
2. Substances in nanoform shall only be used if explicitly authorized and mentioned in Annex I
D. Supporting Documents
1. shall contain the conditions and results of testing, calculations, modelling, other analysis and evidence on the safety or reasoning demonstrating compliance
2. shall be made available by the business operator to the national competent authorities on request
E. Overall migration & Specific Migration Limit
1. Overall Migration
- 10mg/dm² 10
- 60mg/kg 60
2. Specific Migration (Refer to Annex I Union List – When there is no specific migration limit or other restrictions are provided, a generic specific migration limit of 60 mg/kg shall apply)
Union List
Annex I –Monomer and Additive
ANNEX I Contains
1. Monomers or other starting substances
2. Additives excluding colorants
3. Polymer production aids excluding solvents
4. Macromolecules obtained from microbial fermentation
5. 885 authorized substance
Annex II–General restriction on materials & Articles
Specific Migration of Heavy metal (mg/kg food or food simulant)
1. Barium (钡) =1
2. Cobalt (钴)= 0.05
3. Copper (铜)= 5
4. Iron (铁) = 48
5. Lithium (锂)= 0.6
6. Manganese (锰)= 0.6
7. Zinc (锌)= 25
Specific Migration of Primary Aromatic Amines (sum), Detection limit 0.01mg of substance per kg of food or food stimulant
Annex III-Food Simulants
10% Ethanol
Remark: Distilled water may be selected for some instances
Food Simulant A
food with hydrophilic character
3% Acetic Acid
Food Simulant B
acidic food
20% Ethanol
Food Simulant C
food up to 20% alcoholic content
50% Ethanol
Food Simulant D1
food containing > 20% alcohol content
milk product
food with oil in water
Vegetable Oil
Food Simulant D2
food have lipophilic character, free fats
Poly(2,6-diphenyl-p-phenyleneoxide), particle size 60-80mesh, pore size 200nm
Food Simulant E
dry food
Annex IV- Declaration of compliance (DOC)
1. shall be issued by the business operator and shall contain the information in as in ANNEX IV3
2. at the marketing stages other than at the retail stage, DOC shall be available for plastics materials and articles, products from intermediate stages of their manufacturing as well as for the substances intended for the manufacturing
3. Shall permit an easy identification of the materials, articles or products from intermediate stages of manufacture or substances for which it is issued
4. – The composition shall be known to the manufacturer of the substance and made available to the competent authorities on request
Annex V -Testing Condition
OM1 10d at 20° C 20
Any food contact at frozen and refrigerated condition
OM2 10d at 40° C
Any long term storage at room temperature or below, including heating up to 70° C for up to 2 hours, or heating up to 100° C for up to 15 minutes
OM3 2h at 70° C
Any contact conditions that include heating up to 70° C for up to 2 hours, or up to 100° C for up to 15minutes, which are not followed by long term room or refrigerated temperature storage.
OM4 1h at 100° C
High temperature applications for all food stimulants at temperature up to 100° C
OM5 2h at 100° C or at reflux/alternatively 1 h at 121° C
High temperature application up to 121° C
OM6 4h at 100° C or at reflux
Any food contact conditions with food stimulants A, B or C, at temperature exceeding 40° C
Remark: It represents the worst case conditions for all food simulants in contact with polyolefins
OM7 2h at 175° C
High temperature applications with fatty foods exceeding the conditions of OM5
Remark: In case it is technically NOT feasible to perform OM7 with food simulant D2 the test can be replaced by test OM 8 or OM9
OM8 Food simulant E for 2 hours at 175 ° C and food simulant D2 for 2 hours at 100 ° C
High temperature applications only
Remark: When it is technically NOT feasible to perform OM7 with food simulant D2
OM9 Food simulant E for 2 hours at 175 ° C and food simulant D2 for 10 days at 40 ° C
High temperature applications including long term storage at room temperature
Remark: When it is technically NOT feasible to perform OM7 with food simulant D2
Repeal of EU directive
1. 80/766/EEC, Commission Directive method of analysis for the official control of the vinyl chloride monomer level in material contact with food
2. 81/432/EEC, Commission Directive method of analysis for the official control of the vinyl chloride release by material and article into foodstuffs
3. 2002/72/EC, Commission Directive relating to plastic materials and article for foodstuffs
Post time: Oct-19-2021