Update on ISO21469 Foodgrade lubricants

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Update on ISO21469Food-grade lubricants
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Global Awareness

• Benefit of using food-grade lubricant is not yet
  widely recognized
• NSF global outreach seminars
• Global awareness could be promoted through an
  international standard

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Draft ISO 21469 Background

• Following the end of the USDA program, a need was
  recognized for an international standard to be
  developed in this area.
• ISO TC199/WG2 meeting (March 14, 2005)
• Recommend to TC199 that 21469 goes to formal vote
  as joint ISO/CEN documents
• NSF is requesting to be the US administrator of
  the standard

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ISO 21469 Scope

• Hygiene requirements for the formulation,
  manufacture, use and handling lubricants, which
  may come into incidental contact with products
  (food, drugs etc.)
• Linked to the machinery directive 89/392
• Registration criteria that can be used to assess
  conformance registration by ISO IEC guide 65 (EN
  45011) accredited organization

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Hygiene measures basic strategy

• Identify the product/process with which the
  lubricant is to be associated
• Identify hazards (biological, chemical, physical)
• Risk assessment for each hazard identified
• Design methods to reduce risks (corrective
  preventive actions)
• Verify the effectiveness of the risk reduction
  method

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Risk assessment

• Contamination of the lubricant by
• packaging materials
• biological factors
• the product
• water
• Service age
• Chemical/physical changes
• Reasonably foreseeable misuse

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Hygiene design

• Lubricants shall be composed in such a way that,
  if cross-contamination occurs, residues in the
  processed products are innocuous supported by
  H1 registration
• Lubricants shall meet the qualitative and
  compositional requirements by Governments or
  other recognized international organizations
• Good Manufacturing Practice to avoid
  contamination

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ISO 21469
ISO 9000
ISO 21469
H1 Reg.
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ISO 21469 Adoption

• The potential of US adoption is disputed
• National regulation (CFR 178.3570) already exists
  
• Hygiene measures covered by HACCP
• Standard could be adopted by other countries