PCm 29.08.2019 Ed.

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DECLARATION OF COMPLIANCE TO FOOD CONTACT REGULATIONS

We confirm that this product fulfils the applicable requirements on substances used for the
manufacturing of materials and articles or components of articles intended to come into contact with
food as described in the below cited legislation and standards.

EU

The below listed regulations represent harmonised EU legislation and are directly applicable in all EU-
member states. National legislation implementing such regulations is therefore not separately cited in
this document.

We would like to stress that this product is a Plastic Intermediate Material as defined in chapter 4.3.1.
of Union Guidance on Regulation (EU) No 10/2011 on plastic materials and articles intended to come
into contact with food as regards information in the supply chain, from 28.11.2013. Therefore this
confirmation is restricted to the requirements as applicable for Plastic Intermediate Materials used for
the manufacturing of materials and articles or components of articles intended to come into contact with
food.

 Commission Regulation (EC) No 1935/2004. The organoleptic characteristics of food contact

materials are influenced by converting conditions, time and temperature of storage and type of
food, therefore compliance with article 3, §1,c must be verified and tested by the producer of the
final packaging material.
 Commission Regulation (EU) No. 10/2011 as amended. All used monomers and additives are
listed in Annex I of this regulation. For any applicable restrictions see chapter “migration
testing”.
 Commission Regulation (EC) No. 2023/2006. This material has been manufactured in
accordance with the relevant requirements of good manufacturing practice for materials articles
intended to come into contact with food, as described in more detail in the Borealis statement
“Food hygiene demands and standards”.
 Commission Regulation (EC) No. 1895/2005 - BADGE, NOGE and BFDGE are not used for the
production of this grade.
 Commission regulation (EC) No. 450/2009 on active and intelligent materials and articles is not
applicable to Borealis' polymer resins.

Additional national legislation in EU-member states (as amended to date)

Polymerisation production aids, aids to polymerisation, colorants and solvents, if not already listed in
Annex I of Regulation (EU) No. 10/2011 can be used based on their national approval and are subject
to mutual recognition. The process chemicals used for the manufacturing of this grade are permitted by

Borealis AG | Wagramer Strasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

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at least one of the following national regulations/recommendations, or are to be deemed safe based on
a risk assessment conducted in accordance with article 19 of Regulation (EU) No. 10/2011.

France Décret No. 2007-766 du 10 mai 2007 portant application du code de la

consommation en ce qui concerne les matériaux et les objets destinés à entrer en
contact avec les denrées alimentaires, as amended and the French DGCCRF
guidelines on food contact plastics.
Germany BfR-Empfehlung
VII Polypropylen, Stand 01.09.2017
The Netherlands Verpakkingen- en Gebruiksartikelenbesluit, 2014 (Warenwet), Deel A, Hoofdstuk
1, Kunststoffen, as amended (last update from 26.10.2016)

Europe (Non-EU-countries)

Norway Sosial- og helsedepartementets forskrift 1993-12-21-1381 - as amended

(referring to Regulation EU No. 10/2011)
Switzerland Verordnung der EDI über Bedarfsgegenstände vom 16.12.2016 (817.023.21) ;
Stand 01.05.2017, 5. Abschnitt: Bedarfsgegenstände aus Kunststoff

World

Brazil ANVISA RDC nº 56 /2012 - lista positiva de monômeros

(Brazilian implementation of RES 02/12)
ANVISA RDC nº 17/2008 - Lista Positiva de Aditivos
(Brazilian implementation of RES 32/07)
China GB9685-2016 - National standard on the use of additives in food containers and
packaging materials
GB 4806.1-2016 - National standard on general safety requirements for materials
and articles in food contact - so far applicable to polymer resins.
GB 31603-2015 General Hygienic Standard for Production of Food Contact
Materials and Articles - This material has been manufactured in accordance with
the relevant requirements of good manufacturing practice for materials articles
intended to come into contact with food, as described in more detail in the Borealis
statement “Food hygiene demands and standards”.
GB 4806.6-2016 - National standard on plastic resins for food contact use -
Appendix A - 29 Propylene-copolymer - no co-monomers with SML used
Mercosur MERCOSUR/GMC/RES. Nº 02/12 - Lista positiva de monomeros
MERCOSUR/GMC/RES. Nº 32/07 - Lista positiva de aditivos
USA FDA, CFR, Title 21,
177.1520 (a)(3)(i)(c)(1), (b) and (c)3.1a Olefin polymers

Limits of use (FDA) Test samples made from this product fulfilled the extraction requirements
according to FDA CFR 21 §177.1520 (c), as defined for the type of polymer
described above. Therefore this product may be used in contact with all food types

Borealis AG | Wagramer Strasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

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as described in table 1 of CFR 21 §176.170(c), under conditions of use C through

G as described in table 2 of CFR 21 §176.170(c). The product is not intended
for use in packing or articles holding food during cooking. It is the
responsibility of the converter or food packer to control that the final
packaging complies with the requirements of the intended and foreseeable
conditions of use.

