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30 June 2009

Conformity Assessment & the Packaged Water Industry

Jeffrey B Smith & Dr. T.N.V.V. Rao

Underwriters Laboratories

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Agenda

• UL overview• UL’s Packaged Water Certification Program• Value of third-party certification

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UL Overview

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UL Overview

Underwriters Laboratories Inc. (UL) is one of the

world’s leading independent product safety testing

and certification organization.

UL serves 72,302 customers locally in 98 countries.

More than 6,800 UL professionals serve customers from 117

locations worldwide.

In 2008, over 1 billion consumers in Asia, Europe and North

America were reached by UL safety messages.

All figures current as of 12/31/2008

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A Global Company

North America•United States - Northbrook - Camas - Melville - Research TP - San Jose•Canadawww.ul.com Latin America

•Argentina•Brazil•Mexico

www.ul-latinamerica.com

Europe/EMEA•Denmark •France •Germany• Italy•Netherlands•Poland•Spain•Sweden•Switzerland•United Kingdom

www.ul-europe.com

Asia Pacific•China •Hong Kong• India•Japan•Malaysia•Singapore•South Korea•Taiwan

www.ul-asia.com

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Leadership in Safety

20 billion UL Marks appearing on products in the market place

579,684

Products evaluated in 2008

72,302 Manufacturers producing UL certified products worldwide

93,762

Compliance follow-up visits conducted by UL in 2008

All figures current as of 12/31/2008

64 State-of-the-art testing and certification facilities worldwide

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Leadership in Water Product Certification

• ANSI accredited global certification program

• Health effects & performance testing

• Drinking water treatment chemicals

• Disinfectants

• Drinking water system components

• Valves & gaskets

• Fixture fittings

• Tanks & Coatings

• Drinking water treatment units

• Water softeners

• Chillers

• Coolers

• Plastic pipe

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Leadership in Drinking Water Analysis

• Recognized leader in water analysis

• Over 1.5 million water samples analyzed for

• Bottled water & beverage industry

• Public Water Systems

• Engineering firms & consultants

• State & federal agencies including sites around the world for the U.S. Army and Air Force

• State-of-the-art, 70,000 square-foot facility

• Comprehensive analytical scope

• Cutting-edge R&D department

• Most certified laboratory in the U.S. for drinking water

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Leadership in Packaged Water

• Two decades of experience working with FDA and IBWA requirements

• Participation on IBWA Technical and Government Relations committees

• An IBWA-approved inspection firm

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Packaged Water Certification Program Overview

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Certification Program – An Overview

Bi-annual Plant Audit

*As cited in 21 CFR Parts 165

Annual analysis of source & finished product

Verification of FDA Standard of Identity compliance

Use of UL Certified Water Quality Mark on product packaging

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Audit Overview

Facility Management Review• Employee Training• Internal audits• Material Specifications• Non-conforming materials

Verification of Hazard Analysis and Critical Control Point (HACCP) plan implementation

Adherence to Good Manufacturing Practices (GMPs)

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Analytical Testing Overview

Both source and finished products analyzed for compliance with both FDA and IBWA requirements for 107 parameters including

• Microbiological contaminants• Inorganic contaminants• Physical properties• Radionuclides• Synthetic organics contaminants

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Standard of Identity Compliance Overview

Auditor will verify that labels on finished products comply with the FDA’s Standards of Identity.

Standards of Identity regulations for water encompasses a general description of bottled water, names used to identify bottled water products (i.e. mineral water, artesian, spring etc.) and “other label statements”.

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Indicates that a manufacturer’s bottled water product has demonstrated compliance with the requirements of UL’s Bottled Water Program

UL’s Certified Water Quality Mark

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Value of Third-Party Certification

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Value of the UL Certified Water Quality Mark

The UL Mark adds value in the bottled water marketplace because:

• It effectively communicates the high quality of the packaged water bearing the UL Mark

• The UL Mark reinforces the packaged water bearing the mark as the brand of choice relative to the competition

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QUESTIONS?