https://www.avient.com/sites/default/files/2024-11/Terms and Conditions of Sale for Canada.pdf
Buyer
assumes all risks and liabilities (i) arising out of unloading,
discharge, storage, handling and use of the Product, or (ii) arising
out of compliance or non-compliance with federal, state, provincial,
or local laws and regulations governing or controlling such activity.
Re-Sale and Re-Export; Compliance with Laws.
Buyer shall be exclusively responsible for (i) ensuring
compliance with all Laws and Standards associated with its intended
use of Product; and (ii) obtaining all necessary approvals, permits or
clearances for such use.
https://www.avient.com/sites/default/files/2024-12/Terms and Conditions of Sale for Belgium.pdf
Buyer
assumes all risks and liabilities (i) arising out of unloading,
discharge, storage, handling and use of the Product, or (ii) arising
out of compliance or non-compliance with federal, state, provincial,
or local laws and regulations governing or controlling such activity.
Re-Sale and Re-Export; Compliance with Laws.
Buyer shall be exclusively responsible for (i) ensuring
compliance with all Laws and Standards associated with its intended
use of Product; and (ii) obtaining all necessary approvals, permits or
clearances for such use.
https://www.avient.com/sites/default/files/2024-04/Maxxam REC Outdoor Plug Socket Case Study_A4.pdf
However,
they recently reached out to Avient, expressing interest
in switching to a more sustainable, recycled material
for a new product—the cubyko leaf, a waterproof
outdoor socket.
https://www.avient.com/sites/default/files/2023-08/Swellcoat Yarns Product Bulletin.pdf
Precision
wound packages yield the greatest length per
package, provide solid package stability, and ensure
minimum ballooning at speeds reaching 4000 RPM.
https://www.avient.com/sites/default/files/2021-02/versaflex-non-blooming-solution-technical-bulletin.pdf
These engineered TPEs also have
the added benefit of eliminating secondary
processing, which reduces energy use and supports
manufacturers in reaching their sustainability goals.
https://www.avient.com/sites/default/files/2021-11/avient-design-ergonomic-design-guide.pdf
animal derivatives, phthalates, BPA, allergens,
GMOs)
• Will this device be used in a commercial
kitchen where NSF (National Sanitation
Foundation) compliance (e .g ., NSF-51 for food
equipment) will be required for the material or
the final part?
Common regulations
• REACH SVHC, RoHS 3 (EU 2015/863),
CA Prop 65, Heavy Metals (CONEG, 94/62/EC)
and Conflict Minerals
• Substances of Concern (could include
phthalates, latex, PVC, BPA, halogens, PAH,
flame retardants)
Other market-specific regulations
• Consumer Product Safety Improvement Act of
2008 (CPSIA)
- Lead and phthalate limits for products
designed for children
• Chemicals of High Concern for Children (CHCC)
- Several US states (OR, WA, VT, ME, MN) have
lists of chemicals of concern for products
designed for children
• Global Automotive Declarable Substance List
(GADSL)
- Specifically for automotive applications
• End of Life Vehicles (ELV) Directive, 2000/53/EC
- Restrictions on certain heavy metals for .
Material suppliers can provide documentation of compliance
with substance restrictions .
https://www.avient.com/sites/default/files/resources/PolyOne%2520India%2520Terms%2520and%2520Conditions%2520of%2520Sale%2520of%2520Products.May%25202016.pdf
Buyer assumes all risk of patent infringement by
reason of any use Buyer makes of the Product in combination with other
substances or in the operation of any process, and all infringement arising out
of Seller’s compliance with Buyer’s designs, specifications or instructions,
and Buyer shall defend, indemnify and hold Seller harmless from and against
the same.
Buyer assumes all risks and liabilities arising
out of unloading, discharge, storage, handling and use of the Product, or
arising out of compliance or non-compliance with federal, state, municipal or
local laws and regulations governing or controlling such activity, except to
the extent, if any, attributable to Seller’s gross negligence or willful
misconduct.
