Annex 1 - Legal basis - Requirements for placing on the market
1. General
Requirements for machines are uniformly regulated in the single European market. Within the concept of the "New Approach", new machines may fall under the scope of several EU Directives and their configuration must then comply with all the relevant EU Directives.
A product may only be placed on the market, if it complies with the regulations of all applicable directives and if a conformity assessment was carried out in accordance with all applicable directives. The manufacturer identifies the directive under which a product falls in based on a risk analysis of the product and, if applicable, an analysis of the application intended by him - or by the client. That means that the intended use of a machine has a decisive influence on the directives to be considered for the conformity assessment which can be adopted into national legislation by a ProdSG (Product Safety Act) ordinance.
If two or more directives apply to the same product or the same hazard, the application of other directives may be omitted after a procedure including a risk analysis of the product with regard to the intended use defined by the manufacturer is performed. In the case of machine tools, the manufacturer may, for example, omit the application of Directive 94/9/EC. In this particular case, the explosion risk is sufficiently covered by the measures specified in the Machinery Directive.
Depending on the intended use of the machine, different case configurations are possible.
The future user of a machine and/or the client of the machine manufacturer, must observe the safety regulations valid in the Federal Republic of Germany when installing and using the machine. With regard to the health and safety of workers, these are the national and BG regulations for the protection of worker's health and safety; added to these are regulations from other areas of legislation such as the requirements for fire protection contained in the law on buildings (e. g. with regard to requirements for extraction systems) and for environmental protection.
Last but not least, requirements from the area of property insurance, e. g. for fire protection, may also exist.
2. Requirements of the Machinery Directive 2006/42/EC
For machine tools, the Directive 2006/42/EC, also called "Machinery Directive" should be used which is being implemented into national law by the 9th ordinance to the "Produktsicherheitsgesetz" (9. ProdSV) (Product Safety Act).
Annex I, clauses 1.5.6 and 1.5.7 of the Directive 2006/42/EC state that machines shall be designed and constructed in a way to exclude any risk of fire and avoid any explosion hazard. In Annex I under 1.1.2b, the Machinery Directive requires the safe design of machines; applying the principle of intrinsic safety. For this purpose, the necessary protective measures must be taken. In addition, it is required to stipulate the hazards which cannot be avoided in the instruction handbook.
The standards DIN EN 13 478 "Safety of machinery - Fire prevention and protection" and DIN EN 1127-1 "Explosive atmospheres - Explosion prevention and protection - Part 1: Basic concepts and methodology" may provide assistance - but only in a very generalized manner however - in the area of fire prevention and protection and provide guidelines for explosion prevention and protection for machines.
If in the interior of machine enclosures, the formation of a hazardous explosive atmosphere cannot be safely avoided, constructive measures must be taken, which limit the effects of a possible explosion to a harmless level. These include pressure relief devices.
3. Applications of Directive 94/9/EC
While assessing his product for risk, a manufacturer should also identify if it might be subject to the Directive 94/9/EC (also called "ATEX 95"). The Directive 94/9/EC regulates the technical safety requirements for equipment, components and protection systems intended for use in explosive areas as well as associated safety and control devices. The Directive was implemented into national legislation by the 11th ordinance for the "Produktsicherheitsgesetz" (Product Safety Act) - of December 2011.
However, if an explosive mixture is only present within the machine and its encapsulation and not, for example, in a connected extraction duct, then the whole machine is not subject to the Directive 94/9/EC (see also section 4.1.2.3 of "Application guidelines for Directive 94/9/EC", Date: May 2007 (http://ec.europa.eu/enterprise/atex/guide.htm)).
4. Other applicable regulations
Other applicable regulations include, where appropriate, the Low Voltage Directive, the EMC Directive or the Pressure Equipment Directive, which are not further dealt with in these procedural guidelines.