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RDS - AMP Ultra PC 2000

This document provides regulatory compliance information for AMP Multifunctional Amino Alcohols. It lists the product's status on various country and regional chemical inventories. It also discusses the product's food contact status and compliance with various standards like Kosher, Halal and Vegan.

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Ashok Maurya
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0% found this document useful (0 votes)
186 views17 pages

RDS - AMP Ultra PC 2000

This document provides regulatory compliance information for AMP Multifunctional Amino Alcohols. It lists the product's status on various country and regional chemical inventories. It also discusses the product's food contact status and compliance with various standards like Kosher, Halal and Vegan.

Uploaded by

Ashok Maurya
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 17

Regulatory Data Sheet

#N/A

AMP ® Multifuctional Amino Alcohols

Global Chemical Inventory Compliance


Country Inventory Statement

Australia AICS Australian AICS: All ingredients are on the AICS Inventory or are not required to be
listed.
Canada DSL Canadian DSL: All ingredients are on the DSL Inventory or are not required to be listed.

Canada NDSL -

China IECS Chinese IECSC: All ingredients are on the IECSC Inventory or are not required to be
listed.
Europe EINECS European EINECS: All ingredients are on the EINECS Inventory or are not required to
be listed.
Taiwan TCSI All ingredients are on the TCSI Inventory or are not required to be listed.
Japan ENCS Japanese M ITI: All ingredients are on the M ITI Inventory or are not required to be listed.
Korea KECI Korean KECI: All ingredients are on the KECI Inventory or are not required to be listed.

New Zealand NZIoC New Zealand NZIoC: All ingredients are on the NZIoC Inventory or are not required to be
listed.
Philippines PICCS Philippines PICCS: All ingredients are on the PICCS Inventory or are not required to be
listed.
United States TSCA U.S.A. TSCA: All ingredients are on the TSCA Inventory or are not required to be listed.

AMP® Multifuctional Amino Alcohols

AMP-REGULAR® 2-Amino-2-methyl-1-propanol [anhydrous]


AMP-95® 2-Amino-2-methyl-1-propanol [4.8-5.8% aqueous solution]
AMP-90™ 2-Amino-2-methyl-1-propanol [8.8-10.8% aqueous solution]
AMP-75™ 2-Amino-2-methyl-1-propanol [23.8-25.8% aqueous solution]

Supersedes all versions prior to Effective Date


®™Trademark of The ANGUS Chemical Company
Page 1 of 17 Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

US FDA Food Contact Status


FOOD ADDITIVE STATUS - CFR 21:
Please note that this product is not approved as a direct food additive, and therefore, is not marketed into such applications
at this time.
AMP-REGULAR® 2-Amino-2-methyl-1-propanol, AM P-90** 2-Amino-2-methyl-1-propanol; AM P-95** 2-Amino-2-
methyl-1 propanol; AM P-75** 2-Amino-2-methyl-1-propanol; AM P-ULTRA** PC 1000 Neutralizing Amine; AM P-
ULTRA** PC 2000 Neutralizing Amine; AM P-ULTRA** PC 3000 Neutralizing Amine
These AM P products meet the requirements of the Food Additive Regulations as listed below. Uses are subject to good
manufacturing practices and any limitations that are a part of the regulations.
The information given here is for use as a general guideline. The regulations should be consulted for complete details.
Some uses may have been overlooked; specific regulations will be reviewed upon request.
The legal judgments expressed herein are felt to be accurate. The final responsibility is, however, up to the user who
should consult legal counsel.
175.105(c(5) Adhesives.
176.170 & 176.180 Substances for Use Only as Components of Paper and Paperboard. Approved for use in all
food types under conditions of use A-H & J (microwave only container) applications in:
(1) coatings at a level not to exceed 0.25% by weight of the mineral pigment
(2) fillers at a level not to exceed 0.05% by weight of the mineral pigment.

175.300(b(3(xiii(a) Resinous and polymeric coatings. M elamine-formaldehyde chemically modified with one or more of
the following amine catalysts:
The resins and coatings cleared under Section 175.300 have been cleared by cross reference for use as provided in the
following sections:
175.380 Xylene-formaldehyde resins condensed with
4,4'-isopropylidenediphenol- epichlorohydrin epoxy resins
175.390 Zinc-silicon dioxide matrix coatings
177.1210 Closures with sealing gaskets for food containers
177.2260(d)(3) Filter, resin-bonded. M elamine-formaldehyde chemically modified
with one or more of the amine catalysts identified in Sec.
175.300(b)(3)(xiii) of this chapter.

