KNOWLEDGE BASE CE Marking - Licensing
CE Marking And Licensing In Germany
What is CE marking?
According to Wikipedia and the EU, CE marking is a manufacturer’s declaration that a product meets the requirements of the applicable EC directives. Basically, CE marking allows goods to move within the European market.
CE marketing 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 confirm to the legal requirements required for CE marketing.
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 confirm to this regulation if your product requires it.
Provisions and guidelines governing labeling and licensing
Germany 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 licensing and labeling are guided by the membership in the EU but Germany also has it’s own, and at times more strict guidelines around testing, labeling and licensing. Germany often leads the way in creating regulations and guidelines that will eventually become the basis for EU guidelines. Germany is also often quicker to implement upcoming guidelines and requirements which can leave companies unprepared and rushing to meet new regulatory guidelines. We suggest paying close attention to German guidelines and best-practices if you’d like to be ahead of upcoming EU regulations.
The rules governing customs procedures applying to the importing of goods to Germany from places outside the EU as well as the application of visas can be found here:
CE marking is an important part of taking a product into Germany and anywhere in the EU. The EU (European Union) is an economic and political union of 28 countries that operate a single market allowing 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 Iceland, Liechtenstein, and Norway. Switzerland is part of the single market also even though they are not officially part of EEA or EU but Swiss citizens have the rights to live and work in the UK similar to other EEA citizens.
Many people are interested in learning if their produce requires CE marketing, how best to get CE marking, how long it takes and how costly it is. The best answer we can provide is that the answers depends on a number of variables because 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.
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 http://ec.europa.eu/growth/single-market/ce-marking/index_en.htm:
- 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
- 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
- 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:
- cosmetics and foodstuffs
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.
For a full list of harmonized and other standards for goods is available here:
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CE marking process
The price and time required to qualify for CE marketing 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. Below is a brief explanation of the six-step process to CE marking.
Step 1—Identify the relevant directive for each product category.
There are 20 different categories of directives. It is important that you select the directive that is appropriate for the intended use of your product, since products can be covered by more than one CE directive. You should explore the listing of categories outlining each one, to identify which category your product best fits in.
Step 2—Verify the specific requirements for each category.
In order to identify the certification requirements for your product, it is important to review the European harmonized standards, which are developed by recognized Standards Organizations, for that category. http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm
Step 3—Determine whether an independent conformity assessment from a notified body is required.
Many products do not require a conformity assessment from a notified body. This is where a lot of companies that are unclear about the requirements will spend unnecessary money leading to higher CE marking costs. Here is a list of companies that are approved as notified bodies. http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.notifiedbody&cou_id=840
Often, and when the product category allows, the manufacturers can perform a conformity assessment themselves. Refer to the ‘Blue Guide,’ downloadable at the bottom of this link, for additional information. http://ec.europa.eu/growth/single-market/goods/building-blocks/conformity-assessment/index_en.htm
You may want to consider combining CE marking with other markings or certifications, including ENEC14, TUV, GS, NEMKO, DEMKO, SEMKO, among others, since some of the testing and certification bodies are licensed to do more than CE marking.
Step 4—Test your products and check conformity to EU legislation.
Depending on the product category, with appropriate documentation, you can, at times, test products in-house rather than use expensive third-party testing centers. While using harmonized standards is voluntary, it is recommended. You can assess your risk by comparing your testing results to the harmonized standards.
You will need to provide a Declaration of Conformity and some member states will require the document to be translated into their language. Here is an example and template of a Declaration of Conformity.
Declaration of Conformity Example: http://www.export.gov/cemark/eg_main_017272.asp
International Testing Labs http://www.export.gov/cemark/eg_main_017274.asp
One way to reduce the cost, complexity and time required for CE marking is to use components that already have CE marks and other certifications.
Step 5—Draw up and make the required documentation available.
All of the directives require that the technical documentation, also known as the Technical File, provide all of the information necessary to demonstrate that the product conforms to the directives and required standards. Many of the directives provide examples of the data that must be included in the Technical File to prove compliance. Data includes the product design, product manufacturing specifications, components and how to operate the product.
It is recommended that the Technical File be written in English, although you can use the language of the country in which you intend to file. You will also need to make the Technical File available for 10 years in most categories before you enter the market and the Technical File needs to be held within the EU, which means that if your office is not located in the EU, you will need to have a representative you trust secure the information.
Consider carefully who you will trust as a host for all of your technical data and other documentation.
Step 6—Affix the CE marking.
You are not allowed to use the CE mark on any product that is not compliant with EU directives. By using the CE mark, the manufacturer takes full responsibility for compliance with the EU directives. The mark itself has format requirements, including visibility, legibility and permanence so it can’t be removed from the product or data plate.
