A Detailed Guide to CE Marking Compliance

The CE (Conformité Européenne) marking is the EU’s compliance mark for products. Harmonised European product legislation covering 25 sectors of new, finished, manufactured, non-food products require the CE marking for EU single market access.

Several variants of the ‘EC mark’ appeared in early single market legislation including the C-epsilon mark, CE in text and a chunkier version before settling on the final design of the ‘CE marking’ in 1993.

1987

1988

1989

1993

• The CE mark can be any colour as long as it is clear.
• It can be in solid or outline form.
• It must be at least 5mm high.
• The shape, proportions, thickness of the symbols and spacing must be according to the image with the grid published in the legislation.
• CE markings with the wrong proportions are quite common, in particular condensing the space between the letters. They are not correct.

It is a statement by the manufacturer that a product complies with all the applicable EU product legislation and can therefore be supplied anywhere in the European Economic Area (EEA.)

Read more…

The EEA includes the EU, Norway, Iceland Liechtenstein, Switzerland and some related territories. For example by applying the CE marking to a typical electrical appliance like a refrigerator, the manufacturer is indicating that it complies with:

• the safety requirements of the Low Voltage Directive (LVD)
• the electromagnetic compatibility requirements of the EMC directive
• the environmental requirements to limit toxic materials of the Restriction of Hazardous Substances (RoHS) Directive
• the administrative requirements of all three directives to:
  • check and ensure compliance with the above requirements
  • make technical documentation demonstrating compliance available to the EU authorities when they request it.
  • issue a declaration of conformity,
  • apply the CE and identifying markings.

The CE marking is required on products in 25 harmonised sectors covering:

• most complex consumer products
• medical products
• most industrial products and equipment
• toys
• some construction products
• fertilizers

The CE marking allows the same product with a single certification to be placed on the market in any member state of the EEA without needing to meet any further national requirements.

Read more…

Before the EU single market some products needed different variants and different certificates to be sold in different EU member states. These were a ‘technical barrier to trade.’ (TBT) To establish the single market, the EU divided products into groups:

• Those where TBTs were not significant. They were given ‘mutual recognition’ meaning that authorities must allow products that comply with rules in any member state
• Those where TBTs were significant but worth solving. They were divided into harmonised sectors and each sector was given a common set of harmonised rules agreed by member states. Some of these sectors require the CE marking.
• Those where the TBTs were needed or not worth solving, either because there was not much cross border trade or because manufacturers or the member states wanted the TBTs. These remained subject to national legislation and didn’t join the single market.

Usually the manufacturer applies the CE marking when they have ensured conformity with the legislation. They can appoint an authorised representative to do it for them.

If anyone else applies the CE marking, the authorities will consider them to be the manufacturer and expect them fulfil all the obligations of the manufacturer.

If an own-brand-labeller (OBL) puts their name or trade mark on products instead of the original manufacturer’s name, then the OBL is considered to be the manufacturer and must ensure compliance and apply the CE marking.

Imported products must have a responsible economic operator established in the EEA such as an importer or Authorised Representative. They must:

• ensure that the manufacturer has complied with the requirements of the legislation. If not, then they must meet the manufacturer’s obligations and make the product comply before placing it on the market.
• mark the product with their EU name and address. If this is not possible because the product is too small then they can mark the packaging or an accompanying document.
• Be able to deliver the declaration of conformity and technical documentation to the EEA authorities.
• Be able to cooperate with the authorities and manufacturer at any time to deal with any risks from non-compliant products in circulation.

The EEA manufacturer is the responsible person for EEA products.

No. Non-European manufacturers can put the CE marking on their products if they comply with the applicable legislation. There must, however, be a responsible economic operator in the EEA before the products are placed on the market.

They must make sure the product complies with all the requirements of the applicable CE marking directives and regulations. Some of these requirements are about the product and others are about the manufacturer’s information and procedures.

The essential requirements are about the design, manufacture, testing, and user information to minimize the risks from the product. Most legislation is about risks to health and safety but some is about risks to the environment, product performance, compatibility and measuring accuracy.

There are also administrative requirements such as:

• getting compliance approved by a notified body for some products
• keeping compliance information in case it is needed
• completing and, for some products, supplying a declaration of conformity
• applying the CE marking
• being identifiable as the manufacturer
• having adequate traceability of products, components, suppliers, and customers
• being able to mitigate risks in case products present a risk.

Not usually. Most products can be self-certified by the manufacturer by completing a declaration of conformity and applying the CE marking. Some product sectors require higher-risk products to be approved by a Notified Body (an accredited conformity assessment body) before they can be CE marked. A few sectors require this for all products. Depending on the risks, the Notified Body may need to approve the design, manufacturing, testing, or all of them.

Not usually. Most can be placed on the market without any involvement with the authorities. Medical devices, cosmetics and chemicals may require registration or notification to authorities.

No. Only products in the scope of one or more of the 25 EU directives and regulations requiring the CE mark may use it.

Some products have harmonised rules following similar principles but the CE marking is not required or allowed. They include:

• Means of transport for road, rail, air and water
• Chemicals
• Medicines
• Cosmetics

Other products are subject to unharmonized, member state rules including:

• Food, drink, and agricultural products
• Furniture and clothing
• General products for consumer and professional use.
• Forestry products
• Raw materials
• Firearms
• Some construction products
• Buildings and civil engineering structures
• Infrastructure
• Military and nuclear equipment

It is the identification number of the Notified Body that is involved in the production control of the product. Notified Bodies that only approve the design of a product do not have their identification number next to the CE mark.

Not if it has been placed on the market in the EEA before. If it is being imported and is being placed on the market for the first time, then it must be CE marked in accordance with current legislation, whatever it’s age.

If the CE marking is on the same label as the manufacturer’s name, it is much more likely that the manufacturer has applied it after completing the conformity assessment. A separate CE label is a sign that someone else has applied it, who may not have ensured it complies properly.

Other indications of compliance are:

• – A declaration of conformity correctly listing the legislation, standard, and other information. This is sometimes required with the product but not always for consumer products.
• – A certificate from a test laboratory. Some manufacturers give information about certification with the product or on the website.

Member states set the penalties for non-compliance. They vary from small fines for minor infringements, to criminal penalties for major incidents dependent on the damage and injuries caused.

Only if the other marking is concerned with a different characteristic or objective of the product from the CE marked characteristics. For example: a separate marking can be applied for energy efficiency of a product that is CE marked for safety only. A separate energy efficiency marking cannot be applied to a product that is CE marked for both energy efficiency and safety.

Other conformity makings must not confuse or obscure the CE marking or its purpose.

There is no restriction on applying compliance marks for other regions of the world as long as the CE marking is clear.

This is not legitimate and is an infringement of CE marking legislation. The manufacturer and any other economic operators in the EEA making the product on the market are liable to prosecution under CE marking legislation.

Market surveillance authorities in each EEA member state supervise and police the legislation.

The authorities may be alerted to non-compliances by:

• Reports from distributors, retailers, competitors, or end users
• Customs authorities doing border checks
• Market surveillance authorities checking products themselves

It is also possible for non-compliant products to remain undetected for a long time.

European Commission guidance on CE marking

CE logo graphics in various formats from the European Commission

UK government guidance on CE marking for Northern Ireland

Detailed guidance on CE marking – European Commission’s Blue Guide

UK government guidance on CE marking for the EU

Background on the EU single market

List of CE marking sectors with links to legislation and standards