KNOWLEDGE BASE CE Marking - Licensing

 

On March 29, 2017, UK Prime Minister Theresa May triggered Article 50, which formally started the process whereby the UK will leave the European Union. Article 50 was just the beginning of the withdrawal process, as it allows the UK two years to negotiate its leave with the other EU member states. UK laws and regulations did not and will not change overnight. We will update our site with any relevant changes and information as it becomes available. You can learn more on the UK government site.

 

CE Marking - Licensing In The UK

 

CE marking is an important part of taking a physical product into the UK and anywhere in the European Union (EU). Many people are interested in learning if their product requires CE marking, how best to get CE marking, how long it takes and how costly it is. The best answer we can provide is that it depends on a number of variables since each product is different. We can, however, help you understand the overall process, including what variables are involved in CE marking, and point you toward more information, as well as assistance with the process from experienced vendors, should you need it.

 

Governing bodies and regulations

The United Kingdom is part of the European Union (EU), the World Trade Organization (WTO), the Organization for Economic Co-Operation and Development (OECD) and North Atlantic Treaty Organization (NATO).

Many of the provisions governing imports to the UK, primarily around CE marking, are guided by their EU membership, while a few are unique to the UK.

The rules governing customs procedures applying to the importing of goods to the United Kingdom from places outside the EU can be found in the following regulations (or amended regulations), as listed on the UK government Trade Tariff guidance site:

  • Council Regulation (EEC) No. 2913/92 (Articles 37-57)

  • Commission Regulation (EEC) No. 2454/93 (Articles 182-189) Statutory Instrument 1991

  • No. 2724 (The Customs Controls on Importation of Goods Regulations 1991) as amended by Statutory Instrument 1992

  • No. 3095 (The Customs and Excise (Single Market etc) Regulations 1992) prescribe forms, procedures and the penalties for breaches of the rules

Further information can be found in the Customs and Excise Integrated Tariff of the United Kingdom, Customs and Excise Notices, or from the Customs and Excise National Advice Service on +44 (0)845 010 9000 or visit HM Revenue and Customs to access the Starter Pack for Importers and Exporters.

For general information regarding EU customs policy, please visit the European Commission.

 

The European Union (EU) members

The EU is an economic and political union of 28 countries that operate a single market allowing for the free movement of people, goods, capital, and services between each member country.

The EU countries are: Austria, Belgium, Bulgaria, Croatia, Republic of 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.

There is also a group of countries that are part of what’s called the EEA (European Economic Area) which allows them to be part of the single market and have access to the same free movement of people, goods, capital, and services. The countries included in this are the EU members plus Iceland, Liechtenstein, and Norway. Switzerland is also part of the single market even though they are not officially part of EEA or EU, so Swiss citizens have the rights to live and work in the UK similar to other EEA citizens.

 

What is CE marking? 

CE stands for Conformité Européenne (European Conformity) and according to Wikipedia and the EU, CE marking is a physical goods manufacturer’s declaration that a product meets the requirements of the applicable European Commission (EC) directives. Basically, CE marking allows goods to move within the European market.

CE marking shows that manufacturers have confirmed that their products meet EU safety, health and/or environment requirements, that they have complied with EU legislation and that their product is able to freely trade within the single market.

By placing CE marking on a product, a manufacturer is declaring their products conform to the legal requirements required for CE marking.
CE marking is required on many products traded within the single market for the EEA. If you are interested in engaging in trade within the EEA, you will need to conform to this regulation if your product requires it.

 

Products that need CE marking

CE marking applies to products, ranging from electrical equipment to toys and from civil explosives to medical devices. The list of these product categories is below but to confirm if your product must adhere, we recommend visiting the CE Marking page for manufacturers and viewing the product group options.

  • active implantable medical devices

  • appliances burning gaseous fuels

  • cableway installations designed to carry persons

  • 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

  • household refrigerators and freezers

  • in vitro diagnostic medical devices

  • lifts

  • low voltage

  • machinery

  • measuring instruments

  • medical devices

  • noise emission in the environment

  • non-automatic weighing instruments

  • personal protective equipment

  • pressure equipment

  • pyrotechnics

  • radio and telecommunications terminal equipment

  • recreational craft

  • safety of toys

  • simple pressure vessels

The CE marking is not required for the following items although they will have other standards they are required to comply with:

  • chemicals

  • pharmaceuticals

  • cosmetics and foodstuffs

 

Harmonized standards

In order to prepare your testing and declaration of conformity, it’s important to have a standard against which your product will be measured. The standard created by the EU is called a harmonized standard developed by recognized European Standards Organization such as CEN, CENELEC, or ETSI. Manufacturers, or conformity testing agencies will use harmonized standards to demonstrate that products, services, or processes comply with the appropriate EU legislations.

You can find a full list of harmonized and other standards for goods on the EC site.

 

CE marking process

The price and time required to qualify for CE marking will depend on what procedures apply to your product, which is determined by how your product is intended to be used, the specific standards that apply to the directive your product falls under, whether you can do some or all of the conformity assessments yourself, whether the category you are applying for requires third party assessments, the level of support you will need if assistance is desired or required for the compliance documentation, and whether you are able to provide acceptable technical specifications, user manuals, and product labeling.

The European Commission outlines the steps for applying for a CE Mark. In the Labeling & Packaging section of the UK Expansion Plan, Globig walks you through the process with additional tips and information. 

 

For many companies with products that are not a safety risk, that are able to provide good technical documentation, and are compliant with appropriate EU directives, CE marking can be implemented quickly and cost effectively, often without requiring assistance from notified bodies or experienced agents. For companies that require and/or desire assistance, there are vetted agents within the Globig Marketplace in the CE marking and labeling sections and on the EU site that can assist you with this process.

 

HM Revenue and Customs

European Commission

Harmonized and other standards for goods

EC Directive product categories

CE Marking

European harmonized standards

List of companies that are approved as notified bodies

Blue Guide

Declaration of Conformity example

International testing labs

CE Marking consultants

 

KNOWLEDGE BASE CE Marking - Licensing