th plenary workshop of the European Union Reference...

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Report EUR 25474 EN

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Catherine Simoneau

2012 mid-year progress review and establishment of work programme 2013 Dublin, 26-27 June 2012

Report of the 17th plenary workshop of the European Union Reference Laboratory for Food Contact Materials and its Network of National Reference Laboratories

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European Commission Joint Research Centre Institute for Health and Consumer Protection Contact information Catherine Simoneau Address: Joint Research Centre, Via Enrico Fermi 2749, TP 260, 21027 Ispra (VA), Italy E-mail: [email protected] Tel.: +39 0332 78 5889 Fax: +39 0332 78 5707 http://ihcp.jrc.ec.europa.eu/ http://www.jrc.ec.europa.eu/ This publication is a Reference Report by the Joint Research Centre of the European Commission. Legal Notice Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of this publication. Europe Direct is a service to help you find answers to your questions about the European Union Freephone number (*): 00 800 6 7 8 9 10 11 (*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed.

A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa server http://europa.eu/. JRC73184 EUR 25474 EN ISBN 978-92-79-26509-9 (pdf) ISSN 1831-9424 (online) doi:10.2788/44196 Luxembourg: Publications Office of the European Union, 2012 © European Union, 2012 Reproduction is authorised provided the source is acknowledged. Printed in Italy

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EURLFCM VII

Project N°: WP 2012 2.3 EURL technical reports

Plenary workshop of the EURLNRLFCM

Intermediate Report to stakeholders (DG SANCO E6 and National Reference Laboratories)

Input documents: AA

Ref. SANCO: AA No Sanco/2012/FoodSafety/070/Food Contact Materials Ref JRC: EURL‐FCM VII CT 32721

Ver. Written by Reviewed by Approved by CAT Unit Head

Approved by IHCP

Director

Date 16.07.2012

C. Simoneau

19.07.2012

D. Rembges

25.07.2012

P. Aguar

27.08.2012

A. Anklam

Signature (signed) (signed)

(signed) (signed)

JRC.I.1.Form.CAT.032A – Version 2 Chemical Assessment and Testing Unit

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Summary Delegates of 25 National Reference Laboratories (NRLs), and Bastiaan Schupp from the Directorate General for Health and Consumers (DG SANCO) gathered in Dublin for the plenary workshop of June 2012 hosted by the Food Standard Agency of Ireland. The plenary was chaired by C. Simoneau, operating manager of the EURL-FCM. The meeting included a review of the work completed and the mid-year progress, as well as the planning and establishment of the work programme 2013.

In the first half of the year of the WP 2012, two interlaboratory comparisons (ILC) were completed. The first ILC was the validation of a method of a dry material (Tenax) that officially simulates all dry foods presented by Natalia Jakubowska (EURL-FCM). The exercise included 20 matrix-measurands combinations. The other completed work item was presented by Georgia Beldi (EURL-FCM) and consisted of the proficiency testing (PT) of plastics kitchen utensils for the release of formaldehyde and melamine.

The work programme for 2013 was established and will include developments on testing for ceramics in support to the revisions currently discussed for the Directive on ceramics. It will also include 1) a follow up to the validation of method for Tenax consisting of a proficiency testing on unknowns, 2) a PT on fingerprinting as identification of the nature of plastics FCM materials, 3) an exercise on calculation of surface areas in contact for kitchen utensils using different methods, and 4) a workshop on Food Manufacturing Practices (GMPs) and requirements and evaluation of supporting documents for the establishment of compliance. It will also initiate exploratory work on testing of kitchen paper and napkins as a non regulated emerging issue.

Participants Representatives from the EURL, the Commission and the Austrian, Belgian, Bulgarian, Czech, Cyprus, Danish, Dutch, Estonian, Finnish, French, Greek, German, Hungarian, Irish, Italian, Latvian, Lithuanian, Luxembourg, Polish, Portuguese, Slovakian, Slovenian, Spanish, Swedish and United Kingdom, and Swiss NRLs attended the meeting. The NRLs of Poland and France 1 could not attend the meeting and were excused. The NRL of Romania did not attend. NRL-Malta is represented by NRL-UK and NRL-NO is represented by NRL-DK.

The list of participants can be found in Annex 1

Agenda The meeting included a review of the work completed and the progress (agenda given in Annex 2), as well as the planning and establishment of the work programme 2013.

