§277 食品又は化粧品若しくは医薬品とともに使用することを意図した機械の衛生要件

The requirements set out in section 2.1 apply to machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products. The requirements apply whether the foodstuffs or products concerned are for human or animal consumption. The machinery concerned includes, for example, machinery for the manufacture, preparation, cooking, processing, cooling, handling, storage, transport, conditioning, packaging and distribution of foodstuffs, cosmetics and pharmaceutical products.

The requirements set out in section 2.1.1 (a) to (e) aim to avoid any hazardous contamination of the foodstuffs, cosmetics or pharmaceutical products from the materials used to constitute the machinery, from the environment of the machinery or from ancillary substances used with the machinery.

These requirements shall be applied in conjunction with the EHSRs set out in section 1.1.3 relating to materials and products, section 1.5.13 relating to emissions of hazardous materials and substances, and section 1.6 relating to maintenance.

Section 2.1.1 (a) deals with the constituent materials of the machinery that are intended to come into contact with the foodstuffs, cosmetics or pharmaceutical products.

The 'relevant Directives' referred to in section 2.1.1 (a) include:

Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food;

Directive 84/500/EEC on ceramic articles to come into contact with foodstuffs;

on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC. OJ L 338, 13.11.2004, p. 4. According to Article 26 of the Regulation, references to the repealed Directives shall be construed as references to Regulation (EC) No 1935/2004.

Regulation (EC) No 10/2011 on plastic materials and articles intended to come into contact with foodstuffs.

It depends on the category of machinery (intended for use with foodstuffs or with cosmetics or pharmaceutical products) and the scope of the legal acts in the list above, whether a legal act is a "relevant legislation" or not. For example, for a machine intended for use with cosmetics, the EU legal act on materials intended to come into contact with foodstuffs is not a "relevant Directive". Since the list above is non-exhaustive, other EU legal acts could be relevant.

Where the materials intended to be in contact with foodstuffs incorporated into machinery are accompanied by a written declaration (such as the Declaration of compliance foreseen by Article 16 of Regulation (EC) No 1935/2004) that declaration must be included in the technical file for the machinery according to the ninth indent of Annex VII A 1 (a). By his signature on the EC Declaration of Conformity, the manufacturer states that all contact materials in the machine are in compliance with the relevant legislation (e.g. Regulation 1935/2004), and that the documentation is kept in the technical file and will be forwarded to the relevant authority on due request. Such declarations should not be mentioned in the EC Declaration of Conformity of the machinery.

Sections 2.1.1 (b) and (c) require the machinery to be designed and constructed to facilitate complete and thorough cleaning and to enable substances that could contaminate the foodstuffs, cosmetics or pharmaceutical products, such as, for example, waste, cleaning products, disinfectants or rinsing products, to be completely discharged or drained. Where pipes or hoses are used to convey foodstuffs, cosmetics or pharmaceutical products, they may be connected by screw threads, provided the threads are isolated from the product flow, for example, by means of appropriate seals or rings, so they are not in direct contact with the product being processed.

Section 2.1.1 (d) requires the machinery to be designed and constructed to prevent contaminants from the environment of the machinery such as dust or grease, or living creatures such as insects, from entering areas of the machinery that cannot be cleaned, and to prevent any organic matter from accumulating in such parts.

Section 2.1.1 (e) requires the machinery to be designed and constructed to prevent ancillary substances used with the machinery such as, for example, lubricants or hydraulic fluids, from contaminating the foodstuffs, cosmetics or pharmaceutical products.

The requirement set out in section 2.1.2 is complementary to the general requirements relating to the instructions set out in section 1.7.4.

Section 2.1.2 requires the machinery manufacturer to specify the appropriate cleaning methods, including methods for cleaning spaces which are normally inaccessible or to which access could be dangerous. He must also specify the products to be used for cleaning. The machinery manufacturer should not specify relating to ceramic articles intended to come into contact with foodstuffs. OJ L 277, 20.10.1984, p. 12.

intended to come into contact with food. OJ L 12, 15.1.2011, p. 1.

particular brands of cleaning products, but must specify the relevant characteristics of the products to be used, in particular, with respect to the chemical and mechanical resistance of the constituent materials of the machinery. If necessary, warnings must be given against the use of unsuitable cleaning products.

General specifications for the hygiene requirements for machinery are given in standard EN ISO 14159. Specifications for hygiene requirements for food processing machinery are given in standard EN 1672-2.