EN 13130-7:2004
(Main)Materials and articles in contact with foodstuffs - Plastics substances subject to limitation - Part 7: Determination of monoethylene glycol and diethylene glycol in food simulants
Materials and articles in contact with foodstuffs - Plastics substances subject to limitation - Part 7: Determination of monoethylene glycol and diethylene glycol in food simulants
This part of this European Standard specifies methods for the determination of monoethylene glycol and diethylene glycol in the food simulants; water, 3 % w/v acetic acid, 15 % v/v ethanol and olive oil and other fatty food simulants, simulants D, e.g. a mixture of synthetic triglycerides or sunflower oil or corn oil. The methods are capable of determining monoethylene glycol and diethylene glycol in food simulants separately, or combined, at the specific migration limit SML (T) of 30 mg/kg.
NOTE This method was developed for the determination of monoethylene glycol and diethylene glycol in 15 % v/v aqueous ethanol, as required by the regulations in force at the time the development work was carried out. However, this method, developed for 15 (v/v) aqueous ethanol, should be applicable to the determination in 10 (v/v) aqueous ethanol.
Werkstoffe und Gegenstände in Kontakt mit Lebensmitteln - Substanzen in Kunststoffen, die Beschränkungen unterliegen - Teil 7: Bestimmung von Monoethylenglycol und Diethylenglycol in Prüflebensmitteln
Matériaux et objets en contact avec les denrées alimentaires - Substances dans les matières plastiques soumises à des limitations - Partie 7 : Détermination du monoéthylène glycol et du diéthylène glycol dans les simulants d'aliments
La présente partie de cette Norme européenne spécifie les méthodes de détermination du monoéthylène glycol et du diéthylène glycol dans les simulants d'aliments : eau, acide acétique à 3 % (m/v), éthanol à 15 % (v/v) et huile d'olive et autres simulants alimentaires gras, simulants D (mélange de triglycérides synthétiques, huile de tournesol ou huile de maïs par exemple). Ces méthodes permettent de déterminer séparément ou en association, le monoéthylène glycol et le diéthylène glycol dans les simulants alimentaires, à la limite de migration spécifique LMS (T) de 30 mg/kg.
NOTE Cette méthode a été élaborée pour déterminer la quantité de monoéthylène glycol et de diéthylène glycol dans de l'éthanol aqueux à 15 % (v/v), comme exigé par les réglementations en vigueur au moment où le travail de mise au point a été effectué. Cependant, cette méthode, élaborée pour de l'éthanol aqueux à 15 % (v/v), devrait pouvoir s'appliquer à la détermination dans de l'éthanol aqueux à 10 % (v/v).
Materiali in predmeti v stiku z živili - Snovi v polimernih materialih, katerih koncentracija je omejena - 7. del: Določevanje monoetilenglikola in dietilenglikola v modelnih raztopinah za živila
General Information
- Status
- Published
- Publication Date
- 25-May-2004
- Withdrawal Date
- 29-Nov-2004
- Technical Committee
- CEN/TC 194 - Utensils in contact with food
- Drafting Committee
- CEN/TC 194/SC 1/WG 2 - Methods of test for monomers
- Current Stage
- 9092 - Decision on results of review/2YR ENQ - revise - Review Enquiry
- Start Date
- 10-Apr-2018
- Completion Date
- 14-Apr-2025
Relations
- Effective Date
- 22-Dec-2008
Overview
EN 13130-7:2004 is a CEN European Standard that specifies analytical methods for determining monoethylene glycol (MEG) and diethylene glycol (DEG) migrating from plastics into food simulants. It covers aqueous and fatty simulants - water, 3% w/v acetic acid, 15% v/v ethanol (method also applicable to 10% v/v ethanol), olive oil and other fatty simulants (simulant D: synthetic triglycerides, sunflower or corn oil). The methods quantify MEG and DEG separately or combined at the regulatory specific migration limit (SML (T)) of 30 mg/kg.
