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2.1.1

General

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

Full Regulation as PDF

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.

Reesly links every risk in your assessment to the relevant Essential Requirement and generates a Technical File and Declaration of Conformity already aligned with Regulation (EU) 2023/1230.

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How it works in Reesly

One requirement at a time, with evidence attached

For every Essential Requirement in the checklist, you note the solution adopted and attach photos or documents as proof of compliance, straight from your phone. Everything flows automatically into the Technical File and the Declaration of Conformity.

Chapter 2 checklist Preview
2.1.1 General
2.1.2 Instructions for use
Attach photo evidence