Consumer rights: consumer product safety
What national provisions on consumer product safety are currently in force – Do these differ depending on the types of product?
The Ministry of Economic Development – Directorate‑General for the Market, Competition, Consumer Protection and Technical Standards – ensures the conformity and safety of products intended for intermediate and end consumers, by monitoring goods already placed on the market and those imported from non‑EU countries, which, pursuant to Article 27 of Regulation (EC) No 765/2008, must be held at customs.
- operates in the field of product conformity and safety, in particular as concerns:
- toys (Legislative Decree No 54/2011);
- low‑voltage electrical equipment (Legislative Decree No 86/2016);
- personal protective equipment (PPE) (Legislative Decree No 17/2019);
- goods liable to generate electromagnetic disturbance (Legislative Decree No 80/2016);
- goods classified as pressure equipment (Legislative Decree No 26/2016);
- appliances burning gaseous fuels (Legislative Decree No 23/2019);
- construction products (Legislative Decree No 106/2017);
- goods covered by legislation on machinery (Legislative Decree No 17/2010);
- operates in the field of general product safety in accordance with Directive 2001/95/EC, pursuant to Legislative Decree No 206/2005 (Part IV, Title I, of the Consumer Code).
(Legislative Decree No 86 of 19 May 2016)
Directive 2014/35/EU, relating to electrical equipment designed for use within certain voltage limits, is transposed by Legislative Decree No 86 of 19 May 2016. That Decree establishes the essential safety requirements that electrical equipment must meet in order to be made available on the EU market, so as to ensure a high level of protection of the health of persons and domestic animals.
Electrical equipment that falls under the scope of application of Legislative Decree No 86/2016 must generally have a voltage rating of between 50 and 1 000 V for alternating current and between 75 and 1 500 V for direct current. The conformity assessment procedure whereby the manufacturer fulfils the obligations laid down by Legislative Decree No 86/2016 is Form A – Internal production control, as specified in Decision No 768/2008.
There are no discrepancies between the Directive and the Italian transposition.
(Legislative Decree No 80 of 18 May 2016)
Directive 2014/30/EU, relating to electromagnetic compatibility, is transposed by Legislative Decree No 80 of 18 May 2016. That Decree amends preceding Legislative Decree No 194 of 6 November 2007 implementing Directive 2004/108/EC.
Legislative Decree No 80/2016 relates to electrical and electronic equipment that may generate electromagnetic disturbance or the performance of which is liable to be affected by disturbance generated by other sources of disturbance.
Equipment whose emission level does not reach an intensity that prevents normal operation of radio and telecommunications equipment and that has a level of immunity in its intended operating conditions, such as to prevent deterioration of normal operation, are considered to comply with the Directive.
Compliance of apparatus with the essential requirements set out in Legislative Decree No 80/2016 is demonstrated by means of either of the following conformity assessment procedures:
- Form A – Internal production control
- Form B – EU type examination
There are no discrepancies between the Directive and the Italian transposition.
(Legislative Decree No 26 of 15 February 2016)
Directive 2014/68/EU, relating to pressure equipment, is transposed by Legislative Decree No 26 of 15 February 2016. That Decree amends preceding Legislative Decree No 93 of 25 February 2000 implementing Directive 97/23/EC.
The provisions of the Decree apply to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0.5 bar.
Pressure equipment is classified by category according to an ascending level of hazard and the fluid contained therein (oxidising gases, flammable liquids, generation of steam or super‑heated water at temperatures higher than 110°C, etc).
The conformity assessment procedures to be applied vary according to the category to which the pressure equipment belongs (from Form A to Form H).
(Legislative Decree No 17 of 27 January 2010)
Directive 2006/42/EC, commonly known as the Machinery Directive, transposed in Italy by Legislative Decree No 17/2010, applies to the following products:
- machinery itself;
- interchangeable equipment;
- safety components;
- lifting accessories;
- chains, ropes and webbing;
- removable mechanical and partly completed mechanical transmission devices.
The following are excluded:
- safety components intended to be used as spare parts;
- equipment for use in fairgrounds;
- machinery designed or put into service for nuclear purposes;
- motor vehicles;
- means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport;
- vessels and offshore platforms;
- machinery installed on board vessels;
- machinery for military or police purposes;
- machinery for research purposes for temporary use in laboratories;
- mine winding gear;
- machinery intended to move performers during artistic performances;
- electrical equipment falling under Directive 2006/95/EC;
- high‑voltage electrical equipment.
