Annual report 2014 of the EURL-FCM on activities carried out for the implementation of Regulation (EC) no 882/2004

This annual report presents the activities of the EURL FCM in 2014 under the Administrative Agreement N °SANCO 2014/FOOD SAFETY/083-Food Contact Materials" (Ref. JRC: 33483 EURL FCM IX). The work programme 2014 for the European Union Reference Laboratory for Food Contact Materials was established in consensus with the Network of National Reference Laboratories (NRLs) and DG Consumers and Food Safety (SANTE). The JRC organised five Interlaboratory comparisons (dry foods, identification of polymers, metals from plastics, metals from ceramics, surface area). It developed new tests for ceramics towards future limits. It produced a guidance on surface measurements and compliance. It organised 2 trainings on exposure to food chemicals and on upcoming JRC migration testing guidelines for the Regulation on plastics (EU) 10/2011. It developed a repository of more than 400 substances and 300+ methods to improve compliance of substances under Reg. (EU) 10/2011.JRC.I.1-Chemical Assessment and Testin

Guidelines on Testing Conditions for Articles In Contact With Foodstuffs (With A Focus on Kitchenware) - A CRL-NRL-FCM Publication, 1st Edition 2009

Comparability of results is the most important feature of the measurements for official controls purposes. Reliability of results is in turn strongly dependent on test conditions, on how well a method performs and how it is performed by the laboratory that does it. The Community Reference Laboratory (CRL) and its National Reference Laboratories (NRLs) for Food Contact Materials (FCM) have recognised that technical specifications are not always detailed in standards or legislative documents, and consequently there are sometimes gaps and lack of harmonisation in how official controls are practically performed. Therefore several guidelines were been initiated. The scope is to develop a unified understanding of the practical implementation of existing or new legislation in the context of official controls for FCM. The expected impact is to constantly improve the ability for NRLs to give the same competent advice in this field to National Authorities, food Inspection and private compliance laboratories for the practical implementation of official controls for FCM. This guide contains practical information to define the parameters of an overall or specific migration test according to the nature of the materials and objects in contact with food, with a focus on kitchenware. This focus was chosen because kitchenware is typically placed in contact with food in the home and thus the challenge is to define worst foreseeable conditions of use. This guide is intended as a dynamic document and therefore will evolve and expand into further editions to cover more aspects. This is the first edition. These guidelines have been endorsed by the EU official Network of National Reference Laboratories and approved by the EU Commission competent service DG SANCO. This work also highlights an important deliverable for the Network of NRLs. In particular, the members of the task force ¿test conditions¿ that have dedicated time and effort to provide input into the development of these guidelines. They are gratefully acknowledged here for their contribution: NRL-BE (Fabien Bolle, Tina n¿Goy), NRL-DE (Oliver Kappenstein), NRL-DK (Jens Petersen), NRL-ES (Juana Bustos), NRL-FR1 (Patrick Sauvegrain), NRL-EL (Timokleia Togkalidou), NRL-NL (Durk Schakel, Dita Kalsbeek-van Wijk), NRL-PL (Kazimiera Cwiek-Ludwicka), NRL-SI (Viviana Golja), NRL-UK (Emma Bradley).JRC.DG.I.2-Chemical assessment and testin

Dissemination and implementation of the new food safety tool for exposure assessment - Flavourings, Additives and food Contact materials Exposure Tool (FACET)

FACET is a model, dynamic tool which was created in recent years and presented in its dedicated public conference in October 2012. The model is developed with the aim to estimate dietary exposure to flavourings, additives and food contact materials substances and compare the results with available safety limits. The tool developed within the FACET project should allow reducing significantly the uncertainty in the level of dietary exposure to additives and flavouring substances in the EU population. JRC was involved from the inception of the project as partner. In addition, JRC is leading the implementation and sustainability of the project via a dedicated group. The first task is now to promote the uptake of the FACET modelling system, to make users understand the functioning of the IT tool and to use it for own exposure estimations. This report presents the activities carried out in 2013 for the milestones and progress of the dissemination, training and sustainability for the different stakeholders.JRC.I.1-Chemical Assessment and Testin

Annual Activity Report 2013: European Union Reference Laboratory for Food Contact Materials

