Certificates

CE Marking

The CE mark is a mark that must be affixed on certain types of products by the manufacturer itself, which with it self-certifies compliance (or conformity) to the essential requirements for marketing and use in the European Union set out in the New Approach directives.

Compulsory
The CE mark is a mark that must be affixed on certain types of products by the manufacturer itself, which with it self-certifies compliance (or conformity) to the essential requirements for marketing and use in the European Union set out in the New Approach directives. The affixing of the mark is prescribed by law in order to be able to market the product in countries belonging to the European Economic Area (EEA). "Certain directives may exclude the affixing of the CE marking on certain products. 4] Such products may circulate freely on the European market if they are accompanied, for example, by a declaration or certificate of conformity". 3] Examples of some directives requiring CE marking are the Construction Products Directive, the Low Voltage Directive, the Machinery Directive, the Electromagnetic Compatibility Directive, the Pressure Systems Directive, the Medical Devices Directive. The complete list is available at this address.
In the case of imports of products manufactured in countries outside the EU (e.g. China), it is the importer who, prior to the first marketing (even if it is to a distributor if it is different from the importer himself), must check compliance with the Directive. If the importer then sells in his name within the EU, he must also re-issue the mandatory documents required starting with the declaration of conformity. 5] Any responsibility for the marked product would in any case fall on the importer.
The CE marking is not mandatory for all products since European directives only require it for certain categories. These include both products for strictly professional use (e.g. medical devices, lifts, machinery and weighing instruments) and consumer products (such as toys, computers, mobile phones and light bulbs).
The CE symbol
The CE symbol has no stated literal meaning and therefore is not an acronym for any particular description of the type of mark, also because meanings of the acronym such as "European conformity" make sense only in some of the European languages, while the mark always remains the same in all countries, even in those in which the terms "European conformity" are expressed in totally different ways (in Swedish, europeisk standard; in Polish, Europejska Zgodność; in Slovenian, Evropski skladnosti; in Finnish, eurooppalaisesta vaatimustenmukaisuuden; etc.).
It is true that in many of the European languages the two letters CE refer linguistically to that meaning, but the official documents of the European Commission relating to the CE mark do not provide any indication that the CE mark is declaredly an acronym for anything. 6] Simply the choice of CE for the relative mark is the result of a European agreement which, by selecting those two letters in that order, made the meaning to which it referred understandable in the main European languages. The mark simply indicates that the product bearing it complies with the "essential requirements", where applicable, of Directives on safety, public health, consumer protection, applicable to that specific product for that particular use. Therefore, it does not represent a quality mark, let alone "of origin", but that the product enjoys the presumption of conformity.
"The CE marking shall indicate that the product conforms to all Community provisions requiring its use":[3] from design, manufacture, placing on the market, putting into service and disposal. The CE marking covers the entire life cycle of the product from the moment it is placed on the market.
"Member States may not restrict the placing on the market or putting into service of products bearing the CE marking unless it can be shown that the product does not conform in court. The marking must be affixed before the product is placed on the European market or put into service"[3].
Consequences
In addition to the free movement of goods, the CE marking affixed to a product reverses the burden of proof on compliance with the essential requirements of the New Approach Directives. Given that products are placed on the market under the responsibility of the manufacturer or importer, using a legal fiction that reverses the burden of proof means that a compliant product can only be challenged if the infringement of the requirements of the relevant Directive is actually proven (so-called "presumption of conformity").
By affixing the CE mark on a product, the manufacturer declares that it meets all the requirements to obtain the CE mark, taking responsibility for its marketing within the European Economic Area (EEA countries, consisting of the 28 EU Member States, and EFTA countries, i.e. Iceland, Norway, Liechtenstein and Switzerland). CE marking is also provided for goods produced in third countries, then marketed in the EEA area and Turkey.
The CE marking does not imply that a good has been produced within the EEA area, but that it has been checked for conformity with the relevant European standards (e.g. harmonised safety standards) before it is placed on the market. Furthermore, the marking indicates that the manufacturer has verified the conformity of the good with all the fundamental requirements of the relevant directives concerning safety, hygiene and respect for the environment. Where the Directives so provide, the conformity of a product may also be assessed by a certified third party.