Although the definition of machinery is very broad, it can be summarised through three fundamental requirements:
- an assembly of linked components, at least one of which moves;
- the components are joined together for a specific application;
- the components are moved by power other than directly applied human or animal effort.
In the absence of requirement no. 2, the assembly is classified as partly completed machinery. Weight lifting appliances are also classified as machinery in the absence of requirement no. 3. There are no discrepancies between Legislative Decree No 17/2010 and the Directive as regards the scope of application.
REGULATION (EU) 2016/426
(Legislative Decree No 23 of 21 February 2019)
(Presidential Decree No 121 of 6 August 2019)
Appliances burning gaseous fuels
Regulation (EU) 2016/426 on appliances burning gaseous fuels, published in the OJEU on 31 March 2016, does not require transposition, but merely measures for adaptation, which were adopted by way of two separate contextual measures: LEGISLATIVE DECREE No 23 of 21 February 2019, published in Official Gazette of the Italian Republic No 72 of 26 March 2019, and PRESIDENTIAL DECREE No 121 of 6 August 2019, published in Official Gazette No 248 of 22 October 2019.
The Regulation establishes the essential safety requirements on manufacture and conformity assessment procedures of any appliance and fitting that, during normal use, burns gaseous fuel; the Regulation also seeks to monitor gas types and corresponding supply pressures of gaseous fuels used in the individual territories of the European Union – competence of the Directorate‑General for Infrastructure and Security of Energy and Geomineral Systems (information also published in the Official Journal of the European Union).
Specifically, Legislative Decree No 23 of 21 February 2019 lays down provisions on surveillance, as confirmed by Regulation (EC) 765/2008, and sanctions, whereas Presidential Decree No 121 of 6 August 2019 implements all the articles placed at the discretion of the individual Member States, as specified in the Regulation (choice of language, conformity assessment bodies, notification and notifying authorities and charges relating to conformity assessment procedures).
(Legislative Decree No 206 of 6 September 2005)
Legislative Decree No 206/2005 ‘Consumer code’, Part IV ‘Safety and quality’ (Title I ‘Product safety’) which transposed Directive 2001/95/EC on general product safety, applies to all products to be used by consumers supplied in the course of a commercial activity, regardless of whether those products are new, used or reconditioned (with the exception of second‑hand products supplied as antiques or as products to be repaired or reconditioned prior to being used).
The aim is to ensure that products placed on the market are safe under normal or reasonably foreseeable conditions of use, do not present any risk or only the minimum risks compatible with the product’s use, and are consistent with a high level of protection for the safety and health of persons.
The legislation is horizontal insofar as it applies to aspects and risks not covered by specific provisions issued at European level (harmonising legislation of the EU) for products that do not require the CE marking to be affixed (for example childcare articles, furniture, bicycles).
The legislation also regulates:
- the obligations of the manufacturer and the distributor (Article 104);
- the presumption of product safety (Article 105);
- the type of restrictive measures that may be adopted by supervisory authorities (Article 107);
- the tools that can be used to ensure valid and effective market surveillance activities (Article 109); and
- the procedures for notifying and exchanging information on the measures adopted to restrict the movement of products that present a serious risk through the RAPEX system (Article 110).
(Legislative Decree No 54 of 11 April 2011)
Legislative Decree No 54/2011, transposing Directive 2009/48/EU, applies to products designed, whether or not exclusively, for use in play by children under 14 years of age (Article 2), with the exception of:
- playground equipment intended for public use;
- automatic playing machines, whether coin operated or not, intended for public use;
- toy vehicles equipped with combustion engines;
- toy steam engines and slings and catapults.
Annex I contains a list of the products that are not considered to be toys and are excluded from the scope of application of the Decree in question.
The Decree regulates:
- the essential safety requirements (warnings and instructions for use);
- the particular safety requirements indicated in Annex II (physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene and radioactivity);
- the presumption of conformity of toys (Article 15);
- the safety assessments and procedures with which the manufacturer must comply to assess the conformity of a toy (Article 16).
The manufacturer of the toy declares compliance with these requirements by issuing an EU declaration of conformity, whereby it assumes responsibility for assessing the conformity of the toy and affixing the CE marking. Economic operators (manufacturers, authorised representatives, importers and distributors) must comply with the obligations laid down in Articles 3 to 8, with non‑compliance resulting in the market surveillance authority adopting the restrictive measures established in Article 30 (request for compliance, marketing ban, and market withdrawal or recall), proportional to the severity of the infringement committed, and the chambers of commerce issuing the appropriate sanctions under law.
