Frequently Asked Questions

The Framework Law essentially aims to ensure the safety of products intended to be placed on the market and products already on the market. It therefore sets out the general framework of the system needed to achieve that objective, together with the rights and obligations of all parties within that system.

The Framework Law defines terms such as “technical regulation”, which lays down the technical criteria that must be met to ensure product safety; “standard”, which specifies voluntary criteria to be followed for product safety where no technical regulation exists; “competent authority”, which is responsible for preparing technical regulations; “conformity assessment”, which determines whether a product has been manufactured in accordance with its technical regulation before it is placed on the market; “conformity assessment body”, meaning a testing, certification or inspection organization that conducts conformity assessment; “notified body”, a particular form of conformity assessment body; and “manufacturer”, who must comply with the relevant technical regulations, including monitoring conformity assessment activities, in order to place only safe products on the market and who bears ultimate responsibility for product safety.

The Framework Law defines the State’s obligations as follows. First, the public authority responsible for a product establishes the rules that manufacturers in the sector must follow to manufacture products providing the highest possible level of safety for consumers and other entities at risk.

The State’s second obligation is to establish and strengthen pre-market checks, which under the existing system have either been applied weakly or not at all, through third-party conformity assessment. This is the central feature of the new system. Under the system enabled by the Framework Law, the State can effectively check products before they reach the market through conformity assessment bodies and notified bodies acting as independent third-party evaluators. This reduces expenditure on remedying harm caused by unsafe products after they reach consumers and keeps the financial burden of post-market surveillance and inspection at reasonable levels.

Finally, the State is responsible for surveillance and inspection after products have been placed on the market. In the existing system, these checks should play a particularly important role because there are no pre-market controls; however, the scale of the economy and insufficient public resources have prevented them from being carried out adequately. Independent third-party pre-market checks introduced by the Framework Law will allow the relevant public authorities to focus post-market surveillance on higher-risk products and sectors in which unsafe products are encountered more frequently. This will prevent consumers from using products that have not been checked.

The Framework Law also sets out manufacturers’ rights and obligations. Manufacturers must place safe products on the market. Although the Law requires the relevant public authorities to establish safety rules, the obligation to manufacture safe products also applies where the State has set no rules. This is one of the Law’s main innovations. Manufacturers are relieved of responsibility only where the rules imposed by the State themselves cause the product to be unsafe.

When manufacturing safe products, a manufacturer may choose third-party assessment if the applicable technical legislation permits or requires it. Nevertheless, the manufacturer remains ultimately responsible for an unsafe product, even if the problem arises from conformity assessment. Where the manufacturer suffers a loss because of incorrect or incomplete conformity assessment, the right to seek compensation is preserved.

A particularly strong incentive for safe manufacturing is the manufacturer’s obligation to inform purchasers and users about a product’s unsafe characteristics if these are discovered during post-market surveillance. This includes announcing through the media that the manufacturer has produced an unsafe product. The risk of commercial reputational damage encourages manufacturers to exercise maximum care. Withdrawal, correction and, where necessary, destruction of products found to be unsafe are also costly, providing a further incentive to comply with technical legislation.

Conformity assessment bodies undertake pre-market checks on behalf of the public under rules established by the relevant authorities. In doing so, they must remain equally independent of manufacturers and consumers, and must maintain the technical and administrative capabilities they had when authorized throughout the period in which they perform these duties.

If conformity assessment bodies fail to conduct their activities in accordance with the rules, the relevant public authority may impose administrative fines and, depending on the seriousness of the breach, prohibit them from carrying out conformity assessment activities.

The Framework Law includes penalty provisions, but sanctions are not the backbone of the system. Penalties for manufacturers under the Law apply where existing legislation does not provide a sanction.

The three implementing regulations described below entered into force on 11 January 2002.

The Regulation on the Affixing and Use of the CE Conformity Mark establishes the procedures for affixing and using the CE conformity mark within the system established by Law No. 4703. The mark indicates that certain industrial products have been manufactured in accordance with the relevant technical regulations and that this conformity has been verified by the manufacturer or a notified body.