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Table of content

Summary.................................................................................................................................................................4 Participants ...........................................................................................................................................................4 Agenda.....................................................................................................................................................................4 Review of 2012 work programme (to date) ...........................................................................................6 Substances.........................................................................................................................................................6 Analytical methods........................................................................................................................................6 Technical guidelines in support of Regulation (EU) No 10/2011 ............................................6 Inter‐laboratory comparisons (ILCs) ....................................................................................................7 Specific migration into Tenax:.............................................................................................................7 Discussion: ...................................................................................................................................................8 Conclusion:...................................................................................................................................................9 Specific migration of formaldehyde and melamine from solution and from a kitchen utensil.............................................................................................................................................................9 Specific migration of primary aromatic amines from kitchenware solutions.............10

Training...........................................................................................................................................................11 Update on testing migration from gaskets applied to metal lids by the Swiss and German laboratories..................................................................................................................................11 Emerging topics: Implementation of new methods for mineral oils ....................................12 EURL and NRLs Briefing points ............................................................................................................12 FACET..........................................................................................................................................................12 Better Training Safer Food (BTSF).................................................................................................12 Workshop JRC Enlargement and integration countries. .......................................................12 Communication.......................................................................................................................................13 ILSI conference........................................................................................................................................13

Preparation and discussion of the 2013 work programme ..........................................................13 Substances......................................................................................................................................................13 Analytical methods.....................................................................................................................................13 Development work towards interlaboratory comparison for ceramics.............................13 Inter‐laboratory comparisons (ILCs) .................................................................................................14 Follow up exercise on Tenax.............................................................................................................14 ILC on determination of polymer type..........................................................................................14 ILC on determination of utensil contact area.............................................................................15

Emerging topic: PAAs in cold water extracts of napkins ...........................................................15 Expert workshop.........................................................................................................................................15

Ad‐hoc discussion points and items ........................................................................................................15 Measurement uncertainty and evaluation of compliance ....................................................15

Annex 1: participants .....................................................................................................................................16 Annex 2: agenda ...............................................................................................................................................17 Annex 3: Presentation of the results of the ILC on Tenax ILC 02 2011‐2012 (N. Jakubowska).......................................................................................................................................................18 Annex 4: Presentation of the results of the ILC on Formaldehyde and Melamine ILC 01 2012 (G. Beldi) .................................................................................................................................................27

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Review of 2012 work programme (to date)

Substances Work has been carried out to establish sources of analytical standards required as calibrants for the enforcement of Regulation (EU) No 10/2011. Several are not commercially available and are not included in the EURL standards collection (combining the monomers, additives and Bundesministerium fuer Risikobewertung (BfR) standards collections and those chemicals received supporting recent EFSA petitions). The EURL continues to work to trace those that they do not currently have in their collection. 954 substances were currently regulated in early 2012. Traceability to a commercial analytical supplier was achieved for 738 substances; 216 substances were not found commercially so far. Of those, 122 had no CAS number which made the search for suppliers more difficult. 94 substances were not found although they had a CAS number. An update of the database collection and sources has been uploaded onto the EURL-NRL-FCM platform Circabc on 22.05.2012. All standards are available for the NRLs if required.

The next steps are to continue the search via the EFSA or (prior to EFSA) via the Scientific Committee for Food (SCF) dossiers in order to retrace the original petitioners for the substances in question. Another route will be to inquire with the industrial association CEFIC on current suppliers in the EU for the substances. In addition another necessary next step is to develop a mechanism for the provision of substances regulated in the EU in concert with DG SANCO and EFSA. This will be discussed in the second half of 2012.

The EURL also prepared and sent upon request standard calibrants to NRLs and other stakeholders for use for research or enforcement purposes. The requests have all been met timely.

Analytical methods Methodologies for the analysis of plastic food contact materials monomers and additives are collected from petitioners via EFSA and have been collected from former SCF dossiers were the case. For each method, the technical descriptions of applicant's methods are transposed and made anonymous. A database listing of the methods is currently available (on the Circabc platform EURL-NRL-FCM) for NRLs and the full method descriptions are sent upon request. The work is ongoing as methods will be implemented for direct availability and download in the Circabc platform starting in the second half of 2012.

Technical guidelines in support of Regulation (EU) No 10/2011 As a follow up of the 1st edition published in 2009, a 2nd edition to adapt the Guidelines on kitchenware to Regulation (EU) No 10/2011 needs to be undertaken in line with development of a more general migration testing technical guidance for the Regulation (EU) No 10/2011 itself. The guidelines specifically target kitchenware items and aim to address sampling, treatment of specimen, exposure testing (e.g time/temperature, simulant etc), interpretation of results. The priority tasks for revisions are: 1) the fit to the new regulation (test conditions and choice of simulants), 2) the removal of some extraneous items 3) indications for bakeware

At the moment several guidelines are in progress under or on behalf of DG SANCO in support the Regulation EU No 10/2011.

