On July 16, 2021, Regulation (EU) no. 2019/1020 of the European Parliament and of the Council of 20 June 2019, on market surveillance and product conformity, which amended Directive 2004/42 / EC [1] , Regulation (EC) no. 765/2008 [2] and Regulation (EU) no. 305/2011 [3] .
Regulation (EU) 2019/2010, of which only some aspects are analyzed in this document, represents a very broad regulatory instrument that is intended to constitute a precise and articulated reference regarding the obligations of economic operators and market surveillance activities : compliance with it assumes a decisive and essential role in the management of product compliance and commercial relations aimed at placing products on the European market.
For this reason, Eng. Ernesto Cappelletti , of Quadra, and the lawyer. Giorgio Caramori , from Studio De Capoa & Partners, wrote this in-depth article on market surveillance, new obligations for the importation of products from non-EU countries and the role of economic operators.
[1] Directive 2004/42 / EC of the European Parliament and of the Council of 21 April 2004 relating to the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and in certain bodywork products and amending the directive 1999/13 / EC.
[2] Regulation (EC) no. 765/2008 of the European Parliament and of the Council of 9 July 2008 which sets rules on accreditation and market surveillance as regards the marketing of products and which repeals Regulation (EEC) no. 339/93.
[3] Regulation (EU) no. 305/2011 of the European Parliament and of the Council of 9 March 2011 which establishes harmonized conditions for the marketing of construction products and which repeals Council Directive 89/106 / EEC.
1. Regulation (EU) 2019/1020: purpose and scope
For the purposes of this discussion, the most important aspects concern the changes made by the new text to Regulation (EC) no. 765/2008, relating to the provisions concerning market surveillance and product compliance.
We briefly remind you that Regulation (EC) no. 765/2008 established the rules relating to the accreditation of conformity assessment bodies and established the rules on market surveillance in order to guarantee product safety and consumer protection [4] . In particular, Chapter III (Article 16, paragraph 2) provided that:
Market surveillance ensures that products covered by Community harmonization legislation, which are likely to compromise the health or safety of users, when used in accordance with their intended purpose, or under reasonably foreseeable conditions, are installed and maintained correctly or that, for on the other hand, they do not comply with the applicable provisions of the Community harmonization legislation, are withdrawn or their making available on the market is prohibited or restricted and that the public, the Commission and the other Member States are consequently informed.
The aforementioned regulation also established:
- the general operating criteria of the market surveillance bodies and the actions that can be adopted by them in order to guarantee the safety of the products;
- actions for products that “ pose a serious risk ”;
- the restrictive measures to be adopted by the market surveillance bodies;
- the consultation procedures with economic operators;
- a rapid system for the exchange of information at Community level;
- the controls to be adopted in respect of products entering the Community territory (articles 27, 28 and 29);
- general obligations and responsibilities connected with the CE marking of products.
Regulation (EU) no. 2019/1020 sets among its first objectives in the field of market surveillance that of guaranteeing a uniform framework for the control of product conformity in order to "to increase the confidence of consumers and other end users in products placed on the Union market "; to this end, the new regulation amended the previous regulation (EC) no. 765/2008, repealing and replacing some of its articles, rationalizing and simplifying the regulatory system through:
- the alignment of the definitions provided by the previous legislation with reference to the figures of the "manufacturer", the "importer", the "authorized representative" (or "agent") and the "distributor", specifying the respective obligations and responsibilities, also with reference to “spontaneous” actions that they should take in case of non-compliant products [5] ;
- identification of roles, obligations (including cooperation with market surveillance authorities and "reporting" of non-compliant products) and responsibilities of operators who, for various reasons, intervene in the product marketing chain, with reference to compliance to community standards (including technical ones);
- the application of the provisions of the regulation also to online sales;
- the implementation of inspection and control activities, also at customs level, for products from non-EU countries;
- the exercise of powers to prevent the continuation of marketing activities for non-compliant products;
- the exchange of information between the various national supervisory authorities;
- the implementation of customs controls.
The particular relevance of Regulation (EU) 2019/1020 derives from the fact that it concerns a very wide range of products, and therefore its field of application is very vast and articulated.
In fact, Article 2 of the regulation specifies:
This Regulation applies to products subject to Union harmonization legislation set out in Annex I[6] ('Union harmonization legislation'), if the Union harmonization legislation does not contain specific provisions having the same objective, which more particularly regulate certain aspects of market surveillance and enforcement.
