GUIDE PPE - Cyprus Organization for the Promotion of Quality

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Guide on PPE Directive EuropeAid /114385/D/SV/CY Amended by European Parliament and Council Directive 96/58/EC: The requirement to add last two digits of the year in which the CE marking was affixed was deleted. The directive will be amended and the latest working paper can be found at: http://www.europa.eu.int/comm/enterprise/mechan_equipment/ppe/index.htm The obligations created by the PPE Directive concern principally manufacturers of PPE. Other agents, such as importers of PPE from third countries, wholesalers or distributors of PPE, may act as authorised representatives of PPE or take the responsibility themselves for the placing of PPE on the market, but in that case they assume all the duties of the manufacturer. Before production of a given model of PPE, the manufacturer must identify which of the Essential Health and Safety Requirements (EHSRs), detailed in Annex II of the directive, are applicable to the PPE concerned. The PPE must be designed in such a way as to satisfy the relevant requirements. The manufacturer is free to choose the technical means of satisfying the requirements. He may choose to apply a harmonised standard, which both helps to identify the relevant requirements and provides a guide to the choice of technical solutions. The manufacturer must then constitute the technical documentation, showing how the EHSRs have been satisfied. He must be able to produce relevant extracts of this documentation on request of the competent authorities. Before placing production of the model of PPE on the market, the manufacturer submits the model to the appropriate conformity evaluation procedure, which differs according to the risk covered by the equipment. He may then affix the CE marking to the product and draw up the EC conformity declaration. This declaration is an undertaking by the manufacturer as to the conformity of each item of PPE actually placed on the market. It must be stressed that even when the conformity evaluation procedure involves third-party examination of the model by a NB, the manufacturer remains entirely responsible for the conformity of the PPE actually produced and placed on the market. SCOPE, PLACING ON THE MARKET SCOPE OF THE DIRECTIVE The directive applies to PPE, which is defined as follows: For the purposes of this Directive, PPE shall mean any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards. PPE shall also cover: (a) a unit constituted by several devices or appliances, which have been integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous risks. (Such as, for example an industrial safety helmet with hearing protectors and powered filtering device); (b) a protective device or appliance combined, separably or inseparably, with personal non-protective equipment worn or held by an individual for the execution of a specific activity; (such as for example industrial safety helmet equipped with a lamp)
Guide on PPE Directive EuropeAid /114385/D/SV/CY (c) interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment. (Such as, for example components of fall arresting systems or replaceable filters for respiratory protective equipment) The term "worn" must be understood in the sense of wearing clothes, a helmet, a mask, glasses, shoes, etc. The term "held" must be understood as the action of holding the PPE with one’s hand(s) (such as a hand-held protective screen used by welders to protect the face and eyes, for example). The PPE Directive applies to all PPE for sport, domestic and leisure activities as well as for occupational use. The Directive does not apply to PPEs covered by another directive designed to achieve the same objectives as PPE Directive with regard to placing on the market, free movement of goods and safety and to PPE listed in Annex I of the Directive: • PPE for the armed forces or the maintenance of law and order; • PPE for self-defence; • PPE for private use against adverse atmospheric conditions, damp and water and heat; • PPE for the protection or rescue of persons on vessels or aircraft, not worn all the time; • Motorcycle helmets and visors. The guidance, how to apply the directive can be found at: http://www.europa.eu.int/comm/enterprise/mechan_equipment/ppe/guide.htm MANUFACTURER, PLACING ON THE MARKET AND BRINGING INTO SERVICE The PPE Directive aims at ensuring that PPE preserve the health and safety of users when they are placed on the market and brought into service. Placing on the market corresponds to when the PPE is first made available, in return for payment or free of charge, by the manufacturer or his authorised representative in view of its distribution and/or its use in the EEA. Bringing into service includes all operations, which are necessary before the PPE is used by the end user. In practice, most PPE are placed on the market in a state where they are ready for use. Recommendations how custom made (PPE modified according to the characteristics of one specified user) PPE shall be placed on the market are given by the Standing Committee. The manufacturer is defined as follows; • any legal or natural person who takes responsibility for designing and manufacturing a PPE with a view to placing it on Community Market under his own name • any legal or natural person who assembles, packs, processes or re-label ready made products with a view to their being placed on Community Market under his own name • any legal or natural person who changes the intended use of product in such a way that different essential requirements will become applicable • any legal or natural person who customises, modifies or rebuilds a PPE
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