EU 10/2011 Food Contact


Plastics directive (EC 10/2011) (including SM L and dual use additives):
Compliance to Commission Regulation 10/2011 of 14 January 2011 on plastic materials and articles intended to come into
contact with food: 2-Amino-2-methyl-1-propanol is not listed in the so-called Union list in this Regulation (Annex I). This
product can therefore not be used in any plastic in contact with food, if used as a monomer or as an additive.

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®™Trademark of The ANGUS Chemical Company
Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

Animal Derived Components


M aterials of Origin, Animal Derived Ingredients, BSE/TSE:
This product has been evaluated for the source of the raw materials used in its production. It is manufactured from basic
chemicals that have no animal origin. There are no animal source raw materials or additives used in the manufacture of
this product. Therefore, we can state that BSE/TSE (bovine spongiform encephalopathy/transmissible spongiform
encephalopathy) is not a concern with this product.

Food Allergens
Allergens:
This product is not manufactured with or using any of the 26 allergen ingredients in the 7th Amendment of the European
Cosmetic Directive, EU. 'Allergenic substances which must be labelled on packaging of detergents and cosmetics', as
per EU Cosmetics Directive (EC) No 1223/2009 [the recast for the EU Cosmetics Directive 76/768/EEC and
Amendments that are listed at http://ec.europa.eu/consumers/sectors/cosmetics/documents/directive/index_en.htm].
Therefore, none of these substances would be expected to be present in the product.
This product is not manufactured with or using any of the following substances: Cereals containing gluten (i.e., wheat, rye,
barley, oats, spelt, kamut or their hybridized strains) and products thereof. Crustaceans and products thereof. Eggs and
products thereof. Fish and products thereof. Peanuts and products thereof. Soybeans and products thereof. M ilk and
products thereof (including lactose). Nuts i.e., Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut
(Juglans regia), Cashew (Anacardium occi-dentale), Pecan nut (Carya illinoiesis (Wangenh.) K. Koch), Brazil nut
(Bertholletia excelsa), Pistachio nut (Pistacia vera), M acadamia nut and Queensland nut (M acadamia ternifolia) and
products thereof. Celery and products thereof. M ustard and products thereof. Sesame seeds and products thereof.
Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2.

Materials from Genetically Modified Organisms


GM O: we can inform you that the abovementioned product is not manufactured using materials from genetically modified
organisms (GM O), or is handled or stored in such a way that it can become contaminated with such materials. This
assessment is in agreement with EU regulations 1829/2003/EC and 1830/2003/EC and latest amendments.

Kosher
Kosher:
This product has been evaluated for the source of the raw materials used in its production. It is manufactured from basic
chemicals that have no animal origin. There is no animal fat, no animal derived materials, grain derived (rice or corn), or
fermentation products used in this product. The product contains no marine, petrochemical or mineral additives. The
product is not certified as kosher, but will comply with the kosher dietary laws. Therefore, this product can be used with
kosher products without compromising the status of the products.

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®™Trademark of The ANGUS Chemical Company
Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

Halal
Halal:
This product has been evaluated for the source of the raw materials used in its production. It is manufactured from
basic chemicals that have no animal or vegetal origin. There is no animal fat, no animal derived materials, grain
derived (rice or corn), or fermentation products used in this product. The product contains no marine, petrochemical
or mineral additives. The product is not certified as Halal but will comply with the Halal dietary laws. Therefore, this
product can be used with Halal products without compromising the status of the products

Vegan
Vegan:
This product is a synthetic chemical manufactured from basic raw material chemicals that have no animal or plant
origin. There are no genetically modified organisms (GMO) used in the manufacture of this product. There are no
animal source raw materials or additives used in the manufacture of this product. The manufacture of this product
does not exploit the use of animals in any way.

REACH
REACH:
I can confirm that the component(s) in this product were registered under REACh in 2010.
Registration number: 01-2119475788-16-0000
As you probably know, REACH obligations to (pre)register are with the manufacturers in the EU and/or importers of
substances in the EU. Therefore, the fact that ANGUS will (pre)register substances which ANGUS manufactures and/
or imports into the EU, may not satisfy the REACH obligation for other importers of the same ANGUS substance(s).

