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Page 1: BAYFERROX - my.spareparts.live
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NSF_WRAS block
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BAYFERROX®, CHROME OXIDE GREEN and COLORTHERM® pigments for coloring plastics used in food-contact applications

Edition: 2005-07-19 Replaces edition of: -- Page 1 of 4

General

Plastics which are used to make articles which come into brief contact with foods or packaging materials which have long-term contact with foods must satisfy a series of requirements relating to health hazards arising from any contamination of the food by constituents of the plastic. European Directive 2002/72/EG (August 2002), last amended by RL 2004/19/EG (March 2004) defines the principles for this. An appendix to this Directive lists monomers and additives which are approved for plastics used in food-contact applications. The Synoptic Document also lists evaluated monomers and additives approved for articles used in food-contact applications. However, this docu-ment is not a positive list for colorants for articles used in food-contact applications. The additive section includes some pigments such as titanium dioxide and iron oxides but only because these can also be viewed in their wider context as extenders.

As there is no European Directive covering colorants for articles used in food-contact applications, national regulations apply. It is unlikely that a European Directive will come into force for some years yet. The basis for such a Directive may be Council of Europe Resolution AP (89) 1. This largely concerns the ban on the visual migration of colorants, which is of significance for organic pigments and dyes, and the soluble con-tent of certain heavy metals and aromatic amines in the pigments used.

Regulations governing colorants

In various European countries, the use of inorganic pigments is governed by threshold values for their soluble content of certain elements. In Japan, absolute values are specified.

Colorants which satisfy these requirements may be used to color plastics for food-contact applications. In France, Japan and the USA, it must also be borne in mind that the chemical substance forming the basis of the colorant must be included in a posi-tive list or must be proven not to migrate into foods. The legislation and regulations valid in the individual countries are summarized in Table 1.

Note: The information given is based on available knowledge and experience (07/2005).

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BAYFERROX®, CHROME OXIDE GREEN and COLORTHERM® pigments for coloring plastics used in food-contact applications

Edition: 2005-07-19 Replaces edition of: -- Page 2 of 4

Table 1: National regulations on the purity requirements for pigments used to color plastics for food-contact applications

Australia

Australian Standard 2070.6 (1984)

European Union (Council of Europe)

Resolution AP (89) 1 on the use of colorants in plastic materials coming into contact with food. (The requirements correspond with those of BfR Recommendation IX.)

Germany

Recommendation IX of the Federal Institute for Risk Assessment (BfR) dated 1994-06.01. Ordinance on Articles for Food-Contact Applications dated 1997-12-23, pub-lished in the Federal Gazette 1998, Part 1, No. 1, issued on 1998-01.07 last amended on 2004-03.22 (BGBI I 2457)

Belgium

Koninklijk Besluit dated 11.5.1992; Warenwetgeving (1), aanvulling nr. 18 - September 1992

France

Circulaire 176 dated 2.12.1959, published in the Journal Officiel of 30.12.1959 incl. amendments. The colorants must not only comply with the purity requirements of the Resolution AP (89) 1, but also be included in the positive list.

Netherlands

Warenwet/Regeling Verpakkingen - en gebruiksartikelenbesluit; Uitvoeringsvoorschrif-ten CIII-55, entered into force on 21.8.1991.

As well as defining the content of soluble heavy metals in pigments, this regulation specifies maximum permissible migration values for the pigmented articles.

United Kingdom

Plastics for food contact applications, a code of practice for safety in use: BPF in con-nection with BIBRA, revised edition 1986.

Like BfR Recommendation IX, this code does not have the force of law. However, processors view it as binding.

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BAYFERROX®, CHROME OXIDE GREEN and COLORTHERM® pigments for coloring plastics used in food-contact applications

Edition: 2005-07-19 Replaces edition of: -- Page 3 of 4

Table 1: continuation

Italy

Decreto Ministeriale dated 21.3.1973, published in Gazetta Uffiziale No. 104 of 20.4.1973; last amendment in Decreto Ministeriale No. 338 of 22.7.98.

Spain

Resolucion dated 4.1L1982 (BOE 282 of 24.11.1982) in accordance with Article 5 of Royal Decree 211/1992 of March 5, 1992. All colorants are permitted which conform with the migration values defined in Appendix III of the Resolucion. Pigments used in foodcontact applications must be notified to the Health Ministry. All Bayferrox pig-ments which satisfy BgVV Recommendation IX can be used in Spain.

Special cases

USA

The use of pigments for coloring plastics for food-contact applications is regulated by the Code of Federal Regulations 21 “CFR 21). For this application iron oxide and chrome oxide – besides other approved substances - are listed in FDA (“Food and Drug Administration”) § 178.3297 (Colorants for Polymers). In some cases limitations of use are mentioned.

Japan

Since 1977, Japan has maintained a positive list for colorants which can be used in plastics for food-contact applications. It is issued by the Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA) and, strictly speaking therefore, is not a legal requirement.

A further prerequisite for the use of colorants is that they contain no more than 100 ppm lead, 50 ppm arsenic, 50 ppm mercury and 100 ppm cadmium. These require-ments are satisfied with few exceptions by our inorganic color pigments (see Table 2).

