Trends and news on FCMA: interpret the rules in the best possible way

Mar 12, 2019

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The European market for FCMA moves around € 100 billion annually, with 50% of the value coming from the plastics and paper sectors, followed by the glass, metals and the machinery sectors. The need for operators to keep up with constantly evolving laws is imperative, and to carry out their activities by complying with the required obligations without hesitation.

In the 21st edition of the seminar dedicated to the theme of FCMA, organized on December 13th 2018 in Milan by the Italian Institute of Packaging and which saw the standard participation of the working group of Dr. Maria Rosaria Milana of the Istituto Superiore di Sanità (ISS), the modalities of interpretation of the legislation were examined in primis.
It is no coincidence that the day took place according to an innovative and different formula compared to previous editions, designed to offer more space to the participants: in addition to presenting future EC developments, the interactive form, based on question time and direct interventions, achieved the objective of providing operational responses, updates, guidelines.

Goal: clarify the doubts
The application of the so-called “sanctions decree” DM 29 of 10.02.2017 has entailed new controls, giving rise to doubts and questions regarding companies, control bodies and stakeholders.
An increasing number of companies are registering their activities in terms of contact materials, registration that is mandatory and subject to sanctions; in fact, as clarified by Ministerial Decree 29, economic operators who do not fulfill the obligations to communicate their activities are subject to considerable pecuniary administrative sanctions.
In this regard, with the amendment of the law of 25 July 2018, n. 91, which came into force on 09/21/2018, the re-opening of the registration deadlines for a period of 120 days has been envisaged for smallscale producers already operating on the market. An exemption, this, which has probably allowed many companies to communicate their activities, and to improve their system of good manufacturing practices and risk assessment.
The activity involves an increasing number of companies that do not deal only with packaging, but with materials intended for contact with machines or appliances or other tools, often comprising non-traditional materials or those not specifically regulated.
The reason why the Institute’s seminar was a success is because it has met the need for operational responses.

The new features in the FCMA area: prospects
The day opened with the presentation of the current situation and prospects for FCMA regulation.
Regarding the definition of FCMA - food contact materials and articles - it was firstly made clear that we are talking about direct or indirect contact, and also about objects such as containers for food transport, food processing machinery, packaging materials, kitchen and tableware.
The purpose of European legislation is to guarantee compliance with food contact, and therefore the protection of consumer health, as well as the functioning of the internal market.
FCMA legislation falls under the rules relating to food safety, defined by Reg. 178/2002/EC (in revision); the related control over FCMA therefore falls under the general provisions of the official control of food products, defined by Reg 882/2004/EC (revised, with Reg 625/2017/EC in a transitional period).
And it is no coincidence that, in a regime of new definition of controls and sanctions both in Italy and abroad, the methods of official control are pointed out.

A new Framework Regulation is under study
Regarding the future prospects of the legislation, a report was made on the DG Sante workshop in Brussels in September 2018 , in which the discussion underlined that FCMA legislataion is now more than 40 years old and, probably, it is not completely effective, efficient. and sustainable.
Hence a new Framework Regulation is being devised, and we are trying to understand if EC procedures are still adequate. At the same time new rules are being investigated to harmonize non-legislated materials at European level; a public consultation is underway.
On the basis of the evidence, including EURL JRC Ispra studies, considerable disparities between the detailed and harmonized rules of plastics and the absence of Community rules for many other materials emerged.
At the same time, inefficiencies in the approach adopted for plastics and malfunctions in the internal market have also been highlighted for different national laws, with a possible impact on human health. Once again the problems of mutual recognition and the consequent obstacles to free trade were discussed.

Risk assessment. With regard to the new risk assessment approaches assessed by EFSA, it is primarily thought to reconsider the estimates of consumer exposure and the categories of food consumption, correlated with the toxicity of the substances; alternative methods (in silico) are being studied to evaluate the genotoxicity of chemicals, including NIAS, substances not intentionally added to FCMA, for which a risk assessment is required.

“Uniform” compliance. With regards to the critical issues raised by stakeholders, these once again included the lack of guidelines for interpreting conformity, the lack of translated versions of national laws, the different interpretation on conformity by the different member states, the lack of clear requirements for non-EU importers, and finally the lack of testing conditions and pre-established methods for materials other than plastics.

Recycling. The day then recounted the decisions for authorizations for recycling processes, of fundamental importance given the growing concern about the sustainability of packaging. It has been highlighted that the Ceramics Directive, which provides for the lowering of the migration limits of Lead and Cadmium, is not yet definitive and publishable, also because the lowering of the limits risks having a sizeable impact on the market.

Mineral oils. Regarding another aspect of common interest, the issue of mineral oils, it was reported that the method for the determination of mineral oils in preparation by EURL JRC Ispra is in an advanced state, but that it will probably only give the performance criteria and will not feature instrumental details. After the exposure of the future prospects for FCMA regulations, the working group of Dr. Maria Rosaria Milana drew attention to the legislation currently in force on the numerous materials legislated in Italy.

Questions and answers
As anticipated at the beginning, the seminar on December 13th included an afternoon session of Question time, during which the team of the Istituto Superiore di Sanità responded “live” to the written questions received by the participants, launching a series of debates aimed at defining operational aspects.
In addition to the usual doubts related to the supply chain dialogue and the risk assessment methods of polymeric articles, numerous questions concerned the regulatory contextualization of mono or multi-material articles some of which also different from packaging, and for which risk assessment does not follow clear rules. This is the case, for example, of metal alloys such as brass, or materials in contact with technical gases used for food processing and packaging.
Although the criteria are not yet harmonized, it has been clarified once again that there are no materials that - by definition - that may or may not come into contact with food: in all cases, an accurate analysis must be carried out, guided by internationally recognized risk assessment scientific principles, in particular with regard to finished objects, since the basic principle of FCMA legislation is the protection of consumer health.

The activities of the Food Contact Center
Set up in Livorno in 2016 by Marinella Vitulli, and transferred to a new laboratory in Pistoia in 2018, the Food Contact Center provides analysis and consulting services, offering customers with years of experience in study and analysis on packaging. and materials. It provides a personalized and tailor-made service, useful for obtaining technologically appropriate and safe products, through a study and a targeted plan, guided by the knowledge of materials and market regulations, with a view to sustainability and rationality of controls.

Considering the legislative changes, for which a regulatory update service and an online consultation of the global legislation on FCMA has been developed, the support of the Food Contact Center in situations requiring urgent consolidation may lead to the definition of a plan or a self-control manual, risk assessment through tests for compliancy, but not only.

The tests are not the only form allowed for the definition of conformity: with appropriate assessments guided by specific skills, other calculations or considerations can be associated to a limited number of analytical tests, such as calculated migration, estimation of simulants and pejorative situations, also aimed at associating the tested specimens with various references, also through the evaluation of thicknesses, ingredients and processes used; it is thus possible to plan a sustainable test plan for companies, which together with other skills enable the definition of the rsupporting documentation.
At a later date, the Food Contact Center can provide further assistance in the subsequent drafting of the declaration of conformity required by law.