2.1 · Machinery and related products for foodstuffs and machinery and related products for cosmetics or pharmaceutical products

What it requires

2.1 of Regulation (EU) 2023/1230 requires: machinery for foodstuffs, cosmetics or pharmaceutical products: hygiene, cleaning and contact materials. It is unchanged in substance compared with Directive 2006/42/EC and applies to machinery placed on the market from 20 January 2027.

When it applies

Machinery intended for foodstuffs, cosmetics or pharmaceutical products.

What the instruction manual must reflect

Only if the machinery belongs to this category: the specific information and instructions required by the section.

Official text

2.1.1 General: Machinery or related products intended for use with foodstuffs or with cosmetics or pharmaceutical products shall be designed and constructed in such a way as to avoid any risk of infection, sickness or contagion. The following requirements shall be observed: (a) materials in contact with, or intended to come into contact with, foodstuffs or water intended for human consumption or cosmetics or pharmaceutical products shall satisfy the conditions laid down in the relevant Union legal acts; the machinery or related product shall be designed and constructed in such a way that these materials can be cleaned before each use and where this is not possible, disposable parts shall be used; (b) all surfaces in contact with foodstuffs or water intended for human consumption or cosmetics or pharmaceutical products, other than surfaces of disposable parts, shall: (i) be smooth and have neither ridges nor crevices, which could harbour organic materials, and the same applies to their joinings; (ii) be designed and constructed in such a way as to reduce the projections, edges and recesses of assemblies to a minimum; (iii) be easily cleaned and disinfected, where necessary after removing easily dismantled parts; the inside surfaces shall have curves with a radius sufficient to allow thorough cleaning; (c) it shall be possible for liquids, gases and aerosols deriving from foodstuffs, cosmetics or pharmaceutical products as well as from cleaning, disinfecting and rinsing fluids to be completely discharged from the machinery or related product (if possible, in a ‘cleaning’ position); (d) machinery or related products shall be designed and constructed in such a way as to prevent any substances or living creatures, in particular insects, from entering, or any organic matter from accumulating in, areas that cannot be cleaned; (e) machinery or related products shall be designed and constructed in such a way that no ancillary substances hazardous to health, including the lubricants used, can come into contact with foodstuffs or water intended for human consumption, cosmetics or pharmaceutical products; where necessary, machinery or related products shall be designed and constructed in such a way that continuing compliance with this requirement can be checked. 2.1.2 Instructions for use: The instructions for use for machinery or related products for foodstuffs and machinery or related products for cosmetics or pharmaceutical products shall indicate recommended products and methods for cleaning, disinfecting and rinsing, not only for easily accessible areas but also for areas to which access is impossible or inadvisable.

Source: Regulation (EU) 2023/1230, OJ L 165, 29.6.2023, Annex III, 2.1. The sections ‘What it requires’ and ‘What the instruction manual must reflect’ are our own summary and do not replace the official text.