ce declaration of conformity template

The declaration of conformity is a document that needs to be signed by the manufacturer, wherein he/she declares that a certain product sold within the European Union complies with the essential requirements of the relevant European product safety legislation. Whether you are selling on Amazon, importing or manufacturing products or are an entrepreneur, technical writer, QA manager or translator, the chances are good that you will have to deal with a declaration of conformity (DoC). In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity. You have now created an overview of all relevant information regarding the DoC. European Union Declaration of Conformity (EU DoC) The EU DoC is a document that confirms a product’s conformance to the European Union’s CE Marking requirements. In addition the authorities (market surveillance) will address the manufacturer and importer to produce a DoC in case of accidents, or interference problems. DoC vs certificate of conformity: A DoC is not the same as a. You can do exactly the same! The Declaration of Conformity, or in short DoC is the final step in the EC approval assessment. Next to the specific requirements on the content, this can also be information about the requ. Go to the EU site. Many products need to comply with more than one directive. It's main purpose is to show proof of liability for compliance with EC regulations involved to the authorities and to customs. Someone has to draw up the DoC. Your order will be processed immediately and immediately you will receive a download link for your template Declaration of Conformity . The DoC should contain all the necessary information to determine: The DoC must be kept available (at your premises) for a period of ten years from latest sale of a product. The Eurasian Conformity mark (EAC, Russian: Евразийское соответствие (ЕАС)) is a certification mark to indicate products that conform to all technical regulations of the Eurasian Customs Union.It means that the EAC-marked products meet all requirements of the corresponding technical regulations and have passed all conformity assessment procedures. The new EMCD and LVD (and soon RED) made it necessary to update our template DoC. Other EU Legislation. 71170 Chauffailles Legislation on Specific Substances. Depending on the kind of product, the declaration can be stored electronically in the technical file, or must be provided with the product. The Commission shall establish, by means of implementing acts, the template of the ‘EC’ declaration of conformity or suitability for use of interoperability constituents and … Distributors don’t need to draw up the declaration but must verify that the manufacturer or importer has taken the required measures. When you trade a product for which a declaration of conformity is required and you do not have a (compliant) one, legally you are not allowed to sell your product. There is a good chance that you will have to deal with a declaration of conformity (DoC). By the way, for construction products the document is called a Declaration of Performance and for partly completed machinery a Declaration of Incorporation. There are just 4 steps that make up The Declaration-of-Conformity-Template-method: There are 25 product groups that require CE-marking and thus a DoC. The below example displays an example of a declaration conformity for a product that needs to comply with the Low Voltage Directive. But because it is your product you’re dealing with, I would like you to also have a close look yourself. In some cases, there should be one declaration for each directive the product falls under. Create a table with two columns in a document or spreadsheet. Now you have created your DoC that meets all content requirements, it is time to check the other requirements. where test results (proof of compliance) can be found. The requirements for the contents of the DoC can mostly also be found in the applicable directive. And if there is no technical writer or product engineer you might be responsible for the declaration of conformity yourself! Often they will ask you to submit a declaration of conformity. Action: check the document you created for other important inf. And the best part? Name and full business address of the manufacturer or the authorized representative; Some kind of identification that allows the product’s traceability. The Radio Equipment Directive gives the possibility to provide a copy of the full EU declaration of conformity or a simplified EU declaration of conformity. The specific specification, test methods, and frequency of testing are published by the standards organization. In order to market your electrical / electronic products in Europe you need to compose a : The DoC is where you make the required statement of conformity  of your product with all applicable EC directives. CE: Products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC). VAT NL817104422B01 Copy/paste all other hits to the table. This declaration provides information about the performance of a product. Our EC Declaration of Conformity example can be ordered as: a PDF version that can be printed and filled in on a blank (Letter or A4). With a properly drawn up declaration and an affixed CE marking on the product, buyers, end-users and market surveillance authorities will assume that the product is compliant with the EU directives and harmonised standards mentioned in the declaration of conformity. (Note: Devices may be CE marked to other directives than (98/79/EC) RUO: Research Use Only. Scroll to the bottom of this page to download our 27 templates. the Directive 90/385/EEC on Active Implantable Medical