‘’CE MARK’’

The CE mark serves as an indication that a product adheres to the essential criteria outlined by specific New Approach Directives established by the European Union in 1985. This mark indicates that the manufacturer or their authorized representative or a notified body if needed, has fulfilled all the necessary conformity evaluation processes. It guarantees that the product aligns with appropriate technical standards and when used as intended, poses no threat to health, safety or the environment. These directives may cover one or more of these essential criteria. Additionally some directives requiring the CE mark may also relate to factors beyond safety, such as electromagnetic compatibility and energy efficiency.

The CE marking is represented by the following symbol:

The Importance of the CE Marking

The CE marking is required for products that fall under the scope of certain New Approach Directives of the European Union. Given that Türkiye has harmonized its legislation with that of the EU, products placed on the Turkish market are also required to bear this marking, once the suitable legislation enters into force. In base, the CE marking serves as a kind of passport, allowing products to freely circulate within the EU member states.

Importance of the ‘’CE Marking’’ in Türkiye

Articles 8-11 of the Joint Council Decision No. 1/95, which established a Customs Union between Türkiye and the European Union, included the integration of EU measures to eliminate technical trade barriers into Türkiye’s national laws. The Joint Council Decision No. 2/97 outlined the specific EU laws on technical trade barriers and the conditions for their implementation in Türkiye.

Public agencies responsible for aligning this EU legislation were designated by the Council of Ministers’ Decision No. 97/9196, issued on January 15, 1997. While some legislative harmonization efforts have been finalized, others are still underway. As the EU updates its legislation, Türkiye is obliged to follow suit with similar updates. Some of this EU legislation requires products to bear the “CE” marking. Since Türkiye was recognized as a candidate for full EU membership at the Helsinki Summit in 1999, the relationship with the EU has evolved beyond the Customs Union. Efforts to harmonize technical legislation have broadened, encompassing an increasing number of EU technical regulations that need to be aligned with the subsequent “national program”.

To create the legal groundwork for harmonized technical regulations, the Ministry of Commerce, previously known as the Undersecretariat of Foreign Trade, along with contributions from relevant public entities, developed Law No. 4703. This law addresses the Preparation and Implementation of Technical Regulations on Products and was published in the Official No. 24459 on July 11, 2001, taking effect on January 11, 2002. According to this law, several regulations were published in the Official Gazette No. 24643 on January 17, 2002, and came into force on January 11, 2002. These include the “Regulation on Conformity Assessment Bodies and Notified Bodies,” “Regulation on the Affixing and Use of the CE Conformity Marking on Products,” and “Regulation on Market Surveillance and Control of Products.” Another regulation under this law, the “Regulation on the Notification of Technical Regulations and Standards between Türkiye and the European Union,” was published in the Official Gazette No. 24715 on April 3, 2002 and became effective on May 3, 2002.

Nevertheless, the activation of this law and its regulations on January 11, 2002 did not make the CE marking immediately mandatory for products. For the CE marking to be required for products made in Türkiye and sold in the domestic market, relevant ministries and public bodies needed to put in place technical regulations that mandated the CE marking. For technical regulation harmonization to be practically applied, it was not enough just to enact harmonizing regulations; it was also essential to adopt harmonized standards as “Harmonized National Standards” and incorporate them into national legislation. This responsibility has been undertaken by the Turkish Standards Institution according to its own organizational law and the mandate given to it under Law No. 4703.

Authorized institutions must publish the harmonized national standards, along with their relevant regulations and reference numbers, in the Official Gazette. Therefore, there isn’t a single date for CE marking implementation in Türkiye; instead, its use begins gradually as the pertinent product regulations are enforced. In this regard, it is crucial for producers to maintain close contact with authorized public bodies that draft and enforce the necessary legislation.

Requirement for CE marking

Products lacking the mandatory CE marking cannot be exported to EU member states. Moreover, within our domestic market, products that fall under product regulations where legislative conformity has been achieved and mandatory application has commenced but do not bear the CE marking are prohibited from being placed on the market.

Products requiring the CE marking

The CE marking is applied to products covered by certain New Approach Directives, which were developed within the framework of the EU’s New Approach Policy adopted in 1985 to harmonize technical regulations. For EU Directives to be implemented in our country, they must be transposed into our national legal system through “product regulations” prepared by relevant public institutions and organizations. These harmonized regulations can be accessed through the Official Gazette or the websites of the relevant authorities.

