This illustration of the CE label and Declaration of Performance shows where the different sections are explained in this guide and how the label and Declaration are connected.(MANUFACTURERS’ TASKS)
1.1. Why do I need CE marking?
The added value of CE marking is that all EU countries must allow the selling of construction products bearing the CE mark. This means that public authorities cannot ask for any additional marks or certificates, let alone additional testing. Therefore you or the distributors of your product are able to trade your product in any country of the European Internal Market with the same documentation. Together with the Declaration of Performance this will also help your customers and final users to check the performance of the product and compare it with other products under the same technical approach.
When you, as the manufacturer, affix the CE marking to a product it means that you are assuring that the performance of the product you are selling is the same as what you are declaring and that it has been obtained using the right European technical specification (see 1.2).
The CE marking contains certain essential information about the product and provides a link to other additional documents which also contain important information. This brochure covers how to develop these documents and also provides some examples.
1.2. When is CE marking compulsory for my product?
CE marking is compulsory for most construction products to sell them on the European Internal Market. For the rest it is not compulsory but possible under certain rules:
1.2.1. Compulsory CE marking (CEN route)
When you want to know if the CE marking of your product is compulsory the first step is to go to the Official Journal of the European UnionI and search for the last update of the publication of titles and references of harmonised standards. You will find a table like this:
The list can contain two types of references: new harmonised standards and revision of standards. For new standards the “reference of superseded standard” is empty. If your product is in the scope of one of these standards CE marking is voluntary during the co-existence period and compulsory from the end of this period.
You then have to check your product against the titles of standards available to see if your product is covered by any of them.
EXAMPLE: Floor tiles are covered by a harmonised standard when used in floors but not covered when used in window stools.
You can use the search tool in the website of CENII to find the scope of the standards
The products included in the scope (first chapter of the standards) have to be CE marked according to the dates in the table.
When the “reference of superseded standard” is not empty, CE marking of the products covered by the harmonised standards continues to be compulsory. During the co-existence period you can choose which version to use, either the superseded or the new version, but after the date of the end of the co-existence period only the revised version can be used. This allows you to adapt – in general within a year – to any changes in the assessment of your product and/or declaration of performance.
The information relevant for CE marking is in annex ZA of the standard.
1.2.2. Non-compulsory CE marking (EOTA III route)
When the product you are going to sell is not in the scope of any harmonised standard you can voluntarily CE mark your product but you have to check first if it is covered by one of the existing European assessment documents1 (EAD). You can check the list on the website of the European Commission in the area called NANDOIV (New Approach Notified and Designated Organisations). There is a specific page which includes the list of European Assessment DocumentsV.
You can also view the content of the document, including the scope, through the publications area of the EOTA websiteVI. If your product is included in the scope of one of these documents you can ask a Technical Assessment Bodies (TAB) from the official registry of TABsVII to assess your product to CE mark it.
In case your product and the intended use or uses are not in the scope of any of the European Assessment Documents you can request a Technical Assessment Body to develop a European Assessment Document. This process would take longer than if there were a European Assessment Document available for your product.
The EOTA route has two phases similar to the CEN route:
■ The development of a European Assessment Document
■ The assessment of a Technical Assessment Body
Both phases are explained in this guide.
1.2.3. Exemptions from CE marking
In some cases even if the product and intended use are included in the scope of a harmonised standard, you, as the manufacturer, are not obliged to CE mark your product.
The exceptions are cases where the product is individually manufactured or custom-made for a given use or where the manufacturing of the product has to maintain traditional processes to guarantee the conservation of officially protected works (heritage / historical works etc.).
If you wish to use one of these exceptions it is highly recommended to make sure they definitely apply to your product as otherwise you may face problems with the market surveillance authorities. If you have questions about your products, you should contact the product contact point in the country where you want to sell your product.
CE marking does not only consist of affixing a label to your product – manufacturers
have to carry out many tasks to complete the process of CE marking. This chapter
contains detailed information on how to deal with these tasks.
