Application and perspectives of the legislation on FCMA


A detailed report of the issues addressed and debated during the FCMA - Food Contact Material and Article seminar, organized by the Italian Packaging Institute in collaboration with the ISS -  Istituto Superiore di Sanità*.

Edited by Marinella Vitulli

For the second time, the customary annual meeting on FCMA was held. Organized on December 21, 2021 by the Istituto Italiano Imballaggio, as scheduled, it saw the participation of Dr. Maria Rosaria Milana’s team from the Istituto Superiore di Sanità. The event was once again of great interest and was attended by an audience composed of many field experts and insiders.

The morning was dedicated to the exposition of the laws in force and of the important regulatory new features in the offing while, in the afternoon session, there was the question time with interaction with those present, providing operational answers to those who intervened.

The interventions focused on the current situation related to the European and national regulatory framework; the follow-up of ongoing activities was then featured and then possible future perspectives were illustrated.

*The Istituto Superiore di Sanità, also ISS, is an Italian public institution that, as the leading technical-scientific body of the Italian National Health Service, performs research, trials, control, counseling, documentation and training for public health. 

The current framework and future activities related to Framework Regulations

As usual, the meeting opened with the intervention of Dr. Maria Rosaria Milana.

Regarding the current situation, the key principles reported in the framework regulations Reg CE 1935:2004 and Reg CE 2023:2003 were enunciated, reminding that FCMA are part of the food legislation and respect the same food sector rules as far as official controls are concerned.

In 2020, the general revision of the European Commission's "Farm to Fork" Strategy was announced, which represents the 10-year plan developed by the Commission to guide the transition towards a fair, healthy and environmentally friendly food system.

Consequently, member countries, when implementing regulations and laws, must align themselves with EU policies and are bound to respect the objectives set by the Commission.

Hereby, the announced changes in FCMA legislation will have to be implemented, which are to be related to other key strategies such as the Circular economy, the Chemical Strategy for sustainability and a toxic-free environment.

In relation to the Circular Economy Action Plan, the impact on packaging involves reducing over-packaging and packaging waste, driving design towards reuse and recyclability. The complexity of packaging materials must also be reduced, including the number of materials and polymers used, and biodegradable and compostable materials must be used.

With respect to the Chemical Strategy, there is a focus on banning the most hazardous substances in consumer products or using them only when essential. Criteria are being developed for endocrine disruptors applicable to FCMA and for the combined effects of substances used.

Among the most important ongoing review activities, the evaluation of the adequacy of Regulation (EC) 1935/2004 should be mentioned. The persistent lack of specific rules for non-plastic materials, the lack of focus on specific substances, and the difficulties associated with demonstrating compliance are well known. Laboratory approaches may be heterogeneous in the absence of stringent and clear rules. Consistency with other legislation such as REACH must also be assessed.

It is not yet clear when a draft will be published for a new legislature, speculated to be by the fourth quarter of 2022. The assessment exercise has yet to be completed, and the pandemic and the need to accelerate the development of new recycling rules have impacted the timeline.

Regarding difficulties related to conformity assessment, there are plans to establish better addressed rules for final characteristics (finished article in contact with food), to identify the level of safety and how to achieve that level, including strengthening the Good Manufacturing Practices rules.

The exchange of information related to compliance and control is essential, so it is necessary to improve the quality and accessibility of information along the supply chain, through clear rules on data requirements and transfer of information, introducing Declarations of Conformity for all FCMA.

The safety assessment must include NIAS (non-intentionally added substances), CMRs (carcinogenic, mutagenic and toxic to reproduction substances), EDs (endocrine disruptors), persistent, bioaccumulative and toxic substances, and other substances with specific properties (e.g. substances in nanoform).

In order to improve safety levels, it is also appropriate to develop assessment methodologies and specific rules to encourage more sustainable production, for example plant-based or bio-based, the development of rules to support all forms of "safe" re-use and recycling and include all recycling technologies, a fundamental aspect and much debated in recent years.It is important that there is consistency with environmental law.

Evolution of specific community work: state of the art

In detail, the activities carried out by specific institutional technical tables.

In relation to DG Sante, in 2022 work will be done on the preparation of the 16th amendment to the plastics regulation, for which new substances will be introduced; in addition, the elimination of the substance FCM 96 "Flour and wood fibers, untreated" is planned. Salicylic acid and lauric acid will also be eliminated. An amendment related to the use of Biocides is postponed.

The discussion on Styrene continues; the possible genotoxicity of styrene oxide is discussed.

Consequently, a possible definition of a specific migration limit and analysis conditions to be used are being evaluated.

Regarding Bamboo, for which it has been clarified that it is not possible to refer to the substance FCM 96 of the regulation, there are actions taken at national level and harmonized actions, such as a coordinated control plan extended until spring 2022. In Italy, Ministry of Health Notes No. 4238 dated 17.11.2021 have been published to restrict the circulation of objects that do not comply with the legislation.

The ceramics directive (which foresees a significant lowering of the limits of Lead and Cadmium and perhaps also of other elements) will probably finally be finalized, perhaps with an extension to other materials.

Work is also underway on the new regulation on recycling (a report dealt with this subject). In fact, the novelties reported in the amendment to Regulation (EU) 282/2008 on recycled plastics have been illustrated, a subject of great interest given the needs related to the circular economy. Regarding recycling processes, it has been underlined that as long as the processes are not authorized by European law, recycled plastics can be placed on the market under national laws.

The applications for authorization received by the EFSA have been more than expected, and the evaluation of the first applications has taken longer than expected. The new regulation will have an important impact, as it will establish a new legal basis for all processes.

The recycling process will have to be able to reduce any initial contamination to levels that do not pose a risk to human health; there will be a focus on the decontamination phase, and the use of new technologies will be allowed.