The Regulation concerns product groups of significant economic importance. It provides a guide for competent authorities and manufacturers so that legislation requiring the CE conformity mark, whose harmonization is carried out by various organizations, is prepared and implemented using common terminology and rules.

As stated in Article 23, this Regulation, which sets out general principles for affixing and using the CE conformity mark, applies together with the relevant technical regulations only after regulations requiring the mark have been published in the Official Gazette by the competent authorities and entered into force. Publication of this Regulation alone therefore does not make CE marking compulsory for any product group.

The Regulation on Conformity Assessment Bodies and Notified Bodies establishes the conditions to be met by bodies that assess, before products are placed on the market, whether they have been manufactured in accordance with their technical regulations. It also sets out the designation procedure for notified bodies and their operating rules and principles.

This Regulation enables conformity assessment bodies and notified bodies, which are essential to the effective operation of the new system, to begin operating in Türkiye under defined rules.

Under this system, the State can verify compliance with technical legislation before products are placed on the market through conformity assessment bodies and notified bodies acting under its rules and accountable to it. This will reduce the resources required for post-market surveillance and inspection.

The Regulation on Market Surveillance and Inspection of Products sets out principles for preparing technical regulations, compliance and product safety; the obligations of manufacturers and distributors when products are placed on the market; market surveillance procedures; and the powers and responsibilities of competent authorities in determining whether products being placed on, distributed on or already available on the market are safe and compliant. It also establishes the measures to be taken and the composition, duties and operating procedures of the Market Surveillance and Inspection Coordination Board.

By establishing rules for an effective national market surveillance system, this Regulation identifies product safety checks as a duty of the State and describes in detail the measures to be taken against unsafe products.

The Regulation on the Notification of Technical Legislation and Standards between Türkiye and the European Union was published in Official Gazette No. 24715 on 3 April 2002 and is to enter into force on 3 May 2002.

Technical legislation subject to notification under this Regulation concerns products for which no EU legislation exists, and is notified to EU member states through the European Commission. The Regulation governs the standstill period specified by Association Council Decision No. 2/97, assessment of possible comments by member states and the Commission, publication of notified technical legislation, and notifications transmitted to Türkiye by the Commission.

Standards subject to notification are national standards other than the identical adoption of international or European standards. The Turkish Standards Institute is to notify these to the European Commission, European standardization organizations and national standardization bodies of EU member states.

Under the system envisaged by the Framework Law, all products placed on the market must be safe, whether or not they are covered by a technical regulation. Various measures and sanctions support this requirement. The establishment of impartial, independent conformity assessment bodies and notified bodies is another important part of the system.

Introducing the system in Türkiye required either separate amendments to the laws governing the powers and duties of all ministries and organizations responsible for technical legislation, such as the Ministry of Agriculture and Rural Affairs and the Ministry of Industry and Trade, or common provisions in a Framework Law to fill gaps in existing legislation. Following consultations, the relevant ministries and organizations agreed on the latter approach and on preparation of the Law by the Undersecretariat of Foreign Trade, which coordinates technical legislative harmonization with the EU.

Article 4 states that technical regulations concerning products are to be prepared by the competent authorities. Article 3(l) defines a competent authority as a public institution or organization legally empowered to prepare and implement product legislation and to apply the Law to products within its area of responsibility. The Law therefore preserves their existing powers and explicitly confirms their responsibility and authority to prepare and implement technical legislation.

Although some ministries and organizations assigned harmonization responsibilities by Council of Ministers Decision No. 97/9196, such as the ministries responsible for industry and trade, agriculture and rural affairs, and health, have adopted legislation containing market surveillance provisions, their practices are not uniform. Others, including those responsible for public works and settlement, labour and social security, and maritime affairs, have no legislation governing market surveillance for the technical regulations they are responsible for harmonizing.

The Framework Law was prepared at the request of and with the participation of the relevant organizations to establish common market surveillance provisions and provide a legal basis for organizations that previously lacked one, alongside the Law’s other elements.

The CE mark used for products covered by the EU’s New Approach directives, the “e” mark for certain automotive components, the reversed-epsilon “3” mark for aerosol containers and other conformity marks indicate that a product has been manufactured in accordance with the relevant directive and undergone conformity assessment. Products lacking a required mark may not circulate freely in the EU. Such marks therefore act as a form of passport for free movement. Covered products must bear them whether they originate in an EU member state or are imported from a third country.

