Food contact materials technical guidance documents
Technical specifications of performing official controls practically and how to perform compliance testing are generally not detailed in legislative documents, and therefore there can be gaps in a harmonised approach. The food contact material group develops technical guidelines for the implementation of legislation related to food contact materials. This can be done in two ways. Technical guidelines can be developed on request of or in close cooperation with DG SANCO. This is mainly done by the formation of a task force consisting of experts in the field and covering all stakeholders.
The EURL-NRL network can also develop technical guidelines. The guidelines provide a unified understanding of the practical implementation. The impact has been the ability for NRLs to be able to give a harmonised competent advice in this field to their National Authority, Food Inspection and private compliance laboratories. The work is normally organised in the form of dedicated workshops and smaller task forces of volunteer experts within the NRLs. This has allowed generating several much needed guidelines within two years.
These guidelines are published as public documents (see below). These are not legally binding but represent a consensus for the official controls regarding food contact materials.
Guidance document on fat reduction factor, functional barrier concept, phthalates and primary aromatic amines
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food contains four issues for which food inspectors and enforcement laboratories need further guidance. These issues are the concept of the fat reduction factor and the functional barrier, and the restrictions for certain phthalates and primary aromatic amines. The Regulation applies from 1 May 2011. The network of the European Union Reference Laboratory and the National Reference Laboratories for food contact materials created a Task Force in order to give guidance on these issues.
Hoekstra E.J., Petersen J.H., Bustos J. (2011)
Guidance document on fat reduction factor, functional barrier concept, phthalates and primary aromatic amines. Publication Office of the European Union, Luxembourg, JRC Scientific and Technical Report, EUR 25112 EN
Calculator for the correction of the experimental specific migration for comparison with the legislative limit
The EURL-NRL-FCM Taskforce on the Fourth Amendment of the Plastic Directive 2002/72/EC developed a calculator for the correction of the test results for comparison with the specific migration limit (SML). This calculator was updated for the Plastic Regulation (EU) No 10/2011. The calculator calculates the maximum acceptable specific migration under the given experimental conditions in food or food stimulant and indicates whether the test result is in compliance with the legislation. This calculator includes the Fat Reduction Factor, the simulant D2 Reduction Factor and the factor of the difference in surface-to-volume ratio between test and real food contact.
Petersen J.H., Hoekstra E.J. (2011) Calculator for the correction of the experimental specific migration for comparison with the legislative limit in Regulation (EC) No 10/2011 on plastic food contact materials (version January 2012)
FCM FRF-DRF-TRF spreadsheet for Regulation 20120111.xls
Guideline on testing migration of primary aromatic amines from polyamide utensils and for formaldehyde from melamine-based kitchenware in support of Regulation (EU) No 284/2011 on imports from China and Hong-Kong
For the conception of a specific Regulation on imports of certain plastic kitchenware from China and Hong-Kong targeting polyamide and melamine-based kitchen utensils, the role of the EURL-NRL network was to develop specific technical guidelines on sampling and analytical requirements. This work was a pioneering effort giving guidance on sampling of heterogeneous articles and differentiating between types of consignments. The harmonisation of sampling is extremely critical and has its effect on reliability of results and ultimately trust in the ensuing legal decisions for non-compliant articles both under the Regulation (EC) No 882/2004 on official feed and food controls and under this new Regulation.
Simoneau C., Hoekstra E., Bradley E., Busto J., Golja V., Kappenstein O., Kalsbeek D., Keegan J., Milana M.R., Cwiek-Ludwicka K., Petersen J.H., Polz M., Sauvegrain P., Vanhee F. (2011)
Technical guidelines on testing the migration of primary aromatic amines from polyamide kitchenware and of formaldehyde from melamine kitchenware - in support of Commission Regulation 284/2011 laying down specific conditions and detailed procedures for the import of polyamide and melamine plastic kitchenware originating in or consigned from People's Republic of China and Hong Kong Special Administrative Region, China. 1st edition 2011. Office for Official Publications of the European Union, JRC Scientific and Technical Report, EUR 24815 EN
Task force on migration modelling
The European legislation requires verification of compliance for migration of substances from plastic food contact materials with existing specific and overall migration limits. To do so, there are migration tests to carry out using food/food simulants under the test conditions specified in specific Directives 85/572/EEC, 82/711/EEC and amendments (e.g. 97/48/EC). Numerous scientific investigations during the last two decades have demonstrated that migration from food contact materials into food and food simulants are predictable physical processes. In the absence of specific interactions of the migrant with food and in the absence of degradation of the polymer by the food simulant, migration is a mass transfer of substances from a plastic material into food and obeys in most cases to Fick's laws of diffusion. Hence, in addition to experimental methods, an alternative tool based on theoretical migration estimations can be applicable. Modelling potential migration is recognised by the Food and Drug Administration (FDA) in the USA as an additional tool to assist in making regulatory decisions. The European Union introduced this option to use generally recognised migration models as a novel compliance and quality assurance tool with Directive 2001/62/EC, and the EU Directive 2002/72/EC.
The aim of this work item is to assist the users of the described model to predict conservative, upper bound migration values. This will be accomplished in three directions:
Publication of the guide on the updated current validity of the fields of application for the overestimation of diffusion coefficients based on the validation of the model for a given number of polymers and migrants. Development and drafting of experimental procedures for the production of data towards the validation for migration models to include multilayers. Compilation and review of updated data (institutions, industry, CEN) towards the publication of an updated guide on application field of modelling for migration.
Simoneau C. (ed) (2010)
Applicability of generally recognised diffusion models for the estimation of specific migration in support of EU Directive 2002/72/EC, Publication Office of the European Union, Luxembourg, JRC Scientific and Technical Report, EUR 24514 EN. The main contributors to this document are (in alphabetical order): R. Brandsch, B. Brands, R. Franz, M. Klatt, M.R. Milana, O. Piringer, A. Schaefer, C. Simoneau, X. Trier and O. Vitrac
Guidelines on test conditions for kitchenware
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. 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 at home and thus the definition of worst foreseeable conditions of use is a challenge. This guide is intended as a dynamic document and therefore will evolve and expand into further editions to cover more aspects.
Simoneau C. (2009)
Guidelines on Testing Conditions for Articles In Contact With Foodstuffs (With A Focus on Kitchenware) - A EURL-NRL-FCM Publication, 1st Edition. Publication Office of the European Union, Luxembourg, JRC Scientific and Technical Report, EUR 23814 EN
Guidelines to evaluate method performance and conduct validation studies of analytical methods for FCM
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.
Bratinova S., Raffael B., Simoneau C. (2009)
Guidelines for performance criteria and validation procedures of analytical methods used in controls of food contact materials. 1st edition 2009. Publication Office of the European Union, Luxembourg, JRC Scientific and Technical Report, EUR 24105 EN