2004 elgi agm (nsf)
TRANSCRIPT
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Food-grade Lubricants
2004 ELGI AGMMay 16 18Nice, France
Kenji Yano, PhD
NSF International
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NSF International
Created within Univ. of Michigan in 1944
Third party, NGO, NPO
Accredited by ANSI and SCC
Standards development and product certification Management system registration
WHO Collaborating Centre for food, water and
environmental safety
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Compounds Used in Meat / Poultry Plants
Pre-processing compounds (Proprietary Substances)
Fruit / vegetable washes, etc.
Products used in and around food processing facilities(nonfood compounds)
Lubricants, water treatment chemicals,
cleaners, etc.
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End of USDA Regulation
1998 USDA ends compounds authorization
1999 NSF introduces a voluntary program
under the advice of USDA
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USDA Requirements
1998 -USDA authorization
-Self-certification-Third party registration
2001 -USDA authorization should not beused
-Self-certification
-Third party registration
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NSF Listing Policy
1999 List all USDA authorized products
2000 Begin listing new products via NSF registration
2002 Steering Committee recommendssunset for all USDA authorized products
2004 Sunset
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2004 NSF Listing
4800 products listed
480 companies listed
E-White Book (June 2004)
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NSF Listing Website
5000 6000 visits / month
190 visits / day 9 min / visit
35000 hits / month
1200 hits /day
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Product Categories 1998 vs. 2003
2003
H
Lubricants
(12) Water Treatment
(16)
Cleaners
(37)
1998
(33)
(18)
(23)
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Product Categories NSF Registered
2004
(56)
(11)
(10)
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Number of Listed Products
0
2000
4000
6000
8000
10000
12000
14000
16000
2001 2002 2003 2004 2005 2006
H
G
A
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H1 Registration
21 CFR 178.3570
Generally Recognized As Safe (GRAS)
2700 products listed
250 companies listed
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HX-1 Registration
USDA reviewed but did not list raw materials
HX-1 covers raw materials
Registration based on 21 CFR 178.3570 and GRAS
Raw materials not listed in CFR must be FDAapproved prior to HX-1 Registration
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Raw materials not listed in CFR
FDA Letter of Opinion (LOO)
Affirmation of GRAS
Threshold of Regulation (TOR)
Food Contact Notification (FCN)
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Antimicrobial food grade lubricants
Dual regulatory hurdles (if marketed in US)
Must comply with 21 CFR 178.3570
EPA registration required
EPA-registered antimicrobials could be FDA approved LOO
GRAS
TOR
FCN
Risk assessment required
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HT-1 Registration
Incidental food contact heat transfer fluids
USDA listed under P1 (miscellaneous)
Registration based on 21 CFR 178.3570, part 172
(direct food additives) or GRAS
Immersion/spray type must conform to part 172 or
GRAS
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H2 Registration
Must conform to NSF Guideline 5.1
No carcinogens, mutagens, teratogens, mineral acids
No odorous substances
No intentionally added heavy metals
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Proposed Certification Scheme
October 2003 NSF steering committee meeting
Proposal: optional certification with surveillance
Sub-committee group created to study the proposal
April 22 meeting summary available
Straw man proposal to be developed
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ISO Standard
NSF participates on the ISO TC Work Group
NSF requesting to be the standards development
organization to administer the US adoption of the
standard
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International Collaborations
Australian Quarantine Inspection Agency (AQIS)
Canadian Food Inspection Agency (CFIA)
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Collaboration with USDA
NSF will launch a registration program for compounds
used for processing shell eggs identified with theUSDA grademark
Coating oils
Stamping inks
Non-synthetic food additives (organic food processing)
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EPA Antimicrobial Division
Agreement reached to permit NSF Registration Mark
on EPA registered antimicrobial product labels
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EPP Standard Development
EPP: Environmentally Preferable Products
EPA funded standard development
Product Development Process Environmental
Management System (PDP-EMS)
Risk assessment throughout product life cycle
Non-prescriptive product standards (no pass / fail)
Focus on continual development
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EPP Background
Executive Order 13101, Greening the Government
Through Waste Prevention, Recycling, and FederalAcquisition (1998)
EPA to develop guidance for governmentalpurchasing of products and services
NSF received grant to evaluate potential fordevelopment of voluntary consensus standards
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What is EPP?
Products that have a lesser or reduced effect on
human health and the environment when comparedto competing products that serve the same purpose
The product comparison may consider research anddevelopment, raw materials acquisition, production,
manufacturing, packaging, distribution, reuse,
operation, maintenance, or disposal. (EO 13101,Section 201)
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Goals of Standard
Ensure that manufacture has a continuously
improvable PDP-EMS in place for developing an EPP
Promote environmentally preferable purchasingpractices among consumers, industry and
government purchasers world wide
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Product Life Cycle
Formulation Development
Materials Selection
Package Selection/Design
Manufacturing Process
Distribution
Use/Performance of Product
Disposal of Product/Package
Product Performance Criteria
Environmental Impact Risk Assessment
Energy Use
Pollution Generated
Legal/Regulatory Requirements
Documentation
PDP-EMS Audit List
Document control, records, etc.
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Environmental Impact Concept
Soil
Water
Air
How materials would affect organisms(including humans) residing in these
compartments?
Persistent? Bioaccumulate? Toxic? -PBT
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Environmental Impact Factors
Global warming (CO2, CH4, N2O, CFC, etc. releases)
Acidification (NOx, SOx, H2SO4, HCl, NH3 releases)
Eutrophication (N, P releases)
Smog formation (VOC, NOx releases)
Ozone depletion (CFC, HCFC, CCl4, Halon, CH3Br, CH3CCl3releases)
Fossil fuel depletion (quantity used) Water use (quantity used)
Solid waste generation (quantity generated)
Habitat alteration (land use) Indoor air quality (release of VOC, irritants)
Human health risk (methods vary)
Ecological risk (methods vary)