TRACEABILITY REQUIREMENTS

• The traceability requirements allow tracing the history of the product and support market surveillance. It allows market surveillance authorities to find the liable economic operators and obtain evidence of the product compliance.

• The traceability requirements include labelling the product and identifying the economic operators in the distribution chain.

4.2.1. WHY DOES TRACEABILITY MATTER?

Traceability is the ability to trace the history of the product.

From a regulator’s perspective, traceability matters because it enables effective enforcement through market surveillance via corrective measures including withdrawals and recalls. It enables unsafe or non-compliant products to be traced up the distribution chain and identifies roles and responsibilities of the economic operator throughout the chain. Traceability enables market surveillance authorities to trace products up to the factory gate and from factory to the end-user in certain cases.

From a manufacturer’s perspective traceability matters because it enables effective control of the production process and suppliers before the marketing of the products, and control of their distribution chain after the placing of the product on the market. In case of non-compliance, manufacturers are able to reduce the impact of recalls or withdrawals depending on the detail of their traceability system.

4.2.2. TRACEABILITY PROVISIONS

Union harmonisation legislation is prescriptive as to the ends but not as to the means to achieve those ends. This means that Union harmonisation legislation foresees requirements for the traceability of products placed on the market, without stipulating how to achieve or implement these requirements. Union harmonisation legislation is also technology-neutral, meaning it does not prescribe the technology to be used such as printing or moulding. Manufacturers should choose the traceability system which they deem most appropriate in relation to their products and their manufacturing and distribution system.

The indication of the manufacturer’s and for imported products also the importer’s, name and address on the product is a basic traceability requirement. In case of need, it allows market surveillance authorities to quickly get in contact with the economic operator responsible for the placing of an unsafe or non-compliant product on the Union market.

There is no explicit obligation that the addresses have to be preceded by the words “Manufactured by”, “Imported by” or

“Represented by”. This information must however not mislead the end-user and the market surveillance authorities about the place of manufacture and the address of each economic operator¹⁶⁵. If these words are not mentioned, market surveillance authorities will decide what the role of each economic operator is. It is then up to the economic operator to prove than that he has a different role.

There is no obligation to translate into all necessary languages the words “manufactured by”, “imported by” or

“represented by”. These words are considered to be easily understandable in all official EU languages.

Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and Decision No 768/2008/EC on a common framework for the marketing of products establish the current practices regarding traceability by requiring specific traceability labels. The reference provisions of Decision No 768/2008/EC reflected in Union harmonisation legislation require:

1. manufacturers to indicate the following three elements: their (1) name, (2) registered trade name or registered trade mark¹⁶⁶ and (3) the address at which they can be contacted, on the product or, where

165 Such confusion might occur for instance when the name of the distributor appears on the packaging while the manufacturer’s name is shown on the product inside.

166 A trade mark is a distinctive sign or indicator used by an individual, business organisation, or other legal entity to identify that the products or services to consumers with which the trade mark appears originate from a unique source, and to distinguish the products or services in question from those of other entities. A trademark is a type of intellectual property, and typically a name, word, phrase, logo, symbol, design, image, or a combination of these elements.

that is not possible, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted¹⁶⁷;

2. importers to indicate the following three elements: their (1) name, (2) registered trade name or registered trade mark and (3) the address at which they can be contacted, on the product or, where that is not possible, on its packaging or in a document accompanying the product;¹⁶⁸

3. manufacturers to ensure that their products bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product¹⁶⁹ and

4. economic operators to identify any economic operator who has supplied them with a product and any economic operator to whom they have supplied a product¹⁷⁰.

4.2.2.1. The requirement to indicate name and address for manufacturers

The manufacturers must indicate the following three elements: their (1) name, (2) registered trade name or registered trade mark and (3) the address at which they can be contacted on the product, or, where that is not possible, on its packaging and / or in a document accompanying the product. This information has to be the same as the one on declaration of conformity and in the technical documentation.

The name and address 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 affixing it to the product was not possible under reasonable technical or economic conditions excluding however esthetical reasons. It is up to the manufacturer to make this assessment. This assessment has to be done according to the size or nature of the product¹⁷¹. Some products e.g.

hearing aids, sensors or the like are simply too small to carry such information. In such cases the order of priority is that as a first alternative the information should be on the packaging, as a second alternative on an accompanying document, except for the cases where sectoral Union harmonisation legislation requires the information to be on both the packaging and accompanying documents.

