EN 1186-7:2002
(Main)Materials and articles in contact with foodstuffs - Plastics - Part 7: Test methods for overall migration into aqueous food simulants using a pouch
Materials and articles in contact with foodstuffs - Plastics - Part 7: Test methods for overall migration into aqueous food simulants using a pouch
This part of this European Prestandard describes a method of test for the determination of the overall migration from one surface only of plastics in the form of sheet and film, which are intended to come into contact with foodstuffs, by forming the plastics film or sheet into standard pouches and exposure to the aqueous food simulant for 10 days, 24 h or 2 h at 40 °C or for 2 h at 70 °C. A standard pouch is a pouch with the dimensions as described in 6.2. This method is most suitable for plastics in the form of films and sheets which are sealable by heat or pressure.
Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 7: Prüfverfahren der Gesamtmigration in wässrige Prüflebensmittel mit einem Beutel
1 Anwendungsbereich
Dieser Teil dieser Europäischen Norm beschreibt Prüfverfahren zur Bestimmung der Gesamtmigration in wässrige Prüflebensmittel aus Kunststoffen, die dafür vorgesehen sind, mit Lebensmitteln in Berührung zu kommen, durch Herstellen eines Standardbeutels aus dem Kunststofffilm oder -bogen und Befüllen mit ausgewählten Prüflebensmitteln bei Prüftemperaturen bis zu und einschließlich 70 °C für ausgewählte Prüfzeiten.
Dieses Verfahren ist am besten geeignet für Kunststoffe in Form von Folien und Bögen, die durch Hitze oder Druck verschweißt werden können. Die Prüfung ist jedoch speziell anwendbar bei solchen Materialien, die aus mehr als einer Schicht bestehen, die im Kontakt mit Prüflebensmitteln nur mit der Oberfläche geprüft werden, welche vorgesehen ist, mit Lebensmitteln in Kontakt zu kommen.
Ein Standardbeutel ist ein Beutel mit Abmessungen, wie in 6.3 definiert.
ANMERKUNG Beutel mit anderen Abmessungen als 10 cm x 10 cm können zur Prüfung verwendet werden. Diese Beutel sollten wenn möglich so hergestellt werden, dass die gesamte benetzte Oberfläche nicht weniger als 1 dm² beträgt.
Matériaux et objets en contact avec les denrées alimentaires - Matière plastique - Partie 7: Méthodes d'essai pour la migration globale dans les simulants aqueux à l'aide d'un sachet
La présente partie de la norme européenne spécifie une méthode d'essai permettant de déterminer la migration globale dans des simulants aqueux de plastiques sous forme de film ou de feuille, dont seule une face est destinée à entrer en contact avec des denrées alimentaires, en transformant le film ou la feuille plastique en sachets de référence et en les maintenant remplis du simulant choisi pendant les durées spécifiées à une température d'essai inférieure ou égale à 70 °C.
Cette méthode est généralement applicable aux plastiques sous forme de films et de feuilles scellables par chauffage ou par pression, mais plus particulièrement aux matériaux composés de plusieurs couches, qui doivent être essayés avec des simulants uniquement sur la surface destinée à entrer en contact avec les denrées alimentaires.
Un sachet de référence est un sachet dont les dimensions sont celles décrites en 6.3.
NOTE Des sachets de dimensions autres que 10 cm x 10 cm peuvent être utilisés pour les essais. Il convient de les préparer de telle manière que la surface totale exposée ne soit pas inférieure à 1 dm2.
Materiali in predmeti v stiku z živili - Polimerni materiali - 7. del: Preskusne metode za celotno migracijo v vodne modelne raztopine z vrečko
General Information
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Frequently Asked Questions
EN 1186-7:2002 is a standard published by the European Committee for Standardization (CEN). Its full title is "Materials and articles in contact with foodstuffs - Plastics - Part 7: Test methods for overall migration into aqueous food simulants using a pouch". This standard covers: This part of this European Prestandard describes a method of test for the determination of the overall migration from one surface only of plastics in the form of sheet and film, which are intended to come into contact with foodstuffs, by forming the plastics film or sheet into standard pouches and exposure to the aqueous food simulant for 10 days, 24 h or 2 h at 40 °C or for 2 h at 70 °C. A standard pouch is a pouch with the dimensions as described in 6.2. This method is most suitable for plastics in the form of films and sheets which are sealable by heat or pressure.
