Download as pdf or txt
Download as pdf or txt
You are on page 1of 5

CLEAR FORM

REGULATORY INFORMATION FOR RAW MATERIALS


Section 1: Company and Product Information
Supplier Company Name: Physical State: -
Supplier Product Name: Flash Point: °C
Country of manufacture: Flash Point method:
Product Tariff (HTS) Code1:
Are any components used to manufacture this product derived from? Animal origin: ☐ Yes ☐ No
Grains: ☐ Yes ☐ No
Genetically Modified Organisms (GMO)2: ☐ Yes ☐ No
Section 2: Composition Data
Please provide complete composition data for the product. The total target % weight (w/w) should add up to 100%.
For any proprietary components, put “Proprietary” in the CASRN field or give HMIRA3 number.
Additional components may be entered in Addenda B.
Chemical Name Type Target %
ID (IUPAC, not trade name) (Substance, Polymer, Impurity) CASRN Weight (w/w)
1. -
2. -
3. -
4. -
5. -
6. -
7. -
Total weight (w/w): 0 %
Section 3: Chemical Inventory Status
Instructions: Select all as applies. If the aggregate of components contains ‘Listed’ and ‘Exempt’ or ‘Not Listed’ substances, then mark each as
applies and provide the ID’s (from Sect. 2 or Addenda B) as indicated in each subsection.
Asia Pacific
Australia AICS4: ☐ Listed ☐Exempt ☐Not Listed New Zealand NZIOC8: ☐Listed ☐Exempt ☐Not Listed
China IECSC5: ☐ Listed ☐Exempt ☐Not Listed Japan ENCS 9:
☐Listed ☐Exempt ☐Not Listed
Korea KECI6: ☐ Listed ☐Exempt ☐Not Listed Philippines PICCS10: ☐Listed ☐Exempt ☐Not Listed
Taiwan ECSI7: ☐ Listed ☐Exempt ☐Not Listed Exempt/Not Listed Components:

North America
Canada NDSL11: ☐Listed ☐Exempt ☐Not Listed NDSL components:
Canada DSL11: ☐Listed ☐Exempt ☐Not Listed Exempt/Not Listed Components:
United States TSCA : ☐Listed* ☐Exempt ☐Not Listed
12 Exempt/Not Listed Components:
*All components have been notified to the TSCA Active inventory

Europe
Switzerland13: ☐ Listed ☐Exempt ☐Not Listed Exempt/Not Listed Components:
REACH (EU source): If supplied from inside the European Economic Area (EEA), you must complete Addenda A in addition to this form.
REACH (Non-EU source): If supplied from outside the EEA, would you consider a supplier Only Representative (OR) agreement?
☐ Yes If Yes, provide your OR contact details OR Company:
☐ Agreement Attached see note and complete Addenda A. OR Contact Name:
☐ No* or ☐Unsure* E-mail: Phone:
* If no or unsure, you must provide complete CASRN composition in Section 2 and provide the WGK rating of each chemical component
(question1), including monomer composition of all polymers (questions 6-7) in Addenda A.

Initials: . By initialing this statement, I certify that 100% of this material is represented in the
Inventory Certification
country inventories indicated in this Section.

Regulatory Affairs Page 1 of 2 6/22/2018 v2.2


REGULATORY INFORMATION FOR RAW MATERIALS
Section 4: Regulatory Data
Does this product contain any of the following:
Elemental Phosphorus? ☐ No ☐Yes If yes, provide % weight:
Alkylphenol Ethoxylates (APE’s)? ☐ No ☐Yes If yes, provide % weight:
Nonylphenol Ethoxylates (NPE’s)? ☐ No ☐Yes If yes, provide % weight:
Heavy metals? ☐ No ☐Yes If yes, identify each metal with their % weight:

