Product Safety

PRODUCT SAFETY Ing. Hana Věžníková, Ph.D. Subject „Product safety“ •The subject contains information on the system for ensuring the safety of products before they are placed on the market. •Key principle: The producers are obliged to place on the market only products which are safe. •The subject applies to non-food product only. 1 What can be endangered by the product? •Product user safety - danger to health or life of users. •Safety of others persons. •Property and life of animals. •Environment. 2 How can the product endanger the user? •Direct hazards, e.g. ultrasound, laser beam, hot parts, sharp edges, moving parts, insufficient or unclear information - inappropriate instructions and subsequent inappropriate use of the product. •Indirect hazard, e.g. the materials materials that emit toxic substances (children lick their toys - phtalates, some glues in furniters release the solvents). 3 Damage of enviroment •Products that produces impermissible amounts of harmful substances during its operation. •Products containing highly toxic substances that contaminates the environment due to improper disposal. •Product producing an unacceptable noise level. 4 Damage of property •The product endangers its surroundings due to the possibility of fire or explosion. •Destruction of the product during operation and consequent damage to the building. •Subsequent damage caused by product malfunction, eg non-compliance with set temperatures, flow rates, etc. 5 Is there some product without danger by its usage? •No, each product can be dangerous. •The level of danger can be different. •Exmple: spade – excavator. 6 The main regulation – Directive 2001/95/EC •The purpose of this Directive is to ensure that products placed on the market are safe: The producers are obliged to place on the market only products which are safe. •The directive distributes all products to two groups: •the less dangerous products - all its provisions apply, •the more dangerous – only some provisions are valid. 7 DIRECTIVE 2001/95/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 3 December 2001 on general product safety •Each of its provisions shall apply in so far as there are no specific provisions with the same objective in rules of Community law governing the safety of the products concerned. 8 The main legislative documents for unharmonized products •Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council Text with EEA relevance •COUNCIL DIRECTIVE of 25 June 1987 on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers (87/357/EEC) 15 Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (Text with EEA relevance) •The Directive aims at ensuring that each and every products placed on the market are safe. •It applies to all the products which are intended for consumers or likely to be used by consumers even if not intended for them, and are supplied or made available, whether for consideration or not, in the course of a commercial activity, and whether new, used or reconditioned. •The regulation includes definitions, responsibilities of persons and state authorities and information on the RAPEX system •EUR-Lex - 32001L0095 - EN - EUR-Lex (europa.eu) 16 Cardinal definitions •‘product’ shall mean any product — including in the context of providing a service —which is intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them, and is supplied or made available, whether for consideration or not, in the course of a commercial activity, and whether new, used or reconditioned. •This definition shall not apply to second-hand products supplied as antiques or as products to be repaired or reconditioned prior to being used, provided that the supplier clearly informs the person to whom he supplies the product to that effect •note: Antiques, are collectively important items from various fields of fine arts, crafts, industrial design or the history of technology, which have not been produced or used for a long time, and are therefore relatively rare. They are usually made by hand or made in factories made of natural materials, and are often artistically and historically valuable. The Monuments Act sets a minimum age of 50 for antiques, but due to rapid changes in technology and the range of production and fashion, this limit is still decreasing. 17 Safe product •A "safe product" is a product which, under normal or reasonably foreseeable conditions of use including duration and, where applicable, putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons, taking into account in particular its characteristics, package and presentation, special groups of consumers (elderly or young people) and effects on other products. •knife – blade, •iron - hot surface 18 Next definition •‘dangerous product’ shall mean any product which does not meet the definition of ‘safe product’ •‘serious risk’ shall mean any serious risk, including those the effects of which are not immediate, requiring rapid intervention by the public authorities •‘recall’ shall mean any measure aimed at achieving the return of a dangerous product that has already been supplied or made available to consumers by the producer or distributor 19 Producer and distributor •(i) the manufacturer of the product, when he is established in the Community, and any other person presenting himself as the manufacturer by affixing to the product his name, trade mark or other distinctive mark, or the person who reconditions the product; •(ii) the manufacturer's representative, when the manufacturer is not established in the Community or, if there is no representative established in the Community, the importer of the product; •(iii) other professionals in the supply chain, insofar as their activities may affect the safety properties of a product; •‘distributor’ shall mean any professional in the supply chain whose activity does not affect the safety properties of a product; 20 Responsibility of person •It is the producer's responsibility to place only safe products on the market. •Producers shall provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use. •The producer has to take precautionary measures against these risks which can be information for consumers, recall of products or withdrawal products from the market. •If producers or distributors become aware that a product is dangerous, they must inform national authorities and cooperate with them. 21 Responsibility of state authorities •Member States shall ensure that producers and distributors comply with their obligations under this Directive in such a way that products placed on the market are safe. •They shall establish or nominate authorities competent to monitor the compliance of products with the general safety requirements. 