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Regulatory Compliance

USP Class VI:

Pebax® Series and Associated USP Class VI Status:

SeriesProductsUSP class VITechnical Data Sheet

31 Series

1074 SA 01 MED

x

Units: SI / US

33 series

2533 SA 01 MED

x

Units: SIUS

3533 SA 01 MED

x

Units: SIUS

4033 SA 01 MED

x

Units: SIUS

4533 SA 01 MED

x

Units: SIUS

5533 SA 01 MED

x

Units: SIUS

6333 SA 01 MED

x

Units: SIUS

7033 SA 01 MED

x

Units: SIUS

7233 SA 01 MED

x

Units: SIUS

 

Food Contact Approvals:


SeriesProducts10/2011/ECFDA 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

 

 

Units: SIUS

13 series

5513 SA 01

x

 

 

Units: SIUS

31 series

MV 1074 SA 01

x

 

 

Units: SIUS

33 series

2533 SA 01

x

 

 

Units: SIUS

3533 SA 01

x

x

 

Units: SI / US

4033 SA 01

x

 

x

Units: SI / US

4533 SA 01

x

 

x

Units: SI / US

5533 SA 01

x

 

x

Units: SI / US

6333 SA 01

x

 

x

Units: SI / US

7033 SA 01

x

 

x

Units: SI / US

7233 SA 01

x

 

x

Units: SI / US

* 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.

 

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