4.2.2 トレーサビリティ規定

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 made available 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. Products within the scope of application of Article 4 of Regulation (EU) 2019/1020 must indicate the name and address of the economic operator referred to in Article 4 established in the EU. 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’ or ‘Fulfilled 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 operator (205). 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 that he has a different role.

There is no obligation to translate into all necessary languages the English terms ‘manufactured by’, ‘imported by’ or ‘represented by’. These English terms are considered to be easily understandable throughout the EU.

Regulation (EU) 2019/1020 on market surveillance and compliance 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, as well as Regulation (EU) 2019/1020, require:

1.manufacturers to indicate the following elements: their (1) name, registered trade name or registered trade mark (206) and (2) 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 address must indicate a single point at which the manufacturer can be contacted (207);

2.importers to indicate the following elements: their (1) name, registered trade name or registered trade mark and (2) 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; (208)

3.economic operators referred to in Article 4 of Regulation (EU) 2019/1020, to indicate their (1) name, registered trade name or registered trade mark, and (2) contact details, including the postal address, on the product or on its packaging, the parcel or an accompanying document (209), for products which are included within the scope of Article 4 and placed on the Union market;

4.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 product (210) and

5.economic operators to identify any economic operator who has supplied them with a product and any economic operator to whom they have supplied a product (211).

Unless otherwise specified by Union harmonisation legislation, the information on the name and address of the different economic operators does not need to be affixed indelibly, as opposed to other information on the product such as the CE marking. However, this information should be visible on the product, or on the packaging or accompanying documentation.

Manufacturers must indicate the following three elements: their (1) name, registered trade name or registered trade mark and (2) 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.

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 product (212). 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 such as the instructions for use, 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, in particular by market surveillance authorities. The legal text obliges the manufacturer to put a single contact point on the product. Only one single contact point in each product 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 addresses (213) 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 but the characters of the language used must allow identifying the origin and the name of the company.

A website address may be given in addition to, but not instead of a postal 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. Also, it is useful to include an email address and/or phone number to facilitate swift contacts with the relevant authorities.

Importers must also indicate the following elements: their (1) name, registered trade name or registered trade mark and (2) 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, in particular by market surveillance authorities. This is not necessarily the address where the importer is actually established but can for example be the one of the customer services.

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 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 address may be given in addition to, but not instead of a postal 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. Also, it is useful to include an email address and/or phone number to facilitate swift contacts with the relevant authorities.

Where the product falls within the scope of legislation listed in Article 4(5) of Regulation (EU) 2019/1020 and is placed on the Union market, the economic operators referred to in Article 4 must indicate their (1) name, registered name or registered trade mark and (2) their contact details, including a postal address on the product or on its packaging, the parcel or an accompanying document.

A website address may be given in addition to, but not instead of a postal 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. Also, it is useful to include an email address and/or phone number to facilitate swift contacts with the relevant authorities.

The product must always bear the manufacturer’s name and address. Imported products must also bear the importer’s name and address. Products under the scope of Article 4 of Regulation (EU) 2019/1020 and placed on the Union market must bear the name and address of the responsible economic operator established in the EU. Hence, in conclusion, a product normally bears one or two addresses (214):

—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 (215) (216).

—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.

—Where the product falls within the scope of Article 4 of Regulation (EU) 2019/1020 and is placed on the Union market, if the manufacturer is located outside the EU, there is no importer for the product (because it is shipped directly or via fulfilment service provider to the end-user from outside the Union), and the manufacturer has appointed an authorised representative to fulfil on its behalf the tasks of Article 4(3), the product will have to include two addresses (or the packaging or accompanying document, or for the economic operator referred to in Article 4, the parcel): the manufacturer’s and the authorised representative’s as the economic operator referred to in Article 4. This will also be the case if the manufacturer is established inside the EU but has appointed an authorised representative to fulfil on its behalf the tasks of Article 4(3).

—Where the product falls within the scope of Article 4 of Regulation (EU) 2019/1020 and is placed on the Union market, if the manufacturer is located outside the EU, there is no importer and the manufacturer has not appointed an authorised representative, but the product is handled by a fulfilment service provider established in the EU, two addresses must be indicated on the product (or the packaging or accompanying document, or for the economic operator referred to in Article 4, the parcel): the manufacturer’s and the fulfilment service provider’s as the economic operator referred to in Article 4.

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.

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.

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.

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.

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 or other time period provided for in specific Union harmonisation legislation. 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.