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CROPACK 2010

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CROPACK 2010

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    2. Private Testing and Research Institute Legal form: Association / Ltd. ~ 130 employees (status: 12/2009) ~ 7.000 m2 floor space at 2 locations Business Year 2009: Annual turnover: 13,8 Mio. Euro R&D: ~ 26 % Share of export: ~ 24 % Organisation and Facts

    3. Locations and Departments

    4. Certification / Consulting in case of Damage Claims Testing & Quality Assurance Assessment according to the European Food Legislation / LMSVG Clients R&D-Projects Branch-oriented R&D-Projects Branch-oriented Training and Education ... Packaging (incl. food commodities)

    5. Migration

    6. Potential Migrants Glas Silicates, heavy metals Plastics Plasticizers, monomers, antistatics ... Paper Additives and fillers (chalk etc.) Metal Aluminium, tin for acid contents

    7. Migration How can be prevented that an illegitimate amount of contents of the packaging migrates into the product? Choosing the right packaging! Ensured by migration testing Compliance with overall migration limit (OML) Specific migration limits (SML) Maximum legitimate residual content of the substance in the finished food contact material (QMA) !!! Consideration of actual applied conditions (time and temperature combinations)

    8. Migration Testing Test conditions according to 2002/72/EC Basics for migration tests 82/711/EEC Basic rules for testing migration 93/8/EEC 1st amendment 97/48/EEC 2nd amendment List of simulants: 85/572/EEC 2007/19/EEC 1st amendment VC in PVC: 78/142/EEC (residual content and transfer to foodstuff) VC-analysis: 80/766/EEC, 81/432/EEC Certain epoxy derivatives: REG (EC) Nr. 1895 / 2005 Plasticizers in gaskets in lids: REG (EC) Nr. 372/2007

    9. CEN TC 194 Utensils in Contact with Food SC 1: General chemical methods Standard EN 1186: Test methods for overall migration Standard EN or CEN/TS 13130: Standard methods for the specific migration (SML/QM) currently, 28 parts are published within this standard Article 2 of 89/109/EEC: Materials and articles must be manufactured in compliance with good manufacturing practice so that, under their normal or foreseeable conditions of use, they do not transfer their constituents to foodstuffs in quantities which could: endanger human health, bring about an unacceptable change in the composition of the foodstuffs or a deterioration in the organoleptic characteristics thereof. 89/109/EEC = Successor of former Framework Directive 76/893/EECArticle 2 of 89/109/EEC: Materials and articles must be manufactured in compliance with good manufacturing practice so that, under their normal or foreseeable conditions of use, they do not transfer their constituents to foodstuffs in quantities which could: endanger human health, bring about an unacceptable change in the composition of the foodstuffs or a deterioration in the organoleptic characteristics thereof. 89/109/EEC = Successor of former Framework Directive 76/893/EEC

    10. Aqueous foods pH > 4,5 Distilled water (A) Acidic foods pH ? 4,5 3 % (w/v) Acetic acid (B) Alcoholic foods: 10 % (v/v) Ethanol (C) milk / milk products: 50 % (v/v) Ethanol Fatty foods: Rectified olive oil (D) Dry foods: none

    11. Selection of the right Simulant List of simulants: Regulation 85/572/EEC Example:

    12. Migration Testing: Unknown contact time, application for ambient temperature or lower temperatures: 10 d / 40 C (all simulants) Unknown contact time & unknown application temperature: 4 h / 100 C bzw. Reflux (simulant A, B, C) 2 h / 175 C (simulant D) Hot filling (< 15 min at 70-100 C): 2 h / 70 C (all simulants) Standardized Testing Conditions according to European Regulations / Austrian Plastics Regulation

    13. Migration Testing Substitute test for fatty foods If the use of fatty food simulants is not feasible for technical reasons Substitution: defined test media and conditions, corresponding to the simulant D Iso-Octan Ethanol (95 %) Modified Polyphenylenoxid (Tenax)

    14. Migration Testing Consideration of the practical usage conditions of the packaging (e. g. for which foodstuff applied?) Clarification of the usage conditions Selection of the simulant and test conditions (contact time and temperature) Is overall migration limit complied (OML)? Compliance with thresholds of the specific migration (SML) residual content in the commidity (QM)? Kurzer Blick auf die 2002/72/EG sowie auf das Synop. Doc.Kurzer Blick auf die 2002/72/EG sowie auf das Synop. Doc.

    15. Structure of the actual EU-Laws

    16. EU-Substances List / Synoptic Document EU-Substances List Based on: 2002/72/EG incl. supplements Containing an authorised positive list of monomers and an incomplete list of additives For certain substances thresholds are available which are expressed either as maximum quantity in material or article (QM) or as specific migration limit in food (SML). working documents: unterliegen einer regelmigen Vernderung, geben keine Garantie auf Richtigkeit. Dennoch sind dies gngige Grundlagen in der Praxis.working documents: unterliegen einer regelmigen Vernderung, geben keine Garantie auf Richtigkeit. Dennoch sind dies gngige Grundlagen in der Praxis.