REGULATION (EU) 425/2016
(Legislative Decree No 17 of 19 February 2019)
Personal protective equipment
Legislative Decree No 475/92, as amended by Legislative Decree No 17/2019, brought national legislation in line with the provisions of Regulation (EU) 425/2016 on personal protective equipment (PPE). As the Regulation is directly applicable, unlike the Directive, it does not need to be transposed by the Member State, save for the provisions on sanctions regulated by the Member States (Article 14 of Legislative Decree No 475/92). The legislation applies to equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety.
Personal protective equipment used for the following purposes are excluded:
- by the armed forces or in the maintenance of law and order;
- for self‑defence, with the exception of PPE intended for sporting activities;
- for private use to protect against atmospheric conditions that are not of an extreme nature or damp and water during dishwashing;
- for use on seagoing vessels or aircraft that are subject to the relevant international treaties; and
- by drivers and passengers of motorcycles and mopeds (helmets and visors).
PPE must meet the essential safety requirements specified in Annex II to Regulation 2016/425; it is presumed to be compliant if it has the CE marking affixed and the manufacturer provides the documentation required under Article 15 and Annex III to the PPE Regulation (EU declaration of conformity and technical documentation), and, as regards category II and III PPE, the certification required under Annexes V, VI, VII and VIII of the PPE Regulation. PPE may be category I, II or III, depending on the risk against which the PPE is intended to protect:
- Category I – minimal risks;
- Category II – risks other than those under I and III;
- Category III – risks that may cause very serious consequences (Annex I to Regulation 2016/425).
The functions of the supervisory authorities are performed by the Ministry of Economic Development and the Ministry of Labour and Social Policies, according to their respective competencies.
REGULATION (EU) 305/2011
(Legislative Decree No 106 of 16 June 2017)
Legislative Decree No 106/2017 applies to all construction products, lays down harmonised conditions for the marketing of construction products, and repeals Council Directive 89/106/EEC. The Construction Products Regulation (CPR) aims to remove barriers to the free movement of construction products within the European Union through the sharing of common assessment criteria, by defining the concept of ‘CE marking’ within the specific scope of the construction field. Construction products are, by their very nature (namely that of being incorporated into construction works), defined as intermediate products and the concepts of ‘safety’ and ‘general interest’ associated with CE marking are applied in consideration of their contribution to meeting the basic requirements (Annex I) for the works into which they are incorporated. The CPR also aims to ensure that information regarding performance or the essential characteristics of the products (Annex III) and the constancy of their performance (Annex V) is reliable, so as to ensure that the products are used appropriately to carry out civil construction works. Consequently, the CPR sets out the conditions for market placement by establishing harmonised provisions outlining performance of the essential characteristics and to define the guidelines to be adopted on the use of CE marking. Finally, the CPR sets out the requirements of the Technical Assessment Bodies, which are tasked with ensuring the soundness of the basic requirements, the performance of essential characteristics and the constancy thereof (Annex IV), as well as procedures for adopting European Assessment Documents (Annex II).
- LEGISLATIVE DECREE No 86 of 19 May 2016 implementing Directive 2014/35/EU on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
- LEGISLATIVE DECREE No 80 of 18 May 2016 amending Legislative Decree No 194 of 6 November 2007 implementing Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast).
- LEGISLATIVE DECREE No 26 of 15 February 2016 implementing Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast)
- LEGISLATIVE DECREE No 17 of 27 January 2010 implementing Directive 2006/42/EC on machinery, and amending Directive 95/16/EC on lifts
- LEGISLATIVE DECREE No 23 of 21 February 2019 implementing the delegation referred to in Article 7(1) and (3) of Law No 163 of 25 October 2017 for the adaptation of national legislation to the provisions of Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC
- PRESIDENTIAL DECREE No 121 of 6 August 2019 Regulation implementing the delegation referred to in Article 7(4) and (5) of Law No 163 of 25 October 2017 to adapt national regulations to the provisions of Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC
- LEGISLATIVE DECREE No 206 of 6 September 2005 Consumer Code, pursuant to Article 7 of Law No 229 of 29 July 2003
- LEGISLATIVE DECREE No 54 of 11 April 2011 implementing Directive 2009/48/EC on the safety of toys. This Decree applies to products designed, whether or not exclusively, for use in play by children under 14 years of age.
- LEGISLATIVE DECREE No 17 of 19 February 2019 adapting national legislation to the provisions of 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
- LEGISLATIVE DECREE No 106 of 16 June 2017 adapting national legislation to the provisions of Regulation (EU) No 305/2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC