EU Regulations for Food Contact Materials

1935/2004/ EC

The European Union legislation on food contact materials began in the 1970s, the first directive is 76/893 / EEC, this directive is a framework which is to coordinate each member in the fields of legislation, make a consistent trend between different national mandatory technical requirements. The current laws and regulations is (EC) No. 1935/2004 (Regulation No. 1935/2004/ EC of The European Parliament And of The Council of 27 October 2004), which is promulgated on November 13th, 2004 and passed by the European Parliament and the European union Council. So far, the European Union involves food contact materials and products of the instruction or regulations have accumulated morethan 30.

1935/2004 / EC defined the following conditions of the product/material contacted with food: it must accord with Good Manufacturing practices (GMP), when the product contact food, shall not:

1. Release dangerous composition to human health

2. Lead food to change ingredients which can’t be accepted

3. Reduce the sensory characteristics brought by food (make food taste, smell, color change)

Some EU member states, such as Germany, France, etc., in addition to strictly follow the EU 1935/2004, still have alocal food grade regulations must be followed, such as Germany LFGB (LMBG), France French DM/4B/COM/001-DM/4B/COM/004 and Italy bulletin (Gazzetta Ufficiale G.U) legal NO. 283 OF 30/40/1962 and local laws 21/03/1973(D.M. 21/03/73), etc.

EU Regulations for Food Contact Materials

EU Regulations for Food Contact Materials

NoMaterialsTest ItemsLimitsRegulation
1PlasticsOverall   Migration-10%Ethanol10mg/dmor 60mg/kg(For children products)(EU)No.10/2011 and  its amendments
Overall   Migration-3%Acetic acid
Overall   Migration-20%Ethanol
Overall   Migration-50%Ethanol
Overall   Migration-Vegetable oil
Overall   Migration-MPPO
Barium1 mg/kg
Cobalt0.05 mg/kg
Copper5 mg/kg
Iron48 mg/kg
Lithium0.6 mg/kg
Manganese  0.6 mg/kg
Zinc5 mg/kg
Aluminium  1mg/kg
Nickel0.02 mg/kg
Ammonium salt
Calcium
Magnesium
Potassium
Sodium
LeadND(DL=0.01mg/kg)
CadmiumND(DL=0.002mg/kg)
ArsenicND(DL=0.01mg/kg)
MercuryND(DL=0.01mg/kg)
ChromiumTo verify compliance with the Regulation, the detection limit of 0,01 mg/kg shall apply for total chromium. However if the operator that placed the material on the market can prove on the basis of pre-existing documentary evidence that the presence of hexavalent chromium in the material is excluded because it is not used or formed or during the entire production process, a limit for the total chromium of 3,6 mg/kg food shall apply.  
Antimony0.04mg/kg
EuropiumThe sum of all lanthanide substances migrating to the food or food simulant does not exceed the specific migration limit of 0,05 mg/kg;
Gadolinium
Lanthanum
Terbium
Primary   Aromatic Amines(PAA)There are 22 kinds and 1,3phenylenediamines in 43 items of reach appendix 17, a total of 23 kinds, each PAA: 0.002mg/kg;Other total reporting limit: 0.01mg/kg.
Phthalates   Content(5P:DEHP/BBP/DBP/DINP/DIDP)DEHP:0.1%/BBP:0.1%
  DBP:0.05%/DINP:0.1%
  DIDP:0.1%
Specific  Migration  of Phthalates (5P:DEHP/BBP/DBP/DINP/DIDP)DEHP:1.5mg/kg
  BBP:30mg/kg
  DBP:0.3mg/kgDINP+DIDP:9mg/kg(sum)
VCM ContentN.D. (1 mg/kg)
Specific   Migration of AcrylonitrileN.D. (0.01  mg/kg)
Specific  migration  of BPA0.05 mg/kg
BPA ContentN.D (Polycarbonate baby bottle, sucking cup)
Specific   migration of Formaldehyde15mg/kg
Specific   migration of melamine2.5mg/kg
Specific   migration of caprolactam15mg/kg
Specific  migration  of

Hexamethylenediamine
2.4mg/kg
2Ceramic, glassSoluble   Pb & CdRequirements   are different of each shape, please call us for counseling84/500/EEC
  2005/31/EC

3
SiliconeOverall   Migration-10%Ethanol10mg/dm2  or 60mg/kg(For children products)AP2004-5
Overall   Migration-3%Acetic acid
Overall   Migration-20%Ethanol
Overall   Migration-50%Ethanol
Overall   Migration-Vegetable oil
Overall  Migration-MPPO
4CoatingOverall   Migration-10%Ethanol10mg/dm2  or 60mg/kg(For children products)AP2004-1
Overall   Migration-3%Acetic acid
Overall   Migration-20%Ethanol
Overall   Migration-50%Ethanol
Overall   Migration-Vegetable oil
Overall   Migration-MPPO
Specific  migration  of BPAN.D(Varnishes or coatings contact with infant and young  children food)0.05 mg/kg  (Other coating)(EU) 2018/213
5RubberOverall   Migration-10%Ethanol10mg/dm2  or 60mg/kg(For children products)AP2004-4
Overall   Migration-3%Acetic acid
Overall   Migration-20%Ethanol
Overall   Migration-50%Ethanol
Overall   Migration-Vegetable oil
Overall   Migration-MPPO
N-nitrosamines   and N-nitrosatable substancesN.D.
Primary  Aromatic  Amines(PAA)N.D.
6Paper and  Paper BoardPb,Cd,HgPb:0.003mg/dm2
  Cd:0.002mg/dm2
  Hg:0.002mg/dm2
AP2002
PCP0.15mg/kg
SM  of  Formaldehyde15mg/kg
Preserving   effectNo   observed inhibition zone
Fluorescent   matterValue 5 or 50μg/day/person
7Metals and  alloysSpecific  Release of  23 MetalsPlease   call us for counselingEDQM Technical  Guide Resolution CM/Res(2013)9
8Aluminium/Aluminium  alloysComponent  analysisPlease   call us for counselingEN 601EN 602

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