colorFabb HT5300 operation manual

PRODUCT REGULATORY INFORMATION SHEET

Print Date: 5/6/2016
Version: 05/06/2016 (00,000.00,000)
71104518

Eastman Amphora(TM) 3D Polymer HT5300

PRODUCT NAME

Eastman Amphora(TM) 3D Polymer HT5300

COMPANY INFORMATION

Address Eastman Chemical Company

P. O. Box 511
Kingsport, TN 37662

FOOD CONTACT / FOOD ADDITIVE / FEED ADDITIVE INFORMATION

Asia Pacific Region

China This polymer is listed as No. 94 (CAS No. 261716-94-3) on the

official "List of 107 Resin Types Used for Food Packaging
Materials" published by the Chinese Ministry of Health (MOH) in
November 2011.

EMEA Region

European Union

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

North America Region

United States

Food Law Compliance Under regulations administered by the U.S. Food and Drug

This product is a polymer of dimethyl terephthalate (FCM 288, Ref
No. 24970, listed as terephthalic acid, dimethyl ester), 1,4­cyclohexanedimethanol (FCM 210, Ref No. 13390, listed as 1,4­bis(hydroxymethyl) cyclohexane), and 2,2,4,4­tetramethylcyclobutane-1,3-diol (TMCD)(FCM 881, Ref No.

25187). The monomers listed above, except TMCD, are listed
without specific migration limits. TMCD has a specific migration
limit of 5 mg/kg of food for repeated use articles for long term
storage at room temperature or below and hotfill conditions.
Specific migration of TMCD from a representative copolymer was
tested using a protocol for repeated use applications under test
conditions of both 10 days at 40°C and 2 hours at 100°C at a ratio
of 10 dm2 per 1 kg food using 3% acetic acid, 10% ethanol and
olive oil as food simulants. Under these conditions, no migration of
TMCD was detected with a detection limit of 25 micrograms/kg for
aqueous food simulants and 1.3 microgram/kg for olive oil.
Regarding the dual use additives provision in the Plastics
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.

Administration (FDA), this product, as supplied by Eastman
Chemical Company, may lawfully be used on the basis of 21 CFR

174.5(d)(5) as a component in the manufacture of repeated use
food-contact articles as described in Food Contact Notification No.

1041. FCN No. 1041 replaces FCN No. 729 and product as
supplied by Eastman under FCN No. 729 may lawfully be used

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©COPYRIGHT 2015 BY EASTMAN CHEMICAL COMPANY

PRODUCT REGULATORY INFORMATION SHEET

Print Date: 5/6/2016
Version: 05/06/2016 (00,000.00,000)
71104518

Eastman Amphora(TM) 3D Polymer HT5300

under FCN No. 1041. The finished food contact article containing
this polymer is intended to contact all types of food at
temperatures up to and including 100°C (for definitions of food
types, refer to the Food Contact Substances website at
http://www.fda.gov/food/ingredientspackaginglabeling/packagingfc
s/foodtypesconditionsofuse/ucm109358.htm to access the Food
Types and Conditions of Use for Food Contact Substances
Tables).

Other Information This product is manufactured, stored, handled and transported

under conditions adhering to 21 CFR 174.5 on general provision s
applicable to indirect food additives (i.e., current good
manufacturing practices for food contact substances).

OTHER APPLICABLE REGULATIONS

EMEA Region

European Union

Directive 94/62/EC, Packaging
and Packaging Waste (amended
by 2004/12/EC, 2005/20/EC, and
Regulation (EC) No 219/2009)
Substances of Animal Origin
Regulation 999/2001, as
amended

This statement covers the following heavy metals (or their
compounds): Cadmium (Cd), Hexavalent chromium (Cr (6+)),
Lead (Pb), Mercury (Hg). This product complies with the heavy
metal content limits of this legislation.
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. This product is manufactured using non-animal-derived
raw materials. Additionally, this product does not contain, and is
not derived from, specified risk materials as defined in EU
regulations. This product is not derived from any constituent of
animal origin, including ruminants. 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
Directive 2005/84/EC,
Commission Decision
1999/815/EC (Phthalates), as
amended

Based on our knowledge of the raw materials or based on supplie r

information, this product is considered not genetically modified or

not derived from a genetically modified organism as defined in

these regulations.

This product does not contain phthalate esters used as plasticizers

(such as di-2-ethylhexyl phthalate(DEHP), diisononyl phthalate

(DINP), dibutyl phthalate (DBP), di-n-octyl phthalate (DNOP),

benzylbutyl phthalate(BBP), diisodecyl phthalate (DIDP)). The term

"phthalates" refers to diesters of phthalic acid (also known as

ortho-phthalic acid or 1,2-benzenedicarboxylic acid) that are used

to make materials, such as vinyl, more flexible. These are the

substances which are the subject of specific regulations and are

banned or proposed to be banned in certain consumer products.

Phthalate esters are not used in the manufacture of this product.

However, there is potential for confusion resulting from the use of

dimethyl terephthalate as a monomer to manufacture this polymer.

Terephthalates have different physical, chemical, and toxicological

properties than the ortho-phthalate esters, and we are not aware of

any scientific studies linking terephthalates with endocrine effects.

More importantly, dimethyl terephthalate is reacted and becomes

part of a high molecular weight polymer. In contrast, low molecular

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