What Does the CE Mark Mean?

The CE mark is a sign that has been developed for the countries of the European Union but is now accepted worldwide and shows that the products bearing this mark comply with the European Union directives and undergo the necessary conformity assessment activities.

The CE marking application is designed under the New Approach Policy adopted by the European Union in 1985 and relates to products within the New Approach Directives.

The CE marking consists of the initials of the English European Conformity or the French Conformité Européenne, which means compliance with European norms. It is understood that the products bearing the CE marking will not harm human life and property safety, plant and animal existence and environmental conditions if used properly. In short, the CE mark indicates that these products are safe.

The directives published within the framework of the New Approach Policy adopted in the European Union in 1985 contain a detailed description of the various products, minimum safety requirements, risks and conformity assessment processes.

The CE mark indicates that the product has the minimum safety requirements, otherwise it does not give consumers a quality assurance. On the other hand, it constitutes an important assurance from the commercial point of view during the circulation of these products between countries. Under the New Approach directives, it is only possible for a covered product to enter one of the European Union countries if it has the CE mark.

In the light of this information, the principles regarding CE marking can be listed as follows:

• A product bearing the CE mark appears to comply with the requirements of the European Union
• The CE marking affixed to the product refers to the entity's declaration that the product complies with the European Union directives.
• The CE marking also indicates the undertaking of this product that the necessary conformity assessment processes have been completed.

Since the CE marking is a mark placed on the products of the European Union directives, the products which fall within the scope of the relevant directives and which will be placed on the market in European Union countries must bear this mark.

As is known, our country has signed a Customs Union agreement with the European Union in 1996 and this agreement provides for the free movement of goods other than agricultural products. In this way, our country has a different status than the third countries in its relations with the European Union. This different status allows full competition in exports to European Union countries. In practice, this depends on the full implementation of the standards set by the European Union. In this way, CE marking process in our country has become an integral part of production.

This situation also increases the quality of the goods produced in our country. Because the CE marking application is not only limited to the European Union countries, but also for the products offered to the market in our country. It is not possible to export the products that belong to the product groups where the CE marking is obligatory to the European Union countries without the CE marking, nor can they be offered to the domestic market.

In accordance with legal regulations, products may be affixed to products other than the CE marking only if:

• If this mark has a different meaning than the CE mark
• This mark does not lead to confusion with the CE mark
• If this mark does not prevent the CE mark from being read or seen

Today, the number of product groups that have to bear the CE marking under the New Approach Directives is 23. These product groups are:

1. Low voltage equipment (73 / 23 / EEC)
2. Simple pressure vessels (87 / 404 / EEC)
3. Pressure vessels (97 / 23 / EC)
4. Electromagnetic compatibility (89 / 336 / EEC)
5. Personal protective equipment (89 / 686 / EEC)
6. Toys (88 / 378 / EEC)
7. Building materials (89 / 106 / EEC)
8. Machines (98 / 37 / EC)
9. Lifts (95 / 16 / EC)
10. Non-automatic weighing instruments (90 / 384 / EEC)
11. Active implanted medical devices (implantable medical devices) (90 / 385 / EEC)
12. Medical devices (93 / 42 / EEC)
13. In vitro diagnostic medical equipment (98 / 79 / EC)
14. Gas-burning tools (90 / 396 / EEC)
15. Hot water boilers (92 / 42 / EEC)
16. Explosives for civil use (93 / 15 / EEC)
17. Equipment used in explosive atmospheres (94 / 9 / EC)
18. Recreational boats (94 / 25 / EC)
19. Radio and telecommunications terminal equipment and satellite ground stations (99 / 5 / EC)
20. Vehicles moving on passenger cable (2000 / 9 / EC)
21. Energy efficiency in fluorescent lamps (2000 / 55 / EC)
22. Energy efficiency requirements for household electric refrigerators, freezers and combinations thereof (96 / 57 / EC)
23. Noise from outdoor equipment (2000 / 14 / EC)

The CE marking system was introduced by the New Approach Policy adopted in 1985 in European Union countries. The CE mark indicates that products covered by the New Approach Directives comply with the relevant directives and undergo the required conformity assessment activities. The CE marking, which expresses conformity with European Union legislation, indicates that the products bearing this mark comply with the requirements for health, safety, environment and consumer protection set by the European Union directives.

