Regulatory Compliance
*Notice*
USP Class VI:
Pebax® Series and Associated USP Class VI Status:
| Series | Products | USP class VI | Technical Data Sheet |
|---|---|---|---|
|
31 Series |
1074 SA 01 MED |
x |
|
|
33 series |
2533 SA 01 MED |
x |
|
|
3533 SA 01 MED |
x |
||
|
4033 SA 01 MED |
x |
||
|
4533 SA 01 MED |
x |
||
|
5533 SA 01 MED |
x |
||
|
6333 SA 01 MED |
x |
||
|
7033 SA 01 MED |
x |
||
|
7233 SA 01 MED |
x |
Food Contact Approvals:
| Series | Products | 10/2011/EC | FDA 21 CFR 177.2600 100F (40°C) All food type |
FDA 21 CFR 177.2600 150F (65°C) All food type |
Technical Data Sheet |
|---|---|---|---|---|---|
|
11 series |
MH 1657 |
x |
|
|
|
|
13 series |
5513 SA 01 |
x |
|
|
|
|
31 series |
MV 1074 SA 01 |
x |
|
|
|
|
33 series |
2533 SA 01 |
x |
|
|
|
|
3533 SA 01 |
x |
x |
|
||
|
4033 SA 01 |
x |
|
x |
||
|
4533 SA 01 |
x |
|
x |
||
|
5533 SA 01 |
x |
|
x |
||
|
6333 SA 01 |
x |
|
x |
||
|
7033 SA 01 |
x |
|
x |
||
|
7233 SA 01 |
x |
|
x |
* Pebax® MV 1074 SA 01 may be used in polymers at concentrations up to 15% by weight of the polymer, in contact with non-fatty dry foods, under conditions of use E through G, as described in 21 CFR 176.170 (c) Table 2.
However, we point out that it is the duty of the end user to check, in accordance with professional practice, the reciprocal compatibility of the material and the packed foodstuffs (respect of overall and specific migration limits) and also that organoleptic characteristics of the latter remain constant.
Due to evolution of regulations or existing specific restrictions, it is necessary before any usage in food contact to request the related certificates from our commercial representatives.