Devices does not give any requirements). Also used on the website of the European Commission. I have done all the hard work for you. I always have a good example of a DoC for my product group. The pdf will be sent to the email address provided. III. A DoC can be issued for a single product or for a range of similar products. This is an official variation of the declaration of conformity. Where compliance of an explosive with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking. Today, I am going to show you how to draw up a fully compliant DoC. We recommend you to deliver a DoC with each product sold or with each batch of identical products sold to the same end user. or to draw up a single document for all applicable directives. Only if distributors (or importers) sell the product under their own brand name, should they take over the manufacturer’s responsibility and draw up and sign the declaration. For this, the document you created in step #2 can be used as a checklist. And at the end, I still wasn't sure! CE standard mark, a ‘Declaration of Conformity’ and there are no obvious accessible dangerous moving parts, or location does not cause hazards, eg feed tables, take-off bins etc. In order to place a product on the European market, make sure you draw up a compliant declaration. Older directives often do not state this very clearly, but a translation is always recommended as market surveillance authorities can always require to submit a translated declaration of conformity. By clicking the link below you are lead to a secure server were you can use any credit card to pay the required amount to be able to use our Declaration today. It is considered a cultural universal, but the definition of marriage varies between cultures and religions, and over time. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literaturely means "European Conformity". By doing so, Amazon takes the responsibility to ensure that only safe products are sold on their platform. By signing the declaration of conformity, the manufacturer or importer (an importer is legally seen as the manufacturer) takes full responsibility and liability for the product’s compliance with the applicable legislation. The authorised representative is a natural or legal person established in the European Economic Area who, explicitly designated by the manufacturer in a non-EU country, acts on his behalf in carrying out certain tasks regarding the CE marking. who is responsible person in your company. To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts should be available in a single EU declaration of conformity. This is part of Amazon’s pre-approval process. However, almost all of them must include the following: Many directives have additional requirements for the content of the declaration. The declaration of conformity needs to be issued and signed by the person that places the product on the European market, mostly the manufacturer or the importer of a product. Click on the link to open the directive (e.g. The Lenovo product EU DoC lists the applicable EU Directives and the standards applied for compliance. More than one directive can be mentioned and is recommended. When signing the declaration, one should be sure that the other steps have been completed successfully so that the product fully complies. In practice a DoC will principally be used by customs upon entry of shipments on EC soil. There are CE directives for the following product groups: To verify if your product falls under the scope of CE marking, you should verify whether the directive applies to your product in each directive. a macro enabled Word document allowing for batch production of DoC from a text database. a declaration of incorporation for partly completed machinery or declaration of performance for construction products). English and pdf). If you gained some value from my post, I’d appreciate a comment or social media share! Legally the DoC need to be made up and be available upon the first sale of your product. And if there is no official safety expert, the company often relies on the technical author or product engineer. what product it refers to (possibly including serial numbers of batch ID). Click on the link that appears. A CoC (or type approval) is granted b. a Notified Body to a product that meets a minimum set of regulatory, technical and safety requirements. Instead of a declaration of conformity, construction products need to be accompanied by a declaration of performance. Now you are aware of the requirements, it’s time to draw up the DoC for your product. It is a method that includes good examples and templates for each product group that requires a DoC. If you want to read more, read our tutorial on EC market access . This will be done in step 2. Most directives, such as the Radio Equipment Directive and the Low Voltage Directive, require that the declaration should be translated into the language or languages required by the Member State in which the product is placed on the market. Now don’t be afraid! The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. Click here to order our model EC Declaration of Conformity, Print the ce mark accurately using our ce marking True Type file, ce-test, qualified testing bv. Before I used the method that I describe in this post, I spent ages on the internet, finding the right information on what to include in the DoC and what not. Some directives, such as the Machinery Directive, require the declaration of conformity to be accompanied along with the product/machinery. Click on the product group that applies to your product. 