This means that if the harmonization legislation [7] provide for specific provisions on certain aspects of the CE marking, or particular figures who are recipients of legal obligations, these provisions must be integrated with the provisions of the regulation, both with reference to the aspects of compliance and market surveillance obligations, and with reference the identification of new subjects who become recipients of the obligations established by the harmonization legislation.
Therefore the provisions of regulation (EU) 2019/1020 apply in addition to the provisions of the directives and regulations listed in Annex I of the regulation; for example, the machinery directive 2006/42 / EC does not contemplate the figure of the importer or that of the distributor, who will therefore be governed according to the provisions of regulation (EU) 2019/1020 also for products falling within the scope of this directive .
Finally, it should be noted that the regulation "it is mandatory in all its elements and directly applicable in each of the Member States ", which means that its recipients are immediately obliged to comply with its requirements, without the need for any transposition act by the individual Member States.
[1] Directive 2004/42 / EC of the European Parliament and of the Council of 21 April 2004 relating to the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and in certain bodywork products and amending the directive 1999/13 / EC.
[2] Regulation (EC) no. 765/2008 of the European Parliament and of the Council of 9 July 2008 which sets rules on accreditation and market surveillance as regards the marketing of products and which repeals Regulation (EEC) no. 339/93.
[3] Regulation (EU) no. 305/2011 of the European Parliament and of the Council of 9 March 2011 which establishes harmonized conditions for the marketing of construction products and which repeals Council Directive 89/106 / EEC.
[4] Article 1 of Regulation (EC) No. 765/2008:
- This Regulation establishes rules concerning the organization and functioning of the accreditation of conformity assessment bodies in carrying out conformity assessment activities.
- This Regulation provides a framework for market surveillance of products to ensure that they meet requirements that offer a high degree of protection of public interests, such as health and safety in general, health and safety at work, health and safety in the workplace. consumer protection, environmental protection and public safety.
- This Regulation provides a framework for controls on products from third countries.
- This Regulation establishes the general principles of the CE marking .
[5] The text of two "recitals" of regulation no. 2019/1020, to clarify this aspect:
(11) Some definitions currently appearing in Regulation (EC) No. 765/2008 should be aligned with the definitions contained in other legal acts of the Union and should, where appropriate, reflect the architecture of modern supply chains. The definition of 'manufacturer' in this Regulation should not relieve manufacturers of the obligations they may have under Union harmonization legislation where specific definitions of manufacturer apply, which could affect any natural or legal person who modifies a product already placed on the market in such a way that compliance with the applicable Union harmonization legislation can be influenced and places that product on the market, or any other natural or legal person who places a product on the market under their name or trademark.
(12) Economic operators along the entire supply chain, when placing or making products available on the market, should be required to act responsibly and in full compliance with the applicable legal requirements, in order to ensure compliance with the harmonization legislation of the Union relating to products. This Regulation should be without prejudice to the obligations corresponding to the role of each economic operator in the supply and distribution process based on the specific provisions contained in Union harmonization legislation and the manufacturer should retain ultimate responsibility for product conformity. the requirements of Union harmonization legislation.
[6] The Union harmonization legislation listed in Annex I to Regulation (EU) 2019/1020 includes the following regulations and directives:
- Directive 2000/14 / EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the environmental noise emission of machinery and equipment intended for operation outdoors;
- directive 2006/42 / EC of the European Parliament and of the Council of 17 May 2006 relating to machinery and amending directive 95/16 / EC;
- Directive 2009/48 / EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys;
- Directive 2009/125 / EC of the European Parliament and of the Council of 21 October 2009 on the establishment of a framework for the development of ecodesign requirements for energy related products;
- Directive 2011/65 / EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment;
- Directive 2013/29 / EU of the European Parliament and of the Council of 12 June 2013 on the harmonization of the laws of the Member States relating to the making available on the market of pyrotechnic articles;
- Directive 2013/53 / EU of the European Parliament and of the Council of 20 November 2013 relating to recreational craft and personal watercraft and repealing Directive 94/25 / EC;
- Directive 2014/29 / EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to the making available on the market of simple pressure vessels;
- Directive 2014/30 / EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to electromagnetic compatibility;
- Directive 2014/31 / EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments;
- Directive 2014/32 / EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to the making available on the market of measuring instruments;
- Directive 2014/34 / EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres;
- Directive 2014/35 / EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to the making available on the market of electrical equipment intended for use within certain voltage limits;
- Directive 2014/53 / EU of the European Parliament and of the Council of 16 April 2014 on the harmonization of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5 / EC;
- Directive 2014/68 / EU of the European Parliament and of the Council of 15 May 2014 on the harmonization of the laws of the Member States relating to the making available on the market of pressure equipment;
- Regulation (EU) no. 305/2011 of the European Parliament and of the Council of 9 March 2011, which establishes harmonized conditions for the marketing of construction products and which repeals Council Directive 89/106 / EEC;
- Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686 / EEC;
- Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances that burn gaseous fuels and repealing Directive 2009/142 / EC.