22 Responsibility of state authorities •Member States shall ensure that producers and distributors comply with their obligations under this Directive in such a way that products placed on the market are safe. •They shall establish or nominate authorities competent to monitor the compliance of products with the general safety requirements. 23 Responsibility of state authorities •Member States shall ensure that producers and distributors comply with their obligations under this Directive in such a way that products placed on the market are safe. •They shall establish or nominate authorities competent to monitor the compliance of products with the general safety requirements. 24 CE Marking Directives and Regulations 6. Construction Products Regulation –Regulation (EU) No 305/2011 7. Pressure Equipment Directive –2014/68/EU 8. REACH – Regulation (EC) No 1907/2006 9. RoHS – Restriction of Hazardous Substances – Directive – 2011/65/EU 10. Waste Electrical and Electronic Equipment Directive – 2012/19/EU 11. ATEX Directive – 2014/34/EU 12. Toy Directive – 2009/48/EU 31 CE Marking Directives and Regulations 13.Radio Equipment Directive – 2014/53/EU 14.Recreational Craft Directive – 2013/53/EU 15.Active Implantable Medical Devices Directive – 90/385/EEC 16.Explosive for Civil Use Directive – 93/15/EEC 17.Noise Emission in the Environment Directive – 2000/14/EC 18.Gas Appliances Directive – 2009/142/EC 19.Lifts Directive – 2014/33/EU 20.Pyrotechnic Directive – 2007/23/EC 21.Measuring Instruments Directive – 2004/22/EC 32 One or more directive/regulation can apply to a single product •Machinery (such as packaging machines, metal presses, mixers, drills etc), for example may be covered by (among others): •Machinery Directive (2006/42/EC) •EMC Directive (2014/30/EU) •Electrical equipment (such as lighting, power adapters), for example may be covered by (among others): •Low Voltage Directive (2014/35/EU) •EMC Directive (2014/30/EU) •RoHS Directive (2011/65/EU) •Electronic equipment (such as computers, tables, smartphones), for example may be covered by (among others): •EMC Directive (2014/30/EU) •Low Voltage Directive (2014/35/EU) •Radio Equipment Directive (2014/53/EU) •RoHS Directive (2011/65/EU) 33 Do my products need CE marking? •There is no authority that provides a product lists or nomenclature that names the products that require CE. •Recommended method: •The CE marking is required only for certain products intended to be sold in the countries of the European Economic Area (EEA) •The CE marking is required only for products for which a CE marking directive or regulation has been adopted 34 Products that do not require CE •Chemicals •Pharmaceuticals •Cosmetics •Foodstuffs •Products not covered by the European CE marking directives may still fall within the scope of other EU or national legislation. If no CE directive or regulation applies, the General Product Safety Directive (2001/95/EC) may apply. This General Product Safety Directives requires that products are safe, but is does not require any marking. 35 The directives and harmonized standards •Directives set out the essential requirements, written in general terms. They limit legislative harmonisation to a number of essential requirements that are of public interest. •Essential requirements define the results to be attained, or the hazards to be dealt with, but do not specify the technical solutions for doing so. •The precise technical solution may be provided by a standard or by other technical specifications or be developed in accordance with general engineering or scientific knowledge laid down in engineering and scientific literature at the discretion of the manufacturer. •European Harmonized standards provide the detailed technical information to meet the essential requirements. Therefore, harmonized standards are linked to the essential requirements in the directives. This process is called harmonization 36 For example: TOY •Toys products designed or intended for use by children under 14 years of age are covered under the Toy Safety Directive and, as such, need to be CE marked. In order to comply with the directive, besides preparing all the relevant documentation such as Declaration of Conformity and technical file, your toys shall also comply with the EN 71 standards: •Here are some example of EN 71 standards: •EN 71-1: Mechanical and physical properties •EN 71-2: Flammability •EN 71-3: Specification for migration of certain elements •If you are planning to import electronic toys, you shall comply with both EN 71 and EN 62115 standards. 37 Harmonized standards for GPSD •The EU’s General Product Safety Directive covers “any product…which is intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them, and is supplied or made available, whether for consideration or not, in the course of a commercial activity, and whether new, used or reconditioned.” •The Commission of the European Union (EU) has published an updated list of standards that can be used to demonstrate compliance with the essential requirements of its Directive 2001/95/EC, related to general product safety. •https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52017XC0811(14)&from=EN •These standards are intended for certain products only. The directive GPSD applies to many other products. 