Draft Proposal for Certification of Food grade Lubricants Submitted to NSF Steering Committee October 8 2004 Kenji Yano Ph D Program Mana

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Draft Proposal for Certification of Food grade Lubricants Submitted to NSF Steering Committee October 8 2004 Kenji Yano Ph D Program Mana Powered By Docstoc
					Draft Proposal for Certification of
      Food-grade Lubricants

Submitted to NSF Steering Committee
           October 8, 2004

           Kenji Yano, Ph.D.
           Program Manager
           NSF International
I. Introduction
The 10/21/2003 NSF Annual Steering Committee meeting and the subsequent 4/22/2004 NSF Steering
Committee Working Group conference call discussed an industry proposal to develop an optional third-
party certification program for incidental food contact lubricant (H1 lubricant). The current NSF H1
listing program, a re-introduction of the previous USDA H1 authorization program, solely relies on one-
time formulation review. As a result, NSF registration letters posted on the NSF Web site
(www.nsfwhitebook.org), which show the original registration issuance dates, are not routinely updated.

The ISO 65 Guide defines product certification as having surveillance activity in standard conformity
evaluation. Periodic sample checks, for example, can be used to verify that an H1 lubricant is consistent
with the certified formulation (Product Certification). Product certification may also be linked to a
quality management system (e.g. ISO 9000) to increase confidence in the system that controls reliable
production of H1 lubricant.

Apart from product certification, manufacturers may be required to demonstrate that they satisfy process-
based food safety criteria such as Hazard Analysis and Critical Control Point (HACCP), the codex-based
food safety risk management. There are also guidelines in place for manufacturers to develop such
internal processes (e.g. CODEX Alimentarius Basic Texts on Food Hygiene, EHEDG Guidelines Doc. 23
Production and Use of Food-grade Lubricants). Methods available to demonstrate that the process is
appropriate may include, but not limited to:
         (1) Direct audit by customer of lubricant manufacturers,
         (2) Inclusion in the procedure or policy of a quality management system (e.g. ISO 9000),
         (3) Independent Good Manufacturing Practice (GMP) registration or HACCP registration of a
             dedicated manufacturing process by a third party organization,
         (4) Combination of GMP / HACCP registration and ISO-9000 (e.g. HACCP-9000®).

At these meetings, it was pointed out that one of the benefits of product certification is that it enhances
reassurance about the quality of lubricants. However, concerns were expressed regarding the potentially
high costs of certification. International variance in the level of demands for certification was also
mentioned. Based on these considerations, NSF has drafted the following proposal for an optional
product certification program for H1 lubricant.

II. Proposal for product certification
NSF proposes to develop a simple, low-cost product certification program for H1 lubricant compatible
with quality management systems and other food safety risk management processes used by

    • Optional (in addition to existing H1 listing program)
    • Periodic infrared (IR) analysis of sample and IR spectrum review vs. original data
    • Periodic formulation / label check vs. original information submitted
    • Sample collected by mail
    • Certification to both H1 and ISO 21469 criteria available

   • Enhanced customer reassurance about the quality of lubricant
   • Enhanced confidence of a quality management system used
   • Updated online certification letter (www.nsfwhitebook.org)
   • Use of certification logo (to be determined)
Estimated costs (volume discounts available)*
    • IR analysis: $125 / sample (sample mailing cost not included)
    • Formulation / label check and IR spectrum review: $150 / product

    * Subject to change depending on the requirements set forth by the technical standard.

Technical standard requirements (must be developed by the NSF Steering Committee)
   • Sample collection method
   • Number of samples required / analysis
   • Frequency of surveillance check
   • Private labels (re-brand) certification

III. Additional process / system registration
The following options are not part of the proposed product certification. These services can be offered
upon request. Registered facilities will be listed on the NSF Web site.

Food safety risk management process registration
   • GMP evaluation to EHEDG Guidelines Doc. 23 (3.2.1 Raw Materials, 3.2.2 Production,
       3.2.3 Distribution, 3.2.4 Management)

         Application fee:                                 $600
         Initial audit:                                   $1,200 / day, plus expenses:
                                                                  (1 day - less than 150 employees)
                                                                  (2 days - greater than 150 employees)
         Annual re-audit:                                 $1,200 / day, plus expenses: 1-2 day
         Annual listing:                                  $650
         Total cost / year                                $3,650 – 5,400

         Quotes are based on number of employees.

    •    HACCP evaluation to CODEX Alimentarius Basic Texts on Food Hygiene

         Application fee:                                 $600
         1-day off site document review                   $1,200
         2-day pre-audit                                  $2,400 ($1,200 x 2)
         4.5-day registration audit                       $5,400 ($1,200 x 4.5)
         Annual listing                                   $650
         Total cost / year                                $10,250

ISO 9000 quality management system registration
       Application fee:                       $600
       Surveillance audit (2 days per year)   $2,400 ($1,200 x 2)
       Annual listing                         $650
       Total cost / year                      $3,650

         Total time spent on the audits is determined by NSF’s accreditation body and generally based on
         the number of employees. Reductions may apply under specific circumstance.

October 8, 2004/KY

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