4.5.1 CEマーキング

The CE marking is a key indicator (but not proof) of a product’s compliance with EU legislation and enables the free movement of products within the EEA and Turkish market, whether they are manufactured in the EEA, Turkey or in another country.

Member States of the European Economic Area (EEA - EU Member States and certain EFTA countries: Iceland, Norway, Liechtenstein) are not allowed to restrict the placing on the market of CE marked products, unless such measures can be justified on the basis of evidence of the non-compliance of the product. This also applies to products made in third countries which are sold in the EEA.

CE marking does not indicate that a product was made in the European Union. The CE marking indicates conformity with the requirements laid down by the Union harmonisation text(s) in question. Therefore, it is to be considered as essential information to Member States’ authorities as well as other relevant parties (for example distributors). CE marking does not serve commercial purposes i.e. it is not a marketing tool.

CE marking is the visible consequence of a whole process comprising conformity assessment in a broad sense and indicates that a product is declared by the manufacturer as in conformity with Union harmonisation legislation.

Regulation (EC) No 765/2008 lays down the definition, the format and the general principles governing the CE marking. Decision No 768/2008/EC provides for conformity assessment procedures that lead to its affixing.

The sectoral Union harmonisation legislation providing for the affixing of the CE marking mostly follows the principles of the Regulation (EC) No 765/2008 and Decision No 768/2008/EC.

As a general rule (235) the CE marking can be introduced in a Union legislative act as legal conformity marking if:

—the method of total harmonisation is used, which means that diverging national regulations that cover the areas as the legislative act in question are prohibited;

—the Union harmonisation act contains conformity assessment procedures according to Decision No 768/2008/EC.

However there is an exception to this rule.

In duly justified cases a total harmonisation piece of legislation that follows Decision No 768/2008/EC may provide for a different marking instead of the CE marking. For example the Directive on marine equipment does not provide for a CE marking, but for a specific conformity mark - the wheel mark. - The use of the wheel mark also is subject to the general principles set out in Regulation (EC) No 765/2008 and Decision No 768/2008/EC and any reference to CE marking is to be construed as a reference to the wheel mark. Similarly, for transportable pressure equipment, the ‘Pi’ marking is required instead of the CE marking.

The manufacturer, whether established inside or outside the Union, is the entity ultimately responsible for the conformity of the product with the provisions of the Union harmonisation legislation and for the affixing of the CE marking. The manufacturer may mandate an authorised representative to affix the CE marking on his behalf.

By affixing the CE marking on a product, a manufacturer is declaring, on his sole responsibility (and irrespectively of whether a third-party has been involved in the conformity assessment process), conformity with all of the legal requirements to achieve CE marking.

If the importer or distributor or another operator places products on the market under his own name or trademark or modifies them, he then takes over the manufacturer’s responsibilities. This includes the responsibility for the conformity of the product and the affixing of the CE marking. In this case he must have sufficient information on the design and production of the product, as he will be assuming the legal responsibility when affixing the CE marking.

The CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and/or to the accompanying documents. The CE marking may not, in principle, be affixed until the conformity assessment procedure has been completed to ensure that the product complies with all the provisions of the relevant Union harmonisation acts. This will usually be at the end of the production phase. This poses no problem if, for example, the CE marking is on a data plate that is not affixed to the product until after the final inspection. However, if (for example) the CE marking is affixed by stamping or casting, the marking can be affixed at any other stage of the production phase, provided that the conformity of the product is verified as part of the production process.

The requirement for visibility means that the CE marking must be easily accessible for all parties. It could, for instance, be affixed on the back or underside of a product. The requirement for visibility does not necessarily mean that the CE marking must be visible before opening a products’ packaging because affixing the CE marking also to the packaging is only necessary in case this is explicitly required in the relevant Union acts. For products requiring assembly, the CE marking should remain visible after assembly but does not need to be visible after final installation and in normal use. A minimum height of 5 mm is required to ensure that it is legible. However according to the several pieces of legislation (236) the minimum dimension of the CE marking may be waived for small devices or components.

The CE marking can take different forms (e.g. colour, solid/hollow) as long as it remains visible, legible and respects its proportions. It must also be indelible so that it cannot be removed under normal circumstances without leaving noticeable traces (for example some product standards provide for a rub test with water and petroleum spirits). It is up to the manufacturer to ensure that its technological solution satisfies the requirements of visibility, legibility and indelibility. (237) Nevertheless, this does not mean that the CE marking must form an integral part of the product.