[7] Union harmonization legislation are all source provisions whose aim is to create a harmonized legal system that guarantees, on the one hand, the free movement of products within the European Union, on the other, to ensure a high and uniform level of safety for European consumers.
2. The subjects of the production and marketing chain
For the purposes of this discussion, what is of particular interest is the modification of the legislation concerning the identification of the recipients of the compliance obligations of the products, according to their role in the distribution chain or placing on the market of the products: from this point of view the provisions of the new regulation are quite complex and stringent.
Here, particular attention will be paid to the incidence of the regulation with respect to the placing on the market of machines, therefore with reference to the machinery directive 2006/42 / EC.
Products falling within the scope of these legislative provisions can be placed on the market[1] of the European Union only by a "economic operator ", which is identified[2] as "the manufacturer, the authorized representative, the importer or distributor, the logistics service provider or any other natural or legal person subject to obligations in relation to the manufacture of the products, their sale on the market or their entry into service in compliance of the relevant Union harmonization legislation ". Therefore the definition refers to:
- a manufacturer;
- an importer or distributor;
- an authorized representative [3] ;
- a logistics service provider .
The regulation provides distinct definitions for these figures, in part new and in part a "synthesis" of the same definitions made in other documents or community regulatory measures. It is therefore necessary to examine the individual definitions in order to better understand the obligations imposed on the addressees of the regulation.
[1] Regulation (EU) 2019/1020 defines (Article 3, point 2):
'Placing on the market' means the first making available of a product on the Union market.
[2] Article 4 of Regulation (EU) 2019/1020.
[3] The machinery directive uses the term "authorized representative", defined as (directive 2006/42 / EC, article 2, letter j):
'Authorized representative': any natural or legal person established within the Community who has received a written mandate from the manufacturer to carry out on his behalf, in whole or in part, the obligations and formalities associated with this Directive.
3. The manufacturer
Regulation (EU) 2019/1020 (article 3, point 8) defines:
'Manufacturer': any natural or legal person who manufactures a product, or has it designed or manufactured, and markets it under his name or trademark.
So the manufacturer is the person who manufactures (i.e. designs and manufactures) a product, or it has it designed and built by third parties and affixes its name (or trademark) to it: the person who carries out these actions assumes responsibility for the conformity of the product with the requirements of the Union harmonization legislation applicable to that product.
Who designs and builds a product is the "real" manufacturer of the product, but nothing prevents a product from being, in whole or in part, designed or manufactured by a third party for another person, who will then affix his own name and / or trademark on the product (ie becoming the "apparent "): This subject, regardless of whether he has designed and / or manufactured the product, is the" manufacturer "for the purposes of the harmonization legislation and, as such, is obliged to comply with the compliance law. The commercial practice of selling products with a brand other than that of the "real" manufacturer, for example by distributors, is not prohibited by Union harmonization legislation.
The manufacturer can be established in the European Union or in any other non-EU country; some sectoral legislative provisions require entities established in the European Union to carry out specific tasks [1] if the manufacturer is established in a non-EU country [2] .
[1] This is, for example, the case of the person authorized to compile the technical file provided for by the Machinery Directive 2006/42 / EC.
[2] With regard to machinery, even a non-EU manufacturer can directly fulfill the compliance obligations provided for by Directive 2006/42 / EC; the European Commission, in its guide to the application of the machinery directive 2006/42 / EC (edition 2.2, October 2019), clarified that:
- 81 […] If a machinery manufacturer established outside the EU takes the decision to place his products on the market in the EU, he is able to fulfill his obligations under the Machinery Directive himself or mandate an authorized representative to perform all or part of these obligations on his behalf.
is that:
- 84 […] It is not an obligation for a manufacturer established outside the EU to nominate an authorized representative: such a manufacturer can accomplish all of his obligations directly .
