Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances

This European Standard specifies the technical documentation that the manufacturer needs to compile in order to declare compliance with the applicable substance restrictions. The documentation of the manufacturer’s management system is outside the scope of this European Standard.

Technische Dokumentation zur Beurteilung von Elektro- und Elektronikgeräten hinsichtlich der Beschränkung gefährlicher Stoffe

Documentation technique pour l'évaluation des produits électriques et électroniques par rapport à la restriction des substances dangereuses

La présente Norme européenne décrit la documentation technique que le fabricant doit rassembler afin d'être en conformité avec les restrictions sur les substances en vigueur. La documentation du système de management du fabricant est exclue du domaine d'application de la présente norme européenne.

Tehnična dokumentacija za ocenjevanje električnih in elektronskih izdelkov glede na omejitev nevarnih snovi

Ta evropski standard določa tehnično dokumentacijo, ki jo izdelovalec mora sestaviti, da potrdi skladnost s temeljnimi veljavnimi omejitvami. Dokumentacija sistema upravljanja izdelovalca je zunaj področja obravnave tega evropskega standarda.

General Information

Status
Withdrawn
Publication Date
20-Sep-2012
Withdrawal Date
15-Jul-2015
Technical Committee
CLC/TC 111X - Environment
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
07-Dec-2023
Completion Date
07-Dec-2023

Relations

Effective Date
07-Jun-2022

Frequently Asked Questions

EN 50581:2012 is a standard published by CLC. Its full title is "Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances". This standard covers: This European Standard specifies the technical documentation that the manufacturer needs to compile in order to declare compliance with the applicable substance restrictions. The documentation of the manufacturer’s management system is outside the scope of this European Standard.

This European Standard specifies the technical documentation that the manufacturer needs to compile in order to declare compliance with the applicable substance restrictions. The documentation of the manufacturer’s management system is outside the scope of this European Standard.

EN 50581:2012 is classified under the following ICS (International Classification for Standards) categories: 29.020 - Electrical engineering in general; 31.020 - Electronic components in general. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 50581:2012 has the following relationships with other standards: It is inter standard links to EN IEC 63000:2018. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 50581:2012 is associated with the following European legislation: EU Directives/Regulations: 2002/95/EC, 2011/65/EU; Standardization Mandates: M/499. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

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Standards Content (Sample)


SLOVENSKI STANDARD
01-december-2012
7HKQLþQDGRNXPHQWDFLMD]DRFHQMHYDQMHHOHNWULþQLKLQHOHNWURQVNLKL]GHONRYJOHGH
QDRPHMLWHYQHYDUQLKVQRYL
Technical documentation for the assessment of electrical and electronic products with
respect to the restriction of hazardous substances
/
Documentation technique pour l'évaluation des produits électriques et électroniques par
rapport à la restriction des substances dangereuses
Ta slovenski standard je istoveten z: EN 50581:2012
ICS:
01.110 7HKQLþQDGRNXPHQWDFLMD]D Technical product
L]GHONH documentation
29.020 Elektrotehnika na splošno Electrical engineering in
general
31.020 Elektronske komponente na Electronic components in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 50581
NORME EUROPÉENNE
September 2012
EUROPÄISCHE NORM
ICS 29.020; 31.020
English version
Technical documentation for the assessment of electrical and electronic
products with respect to the restriction of hazardous substances

Documentation technique pour l'évaluation Technische Dokumentation zur
des produits électriques et électroniques Beurteilung von Elektro- und
par rapport à la restriction des substances Elektronikgeräten hinsichtlich der
dangereuses Beschränkung gefährlicher Stoffe

This European Standard was approved by CENELEC on 2012-07-16. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the CEN-CENELEC Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the CEN-CENELEC Management Centre has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2012 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 50581:2012 E
Contents
Foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Technical documentation . 5
4.1 Overview . 5
4.2 Content of the technical documentation . 5
4.3 Information on materials, parts, and/or sub-assemblies . 6
4.3.1 Tasks to be undertaken by the manufacturer . 6
4.3.2 Determine the information needed . 6
4.3.3 Collecting information . 7
4.3.4 Evaluation of information . 7
4.3.5 Review of the technical documentation . 8
Annex A (informative) Relationship between Directive 2011/65/EU and the
technical documentation . 9
Annex ZZ (informative) Coverage of Essential Requirements of EU Directives . 10
Bibliography . 11

– 3 – EN 50581:2012
Foreword
This document (EN 50581:2012) has been prepared by CLC/TC 111X "Environment".

