General Rules and Procedures on Technical Regulations and Standarts

05 Eylül 2018
ROLE of MINISTRY of TRADE (MoT)
 
The Ministry of Trade (MoT) – DG Product Safety and Inspection, coordinates the transposition work of the vertical legislation among more than 8 competent authorities in Turkey.
 
MoT is also responsible for transposing the horizontal legislation of the EU, in particular those in the field of product safety. (Besides, MoT is responsible for the coordination of the chapter of “free movement of goods” concerning the accession negotiations of Turkey in the EU.)
 
In order to transpose the rules relating general product safety, CE marking, notified bodies and market surveillance, “the Law on the Preparation and Implementation of Technical Legislation on Products (Law No. 4703)” was put into force as of 11 January 2002.
(Please click here for the Law No. 4703 on the Preparation and Implementation of Technical Legislation on Products.)
 
Law No. 4703 lays down obligations of the producers, distributors and third party conformity assessment bodies and specifies duties of the competent authorities. 
 
Four implementing Regulations of the Law were put into force on 11 January 2002. These regulations are:
 

 
TRANSPOSITION of the EU TECHNICAL LEGISLATION on the REMOVAL of TECHNICAL BARRIERS to TRADE
 
With its large market and the growing industry, Turkey has been a major trading partner of the EU for a long time. This partnership was strengthened with a Customs Union in 1995, and later on, with the perspective of full membership of EU. This status requires Turkey to align itself with technical legislation of the EU and promotes cooperation between the two Parties in the area of standardisation, accreditation, metrology and conformity assessment.  
 
As a matter of fact, Turkey has committed itself to approximate its technical legislation with that of the European Union (EU) within the framework of the Turkey – EU Association Council Decision (ACD) No. 1/95 of 6 March 1995 that establishes a Customs Union.

 
RELEVANT DECISIONS OF TURKEY – EC ASSOCIATION COUNCIL REGARDING TECHNICAL LEGISLATION
 
Within the framework of the Articles 5 - 7 of the ACD No. 1/95 (corresponding to Articles 28-30 of the Treaty), the signatories shall eliminate not only classical trade restricting measures i.e. tariffs, quotas, but also the barriers to trade arising from different regulatory practices on goods both in Turkey and the EU.
 
Within the framework of the Articles 8 - 11 of the ACD No. 1/95, Turkey shall progressively adopt the relevant acquis communautaire on the removal of technical barriers to trade and all other related technical regulations. Thus, a system which is parallel to that of the EU shall be established and the technical barriers to trade shall be removed between Turkey and the EU.
 
(Please click here for those relevant Articles of the Decision No. 1/95 of Turkey – EC Association Council of 22 December 1995 on Implementing the Final Phase of the Customs Union.)
 
- The list of the technical legislation to be transposed by Turkey as well as the conditions governing their implementation has been determined by the ACD No. 2/97 of 21 May 1997, the Annex 1 of which includes provisions stating that Turkey shall have the same rights and obligations with those of the EU Member States in parallel to its transposition.
 
(Please click here for the Decision No. 2/97 of Turkey – EC Association Council of 4 June 1997 establishing the List of Community Instruments relating to the Removal of Technical Barriers to Trade and the Conditions and Arrangements governing their Implementation by Turkey.)
 
- A further ACD No. 1/2006 has been put into force on 15 May 2006 on the implementation of Article 9 of the 1/95 ACD. The ACD No. 1/2006 regulates mainly the rules and procedures on the allocation of identification numbers to the Turkish notified bodies.
 
(Please click here for the Decision No. 1/2006 of Turkey – EC Association Council of 15 May 2006 on the Implementation of Article 9 of Decision No. 1/95 of the EC – Turkey Association Council on Implementing the Final Phase of the Customs Union.)
 
(Please click here for the list of the Turkish notified bodies.)
 
I) Transposed Community Harmonisation Legislation:
 
A) New Approach: As stated in the ACD No. 1/2006, Turkey – EC Customs Union Joint Committee is authorized to adopt a “statement” for ascertaining that Turkey put into force the provisions of the Community instrument or instruments necessary for the elimination of technical barriers to trade concerning the New Approach Directives.
 
Accordingly, two “statements” have been signed by both parties regarding 23 New Approach Directives, in total.
 
(Please click here for the Statements of the Turkey – EC Customs Union Joint Committee on the Implementation of Article 1 of Decision 1/2006.)
 
(Please click here for the list of the Turkish notified bodies.)
 
B) Old Approach: The competent authorities have put approximately 220 technical legislation (of Old Approach) into force out of approximately 280 technical legislation (of Old Approach) listed by the ACD No. 2/97.
 
II) Non-harmonised Area: 
 
In order to explain the rights and obligations of economic operators supplying goods to the EU market from Turkey stemming from the Customs Union between the EU and Turkey, it should be better to quote from the Commission interpretative communication on facilitating the access of products to the markets of other Member States: the practical application of mutual recognition (2003/C 265/02).
 