EU Directive 2002/95/EC (RoHS) as amended by 2008/385/EC


EU RoHS Directive 2002/95/EC as amended by EU Directive 2011/65/EU - Restriction of Hazardous Substances
(RoHS); 1-Jul-2011:
For information on the components of our product and their concentrations, please refer to the M aterial Safety Data
Sheet (M SDS) and the Sales Specification. Any hazardous constituent above 1% (by weight) and carcinogens
above 0.1% will appear in the Ingredients section of the M SDS for this product. In addition, consult the Hazardous
Decomposition Products section of the M SDS and the Sales Specification for further information.
ANGUS does not routinely analyze for additional materials that are not listed in the M SDS or Sales Specification.
Your inquiry addressed the EU Directive 2002/95/EC, on the restriction on the use of certain hazardous substances in
electric and electronic equipment (RoHS), which contains restrictions on the following materials in electric and
electronic equipment: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) or
polybrominated diphenyl ethers (PBDE). None of those materials are intentionally added to this product.

Supersedes all versions prior to Effective Date


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®™Trademark of The ANGUS Chemical Company
Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

EU Directive 2002/96/EC on Waste Electrical and Electronic Equipment


(WEEE)
EU Directive 2002/96/EC, as amended by Directive 2008/34/EC, requires that the formation of waste from electric and
electronic equipment is reduced and properly managed.
This statement is intended to provide information on our product so that you may assess the consequences of these
directives on the E&E articles you manufacture and place on the EU market, or materials you supply to the affected
industry.
EU Directive 2002/96/EC on WEEE: Selective treatment of the waste (Article 6.1 and Annex II)
Article 6 requires that the waste management schemes (to be) set up by the producers, individually or collectively, ensure
that the waste will be selectively treated for materials and components of the E&E waste in line with the requirements of
Annex II.
None of the following substances listed in Annex II are intentionally added or used in the manufacture of this product:
• Asbestos
• Brominated flame retardants
• Ceramic fibers
• Chlorofluorocarbons (CFC)
• Hydrochlorofluorocarbons (HCFC)
• Hydrofluorocarbons (HFC) , Hydrocarbons (HC)
• M ercury
• Ozone depleting gases
• Polychlorinated biphenyls (PCB)
• Polychlorinated terphenyls (PCT)
• Radioactive substances

ASTM F963 - Standard Consumer Safety for Toy Safety


Compliance to Norm DIN EN 71 Part 3 Heavy metals in toys: this standard relates to Safety of Toys - M igration of Certain
Elements (Antimony, Arsenic, Barium, Cadmium, Chromium, Lead, M ercury and Selenium), and is based upon
Directive 88/378/EEC (with amendments) establishing maximum daily leachable metals from toys.
We do not routinely analyze for chemicals which are not on our sales specifications; however, we have performed
occasional analysis on several samples of this product to determine if we had heavy metals in them and have found in our
analysis that the heavy metals levels were below the level of detection of 0.01 ppm (mg/kg) for Lead, Arsenic, Selenium,
Barium, Chromium, Cadmium, Antimony and 0.002 ppm (mg/kg) for M ercury.

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®™Trademark of The ANGUS Chemical Company
Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

Canadian Environmental Protection Act Challenge Substances


CEPA Challenge; Challenge substances on DSL subject to screening assessment, as amended through January
15, 2011:
You asked if this product contains any substances that have been identified by the Canadian Environmental
Protection Agency (CEPA) in the challenge program “Notice of intent to develop and implement measures to assess
and manage the risks posed by certain substances to the health of Canadians and their environment”. The
Chemicals M anagement Plan in this Canadian program involves the collection of information on the properties and
uses of the approximately 200 chemical substances identified through the categorization process as high priorities for
action.
This product has been evaluated for the source of the raw materials used in its production. This product is
manufactured from basic chemicals and has no additional additives, preservatives, or dyes. Although this product is
not analyzed routinely for the substances in question, it is not manufactured or formulated with and, therefore, is not
expected to contain any of the substances of concern that are listed on batches 1-12 of the CEPA Challenge, with the
following possible exception: 2-Nitropropane is an early stage material used to manufacture this product; however,
none of this chemical is anticipated to be present in the final product.

