Product Safety Certification
ABOUT CE MARKING
WHAT IS CE MARKING
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. It is in that sense similar to the FCC Declaration of Conformity used on certain electronic devices sold in the United States.
CE marking is a part of the EU’s harmonisation legislation, which is mainly managed by Directorate-General for Internal market, Industry, Entrepreneurship and SMEs. The CE marking for Restriction of Hazardous Substances is managed by Directorate-General for Environment. Comprehensive guidance on the implementation of EU product rules can be found in the so-called Blue Guide.
Not all products must have CE marking. It is compulsory only for most of the products covered by the New Approach Directives. It is forbidden to affix CE marking to other products.
Please note that a CE marking does not indicate that a product have been approved as safe by the EU or by another authority. It does not indicate the origin of a product either.
How to reproduce the CE mark
Please tell us your requirements
There are two main benefits CE marking brings to businesses and consumers within the EEA:
- Businesses know that products bearing the CE marking can be traded in the EEA without restrictions.
- Consumers enjoy the same level of health, safety, and environmental protection throughout the entire EEA.
The CE marking is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 30 countries of the European Economic Area (EEA).
The great benefit for manufacturers is that there is now only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire EEA. The various and conflicting national regulations are eliminated.
In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims.
How to get CE mark?
Basically designing a product to meet the relevant standards, creating a Technical File and producing a Declaration of Conformity.
What you really need to do is to demonstrate that you have fulfilled the essential requirements of any relevant directives. These are in two parts:
- Protection requirements and
- Administrative requirements.
The protection requirements relate to the design of the product and can be demonstrated by meeting the requirements of the relevant harmonised standards. The administrative requirements relate to how the product is CE marked. This generally involves the manufacturer producing a Declaration of Conformity and a technical file containing design/manufacturing information and also the application of the CE mark to the product.
SECTOR SPECIFIC APPLICATION OF CE MARKING
- Active implantable medical devices (excludes surgical instruments)
- Appliances burning gaseous fuels
- Cableway installations designed to carry persons
- Construction products according to Regulation (EU) No. 305/2011 under specific rules
- Eco-design of energy related products
- Electromagnetic compatibility
- Equipment and protective systems intended for use in potentially explosive atmospheres
- Explosives for civil uses
- Hot-water boilers
- In vitro diagnostic medical devices
- Low voltage
- Measuring Instruments
- Medical devices
- Noise emission in the environment
- Non-automatic weighing instruments
- Personal protective equipment
- Pressure equipment
- Radio and telecommunications terminal equipment
- Recreational craft
- Restriction of the use of certain hazardous substances in electrical and electronic equipment RoHS 2
- Safety of toys
- Simple pressure vessels.
Existing in its present form since 1985, the CE marking indicates that the manufacturer or importer claims compliance with the relevant EU legislation applicable to a product, regardless of the place of manufacture. By affixing the CE marking on a product, a manufacturer effectively declares, at its sole responsibility, conformity with all of the legal requirements to achieve CE marking which allows free movement and sale of the product throughout the European Economic Area.
For example, most electrical products must comply with the Low Voltage Directive and the EMC Directive; toys must comply with the Toy Safety Directive. The marking does not indicate EEA manufacture or that the EU or another authority has approved a product as safe or conformant. The EU requirements may include safety, health, and environmental protection, and, if stipulated in any EU product legislation, assessment by a Notified Body or manufacture according to a certified production quality system. The CE marking also indicates that the product complies with directives in relation to "Electro Magnetic Compatibility" - meaning the device will work as intended, without interfering with the use or function of any other device.
Frequently Asked Questions
An EU Directive is a form of legislation that sets out requirements your products must meet in order to sell them into Europe.
The European Union introduced a series of measures to simplify the movement of goods throughout the European Union (EU) and the European Free Trade Area (EFTA). Some of these measures are known as New Approach Directives. New Approach Directives provide controls on product design and above all, seek to harmonize product safety requirements across Europe.
The directives cover a very wide range of product areas including construction products, personal protective equipment and pressure equipment. Their primary objective is to ensure that the products are well designed, and safe for the user.
Throughout Europe, where a New Approach Directive is in force, it is necessary for the manufacturer to CE mark their product. CE marking requirements vary from Directive to Directive, and even within Directives.
