The recent issue on bronze or brass pasta dies, (1) along with the one that cyclically recurs on wooden cutting boards and utensils, (2) deserves a closer look at materials allowed for food contact (MOCA).
White paper for food, feed and MOCA safety.
The European regulation of materials, substances and objects intended to come into contact with food is rooted in EC Regulation 1935/2004, so-called Food Contact Materials Regulation. A regulatory text that mirrors the so-called General Food Law (reg. EC 178/02), the enactment of which was indicated as a priority in the White Paper for Food Safety (European Commission, 12.2.00).
The European legislator-in the aforementioned regulations, as well as in those forming the so-called Hygiene Package (EC Reg. 853, 854/04 and following), contextually applied throughout the entire internal market through a unified discipline-has designated food safety as a priority objective of European food law.
The cornerstone principles for ensuring a high level of food safety in the EU are risk analysis and integrated supply chain responsibility. The primary responsibility of the operators of the involved supply chains from farm to fork-including those of feed (EC Reg. 183/06) and MOCAs, without excluding intermediate actors (e.g., the import, logistics) – therefore plays a central role and must be ensured through the application of appropriate self-control procedures(Good Manufacturing Practices, GMPs, and Hazard Analysis of Critical Control Points, HACCP).
Food, feed and MOCAs. Approval criteria for various substances
Foods, feeds and their ingredients (as defined in EC Reg. 178/02, Article 2) have been subjected to exhaustive and exhaustive regulation. That is, the placing of ‘novel foods’(Novel Food) on the domestic market is subject to prior European authorization (under EC Reg. 258/97, repealed by the subsequent EU Reg. 2015/2283), as are new feed ingredients and their additives.
So-called Food Improvement Agents (additives, flavorings, and enzymes. EC Reg. 1331-1334/08), feed ingredients and additives, and genetically modified organisms intended for use in food and feed (EC Reg. 1829, 1830/03) are themselves subject to a special centralized authorization procedure at the European level.
MOCAs-materials and objects intended to come into contact with food, vice versa-are not subject to prior European authorization. Outside of only the cases of active and intelligent packaging, as defined by reg. EC 1935/04 (Article 2(2)(a) and (b)), instead subject to specific requirements and special authorization procedure (reg. EC 450/09).
Materials and articles intended to come into contact with food (MOCA), the European framework
Reg. EC 1935/04 establishes the general criteria with which MOCAs must comply, in addition to having to be produced in compliance with the Good Manufacturing Practices applicable to each production sector, with specific reference to the different categories of materials (Article 3, paragraph 1). ‘All materials, substances and articles intended to come into contact with food, under normal or otherwise foreseeable conditions of use, shall not transfer to food any of their constituents (of nature and) in such quantities as to:
(a) pose a danger to human health,
(b) result in an unacceptable change in the composition of food products,
(c) result in deterioration of their organoleptic characteristics.
The labeling, advertising and presentation of a material or object must not mislead consumers‘ (EC Reg. 1935/04, Article 7(2)).
In relation to the individual groups of materials and objects listed in the annex-which include metals and alloys, as well as wood (All. I, points 8 and 17)-the European Commission has mere power to introduce and/or modify specific measures (EC Reg. 1935, Article 5).
MOCA, competing legislation, and current regulations in Italy
The Food Contact Materials Regulation circumscribes the scope of concurrent legislation to only specific measures on individual materials and articles and/or groups thereof, in the absence of harmonized measures (EC Reg. 1935, Article 6). Individual member states are therefore free to maintain or adopt national provisions, within the specific scope of the groups of materials and articles in Annex I to Reg. EC 1935/04, as long as they comply with the TFEU (Treaty for the Functioning of the European Union). Resulting in a duty to notify national technical standards under penalty of their inapplicability, according to EU dir. 2015/2135.
The coeval national regulations go back, in their general terms, to Ministerial Decree 21.3.1973. (4) This decree–adopted in a historical period prior to the new course of European food law–covered a positive list of materials allowed to come into contact with food, limited to some of their categories:
(a) plastics,
(b) rubber,
(c) regenerated cellulose,
(d) paper and cardboard,
(e) glass,
(f) stainless steel.
Regulatory updates
In the interminable wait for a systematic and organic reform of the Food Contact Materials regulation at the European level, (5) some member states have continued the specific regulation of some categories of materials still not subject to harmonized standards.
The Ministry of Health in Italy in turn-after clarifying that Regulation (EC) 1935/04 supersedes Ministerial Decree 21.3.73, insofar as it specifically pertains to the limits of use of MOCAs not covered by the positive (and partial) list provided therein-has adopted numerous circulars, in the 48 years since. (6)
Compliance of metals other than stainless steel
MOCAs made of stainless steel have been the subject of special technical regulations, in Italy, by DM 9.5.19 no. 72. (7) The remaining ‘objects made of metal alloys and on porcelain enamel-coated objects intended for contact with food‘, on the other hand, follow the criteria given in the Ministry of Health Circular 20.5.14. Where it was clarified that metal alloys-in the absence of specific harmonized measures-can be used in MOCAs provided that their compliance with the general criteria set forth in Reg. EC 1935/04.
Conformity assessment-according to Article 3 of the said regulation, the ministry points out-must come on a case-by-case basis. Having regard to three essential factors:
– Knowledge of metal alloying,
– Knowledge of the type of food for which the item is intended,
– Assessment of the risk of possible migration into the indicated food (or type of food) under conditions of use as consistent as possible with actual conditions of use.
Dario Dongo
Notes
(1) Dario Dongo. Bronze-drawn pasta? Antitrust collects information. GIFT (Great Italian Food Trade). 7/24/21, https://www.greatitalianfoodtrade.it/mercati/pasta-trafilata-a-bronzo-l-antitrust-raccoglie-informazioni
(2) Marta Strinati. Plastic or wooden cutting boards? 12 to the test of bacterial contamination. GIFT (Great Italian Food Trade). 7.4.21, https://www.greatitalianfoodtrade.it/imballaggi-e-moca/taglieri-in-plastica-o-legno-12-alla-prova-della-contaminazione-batterica
(3) For further discussion, see theebook ‘Food Safety, Mandatory Rules and Voluntary Standards,’ at https://www.greatitalianfoodtrade.it/libri/sicurezza-alimentare-regole-cogenti-e-norme-volontarie-il-nuovo-libro-di-dario-dongo
(4) Ministry of Health. Ministerial Decree March 21, 1973, on the hygienic regulation of packaging, containers, utensils intended to come into contact with food substances or substances of personal use. Consolidated version as of 6.8.21 on Normattiva, see https://bit.ly/3AlbB2n
(5) Marta Strinati. Food contact materials, reform-slug slips again. GIFT (Great Italian Food Trade). 17.2.20, https://www.greatitalianfoodtrade.it/imballaggi/materiali-a-contatto-con-gli-alimenti-la-riforma-lumaca-slitta-ancora
(6) Min.Sal. Materials and articles intended to come into contact with food. https://www.salute.gov.it/portale/temi/p2_6.jsp?id=1173&area=sicurezzaAlimentare&menu=chimica
(7) Dario Dongo, Luca Foltran. Stainless steel in MOCAs, Ministry of Health decree and gaps in Europe. GIFT(Great Italian Food Trade). 17.8.19, https://www.greatitalianfoodtrade.it/imballaggi/acciaio-inox-nei-moca-decreto-ministero-salute-e-lacune-in-europa
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
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