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HP 3D HR PA11
Summary of Regulatory Compliance and Environmental
Attributes
Introduction
The purpose of this document is to describe the regulatory and environmental attributes of HP Inc.’s (“HP”) HP
3D HR PA11. Safety Data Sheets (“SDSs”) such as those required by the Hazard Communication Standard of the
U.S. Occupational Safety and Health Administration (“OSHA”) and similar requirements in other countries can be
found at www.hp.com/go/ecodata
H
P 3D HR PA11 is a polyamide powder designed by HP and our partner to meet worldwide regulatory
requirements and to address a broad range of health and environmental considerations throughout the entire
life cycle of a print from production to disposal.
Please refer to the HP 3D600 700 710 Agents statement for similar information on the agents.
Regulatory Summary
Chemical Inventory Status
The following countries have chemical inventory requirements and HP 3D HR PA11 can be imported without restriction:
• Australia (AICS)
• Canada (DSL, NDSL)
• Providence of Ontario
• China (IECSC)
• Japan (ISHL)
• Japan (CSCL/ENCS)
• Korea (KECI, K-REACH)
• New Zealand (NZIoC)
• Philippines (PICCS)
• Switzerland (ChemO)
• Taiwan (ECSI)
• United States (TSCA)
.
For EU REACH, HP and/or our partner have completed all necessary pre-registrations/registrations to import HP 3D HR PA11.
Regulated Materials
HP 3D HR PA11 DOES NOT contain the following regulated materials:
• Arsenic, antimony, soluble barium, cadmium, chromium, cobalt, mercury, lead, nickel, copper, and
selenium as intentionally added ingredients
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• Restricted azo colorants
1
• Substances currently regulated under Annex XIV of EU REACH (authorisations) or substances currently
restricted under Annex XVII of EU REACH (restrictions)
• Halogenated organics
Health and Environmental Performance
Human and Ecological Health
HP 3D HR PA11 is considered non-hazardous according to the Globally Harmonized System of Classification
and Labeling of Chemicals (GHS, as implemented by the EU Classification, Labeling and Packing Regulation
No1272/2008/EC (CLP)), US HazCom 2012, and other country-specific GHS regulations.
HP 3D HR PA11 does not contain intentionally added components in the following categories:
• Carcinogens, mutagens, or reproductive toxins (CMRs);
• California Proposition 65 listed chemicals at concentrations requiring labeling;
• Substances identified as endocrine disruptors;
• Substances considered very toxic or toxic;
• Substances classified as respiratory sensitizers;
• Substances identified as "very high concern" (SVHC) according to EU REACH criteria; and
• Substances identified as “very persistent and/or very bioaccumulative” (vPvB) according to EU REACH
criteria.
HP 3D HR PA11 is a 100% bio-based content polymer derived from sustainable castor oil. Castor bean does not
generally compete with food because they are grown in semi-arid to sub-tropical regions often where little else
can be grown sustainably. Castor bean is non-GMO and requires little irrigation. It is naturally pest and drought
resistant.
Transportation
HP 3D HR PA11 is Not Readily Combustible Solid of Division 4.1, Not Classified as a Flammable Solid2, and does
not require special handling, storage, or transportation-related conditions. This formulation is not classified as
Dangerous Goods in accordance with international modes of transport (IATA, IMDG, U.S. DOT, and/or ADR) and
does not contain listed marine pollutants.
1
EU Directive 2002/61/EC, additionally referenced as Regulation (EC) No 1907/2006: REACH, Annex XVI (article 67), restricts the use of azo
colorants that break down to aromatic amines known to cause cancer.
2
HP 3D HR PA11 tested per the Flammability Regultaion (EC) No. 440/2008 – Test A10 Flammability (Solids) UN Recommendations on the
Transport of Dangerous good, Manual of Tests and Criteria – For Solids: Test N1, sub-section 33.2.1.4.
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Waste Profile Datasheet
HP is providing the information in this section voluntarily as a service to assist customers in determining
appropriate disposal methods for this product at the end of life.
Flammability
Not Readily Combustible Solid of Division 4.1, Not Classified as a Flammable Solid per Flammability Regulation
(EC) No. 440/2008 – Test A10 Flammability (Solids) UN Recommendations on the Transport of Dangerous
Good, Manual of Tests and Criteria – For Solids: Test N1, sub-section 33.2.1.4.
