EN 1186-3:2002
(Main)Materials and articles in contact with foodstuffs - Plastics - Part 3: Test methods for overall migration into aqueous food simulants by total immersion
Materials and articles in contact with foodstuffs - Plastics - Part 3: Test methods for overall migration into aqueous food simulants by total immersion
This part of this European Prestandard describes a test method for the determination of the overall migration into aqueous based food simulants from plastics which are intended to come into contact with foodstuffs, by total immersion in aqueous food simulant for 10 days, 24 h or 2 h at 40 °C or for 2 h at 70 °C. This method is most suitable for plastics in the form of films and sheets, but can be applied to a wide range of articles or containers from which test pieces of suitable size can be cut.
Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 3: Prüfverfahren für die Gesamtmigration in wässrige Prüflebensmittel durch völliges Eintauchen
1 Anwendungsbereich
Dieser Teil der Europäischen Norm beschreibt Prüfverfahren zur Bestimmung der Gesamtmigration in wässrige Lebensmittel aus Kunststoffen, die für den Kontakt mit Lebensmitteln vorgesehen sind, durch völliges Eintauchen der Prüfkörper in ein ausgewähltes Prüflebensmittel bei Prüftemperaturen bis zur Rückflusstemperatur und für ausgewählte Prüfzeiten.
Dieses Verfahren ist am besten geeignet für Kunststoffe in Form von Folien und Platten, es kann jedoch auch für eine große Reihe von Gegenständen oder Behältern angewendet werden, aus denen Prüfabschnitte geeigneter Größe geschnitten werden können.
Matériaux et objets en contact avec les denrées alimentaires - Matière plastique - Partie 3: Méthodes d'essai pour la migration globale dans les simulants aqueux par immersion totale
La présente partie de cette norme européenne spécifie une méthodes d'essai de vérification de la migration globale des matériaux et objets en matière plastique destinés à entrer en contact avec les denrées alimentaires par immersion totale d'éprouvettes dans un simulant aqueux choisi à des températures d'essai allant jusqu'au reflux pendant des durées définies.
Cette méthode est plus particulièrement applicable aux matières plastiques sous forme de films et de feuilles, mais peut être aussi appliquée à une large gamme d'objets ou de récipients à partir desquels des morceaux de taille appropriée peuvent être prélevés.
Materiali in predmeti v stiku z živili - Polimerni materiali - 3. del: Preskusne metode za celotno migracijo v vodne modelne raztopine s popolno potopitvijo
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Frequently Asked Questions
EN 1186-3:2002 is a standard published by the European Committee for Standardization (CEN). Its full title is "Materials and articles in contact with foodstuffs - Plastics - Part 3: Test methods for overall migration into aqueous food simulants by total immersion". This standard covers: This part of this European Prestandard describes a test method for the determination of the overall migration into aqueous based food simulants from plastics which are intended to come into contact with foodstuffs, by total immersion in aqueous food simulant for 10 days, 24 h or 2 h at 40 °C or for 2 h at 70 °C. This method is most suitable for plastics in the form of films and sheets, but can be applied to a wide range of articles or containers from which test pieces of suitable size can be cut.
This part of this European Prestandard describes a test method for the determination of the overall migration into aqueous based food simulants from plastics which are intended to come into contact with foodstuffs, by total immersion in aqueous food simulant for 10 days, 24 h or 2 h at 40 °C or for 2 h at 70 °C. This method is most suitable for plastics in the form of films and sheets, but can be applied to a wide range of articles or containers from which test pieces of suitable size can be cut.
