Food Law Compliance of PET Food Packaging Materials

Click here to load reader

download Food Law Compliance of PET Food Packaging Materials

of 29

  • date post

    16-Nov-2015
  • Category

    Documents

  • view

    16
  • download

    2

Embed Size (px)

description

Food Law Compliance of PET Food Packaging Materials

Transcript of Food Law Compliance of PET Food Packaging Materials

  • Chapter 16

    Food Law Compliance ofPoly(ethylene Terephthalate) (PET)

    Food Packaging Materials

    Frank Welle*

    Fraunhofer Institute for Process Engineering and Packaging (IVV),Giggenhauser Strae 35, 85354 Freising, Germany

    *E-mail: welle@ivv.fraunhofer.de.

    Poly(ethylene terephthalate) (PET) is widely used as apackaging material for all kinds of foodstuff. Low diffusivityof the polymer combined with the limited number of additivesand their low concentrations lead to very limited mass transfer(migration) of monomers, catalysts, or impurities from thePET polymer into food. This mass transfer (migration) formonomers, oligomers, catalysts, additives and non-intentionallyadded substances (NIAS) is discussed within this study.

    Based on the data given in the scientific literature it couldbe concluded that overall migration tests as well as specificmigration tests for monomers and catalysts, like ethyleneglycol, diethylene glycol, terephthalic acid, iso-phthalic acidand antimony are superfluous, because their migration limitscannot be exceeded, even if worst case conditions and swellingsimulants like 95% ethanol are applied. A more suitableprocedure for evaluation of the food law compliance of PETis the determination of migration relevant substances in PETand calculation of their migration by use of migration models.In addition, the analytical screening for low molecular weightmigrants (like NIAS) gives an additional safety factor, becausesuch NIAS were not determined using the conventionalmigration testing procedures.

    2014 American Chemical Society

    Dow

    nloa

    ded

    by W

    ASH

    ING

    TO

    N S

    TA

    TE

    UN

    IV o

    n Fe

    brua

    ry 2

    8, 2

    015

    | http

    ://pu

    bs.a

    cs.o

    rg

    Pub

    licat

    ion

    Dat

    e (W

    eb):

    Jul

    y 22

    , 201

    4 | d

    oi: 1

    0.10

    21/b

    k-20

    14-1

    162.

    ch01

    6

    In Food Additives and Packaging; Komolprasert, V., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 2014.

  • Introduction

    The use of poly(ethylene terephthalate) (PET) in packaging applications isincreasing year by year. In 2012 about 15 Mi. t (million tons) of PET wereproduced world-wide for PET packaging materials. In 2019, the predicted amountwill be about 19 Mi. t. Reasons for this trend are the good material properties ofthe PET. PET is a light-weight packaging material, is transparent and is nearlyunbreakable in comparison to glass. In addition, PET can be recycled into newPET bottles up to a recycled content of nearly 100% (1, 2). The good recyclabilityof PET is related to one of the most important properties of PET as a packagingmaterial: a high inertness. This high inertness leads to very low interactionsbetween PET packaging and foodstuff. In addition, PET contains only a smallnumber and amount of additives. Therefore, this leads to very limitedmass transfer(migration) of monomers, catalysts, or impurities from the PET polymer into food.

    The migration of substances from the packaging material into food (orsimulants) depends on the contact conditions, e.g. storage time, temperature aswell as contact area. In addition, diffusion and partition coefficients play alsoan important role. As mentioned above, the high inertness of PET leads to lowmigration into food. Therefore, experimental studies attempting to determinethe migration of monomers and additives through PET failed in most cases dueto insufficient detection limits of the analytical test methods employed and theshort testing timeframes (3, 4). PET is, therefore, a candidate for new food lawevaluation and migration testing concepts. Especially the application of migrationmodeling seems to be a useful tool for compliance evaluation purposes of PETpackaging materials.

    The purpose of this chapter is to give an overview over potential migrantsfrom PET, their typical use levels in PET and concentrations in food (simulants)in relation to the current migration limits set by the U.S. Food and DrugAdministration (FDA), and the European Food Safety Authority (EFSA) as wellas the prediction of the migration by using migration modeling.

