Taking meanders through the regulations on the production and use of plastics and paper-plastic multi-materials in contact with food is no easy task. Besides national norms, various European regulations equally apply. The most comprehensive one is regulation (EU) 10/2011, which was profoundly changed by its 15th amendment, i.e., the new regulation (EU) 1245/2020.
Food contact materials and plastics bound to be used in contact with food is a sensitive issue. Products destined to food contact, in which plastic films are often used together with paper, must comply with strict norms.
At the end of last year Innovhub SSI, in collaboration with the Italian Packaging Institute Istituto Italiano Imballaggiohttps://istitutoimballaggio.org/, focused on these issues on the occasion of a technical workshop devoted to the latest regulatory updates introduced by regulation (EU) no. 1245/2020, which is the latest major amendment to regulation (EU) no. 10/2011 on food contact plastics.
The regulatory framework
The regulatory framework dealing with materials and articles in contact with food is complex and has been enriched with time. It includes regulation no. 178/2002, which deals with food safety and, for the first time, addresses the topic of the packaging in contact with food, and the framework regulation concerning all materials and articles in contact with food, i.e., regulation no. 1935/2004. Article 3 of the latter document defines a very important principle, i.e., that any material or article intended to come in contact with food contact must not endanger human health for consumers or bring a change in the organoleptic properties of food. These pieces of legislation were then followed, over time, by regulation no. 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food, i.e., on all actions guaranteeing compliance of said materials or articles in all processing stages, from production to distribution, to final use. Additional pieces of legislation were five specific regulations on regenerated pulp, ceramics, active and intelligent substances, recycled plastics, and plastic objects; as well as regulations on starting substances for the production of materials and articles intended to come into contact with food.
All other materials that are not regulated by a specific piece of legislation, including paper and cardboard, instead, are left to the discretion of Member States, which can adopt national norms on the matter.
According to Serena Bariselli, who is in charge of the Innovhub SSI Department on eligibility for food contact, Paper Section, the regulation on plastics is to date the most comprehensive one. This is the already mentioned regulation (EU) no. 10/2011 on plastic materials and articles intended to come into contact with food, which includes 48 recitals, 23 articles divided into 6 chapters, and 6 annexes. The European Commission has even adopted two guidelines for a better understanding of regulation no. 10/2011. The regulation also deals with the topic of multi-material and multi-layer materials and articles used in materials and articles intended to come into contact with food, specifically in article 14.
Since its inception, regulation no. 10/2011 has been the subject of several modifications, the latest of which being the 15th amendment by the European Commission.
2020 new developments
Published on 2nd September 2020, the 15th amendment is a major change modifying and amending the previous document, and it is referred to as regulation (EU) no. 1245/2020.
In particular, the new document:
– introduces restrictions and specifications for some substances, by listing new authorized substances in the list and setting new migration limits for other substances;
– replaces Annex I concerning restrictions on materials and articles in plastics related to metals and primary aromatic amines;
– modifies point 6 of Annex IV on the “Declaration of compliance” (DDC);
– modifies and adds some modalities and conditions foreseen in Annex V concerning migration tests.
The main novelties introduced include Annex II to the new regulation, which is an integration, says Carmen Sorice, who is in charge of the Testing Area of the Italian Packaging Institute. Annex II shows the migration and use limits of 24 substances. Furthermore, new heavy metals have been added to the current list. Specifically, these are arsenic, cadmium, lead, mercury and antimony for all types of plastics and lanthanides, i.e., lanthanum, europium, gadolinium and terbium, for polyolefins. The new restrictions, which are also indicated in Annex II, refer to the detection limit for primary aromatic amines, which is set at 0.002 mg/kg of food simulant.
Point 6 of Annex IV, instead, points out that the DDC should indicate the quantity of the substances subject to the limitations set in Annex II. Furthermore, reference is made to “genotoxicity” and to the obligation to provide information on the possible presence of substances in a plastic material or object whose genotoxicity cannot be excluded.
As regards the migration tests foresee in Annex V, the new developments concern the requirements to meet to determine migrations in the “articles of repeated use”. The new regulation foresees that overall and specific migrations should not increase with the shift to the new tests; should this happen, the material cannot be defined as compliant.
Lastly, the same Annex V introduces the new contact condition OM0 (overall migration 0). This new condition will have to be adopted for contact applications of short duration at room temperature or at lower temperatures; in particular, the annex foresees a contact for the test of 30 minutes at 40 °C.
The changes introduced by the new regulation do not, however, nullify what was determined before. As specified by Sorice, the plastics materials and articles that are compliant with the previous version of regulation no. 10/2011, therefore prior to the entry into force of the new regulation, provided that they were introduced in the market for the first time before 23rd March 2021, can continue to be put on the market for another year and a half as of that date, i.e. until 23rd September 2022, and can remain on the market until stocks are exhausted.
What to do for multi-material and multi-layer materials and articles
The paper production and processing industry is specifically concerned with the way multi-material and multi-layer materials and articles coming in contact with food are processed. The already mentioned article 14 of regulation no. 10/2011 rules this aspect, as explained by Sorice. The article provides that all plastic layers shall comply with the same regulation. It also foresees that, in case of a multi-layer material, a plastic layer which is not indirect contact with food and is separated from the food by a functional barrier, may be manufactured with substances not listed among the authorized ones in Annex 1, except for mutagenic, carcinogenic or toxic substances. Furthermore, articles 11 and 12 of the same regulation do not apply to these plastic layers as regards the specific and overall migration limits; said limits can be defined by the national legislation.
In Italy, the piece of legislation regulating this aspect is the Ministerial Decree of 21st March 1973, which introduces the concept of “barrier” in article 5. The article specifies that, in case of coupled or other complex materials, i.e., paper coupled with plastics or a coating, the layer in direct contact with food shall comply with the Ministerial Decree, however, if said layer also serves as a barrier, compliance shall not be deemed necessary. Lastly, article 5 introduces another very important concept, i.e. that of the screening approaches also set out in regulation no. 10/2011. Specifically, reference is made to residual content, mathematical models, and overall migration.