EN 1186-3:2002 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 1186-3:2002 has the following relationships with other standards: It is inter standard links to ENV 1186-3:1994, EN 1186-3:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1186-3:2002 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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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Materiali in predmeti v stiku z živili - Polimerni materiali - 3. del: Preskusne metode za celotno migracijo v vodne modelne raztopine s popolno potopitvijoWerkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Kunststoffe - Teil 3: Prüfverfahren für die Gesamtmigration in wässrige Prüflebensmittel durch völliges EintauchenMatériaux et objets en contact avec les denrées alimentaires - Matiere plastique - Partie 3: Méthodes d'essai pour la migration globale dans les simulants aqueux par immersion totaleMaterials and articles in contact with foodstuffs - Plastics - Part 3: Test methods for overall migration into aqueous food simulants by total immersion67.250Materiali in predmeti v stiku z živiliMaterials and articles in contact with foodstuffsICS:Ta slovenski standard je istoveten z:EN 1186-3:2002SIST EN 1186-3:2002en01-september-2002SIST EN 1186-3:2002SLOVENSKI
STANDARDSIST ENV 1186-3:19971DGRPHãþD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 1186-3April 2002ICS 67.250Supersedes ENV 1186-3:1994English versionMaterials and articles in contact with foodstuffs - Plastics - Part3: Test methods for overall migration into aqueous foodsimulants by total immersionMatériaux et objets en contact avec les denréesalimentaires - Matière plastique - Partie 3: Méthodesd'essai pour la migration globale dans l'huile d'olive parimmersion totaleWerkstoffe und Gegenstände in Kontakt mit Lebensmitteln- Kunststoffe - Teil 3: Prüfverfahren für dieGesamtmigration in wässrige Prüflebensmittel durchvölliges EintauchenThis 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 1186-3:2002 ESIST EN 1186-3:2002
at reflux.11Annex A (informative)
Precision data.14Annex ZA (informative)
Relationship of this European Standard with Council Directive 89/109/EECand Commission Directive 90/128/EEC and associated Directives.15Bibliography.17SIST EN 1186-3:2002
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 1186-3 should be read in conjunction with EN 1186-1.Further Parts of this standard have been prepared concerned with the determination of overall migration fromplastics 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 simulants by total immersionPart 4Test methods for overall migration into olive oil by cellPart 5 Test methods for overall migration into aqueous food simulants by cellPart 6Test methods for overall migration into olive oil using a pouchPart 7Test methods for overall migration into aqueous food simulants 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 triglycerideSIST EN 1186-3:2002
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 foodstuffs – Plastics – Part 1: Guide to the selection ofconditions and test methods for overall migration.EN 10088-1:1995, Stainless steels - Part 1: List of stainless steels.EN ISO 8442-2:1997, Materials and articles in contact with foodstuffs – Cutlery and table holloware – Part 2:Requirements for stainless steel and silver- plated cutlery (ISO 8442-2:1997).ISO 4788, Laboratory glassware - Graduated measuring cylinders.3 Method A - overall migration into aqueous food simulants by total immersion in anoven or incubator or refrigerator3.1 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 following immersion.The selection of the conditions of test and the food simulant(s) shall be determined by the conditions of use; seeclauses 4, 5 and 6 of EN 1186-1:2002.Test specimens of approximately 1 dm², see clause 8 of EN 1186-1:2002, are immersed in the food simulant for theexposure time at temperatures up to and including the temperature of reflux.
At the end of the test period, eachtest specimen is removed from the food simulant.
The food simulant from each test specimen is evaporated todryness, the mass of the non-volatile residue is determined gravimetrically and expressed as milligrams per squaredecimetre of surface area of test specimen.Overall migration is reported as the mean of three determinations on separate test specimens.3.2 ReagentsNOTEFor details of preparation and quality of these reagents, see clause 4 of EN 1186-1:2002.3.2.1Distilled water or water of equivalent quality (simulant A)3.2.2Acetic acid 3 % (w/v) in aqueous solution (simulant B)3.2.3Ethanol 10 % (v/v) in aqueous solution (simulant C)SIST EN 1186-3:2002
Stainless steel X4 CrNi 18 10 according to EN 10088-1: 1995 or of composition, chromium 17 %,nickel 9 %, carbon 0,04 %, is suitable.
Before initial use thoroughly clean the stainless steel supports. The use of adegreasing solvent and then dilute nitric acid has been found to be suitable.
For the aqueous acetic acid foodsimulant, use supports constructed out of glass, as there is a tendency for the acetic acid to corrode stainless steelsupports, particularly if the joints are silver soldered.NOTE 1However stainless steel supports can be used for acetic acid if it can be demonstrated that when immersed on theirown in simulant, for the test period, at the test temperature, the residue after evaporating the simulant to dryness and drying inan oven or incubator or refrigerator to constant mass at 105 °C to 110 °C is less than 5mg/l, see 4.1 ofEN 1186-1:2002.NOTE 2The method has been written for the supports shown in Figure C.1 of EN 1186-1:2002 which have been found to besuitable for holding thin film and sheet test pieces.
However other supports can be used providing they are capable of holdingand keeping the test pieces apart and at the same time ensuring complete contact with the simulant.