The process will therefore have to ensure compliance with the provisions of art. 3 of Reg (EC) 1935/2004, establish conditions of use and any restrictions on use, and demonstrate safety using a specific Declaration of Conformity. It is undeniable that it will be necessary to implement analysis strategies for the identification of unexpected contaminants.

As far as EFSA is concerned, the risk assessment of new substances for plastics continues for the implementation of Regulation 10/2011; the safety assessment for plastics recycling processes continues and there is the possibility of new mandates for criteria on plastics other than PET.

Public consultations on Bisphenol A (update of toxicological assessment) and Phthalates have been published.

At the Council of Europe (EDQM), activities are currently underway on all non-harmonized FCMA; the release limit for many elements is under review for metallic materials, and work is also underway on paper and board; activities on printing inks are on standby.

 An ad hoc group is working to produce a general document on FCMA that deals with Good Manufacturing Practices, Declaration of Conformity, supporting documentation, etc.).

 As far as the JRC ISPRA Reference Laboratory is concerned, guidelines on contact conditions for kitchenware and tableware (plastic and metal objects, rubbers and silicones) have been published. We are also working on migration models, and there is an ad hoc group on NIAS. A guideline on repeated use testing is also being drafted.

The outcomes of the controls carried out by the official control authorities in Europe, published on the RASFF portal, were then described; there were 257 notifications in 2021, thus more than doubling compared to 2020, when there were only 113 notifications; the reasons are attributable to both the introduction of new regulations and the period in which the COVID-19 state of emergency in 2020 probably slowed down activities. The non-compliances relate to Bamboo and new unauthorized fibers, and Melamine materials; there were also many non-compliances related to primary aromatic amines.

Current Legislation and Interpretation

The presentations made by the team of the Istituto Superiore di Sanità concerned in detail the Regulation (EU) n. 10/2011, for which the rules related to the analysis on machinery and the analysis conducted on materials intended for repeated use were clarified.

One report, of great interest to analytical chemistry experts working on FCMA, concerned tests on repeated-use materials, with insights into the assessment of measurement uncertainty related to migration trends, with a focus on melamine materials, on which the Istituto Superiore di Sanità team published a specific paper (Migration of formaldehyde and melamine from melaware and other amino resin tableware in real life service - Food Addit Contam Part A 2017 Jan; 34(1):113-125. doi: 10.1080/19440049.2016.1252467)

Other presentations involved other materials covered by national legislation, such as paper and cardboard and metal objects.

Operational responses for companies

In the afternoon of December 21, a question time was held, with written questions from attendees and answers from the Istituto Superiore di Sanità team followed by comments on operational aspects.

Also this year the debate focused primarily on the novelties introduced by the amendment of EU Reg 10/2011 on materials for repeated use and machinery, the implications on multi-material multilayer objects with regard to analytical tests, and other application aspects of FCMA legislation.

The large audience of economic operators remotely connected to the web event could once again appreciate the competence and readiness of Dr. Maria Rosaria Milana’s working group of the Istituto Superiore di Sanità to actively discuss the complicated issues involved in Food Contact Material legislation.

food contact center team

Food Contact Center Srl

Established in Pistoia in 2016 by Marinella Vitulli, and today also active from its materials laboratory in Brescia and offices in Cuneo, the Food Contact Center provides analysis and consulting activities, offering customers years of experience in study and analysis activities on Packaging and Materials.

It provides a personalized service, useful to obtain products technologically suited for their purpose and safe, through a study and a targeted plan, guided by the knowledge of materials and regulatory affairs related to markets, with a view to sustainability and rationality of controls.

Considering the new legislation - for which a regulatory update and online consultation service of global legislation on FCMs has been developed - the Center’s support in situations that need urgent consolidation can include the definition of a plan or a self-control manual, risk assessment through targeted testing for compliance, and more besides.

Tests are not the only form allowed for the definition of compliance: with proper evaluations, further calculations or considerations can be associated to a limited number of analytical tests, for example related to migration by calculation or estimation of simulants and worst-case situations, associating the tested specimens with several references, also through the evaluation of thicknesses, ingredients and processes used.

In this way a sustainable test plan for the companies can be drawn up, which together with other competences enable the definition of the supporting documentation.

Food Contact Center is also specialized in the evaluation of consumer exposure and execution of food contact contaminant migration tests in food, tests under Accredia accreditation (such as migration in food of Bisphenol A and metal elements, such as Aluminum and Iron, key aspects also in assessing the compliance of machinery and appliances).

Fundamental also is the evaluation of NIAS, non intentionally added substance, through untargeted analytical techniques, a topic on which the Center has specialized through studies and construction of libraries and databases involving the collaboration with the Universities of Pisa and Florence and the instrumentation manufacturer Sciex.

With regard to analytical strategies, the Center actively collaborates in national and international working groups on the recognition and quantification of unknown substances from FCMs, such as the ILSI commission. It is also an official partner in a project on risk assessment of fluorinated substances funded by the European Commission.

Following testing, the Food Contact Center can provide further assistance in the subsequent drafting of the declaration of compliance required by law, as well as in the optimization and control of business management systems, as part of voluntary certifications, including through the execution of inspection visits accredited by Accredia according to ISO 17020.

Other aspects on which the Food Contact Center supports companies are issues related to Life Cycle Assessments, eco-design and environmental impact, and labeling in compliance with environmental legislation in relation to European and non-EU laws.

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Sede operativa e Laboratorio
Via E. Pestalozzi 63
51100 - Pistoia - Italy
Tel. +39 0573 245244
[email protected]

Find out more information about the companies mentioned in this article and published in the Buyers' Guide - PackBook by ItaliaImballaggio
Istituto Italiano Imballaggio