Key topics and technical requirements
- Scope: Determination of MEG and DEG in set food simulants used for migration testing of food-contact plastics.
- Analytical principle: Use of an internal standard (butan‑1,4‑diol), sample preparation (direct injection for aqueous simulants; extraction for fatty simulants), and analysis by gas chromatography with flame ionization detection (GC‑FID) using a cold on‑column injector.
- Sensitivity: Detection limits are approximately 1 mg/kg in the food simulants.
- Calibration & reagents: Methanolic stock solutions of MEG and DEG; preparation of intermediate and working standards; internal standard added prior to analysis.
- Apparatus: GC-FID system capable of resolving MEG, DEG and the internal standard; appropriate glassware, filters or SPE cartridges for sample clean-up; separating funnels for oil extraction.
- Quality control: Procedures for calibration graphs, validation of stock solutions, repeatability/reproducibility assessment, calculation of results (mg/kg or mg/dm2), and requirements for confirmation (e.g., re-analysis or GC‑MS confirmation where required).
- Regulatory context: Prepared to support EU directives on plastics in contact with foodstuffs (e.g., Directive 2002/72/EC and related legislation current at publication).
Applications and who uses this standard
- Testing laboratories performing migration testing on plastic materials and articles intended for food contact.
- Manufacturers and brand owners of food‑contact plastics who need to verify compliance with migration limits for MEG/DEG.
- Regulatory agencies and conformity assessment bodies that enforce compliance with SMLs and food-contact materials legislation.
- Quality assurance and R&D teams developing or reformulating polymer materials to minimize residual glycols.
Practical use cases include routine compliance testing, validation of manufacturing processes to control residual monomers, and investigative testing after non-compliance incidents.
Related standards
- EN 13130-1:2004 - Guide to test methods for specific migration and selection of food simulant conditions (to be read with this part).
- EN 13130 other parts - analytical methods for specific monomers and additives in plastics (listed within the EN 13130 series).
Keywords: EN 13130-7:2004, monoethylene glycol, diethylene glycol, food simulants, plastics, specific migration limit, GC-FID, cold on-column injector, olive oil simulant.
Frequently Asked Questions
EN 13130-7:2004 is a standard published by the European Committee for Standardization (CEN). Its full title is "Materials and articles in contact with foodstuffs - Plastics substances subject to limitation - Part 7: Determination of monoethylene glycol and diethylene glycol in food simulants". This standard covers: This part of this European Standard specifies methods for the determination of monoethylene glycol and diethylene glycol in the food simulants; water, 3 % w/v acetic acid, 15 % v/v ethanol and olive oil and other fatty food simulants, simulants D, e.g. a mixture of synthetic triglycerides or sunflower oil or corn oil. The methods are capable of determining monoethylene glycol and diethylene glycol in food simulants separately, or combined, at the specific migration limit SML (T) of 30 mg/kg. NOTE This method was developed for the determination of monoethylene glycol and diethylene glycol in 15 % v/v aqueous ethanol, as required by the regulations in force at the time the development work was carried out. However, this method, developed for 15 (v/v) aqueous ethanol, should be applicable to the determination in 10 (v/v) aqueous ethanol.
This part of this European Standard specifies methods for the determination of monoethylene glycol and diethylene glycol in the food simulants; water, 3 % w/v acetic acid, 15 % v/v ethanol and olive oil and other fatty food simulants, simulants D, e.g. a mixture of synthetic triglycerides or sunflower oil or corn oil. The methods are capable of determining monoethylene glycol and diethylene glycol in food simulants separately, or combined, at the specific migration limit SML (T) of 30 mg/kg. NOTE This method was developed for the determination of monoethylene glycol and diethylene glycol in 15 % v/v aqueous ethanol, as required by the regulations in force at the time the development work was carried out. However, this method, developed for 15 (v/v) aqueous ethanol, should be applicable to the determination in 10 (v/v) aqueous ethanol.
