Regulatory ESSENTIAL



Regulatory ESSENTIALS - modular information package with all the essential information for compliant products in your target market. Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

Boilers; conformity assessment; declaration of conformity; legal obligations; lifting accessories; machinery; placing on the market; putting into service; risk assessment; safety components; special equipment; technical documentation

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Stakeholders: Manufacturer, Importer
Legislation in force: The purpose of this Regulation is to lay down the essential safety requirements to be complied with during design and manufacturing as well as the conformity assessment procedures to be followed, and the minimum criteria for assignment of notified bodies to carry out conformity assessment to ensure that machinery may be placed on the market and/or put into service only if it does not endanger the health and safety of persons and, where appropriate, domestic animals or property, when properly installed and maintained and used for its intended purpose or under conditions which can reasonably be foreseen.

Application national:

Countries: Image for TR Turkey,  
Status: Published 2022-01-05 by (Marius Galka) and Torsten Sahm
Last change 2022-01-05 by Michael Loerzer: Is a factory inspection legally required, Machine safety and guarding
ROGER WILLCO ID: #zi6w
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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 Directive applies to the following products:
(a) machinery
(b) interchangeable equipment
(c) safety components
(d) lifting accessories
(e) chains ropes and webbing
(f) removable mechanical transmission devices and
(g) partly completed machinery.

This ESSENTIAL describes the regulatory requirements for PARTLY COMPLETED MACHINERY (product category 2) and the legal obligations for manufacturers. For completed machines the "CRF TUR Machine Safety - Product Cat. 1" is applicable.'

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 a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Name of the authority for approval, registration, market surveillance and/or enforcement

Route to compliance

Formal and administrative requirements

Registration at related authority required?
Here you will get textual information

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
Here you will get textual information

[Yes/No]

Equipment authorization (approval process)

Approval process (conformity assessment procedure)
Here you will get textual information

Means each legally required approval process prior placing on the market, importation or putting into service

Conformance document(s) to show compliance to the authority
Here you will get textual information

e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal
Here you will get textual information

Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?
Here you will get textual information

e .g. formal application

Is a factory inspection legally required
Here you will get textual information

Testing & Standards

Specific requirements for testing
Here you will get textual information

e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards
Here you will get textual information

e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

Is in-country testing legally required?
Here you will get textual information

Source for standards for conformity assessment
Here you will get related hyperlink(s)

Acceptance of foreign test reports
Here you will get textual information

Regulatory labelling, markings and user information

Regulatory label (mandatory)
Here you will get textual information

e. g. product label

Required information on the product and/or packaging
Here you will get textual information

e. g. address of the manufacturer/importer, serial number

User instructions language(s)
Here you will get textual information

Regulated by the legal provisions

User instruction requirements and specific compliance notes
Here you will get textual information

Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

Warnings, symbols
Here you will get textual information

e. g. ANSI Z 535.4


Code, ContinentTUR, Europe/Asia
Economic AreaEUCU, BSEC (Black Sea Economic Cooperation)
Official LanguageTurkish - 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 InstituteTSE Turkish Standards Instritute (Türk Standardları Enstitüsü) | https://www.tse.org.tr/en/
HS CodememberYes - since 1951






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