CE MARKING SERVICES

Directive 2006/42/EC (relating to machines) applies to machines; interchangeable equipment; safety components; lifting accessories; chains, ropes and straps; removable mechanical transmission devices; partly completed machinery.

«Machine» means an assembly equipped or intended to be equipped with a drive system other than direct human or animal force, composed of parts or components, of which at least one is mobile, connected together solidly for a well-defined application.

By «partly completed machines» we mean the sets which almost make up a machine, but which alone cannot guarantee a well-defined application. A drive system is a partly completed machine. The partly completed machines are solely intended to be incorporated or assembled to other machinery or to other partly completed machines or appliances to constitute a machine.

In most cases, the Manufacturer can perform the conformity assessment of the machine without involving a Notified Body, by preparing the relative technical file that demonstrates its compliance with the essential requirements of safety and health protection (ERSH) prescribed by the applicable Directives, and referring to one or more harmonized technical standards (presumption of conformity).

For some types of machines, the manufacturer must instead request the intervention of a Notified Body. Annex IV of the Directive lists them specifically: saws for woodworking, presses, injection or compression rubber/plastics molding machines, machines for underground works, people lifting equipment and so on. For a detailed and exhaustive list, you can see Annex IV of the Directive, downloadable here.

The heart of the Directive are E.R.S.H. Essential Requirements for Safety and Health Protection. Among them, for example, the requirements about control systems, about measures of protection from mechanical and other hazards (electrical, electromagnetic, vibrations, noise, radiation …), about guards and protective devices, about maintenance and the information to be provided.

It relates to the placing on the market of electrical material intended to be used within certain voltage limits, between 50 and 1000 V in alternate current and between 75 and 1500 V in direct current (except for some exclusions, e.g. electrical materials for clinical use, the electrical parts of lifts and hoists etc etc).

Internal production control is the conformity assessment procedure with which the Manufacturer complies with the obligations of the Directive, ensures and declares, under its sole responsibility, that the electrical equipment meets the requirements of the Directive itself, applicable to it.

The Manufacturer is required to prepare the technical documentation, which allows to assess the compliance of the electrical equipment with the relevant requirements and includes an adequate analysis and assessment of the risks. The technical documentation specifies the applicable requirements and includes, if necessary for evaluation purposes, the design, manufacture and operation of the electrical equipment.

The Manufacturer takes all necessary measures to ensure that the manufacturing process and the related control ensure the conformity of the electrical material manufactured with the prepared technical documentation.

Finally, the manufacturer affixes the CE marking on each individual electrical material that complies with the applicable requirements of this directive and fills in an EU Declaration of Conformity for each model of the product which, together with the technical file. The manufacturer makes it available to the national market surveillance authorities for ten years from the date on which the electrical equipment was placed on the market.

“Electromagnetic compatibility” means the suitability of a device to function satisfactorily in its electromagnetic environment (immunity) and without producing unacceptable electromagnetic disturbances in other equipment in that environment (emissions).

Under the category “equipment” there are appliances and systems defined as follows:

• “Appliance”: any finished device, or combination of finished devices, made available on the market as an independent functional unit, intended for the end user and capable of generating electromagnetic disturbances, or whose operation may suffer the effects of these disturbances;
• ‘Fixed system’: a particular combination of various types of equipment and possibly other devices, which are assembled, installed and intended to be used permanently in a predetermined place.

When placing their appliances on the market, the Manufacturers ensure that they have been designed and manufactured in accordance with the essential requirements set out in Annex I of the Directive. To this end, they prepare the technical file and carry out or have the Conformity assessment procedure carried out.

If the compliance of a device with the applicable requirements has been demonstrated by this procedure, manufacturers draw up an EU declaration of conformity and affix the CE marking. Technical file and EU Declaration of Conformity are kept for ten years from the date on which the appliance was placed on the market, available to the competent national authority.

Manufacturers shall ensure that the necessary procedures are in place for series production to continue to comply with this directive. In addition, the Manufacturers put their name, registered trade name or registered trademark and full address on the devices. They add the type of appliance, batch, series or any other element that allows its identification or, if the size or nature of the appliance does not allow it, that the information requested is provided on the packaging or in a document accompanying the ‘device.

Finally, manufacturers guarantee that the appliance is accompanied by instructions in a language that can be easily understood by consumers and other end users.

The PED Directive applies to the design, manufacture and conformity assessment of pressure equipment and assemblies subjected to a maximum allowable pressure PS greater than 0.5 bar (referred to atmospheric pressure, relative pressure therefore).

The equipment is classified into categories of increasing danger.

Equipment that does not fall into any category must be designed and manufactured according to correct construction practice in use in one of the Member States, which ensures safe use. These pressure equipment and assemblies must be accompanied by sufficient instructions for use and do not bear the CE marking.