Organics (US EPA Method SW8260B and SW8270C)
None of the substances and compounds with a regulatory threshold as set by California 22 CCR Section
66261.24 Table 1 were detected above the regulatory threshold.
Metals Content – (US EPA Method SW6010B and SW7471A)
Antimony <0.2 mg/kg
Arsenic <0.25 mg/kg
Barium <0.07 mg/kg
Beryllium <0.0800 mg/kg
Cadmium <0.0550 mg/kg
Chromium <0.0500 mg/kg
Cobalt <0.055 mg/kg
Copper <0.650 mg/kg
Lead <0.14 mg/kg
Mercury <0.2 mg/kg
Molybdenum <0.12 mg/kg
Nickel <0.050 mg/kg
Selenium <0.42 mg/kg
Silver <0.37 mg/kg
Thallium <0.49 mg/kg
Vanadium <0.18 mg/kg
Zinc <0.25 mg/kg
Aquatic Toxicity
• LC50 for fish is >750 mg/L per DOHS (Title 22) Hazardous Waste Bioassay using Fathead Minnow
• The powder does not carry an aquatic toxicity classification according to EC Regulation No. 1272/2008.
Restriction of Hazardous Substances (RoHS)
Parts printed on an HP 3D printer using HP 3D600/700 Agents and HP 3D HR PA 11 have been tested for RoHS
(Directive 2011/65/EU as amended by Directive EU 2015/863) restricted substances following IEC 62321
standards. RoHS heavy metals (cadmium, lead, and mercury), bromine, and chlorine were not detected by XRF.
The result for soluble chromium was <2.0 ppm by ASTM F963-17, section 8.3.5. No regulated phthalates were
detected above 50 ppm.
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Polycyclic Aromatic Hydrocarbons (PAHs)
Anthracene
Fluoranthrene
Benzo[a]pyrene
Benzo[e]pyrene
3-Methylcholanthrene
Parts printed on an HP 3D printer using HP 3D600/700 Agents and HP 3D HR PA 11 were tested for PAHs. No PAHs stated in table 1 were detected above the detection limit of 1 ppb using GC/MS.
Table 1. PAHs Tested
Naphthalene
Acenaphthylene
Acenaphthene
Fluorene
Phenanthrene
Pyrene
Benzo[c]phenanthrene
Benzo[c]anthracene
Chrysene
Benzo[b]fluoranthene
Benzo[k]fluoranthene
Benzo[j]fluoranthene
Dibenzo[a,h]anthracene
Indeno[1,2,3-cd]pyrene
Benzo[g,h,i]perylene
Phthalates
Parts printed on an HP 3D printer using HP 3D600/700 Agents and HP 3D HR PA 11 were tested for regulated phthalates listed in table 2 and the results were <50 ppm.
T
able 2. Phthlates Tested
Di-butyl phthalate (DBP)
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Butyl benzyl phthalate (BBP)
Di(2-ethylhexyl) phthalate (DEHP)
Di(n-octyl) phthalate (DnOP)
Di(iso-nonyl) phthalate (DINP)
Di-(is-decyl) phthalate (DIDP)
Di-n-hexyl phthalate (DnHP)
Bisphenol A
Parts printed on an HP 3D printer using HP 3D600/700 Agents and HP 3D HR PA 11 were tested for bisphenol A and was below the detection level of 0.1 mg/kg in printed parts.
Recyclability
HP 3D HR PA11 powder is supplied in containers of which approximately 80% of the weight of the used empty
container is a recyclable cardboard. For disassembly instructions of the container please visit the following
page: https://h30248.www3.hp.com/recycle/supplies/pdf/powder_container_recycling_instructions.pdfe
.
HP Design for Environment (DfE) Program
In 1992, HP adopted a pioneering company-wide Design for the Environment program that considers
environmental impact in the design of every product and solution, from the smallest ink cartridge to entire data
centers.
For more information about HP’s social and environmental responsibility programs, see
www.hp.com/livingprogress.
Food Contact
Currently, no HP 3D materials are designed or approved for direct or indirect food contact applications and
accordingly they should not be used for food applications or direct and indirect food contact applications.
21 HP Development Company, L.P. The information contained herein is subject to change without notice. The only warranties
uting an additional warranty. HP shall not be liable for technical or editorial errors or omissions contained herein.