    Requirements on PET Bottles According to European FoodLaw

    As for any other packaging material, the mass transfer (migration) ofmonomers or additives from PET into foodstuffs is restricted. According toArticle 3 of the European Framework Regulation 1935/2004 for food packagingmaterials (5), materials and articles shall be manufactured in compliance withgood manufacturing practice so that, under normal or foreseeable conditions ofuse, they do not transfer their constituents to food in quantities which could:(a) endanger human health, or (b) bring about an unacceptable change in thecomposition of the food, or (c) bring about a deterioration in the organolepticcharacteristics thereof. EU Regulation 1935/2004 gives, however, only a generalstatement about safety issues on packaging materials. More specific details likea positive list of all compounds, which can be used for manufacturing of food

    168

    Dow

    nloa

    ded

    by W

    ASH

    ING

    TO

    N S

    TA

    TE

    UN

    IV o

    n Fe

    brua

    ry 2

    8, 2

    015

    | http

    ://pu

    bs.a

    cs.o

    rg

    Pub

    licat

    ion

    Dat

    e (W

    eb):

    Jul

    y 22

    , 201

    4 | d

    oi: 1

    0.10

    21/b

    k-20

    14-1

    162.

    ch01

    6

    In Food Additives and Packaging; Komolprasert, V., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 2014.

  • packaging materials as well as specific migration limits are given in Regulation10/2011 (6) and amendments. In general, considering the mass transfer ofsubstances from packaging materials, distinguished distinction is made betweenoverall migration and specific migration. Overall migration can be considered asa measure for the inertness of the packaging material, determined as a gravimetricparameter, whereas specific migration limits are given for individual monomersor additives regarding their toxicological profiles. The overall migration limitfor any packaging material is 10 mg dm-2. The specific migration limits for PETmonomers, some additives and catalysts according to European legislation aresummarized in Table 1.

    Table 1. Specific Migration Limits (SML) for PET Monomers, SomeAdditives, and Catalysts According to European Law (6)

    Substance SML [mg l-1]

    Terephthalic acid 7.5

    iso-Phthalic acid 5

    Mono- and diethylene glycol, inclusive stearic acid glycol ester 30

    Acetaldehyde 6

    Antimony 0.04

    2-Aminobenzamide (anthranilamide) 0.05

    Requirements on PET Bottles According to U.S. Food Law

    Packaging materials as well as other substances, which migrate from thepackaging materials into food, are defined in the U.S. as indirect food additivesor food contact substances. The requirements for food contact materials are laiddown in Chapter 21 of the Code of Federal Regulations (denoted as 21 CFR).The general requirements are given in 21 CFR 174.5 such as good manufacturingpractice (GMP) or the organoleptic inertness of a packaging material. Specificrequirements for all polyethylene phthalate polymers inclusive of their rawmaterials are given in 21 CFR 177.1630 (Polyethylene phthalate polymers).These requirements are summarized in Table 2. In contrast to European law,the compliance of PET articles in the U.S. is shown by the use of short termextraction tests. In addition, the recent Food Contact Notification system of theFDA also has other polyesters related to PET.

    169

    Dow

    nloa

    ded

    by W

    ASH

    ING

    TO

    N S

    TA

    TE

    UN

    IV o

    n Fe

    brua

    ry 2

    8, 2

    015

    | http

    ://pu

    bs.a

    cs.o

    rg

    Pub

    licat

    ion

    Dat

    e (W

    eb):

    Jul

    y 22

    , 201

    4 | d

    oi: 1

    0.10

    21/b

    k-20

    14-1

    162.

    ch01

    6

    In Food Additives and Packaging; Komolprasert, V., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 2014.

  • Table 2. Requirements for Polyethylene Phthalate Polymers According to21 CFR 177.1630 f-j

    Conditions of use Specifications

    (f) Plastics used for packaging,transporting, or holding food,excluding alcoholic beverages,at temperatures not to exceed 250 F.

    chloroform- soluble extractives not toexceed 0.5 mg in-2 of food contact surfaceexposed to(i) distilled water at 250 F for 2 h(ii) n-heptane at 150 F for 2 h

    (g) Plastics used for packaging,transporting, or holding alcoholicbeverages that do not exceed50% (v/v) alcohol

    chloroform- soluble extractives not toexceed 0.5 mg in-2 of food contact surfaceexposed to(i) distilled water at 250 F for 2 h(ii) n-heptane at 150 F for 2 h(iii) 50% ethanol at 120 F for 24 h

    (h) Plastics are used to contain foodsduring oven baking or oven cooking attemperatures above 250 F

    chloroform- soluble extractives not toexceed 0.02 mg in-2 of food contactsurface exposed to(i) distilled water at 250 F for 2 h(ii) n-heptane at 150 F for 2 h

    (j) Plastics used for packaging,transporting, or holding alcoholicbeverages that do not exceed95% (v/v) alcohol

    chloroform- soluble extractives not toexceed 0.5 mg in-2 of food contactsurface exposed to(i) distilled water at 250 F for 2 h(ii) n-heptane at 150 F for 2 h

    chloroform- soluble extractives not toexceed 0.005 mg in-2 of food contactsurface exposed to 95% ethanol at120 F for 24 h for containers withgreater than 500 ml capacity

    chloroform- soluble extractives