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RC - SUKANT Ma S560-Q1 - Us
RC - SUKANT Ma S560-Q1 - Us
Sukano Polymers
To whom it may concern Corporation
295 Parkway East
Duncan
SC
29334
USA
Declaration of Compliance
Page 1 of 6
Confidential Document!
Sukano Polymers
Corporation
Terephthalic acid SML(T): 7.5 mg / kg
295 Parkway East
Isophthalic acid SML(T): 5 mg / kg Duncan
Ethylene glycol SML(T): 30 mg / kg in combination with diethylene SC
glycol 29334
USA
Acetaldehyde SML(T): 6 mg / kg
Antimony trioxide SML: 0.04 mg / kg, expressed as antimony Phone: +1 864 486 1478
Our product may contain up to 300 ppm of Fax: +1 864 486 3681
antimony trioxide mostly embedded in the
polymer matrix
Aluminium SML: 1 mg / kg
Our product may contain up to 1000 ppm of
aluminium mostly embedded in the polymer
matrix
Annex II & point 6 of Annex IV Based on suppliers' information and the
knowledge of our manufacturing process,
the following can be stated: this product may
contain additional substances subject to
restrictions in Annex II at concentrations not
expected to lead to an exceedance of their
migration limits, provided that the product is
used at recommended dosage levels.
Additional substances for which genotoxicity
has not been ruled out, and which originate
from an intentional use, as stated by the
point 6 of Annex IV, are not known or
expected to be present in our product. The
product is however not analyzed for these
substances
None
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Confidential Document!
Sukano Polymers
Corporation
Allergen Information
295 Parkway East
We herewith state that that based on suppliers’ information and the manufacturing Duncan
process of our product SUKANO®T ma S560-Q1, it is unlikely that substances listed in SC
Annex II of the Regulation (EU) No. 1169 / 2011 and in the FDA Food Allergen Labelling 29334
USA
and Consumer Protection Act of 2004 (FALCPA) are present in the product. We do not
intentionally add these substances to our product nor do our suppliers in the raw Phone: +1 864 486 1478
materials used. Fax: +1 864 486 3681
Nanomaterial
Our product SUKANO®T ma S560-Q1 does not contain any nanomaterials
as defined by the Commission Recommendation 2011 / 696 / EU on the
definition of nanomaterial. None of the additives used in our mentioned
product contains particles in the size range of 1 nm - 100 nm at a level of
50% or more.
Chapter XVII
Chapter LII
For the use as additive in plastic articles coming into contact with food.
The migration limits of the German Ordinance on Commodities are identical to that of the
Commission Regulation (EU) No. 10 / 2011 above.
US FDA Status
Our product SUKANO®T ma S560-Q1 is in compliance with the US FDA Food Packaging
Regulation 21 CFR to be used as additive in plastic articles coming into contact with food
in accordance with the following paragraphs:
Polymer §177.1630
Inorganic matting agent §178.3297
The product can be used in food packaging material under conditions of use as described
in §176.170(c) A through H.
The product is approved for the use in food contact applications coming into contact with
all types of food according to the description in §176.170 (I-IX).
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Confidential Document!
Sukano Polymers
Corporation
94 / 62 / EC and its amendments on packaging and packaging waste. The given limits for
295 Parkway East
the heavy metals lead (Pb), cadmium (Cd), mercury (Hg) and hexavalent chromium (Cr Duncan
VI+) are never exceeded. Heavy metals such as Pb, Cd, Hg and Cr VI+ are neither SC
intentionally added nor used in the manufacture of our mentioned product. 29334
USA
Model Toxics in Packaging Legislation (formerly CONEG) Phone: +1 864 486 1478
Based on suppliers’ information, we confirm that all ingredients used in the formulation of Fax: +1 864 486 3681
our product SUKANO®T ma S560-Q1 do not contain the heavy metals lead (Pb),
cadmium (Cd), mercury (Hg) and hexavalent chromium (Cr VI+) as intentionally added
substances. Moreover, these metals are not intentionally used in the manufacture of our
product. The sum of the concentration levels of these metals in our product is therefore
not expected to exceed the set limit of 100 ppm by weight.
Additionally, based on raw materials’ information, we confirm that all ingredients used do
not contain any phthalates as intentionally added substances. Moreover, phthalates are
not intentionally used in the manufacture of our product. The sum of the concentration
levels of phthalates in our product is therefore not expected to exceed the set limit of 100
ppm by weight.
Furthermore, it must be stated that based on raw materials’ information and the
knowledge of our manufacturing process per- and polyfluoroalkyl substances (PFAS) are
not expected to be present in our product.
Toy Standards
We confirm that our product SUKANO®T ma S560-Q1 complies with the restrictions of
the Toy Standard DIN EN 71 part 3 and part 9 as well as with the ASTM F963-08 Standard
Chapter 4.3. However, it is to mention that no migration tests were done on our product
as they have to be done on the final end application.
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Confidential Document!
Sukano Polymers
Corporation
European Regulation (EC) No. 1005 / 2009 on Substances that Deplete the Ozone
295 Parkway East
Layer Duncan
Herewith, we confirm that our product SUKANO®T ma S560-Q1 does not contain any SC
substances listed in the European Regulation (EC) No. 1005 / 2009 as ozone depleting 29334
USA
substance.
According to suppliers’ information, ozone depleting substances do not appear in any of Phone: +1 864 486 1478
the ingredients used in our mentioned product. Furthermore, we confirm that ozone Fax: +1 864 486 3681
depleting substances are neither part of our formulation nor are they intentionally added
to our product during the manufacture.
California Proposition 65
The substances listed in the table below, which fall under the reporting requirements of
the State of California Safe Drinking water and Toxic Enforcement Act of 1986, known as
California Proposition 65 (status: April 21st, 2023), can be present in our product
SUKANO®T ma S560-Q1.
Absence of Bisphenol A
Herewith, we declare that our product SUKANO®T ma S560-Q1 does not contain
Bisphenol A (4,4′-Isopropylidendiphenol, CAS: 80-05-7). This substance is neither
intentionally added to any of the ingredients used in this product, nor is it part of the
product's formulation.
Disclaimer
This regulation is valid for the above mentioned product only. It is not applicable to:
- a later change of the formulation of the masterbatch
- any treatment leading to a change of the masterbatch properties
- the compatibility with packed goods in relation to a possible change in smell or taste of
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Confidential Document!
Sukano Polymers
Corporation
the foodstuff.
295 Parkway East
Duncan
SC
It is the responsibility of our customer to determine that their use of our product is safe, 29334
USA
lawful and technically suitable for their intended applications. Furthermore, it is the
customer's responsibility to check whether the intended use of the product infringes third Phone: +1 864 486 1478
party intellectual rights. Sukano accepts no responsibility for the suitability of its products Fax: +1 864 486 3681
for use in the application intended by the customer and offers no guarantee that its
products can be used in any specific combination or in any manufacturing process
without infringing third party rights. Because of possible changes in the law and in
regulations, as well as possible changes in our products, we cannot guarantee that the
status of this product will remain unchanged. We therefore recommend that customers
continuing to use this product verify its status periodically.
Sukano AG
Augustin Tchawou
Regulatory Affairs Manager
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