CE

It is a statutory obligation for a product to be sold in the market of the European Union to bear CE Mark if such products are included in the scope of one or several European Union Directives.


“CE” Mark is derived from the first letters of the word “Conformité Européene” in French which means “Compliance in Europe”. This regulation entails producers to use the CE mark on their products, packages and all documents related to the product. 



CE mark enables users to know that product is in compliance with elementary quality and safety standards while imposing producers an obligation to ensure compliance of their products with certain standards and requirements. CE mark is known as a quality symbol by many users, CE mark (document) shows that products will not damage to human’s safety of life and property, plant and animal existence and environment, in other words the product is safe if used according to their intended use. 

CE Certificate (Mark) is obligatory for all products produced in the European Union and included in one or several scopes of the EU Directives, and also required to sell the product produced in countries which are not EU members within the EU.

Benefits of CE Mark (CE Certificate)

  • CE Mark ensures free movement and marketing of the product in the EU states,
  • Industrialists must have “CE” mark on their products in order to market their products at national and international levels,
  • CE Mark states the compliance of the product with the EU technical regulation,
  • CE Mark serves as a kind of product passport,
  • CE Mark is exactly not a quality brand or warranty certificate,
  • CE Mark shows the level at which quality starts,
  • Products under the level of CE Mark are deemed as unsafe and not presented to the market, thus accepted as common,
  • Product with CE Mark cannot be rejected in the EU states by putting legal reasons related to norms forward,
  • CE Mark is the indication of compliance with new approach directives.

Therefore, CE Certificate (Mark) serves as a passport for products produced outside the EU.

CE Certification Scope / CE Mark Directives (Directives, Regulations)

  • Low Voltage Directive 2006/95/EC and amendments
    Electromagnetic Compatibility 89/336/EEC and amendments (for Industrial Kitchen)
  • Machinery Directive 98/37/EC
  • Personal Protective Equipment Directive 89/686/EC
  • Lift Directive 95/16/EC
  • Medical Devices Directive 93/42/EC
  • ATEX Directive 94/9/EC
  • Radio Equipment and Telecommunications Terminal Equipment Directive 99/5/EC
  • Noise Directive 2000/14/EC
  • Machinery and Tool Tests (LVD, EMC etc.) (For Industrial Kitchen)
  • Toy Directive 88/378/EEC
  • Directive on Energy Efficiency Requirements For Ballasts For Fluorescent Lighting (2000/55/EC)
  • Transportable Pressure Equipment Directive (99/36/EC)
  • Directive on Energy Efficiency Requirements of Household Electric Refrigerators, Freezers and Combinations Thereof (96/57/EC)  
  • Measuring Instruments Directive   
  • Directive on Cableway Installations Designed To Carry Persons (2000/9/EC)     
  • In Vitro Diagnostic Medical Devices Directive 
  • Pressure Equipment Directive (97/23/EC)     
  • Directive on Equipment and Protective Systems for Potentially Explosive Atmospheres (94/9/EC)
  • Directive on Gas Burning Appliances (90/396/EC)  
  • Directive on Active Implantable Medical Devices 
  • Directive on Non-Automatic Weighing Instruments (90/384/EC)
  • Directive on Harmonization Of The Provisions Relating To The Placing On The Market and Supervision Of Explosives for Civil Use (93/15/EC)
  • Packaging and Packaging Waste Control Directives  
  • Building Materials Directive 
  • Recreational Craft Directive
  • Simple Pressure Vessels Directive
  • Marine Equipment Directive

WHY CE CERTIFICATE (MARK) ?

Since CE Certificate (Mark) is related to the products which are within the scope of certain New Approach Directives of the EU which require compliance, products which are within the scope of the directive and to be presented to the market in EU member states must bear this mark. Customs Union which entered into force in early 1996 between the EU and Turkey provides free movement of goods other than agricultural products. Turkey has gained a different position than 3rd countries in relationships with the EU.This difference is making standards determined within the Union in goods production obligatory for Turkey as well as making us enter into a full competition with member states in goods sales to the EU.Within this scope, CE certificate has become an inseparable part of production in Turkey, and will increase the quality of Turkish goods.At this stage, CE mark (certificate) which was obligatory for producers of 23 product groups only in export to the EU from Turkey before will also be obligatory for the products to be presented to the market in Turkey as of then.

WHAT HAPPENS IF THE CE MARK (Certificate) DOES NOT APPEAR?

All products within 23 product groups which are obliged to bear CE Mark (certificate) cannot be exported to the EU without CE Mark (certificate)According to the latest legal modifications in Turkey, products must have CE mark (certificate).This will be applied on all products obliged to have CE mark (certificate).

CE MARK (certificate) IN IMPORT FROM THIRD COUNTRIES ?

3. A manufacturer in a world country must have CE mark (certificate) while presenting a product to the EU market as a manufacturer in a Member State.They must design and produce the product according to the New Approach Directives and perform necessary compliance assessment procedures.If the manufacturer or representative of the manufacturer is not a member of the European Union, this responsibility must be taken by the importer. In other words, in imports from 3rd companies, importer company will be responsible for CE Mark (certificate).It means companies must guarantee that products they import are in compliance with the EU norms.

HOW IS CE MARK (CERTIFICATE) ISSUED?