One is a legal general guidance developed by DG SANCO, one specific to the Documentation of Compliance (also developed under DG SANCO with a small task force of experts). There is also a number of technical guidance specific to issues requiring further assistance including: migration testing (developed by JRC for DG SANCO with a small task force of experts), modelling (also developed by JRC with a small task force of experts),

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validation of methods (published under the EURL-NRL Network), kitchenware test conditions (published under the EURL-NRL Network).

Once the guidelines on migration testing in support of Regulation 10/2011, are prepared they will be available for comments and ultimately for endorsement by all NRLs. Consequently the update of the guidelines of kitchenware needs to await the development of these overarching Guidelines under Reg. 10/2011. The update could be reduced to tables. The situation will become better defined at the end of October.

Inter-laboratory comparisons (ILCs)

Two ILCs were completed in the first half of 2012. Their results were discussed.

Specific migration into Tenax: Regulation (EU) No 10/2011 establishes Tenax® as a food simulant E for testing specific migration into dry foodstuffs. Although research data has been available, there was to date no data on the ability of a method for the specific migration testing and subsequent quantification of representative substances from Tenax.

Therefore research done in 2010 focused first on comparing, improving and harmonising method descriptions for the analysis of model substances in Tenax®. This research led to the selection of substances that responded to the following criteria: 1) be able to migrate in Tenax from a spiked film, 2) be amenable to be homogeneously spiked in Tenax and in a plastic sheet, 3) be stable in the film and in Tenax, and 4) be representative of a range of substances that are common food contact additives. This scoping study also led to the development of a Standard Operating Procedure (SOP) which was based on modifications to standards CEN 1186-13 and CEN 14338.

The general aim of the ILC 02 2011 was evaluate the laboratory performance and precision criteria of the harmonised methods

1) for the determination and quantification of typical food contact migrants into Tenax® and

2) from a migration test from a fortified plastic film into Tenax and subsequent quantification.

The exercise was based on volunteer participation due to the level of complexity of the exercise.

The test materials used in this exercise were spiked Tenax® samples prepared by EURL-FCM with three levels of model substances and fortified plastic film (LDPE foil) to perform migration part of the exercise.

Butylhydroxytoluene (BHT), an antioxidant

Benzophenone (BP), a light stabilizer (UV absorber)

Diisobutylphthalate (DiBP), a plasticizer

Diethylhexyladipate (DEHA), a plasticizer

1,2-cyclohexanedicarboxylic acid diisononyl ester (DINCH), a plasticizer

They were the final substances chosen as the model substances for the ILC exercise due to their migration properties and stability characteristics in LDPE foil and the Tenax®.

The exercise foresaw: 1) one part using a spiked Tenax for which the ILC focused on extraction from Tenax itself and quantification of surrogate substances 2) another part using a film specifically contaminated with a selection of substances for which the ILC consisted of the exposure of a film to Tenax and subsequent extraction. This allowed to obtain data on precision and laboratory performance for both migration and quantification. The homogeneity and stability studies were performed by the EURL-FCM laboratory.

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The EURL prepared and proposed a SOP describing the exposure of a plastic material or article (intended for use with dry foods) to Tenax and the subsequent extraction of the Tenax and analysis of the extract. The methodology to be followed to perform the migration test was provided and followed exactly as this exercise was designed to test the methodology following the introduction of Tenax as a simulant for specific migration in Regulation EU No 10/2011.

The spiked samples and SOP were sent in November and the deadline for the submission of results was 9th of January. 15 NRLs and 2 guests from Germany participated. There were 17 volunteer participants (15 NRLs and 2 Official Control Laboratories (OCLs) from Germany) to whom samples were dispatched. 14 NRLs out of 15 and the 2 OCLs submitted results.

Since the aim of the ILC was evaluation of the laboratory performance and precision criteria there was a communication to the participants that different techniques were not fit to the scope of this ILC. Participants were invited to report four replicates measurements in repeatability conditions. This was done by most of the participants. The ILC was closed permanently in the end of January 2012 for statistical interpretation. The results of analyses were received and statistically interpreted. The assigned values were obtained as a consensus values after applying the robust statistics to the results obtained from the participants. Laboratory results were rated with z-scores in accordance with ISO 13528.

The participation of the laboratories was regarded as satisfactory for the aim of the precision experiment with regards of the numbers of received results. Absolute minimum of participating laboratory for conducting a precision experiment was 8.

