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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)