The manufacturer has to comply with this obligation regardless of his location (within or outside the EU). This provision implies that products sold without packaging or any accompanying documents, must bear the name and address of the manufacturer on the product itself.

The address must indicate a single point at which the manufacturer can be contacted. The legal text obliges the manufacturer to put a single contact point on the product. Only one single contact point in the EU is allowed. This is not necessarily the address where the manufacturer is actually established. This address can for example be the one of the authorised representative or of the customer services.

The single contact point does not need to be in every Member State where the product is made available. The manufacturer may however put other addresses¹⁷² provided that it is clear which one is the single contact point. The latter is then to be indicated on the product/documentation as the “single contact point”. The address or the country does not necessarily have to be translated into the language of the Member State where the product is made available on the market.

A website is additional information, but is not enough as an address. Normally an address consists of a street and number or post-box and number and the postal code and town, but some countries might deviate from this model.

4.2.2.2. The requirement to indicate name and address for importers

Importers must also indicate the following three elements: their (1) name, (2) registered trade name or registered trade mark and (3) the address at which they can be contacted on the product, or, where that is not possible, on its packaging or in a document accompanying the product. The provision refers to an address at which they can be contacted, so this is not necessarily the address where the importer is actually established. The information has to be the same as the one on declaration of conformity and in the technical documentation.

As a rule, the identification and the address of importer must be indicated on the product. Only where it is not possible, the identification and address of the importer may be indicated on the packaging and / or in a document accompanying

167 Article R2(6) of Annex I of Decision No 768/2008/EC 168 Article R2(3) of Annex I of Decision No 768/2008/EC 169 Article R2(5) of Annex I of Decision No 768/2008/EC 170 Article R7 of Annex I of Decision No 768/2008/EC 171 see Recital 25 of Decision No 768/2008/EC

172 For instance, an address serving as an information point for consumers and other users in the Member State where the product is made available

the product. This may be the case when the importer would have to open the packaging to put his name and address.

The additional information from the importer shall not hide the information put on the product by the manufacturer.

A website is additional information, but is not enough as contact address. Normally an address consists of a street and number or post-box and number and the postal code and town, but some countries might deviate from this model.

The product must always bear the manufacturer’s name and address. Imported products must also bear the importer’s name and address. Hence, in conclusion, a product normally bears one or two addresses¹⁷³:

‣ If the manufacturer is within the European Union, the product will bear only one (manufacturer’s) address as there is no importer involved.

‣ If the manufacturer (declaring himself as a manufacturer by putting his name and address on the product) is outside the EU and the products are placed on the Union market by an importer, the product will bear two addresses: the one of the manufacturer and the one of the importer.

‣ If the original manufacturer is outside the EU and the importer places the product on the market under his own name or trademark or modifies the product already placed on the market (in such a way that compliance with the applicable requirements may be affected), the importer is considered the manufacturer. The only address that in this case will figure on the product (or packaging or accompanying document) is the address of the importer who is considered as the manufacturer.¹⁷⁴

‣ If the manufacturer is within the EU (a company located in the EU declaring itself to be a manufacturer by putting its name and address on the product) although the products are manufactured outside the EU, that company is considered to be the manufacturer who places the product on the Union market, even if actual importation is done by another company. In this case there is no importer in the meaning of the importer’s definition and it is sufficient to put only the manufacturer’s address.

4.2.2.3. 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 impossible¹⁷⁵. 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. This identification element of the product is identical to the one used on the EU Declaration of Conformity.

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 (DoC) 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

173 In the medical devices sector, the product must also bear the authorised representative’s name and address.

174 If the importer is only affixing his name and address and leaves the trademark of the original manufacturer, he remains importer. The address of importer and manufacturer will appear on the product (or packaging or accompanying documents)

175 In the case of toys, this might be the case for toys consisting of several parts or an assembly of several parts.

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 a 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 DoC.

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 DoC (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 DoC, on the packaging. This will also facilitate market surveillance authorities to link the product to the EU DoC.

4.2.2.4. Identification of economic operators

Economic operators are obliged to keep track of the economic operators they supplied their product to or from whom they bought products for a period of 10 years. Bear in mind that the end user (consumer) is not covered by this requirement as they are not considered to be economic operators.

The way to comply with this requirement by economic operators is not prescribed by Union harmonisation legislation, but it must be noted that market surveillance authorities can ask for relevant documents, including invoices, allowing the origin of the product to be traced. Hence, it could be useful to keep invoices for a longer period than envisaged in accounting legislation to comply with the requirements on traceability.