As these technical regulations are incorporated into and brought into force under Turkish legislation, the corresponding conformity marks will also become compulsory for both domestic and imported products on Türkiye’s internal market.

Article 7 of Association Council Decision No. 2/97 states that rights granted to EU member states, their public or private bodies or persons in relation to one another will also apply to Türkiye, its competent authorities, public or private bodies and persons.

This provision applies to each harmonized technical regulation. Organizations designated to conduct testing, inspection and certification under that regulation, and the certificates and marks they issue, will therefore be recognized by the EU. However, conformity assessment bodies must meet the criteria applicable to equivalent bodies in the EU and complete the necessary recognition procedures.

If meeting the essential requirements in harmonized technical legislation requires a technological change to a manufacturer’s production line, it will naturally create a financial need.

Discussions with representatives of medium-sized and large companies in many sectors indicated that harmonization would not cause major changes in production lines because most standards applied in Türkiye are identical to EU or ISO standards. Certification costs were therefore considered more significant than costs arising from production-line changes.

However, these financial needs are important for small and medium-sized enterprises (SMEs). Measures may be needed to reduce their burden. The following measures are considered potentially helpful:

1. Review the investment incentive system for SMEs and provide additional opportunities. 2. Increase SMEs’ share of total lending. 3. Continue support for certification expenditure during the transition under the Money-Credit and Coordination Council’s Communiqué No. 97/5 on Support for Environmental Costs, published in the Official Gazette on 31 July 1997 as part of export-oriented State aid. 4. Use EU funds to provide financial assistance to SMEs. 5. KOSGEB and chambers of industry should take measures enabling SMEs to follow technical and commercial developments in Türkiye and abroad.

Manufacturers should also obtain the directives relevant to their products from the responsible public authorities and begin making the necessary investments.

The European Commission approved a technical assistance project under the MEDA-II programme to support the development of Türkiye’s quality infrastructure. The agreement was signed on 17 April 2001 by a Commission representative and representatives of the Undersecretariat of Foreign Trade, the Treasury and Kalder, which are parties to the project.

The project lasts five years. The EU will provide EUR 13 million in grant funding, and activities are planned to begin in the first half of 2002.

Taking account of accession criteria within Türkiye’s EU candidacy, the project aims to:

- Facilitate technical legislative harmonization and bring Türkiye’s quality infrastructure closer to that of the EU. - Support businesses, within their capacities, in manufacturing goods that meet the quality requirements forming part of the internal market’s instruments. - Increase awareness among Türkiye’s private sector, public sector and consumers of the importance of adopting EU legislation.

Similar projects are planned under the Administrative Cooperation Fund and through individual EU member states. The European Commission is also continuing work on larger amounts of financial assistance under the MEDA programme.

The Framework Law does not by itself transpose EU technical legislation into Turkish law. Full alignment requires the relevant public authorities to incorporate product-specific EU legislation into national law and implement it effectively, taking account of the Framework Law and its implementing regulations. It also requires conformity assessment bodies and notified bodies to be established in Türkiye in parallel with the EU system.

Enactment of the Framework Law will provide the legal infrastructure and common implementation rules needed to fulfil Türkiye’s commitments on technical legislative harmonization under the Türkiye-EU Customs Union and establish a standardization system parallel to the EU system.

Applying such a system will help Turkish industry move towards higher technology and higher added-value products. This transformation will also increase the technological capabilities of SMEs, which account for a significant share of production and employment.

The new system resulting from completed harmonization and the operation of the Turkish Accreditation Agency (TÜRKAK) will advance integration into world markets. Domestic products will become more competitive against imports, Turkish products’ market share abroad will increase, and the image of Turkish products will improve.

Manufacturing and marketing all products in accordance with technical regulations and product safety criteria will enable consumers to use higher-quality products meeting international standards more widely.

As long as Türkiye’s objective of integration with world markets and the EU remains unchanged, the long-term benefits of harmonization should receive greater consideration than short-term problems. Participating in regional integration is one way to secure a greater share of world trade. Since the EU, which accounts for almost half of Türkiye’s foreign trade, determines complex standardization systems, all sectors of the economy should begin learning and properly applying those systems as soon as possible, until Türkiye can participate in their decision-making mechanisms.