Third-party testing, systems assessment and technical file assessments can be mandatory, but sometimes the manufacturer's unverified claim is all that's asked for. But beware! If you claim your product complies and it doesn't, you will be prosecuted. Where a Directive requires products and/or systems to be independently tested, certified, or inspected, this must be done by a "Notified Body" or "Competent Body".
The countries that require CE marking are the 31 countries in the European Economic Area. This includes:
All of the 28 EU member states: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the UK.
Three members of the European Free Trade Association: Iceland, Liechtenstein and Norway.
In addition, Turkey has fully implemented many of the CE marking directives, even though it’s not a member of the EU or the EEA.
Switzerland is also not an EU or EEA member. However, it is part of the European Free Trade Association, so accepts CE marking as a presumption of conformity with its own national technical regulations for some products.
CE marking is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing certain European Directives. CE marking gives companies easier access into the European market to sell their products without adaptation or rechecking. The initials “CE” do not stand for any specific words but are a declaration by the manufacturer that his product meets the requirements of the applicable European Directive(s).
You need to establish first which, if any, of the New Approach Directives or older Global Approach Directives applies to your product. CE marking only applies to products within the scope of these Directives. It should not be applied to products if they are outside the scope of the Directives.
The same principles above apply to imported products. It is the responsibility of the importer / person placing the product on the market to ensure that the product is correctly CE-marked.
It is necessary first to establish which Directives apply to the product. It is impossible to draw up hard-and-fast rules, and it is important to seek independent and impartial advice if you are in any doubt. Guidance booklets on many of the EC Directives (or UK regulations implementing those Directives) that contain CE marking requirements are available.
It is important also to understand that not all EC Directives relating to products, e.g. the General Product Safety Directive, require CE marking, nor that a particular Directive applies to all products that could be described by its title e.g. the Machinery Directive does not apply to every conceivable product that might be termed a machine. Most of the Directives set out ‘scopes’ i.e. the range of products to which they apply.
You should therefore study the UK regulations implementing the Directives. Copies of the regulations can be obtained from The Office of Public Sector Information (OPSI).
In general CE marking must appear on the product but see the individual guidance for exceptions. It may also appear on the packaging, in manuals or other supporting literature, but again it is best to study the guidance.
The CE mark must not be less than 5mm in its vertical height, and the proportions maintained. It is generally shown on a grid in the guidance booklets, as at the top of this page (the grid does not form part of the marking and is for information only):
This mark looks the same as some previous marks, but there are subtle changes, and it should be studied closely. It should be noted, for example, that the C and E are not formed by perfect semi-circles, i.e. the top and bottom arms extend one square beyond the semi-circles, and the middle arm of the E stops one square short.
CE-marking applies to the circulation of a product within the EEA. It is not required for exporting a product to non-EEA countries. You need to check on the particular regulatory requirements or standards that apply to your product in the country in question. The same standards may apply but they may also be different.
Advice on exporting is available from the UK Trade & Investment network, which delivers services co-ordinated by the former British Trade International, the organisation set up in May 1999 to take lead responsibility within Government for trade development and promotion.
The Technical Help for Exporters service run by the BSI may also be able to offer some advice.
Enforcement varies according to the Directives. Some are enforced by local Trading Standards Departments , others by HSE and yet others by the Medical and Healthcare Products Regulatory Agency and the Vehicle Certification Agency.
Enforcement procedures/penalties: Except where safety is at risk, the relevant enforcement authority will usually provide you with an opportunity to ensure that your product is correctly CE-marked. If you fail to comply then you will be obliged to take your product off the market, and you may also be liable to a fine and/or imprisonment.
Any supply of the (individual) construction product for the first time within the European Internal Market for distribution or use in the course of a commercial activity, whether in return for payment or free of charge.
NB: Every product or batch of products (that is, every window or every package / truckload of bricks) is placed on the market individually. The fact that similar products have been marketed before, does not change this. Therefore, manufacturers have to draw up a Declaration of Performance (DoP) and affix the CE marking pursuant to the Construction Products Regulation (CPR) for all the products entering the market from 01/07/2013 onwards, even if similar products had been commercialised before this date.
No. Essential characteristics included in hENs cannot be attested again in any kind of other (public or private) marks for construction products than the CE marking. (see Articles 4(2) and 8(3) of the CPR).