FCMs are materials and objects that come into contact with the food that we use in everyday life at home and in our businesses. For this reason, the production of FCMs needs to be controlled in order to protect the quality and health of the food we eat.
Based on the precautionary principle and with the aim of aligning legislation regarding food matters across the EU’s various member states, the EC published Regulation 1935/2004 under which any materials and items that are intended to come into direct or indirect contact with food must not transfer substances that may endanger human health, involve an unacceptable change in the composition of foodstuffs or a deterioration in their organoleptic characteristics. EC Regulation 2023/2006 on Good Manufacturing Practices (GMP) requires companies to apply GMP and ensure the compliance of FCM at all stages of processing, from production to distribution and end use.
In addition, operators in the sector must establish and maintain an effective Assurance and Quality Control system, and ensure that relevant documentation is drawn up and operational documents and records are archived.
The implementation of management procedures develops the following points:
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Selection and qualification of suppliers from whom to buy certified materials;
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Implementation and control of processing systems (GMP);
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Use of equipment that is in line with production standards;
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Management of transport and storage of both raw materials and finished products;
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Training, information and retraining of staff;
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Traceability of raw materials, semi-finished products and finished products;
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Suitable labelling and packaging;
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Management of non-compliance.
As mentioned above, EC Regulation 1935/2004 has tried to align legislation on the production and packaging of food in EU member countries, but has only partly succeeded and only for certain materials. The production of rubber and silicone products refers manufacturers to the implementation of the regulations of the countries where the product will be sold.
Italian regulation: Decreto Ministeriale 21 marzo 1973
German regulation: BfR-Empfehlungen für Materialien im Lebensmittelkontakt
French regulation: Arrêté du 5 août 2020, Arrêté du 9 novembre 1994, Arrêté du 25 novembre 1992
Alternatively, by using global migration analysis, organoleptic testing and with the full and sole responsibility of the producer, products can be placed on the market the materials of which are not on the positive list of the countries of sale (e.g. platinum-catalysed silicone cake tins sold and marketed in Italy).
CAMISANA has started producing food contact materials and objects (FCM) and implemented good manufacturing practices (Good Manufacturing Practices, GMP), as regulated by EC Regulation 2023/2006. This regulation, in addition to product regulation (Regulation 1935/2004), requires a continuous monitoring of process compliance, as well as the creation of appropriate documentation of any actions relating to this.
Our production of FCM materials and objects designed to come into contact with food takes into account the highest standards of quality with the aim of minimising the chances of migration. By implementing specific procedures and working together with customers. we are able to produce rubber or silicone FCM items for food production plants and processing machinery such as:
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Sealing gaskets
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Caps
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Valves
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Steel/plastic/textile overmoulding
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Food-processing machine components
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Custom-made items
And all items for sale to the public:
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Silicone moulds and cake tins
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Custom gaskets for containers
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Stainless steel/plastic overmoulding
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Airtight membrances for containers
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Cooking utensils
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Custom-made items
To fulfil the needs of food companies, CAMISANA produces FDA metal-detectable silicone products or metal inserts that are detectable by metal detectors. Our technicians allow us to examine, develop and carry out customer projects while ensuring compliance with standards. In addition to complying with Regulation 1935/2004, our products comply with FDA Regulation 21 CFR2600 and WRAS, UBA, NSF, KIWA, ACS and DM 174/2006 standards for contact with drinking water.
CAMISANA has been working under this philosophy for over 40 years, implementing year after year a careful attention to detail in terms of choosing raw materials and defining processes.
For further information regarding our FCM compliance and products, please contact us via info@camisana.it