Natural Rubber, Latex, Parabens, Gluten, Palm Oil, and Mineral Oil
Substances of Concern: Natural Rubber, Latex, Parabens, Gluten, Palm Oil, and Mineral Oil:
This product has been evaluated for the source of the raw materials used in its production. It is a synthetic chemical
manufactured from basic raw material chemicals that have no animal or plant origin. There are no additives,
colorants or preservatives added to this product. Although we do not test for the chemical you question routinely, this
product is not produced with or manufactured using these materials, and therefore, would not be expected to contain
any of these substance(s):
• Natural rubber
• Latex
• Parabens
• Gluten
• Palm Oil
• Mineral Oil
• Melamine
• Aflatoxin
• Pesticides
• Phosphates
• Bisphenols

Supersedes all versions prior to Effective Date


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Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

Phthalate Esters
Substances of Concern; Phthalates:
This product is not intentionally manufactured or formulated with the following phthalate esters; however, we do not analyze
for these specific substances or compounds.
• Butyl benzyl phthalate (BBP) CAS 000085-68-7
• Diethyl hexyl phthalate (DEHP) CAS 117-81-7
• Diethyl phthalate CAS 000084-66-2
• Diisobutyl phthalate (DIBP) CAS 000084-69-5
• Di-iso-decyl phthalate (DIDP) CAS 26271-40-0
• Di-isononyl phthalate (DINP) CAS 28553-12-0
• Dimethyl phthalate CAS 131-11-3
• Di-n-butyl phthalate (DBP) CAS 000084-74-2
• Di-n-hexyl phthalate (DnHP) CAS 000084-75-3
• Di-n-octyl phthalate (DNOP) CAS 117-84-0.

Halogenated Flame Retardants


Substances of Concern; Halogenated Compounds:
This product has been evaluated for the source of the raw materials used in its production. It is a synthetic chemical
manufactured from basic raw material chemicals that have no animal or plant origin. There are no additives, colorants or
preservatives added to this product. Although we do not test for the chemical(s) you question routinely, this product is not
produced with or manufactured using halogenated compounds, and therefore, would not be expected to contain any of
these substance(s):
1.1.1-Trichloroethane (CAS 71-55-6)
1.1.2-Trichloroethane (CAS 79-00-5)
1.1.1.2- Tetrachloroethane (CAS 630-20-61)
1.1.2.2- Tetrachloroethane (CAS 79-34-51)
1.1-Dichloroethylene
Trichloroethylene (CAS 79-01-6)
Tetrachloroethylene (CAS 127-18-4)
Bromochloromethane (CAS 74-95-5)
Carbon Tetrachloride (CAS 56-23-5)
Chlorobenzene
Chlorofluorocarbons (CFCs)

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AMP® Multifuctional Amino Alcohols

Chloroethylene
Chloroform (CAS 67-66-3)
Chlorotoluenes
Dichlorobenzenes
Dichlorotoluenes
Dioxins or furans
Halons or Halogenalkanes
Hydrobromofluorocarbons (HBFCs)
Hydrochlorofluorocarbons (HCFCs)
Hydrofluorocarbons (HFCs)
Pentachlorobenzenes
Hexachlorobenzenes
Pentachloroethane
Pentachlorotoluenes
Perfluorinated Chemicals (PFCs)
Polychlorinated Biphenyls(PCBs)
Polychlorinated Terphenyles(PCTs)
Polychlorinated Naphthalenes(PCNs)
Polyvinyl chloride (PVC)
Polyvinylidene chloride (PVDC)
Tetrachlorobenzenes
Tetrachlorotoluenes
Trichlorobenzenes
Trichlorotoluenes

Fluorotelomers, Perfluorooctanoic acid (PFOA) and Derivatives


Substances of concern; PFOS/PFOA:
This product has been evaluated for the source of the raw materials used in its production. This product is manufactured
from basic chemicals and this product has no additional additives, preservatives or dyes. Although this product is not
analyzed routinely for the substances in question, it is not manufactured or formulated with and, therefore, is not expected to
contain: Perfluorooctanoic Acid (PFOA) or Perfluorooctane Sulfonate (PFOS).

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Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

Residual Volatile Organic Compounds (VOC)


Volatile Organic Compounds (VOC) – USA-EPA:
With regard to Volatile Organic Compounds (VOC) content, one Environmental Protection Agency (EPA) definition of a
VOC is any compound of carbon excluding carbon monoxide, carbon dioxide, carbonic acid, metallic carbides or
carbonates, and ammonium carbonate and excluding compounds which have negligible photochemical reactivity such
as: ethane, methane, and also methylene chloride, perchloroethylene and acetone.
For other compounds, see 40 Code of Federal Regulations Section 51.100(s) and check for any recent Federal Register
notices possibly exempting other negligibly reactive VOCs. Under this broad definition, this product is a VOC.
The water portion of this product, if present, is not considered a VOC. Since state or local governments and some specific
EPA regulations may be more restrictive than the definition above, please check these sources also.
The following data was generated for weight percent volatility of these products using EPA M ethod 24:
ANGUS Weight % Specific Water Content
Product Name Volatility Gravity in Weight %
(anhydrous)
AM P-REGULAR 100% 0.93 @ 40/40°C < 1%
AM P-95 100% 0.94 @ 25/25°C 6% max
AM P-90 100% 0.95 @ 25/25°C 11% max
NOTE: Please note that this information is not a statement as to whether or not any of these products is a VOC. It is the
responsibility of the user to determine the appropriate regulatory requirement for their operation.