4. The authorized representative
The authorized representative is a person who has received a mandate from a manufacturer to perform certain tasks on his behalf , as defined by Regulation (EU) 2019/1020 (article 3, point 12):
'Authorized representative' means any natural or legal person established in the Union who has received a written mandate from a manufacturer authorizing him to act on his behalf in relation to certain tasks with reference to the manufacturer's obligations under the relevant harmonization legislation Union or pursuant to the provisions of this Regulation.
A manufacturer established outside the EU does not necessarily have to appoint an authorized representative in the EU territory; the designation of an authorized representative is an opportunity that is left to manufacturers, but it is absolutely not an obligation: in fact, a non-European manufacturer can easily carry out directly and in first person all the obligations relating to the Union harmonization legislation.
The authorized representative can be the economic operator identified by Article 4 of Regulation (EU) 2019/1020 only if the mandate includes all the tasks listed in Article 4, paragraph 3 of the aforementioned Regulation [1] .
If the product is shipped from outside the EU directly to an end user in the EU and an authorized representative has been instructed in writing to carry out the specific tasks referred to in Article 4 (3) of Regulation (EU) 2019/1020 , this is the economic operator responsible for placing the product on the market. If the manufacturer has not appointed an authorized representative, the product cannot be offered for sale to EU end users [2] .
[1] See what is indicated in paragraph 8.
[2] See what is illustrated in Figure 1 at paragraph 7 of this document.
5. The importer and the distributor
The figure of the importer is defined by Regulation (EU) 2019/1020 (article 3, point 9):
' Importer ' means any natural or legal person established within the Union who places a product from a third country on the Union market.
This definition assumes particular importance in identifying the recipients of the tasks imposed by the regulation, because it further establishes what are the obligations of the subject who, even without the awareness of this role (in relation to the "dynamism" of commercial relations), finds himself taking on the status of "importer". In fact, anyone who places a product from a third country on the European Union market, or makes it available for the first time, becomes its importer .
An importer established in the European Union is therefore the economic operator who will have to carry out the tasks listed in Article 4 (3) of Regulation (EU) 2019/1020 [1] , unless the manufacturer has appointed an authorized representative.
In other words, the obligation introduced by regulation (EU) 2019/1020 for non-European manufacturers is to have either an authorized representative (in the field of machinery, the so-called agent) or, otherwise, an importer who assumes the obligations provided for by the regulation same.
The problem may arise in the if the non-European manufacturer has not appointed an importer; in the machinery sector, the status of importer is assumed either on the basis of specific commercial agreements or "de facto", in order to have the subject materially placed on the market or put into service the machine. Therefore, in the event that the non-European manufacturer has not appointed an importer, it may be the European user himself who is identified as an "importer" pursuant to Regulation (EU) 2019/1020 and, therefore, as an economic operator they will be burdened by him. the obligations established by the regulation itself.
If several importers manage the same type of product, each of them will be the economic operator, within the meaning of Regulation (EU) 2019/1020, for the units it places on the EU market. In particular, each imported unit must report information on the entity that imported it [2] : identical units will therefore bear different names if imported from different entities.
Regulation (EU) 2019/1020 identifies the figure of the "distributor" - already qualified in other Community legislation, including regulation (EC) 765/2008 - defining it as (article 3, point 10):
any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.
The figure of the distributor also falls within the definition of economic operator pursuant to the regulation, but all the obligations - provided for by Regulation (EU) 2019/1020 - which, for example, weigh on importers are not directly applicable to him. Consequently, the distributor will be subject to the obligations (generally of control regarding the presence of the documentary elements of the CE marking) provided for by the specific community regulations [3] .
[1] See what is indicated in paragraph 8.
[2] See what indicated in paragraph 9.
[3] For example, the EU regulation 2017/1369 on energy labeling defines:
'Distributor' means the retailer or other natural or legal person who offers for sale, rental, lease-sale or exhibits products to customers or installers in the course of a commercial activity, whether for consideration or not.
Directive 2014/30 / EU relating to electromagnetic compatibility defines instead:
'Distributor': the natural or legal person in the supply chain, other than the manufacturer and the importer, who makes an appliance available on the market.
In a completely similar way, Directive 2014/35 / EU concerning electrical equipment intended to be used within certain voltage limits defines:
'Distributor': the natural or legal person in the supply chain, other than the manufacturer or the importer, who makes electrical equipment available on the market.
6. The logistics service provider
The logistics service provider is [Regulation (EU) 2019/1020, Article 3, point 11]:
any natural or legal person who offers, in the context of a commercial activity, at least two of the following services: storage, packaging, addressing and shipment , without being the owner of the products concerned, excluding the postal services defined in Article 2, point 1 of Directive 97/67 / EC of the European Parliament and of the Council[1] , parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council[2] , as well as any other postal or freight transport service.