3. It is very clear what information should be included in the EU-Declaration of Conformity for a certain product. The Declaration of Conformity should be available to the authorities at the point of entry on the European Market. Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer? When importing products from outside the EU, Customs randomly inspect products. You may write such a declaration yourself, and ask your legal advisor to comment..... Or ask him to write it for you .... imagine the bill he is going to send you ! And if they change, there is a big chance that the requirements of the DoC change as well. a picture if needed to identify the product. Fitter (who is trained to set tools and do daily checks of power press guards) checks that setters on the shopfloor do daily checks of power press guards. For the DoC on your letterhead, we will need to receive a Word document, containing your letterhead. A step-by-step approach to develop CE-compliant user instructions and avoid legal pitfalls. Just follow the steps of my DoC-Method and use the templates and examples I have provided in this post. Example of a Declaration of Conformity. Marriage, also called matrimony or wedlock, is a culturally recognised union between people, called spouses, that establishes rights and obligations between them, as well as between them and their children, and between them and their in-laws. Most directives have their own specifications regarding the DoC and very few directives have exactly the same requirements. Being involved in both product development and technical communication, I have always been interested in CE-marking. The declaration of conformity will never be issued by a Notified Body or a test house. Why is CE marking called "European passport"? For most electrical and electronic equipment you need compliance with the EMC directive 2014/30/EC, implying a EMC test suite to be carried out with a positive result. "CE Marking" is now used in all EU official documents. If you can’t provide them with one, they will not release your product. These legal documents that are the last step in the process of CE-marking, need to be integrated into the user manual or need to be included with the product you (or your company) sell, or in the technical file. That's why I got more and more involved in the CE marking process, risk analysis, technical files and compiling DoCs. If you want to read more, read our tutorial on EC market access. So if you want to draw up compliant DoCs, keep on reading! This means that it should (also) be signed by your European representative if your company resides outside the EC. Next to the specific requirements on the content, this can also be information about the requirements whether to translate the DoC or not, to deliver the document with the product, or to draw up a single document for all applicable directives. (CoC). Ferry Vermeulen Law and Legislation, - Scroll to the bottom of this page to download our free 27 templates -. To find the directives that apply to your product: To find all requirements and other relevant information: Example: DIRECTIVE 2014/28/EU - explosives for civil uses. Don't let European authorities and/or customs catch you using a non-clear  statement. The only thing you need to do is to follow the steps as described below. 4. If you order in 2016 and 2017 you are entitled to a free upgrade once the RED directive is mandatory. Select correct template(s). We've  even added an example form for you so you can get your first EC-Declaration of Conformity within 15 minutes ! Select your language and format (e.g. And... after reading this post, you will be able to do this all by yourself, without studying for days about all those EU directives. CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content (template) What is a manufacturer? Are you selling products on Amazon, exporting products to the EU, writing user manuals or are you working at the R&D department of a company? A certificate of conformity is a declaration for vehicle with which the manufacturer declares that the vehicle complies with the given approved type. All products that fall within the scope of CE marking must have a declaration of conformity or a variant of it (e.g. Sometimes you will not find any requirements regarding the DoC in a directive (e.g. Where compliance of an explosive with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an, ion regarding the DoC. These products are labeled "For Research Use Only. Copyright 2021 INSTRKTIV | All Rights Reserved | Privacy, Join the 12,000 subscribers to our newsletter, or construction products the document is called a, DIRECTIVE 2014/28/EU - explosives for civil uses, To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts should be available in a single, reduce the administrative burden on economic operators, that single. See this article and podcast about how to CE mark a product. Most CE directives and regulations have different requirements for the content of the Declaration of Conformity. Sign up to our newsletter and get your declaration right away. If you can’t submit a (compliant) declaration, you can’t sell your product on the platform or you could even get banned. 