CEN/TC 194/SC 1 - General chemical methods of test for materials and articles intended to come into contact with foods

This European standard describes the determination of NOGE components with more than two aromatic rings (the two-ring NOGE is equal to BFDGE = Bis(2-hydroxyphenyl)methane bis(2,3-epoxypropyl)ether) and at least one epoxy group as well as their derivatives containing chlorohydrin functions and having a molecular mass less than 1000 Daltons in can coatings.
A high performance liquid chromatography (HPLC) method is employed based on reversed phase HPLC and fluorescence detection.
The method is capable of determining NOGE and its derivatives at a minimum level of 1 mg/ml in solution.
Direct HPLC analysis of the can coating extract may result in chromatograms difficult to interpret, due to interference from other components or the instability of the monomer resulting in a complex mixture of derivatives and/or reaction products. By forced hydrolysis of all epoxy groups and their reaction products, the quantification of the NOGE is simplified and the identities of the substances are indicatively confirmed.
NOTE   In this European standard the term “NOGE and its derivatives” refers to the requirements of Directive 2002/16/EC [1]. This includes NOGE components with more than two aromatic rings and at least one epoxy group as well as their derivatives containing chlorohydrin functions and having a molecular mass less than 1000 Daltons.

This European standard describes a method for the determination of BADGE, BFDGE and their reaction products in food simulants: distilled water, 3 % w/v aqueous acetic acid, 10 % v/v aqueous ethanol solution and olive oil or sunflower oil.
A high performance liquid chromatography (HPLC) method is employed based on reversed phase HPLC and fluorescence detection.
The method is capable of determining BADGE and its derivatives at a minimum level of 0,05 µg/ml food simulant.
BFDGE and its derivatives can be determined at a minimum level of 0,1 µg/ml food simulant.
Direct HPLC analysis of the migration solutions may result in chromatograms difficult to interpret, due to interference from other components or the instability of the monomers resulting in a complex mixture of derivatives and/or reaction products. By forced hydrolysis of all epoxy groups and their reaction products, the quantification of the relevant substances is simplified and in addition the identities of the substances are indicatively confirmed.
NOTE   In this European standard the term “BADGE, BFDGE and their derivatives” refers to the substances listed in Directive 2002/16/EC. These substances are listed in 4.1.

This Technical Report gives guidance in support of Directives adopted by the European Union in the Food Contact Materials Sector and is intended to aid Food Control Authorities and industry enforce and comply with those Directives.

This Technical Specification, part of EN 13031, specifies an analytical procedure for the determination of acrylamide in the food simulants water, 3 % w/v aqueous acetic acid, 15 % v/v aqueous ethanol and fat simulant. The level of acrylamide monomer determined is expressed as milligrams of acrylamide/kg of food simulant. The method is appropriate for the quantitative determination of acrylamide in approximate analyte concentration range of 0,01 mg/kg to 0,1 mg/kg of food simulants.
The method should also be applicable to other fat simulants.
NOTE   The suitability of the fat simulant should be assessed prior to setting up migration tests - it may be found necessary to use sunflower oil or a mixture of synthetic triglycerides if unacceptable interferences are found with olive oil.

This document, part of EN 13130, specifies a procedure for the determination of 1,3-benzenedimethanamine (also known as 3-(aminomethyl)-benzylamine or m-xylylene diamine (m-XDA)) monomer, hereinafter referred to as m-XDA, in the food simulants water, 3 % w/v aqueous acetic acid, 15 % v/v aqueous ethanol and olive oil. The level of m-XDA monomer determined is expressed as milligrams of m-XDA per kilogram of food simulant in the above mentioned food simulants.
NOTE   In addition to the instability of m-XDA observed in olive oil, the test laboratory could not detect any
m-XDA peak from the olive oil work-up procedure. Based on some control checks, the assumption of the test laboratory was that the extraction from the olive oil does not work. Therefore, it is recommended that the food simulant 95 % ethanol or iso-octane be applied as substitute fatty simulants instead of olive oil.  It is believed that 95 % ethanol and iso-octane can be treated in the same way as 15 % v/v aqueous ethanol and olive oil simulant, respectively. Corresponding investigations were not possible within the project.

