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14.5 Food Regulatory Approvals


PE-F series polyethylene hoses



PUR MHF series polyurethane hoses

Polyurethane hoses of the NORRES PUR MHF series, which are made from special, particularly high-quality raw materials, are perfectly suited for many applications in the food sector. This product series includes the following hose types among others:
  • PROTAPE® PUR 331 MHF
  • PROTAPE® PUR 330 MHF and PROTAPE® PUR VA 330 MHF
  • Special Hose PUR 335 MHF
  • AIRDUC® PUR 350 MHF
  • AIRDUC® PUR 351 MHF and AIRDUC® PUR VA 351 MHF
  • AIRDUC® PUR 355 MHF and AIRDUC® PUR VA 355 MHF
  • AIRDUC® PUR 356 MHF and AIRDUC® PUR VA 356 MHF
  • BARDUC PUR VA 382 MHF
  • CP PUR VA 455 MHF
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  • NORFLEX PUR 401 MHF
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These hose types have official legal and regulatory approvals for food applications from independent institutes and comply with many food industry guidelines.

Amongst other things, the material used for the hose wall has the following properties:

  • FDA compliance (US Food and Drug Administration):
    All raw materials and additives used (other than stabilisers) are listed in the FDA's Code of Federal Regulations, Title 21 §177.2600 ?Rubber articles intended for repeated use?, published on April 1, 2007. All antioxidants / stabilisers used are listed in §178.2010 ?Antioxidants and/or stabilisers for polymers?.
  • BfR (German Federal Institute for Risk Assessment, formerly BgVV):
    All monomers used in the manufacturing process are listed in the German Regulations on Commodities, published on December 23, 1997 (BGBI. 1998 I, p. 5), last amended on July 13, 2005 (BGBI. I, p. 2159).
    All monomer raw materials used are listed in Section 2 of the BfR?s Recommendation XXXIX, ?Commodities based on polyurethane?
  • EC Directive 2002/72/EC (formerly 90/128/EEC):
    All monomers used are listed in the Appendices to Directive 2002/72/EC in the version applicable following the latest amending Directive 2007/19/EC, published on March 30, 2007.
    All additives used (other than catalysts) are listed in the provisional lists of additives contained in Appendix III to Directive 2002/72/EC, recently amended by Directive 2007/19/EC. Catalysts are not regulated by EU Directives.


Furthermore, an official approval for the complete hose has been issued by an independent testing institute for all hoses marked with the glass / fork symbol, the EU?s official food logo, in accordance with EU Directive 2002/72/EC, including the latest amending Directive 2007/19/EC. These hoses can be recognised by the following symbol on the data sheets:



The analyses carried out by an independent testing laboratory show that these product series meet the requirements of EU Directive 2002/72/EC, including the amending Directive 2007/19/EC (which replaces Directive 90/128/EEC and its amendments), relating to ?Synthetic materials and articles that come into contact with food? as well as the German Regulations on Commodities for food contact materials. Please note the official test certificate.
The food and food groups listed in EU Directive 85/672/EEC and Method B 80.30-2 of the Official Methods of Analysis according to §35 LMBG require no migration testing and may therefore come in contact with these products.

(Note: None of the directives for food contact cited above, which are based on EU Directive 2002/72/EC, mention limitations on the residual content of individual components of synthetic materials. However, it should be noted that EU Directive 2002/72/EC, which applies to all EU member states, sets a limit value of 10 mg/dm² for the overall constituent migration in synthetic products for food sector use. Even if, as in this case, an official statement is available from the manufacturer, these tests should nevertheless be performed on the end product by the processor according to EU Directive 2002/72/EC in contact with the corresponding foods or food simulation materials. The measurement time and temperatures should be chosen to reflect actual conditions during the normal use of the articles, in accordance with the rule laid down in EU Directives 97/48/EC ? Amendment to 82/711/EEC ? and 85/572/EEC. It is the responsibility of the processor to ensure that the article is suitable for its intended purpose. We advise against continuous use at temperatures higher than 40°C as well as pasteurisation in hot steam.)

PUR-MHF-AS series polyurethane hoses

The polyurethane hoses in the NORRES PUR-MHF series, which are made from special, particularly high-quality raw materials, are perfectly suited for many applications in the food sector. This product series includes the following hose types, amongst others:
  • BARDUC PUR-VA 382 MHF-AS
  • AIRDUC® PUR 351 MHF-AS
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PE-F series polyethylene hoses

Polyethylene hoses of the NORRES PE-F series, which are made from special, particularly high-quality raw materials, are perfectly suited for many applications in the food sector. This product series includes the following hose types among others:
  • PROTAPE® PE 322 F
  • AIRDUC® PE 362 F
The raw material used for the wall of these hose types has official legal and regulatory approvals for food applications from independent institutes, complies with many food industry guidelines and can also be used with certain restrictions in the medical sector. Amongst other things, the material used for the hose wall has the following properties:
  • FDA compliance (US Food and Drug Administration):
    The material complies with FDA 21 CFR 177.1520(c)3.2a, published on April 1, 2002, and meets the extraction limit values of the BPF/BIBRA as described in ?Polymer Specification 4, ITEM 4, Polymer Category 1.3? (2.6% in n-hexane and 30% in xylene). These FDA and BPF/BIBRA regulations govern the use of synthetic materials in articles intended for cooking food. The statement only refers to extraction limit values, not to the products? physical suitability for use.
  • BfR (German Federal Institute for Risk Assessment, formerly BgVV):
    The material meets the requirements of the Eighth Amendment to the German Regulations on Commodities (BedGgstV), published on December 21, 2000, Appendix 3 Section A and Appendix 3a, including the Appendices to BedGgstV published on April 7, 2003, Appendix 3.
    In addition, it complies with BfR Recommendation III, published on April 1, 2004.
  • EC Directive 2002/72/EC (formerly 90/128/EEC):
    EU Directive 2002/72/EC, Appendix II Section A and Appendix III (6.8.2002) + EU OJ (February 13, 2003), including the latest amending Directives 2005/79/EC, published on November 18, 2005 (applies to all member states)
    (Note: Directive 90/128/EEC and its amendments, Directives 92/39/EEC, 93/9/EEC, 95/3/EC, 96/11/EC, 1999/91/EC, 2001/62/EEC and 2002/17/EC, have been repealed and replaced by Directive 2002/72/EC.)

(Note: None of the directives for food contact cited above, which are based on EU Directive 2002/72/EC, mention limitations on the residual content of individual components of synthetic materials. However, it should be noted that EU Directive 2002/72/EC, which applies to all EU member states, sets a limit value of 10 mg/dm² for the overall constituent migration in synthetic products for food sector use. Even if, as in this case, an official statement is available from the manufacturer, these tests should nevertheless be performed on the end product by the processor according to EU Directive 2002/72/EC in contact with the corresponding foods or food simulation materials. The measurement time and temperatures should be chosen to reflect actual conditions during the normal use of the articles, in accordance with the rule laid down in EU Directives 97/48/EC ? Amendment to 82/711/EEC ? and 85/572/EEC. Furthermore, specific migration limits (SML) are imposed in EU/EFTA member states on certain individual components of the synthetic material used. It is the responsibility of the processor to ensure that the article is suitable for its intended purpose.)


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Engineering modifications subject to change.

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