Seven Steps to a CE Mark: Step Two, Check the Appplication of Additional Directives

Where machinery is also subject to other EU directives, which cover different aspects but also provide for the affixing of the CE mark, the provisions of these directives must be met before the CE mark is applied. If the machine contains electrical equipment, for example, it will often be subject to the Low Voltage Directive and, possibly, the EMC Directive too.

Legal Principles of the CE Mark and the Machinery Directive

The obligation to affix CE marking extends to all products which fall under the scope of directives providing for such marking and which are destined for the single market. CE marking should therefore be affixed to the following products that fall under the scope of a directive:

• All new products, irrespective of whether they were manufactured in member states or third-party  countries
• Used products imported from third-party countries and second hand products
• Products that have been substantially modified and fall under the scope of the directives as new products.

The directives may exclude certain products from CE marking.

The manufacturer uses the declaration of conformity to confirm that his product meets the requirements of the relevant directive(s).

The information that follows is intended to explain CE marking in terms of the Machinery Directive.

The Seven Steps of CE Marking Explained: Step 3- Ensure that Safety Regulations are Met

Step 3: Ensure that safety regulations are met

It is the responsibility of the machine manufacturer to comply with the essential health and safety requirements in accordance with Annex I of the Machinery Directive. The formulation of these requirements is relatively abstract, but specifics are provided through the EU standards.
The EU publishes lists of directives and the related harmonized standards. Application of these standards is voluntary, but compliance does provide presumption of conformity with the regulations. This can substantially reduce the amount of evidence required, and a lot less work is needed to incorporate the risk assessment.

The Seven Steps of CE Marking Explained: Step 1- Categorize the Product

Step 1: Categorize the product
The CE marking process starts by categorizing the product.
The following questions need to be answered:

• Is the product subject to the Machinery Directive?

Here it's important to note that, when the new Machinery Directive comes into force, some products have been introduced (e.g. pressure vessels, steam boilers and funicular railways), while others have been omitted (e.g. electrical household and office equipment).

• Is the product listed in Annex IV of the Machinery Directive?

Annex IV of the Machinery Directive lists machinery that is considered “particularly hazardous”, such as presses, woodworking machinery, service lifts, etc. In this case, CE marking and the declaration of conformity must meet special requirements.

• Is the machine a subsystem or partly completed machinery?

Manufacturers issue an EC declaration of conformity for functional machines that meet the full scope of Annex I of the Machinery Directive. For subsystems, e.g. robots, which cannot yet meet the full scope of Annex I, the manufacturer issues a manufacturer's declaration in accordance with Annex II B.
The new Machinery Directive refers to subsystems as “partly completed machinery”. From the moment the new Machinery Directive becomes valid, all partly completed machinery must be accompanied by a declaration of incorporation in accordance with Annex II. At the same time the manufacturer must perform a risk assessment and provide assembly instructions in accordance with Annex VI. Effectively the manufacturer's declaration or declaration of incorporation bans the subsystem from being put into service, as the machine is incomplete and as such may not be used on its own.

• Is it a safety component?

Under the old Machinery Directive, safety components are treated separately and are not awarded a CE mark, although it is necessary to produce a declaration of conformity. Under the new Directive they will be treated as machinery and will therefore be given a CE mark.

CE Marking of Plant and Machinery, The Basics

According to the Machinery Directive, a machine manufacturer is anyone who assembles machines or machine parts of various origins and places them on the market. A manufacturer may be the actual machine builder or – where a machine is modified – the operator. In the case of assembled machinery, it may be the manufacturer, an assembler, the project manager, an engineering company or the operator himself, who assembles a new installation from various machines, so that the different machine parts constitute a new machine.

However, according to the Machinery Directive, only one manufacturer is responsible for the design and manufacture of the machine. This manufacturer or his authorized representative takes responsibility for implementing the administrative procedures for the entire plant. The manufacturer may appoint an authorized representative, who must be established in the EU, to assume responsibility for the necessary procedures for placing the product on the market:

• Compiling the plant’s technical documentation
• Complying with the technical annex
• Providing operating instructions for the plant
• Affixing the CE mark in a suitable position on the plant and drawing up a declaration of conformity for the entire plant

Pilz CE Marks Machines for Saint-Gobain Performance Plastics

Pilz Automation Safety L.P. provides technical consulting services such as CE Marking, engineering, risk assessment and training, in addition to producing automation and safety products. Saint-Gobain Performance Plastics chose to utilize Pilz’s experience and expertise in the CE marking of several pieces of equipment including, Sani-Tech Fusion Welder, SaniPro Flange Former and SaniSeal Label Molder.  This equipment is used to work with and install performance plastic products. For instance, the Flange Former is used to thermally form a flange on the end of a plastic pipe, the label molder is used to seal a label and a color code panel onto a pipe section and the welder joins sections of pipe. All of these tasks are critical to Saint-Gobain’s customer base to properly use and install its products. Pilz Automation Safety L.P. identified the various CE Marking directives that apply to each of the machines and selected the standards associated with the relevant directives to ensure conformance as required by law for CE certification.

The process of CE marking, as required by EU law, is designed to ensure that a product has met consumer safety, health and environmental requirements. By bringing Pilz in as consultants Saint-Gobain was able to leverage Pilz’s expertise and experience in CE marking, shortening the time the overall process took while allowing their specialized staff to continue to focus on core competencies. The out-sourcing process also allowed them to bring in highly skilled and competent engineering teams to conduct governmentally required work while still maintaining their own high level of customer satisfaction and support.