Source: http://www.docstoc.com/docs/101643526/Guidance
Timestamp: 2014-04-16 18:03:38
Document Index: 602276729

Matched Legal Cases: ['art 1910', 'art 172', 'art 205', 'arts 250', 'art 1910', 'art 172', 'art 205']

HARMONIZED RAW MATERIAL INFORMATION FORM
This form has been created with a view to help capture as much information as possible in one document regarding
the global regulatory, safety and physico-chemical properties of each ingredient or ingredient blend. It is intended to
save time for both the customer and the manufacturer. Once completed, it can serve as the vehicle for information
exchange, eliminating the often tedious process of collating data and documents ad hoc for each individual request.
The form consists of the following required sections:
1. General Information*
2. Regulatory Form*
3. Physical Chemical Properties Form*
4. Safety Form*
The following section is viewed as helpful but not mandatory:
5. Environmental Form
The following sections are to be filled out for relevant materials:
6. Plant Derived Form
7. TSE Certification
This section is intended for Fragrance Materials only:
8. Fragrance Information Form
In addition all materials will require a fully compliant 16 section MSDS and EU SDS with full transportation,
emergency response measures, storage and handling information.
General Comments: The form is housed in EXCEL to facilitate data entry and enable wide use. It is saved as a
template so that the opening of the form automatically creates a new file separate from the original. We suggest
saving the completed form using the trade name of the material being summarized and converting to a Portable
Document File (pdf) to ensure data integrity.
Please Note: If the raw material in question is a fragrance, please go directly to Section 7 of these instruction.
September 12, 2007                                          Page 1 of 35
Section 1: General Form
1. Material/Supplier Identification : Basic information regarding the supplier and the subject material/trade name.
2. Trade Name: The unique name used to identify the ingredient/ingredient blend by the supplier and as is noted in
the CTFA Buyer’s Guide or also at
http://www.ctfa-online.org
3. INCI Name : The International Nomenclature for Cosmetic Ingredient designation as noted on the registration of
the Trade Name as maintained by the CTFA (Cosmetic, Toiletry and Fragrance Association; use above link).
4. Material Manufacturer Name : Name of the corporate entity responsible for manufacture of the material.
5. Material Supplier Name : Name of supplier/distributor if other than the manufacturer.
6. Supplier Technical Contact : Name of primary technical person in case of additional questions.
7. Contact Information for person to whom questions should be directed should the need arise.
8. Country of Origin : Country of Manufacture.
9. Harmonized Tariff Code: For tariff treatment of imported goods. The ten digit Code is available at:
For NAFTA Eligible materials the form 434 is available at         http://www.cbp.gov/xp/cgov/toolbox/forms/
10. Composition &amp; Material Identification :
11. INCI Name of each individual constituent (see above).
12. CAS #: Chemical Abstracts Service Registry Number is a unique identifier for each chemical substance. Please
avoid using generic CAS #s. For more information see
13. Percent Composition Ranges: Max% &amp; Min% per manufacturing acceptance criteria. Also requested is the
target percentage level for each constituent (ie what is the intended level?).
14. Function &amp; Feedstock Origin : require categorization using a validated data list. Please choose the appropriate
response for each constituent.
15. EINECS/ELINCS #: The EINECS number is a registry number given to each chemical substance commercially
available in the EU between January 1, 1971 and September 18, 1981.
The inventory was created by                   Directive 67/548/EEC
As of September 19, 1981, the inventory has been replaced by the ELINCS. All &quot;new&quot; substances brought in to the
European market are allocated an ELINCS number after their notification to the European Commission.
16. The following fields have embedded pick lists to direct responses. Please choose from the list.
17. TSCA: The Toxic Substances Control Act (TSCA) became law on October 11, 1976 and took effect on January
1, 1977, except Section 4 (f) became effective two years later. The Act authorized EPA to secure information on all
new and existing chemical substances, and to control any of the substances that were determined to cause
unreasonable risk to public health or the environment. The TSCA is found in United States law at the following site:
15 USC (C. 53) 2601-2692
18. DSL/NDSL: The DSL (Domestic Substance List) is the sole basis for determining whether a substance is new for
the purposes of the Canadian Environmental Protection Act, 1999. Substances not appearing on the DSL are
considered to be new to Canada and are subject to notification under the New Substances Notification Regulations of
CEPA, 1999. The Non-Domestic Substances List (NDSL) specifies substances that are not on the DSL but are in
commercial use internationally. Substances on the NDSL are subject to notification under the Regulations of CEPA,
1999 but may require different information in the New Substance Notification (NSN) packages. The list is available
DSL/NDSL List
19. AICS: Australian Inventory of Chemical Substances. A list of chemical identity data maintained by NICNAS;
legal device that distinguishes new from existing chemicals and lists all industrial chemicals in use in Australia
between January 1, 1977 and February 28, 1990; includes newly assessed chemicals since February 1990. The
Australian Inventory of New and Existing Substances is available at
AICS List
September 12, 2007                                         Page 2 of 35
20. IECSC : The People’s Republic of China, SEPA (State Environmental Protection Administration) put forth the
Inventory of Existing Chemical Substances Manufactured or Imported in China (IECSC) for the purpose of
identifying new chemical substances and to master the status of existing chemical substances in China.
21. ENCS : The ENCS is the list of Existing and New Chemical Substances promulgated by the Kashin Act of Japan,
which regulates chemical substances that are either manufactured or imported in Japan: Comprehensive Licensing
Standards [of Cosmetics by Category].
22. ECL : Korean Existing and Evaluated Chemical Substance Inventory
23. Substances or Impurities of Concern : Requires the disclosure of the existence and level of identified chemicals
of general concern. Identify if the materials in question are present and if so at what level. Examples of ingredients
of concern are listed in the following table. The list is not exhaustive.
Name                              CAS #                      Name                 CAS #
Acrylamide                                              79-06-1     Nitrosamines
Chloroacetic acid, total                                            Phenylacetaldehyde                 122-78-1
Dichloro acetic acid       79-43-6     Polycyclic Musks
Monochloro acetic acid       79-11-8                              AHTN     15323-35-0
Cyclotetrasiloxane (D4)                                556-67-2                             HHCB      1222-05-5
Alkanolamines                                                               Other Polycyclic Musks
Diethanolamine (DEA)        111-42-2     Tested for Heavy Metals?
Triethanolamine (TEA)       102-71-6                             Copper
Phthalates                                                                                  Arsenic
1,4-Dioxane                                           131151-09-2                        Cadmium
Ether Glycols                                                                       Chromium(VI)
EGBE: 2-butoxyethanol       111-76-2                              Cobalt
DEGBE: 2-(2-butoxy ethoxy)ethanol        112-34-5                               Lead
DEGEE: 2-(ethoxy ethoxy)ethanol       111-90-0                            Mercury
Ethylene Oxide                                          75-21-8                              Nickel
Nitrilotriacetic acid/acetate (residual in Na 2
EDTA)                                                  139-13-9                               Zinc
Musk Ketone      81-14-1
Musk Xylene     81-15-2
Other Nitro Musks
24. Feedstock Origin Clarification : If “Other” is chosen for feedstock origin please explain the nature of the choice.
25. If the Feedstock is Animal: Please fill out the TSE Certification and attach.
Halal Compliance: Further information on compliance with Halal standards is available at:             IFANCA-Halal.
Kosher Compliance: Further information on compliance with Kosher standards is available at:
26 . If “vegetable” is chosen please answer the questions regarding Genetically Modified Organisms: A genetically
modified organism (GMO) is an organism whose genetic material has been altered using techniques in genetics
generally known as recombinant DNA technology.
27. LOT Declaration : Certification that all lots that are supplied of this material comply with the data disclosed in
28. Contact Person to whom questions should be directed should the need arise.
29. Checklist at the end of the general form allows the supplier to denote which forms are attached and which require
special confidentiality precautions.
September 12, 2007                                             Page 3 of 35
Section 2: Regulatory Form
1. Trade Name , INCI Name etc., are automatically filled from the previous form.
2. Constituent Name is also filled from the General Form.
NOTE: The questions below and throughout the rest of the addenda refer to each individual constituent.