This document, part of EN 13130, specifies a method for the determination of Bisphenol A in the food simulants water, 3 % w/v acetic acid aqueous, 15 % v/v ethanol aqueous solution and rectified olive oil. The level of Bisphenol A monomer determined is expressed as milligrams Bisphenol A per kilogram of food simulant. The method is applicable to the quantitative determination of Bisphenol A at a minimum level of 0,2 mg/kg to 0,7 mg per kilogram of food simulants.
NOTE   The method should also be applicable to other aqueous food simulants as well as to the other fatty food simulants, sunflower oil and a mixture of synthetic triglycerides.

This document, part of EN 13130, specifies an analytical procedure for the determination of 3,3-bis(3-methyl-4-hydroxyphenyl)-2-indolinone in the food simulants water, 3 % w/v aqueous acetic acid, 15 % v/v aqueous ethanol and olive oil or approved substitute.  The level of
3,3-bis(3-methyl-4-hydroxyphenyl)-2-indolinone determined, is expressed as milligrams of
3,3-bis(3-methyl-4-hydroxyphenyl)-2-indolinone per kilogram of food or food simulant.  The method is applicable to the quantitative determination of 3,3-bis(3-methyl-4-hydroxyphenyl)-2-indolinone in an approximate analyte concentration range of 0,18 mg/kg to 4/ kg of food simulants.
NOTE 1   The method should also be applicable to other aqueous food simulants as well as to the other fatty food simulants e.g. a mixture of synthetic triglycerides or sunflower oil.
NOTE 2   The suitability of the fat simulant should be assessed prior to setting up migration tests. Olive oil has been found to give unacceptable interference in some cases.

This document, part of EN 13130, specifies an analytical procedure for the determination of ethylene oxide (EO) or propylene oxide (PO) in polymers.
The method is appropriate for the quantitative determination of ethylene oxide or propylene oxide in an analyte concentration range of approximately 0,2 mg/kg to 2 mg/kg of polymer.

This document, part of EN 13130, specifies an analytical procedure for the determination of butadiene monomer in the food simulants water, 3 % w/v aqueous acetic acid, 15 % v/v aqueous ethanol and olive oil. The level of butadiene monomer determined is expressed as mg butadiene/kg of food. The method is appropriate for the quantitative determination of butadiene at a range of 0,01 mg/kg to 0,1 mg/kg in food simulants.
NOTE   The method should also be applicable to other aqueous food simulants and to the other fatty food simulants such as sunflower oil and a mixture of synthetic triglycerides.

This document, part of EN 13130, specifies an analytical procedure for the determination of 4-methyl-1-pentene in food simulants distilled water, 3 % (w/v) aqueous acetic acid aqueous solution, 15 % (v/v) aqueous ethanol aqueous solution and rectified olive oil. The level of
4-methyl-1-pentene monomer determined is expressed as milligrams per kilogram of food simulant. In principle, the method is appropriate for the quantitative determination of 4-methyl-1-pentene at a minimum level of 0,005 mg/kg in all of the four food simulants. However, in the case of interferences, which have been observed for some olive oil batches, the detection limit can be compromised correspondingly.
NOTE   The method should also be applicable to other aqueous food simulants as well as to other fatty food simulants such as corn oil, sunflower oil and a mixture of synthetic triglycerides.

This document, part of EN 13130, specifies an analytical procedure for the determination of vinyl acetate in the four conventional EU food simulants, water, 10 % (v/v) ethanol aqueous solution; 3 % (w/v) acetic acid aqueous solution and olive oil or an approved substitute. The level of vinyl acetate monomer determined is expressed as milligrams of vinyl acetate per kilogram of food simulant. The method is appropriate for the quantitative determination of vinyl acetate in approximate analyte concentration range of 1,2 mg/kg to 24 mg/kg food simulant.
NOTE 1   The method should also be applicable to other aqueous food simulants as well as to other fatty food simulants such as sunflower oil and a mixture of synthetic triglycerides.
NOTE 2   The suitability of the fat simulant should be assessed prior to setting up migration tests - it may be found necessary to use sunflower oil or a mixture of synthetic triglycerides if unacceptable interferences are found with olive oil.

