Machinery for the food industry and food contact materials: legislation and compliance

Machinery for food

Food is not only the basis of livelihood, but is an essential element of human health and well-being, and national and international authorities have therefore considered it necessary to properly regulate the process, distribution and control along the entire production chain.

Food, before consumption, comes into contact with numerous materials and objects throughout the production cycle: production, processing, storage, preparation and administration.

Such materials are referred to as MOCA (Materiali e Oggetti a Contatto con gli Alimenti): “Food Contact Materials” (FCMs) in english.

The category therefore encompasses: containers for the transport of food, packaging materials, kitchenware, cutlery and crockery, but also machinery for the food industry.

These materials should be sufficiently inert to prevent their constituents from damaging the health of the consumer or affecting the quality of the food.

Materials and articles in contact with food, even accidental, were already covered by the EU Machinery Directive in its original version (89/392/EEC): in fact, the current legislative cogency requires that food machines must comply with the Essential Health and Safety Requirements in point 2.1 of Annex I of the Machinery Directive (2006/42/EC).

In particular, RESS 2.1.1 in point a) shows:

“materials in contact or liable to come into contact with food, cosmetics or pharmaceutical products must comply with the relevant Directives.” 

These requirements apply to machinery for food products intended for both human and animal consumption and include, for example, machinery for the manufacture, preparation, cooking, processing, cooling, handling, storage, transport, conditioning, packaging and distribution of foodstuffs.

These requirements are intended to prevent the risk of contamination by the constituent materials of the machine, by the environment in which it is located or by ancillary substances used with it.

Furthermore, as is implied in RESS 2.1.1, it should not be forgotten that Article 3 of the Machinery Directive, provides for the possibility that the envisaged provisions may be totally or partially replaced by other EU directives regulating more specifically hazards.

It is precisely in this context that directives and regulations come into play and overlap, applying instead of the Machinery Directive to specific hazards related to food industry.

The EU law, in fact, provides binding rules that economic operators must comply with and these may have a general scope, that is, apply to all FCMs, or viceversa only to specific materials.

Therefore, for food machines it is not enough to apply the Machinery Directive, which is also supported by Regulation 1935/2004, complemented vertically by specific legislation on some materials (for example, plastic materials).

The regulation is also superimposed by a substantial applicable national legislation.

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

  • (E.C.) No 1935/2004 providing for a harmonized Community regulatory framework establishing general principles of safety and inertia for all FCMs.
  • CE 2023/2006, which guarantees constant compliance with the requirements for good manufacturing practices (in ing. GMP – Good Manufacturing Practice), through documented systems of quality assurance and control.

In terms of EU legislation on specific materials and substances, the following should be mentioned:

  • (UE) n. 10/2011 – Rules on the composition of plastic MOCA.
  • (CE) n. 282/2008 – Rules on recycled plastic.
  • (CE) n. 450/2009 – Requirements for active and intelligent materials and objects.
  • (UE) n. 284/2011 – Special conditions and procedures for the import of plastic kitchenware originating in Hong Kong and China.

The Italian legislation on food, however, consists of several notes, amendments and ministerial decrees specifically governing materials intended for food contact, the most important of which are:

  • Ministerial Decree 21 March 1973 regulating plastics, rubber, regenerated cellulose, paper and cardboard, glass and stainless steel.

Reg. (CE) 1935/2004

Reg. (EC) 1935/2004

It requires industry operators to ensure and guarantee the compliance of each product, following the GMP and comparing with the regulations in force.

All materials and articles in contact with food must be accompanied by the Declaration of Conformity (MOCA) of the manufacturer, to be shown in case of control by the competent authorities.

The principles of the regulations provide that materials shall not:

  • release their constituents into food in amounts that endanger human health;
  • lead to any unacceptable change in the composition, taste and odour of food.

In addition, the regulatory framework mainly provides for:

  • special rules for active and intelligent materials (not designed to be inert) and the possibility of taking additional EU measures for specific materials (e.g. plastics);
  • labelling rules, including an indication of their use (e.g. as a coffee machine, wine bottle or soup spoon) or by reproduction of the symbol;
  • documentation to demonstrate compliance including documents and laboratory analysis test reports, necessary to demonstrate what stated in the Dichiarazione (MOCA) di Conformità;
  • traceability throughout the process to facilitate control, recall of defective products, consumer education and accountability.

In particular, Article 17 of Regulation 1935/2004/EC prescribes that the traceability of the components consists in the ability to reconstruct the history of a part or lot belonging through a series of associated documents during production, including chemical analysis of casting for metals and metal alloys, production batch for commercial materials, accompanied by the declaration of food conformity.

Special attention should be paid to several usual suppliers of the same party: in the event of a dispute, the impossibility of identifying the supplier of a particular part forces the indiscriminate withdrawal of all the parts sold, with obvious economic and image damage.

Wether a manufacturer relies on sub-contractors for full or partial traceability, these sub-contractors need to be qualified and supervised.

Reg. (CE) 2023/2006

Regulation CE 2023/2006 is applicable to all materials and all sectors of MOCA and provides for the preparation of extensive documentation to support the conformity of the finished product in compliance with the requirements of art. 3 of EC Regulation 1935/2004.

The Regulation provides that all materials and articles listed in Annex I to Reg. EC 1935/2004 and their combinations, as well as recycled materials and articles, shall be manufactured in accordance with the general and specific rules on good manufacturing practice, Good Manufacturing Pratices (GMP).

