The Machinery Directive – what it means for manufacturing
01 September 2014
Author: John Colreavy, inspector, Health and Safety Authority
From powered hand-tools to robot-assisted assembly lines, lawnmowers to combine harvesters, lifting slings to tower cranes, the scope of the Machinery Directive is enormous. It is one of a number of European Directives linked to the concept of a single market, i.e. free movement of goods if the product is deemed safe by meeting the health and safety requirements of the relevant Directives.
The current Machinery Directive 2006/42/EC, which came into force on 29 December 2009, was transposed into national legislation by the European Communities (Machinery) Regulations 2008 [S.I.No.407 of 2008]. This Directive is amended by Directive 2009/127/EC to cover machinery for pesticide application, which is transposed by S.I.No.310 of 2011. The object of this amendment is environmental and human health protection through the provision of machinery that provides close control over pesticide application.
The Health and Safety Authority is the national competent authority for the Directive; the regulations permit functions to be assigned to the National Consumer Agency but, to date, this has not taken place.
The supply of machinery for work-related purposes is also subject to the 2005 Safety, Health and Welfare at Work Act, which requires that any article complies with any national legislation implementing any relevant Directive.
SCOPE OF DIRECTIVE
It is easy to underestimate the scope of the Directive. It applies to machinery in the classical sense of an assembly of linked parts, of which at least one part moves and which are joined for a specific application or which is not yet fully functional unless it is fitted with a power source or mounted on a means of transport/structure. However, it also designates the following as machinery:
- Safety components;
- Chains, ropes and webbing designed for lifting purposes as part of lifting machinery or lifting accessories;
- Lifting accessories;
- Power take-off drives; and
- Interchangeable equipment that is added by the user to other machines to change their function.
It sets down requirements for partly completed machinery supplied for incorporation into other products. It applies to machinery for both commercial and recreational/domestic use and it applies to machinery a company might build for its own use.
The Directive identifies certain types of machinery as being outside its scope such as tractors, fairground equipment, weapons, motor vehicles, trains, ships, mobile offshore platforms, bespoke laboratory machinery and certain types of electrical/electronic machinery. A flat -bed truck is outside the Directive, but a machine fitted to a truck such as a tipping trailer, crane or cement mixer is within its scope.
The Directive deals with the first placing on the market of new machinery, but it also applies to the import of second-hand machinery into the EU.
The Machinery Directive does not cover the use, including in-service inspection, of existing equipment, which is addressed by the Use of Work Equipment Directive, transposed into national law through the Safety, Health and Welfare at Work (General Application) Regulations. However, these regulations require employers to provide employees with equipment that complies with the machinery and any other relevant Directives in force at the time of its manufacture.
The Directive defines its scope of application and identifies products that are not covered by it. It sets down in Annex 1 the essential health and safety requirements that must be met and the procedures to be followed for assessing the conformity of a product. It sets out the administrative requirements for CE marking, declarations of conformity, user information and technical files. It also imposes obligations on EU Member States to conduct market surveillance to ensure that the Directive is being followed. It deals with the administrative arrangements between the European Commission and Member States.
ROLE OF HARMONISED STANDARDS
A standard is a technical specification and is classified into three types:
- A-type standards specify basic concepts, terminology and design principles applicable to all categories of machinery, e.g. EN ISO 12100:2010: Safety of machinery – General principles for design – Risk assessment and risk reduction;
- B-type standards deal with specific aspects of machinery safety or specific types of safeguard that can be used across a wide range of categories of machinery, e.g. EN ISO 13857: 2008: Safety of machinery – Safety distances to prevent hazard zones being reached by upper and lower limbs;
- C-type standards provide specifications for a given category of machinery e.g. EN 1114-1:2011: Plastics and rubber machines – Extruders and extrusion lines – Part 1: Safety requirements for extruders.
A standard becomes identified as a harmonised standard when the European Commission publishes a reference to it in the Official Journal (OJ) of the EU, which also can be found on the Commission’s website for the Machinery Directive. Manufacture of a product in accordance with a harmonised standard permits a presumption of conformity with the essential health and safety requirements of the Directive, but it is not mandatory to follow a harmonised standard. If a manufacturer chooses not to follow a harmonised standard if one is available, they will need to be able to demonstrate that an equivalent level of safety has been achieved.
When using a harmonised standard one should check its Annex Z to see if all parts of the standard carry a presumption of conformity or whether certain parts lie outside this presumption. The citation in the OJ should also be checked to see if any warning about presumption has been attached.
Procedures exist to raise a formal objection against a standard if it is considered that the standard does not provide compliance with the essential health and safety requirements of the Directive or no longer reflects the ‘state of the art’ for the product in question.
The Directive requires that before first placing machinery on the market, the following conditions must be met:
- It meets the essential health and safety requirements set out in Annex 1 to the Directive, the first of which is the conduct of an appropriate risk assessment;
- A technical file is available for examination by market surveillance authorities;
- User instructions are provided in a language understood by users in the country where the product is marketed;
- The machinery has undergone the correct conformity assessment procedure;
- The machinery is accompanied by a Declaration of Conformity;
- The machinery is CE marked.
The supply of partly completed machinery is subject to different requirements since it is not yet a final product. In the first instance, these duties fall to manufacturers but the importer takes on the responsibilities of the manufacturer if the equipment has not been originally been designed and constructed for use inside the EU .
Similarly, if a company decides to import a product and market it as their own without any reference to the actual manufacturer, they shall be considered to be the manufacturer. The Directive requires Member States to carry out market surveillance and such duties are further developed in EU Regulation 765 of 2008 on accreditation and market surveillance. Procedures exist to take safeguard actions on a Europe-wide basis against machinery or a class of machinery products found to be dangerous.
CONFORMITY ASSESSMENT AND VIGILANCE
For most machinery, the manufacturer can issue the declaration of conformity and affix the CE marking without reference to a third party, known as a notified body. However, Annex IV to the Directive lists 23 categories of machinery where a notified body must be used unless a harmonised C standard that covers all the essential health and safety requirements is followed and the production process is subject to internal checks as set out in Annex VIII.
Details of notified bodies that have been notified by the Member States to the Commission can be found on the European Commission’s Nando database.
Anybody involved in the specification, design, manufacture, import, supply, purchase or modification of machinery should be familiar with the Directive. Clearly, the degree of involvement will vary from case to case but, in addition to checking the suitability and safety of a machine, issues related to CE Marking, Declarations of Conformity, EC Type Examination Certificates (if applicable) and user instructions should be addressed before any purchase. Knowledge of the relevant harmonised standards will help decision makers to determine if a product under review is compliant.
The main objective is the supply of safe equipment but, irrespective of any accidents, non-compliance with the Directive can result in prohibition of the sale and use of machinery, import restrictions, expensive modifications, adverse publicity if safety alerts become necessary and, finally, prosecution.
This article has provided only a broad outline of the Directive and original texts should be consulted for full details. The European Commission has produced a comprehensive guide to the Machinery Directive available on their website. Advice about the application of the Directive can be obtained from the Health and Safety Authority and information on standards is available from the National Standards Authority of Ireland.http://www.engineersjournal.ie/2014/09/01/machinery-directive/http://www.engineersjournal.ie/wp-content/uploads/2014/08/Crane-1024x682.jpghttp://www.engineersjournal.ie/wp-content/uploads/2014/08/Crane-300x300.jpgMechEuropean Union,machinery,manufacturing