Anwendungsbereich des Regulatory Essentials
Geltende Rechtsvorschriften:
Machinery Directive, applicable until January 2027.
Repealed and replaced by the EU Machinery Regulation, published in June 2023)
ANNEX I -Essential health and safety requirements relating to the the design and construction of machinery
GENERAL PRINCIPLES
2. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CERTAIN CATEGORIES OF
MACHINERY
Foodstuffs machinery, machinery for cosmetics or pharmaceutical products, hand-held and/or hand-guided machinery, portable fixing and other impact machinery, machinery for working wood and material with similar physical characteristics must meet all the essential health and safety requirements described in this chapter (see General Principles, point 4).
2.1. FOODSTUFFS MACHINERY AND MACHINERY FOR COSMETICS OR PHARMACEUTICAL PRODUCTS
2.1.1. General
Machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products must be designed and constructed in such a way as to avoid any risk of infection, sickness or contagion.
The following requirements must be observed:
(a) materials in contact with, or intended to come into contact with, foodstuffs or cosmetics or pharmaceutical products must satisfy the conditions set down in the relevant Directives. The machinery must be designed and constructed in such a way that these materials can be cleaned before each use. Where this is not possible disposable parts must be used;
(b) all surfaces in contact with foodstuffs or cosmetics or pharmaceutical products, other than surfaces of disposable parts, must:
— be smooth and have neither ridges nor crevices which could harbour organic materials. The same applies to their joinings,
— be designed and constructed in such a way as to reduce the projections, edges and recesses of assemblies to a minimum,
— be easily cleaned and disinfected, where necessary after removing easily dismantled parts; the inside surfaces must have curves with a radius sufficient to allow thorough cleaning;
(c) it must 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 (if possible, in a ‘cleaning’ position);
(d) machinery must 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 must 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, cosmetics or pharmaceutical products. Where necessary, machinery must be designed and constructed in such a way that continuing compliance with this requirement can be checked.
2.1.2. Instructions
The instructions for foodstuffs machinery and machinery for use with cosmetics or pharmaceutical products must 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.
The principle underlying this Regulation is that any material or article intended to come into contact directly or indirectly with food must be sufficiently inert to preclude substances from being transferred to food in quantities large enough to endanger human health or to bring about an unacceptable change in the composition of the food or a deterioration in its organoleptic properties.
"General Food Law"
Article 1:
3. This Regulation shall apply to all stages of production, processing and distribution of food and feed. It shall not apply to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption.
ANNEX II - GENERAL HYGIENE REQUIREMENTS FOR ALL FOOD BUSINESS OPERATORS
CHAPTER V
EQUIPMENT REQUIREMENTS
1. All articles, fittings and equipment with which food comes into contact are to:
(a) be effectively cleaned and, where necessary, disinfected. Cleaning and disinfection are to take place at a frequency sufficient to avoid any risk of contamination;
(b) be so constructed, be of such materials and be kept in such good order, repair and condition as to minimise any risk of contamination;
(c) with the exception of non-returnable containers and packaging, be so constructed, be of such materials and be kept in such good order, repair and condition as to enable them to be kept clean and, where necessary, to be disinfected; and
(d) be installed in such a manner as to allow adequate cleaning of the equipment and the surrounding area.
2. Where necessary, equipment is to be fitted with any appropriate control device to guarantee fulfilment of this Regulation's objectives.
3. Where chemical additives have to be used to prevent corrosion of equipment and containers, they are to be used in accordance with good practice.
Kommentar bezüglich der Vergleichbarkeit mit der EU-Gesetzgebung: