FCMs CERTIFICATION FOR CERAMIC PRODUCTS

Food-use products made of ceramic materials also fall under the FCM – Materials and objects in contact with food – category and are therefore subject to all legislation governing them, as they must not pose a risk to consumers who use them.

What should a ceramist or a business that produces objects made of ceramic material that wants to market its own product do?

Below are the 5 points to be fulfilled in order to trade a ceramic material product that will come into contact with food during its lifetime.

Registration of the start of business

Obligation to notify the competent health authority of the start of the activity of production, processing and distribution of FCM materials and objects by registering as an economic operator (EO). As prescribed in Legislative Decree no. 29/2017, this communication should be forwarded to the competent ASL (Local Health Authority) through the SUAP (One Stop Shop for Productive Activities).

Traceability

The traceability of FCMs, as stated in Art. 17 of the regulation, must be ensured at all stages of product life to facilitate inspections, product withdrawal, consumer information, and allocation of responsibility. Companies must therefore always be in a position to identify and declare the companies from which and to which the items were supplied, when necessary even the substances and products used during processing. Therefore, it is necessary to develop and maintain a traceability record that can monitor and correlate the batch of raw materials (clays, glazes, colors, crystals, decals, etc.) and finished products (batch, item, quantity, etc.) during processing.

Good Processing Practices and Quality Control

Regulation (EC) no. 1935/2004 requires that all FCMs are produced following good manufacturing practices (GMP) to ensure that they are inert, avoid the transfer of chemicals to food products in quantities that endanger the consumer and avoid unacceptable changes to the composition and/or deterioration of the organoleptic characteristics of the food itself.

Further elaboration on this detail is made in Regulation (EC) No.2023/2006, and it stipulates that at the stages of production, processing and distribution of materials and objects, a certified and documented quality control procedure must be in place. This procedure must take intoaccount the adequacy of personnel, equipment and size of the enterprise.

The standard refers to specific measures to be implemented for particular materials to address risks related to their use attributable to migration of components, irregular presence of metals, or contamination by enamels.

Release limits for elements such as lead and cadmium are defined for ceramic products. Specifically, Council Directive 84/500/EEC, later amended in some places by Commission Directive 2005/31/EC, sets quantitative limits (mg/dm2) for these substances based on the ceramic object under consideration (fillable and unfillable objects, internal depth, utensils and vessels).

Declaration of Conformity

Another specification is given in Art. 2-bis of Directive 2005/31/EC, which complements what is defined in Article 16 of the framework standard and concerns the declaration of compliance, that is, a written statement attesting to the compliance of materials and objects with applicable standards. This declaration must be issued by the manufacturer or a seller based in the European Union (Art.2 D.M. 01/02/2007).

The declaration must be included at the various stages of marketing, including the retail stage for ceramic items.

Annex III of the directive lists the information that should be reported:

• identity and address of the company manufacturing the finished object and the importer importing it into the Community;
• Item identification and possible uses;
• date of the statement;
• certificate that the ceramic object meets the requirements of Directive 2005/31/EC and Regulation (EC) No.1935/2004.

Labeling requirement

Art. 15 of Reg. (EC) No. 1935/2004 regulates the labeling of FCMs. The information that must be stated on the label is as follows:

• The words “for food contact” or specific indication of their use or the recognized symbol

• the name or company name and address of the manufacturer, processor or seller responsible for placement on the market, established within the Community;
• Presence of the lot on the item or sales package;
• If necessary, special instructions to ensure safe and appropriate use.

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