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January
ISO 10993, US FDA, and USP Class I-VI Medical Devices Statement
HP 3D600 Fusing and Detailing Agents and HP 3D HR PA11
Original HP 3D600/3D700 Fusing and Detailing Agents and HP 3D HR PA11 material (“HP Agents & PA11
Material”) have undergone the following tests at a certified third-party laboratory:
1. Cytotoxicity – ISO 10993-5, Biological evaluation of medical devices – part 5: Tests for in vitro
cytotoxicity. The test article extract showed no evidence of causing lysis or toxicity. The test article
extract met the requirements of the test.
2. Sensitization and irritation – ISO 10993-10, Biological evaluation of medical devices – Part 10: Tests
for irritation and skin sensitization.
a. The test article extracts showed no evidence of causing delayed dermal contact sensitization
in the guinea pig. The test article was not considered a sensitizer in the guinea pig test.
b. The test article met the requirements of the intracutaneous injection in rabbits with test
article extracts of 0.9% sodium chloride USP solution and sesame oil, NF.
3. Acute systemic toxicity – ISO 10993-11, Biological evaluation of medical devices – Part 11: Tests for
systemic toxicity. There was no mortality or evidence of systemic toxicity from the extracts of 0.9%
sodium chloride USP solution and sesame oil, NF injected into mice. Each test article extract met the
requirements of the study.
4. Muscle implantation - USP, General Chapter <88>, Biological Reactivity Tests, In vivo – Muscle
implantation. The test article was implanted for seven days and the implanted test article met the USP
requirements.
5. Pyrogenicity – USP, General Chapter <151>, Pyrogen test. Recommended in ISO 10993-11, Biological
evaluation of medical devices – Part 11: Tests for systemic toxicity. The total rise of rabbit
temperatures during the 3-hour observation period was within acceptable USP requirements. The test
article met the requirements for the absence of pyrogens.
The results from the above-referenced testing are representative of parts produced on the HP Jet Fusion 3D
4200/4210 printers over the range of available printmodes with HP Agents & PA11 Material. HP 3D HR PA11
fresh and recycled (70% recycled/30% fresh) material was used for the Cytotoxicity, Sensitization, Irritation, and
Acute Systemic Toxicity tests. HP 3D HR PA11 100% fresh powder was used for the Muscle Implantation test.
HP 3D HR PA11 recycled (70% recycled/30% fresh) material was used for the Pyrogenicity test. The only post
processing that the parts underwent were sand blasting, a soak in isopropanol for 30 minutes, and a rinse in
deionized water.
Material under recommended operating conditions as per the site preparation guide will meet the testing stated
above.
2-pyrrolidone (2P) (CAS No. 616-45-5) is present in the 3D600/3D700 Fusing and Detailing Agents at <20% and
5% by weight, respectively. 2P is a Category 1B reproductive toxin according to the Globally Harmonized
System of Classification and Labeling of Chemicals (GHS, as implemented by the EU Classification, Labeling and
Packing Regulation No1272/2008/EC (CLP)), US HazCom 2012, and other country-specific GHS regulations.
Based on HP internal testing (December 2019) of HP HR PA11 printed parts using GC/MS, 2-pyrrolidone can be
present in the range of 0.29 - 0.34% by weight.
conducted for reproductive/developmental toxicity.
2-Methyl-2H-isothiazol-3-one (MIT) (CAS No. 2682-20-4) is present in the 3D600/3D700 Fusing and Detailing
Agents at <0.1% by weight in these formulations. MIT is a Category 1 skin sensitizer according to the Globally
Harmonized System of Classification and Labeling of Chemicals (GHS, as implemented by the EU Classification,
Labeling and Packing Regulation No1272/2008/EC (CLP)), US HazCom 2012, and other country-specific GHS
regulations. MIT may be present in the final printed HD 3D HR PA 11 part.
Based on these results, HP expects that similar parts made from the HP Agents & PA11
No testing of HP 3D HR PA 11 printed parts has been
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January
It is the responsibility of each customer to determine that its use of HP Agents and PA11 material is safe and
technically suitable to the customer’s intended applications and consistent with the relevant regulatory
requirements (including FDA requirements) applicable to the customer’s final product. HP PA11 powder is not
intended to be used in medical device applications that constitute a non-temporary implant (i.e., that, in whole
or in part, may be in contact with a patient’s skin, body fluids or tissues for more than 30 days.) Customers
should conduct their own testing to ensure that this is the case. Results may vary if the testing is performed
under different conditions than those existing at HP’s laboratories at testing time and those that applied for the
purposes of the biocompatibility tests as referenced above. Because of possible changes in the relevant
industry standards, FDA guidance, and other legal or regulatory requirements, as well as possible changes in HP
Agents and PA11 material, HP cannot guarantee that the status of HP Agents and PA11 powder will remain
unchanged or that it will qualify and or comply with ISO 10993, US FDA’s guidance or USP Class I-VI Certification
for any particular use.