One objective of Association Council Decision No. 1/95 is full free movement of goods. It therefore requires Türkiye to adopt Community instruments for removing technical barriers to trade and provides a five-year transition period for this purpose.

Articles 7 and 8 of Annex I to Decision No. 2/97 specify that references to the Community in harmonized legislation are understood to include Türkiye, and that rights granted to member states, their public and private bodies or persons also apply to Türkiye. This is important because it allows Türkiye to cease being treated as a third country for a product whose legislative harmonization has been completed.

However, establishing a legal framework alone is insufficient. Implementing it also requires adequate technical infrastructure and EU confidence that conformity assessment bodies and notified bodies perform their tasks properly. This will be achieved through independent and impartial bodies operating in accordance with international technical criteria.

An essential element is completion of the establishment of TÜRKAK, commencement of its activities, and accreditation activities of a quality acceptable to the EU.

Costs vary according to the conformity assessment procedure required by the product’s risk level, whether the product falls under more than one directive, and the scope of testing, inspection and certification carried out by the conformity assessment body or notified body. Different fees may also be charged in EU member states for the same assessment procedure on the same product. The number of bodies operating in Türkiye under the Framework Law and implementing regulation is expected to increase. Given the generally high service fees in EU member states, fees charged by Turkish testing, inspection and certification bodies are expected to be lower.

The CE mark is a Community mark indicating that products covered by the New Approach directives, prepared under the EU’s New Approach policy adopted in 1985, comply with those directives and have undergone all necessary conformity assessment activities.

It indicates that, when used as intended, a product will not harm human life and property, plants, animals or the environment; in other words, that it is a safe product.

In addition to indicating safety and compliance with the technical regulation requiring it, the CE mark acts commercially as a passport for products moving between EU member states. Products covered by CE marking may not be placed on the EU market without it. This applies both to products manufactured within the EU and to imports from third countries.

Exporters in Türkiye must therefore pay attention to CE marking when exporting to the EU. Turkish companies exporting to member states can already do so after obtaining conformity assessment from an EU-based notified body and affixing the CE mark.

Before a product is placed on the market, conformity assessment is performed so that the mark may be used. This prevents unsafe products from reaching the market and protects consumers.

Articles 8-11 of Association Council Decision No. 1/95, establishing the Türkiye-EU Customs Union, require incorporation of EU instruments for removing technical barriers to trade into Turkish law to ensure free movement of goods.

Decision No. 2/97 identifies the relevant EU legislation and the conditions and rules for its implementation by Türkiye.

Following work coordinated by the Undersecretariat of Foreign Trade, Council of Ministers Decision No. 97/9196 of 29 April 1997 identified the public authorities responsible for harmonizing that legislation.

Some harmonization work under this assignment has been completed, while other work continues. Some directives still being harmonized require products to bear the CE mark.

Law No. 4703, prepared by the Undersecretariat of Foreign Trade with the participation of the relevant public authorities to provide the legal basis for harmonized technical legislation, was published in Official Gazette No. 24459 on 11 July 2001 and entered into force on 11 January 2002. The implementing regulations on conformity assessment bodies and notified bodies, affixing and using the CE conformity mark, and market surveillance and inspection were published in Official Gazette No. 24643 on 17 January 2002 with effect from 11 January 2002. The Regulation on the Notification of Technical Legislation and Standards between Türkiye and the EU was published in Official Gazette No. 24715 on 3 April 2002 and is to enter into force on 3 May 2002.

The Law and implementing regulations entering into force on 11 January 2002 does not mean that CE marking becomes compulsory on that date. The product-specific legislation prepared by the relevant ministries and public authorities and requiring CE marking must also enter into force in Türkiye.

For example, machinery placed on the domestic market will have to bear the CE mark after the Ministry of Industry and Trade transposes the EU machinery directive, publishes it in the Official Gazette and brings it into force. This date will in any event be later than 11 January 2002.

Until the relevant directives have been incorporated into national law and entered into force, CE marking cannot be made compulsory for the covered products on Türkiye’s domestic market.

