Paper and board intended to come into contact with foodstuffs - Determination of the transfer of antimicrobial constituents

This European Standard specifies a method for the determination of transfer of antimicrobial constituents from paper and board materials and articles intended for food contact.
NOTE   The need of using this Standard can be specified by the legislation regarding paper and board intended to come into contact with foodstuffs.

Papier und Pappe vorgesehen für den Kontakt mit Lebensmitteln - Bestimmung des Übergangs antimikrobieller Bestandteile

Diese Europäische Norm legt ein Verfahren zur Bestimmung der Übertragung antimikrobieller Bestandteile von Materialien und Artikeln, bestehend aus Papier, Karton und Pappe fest, die für den Kontakt mit Lebensmitteln vorgesehen sind.
ANMERKUNG   Die Notwendigkeit der Verwendung dieser Norm kann durch die Vorschrift für Papier und Pappe, die für den Kontakt mit Lebensmitteln vorgesehen sind, festgelegt sein.

Papier et carton destinés à entrer en contact avec les denrées alimentaires - Détermination du transfert des constituants antimicrobiens

La présente Norme européenne spécifie une méthode de détermination du transfert des constituants antimicrobiens des papiers, cartons et articles destinés à entrer en contact avec des denrées alimentaires.
NOTE   La nécessité d’utiliser la présente norme peut être spécifiée par la législation relative au papier et au carton destinés à entrer en contact avec des denrées alimentaires.

Papir, karton in lepenka v neposrednem stiku z živili - Določanje izločanja antimikrobnih snovi

Ta evropski standard določa metodo za določanje izločanja antimikrobnih snovi iz papirnatih in kartonskih materialov ter izdelkov, namenjenih za stik z živili.
OPOMBA:   Potreba po uporabi tega standarda je lahko določena z zakonodajo v zvezi s papirjem in kartonom, namenjenim za neposreden stik z živili.

General Information

Status
Published
Public Enquiry End Date
04-Sep-2017
Publication Date
05-Dec-2018
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
26-Nov-2018
Due Date
31-Jan-2019
Completion Date
06-Dec-2018

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Papier und Pappe vorgesehen für den Kontakt mit Lebensmitteln - Bestimmung des Übergangs antimikrobieller BestandteilePapier et carton destinés à entrer en contact avec les denrées alimentaires - Détermination du transfert des constituants antimicrobiensPaper and board intended to come into contact with foodstuffs - Determination of the transfer of antimicrobial constituents85.060Papir, karton in lepenkaPaper and board67.250Materiali in predmeti v stiku z živiliMaterials and articles in contact with foodstuffsICS:Ta slovenski standard je istoveten z:EN 1104:2018SIST EN 1104:2019en,fr,de01-januar-2019SIST EN 1104:2019SLOVENSKI

STANDARDSIST EN 1104:20051DGRPHãþD
SIST EN 1104:2019
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1104
November
t r s z ICS
x yä t w râ
z wä r x r English Version

Paper and board intended to come into contact with foodstuffs æ Determination of the transfer of antimicrobial constituents Papier et carton destinés à entrer en contact avec les denrées alimentaires æ Détermination du transfert des constituants antimicrobiens

Papier und Pappe vorgesehen für den Kontakt mit Lebensmitteln æ Bestimmung des Übergangs antimikrobieller Bestandteile This European Standard was approved by CEN on

s w July
t r s zä

egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä

translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä

CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä

EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre:
Rue de la Science 23,
B-1040 Brussels