“Articles 5 to 7 of Decision No 1/95 of the EC-Turkey Association Council of 22 December 1995 on implementing the final phase of the Customs Union (OJ L 35, 13 February 1996, p. 1) provide for the elimination of measures having an effect equivalent to customs duties between the European Union and Turkey. Pursuant to Article 66 of Decision 1/95, Articles 5 to 7 must, for the purposes of their implementation and application to products covered by the Customs Union, be interpreted in conformity with the relevant Judgments of the Court of Justice. Consequently, principles resulting from the Court of Justice's case law on issues which are related to Articles 28 and 30 of the EC Treaty, particularly the ‘Cassis de Dijon’ case, apply to the Member States and to Turkey.”(Page 13, Footnote 18) 
 
“This communication (2003/C 265/02) makes it clear that the Member State of destination of a product must allow the placing on its market of a product lawfully manufactured and/or marketed in another Member State or in Turkey,….., provided that this product provides an equivalent level of protection of the various legitimate interests involved.”(Page 2, paragraph 4)
 
“The Court of Justice recognises that, in the absence of harmonised Community rules, the Member States have the power to adopt technical rules.”(Page 3, Section 1.2., paragraph 8)
 
“However, the Member State of destination must allow an EEA/Turkish product free access to its market, provided that it provides an equivalent level of protection of the various legitimate interests at stake. This principle will henceforth be referred to as the principle of ‘mutual recognition’.”(Page 4, Section 1.2., paragraph 9) 
 
“An essential principle of Community law is that an EEA/Turkish product enjoys the basic right of free movement of products, guaranteed by the EC Treaty, provided that the Member State of destination has not taken a reasoned decision of refusal, based on proportionate technical rules.”(Page 5, Section 4, paragraph 1)
 
“However, mutual recognition is not always automatically applicable: it can be affected by the right of the Member State of destination to verify the equivalence of the level of protection provided by the product under scrutiny, compared with that provided by its own national rules.”( Page 3, Section 1.2., paragraph 10)
 
“This supervision must be based on objective, non-discriminatory criteria which are known in advance, in such a way as to circumscribe the exercise of the national authority's discretion so that this discretion is not used arbitrarily.”(Page 5, paragraph 3)
 
“…….. In any event, supervision should always be exercised in the framework of a procedure that is as short, effective and inexpensive as possible. In principle, there can be no systematic control in the Member State of destination before release on the market. As a result, as a general rule, the Member State of destination can only examine the conformity of an EEA/Turkish product with its own technical rules as part of an inspection undertaken as part of its market monitoring activities, and after release on the national market.”(Page 5, Section 4 Supervision by the Member State of Destination, paragraph 4)
 
“………The Member State of destination will only have the right to require additional tests when all the following conditions have been met:
— these tests have not already been carried out or have not been carried out by a body providing equivalent guarantees to those required for the national bodies,
— this type of test is also imposed on national product's,
— these tests are necessary to provide the competent authority with the information required to evaluate the level of protection afforded by the product.” (Page 7, paragraph 9)
 
“A negative decision by the Member State of destination regarding the access of an EEA/Turkish product to its market is, in principle, likely to constitute a measure having an equivalent effect to a quantitative import restriction, prohibited by Article 28 of the EC Treaty. Thus, the economic operator may always contest under national law a negative decision taken against him.”(Page 10, Section 5.2., paragraph 1)
 
(Please click here for the Commission’s Interpretative Communication on facilitating the access of products to the markets of other Member States, the practical application of mutual recognition (2003/C 265/02).)

 
NOTIFICATION of the DRAFT TECHNICAL REGULATIONS in ACCORDANCE with DIRECTIVE 98/34/EC
 
The draft technical regulations in the non-harmonised area have been notified to the European Commission since 2002 within a mechanism that is foreseen in the Directive No. 98/34/EC together with the relevant adaptations mentioned in the ACD No. 2/97. Furthermore, MoT – DG product Safety and Inspection (as the central unit in Turkey) sends the notifications received from EU Member States to relevant public authorities in Turkey.
 
 
(Please click here for the “Presentation on the Information Procedure in the Field of Technical Regulations, Directive 98/34/EC, by the European Commission” within the scope of the seminar held about the functioning of the notification procedure in Ankara on 1 June 2007.)

 
INFRASTRUCTURE for an EFFECTIVE IMPLEMENTATION of the TRANSPOSED EU INSTRUMENTS

For the effective implementation of the transposed legislation, considerable steps have been taken for building up the required infrastructure and setting the administrative framework for conformity assessment, accreditation and market surveillance in Turkey.
 
Turkey has transposed hundreds of EU acts including almost all the New Approach directives and is implementing them now with all the accompanying mechanisms. As part of these mechanisms –for example- Turkey has notified 47 national conformity assessment bodies as Notified Body under 14 New Approach directives. Turkish Accreditation Agency became a full member of European Cooperation for Accreditation (EA) in 2004 and has signed all EA Multilateral Agreements. Furthermore, Turkey has also been part of the notification mechanism as laid down in Directive 98/34/EC since 2004. With the accession of the Turkish Standards Instution to CEN and CENELEC, in the beginning of 2012 an important missing part is now completed.
 
Besides, a “Working Group Technical Legislation” was established under the Customs Union Joint Committee on 6 May 2004. This Group plays an important role in eliminating problems in the area of the approximation of technical legislation, and constitutes a platform to exchange and discuss information on technical regulation of products.

 
NOTIFIED BODIES
 
Notified body is any public or private body designated and authorized by the related public authority from among the testing, inspection and/or certification bodies to carry out conformity assessment procedures. 
 
The criteria for the designation of these bodies and their responsibilites are laid down under the Law No. 4703 (4) and its implementing Regulation on Conformity Assessment Bodies and Notified Bodies (6).
 
The candidate notified bodies are selected by the relevant competent authority and their names, addresses and duty scope are notified to the Europan Commission via the NANDO system. After the approval of the Commission, these bodies start operating as notified bodies following a communique published in the Official Gazetta.  
 
“Please click here for the list of Turkish Notified Bodies”