The following dates are fixed:

(dop) 2013-07-16
• latest date by which this document has to
be implemented at national level by
publication of an identical national standard
or by endorsement
• latest date by which the national standards (dow) 2015-07-16
conflicting with this document have to
be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the
subject of patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying
any or all such patent rights.

This document has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and supports essential requirements
of EU Directive 2011/65/EU.
For the relationship with EU Directive see informative Annex ZZ, which is an integral part of
this document.
Introduction
Certain substances contained in electrical and electronic products are restricted by legislation
and/or customer specifications. Manufacturers of final products therefore need to be able to
demonstrate that their products meet the applicable substance restrictions.
For those restrictions that apply at the “homogeneous material" level, it is impractical for
manufacturers of complex products to undertake their own testing of all materials contained in
the final assembled product. Instead, manufacturers work with their suppliers to manage
compliance and compile technical documentation as evidence of compliance. This approach is
well recognised by both industry and enforcement authorities.
The aim of this European Standard is to specify the technical documentation that the
manufacturer needs to compile in order to declare compliance with the applicable substance
restrictions. In this way, this European Standard supports Directive 2011/65/EU of the
European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain
hazardous substances in electrical and electronic equipment (RoHS).
This European Standard can also find an application in demonstrating conformity to other
substance regulations worldwide.

– 5 – EN 50581:2012
1 Scope
This European Standard specifies the technical documentation that the manufacturer needs to
compile in order to declare compliance with the applicable substance restrictions.
The documentation of the manufacturer’s management system is outside the scope of this
European Standard.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any
amendments) applies.
EN 62321:2009, Electrotechnical products  Determination of levels of six regulated
substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls,
polybrominated diphenyl ethers) (IEC 62321:2008)

NOTE  EN 62321 will be replaced by a series of standards designated EN 62321-x.

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
restricted substance
substance which is limited in its use in a product, part or material
3.2
manufacturer
natural or legal person who manufactures a product or has a product designed or
manufactured, and markets that product under his name or trademark
[SOURCE: Regulation (EC) N° 765/2008 or Decision N° 768/2008/EC]
Note 1 to entry: In certain circumstances, an importer or distributor is considered a manufacturer for the
purposes of Directive 2011/65/EU.
3.3
supplier
organisation that provides the manufacturer with materials, parts and/or sub-assemblies
4 Technical documentation
4.1 Overview
The manufacturer shall compile technical documentation to demonstrate that electrical and
electronic products comply with substance restrictions (see 4.2 and 4.3).
4.2 Content of the technical documentation
The technical documentation shall include at least the following elements:
– a general description of the product;
NOTE 1 Directive 2011/65/EU specifies 11 product categories. The product category is one of the
factors that determines which exemptions apply.
– documents for materials, parts, and
...