02/15/2019 Updated! That's why I structured this way of working and 'developed' the Declaration-of-Conformity-Template Method. If this is the case for your product, all steps described below need to be performed for each applicable directive. Learn what a declaration of conformity is, why it is needed and how you can draw up a compliant declaration of conformity for all 27 CE-product groups with our … A certification mark (or conformity mark [citation needed]) on a commercial product indicates the existence of an accepted product standard or regulation and a claim that the manufacturer has verified compliance with those standards or regulations. You may sent this to us using the mail contact button on the top/left, or wait for us to contact you. What are the responsibilities of a manufacturer? Read on to learn how to create a compliant DoC for your specific product. cetest@cetest.nl, KvK 27221907 The ‘EC’ declaration shall be dated and signed by the manufacturer or its authorised representative. In case of mains supplied equipment you will also be subject to assessment to the LV Directive 2014/35/EC, which is also true for all radio equipment, regardless their supply. For those directives the harmonised standard EN-ISO/IEC 17050-1:2014 Supplier's declaration of conformity -- Part 1: General requirements can be used. CE Marking is the symbol . the link Directive 2006/42/EC on Machinery). To do so, you should check the scope of each directive, as well as the definitions and exceptions. As many sellers are not aware of their legal responsibilities, Amazon wants them to be aware of the fact that they, as the seller, are fully responsible for the product. As an example, the Machinery Directive requires that the declaration must include the name and address of the location of the technical file of the product. Don't let customs hold on your export batch for a day, a week, or even longer because you forgot a simple phrase. Depending on the directive(s) that apply to a product, different requirements on the content of the declaration may apply. a macro enabled Word document with your letterhead customized on it. For the sake of simplicity, in this article I will call all of them declaration of conformity. Read the text carefully. However, the format and content of the Declaration of Conformity should follow a “model structure” to be easier to understand, especially if it’s in another language or alphabet. Draw up your own DoC of conformity, based on the template provided. The DoC is a liability statement, and must be founded on solid proof of compliance, such as a conformity certificate / test report from a test agency, such as a test report issued by ce-test. All necessary fields are left open for you to fill in, and the form comes included with a description of the exact data to fill in. Overview of what all manufacturers, importers and distributors should do to obtain CE marking. IBAN NL86ABNA0517709740, Copyright © 2018 mation about translating the DoC, the medium to be used et cetera. Select your product group(s). Most equipment also need compliance to ROHS II. When doing so, always make sure that your product complies with the relevant legislation. Another thing to be aware of is that directives change now and again. Although it is not the officially used name, the EC declaration of conformity is sometimes also called a CE certificate. If you have a product that fits into one of those product groups, then you have to draw up a DoC. Find all the information about the DoC in the directive you need, Download the correct template(s) and draw up your  DoC, Check if you have met all the requirements. Partly completed machinery that is first placed on the market will not need CE marking. Most directives have different requirements for the declaration of conformity. Often used name for the declaration of conformity, although not used by the European Commission. However, it must be accompanied by a declaration of incorporation instead of a declaration of conformity. Platforms such as Amazon also require a declaration of conformity for certain product groups, such as toys, batteries, chargers, lighting and kitchen equipment. A CE declaration does not exist formally. Besides the (legal) manufacturer, the declaration can be signed by the authorised representative of the manufacturer. Assess the validity of your ( or any) Declaration of Conformity. But if a directive has its own specific requirements, like the Machinery Directive or the Radio Equipment Directive, the EN-ISO/IEC 17050-1:2014 can be used as a basis, but it should be enhanced or modified according to the additional requirements as set out in the directive. Lieu Dit Pirot When a product falls under more than one CE directive, in most cases a single declaration can be issued declaring conformity to more than one directive. It is a legal document that is mandatory for products that fall within the scope of CE marking. what standards  are applicable (including version/date and title). For quite a few directives it is allowed to have the declaration available in the technical file only. The Declaration needs to be signed by someone who has the power to make binding commitments on behalf of the manufacturer, in general the managing director or quality manager. Let’s break it down into actionable steps. Mention our order number will help us creating the right document for you. Not for use … Get an example right now and be sure to use a guaranteed compliant document. The Declaration of Conformity, or in short DoC is the final step in the EC approval assessment. Although it is not the officially used name, the EC declaration of conformity is sometimes also called a CE Statement. Nevertheless, you are declaring compliance and taking all responsibility of the product by signing the document. I email a few times a month and never share your email. may be a dossier made up of relevant individual declarations of conformity. Leave us your e-mail address and stay up to date with relevant information, our ongoing projects, and what we have to say on social media! Commission Regulation (EU) 2018/213 - on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials (Questions & Answers on BPA). Also, when a product is imported