Analysis of regulatory requirements

Legislation in force for this PCT

Here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO license) Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Scope of legislation

This ESSENTIAL describes the legal obligations for manufacturers of articles and the regulatory requirements for substances in articles. The Turkey REACH like-law: KKDIK is closely harmonized with the EU REACH provisions and requires companies to pre-register and register substances (on their own, in mixtures or in articles) manufactured in Turkey or imported into Turkey with volumes equal to or above 1 tone per year: - Substances in quantities of one ton or more per year manufactured in or imported into Turkey; - Substances in mixtures in quantities of one ton or more per year manufactured in or imported into Turkey; - Substances in articles manufactured in or imported into Turkey which are intended to be released under normal or reasonably foreseeable conditions of use and the quantity totals 1 ton per year or more. '

Responsible actors

Here you will get textual information Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)

Here you will get textual information What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Exemption clauses

Here you will get textual information Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties

Here you will get textual information E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU

Here you will get textual information Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority

Here you will get related hyperlink(s) Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)

Here you will get textual information

Hints

Here you will get textual information Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?

Here you will get a table Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?

Here you will get textual information [Yes/No]

Hints

Here you will get textual information Specific recommendations, information or most common mistakes

Obligations of producers, suppliers and users of articles Producers, suppliers and users of articles can have information and notification obligations as well as the obligation to register substances in certain circumstances.

Registration obligations for substances

Here you will get textual information Registration requirements for substances in articles

Registration obligations for articles

Here you will get textual information

Hints

Here you will get textual information

Obligations for substances of very high concern (SVHC) Obligations (notification, information) in relation to substances of very high concern (SVHC) or other special substances

Substances of very high concern (SVHC)

Here you will get textual information what are the criteria for these substances? (e.g. Art. 57 REACH)

Notification obligations

Here you will get textual information e.g. Art. 7 (2) REACH Notification to ECHA if SVHC is present in those articles above a concentration of 0,1 % weight by weight (w/w).

Required information for notification

Here you will get textual information Which information shall be submitted?

Deadline for the notification

Here you will get textual information

Hints

Here you will get textual information Specific recommendations, information or most common mistakes

Duty to communicate information on substances in articles

Here you will get textual information

Duty to communicate information on substances in articles 2

Here you will get textual information

Required information to communicate

Here you will get textual information

Deadline for the information

Here you will get textual information

Code, Continent	TUR, Europe/Asia
Economic Area	EUCU, BSEC (Black Sea Economic Cooperation)
Official Language	Turkish - Law Numbered 805 on Mandatory Use of Turkish Language by Economic Enterprises | https://www.mevzuat.gov.tr/mevzuat?MevzuatNo=805&MevzuatTur=1&MevzuatTertip=3
Standard Institute	TSE Turkish Standards Instritute (Türk Standardları Enstitüsü) | https://www.tse.org.tr/en/
HS Codemember	Yes - since 1951