3. Restriction Limits: For each constituent denoted as a “key ingredient,” please indicate if there exists a restriction
limit for each of the countries indicated. If there are no specified limits (including CIR or SCCP) please indicate
4. Compliance Battery : The questions in this section are asked to ascertain compliance with various regulatory
instruments globally and inclusion on various lists. Each question must be answered by choosing yes or no for each
component. An answer of yes will require further specification.
a. The EU Dangerous Substance Directive applies to pure chemicals and to mixtures of chemicals (preparations)
which are placed on the market in the EU, therefore it does not apply directly to substances created purely for
research purposes. The List is found at the following site:
EU Dangerous Substance List
b. The EU Cosmetics Directive applies to cosmetics placed on the market in the EU. Annex II lists chemicals that are
not to be used in the formulation of cosmetics. The full legislation is found at the following link:
c. The International Agency for Research on Cancer publishes monographs to make available the conclusions of their
expert panels. IARC Monographs may be reviewed at the denoted website.
d. The Report on Carcinogens is published by the National Toxicology Program and is found at:
NTP/RoC .
e. The US Department of Labor’s Occupational Safety &amp; Health Administration publishes standards for safety in the
workplace. See the link below:
29 CFR Part 1910 Subpart Z
f. California’s Office of Environmental Health &amp; Hazard Assessment publishes the most current list of chemicals at
g. Animal Testing questions attempt to ascertain compliance with the 7th Amendment to the Cosmetic Directive. The
EU position on animal testing may be found at:
5. Volatile Organic Compounds are regulated by the US EPA, California EPA and Switzerland. VOC &amp; ROG
Definitions per the US EPA and CARB are available for review so that the proper classification of each material may
be made (HVOC, MVOC, LVOC, ROG, Exempt VOC) using the pick list provided. The list of exempt VOCs is
available using the link in the template as well as the MIR (Maximum Incremental Reactivity index) of each VOC.
VOC &amp; ROG Regulations
6. Percent (w/w) of each VOC (HVOC, MVOC, LVOC) is required.
7. Contact Person to whom questions should be directed should the need arise.
September 12, 2007                                         Page 4 of 35
Section 3: Physical Chemical Properties Form
3. GMP Certificate: If the titled raw material is manufactured under GMP procedures, then submit suitable
documentation, such as an FDA Facility Registration, Form 2656.
4. Appearance: The Physical Form will determine how to describe the Appearance. For a gas, Color and Odor are
probably sufficient. For a liquid, clear, turbid, opaque, with suspended particles might be useful. For a gel, semisolid,
solid or paste the liquid descriptors plus smooth or lumpy might apply.
5. Particle Size/Range for Powder: Provide the Average Particle Size and the Particle Size Distribution.
6. Density: Be sure to include the measurement units and the temperature for the determination.
7. Viscosity : Include the type of viscosity, the make and model of the viscometer, spindle size, conditions,
temperature and other information to allow the understanding of the measurement supplied.
8. Flash Point : Indicate open or closed cup method, and instrument used.
9. Spectra and Chromatograms : Enclose instrument conditions used to perform the determination.
10. Contact Person to whom questions should be directed should the need arise.
September 12, 2007                                           Page 5 of 35
Section 4: Human Safety Form
3. Toxicological Studies: Standard Toxicological tests are identified. The first set is concerned with the existence of
data. Please check only those tests that have been performed. If the test has been undertaken a summary must be
attached . If the components were tested individually or as a whole please specify.
Acute Oral Toxicity Summary
Subchronic Toxicity Summary
4. LD 50 : If an LD50 was determined please specify.
5. NOEL: If a No Observed Effect Level has been determined please indicate here.
September 12, 2007                                          Page 6 of 35
Section 5: Environmental Form
3. US EPA regulated: Information on materials regulated by the US Environmental Protection Agency as described
a. Carcinogenicity: This is covered in the Regulatory tab.
b. SARA: Superfund Amendments and Reauthorization Act of 1986. Title III of SARA authorized the Emergency
Planning and Community Right-to-Know Act.
c. RCRA: Resource Conservation and Recovery Act. Please note if this raw material must be disposed as hazardous
waste. List the waste code (i.e., D001).
d. OSHA: This is covered in the Regulatory tab.
4. PBT: Persistent, Bioaccumulative or Toxic. Please note which by definition.
a. PBT List               b. European Chemicals Bureau
5. vPvBT: Very persistent, very bioaccumulative as determined by the European Chemicals Bureau.
6. Biodegradable: Per the European Norm EN13432, Japanese Greenpla Standard and the American Society for
Testing and Materials (ASTM International), a material is deemed compostable if it will break down to the extent of
at least 90% to H2O and CO2 and biomass within a period of 6 months. ASTM D6400-99 also imposes a time period
7. Bioaccumulation: This is covered with the vPvBT question.
8. Water solubility (μg/l): The maximum possible concentration of a chemical compound dissolved in water.
9. Molecular weight (kDa): The sum of the atomic weights of all the atoms in a molecule.
10. Molecular diameter (Ǻ): The diameter of a molecule, assuming it to be spherical.
11. Octanol/water partition, logP: The partition coefficient.
12. Ecological Toxicity Studies: The studies listed are required under the European Union’s REACH
(Registration, Evaluation and Authorization of Chemicals) legislation. It is not expected that all studies have been
completed for a material. Please note if the study is summarized in the Excel spreadsheet, attached, not available or
European Union REACH
13. Contact Person to whom questions should be directed should the need arise.
September 12, 2007                                         Page 7 of 35
Section 6: Plant Derived Form
3. Identification of Plant Material: Materials derived from plant extracts must specify plant part used, level of plant
material in raw material (e.g., concentration make up of plant material if a blend, percent solid level), and identify
phylogenetic name of plant material used.
4. Manufacturing Flow Chart: Manufacturing process for plant material needs to be provided.
5. Presence of Pesticides: Materials derived from plant extracts must disclose pesticide residues if present. Were the
pesticide residues directly measured or calculated?
6. Presence of Denatured Alcohol: Indicate whether or not the botanical contains denatured alcohol, and specifiy
the denaturant.
7. Processing Aids: Indicate whether the botanical material in question does not contain the materials listed by using
the checkbox. If the material is in the botanical then specify what percentage is natural source, directly added and
total %.
8. Allergen Disclosure: List includes the 26 allergens identified by the SCCP and regulated by the 7th Amendment
to the Cosmetic Directive. Direct addition, natural source and total content by %
http://ec.europa.eu/enterprise/cosmetics/doc/200315/200315_en.pdf
9. Ingredients of Concern: Indicate whether the botanical material in question does not contain the materials listed
by using the checkbox. If the material is in the botanical then specify what percentage is natural source, directly
added and total %.
10. Contact Information for person to whom questions should be directed should the need arise.
September 12, 2007                                          Page 8 of 35
Section 7: TSE Certification
3. The questions contained in this form are geared to gathering information on animal derived ingredients as required
by multiple governments globally.
a. Species Identification: choose from list (Bovine, Caprine, Marine, Ovine, Porcine, Other.
b. Organ source: Please specify the organs harvested to isolate ingredient.
c. Age of Animal: at harvest. Choices are &lt;1 year, &lt;2 years and &gt; 2 years.
d. BSE Country Status: Indicate GBR level as specified by the             European Food Safety Authority
Category rating based on the EU Commission scientific steering committee (SCC) Regulation 999/2001-
Geographical Risk of Spongiform Encephalopathy (GBR) Adopted on January 11, 2002. Updated on August 20,
4. Contact Person to whom questions should be directed should the need arise.
September 12, 2007                                         Page 9 of 35
Section 8: Fragrance Information Form
The FMA Fragrance Product Information Form (FPIF) is used for exchanging regulatory and safety information on
fragrance raw materials. Although the FPIF could accompany some simple fragrance bases, it is not intended for
finished fragrances. The FPIF addresses information required to satisfy customer and regulatory requirements
The FPIF contains the following sections:
1 General Product Information
2. Regulatory Status Information
3. Hazard Identification Information
5. Fragrance Information
6. IFRA Certificate
7. TSE Certification (Please use TSE Certificate Tab in the body of the form).
Please complete all applicable sections and attach all required documents included on the FPIF Documentation
This section captures basic information concerning the material.
INCI Name - The International Nomenclature of Cosmetic Ingredients, abbreviated INCI, is a system of names for
waxes, oils, pigments, chemicals, and other ingredients of cosmetics. INCI names are based on scientific names and
other Latin and English words. The INCI dictionary is maintained by the U.S. Cosmetic, Toiletry and Fragrance
Association (CTFA). INCI names are also available in the RIFM/FEMA Database and the CTFA On-Line.
RIFM Home                                       CTFA On-Line
CAS Number - Chemical Abstract Service Registry Number - The CAS Registry covers substances identified in the
scientific literature. Each substance in the Registry is identified by a unique numeric identifier called a CAS Registry
Number. For more information or to locate a CAS Number go to: http://cas.org.
FEMA GRAS Number - Recognition by the Expert Panel of the Flavor and Extract Manufacturers Association
(FEMA) that a flavoring substance is
1 &quot;Generally Recognized As Safe&quot; under Section 201 (s) of the U.S. Federal Food, Drug &amp; Cosmetic Act. Since
1965, lists of flavoring substances that have been determined to be GRAS have been published in a series of
publications in the journal Food Technology. A comprehensive list of all the FEMA GRAS flavor ingredients and a
list of (GRAS publications) is available. Please note that the vast majority of the substances listed in the CFR are
FEMA GRAS substances. For more information go to or call 202-293-5800.
