Regulatory Information Sheet (RIS)

Polypropylene Heterophasic Copolymer

CP 204

CHEMICAL INVENTORIES
All ingredients in this product are in compliance with the following chemical inventories:

• ASIA-PACIFIC
• AUSTRALIA: Australian Inventory of Chemical Substances (AICS)
• KOREA: Korean Existing Chemicals List (KECL)
• UNITED STATES: Toxics Substances Control Act Inventory (TSCA)

BRAZIL FOOD CONTACT

The Polypropylene Heterophasic Copolymer CP 204, manufactured by Braskem S.A. Brazil, complies with
the requirements defined in Resolution RDC n. 91/2001 of the National Agency of Sanitary Control –
ANVISA –, published on May 11, 2001, which “establishes the general criteria and classification of
materials for packaging and equipment in contact with food”, as well as their components are comprised
in the Positive Lists described in Part I – Positive List of Monomers and other starting substances
authorized in the Resolution RDC n. 56/2012 of ANVISA, published on November 16, 2012 and in
Resolution RDC n. 17/2008 of ANVISA, published on March 17, 2008 – Positive List of additives for plastic
materials for the purpose of packaging and equipment manufacturing for contact with food.

Taking into consideration the components present in the resin composition, there is no restriction
regarding the type of food and/or temperature and time of contact during processing and/or Positive List
of the present Resolution. The monomers and additives used on the formulation of this product are listed
in the Positive List of the present Resolution.

This product does not contain monomers and/or additives with specific migration limit (SML) and/or a
total specific migration limit (SML(T)) and/or a QMA (residual content per food contact surface area).

In order to guarantee the compliance with the Resolution mentioned above, the packaging and/or the
end plastic product must be analyzed by the manufacturer concerning total migration limit and such limit
must be less than 50 mg/kg or 8 mg/dm2.

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 MERCOSUR FOOD CONTACT
This product complies with the requirements defined in Resolution GMC n. 3/92 of MERCOSUR, published
on April 1, 1992, which “establishes the general criteria and classification of materials for packaging and
equipment in contact with food”, as well as their components are comprised in the Positive Lists
described in Resolution GMC n. 02/2012 - Positive List of Resins and Polymers for plastic packaging and
equipment in contact with food, published on April 19, 2012, and in Resolution GMC n. 32/07, Positive
List of additives for plastic materials for the purpose of packaging and equipment manufacturing for
contact with food published on December 11, 2007.

Taking into consideration the components present in the resin composition, there is no restriction
regarding the type of food and/or temperature and time of contact during processing and/or Positive List
of the present Resolution. The monomers and additives used on the formulation of this product are listed
in the Positive List of the present Resolution.

This product does not contain monomers and/or additives with specific migration limit (SML) and/or a
total specific migration limit (SML(T)) and/or a QMA (residual content per food contact surface area).

In order to guarantee the compliance with the Resolution mentioned above, the packaging and/or the
end plastic product must be analyzed by the manufacturer concerning total migration limit and such limit
must be less than 50 mg/kg or 8 mg/dm2.

UNITED STATES FOOD CONTACT

This product complies with the FDA (Food and Drugs Administration) Regulations, Edition 2015, as
defined in 21 CFR, section 177.1520 (Olefin polymers) paragraph (c) 3.1a. The additives are covered in
the sections 177.1520, 178.2010, 181.29 and as describe FCN N° 67.

This product can also be used in contact with all types of food from “I to IX” as described in Table 1 of
Section 176.170(c) of this chapter, and under conditions of use from “C” to “H” described in Table 2 of
Section 176.170(c) of this chapter.

EUROPE FOOD CONTACT

This product complies with the requirements defined in Regulation EU 10/2011 and its amendments
(includes Regulations (EU) No 321/2011, (EU) No 1282/2011, (EU) No 1183/2012, (EU) No 202/2014,
(EU) 174/2015 and (EU) 1416/2016) on regarding plastic materials and products for contact with food.

