Food-grade Lubricants

2004 ELGI AGM

May 16 18
Nice, France

Kenji Yano, PhD

NSF International

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

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.

End of USDA Regulation

1998

USDA ends compounds authorization

1999

NSF introduces a voluntary program

under the advice of USDA

USDA Requirements
1998

-USDA authorization
-Self-certification
-Third party registration

2001

-USDA authorization should not be

used
-Self-certification
-Third party registration

NSF Listing Policy

1999

List all USDA authorized products

2000

Begin listing new products via NSF registration

2002

Steering Committee recommends

sunset for all USDA authorized products

2004

Sunset

2004 NSF Listing

4800 products listed
480 companies listed
E-White Book (June 2004)

NSF Listing Website

5000 6000 visits / month
190 visits / day
9 min / visit
35000 hits / month
1200 hits /day

Product Categories 1998 vs. 2003

1998

2003

(23)
Cleaners
(37)

H
Lubricants
(12)
Water Treatment
(16)

(18)
(33)

Product Categories NSF Registered

2004

(10)
(11)

(56)

Number of Listed Products

16000
14000
12000
10000
8000

6000
4000

2000

0
2001 2002 2003 2004 2005 2006

H1 Registration
21 CFR 178.3570
Generally Recognized As Safe (GRAS)
2700 products listed
250 companies listed

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 FDA
approved prior to HX-1 Registration

Raw materials not listed in CFR

FDA Letter of Opinion (LOO)
Affirmation of GRAS
Threshold of Regulation (TOR)
Food Contact Notification (FCN)

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

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

H2 Registration
Must conform to NSF Guideline 5.1
No carcinogens, mutagens, teratogens, mineral acids
No odorous substances
No intentionally added heavy metals

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

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

International Collaborations
Australian Quarantine Inspection Agency (AQIS)
Canadian Food Inspection Agency (CFIA)

Collaboration with USDA

NSF will launch a registration program for compounds
used for processing shell eggs identified with the
USDA grademark
Coating oils
Stamping inks
Non-synthetic food additives (organic food processing)

EPA Antimicrobial Division

Agreement reached to permit NSF Registration Mark
on EPA registered antimicrobial product labels

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

EPP Background
Executive Order 13101, Greening the Government
Through Waste Prevention, Recycling, and Federal
Acquisition (1998)
EPA to develop guidance for governmental
purchasing of products and services
NSF received grant to evaluate potential for
development of voluntary consensus standards

What is EPP?
Products that have a lesser or reduced effect on
human health and the environment when compared
to competing products that serve the same purpose
The product comparison may consider research and
development, raw materials acquisition, production,
manufacturing, packaging, distribution, reuse,
operation, maintenance, or disposal. (EO 13101,
Section 201)

Goals of Standard
Ensure that manufacture has a continuously
improvable PDP-EMS in place for developing an EPP
Promote environmentally preferable purchasing
practices among consumers, industry and
government purchasers world wide

Product Life Cycle

Formulation Development
Materials Selection
Package Selection/Design
Manufacturing Process

9Product Performance Criteria

9Environmental Impact Risk Assessment
9Energy Use
9Pollution Generated
9Legal/Regulatory Requirements
9Documentation

Distribution
Use/Performance of Product
Disposal of Product/Package

PDP-EMS Audit List

Document control, records, etc.

Environmental Impact Concept

Air
Water
Soil

How materials would affect organisms

(including humans) residing in these
compartments?

Persistent? Bioaccumulate? Toxic?

-PBT

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, CH3CCl3
releases)
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)