1. 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.
No | Materials | Test Items | Limits | Regulation |
1 | Plastics | Overall Migration-10%Ethanol | 10mg/dm2 or 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 | ||||
Barium | 1 mg/kg | |||
Cobalt | 0.05 mg/kg | |||
Copper | 5 mg/kg | |||
Iron | 48 mg/kg | |||
Lithium | 0.6 mg/kg | |||
Manganese | 0.6 mg/kg | |||
Zinc | 5 mg/kg | |||
Aluminium | 1mg/kg | |||
Nickel | 0.02 mg/kg | |||
| Ammonium salt | - | |||
| Calcium | - | |||
| Magnesium | - | |||
| Potassium | - | |||
| Sodium | - | |||
| Lead | ND(DL=0.01mg/kg) | |||
| Cadmium | ND(DL=0.002mg/kg) | |||
| Arsenic | ND(DL=0.01mg/kg) | |||
| Mercury | ND(DL=0.01mg/kg) | |||
| Chromium | To 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. | |||
| Antimony | 0.04mg/kg | |||
| Europium | The 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% | |||
Specific Migration of Phthalates （5P:DEHP/BBP/DBP/DINP/DIDP） | DEHP:1.5mg/kg DINP+DIDP:9mg/kg（sum） | |||
VCM Content | N.D. (1 mg/kg) | |||
Specific Migration of Acrylonitrile | N.D. (0.01 mg/kg) | |||
Specific migration of BPA | 0.05 mg/kg | |||
BPA Content | N.D (Polycarbonate baby bottle, sucking cup) | |||
Specific migration of Formaldehyde | 15mg/kg | |||
Specific migration of melamine | 2.5mg/kg | |||
Specific migration of caprolactam | 15mg/kg | |||
Specific migration of Hexamethylenediamine | 2.4mg/kg | |||
2 | Ceramic, glass | Soluble Pb & Cd | Requirements are different of each shape, please call us for counseling | 84/500/EEC |
3 | Silicone | Overall Migration-10%Ethanol | 10mg/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 | ||||
4 | Coating | Overall Migration-10%Ethanol | 10mg/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 BPA | N.D (Varnishes or coatings contact with infant and young children food) 0.05 mg/kg (Other coating) | (EU) 2018/213 | ||
5 | Rubber | Overall Migration-10%Ethanol | 10mg/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 substances | N.D. | |||
Primary Aromatic Amines（PAA） | N.D. | |||
6 | Paper and Paper Board | Pb，Cd，Hg | Pb:0.003mg/dm2 | AP2002 |
PCP | 0.15mg/kg | |||
SM of Formaldehyde | 15mg/kg | |||
Preserving effect | No observed inhibition zone | |||
Fluorescent matter | Value 5 or 50μg/day/person | |||
7 | Metals and alloys | Specific Release of 23 Metals | Please call us for counseling | EDQM Technical Guide Resolution CM/Res(2013)9 |
8 | Aluminium/Aluminium alloys | Component analysis | Please call us for counseling | EN 601 EN 602 |
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