The ILC on Tenax was successfully completed. Overall the results were good although as could be expected there appeared to be some higher variability between replicates for the analysis of certain substances at the lowest concentration level.

The obtained precision results are shown in table 1. The summary of the presentation can be found in Annex 3.

Substance

Precision results

BHT

45% Reproducibility SD and 7% repeatability SD for the 0.22 mg/kg level; 28% Reproducibility SD and 9% repeatability SD for the 1.70 mg/kg level; 19% Reproducibility SD and 12% repeatability SD for the 3.58 mg/kg level; 41% Reproducibility SD and 15% repeatability SD for the migration, 15.61 mg/kg.

BP


DiBP


DEHA


DINCH

24% Reproducibility SD and 7% repeatability SD for the 9.20 mg/kg level; 21% Reproducibility SD and 6% repeatability SD for the 46.68 mg/kg level; 16% Reproducibility SD and 8% repeatability SD for the 91.71 mg/kg level; 27% Reproducibility SD and 16% repeatability SD for the migration,70.24 mg/kg.

Considering the lack of the data previously available in the literature, this interlaboratory comparison exercise provides a great breadth of valuable detailed and traceable precision data, and a protocol method description which was also tested and evaluated.

Discussion: A forum was held on whether the protocol was clear enough to be easily implemented. The NRLs reported that the protocol was clear and with no difficulties in following it. The relatively small quantities of Tenax used in the experimental design developed by the EURL for the specific migration test (to cope with the high costs of Tenax) was not difficult to handle.

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No validation data were available previously and the study generated a body of useful data. A standardised protocol could now be set up. Participants that had never used Tenax before were happy for the easiness to implement it.

N-hexane as extraction solvent was recognized as the best with respect to other mixtures, but it needs to be adapted to the analytes. Dichloromethane (DCM) could have been better, but was not used in this exercise because 1) it had been reported as damaging to the structure of Tenax in some studies, rendering it not apt to be cleaned-up and recycled and 2) it would attract criticism for environmental reasons.

The opportunity to have available the draft of the ILC reports before discussion was raised. In this instance it was due to the short time frame and an internal review process for JRC reports. This will be resolved for the next reports to come. The reports will be completed and published after the summer.

Conclusion: The next steps were discussed. From the study within and between laboratory validation data is now available and C. Simoneau will contact CEN/TC194 to establish whether or not this can be taken on as a work item and whether or not a CEN standard method can be prepared. It is the very first time that a method has been validated at EU level for a set of substances with specific migration limits with precision data both for the migration step and the quantification step.

The exercise has demonstrated that the validation of a method is possible both for migration and for quantification. As another added value, the EURL together with its network of NRLs agreed that a strategy of follow up is warranted for this topic, and therefore that the WP 2013 will contain a work item using Tenax this item in an exercise of true proficiency testing and laboratory performance since the method was shown to be easy to implement.

Specific migration of formaldehyde and melamine from solution and from a kitchen utensil The second ILC involved the determination of melamine and formaldehyde in solutions of 3% acetic acid simulant exposed to a melamine-ware spoon. The summary of the presentation can be found in Annex 4.

The exercise aimed at proficiency testing. The purpose of the exercise was 3 fold:

• Demonstration of the continued capacity of NRLs and guests to perform adequately the measurement of formaldehyde from a migration solution in the context of support to Regulation (EU) No 284/2011 for melamine kitchenware.

• Demonstration and provision to the accreditation body of the third line control for the accreditation of NRLs and guests for the method for formaldehyde.

• Demonstration of the capacity of NRLs and guests to execute the measurement (quantification) of melamine from melaware at the new limit foreseen under an upcoming amendment of Regulation (EU) 10/2011

The general aim of the exercise was to assess the performance of the official control laboratories (proficiency test) and was mandatory for NRLs and open to guest OCLs for the test solutions. As a PT, participants were free to use any analytical method of their choice. Spoons had been purchased and were available to be tested on a voluntary basis since they did not pass the homogeneity test.

The test material used for preparation of the migration solutions were melamine kitchenware (spoons) containing formaldehyde and melamine. The EURL prepared and distributed three concentration levels of migration solutions in 3% acetic acid and three spoon samples (only for NRLs). The migrate was diluted with different volumes of 3% acetic acid to generate the 3 test solutions F&M01 and F&M02 and without dilution to generate test solution F&M03. The

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homogeneity and stability studies were performed by the EURL-FCM laboratory. The stability test were performed according to ISO Guide 35:2006 at 3 levels and 3 temperatures.

