Unfinished Machinery: Who Is Responsible For CE Marking?
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What if a manufacturer delivers machines without controls because the customer takes care of this himself or by others? The manufacturer has tags in use with and without the CE mark.
The questions that may arise in a case like this are:
It is often thought that as long as the machine does not have control it cannot produce anything anyway and that it is then a so-called &#;incomplete machine&#;.
Definition g) in article 2 of the current directive (/42/EC) reads:
A key role in determining whether there is an incomplete machine or a completed machine is reserved for the word &#;specific application&#;. The current interpretation of the Machinery Directive is set out in the document &#;Guide for the application of Machinery Directive /42/EC &#; 2th edition &#; June &#; and in this the following is written about &#;specific application&#;:
&#;Typical machinery-specific applications include, for example, the processing, treatment, or packaging of materials, or the moving of materials, objects or persons.&#;
When a manufacturer is supplying their customer with a machine that will surely achieve a &#;specific application&#; if fitted with a correct control system, the question of CE-labelling arises. In many cases, the manufacturer would deliver it to their clients with a CE mark when the machine indeed was fitted by a control system that the manufacture provided internally.
Such examples often occur with larger users in the process industry who purchase several machines and want to control them from one and the same basic process control system (BPCS). Think, for example, of a so-called &#;reaming bridge&#; or auger press that is supplied to a sewage treatment plant.
When the user is provided with a working machine that is equipped with all the necessary drives, motors, and sensors, which can perform its specific application simply by using its own switch box with control, the manufacturer will also be expected to provide the user with time sequence diagrams and all the necessary information to enable correct control. There is a separate definition for such a machine in the current Machinery Directive under a) second indent.
Definition a) second indent:
&#;an assembly referred to in the first indent, missing only the components to connect it on-site or to sources of energy and motion.&#;
Based on the above analysis, the answer to the first two questions is that the manufacturer must supply their machine without a controller with CE marking. However, the manufacturer will be well advised to provide a clear annex to the EC Declaration of Conformity stating the safety conditions under which the CE marking is valid.
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It is often thought that a machine builder who delivers a machine that will later be built into a production line must deliver this machine without CE marking. This thought stems from the last line of the definition of &#;incomplete machine&#;:
&#;Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies&#;
Reading this, one might conclude that any machine that is assembled with one or more machines to eventually form a production line should be delivered under the heading of &#;partly completed machinery&#;. However, this is an incorrect idea because an incomplete machine must be a machine that &#;cannot independently&#; fulfill its specific application.
According to the &#;Guide for the Application of the Machinery Directive /42/EC &#; 2nd edition &#; June &#; this means the following:
Partly completed machinery subject to the Machinery Directive is a product intended to form machinery that is in the scope of the Machinery Directive after incorporation.
&#;An assembly which is almost machinery&#; means that partly completed machinery is a product that is similar to machinery in the strict sense referred to in Article 1 (1) (a), that is to say, an assembly consisting of linked parts or components at least one of which moves, but which lacks some elements necessary to perform its specific application. Partly completed machinery must thus undergo further construction in order to become final machinery that can perform its specific application.
As an example, industrial robots are usually designed without a specific application until incorporated into the final machinery &#; see Article 2(g) of the Machinery Directive. The manufacturer of the final machinery takes the necessary measures so that the robot can perform its specific application safely within the assembly. In practice, only an industrial &#;stand and function alone-robot&#; provided with both an end-effector and control system so that it can itself perform a specific application, is a complete machinery under the Machinery Directive.
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This further construction is not the fitting of a drive system to machinery supplied without a drive system where the drive system to be fitted is covered by the manufacturer&#;s conformity assessment &#; see §35: comments on the first indent of Article 2 (a) &#; or the connection on site or with sources of energy or motion &#; see §36: comments on the second indent of Article 2 (a). Partly completed machinery should also be distinguished from machinery ready to be installed on a means of transport or in a building or a structure &#; see §37: comments on the third indent of Article 2 (a).
Machinery that meets the definition in the first three indents of Article 2(a) so it can in itself operate independently, performing its specific application &#; see §35: comments on the first indent of Article 2 (a) &#; but which only lacks the necessary protective means or safety components, such as guards, is not to be considered as partly completed machinery. Such incomplete machinery does not meet the requirements of the Machinery Directive and must not be CE marked and cannot be placed on the EU/EEA market &#; see §103: comments on Article 5 (1).
If a machine is purchased by an end-user to be incorporated into a production line, it may be that it is explicitly required that the machine not be equipped with the necessary protective devices on the input and output sides. This is because the machine will be tightly packed.
As is clear from the above explanation the manufacturer must provide the machine with a nameplate with CE marking. It is wise to include a clear annex to the EC Declaration of Conformity stating under which safety conditions the CE marking is valid.
In the article &#;Unfinished Machinery: Who Is Responsible For CE Marking?&#; the guide mentioned below is consulted as well as Machinery Directive /42/EC.
Guide for the Application of the Machinery Directive /42/EC &#; 2nd edition &#; June .
Several manufacturers have placed machinery on the EU market after without affixing the CE mark. Machinery as such is in use even though it does not meet the requirements set up in the Machinery Directive and other legislative pieces. Specifically the Work Equipment Directive and its UK implementation, The Provision and Use of Work Equipment Directive.
CE marking of industrial machines is mandatory. All machines that are put into service or put on the market in the EU since must comply with the directives and regulations drawn up by the EU. Despite this, industrial machines that are not correctly declared in full conformity are still in use because of inconsistent enforcement by authorities where has not yet been checked. Industrial machines that are not fully or correctly declared put the employer or the integrator (manufacturer) at risk of penalties, unnecessary incident not to mention commercial consequences both immediate and deferred.
Immediate Consequences
Deferred Consequences
How the directives of the EU are enforced, depends on the country you&#;re in. Each member state has the right to handle enforcement their own way. This means that machinery placed in the UK will not be enforced in the same way as machinery placed in Belgium.
The member states have their own Market Surveillance Authorities that respond to complaints and conduct spot checks. If a product does not comply, often a financial penalty, prohibition notice and/or product recall follows.
Enforcement of CE marking is mainly reactive. When an accident occurs involving machinery, authorities are notified and action is taken to check whether the machinery conforms to the directives and regulations set up by the EU.
In the UK, the Health and Safety Executive is an example of an authority enforcing compliance with CE marking. In most cases the users/employers are penalised, rather than the manufacturers.
The manufacturer is responsible for constructing a product that is safe, does not cause health risks and meets environmental requirements. Once the manufacturer conforms to all the applicable directives, it can affix the CE marking and place the product on the market.
From that moment, the manufacturer is liable to comply with the directives for 10 years. This also means that manufacturers must have the technical file and Declaration of Conformity available for 10 years.
For industrial machinery, it is important to realise many directives are of relevance. Although the CE marking process mainly focuses on the responsibility at the end of the manufacturer, the employer holds many responsibilities as well.
The Work Equipment Directive put duties on the user. This directive has been put in place to ensure employers use equipment that are safe to use and this is achieved by using correctly CE marked industrial machines.
As a part of this directive, the employer is required to keep the equipment in a state of conformity by proper maintenance and inspections. This does not just account for the 10 years after the machinery has been delivered, but continues after this equipment is in use as well.
It is recognised that despite good design, manufacture, selection, inspection and maintenance of industrial machines that some risk will persevere. In this case the employer has to make sure access to the equipment is restricted to those that have received suitable information, training and supervision.
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