With regard to pressure equipment and assemblies which are classified according to a risk category, the Manufacturers ensure that they have been designed and manufactured in compliance with the essential safety requirements of the Directive.

To this end, the manufacturers prepare the technical documentation and perform or have the relevant conformity assessment procedure performed. After demonstrating compliance, the manufacturers draw up an EU declaration of conformity and affix the CE marking. In addition, they retain the technical documentation and the EU declaration of conformity for a period of ten years from the date on which the pressure equipment or assemblies were placed on the market.

With regard to production, manufacturers ensure that the necessary procedures are in place to ensure that series production continues to comply with this Directive. Where deemed necessary in view of the risks posed by pressure equipment or assemblies, to protect the health and safety of consumers and other users, manufacturers carry out a sample test of pressure equipment or assemblies made available on the market. , examine complaints, pressure equipment and non-compliant assemblies and recalls of such equipment, maintain, if necessary, a register of the same and inform distributors of such monitoring.

Finally, manufacturers ensure that their name, registered trade name or registered trademark and full address are affixed to their pressure equipment or assemblies. They affix a type, batch, serial number or any other element that allows their identification or, if it is not possible, guarantee that the prescribed information is provided on the packaging or in a document accompanying the equipment.

Manufacturers ensure that pressure equipment or assemblies are accompanied by instructions and safety information compliant with the Directive, in a language that can be easily understood by consumers and other users.

It deals with the minimum safety and health requirements relating to the exposure of workers to the risks deriving from physical agents (artificial optical radiation). “Optical radiation” means all electromagnetic radiation in the wavelength range between 100 nm (ultraviolet) and 1 mm (infrared).

The directive sets out the exposure limit values ​​for incoherent radiation (Annex I) and the exposure limit values ​​for laser radiation (Annex II).

The obligations for employers consist in the identification of the exposure, in the risk assessment, in the implementation of provisions aimed at eliminating or reducing the aforementioned risks, in the training and information of the operators exposed to these risks.

Looking at the issue from the point of view of machines manufacturer, the Machinery Directive and harmonized standards, specific to the type of machine, are applicable.

The Directive applies to products designed or intended, exclusively or not, to be used for play by children under the age of 14 (“toys”).

Exclusions include some models of bicycles, skates, collectibles for adults, puzzles with more than 500 pieces, products with pointed darts etc etc.

When placing their toys on the market, manufacturers ensure that they have been designed and manufactured in accordance with the requirements of the Directive. These requirements refer to the physical-mechanical characteristics of the toy, flammability, chemical and electrical properties, hygiene and radioactivity.

To this end, manufacturers prepare the technical documentation and carry out or have the Conformity assessment procedure carried out. Having demonstrated compliance, the manufacturers draw up an EC declaration of conformity and affix the CE marking. Technical documentation and EC Declaration of Conformity must be kept for a period of ten years after the toy has been placed on the market.

Manufacturers ensure that the necessary procedures are in place for series production to continue to comply. Where deemed necessary in view of the risks posed by a toy, manufacturers carry out a sample test of the marketed toys to protect the health and safety of consumers, carry out investigations and, where appropriate, keep a register of complaints, of toys non-compliant and toy recalls and inform distributors of such monitoring.

Manufacturers ensure that a type, batch, serial, model number or other element allowing their identification is affixed to their toys, or, if the size or nature of the toy does not allow it, that the information required are provided on the packaging or in an accompanying toy document.

The manufacturers indicate their name, their registered trade name or their registered trademark and the address where they can be contacted on the toy or, if this is not possible, on the packaging or in a document accompanying the toy. Manufacturers ensure that the toy is accompanied by instructions and safety information provided in a language or languages ​​that can be easily understood by consumers.

STEM, on the basis of the experience and competence acquired in the regulatory field, offers assistance and consultancy for the research, interpretation and correct application of technical standards and relevant EU Directives for the machine / product of interest.

This is an increasingly frequent situation, given the obvious difference in production costs between one site located in Italy and another in Asia. What is not always evident is that, in most cases, the Chinese manufacturer does not know and therefore does not refer to the Directives of the European Community and to the safety requirements necessary for the placing of its products on our market.

The consequences of this non-compliance are reflected on the importer who intends to distribute the Asian product on the Italian and EU market.

STEM offers assistance and technical advice on the machine and on the product, both about documentation (technical file, risk analysis and assessment, use and maintenance manual, declaration of conformity etc etc) and about tests, indicating which measures and experiments are to be performed for evaluating the conformity of the machine / product. At the same time, the roles (manufacturer, authorized representative, importer) and the respective duties are clarified.

Goal of STEM service is to enabling the importer to place the product on the Italian and European market in a conscious and safe way.