For additional information about HP 3D600/3D700 Fusing and Detailing Agents and HP 3D HR PA11, please
contact our HP 3D Printing Materials team at 3dmaterials@hp.com.
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January
Statement of Composition for Toy Applications
HP Material
Sample
Synthetic Gastric Fluid,
mg/kg
Synthetic Saliva, mg/kg
HP HR PA11
1
0.30
0.40
HP 3D600 Fusing and Detailing Agents and HP 3D HR PA11
Parts made with HP 3D600 Fusing and Detailing Agents and HP 3D HR PA11 have undergone the following
tests:
eavy Metal: No metals were detected in the study with a limit of detection of 2.0 ppm. The submitted
1. H
samples comply with the soluble heavy metals requirements according to section 8.3.5 of ASTM F963-
17.
2. P
hthalates: No phthalates were detected down to 0.005% in the study. The submitted sample passed
the applicable requirements for phthalates as recommended by the Consumer Product Safety
Improvement Act of 2008, Section 108.
3. Bisphenol A (BPA): No Bisphenol A was detected in the sample down to 0.1 ppm.
The
testing referred to above is typical of parts produced with HP 3D600/3D700 Fusing and Detailing Agents
and fresh HP 3D HR PA11 powder
rrolidone (2P) (CAS No. 616-45-5) is present in the 3D600/3D700 Fusing and Detailing Agents at <20% and
2-py
5% by weight, respectively. 2P is a Category 1B reproductive toxin according to the Globally Harmonized
System of Classification and Labeling of Chemicals (GHS, as implemented by the EU Classification, Labeling and
Packing Regulation No1272/2008/EC (CLP)), US HazCom 2012, and other country-specific GHS regulations.
Based on HP internal testing (December 2019) of HP HR PA11 printed parts using GC/MS, 2-pyrrolidone can be
present in the range of 0.34 - 0.39% by weight.
conducted for reproductive/developmental toxicity.
3
on the HP Jet Fusion 3D 4200/4210 printers.
No testing of HP 3D HR PA 11 printed parts has been
ewly printed parts from an HP 3D printer using HP 3D600/700/710 Agents and HP PA11 3D materials were
N
tested to to perform a targeted migration study for 2-pyrrolidone in both synthetic saliva and gastric fluid for
incidental ingestion or “mouthing” (February 2020) with potential toy applications in mind. The migration study
was performed in triplicate on the two samples by placing 4 squares of the sample in 50 ml of either synthetic
saliva or synthetic gastric fluid for 2 hours at room temperature. 2-pyrrolidinone was analysed and quantified
by LC-MS/MS analysis.
Migration test results
2 0.27 0.43
3 0.30 0.38
2-M
ethyl-2H-isothiazol-3-one (MIT) (CAS No. 2682-20-4) is present in the 3D600/3D700 Fusing and Detailing
Agents at <0.1% by weight in these formulations. MIT is a Category 1 skin sensitizer according to the Globally
Harmonized System of Classification and Labeling of Chemicals (GHS, as implemented by the EU Classification,
Labeling and Packing Regulation No1272/2008/EC (CLP)), US HazCom 2012, and other country-specific GHS
regulations. MIT may be present in the final printed HD 3D HR PA 11 part.
I
t is the responsibility of each customer to determine that its use of HP 3D600 Fusing and Detailing Agents and
HP 3D HR PA11 powder is safe and technically suitable to the customer’s intended applications and consistent
3
Testing performed with 100% fresh powder.