FDA GRAS Number - General recognition of safety under Section 201 (s) of the U.S. Federal Food, Drug &amp;
Cosmetic Act, and 21 CFR &#167; 170.30, and 21 CFR Part 172.
Country of Origin -      NAFTA eligible
For purposes of obtaining preferential tariff treatment, Customs and Border Protection (CBP) Form 434 must be
attached. Form 434 is available at:
http://www.customs.gov/xp/cgov/toolbox/forms
Harmonized Tariff Code - The code from the Harmonized Tariff Schedule of the U.S., based on the International
Harmonized System, the global system of nomenclature that is used to describe most world trade goods.
September 12, 2007                                          Page 10 of 35
Country of Production - The country where the product is produced.
September 12, 2007                                     Page 11 of 35
FDA Bioterrorism - Under the U.S. Public Health Security and Bioterrorism Preparedness and Response Act of
2002, facilities that manufacture, process, pack or hold food intended for consumption in the U.S. must be registered
with the U.S. Food and Drug Administration.
Source Information - Indicate the origin of the material being used.
GMO Statement - Indicate whether this product or any of its ingredients are derived from genetically modified
Organic Status - U.S. organic regulations are found at 7 CFR Part 205 and
Impurities - Include impurities that are to be expected in the final product (e.g. residual solvents, residual monomers,
reagents intermediate synthesis phases, heavy metals, etc.
Regulatory Status of ingredient (s)
US - TSCA - Toxic Substances Control Act - TSCA regulates the importation, manufacture and distribution of
chemicals in the United States. For information go to:
Any person intending to manufacture or import a chemical substance must first determine whether the substance is
TSCA &#167; 4 - This section requires testing of certain chemicals and mixtures.
TSCA &#167; 5 - Manufacturers intending to manufacture or import a new chemical substance must give the U.S. EPA 90
days prior notice. TSCA &#167; 5 authorizes EPA to evaluate and, in certain, instances, to regulate new chemical
substances. Specifically, &#167;5(a)(1) requires a manufacturer (which, by definition, includes an importer) of a new
chemical substance to file a Pre-Market Notification (PMN) at least ninety days prior to the commencement of the
commercial production or importation. 1
Significant New Use Rule (SNUR) - If EPA determines by rule that a particular use of a chemical already on the
Inventory constitutes or would constitute a &quot;significant new use,&quot; the Agency can issue a significant new use rule
(SNUR).
TSCA &#167; 6 - This section gives EPA authority to prohibit or limit production and to impose labeling or other
TSCA &#167; 7 - This section authorizes EPA to commence a judicial action for seizure of a chemical substance, mixture,
or article containing such a chemical substance or mixture, which EPA has determined is imminently hazardous.
TSCA &#167; 12(b) - This section requires exporters to notify EPA before shipment abroad of any substance for which test
data are required under &#167;&#167; 4 or 5(b), regulatory action has been proposed or taken under &#167;&#167; 5 or 6, or an action is
pending or relief has been granted under &#167;&#167; 5 or 7.
SARA 302 - Section 302 of the Emergency Planning and Community Right-to-Know Act. The list of chemicals may
be reviewed at:
SARA 311/312 - Sections 311 and 312 are chemical inventory reporting requirements of the Emergency Planning and
Community Right-to-Know Act.
McKenna &amp; Cuneo, LLP, TSCA Handbook 55 (3d ed. 1997)                             EPA TRI: TRI Chemicals
September 12, 2007                                       Page 12 of 35
The list of chemicals may be viewed at:
SARA 313 - Toxic Release Inventory (Form R) reporting requirements for Superfund Amendments and
Reauthorization Act, Title 111, Section 313 (SARA 313). The current list of TRI chemicals can be reviewed at:
http://www.epa.gov/tri/chemical/index.htm
EPA Hazardous Air Pollutants (HAPS) - Substances identified as Hazardous Air Pollutants in the U.S. Clean Air
Act Amendments of 1990. For information on EPA Hazardous Air Pollutants go to:
EPA CERCLA - Under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA),
the U.S. Environmental Protection Agency (EPA) prepares a list of substances determined to pose the most
significant potential threat to human health due to known or suspected toxicity. The CERCLA priority list is revised
and published every two years. For information and to review the lists go to the Agency for Toxic Substances and
Disease Registry at
http://www.atsdr.cdc.gov/cercla
FDA Prohibited Cosmetic Ingredients - U.S. regulations specifically prohibit or restrict the use of certain
ingredients in cosmetics, see 21 CFR Parts 250.250 and 700.11 through 700.23.
http://www.gpoaccess.gov.
DEA List I or List II Chemicals - Certain chemicals have been specifically designated by the U.S. Drug
Enforcement Administration as listed chemicals subject to the provisions of 21 CFR &#167;&#167;1309, 1313, and 1310.02. This
list of covered chemicals is found in 21 CFR &#167; 1310.02
California Prop. 65 - The Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as
&quot;Proposition 65&quot; (Prop. 65). The updated Prop. 65 list of carcinogens and reproductive toxins is on the website of the
California Office of Environmental Health Hazard Assessment (OEHHA) at:
OEHHA Site
California Safe Cosmetics Act of 2005 , SB-484 - Will require after January 2007, the disclosure of chemicals in
cosmetic products that meet any of the following criteria:
1. Chemicals identified pursuant to regulations under the California Safe Drinking Water and Toxic Enforcement Act
of 1986, also known as &quot;Prop. 65,&quot;
2. Substances listed as known or reasonably anticipated to be a human carcinogen in a National Toxicology Report on
3. Substances given an overall carcinogenicity evaluation of Group 1, Group 2A, or Group 2B by the International
Agency for Research on Cancer,
4. Substances identified as Group A, Group B1, or Group B2 carcinogen, or as a known or likely carcinogen by the
U.S. Environmental Protection Agency, or
5. Substances identified as having some or clear evidence of adverse developmental, male reproductive, or female
reproductive toxicity effects in a report by an expert panel of the National Toxicology Program&#39;s Center for the
Evaluation of Risks to Human Reproduction.
State Right-to-Know Lists
Massachusetts - Include all substances that appear on the Massachusetts Substance List for Right to Know law. This
list consists of toxic and hazardous substances regulated by Massachusetts General Law C.111 F.
Massachusetts RTK
New Jersey - Include any substance found on the New Jersey Right to Know Hazardous Substances list.
New Jersey RTK
September 12, 2007                                         Page 13 of 35
Pennsylvania - Include any substance found on the Pennsylvania Right to Know Act Hazardous Substances List.
EINECS - The European Inventory of Existing Commercial Substances is a registry number given to each chemical
substance commercially available in the European Union between January 1, 1971 and September 18, 1981. The
inventory was created by Directive 67/548/EEC concerning the labeling of dangerous substances. For more
information go to the European Chemicals Bureau at:
http://ecb.irc.itlexistinQ-chemicals/
ELINCS - The European List of Notified Chemical Substances are substances introduced after the creation of the
EINECS List. For more information go to the European Chemicals Bureau at:
http://ecb.irc.itl
Cosmetic Directive Number 76/768/EEC - Council Directive 76/768/EEC of July 27,1976 sets out a list of
substances which cannot be included in the composition of cosmetic products (Annex II) and a list of substances
which cosmetic products may not contain, outside the restrictions and conditions laid down (Annex III). For more
http://europa.eu/scadplus/leg/en/lvb/l21191.htm
Volatile Organic Chemicals in Switzerland - The Swiss VOC ordinance of November 12,1997 (814.018) refers to
two lists, Annexes 1 &amp; 2, of substances that are considered VOCs.
DSL- The Domestic Substances List includes substances that were, between January 1, 1984 and December 31,
1986, in Canadian commerce, used for manufacturing purposes, or manufactured in or imported into Canada in a
quantity of 100 kg or more in any calendar year.
NDSL - The Non-domestic Substances List specifies substances that are not on the DSL but are in commercial use
in the United States. As a basis for this list, Environment Canada used the U.S. Toxic Substances Control Act
(TSCA).
The DSL and NDSL are found at:                The Substance List
CEPA - Canadian Environmental Protection Act please consult:              CEPA Environmental Registry - The Act
ENCS - Existing and New Chemical Substances List
Poisonous and Deleterious Substances Control Law
http://www.nihs.go.jp/law/dokugeki/edokugeki.html
Pollutant Release and Transfer Registry:
http://www.nihs.go.jp/GINC/collabo.html
AICS - The Australian Inventory of Chemical Substances: For more information go to:
NICNAS - The National lndustrial Chemicals Notification and Assessment Scheme: For more information go to:
http://www.nicnas.gov.au/
PICCS - Philippine Inventory of Chemicals and Chemical Substances - The PICCS is available for purchase on CD
from the Philippine government and from commercial services.