Questions, Comments and Discussion

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EN 50581:2012 serves as a crucial standard that outlines the technical documentation necessary for assessing electrical and electronic products concerning the restriction of hazardous substances. This European Standard is particularly relevant in today's manufacturing landscape, where environmental regulations and consumer safety are paramount. The scope of EN 50581:2012 is clearly defined, focusing on the requirements for manufacturers to compile appropriate documentation that affirms their compliance with substance restrictions. This specificity helps streamline the compliance process, ensuring that companies can effectively demonstrate adherence to environmental standards without ambiguity. By concentrating on the technical documentation aspect, the standard aids manufacturers in fulfilling their regulatory obligations while maintaining transparency concerning the materials used in their products. One of the significant strengths of EN 50581:2012 is its emphasis on clarity and structure within the documentation required for compliance. It provides manufacturers with a standardized approach to compiling technical files, thereby minimizing discrepancies and fostering uniformity in compliance reporting across the European market. The standard not only enhances the quality of the documentation but also alleviates potential challenges associated with gathering and presenting information related to hazardous substances. Moreover, the relevance of EN 50581:2012 extends beyond mere compliance; it plays a vital role in promoting sustainable practices within the electrical and electronic industries. By ensuring products are free from harmful substances, the standard supports initiatives aimed at reducing environmental impact and safeguarding public health. In a time when consumers are increasingly concerned about the safety and eco-friendliness of products, adherence to EN 50581:2012 demonstrates a commitment to responsible manufacturing. In conclusion, EN 50581:2012 is a pivotal standard that provides a robust framework for manufacturers aiming to declare compliance with hazardous substance restrictions. Its focus on technical documentation not only streamlines compliance efforts but also underlines the importance of sustainability in product development.

EN 50581:2012 표준은 전기 및 전자 제품의 유해 물질 제한 준수를 평가하기 위한 기술 문서를 제정하고 있습니다. 이 표준의 주요 범위는 제조업체가 규정된 유해 물질 제한에 따라 적합성을 선언하기 위해 필요한 기술 문서를 작성하는 방법에 대한 가이드라인을 제공합니다. 이 표준의 강점 중 하나는 사용자 친화적인 구조로, 제조업체가 유해 물질의 식별 및 관리 방법을 체계적으로 문서화할 수 있도록 돕는 것입니다. 따라서 전 세계적으로 환경 규제에 대한 준수를 지원하고, 제품의 안전성을 높이며, 소비자 신뢰를 증진시키는 데 기여합니다. EN 50581:2012는 전기 및 전자 제품의 설계 및 제조 과정에서 발생할 수 있는 위험 요소를 명확하게 인식하고, 이를 효과적으로 관리할 수 있는 도구를 제공합니다. 이 표준은 특히 유럽 연합 내에서 제품을 판매하고자 하는 제조업체에게 중요한 기준이 되며, 향후 유해 물질 제한과 관련된 규제 변화에 대해 신속하게 대처할 수 있는 기반을 마련해 줍니다. 결론적으로, EN 50581:2012 표준은 유해 물질 제한 준수를 위한 필수적인 지침을 제공하며, 제조업체의 경영 시스템 문서는 이 표준의 적용범위에 포함되지 않음을 명확히 하고 있습니다. 이로 인해 제조업체는 제품의 안전성을 높이는 동시에, 법적 요구 사항을 충족할 수 있는 명확한 길잡이를 받을 수 있습니다.

Le document standard SIST EN 50581:2012 constitue une référence essentielle pour la documentation technique nécessaire à l'évaluation des produits électriques et électroniques en relation avec les restrictions sur les substances dangereuses. Son champ d'application est clairement défini, indiquant que cette norme européenne spécifie les exigences en matière de documentation que les fabricants doivent rassembler pour prouver leur conformité avec les restrictions de substances applicables. Parmi les points forts de cette norme, on trouve sa capacité à garantir la transparence et la traçabilité des matériaux utilisés dans la fabrication de produits électriques et électroniques. En exigeant une documentation rigoureuse, la norme permet non seulement de protéger l'environnement, mais aussi d'assurer la sécurité des consommateurs face aux risques liés à l'usage de substances dangereuses. La pertinence de la norme SIST EN 50581:2012 est particulièrement évidente dans le cadre de la législation européenne sur les substances restrictives, notamment la directive RoHS. En alignant les exigences de documentation avec les réglementations actuelles, cette norme soutient les efforts des fabricants pour rester conformes tout en favorisant une compétitivité accrue sur le marché. Enfin, l'accent mis sur la compilation de documents par le fabricant, sans inclure le système de gestion de l'entreprise, souligne la spécificité de cette norme dans le contexte de la conformité aux restrictions de substances. Cela permet aux fabricants de se concentrer sur les aspects techniques nécessaires pour démontrer la conformité, rendant le processus d'évaluation plus efficient. Dans l'ensemble, la norme SIST EN 50581:2012 se révèle être un instrument fondamental pour toute entreprise cherchant à naviguer dans le paysage complexe des réglementations sur les substances dangereuses.

