Anwendungsbereich des Regulatory Essentials
This ESSENTIAL describes the regulatory requirements for non-automated weighing instruments (NAWI) as defined in in Article 1 section for the following categories of instruments:
(a) determination of mass for commercial transactions;
(b) determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;
(c) determination of mass for the application of laws or regulations or for an expert opinion given in court proceedings;
(d) determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;
(e) determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories;
(f) determination of price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages;
(g) all applications other than those listed in points (a) to (f).
What is a "non-automated weighing instrument" (see 2.2 of the Directive):
‘non-automatic weighing instrument’ or ‘instrument’ means a weighing instrument requiring the intervention of an operator during weighing
Geltende Rechtsvorschriften:
The applicable harmonization legislation is the so-called NAWI (non-automated weighing instrument) Directive 2014/31/EU, which is mandatory since 20 April 2016 (Text with EEA relevance)
Nationale Anwendungsebene:
European Economic Area, Legal Metrology, Non-automatic weighing instruments
European Economic Area (EU + Iceland, Lichtenstein, Norway)
Published 2020-05-04 by Anette Dunkel-Reinboth and Torsten Sahm
Last change 2025-08-07 by Anette Dunkel-Reinboth: Link/Reference to other reference document(s), 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) |
Hier erhalten Sie textbasierte Informationen
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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| Link/Reference to other reference document(s) |
Hier erhalten Sie zugehörige weiterführende Links
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| Link/Reference to other reference document(s) |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
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| Link/Reference to other reference document(s) |
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| Abbrevations |
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Important abbreviations which are special for this legislation or theme.
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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) |
Hier erhalten Sie textbasierte Informationen
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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| 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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| Hints |
Hier erhalten Sie textbasierte Informationen
Specific recommendations, information or most common mistakes
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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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| Regulatory label (mandatory) |
Hier erhalten Sie ein Foto oder Diagram
e. g. product label
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| Regulatory label (mandatory) |
Hier erhalten Sie textbasierte Informationen
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 |
Hier erhalten Sie textbasierte Informationen
e. g. address of the manufacturer/importer, serial number
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| Required information on the product and/or packaging |
Hier erhalten Sie textbasierte Informationen
e. g. address of the manufacturer/importer, serial number
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| User instructions language(s) |
Hier erhalten sie eine Tabelle
Regulated by the legal provisions
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| User instruction requirements and specific compliance notes |
Hier erhalten Sie textbasierte Informationen
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? |
Hier erhalten Sie textbasierte Informationen
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
European Economic Area (EU + Iceland, Lichtenstein, Norway)
Code, Kontinent, Wirtschaftsraum
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