t r s z CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN

s s r vã t r s z ESIST EN 1104:2019
EN 1104:2018 (E) 2 Contents

Page European foreword ....................................................................................................................................................... 4 1 Scope .................................................................................................................................................................... 5 2 Normative references .................................................................................................................................... 5 3 Terms and definitions ................................................................................................................................... 5 4 Principle ............................................................................................................................................................. 5 5 Apparatus ........................................................................................................................................................... 6 6 Reagents and media ....................................................................................................................................... 6 6.1 General ................................................................................................................................................................ 6 6.2 Non ionic wetting agent ................................................................................................................................ 6 6.3 Nutrient medium for the preparation of Bacillus subtilis spores .................................................. 6 6.3.1 Composition ...................................................................................................................................................... 6 6.3.2 Preparation ....................................................................................................................................................... 6 6.4 Nutrient medium of Sabouraud for the preparation of Aspergillus niger spores .................... 7 6.4.1 Composition ...................................................................................................................................................... 7 6.4.2 Preparation ....................................................................................................................................................... 7 6.5 Nutrient medium for the inhibition test with Bacillus subtilis ....................................................... 7 6.5.1 Composition ...................................................................................................................................................... 7 6.5.2 Preparation ....................................................................................................................................................... 7 6.6 Nutrient medium of modified Sabouraud for the inhibition test with Aspergillus niger ..................................................................................................................................................................... 8 6.6.1 Composition ...................................................................................................................................................... 8 6.6.2 Preparation ....................................................................................................................................................... 8 6.7 Tryptone salt solution ................................................................................................................................... 8 6.7.1 Composition ...................................................................................................................................................... 8 6.7.2 Preparation ....................................................................................................................................................... 8 6.8 Test microorganisms ..................................................................................................................................... 8 6.8.1 General ................................................................................................................................................................ 8 6.8.2 Preparation of working cultures ............................................................................................................... 8 6.8.3 Preparation of inoculating spore suspension of Bacillus subtilis .................................................. 9 6.8.4 Preparation of inoculating spore suspension of Aspergillus niger ............................................... 9 6.8.5 Concentrations of spores for inhibition test ......................................................................................... 9 6.9 Positive controls ........................................................................................................................................... 10 6.9.1 Antibiotic ......................................................................................................................................................... 10 6.9.2 Antifungal agent ........................................................................................................................................... 10 7 Sampling and preparation of test pieces ............................................................................................. 10 8 Procedure........................................................................................................................................................ 10 8.1 General ............................................................................................................................................................. 10 8.2 Preparation of plates .................................................................................................................................. 10 8.2.1 General ............................................................................................................................................................. 10 8.2.2 Test with Bacillus subtilis .......................................................................................................................... 10 8.2.3 Test with Aspergillus niger ....................................................................................................................... 11 8.3 Incubation ....................................................................................................................................................... 11 9 Evaluation ....................................................................................................................................................... 11 SIST EN 1104:2019

EN 1104:2018 (E) 3 10 Test report ...................................................................................................................................................... 12 Annex A (informative)

Guidelines for interpreting results ........................................................................ 13 A.1 General ............................................................................................................................................................. 13 A.2 Negative and positive controls ................................................................................................................ 13 A.2.1 Negative controls .......................................................................................................................................... 13 A.2.2 Positive controls ........................................................................................................................................... 14 A.3 Paper and board samples .......................................................................................................................... 15 A.3.1 General ............................................................................................................................................................. 15 A.3.2 Case of Bacillus subtilis ............................................................................................................................... 15 A.3.3 Case of Aspergillus niger ............................................................................................................................. 19

SIST EN 1104:2019

EN 1104:2018 (E) 4 European foreword This document (EN 1104:2018) has been prepared by Technical Committee CEN/TC 172 “Pulp, paper and board”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2019, and conflicting national standards shall be withdrawn at the latest by May 2019. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 1104:2005. With regards to EN 1104:2005 the following changes have been made: a) The definition of the inhibition zone has been clarified; b) Modified Sabouraud nutrient medium for the preparation of Aspergillus niger spores has been replaced by 4 % Sabouraud; c) Guidelines for interpreting the results in Annex A have been added, including figures: these guidelines are intended to aid the interpretation of results obtained in the framework of application of EN 1104 standard for the various controls performed and for the samples tested; d) Editorial updating. According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 1104:2019

EN 1104:2018 (E) 5 1 Scope This document specifies a method for the determination of transfer of antimicrobial constituents from paper and board materials and articles intended for food contact. NOTE The need of using this Standard may be specified by the legislation regarding paper and board intended to come into contact with foodstuffs. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN ISO 186, Paper and board — Sampling to determine average quality (ISO 186) EN ISO 7218, Microbiology of food and animal feeding stuffs — General requirements and guidance for microbiological examinations (ISO 7218) EN ISO 11133, Microbiology of food, animal feed and water — Preparation, production, storage and performance testing of culture media (ISO 11133) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses:

IEC Electropedia: available at http://www.electropedia.org/

ISO Online browsing platform: available at http://www.iso.org/obp 3.1 inhibition zone obvious area in which growth is absent and which forms around test pieces placed on a nutrient medium inoculated with a preselected test microorganism, due to the release of water-soluble antimicrobial constituents; proof of the presence of an inhibition zone is provided by the absence of test micro-organism growth (translucent zone) in a minimum of 2 mm width zone at the edges of the test pieces 4 Principle A prepared nutrient medium is mixed with an appropriate inoculum and poured into Petri dishes. The test pieces are placed on the nutrient medium before its complete solidification and then incubated. When incubation is terminated, the existence of an inhibition zone is an indicator of the release of antimicrobial constituents. The test is performed with a bacterium, Bacillus subtilis, and with a fungus, Aspergillus niger. NOTE The result is based on a visual decision. SIST EN 1104:2019

