Basically, there are two general regulations issued by the European Union:

• EC Reg. No. 1935/2004, which provides a harmonized EU regulatory framework establishing general principles of safety and inertness for all MOCAs
• EC Reg 2023/2006, which ensures continued compliance with the requirements for good manufacturing practices through documented quality assurance and control systems

EC Reg. 1935/2004 requires food handlers to ensure and guarantee the compliance of each product by following Good Manufacturing Practices (GMP) and comparing with current regulations. All materials and objects in contact with food must be accompanied by the Declaration (MOCA) of Conformity, to be shown in case of inspection by the competent authorities.

The principles established by the regulation require that the materials:

• do not release components into food in quantities that endanger human health
• do not result in an unacceptable change in the composition, taste and odor of food

In addition, the regulatory framework provides:

• special rules for active and intelligent materials (not designed to be inert) and the possibility of additional EU measures for specific materials (e.g., plastics)
• labeling rules including an indication about their use (e.g., as a coffee maker, wine bottle or soup spoon)
• documentation to demonstrate compliance, which includes documents and test reports related to laboratory analyses necessary to prove what is claimed in the Declaration (MOCA) of Compliance
• traceability at all stages of the process to facilitate inspection, recall of defective products, consumer information and allocation of responsibility

In particular, Article 17 prescribes that traceability of parts (i.e., reconstructing the history of a part or batch to which it belongs) must be possible through a series of associated documents during production. Particular care is needed in the case of multiple usual suppliers of the same part: in the event of disputes, the inability to identify the supplier of a particular part forces the indiscriminate recall of all parts sold, with obvious economic and image damage.

EC Reg. 2023/2006 is applicable to all materials and sectors of MOCAs, and requires the preparation of extensive documentation to support compliance of the finished product in compliance with the requirements of Article 3 of EC Reg. 1935/2004.

The Regulation stipulates that all materials and articles (and combinations thereof) listed in Annex I of EC Reg. 1935/2004, as well as recycled materials and articles, must be manufactured in compliance with general and specific Good Manufacturing Practice (GMP) rules. In Italy, all MOCAs must be accompanied by the DdC (Dichiarazione di Conformità – MOCA Declaration) and the DdS (Documentazione di Supporto – Supporting Documentation), demonstrating how the conformity of a particular manufactured article with the relevant legislation was arrived at.

The DdS should include any kind of information that is relevant and useful in demonstrating the claimed conformity, such as technical information, supplier declarations, certificates of analysis, test reports, scientific arguments, calculations, and reference to operating procedures. The DdS does not accompany the goods, nor does it have to be delivered to the customer (only the DdC is delivered), but it must be available upon request from the competent authorities. The purpose of the DdS is to provide evidence of the proper management and compliance verification activities of a MOCA.

In addition to the relevant compulsory legislation, the market is increasingly moving toward the application of voluntary food safety standards, such as EN 1672-2:2005+A1:2009 (a Type C standard on hygiene requirements for food processing machinery).

In short, the EN 1672-2 standard:

• defines hazards commonly occurring on food processing machinery
• specifies hygiene requirements common to food processing machinery to eliminate or minimize the risk of contagion, infection, disease, or harm due to such food
• provides a methodology on the assessment, estimation and classification of hygiene hazards
• provides guidance and specifications on materials of construction
• provides guidance, specifications and examples of valid hygienic design compared with deficient design on:
• food zone, splash zone and non-food zone
• permanent and removable joints
• fasteners for food zone
• vessel, pump and piping drainage
• internal corners and edges
• dead spaces
• bearings and shaft entry point
• instrumentation and sampling devices
• splash zone fasteners

provides guidance on information to be included in the instruction manual, particularly referring to procedures for installation, maintenance, cleaning, and any limitations on use.