Technical harmonization
The CE marking is intended to remove the barriers to the free movement of products within the European Single Market caused by the different systems of product qualification contained in the national legislation of the individual member states. 7] For this reason, a process of technical standardization has been started, and is still in progress, whose legal cornerstones are represented by Directive 98/34/EC (third revision of Directive 83/189/EEC) and Decision 93/465/EEC (renewed by Decision 768/2008/EC). [8]
Directive 98/34/EC provides for a procedure obliging Member States to notify draft technical regulations relating to products to the Commission and the other Member States before they are adopted in national legislation. [9] The so-called "98/34 procedure" ensures the Commission's control over technical regulations that could give rise to unjustified barriers between Member States. To cite cases of Italian technical regulation, the Technical Regulations for Construction (D.M. 14/01/2008)[10] have been submitted to this procedure as much as the Legislative Decree 81/08 (Consolidated Law on Safety at Work). [11]
Decision 93/465/EEC establishes a series of procedures for assessing the conformity of industrial products with the essential requirements set out in the technical harmonisation directives (i.e. the New Approach). The Decision provides for eight assessment procedures (called modules) that apply to the design and production phases of products that can thus circulate freely within the Single Market. [3]
New approach directives
By adopting the so-called "new approach" (new approach), the Member States of the European Union have sought to break down barriers to trade in goods caused by uneven technical regulations between the co-signatories of the EC Treaty (Cassis de Dijon judgment)[12]. The New Approach Directives consist of technical harmonisation at Community level, aimed at:
to set up Community technical standardisation bodies such as CEN (European Committee for Standardisation), CENELEC, CEI and EOTA (if the guidance papers for achieving ETA are considered to be a legal act), to be entrusted with the production of product-specific standards (called harmonised standards) under a mandate from the Commission;
set only the general essential requirements for the products;
reduce the control of public authorities before a product is placed on the market;
integrate Quality Assurance and other modern conformity assessment techniques[13].
With the introduction of the New Approach Directives "The manufacturer is responsible for controlling each product he places on the market and verifying its conformity with EU legislation (conformity assessment procedure). This procedure can be of two types:
based on internal production control;
entrusted to a notified body. [14]
Compliance with the New Approach Directives therefore consists in the application of a harmonised standard (but also with the achievement of an ETA) that has been published in the Official Journal (O.J.) even if this has not been transposed by the internal legal system of a member state. [15] The publication in O.J. serves to fix the first useful date on which the presumption of conformity takes effect.
The act of transposition of Community directives is called descending phase[16] and commonly occurs with the preparation and approval of dedicated legislative decrees.
Harmonised standards
The essential requirements contained in the New Approach Directives do not contain any indication as regards the technical specifications of the products regulated in them (although they are mandatory for the manufacturer or importer). Directive 98/34/EC defines the European standard (EN) as a technical specification approved by a European body recognised for regulatory activities. According to the internal rules of these bodies, European standards must be transposed at national level (through legal instruments of national law) and all national standards in conflict with them must be repealed within a certain period of time[17].
The harmonised standards therefore represent the technical specifications to be applied to a given product so that it meets the essential requirements in a species-to-genus relationship with the New Approach Directives (covering entire product categories).
However, it is still understood that the manufacturer is free to adopt other technical specifications to demonstrate the conformity of its products to the reference Directives: the application of a harmonised standard is always voluntary[18] even if the danger of abandoning the presumption of conformity is not escaped, especially for modules that provide for the exclusive responsibility of the manufacturer (or importer).
In addition to voluntary application (it should be noted that voluntary is the application of the standard but not the obligation to qualify the products or subject them to CE marking), harmonised standards:
involve the participation of all stakeholders (producers, users, notified bodies, institutions, etc.) in their development;
presuppose the existence of a mandate to CEN or CENELEC by the Commission;
need to be transposed by national legal systems;
are published as national standards, without any modification, by the national standardisation bodies (which in this case is UNI. In some cases, the locution without any modification is correctly interpreted by the Italian standards body with the mother tongue translation of the first page only[19].