Does this product contain any chemical substance(s) required for reporting/compliance under or as:
Chemical Weapons Convention 14 ☐No ☐Yes If yes, list ID(s) from Sect.2 or Addenda B with ECCN(s):
Drug Precursor Substance 15 ☐No ☐Yes If yes, list ID(s) from Sect.2 or Addenda B:
For North America
DHS: COI 16 ☐No ☐Yes If yes, list ID(s) from Sect.2 or Addenda B:
Clean Water Act 17
☐No ☐Yes If yes, list ID(s) from Sect.2 or Addenda B:
Clean Air Act 18 ☐No ☐Yes If yes, list ID(s) from Sect.2 or Addenda B:
CEPA List of Toxic Substances 19 ☐No ☐Yes If yes, list ID(s) from Sect.2 or Addenda B:
EPCRA, Section 302 20 ☐No ☐Yes If yes, list ID(s) from Sect.2 or Addenda B:
SARA 313 21 ☐No ☐Yes If yes, list ID(s) from Sect.2 or Addenda B:
California Prop 65 22 ☐No ☐Yes If yes, list ID(s) from Sect.2 or Addenda B:
Canada ERAP 23 ☐No ☐Yes If yes, list ID(s) from Sect.2 or Addenda B:
FDA ☐No ☐Yes If yes, please indicate CFR reference:
CARB VOC 24 ☐No ☐Yes If yes, list ID(s) from Sect.2 or Addenda B:
Other region or state regulations, substance concerns, or restrictions:

For Europe
Nano Material 25 ☐No ☐Yes If yes, list ID(s) from Sect.2 or Addenda B:
PIC 26 ☐No ☐Yes If yes, list ID(s) from Sect.2 or Addenda B:
SVHC 27 ☐No ☐Yes If yes, list ID(s) from Sect.2 or Addenda B:
Other region or country regulations, substance concerns, or restrictions:

For Latin America


Prohibitive list of cosmetics (RDC 48/2006) – ANVISA/BRAZIL 28 ☐No ☐Yes ☐Not applicable
MERCOSUR 29 ☐No ☐Yes ☐Not applicable

Section 5: Data Certification & Acknowledgement


I certify, to the best of my knowledge, that the above information, including any Addendum and/or supplemental documents, are accurate
for the product being offered for sale and my company will immediately update PE Chemicals and/or its subsidiaries and issue a Safety Data Sheet
(SDS) reflecting any significant change – including, but not limited to, substance classification changes. I also confirm that I am considered a
competent person within my company in filling out such information.

The undersigned acknowledges that completion of this form does not constitute approval by PE Chemicals or its subsidiaries and will need
to be evaluated by PE Chemicals Regulatory Affairs prior to approval. The undersigned also acknowledges that approval by Regulatory Affairs does
not guarantee purchase.

Name: Attachments Note: If you’ve indicated anywhere on this form that


attachments will accompany your submission (i.e. OR Agreement),
Title: please review and confirm these attachments prior to submitting this
Phone: form.
E-mail:

Signature:
Regulatory Affairs Page 2 of 2 6/22/2018 v2.2
REGULATORY INFORMATION FOR RAW MATERIALS
Addenda A: EU / Non-EU Supplier Questionnaire
1. Provide the EINECS number, REACH registration status, and WGK30 rating for each component you provided from Section 2 of the form.
Additional components may be entered in Addenda B.
REACH
ID Chemical Name EINECS WGK Rating
Status Registration #, Date, or Exemption Status
1. - -
2. - -
3. - -
4. - -
5. - -
6. - -
7. - -

2. Has full composition disclosure, with all CASRNs, been given in Section 2 and/or Addenda B (i.e. no substances marked as proprietary)?
☐ Yes, skip to question 5
☐ No, continue to question 3

3. Does the product, and/or any of the substances within it, fall under any EU legislation, which would affect the product’s marketability? (i.e.
REACH marketing and use restrictions/ozone depleting substances/endocrine disruptors/Biocide products/etc.)
☐ Yes
☐ No

4. If the product’s composition is proprietary, are all components pre-registered or registered by you or your supplier, and if pre-registered, there is
intent to register?
☐ Yes
☐ No

5. If a list of our company’s “uses” have been provided, do you and your suppliers support them in their entirety?
☐ Yes
☐ No*
☐ Not applicable – no list provided*
*If no list of uses have been provided, or you selected “No” to the question above, please identify all uses you or your suppliers support:
Comments:

6. If the product contains (a) polymer(s) as identified in Section 2, please confirm the following statement by checking the box below:
☐ All polymers within the product, , meet the EU polymer
definition given in the REACH regulation (EC) No 1907/2006.