SIST EN 50581:2012は、有害物質の制限に関する適用規制に準拠した電気および電子製品の評価に必要な技術文書を詳細に定めた欧州標準です。この標準の主な目的は、製造業者が該当する物質制限に対する遵守を宣言するために必要な技術文書を効果的に編纂できるようにすることです。 この標準の強みは、文書化の要求基準が明確である点です。製造業者は、製品が有害物質の制限に適合しているかを示すための具体的なガイダンスを受け取ることで、製品の市場適合性を保証できます。また、SIST EN 50581:2012は、管理システムの文書化はこの標準の範囲外であることを明示しているため、製造業者は関連する手続きや要求事項に集中できるという利点があります。この明確さは、企業が遵守すべき基準を理解し、適切な対応をするのに役立ちます。 さらに、SIST EN 50581:2012の重要性は、持続可能な製品開発の推進にあります。この標準に準拠することにより、企業は環境に対する責任を果たし、有害物質の使用を最小限に抑える努力をすることが求められます。その結果、業界全体での環境への配慮が高まり、消費者に対してもより安全な製品を提供することが可能になります。 全体として、SIST EN 50581:2012は、電気および電子製品の設計と製造に関わるすべての利害関係者にとって非常に重要な標準であり、特に有害物質の制限に関わる側面において、その適用と遵守が期待されるものとなっています。

Die EN 50581:2012 ist eine europäische Norm, die sich auf die technische Dokumentation für die Bewertung von elektrischen und elektronischen Produkten im Hinblick auf die Beschränkung gefährlicher Stoffe konzentriert. Die Norm legt klar fest, welche Anforderungen an die technische Dokumentation gestellt werden müssen, damit Hersteller die Einhaltung der geltenden Stoffbeschränkungen deklarieren können. Dies ist von zentraler Bedeutung, da der Schutz der Umwelt und die Gesundheit des Verbrauchers in der heutigen Zeit höchste Priorität haben. Ein wesentlicher Stärke der EN 50581:2012 ist ihre klare und strukturierte Vorgehensweise, die es Herstellern ermöglicht, die erforderlichen Informationen systematisch zu sammeln und darzustellen. Dadurch wird die Compliance mit den gesetzlichen Anforderungen erheblich vereinfacht und effizienter gestaltet. Der Fokus auf die Dokumentationspflichten sorgt dafür, dass alle relevanten Informationen zur Bewertung der Produktkonformität bezüglich gefährlicher Stoffe ordnungsgemäß erfasst werden. Ein weiterer positiver Aspekt ist die internationale Relevanz der Norm. Sie stellt sicher, dass Unternehmen, die elektrische und elektronische Produkte herstellen, eine einheitliche Grundlage haben, um die Einhaltung der Richtlinien festzustellen. Dies fördert nicht nur den Wettbewerb innerhalb Europas, sondern unterstützt auch die internationale Handelsfähigkeit und die Marktakzeptanz. Zusätzlich wird in der EN 50581:2012 klargestellt, dass die Dokumentation des Managementsystems des Herstellers nicht Teil der Norm ist. Diese Eingrenzung der Norm ermöglicht es den Herstellern, ihren Fokus auf die relevanten Aspekte der Stoffbeschränkungen zu richten, ohne dabei von einer Überregulierung in Bezug auf andere Managementprozesse abgelenkt zu werden. Insgesamt ist die EN 50581:2012 von großer Bedeutung für die Elektro- und Elektronikindustrie. Sie bietet eine solide Grundlage zur Gewährleistung der Einhaltung der restriktiven Vorschriften hinsichtlich gefährlicher Stoffe und stellt sicher, dass sowohl Hersteller als auch Verbraucher von einem höheren Schutzniveau profitieren.