For rigid samples,supports with a single cross arm may be used.3.3.9Gauze, pieces of fine stainless steel gauze, with a mesh size of 1 mm have been found to be suitable,approximately 25 mm ´ 100 mm or, glass rods, 2 mm to 3 mm in diameter and approximately 100 mm long to beused with the acetic acid food simulant, for insertion between the test pieces. Before initial use thoroughly clean thegauze, first with a degreasing solvent and then with dilute nitric acid.3.3.10Glass tubes, ground neck, for retaining the food simulant and test specimens. Tubes with an internaldiameter of approximately 35 mm and length of between 100 mm and 200 mm, excluding the ground neck (see 7.2of EN 1186-1:2002) have been found to be satisfactory.3.3.11Glass beads, 2 mm to 3 mm diameter or glass rods, 2 mm to 3 mm in diameter and approximately 100 mmlong (see 7.2 of EN 1186-1:2002).3.3.12Thermostatically controlled oven or incubator or refrigerator capable of maintaining the set temperaturewithin the tolerances specified in Table B.2 of EN 1186-1:2002.3.3.13Dishes, stainless steel, nickel, platinum, platinum alloy, gold 50 mm to 90 mm diameter and maximummass 100 g, for evaporation of food simulants and weighing of residues.
Glass, glass ceramic or ceramic dishesmay be used provided that the surface characteristics are such that the masses of the dishes after evaporation ofany specified 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 or, platinum alloy or gold dishes are suitable for all three simulants.SIST EN 1186-3:2002
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 samplewith water or solvent. If it is specified in the instructions for use of the article that it should be washed or cleanedbefore use see 8.1 of EN 1186-1:2002.
Minimise handling of the samples and where necessary, wear cottongloves.To ensure that test pieces are well separated and that the surfaces are freely exposed to the food simulant duringthe period of the test, for thin films, insert a piece of fine stainless steel gauze, or glass rods with the acetic acidsimulant, between the test pieces or for thick samples not placed on the supports, insert glass rods between thetest pieces after immersion in the food simulant.
Where specimen supports are used, label the supports with a tagbearing the test specimen identification.When preparing test specimens measure the surface area according to 8.3 of EN 1186-1:2002.3.4.2 Number of test specimensThree test specimens are required for samples, in the form of thin films, sheets, cut sections from containers orsimilar articles.
Five test specimens, similar dimensionally one to another, are required for samples of articles ofirregular shape.
These test specimens are utilized as follows:a) three test specimens for the migration test;b) two test specimens for determination of the surface area, in the case of samples of irregular shape(3.4.5).3.4.3 Films and sheetsLay the sample on the cutting slab (3.3.1) and cut the test specimens of 1 dm² (see 9.3 of EN 1186-1:2002), usingthe 100 mm ´ 100 mm template (3.3.4).
Check, using the rule (3.3.6), that the dimensions of the specimen arewithin the specified tolerance (± 1 mm).Cut each test specimen into four test pieces 25 mm ´ 100 mm using the rule (3.3.5).
Assemble one test specimenonto the support (3.3.8) by piercing suitable holes in the test pieces and placing two test pieces on each side of thecross arms of the support. Repeat this procedure for all remaining test specimens.3.4.4 Containers and other articlesCut sections from the walls of the container or article to give test specimens each of area approximately 1 dm².
Forarticles with individual areas less than 1 dm², use a number of articles to provide each test specimen.
Measure thedimensions of each test specimen to the nearest 1 mm, using the rule.
Calculate only the surface area of thesample which is intended to come into contact with foodstuffs, see 8.3 of EN 1186-1:2002.Calculate the area of each test specimen to the nearest 0,01 dm² and record. If necessary, cut each test specimeninto smaller pieces to enable them to fit into the glass tubes (3.3.10).
The test specimens or pieces are placed onthe specimen supports if these are appropriate or, if the test specimens or pieces are sufficiently rigid, they can betested unsupported.SIST EN 1186-3:2002
Measure only the surface areaintended to come into contact with foodstuffs of two of these test specimens to the nearest 0,05 dm² using theSchlegel Method, as described in EN ISO 8442-2:1997, annex B, or any other suitable method.
Record the surfacearea of each test specimen.3.5 Procedure3.5.1 Exposure to food simulantTake three of the glass tubes, for the test specimens and a further two to provide blanks, measure by measuringcylinder 100 ml ± 2 ml of the food simulant into each tube and stopper the tube.
Insert a thermometer orthermocouple, if applicable see NOTE 2, in one of the test specimen tubes, and stopper all five tubes.
Place thefive tubes in the thermostatically controlled oven, incubator or refrigerator, set at the test temperature, and leaveuntil the simulant has attained the test temperature.Place a test specimen into each of the three tubes containing 100 ml of simulant, re-insert the thermometer orthermocouple and stopper the tubes.
Mark the tubes for identification.
Ensure that the test specimens are totallyimmersed in the simulant; if they are not then add either glass beads or rods to raise the level of the simulant untiltotal immersion is achieved.