EN 13130-7:2004 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 13130-7:2004 has the following relationships with other standards: It is inter standard links to ENV 13130-7:1999. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13130-7:2004 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 - Substanzen in Kunststoffen, die Beschränkungen unterliegen - Teil 7: Bestimmung von Monoethylenglycol und Diethylenglycol in PrüflebensmittelnMatériaux et objets en contact avec les denrées alimentaires - Substances dans les matieres plastiques soumises a des limitations - Partie 7 : Détermination du monoéthylene glycol et du diéthylene glycol dans les simulants d'alimentsMaterials and articles in contact with foodstuffs - Plastics substances subject to limitation - Part 7: Determination of monoethylene glycol and diethylene glycol in food simulants67.250Materiali in predmeti v stiku z živiliMaterials and articles in contact with foodstuffsICS:Ta slovenski standard je istoveten z:EN 13130-7:2004SIST EN 13130-7:2004en,fr,de01-september-2004SIST EN 13130-7:2004SLOVENSKI
STANDARDSIST ENV 13130-7:20001DGRPHãþD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13130-7May 2004ICS 67.250English versionMaterials and articles in contact with foodstuffs - Plasticssubstances subject to limitation - Part 7: Determination ofmonoethylene glycol and diethylene glycol in food simulantsMatériaux et objets en contact avec les denréesalimentaires - Substances dans les matières plastiquessoumises à des limitations - Partie 7 : Détermination dumonoéthylène glycol et du diéthylène glycol dans lessimulants d'alimentsWerkstoffe und Gegenstände in Kontakt mit Lebensmitteln- Substanzen in Kunststoffen, die Beschränkungenunterliegen - Teil 7: Bestimmung von Monoethylenglykolund Diethylenglykol in Lebensmittel-SimulantienThis European Standard was approved by CEN on 24 March 2004.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 Central Secretariat 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 Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2004 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13130-7:2004: ESIST EN 13130-7:2004
EN 13130 are as follows. Part 1: Guide to test methods for the specific migration of substances from plastics to foods and food simulants and the determination of substances in plastics and the selection of conditions of exposure to food simulants Part 2: Determination of terephthalic acid in food simulants Part 3: Determination of acrylonitrile in food and food simulants Part 4: Determination of 1,3-butadiene in plastics
Part 5: Determination of vinylidene chloride in food simulants Part 6: Determination of vinylidene chloride in plastics Part 8: Determination of isocyanates in plastics Part 9: Determination of acetic acid, vinyl ester in food simulants Part 10: Determination of acrylamide in food simulants
Part 11: Determination of 11-aminoundecanoic acid in food simulants
Part 12: Determination of 1,3-benzenedimethanamine in food simulants Part 13: Determination of 2,2-bis(4-hydroxyphenyl)propane (Bisphenol A) in food simulants Part 14: Determination of 3,3-bis(3-methyl-4-hydroxyphenyl)-2-indoline in food simulants SIST EN 13130-7:2004
Part 16: Determination of caprolactam and caprolactam salt in food simulants Part 17: Determination of carbonyl chloride in plastics
Part 18: Determination of 1,2-dihydroxybenzene, 1,3- dihydroxybenzene, 1,4- dihydroxybenzene, 4,4’-dihydroxybenzophenone and 4,4’dihydroxybiphenyl in food simulants Part 19: Determination of dimethylaminoethanol in food simulants Part 20: Determination of epichlorohydrin in plastics Part 21: Determination of ethylenediamine and hexamethylenediamine in food simulants Part 22: Determination of ethylene oxide and propylene oxide in plastics Part 23: Determination of formaldehyde and hexamethylenetetramine in food simulants Part 24: Determination of maleic acid and maleic anhydride in food simulants Part 25: Determination of 4-methyl-pentene in food simulants Part 26: Determination of 1-octene and tetrahydrofuran in food simulants Part 27: Determination of 2,4,6-triamino-1,3,5-triazine in food simulants Part 28: Determination of 1,1,1-trimethylopropane in food simulants
Parts 1 to 8 are European Standards.