However in certain cases affixing of the CE marking to the product is impossible (for example on certain types of explosives) or not possible under reasonable technical or economic conditions. Furthermore there can be cases where the minimum dimensions for the affixing cannot be respected, or it cannot be ensured that the CE marking is visibly, legibly and indelibly affixed.

In such cases, the CE marking can be affixed to the packaging, if it exists, and / or to the accompanying document, where the Union harmonisation legislation concerned provides for such documents. The CE marking on the product may neither be omitted nor be moved to the packaging or accompanying documents on purely aesthetic grounds.

Regulation (EC) No 765/2008 and Decision No 768/2008/EC lay down that the CE marking must have the dimensions, format and proportions defined in Annex II of Regulation (EC) No 765/2008 and be legible and clearly affixed. Regulation (EC) No 765/2008 and Decision No 768/2008/EC do not forbid any kind of design (e.g. ‘hollow’ design) as long as the above conditions are respected. However, electronic labelling only is not allowed.

In addition, if products are sold online, it is useful that the CE marking and any required warnings according to applicable legislation are indicated in that website and are visible before the end user is carrying out the purchase.

Where a notified body is involved in the production control phase according to the applicable Union harmonisation legislation, its identification number must follow the CE marking. The manufacturer or the authorised representative affixes the identification number if the legislation so requires, under the responsibility of the notified body.

A notified body may be involved in the production phase, depending on the conformity assessment procedures applied. The CE marking must be followed by the identification number of the notified body only if it is involved in the production phase. Thus, the identification number of a notified body involved in conformity assessment in the design phase according to module B does not follow the CE marking. Sometimes several notified bodies are involved in the production phase, which is possible where more than one Union harmonisation text is applicable. In these situations several identification numbers follow the CE marking.

Thus, if the CE marking appears on products without an identification number, this means that:

—either no notified body intervened in the design or production phase (module A);

—or upon manufacturer’s choice the in-house accredited body intervened in the production phase (modules A1, A2);

—or a notified body intervened in the design phase (module B) but no notified body intervened in the production phase (module C following module B);

—or a notified body intervened in the design phase (module B) and upon manufacturer’s choice the in-house accredited body intervened in the production phase (modules C1, C2 following module B).

If however the CE marking appears on products with an identification number (238), this means that:

—either upon manufacturer’s choice a notified body intervened in the production phase (modules A1, A2);

—or a notified body intervened in the design phase (module B) and upon manufacturer’s choice a notified body (not necessarily the same one but the one whose identification number appears) intervened in the production phase (modules C1, C2 following module B);

—or a notified body intervened in the design phase (module B) and a notified body (not necessarily the same one but the one whose identification number appears) intervened in the production phase (modules C1, C2, D, E, F following module B);

—or a notified body intervened in the design and production phase (modules D1, E1, F1, G1 H, H1).

The CE marking and the identification number of the notified body do not necessarily have to be affixed within the Union. They may be affixed in a third country, for example if the product is manufactured there and the notified body carried out conformity assessment in that country in line with the relevant Union harmonisation legislation. The CE marking and the identification number can also be affixed separately, as long as they remain combined.

Not all products have to be CE marked (239). The obligation to affix the CE marking extends to all products within the scope of legislative acts providing for its affixing, and which are intended for the Union market. Thus, the CE marking must be affixed:

—to all newly manufactured products that are subject to legislation providing for CE marking, whether manufactured in the Member States or in third countries;

—to used and second-hand products imported from third countries that are subject to legislation providing for CE marking;

—to substantially modified products that, as new, are subject to legislation providing for CE marking and which have been modified in a way that could affect the safety or the compliance of the product with the applicable harmonisation legislation.

In some cases, a product is deemed final for the purposes of a particular Union harmonisation act and has to be CE marked. This same product then is incorporated in another final product which is itself subject to another Union harmonisation act which also requires CE marking. This produces a situation where more than one CE marking can be found on a product (240).