Migration limits and testing

Migration limits The product contains traces of Aluminium, which is regulated with a specific
migration limit in EU (Commission Regulation 10/2011; Article 6.3.a and Annex II)
and Switzerland (Bedarfsgegenständeverordnung 817.023.21, Anhang 2.3.1); (1
mg/kg expressed as Al). Representative worst case tests (3% acetic acid;
4h/100°C; S/V-ratio 6) did not show any migration above 0,04 mg/kg.

The product may contain a residual component from the catalyst system which is
regulated with a specific migration limit in EU. Migration tests in 95% Ethanol for
10 days at 60°C showed a migration level significantly below the SML, so when
applying a standard surface volume ratio of 6, this SML cannot be exceeded under
any forseeable conditions of use. For more details pls. ask your Borealis sales
contact.

Other used monomers and additives are not regulated with specific migration
limits.

Substances also authorised as direct food additives ("Dual use additives") are
either not used for the manufacturing of this product, kind of not migrating, or only
present in quantities that in case of their migration don't allow relevant contribution
to exceed of the limits as set in the applicable food legislation.

Migration testing In accordance with article 12 of Commission Regulation (EU) 10/2011, article 12 of
Swiss ordinance 817.023.21 and article 2.12 of Chinese standard GB4806.1 the
overall migration shall not exceed 10 mg/dm² from plastic materials and articles,
with the exception for plastic materials and articles intended to contact infant or
child food (60mg/kg);(Mercosur GMC Res No. 56/92 - 8 mg/dm2 and 50 mg/kg
food).

A representative sample from this or a comparable material, tested for 2d at 20°C

in isooctane (1 mm plate / total immersion) did not exceed the limit of 10 mg/dm²
for overall migration. This test result is only valid for orientation purposes but must
not be used to confirm legal compliance of the finished article.

Compliance with the overall and specific migration limits as described above must
be measured from the final packaging intended to come into contact with foodstuff
by using real food or appropriate food simulants at the intended and foreseeable

Borealis AG | Wagramer Strasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

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conditions of use as specified in Annex III of Commission Regulation (EU)

10/2011; Annex 4 of Swiss Ordinance 817.023.21; Chinese standard GB31604.8-
2016; Mercosur GMC Res No. 32/2010. It is the responsibility of the converter or
food packer to verify that the final packaging complies with the overall and specific
migration limits as set out by the applicable legislation.

Non-intentionally added substances - NIAS

Commission Regulation (EU) 10/2011 notes that not all contaminants and reaction products of authorised
monomers and additives can be listed in its Annex I. The identification of non-listed migrants may therefore not be
an exclusion criterion in itself. However, a toxicological evaluation of these migrants needs to be performed.

The major fractions of NIAS in Polyolefins are the oligomers, which are unavoidably formed during polymerisation
and cannot be removed. A recent joint study of polyolefin producers demonstrated that oligomers migrating from all
types of polyolefins only consist of linear and branched alkanes (POSH) and alkenes (POMH), no cyclic or aromatic
compounds were found. The toxicological assessment of such migrants concluded that they are sufficiently
characterised by the existing overall migration limit.

Further a variety of representative Borealis products, covering the whole Borealis product spectrum, was assessed
in relation to migrating NIAS by renowned test institutes. Beside oligomers the typical NIAS are reaction- and
decomposition products from antioxidants, many of them known as “Arvin-substances”. Another joint industry study
confirmed that none of these Arvin-substances are genotoxic and can therefore be rated at least as “Cramer-class
III”, allowing a daily consumption of 90 µg/person/day.

However, we wish to stress that a NIAS-assessment is subject to the finished food contact article and the formation
of NIAS is influenced by thermal and mechanical treatment during conversion, mixture with other substances and
the applied test conditions. A raw material screening therefore can never monitor all potential criteria.

Prepared by Borealis, Group Product Stewardship / Jürgen Emig

Borealis AG | Wagramer Strasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

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Disclaimer

To the best of our knowledge, the information contained herein is accurate and reliable as of the date of publication.

The legislation cited above applies to the final packaging which is intended to come or is brought into
contact with foodstuff. This statement however is restricted to the Borealis product as it leaves production.
It is the customers responsibility to verify compliance with applicable legislation of the final packaging
under actual and foreseeable conditions of use.

Borealis makes no warranties which extend beyond the description contained herein. Nothing herein shall
constitute any warranty of merchantability or fitness for a particular purpose.

No liability can be accepted in respect of the use of Borealis' products in conjunction with other materials. The
information contained herein relates exclusively to our products when not used in conjunction with any third party
materials.

Borealis AG | Wagramer Strasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

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