Parts 9 to 28 are Technical Specifications, prepared within the Standards, Measurement and Testing project, MAT1-CT92-0006, “Development of Methods of Analysis for Monomers”. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. SIST EN 13130-7:2004
Residues of monoethylene glycol and diethylene glycol can remain in the plastic after processing to form materials and articles for food contact use, and can migrate into foodstuffs.
NOTE Commission Directive 2002/72/EC lists a combined specific migration limit of 30 mg/kg (T) of monoethylene glycol and diethylene glycol in foods or food simulants.
1 Scope This part of this European Standard specifies methods for the determination of monoethylene glycol and diethylene glycol in the food simulants; water, 3 % (w/v) acetic acid, 15 % (v/v) ethanol and olive oil and other fatty food simulants, simulants D, e.g. a mixture of synthetic triglycerides or sunflower oil or corn oil.
The methods are capable of determining monoethylene glycol and diethylene glycol in food simulants separately, or combined, at the specific migration limit SML (T) of 30 mg/kg.
NOTE This method was developed for the determination of monoethylene glycol and diethylene glycol in 15 % (v/v) aqueous ethanol, as required by the regulations in force at the time the development work was carried out.
However, this method, developed for 15 (v/v) aqueous ethanol, should be applicable to the determination in 10 (v/v) aqueous ethanol. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications.
These normative references are cited at the appropriate places in the text, and the publications are listed hereafter.
For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision.
For undated references the latest edition of the publication referred to applies (including amendments).
EN 13130-1:2004, Materials and articles in contact with foodstuffs - Plastics substances subject to limitation - Part 1: Guide to test methods for the specific migration of substances from plastics to foods and food simulants and the determination of substances in plastics and the selection of conditions of exposure to food simulants. EN ISO 1042; Laboratory glassware – One-mark volumetric flasks (ISO 1042:1998). ISO 385 (all parts), Laboratory glassware – Burettes. ISO 835 (all parts); Laboratory glassware – Graduated pipettes. ISO 4788, Laboratory glassware – Graduated measuring cylinders. 3 Principle After addition of an internal standard the aqueous food simulants or the olive oil water extract is directly injected for gas chromatographic analysis using a cold on-column injector.
Detection limits are approximately 1 mg/kg in the food simulants.
The concentrations of monoethylene glycol and diethylene glycol are measured by comparison of peak height or area ratios against standards. 4 Reagents WARNING:
All chemicals are hazardous to health to a greater or lesser extent.
It is beyond the scope of this standard to give instructions for the safe handling of all chemicals, that meet, in full, the legal obligations in all countries in which this standard may be followed.
Therefore, specific warnings are not given and users of this standard shall ensure that they meet all the necessary safety requirements in their own country. 4.1 Methanol
4.2 Monoethylene glycol SIST EN 13130-7:2004
4.4 Butan-1,4-diol, internal standard 4.5 Water (HPLC or deionized)
4.6 Heptane
4.7 Prepare a monoethylene glycol and diethylene glycol standard stock solution as follows:
Weigh accurately about 0,75 g each of monoethylene glycol and diethylene glycol into a beaker, dissolve in methanol and transfer with washings to a 100 ml volumetric flask. Dilute to the mark with methanol. This solution is stable for 1 month if stored in the dark at 5 °C in a stopped flask. Prepare a second stock solution for validation purposes, see 7.2.2.
4.8 Prepare a butan-1,4-diol internal standard stock solution as follows:
Weigh about 1 g of butan-1,4-diol into a beaker, dissolve in methanol and make up to 100 ml mark with methanol in a volumetric flask.
