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This ESSENTIAL decribes hygienic design requirements on the basis of
- the European Machinery Directive, adopted by Turkey as Regulation 2006/42/AT
- Turkish legislation
For other aspects of food contact (e.g.: materials, migration limits), see: ESSENTIAL TUR Food Contact Materials.
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| Legislation in force: |
Appendix I - Basic health and safety rules for the design and manufacture of machinery
General principles, Article 4 - This Annex is organized in several parts. The first part has a general scope and is applicable to all machine types. Other sections deal with some types of more specific hazards.
Moreover, it is necessary to review this annex in its entirety to ensure that it meets all relevant essential requirements. When designing machinery, the rules of the general part and the rules of one or more of the other parts should be taken into account, depending on the results of the risk assessment carried out in accordance with Article 1 of these General Principles.
2 - Additional essential health and safety requirements for certain categories of machinery
Food machinery, machinery for cosmetics and pharmaceuticals, hand-held or hand-guided machinery, portable fastening or other impact machinery, machinery for processing wood or similar physical materials must comply with all essential health and safety requirements defined in this section (General Principles, Article 4).
2.1 Food machinery and machinery for cosmetics or pharmaceuticals
2.1.1 General
Machinery intended for use with foodstuffs or cosmetics or pharmaceuticals must be designed and constructed in such a way as to prevent the risk of infection, disease or communicable disease.
The following conditions must be complied with:
(a) Materials that come into contact with, or are intended to come into contact with, food or cosmetics or pharmaceuticals.
It must meet the conditions set out in the regulations. Machinery should be designed and constructed in such a way that these materials can be cleaned before each use. If this is not possible, disposable parts should be used.
(b) All surfaces in contact with food or cosmetics or pharmaceuticals, except the surfaces of disposable parts:
- It should be smooth, including the joints, and should not have protrusions or cavities where organic materials can settle,
- It should be designed and manufactured in such a way that protrusions, edges and recesses of its components are minimal,
- When necessary, the easily removable parts should be easily cleaned and disinfected after they are removed. The inner surfaces must have curves of a sufficient radius to allow thorough cleaning.
(c) Liquids, gases and aerosols from foods, cosmetics or pharmaceuticals, as well as cleaning, disinfecting and washing liquids must be able to be completely discharged from the machine (in the 'cleaning' position, if possible).
(d) Machinery should be designed and constructed in such a way as to prevent any substances or living creatures, especially insects, from entering areas that cannot be cleaned or organic matter accumulating in them.
(e) Machinery should be designed or constructed in such a way that it is not in contact with any excipients, food, cosmetics or pharmaceuticals, including the lubricants used. Where necessary, machinery should be designed and constructed in such a way that continuous compliance with this requirement can be checked.
2.1.2 Instructions
Instructions for food machinery or machinery intended for use with cosmetics or pharmaceuticals: Recommended products and methods for cleaning, disinfecting and washing should be specified not only for easily accessible areas, but also for areas where access is not possible or not recommended.
Art.1 (1) The objective of the present Regulation is to define the general rules pertaining to food hygiene to be complied with by food business operators starting with the primary production of food to its provision to the final consumer with the aim of ensuring the protection of consumers in terms of food safety.
Art. 5 (1) Food business operators is responsible for ensuring that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in this Regulation.
Art. 8 General hygiene rules for primary production and associated operation
(3) Food business operators rearing, harvesting or hunting animals or producing primary products of animal origin shall take adequate measures with regard to the following:
a) Keeping any facilities used in connection with primary production and associated operations, including facilities used to store and handle feed, clean and, where necessary after cleaning, to disinfect them in an appropriate manner.
b) Keeping clean and, where necessary after cleaning, to disinfect, in an appropriate manner, equipment, containers, crates, vehicles and vessels.
(4) Food business operators producing or harvesting plant products shall take adequate measures for the following:
a) Keeping clean and, where necessary after cleaning, to disinfect, in an appropriate manner, facilities, equipment, containers, crates, vehicles and vessels.
Art. 11 Specific requirements for rooms where food is prepared, treated or processed
(1) Rooms where food is prepared, treated or processed, including rooms where transport vehicles are stored, shall be designed and planned to permit good food hygiene practices, including protection against contamination between and during operations:
f) Surfaces in areas where foods are handled and in particular those in contact with food, including equipment surfaces, shall be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. Surfaces should be constructed of smooth, washable, corrosion-resistant and non-toxic materials.
(2) Adequate facilities shall be provided, where necessary, for the cleaning, disinfecting and storage of working utensils and equipment. These facilities shall be constructed of corrosion-resistant materials, be easy to clean and have an adequate supply of hot and cold water.
Art.14 Equipment requirements
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-recycled 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.
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.
Art. 3 - Definitions
72) Stages of production, processing and distribution: Any stage, including import and primary production, of production, processing, storage, transport, sale or supply to the final consumer of the food,
Art.29 - Hygienic rules, guidelines for good practice
(1) In order to ensure highest level of protection of the consumers, the Ministry shall lay down general and specific hygiene rules concerning food and feed, andhygiene rules covering provisions based on the principles of hazard analysis and critical control points, health marks indicating the official controls, identification marks and special arrangements regarding traceability.
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| Comment on the comparability to EU legislation: |
The European Machinery Directive has been adopted in the form of Regulation 2006/42/AT:2009-03-03, plus harmonized standards.... |