With the implementation of the CE marking, our country's economy has achieved many gains in the medium and long term. These gains are:

• Quality is improving in the infrastructure of our country's industry
• Competitiveness of our products is increasing in domestic and foreign markets
• The rights and interests of consumers are protected by offering only products that comply with technical regulations.
• Serious steps have been taken in the integration of our country with the European Union and world markets.
• Some technical barriers to the entry of our products into the European Union market have been eliminated

Legal Regulations in Turkey on CE Mark Application

The Association Council Decision No. 1 / 95, which establishes the customs union of our country with the European Union, foresees that the legal arrangements made in the European Union shall be created in the domestic legislation of Turkey in order to eliminate technical barriers to trade in order to ensure the free movement of goods. The laws and regulations issued to prepare the necessary legal infrastructure are as follows:

• The Law on the Preparation and Implementation of Technical Legislation on Products by the Undersecretariat of Foreign Trade entered into force in 2002.
• The following regulations, which were prepared based on this law, came into force in the same year:
• Regulation on Conformity Assessment Bodies and Notified Bodies
• Implementing Regulation on the Attachment and Use of the CE Conformity Mark to the Product
• Regulation on Market Surveillance and Inspection of Products

Along with these legal regulations, the relevant Ministries and public institutions prepared technical legislation stipulating that the CE marking shall be attached to the products.

Within the framework of these regulations, the CE mark indicates that the product is produced and certified in accordance with the New Approach Directives on the basis of the relevant product groups. In other words, the CE mark is a sign that these products meet minimum safety requirements in terms of human health, human life and property safety, animal and plant health, environmental conditions and consumer protection, which are defined as basic requirements.

With the CE mark which is accepted all over the world, whether or not it is a member of the European Union, manufacturers are primarily responsible for the conformity of the product with the directive principles and the CE marking on the product.

Application of CE Marking

The format of the CE mark is determined. The CE marking must comply with this format. The size or size of the CE mark may vary, provided the rates are maintained. Unless otherwise specified in the relevant technical regulation, the CE marking must consist of CE letters of at least 5 mm. The CE marking must be affixed directly to the product or to the information card attached to the product in a readable, visible and indelible way. It is only possible to affix the CE marking on the package or, if there are documents required by the relevant directive, if the product is not suitable for doing so or if the marking is not possible due to the nature of the product.

The CE mark of conformity must be affixed to the product at the end of the inspection stage after production is completed. If the product is a high-risk product and conformity has been granted by the notified body, the identification number issued by that body must also be shown on the product. No other markings should be placed on the product that may mislead third parties about the shape and meaning of the CE conformity marking.

There are a number of alternatives for manufacturers to put CE marking on their products according to their risk values:

• Low risk products

Most of the products fall into this group. For the products included in this group, the manufacturer conducts a self-assessment and declares that the product complies with the mandatory health, safety, environmental and consumer protection standards.

• High risk products

It is not sufficient for manufacturers to declare high-risk products. Such products must be inspected and tested by notified bodies. If the results of the notified body are positive, the manufacturer may place the CE mark on the product.

The risk group of a product is explained in the relevant directive.

If there is more than one technical regulation requiring the CE marking on a product, the CE conformity marking affixed indicates that this product complies with the principles of all relevant technical regulations.

New Approach Directives that do not require CE marking on the product under the New Approach Policy are:

• Packaging and wastes
• High speed rail systems
• Normal speed rail systems
• Marine equipment
• Portable pressure equipment

If the manufacturing companies operating in third world countries send their products to European Union countries, they must put CE mark on their products. These manufacturers are also required to design, manufacture and implement the necessary conformity assessment processes in accordance with the principles of the New Approach Directives.

If the manufacturer or the representative of the manufacturer is not within the European Union, this responsibility lies with the importer. In short, manufacturers or importers must in some way guarantee that the products comply with the norms of the European Union.

What is a Notified Body?

According to the European Union directives, if the products that are required to bear the CE marking are in the high-risk product group, they must be subjected to a conformity assessment by a competent third party before they are placed on the market. These organizations are called notified bodies and are published in the Official Journal of the European Union. Notified bodies are those which operate in European Union countries, but may open branches or representative offices in other countries.

Notified bodies in accordance with the legislation of the European Union are products with the infrastructure to carry out the testing, inspection and certification of the products. These organizations acquire this identity after being published in the Official Journal of the European Union. Institutions notified by the Member States to the European Commission are examined in detail by this commission and approved if appropriate. They may be a certification body, or an organization or laboratory that provides testing and inspection services only.