Commission Communication 2021 / C 100/01 [3] clarified the role of logistics service providers:
- 4.4 […] Logistics service providers generally stock products in the EU, so that they can be quickly delivered to consumers or other EU end-users as soon as they are ordered online. Therefore, they provide services to other economic operators. Upon receipt of an order, they pack the product (unless it has already been properly packaged for transport), affix the delivery address and ship it, either by delivering it to a postal, parcel delivery or transport service or by handing it over directly. [...]
Logistics service providers established in the EU act as an economic operator […] for the products they manage if there are no manufacturers, importers or authorized representatives in the EU for those products. Therefore, before agreeing to provide the logistics service for a product […], they should check with their customer whether one of the other types of economic operator for that product already exists in the EU. If not, they assume the role of economic operator […].
Unlike importers and authorized representatives, logistics service providers do not automatically have a formal link with the manufacturer that allows them to carry out the tasks of the economic operator listed in Article 4 (3) of Regulation (EU) 2019 / 1020 [4] . They will therefore have to conclude agreements with economic operators to whom they provide logistics services (their "customers") to ensure that they, or the manufacturer directly, provide them with the means to fulfill their obligations as an economic operator, for example all information and documentation necessary to demonstrate the conformity of the product with the requirements of Union harmonization legislation.
[1] Directive 97/67 / EC of the European Parliament and of the Council of 15 December 1997 concerning common rules for the development of the internal market in Community postal services and the improvement of service quality.
[2] Regulation (EU) 2018/644 of the European Parliament and of the Council of 18 April 2018 on cross-border parcel delivery services.
[3] Communication from the Commission 2021 / C 100/01 - Guidelines for economic operators and market surveillance authorities on the practical implementation of Article 4 of Regulation (EU) 2019/1020 on market surveillance and product compliance .
[4] See what is indicated in paragraph 8.
7. Application of Article 4 of Regulation (EU) 2019/1020
The European Commission intervened to clarify some interpretative doubts precisely in relation to Article 4 of Regulation (EU) 2019/1020 with the publication of the Commission communication 2021 / C 100/01.
In fact, some interpretative problems have arisen in relation to the provisions of theArticle 4 of the regulation, which, as we have seen, provides that a product subject to harmonization legislation can be placed on the market only if there is an economic operator established in the Union who is responsible for the tasks referred to in paragraph 3 .
This formulation leads to two considerations: the first concerns the fact that the tasks normally envisaged in the field of CE marking, to be carried out by the authorized representative (but also by the importer), appear to be further specified and detailed in particular as regards the "response "To any market surveillance actions; the second - but not in order of importance - concerns the fact that, remaining in the field of machines, the importation of machines from non-EU countries is possible only if an economic operator is established in the European territory who is responsible for specific obligations provided for by the regulation in paragraph 3 of the same article 4[1] .
Therefore, if a non-European manufacturer intends to place a machine (also CE marked) on the European market, it is necessary that in the European territory an economic entity - an importer, a distributor, a supplier of logistics services - takes on, in particular, the foreseen tasks. by regulation (EU) 2019/1020 [2], first of all that which concerns the verification that the declaration of conformity or the declaration of performance and the technical documentation have been drawn up, the obligation to keep the declaration of conformity or the declaration of performance available to the market surveillance authorities for the period prescribed by this legislation, the guarantee that the technical documentation is made available to said authorities when requested.
As can be seen in the flowchart shown in Figure 1, the manufacturer established in the European Union may not be the economic operator responsible for placing a product on the market if he has mandated in writing an authorized representative to carry out the specific tasks referred to in Article 4 (3) of Regulation (EU) 2019/1020.
[1] See what is indicated in paragraph 8.
[2] See what is indicated in paragraph 8.
8. Tasks of economic operators
The tasks of economic operators are listed in Article 4 (3) of Regulation (EU) 2019/1020.
In particular, an economic operator, for each product it places on the market, must :
- verify that the declaration of conformity [1] (or of performance) has been drawn up and keep it for at least ten years from the date the product is placed on the market;
- verify that the technical documentation required by Union harmonization legislation [2] has been drawn up and can be made available to market surveillance authorities when required; the technical documentation can be kept by the economic operator or the latter must obtain adequate guarantees from the manufacturer that this documentation, following a request from a market surveillance authority, will be transmitted to the economic operator or directly to the requesting authority itself.