California Proposition 65 (Safe Drinking Water and Toxic Enforcement Act of


1986)
California Proposition 65 (also known as the California Safe Drinking Water and Toxic Enforcement Act of 1986):
This product contains no listed substances known to the State of California to cause cancer, birth defects, or other
reproductive harm, at levels which require a warning under the statute.

BfR Bundesinstitut für Risikobewertung Recommendation


BfR XIV, XXXVI et XXXVI/2; Food contact approval in Germany:
2-Amino-2-methyl-1-propanol has received BgVV approval from the German Federal Institute for Risk Assessment
under recommendation XXXVI “production aid as dispersant and flotation agent in the manufacture of paper and board for
food contact use”. It is not in recommendation XIV (plastics dispersions) nor is it in recommendation XXXVI/2 (Paper
and Paperboard for Baking Purposes).

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®™Trademark of The ANGUS Chemical Company
Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

Food Contact COE Council of European Resolution


Framework Resolution ResAP(2004)1 :
Resolution AP(2004)1 on coatings intended to come into contact with foodstuffs (replacing Resolution AP (96) 5): we
can inform you that our substance 2-Amino-2-methyl-1-propanol is listed in the Synoptic document AP 20024/1 only
in SCF list 8 “Substances for which no or only scanty and inadequate data was available”

Food Contact Switzerland LGV


SR 817.023.21 Annex 10 Part A or B + restrictions if any:
I can confirm that 2-Amino-2-methyl-1-propanol is listed in annex 10 on the Swiss Ordinance 817.023.21 on M aterials
and Articles in contact with food. It is in the list of binders, in the list of solvents and in the list of additives, part A,
evaluated substances with an SM L of 5 mg/kg in these three lists.

Ecolabel
Ecolabel being essentially relevant to the finished products, it is up to the formulators to determine whether their
finished products deserve the Ecolabel certification. However, the following information about our product that you use
as a raw material will be of help to this aim:
- presence of VOC: the 2-amino-2-methyl-1-propanol molecule is a VOC. In the calculation, water should not be taken in
account.
- presence of the different substances (including metal elements) of concern as listed in the Ecolabel Regulation: although
we do not analyze this product for the specific chemicals you list routinely, it is not manufactured with or formulated using
and, therefore, is not expected to contain any of them.
- presence of substances classified as dangerous to the environment: as can be seen in our Safety Data Sheet of this
product, and in agreement with annex I to the Dangerous Substances Directive 67/548/EEC and amendments, AM P is
classified as “Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment” with risk
phrases R52/53. However, when registering this substance for REACH, we found that it is readily biodegradable, therefore
we have proposed to the competent authorities to remove R52/53 from the classification of 2-Amino-2-methyl-1-propanol.

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Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

Coalition of Northeastern Governors (CONEG)


CONEG:
Regarding the Coalition of Northeastern Governors (CONEG) legislation, although we do not analyze for the substances in
question routinely, occasional samples of a similar 2-amino-2-methyl-1-propanol product containing approximately 5%
water have been tested for some of the ingredients that you are requesting with the following results:
Cadmium: None detected at 0.05 ppm limit of detection.
Chromium: None detected at 0.05 ppm limit of detection.
Chromium VI: None detected at 0.05 ppm limit of detection.
Lead: None detected at 0.05 ppm limit of detection.
M ercury (Hg): None detected at 0.05 limit of detection.

Hazardous Air Pollutants (HAPs)


HAPS:
With regard to your inquiry on Hazardous Air Pollutants (HAPs) under the Clean Air Act, this product is a blend as
described in the M aterial Safety Data Sheet (M SDS). In addition, please also consult the Hazardous Decomposition
Products section of the M SDS and the Sales Specification for any further information. I am not aware of this product
containing any HAPs above 0.1%. The following Environmental Protection Agency (EPA) websites are also available for
your reference of the most current HAPs listings, including recent modifications to the listings:
http://www.epa.gov/ttn/atw/orig189.html. Federal Register notices containing modifications to the original Clean Air Act
HAP list are located here: http://www.epa.gov/ttn/atw/pollutants/atwsmod.html.

