CE-MARKING

How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.

The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA).

The CE marking is required for many products. CE marking:

shows that the manufacturer has checked that these products meet EU safety, health or environmental requirements
is an indicator of a product’s compliance with EU legislation
allows the free movement of products within the European market

By placing the CE marking on a product a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve CE marking. The manufacturer is thus ensuring validity for that product to be sold throughout the EEA. This also applies to products made in third countries which are sold in the EEA and Turkey.

Not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked.

CE marking does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there. It means that the manufacturer has checked that the product complies with all relevant essential requirements, for example health and safety requirements.

If you are a manufacturer it is your responsibility to:

carry out the conformity assessment
set up the technical file
issue the EC Declaration of Conformity (DoC)
place CE marking on a product

If you are a distributor you must check the presence of both the CE marking and the necessary supporting documentation.

If you are importing a product that is from a third country you have to check that the manufacturer outside the EU has undertaken the necessary steps. You must check that the documentation is available.

Products that need CE marking

CE marking is mandatory, but only for those products which are covered by the scope of one or more of the New Approach Directives.

Even if your product is manufactured outside the EEA, you must ensure the product bears CE marking if your product comes under the scope of a directive requiring CE Marking. Not all products sold in the EU need to bear CE marking.

CE marking applies to products, ranging from electrical equipment to toys and from civil explosives to medical devices. The full list of these product categories is below:

Active implantable medical devices
Appliances burning gaseous fuels

Appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing.

It also covers fittings, defined as safety devices, controlling devices or regulating devices and sub-assemblies thereof designed to be incorporated into an appliance.

Cableway installations designed to carry persons :

Funicular railways, gondolas and chair lifts or drag lifts

Construction products
Eco-design of energy related products :

The sector of energy-related products

Electromagnetic compatibility :

Vast range of equipment encompassing electrical and electronic appliances, systems and installations

Equipment and protective systems intended for use potentially explosive atmospheres :

Equipment and protective systems for potentially explosive atmospheres (ATEX)

Explosives for civil uses
Hot-water boilers
In vitro diagnostic medical devices
Lifts :

lifts and safety components for lifts

It does not cover lifting appliances whose speed is not greater than 0,15 m/s; construction site hoists; cableways, including funicular railways; lifts specially designed and constructed for military or police purposes; lifting appliances from which work can be carried out; mine winding gear; lifting appliances intended for lifting performers during artistic performances; lifting appliances fitted in means of transport; lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery; rack and pinion trains; escalators and mechanical walkways.

Low voltage :

low voltage electrical equipment

Low voltage electrical equipment’ are defined as any equipment designed for use with a voltage rating between 50 and 1,000 V for alternating current and between 75 and 1,500 V for direct current.

Machinery :

covers machinery; interchangeable equipment; safety components; lifting accessories; chains, ropes and webbing for lifting purposes and removable mechanical transmission devices. It also includes requirements for partly completed machinery.

Measuring Instruments :

The Directive covers the following measuring devices and systems: water meters, gas meters and volume conversion devices, active electrical energy meters, thermal energy meters, measuring systems for continuous and dynamic measurement of quantities of liquids other than water, automatic weighing instruments, taximeters, material measures, dimensional measuring instruments and exhaust gas analyzers.

Medical devices:

diagnostic medical device

Noise emission in the environment:

Noise Emission in the Environment specifies essential requirements regarding the permissible sound power level of specific equipment

Machines and equipment used for construction, gardening and others

Non-automatic weighing instruments :

a non-automatic weighing instrument as ‘a measuring instrument serving to determine the mass of a body by using the action of gravity on that body’ and ‘requiring the intervention of an operator during weighing’.

Personal protective equipment:

The Regulation defines personal protective equipment (PPE) as:

(a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety
(b) interchangeable components for equipment referred to in point (a) which are essential for its protective function
(c) connection systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use.

Pressure equipment:

The Directive defines pressure equipment as vessels, piping, safety accessories and pressure accessories, including, where applicable, elements attached to pressurized parts, such as flanges, nozzles, couplings supports, lifting lugs, and applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5 bar.

Pyrotechnics:

Equipment such as fireworks, theatrical pyrotechnic articles and pyrotechnic articles for technical purposes, such as gas generators used in airbags or in seatbelt pretensioners

The Directive excludes pyrotechnic articles intended for non-commercial use by the armed forces, the police or fire departments, equipment falling within the scope of Directive 96/98/EC on marine equipment, pyrotechnic articles intended for use in the aerospace industry and percussion caps intended specifically for toys (Directive 2009/48/EC of 18 June 2009 applies in this case). Furthermore, explosives falling within the scope of Directive 93/15/EEC on Explosives for Civil Use and ammunition are not subject to the Directive on Pyrotechnic Articles. Finally, fireworks which are built by a manufacturer for his own use and approved for use exclusively on its territory by the Member State in which the manufacturer is established, and which remain on the territory of that Member State, are also excluded from the application of the Directive.

Recreational craft:

recreational crafts and personal watercraft

any watercraft of any type, excluding personal watercraft, intended for sports and leisure purposes of hull length from 2,5 m to 24 m, regardless of the means of propulsion and as 'Personal watercraft' - watercraft intended for sports and leisure purposes of less than 4 m in hull length which uses a propulsion engine having a water jet pump as its primary source of propulsion and designed to be operated by a person or persons sitting, standing or kneeling on, rather than within the confines of, a hull.

Among products excluded are crafts intended solely for racing, canoes and kayaks, gondolas and pedalos, sailing surfboards, powered surfboards, along with others.

Restriction of Hazardous Substances in Electrical and Electronic Equipment: (RoHS)

on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)

Safety of toys:

Any product or material designed or intended, whether or not exclusively, for use in play by children under 14 years of age

puzzles with more than 500 pieces or babies’ soothers, which are not considered toys but could easily be confused as such.

Simple pressure vessels:

simple pressure vessels manufactured in series with the following characteristics:

(a) the vessels are welded, intended to be subjected to an internal gauge pressure greater than 0,5 bar and to contain air or nitrogen, and are not intended to be fired

(b) the parts and assemblies contributing to the strength of the vessel under pressure are made either of non-alloy quality steel or of non-alloy aluminium or non-age hardening aluminium alloys

(i) a cylindrical part of circular cross-section closed by outwardly dished and/or flat ends which revolve around the same axis as the cylindrical part or

(ii) two dished ends revolving around the same axis

(d) the maximum working pressure of the vessel does not exceed 30 bar and the product of that pressure and the capacity of the vessel (PS × V) does not exceed 10 000 bar.L

(e) the minimum working temperature is no lower than – 50 °C and the maximum working temperature is not higher than 300 °C for steel and 100 °C for aluminium or aluminium alloy vessels.

The CE marking is not required for items, for example:

chemicals
pharmaceuticals
cosmetics and foodstuffs

In case you need to export to EU and need CE Maerking, send an email to: info@sohainvest.cz