This solution is stable for 1 month if stored in the dark at 5 °C in a stoppered flask.
5 Apparatus 5.1 Analytical balance capable of weighing to 0,1 mg. 5.2 Graduated pipettes, conforming to the minimum requirements of ISO 835 and of 1 ml and 2 ml capacity. 5.3 Burette, conforming to the minimum requirements of ISO 385 and of 25 ml capacity. 5.4 Volumetric flasks, conforming to the minimum requirements of EN ISO 1042 and of 25 ml, 50 ml and
100 ml capacity. 5.5 Separating funnels with polytetrafluoroethylene stopcock, of 250 ml capacity. 5.6 Glass syringe, of 50 ml capacity. 5.7 0,2 µm disposable HPLC filters, or disposable C18 solid phase extraction cartridges 400 mg size.
5.8 Measuring cylinders, conforming to the minimum requirements of ISO 4788 and of 25 ml and 50 ml
capacity. 5.9 Gas chromatograph (GC) fitted with a flame ionization detector (FID) and a cold on-column injector.
NOTE 1 This method has been developed for use with cold on-column injectors, which are available from all major GC suppliers.
Previous studies at other
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記事のタイトル：EN 13130-7:2004 - 食品と接触する材料 - 制限を受けるプラスチック材料 - 第7部：食品模擬体中のモノエチレングリコールおよびジエチレングリコールの決定 記事の内容：この欧州規格の一部である本部分は、食品模擬体である水、3％ w/v 酢酸、15％ v/v エタノール、オリーブオイルなどの脂肪性食品模擬体、模擬体D（合成トリグリセリドやひまわり油、とうもろこし油などの混合物）中のモノエチレングリコールおよびジエチレングリコールの決定方法を規定しています。この方法は、モノエチレングリコールおよびジエチレングリコールを食品模擬体で個別にまたは組み合わせて30 mg/kgの特定の移行限界SML（T）で決定することができます。 注：この方法は、開発作業が行われた時点での有効な規制に従って、15％ v/v 水性エタノール中のモノエチレングリコールおよびジエチレングリコールの決定のために開発されました。ただし、この方法は、10％ v/v 水性エタノール中の決定にも適用できるとされています。
The article discusses European Standard EN 13130-7:2004, which focuses on the testing and determination of monoethylene glycol and diethylene glycol in food simulants. The methods outlined in the standard can be used to measure the presence of these substances separately or combined, at a specific migration limit of 30 mg/kg. It is noted that the method was primarily developed for testing in 15% aqueous ethanol, but it should also be suitable for testing in 10% aqueous ethanol.
기사 제목: EN 13130-7:2004 - 식품과 접촉하는 소재 - 제한을 받는 플라스틱 물질 - Part 7: 식품 대용액에서 단일에틸렌 글리콜과 디에틸렌 글리콜의 결정. 기사 내용: 이 유럽 표준의 일부인 이 부분은 식품 대용액인 물, 3 % w/v 초산, 15 % v/v 에탄올 및 올리브 오일과 기타 지방 식품 대용액인 대용액 D (합성 트리글리세라이드 또는 해바라기 오일 또는 옥수수 오일과 같은 혼합물)에서 단일에틸렌 글리콜과 디에틸렌 글리콜을 결정하기 위한 방법을 명시합니다. 이 방법은 단일에틸렌 글리콜과 디에틸렌 글리콜을 식품 대용액에서 분리하여 30 mg/kg의 구체적인 이주 한계인 SML (T)에서 결정할 수 있습니다. 참고: 이 방법은 개발 작업이 진행된 시점에서 유효한 규정에 따라 15 % v/v 수용성 에탄올에서 단일에틸렌 글리콜과 디에틸렌 글리콜을 결정하기 위해 개발되었습니다. 그러나 이 방법은 10 % v/v 수용성 에탄올에서의 결정에도 적용될 수 있다고 언급됩니다.
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