What are the current national standards for consumer product safety - Are there differences according to product types?
The Ministry of Enterprises and Made in Italy ensures the conformity and safety of products intended for final consumers and others through surveillance actions on goods already placed on the market and those imported from non-EU countries that, according to the provisions of Article 25 of EU Regulation 2019/1020, are subject to customs detention.
- Operates in the field of product conformity and safety, in particular as it concerns:
- Toys (Legislative Decree N. 54/2011);
- Low‑voltage electrical equipment (Legislative Decree N. 86/2016);
- Personal protective equipment (PPE) (Legislative Decree N. 17/2019);
- Goods liable to generate electromagnetic disturbance (Legislative Decree N. 80/2016);
- Goods classified as pressure equipment (Legislative Decree N. 26/2016);
- Simple pressure vessels (Legislative Decree N. 311/91)
- Appliances burning gaseous fuels (Law N. 1083/1971 as amended);
- Construction products (Legislative Decree N. 106/2017);
- Machinery (Legislative Decree N. 17/2010);
- Recreational craft and personal watercraft (Legislative Decree N. 5/16)
- Lifts and safety components (Decree of the President of the Republic N. 162/99)
- Equipment and protective systems intended for use in potentially explosive atmospheres (Legislative Decree N. 85/16).
- Operates also in the field of general product safety in accordance with Directive 2001/95/EC, pursuant to Legislative Decree N. 206/2005 (Part IV, Title I of the Consumer Code).
(Legislative Decree N. 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 N. 86 of 19 May 2016. That Decree establishes the essential safety requirements that electrical equipment must have in order to be made available on the EU market, so as to ensure a high level of protection of the health of people and domestic animals.
Electrical equipment that falls under the scope of application of Legislative Decree No 86/2016 must have a voltage rating of between 50 and 1 000 V for alternating current and between 75 and 1 500 V for direct current, excluding the following materials and phenomena:
- Electrical equipment for use in an explosive atmosphere
- Electrical equipment for radiology and medical purposes
- Electrical parts for goods and passenger lifts
- Electricity meters
- Plugs and socket outlets for domestic use
- Electric fence controllers
- Radio-electrical interference
- Specialised electrical equipment, for use on ships, aircrafts or railways, which complies with the safety provisions drawn up by international bodies in which the Member States participate.
- Custom-built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.
When placing their electrical equipment on the market, manufacturers shall ensure that it has been designed and manufactured in accordance with the safety objectives referred to in Article 3 and set out in Annex I. Manufacturers shall draw up the technical documentation referred to in Annex III and carry out the conformity assessment procedure referred to in Annex III or have it carried out.
Where compliance of electrical equipment with the safety objectives referred to in Article 3 and set out in Annex I has been demonstrated by the conformity assessment procedure referred to in the first subparagraph, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.
(Legislative Decree 6 November 2007, n. 194 as amended)
Directive 2014/30/EU, relating to electromagnetic compatibility, is transposed by Legislative Decree N. 80 of 18 May 2016. That Decree amends preceding Legislative Decree N. 194 of 6 November 2007 implementing Directive 2004/108/EC.
Legislative Decree N. 80/2016 relates the ability of equipment to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to other equipment in that environment. It concerns any finished appliance or combination thereof made available on the market as a single functional unit, intended for the end-user and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance, including components’ or ‘sub-assemblies’ intended for incorporation into an apparatus by the end-user, which are liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance; (2) ‘mobile installations’ defined as a combination of apparatus and, where applicable, other devices, intended to be moved and operated in a range of locations.
When placing their apparatus on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in Annex I. Manufacturers shall draw up the technical documentation referred to in Annex II or Annex III and carry out the relevant conformity assessment procedure referred to in Article 14 or have it carried out. Where compliance of apparatus with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.
(Legislative Decree N. 25 february 2000, n. 93 as amended)
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. Excluded from the scope of the directive are the cases referred to in Article 2, Paragraph 2.
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 superheated water at temperatures higher than 110°C, etc).
The conformity assessment procedures to be applied vary module according to the category to which the pressure equipment belongs (from Form A to Form H).
(Legislative Decree No. 311, Sept. 27, 1991, as amended).
Simple pressure vessels
The Legislative decree shall apply to simple pressure vessels (‘vessels’) manufactured in series with the following characteristics:
(a) The vessels are welded, intended to be subjected to an internal gauge pressure greater than 0,5 bar and to contain air or nitrogen, and are not intended to be fired;
(b) The parts and assemblies contributing to the strength of the vessel under pressure are made either of non-alloy quality steel or of non-alloy aluminium or non-age hardening aluminium alloys;
(c) The vessel is made of either of the following elements: (i) a cylindrical part of circular cross-section closed by outwardly dished and/or flat ends that revolve around the same axis as the cylindrical part; (ii) two dished ends revolving around the same axis;
(d) The maximum working pressure of the vessel does not exceed 30 bar and the product of that pressure and the capacity of the vessel (PS × V) does not exceed 10 000 bar.L;
(e) The minimum working temperature is no lower than – 50 °C and the maximum working temperature is not higher than 300 °C for steel and 100 °C for aluminium or aluminium alloy vessels.