REACH SVHC
EU REACH SVHC; [Candidate List of Substances of Very High Concern (SVHC) for authorization]; 25-Jun-2020:
This product is manufactured from basic chemicals and has no additional additives, preservatives or dyes. Although we
do not analyze this product routinely for the substances in the EU REACH "SVHC" Proposed List of Chemicals; ANGUS
does not manufacture with or produce the product using any of the substances on the referenced list, and therefore, would
not expect any to be present.

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Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

Shelf Life
Shelf Life:
ANGUS AMP® Multifuctional Amino Alcohols products should meet original specification for a period of five (5)
years from the date of manufacture, provided the product, in original packaging, has not been used or modified in
any manner, and has been kept under recommended storage conditions.
Historical performance data available for the product has yielded no increase in levels of impurities, no changes in
purity, and no other indications of product degradation.
If additional information is needed, please contact Customer Service or local sales.
We appreciate your inquiry on this issue and value your continuing interest in ANGUS products. If you have further
questions regarding ANGUS products, please do not hesitate to contact us.

Formaldehyde and Nickel Content


Formaldehyde and Nickel Content:
AM P products have been evaluated for the source of the raw materials used in production. These products are
manufactured from basic chemicals and have no additional additives, preservatives or dyes. Although we at ANGUS
do not analyze for trace substances in question routinely, these products are manufactured using the following
materials:
Nickel and Nickel Compounds: This product is made from an ingredient which uses a very small amount of nickel in
the manufacture of that ingredient. Although, we do not analyze for nickel routinely, occasional samples of AM P
products have been tested for nickel and the results of those tests have shown less than 10 ppm of nickel.
Formaldehyde: We do not measure free formaldehyde routinely in our product. The free formaldehyde concentration,
when the product is sold, is essentially nil because the 2-amino-2-methyl-1-propanol would react with any free
formaldehyde present and form a stable oxazolidine compound. Certain processes or conditions resulting in an acidic
pH will decompose any trace oxazolidine present and consequently, liberate formaldehyde. In fact, most analytical
procedures for measuring formaldehyde give false positives due to this situation. Bound formaldehyde is mistakenly
reported as free formaldehyde because of the oxazolidine decomposition reaction under acidic conditions.

EU Cosmetics
EU Cosmetics Directive (EC) No 1223/2009; the recast for the EU Cosmetics Directive 76/768/EEC and Amendments:
Information regarding the purity, secondary amine content, and potential for nitrosamines, below isan example AMP®
Multifuctional Amino Alcohols product which you purchase from ANGUS Chemical Company: AM P-95** 2-
Amino-2-methyl-1-propanol.
Composition:
Chemical Name Weight % CAS Number
2-Amino-2-methyl-1-propanol >89 % wt 000124-68-5
2-M ethylamino-2-methyl-1-propanol <7 % wt 027646-80-6
Water 5 % wt 007732-18-5

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Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

INCI Name: Aminomethyl Propanol


Secondary Amines:
The 2-(M ethylamino)-2-methyl-1-propanol in the composition above is considered to be a secondary amine.

Purity:
The purity of this product is generally in the range described in the composition above; however, purity is not assessed in
the product specification for this product, as is shown on the sales specification.
Nitrosamines:
We have no reason to believe that there are nitrosamines at levels over the detection limit of 50 µg/kg (50 ppb) in any of
the AM P products. This statement is based on our knowledge of the fabrication process and the raw materials used
during manufacture. We do not analyze routinely for nitrosamines in these products, however, occasional analysis
performed on several samples of various AM P products showed no nitrosamines at the limit of detection (50 ppb).
EU Cosmetics Directive (EC) No 1223/2009; the recast for the EU Cosmetics Directive 76/768/EEC and Amendments:
For products that are marketed into cosmetics applications and that we can confirm are in compliance with the EU
Cosmetics Directive and Amendments, please consider the following:

AM P-ULTRA** PC 1000 Neutralizing Amine [anhydrous]


AM P-ULTRA** PC 2000 Neutralizing Amine [4.5-5.5% aqueous solution]
AM P-ULTRA** PC 3000 Neutralizing Amine [10.5-11.5% aqueous solution]

These AM P-ULTRA grade products are compliant with the EU Cosmetics Directive as amended. The section of the
Directive relevant to ANGUS aminoalcohols states, among other requirements, that our products as raw materials in
cosmetics should have a minimum purity of 99%, contain no greater than 0.5% secondary amines, and have no greater
than 50 ppb nitrosamines.
Nitrite-Free:
We have confirmed with our drum supplier that the drums used for this product are considered to be "nitrate-free" and
“nitrite-free”. Their steel, plug/washers and seal coating suppliers have also confirmed that these components are free of
nitrate and nitrite.