Before starting and during the whole process you will need the following documents:
■ (For the CEN route) The harmonised standard or standards applicable to your product. You can purchase them in your language through the standardisation body in your Member State. The list of national standardization bodies in EuropeVIII is accessible on the website of CENIX. Sometimes the harmonised standard
contains references to other standards (test methods, tabulated values, etc.) that may be important.
■ (For the EOTA route) The European assessment document or documents applicable to your product.
You can download them from the publications area of the EOTA websiteX. Sometimes the European assessment document contains references to standards that may be important.
As part of your internal quality procedures, and sometimes with the collaboration of external laboratories or service providers, you are responsible for assessing product performance and putting in place factory production
control. The assessment results and factory production control allows you to check that the performance does not change over time. The legal terminology used to describe this is “assessment and verification of constancy of performance” (AVCP2) and the third party verifier or verifiers are called Notified Bodies.
2.1.1. Essential characteristics
The assessment of the product is done by defining the value of a list of characteristics called essential characteristics.
You will find the full list in the annex ZA of the harmonised standards and in the European Assessment Documents (EAD). The list can be different for each intended use and in the case of your product with more than one intended use the list should cover the characteristics linked to each of them. The list also includes the AVCP system for each essential characteristic. Depending on the AVCP system you may need one or a number of Notified Bodies to carry out tasks related to it.
2.1.2. Assessment and verification of constancy of performance systems (AVCP systems)
Once you have the list of essential characteristics relevant for your product you must check the procedures you have to follow to declare the performance of each essential characteristic, such as test methods, tabulated values, etc. You are obliged to use these procedures for the testing of samples. You have to also define your
detailed factory production control.
The AVCP system applicable to each essential characteristic will require in some cases that a Notified Body performs some additional tasks. In the following table you will see the task you and Notified Bodies must carry out depending on the AVCP system.
If all your characteristics come under AVCP system 4 you will not need to contract a Notified Body. When they are covered by system 3 your product has to be tested by a Notified Body (in this case a notified laboratory) that can be different for each essential characteristic. If they are under system 1, 1+ or 2+ the Notified Body will collaborate with you during the assessment and will do some tasks in your manufacturing plant so the best option is usually to contract only one Notified Body to carry out all the tasks. EXAMPLE: One important essential characteristic of some structural products is their compressive strength. You will find it in the list of essential characteristics in the annex ZA of the harmonised standard. The AVCP system defined for this essential characteristic of these products is 2+. It means that the manufacturers of the product have to do an initial test of the product, put in place factory production control of the production and test the product according to their quality system. They are also obliged to hire a Notified Body to do an initial inspection (including the plant and the factory production control) and to assess the factory production control periodically. You will find the official registry of Notified BodiesXI, notified by Member States to perform the third party tasks, in the NANDO website. You can use one or more Notified Bodies from any country.
2.1.3. No performance determined
Member States have different demands in place for the essential characteristics of products used in each country. You will find more information through the product list of product contact points of the Member States
where your product is going to be sold. This information you should take into account when deciding which characteristics you declare. You may also decide that some essential characteristics are not relevant for your product, if they are not requested by your customers. In both these cases where you have decided not to declare specific characteristics you write “no performance determined” using the acronym “NPD”. The use of “NPD” is possible following certain conditions:
■ For products following the CEN route you have to declare the performance of at least one of the essential characteristics.
■ For certain essential characteristics it could be that declaring NPD is not allowed. You will find more information in the annex ZA of the harmonised standard.
2.1.4. Additional requirements when using the EOTA route
The first step when using this route is to contact the Technical Assessment Body that will then carry out the tasks according to the European Assessment Document. The Technical Assessment Body will issue a document for you called European Technical Assessment (ETA) that will be necessary in the next steps.
For some essential characteristics you will not need to do any assessment because a generic value or declaration is accepted at European level. In this case the European Commission publishes a legal act containing this information. But to benefit from this option you will have to develop a document explaining that your product is covered by this legal act. This document is officially called “appropriate technical documentation”. If the essential characteristic is under AVCP system 1 or 1+ the Notified Body must verify this document.
