Use and Care Manual

1 Atir Yeda St., P.O.Box 2289, Kfar Saba 4464301, Israel, Tel: 972-3-9762400
8-Feb-2021
Declaration of Compliance for Articles intended to come into Contact with Foodstuffs
according to Art. 16 of Regulations (EC) 1935/2004 and Annex IV of Regulation 10/2011
We hereby confirm that our product
Carbonating Bottles from Polyethylene terephthalate (PET)
Including 1L Fuse, 1/2L Fuse, 1L Regular, 1/2L Regular carbonating bottles,
Comply with legal requirements laid down in the EU Regulation 1935/2004 and Regulation 10/2011, both as amended.
and following Italian legislation
Decree from 21/03/1973 as amended
DPR 777/82 as amended
The above mentioned product is manufactured with the following materials suitable for food contact:
Components of Article
Polymer
CAS No
Carbonating Bottle
PET
25038-59-9
Closure - Screw cap
ABS
9003-07-0
Seal for closure
Silicone rubber
63394-02-5
PET Pellets supplier: Sk Chemicals
pangyo-ro bundang-gu
seongnam-si gyeonggi-do 486-400
South Korea
According to the information provided by our raw material suppliers:
Monomers/additives subject to restriction can be contain or included in the composition of the current products.
Material meets requirements of Regulations (EC) 1935/2004 and 10/2011 with Annex 1 as a positive list
for monomers and additives.
The ingredients used in formulation are not likely to alter the organoleptic properties of foodstuffs.
Dual use additives can be added in the articles according to the information provided by our raw materials
suppliers with no intention to be released into food and no impart odor or taste, nor should the SML
be exceeded. Below substances do not exhibit technological function in the food and present below limits subject
to a restriction as defined in Regulation 10/2011
GMS
E471
Calcium stearate
Silicon dioxide
E551
2,6- di-tert-butyl-p-cresol (BHT)
Above mentioned article do not contain postconsumer recycled plastics, statement of compliance
with Regulation 282/2008 is not required.
GMP - Good Manufacturing
Practice
This article manufactured according to GMP as set out in Regulation (EC) 2023/2006.
Traceability as defined in art. 17 of Regulation 1935/2004 is ensured by the lot number on the tube
and box label - part 4: traceability applied in the plastic chain.
Specification of the intended use or restrictions
The above article under normal and foreseeable conditions of use is suitable for contact with acid, aqueous
foodstuffs, for any long term storage at room temperature or below.
A functional barrier plastic does not used in the above-mentioned product.
Overall migration
When used as specified, the overall migration (OM) as well as specific migration do not exceed the legal limits.
Migration tests carried out following the Regulation 10/2011 confirm an OM results below to 10 mg/sq.dm or
60 mg/kg of food simulant B, C for 10 days at 40
o
C
Simulant B
Simulant C
All product types
<10

Summary of content (3 pages)