In general, you should attach the CE marking to the product itself it at all possible but you are also able to attach it to the packaging and on literature such as manuals. Depending upon which directive your product fits into, there are different rules about how CE marking is allowed to be used.
Some general requirements include:
-no CE marketing is allowed to be used on products that doesn’t conform to the appropriate EU directives
-only you or an authorized representative can apply the CE markings
-you as the manufacturer take full responsibility for conforming to all applicable directives
-there must be no confusion or misrepresentation of what the CE marking means
-no other markings or labeling can cover up the CE marking
CE marking image requirements
Similar to style guides for company logos and images, there are specific guidelines to follow with the actual CE marking itself that are standardized. The directive for your product will set the standard and here are some general guides:
-all size changes must be in proportion to the standard
-CE marking must be at least 5 millimeters in diameter unless a larger size is required for your products directive
-the CE marking is placed on the product or data plate if possible or the packaging and supporting documentation such as manuals
-the CE marking is permanent, easy to read and easily visible
Save yourself long-term problems by doing it right from the beginning. While there is not a EU enforcement agency, the individual member states have authorities charged with investigating product compliance and can require product recalls, severe penalties and even criminal charges if they find infringements.
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.
Additional performance & quality marks
While CE marking is mandatory, the German buyer my expect additional performance and quality testing and marks which are not legally required on products in order to be competitive in the market even though they are not legally required. The German market may even require product modifications in order for customers to consider your brand as compared to other competitors and some marks are required for meeting insurance guidelines instead of regulatory ones.
Some examples of these expectations that are not current regulations can include marks such as GS = ‘geprüfte Sicherheit’ which means tested or proven safety. Another mark that is a competitive advantage in the electronic component category is the mark is the VDE= ‘Verband Deutscher Elektrotechniker’ which is the organization or institution for Germany electronics technologists.
Many of the testing services that provide CE marketing and other safety or environmental standards testing will also provide marking advice and testing for non-required marks that could be important from a market acceptance perspective.
EU standards organizations
Many standards in the EU are adopted from international standards bodies such as the International Standards Organization (ISO). The drafting of specific EU standards is handled by three European standards organizations:
ETSI, European Telecommunications Standards Institute (www.etsi.org/)
CEN, European Committee for Standardization, handling all other standards(www.cen.eu/cenorm/homepage.htm)
The German organization that compiles standards is the Deutscher Industrie Normenausschuss - DIN (German Standards Institute, www.din.de). The DIN also compiles the standards that lay down the requirements for a "GS" mark, DIN has 76 standards committees that maintain their own websites. Basic details of their area of activity and a list of the standards are published in English. Links to these committees are available on the DIN website www.din.de.
Sign up for the U.S. Service Member NIST alert to get updates on any changes that may impact technical barriers to trade. Notify U.S. is a free, web-based e-mail subscription service that offers an opportunity to review and comment on proposed foreign technical regulations that can affect your access to international markets.
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Textiles Labeling (furniture, clothing)
In order to sell clothing or furniture in Germany, textiles require specific labeling. Overall, the label must be in German and contain information such as the fiber content. You are not required to specific the country of origin for textiles but if you do, it must be accurate.
Germany textiles measurement uses the metrics system. Sizing for clothing is completely different from the US and many other countries.
For care labeling information contact:
Modeverband Deutschland e.V.
Tel: +49 0221 77 44 0
The regulations and authority on this is the:
Bundesministerium für Wirtschaft und Arbeit- BMWA (Federal Ministry of Economics and Labor)
EU product legislation
Visit the European Commission’s website on growth: international market, industry, entrepreneurships and SMES http://ec.europa.eu/growth/single-market/ce-marking/index_en.htm
General information: http://ec.europa.eu/growth/single-market/european-standards/index_en.htm
European Standards are under the responsible for the European Standardisation Organisations:
European Committee for Electrotechnical Standardization: https://www.cenelec.eu/
European Committee for Standardization: https://www.cen.eu/Pages/default.aspx
European Telecommunications Standards Institute: http://www.etsi.org/
Test Labs, EU Notified Body, US Subcontractors, Conformity Assessment Body lists:
Nando (New Approach Notified and Designated Organisations) Information System:
National Institute of Standards and Technology, U.S. Department of Commerce: http://gsi.nist.gov/global/index.cfm/L1-4/L2-16/L3-85/A-90
CE Marking- Consultants/ Ordering Standards, U.S. Commercial Service Department: http://www.export.gov/cemark/eg_main_017270.asp
ANSI, American National Standards Institute: https://ansi.org/default.aspx
European Co-operation for Accreditation: http://www.european-accreditation.org?
European Union law portal: http://europa.eu/eu-law/index_en.htm
Labeling Requirements (Textiles)
KNOWLEDGE BASE CE Marking - Licensing