Furthermore, where the economic operator has reason to believe that a product presents a risk [3] , it must:
- inform the market surveillance authorities in each Member State where the product has been made available;
- ensure that adequate corrective action is promptly implemented to resolve the non-conformities present on the product or, if this is not feasible, at least reduce the risks generated by the product; market surveillance authorities will need to be informed of the corrective action that has been or will be taken.
Finally, at the request of a market surveillance authority, the economic operator must:
- provide the declaration of conformity (or performance) and the technical documentation relating to the product requested by this authority; if the technical documentation is not kept by the economic operator, the latter must ensure that the required technical documentation is provided to the authority by the manufacturer (or by any person delegated by it, for example by the authorized representative);
- cooperate with the authority as requested by it [4] ;
- ensure that an adequate corrective action [5] is promptly implemented to resolve the non-conformities present on the product or, if this is not feasible, at least reduce the risks generated by the product; market surveillance authorities will need to be informed of the corrective action that has been or will be taken.
As can be seen, the obligations described above, only partially already deducible from other Community legislation, are now decidedly specified and increased: their binding nature is strengthened not only by the hypothetically negative consequences of a market surveillance measure (in terms of "usability "And marketability of a product), including the prohibitions of use, the obligation to withdraw from the market or the obligation to destroy, including the" cost recovery "of such measures and the penalties that are provided for by individual Member States.
[1] The Machinery Directive 2006/42 / EC provides that partly completed machinery must be accompanied by a declaration of incorporation, drawn up in accordance with Annex II, Part 1, Section B of the aforementioned directive.
[2] For example, the Machinery Directive 2006/42 / EC requires that a technical file be created for machinery (Annex VII, part A) and that the relevant technical documentation is prepared for the partly completed machinery (Annex VII, part B).
[3] Regulation (EU) 2019/1020 defines (Article 3, point 19):
'Product presenting a risk' means a product that could potentially adversely affect the health and safety of people in general, health and safety in the workplace, consumer protection, the environment and public safety, as well as other interests protected by the applicable Union harmonization legislation, beyond what is deemed reasonable and acceptable in relation to the intended use of the product or under normal or reasonably foreseeable conditions of use, including the duration of use and, where applicable, the related requirements commissioning, installation and maintenance.
[4] Requests from the market surveillance authority must comply with the principle of proportionality, as set out in Regulation (EU) 2019/1020 (Article 14 (2)):
Market surveillance authorities shall exercise their powers referred to in this Article efficiently and effectively and in accordance with the principle of proportionality, insofar as this exercise relates to the object, purpose of the measures, the nature and actual damage or overall potential of the case of non-compliance.
[5] Commission Communication 2021 / C 100/01 specified that:
- 3 [...] The economic operator referred to in Article 4 is not required to take corrective action or mitigate the risk if this is not required by sectoral legislation, but must ensure that such action is taken, for example by asking the manufacturer to respond to the request and verifying that he has done so.
9. Information on the economic operator
Regulation (EU) 2019/1020 requires that (Article 4 (4)):
Without prejudice to the respective obligations of economic operators established by the applicable Union harmonization legislation, the name, registered trade name or registered trade mark as well as the contact details, including the postal address of the economic operator referred to in paragraph 1, are indicated on the product or on its packaging, on the package or in an accompanying document.
It is therefore necessary that the name (or brand) and contact details of the economic operator are indicated on at least one of the following elements:
- the product;
- the packaging, or the packaging used for the sale;
- the package, i.e. the packaging to facilitate handling and transport;
- an accompanying document, for example the declaration of conformity (or performance).
The contact details of the economic operator must include a postal address - usually consisting of street / PO box, house number, postal code and location - and may also contain a website, an e-mail address and / or a telephone number to facilitate contacts with the competent authorities.
Commission communication 2021 / C 100/01 clarified that the data of several economic operators can be reported:
- 2.3 […] The names and contact details of several economic operators may be indicated on the product or together with the product.
While there may not be an explicit requirement that such information be preceded by the terms 'manufactured by', 'imported by', 'represented by' or 'fulfilled by', the information should not mislead market surveillance authorities. . If the roles of the operators are not specified, the authorities will have to determine them themselves. Each economic operator should be able to demonstrate their role.
There is no obligation to translate the English terms "manufactured by", "imported by", "represented by" or "fulfilled by"; these English terms are considered to be easily understood across the EU.