IECS - China chemical inventory
REPUBLlC OF SOUTH KOREA
ECL - Republic of South Korea chemical inventory
September 12, 2007                                        Page 14 of 35
OSHA Hazard Communieations Standard - U.S. Occupational Safety, Health and Environment Administration,
Department of Labor: 29CCFR &#167; 1910.1200:
Hazardous Material lnformation System (HMIS) rating - System developed by the National Paint and Coatings
http://www.paint.org/hmis/index.cfm
National Fire Protection Association (NFPA) 704 rating - NFPA 704, Standard for the Identification of the Fire
Hazards of Materials for Emergency Response, 2001 Edition. The NFPA 704 ratings are displayed in markings
that are commonly referred to as the &quot;NFPA hazard diamond&quot; :
Carcinogens definitions
NTP - National Toxicology Program, Report on Carcinogens (ROC) - The ROC is a congressionally mandated
document prepared by the National Toxicology Program. The ROC is published biennially and the 11th edition was
released on January 31, 2005.
IARC - International Agency for Research on Cancer - The IARC program evaluates the carcinogenic risk of
chemicals. The IARC Monograph series publishes independent assessments by international experts of the
carcinogenic risks to humans posed by a variety of chemicals and chemical mixtures.
OSHA - U.S. Occupational Safety and Health Administration - OSHA considers the following sources as
establishing that a chemical is a carcinogen or potential carcinogen for hazard communications purposes:
(i) National Toxicology Program (NTP), Annual Report on Carcinogens (Latest edition):
(ii) International Agency for Research on Cancer (IARC), Monographs (Latest edition):
(iii) 29 CFR part 1910, subpart Z, Toxic and Hazardous Substances, OSHA,
ACGIH - Threshold Limit Values for Chemical Substances and Physical Agents in the Work Environment, American
Conference of Governmental lndustrial Hygienists (Latest edition):
WHMIS - Workplace Hazardous Materials Information System is Canada&#39;s national hazard communication program
for hazardous workplace chemicals:
EEC Directive 67/548 - on the approximation of laws, regulations and administrative provisions relating to the
classification, packaging and labeling of dangerous substances:
http://europa.eu.intlcomm/environmentldansub/main67548/indexen.htm
EEC Directive 99/45 - on the approximation of laws, regulations and administrative provisions relating to the
classification, packaging and labeling of dangerous preparations:
http://europa.eu.intleur-lexlpri/en/oi/datl1999/1200/120019990730enOO010068.pdf
WGK - Wassergefahrdungsklasse - The German Federal Water Management Act requires that substances be
evaluated for negative influence on the physical, chemical or biological characteristics of water:
http://www.umweltbundesamt.de/wgs-e/index.htm
WGK hazard classes:
O = not hazardous            1 = slightly hazardous to water      2 = hazardous to water
3 = extremely hazardous to water
September 12, 2007                                        Page 15 of 35
Hazardous under transportation regulations - A substance or material that the Secretary of Transportation has
determined is capable of posing an unreasonable risk to health, safety, and property when transported in commerce,
and has designated as hazardous under section 5103 of the Federal Hazardous Materials Transportation law. See 49
CFR &#167; 171.8.
UN Number - UN Numbers or UN IDs are four-digit numbers that identify dangerous goods, hazardous substances
and articles (such as explosives, flammable liquids, toxic substances, etc.) in the framework of international
Hazard Class or Division - The U.S. DOT divides regulated hazardous materials into nine classes, some of which
are further divided into divisions. Also see 49 CFR Part 172.
Natural designation - Association Francaise de Normalization (AFNOR) Huiles essentielles Tome 2 Volume 1,
NFT 75-006 - - &quot;raw material of vegetable, animal or microbiological origin, including the products derived from
this material by enzymatic processes or by traditional procedures of preparation (e.g. drying, torrefaction or
fermentation).&quot;
IFRA Declaration - The Code of Practice of the International Fragrance Association is located at:
Safety and Toxicological lnformation for Fragrances
RIFM - Research Institute for Fragrance Materials. Please indicate if this ingredient has been tested by RIFM or by
your company and provide all requested information.
http://www.rifm.org/
IFRA - The International Fragrance Association, see for information concerning restricted or banned ingredients.
EU Fragrance Allergens - The 7th Amendment to the European Cosmetics Directive - published as Directive
2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive
76/768/EEC.
7th Amendment to the Cosmetic Directive
Additives - Ingredients that may be present as part of the fragrance but which are not fragrance ingredients. If present
include concentration.
Colors and Dyes - Ingredients that may be present as part of the fragrance but which are not fragrance ingredients. If
present include color index number and concentration.
IFRA Certificate - This section should be completed and documentation attached to confirm compliance with the
International Fragrance Association Code of Practice.
Supplier Guarantee - This section addresses application of the answers to future shipments.
TSE - Please answer the following questions related to Transmissible Spongiform Encephalopathy (TSE), Bovine
Spongiform Encephalopathy (BSE).
September 12, 2007                                         Page 16 of 35
Acronym                                             Description
AICS      Australian Inventory of Chemical Substances
CAS       Chemical Abstracts Service Registry Number
CERCLA    Comprehensive Environmental Response, Compensation, and Liability Act
CHiPS     Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 in the UK
DSL       Domestic Substance List (Canada)
ECL       Existing and Evaluated Chemical Substance Inventory (Korea)
EINECS    European Inventory of Existing Chemical Substances
ELINCS    European List of Notified Chemical Substances
ENCS      Existing and New Chemical Substances (Japan)
GMO       Genetically Modified Organism
HAPS      Hazardous Air Pollutants (US EPA)
HMIS      Hazardous Material information System (US)
HTC       Harmonized Tariff Code
IARC      International Agency for Research on Cancer
IECSC     Inventory of Existing Chemical Substances Manufactured or Imported in China
IFANCA    The Islamic Food and Nutrition Council of America
INCI      International Nomenclature for Cosmetic Ingredients
MIR        Maximum Incremental Reactivity index for VOCs (US-CA)
NDSL      Non Domestic Substance List (Canada)
NFPA      National Fire Protection Association (US)
NTP       National Toxicology Program (US)
OEHHA     Office of Environmental Health &amp; Hazard Assessment (US-CA)
OSHA      Occupational Safety &amp; Health administration (US)
OU        Orthodox Union (Kosher)
PBT       Persistent, Bioaccumulative &amp; Toxic
RCRA      Resource Conservation and Recovery Act (US)
RoC       Report on Carcinogens
ROG       Reactive Organic Gases
SARA      Superfund Amendments and Reauthorization Act (US EPA)
TSCA      Toxic Substance Control Act (US EPA)
TSE       Transmissible Spongiform Encephalopathy
VOC       Volatile Organic Chemical
vPvBT     very Persistent, very Bioaccumulative &amp; Toxic
Please provide a Specification Sheet, a Material Safety Data Sheet (MSDS) and Certificate Of Analysis (COA) with this completed form.
This form is intended to help in the technical approval and qualification of potential suppliers. As such, the prompt and accurate completion of all sections will facilitate this
process and the data on the form is treated as critical base data for safety and regulatory work. All information will be treated as strictly confidential. If the information being
requested is either unavailable or not applicable, please indicate and explain
MATERIAL / SUPPLIER IDENTIFICATION:
Material Chemical Name(s)
Material INCI Name(s)
Material Manufacturer Name
(If different from Supplier)
Material Supplier Name
Supplier Technical Contact
Supplier E-Mail Address
Supplier Phone / Fax No.
Supplier Address                                                                                                                                                  Country of
(address where material is manufactured)                                                                                                                          Origin:
Is the material a Fragrance?                           Select               If &quot;YES&quot; please proceed to the Fragrance section of this form
COMPOSITION &amp; MATERIAL IDENTIFICATION:
Total target contents of the components should sum up to 100%. List all intentionally-added constituents in this table.
INGREDIENT FUNCTION: (This is intended to identify possible function and is not meant to be limiting in anyway)
Key Ingredients - defined as chemical intended to demonstrate its functionality in finished products.
Carryover Ingredients – defined as chemical intentionally added to material to maintain its quality or stability, such as preservative, anti-oxidant, UV filter, that does not
function in finished product formula.
CONSTITUENT                                           CAS#                                Min.        Target       Max.                      Function *                       Feedstock Origin
(INCI Name)                                  (Avoid generic CAS#)                      (wt %)       (wt %)      (wt %)               (Select from the pick list)        (Select from the pick list)
1                                                                                                                                                   Please Select                      Select
2                                                                                                                                                   Please Select                      Select
3                                                                                                                                                   Please Select                      Select
4                                                                                                                                                   Please Select                      Select
5                                                                                                                                                   Please Select                      Select
6                                                                                                                                                   Please Select                      Select
7                                                                                                                                                   Please Select                      Select
Total:           0              0                                                  0
*** If you select the Feedstock Origin &quot;Animal&quot;, Please use TSE Certificate in this form
Halal Certification?                                            Select
Kosher Certification?                                           Select
*** If you select the Feedstock Origin &quot;Other&quot;, please explain:
Is the material Food Grade? GRAS? USP? Other? (Please Specify)
In the table below, Constituent column data is automatically fed from the above table. Please put Inventory Number or Choose status in each column.)
