Anwendungsbereich des Regulatory Essentials
This ESSENTIAL describes the regulatory requirements for non-automated weighing instruments as defined in in Article 2 of 2014/31/AB(EU) for the following categories of instruments:
a) First category;
1) determination of mass for commercial transactions,
2) Bridge or road toll, tariff, tax, penalty, bonus, compensation or similar payments - determination of mass for calculation,
3) Application of relevant legislation provisions, determination of mass for expert opinion given in court minutes,
4) Determination of mass by weighing the patients for the purpose of medical monitoring, diagnosis and treatment,
5) Determination of mass for the preparation of the drugs in the prescription in the pharmacy and mass determination in the analyzes carried out in the medical and pharmaceutical laboratories,
6) For direct sales to consumers and pre-packaged products in public places of sale
b) The second category; determination of mass for all processes other than those listed in (a).
Manufacturer, B2C products, B2B products
Geltende Rechtsvorschriften:
The applicable legislation is the Law No. 3516 of 1989.
Product Safety and Technical Regulations Law
The purpose of this Law is to ensure that the products are safe and comply with the relevant technical regulations; to determine the principles of market surveillance and inspection, the duties of authorized institutions and the obligations of economic operators and conformity assessment bodies.
The purpose of this Regulation is to determine the basic requirements for non-automatic weighing instruments and the procedures and principles regarding the conformity assessment procedures required for placing these instruments on the market.
It is the adoption of the Directive 2014/31/EU into the Turkish law.
CE Mark Regulation
Nationale Anwendungsebene:
Turkey, Legal Metrology, Non-automated weighing instruments
Turkey
Kommentar bezüglich der Vergleichbarkeit mit der EU-Gesetzgebung:
The European Non-Automated Weighing Instruments Directive has been adopted in the form of Regulation 2014/31/AB:2016-07-02, plus harmonized standards....
Published 2020-05-04 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2024-04-10 by Anette Dunkel-Reinboth: Market surveillance authority, Metrology and legal metrology
Inhalt des Regulatory Essentials
| Responsible actors |
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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)?
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| Regulatory market access conditions for the actor(s) |
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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)
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| Penalty by this legislation |
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What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?
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| Exemption clauses |
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Exempted devices/products or industry sectors.
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| Sub-federal legislation of states/counties |
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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.
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| FTA/MRA status with EU |
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Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?
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| Authority |
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Name of the authority for approval, registration, market surveillance and/or enforcement
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| Market surveillance authority |
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Name of the authority for market surveillance and/or enforcement
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| Comment on the comparability to EU legislation |
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| Abbrevations |
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Important abbreviations which are special for this legislation or theme.
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| Hints |
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Specific recommendations, information or most common mistakes
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Formal and administrative requirements
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| Registration at related authority required? |
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Product registration?
Manufacturer registration?
Importer / Representative registration?
if required.
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| Local representative legally required? |
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[Yes/No]
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| Member of International Metrology Organizations |
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e.g. OIML
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| Hints |
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Specific recommendations, information or most common mistakes
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Equipment authorization (approval process)
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| Approval process (conformity assessment procedure) |
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Means each legally required approval process prior placing on the market, importation or putting into service
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| Conformance document(s) to show compliance to the authority |
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e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)
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| Conformance document validity and renewal |
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Validity for Conformance document name mentioned. For mandatory certification validity is important.
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| Which documents are required by an approval body? |
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e .g. formal application
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| Is a factory inspection legally required |
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| Hint to voluntary certification scheme |
Hier erhalten Sie textbasierte Informationen
If a important voluntary certification schemes exists, one link will be given.
Important voluntary schemes are for example: UL, CSA, VCCI (Japan)
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| Specific requirements for testing |
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e. g. is an accredited test lab. mandatory, limits, test samples, product description
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| General information to the application of standards |
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e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"
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| Source for standards for conformity assessment |
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| OIML Recommendations adopted? |
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OIML is publishing international standards.
IEC and ISO are not relevant for this theme.
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| National Standardisation Organisation |
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Link to organisation
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| Is in-country testing legally required? |
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| Acceptance of foreign test reports |
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| Country gravity zones |
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| Verification Regulation |
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DE: Eichwesen
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Regulatory labelling, markings and user information
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| Regulatory label (mandatory) |
Hier erhalten Sie ein Foto oder Diagram
e. g. product label
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| Specific Metrology Marking(s) |
Hier erhalten Sie ein Foto oder Diagram
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| Regulatory e-labelling allowed? |
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e. g. put the regulatory information and labels in a software menu
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| Required information on the product and/or packaging |
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e. g. address of the manufacturer/importer, serial number
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| User instructions language(s) |
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Regulated by the legal provisions
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| User instruction requirements and specific compliance notes |
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Form, sentence inside, simple text.
E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste
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| Digital user documentation allowed? |
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User instructions allowed by QR-Code/internet or digital medium or integrated in device with display?
Safety instruction allowed by QR-Code or digital medium?
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Allgemeine Informationen
Turkey
Code, Kontinent, Wirtschaftsraum
EUCU, BSEC (Black Sea Economic Cooperation)
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
TSE Turkish Standards Instritute (Türk Standardları Enstitüsü) | https://www.tse.org.tr/en/
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