EC regulations and standards
To reduce the health risk for the customer and for infustrial plants, when using butterfly valves in the European Community, the EU legislation has launched the following directives/regulations .
| Risk | EC directive | Requirements | Valve design sepcified by |
| Fluids ejected·from pipe/vessel:by pressure > 0.5 bar (7.2 PSI) | Pressure Directive 2014/68/EU (formerly:97/23/EC) | Specific req uirements ror the "pressure re sistant envelope" i.e. dimensioning, materials, testing and documentation | EN 16668 |
| Risk from actuated parts: squeezing one's fingers or other pa rts of the human body | Machinery Directive 2006/42/EC | All actuated or oscillating parts of the "machine" must be covered by a "protect ing device" to ensure no conlact can be made and thus no harm to the body. |
EN 12100 |
| Ignition: in the case of potentially explosive atmospheres on site | ATEX Directive 100a 2014/34/EC (formerly:94/9/EC) | Sparking - specifically as 'the result of electrostatic charging - must be prevented, i.e. by earthing or by a protecting device (casing) to encapsulate the plant (or the butterfly valve inside) against explosion. | EN 13463, Parts 1 and 5 |
| Contamination as a health hazard: in pipe systems carrying food for human consumption | Regulation EC 1935/2004 | The valve must not be able to tra nsfer its contents into food in quan·tities that endanger human health or that change the organoleptic characteristics of the food. | For valve materials in contact with food: EC 1935/2004 mandates reference to the prevailing national regulations (i.e."Elastomer-Leitlinie", UBA 11/2011 in Germany) |
The ''Pressure Directive" 2014/68/EU (PED) valid for ''pressure retaining'' parts: All metallic parts of body, cover and bolting of a butterfly valve >DN25 ( 1 '') and those under pressure > 0.05 MPa (7.2 PSI) must follow '' Harmonised '' EN standards for design, material, manufacture (i.e. casting and welding), testing (specifically '' non-destructive testing = NDT) and their certification . The risk depends on size (i.e. DN), and press ure (i.e. PS) is classified by PED in 4 '' categories '' (category I = lowest, category IV = highest· the category IV applies for butterfly valves with a specific safety function only) - the higher the risk, the higher the requirements for NDT testing and supervision. Each valve user must have access to the "maintenance & service instructuions" published by the valve manufacturer The "Machinery Directive" 2006/42/EC (MD) applies for butterfly valves actuated other than manually and excludes the risk for the user of trapping fingers or hands when the disc rotates through 90 in the valve at opening/closing positions. Due to the fact that the installed inlet and outlet. piping is always 100% protected, but is not supplied by the valve manufacturer, a butterfly. valve with actuator is then supplied as "an in complete machine" in the definition of the MD and must be accompanied by an "Installation Instruction" with relevant warnings. Observing this instruction, when installed in the pipeline, the valve can later be certified by the pipe sys tem manufacturer as "a complete machine" in the definition of the MD, and this should be pointed out in the "Installation instruction" and in the valve manufacturer's "Declaration of Conformity". But for all other oscillating/rotat ing parts at the outside of the valve/actuator unit, it is the valve manufacturer's responsibility to reduce the risks of use as far as possible.
The "Explosive Directive" 2014/34/EC (ATEX 100a) applies for a butterfly valve on request only: The customer/user must point out in the case of an order that the valve will be installed in a "potentially explosive" envir onment. The valve design and the valve ma terials must reduce the risk of any ignition sparks occurring in such an environment or additionally when requested - for the fluid in side the valve. These risks are divided by ATEX into categories: Group I with cat egories M1 and M2 applies for mining applications only with severe design requirements. For other applications, Group II splits the ex plosive risk into 3 categories with correspond ingly reduced design requirements. The Regulation EC 1935/2004 "Materials in contact with food" applies on request only:
Wherever a butterfly valve is installed in pipe system for the food industry, it must neither transfer its contents to food in quan tities that endanger human health nor deteri orate the organoleptic characteristics of the food. Valves with inside surfaces made of stainless steel (18/8 CrNi) are suitable, but any elastomeric/pla meric valve parts must in line with the requirements of EC 1935/2004. Where this regulation does not specify precise lists of acceptable materials, national regula tions i.e. the "Elastomer guideline" UBA11/2011 in Germany - must be applied. For other European countries, the relevant regulations must be observed.
For countries outside the EU, other national standards, e.g. FDA, will apply and should be noted. Where electric actuators or electric/elec tronic components are used for valve actuation, the number of appropriate EC directives/regu lations must be published by the component manufacturer and the necessary documentation provided.