There were 70 participants to whom samples were dispatched (EURL, 27 NRLs + 42 national control laboratories from Belgium, France, Germany, Italy, Poland, Slovenia, Spain and United Kingdom) and 66 of which submitted results. Four laboratories did not submit results, 35 laboratories submitted results for formaldehyde and melamine, 27 submitted only results from formaldehyde and 4 laboratories only melamine results. The homogeneity and stability studies were performed by the EURL-FCM laboratory. Participants were invited to report 4 results for each concentration level and 2 results for each spoon. Laboratory results were processed using several algorithms: ISO 13528, Harmonized protocol, DIN 38402 A45 (Q-Hampel) and ISO GUIDE 35:2006. The assigned values were obtained after applying the robust statistics to the results of the participants. Standard deviations for proficiency assessment (also called target standard deviations) were set based on Horwitz equation.

The participation in the ILC was satisfactory regarding the number of the participating laboratories. Sixty six participant laboratories submitted their results and four laboratories did not send results; For the overall exercise, 80% of the results (79% for NRLs only) reported for formaldehyde were properly estimated; and 89% of the results (88% for NRLs only) reported for melamine were properly estimated. The results for F&M01 and F&M02 were good with only 7 of the 62 laboratories returning questionable or unsatisfactory results. For the third solution, F&M03, 23 of the 62 laboratories returned questionable or unsatisfactory results. Possible reasons were discussed.

The EURL will follow up the poor performance with a questionnaire/e-mail to determine the processes that led to the questionable or unsatisfactory performance (including how and when diluted, what was the measured concentration and what was the calibration range). This will constitute the first measure (root cause analysis) as prescribed by Eurachem for underperformance. The second measure will be the production of a new blind solution that will be sent to underperforming NRLs give the opportunity to improve performance.

For melamine 5 of 36 or 4 of 39 laboratories returned unsatisfactory or questionable results for the three solutions. The final report of the ILC is not yet available and therefore the absolute values and z-scores may be revised in the future.

Nineteen volunteer laboratories from the NRL-FCM network participated in the migration exercise by analysing melamine kitchenware (spoons). All the laboratories submitted their results. An optional part of this exercise was to determine the contact area of the utensils. Only a small number of laboratories returned results however the distribution of results was wide. The EURL will collate information/approaches on surface area determination and a follow up exercise will be carried out in second half of 2013. Methods for measuring surface area were discussed and the use of 3D scanners was suggested and will be looked into.

Specific migration of primary aromatic amines from kitchenware solutions The other ILC planned for 2012, primary aromatic amines (PAAs) in 3% acetic acid exposed to nylon utensils, will be carried out between July and September.

The exercise will aim at proficiency testing. The purpose of the exercise is 2 fold:

• Demonstration of the continued capacity of NRLs and guests to perform adequately the measurement of PAAs from a migration solution in the context of support to Regulation (EU) No284/2011 for polyamide kitchenware.

• Demonstration and provision to the accreditation body of the third line control for the accreditation of NRLs and guest for a method of PAAs.

The solution will be provided by NRL UK. It is a ‘real’ solution from migration. Aniline, 2,4 TDA, 2,6 TDA and 4,4 MDA were selected to be the migrants. The section was based on

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questionnaires sent to all NRLs on substances 1) most commonly found 2) most used as target monitoring substances in the official controls.

The test samples will be 2 solutions with a cocktail of substances at different concentrations. The solutions are intended to be used not for screening method but for compliance testing (i.e. HPLC or LC-MS). The sample codes will be provided by e mail.

The general aim of the exercise will be to assess the proficiency of the official control laboratories and consequently the participants will be free to use any analytical method of their choice. However, in view of the support to Regulation 284/2011, the methods of choice will focus on the procedures described in the Annex of the JRC technical guidelines (EUR 24815 EN 2011) in support of Regulation 284/2011.

The homogeneity and stability studies will be performed. The stability test will be performed according to ISO Guide 35:2006 at 3 temperatures.

The assigned values will be obtained after applying the robust statistics to the results of the participants. Participants will be invited to report 4 results for each concentration level. Laboratory results will be processed using several algorithms: ISO 13528, Harmonised protocol, DIN 38402 A45 (Q-Hampel) and ISO GUIDE 35:2006. Standard deviations for proficiency assessment were set based on Horwitz equation.

The results will be presented and discussed in the plenary of December 2012.

