NSF International Nonfood Compounds Registration Program Steering Committee Meeting Update: ISO Standard for Incidental Contact Lubricants

ISO ICL Standard Update  Safety of Machinery – Hygiene Requirements for the use and handling of lubricants with Incidental Product Contact  ISO TC 199 WG2

ISO ICL Standard Update  Still a draft standard  Scope: Similar to NSF 116  No category codes (“H1”, “H2”, etc.)  Only “ICL”  Includes criteria for ingredients  Includes criteria for GMP in mfr and use

ISO ICL Standard Update  Last WG meeting: June 2002, London  Removed 21 CFR as normative criteria  Pressure from France and Sweden only  21CFR: 20+ years world-wide acceptance  21 CFR already accepted internationally  Reliance by Asian, SA, NA, EU, other countries  “21 CFR”, “H1” cited/marketed internationally by ~all manufacturers

ISO ICL Standard Update If 21 CFR not sole source criteria:  Confusion in marketplace  Introduction of ISO-compliant products not accepted by some countries  Standard based on incomplete sources, not what is in-use

ISO ICL Standard Update Discussion Should the ISO standard reference US FDA 21 CFR as its sole source for criteria for assessing ICL ingredients?

ISO ICL Standard Update Next ISO TC 199 WG2 meeting:  Paris, Oct 7-8, 2002  Deadline for comments on draft:  Sept 19, 2002 (extension requested)  Recommendations of the NSF Nonfood Compounds Steering Committee???