This document, part of EN 13130, specifies two methods as follows.
Method A is an analytical procedure for the determination of the monomers 1,2-DHB,
1,3-DHB and 1,4-DHB in the food simulants water, 3 % w/v aqueous acetic acid, 15 % v/v aqueous ethanol and olive oil. The levels of monomer determined are expressed in milligrams of monomer per kilogram of food simulant. The method is appropriate for the quantitative determination of 1,2-DHB and 1,3-DHB at a minimum level of 0,15 mg/kg in food simulants and, of 1,4-DHB at a minimum level of 0,10 mg/kg in food simulants.
Method B is an analytical procedure for the determination of DHBphen and DHBiph in the food simulants water, 3 % w/v aqueous acetic acid, 15 % v/v aqueous ethanol and olive oil. The method is appropriate for the quantitative determination of DHBphen or DHBiph at minimum levels of 0,2 mg/kg and 0,25 mg/kg, respectively, in food simulants.
NOTE   The methods should also be applicable to other aqueous food simulants as well as to the other fatty food simulants e.g. sunflower oil, corn oil or a mixture of synthetic triglycerides.

This document, part of EN 13130, specifies an analytical procedure for the determination of EDA monomer and HMDA monomer in the food simulants water, 3 % w/v aqueous acetic acid, 15 % v/v aqueous ethanol and olive oil as well as in the substitute food simulants 95 % v/v ethanol and iso-octane. The level of EDA monomer and HMDA monomer determined are expressed as milligram EDA per kilogram of food simulant and as milligrams HMDA per kilogram of food simulant. The method is appropriate for the quantitative determination of EDA at a minimum level of 1 mg per kilogram of food simulants and for the quantitative determination of HMDA at a minimum level of 0,5 mg per kilogram of food simulants.
The method should also be applicable to other aqueous food simulants as well as to the other fatty food simulants sunflower oil and a mixture of synthetic triglycerides.

This document, part of EN 13130, specifies an analytical procedure for the determination of carbonyl chloride monomer in polymers. The method is applicable to polycarbonate as well as to other polymers and copolymers where these are soluble in methylene chloride. The level of carbonyl chloride monomer determined is expressed as milligrams of carbonyl chloride per kilogram of polymer. The method is appropriate for the quantitative determination of carbonyl chloride at a minimum level of 0,3 mg per kilogram of polymer.

This document, part of EN 13130, specifies an analytical procedure for the determination of caprolactam in the food simulants distilled water, 3 % w/v aqueous acetic acid,
15 % v/v aqueous ethanol and rectified olive oil. The level of caprolactam monomer determined is expressed as mg caprolactam/kg of food or food simulant. The method is appropriate for the quantitative determination of caprolactam in an approximate analyte concentration range of 1,5mg/kg to 30 mg per kilogram of food simulant.
This method is also applicable to the determination of the specific migration of caprolactam sodium salt, PM/Ref No 14230, as caprolactam sodium salt instantaneously hydrolyzes to caprolactam when in contact with aqueous media.
NOTE   The method should also be applicable to other aqueous food simulants as well as to other fatty food simulants e.g. sunflower oil, a mixture of synthetic triglycerides and volatile substitutes for fat simulants.

This document, part of EN 13130, specifies an analytical procedure for the chemical conversion of HMTA to formaldehyde and the determination of formaldehyde in food simulants water, 3 % w/v aqueous acetic acid, 15 % v/v aqueous ethanol and rectified olive oil.
The method is appropriate for the quantitative determination of formaldehyde in approximate analyte concentration range of 3,0 mg to 30 mg formaldehyde per kilogram of food simulant, which corresponds to
2,3 mg to 23,3 mg hexamethylenetetramine per kilogram of food simulant.
NOTE   The method should also be applicable to other aqueous food simulants as well as to other fatty food simulants e.g. sunflower oil, corn oil or a mixture of synthetic triglycerides.

This document, part of EN 13031,13130, specifies an analytical procedure for the determination of 2,4,6-triamino-1,3,5-triazine in food simulants distilled water, 3 % (w/v) acetic acid aqueous solution, 15% (v/v) ethanol aqueous solution and rectified olive oil. The level of
2,4,6-triamino-1,3,5-triazine monomer determined is expressed as milligrams per kilogram food simulant. The method is appropriate for the quantitative determination of 2,4,6-triamino-1,3,5-triazine in approximate analyte concentration range of 2 mg/kg to 60 mg/kg food simulant.
NOTE   The method should also be applicable to other aqueous food simulants as well as to the other fatty food simulants e.g. sunflower oil, corn oil or a mixture of synthetic triglycerides.