Overall conclusion A discussion took place (also during the discussion of the upcoming work programme 2013) on the lifecycle of ILCs. B. Schupp pointed out to the identification of three stages; a development/preparation stage, a validation stage, and the actual comparative testing. It was recommended to separate in the yearly work plan the first two stages and list them under heading 2, 'production and validation of methods', the third under heading 1, 'coordination of analytical method by comparative testing'; for this last stage a high level of participation will then be expected (basically all NRLs), together with a high success rate, which can be made visible in the Performance Indicators. This terminology should be clearly used in the future current discussions in SANCO on comparing the EURLs. IT was also recommended to develop a strategic planning document towards future ILCs and their stages, including with a more long term view (e.g. 5 years). This could be foreseen to be discussed in the next meeting.

Training

Training requests had been received from three NRLs (Romania, Hungary and Sweden) and will be addressed later in the year. Attention was also drawn to the Better Training Safer Foods training being co-ordinated by the Danish NRL.

In addition the JRC has to conduct on behalf of the JRC Programme for enlargement and Integration a dedicated workshop in September-October 2012. Therefore it was thought to combine the two events into one week (with workshop for E&I comprising also NRLs staff) and followed by the hands on training only for NRL staff. Care will be taken to avoid dates or attendance conflicting with the intents of the BTSF training.

Update on testing migration from gaskets applied to metal lids by the Swiss and German laboratories

All NRLs have received the report of their samples and the combined results have been published in a peer reviewed journal. 25% of the products tested were non-compliant. Some,

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but not all, Member States took action to withdraw the non-compliant foodstuffs from the market. A follow-up exercise has been proposed which involves testing and checks on documentation. The Commission was asked whether or not the results prompted any action from them. No specific action is planned. The Swiss authorities would like to enforce the GMP Regulation and Declaration of Compliance (DoC) to identify problems with the lid manufacture. It was agreed that enforcing these is something that many NRLs and OCLs have problems with. Currently there is no consensus on this and so it was agreed that guidance is required. Points of critical interest are in particular: how to enforce the DoC, what documents should be checked and what questions need to be asked. NRL-Italy raised the issue of article 5 of Regulation EC No 882/2004 on the “Delegation of specific tasks related to official controls” and DG SANCO will examine this point. It was agreed that as a first the EURL could organise a dedicated expert workshop with invited speakers on the topic of GMP (see section on work programme 2013).

Emerging topics: Implementation of new methods for mineral oils

A conference forum in September 2011 organised by BFR (NRL-DE) highlighted the occurrence, methodology, toxicity and various methods in the context of occurrence of contamination of mineral oils from cardboard. A ‘method development kit’ including standard solutions of n-alkanes, standard solutions of typical mineral oils, extracts of carton board and mineral oil spiked food (rice) was in development in BfR. In this context, the WP 2012 had a work item of voluntary collaboration in this emerging area towards the development and improvement of emerging methods for the analysis of mineral oils from paper and board. The objective was first and foremost to exchange information during the plenaries.

The latest news in the field were discussed as a forum. A briefing was given by O. Kappenstein (NRL-DE) on the method development kit developed by BfR. Kits have been sent to laboratories all over the world and can still be made available for the NRLs. Information on methods is available on the BfR homepage. Both manual method and on-line LC/GC method are going to be published in the next 2 months. Only a small number of NRLs are currently working in this area. The EURL has recently purchased the LC-GC instrumentation and is currently working with the BfR kit. The intent is to establish the methodology in-house over the next months and report in the December plenary.

EURL and NRLs Briefing points

FACET The FACET project was briefly described by C. Simoneau, since JRC is a partner (together with NRL-UK, FERA) in this project. The JRC is also responsible of the organisation of the final conference and of the afterlife and use of the project output, which will be software.

The project closing conference will be held on 26th October in Brussels and the software generated from the project will be demonstrated. The software will continue to be available under the stewardship of the JRC. Training will be arranged first of all for EFSA and then for regulators including NRLs who wished so.

Better Training Safer Food (BTSF) Seven courses on food contact materials (FCMs) and articles for food inspectors and administrators are planned in the next year, starting in September 2012.

Workshop JRC Enlargement and integration countries. [see under training above]

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Communication The web portal http://ihcp.jrc.ec.europa.eu/our_labs/eurl_food_c_m was maintained and updated. The platform supports the public dissemination of the work on food contact. The website holds information about the activities and events carried out by the EURL as well as published reports available and scientific papers. It was suggested to make the Network pages more visible as the new format and tabs do not highlight them as well as before. This will be taken on board and a dedicated web page will be highlighting the role and achievements of the NRL network and provide the direct contacts.