Manufacturer is responsible for presenting products to the market with CE mark (certificate) and attaching the CE mark to the product.Various alternatives are presented for manufacturers to attach this mark to their products :

  • Low-risk products : Many products are included in low-risk product groups in terms of safety.Therefore, producer states that the product is in compliance with obligatory safety, health, environment and consumer protection standards by publishing a declaration after compliance assessment is performed. This declaration must be issued in accordance with the norms.
  • High-risk products : Declaration of the manufacturer is not sufficient for those products.In such case, products must be tested by notified bodies.After the review of the notified body, manufacturer may have CE mark to the product.Manufacturers of all systems and units to be used in the final product will deliver to the manufacturers to perform the integration with a document and declaration of components and elements in accordance with related directive (enactment) conditions.Organizations producing parts or components to integration cannot have CE mark on their products.

Organizations which are responsible for product groups requiring CE Mark and compliance of these product groups with the EU directive in Turkey are indicated in the table below.

Item

Field Included in the Scope of the Directive

Organization Responsible for Conformity

1

Low Voltage Devices

Ministry of Industry and Trade

2

Simple Pressure Vessels

 

Ministry of Industry and Trade

3

Gas Burning Appliances

Ministry of Industry and Trade

4

Hot Water Boilers

Ministry of Industry and Trade

5

Electromagnetic Compatibility

Ministry of Industry and Trade

6

Machinery

Ministry of Industry and Trade

7

Explosives for Civil Uses

Ministry of Industry and Trade

8

Non-automatic Weighing Instruments

Ministry of Industry and Trade

9

Equipment used in explosive atmospheres

Ministry of Industry and Trade

10

Lifts

Ministry of Industry and Trade

11

Freezers

Ministry of Industry and Trade

12

Pressure Vessels

Ministry of Industry and Trade

 

13

Airborne noise emitted by equipment used in outdoor

Ministry of Industry and Trade

14

Energy efficiency in fluorescent lights

Ministry of Industry and Trade

15

Active implantable medical devices

Ministry of Health

16

Medical devices

Ministry of Health

17

In vitro diagnostic medical devices

Ministry of Health

18

Toys

Ministry of Health

19

Recreational crafts

Undersecretariat of Maritime Affairs

20

Building materials

Ministry of Public Works and Settlement

21

Personal protection equipment

Ministry of Labor and Social Security

22

Radio and telecommunication terminal devices

Telecommunication Authority

23

Cableway installations designed to carry persons

Ministry of Industry and Trade

ATTACHING CE MARK (certificate) TO THE PRODUCT?

Detailed information about how to attach CE mark to the products are provided in directives on product groups. ÜManufacturers should have CE mark on their products in accordance with these directives. CE Mark (certificate):

  • is applied for all products of which manufacturer is/is not in the EU and which will be presented to the market for the first time,
  • Used products to be imported to the market of the union,
  • Completely-renewed products which are presented to the market of the union. Directives allow industrial products to be moved freely in the market of the Union regardless of CE mark (certificate) in some conditions.

These special cases;



  • According to Building Materials Enactment, some products which do not treat health and safety of human directly may be presented to the market of the Union by issuing only one declaration of conformity.
  • Active implantable medical devices, and medical materials and equipments produced for clinical needs or as customized for the order, and products produced for performance assessment can be presented to the Union with one declaration in accordance with In Vitro Diagnostic Devices Enactment.
  • According to the Enactment on Equipment Used In Potentially Explosive Atmospheres; products functioning as a compound of machinery-equipment or as a protective system and connection elements and fittings used in installations in accordance with Gas Burning Appliances can be presented to the market of the Union with a certificate of compliance.
  • In accordance with Non-automatic Weighing Instruments enactments, instruments of which manufacturer name and maximum capacity information are labeled can be presented to the market of the Union without a conformity assessment process. 
  • According to Simple Pressure Vessels and Pressure Vessels enactments, a separate conformity certifying process is not sought for vessels and instruments produced with excellent engineering skills. In production of such products, independent organizations who control the production are in charge, and producers should have special training and skills qualification.
  • Packing and wastes, high-speed rail systems, normal-speed rail systems are also included in this scope.

WHAT IS NOTIFIED BODY?

European Union regulation requires to subject high-risk products which must bear CE mark (certificate) to conformity assessment by bodies which are experienced in their fields, third parties and published on the EU Official Gazette before they are presented to the market.Organizations of which infrastructure is deemed adequate by the member states, which are elected from test, examination and/or certification organizations and published on the EU Official Gazette to perform test, examination and/or certification of these products are granted to the status of “notified body”.List of notified bodies determined by the member states are sent to the EU Commission and these lists are published on the EU Official Gazette to announce them to the other member states. These organizations should be competent technically.


NOTIFIED BODIES IN TURKEY?

In Turkey, there are over 10 notified bodies which are active.


HOW TO BECOME NOTIFIED BODY?

Single condition for a test, examination and/or certification organization to become a “notified body” is to fulfill requirements in related regulations.First of all, test, examination and/or certification organization which desires to be a notified body prepares technical structuring in fields from 23 product groups. Basis of such technical structuring is Regulation on Notified Bodies published in the Official Gazette with no 24643 dated 17.1.2002, regulation on related product group and declarations issued by related Ministry of related product group.After infrastructure preparations are completed, the application is made to related Ministry with the technical file prepared.Ministry sends the application to the Turkish Accreditation Agency (TÜRKAK) after making necessary examinations.TÜRKAK delivers positive/negative report or the report only notifying opinion to the Ministry after reviewing the application. Ministry takes the decision by taking this report into consideration.Ministry notifies the names of notified bodies approves to the Undersecretariat of Foreign Trade (DTM). DTM also notifies the EU Commission. After notified body is approved by the EU and published on the EU Official Gazette, it may commence its operations.