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January
with the relevant regulatory requirements applicable to the customer’s final product. HP’s testing focused on
the chemical composition of the printed parts and did not focus on physical requirements such as choking
hazards. It is the responsibility of each customer to conduct their own testing to ensure that physical,
mechanical, flammability, microbiological, acoustic, electrical, temperature, magnetism, and other relevant
requirements for toys are met for their final product. Results may vary if the testing is performed under
different conditions than those existing at HP’s laboratories at testing time and those that applied for the
purposes of the tests above. HP cannot guarantee compliance of HP 3D600 Fusing and Detailing Agents, HP 3D
HR PA11 powder or any printed parts made with HP 3D600 Fusing and Detailing Agents and HP 3D HR PA11
with any legislation or industry standard that may be applicable to toys. Because of possible changes in the
relevant industry standards, FDA and EU guidance, and other legal or regulatory requirements, as well as
possible changes in HP 3D600 Fusing and Detailing Agents and HP 3D HR PA11 powder, HP cannot guarantee
that the status of HP 3D600 Fusing and Detailing Agents and HP 3D HR PA11 powder will remain unchanged.
For additional information about HP 3D600 Fusing and Detailing Agents and HP 3D HR PA11, please contact our
HP 3D Printing Materials team at 3dmaterials@hp.com.
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No critical particle emissions from HP Jet Fusion 3D printers
Device performance undergoes strict safety consideration
Customers expect safe particle release behavior from their HP Jet Fusion 3D printing solutions. Evaluation
needs to include different particle types potentially emitted – in particular fine and ultrafine particles. Indicative
testing demonstrates that HP devices provide a high level of safety.
Fine dust emissions are negligible
Emissions of HP Jet Fusion 3D printing solutions in the fine particles size range of 0.3 to 10.0 micrometers (µm)
are well below below a variety of mandatory and voluntary environmental requirements, as indicative testing
has shown.
When compared against mandatory occupational limits and toxicologically based indoor air guide values,
devices are far below relevant values. For example, the devices meet the fine particles criteria of the Germany
AGW
expected when the devices are used and maintained as intended.
Ultrafine particles release is very low as well
4
5
and the U.S. Permissible Exposure Limits (PELs) 6. Accordingly, testing concluded that no health risks are
For the extremely small ultrafine particles (UFPs) with a diameter of below 0.1 µm, concentrations resulting
7
from the operation of HP Jet Fusion 3D printers are also quite low.
8
precautionary guide value of the German Blue Angel.
And due to the UFPs’ volatile nature, they do not hold
Particle numbers lie well below the
the health hazardous potential associated with the solid consistency of particles in the ultrafine size range.
Based on these observations, no health risks due to UFP release by HP Jet Fusion 3D printers have to be
expected under reasonably foreseeable conditions of use as well.
Larger particles uncritical from a safety perspective
Particles with an average diameter of more than 10 µm generally have a lower exposure potential due to the
propensity of these particles dripping out of the air. And, if inhaled, particles of this size are deposited in the
upper regions of the human respiratory tract where they are subject to efficient clearance mechanisms. In
addition to these physical considerations, the inherent chemical properties of the HP 3D materials do not
indicate a health risk as they are not classified or labelled as hazardous according to the Globally Harmonized
system of classification and Labelling of chemicals (GHS)
10
Union
4
5
6
7
8
9
10
11
, and applicable requirements in the United States.
HP commissioned indicative testing of HP Jet Fusion 3D 3200 and 4200 Printers operated with HP 3D PA12 material, carried out by the
Fraunhofer Wilhelm-Klauditz-Institue (WKI), Braunschweig, Germany, 2016/2017.
Workplace limits (AGW), TRGS 900, German Ordinance of Hazardous Substances (GefStoffV), German Comitte on Hazardous Substances
(AGS), 2006 (as amended).
PELs-TWA, 29 CFR 1910.1000 Z-1 and Z-2, OSHA, 2006.
HP commissioned indicative testing of HP Jet Fusion 3D 3200 and 4200 Printers operated with HP 3D PA12 material, carried out by the
Fraunhofer Wilhelm-Klauditz-Institue (WKI), Braunschweig, Germany, 2016/2017.
Basic criteria for award of the German Blue Angel (BA) environmental label for Office Equipment with Printing Function, RAL-UZ 171 or
RAL0UZ 205, RAL gGmH.
GHS, ST/SG/AC. 10/30/Rev. 5, United Nations, 2013.
REG. (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, European Parliament and Council, 2008
(as amended).
Occupational Safety and Health Standards, Toxic and Hazardous Substances, 1910.1200, OSHA, 2012 (as amended).
9
, the assessment criteria for mixtures in the European
11
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4AA7-6987ENW, January 2021
g herein
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