7. Please break down all polymers into their respective bound monomers and other substance units that they are comprised of.
Type Status
Polymer CASRN Component CASRN % of Polymer
(Monomer, Other Substance)
(Registered, Pre-registered, Planning to
Register)
- -
- -
- -
- -
- -
- -
- -

Regulatory Affairs Addenda A 6/22/2018 v2.2


REGULATORY INFORMATION FOR RAW MATERIALS
Addenda B: Raw Material Composition Supplement
Use this supplement to disclose additional substance data as required in Section 2 and Addenda A (Question1). Data entered in Section 2 and Addenda A (Question1) are connected to rows 1-7 of this
supplement.
Total weight (w/w): 0 % ADDENDA A
Type Target %
Chemical Name Registration #, Date, or WGK
ID (Substance, Polymer, CASRN Weight EINECS REACH Status
(IUPAC, not trade name) Impurity) Exemption Status Rating
(w/w)
1. - - -
2. - - -
3. - - -
4. - - -
5. - - -
6. - - -
7. - - -
8. - - -
9. - - -
10. - - -
11. - - -
12. - - -
13. - - -
14. - - -
15. - - -
16. - - -
17. - - -
18. - - -
19. - - -
20. - - -
21. - - -
22. - - -
23. - - -
24. - - -
25. - - -
26. - - -
27. - - -
28. - - -
29. - - -
30. - - -

