FCM regulation in Europe and Italy: upcoming changes

What follows is a brief summary of a day dedicated to changes to legislation governing materials and objects in contact with food products. Current and forthcoming guidelines; a brief overview of recycling plastics and active and intelligent packaging; future sanctions.
By Daniela Aldrigo

In the regulation of food contact materials (FCMs), plastic remains the most closely monitored and regulated at the European level, and consequently in Italy as well.
As much emerged from the 18th edition of a seminar dedicated to the topic held in Milan on December 10th. The event was organized by Istituto Italiano Imballaggio and saw the usual participation of the work group of Maria Rosaria Milana of the National Institute of Health (ISS).
Without entering into the details of the conversation and of EU Regulation 10/2011, the regulation’s field of application is illustrated here in relation to Ministerial Decree 21/3/73, whose compliant sections will continue to govern plastics.
In any case, it is useful to keep in mind that European regulation covers homogeneous plastic materials and only the plastic component of heterogeneous materials (plastic layer in multilayer multi-material), while the Italian legislation covers polymer coatings on materials other than plastic, silicones, epoxy resins and testing of multilayer multi-material (e.g. “bricks”).

What’s new
The changes have to do in particular with new deadlines for migration testing, which starting in January 2016, must be carried out following the dictates of Regulation 10/2011. Until 31/12/2015, testing can be carried out in accordance with either of the older directives 82/711 and 85/572.
Thus far, the amendments to Reg. 10/2011 have had to do above all with the restrictions and stipulations of the list of authorized substances (App. I), but a forthcoming sixth amendment will bring changes to how the regulation is to be interpreted and applied.

The guidelines
In the meantime, two of the four European Guidelines for Regulation 10/2011 are already available.
One of the guidelines gives a general overview of the legal framework to help correctly interpret the various articles and appendices, explaining terms not defined in the regulation, for example “nanomaterial”, “commercialization”, etc… It also explains, for example, how to approach unlisted substances and those authorized by derogation.
The other deals with data transmission along the supply chain, focusing on subjects responsible for compiling compliance declarations and communication of what is referred to in the regulation as “adequate information”.
Forthcoming is publication of the guideline on migration testing, while the one dealing with migration modeling and theoretical calculation is still being written.
The guidelines on migration testing are set for approval in the coming months and are the joint work of leading national laboratories, industry experts, DG Sanco and the JRC. The guidelines are divided into two parts: a general section and a technical section with eight appendices.
The general part highlights the importance of sampling: which are the authorized subjects, the strategies and precautions to enact in order to guarantee that the testing is appropriate and representative, especially in the case of official controls, and finally, how to adequately identify and label samples.
The technical section describes modalities for testing food products and simulants (choosing a simulant and testing conditions), testing for polar and apolar polymers and managing migration limit threshold results according to margin of error.
One chapter is dedicated to screening tests, and another to an analysis of migrating agents in packaged food products and simulants or as residue in the material, illustrating how the choice of method depends on the nature of the phenomena under analysis (e.g. volatile vs. semi-volatile organic substances).
A section is also dedicated to identifying the type of polymer through IR analysis, identifying layers and separating them.
Also, the guidelines indicate how to measure the food-packaging contact surface area, as well as how to write up an analysis report (which pertinent information to include), keeping in mind that the outcome should always be accompanied by the unit of measurement and margin of error.

Future harmonization and register of authorized substances
• Still considering European legislation, the most immediate changes have to do with recycling plastics, with deadlines set by Reg. 282/2008 fast approaching and pursuant to authorization of recycling processes by European decision with which the Register of authorized processes will be published. Until then, in Italy, post-consumption recycled plastic in direct contact with food will be governed by articles 13bis and 13ter of Ministerial Decree 21/3/73, which only authorize certain packaging types made with post-consumption recycled plastic, and which will only expire with the European regulation’s full implementation.
 
• The second step will have to do with active and intelligent packaging. Also in this case, deadlines set by reg. 450/2009 are nearing and the EFSA will soon conclude its evaluation of requests for authorization to allow the Commission to proceed with publication of the Register of authorized substances. At the moment, permitted substances must be authorized for use in food products.

• In the meantime, the European road map continues on non-harmonized materials like rubbers, which could be the first new materials to be regulated at the European level, but it’s still a long road. From a European standpoint, new legislative approaches are in any case aimed at strengthening risk assessment approaches and allocating responsibility along the supply chain.

• At the national level, the stipulations of Ministerial Decree 21/3/73 are confirmed, in particular as regards materials not harmonized at the European level, such as paper, glass and stainless steel, and those specifically concerning aluminium (DM 76/2007) and tin plate (DM18/2/84).
DM 21/3/73, in particular, is undergoing “restructuring”, since the law is now quite dated and has undergone around 50 amendments. In particular, the positive lists and pertinent restrictions are being revised, in addition to the methods included.
In recent years, the main updates to the decree have had to do with plastics due to the reasons already explained, and stainless steel, a material that often originates in East Asia and which often draws scrutiny from customs officials, especially kitchenware destined for food contact, which sometimes figures in European food safety alerts.
The new updates of the decree could concern paper, that has not been the rulings of which have not been revised for some time.

• Finally, a forthcoming sanctions decree will regulate FCMs, including provisions for a census of FCM manufacturers.
At the moment, sanctions exist but are subject to interpretation “in the field” by individual inspectors, with resulting disparities in outcome. The new decree will thus have the principal objective of univocally codifying FCM sanctions
             
Daniela Aldrigo
Technical Unit, Istituto Italiano Imballaggio