This part of this European Prestandard describes a method of test for the determination of the overall migration from one surface only of plastics in the form of sheet and film, which are intended to come into contact with foodstuffs, by forming the plastics film or sheet into standard pouches and exposure to the aqueous food simulant for 10 days, 24 h or 2 h at 40 °C or for 2 h at 70 °C. A standard pouch is a pouch with the dimensions as described in 6.2. This method is most suitable for plastics in the form of films and sheets which are sealable by heat or pressure.
EN 1186-7:2002 is classified under the following ICS (International Classification for Standards) categories: 67.250 - Materials and articles in contact with foodstuffs. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1186-7:2002 has the following relationships with other standards: It is inter standard links to ENV 1186-7:1994, EN 1186-3:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1186-7:2002 is associated with the following European legislation: EU Directives/Regulations: 89/109/EEC; Standardization Mandates: M/052. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 7: Prüfverfahren der Gesamtmigration in wässrige Prüflebensmittel mit einem BeutelMatériaux et objets en contact avec les denrées alimentaires - Matiere plastique - Partie 7: Méthodes d'essai pour la migration globale dans les simulants aqueux a l'aide d'un sachetMaterials and articles in contact with foodstuffs - Plastics - Part 7: Test methods for overall migration into aqueous food simulants using a pouch67.250Materiali in predmeti v stiku z živiliMaterials and articles in contact with foodstuffsICS:Ta slovenski standard je istoveten z:EN 1186-7:2002SIST EN 1186-7:2002en01-september-2002SIST EN 1186-7:2002SLOVENSKI
STANDARDSIST ENV 1186-7:19971DGRPHãþD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 1186-7April 2002ICS 67.250Supersedes ENV 1186-7:1994English versionMaterials and articles in contact with foodstuffs - Plastics - Part7: Test methods for overall migration into aqueous foodsimulants using a pouchMatériaux et objets en contact avec les denréesalimentaires - Matière plastique - Partie 7: Méthodesd'essai pour la migration globale dans les liquidessimulateurs aqueux à l'aide d'un sachetWerkstoffe und Gegenstände in Kontakt mit Lebensmitteln- Kunststoffe - Teil 7: Prüfverfahren der Gesamtmigration inwässrige Prüflebensmittel mit einem BeutelThis European Standard was approved by CEN on 4 January 2002.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 1186-7:2002 ESIST EN 1186-7:2002
Example of a pouch holder.11Annex B (informative)
Precision data.12Annex ZA (informative)
Relationship of this European Standard with Council Directive 89/109/EECand Commission Directive 90/128/EEC and associated Directives.13Bibliography.15SIST EN 1186-7:2002
Further Directives andamendments to existing Directives are expected which could change the legislative requirements which thisstandard supports.
It is therefore strongly recommended that users of this standard refer to the latest relevantpublished Directive(s) before commencement of any of the test or tests described in this standard.EN 1186-7:2002 should be read in conjunction with EN 1186-1:2002.Further Parts of this standard have been prepared, and others are in preparation, concerned with the determinationof overall migration from plastics materials into food simulants.Their titles are as follows:EN 1186 - Materials and articles in contact with foodstuffs - Plastics –Part 1Guide to the selection of conditions and test methods for overall migrationPart 2Test methods for overall migration into olive oil by total immersionPart 3Test methods for overall migration into aqueous food simulants by total immersionPart 4Test methods for overall migration into olive oil by cellPart 5Test methods for overall migration into aqueous food simulants by cellPart 6Test methods for overall migration into olive oil using a pouchPart 8Test methods for overall migration into olive oil by article fillingPart 9Test methods for overall migration into aqueous food simulants by article fillingPart 10Test methods for overall migration into olive oil
(modified method for use in cases whereincomplete extraction of olive oil occurs)Part 11Test methods for overall migration into mixtures of 14C-labelled synthetic triglyceridePart 12Test methods for overall migration at low temperaturesSIST EN 1186-7:2002
These pouches should be preparedwhere possible so that the total surface area exposed is not less than 1 dm².2 Normative referencesThis European Standard incorporates by dated and undated reference, provisions from other publications.
Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter.
Fordated references, subsequent amendments to and revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision.
