Toys that are in the stores in Western or Central Europe should bear the letters CE. This stands for “Conformité Européenne”. It means that the party that places the product on the market within the borders of the European Economic Area (European Union plus Iceland, Liechtenstein and Norway) (the manufacturer or the importer – hereinafter referred to as the manufacturer for convenience) declares that its product is compliant with requirements in the field of safety, health, environment and consumer protection, laid down in the European directives relevant to that product.
Behind this simple mark lies a world of (European) legislation, standardization and certification, with far-reaching consequences for producers. And it is not just toys, for more than half of all types of products marketed in Europe CE marking is now mandatory. This mainly concerns products with a high safety risk: almost all electrical and electronic products, most products involving mechanical movement, and products that are fully or partially pressurized, such as pressure vessels.
With such requirements, the European Commission wants to protect citizens and it wants to prevent requirements from differing from country to country and thus hindering free trade. It therefore lays down the essential product requirements in European directives, these are laws at European level that the member states must adopt in their national legislation in terms of scope. The guidelines are therefore guiding for national legislation in all EU countries.
This combination of legislation and standards has been referred to as the “new approach”. In the “old approach” there was no added role of standards, but detailed technical requirements were laid down in European legislation. Due to the laborious process of drafting this legislation, the requirements were sometimes already outdated by the time they came into effect. This approach also hindered new technical developments. The “new approach” is much more flexible: standards can be adapted to new technical developments, while legal requirements remain unchanged.
The manufacturer affixes the CE marking to the product itself (for example, on the type plate, on a label or on a sticker) or, if permitted, on the packaging (for example, for contact lenses). He may do this if he can demonstrate that his product meets the requirements of the New Approach Directives applicable to his product. He must therefore translate the requirements in the directive into his own products. Most manufacturers prefer to make this translation on the basis of European standards, which are linked to the Directive through publication in the Official Journal of the European Union. However, they may also make the translation without using these standards. However, compliance with the requirements is then more difficult to demonstrate. That is why this option is hardly used in practice.
Because the essential requirements are formulated globally, different interpretations are possible, which could lead to trade barriers. However, this is prevented with European standards.
The standards are drawn up by committees of the European standardization body CEN CENELEC. A practical problem is that some directives are already in force, without all the corresponding standards being ready. The possible difference in interpretation of the essential requirements could then create new technical barriers to trade.
With the CE marking, the manufacturer only declares that he meets the essential requirements for his product from all applicable directives. The CE marking does not say anything more, for example it does not give an indication of the quality level of the product, which is why we do not speak of the “CE mark”. They are also only minimum safety requirements – some manufacturers place higher demands on their products. Buyers of products can of course also set higher requirements for the products of their suppliers.
The CE marking can be regarded as a “border document”, such as a passport: without a CE marking, the product may not cross the border. By the way: companies that do not export must also affix the CE marking: without a CE marking, the product may not be placed on the market.
The CE mark has hardly any value for consumers. It does not guarantee that those products are safe or environmentally friendly. It only says that according to the manufacturer they meet requirements in applicable European directives. By affixing the CE marking, the manufacturer has “signed” it, as if with a signature under a letter.
Because the control mechanisms are inadequate, products sometimes come onto the market that bear the CE marking, but do not meet the legal requirements. In this respect, it is the same as with enforcing the maximum speed on the road: too little control leads to massive violations. That also happens with European security legislation. Usually, the CE marking is affixed, but that does not mean that all manufacturers actually meet the requirements. Especially imported goods from, for example, South America or Southeast Asia often do not meet the requirements. This is a problem not only for the users, who can get unsafe products, but also for bona fide producers – they sometimes have to incur extra costs to get their products up to standard and they face unfair competition. Now it is not easy for the government to supervise enough. In the field of toys alone, tens of thousands of different new products appear on the European market every year. It is almost impossible to check them all. But the government could perform random checks more often. Now it is the case that a breach of the requirements is usually only detected when something went wrong. The CE marking thus offers a false sense of security.
What should the manufacturer do to be able to affix the CE marking? This differs per product and depends on which European directives apply to that product. The figure below shows the various options.
The “lightest” variant, “module A”, is the so-called “manufacturer’s declaration”. The manufacturer hereby declares that his product meets the essential requirements stated in the applicable directives. The following is expected from the manufacturer:
- ensure that his product meets the requirements;
- in the design phase of the product: create a file with technical information about the product, and keep this file available for the national authorities for up to 10 years after the last product manufactured;
- draw up a statement in which the manufacturer declares that his product meets the applicable essential requirements;
- affix the CE marking.
