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 SANTE. This is mainly done by the formation of a task force consisting of experts in the field and covering all stakeholders.
The EURL-NRL-FCM 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.
Test conditions for kitchenware
Mineral oil
Guidance on sampling, analysis and data reporting for the monitoring of mineral oil hydrocarbons in food and food contact materials – 2nd Edition
Four years after the first edition, drafting this second edition of the guidance document was triggered both by DG SANTE’s request to update the instructions for reporting and by the need to reflect the experience acquired in the field of the mineral oil analyses .
As in the first edition, this guidance document provides specific recommendations for sampling and analysis of mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH) in food and food contact materials (FCM) in the frame of Recommendation (EU) 2017/84 for the monitoring of mineral oils. In addition, it addresses the requirements resulting from the Joint Statement of the Member States (dated April 21, 2022) and the clarifications to the statement (dated October 19, 2022) regarding the presence of MOAH in food, including food for infants and young children.
Minimum performance requirements are specified for the analytical methods fit for MOSH and MOAH monitoring and control. The guidance should be used by all stakeholders concerned, i.e. food inspectors, official control laboratories, laboratories in industry and laboratories of non-governmental organisations.
This guide aims to support the reporting of reliable data when quantifying both MOSH and MOAH fractions by laboratories that are familiar with the analytical approaches and that have demonstrated satisfactory analytical performance in relevant proficiency testing (PT) schemes. In addition, this guide provides references to current analytical approaches described in the scientific literature to laboratories that are not familiar with MOSH/MOAH analysis, even though it does not provide any standard operating procedures.
S. Bratinova, P. Robouch, E. Hoekstra, Guidance on sampling, analysis and data reporting for the monitoring of mineral oil hydrocarbons in food and food contact materials – 2nd Edition, Publications Office of the European Union, Luxembourg, 2023, doi:10.2760/963728, JRC133174
Plastic multi-layers
Guidance on characterisation of the composition of plastic multi-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.
Mieth A., Hoekstra E., Simoneau C. (2016) 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. EUR 27816. http://dx.doi.org/10.2788/10593
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 Regulation (EU) No 10/2011. 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.
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.
Brandsch R., Dequatre C., Mercea P., Milana M.R., Störmer A., Trier X., Vitrac O., Schäfer A., Simoneau C., Hoekstra E.J. (2015) Practical guidelines on the application of migration modelling for the estimation of specific migration. Publication Office of the European Union, Luxembourg, JRC Scientific and Technical Research Report, EUR 27529 EN (Annex – List of substances from the positive list of amended Regulation (EU) No 10/2011, indicating their eligibility for migration modelling)
A data request form is available for submission of new data for expansion of the applicability of migration modelling
Correction specific migration result
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
Analytical method performance
Guidelines to evaluate method performance and conduct validation studies of analytical methods for FCM
please note that this guideline is under revision from 2019.
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