This Directive shall not apply to: (a) vessels specifically designed for nuclear use, failure of which may cause an emission of radioactivity; (b) vessels specifically intended for installation in or the propulsion of ships and aircraft; (c) fire extinguishers.
Before placing on the market a vessel of which the product of PS × V exceeds 50 bar.L, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 13 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the vessel bears the CE marking and the inscriptions provided for in point 1 of Annex III and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article 6(5) and (6).
(Legislative Decree N. 17 of 27 January 2010)
Directive 2006/42/EC, commonly known as the Machinery Directive, transposed in Italy by Legislative Decree N. 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 on 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.
The definition of a machine includes:
- An assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which is joined together for a specific application,
- An assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,
- An assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure,
- Assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole, — an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort.
Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall ensure that it satisfies the relevant essential health and safety requirements set out in Annex I and that the technical file referred to in Annex VII, part A is available; also, provide, the necessary information, carry out the appropriate procedures for assessing conformity in accordance with Article 12 and draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A that it accompanies the machinery and affixes the CE marking in accordance with Article 16.
REGULATION (EU) 2016/426
(Law No. December 6, 1971, No. 1083, as amended)
Appliances burning gaseous fuels
The Regulation establishes the essential safety requirements for the manufacture and conformity assessment procedures of any appliance and fitting that, during normal use, burns gaseous fuel for cooking, refrigeration, air-conditioning, space heating, hot water production, lighting or washing, and also requires draught burners and heating bodies to be equipped with such burners.
This Regulation does not apply to appliances specifically designed:
(a) For use in industrial processes carried out on industrial premises;
(b) For use on aircrafts and railways;
(c) For research purposes for temporary use in laboratories.
When placing their appliances or fittings on the market or when using the appliances for their own purposes, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in Annex I. Manufacturers shall draw up the technical documentation referred to in Annex III (‘technical documentation’) and carry out the relevant conformity assessment procedure referred to in Article 14 or have it carried out. Where compliance of an appliance or a fitting with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.
(Legislative Decree N. 206 of 6 September 2005)
Legislative Decree N. 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, provided or made available for consideration or free of charge as part 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, including duration and, where appropriate, commissioning, installation and maintenance, either presents no risk or presents only minimal risks that are compatible with the use of the product and are considered acceptable in observance of a high level of protection for the health and safety of persons in accordance with the elements set out in Article 103. 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).
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/SAFETY GATE system (Article 110).
(Legislative Decree N. 54 of 11 April 2011)
Legislative Decree N. 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, slings and catapults.
Annex I contains a list of the products that are not considered 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 for 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.
REGULATION (EU) 425/2016
(Legislative Decree No 17 of 19 February 2019)
Personal protective equipment
Legislative Decree N. 475/92, as amended by Legislative Decree N. 17/2019, brought national legislation in line with the provisions of Regulation (EU) 425/2016 on personal protective equipment (PPE). The Regulation is directly applicable and it 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 is 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. When placing PPE on the market, manufacturers shall ensure that it has been designed and manufactured in accordance with the applicable essential health and safety requirements set out in Annex II. L 81/58 EN Official Journal of the European Union 31.3.2016 2. Manufacturers shall draw up the technical documentation referred to in Annex III (‘technical documentation’) and carry out the applicable conformity assessment procedure referred to in Article 19 or have it carried out. Where compliance of PPE with the applicable essential health and safety requirements has been demonstrated by the appropriate procedure, manufacturers shall draw up the EU declaration of conformity referred to in Article 15 and affix the CE marking referred to in Article 16. PPE may be category I, II or III, depending on the risk against which the PPE is intended to protect (Annex I to Regulation 2016/425):
- Category I – minimal risks;
- Category II – risks other than those under I and III;
- Category III – risks that may cause very serious consequences, such as death or irreversible damage to health.
The functions of the supervisory Authorities are performed by the Ministry of Enteprises and Made in Italy and the Ministry of Labour and Social Policies, according to their respective competencies.
REGULATION (EU) 305/2011
(Legislative Decree N. 106 of 16 June 2017)
Regulation (EU) No. 305/11 - Construction Products Regulation (CPR) No. 305/11 is implemented by Legislative Decree No. 106/2017. The CPR applies to construction products and repeals Council Directive 89/106/EEC.
The Regulations set conditions for placing or making available on the market of construction products by establishing harmonized provisions for the description of the performance of such products in relation to their essential characteristics and for the use of CE marking on such products. ‘Construction product’ means any product or kit that is produced and placed on the market for incorporation in a permanent manner in construction works or parts thereof and whose performance has an effect on the performance of the construction works with respect to the basic requirements for construction works. The competent Administrations are: the Higher Council of Public Works at the Ministry of Infrastructure and Transport, for the basic requirement of works No. 1 (Mechanical Strength and Stability), the Ministry of the Interior for the basic requirement of works No. 2 (Safety in case of fire), and the Ministry of Enterprise and Made in Italy for the remaining basic requirements of construction works in Annex I of Regulation (EU) No. 305/2011. In addition, the essential characteristics of construction products are established in the harmonized technical specifications according to the basic requirements of construction works. When a construction product falls within the scope of a harmonized standard or is in conformity with a European Technical Assessment issued for that product, the manufacturer shall draw up a declaration of performance when placing that product on the market. CE marking may be affixed only to construction products for which the manufacturer has drawn up a declaration of performance.