Either party may suspend performance hereunder (except to
pay for Product already received) in the event of: (1) acts of God, fire,
explosion, flood, hurricanes; (2) strikes, lockouts or other industrial
disturbances or riots; (3) war, declared or undeclared, or acts of terrorism; (4)
compliance with any Federal, state, provincial, municipal or military law,
regulation, order, or rule, foreign or domestic, including priority, rationing,
allocation or preemption orders or regulations, or cancellation of Seller’s or
Buyer’s license to operate its plant; (5) catastrophic failure of facilities used
to manufacture Product, interruption or shortage of transportation, labor,
power, fuel or raw materials; (6) total or partial shutdown due to Seller’s
normal plant turnaround; or (7) any other cause or causes of any kind or
character reasonably outside the control of the party failing to perform,
whether similar or dissimilar from the enumerated causes (a “force
majeure”).
https://www.avient.com/sites/default/files/2023-01/Mevopur Standard Colors Product Bulletin _ Color Card.pdf
With
robust raw material testing and a comprehensive
change control policy, these medical-grade
concentrates and pre-colored formulations can
help minimize risk and avoid non-compliance.
KEY CHARACTERISTICS
• Globally harmonized formulations are
manufactured at four ISO 13485 certified
medical sites, providing global consistency
and increased security of supply
• Documented change control available
• A range of standard colors eliminates color
matching to expedite development time
• The portfolio includes compliant colors for
use in:
- Needle hub applications: ISO 6009
- Ophthalmic container closures
(American Academy of Ophthalmology)
REGULATORY SUPPORT
• A library of pre-tested raw materials including:
- ISO 10993-1 and USP biological
evaluation
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact established with FDA/EU*
HEALTHCARE APPLICATIONS
• Medical devices such as catheters, surgical and
dental instruments, and drug delivery devices
• Pharmaceutical packaging including vials
and bottles
• Diagnostics for blood analysis or In Vitro
Diagnostics (IVD)
PRODUCT BULLETIN & COLOR CARD
* FDA/EU compliance information available upon request; exceptions may occur
Color Pantone Reference PE Base PP Base
Transparent
PP Base PEBA Base PC Base
Transparent
PC Base* ABS Base*
White — PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206
Yellow 102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958
Orange 158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939
Red 199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037
Pink 196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039
Violet 2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978
Light Blue 292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402
Mid Blue 285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404
Dark Blue 288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406
Light Green 346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070
Bluish Green 3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068
Medium Green 348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072
Dark Gray 425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297
Mid Gray Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295
Beige 7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871
Brown 463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869
Black Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896
Colors may vary from actual color shown.
It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including
the suitability of all raw materials and components used for its manufacture.
https://www.avient.com/sites/default/files/2021-10/remafin-ep-white-masterbatches-for-pharma-application-bulletin_0.pdf
FDA/EU compliance information available upon request
REMAFIN™ EP White Colorants
for Pharmaceutical Packaging
REMAFIN™ EP is a range of PE and PP based
masterbatches designed for protecting oral,
topical, parenteral, ophthalmic and nasal
pharmaceuticals by opacifying primary and
secondarypharmaceutical packaging.
KEY CHARACTERISTICS
• Manufactured under change control principles
beyond CAS number (similar level as MEVOPUR
concentrates), reducing risk of change
• Free from animal-derived substances and
phthalates
• Suitable for blown film, injection molding,
blow molding and extrusion
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1
- USP chapters , including Class VI,
a requirement for ophthalmic and nasal drugs
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
- USP and USP light transmission
• Registered Drug Master File (Type III)
• Food contact compliance established with
FDA/EU*
APPLICATION BULLETIN
CARRIER
MATERIAL
PIGMENT
CONTENT/TYPE
LIGHT
FASTNESS
THERMAL
STABILITY
PRODUCT
CODE
HDPE 50% TiO2 8 300°C PH00075525
LLDPE 60% TiO2 8 300°C PL00075542
LLDPE 70% TiO2 8 300°C PL00075545
PP 50% TiO2 8 300°C PP00075717
Healthcare use limitations apply—see below.
It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device, including the suitability of all raw materials and
components used for its manufacture, and with all applicable laws and regulations.
1.844.4AVIENT
www.avient.com
https://www.avient.com/sites/default/files/2024-06/EEO Policy Jan 2024.pdf
All employees,
supervisors, and members of management must accept individual responsibility for ensuring
compliance with this policy.
You are encouraged to contact your supervisor, your Human
Resources representative, or the Corporate Human Resources department if you believe that there
has been a violation of this policy, or you can notify the company’s EEO/AA compliance officer at
PeopleLink@avient.com.