The dedicated website on Circa specifically for NRLs is designed to support dissemination of information and network activities. The platform represents a main source of information exchange between the EURLs and the NRLs as well as it is used for repository of working documents and traceability purposes. In May 2012, the Commission started a complete overhaul from the former Circa platform to the a new Circabc platform. The EURL-NRL platform was in the first batch moved. The transition is not easy as the new platform seems to be missing quite a lot of features that were more straightforward on the former platform (bulk uploads of documents, moving documents between folders while keeping the traceability of the original dates). In addition the system was particularly slow in the first months of operation so far. C. Simoneau showed the new platform and how an upload was typically done (the uploads demonstration were those of the presentations of the two ILCs).

ILSI conference The dates of the ILSI conference were recalled to the NRLs: 14-16 November Berlin.

From the EURL-NRL side, there will be a poster on the EURL-FCM activities and overview of ILCs and their performance over the years.

Preparation and discussion of the 2013 work programme

Substances

In collaboration with EFSA and the Commission analytical standards for the outstanding chemicals (i.e. those for which no standard is included in EURL the collection) will continue to be sought.

Analytical methods All methods received will continue to be made available on the EURL Circabc platform. For 2013, the methods will also be systematically connected to their respective substance characteristics and availability.

Development work towards interlaboratory comparison for ceramics. The Commission explained that they are in the process of re-drafting the Regulation on ceramic materials and articles. In the first instance this lower limits for Cd and Pb will be introduced taking into account the revised EFSA opinion for these elements. These are likely to be consistent with the limits for drinking water. In the second phase limits for other metals (e.g. Co) and other substrates (e.g. glass) will be considered. Further the use of other simulants (e.g. organic acid) and different test conditions (e.g. repeat use) may also be considered. This follows work by the Belgian NRL who conducted a large study on metal migration from ceramics and the determination of appropriate simulants to mimic the migration into foods. This suggested that any amendment to legislation may need changes in

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methodology, especially if new simulants and limits are included. Therefore work may be required by the EURL to establish methodology prior to running an ILC in 2014. The Commission will confirm what changes will be made and what will be required. The work programme for 2013 should thus include a work of development on the side of the EURL to prepare for a future proficiency testing .The development would focus on the development or preparation of test or reference samples and homogeneity. C. Simoneau will work closely with B. Schupp (DG SANCO) and F. Bolle (NRL-BE) to prepare a stepwise project, following the consolidation of decisions at DG SANCO level.

Inter-laboratory comparisons (ILCs) NRL's were informed about the now follow ups of evaluation of all 26 EU-RLs activities in the field of food and feed. The Evaluation of all EURLs was conducted in 2010-2011 on a request of DG SANCO by a specialised consortium and that the EURL-FCM previously presented in the December 2011 plenary. The results were presented in December 2011 to EURLs together with the creation of proposed Key Performance Indicators (KPIs). The proposal for assessment of the EURLs by the Commission will involve marking against a series of Key Performance Indicators (KPIs). The tables of these foreseen KPIs were presented and shortly discussed. These are available to NRLs for review on the private Circabc platform.

The formats of these indicators seem so far to encourage EURLs to carry out very simple ILCs rather than those that challenge laboratories or develop new methodology. The NRLs and EURL felt that it was more important that the ILCs were relevant and in support of legislation rather than simple tests used by all and that all would succeed at with only minimal effort. All laboratories were asked which ILCs they would like to see developed in the 2013 work programme. The following were agreed:

Follow up exercise on Tenax A follow-up exercise on Tenax to fully validate methodology for all applications and potential migrants (i.e. taking into account polarity and volatility) and to include screening of unknowns.

The work carried out in the 2012 ILC on extraction from and migration into Tenax was considered successful but only looked at a limited number of analytes and one extraction solvent.

Tenax will be fortified with 2 to 3 substances undisclosed out of a range of six, with different polarities and including polar substances as well). The spiked Tenax will also contain one or more unknown substance for the NRLs to identify using analytical screening methodology.

Instructions will be given, but freedom will be left to use more or less polar extraction solvents. Tenax in this case could be used a a screening tool.

This exercise will provide more data to support the validation of the methodology as well as assessing a laboratories ability to quantify migrants in Tenax and identify unknowns in migration extracts.

ILC on determination of polymer type To demonstrate compliance with Regulation 321/2011 restricting Bisphenol A use in plastic infant feeding bottles requires the ability to determine the polymer type of the baby bottle is required.

An exercise will be organised to identify polymer type for a range of plastics that may be used as baby bottles as well as other FCM plastics.