38 Technical standards Technical standards are inevitable tools that can help to provide product safety. The Standards can fulfill a number of tasks: •ensure the quality and safety of products and/or services •achieve compatibility between products and/or components •access markets and sell to customers in other countries •satisfy your customers’ expectations and requirements •reduce costs, eliminate waste and improve efficiency •comply with relevant legislation including EU regulations •gain knowledge about new technologies and innovations 39 Standardization •Law regulates the development of standards, their use and enforcement. •The standardization process in EU is concerned by EU Regulation on European Standardization 1025/2012. (REGULATION (EU) No 1025/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 on European standardisation) •The primary objective of standardization is the definition of voluntary technical or quality specifications with which current or future products, production processes or services may comply. Standardization can cover various issues, such as standardization of different grades or sizes of a particular product or technical specifications in product or services markets where compatibility and interoperability with other products or systems are essential. 40 Application of harmonisation legislation •Union harmonisation legislation applies when the product is placed on the market and to any subsequent operation which constitutes making available until it reaches the end-user. •Union harmonisation legislation applies to all forms of selling. A product offered in a catalogue or by means of electronic commerce has to comply with Union harmonisation legislation when the catalogue or website directs its offer to the Union market and includes an ordering and shipping system. •The Union harmonisation legislation applies to newly manufactured products but also to used and secondhand products imported from a third country when they enter the Union market for the first time •Union harmonisation legislation applies to finished products. •A product which has been subject to important changes or overhauls aiming to modify its original performance, purpose or type may be considered as a new product. The person who carries out the changes becomes then the manufacturer with the corresponding obligations. 47 Which Products Are Covered By The ATEX Directive (2014/34/EU)? •The ATEX Directive applies to equipment and protective systems intended for use in potentially explosive atmospheres. Safety devices, controlling devices, and regulating devices intended 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 are also covered by the scope of this Directive. •According to this Directive, ‘equipment’ means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy and/or the processing of material and which are capable of causing an explosion through their own potential sources of ignition. 48 Which Products Are Covered By The ATEX Directive (2014/34/EU)? •‘Protective systems’ means devices other than components of the equipment defined above which are intended to halt incipient explosions immediately and/or to limit the effective range of an explosion and which are separately placed on the market for use as autonomous systems. 49 Which Products Are Not Covered By The ATEX Directive (2014/34/EU)? •a) medical devices intended for use in a medical environment; •(b) equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances; •(c) equipment intended for use in domestic and noncommercial environments where potentially explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of fuel gas; •(d) personal protective equipment covered by Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment; •(e) seagoing vessels and mobile offshore units together with equipment on board such vessels or units; •(f) means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air or by road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, by public road or rail networks or by water. Vehicles intended for use in a potentially explosive atmosphere shall not be excluded from the scope of this Directive; •(g) the equipment used for national security by armed forces, police etc. 50 How to Comply with the ATEX Directive (2014/34/EU): •The ATEX Directive offers two ways to perform conformity assessment: 1.Internal Production Control or CE marking self-certification: the manufacturer performs the conformity assessment and documents the assessment in his own right. The internal production control applies to equipment and devices under Group II, Category 3. 2.Involvement of a Notified Body: in the case of equipment; autonomous protective systems; for safety devices for such equipment or systems; and for components for such equipment, systems or devices, under Groups I and II, Categories M1, M2, 1 and 2. 51 Classification of equipment and safety devices Group I •ANNEX I - CRITERIA DETERMINING THE CLASSIFICATION OF EQUIPMENT-GROUPS INTO CATEGORIES •Equipment-group I: equipment is intended for use in underground part of mine (gases, dust) •category M1 Equipment in this category is required to remain functional, even in the event of rare incidents relating to equipment, with an explosive atmosphere present. For example •employee life support systems –ventilation. •category M2 - This equipment is intended to be de-energised in the event of an explosive atmosphere. 