For undated references the latest edition of thepublication referred to applies (including amendments).EN 1186-1:2002, Materials and articles in contact with food – Plastics – Part 1: Guide to the selection of conditionsand test methods for overall migration.ISO 648, Laboratory glassware - One mark pipettes.ISO 4788, Laboratory glassware - Graduated measuring cylinders.3 PrincipleThe overall migration of non-volatile substances from a sample of the plastics is determined as the mass of non-volatile residue after evaporation of the food simulant, see clauses 4, 5 and 5 of EN 1186-1:2002.Test specimens in the form of pouches are filled with the aqueous food simulant for the exposure time attemperatures up to and including 70 °C.
At the end of the test period, the food simulant is removed from each testspecimen.
The food simulant from each test specimen is evaporated to dryness, the mass of the non-volatileresidue is determined and expressed as milligrams per square decimetre of surface area of test specimen.NOTEIn some circumstances the procedure described in this standard can be used for exposure at temperatures above70 °C.Overall migration is reported as the mean of three determinations on separate test specimens.4 ReagentsNOTEFor details of the preparation and purity of these reagents see clause 4 of EN 1186-1:2002.4.1Distilled water or water of equivalent quality (simulant A)4.2Acetic acid 3 % (w/v) in aqueous solution (simulant B)SIST EN 1186-7:2002
Glass, glass ceramic or ceramic dishes may beused provided that the surface characteristics are such that the masses of the dishes after evaporation of anyspecified food simulants followed by conditioning in the desiccator used achieves a constancy of ± 0,5 mg.Stainless steel and nickel dishes are suitable only for distilled water and ethanol solutions.
Glass, glass ceramic,glazed ceramic, platinum, platinum alloy or gold dishes are suitable for all three simulants.5.12Steam bath, hot plate, distillation apparatus or rotary evaporator for evaporation of food simulant at the endof test period.5.13Desiccator with anhydrous calcium chloride or self indicating silica gel.5.14Heat or pressure sealing device, for use in forming pouches.5.15Measuring cylinders, 100 ml, complying with the minimum requirements of ISO 4788.6 Preparation of test specimens6.1 GeneralIt is essential that test specimens are clean and free from surface contamination (many plastics can readily attractdust due to static charges). Before preparing test specimens, remove any surface contamination from the sampleby gently wiping it with a lint-free cloth, or by brushing with a soft brush. Under no circumstances wash the sampleSIST EN 1186-7:2002
Minimize handling of the samples and where necessary, wear cottongloves.6.2 Number of test specimensThree test specimens are required.6.3 Cutting and preparation of specimensLay the sample on the cutting slab (5.1) with the surface to be in contact with the food simulant uppermost and cutthe test specimens using the 120 mm ´ 120 mm template (5.5).Place pairs of the test pieces together with the surfaces to be in contact with the food simulant facing.
Using theheat or pressure sealer (5.14), join to form pouches with four seals parallel to all four edges, 10 mm from the edge.Measure the distances between the inner edges of the seals to the nearest 1 mm and calculate the total surfacearea of the test specimen which will be exposed to the food simulant, to the nearest 0,01 dm².
This shall beapproximately 2 dm2.
Using the cutting implement (5.3), remove excess film from the sealed area (to reduce areaof film not directly exposed to food simulant whilst leaving enough to withstand the test conditions without leaking.Measure and record the surface area of the pouch which will be in contact with the simulant and the total externalarea of the pouch after trimming excess material.Mark each pouch for identification.
Cut off one corner of the pouch to leave a hole sufficiently large to insert a100 ml pipette.7 Procedure7.1 Exposure to food simulantTake three glass tubes (5.9), for the simulant for filling the pouches and a further two to provide the blanks,measure by measuring cylinder 100 ml ± 2 ml of the food simulant into each tube. Insert a thermometer orthermocouple, if applicable, see NOTE 3, in one of the tubes and stopper the tubes.