EN 1104:2018 (E) 6 5 Apparatus All laboratory equipment and parts of the equipment shall be as described in the EN ISO 7218. 5.1 Punch iron Diameter = 10 mm to 15 mm, sterilizable. 5.2 Pressing device suitable for pressing the test pieces on the agar plates (e.g. Drigalski spatula). 5.3 Zone reading device (facultative) allowing the measurement of the width of the inhibition zone. NOTE Measuring the width of the inhibition zone is not compulsory. 6 Reagents and media 6.1 General When water is mentioned in a formula, use distilled water or purified water, as mentioned in EN ISO 11133. For preparing culture media, general requirements are described in EN ISO 11133. Culture media shall be prepared as follows, or from commercially available dehydrated culture media according to the manufacturer's instructions. Ready-to-use medium may be used when its composition and/or growth performance is comparable to that of formula given hereafter. (according to EN ISO 11133). 6.2 Non ionic wetting agent For example polyoxyethylenesorbitane monooleate. 6.3 Nutrient medium for the preparation of Bacillus subtilis spores 6.3.1 Composition — Beef extract 3,0 g — Peptone from casein, tryptic digest 5,0 g — Sodium chloride, pure 5,0 g — Agar-agar 12,0 g — Water 1 000,0 ml NOTE The addition of 10 mg/l MnSO4 to the nutrient medium for Bacillus subtilis will support the formation of spores. 6.3.2 Preparation Dissolve the components, or a dehydrated ready-to-use medium, in the water by mixing while heating. Separate the nutrient medium into two parts: — Dispense one part in 300,0 ml portions into 600,0 ml sterile flasks, for example Roux flasks, closed with filter screw caps. — Use the other part for the preparation of the working culture media into test tubes: dispense 10,0 ml portions into 15 to 20 test tubes and seal them with stoppers, for example cellulose stoppers. SIST EN 1104:2019

EN 1104:2018 (E) 7 Sterilize flasks and test tubes in an autoclave for 15 min at 121 °C. After sterilization, the pH shall be equivalent to 7,2 ± 0,2 when measured at 45 °C. Before solidification, position the test tubes in such a way that the nutrient medium solidifies with a sloping surface. Medium may be stored according to EN ISO 11133 prescriptions. 6.4 Nutrient medium of Sabouraud for the preparation of Aspergillus niger spores 6.4.1 Composition — Peptone from casein, tryptic digest 5,0 g — Meat peptone 5,0 g — D (+) glucose C6H12O6 H2O (Dextrose) 40,0 g — Agar-agar 10,0 g to 15,0 g — Water 1 000,0 ml 6.4.2 Preparation Dissolve the components, or a dehydrated ready-to-use medium, in the water by mixing while heating. Proceed as described in 6.3 by dispensing the medium into sterile flasks or Roux flasks and sterile test tubes. Sterilize in an autoclave for 15 min at 121 °C. After sterilization, the pH shall be equivalent to 5,6 ± 0,2, when measured at 25 °C. 6.5 Nutrient medium for the inhibition test with Bacillus subtilis 6.5.1 Composition — Peptone from casein, tryptic digest 3,45 g — Meat peptone 3,45 g — Sodium chloride, pure 5,1 g — Agar-agar 13,0 g — Water 1 000,0 ml 6.5.2 Preparation Dissolve the components, or a dehydrated ready-to-use medium, in the water by mixing while heating. Dispense the medium into sterile flasks and close them with filter screw caps. Sterilize in an autoclave for 15 min at 121 °C. After sterilization, the pH shall be equivalent to 6,0 ± 0,2, when measured at 45 °C. Cool the flasks to below 60 °C for the preparation of the inoculation medium (8.2.2) or allow to solidify. Medium may be stored according to EN ISO 11133 prescriptions. SIST EN 1104:2019

EN 1104:2018 (E) 8 6.6 Nutrient medium of modified Sabouraud for the inhibition test with Aspergillus niger 6.6.1 Composition — Peptone from casein, tryptic digest 5,0 g — Meat peptone 5,0 g — D (+) glucose C6H12O6 H2O (Dextrose) 10,0 g — Maltose C12H22O11 H2O 10,0 g — Agar-agar 10,0 g to 15,0 g — Water 1 000,0 ml 6.6.2 Preparation Dissolve the components, or a dehydrated ready-to-use medium, in the water by mixing while heating. Dispense the medium into steri

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