DSL/ICL/
CONSTITUENT                                           EINECS/                        TSCA                     AICS               IECSC               ENCS            ECL               PICCS
#                                                                                                                      NDSL
(INCI Name)                                        ELINCS# (EU)                      (U.S.)                (Australia)          (China)              (Japan)       (Korea)          (Philippines)
1 0                                                                                                   Select         Select      Select             Select             Select          Select             Select
2 0                                                                                                   Select         Select      Select             Select             Select          Select             Select
3 0                                                                                                   Select                     Select             Select             Select          Select             Select
4 0                                                                                                   Select         Select      Select             Select             Select          Select             Select
Select         Select      Select             Select             Select          Select             Select
6 0                                                                                                   Select                     Select             Select             Select          Select             Select
Impurities/Residues/Catalysts/Monomers/By-Product
An impurity is any chemical substance that is unintentionally present in the new chemical substance. List all       CAS #     % or ppm                                         Comment
impurities (regardless of weight percent).
Confidential                                                                         98b841d8-0592-4e37-81db-95be0e9525c2.xls - General Form                                                                        11/4/2011
LOT DECLARATION:
Do you certify that all the lots you supply will comply with all the questions until further notice from you?                Agree        Disagree
E-Mail Address                                                                                  Phone
CHECK LIST FOR ADDITIONAL INFORMATION REQUIRED
Certificate of Analysis (3 lots if available)
Special document handling requirement
MSDS (US &amp; EU)                                    - please mark if applicable.
Mandatory                                                         Specification Sheet
Regulatory Form                                                    Restricted Data
Safety Form                                                        Restricted Data
Physical-Chemical Properties Form                                  Restricted Data
Provide if available:                                             Environmental Form                                                 Restricted Data
If any component origin is Botanical Extract:                     Botanical Form                                                     Restricted Data
If any component origin is Animal derived:                        TSE Certification                                                  Restricted Data
Please submit this form and the additional forms as appropriate for the nature of the material. If information on the attached form(s) would include
confidential data which should be shared only to a pre-identified contact, such condition should be indicated by check mark next to the form and to be sent to
the designated party ONLY. Thank you.
Confidential                                              98b841d8-0592-4e37-81db-95be0e9525c2.xls - General Form                                               11/4/2011
REGULATORY FORM
Material Trade Name                                  0
Material Chemical Name(s)                            0
Material INCI Name(s)                                0
Color Index Number (If Any)                          0
In the table below, Constituent column data is automatically fed from the General Form.
RESTRICTION LIMITS (If Any): Please respond if the region in question has any restriction limits on the ingredient and if what is the maximum use level allowed.
US                           Restriction%
CAN                           Restriction%
EU                           Restriction%
AUS                           Restriction%
CHINA                          Restriction%
JAPAN                          Restriction%
KOREA                          Restriction%
Compliance with Regulation (Choose from list)                                                                                                              Comments
Is the ingredient a Carcinogen/Mutagen/ Reproductive                Select    Select      Select       Select      Select       Select      Select
Toxicant as defined in Annex 1 Directive 67/548/EEC?
Is the ingredient listed in the European Dangerous Substance
Select    Select      Select       Select      Select       Select      Select
Directive (67/548/EEC : 79/831/EEC)?
Is the ingredient in compliance with European Cosmetic              Select    Select      Select       Select      Select       Select      Select
Directive (76/768/EEC)?
Information on suitability for Japanese Quasi-Drug use?
Is the ingredient found to be Carcinogenic by IARC?                 Select    Select      Select       Select      Select       Select      Select
Is the ingredient found to be Carcinogenic by NTP?                  Select    Select      Select       Select      Select       Select      Select
Is the ingredient found to be Carcinogenic by OSHA?                 Select    Select      Select       Select      Select       Select      Select
Does this material contain any chemical listed by California&#39;s
Proposition 65 inclusive of any impurities, residues, catalysts,
monomers, by-products,?**
Please attach an affidavit attesting to the accuracy of the Proposition 65 Disclosure signed by the appropriate person of authority in the
Animal Testing: see link for further information         Europe-Animal Testing                                                       If Yes Specify
Are you in compliance with the 7th Amendment of the
European Cosmetic Directive 74/768/EEC on animal testing?
Links:                                                             VOC &amp; ROG Definitions                           Exempt VOC per US EPA
Is the ingredient classified as a VOC or ROG? (Choose from         Select     Select      Select      Select       Select      Select       Select
If Yes what is the classification ? (Choose from List)              Select    Select      Select      Select       Select      Select       Select
Water is the partial pressure of the material? (mm Hg at ST)
What is the MIR Value? (g O3 formed/g M reacted)                                                                                                         MIR Definition
Total Raw Material                                                    (W/W)
If different from the person identified on the General Form:
E-Mail Address                                                                                        Phone
Confidential                                             98b841d8-0592-4e37-81db-95be0e9525c2.xls - Regulatory                                              11/4/2011
PHYSICAL-CHEMICAL PROPERTIES FORM
Material Trade Name                  0
Material Chemical Name(s)            0
Material INCI Name(s)                0
Color Index Number                   0
GMP Certificate Select
Level of Industrialization Select
Manufacturing Process and/or Flowchart PLEASE ATTACH
Technical                                                                                                                                  Tested as
0               0                0             0            0            0            0 Entity
Physical Form                             Select       Select          Select           Select        Select       Select       Select
Particle Size/Range for Powder            Select       Select          Select           Select        Select       Select       Select
If the Material is a Polymer please answer the following questions: Attach GPC
Average Molecular Weight                                                        Fraction of material &lt; 1000 Daltons?
Physical Constants: ( C/ F)
Spectral Data (As applicable) Attach All Spectra &amp; Chromatographs
UV/Visible    Select       Select          Select           Select        Select       Select       Select
IR    Select       Select          Select           Select        Select       Select       Select
Mass    Select       Select          Select           Select        Select       Select       Select
Fluorescence   Select       Select          Select           Select        Select       Select       Select
NMR     Select       Select          Select           Select        Select       Select       Select
Separation/ Analysis Data
GC    Select       Select          Select           Select        Select       Select       Select
HPLC     Select       Select          Select           Select        Select       Select       Select
HPTLC     Select       Select          Select           Select        Select       Select       Select
Confidential                                               File - ]Physical-Chemical Properties                                              11/4/2011
Material Trade Name                 0
Material Chemical Name(s)           0
Material INCI Name(s)               0
Color Index Number                  0
Does the material contain any protein?              Select         If so specify type:                                  Level
Protein MW (Daltons)
Toxicological Studies: Please indicate availability of summaries by choosing the appropriate answer.
In the table below, Constituent column data is automatically fed from the General Form. Check if study summary is available
If Raw Material
was tested as
Test                                                                                                                            one entity
choose Yes or
Acute Oral Toxicity                                                                                                Select
Subchronic Toxicity (28 / 90 day test)
Mucous Membrane Irritation (Eye)
LOEL/NOEL
ATTACH SUMMARIES.
Confidential                                      98b841d8-0592-4e37-81db-95be0e9525c2.xls - Safety                                     11/4/2011
Material Trade Name         0
Characteristics (Choose from list or provide specific information as applicable)                                                         If Other Specify
Select       Select       Select       Select       Select       Select       Select
Is this material classified as PBT?
If yes, please specify by what criteria (US   Select       Select       Select       Select       Select       Select       Select
EPA, EU ECB, etc.).
Is this material classified as vPvB?          Select       Select       Select       Select       Select       Select       Select
If yes, please specify by what criteria.
Is this material readily biodegradable?       Select       Select       Select       Select       Select       Select       Select
Does this material have the potential to      Select       Select       Select       Select       Select       Select       Select
bioaccumulate?
What is the water solubility of the substance Select       Select       Select       Select       Select       Select       Select
(&#181;g/l)?
What is the molecular weight of the           Select       Select       Select       Select       Select       Select       Select
substance (kDa)?
What is the molecular diameter of the
substance (&#197;)?
What is the Log P or octanol/water
partition coefficient of the substance?