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The EN 1186-7:2002 standard is an essential contribution to the realm of food safety, focusing specifically on materials and articles in contact with foodstuffs, particularly plastics. It establishes a robust methodology for testing overall migration into aqueous food simulants, utilizing a pouch approach that is both practical and effective for evaluating the safety of plastic materials intended for food contact. One of the primary strengths of this standard is its clear and concise scope, which outlines the testing requirements for plastics in the form of sheet and film. By specifying that the method is suitable for sealable materials, the standard ensures relevance to the packaging industry, where heat or pressure sealing is commonly employed. This focus on practical applications enhances the usability of the standard within industrial settings, providing manufacturers with a reliable framework for compliance with safety regulations. The test method detailed in the standard involves the preparation of standard pouches, which are crucial for maintaining consistency across tests. The procedure allows for varying exposure times and temperatures, making it versatile for different types of plastic materials. The flexibility to conduct tests over 10 days, 24 hours, or 2 hours at specified temperatures (40 °C and 70 °C) is particularly beneficial, accommodating the diverse range of plastics used in food packaging. Moreover, the relevance of EN 1186-7:2002 extends to ensuring that manufacturers can adequately assess potential migration risks posed by their products. This ensures consumer protection and supports the compliance with food safety regulations across Europe. By standardizing testing methods for overall migration, this document plays a vital role in harmonizing safety practices and ensuring that all food contact materials meet rigorous safety standards. In summary, EN 1186-7:2002 stands out due to its comprehensive scope, practical applicability, and direct relevance to food safety. This standard provides an effective framework for testing the safety of plastics in contact with foodstuffs, ultimately safeguarding consumer health and contributing to the integrity of the food supply chain.
EN 1186-7:2002 표준은 식품과 접촉할 수 있는 플라스틱 재료 및 제품에 대한 포괄적이고 체계적인 테스트 방법을 제시합니다. 이 표준의 주요 목적은 플라스틱 필름 또는 시트에서 발생하는 전체 이행(migration) 양을 측정하는 방법을 상세히 설명하는 것입니다. 특히, 표준 파우치의 형태를 사용하여 10일, 24시간 또는 2시간 동안 40°C 또는 70°C에서 수용성 식품 시뮬레이터에 노출시키는 방식을 통해 측정합니다. 이 표준의 강점은 우선, 플라스틱 제품의 안전성을 확보하는 데 중추적인 역할을 한다는 점입니다. 과학적이고 재현 가능한 방법을 제공하여, 제조업체는 자사 제품이 식품 안전 기준을 충족하는지 확인할 수 있습니다. 또 다른 장점으로는, 이 방법이 열 또는 압력으로 밀봉 가능한 필름 및 시트를 가장 적합하게 다룬다는 점을 꼽을 수 있습니다. 따라서 생산자들이 이 표준을 참고함으로써 생산 과정에서의 안전성을 높이고, 소비자의 신뢰를 얻을 수 있도록 돕습니다. EN 1186-7:2002는 식품과 접촉하는 플라스틱 제품에 관한 규정이 강화되고 있는 현재의 추세와 맞물려 큰 관련성을 지니고 있습니다. 유럽연합에서의 식품 안전 기준이 강조되면서, 이 표준은 실질적으로 산업 전반에서 플라스틱 사용과 관련된 법적 요구를 충족하는 매우 중요한 기준으로 자리잡고 있습니다. 따라서 이 문서는 식품과 직접 접촉하는 플라스틱 품목의 안전성과 규정을 준수하는 데 필수적인 지침이 됩니다.
SIST EN 1186-7:2002は、食材と接触する材料および製品に関するEUのプレスタンダードの一部で、特にプラスチックのシートやフィルムの全体移行試験に関する手法を記述しています。この標準は、食品への安全性を確保するための試験方法を提供し、プラスチック製品が食品に接触する際のリスク評価を可能にします。 この基準の範囲は、プラスチックのシートおよびフィルムが食品との接触を目的としている場合に、特定の条件下で水性食品模擬物質への全体移行を測定する方法を設定しています。試験は、標準的なサイズのポーチを形成し、10日、24時間、または2時間の間、異なる温度条件（40 °Cおよび70 °C）で模擬物質にさらすことで実施されます。このプロセスにより、プラスチックの安全性が科学的に評価されます。 この標準の強みは、実用的かつ具体的な試験手法を提供している点です。特に、熱または圧力で密封可能なフィルムやシートに対して最適化されており、業界で広く使用されている製品の評価に適しています。また、標準ポーチの明確な寸法によって、試験の再現性が保証され、異なる研究機関や企業間での一貫した評価が可能となります。 SIST EN 1186-7:2002は、食品接触材料の安全性と性能を評価する上で不可欠な標準として、食品業界や材料科学の分野において非常に重要な役割を果たしています。この標準に準拠することにより、メーカーは製品の市場適合性を保証し、消費者に対して高い水準の安全性を提供することができます。
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