The circumstances under which manufacturers can affix the CE mark on their products without applying to the notified body are included in the relevant directives. For this reason, manufacturers should review the directives regarding their products.

Candidates of the notified bodies from Turkey were sent to the European Commission. However, on the one hand it takes time for the European Union harmonization efforts and on the other hand it takes time to evaluate the competence of the candidate institutions. When evaluating the candidate institutions of the Council of Europe, whether the relevant directive requirements have been met within the scope of the harmonization studies, whether the candidate institution has an adequate and effective audit infrastructure for implementation, whether the metrology, certification, calibration and similar systems for the application in the candidate institution are adequate and the technical infrastructure whether it is sufficient or not.

In accordance with the qualifications required by the notified bodies in our country, the working principles and notification of the relevant places in accordance with the international obligations of our country, the Regulation on Conformity Assessment Bodies and Notified Bodies issued by the Ministry of Economy in 2012 is explained.

There is only one condition for a certification body, or a testing and inspection body, or a laboratory to obtain the status of a notified body. It is also the fulfillment of the requirements of this regulation.

The first step to be taken by the candidate organization is to determine the areas in which 23 product group will be operating in the European Union Directives and to prepare the technical infrastructure in these areas. These principles are included in the said regulation and in the communiqués issued by the Ministry to which the relevant product group belongs. After the completion of these infrastructure works, the relevant Ministry should apply with the technical dossier prepared. The Ministry conducts the necessary examinations upon application and sends this application to the Turkish Accreditation Agency (TÜRKAK) in accordance with the signed protocol. TURKAK shall submit the report, which expresses positive or negative opinion, to the Ministry after conducting the necessary examination. The Ministry shall take this decision into consideration. After that, the Ministry shall notify the names of the notified bodies to the Undersecretariat of Foreign Trade. This organization sends the list to the European Commission. If the European Union Commission approves the request, the decision shall be published in the Official Journal of the European Union and the organization shall be granted the status of notified body.

Today, the number of notified bodies in the European Union that provides conformity assessment services for the CE marking is around 1500.

What Does CE Marking Provide to Manufacturer?

In order to trade with European Union countries, it is necessary to produce in accordance with the relevant directives. However, of course, this brings along many gains for manufacturers. These benefits can be listed as follows:

• The CE marking allows products to be freely circulated and marketed in European Union countries and third world countries.
• CE marking can be considered as the passport of the product to a large extent.
• Commercially CE marked products are freely available in the European Union.
• Producers have the opportunity to market their CE marked products on an international level.
• CE marking is sufficient for the products included in the New Approach Directives to be offered to consumers in any European Union country.
• The CE mark is an indication that the products comply with the New Approach Directives and other legal regulations.
• The CE mark confirms that these products are manufactured in accordance with health and safety requirements.
• The CE marking does not in any way imply that the products are of good quality or a guarantee.
• Products without CE marking are considered unsafe and unhealthy and are not placed on the market. In this respect, these products cannot be said to be of good quality.
• Products bearing the CE marking cannot be rejected solely on the basis of legal justifications for norms.

These benefits give the manufacturers a competitive advantage to a large extent. Although CE marking is not a quality indicator, the error rates of the enterprise decrease, their costs decrease and their profitability increases as the production will be made within the framework of legal regulations and in accordance with the determined criteria. In this respect, it would not be wrong to mention that quality production is made in the enterprise.

How to put CE Mark on the products?

Producers who want to put a CE mark on their products should first prepare a technical file. This technical file forms the basis of CE marking studies.

Even if the products to be CE marked fall into the low risk group or high group, this technical file must be prepared. In addition, manufacturers must keep the technical file prepared during production activities and unless there is a functional change in the products.

The technical file will generally include product design studies, production processes and operational information. The main information and documents that should be included in a technical file are:

• Title, field of activity and similar basic information of the manufacturer
• A label describing the product's technical information
• For what purpose the product is manufactured and for what purpose
• If there are tests related to the product, their reports
• List of domestic and foreign standards used in production
• List of Companies
• If the supplied products are also covered by CE, their documentation and test reports
• Declaration of Conformity to the European Union
• Description of the product for transport, installation, adjustment, operation and maintenance work
• If there are components of the product, their manufacturers, code numbers, technical specifications and reports of tests performed
• Product instruction manual

The document that must be included in the technical file is the declaration of conformity prepared by the manufacturer or the report prepared by the notified body.