The studies listed below are not applicable to all materials. Decisions regarding the applicability of the studies are                   was tested as
based on the characteristics requested above.                                                                                            one entity
Aquatic Toxicity                                                                                                                         No
Short-term toxicity testing on Daphnia*       Select       Select       Select       Select       Select       Select       Select       Select
Long-term toxicity testing on Daphnia         Select       Select       Select       Select       Select       Select       Select       Select
Growth inhibition study on algae              Select       Select       Select       Select       Select       Select       Select       Select
Short-term toxicity testing on fish*          Select       Select       Select       Select       Select       Select       Select       Select
Long-term toxicity testing on fish (OECD      Select       Select       Select       Select       Select       Select       Select       Select
210, OECD 212 or OECD 215)
Activated sludge respiration inhibition       Select       Select       Select       Select       Select       Select       Select       Select
Nitrification inhibition testing              Select       Select       Select       Select       Select       Select       Select       Select
Biodegradability Study                        Select       Select       Select       Select       Select       Select       Select       Select
Simulation testing on ultimate degradation    Select       Select       Select       Select       Select       Select       Select       Select
Soil simulation testing                       Select       Select       Select       Select       Select       Select       Select       Select
Sediment simulation testing                   Select       Select       Select       Select       Select       Select       Select       Select
Aerobic rate of biodegradation (please        Select       Select       Select       Select       Select       Select       Select       Select
specify media)
Anaerobic rate of biodegradation (please      Select       Select       Select       Select       Select       Select       Select       Select
Hydrolysis as a function of pH                Select       Select       Select       Select       Select       Select       Select       Select
Identification of degradation products        Select       Select       Select       Select       Select       Select       Select       Select
Fate &amp; Behavior in the Environment
Life cycle analysis (LCA)                     Select       Select       Select       Select       Select       Select       Select       Select
Adsorption/desorption screening study         Select       Select       Select       Select       Select       Select       Select       Select
Confidential                                      98b841d8-0592-4e37-81db-95be0e9525c2.xls - Environmental                                        11/4/2011
Bioconcentration in an aquatic species       Select       Select       Select       Select       Select       Select       Select       Select
Short-term toxicity testing on earthworms*   Select       Select       Select       Select       Select       Select       Select       Select
Long-term toxicity testing on earthworms     Select       Select       Select       Select       Select       Select       Select       Select
Long-term toxicity testing on soil           Select       Select       Select       Select       Select       Select       Select       Select
invertebrates other than earthworms
Effects on soil microorganisms               Select       Select       Select       Select       Select       Select       Select       Select
Short-term toxicity testing to plants*       Select       Select       Select       Select       Select       Select       Select       Select
Long-term toxicity testing to plants         Select       Select       Select       Select       Select       Select       Select       Select
Long-term toxicity testing to sediment       Select       Select       Select       Select       Select       Select       Select       Select
Long-term or reproductive toxicity testing   Select       Select       Select       Select       Select       Select       Select       Select
*Short-term studies are not necessary if long-term studies are available.
Attach summaries as appropriate
E-Mail Address                                                                                   Phone
Confidential                                     98b841d8-0592-4e37-81db-95be0e9525c2.xls - Environmental                                        11/4/2011
PLANT DERIVED FORM
Material Trade Name                          0
Material Chemical Name(s)                    0
Material INCI Name(s)                        0
Please specify plant part:                   Select                        Extract %
Please specify Phylogenetic name:
Please attach a manufacturing flowchart
If you select the Feedstock Origin &quot;Plant&quot;, please specify the plant species, plant part and the GMO (Genetically
Modified) Status:
If GMO, please provide the detailed condition:
Is this material certified Organic? Provide Certification.
If the INCI Name includes the phylogenetic name of the plant please answer the following questions:
Is this Raw Material included in the IFRA guidelines?                      Select
If yes, does the Raw Material meet the IFRA guidelines?
If yes, please specify the amendment:
For this plant material, please answer the following questions:
Was this plant material screened for pesticides?                           Select
Were the pesticide residue levels:                                         Select
Do the pesticide residues present meet the European Pharmacopoeia
Does it contain any denatured alcohol?                                     Select
If yes, please specify the denaturant:
Does the botanical contain, by addition or as a processing aid, any of the following nut/seed products?
Does ALL SOURCES Added Ingredient Natural Source
Not    Total Inclusion   Contribution      Contribution
Materials                             Contain    Level %      Inclusion level % Inclusion Level %
Seed Products, Oils, or Derivatives
Other (please specify &amp; describe)
Does the botanical contain any of the following materials?
Not      Total Inclusion   Contribution      Contribution
Confidential                            98b841d8-0592-4e37-81db-95be0e9525c2.xls - Plant Derived
Regulated Allergens                       CAS#     Contain       Level %
Inclusion level % Inclusion Level %
Material Trade Name                      0
Material Chemical Name(s)                0
Material INCI Name(s)                    0                                 Does ALL SOURCES Added Ingredient Natural Source
Regulated Allergens                         CAS#       Contain    Level %      Inclusion level % Inclusion Level %
Alpha-Isomethyl Ionone                                        127-51-5
Amyl Cinnamal                                                 122-40-7
Amylcinnamyl Alcohol                                          101-85-9
Anise Alcohol                                                 105-13-5
Benzyl Alcohol                                                100-51-6
Benzyl Benzoate                                               120-51-4
Benzyl Cinnamate                                              103-41-3
Benzyl Salicylate                                             118-58-1
Butylphenyl Methylpropional                                    80-54-6
Cinnamal                                                      104-55-2
Cinnamyl Alcohol                                              104-54-1
Citral                                                        5392-40-5
Citronellol                                                   106-22-9
Coumarin                                                       91-64-5
Eugenol                                                        97-53-0
Isoeugenol                                                     97-54-1
Evernia Furfuracea (Treemoss) Extract                        90028-67-4
Evernia prunastri (Oakmoss) Extract                          90028-68-5
Farnesol                                                      4602-84-0
Geraniol                                                      106-24-1
Hexyl Cinnamal                                                101-86-0
Hydroxycitronellal                                            107-75-5
Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (Lyral)         31906-04-4
Limonene                                                      5989-27-5
Linalool                                                       78-70-6
Methyl 2-octynoate                                            111-12-6
Material(s) of                                       Not    Total Inclusion   Contribution      Contribution
Concern                                  CAS#      Contain    Level %      Inclusion level % Inclusion Level %
Bourgeonal (p-tert-butyl-dihydrocinnamaldehyde)            18127-01-0
Camphor                                                      76-22-2
Diethyl phthalate (DEP)                                      84-66-2
Estragole, tarragon, 4-allylanisole                         140-67-0
Ether Glycols
EGBE: 2-butoxyethanol 111-76-2
DEGBE: 2-(2-butoxy ethoxy)ethanol 112-34-5
DEGEE: 2-(ethoxy ethoxy)ethanol 111-90-0
Geranyl Nitrile                                             5146-66-7
Menthol: cyclohexanol                                        89-78-1
2-Methoxy-4-methylphenol: creosol, valspice                  93-51-6
5-Methoxy-psoralen                                          484-20-8
8-Methoxy-psoralen: MOP                                     298-81-7
Methyl eugenol                                               93-15-2
Methyl iso-eugenol                                           93-16-3
Methyl octine carbonate                                     111-80-8
Confidential                          98b841d8-0592-4e37-81db-95be0e9525c2.xls - Plant Derived                           11/4/2011
Material Trade Name                       0
Material Chemical Name(s)                 0
Material INCI Name(s)                     0
Nonoxynols or nonyl phenols
Peru balsam                                                   8007-00-9
Pinacea oils and derivatives
AHTN, tonalide, fixolide, ethanone   15323-35-0
HHCB, galaxolide, pearlide    1222-05-5
Other polycyclic musks
Rose crystals: trichloromethyl carbinyl acetate                90-17-5
Rose ketones: 1-(Trimethylcyclohexenyl/ cyclohexadienyl)-
Rue oil                                                        8014-29-7
Safrole                                                         94-59-7
iso-Safrole                                                    120-58-1
Dihydro-safrole                                                 94-58-6
Safranal: 2,6,6-Trimethylcyclohexan-1,3-dienyl methanal        116-26-7
Styrax                                                         8046-19-3
Tea Tree Oil: Melaleuca alternifolia                          68647-73-4
Thyme Oil                                                      8007-46-3
Tobacco extracts                                               8037-19-2
Confidential                         98b841d8-0592-4e37-81db-95be0e9525c2.xls - Plant Derived   11/4/2011
Material Trade Name           0
Material Chemical Name(s) 0
Material INCI Name(s)         0
Color Index Number            0
Please Identify Species    Select        Select       Select          Select       Select       Select       Select
Identify Source Organs
Age of Animal      Select        Select        Select         Select       Select       Select       Select
BSE Country Status GBR#       Select        Select       Select          Select       Select       Select       Select
** Category rating based on the EU Commission scientific steering committee (SCC) Regulation 999/2001-Geographical Risk of
Spongiform Encephalopathy (GBR) Adopted on January 11, 2002. Updated on August 20,2004. As noted on the EFSA website:
Please use link.