This part of the operation should be carried out in the minimum time to prevent undueheat loss from the simulant.Mark the liquid level on the outside of each tube with a suitable marker.Replace all of the tubes in the thermostatically controlled oven, incubator or refrigerator, set at the test temperature.Observe the temperature and leave the tubes for the selected period of time after the temperature of the simulanthas reached a temperature within the permitted tolerance for the test temperature, see Tables B.1 and B.2 ofEN 1186-1:2002 for permitted tolerances on test times and temperature.NOTE 1Annex B of EN 1186-1:2002 inc
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SIST EN 1186-3:2002 표준은 식품과 접촉하는 재료 및 기사의 플라스틱에 대한 테스트 방법으로, 수용성 식품 시뮬런트에 대한 전체 이주를 측정하는 방법을 규정하고 있습니다. 이 표준의 범위는 특히 40 °C에서 10일, 24시간 또는 2시간, 또는 70 °C에서 2시간 동안 수용성 식품 시뮬런트에 완전 침지하여 플라스틱에서의 전체 이주를 결정하는 방법에 초점을 맞추고 있습니다. 이 표준의 강점은 다양한 유형의 플라스틱 제품, 특히 필름 및 시트 형태의 플라스틱에 가장 적합하다는 점입니다. 또한, 이 기준에 따라 적절한 크기의 테스트 샘플을 잘라낼 수 있는 다양한 용기나 기구에 적용할 수 있다는 유연성을 가지고 있습니다. 이는 식품 안전성 및 품질 보증을 위해 필수적인 요소로 작용합니다. 아울러, SIST EN 1186-3:2002는 식품과의 접촉을 고려할 때 플라스틱이 이주하는 물질의 양을 신뢰성 있는 방법으로 측정할 수 있도록 함으로써 식품 안전 기준을 충족하는 데 매우 중요한 역할을 합니다. 이러한 테스트 방법은 식품 산업에서 사용되는 플라스틱 제품의 안전성을 확보하기 위한 기본적인 기준으로, 관련 규제 준수를 지원하고 소비자의 신뢰를 구축하는 데 기여합니다. 따라서, 이 표준은 식품 재료와 플라스틱의 상호작용을 이해하고 평가하는 데 필수적인 도구로 자리잡고 있으며, 식품 안전 및 품질 관리를 증진하는 데 있어서 큰 의미를 가집니다.
The EN 1186-3:2002 standard is a pivotal document in the realm of food safety, specifically concerning materials and articles in contact with foodstuffs. Its primary focus is on the determination of overall migration from plastics into aqueous food simulants, employing a total immersion method. This standard operates within a clearly defined scope, detailing specific test conditions such as immersion times of 10 days, 24 hours, or 2 hours at temperatures of 40 °C and 70 °C. One of the noteworthy strengths of this standard is its adaptability; while it is primarily tailored for plastics in the form of films and sheets, it can also be utilized for a diverse array of articles or containers, provided that suitable test pieces can be obtained. This broad applicability underscores the standard’s relevance in a variety of industrial contexts where food safety is paramount. Furthermore, the standardized test methods proposed in EN 1186-3:2002 facilitate compliance with regulatory requirements, ensuring that materials intended for food contact meet safety thresholds. This not only enhances consumer protection but also promotes trust in food packaging materials. The rigorous approach to testing and the emphasis on migration analysis address some of the critical concerns associated with plastic materials in contact with food, thereby reinforcing the integrity of the food supply chain. In summary, the EN 1186-3:2002 standard stands as a comprehensive guide for manufacturers and regulatory bodies alike, with its robust methodology and broad applicability contributing significantly to the safety of food packaging materials. Its relevance in addressing migration concerns makes it an essential reference within the food industry and beyond.
SIST EN 1186-3:2002は、食品と接触するプラスチック材料および製品に関する非常に重要な標準であり、その範囲は明確に定義されています。この標準は、食品用シミュラントへの全体移行の試験方法を詳細に説明しており、食品と接触することを意図したプラスチックからの全体移行を測定するための手順を提供しています。特に、10日間、24時間または2時間の間、40℃または70℃での全浸漬法により試験が行われます。 この標準の大きな強みは、プラスチックフィルムやシートの形状に最も適している一方で、適切なサイズにカットされた試験片を用いることで、さまざまな容器や製品に応用できる点です。この柔軟性により、異なる用途や製品形態に対して広範な検討が可能になり、さまざまな業界での実用性が高まります。 また、SIST EN 1186-3:2002は、食品安全性を確保するための重要な基準であり、製品の設計者や製造者にとって、法律や規制を遵守するための基盤を提供します。全体移行の試験方法を通じて、消費者が安全で信頼できる食品を享受できるようにするための守り手としての役割も果たしています。このように、SIST EN 1186-3:2002は、食品と接触するプラスチック材料に対する非常に重要な標準であり、食品の安全性に直結する課題に対応するためのものであると言えるでしょう。
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