This document, part of EN 13130, specifies an analytical procedure for the determination of residual epichlorohydrin in coatings.
The method is appropriate for the quantitative determination of epichlorohydrin in the analyte concentration range of 5 ng/ml to 80 ng/ml of extract.  In general this allows for the detection of epichlorohydrin at the level of 1 mg/kg of polymer or in the case of coatings, where the amount of polymer cannot be determined, detection of 1 µg epichlorohydrin per square decimetre of coating is feasible.
In order to obtain reliable and reproducible results, it is essential that the method described in this part of EN 13130 is followed as closely as possible.

This document, part of EN 13130, specifies an analytical procedure for the determination of 1,1,1-trimethylolpropane in food simulants distilled water, 3 % (w/v) acetic acid aqueous solution, 15 % (v/v) ethanol aqueous solution and rectified olive oil. The method is appropriate for the quantitative determination of 1,1,1-trimethylolpropane in approximate analyte concentration range of 0,6 mg/kg to 12 mg/kg food simulant.
NOTE   The method should also be applicable to other aqueous food simulants as well as to the other fatty food simulants e.g. sunflower oil, corn oil or a mixture of synthetic triglycerides.

This document, part of EN 13130, specifies analytical procedures for the determination of 1-octene and THF in food simulants water, 3 % w/v aqueous acetic acid, 15 % v/v aqueous ethanol and olive oil. The level of 1-octene and THF monomer determined is expressed as milligrams of monomer per kilogram of food simulant. The methods are appropriate for the quantitative determination of 1-octene in the range of 2 mg/kg to 30 mg/kg in food simulants and of THF in the range of 0,06 mg/kg to 1,5 mg/kg in food simulants.
NOTE   The method should also be applicable to other aqueous food simulants as well as to the other fatty food simulants e.g. sunflower oil, corn oil or a mixture of synthetic triglycerides.

This document, part of EN 13130, specifies a method for the determination of
11-aminoundecanoic acid in the food simulants water, 3 % w/v aqueous acetic acid, 15 % v/v aqueous ethanol, olive oil and iso-octane. The level of 11-aminoundecanoic acid determined is expressed as milligrams per kilogram of food simulant.
The method is appropriate for the quantitative determination of 11-amino-undecanoic acid in approximate analyte concentration range of 0,5 mg/kg to 10 mg/kg of food simulants.

This document, part of EN 13130, specifies an analytical procedure for the determination of maleic acid in the four conventional food simulants, water, 3 % w/v aqueous acetic acid, 15 % v/v aqueous ethanol and olive oil or approved substitute. The level of maleic acid determined is expressed as milligrams of maleic acid per kilogram of food or food simulant. The method is appropriate for the quantitative determination of maleic acid in approximate analyte concentration range of 5 mg/kg to 60 mg/kg in the above mentioned food simulants.
This method is also suitable for the determination of maleic anhydride in the four food simulants as the anhydride is hydrolyzed rapidly and completely to maleic acid during sample preparation. The level of maleic anhydride is then expressed as milligrams of maleic acid per kilogram of food simulant.
NOTE   The method should also be applicable to other aqueous food simulants as well as to the other fatty food simulants, e.g. sunflower oil, corn oil or a mixture of synthetic triglycerides. The suitability of the fat simulant should be assessed prior to setting up migration tests - it may be found necessary to use sunflower oil or HB 307 if unacceptable interferences are found with olive oil.

This document, part of EN 13130, specifies an analytical procedure for the determination of dimethylaminoethanol in food simulants: distilled water, 3 % w/v aqueous acetic acid, 15 % v/v aqueous ethanol and rectified olive oil. The method is appropriate for the quantitative determination of dimethylaminoethanol in an approximate analyte concentration range of 3,4 mg/kg to 36 mg per kilogram of food simulant.
NOTE   The method should also be applicable to other aqueous food simulants as well as to other fatty food simulants e.g. sunflower oil and a mixture of synthetic triglycerides.

