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Filtration and Food Contact ComplianceFiltration and Food Contact ComplianceOne Step Closer to Consumer Protection

IntroductionHigher quality standards and focus on improved customer protectionlead to a series of compliance requirements in the Food and Beverageindustry, consolidating and extending existing regulations on foodsafety. This includes requirements for products intended to come incontact with food leading to specific standards relevant for foodmanufacturers and their suppliers

Filtration and Food Contact CompliancePall® FCC Products

For food contact materials in the Foodand Beverage industry, the EUFramework Regulation on Food ContactMaterials — European RegulationNumber (EC) 1935/2004 applies.

The primary premise of all food contactregulations is that materials or articleswhich are intended to come into contactwith foods, beverages, or otherconsumable ingredients should notrelease materials considered harmful tohealth or detrimental to product qualityunder normal foreseeable conditions.However, there is as yet no globalharmonized approach to evaluatingmaterials. While the US Food and DrugAdministration (FDA) affirms a positivelisting of monomer and additivesubstances plus some materials testing,dependent on the polymer as detailed inthe Code of Federal Regulations 21 CFR170-199, the EU requirements establishmethods by which all finished polymermaterials or articles that come intocontact with food and beverages mustbe evaluated.

Initially the Food and Beverage industryfocused on packaging materials. It also considers products used in theproduction process – e.g. filters.

Filters are critical components and widelyused in the Food and Beverage Industrysuch that finished article or materialsextractable testing are mandatory inEurope. Meeting a relevant section of21CFR for FDA is not sufficient to complywith EU requirements. To ensure foodcontact compliance manufacturers shouldconsider the specific regulations wherethe food or beverage is produced andwhere it is sold.

Good manufacturing practices andquality systems (International StandardsOrganization, ISO), Hazard Analysis and Critical Control Point (HACCP), Food Safety Modernization Act (FMSA)and International Food Standard (IFS)audits have increased the need fordocumentation. Declarations ofCompliance for food contact materialsused in packaging and production helpto satisfy audit requirements.

The Pall Solution Pall Food and Beverage has undertakenan exhaustive review and qualification ofproducts sold in the Food and Beverageindustry to the current regulations. Afterintensive test programs includingsubstitution of critical substances wehave qualified a specific range of foodcontact compliant (FCC) products for theFood and Beverage market.

Many of these products may beidentified by the letter ‘W’ in the Pallproduct part number. There are otherproducts with numerical part codes thatare also part of the program. All products,regardless of part number, to be used inliquid food contact applications have afork and glass symbol on the productexternal and internal packaging.Products intended only for indirect foodcontact (e.g. air/gas applications) are ‘W-Coded’ but do not have a fork andglass symbol on the product.

• Vendor declarations confirm materialsof construction are appropriately listedfor use with food or are specificallyexcluded from local regulatoryrequirements.

• Extractables testing has includedindependent test laboratories utilizingrelevant model fluids or simulantsdeemed appropriate for intendedapplications. Filters and/or componentmaterials were evaluated in appropriatemodel simulants (e.g. extended contacttime and elevated temperature), asidentified on the Declaration ofCompliance.

Specific Declarations of Compliance forthese filters are available on the Pallwebsite http://www.pall.com/foodandbev.These “Declaration of Compliance”statements are reviewed on an ongoingbasis to ensure compliance to new orchanges in the regulations.

By investing in a Food and Beveragespecific and ‘fit-for-purpose’ productportfolio Pall supplies products thatcomply with the most current regulationsallowing the industry to maintain thehighest good manufacturing practicestandards.

Contact your sales representative for more information.

Filtration and Food Contact CompliancePall® FCC Products

Filtration and Food Contact CompliancePall® FCC Products

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Pall Food and Beverage

25 Harbor Park DrivePort Washington, NY 11050 USA+1 516 484 3600 telephone +1 866 905 7255 toll free US foodandbeverage@pall.com

Visit us on the Web at www.pall.com/foodandbev

Pall Corporation has offices and plants throughout the world. For Pall representativesin your area, please go to www.pall.com/contact

Please contact Pall Corporation to verify that the product conforms to your nationallegislation and/or regional regulatory requirements for water and food contact use.

Because of technological developments related to the products, systems, and/orservices described herein, the data and procedures are subject to change withoutnotice. Please consult your Pall representative or visit www.pall.com to verify thatthis information remains valid.

© Copyright 2014, Pall Corporation. Pall and Oenoflow are trademarks of Pall Coporation. ® Indicates a trademark registered in the USA. Filtration. Separation. Solution.SM is a service markof Pall Corporation.