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®™Trademark of The ANGUS Chemical Company
Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

Substances of Concern
Presence of substances of concern: this product is made from basic chemicals containing no additives, dyes or
preservatives. Although we do not analyze this product for the specific chemicals you list routinely, it is not manufactured
with or formulated using and, therefore, is not expected to contain:
- any chlorinated compound
- any phthalate ester
- any fluorotelomer, perfluorooctanoic acid (PFOA), or perfluorooctane sulfonate (PFOS)

Materials of Origin, Plant Derived Ingredients

M aterials of Origin, Plant Derived Ingredients:


This product has been evaluated for the source of the raw materials used in its production. It is manufactured from basic
chemicals that have no plant origin. There are no plant source raw materials or additives used in the manufacture of this
product.

Animal Testing
Animal Testing:
Animal testing has not been conducted to support the safe use of AMP-95™ in cosmetic products. However,
AMP-95 has been tested in animals to fulfill commitments to the United States EPA for High Production Volume
Chemicals (HPV) Testing and to the European Chemicals Agency (ECHA) under the REACH Registration
framework as recent as 2017. ANGUS Chemical Company does offer high-purity, personal care grades of AMP-
ULTRA™ PC, 2-Amino-2- methyl-1-propanol, which have not been tested in animals.
For products that are marketed into cosmetics applications and that we can confirm are in compliance with the EU
Cosmetics Directive and Amendments, please consider the following:

AM P-ULTRA™ PC 1000 Neutralizing Amine [anhydrous]


AM P-ULTRA™ PC 2000 Neutralizing Amine [4.5-5.5% aqueous solution]
AM P-ULTRA™ PC 3000 Neutralizing Amine [10.5-11.5% aqueous solution]
These AM P-ULTRA grade products are compliant with the EU Cosmetics Directive as amended. The section of the
Directive relevant to ANGUS aminoalcohols states, among other requirements, that our products as raw materials in
cosmetics should have a minimum purity of 99%, contain no greater than 0.5% secondary amines, and have no greater
than 50 ppb nitrosamines

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®™Trademark of The ANGUS Chemical Company
Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

Residual Solvents
Residual Solvents According to ICH (International Conference Harmonization):
Due to the manufacturing process, this product does not contain any residual solvent except traces of methanol. This
solvent is classified as Class 2 according to ICH and our product contains less than the allowed limit of 3000 ppm of
methanol.

European Volatile Organic Compound


Volatile Organic Compound (VOC) content: 2-Amino-2-methyl-1-propanol (AM P) has a boiling point of 165 °C, therefore
the AM P portion of this product is a VOC according to EU criteria. Water, if present, is not considered a VOC.

CMR
CM R (Carcinogens, M utagens, Reproductive Toxins):
This product contains no known substances, which are classified in Annex 1 Directive 67/548/EEC on Dangerous
Substances and its latest amendments, or in the European GHS Classification CLP 1272/2008 of 16-Dec-2008 as
carcinogenic, mutagenic or toxic for reproduction (C, M , R).
There are no components in this product which are classified as carcinogenic under IARC-1, IARC-2A or IARC-2B;
classified by National Toxicology Program (NTP) as ‘known’ or ‘anticipated’ carcinogens; classified by EPA IRIS as
Group A, B1, B2 or C; or classified as carcinogens under the USA Occupational Health and Safety Administration
(OSHA). Components classified as carcinogens under these definitions would be listed as such on the relevant M aterial
Safety Data Sheet (M SDS) for this product.
There are no components in this product which are classified as mutagenic under the Globally Harmonized System
(GHS) for the classification of chemicals as Category 1, i.e. “Chemicals known to induce heritable mutations in germ cells
of humans” or “Chemicals which should be regarded as if they induce heritable mutations in germ cells of humans”.

European REACH Annex XVII and Amendments


EU REACH Annex XVII and Amendments; [Substances subject to marketing and use restrictions, excluding CLP Annex
VI Table 3.2 CM R-Cat.1,2]; EC No 494/2011; 15-Apr-2011:
This product has been evaluated for the source of the raw materials used in its production. This product is manufactured
from basic chemicals and has no additional additives, preservatives or dyes. Although this product is not analyzed
routinely for the substances in question, it is not manufactured or formulated with and, therefore, is not expected to contain
any of the Carcinogens, M utagens, Reproductive Toxins, Azocolourants, Tin Compounds/PFOS or PFOA, or other
compounds which are on this list of chemicals.