The manufacturer carries out CE marking in two ways depending on the risk level of the product. If the product is a low risk product, that is, the product does not fall into the risk class, the manufacturer is authorized to put the CE label. All he has to do is put his declaration of conformity into the technical file. However, if the product is a high-risk product, that is, the product falls into the risk class, then the product must be inspected by a notified body. In this case, the report prepared by this organization will be included in the technical file.

The technical dossier must be kept for a maximum of ten years from the last production date of the product, unless otherwise specified. If the CE marking is carried out by an authorized certification body, the manufacturer must obtain and keep a copy of the work.

The European Union Declaration of Conformity, which will be included in the technical dossier, is a requirement of the conformity assessment processes described in the New Approach Directives. This declaration shall include the directives applied, manufacturers, representatives of manufacturers within the European Union, the standards applied and the waste made to other documents.

What Happens if Abuse of CE Marking?

In fact, it is not the case that the CE marking system, which is an important convenience for the free movement of technical products in the European Union, is misused. It is a known fact that some products are illegally affixed with the CE marking and are therefore easily placed on the European Union market. The reason for such unfair practice is to introduce non-standard products produced outside Europe into the customs union area. Our country is also suffering from such situations. The most common unfair practice is that the CE marking, which means China Export, is placed on the product in a way that cannot be distinguished from the original. Another deliberate application is to place the CE mark on the product without the necessary technical documentation.

For products that are found to be in any way not in conformity with safety standards and legal regulations, a technical file is first requested from the manufacturer. If the technical file is not sent to the European courts within the 15 day, the sale of the product is suspended and the product is recalled if necessary. In this case, the manufacturer or its representative in Europe is faced with claims for compensation and cannot offer products to the European Union countries any more.

Testing the Conformity to CE Marking

With the New Approach Directives adopted by the Council of the European Union, a more macro approach has been adopted and a modular system has been put in place, rather than applying a specific conformity assessment for each product separately. In this way, conformity assessment processes have been determined within the scope of the module selected for the purpose of human and animal health, life and property safety and environmental protection, depending on the characteristics of the goods produced and the risk ratio they carry.

In this context, the Council of Europe has incorporated the Quality Management System into eight conformity assessment processes, including the more traditional product certification processes, including type testing, unit verification and the manufacturer's declaration of conformity. In this way, CE marking system and quality standards cross.

The eight modules identified may be related to product design studies, production studies or both studies. As a general rule, products can only be evaluated according to one module during the design and production stages.

• Module A: Internal production control (includes design and production steps, used for simple and non-hazardous products, the manufacturer himself tests and declares that the product complies with the technical regulations)
• Module B: Type inspection (only related to the design phase, usually used in conjunction with modules C, D, E and F, where the notified body enters into action and determines whether the product sample planned to be produced complies with the technical regulations)
• Module C: Declaration of conformity to the type (relates to the production phase, this module is not to be used alone, the manufacturer declares that the product conforms to the type and technical requirements defined in the type examination certificate, at which stage a CE mark may be attached)
• Module D: Production quality assurance (includes production steps and follows module B, where CE mark and quality standards meet, which requires the implementation of a Quality Management System by the manufacturer, ISO 9001 standard, which requires a notified body)
• Module E: Product quality assurance (this module also monitors module B, establishes a Quality Assurance System with final inspection and testing, ISO 9003 standard)
• Module F: Product verification (applies only to the production phase and follows module B, where the manufacturer guarantees that the production method used complies with the technical regulatory requirements, the notified body carries out the tests and inspections of the products and the CE mark can be placed on the product)
• Module G: Unit verification (relates to the design and production stages, used for custom-made or small-scale series production, the manufacturer prepares a technical file, the notified body tests and inspects the product and issues a certificate of conformity, the product can now be CE marked)
• Module H: Full quality assurance (same as module D and module E, except that this module is related to the design, production, installation and service phases, so the manufacturer must apply the Quality Assurance System, ISO 9001 standard, the notified body must comply with the requirements of this system. evaluates whether it has been fulfilled)

The modules can be outlined as follows:

 

Design phase	Production stage
Module A Internal production control
Module B: Type examination	Module C Declaration of conformity to type
	Module D Production quality assurance
	Module E Product quality assurance
	Module F Product verification
Module G Unit verification
Module H Full quality assurance

 

Simply put, low-risk products are evaluated according to Module A and the CE marking can be affixed directly to the product by the manufacturer. However, if the risk level of the product is high, it is evaluated according to Module D and conformity assessment is carried out by the notified body considering whether the manufacturer has implemented the Quality Management System.