52 Classification of equipment and safety devices Group II •Equipment category 1 - Equipment in this category is intended for use in areas in which explosive atmospheres caused by mixtures of air and gases, vapours or mists or by air/dust mixtures are present continuously, for long periods or frequently. •Equipment category 2 - Equipment in this category is intended for use in areas in which explosive atmospheres caused by gases, vapours, mists or air/dust mixtures are likely to occur occasionally. •Equipment category 3 - Equipment in this category is intended for use in areas in which explosive atmospheres caused by gases, vapours, mists, or air/dust mixtures are unlikely to occur or, if they do occur, are likely to do so only infrequently and for a short period only. 53 Notified body •Each directive covering your product specifies whether an authorised third party (Notified Body) must be involved in the conformity assessment procedure necessary for CE marking. •This is not obligatory for all products, so it is important to check whether the involvement of a Notified Body is indeed required. •These Bodies are authorised by national authorities and officially “notified” to the Commission and listed in the NANDO (New Approach Notified and Designated Organisations) database. 54 Type of assesment •Assesment of first party – producer: •conformity assessment is performed by the entity that is the supplier of the subject of conformity assessment, ie. the inspection is performed by an in-house entity that is also the author of the certificate of conformity (metallurgical certificate) • the second party - customer representative - Conformity assessment is performed by a person or organization that represents the interests of the user, ie the customer: customer audit input control 55 Customer audit •Customer audit serves to strengthen supplier-customer relationships, which are clearer and more transparent, increases the supplier's credibility and verifies its ability to deliver under the contract, respond to special customer requirements and, last but not least, increases customer confidence. In many companies, customer audit is part of the selection or supplier approval. •The third party - independent body, without obligation, any relationship to the manufacturer or product •Authorized body 56 Product testing by accredited laboratory •Laboratory are accredited by CAI – independent third party •Czech Accreditation Institute •In the Czech Republic, CAI has developed an accreditation system, in compliance with international requirements and rules (established by EC and EA), which seeks an achievement of a system comparable with the systems used in EU and EFTA countries. The activity was therefore, from the outset, focused on international co-operation with an objective to become member in the reputable international organisations dealing with accreditation and a signatory of multilateral agreements. 63 CAI – member of international organization 64 European Accreditation International Laboratory Accreditation Cooperation Technical documentation •The manufacturer has to establish the technical documentation required by the directive(s) for the assessment of the product’s conformity to the relevant requirements, and for the risk assessment. •Together with the EC declaration of conformity, the technical documentation must be presented on request to the appropriate national authorities (e.g. drawings, diagrams, protocol, test results) 65 Instruction to use – essential requirements – annex 2 •All equipment and protective systems must be accompanied by instructions, including at least the following particulars: •a recapitulation of the information with which the equipment or protective system is marked, together with any appropriate additional information to facilitate maintenance (e.g. address of the repairer, etc.); •instructions for safe: putting into service, use, assembling and dismantling, maintenance (servicing and emergency repair), installation and adjustment; •where necessary, an indication of the danger areas in front of pressure-relief devices and training instructions; •details which allow a decision to be taken beyond any doubt as to whether an item of equipment in a specific category or a protective system can be used safely in the intended area under the expected operating conditions; •electrical and pressure parameters, maximum surface temperatures and other limit values; where necessary, special conditions of use, including particulars of possible misuse which experience has shown might occur and the essential characteristics of tools which may be fitted to the equipment or protective •The instructions must contain the drawings and diagrams necessary for the putting into service, maintenance, inspection, checking of correct operation and, where appropriate, repair of the equipment or protective system, together with all useful instructions, in particular with regard to safety. 66 ANNEX X - Content of EU DECLARATION OF CONFORMITY •1.Product model/product (product, type, batch or serial number): •2. Name and address of the manufacturer and, where applicable, his authorised representative: •3. This declaration of conformity is issued under the sole responsibility of the manufacturer. •4. Object of the declaration (identification of product allowing traceability; it may, where necessary for the identification of the product, include an image): •5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation - i.e. references to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared •7. Where applicable, the notified body … (name, number) performed … (description of intervention) and issued the certificate: •8. Additional information – signature, name … 67 CE marking •The CE marking must be affixed by the manufacturer, or by his authorised representative. •It must be affixed according to its legal format visibly, legibly and indelibly to the product or its data plate. •If a Notified Body was involved in the production control phase, its identification number must also be displayed. •It is the manufacturer’s responsibility to draw up and sign an “EC declaration of conformity” proving that the product meets the requirements. 68 Thank you for your attention hana.veznikov[email protected] This work is licensed under CC BY 4.0 NPO_VŠB-TUO_MSMT-16605/2022 69