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ILC on determination of utensil contact area As a follow up to the variable results obtained in the exercise held in 2012 to determine contact area of a melamine-ware spoon a range of utensils will be provided and the area determined.

Information on methods to determine surface area will also be provided.

Emerging topic: PAAs in cold water extracts of napkins This was suggested by NRL-DE who explained that many of the red and yellow napkins available on the market contain primary aromatic amines (PAAs) that are readily extracted into cold water. Typically o-anisidine, o-toluidine and chlorinated PAAs are present. It was noted that many of the NRLs and OCLs will not have these PAAs in their analytical suite and so any ILC may also need a method development phase. The German NRL reported that data for cold water extraction gave similar results to migration into acidic foodstuffs. The German NRL will provide samples for the ILC.

Expert workshop. Declaration of Compliance and Good Manufacturing Practice are topics causing a great deal of confusion for NRLs and their inspection services.

It was proposed that the EURL should hold a workshop to establish what the Member States are doing with respect to the enforcement of these two important aspects of legislation. The aim being that a consensus of approach should be reached and a guidance document produced.

Ad-hoc discussion points and items

Measurement uncertainty and evaluation of compliance Following on from a BfR workshop a consensus of approach across the EURL regarding measurement uncertainty was proposed. It was agreed that this should be taken forward.

The Network had a discussion on the clarification on whether or not to fail a sample was discussed when taking the measurement uncertainty into account. The general consensus amongst the NRLs was that for a sample to fail the measured value minus the uncertainty should be above the migration limit. Clarification was also sought as to whether or not a batch of samples passes if one of the three articles taken for testing is considered non-compliant but the average of the three is compliant. The consensus was that if one fails then the whole batch fails.

Date and place of next meeting

The next meeting was proposed to be held on 29th and 30th November 2012 (location to be confirmed).

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Annex 1: participants

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Annex 2: agenda

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Annex 3: Presentation of the results of the ILC on Tenax ILC 02 2011-2012 (N. Jakubowska)

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Annex 4: Presentation of the results of the ILC on Formaldehyde and Melamine ILC 01 2012 (G. Beldi)

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European Commission EUR 25474 – Joint Research Centre – Institute for Health and Consumer Protection Title: 17th plenary workshop of the European Union Reference Laboratory for Food Contact Materials Author(s): Catherine Simoneau Luxembourg: Publications Office of the European Union 2012 – 39 pp. – 21.0 x 29.7 cm EUR – Scientific and Technical Research series –ISSN 1831-9424 (online) ISBN 978-92-79-26059-9 (pdf) doi:10.2788/44196 Abstract Delegates of 25 National Reference Laboratories (NRLs), and Bastiaan Schupp from the Directorate General for Health and Consumers (DG SANCO) gathered in Dublin for the plenary workshop of June 2012 hosted by the Food Standard Agency of Ireland The plenary was chaired by C. Simoneau, operating manager of the EURL-FCM. The meeting of June included a review of the work completed and the progress, as well as the planning and establishment of the work programme 2013. In the first half of the year of the WP 2012, two interlaboratory comparisons (ILC) were completed. The first ILC was the validation of a method of a dry material (Tenax) that officially simulates all dry foods presented by Natalia Jakubowska (EURL-FCM). The exercise included 20 matrix-measurands combinations. The other completed work item was presented by Georgia Beldi (EURL-FCM) and consisted of the proficiency testing (PT) of plastics kitchen utensils for the release of formaldehyde and melamine. The work programme for 2013 was established and will include developments on testing for ceramics in support to the revisions currently discussed for the Directives on ceramics. It will also include a follow up on Tenax as a proficiency testing on unknowns since the validation was successful, a PT on fingerprinting as identification of the nature of plastics FCM materials, an exercise on calculation of surface areas in contact for kitchen utensils using different methods, and a workshop on GMP and requirements and evaluation of supporting documents for the establishment of compliance. It will also initiate exploratory work on testing of kitchen paper and napkins as a non regulated emerging issue

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As the Commission’s in-house science service, the Joint Research Centre’s mission is to provide EU policies with independent, evidence-based scientific and technical support throughout the whole policy cycle. Working in close cooperation with policy Directorates-General, the JRC addresses key societal challenges while stimulating innovation through developing new standards, methods and tools, and sharing and transferring its know-how to the Member States and international community. Key policy areas include: environment and climate change; energy and transport; agriculture and food security; health and consumer protection; information society and digital agenda; safety and security including nuclear; all supported through a cross-cutting and multi-disciplinary approach.

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