Regulatory Affairs Addenda B 6/22/2018 v2.2


REGULATORY INFORMATION FOR RAW MATERIALS
Footnotes:
1. Harmonized Tariff System (HTS) Code: For information regarding HTS codes, visit: http://www.usitc.gov/tata/hts/bychapter/index.htm
2. World Health Organization: Frequently Asked Questions on Genetically Modified Foods, visit: http://www.who.int/foodsafety/areas_work/food-
technology/faq-genetically-modified-food/en/
3. Hazardous Material Information Reference Act: (HMIRA): An HMIRA (formerly HMIRC) number is assigned by Health Canada for use in Canada when
trade secret status has been granted. For more information, visit: https://www.canada.ca/en/health-canada/services/environmental-workplace-
health/occupational-health-safety/workplace-hazardous-materials-information-system/claims-exemption-under-hmira.html
4. Australia Inventory of Chemical Substances (AICS): To search AICS, visit: http://hcis.safeworkaustralia.gov.au/HazardousChemical
5. Inventory of Existing Chemical Substances Produced or Imported in China (IECSC): To download IECSC document, visit:
http://www.mep.gov.cn/gkml/hbb/bgg/201301/t20130131_245810.htm
a. IECSC 2016 Supplement: http://www.mep.gov.cn/gkml/hbb/bgg/201603/t20160315_332884.htm
6. Korea Existing Chemicals Inventory (KECI): To search KECI, visit: http://ncis.nier.go.kr/main/Main.jsp
7. Taiwan Existing Chemical Substances Inventory (ECSI): To search ECSI, visit: https://csnn.osha.gov.tw/content/home/Substance_Query_Q.aspx
8. New Zealand Inventory of Chemicals (NZIOC): For information on and to search NZIOC, visit: http://www.epa.govt.nz/search-databases/pages/nzioc-
search.aspx
9. Japanese Existing and New Chemical Substances (ENCS): To search ENCS, visit:
http://www.safe.nite.go.jp/english/sougou/view/TotalSrchInput_en.faces
10. Philippine Inventory of Chemicals and Chemical Substances (PICCS): To search PICCS, visit: http://emb.gov.ph/internal/CasREgistry.aspx
11. Canadian Domestic Substances List (DSL) / Non-Domestic Sustances List (NDSL):To search for DSL/NDSL, visit: http://www.ec.gc.ca/lcpe-
cepa/eng/substance/chemicals_polymers.cfm
12. United StatesToxic Substances Control Act (TSCA): To access TSCA’s non-confidential Inventory, visit:
http://www.epa.gov/oppt/existingchemicals/pubs/tscainventory/howto.html
13. Switzerland Common notification authority for chemicals – Substances: https://www.anmeldestelle.admin.ch/chem/en/home/themen/pflicht-
hersteller/stoffe.html
14. Chemical Weapons Convention (CWC) / Dual-use goods (EU (EC) No 394/2006 and Amendments): For information on CWC, visit: http://www.cwc.gov/;
For information on Duel-use controls, visit: http://ec.europa.eu/trade/import-and-export-rules/export-from-eu/dual-use-controls/
15. US Department of Justice Drug Enforcement Administration (USDJ DEA) Drug Precursor List: For information on the Drug Precursor List, visit:
http://www.deadiversion.usdoj.gov/fed_regs/rules/2004/fr1215.htm
16. Department of Homeland Security Chemicals of Interest (DHS:COI): To access the Department of Homeland Security: Chemicals of Interest List, visit:
www.dhs.gov/publication/cfats-coi-list
17. Refers to 33 U.S.C. §1251 et seq. (1972): For information on the Clean Water Act, visit: http://www2.epa.gov/laws-regulations/summary-clean-water-act
18. Refers to 42 U.S.C. §7401 et seq. (1970): For information on the Clean Air Act, visit: http://www2.epa.gov/laws-regulations/summary-clean-air-act
19. Canadian Environmental Protection Act (CEPA): For information on the CEPA List, visit: http://www.ec.gc.ca/lcpe-
cepa/default.asp?lang=En&n=D44ED61E-1
20. Emergency Planning and Community Right-to-Know Act (EPCRA) Section 302 – Revised Emergency Planning Notification Requirements for Extremely
Hazardous Substances (EHS) that are Solids in Solution: For more information on EPCRA Section 302, visit: https://www.epa.gov/epcra/epcra-non-
section-313-amendments-and-guidance
21. The Superfund Amendments and Reauthorization Act (SARA) Title III Section 313 or EPCRA Section 313 – Toxic Release Inventory: For more
information on SARA 313, visit: http://www2.epa.gov/toxics-release-inventory-tri-program; To download EPA’s List of Lists, visit:
https://www.epa.gov/epcra/consolidated-list-lists
22. State of California Proposition 65: For information on Prop 65, visit: http://www.oehha.ca.gov/prop65.html; For current list, visit:
http://www.oehha.ca.gov/prop65/prop65_list/Newlist.html
23. Emergency Response Assistance Plans (ERAPs) – Transport Canada: For information on ERAPs, visit: http://www.tc.gc.ca/eng/tdg/erap-menu-72.htm
24. California Air Resources Board (CARB) Volatile Organic Compounds (VOC): For information on CARB VOC, visit:
http://www.arb.ca.gov/consprod/regs/regs.htm; California Code of Regulations (17 CA ADC §94508):
https://govt.westlaw.com/calregs/Document/I93A3E17045DC11E4A10180321CCBA1E2?viewType=FullText&originationContext=documenttoc&transition
Type=CategoryPageItem&contextData=(sc.Default)
25. Nano material (as defined in EU COMMISSION RECOMMENDATION 2011/696/EU): For information on nano material reporting, visit:
http://echa.europa.eu/regulations/nanomaterials
26. Prior Informed Consent (PIC) Regulation (EU) 649-2012): For information on PIC, visit: http://echa.europa.eu/regulations/prior-informed-consent-
regulation
27. Substances of Very High Concern (SVHC) or Candidate List for Authorisation: For information on EU SVCH, visit:
http://echa.europa.eu/web/guest/candidate-list-table
28. Prohibited list of cosmetics (RDC 48/2006) – ANVISA/BRAZIL: Visit: http://www.cosmeticsonline.com.br/ct/painel/fotos/assets/uploads/regulatorios/61bee-
Rdc-48.pdf
29. MERCOSUR: Visit: http://www.puntofocal.gov.ar/doc/r_gmc_40-15_fe.pdf
30. GermanWassergefährdungsklassen (WGK) Water hazard classification rating: Visit
http://webrigoletto.uba.de/rigoletto/public/language.do?language=english

Regulatory Affairs Footnotes 6/22/2018 v2.2

You might also like