# NOTE: Level I--Highly Unlikely, Level II--Unlikely but Not Excluded, Level III--Likely but Not Confirmed or Confirmed at a
Lower Level, Level IV--Confirmed at a Higher Level
We hereby certify that the method of isolation used conforms to the EU Directive 76/768/EEC; Annex II, Entry
419, the following methods have to be used and strictly certified by the producer when using tallow:
A. Transesterification or Hydrolysis at least 200 &#186;C at an appropriate corresponding pressure for 20 minutes              Agree
(Glycerol, fatty acids, and fatty acid esters): or                                                                     Disagree
B. Saponification with NaOH, 12M (Glycerol and Soap); Batch process at 95 &#186;C for 3 hours or continuous pressure
at 140 &#186;C, 2 bars (2000hPa) for 8 minutes or equivalent conditions.
E-Mail Address                                                                          Phone
Confidential                                               11/4/2011                                                       Page 28
FRAGRANCE INFORMATION FORM
Material Trade Name                                     0
Material Chemical Name(s)                               0
Material INCI Name(s) US                                0
Type of product: (Choose from list)
INCI name: (EU)
FEMA GRAS number:                           FDA GRAS citation:
Molecular formula:                       Molecular weight:
FDA Bioterrorism: Is the facility where this product is manufactured registered with the FDA under the Public Health and
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act)?
Souce Information                                              Yes           No   If Yes…
Animal                              Attach TSE/BSE/SARS Certification
Plant                             See GMO Statement
GMO Statement                                          Yes         No     If Yes, the specific source of the GMO is:
This product or any of its ingredients are derived
form genetically modified organism material:
Country of Origin of GMO
This product or any of its ingredients are contain
genetically modified organism material:
Organic Status: (use Link)                         Organic Definfiton see 7 CFR Part 205.
Yes         No         If yes plase attach certificate
Organic Certified (100%)
Made with Organic (&gt;70% organic)
Ingredients registered in compliance with TSCA Section 5?
Ingredients subject to Rules 4, 5 6, 7, or 12(b) under TSCA?                         YES                     NO
Name                                         CAS #            %             Rule #
Contain ingredients listed under EPCRA Extremely Hazardous
Substances (SARA 302)?
SARA 311/312 Hazard Categories (choose those that apply)
Contains any ingredients listed under SARA 313?                                      YES                     NO
Name                                            CAS #            %
Contains any ingredients listed under EPA Hazardous Air Pollutants
(HAP)?
Confidential                                                11/4/2011                                            Page 29
Name                                      CAS #       %
Contains any ingredients listed under EPA CERCLA?                             YES                 NO
Contains any ingredients forbidden for use in Cosmetics under
Name                                  CAS #           %
Contains any ingredients listed US DEA List I or II?                          YES                 NO
Name                                      CAS #        %
Contains any ingredients listed on California&#39;s Proposition 65?               YES                 NO
Contains any ingredients identified California&#39;s SB 484 as
carcinogenic or reproductive toxin?                                           YES                 NO
Ingredients Listed on EINECS?                                                 YES                 NO
Ingredients Listed on ELINCS?                                                 YES                 NO
Limited         Full
Name                                      EINECS          ELINCS       &lt; 1000kg/yr   &gt; 1000kg/yr
Cosmetic Directive 76/768/EEC: Substances which are mentioned in Annex II - IV of the EU Cosmetic Directive (other
than preservatives, dyes, U filters, fragrance allergens listed in 7th Amendment
Name                                      Annex            %
Volatile Organic Chemicals according to the Swiss VOC legislation?                     YES                      NO
Confidential                                                 11/4/2011                                    Page 30
Canada                                                     DSL            ICL     NDSL          CEPA
Contains ingredients listed on:
For Bases and Compounds: Percentage on
Listed on Existing and New Chemical Substances (ENCS)                               YES                       NO
Low          Low
Name                                      ENCS #            CAS #           %       &lt; 1 ton/yr   &lt; 10 ton/yr
Listed on Industrial Safety &amp; Health (ISHL) Law Inventory?                          YES                          NO
Name                                    ISHL #            CAS #           %
Listed on AICS or notified under NICNAS?                                            YES                          NO
Low Volume Notification?                                                            YES                          NO
Listed or notified under PICCS?                                                     YES                          NO
Listed on IECS?                                                                     YES                          NO
Listed on ECL?                                                                      YES                          NO
Attach US MSDS
Attach EU SDS
For this fragrance, please answer the following questions:
Was this fragrance screened for pesticides?                                                   Select
Were the pesticide residue levels:                                                            Select
Do the pesticide residues present meet the European Pharmacopoeia                             Select
Natural Designation: Natural Product means all the odoriferous ingredients meet a definition of &quot;aromatic natural raw materials&quot; in
ISO Standard 9235 or are substances already present in these natural materials and are isolated from them by physical means.
100% pure and natural?                                                   YES                         NO
For plant derived materials please provide the Phylogenetic name:
Are all processes in production accepted physical means?                                          YES                       NO
Safety &amp; Toxicological Information
This product has been tested:                       Yes         No       If yes, the literature reference is:
By RIFM:
Yes         No       If yes, specified in the following table
By our Company:
Yes         No        If yes, specific details are:
By other(s):
Confidential                                                11/4/2011                                                 Page 31
Test Type                        Method/species          Concentration/          Reference
IFRA Certification:                                             YES                      NO
PLEASE ATTACH CERTIFICATE OF COMPLIANCE
Does the fragrance contain any material restricted by IFRA?                              YES                 NO
Name                                              CAS #             Percentage
5-Acetyl-1,1,2,3,3,6-hexamethyl indan (AHMI, Phantolid)                                15323-35-0
Allyl heptine carbonate                                                                73157-43-4
Amyl cyclopentenone (2-pentyl-2-cyclopenten-1-one)                                     25564-22-1
Angelica root oil                                                            8015-64-3/84775-41-7
cis-and trans-Asarone ((E)-and(Z)-2,4,5-Trimethoxypropen-1-yl benzene) -     2883-98-9/ 5273-86-9
Benzyl cyanide – indirectly added from naturals                                          140-29-4
Bergamot oil expressed                                                      8007-75-8/ 89957-91-5
Bitter orange peel oil expressed                                           68916-04-1/ 72968-50-4
BMHCA (p-t-Butyl-alpha-methylhydrocinnamic aldehyde)                                      80-54-6   See allergens
p-tert-Butyl dihydrocinnamaldehyde (Bourgeonal)                                        18127-01-0
Cedarmoss                                                                  68648-41-9/ 90028-67-4
Cinnamic alcohol                                                                         104-54-1   See allergens
Cinnamic aldehyde                                                                        104-55-2   See allergens
Cinnamyl nitrile                                                             1885-38-7/ 4360-47-8
Citral (Lemarome)                                                                       5392-40-5   See allergens
Cumin oil                                                                   8014-13-9/ 84775-51-9
Eugenol                                                                                   97-53-0   See allergens
Farnesol                                                                                4602-84-0   See allergens
Grapefruit oil expressed                                                    8016-20-4/ 90045-43-5
trans-2-Hexenal – directly added                                                        6728-26-3
trans-2-Hexenal – indirectly added from naturals                                        6728-26-3
alpha-Hexylidene cyclopentanone                                                        17373-89-6
HMPCC (3 and 4-(4-Hydroxy-4-methylpentyl)-3-cyclohexene-1-                             31906-04-4   See allergens
carboxaldehyde)
Hydroxycitronellal                                                                       107-75-5   See allergens
Isocyclogeraniol                                                                       68527-77-5
Isoeugenol                                                                                97-54-1   See allergens
Lemon oil cold pressed                                                      8008-56-8/ 84929-31-7
Lime oil expressed                                                          8008-26-2/ 90063-52-8
Menthadienyl formate                                                                   68683-20-5
Methoxy dicylopentadiene carboxaldehyde (Scentenal)                                    86803-90-9
2-Methoxy-4-methylphenol                                                                  93-51-6
Methyl Eugenol – directly added                                                           93-15-2
Methyl Eugenol – indirectly added from naturals                                           93-15-2
Methyl heptadienone (6-Methyl-3,5-heptadienone)                                         1604-28-0
Methyl heptine carbonate                                                                 111-12-6   See allergens
p-Methyl hydrocinnamic aldehyde                                                         5406-12-2
Confidential                                         11/4/2011                                            Page 32
Methyl N-methyl anthranilate - directly added                                             85-91-6
Methyl N-methyl anthranilate – indirectly added from naturals                             85-91-6
Methyl beta-naphthyl ketone                                                               93-08-3
3-Methyl-2(3)-nonenenitrile (Citgrenile)                                               53153-66-5
Methyl octine carbonate                                                                  111-80-8       See allergens
Oakmoss extracts                                                            9000-50-4/ 90028-68-5       See allergens
1-Octen-3-yl acetate (amyl vinyl carbinyl acetate)                                        198242
Opoponax                                                                     8021-36-1/ 9000-78-6
Perilla aldehyde                                                                        2111-75-3
Peru balsam extracts and distillates                                                    8007-00-9
Petitgrain Mandarin Oil                                                     8014-17-3/ 93686-22-7
Phenyl acetaldehyde (Hyacinthin)                                                         122-78-1       See allergens
Propylidene phthalide                                                                  17369-59-4
Rue oil                                                                     8014-29-7/ 84929-47-5
Safrole – indirectly added from naturals                                                  94-59-7
Styrax extracts and distillates (prepared from exudations of Liquidambar    8024-01-9/ 8046-19-3/
styraciflua L. var. macrophylla or Liquidambar orientalis Mill.)           94891-27-7/ 94891-28-8
Tagetes oil and absolute                                                    8016-84-0/ 91722-29-1
Tea absolute (Camellia sinensis absolute)                                              84650-60-2
Treemoss extracts                                                          68648-41-9/ 90028-67-4       See allergens
2,6,6-Trimethylcyclohexa-1,3-dienyl methanal (Safranal)                                  116-26-7
1-(Trimethylcyclohexenyl/cyclohexadienyl)-2-buten-1-ones (Rose                            Various
Verbena absolute                                                            8024-12-2/ 85116-63-8
Benzene (indirect)                                                                        71-43-2
Toluene (indirect)                                                                       108-88-3
5-Methoxypsoralen (Bergaptene)                                                           484-20-8
Does the fragrance contain any material prohibited by IFRA?                               YES                      NO
Name                                              CAS #             Present?
