PUR MHF series polyurethane hoses

• PROTAPE^® PUR 330 MHF and PROTAPE^® PUR-INOX 330 MHF
• PROTAPE^® PUR 331 MHF
• PROTAPE^® PUR 335 MHF FLAT
• AIRDUC^® PUR 350 MHF
• AIRDUC^® PUR 351 MHF and AIRDUC^® PUR-INOX 351 MHF
• AIRDUC^® PUR 355 MHF and AIRDUC^® PUR-INOX 355 MHF
• AIRDUC^® PUR 356 MHF and AIRDUC^® PUR-INOX 356 MHF

• NORFLEX^® PUR 401 MHF
• NORFLEX^® PUR 441 MHF
• CP PUR-INOX 455 MHF
• BARDUC^® PUR-INOX 382 MHF

These hose types have official legal and regulatory approvals for food applications from independent laboratories, comply with numerous 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 (US Food and Drug Administration) conformity:
  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, 2009. All antioxidants / stabilisers used are listed in § 178.2010 &ldquot;Antioxidants and / or stabilisers for polymers”.
• BfR (German Federal Institute for Risk Assessment):
  All monomers used in the manufacturing process are listed in the version of the German Regulations on Commodities published on December 23, 1997 (BGBI. 1998 I, p. 5) and last amended on September 23, 2009 (BGBI. I, p. 3130). All raw materials used are listed in BfR Recommendation XXXIX, “Commodities based on polyurethane”, under No. 2.1, Category 1.
• EU Directive 2002/72/EC:
  All monomers used are listed in the Annexes to Directive 2002/72/EC in the version applicable following the latest amending Directives 2007/19/EC and 2008/39/EC, as well as in EU Directive 975/2009.
  All additives used (other than catalysts) are listed in Annex III to Directive 2002/19/EC, recently amended by Directives 2007/19/EC and 2008/39/EC, as well as in EU Directive 975/2009 in Annex 3a of the German Regulations on Commodities and / or Synoptic Document N.7 (with a classification in SCF lists 0 to 3). Catalysts are not regulated by EU Directives. (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its amendments, Directives 92/39/EEC, 93/9/EEC, 95/3/EC, 96/11/EC, 1999/91/EC, 2001/62/EEC and 2002/17/EC, have been repealed and replaced by Directive 2002/72/EC.)

Furthermore, an official approval for each complete hose has been issued by an independent testing laboratory in accordance with EU Directive 2002/72/EC, including the latest amending Directives 2007/19/EC and 2008/39/EC, as well as with EU Directive 975/2009. As a result of this, we are entitled to include the EU's official food logo – the glass / fork symbol – on these hose types. The icon shown opposite is used to identify these hoses in the data sheets:

Analyses carried out by an independent testing laboratory show that these product series meet the requirements of the latest EU Directive 2002/72/EC, including the amending Directives 2007/19/EC and 2008/39/EC, as well as EU Directive 975/2009 (which replaces Directive 90/128/EEC and its amendments) relating to “Synthetic materials and articles intended to come into contact with food” and 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 into 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 an article is suitable for its intended purpose.)

PE-F series polyethylene hoses

• PROTAPE^® PE 322 F
• AIRDUC^® PE 362 F

• FDA (US Food and Drug Administration) conformity:
  The material complies with the regulations of the US Food and Drug Administration for food contact substances (FCN) and is the result of a premarket notification (FCN741) dated September 28, 2007. This notification permits the use of this material in contact with all food types under conditions A to H, as described in Table 2 of the FDA CFSAN information on Food Additive Safety, April 2006, "Definitions of Food Types and Conditions of Use for Food Contact Substances". All auxiliaries used in the manufacture of the polyolefin copolymers cited here comply with the requirements and limit values specified in 21 CFR 177.1520(c), item 3.1 or 3.2.
• BfR (German Federal Institute for Risk Assessment, formerly BgVV):
  BfR Recommendation III, published June 1, 2007 (Note: Monomers and additives listed in the German Regulations on Commodities (“Bedarfsgegenständeverordnung”), as amended, are no longer listed in “Recommendation III”.)
• EU Directive 2002/72/EC (formerly 90/128/EEC):
  EU Directive 2002/72/EG, Annex II, Sections A+B, and Annex III (August 6, 2002) + EU-OJ (February 13, 2003), including the amending Directives: 2004/1/EC (January 6, 2004), 2004/19/EC (March 1, 2004), 2005/79/EC (November 18, 2005), 2007/19/EC (April 2, 2007), 2008/39/EC, 975/2009 (October 19, 2009).

(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 an article is suitable for its intended purpose.)