|Module A. Internal manufacturing control||Module B. Type examination||Module G. Unit verification||Module H. Full quality assurance|
|Design phase||(EN 29001)|
|The manufacturer: keeps technical documentation at the disposal of the national authorities||The manufacturer must submit to the notified body: technical documentation (proto) type The notified body assesses conformity with the essential requirements carries out tests if necessary issues EC type-examination certificate||The manufacturer submits technical documentation to the notified body||The manufacturer applies an approved quality management system (qms) for the design|
|A bis Notified body action||The notified body supervises the km checks conformity of the design * issues certificate of EC design *|
|Production phase||Module C. Conformity with the type||Module D. Product quality assurance||Module E. Product quality assurance||Module F. Product verification|
|(EN 29002)||(EN 29003)|
|A. Manufacturer applies declaration of conformity affixes CE marking||The manufacturer applies declaration of conformity affixes CE marking||The manufacturer applies an approved quality management system (qms) for production and inspection adjusts declaration of conformity produces CE marking||The manufacturer applies an approved quality system for inspection and testing draws up a declaration of conformity with the approved type or the essential requirements applies the CE marking||The manufacturer declares conformity with the approved type or affixes the essential requirements CE marking.||The manufacturer applies the product proposes a declaration of conformity affixes the CE marking||The manufacturer applies an approved qms for production and approves the declaration of conformity and applies the CE marking|
|A bis The notified body: carries out tests on specific aspects of the product * takes random samples*||The notified body: performs tests on specific aspects of the product * takes random samples *||The notified body: approves the qms and monitors the qms||The notified body: approves the kms and monitors the qms||The notified body: checks conformity issues and certificate of conformity||The notified body: checks compliance with the essential requirements issues certificate of conformity||The notified body: supervises the qms|
* The separate directives may contain additional provisions.
Modules with requirements for being allowed to affix the CE marking.
In a number of cases prescribed in the guidelines, a “notified body” (often referred to by the English term “notified body”) must also inspect the product, after which an EC “type-examination” certificate can be issued. According to the EMC directive (EMC 89/336 / EC), a directive that covers almost all electrical appliances, a ‘competent body’ can also be called in instead of a ‘notified body’ if the manufacturer does not want to use European standards (he can always use standards for this directive, because generally applicable EMC standards have been developed). And even if the manufacturer does use the European standards, he can, if desired, have inspections carried out by a “competent body”. In addition to the “notified bodies”, the Pressure Equipment Directive (Pressure Equipment, 97/23 / EC) also contains “recognized third-party organizations”, which are also “notified bodies” that have an inspection task during the use phase of the equipment. To illustrate the complexity of some directives: the directive for “transportable pressure equipment” (99/36 / EC) not only refers to “notified bodies”, but also to “approved bodies”, which must carry out inspections on shut-off valves, among other things.
Many manufacturers purchase parts from suppliers. They must ensure that all purchased components also meet the requirements.
Module A is only used for products for which European standards linked to the directive exist. If there is no European standard, a “notified body” (“notified body”; some guidelines refer to a “Competent Body”), namely an inspection laboratory, must determine whether the product meets the essential requirements. This is module B.
The “heaviest” variant for obtaining the CE marking is module H. This applies to products such as pacemakers, where it is particularly important whether the product indeed meets all requirements. Even at the stage of product development, strict requirements apply here, because if the requirements from the relevant European directives are not sufficiently taken into account in the design, this can cause problems in the final products. Manufacturers of such products are expected to:
- a quality management system according to the standard EN-ISO 9001, approved by a certification body that is also a “notified body”;
- approval of the product design by a notified body: a certificate shows that the product design meets the essential requirements;
- a statement in which the manufacturer declares that his product meets the essential requirements (a model for this can be found in the European standard NEN-EN 45014 “General criteria for suppliers’ declarations of conformity”);
- affix the CE marking.
There are also all kinds of intermediate variants. The module scheme shows these. In this diagram a clear distinction is made between two phases: the design phase and the production phase. Requirements are set in both phases. Module A is the lightest variant, module H the heaviest. Control is increasing from left to right in the diagram. Generally speaking, producers will prefer to use the lightest variant, module A. In fact, this variant is nothing more than what is already expected of the manufacturer from the perspective of liability legislation. The only difference is that the manufacturer must declare compliance with the requirements in writing (the manufacturer’s declaration) and affix the letters CE to the product.
If external parties (“notified bodies”) have to screen the products and / or business operations, the manufacturer has less control. This does not relieve the manufacturer of its ultimate responsibility and liability. Demonstrating compliance with the essential requirements then requires extra attention. In addition to own time, it also costs money to be paid to certification and inspection bodies.
The modules can also be used in combination with each other: module C is always used in combination with module B; modules D, E and F are often used in combination with module B. The modules H, D and E refer to the standards EN 29001, EN 29002 and 29003 respectively. This refers to the standards NEN-EN-ISO 9001: 1994, NEN-EN-ISO 9002: 1994 and NEN-EN-ISO 9003: 1994 . These standards have since been replaced by one new standard: NEN-EN-ISO 9001: 2000. This contains extra requirements compared to the 1994 standards. Manufacturers are therefore allowed to exclude some requirements from NEN-EN-ISO 9001: 2000, without thereby removing the presumption of conformity with the legal requirements.
The road to CE-markering
To be able to affix the CE marking, the manufacturer must do the following:
Finding out requirements
There are now a large number of New Approach Directives. Three of these relate to a very large number of products:
- Machinery Directive (mechanical safety);
- Low voltage directive (electrical safety);
- EMC directive (prevent electrical / electronic
- devices interfere with each other).