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BAYFERROX®, CHROME OXIDE GREEN and COLORTHERM® pigments for coloring plastics used in food-contact applications

Edition: 2005-07-19 Replaces edition of: -- Page 4 of 4

Tabelle 2: Coloring food packaging and other articles for food-contact applications with inorganic color pigments of LANXESS

Bayferrox Resolution AP (89)

Aus-tralia

Germany Belgium United Kingdom

France Nether-lands

Italy Spain Japan USA

110-180,110 M-180 M X X X X X X X X X - X 1) 303 T

- - - - - - - - - - X 2) 306-318,318 M X X X X X X X X X - X 1) 415, 420,1420, 1420 M, 3420, X X X X X X X X X

X excl. 415 X 1)

600-686,ohne 645 T X X X X X X X X X - X 1) 645 T

X X X X X X X X X - - 910-943 3905 -3920 X X X X X X X X X X X 1) 960

X X X X X X X X X - X 1) Chromoxid-grün

Resolution AP (89)

Aus-tralia

Germany Belgium United Kingdom

France Nether-lands

Italy Spain Japan USA

alle Typen X X X X X X X X X X X 3)

Colortherm Resolution AP (89)

Aus-tralia

Germany Belgium United Kingdom

France Nether-lands

Italy Spain Japan USA

Black 303 T - - - - - - - - - - X 2)

Brown 645 T X X X X X X X X X - X 2)

Green GN, GN-M, GX X X X X X X X X X X X 3) Red 110-180

X X X X X X X X X - X 1) Red 520

X X X X X X X X X - X 1) Yellow 10

X X X X X X X X X X X 1) Yellow 20

X X X X X X X X X X - Yellow 30

X X X X X X X X X X X 2) Yellow 3950

X X X X X X X X X X X 2)

x approved without restriction x 2) In compliance with applicable FDA-regulations for use at 2 % or less in polymers and resins having food-contact end-uses subject to these

x 1) According to § 178.3297 limitations and any other applicable regulations.

x 3) For plastics with food contact application up to a concentration of 5 % with the following exceptions: - olefin polymers according to § 177.1520- rubber articles for multiple use according to § 177.2600, concentration not more than 10 %

NB: This information and our technical advice - whether verbal, in writing or by way of trials - are given in good faith but without warranty, and this also applies where proprietary rights of third parties are involved. Our advice does not release you from the obligation to check its validity and to test our products as to their suitability for the intended processes and uses. The applica-tion, use and processing of our products and the products manufactured by you on the basis of our technical advice are beyond our control and, therefore, entirely your own responsibility. Our products are sold in accordance with our General Conditions of Sale and Delivery.

LANXESS Deutschland GmbH Business Unit Inorganic Pigments D-51369 Leverkusen

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C0099509

Note: Additions shall not be made to this document without prior evaluation and acceptance by NSF International.

NSF International

789 N. Dixboro Road, Ann Arbor, Michigan 48105-9723 USA1-800-NSF-MARK / 734-769-8010

www.nsf.org

1 of 2

OFFICIAL LISTING

NSF International Certifies that the products appearing on this Listing conform to the requirements of

This is the Official Listing recorded on April 25, 2012.

Sintoil SrlVia Monte Rosa 320149 MilanoItaly

NSF/ANSI Standard 51 - Food Equipment Materials

39 02 9679 9075

Facility: Solaro, Italy

EPDM for Food Zone[1]

EPM for Food Zone[1]

Maximum TemperatureTrade Designation Color Type of food of Use in °F

F3610 - EPDM ALL

F3615 - EPDM ALV

Black

Aqueous acidic 

Aqueous non-acidic 

Dry solids 

212°

Black

Aqueous acidic 

Aqueous non-acidic 

Dry solids 

212°

Black

Aqueous acidic 

Aqueous non-acidic 

Dry solids 

212°

Black 212°

Black 212°

Alcohol greater than8% 

Alcohol less than orequal to 8% 

Bakery products withno free fats or oilson surface 

Alcohol greater than8% 

Alcohol less than orequal to 8% 

Bakery products withno free fats or oilson surface 

Alcohol greater than8% 

Alcohol less than orequal to 8% 

Bakery products withno free fats or oilson surface 

All food contacttypes

All food contacttypes

F3602 - EPDM AL60/65

F3603 - EPDM AL70/75

F3604 - EPDM AL80/85

Page 9: BAYFERROX - my.spareparts.live

C0099509

Note: Additions shall not be made to this document without prior evaluation and acceptance by NSF International.

NSF International

789 N. Dixboro Road, Ann Arbor, Michigan 48105-9723 USA1-800-NSF-MARK / 734-769-8010

www.nsf.org

2 of 2

Fluoroelastomer for Food Zone[1]

NBR for Food Zone[1]

E3104 - EPM PX

S8105 - GMS

T7118 - FKM A75/80

G4007 - NBR 60 US

Black

Aqueous acidic 

Aqueous non-acidic 

Dry solids 

275°

Natural 275°

Green 250°

Black

Aqueous acidic

Aqueous non-acidic

Dry solids

250°

Natural 212°

Black

Aqueous acidic 

Aqueous non-acidic 

Dry solids 

212°

Alcohol greater than8% 

Alcohol less than orequal to 8% 

Bakery products withno free fats or oilson surface 

All food contacttypes

All food contacttypes

Alcohol greater than8%

Alcohol less than orequal to 8%

Bakery products withno free fats or oilson surface

All food contacttypes

Alcohol greater than8% 

Alcohol less than orequal to 8% 

Bakery products withno free fats or oilson surface 

T7117 - FKM A75/80VR

G4023 - NBR Al 75/80

This material is only acceptable for repeated use.[1]

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