This part of this European Standard specifies methods for the determination of the monomer terephthalic acid in food simulants; distilled water, 3 % w/v acetic acid aqueous solution, 15 % v/v ethanol aqueous solution 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 terephthalic acid in the food simulants at the level of the specific migration limit of 7,5 mg of terephthalic acid per kilogram of food simulants.
NOTE   This method was developed for the determination of terephthalic acid 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 a method for the determination of butadiene monomer in polymers.
The method is applicable to acrylonitrile-butadiene-styrene copolymer (ABS) and to high-impact polystyrene (HIPS) as well as to other 1,3-butadiene polymers and copolymers where these are soluble in N,N-dimethylacetamide or finely dispersed, swollen suspensions in N,N-dimethylacetamide. The level of 1,3-butadiene monomer determined is expressed as milligrams of 1,3-butadiene per kilogram of polymer.  The method is appropriate for the quantitative determination of 1,3-butadiene at a level of 0,1 mg/kg in the polymer.

This part of this European Standard specifies a method for the determination of vinylidene chloride (VdC) in plastics materials and articles.
The method is applicable to poly(vinylidene chloride) (PVdC) films, PVdC coated films, and laminates and coextruded materials containing PVdC.  The level of vinylidene chloride determined is expressed as milligrams of vinylidene chloride per kilogram of polymer.  The method is appropriate for the quantitative determination of vinylidene chloride at a level of 5 mg/kg in plastics materials and articles.

This part of this European Standard describes a method for the determination of individual and total levels of residual isocyanates in plastics materials and articles.
This method is applicable to the analysis of polyurethane polymers.  The total level of isocyanate monomers in materials and articles determined according to the procedure described in this standard is given in milligrams of NCO per kilogram of material or article.  The method is capable of quantitative determination of individual isocyanates measured as NCO at 0,04 mg/kg and total isocyanates at 1,0 mg/kg.
NOTE   The method has been applied to the analysis of 9 isocyanate monomers listed in 3.1.  It has not been applied to the analysis of octadecyl isocyanate, diphenylether-4,4'-diisocyanate or 3,3'-dimethyl-4,4'-diisocyanatobiphenyl as samples of these monomers have not been obtained.  There is no reason to anticipate that the method may not be suitable for the analysis of these monomers also.

This part of this European Standard specifies a method for the determination of acrylonitrile monomer in foods and food simulants. The method is applicable to aqueous food simulants, to the fatty food simulant olive oil and other fatty food simulants, simulants D, e.g. a mixture of synthetic triglycerides or sunflower oil or corn oil, as well as to liquid and solid foodstuffs such as beverages and soft margarine.  The level of acrylonitrile monomer determined is expressed as milligrammes of acrylonitrile per kilogram of food or food simulant.
The method is appropriate for the quantitative determination of acrylonitrile monomer at minimum levels of down to 0,01 mg/kg to 0,005 mg/kg, or lower, in food simulant, depending on the applied test conditions (see NOTE in 8.2.3).  With regard to the performance in the mentioned foodstuffs, in general, a direct detection limit of 0,02 mg/kg is achievable.
NOTE   This method was developed for the determination of acrylonitrile 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.

This part of this European Standard specifies a method for the determination of vinylidene chloride monomer in food simulants.  The method is applicable to aqueous food simulants, to the fatty food simulant olive oil and other fatty food simulants, simulants D, e.g. a mixture of synthetic triglycerides or sunflower oil or corn oil.  The level of vinylidene chloride determined is expressed as milligrams of vinylidene chloride per kilogram of food simulant.  The method is appropriate for the quantitative determination of vinylidene chloride at a level of 0,05 mg/kg.
NOTE   This method was developed for the determination of vinylidene chloride 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 provides a guide to the selection of the appropriate conditions of contact of food simulants with the test article before the determination of specific migration of those substances subject to a migration limit.
NOTE   According to Directive 90/128/EEC[2] the determination of the migration of specified components in foodstuffs instead of the use of simulants is permitted.  However, in that situation there is no need to give guidance on the test conditions of time and temperature as contact conditions shall be equal to conditions applied in real.
Also general guidance is given for the determination of the amount of the substance in the final plastics material or article.

This Technical Specification specifies a test method to determine the mass fraction of a polymeric additive that falls below a MW of 1000.  The method is applicable to polymeric additives per se - i.e. supplied in their usable form, before formulation into a plastic.  The method is also applicable to polymeric additives extracted from finished plastic materials and articles, provided that precautions are taken to ensure the absence of any interference from any other co-extractives derived from the plastic.