It is therefore required a Supporting Documentation (DdS). In Italy, all materials and objects intended to come into contact with food must be accompanied by the ddc (Declaration of Conformity – MOCA Declaration) in support of which adequate documentation (DdS) must be made available to demonstrate to the competent authorities how the conformity of a particular article with the relevant legislation has been declared.

The DdS should include any kind of relevant and useful information or data to demonstrate the declared compliance, e.g. technical information, supplier declarations, analysis certificates, test reports, scientific arguments, calculations, recall of operating procedures, etc.

The DdS does not accompany the goods, nor must it be delivered to the customer, but must be available and shown, on request, to the competent authorities, for example during inspections or checks.

In fact, the purpose of the DdS is precisely to provide proof to the competent authorities of the good management and verification of the compliance of an MOCA.

Both national and community law does not provide that the Dds is compulsorily shown or transferred to customers, since it is kept “in house”, while only the DdC is delivered.

Voluntary Standards harmonized with the Machinery Directive

In addition to the mandatory legislation in this area, the market is increasingly moving towards the application of voluntary food safety standards, requiring the adoption of integrated hygiene management systems in the design of food machinery, as described in the standards harmonised to the Machinery Directive:

  • EN ISO 14159:2008: Type B standard for generic hygiene requirements for machinery design
  • EN 1672-2:2005+A1:2009: Type C standard specific to common hygiene requirements for machinery of food industry

In short, the EN 1672-2 standard, specific for food industry machinery:

  • defines the hazards that commonly occur on food processing machines;
  • specifies common hygiene requirements for food machines in order to eliminate or minimize the risk of infection, infection, disease or harm caused by those foods;
  • provides a methodology for evaluating, estimating and classifying hygiene risks;
  • provides guidance and specifications on building materials;
  • provides guidance, specifications and examples of valid hygienic design versus deficient design, on:
    • food zone, spray zone and non-food zone
    • permanent and removable joints
    • fasteners for food area
    • drainage vessel, pump and piping
    • internal corners and edges
    • dead spaces
    • bearings and shaft entry point
    • instrumentation and sampling devices
    • fasteners for spray area
  • provides, as well, diections on the information to be included in the instruction manual, in particular relating to the installation, maintenance, cleaning and any restrictions on use.

In conclusion, in addition to the standard EN 1672-2 which confers the presumption of conformity for the requirements related to the hygiene of machinery, a series of voluntary standards specific to individual types of machinery have been issued at European level.

Compliance with these rules implies a presumption of conformity with the specific requirements of the relevant legal obligations of the food machine. Those who do not adopt them assume the burden of a documented validation of their machine to demonstrate compliance.

For simplicity, the following is a list of standards harmonized with the Machinery Directive for certain machinery in the food industry:

  • EN 453:2014 – mixing machines for food products
  • EN 454:2014 – planetary mixers
  • EN 1673:2000+A1:2009 – rotary rack ovens
  • EN 1674:2015 – dough sheeters
  • EN 1678:1998+A1:2010 – vegetable cutters
  • EN 1974:1998+A1:2009 – Slicing machines
  • EN 12041:2014 – shaping machines
  • EN 12042:2014 – automatic dividers
  • EN 12043:2014 – Intermediate leavening cells
  • EN 12267:2003+A1:2010 – circular saws
  • EN 12268:2014 – band saws
  • EN 12331:2003+A2:2010 – Meat grinders
  • EN 12355:2003+A1:2010 – Skinning, trimming and membrane removal machines
  • EN 12463:2004+A1:2011 – Filling and auxiliary machines
  • EN 12505:2000+A1:2009 – Centrifuges for the treatment of food oils and fats
  • EN 12621:2006+A1:2010 – Dryers salad
  • EN 12852:2001+A1:2010 – Food processing machines and blenders
  • EN 12853:2001+A1:2010 – Portable blenders and mixers
  • EN 12854:2003+A1:2010 – hand blenders
  • EN 12855:2003+A1:2010 – rotating pan Cutter
  • EN 12984:2005+A1:2010 – Portable machines and appliances with mechanically operated cutting tools
  • EN 13208:2003+A1:2010 – vegetable peeler
  • EN 13288:2005+A1:2009 – Machines for lifting or reversing containers
  • EN 13389:2005+A1:2009 – Mixers with horizontal shafts
  • EN 13390:2002+A1:2009 – Machines for cakes and tarts
  • EN 13534:2006+A1:2010 – Syringe machines for salting
  • EN 13570:2005+A1:2010 – Mixing machines
  • EN 13591:2005+A1:2009 – Loaders for fixed shelves ovens
  • EN 13621:2004+A1:2010 – Dryer Salad Spinner
  • EN 13732:2013 – Bulk milk coolers on farms  (Requirements for construction, performance, suitability for use, safety and hygiene)
  • EN 13870:2015 – Portioning machines
  • EN 13871:2014 – dicing machine
  • EN 13885:2005+A1:2010 – Clipping machines
  • EN 13886:2005+A1:2010 – Cooking boilers equipped with Motor-driven mixers and/or mixers
  • EN 13954:2005+A1:2010 – Bread cutters
  • EN 14655:2005+A1:2010 – baguette cutters
  • EN 14957:2006+A1:2010 – Dishwasher machines with conveyor
  • EN 14958:2006+A1:2009 – Machines for grinding and processing flour and meal
  • EN 15166:2008 – Automatic slaughter frame back separation machines
  • EN 15774:2010 – Machines for fresh and filled pasta process
  • EN 15861:2012 – smokehouse
  • EN 16743:2016 – Automativ industrial-size professional slicer

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