The guideline is based on work by the Council of Europe, risk assessments from the European Food Safety Authority (EFSA), the Joint Expert Committee on Food Additives (JECFA) from the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO).
Risk assessment of chemical release from FCM to food is needed
“The control and documentation of compliance, trade and production of FCMs in the Nordic countries is based on the general requirements in EU regulation 1935/2004 and 2023/2006,” said co-author Dorthe Licht Cederberg, Food contact materials - metals and alloys: Nordic guidance for authorities, industry and trade.
“One main requirement in regulation 1935/2004 is that FCMs must not release constituents in amounts that can endanger human health.
“To fulfil this requirement a risk assessment of chemical release from FCM to food is needed. However, this can be difficult to perform. Especially for materials which have no detailed regulation, as for metal and alloys.
“This report is meant to serve as a guidance document to support compliance work in trade and industry, but also as a tool for the official food inspection with regard to FCM composed of metals and alloys.”
Plastic Food Contact Material Regulation
The guide collates, evaluates and recommends risk based guidance limits for release from metals and alloys used as food contact material.
Sources of information also include the Plastic Food Contact Material Regulation (EU) No 10/2011 and the Foodstuff Contaminants Regulation (EC) 1881/2006.
Norden recommends the specific release limits (SRLs in mg/kg) as suggested by the Council of Europe for the metals aluminum, antimony, arsenic, barium, beryllium, cadmium, chromium, cobalt, copper, iron, lead, lithium, magnesium, manganese, mercury, molybdenum, nickel, silver, thallium, tin, titanium, vanadium and zinc.
These metals and metalloids are typically used in FCMs or found as impurities, e.g. in alloys used in FCMs.
The document is intended to be a useful tool for industry and official food inspectors. To date there is no specific regulation for metals and alloys used in FCMs apart from Regulation (EU) No 1935/2004 which covers general requirements for all types of FCMs.
Process equipment in the food industry
“Metals and alloys are widely applied as food contact materials, e.g. as process equipment in the food industry and as household utensils. Therefore, they are a potential source of food contamination,” added Cederberg.
“Migration of substances from food contact materials to food must not occur in amounts that endanger human health. Relevant for food contact materials made from metals and alloys are the migration (release) of metals, both the main components and foreseen impurities.
“In-house control based on a declaration of compliance, DoC, and supporting documentation at the producers and importers are important prerequisites to limit this contamination and to ensure compliance with the legislation.
“This is considered a general part of quality assurance, even though the European legislation does not specifically require a DoC for metals and alloys used as food contact materials.
“For some metals knowledge on actual release of metal ions is limited. The guidance release values are to a large extent based on theoretical estimations and calculations based on toxicological threshold values, but lower limits could possibly be achievable.
“Many metal food contact materials are coated – like aluminium frying pans coated with the fluoropolymer Teflon (PTFE). Knowledge on impurities in the metals used and released when the coating is no longer intact is limited.”
Source: Nordic Council of Ministers, Nordic Council of Ministers Secretariat 2015.
Title: Food contact materials - metals and alloys: Nordic guidance for authorities, industry and trade.
Author(s): Dorthe Licht Cederberg; Susanne Ekroth; Joakim Engman; Bente Fabech.
TemaNord, ISSN 0908-6692; 2015:522