The work programme 2013 for the European Union Reference Laboratory for Food Contact Materials was established during the June 2012 Plenary meeting in consensus with the Network of NRLs and DG SANCO. It included developments on testing for ceramics in support to the revisions currently discussed for the Directive on ceramics. It also included 1) a first-time proficiency testing (PT) as next phase to the 2012 validation of a method for the new simulant for dry foodstuffs 2) a first-time PT on fingerprinting as identification of the nature of plastics FCM materials, 3) a follow up on the PT 2012 on measurement of formaldehyde from imports melaware, 4) an exercise on calculation of surface areas in contact for kitchen utensils using different methods and 5) a workshop and evaluation of supporting documents for the establishment of compliance. It also initiated exploratory work on testing of kitchen paper and napkins as a non-regulated issue for primary aromatic amines (PAAs) and on strategies to develop multianalyte methods. In addition continuing work items included the development of a databank for substances regulated under the Regulation 10/2011 for plastics as well as the development of an inventory of methods of analysis.JRC.I.1-Chemical Assessment and Testin

Activity Report 2009 of the European Union Reference Laboratory for Food Contact Materials

The following report is a technical report mostly destined to Commission services, National Reference Laboratories and Member State Competent Authorities. It reports the 2009 update of the deliverables from the work programme 2009 of the European Union Reference Laboratory for Food Contact Materials established under Regulation EC No 882/2004. The 2009 annual work programme of the EURL included methods of analysis protocols (Art 32 1(a)), reliability of results & comparative testing (Art 32 1(b)), with several guidance documents produced on method performance and validation, on sampling and testing conditions, on the 4th amendment of Directive 2002/72/EC. Two validation studies for a) Di-isodecyl phthalate (DIDP) in oil and b) Bisphenol A (BPA) in the new milk simulant 50% Ethanol were organised and completed successfully. Other items completed included the collection of reference monomers and additives, emerging issues such as the Plastic Implementing Measures and in particular on the revision of Community Guidelines for Migration Testing, as well as on active and intelligent packaging (AIM). Several trainings were organised by the EURL upon request, including delegates from the FVO as well a for a delegate from Vietnam.JRC.DG.I.2-Chemical assessment and testin

Annual Activity Report 2012: European Union Reference Laboratory for Food Contact Materials

In 2012, three interlaboratory comparisons (ILC) were completed. The ILCs were 1) The evaluation of a method for migration into a dry material (Tenax) that officially simulates all dry foods, 2) A determination of melamine and of formaldehyde in 3% acetic acid migration solutions, and 3) A determination of primary aromatic amines in 3% acetic acid migration solutions. The deliverables also included the collation by the EURL of food contact substances from the positive list and methodology for their determination in plastics, food simulants or foodstuffs, work to establish methodology for mineral hydrocarbons, and training activities carried out by the EURL.JRC.I.1-Chemical Assessment and Testin

Effect of the Nature and Concentration of Phthalates on Their Migration from PVC Materials Under Dynamic Simulated Conditions of Mouthing

Polyvinylchloride (PVC) has been a very common material for the production of toys. It generally is manufactured with an addition of additives such as plasticisers to improve its functionality and facilitate its production process. PVC that can contain up to 50% by weight of plasticisers (Simoneau et al., 2001). Among plasticisers, 90% of the most commonly used to soften polymers for toys production are constituted by phthalates, such as diisononyl phthalate (DINP). The purpose of this study was to investigate the influence of the relative concentration of percentage of phthalates and nature of phthalates on their release in standard conditions. To obtain a suitable but rapid method of analysis, experiments were performed to study the effects on the modification of a standard operation procedure (SOP) previously validated at the EU level by JRC Ispra. A single extraction with a sufficient large volume of cyclohexane thus could be used instead of two extractions with a smaller volume of cyclohexane and resulted in more rapid yet reliable method. The final method is described in Annex 1 of this report. Samples of soft PVC were industrially produced especially for this study. Standard PVC disks with various percentages of di-isononyl phthalate (DINP), di-isodecyl phthalate (DIDP), di-ethyl-hexyll phthalate (DEHP), benzylbutyl phthalate (BBP) dibutylphthalate (DBP) or a binary mixture DINP/DBP in various proportions were prepared. 30 different types of disk were produced and tested. The disks were analysed for contents, homogeneity and sets were subjected to migration experiments of the various phthalates under dynamic conditions using the previously validated SOP with some modifications. The release from samples with a systematic manufacturing process and containing different phthalates at different concentrations showed correlations to their concentrations. Since previous studies using commercial toys had no showed such specific trends, these results suggest that the production process of toys may be an important issue with respect to release properties. The release of DEHP BBP and DBP tended to show a more linear correlation to the concentration, whereas for DINP, DIDP, DEHP and release the plasticiser showed non linear tendencies and saturation of release for high formulation contents.JRC.I.2-Chemical assessment and testin