A particular clause in the CEN/CENELEC Statutes obliges the Member States not to carry out any activity (stand still)[20], during the preparation of a harmonised standard, which may prejudice the harmonisation process[21].
The standardisation procedure (development of a European standard) consists of the following procedure:
the Commission shall prepare a mandate, after consulting the Member States;
the mandate is transmitted to the European standardisation bodies, which usually accept the mandate (but may refuse it);
the standardisation bodies shall set up a technical committee to which the preparation of a draft standard shall be entrusted;
the European standardisation bodies and the national standardisation bodies shall organise a public survey and the Technical Committee shall examine the comments received;
the national standards bodies shall vote on the draft standard through their representatives in the European standards bodies they ratify;
the European standardisation bodies shall send the references to the Commission, which in turn shall publish them in the Official Journal[22] (OJ);
the national standardisation bodies shall transpose the European standard and the national authorities shall publish the references of the standards, making them acts which have the force of national law.
Compliance
One of the basic principles of the New Approach is to limit legislative harmonisation to essential requirements of public interest (E.R. acronym) which relate in particular to the protection of the health and safety of users (consumers and workers), the protection of property or the protection of the environment. Therefore, conformity means compliance with the essential requirements.
E.R. are related to certain risks associated with the product[23] or may refer to its performance. [24] The application of the essential requirements must be based on the risk inherent in a given product. Manufacturers (or importers) must therefore carry out a risk analysis to determine which essential requirements are applicable to the product in question, especially if the product is subject to several Directives or harmonised standards. The analysis should be documented and included in the technical documentation[25].

Declaration of conformity
The EC declaration of conformity is an attestation by which the manufacturer (resident in the European Community), the authorised representative (resident in the European Community and sole authorized representative of the non-European manufacturer) or the importer (resident in the European Community) certifies the conformity of a product to the essential requirements by drawing up this declaration as explicitly indicated in Annex IV of Directive 2004/108/EC[29] and in the reference standard ISO/IEC 17050-1:2004[30] and subsequent updates.
It should be noted that CE certificate and CE marking are two clearly distinct concepts. As stated above, only in very specific cases is it necessary to have a CE certificate (issued by the notified bodies), as proof of passing the tests (tests, trials, etc.) provided for in the scheme or the Directive in order to obtain the CE marking.
In this sense, the affixing of the CE marking on the label of a product presupposes that it is accompanied by a declaration of conformity, or a certificate depending on the modules, which is the real document binding on the manufacturer, the authorised representative or the importer. It is worth pointing out that those responsible for factory production control (a figure equivalent to the quality manager or internal auditor for the CE marking of the product) are not ipso facto representatives. However, in view of the definition of authorised representative[31] and having provided for the figure of the importer, the Community legislature has implicitly provided for the possibility of establishing those responsible for factory production control (FPC) as authorised representatives and therefore solely responsible for the obligations relating to the CE marking of products (provided that the mandate is given in writing) in place of the managing directors.
The declaration of conformity may be a document, label or something equivalent[32] and must contain the following minimum information:
name and address of the manufacturer or his authorised representative issuing the declaration (and the identification number of the notified body where the module applied provides for the intervention of a third party);
identification of the product (name, type or model number and any additional information such as batch, batch or serial number, sources and number of items);
all the relevant provisions that have been met;
standards or other normative documents followed (e.g. national standards and technical specifications) indicated in a precise, complete and clear manner;
any additional information required (e.g. class or category when provided for in the technical specifications);
date of issue of the declaration;
signature and title or equivalent mark of the representative;
declaration that the declaration of conformity is issued under the full responsibility of the manufacturer and, where appropriate, his authorised representative.
All this being said, it is clear that the central document on which the system of product qualification known as the CE marking revolves does not insist on the mark to be affixed on the label but on the declaration of conformity (i.e. the certificate of conformity), in which someone takes legal responsibility for affirming the conformity of a given product and thus becomes the legitimate passive party in the event of a judgment.
