Low Migration

Avery Dennison now off ers low-migrati on adhesives that are pretested to meet regulatory requirements in the North American and European markets. By choosing pretested, low-migrati on adhesives in combinati on with low-migrati on base materials, inks and varnishes for plasti c containers, pharmaceuti cal companies can minimize the ti me and money they spend on migrati on certi fi cati on, and in some cases can bypass it altogether. Other benefi ts include faster product approval and ti me to market, and the peace of mind of knowing that their medicinal products are safe for pati ents.

Key features –High initi al tack and very good adhesion to glass, PE, PP –Excellent mandrel performance on glass, PE and PP containers –Complies with the European food directi ves and legislati ons, FDA 175.105 and the German recommendati ons XIV as published by BfR. BfR (Bundesinsti tut für Risikobewertung) is the German Federal Insti tute for Risk Assesment. –The adhesives can be used in direct contact with dry, nonfatt y foodstuff s. –Dramati cally reduce the risk of contaminati on with our industry proven low-migrati on adhesives

* Only applies to the following adhesives: S2000NP, S2045NP, S717P, S692NP

Product informati on

Code Descripti on Size (mm × mtrs) Locati on Lead ti me

ALV434 Fasson® LW/PERMANENT(S692NP)/BG40 1500 X 1000 Pune 3 Days

AE947

AE948

AE949

SW4115

BW8005 Fasson® PE Top White/S692NP/BG40 WH IMP 1500 X 1000 Pune 7 Days

Fasson® PP Top White/S692NP/BG40 WH IMP 1500 X 1000 Pune 7 Days

Fasson® PP Top Clear/S692NP/BG40 WH IMP 1500 X 1000 Pune 7 Days

Fasson® Silver Met.Paper/S692NP/BG40 WH IMP 1500 X 1000 Pune 7 Days

FASSON 85U TRANSPARENTPE TC/S692NP/BG40 WH IMP

The need for low migrati on As per the European Union’s 2005 guidelines around plasti c packaging materials, & U.S. FDA guidelines for pharmaceuti cal industry: Container Closure Systems for Packaging Human Drugs and Biologics.” the “packaging components should be constructed of materials that will not leach harmful or undesirable amounts of substances to which a pati ent will be exposed when being treated with a drug product.” The chief way that regulatory agencies in the U.S. and Europe are encouraging pharmaceuti cal companies to address migrati on issues is by requiring that they use low-migrati on label materials.

The term low migrati on is used because some amount of migrati on will always occur in plasti c packaging. However, if the migrati on or interacti on happens within the accepted window determined by regulatory authoriti es, the packaging components are deemed safe for use. There are two certi fi cati ons that pharmaceuti cal companies can obtain to certi fy low-migrati on label materials.

Certi fi cati ons can be secured through the independent, globally accepted testi ng agency, under ISEGA (As per EU guidelines ) & 21 CFR 175.105,(US Regulati on) guidelines Typically, ISEGA certi fi cati on can take up to two years to complete before the label is cleared for companies to use in producti on, making it a long and costly process for businesses that want to get their products to market quickly and effi ciently. At the same ti me, this certi fi cati on is necessary for pharmaceuti cal companies if they want to sell products with plasti c containers to the European or the U.S. markets.