    17. SML / QM Test Methods: migration test medium + GC, HPLC Positive List (excerpt):

    18. SML Save Testing Costs Special Cases: 100% migration < SML Calculation model

    19. Gas Chromatography Vorlufer der Chromatographie reichen weit zurck, bersetzt heit Chromatographie Farbschreiber, trennte z.B. Karotinoide, Chlorophyll,... Definition: Chromatographie ist eine Trennmethode, bei der Stoffe durch ihre unterschiedliche Verteilung zwischen einer stationren und einer mobilen Phase getrennt werden hohe Trennleistung geringe Menge der aufzutrennenden Mehrkomponentengemische getrennte Komponenten knnen direkt auf der Trennstrecke oder im Detektor nachgewiesen werden und quantitativ bestimmt werden Einteilung: Arbeitstechnik (Eluierung, Frontal, Verdrngung) oder nach Phasenaufbau der Trennsule/mobile Phase: flssig/fest (Papierchromatographie, Ionenaustausch); fl/fl; gas/fest oder nach Art des Trennsystems: Sulenchromatographie, Planar- oder Schichtenchromatographie hier: stationre Phase in Sule, wird von mobiler gasfrmiger Phase durchstrmt, Sule, Elution Vorlufer der Chromatographie reichen weit zurck, bersetzt heit Chromatographie Farbschreiber, trennte z.B. Karotinoide, Chlorophyll,... Definition: Chromatographie ist eine Trennmethode, bei der Stoffe durch ihre unterschiedliche Verteilung zwischen einer stationren und einer mobilen Phase getrennt werden hohe Trennleistung geringe Menge der aufzutrennenden Mehrkomponentengemische getrennte Komponenten knnen direkt auf der Trennstrecke oder im Detektor nachgewiesen werden und quantitativ bestimmt werden Einteilung: Arbeitstechnik (Eluierung, Frontal, Verdrngung) oder nach Phasenaufbau der Trennsule/mobile Phase: flssig/fest (Papierchromatographie, Ionenaustausch); fl/fl; gas/fest oder nach Art des Trennsystems: Sulenchromatographie, Planar- oder Schichtenchromatographie hier: stationre Phase in Sule, wird von mobiler gasfrmiger Phase durchstrmt, Sule, Elution

    20. Chromatographic Separation

    21. Definitions DECISION LIMIT: Threshold for the presence of an analyte (yes/no). If a sample possessed the exact content of the dicision limit, the analyte wouldnt be detected in 50 % of the measurements despite the presence of the analyte (false negative). DETECTION LIMIT: minimal concentration of an analyte, which is detected with a high likeliness (e. g. 95 %). The detection limit is usually twice the amount of the decision limit. DETERMINATION LIMIT: lowest concentration of an analyte, which can be quantitatively detected with a determined accuracy. Quantitative analyse results are only declared above the determination limit. The determination limit equals approximately the triple amount of the decision limit.

    22. Thermodesorber: Gas Chromatography GC/MSD Agilent 6890N/5973N TurboMatrix ATD 400 Automatischer Probengeber (50 Pltze) GC/MSD Agilent 6890N/5973N TurboMatrix ATD 400 Automatischer Probengeber (50 Pltze)

    23. Screening Methods Migration or directly in food Which peaks are explainable, which are not? Criticism: Analysis method? Comparability? Undetected substances?

    24. Special Regulation Lid Gaskets

    25. Example - ITX Isopropylthioxanthone (ITX) Photointitiator in UV-curing printing inks Application: outside of food packaging (compound for milk, cacao, juice) Problems: Set offeffect Migration !!! Threshold 0,05 mg/kg ITX in food Fotoinitiator in UV hrtenden Druckfarben: Bewirkt Trocknung / Hrtung der Druckfarbe bei UV-Kontakt Fotoinitiator in UV hrtenden Druckfarben: Bewirkt Trocknung / Hrtung der Druckfarbe bei UV-Kontakt

    26. How to test Set off? IVLV cluster commodities Working group of German-speaking testing laboratories eurofins, Fresenius, GALAB, GfU, innoform, ISEGA, MUVA, Nehring, ofi, SQTS Agreement on common test conditions: Time / Temperature - at customer - at laboratory: a) guideline value 10 days at 40 C b) alternatively according to actual application Pressure - three-dimensional - pile (according to customer) - flat/foil a) roll b) pile - full-surface contact - flexible - 1kg/dm Sample Name / Storage

    27. PIM whats next? New simulants e. g. Tenax:

    28. PIM whats next? Priority: 1. Specific migration 2. Overall migration Overall migration: Test conditions OM1-9 Regulations for repeated contacts Multi-layer materials and articles Test at 10 d 60 C for storage times > 30 d Substitute simulants (scientific evidence)

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