Acetyl ethyl tetramethyl tetralin (AETT, Versalide)                                       88-29-9
Acetyl isovaleryl (5-Methyl-2,3-hexanedione)                                           13706-86-0
Allantroot oil (Elecampane oil)                                                        97676-35-2
Allylisothiocyanate                                                                       57-06-7
Anisylidene acetone (4-(4-methoxphenyl)-3-buten-2-one)                                   943-88-4
cis-and trans-Asarone ((E)-and(Z)-2,4,5-Trimethoxypropen-1-yl benzene)       2883-98-9/ 5273-86-9
Benzene                                                                                   71-43-2
Benzyl cyanide                                                                           140-29-4
Benzyildene acetone (4-Phenyl-3-buten-2-one)                                             122-57-6
Birch wood (bark) pyrolysates (oils), crude                                8001-88-5/ 84012-15-7/
3-Bromo-1,7,7-trimethylbicylo[2.2.1]heptane-2-one                                         76-29-9
Bromstryene                                                                              103-64-0
p-tert-Butylphenol                                                                        98-54-4
Cade oils, crude                                                            8013-10-3/ 90046-02-9
Carvone oxide                                                                          33204-74-9
Chenopodium oil                                                             8006-99-3/ 89997-47-7
Cinnamylidene acetone                                                                   4173-44-8
Colophony                                                                               8050-09-7
Costus root oil, absolute and concrete                                      8023-88-9/ 90106-55-1
Cyclamen alcohol (3-(4-Isopropylphenyl)-2-methylpropanol)                               4756-19-8
1,3-Dibromo-2-methoxy-4-methyl-5-nitrobenzene (Musk KS)                                62265-99-0
1,3-Dibromo-4-methoxy-2-methyl-5-nitrobenzene (Musk alpha)
2,2-Dichloro-1-methylcyclopropylbenzene                                                3591-42-2
Diethyl maleate                                                                         141-05-9
Dihydroabietyl alcohol                                                                26266-77-3
Dihydrocoumarin (Melilotine)                                                            119-84-6
2,4-Dihydroxy-3-methyl-benzaldehyde                                                    6248-20-0
4,6-Dimethyl-8-t-butyl coumarin (Butolia)                                             17874-34-9
Dimethyl citraconate (cis-Methylbutenedioic acid, dimethyl ester)                       617-54-9
Confidential                                          11/4/2011                                               Page 33
3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol)                                           40607-48-5
Diphenyl amine                                                                              122-39-4
Esters of 2-nonynoic acid, except methyl octine carbonate                                    Various
Esters of 2-octynoic acid, except methyl and allyl heptine carbonate                         Various
Ethyl acrylate                                                                              140-88-5
Ethylene glycol monoethyl ether                                                             110-80-5
Ethylene glycol monoethyl ether acetate                                                     111-15-9
Ethylene glycol monomethyl ether                                                            109-86-4
Ethylene glycol monomethyl ether acetate                                                    110-49-6
Fig leaf absolute                                                             68916-52-9/90028-74-3
Furfurylideneacetone                                                                        623-15-4
trans-2-Heptenal                                                                          18829-55-5
Hexahydrocoumarin                                                                           700-82-3
trans-2-Hexenal diethyl acetal                                                            67746-30-9
trans-2-Hexenal dimethyl acetal                                                           18318-83-7
Hydroabietyl alcohol (Abitol)                                                 13393-93-6/ 1333-89-7
Hydroquinone monoethylether (4-Ethoxy phenol)                                               622-62-8
Hydroquinone monomethylether (4-Methoxy phenol)                                             150-76-5
Isophorone                                                                                   78-59-1
6-Isopropyl-2-decalol                                                                     34131-99-2
Massoia bark oil                                                                          85085-26-3
Massoia lactone                                                                           54814-64-1
Melissa oil (genuine Melissa officinalis)                                     8014-71-9/ 84082-61-1
7-Methoxycoumarin                                                                           531-59-9
alpha-Methyl anisylidene acetone (1-(4-Methoxphenyl)-1-penten-3-one)                        104-27-8
6-Methyl coumarin (Toncarine)                                                                92-48-8
7-Methyl coumarin                                                                          2445-83-2
Methyl crotonate                                                                            623-43-8
4-Methyl-7-ethoxycoumarin (Maraniol)                                                         87-05-8
Methyl methacrylate                                                                          80-62-6
Moskene                                                                                     116-66-5
Musk ambrette                                                                                83-66-9
Musk tibetine                                                                               145-39-1
Nitrobenzene                                                                                 98-95-3
Pentylidene cyclohexanone                                                                 25677-40-1
Peru balsam (exudation from Myroxylon pereirae (Royle) Klotzsch)                           8007-00-9
Phenyl acetone (Methyl benzyl ketone)                                                       103-79-7
Phenyl benzoate                                                                              93-99-2
Pseudoionone (2,6-Dimethylundeca-2,6,8-trien-10-one)                                        141-10-6
Pseudomethylionones                                                                       26651-96-7
Safrole, isosafrole, dihydrosafrole (directly and indirectly added from     94-59-7/ 120-58-1/ 94-58-
naturals)                                                                                          6
Santolina oil                                                                             84961-58-0
Styrax gums, crude                                                            8024-01-9/ 8046-19-3/
Toluene                                                                                     108-88-3
Verbena oil                                                                   8024-12-2/ 85116-63-8
Allergen Disclosure                                                  EINECS % Natural       % By      % Total
INCI Name                         CAS #         #        Source      Addition     Content
Alpha-Isomethyl Ionone                              127-51-5   204-846-3
Amyl Cinnamal                                       122-40-7   204-541-5
Amylcinnamyl Alcohol                                101-85-9   202-982-8
Anise Alcohol                                       105-13-5
Benzyl Alcohol                                      100-51-6   202-859-9
Benzyl Benzoate                                     120-51-4   204-402-9
Benzyl Cinnamate                                    103-41-3   203-109-3
Benzyl Salicylate                                   118-58-1   204-262-9
Butylphenyl Methylpropional                         80-54-6    201-289-8
Cinnamal                                            104-55-2   203-213-9
Confidential                                         11/4/2011                                              Page 34
Cinnamyl Alcohol                         104-54-1   203-212-3
Citral                                  5392-40-5   226-394-6
Citronellol                              106-22-9   203-375-0
Coumarin                                  91-64-5   202-086-7
Eugenol                                  97-53-0    202-589-1
Evernia Furfuacea (Treemoss) Extract   90028-67-4   289-860-8
Evernia Prunastri (Oakmoss) Extract    90028-68-5   289-861-3
Farnesol                                4602-84-0   225-004-1
Geraniol                                 106-24-1   203-377-1
Hexyl Cinnamal                           101-86-0   202-983-3
Hydroxycitronellal                       107-75-5   203-518-7
Hydroxyisohexyl 3-Cyclohexene          31906-04-4   250-863-4
Isoeugenol                                97-54-1   202-589-1
Limonene                                5989-27-5
Linalool                                 78-70-6    201-134-4
Methyl Octine Carbonate                  111-80-8
Phenyl Acetaldehyde                      122-78-1
Methyl 2-Octynoate                       111-12-6
SOLVENTS USED?                                        YES           NO
Name                     CAS #             %
ANTI-OXIDANTS/STABILIZERS?                            YES           NO
Name                           CAS #             %
EMULSIFIERS USED?                                     YES           NO
COLORANTS/ DYES USED?                                 YES           NO
Name                            CAS #             %
Confidential                              11/4/2011                   Page 35
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