Union harmonisation legislation providing in general for CE marking may exclude the application of the CE marking on certain products. As a general rule, such products are subject to free circulation, if:

a.They are accompanied by:

—a Declaration of incorporation for partly completed machinery, according to the Machinery Directive;

—a Declaration by the manufacturer or the importer in the case of partly completed watercraft referred to in the Directive on recreational craft and personal watercraft.

b.They are accompanied by an attestation of conformity in the case of components as defined in the Directive on equipment and protective systems intended for use in potentially explosive atmospheres (ATEX).

c.They are accompanied by a statement in the case of:

—custom-made medical devices and devices intended for clinical investigations referred to in the legislation on medical devices;

—devices intended for performance evaluation referred to in the legislation on in vitro diagnostic medical devices.

d.They are accompanied by a certificate of conformity in the case of fittings referred to in the Directive relating to gas appliances.

e.The product bears the manufacturer’s name and an indication of maximum capacity in the case of instruments not subject to conformity assessment according to the Directive relating to non-automatic weighing instruments.

f.The product is manufactured in accordance with sound engineering practice in the case of certain vessels referred to in the Directives relating to simple pressure vessels and pressure equipment.

In addition, the Directive on pressure equipment entitles Member States to authorise, on their territory, the placing on the market and the putting into service by users, of pressure equipment or assemblies not bearing the CE marking, but that have been subject to a conformity assessment carried out by a user inspectorate instead of a notified body.

The CE marking replaces all mandatory conformity markings having the same meaning, which existed before harmonisation took place. Such national conformity markings are incompatible with CE marking and would constitute an infringement of the applicable European legislation in question. When transposing Union harmonisation legislation, Member States are required to incorporate the CE marking into their national regulations and administrative procedures. They must also refrain from introducing any other conformity marking into their national legislation that has the same meaning as the CE marking.

However, other markings may be used as long as they contribute to the protection of public interests, are not covered by Union harmonisation legislation and their affixing does not impair the visibility, legibility and meaning of the CE marking. The affixing of additional markings (such as a protected trademark of a manufacturer or other private/national markings) is allowed to the extent that such markings do not create confusion with the CE marking. This confusion may either refer to the meaning or form of the CE marking.

In this respect, other markings additional to the CE marking need to fulfil a different function from that of the CE marking. Thus, they should provide information on conformity with objectives that are different from those to which the CE marking relates (for example environmental aspects not covered by the applicable Union harmonisation legislation).

Furthermore several Union harmonisation acts foresee additional markings that are complementary and non-overlapping to the CE marking (see under 4.5.2).

The CE marking provides the first indication that the necessary controls can be assumed to have been carried out, before the product in question is placed on the market, in order to ensure its compliance to the legislative requirements. Market surveillance authorities are entitled to proceed to additional controls for the protection of public interest. The action to be taken by market surveillance authorities should be decided on a case by case basis according to the principle of proportionality.

Member States must provide in their national legislation for appropriate measures both to prevent the abuse and misuse of CE marking, and to redress the situation if such abuse or misuse takes place. Those measures need to be effective, proportionate to the seriousness of the offence and dissuasive and may be increased if the relevant economic operator has previously committed a similar infringement. They may include withdrawal, recall of products, penalties and criminal sanctions (such as fines and imprisonment) wherever necessary.

The measures are imposed without prejudice to other measures taken where the market surveillance authorities find that a product presents a risk or does not comply with the applicable legislation. Furthermore Member States must ensure that the measures are implemented.

In this respect the affixing of the CE marking to a product that is not covered by any of the Union harmonisation legislation providing for its affixing is considered to be deceiving because consumers or users, for instance, are likely to get the impression that the product in question satisfies certain Union harmonisation legislation provisions. Competent authorities must, therefore, have at their disposal legal instruments that enable them to act against the deceptive use of CE marking. Action must be taken also against those responsible for a non-compliant product bearing the CE marking.

The affixing of markings in addition to the CE marking is subject to certain restrictions (241). The surveillance authority has to take the necessary measures to ensure that these principles are respected and, where necessary, take appropriate action.

A Member State must inform the Commission and the other Member States of its decision to restrict free movement due to incorrect affixing of the CE marking, and of its action against the person responsible for affixing the CE marking to a non- compliant product. It is then up to the other Member States to decide whether or not similar action is necessary. In the case of unduly affixed CE marking to products not subject to the CE marking requirement, Member States should inform the Commission and the other Member States about it.