Ways to affix the CE marking to a product

The way in which the CE mark is attached to a product is guided by applicable regulations. It is the responsibility of manufacturers and their authorized agents to ensure that products released in the market display the CE mark. If neither the manufacturer nor the authorized agent is located in the EU or Türkiye, the onus falls on the importer to confirm the presence of the CE mark on the product. Essentially, importers must ensure that the products they bring in comply with EU standards. Manufacturers have multiple methods to place the CE mark on their products.

• In the case of certain product groups (typically low-risk products or those where risks are easily identifiable, like some machinery), manufacturers can self-certify compliance with the directive’s essential requirements. This can be done by conducting tests using their own facilities or those of a third party. Once conformity is established, the manufacturer can affix the CE marking based on their declaration of conformity.
• Some products (e.g., certain medical devices and machinery) require conformity assessment by a notified body listed on the NANDO database. Following a positive assessment, the manufacturer is authorized to affix the CE marking.

The role of a Notified Body

The European Union’s regulations require that products displaying the CE mark, particularly those with higher risk levels, must be evaluated for compliance by a notified body. A notified body is an independent expert organization recognized in the Official Journal of the European Union. Before products can enter the market, these bodies, chosen by member states from testing, inspection and certification organizations with appropriate resources, have the authority to evaluate, inspect and certify them. Once designated by member states, these notified bodies are reported to the European Commission, and their information is published in the Official Journal. You can access a list of these bodies, including their names and addresses, through the NANDO database.

As part of the New Approach Directives, which aim to ensure complete regulatory compliance, our nation has also gained the power to designate notified bodies, similar to other EU member states. Turkish notified bodies, appointed by our national authorities, are listed on our Ministry’s website or the European Commission’s NANDO database.

It’s crucial to understand that manufacturers can, in certain situations, apply the CE mark to their products without a notified body’s involvement. These situations are outlined in the relevant directives for each product or product category. Therefore, manufacturers should thoroughly review the directives pertinent to their products and maintain a strong relationship with the public authorities responsible for creating and enforcing the relevant regulations.

The presence of notified bodies is driven entirely by market demand. Based on industry requirements and the feasibility for notified bodies, the competent authority might designate several notified bodies to work in the same area. Alternatively, if a sector is not considered profitable for notified body activities, no notified body may be assigned to that area. In such instances, certification services for that sector must be sought from notified bodies based in EU countries, which may also have representatives in our country.

Key considerations for our manufacturers

Our manufacturers should identify which directives their products fall under, thoroughly examine these directives, and fully understand all their elements. If necessary, they should make changes to their production processes and carry out the necessary certification procedures. It’s important to remember that not every New Approach Directive requires the CE marking to be affixed to a product. Some directives, based on earlier New Approach principles, may not require the CE marking but may involve other types of marking.

These Product Groups:

1. Packaging and Packaging Waste
2. Compatibility of Trans-European High-Speed Rail Systems
3. Marine Equipment (Ship Equipment)
4. Portable Pressure Equipment
5. Compatibility of Trans-European Conventional Rail Systems

TSE Service Location Certificate and TSE Product Certification

A TSE Certificate is granted to businesses that produce items in alignment with Turkish standards, serving as a symbol of quality. To obtain this certification, a business must adhere to all applicable regulations. Every Turkish business, particularly those in the food sector, requires a TSE Certificate. It verifies that a product is manufactured in Türkiye, regardless of whether it is made locally or involved in import/export activities.

The certificate is product and brand-specific, detailing its production and expiration dates. It remains valid for one year and must be renewed with each new production cycle. While it facilitates both domestic and international sales, additional permits are necessary for import and export operations.

TSE Certificates are advantageous for consumers, as they guarantee that products are manufactured under strict supervision. If any issues arise, consumer rights are safeguarded. The certificate stands as a testament to quality, reliability, and legal adherence.

To apply for a TSE Certificate, businesses must submit legal documents, including a notarized proof of operations. Upon verification, the certificate is issued to the company.

Similarly, a TSEK Certificate is intended for international companies producing goods that comply with Turkish standards. It functions similarly to a TSE Certificate but is tailored for foreign enterprises. Both types of certificates are valid for one year. Our company provides consultancy services to expedite the process of obtaining these certificates.