(Legislative Decree N. 5 of April 18, 2016)
Recreational craft and personal watercraft
The Directive establishes requirements for the design and manufacture: of recreational craft and partially completed recreational craft; personal watercraft and partially completed personal watercraft; components listed in Annex II when placed on the Union market separately; propulsion engines installed or specifically intended for installation on or in recreational craft; propulsion engines installed on or in recreational craft subject to major engine modification; and recreational craft subject to major conversion.
Products referred to in Article 2, Paragraph 1 of Legislative Decree 5/16 may be made available or put into service only if they do not endanger the health and safety of persons, property, or the environment, when properly maintained and used in accordance with their intended purpose, and only on the condition that they meet the essential requirements of Annex II of Legislative Decree N. 171 of July 18, 2005, as replaced by Annex I of Legislative Decree 5/16.
The prevailing functions of the market surveillance Authority are carried out by the Ministry of Infrastructure and Transport - General Command of the Port Authority Corps.
(Decree of the president of the Republic 30 aprile 1999, n. 162 as amended)
Lifts and safety components for lifts
The Lifts Directive applies to lifts permanently serving buildings/constructions and intended for the transport of: a) persons; b) persons and goods; c) goods alone if the carrier is accessible (meaning that a person may enter it without difficulty) and is fitted with controls situated inside the carrier or within reach of a person inside the carrier.
The Lifts Directive does not apply to: a) lifting appliances whose speed is not greater than 0,15 m/s; b) construction site hoists; c) cableways, including funicular railways; d) lifts specially designed and constructed for military or police purposes; e) lifting appliances from which work can be carried out; f) Mine winding gear; g) lifting appliances intended for lifting performers during artistic performances; h) lifting appliances fitted in means of transport; l) Lifting appliances connected to machinery and intended exclusively for access to workstations, including maintenance and inspection points on the machinery; m) Rack and pinion trains; n) Escalators and mechanical walkways.
If, for a lift or a safety component for lifts, the risks referred to in this Regulation are regulated, in whole or in part, by specific Union legislation or the relevant national implementing rules, the Decree shall not apply or shall cease to apply to these elevators or safety components for elevators and these risks as soon as such specific Union legislation or the relevant national implementing rules become applicable.
(Legislative Decree 19 maggio 2016, n. 85 e s.m.i.)
EQUIPMENT & PROTECTIVE SYSTEMS FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES
The Directive 2014/34/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 equipment and protective systems intended for use in potentially explosive atmospheres Scope The Directive (ATEX) applies to the following (hereafter referred to as “products”): a) Equipment, or combinations of equipment, and protective systems intended for use in potentially explosive atmospheres; b) Safety devices, controlling devices and regulating devices for use outside potentially explosive atmospheres but required for or contributing to the safe functioning of equipment and protective systems with respect to the risks of explosion.
The ATEX Directive does not regulate the explosion protection at the workplace. Protective measures to avoid explosion hazards, amongst others the installation and use of equipment in a potentially explosive atmosphere, are covered by different EU or national legislation (for instance, Directive 1999/92/EC on minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres, Council Directive 89/391/EEC on improving the safety and health of workers at work and Directive 2012/18/EU on prevention of major accidents involving hazards dangerous substances).
- LEGISLATIVE DECREE N. 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 N. 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 N. 93, of 25 Febraury, 2000, as amended Implementing Directive 97/23/EC on pressure equipment and Directive 2014/68/EU on the harmonization of the laws of the Member States concerning the making available on the market of pressure equipment (recast), providing for its repeal.
- LEGISLATIVE DECREE N. 17 of 27 January 2010 implementing Directive 2006/42/EC on machinery, and amending Directive 95/16/EC on lifts
- LEGISLATIVE DECREE N. 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
- LAW n. 1083 of 6 December, 1971, as amended 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 N. 206 of 6 September 2005 Consumer Code, pursuant to Article 7 of Law No 229 of 29 July 2003
- LEGISLATIVE DECREE N. 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 N. 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 N. 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
- DECREE OF THE PRESIDENT OF THE REPUBLIC N. 162 of April 30, 1999, Regulation laying down rules for the implementation of Directive 2014/33/EU, relating to elevators and safety components of elevators, and for the operation of elevators.
- LEGISLATIVE DECREE N. 85 of May 19, 2016 Implementation of Directive 2014/34/EU on the harmonization of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres
- LEGISLATIVE DECREE No. 311 of September 27, 1991 Implementation of Directives No. 87/404/EEC and No. 90/488/EEC on simple pressure vessels, pursuant to Article 56 of Law No. 428 of December 29, 1990.
- LEGISLATIVE DECREE N. 5 of January 11, 2016 Implementation of Directive 2013/53/EU of the European Parliament and of the Council of November 20, 2013, relating to recreational craft and personal watercraft and repealing Directive 94/25/EC