The other New Approach Directives relate to specific product groups, for example:
- devices in an explosive environment;
- building products;
- pressure vessels of simple form;
- explosives for civilian use;
- Medical instruments;
- non-automatic weighing instruments;
- passenger lifts;
- personal protective equipment;
- pleasure craft;
- audio equipment and telecommunication terminal equipment;
Many products and product groups fall under the scope of more than one directive. Moreover, there is other product legislation besides the New Approach Directives: the general Product Liability Directive and more specific legislation, such as the Environmental Management Act, the Public Procurement Directive and the Work Equipment Directive. The manufacturer must find out which legal requirements his product must meet. In addition, he will want to monitor what legal requirements can be expected in the future, so that he can adapt his product design accordingly in time, or even influence the development of legislation.
Determining who is responsible
For products produced within the EEA, the manufacturer is responsible for conformity with the essential requirements and for affixing the CE marking. If the products come from outside the EEA, the responsible person is the importer or a “authorized representative” established in the community of the manufacturer or importer. The trading company that assembles, modifies or expands products that changes the safety level or sells a product under its own name (private label) is considered a producer. A trading company that is not classified as a producer is nevertheless obliged to check whether agreements about CE marking have been laid down in purchase agreements, whether a user manual and an EC declaration of conformity are present and whether the CE marking has been affixed.
A risk analysis of a product (group) is recommended, even if the applicable guidelines do not make it mandatory. In order to be able to affix the CE marking, the manufacturer must be able to demonstrate that he intended his product to comply with the essential requirements. It concerns, for example, (safety) risks in, among other things, use, assembly, maintenance, service, transport and demolition / recycling. A risk analysis shows what the risks present are and how they can be reduced.
In the first place, the manufacturer must ensure that his product meets the essential requirements. He tests his product against the requirements and adjusts the product design if necessary. Risk reduction can also take place by:
- shielding from the hazard (e.g. protective hood);
- use of personal protective equipment (e.g. safety goggles);
- safety instructions (pictogram on the product, manual, course).
Yes or no applying standards
If the European standards associated with the European directive (s) are available, it makes sense to use them – after all, there is a “presumption of conformity” with the essential requirements. If the company does not use the standards, it is more difficult to demonstrate compliance with the requirements. But that manufacturer is free to do this – he will have to make a well-considered choice whether or not to apply the standards. See here for an overview of standards per directive.
In many cases, the guidelines require a user manual. The user manual includes:
- a description of the intended conditions of use;
- instructions for specialized personnel installing, commissioning or maintaining the product;
- if necessary, lesson instructions;
- instructions for use for the user of the product;
- a warning of possible danger of (improper) use of the product.
Instructions for use are sufficient for consumer items. The manual must be translated into the language of the country where the product is used.
Technical construction file
A technical construction file includes:
- the technical specifications of the product (designs, drawings);
- list of requirements from the directive (s), standards and other technical specifications that have been taken into account in the design;
- description of the measures taken to meet the requirements;
- inspection reports and certificates.
It can serve as evidence for the manufacturer in case problems arise. He does not have to have it available in its entirety, but must be able to compile and submit it within a reasonably short period of time if requested. The Machinery Directive obliges the manufacturer to have the corresponding documentation available for control purposes up to 10 years after the last product produced. For products covered by other directives, a construction file is not always mandatory, but it is useful.
Testing and certification
For low-risk products, internal manufacturing control is sufficient to demonstrate that the product complies with the requirements of the directive (s). The guidelines also contain the inspection procedures that the manufacturer is required to follow as a minimum. Products with greater risks, or which are not produced according to the standards associated with the guideline (s), must be inspected by an external inspection body. This must be a competent body: “notified body” or “competent body”. The manufacturer must then select an inspection body, have his products inspected and keep the certificate (the “declaration of conformity”). Even if inspection or testing is not mandatory, he can, if desired, engage a “competent authority” to have his product inspected. A competent authority can only issue advice and inspection reports.
A manufacturer who assembles products and buys parts for them is wise to make agreements with its suppliers about CE marking and to record these agreements in a purchase agreement. The agreements not only concern compliance with technical requirements, but also, for example, calling in an inspection body or compiling parts of the technical construction file. The person who markets the product also bears ultimate responsibility.
EC Declaration of Conformity
The manufacturer or its representative in Europe draws up a “declaration of conformity” for each product or product series for which CE marking is mandatory. This indicates that the product complies with the requirements of the directive (s), which are subsequently named by name. The statement is drawn up in the language of the user manual and is sent with the product. A copy goes into the technical construction file. Example statements can be found in appendices to the guidelines.
The manufacturer will have to embed the package of measures in his organization. Responsibilities, powers and tasks must be clear and agreements with, for example, suppliers and inspection bodies must be arranged. It is obvious – but usually not mandatory – to use a quality management system for this. If the manufacturer already has an ISO 9001 quality management system, ISO 9001 obliges him to integrate the CE measures into that management system.