This Part of this European Standard specifies a test method to determine whether there is fatty contact and is applicable to all foods.  Testing some foods can require modifications to the method.  The method is applicable to contact situations from -20 °C to 100 °C.

This European Standard specifies methods to measure the temperature reached by plastics materials and articles in contact with foodstuffs during microwave heating and conventional oven heating in order to select the appropriate temperature for migration testing.  
It is applicable to all plastics materials and articles for which the food(s) with which they will come into contact under worst foreseeable conditions of use is/are known. This includes pre-packaged foods such as ready meals which will be heated in the packaging, and for foods which need some pre-preparation but which include the cooking container in the pack, e.g. cake mixes. The method is also suitable for plastics materials and articles to be used for preparing foods in the home or for use in commercial food preparation where the article is supplied as a stand-alone item, i.e. not containing or not including food at the point of sale.
NOTE   Although the method has been developed for plastics materials and articles, it is also applicable to other packaging materials including paper and board, rubber and elastomers, ceramics, glass etc. Temperature measurements using conventional oven heating are suitable for metal materials but these items should generally not be heated in microwave ovens due to possible problems with arcing.

This European Standard describes test methods for the determination of the overall migration into fatty food simulants from plastics materials and articles, by total immersion of test specimens in a fatty food simulant at temperatures from 100 °C up to and including, 175 °C for selected times.  Also described is a procedure with a substitute test medium.  In this substitute procedure the mass of components adsorbed on modified polyphenylene oxide (MPPO) is taken as a measure for the assessment of the overall migration into olive oil.
NOTE 1   The total immersion test method has been written for use with the fatty food simulant, olive oil.  The test method can also be used with appropriate modifications with 'other fatty food simulants ' called simulant D - a synthetic mixture of triglycerides, sunflower oil and corn oil.  These other fatty food simulants will produce different chromatograms for the simulant methyl esters to those of the methyl esters of olive oil.  Select suitable chromatogram peaks of the methyl esters of the other fatty food simulants for the quantitative determination of the simulant extracted from the test specimens.
NOTE 2   A comparative migration test carried out with polypropylene and polyethylene terephthalate high temperature application containers as test samples at conditions 2 h at 100 °C and 2 h at 175 °C, respectively, in contact with 14C-labelled synthetic triglyceride and MPPO provided test results comparable within the analytical tolerance of the methods.
NOTE 3   To obtain reproducible and repeatable results using the MPPO method it may be necessary to measure the temperature of the test specimen before starting the migration period.  An appropriate method for measuring the temperature of the test specimen needs to be established.
The described methods are most suitable for food contact articles in the form of sheets and films, but can also be applied to a wide range of articles and containers.

This European Standard describes test methods for the determination of the overall migration into fatty food simulants from plastics materials and articles into a mixture of 14C-labelled synthetic triglycerides at temperatures above 20 °C and up to, and including, 121 °C for selected times.
These methods are suitable for plastics in the form of films and sheets, a wide range of articles or containers from which test pieces of a suitable size can be cut and containers and articles that can be filled.
The test methods described are applicable to all plastics.

This part of this European Prestandard provides a guide to the selection of the appropriate conditions and methods of test for the determination of overall migration into food simulants from plastics which are intended to come into contact with foodstuffs.

This Technical Specification specifies test methods for 'alternative tests' and 'substitute tests' performed with volatile test media, iso-octane and a volume fraction of 95 % aqueous ethanol, for the determination of overall migration from polymeric coatings on paper and board intended to come into contact with fatty foodstuffs.
NOTE 1   It also includes guidance for the application of Council Directive 82/711/EEC [1], as last amended by Commission Directives  93/8/EC and  97/48/EC [2] [3] as regards the determination of the specific and overall migration into fatty food simulants (fat test) and includes a glossary to clarify the terminology used, see annex B.
NOTE 2   The iso-octane and a volume fraction of 95 % aqueous ethanol volatile test media used in these test methods are those specified for 'substitute tests' in Council Directive 82/711/EEC and its subsequent amendments. In addition to the use of iso-octane and 95 % v/v aqueous ethanol as test media for 'substitute tests', Council Directive 82/711/EEC and its subsequent amendments specifies the use of modified polyphenylene oxide as a test medium for use at temperatures of 100 °C and above.  A test method for overall migration from polymeric coatings intended to come into contact with fatty foodstuffs using modified polyphenylene oxide (MPPO) is in preparation.