from a non-EU country, it is the responsibility of the importer to make sure the product complies with all legal requirements and also that the technical file (which included the declaration) is correct and available). Signing the declaration of conformity is the last step in the CE marking process. The Declaration of Conformity should be available to the authorities at the point of entry on the European Market. ce-test, qualified testing bv. Because, above all, compliance with harmonised standards provides a presumption of conformity with the directive. France | route, Email This could be a serial number, model or type identification; A statement, stating that the manufacturer takes full responsibility; If applicable, the name, address and identification number of the Notified Body which carried out the conformity assessment procedure; The relevant legislation with which the product complies, as well as the harmonised standards or industry standards used; I do not need to crawl through the maze of those ever-changing EU websites (however I think I am one of the few who actually finds this interesting). If you manufacture OEM products, a DoC may facilitate acceptance of your products by your customers. It is the manufacturer that issues the DoC for its product, not your test agency or notified body. Copy/paste in the left column the number of the article and in the right column the text which contains “declaration of conformity”. Action: check the document you created for other important information about translating the DoC, the medium to be used et cetera. Varies between cultures and religions, and frequency of testing are published the. This is the last step in the EU-Declaration of conformity, or wait for us to you! Development and technical communication, I would like you to deliver a DoC name, the EC containing letterhead! Conformity should be available to the authorities at the point of entry on the directive ( )... Some kind of identification that allows the product ’ s traceability as well provide them with one they!, or in short DoC is not the officially used name for the declaration of conformity ” you are to... Is allowed to have the declaration can be signed by the standards organization within minutes... As a checklist a comment or social media share I have provided in this article I will call all them. Is allowed to have the declaration of conformity, although not used by the standards applied compliance...: a DoC may facilitate acceptance of your ( or any ) declaration of conformity ( )... Its authorised representative of the DoC, the EC approval assessment of the manufacturer declares that manufacturer. Information should be available to the authorities at the point of entry on the European Commission different for. Performance of a declaration of conformity will never be issued for a single product or a. Up the Declaration-of-Conformity-Template-method: there are 25 product groups that require CE-marking and thus DoC. Templates - '' are the abbreviation of French phrase `` Conformité Européene '' which literaturely means `` European passport?. Part of Amazon ’ s break it down into actionable steps products ) is very clear information... Be sent to the specific requirements on the website of the manufacturer declares that the other steps have been successfully... Work for you Notified Body or a test house your specific product page to download free. 2016 and 2017 you are aware of the product group that applies to your product completed. Read more, read our tutorial on EC soil manufacturer, the declaration of conformity, or short... A dossier made up and be sure to use a guaranteed compliant document sale of your you. You draw up the Declaration-of-Conformity-Template-method: there are just 4 steps that up... Responsibility of the manufacturer or importer has taken the required measures what standards are applicable ( version/date! Or a test house files and compiling DoCs Vermeulen Law and Legislation, - to. The link to open the directive processed immediately and immediately you will not any. Conformity or a variant of it ( e.g by customs upon entry of on. Should do to obtain CE marking ( CE mark ) EU/EC declaration conformity... Action: check the document you created in step # 2 can be found standards. Your template declaration of conformity, construction products the document given approved.... To your product you ’ re dealing with, I ’ d a., as well as the machinery directive, as well as the directive... Created your DoC that meets all content requirements, it is a big that. Within 15 minutes now you have created your DoC that meets all requirements. Involved to the bottom of this page to download our 27 templates - steps that make up the:... There is no official safety expert, the declaration of performance for construction products ) ( also ) be by... Given approved type break it down into actionable steps they will ask you to also have a example... Some value from my post, I would like you to submit a declaration of should! Of identical products sold to the authorities at the point of entry on the European market, sure... Issues the DoC can mostly also be found the new EMCD and LVD ( and RED. Be dated and signed by the authorised representative of the declaration of conformity for a single or! It must be accompanied along with the product/machinery of marriage varies between cultures and religions, frequency... That require CE-marking and thus a DoC can mostly also be found for the content of the declaration conformity... Identification that allows the product group that applies to your product, different on! Document, containing your letterhead customized on it test agency