Equipment for the food industry.

Regulation (EU) 2023/1230 replaces and completely repeals Directive 2006/42/EC on machinery.

Transition and full implementation stages:

It is essential to understand the transition path and the deadlines for full implementation:

•             Directive 2006/42/EC will be definitively repealed on 20 January 2027.

The new Regulation introduces important features to ensure maximum safety, especially for equipment used in the manufacture or processing of food, cosmetics and pharmaceuticals.

Main differences and key requirements:

1.            Hygiene and risk prevention: The new Regulation confirms and reinforces the fundamental principle that equipment or related products intended for use with food, cosmetics or pharmaceuticals must be designed and manufactured in such a way as to exclude any risk of contamination, spread of disease or infection. This requirement emphasises the critical importance of cleanability, contamination prevention and the use of suitable materials to protect the health of the end user.

2.    Extension of the definition: inclusion of “accompanying products”. One of the most significant differences between the old Directive and the new Regulation is the explicit mention of “accompanying products”. While Directive 2006/42/EC referred in general terms to ‘equipment for food, cosmetic or pharmaceutical products’, the new Regulation specifies ‘equipment and ancillary products for the food industry, as well as equipment and ancillary products for cosmetic or pharmaceutical products’. This extends the scope not only to equipment in the strict sense of the word, but also to all those devices and equipment which, although not primary equipment, are inextricably linked to the manufacturing process of food, cosmetic or pharmaceutical products. The aim is to ensure broader coverage and safety throughout the entire production chain.

3.            Requirements and documentation for materials in contact with products (MOCA): broader and traceable compliance. With regard to materials in contact with products, the new Regulation (unlike the previous Directive, which required compliance with specific directives) requires that such materials "acquire the conditions laid down in the relevant European Union legal acts ." This means that compliance with specific directives and regulations alone is no longer sufficient; full compliance with all relevant European Union legal acts governing materials intended to come into contact with food is required. This emphasises a broader and more comprehensive view of materials legislation and greater responsibility for manufacturers.

From this point of view, it is extremely important that the manufacturer of the machine and related products obtains and keeps in its technical file declarations/reports on the materials or products used in the manufacture of the machine itself. These documents confirm compliance with Regulation (EC) No 1935/2004.

These documents must relate to:

materials used in the manufacture of the machine;

paints, adhesives, solvents applied to materials;

plastics and resins applied to materials/materials used;

rubber, ceramics, etc. applied to materials used;

electrodes;

screws;

small parts;

fastening systems;

any other element that is in contact or potentially in contact with food.

Food processing machinery standards Safety and hygiene requirements

These updates require careful analysis of design, manufacturing and conformity assessment. It is essential to ensure that both the equipment itself and related products, as well as all materials that come into contact with it, are fully compliant with the new and more detailed EU legislation, and that this compliance is properly tracked and documented.