You are on page 1of 3

Statement of Compliance

For plastic materials & articles intended to come into contact with food

Name and address of the issuer:

Hereby we declare that the product FIBCs (Flexible Intermediate Bulk Container's)
manufactured & supplied by us are comply with the following legal regulations:-
EC regulation No 10/2011, No 1935/2004, Regulation No 2023/2006, Proposition 65 and
Regulation No. 94/62/EC, Regulation (EC) No 1333/2008, (EC) No. 1334/2008 in
current version & Swiss Ordinance RS 817.023.21 - Annex 6 on substances for the
manufacturing of FCM inks, Exclusion list of EuPIA (European Printing Ink
Association).

When used as specified, the overall migration as well as the specific migration does not
exceed the legal limits of the plastic material as a whole (including color/inks/coatings
etc).
To the best of our knowledge, all other ingredients used in FIBC bags manufactured &
supplied by us meet the requirements of their respective FDA regulations and 21CFR
177.1520(b).
During the production of fabric for FIBC's, we use following additives which are
included in the Union list of authorized monomers and other starting substances in
Annex-I of EC Directive 10/2011 and its successive amendment EU 2020/1245 of 2
September, 2020.

List of substances subject to limitations and/or specifications:-

Name of substance CAS-No Restriction (SML) PM Ref Number


UV-9440 0071878-19-8 3 mg/kg 81200
UV-62 0065447-77-0 30 mg/kg 60800

DUAL USE ADDITIVES :-


Our Polyester Yarn may contain following food additive

Name of substance CAS-No E Number


Calcium carbonate 471-34-1 E 170

HEAVY METALS:-

The raw materials used in the production of said FIBC’s do not contain heavy metals such
as cadmium, hexavalent chromium, lead, antimony, nickel, tin, arsenic and mercury, as
declared by the suppliers of the raw materials.
Neither the said heavy metals nor their compounds are intentionally added during the
production of the FIBC nor they are used, directly or indirectly, in the production process
itself.

Contd.

SPECIFIC MIGRATION OF HEAVY METALS :-


Specific migration analysis of Aluminum, Barium, Cobalt, Copper, Iron, Lithium,
Manganese, Zinc and Nickel were analyzed as per Directive 1935//2004 (EU) and
commission on regulation (EU) 10/2011 with reference to EN 13130-1:2004. These tests
were performed in the simulant of 3% acetic acid for 2 hours at 90 º C.

Heavy Metals Result (mg/kg) SML (mg/kg)


Aluminium < 0.1 1
Barium < 0.5 1
Cobalt < 0.05 0.05
Copper < 0.05 5
Iron 0.20 48
Lithium < 0.5 0.06
Manganese 0.02 0.6
Zinc < 0.05 5
Nickel < 0.01 0.02
Lanthanum < 0.01 0.05
Europium < 0.01 0.05
Gadolinium < 0.01 0.05
Terbium < 0.01 0.05
Arsenic < 0.01 Not Defined
Cadmium < 0.1 Not Defined
Chromium < 0.1 Not Defined
Lead < 0.5 Not Defined
Mercury < 0.05 Not Defined

SVHC:-
ECHA has so far identified 211 chemical substances as the substances of very high
concern (SVHC) as per list updated on 19th January 2021. We confirm that these
substances are not present in the Polyester Yarn manufactured & supplied by us.

SPECIFICATIONS OF THE INTENDED USE OR RESTRICTIONS:-


- Type or types of food with which it is intended to be put in contact: All type of food
products.
- Type(s) of food that shall not come into contact with the material: None
- Time and temperature of treatment and storage in contact with the food: Tested
for 10 days at 40 º C
(Tested in 10% ethanol, 3% Acetic Acid, 20% ethanol, 50% ethanol, 95% ethanol,
ISO Octane, Poly (2,6- Diphenyl-p-phenelene oxide) or Tenax. Particle size 60-80
mesh, pore size 200 nm} .
- Ratio of food contact surface area to volume used to establish the compliance of the
material or article:
S/V = 6.
FIBC's do not contain any "functional plastic barrier" and also do not influence
sensorial properties.

Signed in .....................................on .......................................

Prakash Mukherjee
Function: Head-QA/QC
Stamp of the Company:

You might also like