FRESENIUS KABI

Template Declaration of Conformity

Seite 1

Declaration of Conformity
for plastic materials that come into contact with food
Name and address of issuer: Technopac GmbH , Schleupestrae 15 , 48431 Rheine, Germany
if other than name and address of the manufacturer: Shankar pack Poland , UL energetykow 3 , 57-100 Strzelin
poland
Date of issue: 5-07-2016
I hereby declare that the product / products
article number: 0320931 material composition: FIBC type B , Q bag without in liner
comply with Regulation (EC) No 10/2011 (plastic Regulation) and Regulation (EU) No 1935/2004 (the framework
Regulation) - in the current version respectively including the relevant amending Regulations.
The products are manufactured according to GMP Regulation (EC) no. 2023/2006.
The product meets the requirements of Directive 94/62 / EC on packaging and packaging waste.
The 100 ppm limit for the heavy metal content (total content of lead, cadmium, mercury and hexavalent chromium 6)
is not exceeded.
The total migration and the specific migrations are in specification intended use below the legal limits. The
tests were carried out according to article 17 and 18 of Regulation (EU) No 10/2011 in conjunction with Annex V.

Test Overall Migration:

Food Simulant
Type A ( 10% ethanol )

Testing Conditions
(Time /Temperatur)
10 day 40 degree C

Global Migration
[mg/dm]
Less than 5

Type B ( 3% acetic acid )

10 day 40 degree C

7.6

Type C ( 20% ethanol )

10 day 40 degree C

Less than 5

Type D1 ( 50% ethanol)

10 day 40 degree C

Less than 5

Type D2 ( vegetable oil )

10 day 40 degree C

Less than 5

Type E ( tenax )

10 day 40 degree C

Less than 5

Global Migration
[mg/kg]
Less than 60 mg / kg
food
Less than 60 mg / kg
food
Less than 60 mg / kg
food
Less than 60 mg / kg
food
Less than 60 mg / kg
food
Less than 60 mg / kg
food

The used materials and raw materials are in accordance with the Regulation (EU) no. 10/2011.
The following substances with restrictions and / or specifications are used in the above mentionned product:
Chemical Name

CAS-No.

Restriction

Titanium Dioxide

0013463-67-7

60 mg/ kg

1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine2,4,6(1H,3H,5H)-trione

0027676-62-6

Ident.Nr.:

F/3.04/082e

RevNr.:

Gltig ab

24.Mai.2016

5 mg/kg

Ersteller:

Claudia Kuntzsch

Freigabe

24.05.2016

FRESENIUS KABI
Template Declaration of Conformity

Seite 2

1-(2-hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl piperidinesuccinic acid, dimethylester, copolymer

poly[6-[(1,1,3,3- tetramethylbutyl)amino]-1,3,5-triazine-2,4-diyl][(2,2,6,6-tetramethyl-4-piperidyl)-imino] hexamethylene[(2,2,6,6tetramethyl-4-piperidyl) imino]

65447-77-0

30 mg/ kg

71878-19-8

3 mg/ kg

119345-01-6

18mg/kg

reaction product of di-tert-butylphosphonite with biphenyl,

obtained by condensation of 2,4-di-tert-butylphenol with Friedel
Craft reaction product of phosphorous trichloride and biphenyl
Note on "Dual-use Materials", if used
This product contains Calcium Carbonate (E 170) approved as authorized food additives
in the Annex II of Regulation (EC) No 1333/2008, as amended by Commission Regulation (EU) No 1129/2011
(11.11.2011) and Commission Regulation (EU) No 380/2012 (03.05.2012), and considered as dual use additives
and GRAS ( Generally Recognized As Safe ) as per sections 201(s) and 409 of the Federal Food, Drug, and
Cosmetic Act (the Act),.......

Information about the Specific Migration:

Specific migration of substance having specifc migration limit has been calculated as per mathematical migration
modelling . as per calculation all the substance are evaluated and its migration are under the limit in worst foressen
condition

Printing colors:
The inks we use are formulated and manufactured in accordance with the " EuPIA guideline and EuPIA GMP on
Printing Inks to be applied on the non-food contact surface of food packaging materials and articles".

Dyestuff / Masterbatches:
BfR Recommendation XXXVI (01.10.2014) for the health assessment of plastics and other high polymers according
to the German Food and Feed Act (LFGB)
Coatings:
EU 10/2011 compliance
Adhesives:
No adhesive
Other ingredients:
All of the ingredients, which are used for the manufacture of this product are free of bisphenol A,latex, phthalate
plasticizers and PVC.
All of the ingredients, which are used for the manufacture of this product are free of allergens and GMO.

Ident.Nr.:

F/3.04/082e

RevNr.:

Gltig ab:

24.05.2016

Ersteller:

Claudia Kuntzsch

Freigabe

24.Mai.2016

FRESENIUS KABI
Template Declaration of Conformity

Seite 3

Sensory evaluation / colour migration:

sensory evaluation has been done as per DIN 10955:2004-06 and no perceptible off-odour ( scale result -0)
Specification for intended use or restrictions:
- Type / types of food that are to come into contact with the material:
All kind of food material
Dry food
Dry and non-fatty food
Wet and aqueous food
Fatty food (correction factor if applicable)
Specific food (e.g. acid, alcoholic)
Frozen food (freeze and defreeze in packaging or freeze and defreeze outside packaging)

- Conditions of use, such as time and temperature of treatment and storage in contact with food:
room temperature and for long term storage ( 6 month )
- Ratio of food contact surface area to volume, by which was found the compliance of the material or
article:
6 dm2/ kg
Unless a functional barrier of plastics is used in mentioned product, it is confirmed that it complies with
the special requirements of Regulation (EU) no. 10/2011.

Strzeling , Poland , 5-06-2016,

_______________________________________________________________
Place, Date, Signature
Validity: until revocation by reissuing

Ident.Nr.:

F/3.04/082e

RevNr.:

Gltig ab:

24.05.2016

Ersteller:

Claudia Kuntzsch

Freigabe

24.Mai.2016