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 Taking into consideration the components present in the resin composition, there is no restriction
regarding the type of food and/or temperature and time of contact during processing and/or storage. The
monomers and additives used on the formulation of this product are listed in the Union List of Authorized
Substances of the present Regulation.

This product contains monomers and/or additives and/or product production aids (PPAs) with specific
migration limit (SML) and/or a total specific migration limit (SML(T)) and/or a QMA (residual content per
food contact surface area) as defined in Tables 1-3 of Annex I of EC 10/2011.

In order to guarantee the compliance with the Regulation mentioned above, the packaging and/or the
end plastic product must be analyzed by the manufacturer concerning total migration limit and such limit
must be less than 10 mg/dm². For further information on substances containing SML and/or SML(T)
and/or QMA please contact your regular commercial or technical service contact at Braskem.

Braskem declares that specific measures are adopted for resin CP 204, complying with article 5th of
Regulation (EC) n° 1935/2004.

DUAL USE ADDITIVE

This product contains one or more additives approved as authorized food additive in the Annex II of
Regulation (EC) No 1333/2008, as amended by Commission Regulation (EU) No 1129/2011 (11.11.2011)
and Commission Regulation (EU) No 380/2012 (03.05.2012), and considered as “dual use additive”. For
further information on dual use additives, please contact your regular commercial or technical service
contact at Braskem.

CANADA FOOD CONTACT

This product has not been assessed by Health Canada.

ODOR & TASTE

This product complies with the FDA requirements for use in contact with food, as described above.
Aspects such as processing, storage period, storage conditions, type of food intended to be in contact
with the resin, or other likely conditions may affect the smell or the taste of the food.

ANIMAL ORIGIN
Additives from animal origin may be used in the manufacture of this product. According to information
provided by suppliers, these raw-materials are free from Bovine Spongiform Encephalopathy (BSE) and
Transmissible Spongiform Encephalopathy (TSE).

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 ALLERGENS
With regards to the manufacture of this resin the following food allergens or products thereof are not
intentionally added to the process/ product: cereal containing gluten, crustaceans, eggs, fish, peanuts,
soybeans, milk, nuts, celery, mustard, sesame seeds, sulphur dioxide and sulphites.

As these substances are not intentionally added, we inform that they are not tested during our processes.

GENETICALLY MODIFIED ORGANISM (GMO)

With regards to the manufacture of this resin genetically modified organisms (GMOs) are not intentionally
added to the process/ product. As these substances are not intentionally added, we inform that they are
not tested during our processes.

BRAZILIAN PHARMACOPEIA
This product has not been tested and assessed according to the criteria for approval of the Brazilian
Pharmacopeia.

UNITED STATES PHARMACOPEIA (USP)

This product has not been tested and assessed according to the criteria for approval of the. US
Pharmacopeia (USP).

EUROPEAN PHARMACOPEIA (EP)

This product has not been tested and assessed according to the criteria for approval of the. European
Pharmacopeia.

TOYS
This product has not been tested and assessed according to the criteria for approval of the NBR NM 300-
3: 2011 - Safety of toys - Part 3: Migration of certain elements.

This product has not been tested and assessed according to the criteria for approval of the European
Standard EN 71-3:2013 + A1:2014 - Safety of toys.

BISPHENOL A, BISPHENOL F & BISPHENOL S

This product is not manufactured or formulated with Bisphenol A (BPA, CAS number 80-05-7), Bisphenol
F (BPF, CAS number 620-92-8) and Bisphenol S (BPS, CAS# 80-09-1).

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 LATEX
With regards to the manufacture of this resin, “natural rubber latex", "dry natural rubber", "synthetic latex or
"rubber that contains natural rubber" are not intentionally added to the process/ product.
As these substances are not intentionally added, we inform that they are not tested during our processes.

DYES OR PIGMENTS
This product is not manufactured or formulated with dyes or pigments.

PHTHALATES
Braskem S.A. does not intentionally add phthalate additives or plasticizers in the manufacture of its
polypropylene grades; however, this product may contain trace levels of phthalates from the polymerization.
Any trace levels of phthalates in the product would be below regulatory and advisory standards. For more
specific information, please contact your Technical Assistance.

