§4.2.2.5 Identification element

The product must bear a type, batch, serial or model number or other element allowing its identification. The identification must, as a rule, be affixed to the product. However, it may exceptionally be moved from the product if this rule cannot be followed. This would be justified where the size and/or the nature of the product makes the indication illegible or technically impossible (217). In such cases, the identification has to be affixed to the packaging, if it exists, and/or to the accompanying document. The identification on the product may neither be omitted nor be moved to the packaging or accompanying documents on purely aesthetic or economic grounds. It is up to the manufacturer to make this assessment. This provision implies that if the product has no packaging or is not accompanied by any document, the identification must be on the product itself. The requirement gives the freedom to the manufacturers to choose the element they want to use as identification of the product, as long as traceability is ensured. The identification element used must ensure a clear link to the relevant documentation that demonstrates the conformity of the specific type of product, in particular the EU Declaration of Conformity. This identification element of the product shall be the same as on the EU Declaration of Conformity. The identification element chosen by the manufacturer is also important in case of a withdrawal or recall, since all products bearing the same identification element will have to be withdrawn or recalled from the market. In some cases, e.g. when a product consists of several parts or is an assembly of several parts, its nature does not allow for the affixing of the identification element. The identification of the product has in these cases to be affixed to the packaging (or accompanying document). In addition to the marking with an identification element on the packaging, additional marking of individual products/parts/components can be made based on the manufacturer’s internal rules and ambitions to minimise the extent of a potential recall by having an advanced system for traceability of individual items (e.g. batch codes, production dates). According to some economic operators, one way to refer to products is to use an item number (a so-called ‘SKU’-’Stock keeping unit’) as identification. This item number can also be used as an identifier on the EU Declaration of Conformity together with other elements allowing traceability. The product consists of several parts/components Each product is enclosed in one packaging but typically some parts/components could/would also be sold in another packaging as separate parts/components or in other combinations of parts/components. Some of the parts/components in these packages may be possible to mark, while others may be too small or have a shape which does not allow the marking to be on the part. For these reasons, it is allowed to give the set/packaging an item number and to use the same item number on the EU Declaration of Conformity. The main purpose of the identification element is to enable market surveillance authorities to identify an individual product and to link it to an EU Declaration of Conformity. If, when the market surveillance takes place, the product is still in its packaging, it will be easy to identify the element and thus ensure that the corresponding EU Declaration of Conformity regards the product in question. It would be more complicated to have to open the packaging and find elements on the individual items and then link these to a particular EU Declaration of Conformity. The product consists of one assembled item Also when a product consists of only one ‘item’, it is not uncommon that this item has been assembled by the manufacturer, using several parts (but it is not intended to be disassembled by the consumer). The parts composing the item (product) are often used in more than one design of products. Normally, some parts would not be large enough to bear an identification element and yet other parts might not allow marking with an identification element for technical reasons (uneven surface, spherical shaped surface etc.). Also in this case it is allowed to affix an item number on the packaging and to use the same number on the EU Declaration of Conformity. The product consists of one item which has not been assembled of several parts This is a case where it may seem simple to mark the product itself with an identification element that is identical to the one on the EU Declaration of Conformity (i.e. an item number). However, the same product might be sold in combination with other products/items in a set. Since at the point of production, it is not known which of the items will be sold ‘alone’ and which will be in a packaging together with other products, it is easier to mark the item number, corresponding to the EU Declaration of Conformity, on the packaging. This will also facilitate market surveillance authorities to link the product to the EU Declaration of Conformity.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07