The declaration of conformity shall:
be made available immediately to the supervisory authorities at their request;
be drawn up in one of the official languages of the Community (for products which must be accompanied by a declaration of conformity, this declaration must be drawn up in the language of the country where the product is marketed)
be stored for 10 years (unless otherwise stated).
Distributors are not directly appointed in the New Approach Directives, but they must always be able to demonstrate to the authorities that they have acted in compliance with the Directives and obtain a declaration of conformity to the Directives from the manufacturer, authorised representative or importer (to be made available to the supervisory authorities).
If the goods are manufactured in third countries, the importer must verify that the manufacturer has undertaken the procedures for the attestation of conformity and has made the required documentation available. It is also the importer's responsibility to ensure that the manufacturer is always available. If the importer or distributors market the products on their behalf, they will be required to assume the responsibilities of the manufacturer. [33]
Scope of the CE marking
The CE marking is required, in abstract terms, for all products marketed within the European Economic Area (EEA[49]) which must comply at least with Directive 2001/95/EC (general product safety). Conversely, the CE marking with the affixing of the CE mark is provided for[50]:
active implantable medical devices;
gas appliances;
cable cars for transporting people;
eco-design of products related to energy consumption;
equipment for measuring electromagnetic compatibility;
explosive atmospheres protection devices;
explosives for civilian use;
vertical road signs
hot water boilers powered by liquid or gaseous fuel;
refrigerators and freezers for domestic use;
in vitro medical diagnostic devices;
elevators;
weighing instruments;
medical devices;
equipment with noise emission into the environment;
non-automatic weighing instruments;
personal protective equipment;
pressure instruments;
pyrotechnic devices;
radio and telecommunications devices;
hobby and leisure products;
toys;
pressure vessels;
construction materials and products;
cars
Features of the CE mark
The rules relating to the characteristics of the CE marking are set out below:
The CE mark must be affixed by the manufacturer (or by an authorized representative within the European Community) in the format required by law, legibly and indelibly;
the CE marking must measure at least 5 mm and maintain the initial proportions in the event of enlargement; where the final characteristics of the product or its workmanship do not allow the CE marking to be affixed directly to the product, the marking must be affixed to the packaging or accompanying documentation;
where the Directives provide for an assessment by a certified body, the identification number of the body must be included on the label containing the CE marking by the manufacturer (or importer) under the responsibility of the body.

Legal consequences
The CE marking of a product implies the presumption that it complies with European Directives[51]. The legal value of the CE marking implies:
not to be restricted to the free movement of the product in the area of the European Single Market in accordance with Articles 28 and 30 of the EC Treaty;
the reversal of the burden of proof on compliance with the essential requirements set out in the New Approach Directives.
In particular, this last point is no small thing. Given that products are placed on the market under the responsibility of the manufacturer, the authorised representative or the importer, using a legal fiction that reverses the burden of proof means that a product bearing the CE marking can only be challenged if the infringement of the requirements of the relevant directive is actually proven in court.
Conversely, failure to comply with the obligations relating to the CE marking or the undue CE marking, where it is mandatory, leads to the withdrawal of the product by the competent market surveillance authority[52]. The procedures and sanction measures laid down for the infringement of the CE marking vary according to the legislation in force in the individual Member States. In proportion to the extent of the infringement, economic operators are subject to penalties ranging from fines to imprisonment. If the infringement does not involve immediate health risks for users, the producer will not be obliged to withdraw the goods from the market, provided that he takes the necessary measures to obtain CE conformity. However, the provisions concerning civil law remain unaffected.
In the civil law field, given that the mandatory CE marking represents a precondition for the placing on the market of products, the defect in the CE marking[53] completes the case of the sale of aliud pro alio. The aliud pro alio formula means the breach of contract in the performance obligations[54] for which the buyer who finds such a defect will be protected by the general rules on termination for breach of contract pursuant to Article 1453 et seq. of the Civil Code.

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