EXAMPLE: The manufacturers of steel sheets with polyester coating used as single skin (without insulation behind) can use the Commission decisionXII and can declare that the class for reaction to fire is A1 without any assessment. According to the text of the decision, it is applicable only if the nominal thickness of the metallic coated steel sheet is between 0.4 and 1.5 mm. So if the product fulfils this condition the manufacturer only has to develop a document (the appropriate technical documentation) including the legal reference to the Commission decision and the results of measuring the thickness of the product with a value within the limits.
Another option available to simplify the assessment of the product is the possibility to share the testing of the product with other manufacturers. To use shared assessments you would have to develop additional “appropriate technical documentation” which would include:
■ Test results obtained by the other manufacturer;
■ The authorisation of the other manufacturer to use these results;
■ The documentation that proves that both manufacturers use corresponding processes and raw materials.
When your product is a system made of components you assemble or manufacture and some of the essential characteristics of the component have already been assessed by its manufacturer, you can use the test results obtained by your provider. This procedure is called cascading and to use it you would also have to develop “appropriate technical documentation” which would include:
■ Test results obtained by the system provider;
■ The authorisation of the other manufacturer to use these results;
■ The documentation that proves that the assessment of the component or the whole system can be applied.
This includes also that the system has been assembled according to instructions.
After the assessment of the essential characteristics you should have the following documents:
Initial testing of the product including the list of essential characteristics and the results of the assessment (testing, tabulated values, etc.).
■ European Technical Assessment (only for EOTA route, replacing other initial testing).
■ Documented factory production control procedure.
■ Certificate or certificates from the Notified Body or Bodies, if required.
■ Appropriate technical documentation where necessary.
■ Specific technical documentation where necessary. You must archive all these documents. The market surveillance authorities may request them.
Once the assessment is finished you have to assign a code to your product. The name of this code is “unique identification code of the product type” and it is linked to the sort of product you are manufacturing and to the performance of its essential characteristics. When you develop a new product you have to assign a new unique ID-code to it and in case the performance of a product changes you would also have to change the code.
EXAMPLE: You can choose a code consisting of the commercial name of the product, an internal code linked to the manufacturing process and the date the assessment of the product was done: AnyProduct-123.ABC-2014.07.17
This combination would allow you to easily classify and update the product types.
2.2. When do you have to start a new assessment?
2.2.1. New products
Each time you develop a new product you will have to repeat all the tasks including, if necessary, contracting a Notified Body and a technical assessment body.
2.2.2. Changes in production
If you make changes or adjustments to your production or your factory production control detects such changes in production, you will have to verify that the performance of the product for all the essential characteristics you declare has not changed. In the case a change had occurred you would either have to readjust your production to go back to the declared performance or you can carry out all the AVCP tasks again (for the essential characteristics that have changed). You should be aware that if the characteristic is declared under AVCP system 1, 1+ or 3 you would also have to contract a Notified Body to carry out the corresponding tasks. When following the EOTA route the changes of the performance will not only involve the Notified Bodies but also the technical assessment body since a new ETA is required.
In both cases, the development of a new product and a change of the declared performance, you will have to create or update the relevant background documents. The documents to be provided to your customers have to be updated as well.
2.3. Documents to be provided to your customers
Now with all the information ready you will have to draw up the following documents:
■ Declaration of performance (DoP) of the product
■ CE marking and accompanying information of the product
■ Instructions and safety information
■ REACH information (see 2.3.4)
2.3.1. Declaration of performance
Using the information compiled, the first document you have to draw up is the declaration of performance. It is the most important document supporting the CE marking because it contains the full information about the manufacturer, the product and its performance. The CE label will be only a summary of the information contained in the declaration of performance.
When developing your own format for the declaration of performance of your products, you have to follow the instructions published in the Official Journal of the European Union: Delegated Regulation amending Annex III of the CPRXIII. The following table describes each point you have to fill in for the declaration of performance and some additional explanations that will help you to understand the information to include:
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