Food contact: changing regulatory landscape
More controls and focus on harmonizing legislation underway at European level: notes and considerations on the 19th edition of the seminar “Materials and articles in direct food contact” of last December 15, 2016 - organized by the Istituto Italiano Imballaggio - which saw the regular participation of the work group of Dr.ssa Maria Rosaria Milana (ISS:Italian National Institute for Health). By Marinella Vitulli
The by now traditional Milanese day dedicated to “Materials and articles for direct food contact” featured significant developments in the regulatory field, designed to strengthen the attention of companies to the issue of compliance with food contact regulations and, and hence to ever increasing protection of consumer health.
Even if it is confirmed that plastics are the most regulated material at European and consequently at national level - and that laws and drafts that will define the methods of carrying out the conformity tests have been recently subjected to numerous revisions, other interesting themes are emerging and are being brought to the attention of companies, regulatory agencies and stakeholders.
The European Parliament and Commission are working to ensure the intensification of control and harmonization of legislation for materials that have yet to be harmonized; individual Member States are therefore stepping up auditing and monitoring activities all along the food contact material supply chain.
What’s new
The changes concern both the amendments to the harmonized European regulation on plastics - for which the European JRC technical center extremely active, that in 2017 should finally publish the guidelines for the execution of tests - as well as other materials, and in general the system of checks and sanctions.
Plastics. Plastics continue to be subject to the attention of the European legislator; in the August 2016 the new EU Regulation N. 1416/2016 was published, the sixth amendment amending and correcting EU Regulation n.10/2011. This new regulation came into force on 14 September 2016, but the materials and objects in plastic in accordance with the EU Regulation n.10/2011 may be marketed until 14 September 2017 and remain on the market until stocks are exhausted.
The new provisions on migration limits though apply from 14 September 2018. In particular, among the main aspects changed, 14 new substances have been added to the list in Annex I, along with the information on food simulants to be used for compliance testing. Among the metallic elements that could migrate, laid out in Annex II, there are changes in the migration limit of zinc, and aluminium has been included among the elements.
The new regulation also clarifies that, for food machinery, tests can be performed using the worst foreseeable conditions of contact that can occur during food processing on the equipment in question.
European guidelines on Plastics Regulations. The guidelines published to date concern general information, the flow of information along the supply chain, and migration patterns.
The guidelines on migration testing are undergoing final draft, pending advice from stakeholders. The document is therefore at an advanced stage, but still under discussion, and approval is expected in the coming months.
The guidelines will include information on sampling, the specific migration limits of foods and food simulants, the screening tests and the contaminant analysis methods.
The cases where the use of the oil simulant is not technically possible will be clarified, and the alternative test conditions for polar polymers and non-polar polymers.
The determination of the contact surface to be exposed to the simulant will also be clarified in the document.
The other materials and control systems. The European Parliament and Commission performed actions aimed at clarifying the status of implementation of the provisions laid down by the EC Framework Regulation 1935: 2004.
In 2016 a study, coordinated by the European Parliament and called European Implementation Assessment was carried out; the contents of the document concern the verification of the status of implementation of laws on materials for food contact, and the problems encountered.
It highlights the lack of specific laws, with a negative impact on the internal market for all member countries; this is accompanied by difficulties in the implementation of controls for non-harmonized materials. A clear signal showing awareness of the need for targeted actions.
Indeed the document has a strong strategic connotation on future activities, which will lead to a greater number of harmonized rules on materials other than plastic, more controls and a drive towards greater traceability.
Work in progress in Europe
In line with this trend, the activities of bodies such as the DG Sante, the JRC Science Centre, the Council of Europe and the EFSA are numerous and involve a series of different materials and themes.
• The DG Sante is involved in the activities related to the guideline on migration testing, in the production of the seventh amendment of Reg. (EU 10/2011), in the publication of a regulation specific to Bisphenol A, in the publication of decisions for authorizations for the recycling processes and in the publication of the Ceramics Directive, which will announce the lowering of the limits on the migration of Lead and Cadmium. A new Community measure on printed materials for food contact is also under study. 2017 will also witness the start-up of consultation between the Member States in order to understand what the existing problems are, especially for non-regulated materials at European level.
Another important activity also regards mineral oils, resulting in the publication of EU Recommendation 2017/84 of the Commission of 16 January 2017 on the monitoring of mineral oil hydrocarbons in food products and in materials and articles intended for food contact. Of note also the activity that led at the beginning of 2017 to the publication by the JRC of a baseline study to support decisions from the EC on the harmonization of non harmonized FCM.
• EFSA and the CEF Panel are involved in the continuation of the evaluation of the toxicity of Bisphenol A, in the study of new approaches to risk assessment, and coordination of the activities of the Member States regarding materials other than plastics; assessment studies of new substances for plastics and related activities in active and intelligent packaging and recycling processes are continuing.
• The Council of Europe continues with activities focused on materials and issues on which the European Union is not working; the numerous resolutions issued by the Council of Europe include activities aimed at the renewal of almost all documents.
• Lastly, the data relating to the European notifications system RASFF were presented; in 2016 126 notifications regarding materials intended for food contact were registered; 32% of these were from Italy, symptom of an active system, especially with regard to customs controls. And indeed the auto-control activities established in Italy constitute one of the major new elements in the food contact material landscape.
In Italy: The Penalties Decree and list of specialized producers
In 2016 Italy witnessed intensification of actions that led to the production of so-called Penalties Decree, definitively approved by the Italian Government February 10, 2017; the decree concerns the rules on penalties for the violation of the provisions laid down in EC Regulations n. 1935/2004, n. 1895/2005, n. 2023/2006, n. 282/2008, n. 450/2009 and n. 10/2011 relating to materials and articles intended for food contact; It consists of 15 items, designed to clarify and modify the penalty system, and also to eventually create a registry of manufacturers of food contact materials.
The measure specifically clarifies the penalties for different violations. Article n.1 is exemplary. It states that an economic operator who, in violation of Article 3 of Regulation 1935: 2004 manufactures, markets or uses in any stage of production, processing or distribution, materials or objects which transfer to food components in such quantity as to constitute a hazard to human health, is subject to the administrative penalty of the payment of a sum of 10,000 to 80,000 euros.
Food Contact Center: purpose and function
Founded in Livorno in 2016, the Food Contact Center Srl provides analysis and advice in the consumer goods field, in particular on FCMA. Founded by Marinella Vitulli, it offers the market years of experience in the study and analysis of packaging and materials. Objective of the Center: to provide a personalized, tailored service, helping to obtain products that are technologically suited to the set purpose and safe, through a study and a targeted plan, guided by the knowledge of market related materials and regulatory affairs, while considering sustainability and the rationality of controls.
Actual activity. Given the legislative changes, the support of the Food Contact Center in situations which require urgent consolidation may include the definition of a self-control plan or manual, as well as risk assessment through tests on conformity, and more besides.
The tests are not in fact the only admissible form for defining conformity: Guided by appropriate assessments of specific competencies, other calculations or considerations can be associated with a limited number of analytical tests, for example related to migration by calculation or estimation of simulants and worsening situations, also aimed at associating the specimens tested with various references, this too via the evaluation of gauges, ingredients and process used. In this way a sustainable test plan can be devised for companies, which together with other competencies enables the definition of the supporting documentation.
In a second step the Food Contact Center can provide further assistance in the drafting of the declaration of conformity, required by law.
Marinella Vitulli
Technical Director General Food Contact Center