Harmonized Tariff Code


Harmonized Tariff Code USA:
The HTC for this product is: 2922.19.9690

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®™Trademark of The ANGUS Chemical Company
Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

Export Control Classification Number


Export Control Classification Number (ECCN):
The ECCN for this product is: EAR99

United States Ozone Depleting Substances


Ozone Depleting Substances:
This product is not "manufactured with" and does not "contain" any Class I or Class II substances as defined in Title VI of
the Clean Air Act of 1990, as per the final rule published in the Federal Register on February 11, 1993 (58 FR 8136).

Heavy Metals
M etals:
Although we at ANGUS do not analyze for the substances in question routinely, occasional samples of a similar 2-amino-
2-methyl-1-propanol product containing approximately 5% water have been tested for some metals with the following
results:
Arsenic (As): None detected at 0.02 ppm limit of detection.
Cadmium (Cd): None detected at 0.01 ppm limit of detection.
Chromium (Cr): None detected at 0.01 ppm limit of detection.
Chromium VI (Cr +6): None detected at 0.01 ppm limit of detection.
Lead (Pb): None detected at 0.05 ppm limit of detection.
M ercury (Hg): None detected at 0.05 ppm limit of detection.

Conflict Minerals
Conflict M inerals; Dodd-Frank Wall Street Reform and Consumer Protection Act:
This question is regarding the Dodd-Frank Wall Street Reform and Consumer Protection Act, which imposes
requirements regarding “conflict” minerals from the Democratic Republic of Congo or surrounding countries, in products
or in the manufacturing process; these are columbite-tantalite (coltan), cassiterite, wolframite (from which tantalum, tin,
tungsten are commonly derived) and gold, or their derivatives.
This product has been evaluated for the source of the raw materials used in its production. It is a synthetic chemical
manufactured from basic raw material chemicals that have no animal or plant origin. There are no additives, colorants or
preservatives added to this product. Although we do not test for the chemicals you question routinely, this product is not
produced with or manufactured using any of these compounds, and therefore, would not be expected to contain any of
these substances listed in your inquiry: columbite-tantalite (coltan), cassiterite, wolframite (from which tantalum, tin,
tungsten are commonly derived), or gold from any countries.

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®™Trademark of The ANGUS Chemical Company
Effective Date: 30-June-2021
AMP® Multifuctional Amino Alcohols

Nanomaterials

This product is made from basic chemicals containing no additives, dyes or preservatives. Although we do not
analyze our products for the specific chemicals you list routinely, they are not manufactured with or formulated
using and, therefore, are not expected to contain any nanomaterials as defined in Regulation EC 1223/2009 and
amendments.

Product Stewardship
The ANGUS Chemical Company has a fundamental concern for all who make, distribute, a nd use its products, and for the environment in which we live. This
concern is the basis for our Product Stewardship philosophy by which we assess the safety, health, and environmental information on our products and then
take the appropriate steps to pro tect employee and public health and our environment. The success of our product stewardship program rests with each and
every individual involved with ANGUS products—from the initial concept and research, to manufacture, use, sale, disposal and recycle of each product.

Customer Notice
ANGUS strongly encourages its customers to review both their manufacturing processes and their applications of ANGUS products fro m the standpoint of
human health and environmental quality to ensure that ANGUS products are not used i n ways for which they are not intended or tested. ANGUS personnel are
available to answer your questions and to provide reasonable technical support. ANGUS product literature, including safety data sheets, should be consulted
prior to use of ANGUS products. Current safety data sheets are available from ANGUS.

Disclaimer
NOTICE: No freedom from infringement of any patent owned by ANGUS or others is to be inferred. Because use conditions and applicable laws may differ from
one location to another and may change with time, the Customer is responsible for determining whether products and the information in this document are
appropriate for the Customer’s use and for ensuring that the Customer’s workplace and disposal practices are in compliance with applicable laws and other
governmental enactments. ANGUS assumes no obligation or liability for the information in this document. NO WARRANTIES ARE GIVEN; ALL IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ARE EXPRESSLY EXCLUDED.

For additional information, not covered by the content of this document, contact us via our web site http://www.angus.com

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®™Trademark of The ANGUS Chemical Company
Effective Date: 30-June-2021

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