EN 13628-1:2002
(Main)Packaging - Flexible packaging material - Determination of residual solvents by static headspace gas chromatography - Part 1: Absolute methods
General Information
- Abstract
This part 1 describes methods for the quantitative determination of residual solvents in flexible packaging by static headspace chromatography. The chemical identities of the residual solvents to be determined by this must be known before commencing the analysis. During the analysis there may be interferences from possible products of thermal decomposition. Residues from thermal decomposition products are not within the scope of this standard. Additional peaks due to these products shall not be considered for evaluation of residual solvents.
- Status
- Published
- Publication Date
- 15-Oct-2002
- Technical Committee
- CEN/TC 261 - Packaging
- Current Stage
- 9093 - Decision to confirm - Review Enquiry
- Start Date
- 11-Sep-2024
- Completion Date
- 17-Sep-2026
Overview
EN 13628-1:2002 is a CEN European standard for the quantitative determination of residual solvents in flexible packaging materials by static headspace gas chromatography (HS-GC). Part 1 defines absolute methods where the chemical identities of the solvents to be measured are known in advance. The standard applies to mono- or multilayer plastic films, paper/board, foils and combinations, and excludes residues arising from thermal decomposition products. It also does not cover solvent amounts below 0.5 mg/m².
Key topics and requirements
- Analytical principle: Place specimen in a hermetically sealed vial, heat to vaporize solvents into the headspace and transfer an aliquot to a gas chromatograph for quantification.
- Two validated approaches:
- Multiple Headspace Extraction (MHE) - suitable for automated/semi-automated headspace samplers; uses external or internal standards and repeated extractions for accurate quantification.
- Standard Addition - used when manual or non-pressurized sampling (heated gas-tight syringe/loop) is employed.
- Sampling and specimen preparation: Prevent loss or contamination of volatiles; specimen area to vial volume ratio should be between 3 and 5 (cm²/ml); roll samples preferred; sheets handled/packed to avoid atmospheric contamination.
- Incubation: Heating temperature and time must be optimized per material/solvent system to reach partition equilibrium (example guidance: 100 °C for 60 min, though 80–150 °C and 15–60 min are also referenced). Temperature control within ±2 °C is recommended.
- Apparatus & reagents: Gas chromatograph with flame ionization detector, appropriate headspace vials and septa (PTFE-lined elastomers), automatic headspace sampler for MHE, and chromatographic columns suitable for solvent separation (examples for packed and capillary columns are given).
- Exclusions: Peaks from thermal decomposition products may appear during heating but shall not be evaluated as residual solvents.
Applications and users
- Who uses it: Packaging manufacturers, quality control laboratories, contract testing labs, regulatory compliance teams, and materials R&D groups involved in food packaging, medical packaging or consumer goods where solvent residues must be quantified.
- Practical uses:
- Routine QC checks for solvent residues in flexible films and laminates.
- Verification of process solvent removal after printing, coating or lamination.
- Supporting regulatory compliance and safety assessments for packaged products.
Related standards
- EN 13628-2 (Industrial methods) - companion part for industrial-scale testing.
- ISO 5725-2 - referenced for precision (repeatability/reproducibility) assessment.
Keywords: EN 13628-1:2002, residual solvents, static headspace gas chromatography, flexible packaging, multiple headspace extraction, standard addition, headspace sampler, packaging materials.
Relations
- Effective Date
- 25-Aug-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 13628-1:2002 is a standard published by the European Committee for Standardization (CEN). Its full title is "Packaging - Flexible packaging material - Determination of residual solvents by static headspace gas chromatography - Part 1: Absolute methods". This standard covers: This part 1 describes methods for the quantitative determination of residual solvents in flexible packaging by static headspace chromatography. The chemical identities of the residual solvents to be determined by this must be known before commencing the analysis. During the analysis there may be interferences from possible products of thermal decomposition. Residues from thermal decomposition products are not within the scope of this standard. Additional peaks due to these products shall not be considered for evaluation of residual solvents.
This part 1 describes methods for the quantitative determination of residual solvents in flexible packaging by static headspace chromatography. The chemical identities of the residual solvents to be determined by this must be known before commencing the analysis. During the analysis there may be interferences from possible products of thermal decomposition. Residues from thermal decomposition products are not within the scope of this standard. Additional peaks due to these products shall not be considered for evaluation of residual solvents.
EN 13628-1:2002 is classified under the following ICS (International Classification for Standards) categories: 55.040 - Packaging materials and accessories. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 13628-1:2002 has the following relationships with other standards: It is inter standard links to ISO 5725-2:1994, ENV 14237:2002, CEN/TS 13778:2004. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13628-1:2002 is associated with the following European legislation: EU Directives/Regulations: 80/232/EEC, 87/356/EEC. 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.
EN 13628-1:2002 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Verpackung - Flexible Packstoffe - Bestimmung der Restlösemittel durch statische Dampfraumanalyse mittels Gaschromatographie - Teil 1: Absolute VerfahrenEmballage - Matériaux d'emballages souples - Détermination des solvants résiduels par chromatographie en phase gazeuse et espace de tete statique - Partie 1: Méthodes absoluesPackaging - Flexible packaging material - Determination of residual solvents by static headspace gas chromatography - Part 1: Absolute methods55.040SDNLUDQMHPackaging materials and accessoriesICS:Ta slovenski standard je istoveten z:EN 13628-1:2002SIST EN 13628-1:2003en01-julij-2003SIST EN 13628-1:2003SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13628-1October 2002ICS 55.040English versionPackaging - Flexible packaging material - Determination ofresidual solvents by static headspace gas chromatography -Part 1: Absolute methodsEmballage - Matériaux d'emballages souples -Détermination des solvants résiduels par chromatographieen phase gazeuse et espace de tête statique - Partie 1:Méthodes absoluesVerpackung - Flexible Packstoffe - Bestimmung derRestlösemittel durch statische Dampfraumanalyse mittelsGaschromatographie - Teil 1: Absolute VerfahrenThis European Standard was approved by CEN on 26 August 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 13628-1:2002 ESIST EN 13628-1:2003
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