This Technical Specification gives guidelines for the selection of the appropriate conditions and test methods for the determination of overall migration into food simulants and test media from polymeric coatings on metal substrates which are intended to come into contact with foodstuffs and a test method for overall migration into aqueous simulants by article filling from polymeric coatings on food and beverage cans and non-stick coatings.
NOTE   Polymeric coatings on metal substrates are not yet included in the scope of any European Union Directive. This Technical Specification has been prepared to assist in the development of such a Directive.

This European Standard specifies a reference method for determining the release of lead and cadmium from ceramic articles which are intended to come into contact with foodstuffs.

This European standard specifies a reference method for determining the release of lead and cadmium from articles with silicate surfaces of glass, glass ceramic and vitreous enamel which are intended to come into contact with foodstuffs. This European standard also applies to vitreous enamelled containers  and to parts of equipment intended for industrial use with foodstuffs.

This European Standard specifies two alternative test methods, in the sense of an extraction test with a 'more severe' test character, for the assessment of the overall migration into fatty food simulants.  
Method A is based on the determination of the extraction of migrateable substances from plastics which are intended to come into contact with foodstuffs, by total immersion in non-polar, iso-octane, and/or polar, ethanol, solvents depending on the polarity of the packaging material.  According to results obtained by this method (see [1],[2],[3],[4],[5],) and taking physio-chemical considerations into account, the obtained extraction efficiency has, generally, been found to be equivalent to or higher than overall migration results obtained under the test conditions, 10 days at 40 °C, 2 h at 70 °C, 1 h at 100 °C, 30 min at 121 °C and 30 min at 130 °C.
To ensure as complete as possible extraction of the potential migrants, a strong interaction, e.g. swelling, of the sample by the extraction solvent is necessary.  For this purpose, iso-octane is used as an extraction solvent for plastics materials and articles containing non polar food contact layers, such as polyolefins.  For test samples made from polar food contact plastics such as polyamide and polyethylene terephthalate, 95 % (v/v) aqueous ethanol is used.  For polystyrenes, plasticized polyvinyl chloride and other polymers where the identification or polarity of the polymer is not clear, two parallel extraction tests should be conducted using both of the proposed extraction solvents and taking the higher value obtained as the relevant result.
NOTE 1   In case of multilayer structures such as plastics laminates and co-extruded plastics, the nature of the food contact layer determines the selection of the extraction solvent(s).

This European Standard describes test methods for the determination of the overall migration into fatty food simulants from plastics materials and articles, by total immersion of test specimens in a fatty food simulant at temperatures from 100 °C up to and including, 175 °C for selected times.  Also described is a procedure with a substitute test medium.  In this substitute procedure the mass of components adsorbed on modified polyphenylene oxide (MPPO) is taken as a measure for the assessment of the overall migration into olive oil.
NOTE 1   The total immersion test method has been written for use with the fatty food simulant, olive oil.  The test method can also be used with appropriate modifications with 'other fatty food simulants ' called simulant D - a synthetic mixture of triglycerides, sunflower oil and corn oil.  These other fatty food simulants will produce different chromatograms for the simulant methyl esters to those of the methyl esters of olive oil.  Select suitable chromatogram peaks of the methyl esters of the other fatty food simulants for the quantitative determination of the simulant extracted from the test specimens.
NOTE 2   A comparative migration test carried out with polypropylene and polyethylene terephthalate high temperature application containers as test samples at conditions 2 h at 100 °C and 2 h at 175 °C, respectively, in contact with 14C-labelled synthetic triglyceride and MPPO provided test results comparable within the analytical tolerance of the methods.
NOTE 3   To obtain reproducible and repeatable results using the MPPO method it may be necessary to measure the temperature of the test specimen before starting the migration period.  An appropriate method for measuring the temperature of the test specimen needs to be established.
The described methods are most suitable for food contact articles in the form of sheets and films, but can also be applied to a wide range of articles and containers.