Where a directive requires it, notified bodies that will assess conformity under the harmonized legislation should be designated by the relevant public authorities before that legislation enters into force.

Mandatory CE marking will therefore begin on separate dates for each product or product group, all later than 11 January 2002.

Manufacturers should maintain close contact with the public authorities responsible for preparing and implementing the relevant legislation.

A product that is required to bear the mark but does not may not be exported to EU member states. Once legislative harmonization is completed, such products may not be placed on Türkiye’s domestic market either.

The CE mark is used on products covered by the New Approach directives prepared under the EU’s New Approach policy adopted in 1985 as part of technical legislative harmonization. Draft Turkish legislation corresponding to these directives can be obtained from the relevant organizations.

The relevant directives specify how the CE mark is affixed.

The manufacturer is responsible for placing CE-marked products on the market. If neither the manufacturer nor its authorized representative is established in the EU, the importer must fulfil this responsibility and guarantee that imported products comply with EU requirements. Manufacturers have various options:

1. For low-risk products, such as certain machines, the manufacturer may itself test compliance with the directive’s safety requirements and affix the CE mark on the basis of its declaration of conformity. 2. High-risk products, such as certain medical devices and machines, must be tested by authorized testing and certification bodies whose names are published in the EU Official Journal (notified bodies). The manufacturer affixes the CE mark following the notified body’s assessment.

For some products requiring CE marking, confirming compliance with the directive’s essential requirements (minimum safety requirements) involves preparing a technical file and applying to a notified body for certification, for which a fee must be paid. Costs depend on the product’s risk level, the tests required and the amounts payable to notified bodies for certification.

This information can be obtained from the public authorities that transpose the EU New Approach directives requiring CE marking into national legislation.

EU technical legislation is dynamic, with new legislation being prepared and brought into force. The number of products requiring CE marking may therefore increase.

EU legislation requires high-risk products covered by CE marking to undergo conformity assessment before being placed on the market by an independent third party whose name and Commission-issued identification number are published in the EU Official Journal.

Member states select bodies with adequate infrastructure for testing, inspection and/or certification. Those receiving an identification number from the Commission and being published in the Official Journal acquire notified-body status. Member states submit their lists to the Commission, and the lists are published so that other member states are informed. These bodies must have sufficiently knowledgeable and experienced personnel and the technical infrastructure needed to conduct assessments under the relevant regulation.

Notified bodies operating in Türkiye will be selected by the competent ministry or authority from public or private testing, inspection and/or certification organizations to conduct assessments under one or more technical regulations, and notified to the Commission. Within three months of receiving the Commission’s identification number, the competent authority will designate the body by publishing its name, address, identification number and scope of activities in the Official Gazette.

Since the directives requiring CE marking are not yet in force in Türkiye, the bodies that will operate under this legislation have not yet been identified by the relevant authorities.

When these directives enter into force, the bodies responsible for conformity assessment will also have been designated by the relevant ministries or public authorities.

Public and private organizations interested in this role should study the directives for the product groups concerned and make the necessary preparations.

In some cases manufacturers may affix the CE mark without applying to a notified body. The relevant directives specify this for each product or product group.

Manufacturers should therefore examine the directives relevant to their products and maintain close contact with the public authorities responsible for preparing and implementing the corresponding legislation.

No. Of the 24 New Approach directives at the time of the source document, three do not require CE marking.

The directives that do not require it are:

a) Packaging and packaging waste. b) High-speed rail systems. c) Marine equipment.

Under Communiqué No. 97/5 on Support for Environmental Costs and amending Communiqué No. 98/13, SMEs manufacturing and exporting products that require CE marking can receive support covering up to 50% of certification expenditure when the mark is obtained.

To benefit, SMEs must apply to the Undersecretariat of Foreign Trade (Directorate General of Exports) in accordance with the communiqués.

SMEs may also benefit, through projects they prepare, from the EUR 13 million in technical assistance allocated by the EU under the MEDA programme to support Türkiye’s quality infrastructure. The Undersecretariat of Foreign Trade (Directorate General for Standardization in Foreign Trade) is one of the Turkish parties implementing this programme.