ORGANO-TIN COMPOUNDS
With regards to the manufacture of this resin the following tin compounds are not intentionally added to
the process/product: dibutyltin (DBT, CAS# 1002-53-5), diphenyltin (DPhT, cas# 1011-95-6), dioctyltin
(DOT, CAS# 15231-44-4), monobutyltin (MBT, CAS# 78763-54-9), monooctyltin (MOT, CAS# 15231-57-
9), tetrabutyltin (TTBT/TEBT, CAS# 1461-25-2), tributyltin (TBT, CAS# 688-73-3), tricyclohexyltin (TCyT,
CAS# 3047-10-7) and thiphenyltin (TPhT, CAS# 892-20-6).

As these substances are not intentionally added, we inform that they are not tested during our processes.

CALIFORNIA PROPOSITION 65
This product may contain one or more chemical substances as set forth in California Proposition 65
chemicals list dated August 5, 2016. For further information on substances, please contact your regular
commercial or technical service contact at Braskem.

Every company that sells its products in the territory of California shall be responsible for informing the
status of its own products under Prop 65 and developing its own regulatory plan. Braskem makes no
representation or Regulatory Information Sheet of its clients’ products regarding the Proposition 65.

NSF INTERNATIONAL
At this time Braskem holds no NSF certifications for this product.

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 UL CERTIFICATION
At this time Braskem holds no UL certifications for this product.

DIRECTIVE RoHS (Restriction of Hazardous Substances) (2011/65/EU)

RoHS Regulation refers to electrical and electronic equipment and not specifically to plastic raw materials.
However, based on the available documentation from raw materials suppliers and /or specific analyzes, this
resin is in compliance with Directive 2011/65/EU (RoHS) as it relates to the restriction of the use of certain
hazardous substances (such as lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls
(PBB), polybrominated diphenyl ethers (PBDE), Butyl Benzyl Phthalate (BBP), Dibutyl phthalate (DBP), Di (2-
ethylhexyl) phthalate(DEHP) and Diisobutyl phthalate (DIBP).

COALITION OF NORTHEASTERN GOVERNORS (CONEG) and EUROPEAN DIRECTIVE 94/62/EC

Based on the available documentation provided by our raw material suppliers and /or specific analyzes, this
product complies with the CONEG Model Legislation for requirements regarding the defined limit for the sum
of heavy metals (lead, mercury, cadmium and hexavalent chromium.

Additional information on the health and safety aspects of our product is listed in the MSDS of
the product.

Further information about SVHC please visit our web site:

http://www.braskem.com.br/site.aspx/Quality-REACH

This Regulatory Information Sheet herein relates only to the specific product designated and
may not be valid for such product used in combination with any other product or in any
process, unless otherwise specified. This information provided is of the date hereof and
Braskem may update, revise or amend such Regulatory Information Sheet or the information
contained herein whenever possible.

The user hereby acknowledges and accepts its responsibility to determine, run all trials in its
final products and ensure that all conditions, specifications, laws and regulatory requirements
are met and the products fabricated from the specific product designated are acceptable for
use in the intended application, including for food contact.

Disclaimer: Braskem S.A. and its affiliates (“Braskem”) do not make, and expressly disclaim, all
warranties, including warranties of merchantability or fitness for a particular purpose,
regardless of whether oral or written, express or implied, or allegedly arising from any usage of
any trade or from any course of dealing in connection with the use of the information contained
herein or the product itself. The user expressly assumes all risk and liability, whether based in
contract, tort or otherwise, in connection with the use of the information contained herein or
the product itself. Further, information contained herein is given without reference to any
intellectual property issues, as well as national, federal, state or local law, statute, regulation,

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 order or rule (“Laws”) which may be encountered in the use thereof. Such questions should be
investigated by the user. The data provided in this document is limited to the extent of
Braskem’s knowledge and/or supplier’s information provided to Braskem.

Gabriela Baldino Letícia Lopes

Regulatory Affairs Regulatory Affairs
Braskem S.A. Braskem S.A.

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