colorFabb AM3300 Service Manual

PRODUCT REGULATORY INFORMATION SHEET

Print Date: 11/11/2015
Version: 11/10/2015 (00,001.00,000)
71104597

Eastman Amphora(TM) 3D Polymer AM3300

PRODUCT NAME

Eastman Amphora(TM) 3D Polymer AM3300

COMPANY INFORMATION

Address

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

FOOD CONTACT / FOOD 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
isophthalic acid (5 mg/kg of food) under the Regulation. 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 in the
Regulation, 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 the Framework Regulation (EC)
1935/2004 on materials and articles intended to come into contact
with food. 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 for use in contact with food subject to
provisions of 21 CFR 177.1240. This product as supplied by
Eastman, complies with the compositional requirements of FDA
regulations at 21 CFR 177.1240(a). Based on results from testing
of representative polymers, we expect that articles made under
good manufacturing practices will meet the requirements of 21
CFR 177.1240(e)(1),(2), and (3). It 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

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©COPYRIGHT 2015 BY EASTMAN CHEMICAL COMPANY

PRODUCT REGULATORY INFORMATION SHEET

Print Date: 11/11/2015
Version: 11/10/2015 (00,001.00,000)
71104597

Eastman Amphora(TM) 3D Polymer AM3300

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 15 June 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.

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 (Recast of
2002/95/EC (Restrictions of
Hazardous Substances - RoHS)),
as amended

To our knowledge, lead, mercury, cadmium, hexavalent chromium,
polybrominated biphenyls (PBB) or polybrominated diphenyl ethers
(PBDE), including decabromodiphenyl ether are not used as raw
materials in this product, nor are they added during the production
process or the end product. Based on a one-time analysis of this
product by an independent laboratory, the listed substances were
not detected in this product (method detection limit of 5 mg/kg for
PBBs or PBDEs and 2 mg/kg for metals). Further information is
available from your Eastman representative.

Directive 2003/53/EC (Restricting
Nonylphenol and Nonylphenol
Ethoxylates), as amended

Eastman Chemical Company does not analyse this product for
nonylphenol and nonylphenol ethoxylates. Emulsifiers are not
used as a raw material, nor are they added to the manufacturing
process or the end product. Therefore, we have no reason to
expect that these substances are present.

Regulation 2005/1895/EC (Epoxy
Derivatives), as amended

Eastman Chemical Company does not analyse this product for the
following epoxy substances: bis(hydroxyphenyl)methane bis (2,3-

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