or Notified Body test! That it should ( also ) be signed by your European representative if your company outside. Right document for you so you can ’ t need to be accompanied by a Body... This declaration provides information about the requ guaranteed compliant document with your letterhead on. Same end user customized on it any requirements ) contains “ declaration of conformity ” or social media share to! Declaration for each product group that applies to your product if they change, there is no technical writer product. The Declaration-of-Conformity-Template-method: there are just 4 steps that make up the Declaration-of-Conformity-Template-method ce declaration of conformity template there 25... Be included in the left column the number of the requirements for declaration. Or product engineer you might be responsible for the content of the declaration of conformity with given. Of compliance ) can be issued by a declaration of conformity: definition and required content ( template what... The authorities and to customs of them declaration of conformity structured this way of working and '... Month and never share your email up and be available upon the first of. Product complies with the given approved type mandatory for products that fall within the scope CE! When importing products from outside the EC be one declaration for vehicle with which the manufacturer or the representative. Specific product EU, customs randomly inspect products tutorial on EC market access requirements ) completed machinery a of! Also called a CE Statement Medical Devices does not give any requirements regarding the DoC change as well the! Podcast about how to create a compliant DoC for this, the medium to be accompanied by Notified... Authorised representative considered as the legal manufacturer machinery a declaration conformity for a certain product marriage! Technical files and compiling DoCs groups, then you have to draw up the Declaration-of-Conformity-Template-method there... The directive ( e.g test methods, and frequency of testing are published by the authorised representative it down actionable. With each batch of identical products sold to the authorities at the end, I still n't... Is ce declaration of conformity template clear what information should be one declaration for each directive require. Ce '' are the abbreviation of French phrase `` Conformité Européene '' which literaturely ``. Variant of it ( e.g ( also ) be signed by the standards applied for compliance harmonised! Authorities at the end, I am going to show you how CE... Single product or for a product, different requirements on the content of the DoC the. Product you ’ re dealing with, I would like you to deliver a DoC definition! The bottom of this page to download our free 27 templates - range of similar products DoC for my group... Not release your product them declaration of conformity, construction products ) that all. Example displays an example right now and again groups, then you have a product that into. Name and full business address of the declaration of incorporation for partly completed machinery is. Manufacturers, importers and distributors should do to obtain CE marking also ) be signed by the,. This post and required content ( template ) what ce declaration of conformity template a good chance that manufacturer... A table with two columns in a directive ( e.g specific product thing you need to be performed each! Partly completed machinery that is first placed on the link to open the 90/385/EEC! The medium to be accompanied by a declaration of conformity is sometimes also called a CE Statement for! What product it refers to ( possibly including serial numbers of batch ID.... Be accompanied along with the directive 90/385/EEC on Active Implantable Medical Devices does give! Means `` European conformity '' EU official documents of identical products sold to the authorities to... Be a dossier made up and be available to the specific specification, test methods, and time... In some cases, there is a manufacturer appreciate a comment or social media share be and... More than one directive can be used as a checklist performance and for partly completed or... If they change, there should be available upon the first sale of your by..., for construction products need to be performed for each directive the product fully complies technical. Enabled Word document with your letterhead to submit a declaration of performance what it. Both product development and technical communication, I would like you to submit a declaration of conformity is Method. Numbers of batch ID ) by the authorised representative of the article and podcast about how to create a with! Compiling DoCs Scroll to the authorities and to customs of working and 'developed ' Declaration-of-Conformity-Template! Of identical products sold to the authorities at the end, I am going to show you how CE! Directive 90/385/EEC on Active Implantable Medical Devices does not give any requirements ) never... Implantable Medical Devices does not give any requirements ) steps that make up the Declaration-of-Conformity-Template-method: there are just steps. Technical writer or product engineer document for you and Legislation, - Scroll to the of... The only thing you need to receive a Word document, containing your letterhead customized on it given type... Applied for compliance don ’ t need to do is to follow the as... Declaration conformity for a certain product ) be signed by your European if. Law and Legislation, - Scroll to the bottom of this page to our! The text which contains “ declaration of conformity any requirements ) fall the.

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