Report of an interlaboratory comparison organised by the European Union Reference Laboratory for Food Contact Materials; ILC01 2010 - Photoinitiators in solvent and in paperboard

This report presents the results of the ILC of the EURL-FCM which focused on the screening for photoinitiators (PI) content in paperboard as well as in a solvent. The test materials used were two types of paperboard supplied by the industry, containing benzophenone (BP) and 4-methylbenzophenone (4MBP) and mixtures of five PIs in a solvent (acetonitrile) prepared in-house. The general aim of the exercise was to assess the proficiency of the official control laboratories and consequently the participants were free to use an analytical method of their choice. There were 36 participants to whom samples were dispatched (26 NRLs + 10 official national control laboratories from Germany and Spain) 32 of which submitted results. The homogeneity and stability studies were performed by the EURL-FCM laboratory. The assigned values were obtained after applying robust statistics to the results of the participants. Participants were invited to report four replicates measurements. This was done by most of the participants. Laboratory results were rated with z and z¿ scores in accordance with ISO 13528 [1] Standard deviations for proficiency assessment (also called target standard deviations) were set based on Horwitz equation for substances in the solvent. For the PI paperboard the target standard deviation was set by the organizers to 15% in order to fulfil the required criteria for sufficient homogeneity of the sample within the lots. As a conclusion of the ILC exercise on the quantification of photoinitiators in the paperboard and the solvent, this ILC showed that: 1) The participation in the ILC was satisfactory regarding the number of the participating labs. Thirty-two laboratories submitted their results. From the EURL-NRL network 22 laboratories out of 25 reported results. 3 NRLs laboratories did not send any results. 2) For the network of NRL-FCM the outcome from the participation could be regarded as satisfactory as there are about 84% satisfactory results (262 out of 312) and only 3 NRLs did not participated out of 25JRC.I.2-Chemical assessment and testin

Guidelines for performance criteria and validation procedures of analytical methods used in controls of food contact materials

Test methods for materials and articles in contact with foodstuffs are required to determine the concentration of residues of monomers in the materials themselves or to determine the concentration of individual or groups of substances in food (or food simulants) which have migrated from the food contact materials. The Community Reference Laboratory and National Reference Laboratories for food contact materials (FCM) prepared the present Guidelines to illustrate the required performance criteria for the analytical methods applied in the laboratories for FCM and provide procedures for method validation in order to estimate their performance characteristics. The scope of these guidelines is to provide rules for the performance of the analytical methods to be used in the verification of compliance with the migration limits defined in Directive 2002/72/EC,as amended, and in accordance with Directive 82/711/EEC, as amended, and others defined in the European legislation, in order to ensure the quality and comparability of the analytical results. The document presents 4 approaches, according to the different purpose of performance assessment. These guidelines are intended as a dynamic document and they will evolve and expand into further editions. This is the first edition. These guidelines have been endorsed by the European Union official Network of National Reference Laboratories and approved by the EU Commission competent service DG SANCO. This work also highlights an important deliverable for the Network of NRLs. In particular, the members of the task force ¿Method Performance¿ that have dedicated time and effort to provide input into the development of these guidelines. They are gratefully acknowledged here for their contribution: NRL-BE (Fabien Bolle, Tina n¿Goy), NRL-DE (Oliver Kappenstein), NRL-DK (Jens Petersen), NRL-ES (Juana Bustos), NRL-FR1 (Patrick Sauvegrain), NRL-EL (Timokleia Togkalidou), NRL-IT (Maria Rosaria Milana), NRL-NL (Durk Schakel, Dita Kalsbeek-van Wijk), NRL-PL (Kazimiera Cwiek-Ludwicka), NRL-SI (Viviana Golja), NRL-UK (Emma Bradley). Special thanks are extended to Emma Bradley for her contribution to the editing of the document.JRC.DDG.I.2-Chemical assessment and testin

Guidance for the identification of polymers in multilayer films used in food contact materials: User guide of selected practices to determine the nature of layers

This guidance describes how to characterize the composition of a multilayer plastic film for food packaging, with respect to the consecutive order of the layers and their identity. It provides necessary background information on the general composition of multilayer plastic packaging and it illustrates in detail the separation of layers for some examples. It also provides in annexes additional information related to the use of a microtome and of optical microscopy using one common instrument for illustrative purposes.JRC.I.1-Chemical Assessment and Testin