colorFabb AM1800 Service Manual

PRODUCT REGULATORY INFORMATION SHEET

Print Date: 4/29/2016
Version: 12/18/2015 (00,001.00,005)
71100831

Eastman Amphora(TM) 3D Polymer AM1800

PRODUCT NAME

Eastman Amphora(TM) 3D Polymer AM1800

COMPANY INFORMATION

Address

Eastman Chemical Company
P. O. Box 511
Kingsport, TN 37662

FOOD CONTACT / FOOD ADDITIVE / FEED ADDITIVE INFORMATION

EMEA Region

European Union

Declaration of Compliance for
Food Contact: Commission
Regulation (EU) No. 10/2011
(and amendments)

This product complies with the compositional requirements of this
regulation for plastics used in food-contact applications. The final
product must meet the overall migration limit of 60 mg/kg of food or
10 mg/square decimeter of the plastic. There are also specific
migration limits for terephthalic acid (7.5 mg/kg of food) and
ethylene glycol or diethylene glycol (30 mg/kg of food). Based on
data obtained by Eastman, articles produced from this polymer
should comply with the applicable overall and specific migration
limits when tested with 3% acetic acid, 10% ethanol and simulant
D under conditions including 2 hours at 70°C followed by 10 days
at 40°C. Regarding the dual use additives provision, there are no
additives subject to restrictions on concentrations in food as a food
additive. This product is intended for use to manufacture materials
and articles in compliance with the general requirements of
Regulation (EC) 1935/2004. This product is produced under good
manufacturing practices in compliance with EU Regulation
2023/2006.

North America Region

United States

Food Law Compliance

Under regulations administered by the U.S. Food and Drug
Administration (FDA), this product may lawfully be used as articles
or components of articles intended for use in contact with food
subject to provisions of Food Contact Notification Nos. 937 and

1234. This polymer may be used in the manufacture of articles
intended for use (1) in contact with aqueous, acidic, low-alcohol
(up to 13 percent by volume), and fatty foods under Conditions of
Use C ("Hot filled or pasteurized above 150°F") through G
("Frozen storage (no thermal treatment in the container"), and for
use in contact with foods containing up to 50 percent by volume
alcohol under conditions of use E ("Room temperature filled and
stored (no thermal treatment in the container") through G ("Frozen
storage (no thermal treatment in the container") as described in
Table 2 at website
http://www.fda.gov/Food/IngredientsPackagingLabeling/Packaging
FCS/FoodTypesConditionsofUse/ucm109358.htm. This product
is cleared by the above FCNs and, thus, may be used as intended
in full compliance with the Federal Food and Drug, and Cosmetic
Act, provided that polymers otherwise meet the limitations set forth

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PRODUCT REGULATORY INFORMATION SHEET

Print Date: 4/29/2016
Version: 12/18/2015 (00,001.00,005)
71100831

Eastman Amphora(TM) 3D Polymer AM1800

in the FCNs
(http://www.fda.gov/Food/FoodIngredientsPackaging/FoodContact
SubstancesFCS/ucm116567.htm).

Other Information

This product is manufactured, stored, handled and transported
under conditions adhering to 21 CFR 174.5 on general provisions
applicable to indirect food additives (i.e., current good
manufacturing practices for food contact substances).

OTHER APPLICABLE REGULATIONS

EMEA Region

European Union

Regulation (EC) No. 1907/2006
on the Registration, Evaluation
and Authorisation of Chemicals
(REACH) - Substances of Very
High Concern

With reference to the SVHC Candidate List, as amended up to and
including the 17 December 2015 update, this product placed on
the market in the European Union is not known to contain any
substances listed on the candidate list of Substances of Very High
Concern (SVHC) in concentrations greater than or equal to 0.1%
or those otherwise established under paragraph 6(b) of Article 56.
For further information, refer to our website:
www.eastman.com/reach.

Directive 94/62/EC, Packaging
and Packaging Waste (amended
by 2004/12/EC, 2005/20/EC, and
Regulation (EC) No 219/2009)

This statement covers the following heavy metals (or their
compounds): Cadmium (Cd), Hexavalent chromium (Cr (6+)),
Lead (Pb), Mercury (Hg). Based on our knowledge of the raw
materials and the manufacturing process, it is unlikely that any of
these elements would be present in this product in concentrations
exceeding the legislation limits.

Substances of Animal Origin
Regulation 999/2001, as
amended

Based on our knowledge of the raw materials and processes used
in the manufacture of this product, we have no reason to expect
that animal-derived or bovine-derived materials are present in this
product. The equipment used in the manufacturing process of the
product did not come into contact with a substance derived from
animal origin.

Directive 2001/18/EC and
Regulations 1829/2003 and
1830/2003 (Genetically Modified
Organisms), as amended

Based on our knowledge of the raw materials or based on supplier
information, this product is considered not genetically modified or
not derived from a genetically modified organism as defined in
these regulations.

Directive 2005/84/EC,
Commission Decision
1999/815/EC (Phthalates), as
amended

This Directive states that certain phthalates shall not be used as
substances or as constituents of preparations, at concentrations of
greater than 0.1% by mass of the plasticised material, in toys and
childcare articles. The listed phthalates are as follows: bis(2­ethylhexyl) phthalate (DEHP); dibutyl phthalate (DBP); benzyl butyl
phthalate (BBP); di-iso-nonyl phthalate (DINP); di-isodecyl
phthalate (DIDP); di-n-octyl phthalate (DNOP). We do not analyse
this product for these phthalates. However, these substances are
not used as a raw material, nor are they added to the
manufacturing process or the end product.

Regulation (EC) No. 1005/2009
on Substances that Deplete the
Ozone Layer

Eastman Chemical does not analyse this product for ozone
depleting substances (ODS) that are classified as such by this
legislation. Based on our knowledge of the raw materials and our
manufacturing process, we do not expect the listed substances to
be present in our product.

Directive 2011/65/EU

To our knowledge, lead, mercury, cadmium, hexavalent chromium,

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