This European Standard describes test methods for 'substitute tests' performed with volatile test media, iso-octane and 95 % v/v aqueous ethanol, for the determination of overall migration from plastics intended to come into contact with fatty foodstuffs at all temperatures and for any period of time.
These test methods are suitable for plastics samples in a wide variety of forms.
NOTE 1   The iso-octane and 95 % v/v aqueous ethanol volatile test media used in these test methods are those specified for 'substitute tests' in Commission Directive 82/711/EEC [3]and its subsequent amendments [4], [5].  In addition to the use of iso-octane and 95 % v/v aqueous ethanol as test media for 'substitute tests', Commission Directive 82/711/EEC and its subsequent amendments specifies the use of modified polyphenylene oxide as a test medium for use at temperatures of 100 °C and above.  For a test method for overall migration from plastics intended to come into contact with fatty foodstuffs using modified polyphenylene oxide as a test medium, see EN 1186-13.  
NOTE 2   These test methods can also be used for the 'alternative tests' described in Council Directive 82/711/EEC and its subsequent amendments, when the chosen volatile test media are iso-octane and 95 % aqueous ethanol, provided equivalence is shown with olive oil, see prEN 1186-1:2001.

This European Standard specifies two alternative test methods, in the sense of an extraction test with a 'more severe' test character, for the assessment of the overall migration into fatty food simulants.  
Method A is based on the determination of the extraction of migrateable substances from plastics which are intended to come into contact with foodstuffs, by total immersion in non-polar, iso-octane, and/or polar, ethanol, solvents depending on the polarity of the packaging material.  According to results obtained by this method (see [1],[2],[3],[4],[5],) and taking physio-chemical considerations into account, the obtained extraction efficiency has, generally, been found to be equivalent to or higher than overall migration results obtained under the test conditions, 10 days at 40 °C, 2 h at 70 °C, 1 h at 100 °C, 30 min at 121 °C and 30 min at 130 °C.
To ensure as complete as possible extraction of the potential migrants, a strong interaction, e.g. swelling, of the sample by the extraction solvent is necessary.  For this purpose, iso-octane is used as an extraction solvent for plastics materials and articles containing non polar food contact layers, such as polyolefins.  For test samples made from polar food contact plastics such as polyamide and polyethylene terephthalate, 95 % (v/v) aqueous ethanol is used.  For polystyrenes, plasticized polyvinyl chloride and other polymers where the identification or polarity of the polymer is not clear, two parallel extraction tests should be conducted using both of the proposed extraction solvents and taking the higher value obtained as the relevant result.
NOTE 1   In case of multilayer structures such as plastics laminates and co-extruded plastics, the nature of the food contact layer determines the selection of the extraction solvent(s).

This part of this European Prestandard describes a method of test for the determination of the overall migration into aqueous based food simulants from plastics which are intended to come into contact with foodstuffs, by filling articles with 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 containers and articles that can be filled.

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, into aqueous based food simulants, by exposure in a standard cell 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 is particularly applicable to those materials consisting of more than one layer or of surfaces that differ in their migration characteristics,...

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 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 European Standard describes test methods for the determination of the overall migration into fatty food simulants from plastics materials and articles, by total immersion of test specimens in a fatty food simulant at any temperatures above 5 °C  up to and including, 175 °C for selected times.
When some plastics are tested by the methods in prEN 1186-2, prEN 1186-4, prEN 1186-6, prEN 1186-8, prEN 1186-12 and prEN 1186-13, the soxhlet extraction process does not achieve complete recovery of the absorbed olive oil from the test specimens.  In this method, the olive oil is released from the plastics test specimens by dissolving them in chloroform, toluene, xylene or tetrahydrofuran.
This method is suitable for plastics when exposure to olive oil is by total immersion as described in prEN 1186-2, in a cell, as described in prEN 1186-4, in a pouch, as described in prEN 1186-6, and by filling, as described in prEN 1186-8 and to tests carried out at low and high temperature, as described in prEN 1186-12 and prEN 1186-13.
This is provided the plastics are soluble in chloroform, toluene, xylene or tetrahydrofuran and insoluble in methanol and that whenever prEN 1186-2 is referred to in this method the appropriate clause of the relevant part of prEN 1186 is substituted.
The method may also be suitable for plastics which are only partially soluble in chloroform, toluene, xylene or tetrahydrofuran and insoluble in methanol.
NOTE 1   This test method has been written for use with the fatty food simulant, olive oil.  The test method can also be used with appropriate modifications with 'other fatty food simulants ' called simulant D - a synthetic mixture of triglycerides, sunflower oil and corn oil.  These other fatty food simulants will produce different chromatograms for the simulant methyl esters to those of the methyl esters of olive oil.