Safety requirements for personal protective equipment in CU

1. Safety requirements for personal protective equipment in CU Eero Korhonen

2. Technical Regulations – an integration instrument • elimination of technical barriers to trade, the harmonization of technical regulations and standards and finally the creation of a single European market where the free circulation of goods, services and capital has been ensured. Eero Korhonen

3. Accreditation, conformity assessment, standardization, market surveillance • Approximation of sector technical regulations can only become successful if also the underlying horizontal concepts such as the ones relating to conformity assessment, accreditation, use of voluntary standards and market surveillance will be aligned Eero Korhonen

4. Approximation of Technical Regulations, Conformity assessment and Standardization • Regulations and standards in Russia will be harmonized with EU • Priorities in harmonization coves electrical appliances, machines, toys and construction products • Majority of thr technical standards and regulations are already harmonized Eero Korhonen

5. Directive 89/686/EEC • Council Directive of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (PPE) • an early New Approach Directive

6. Personal Protective Equipment - PPE • 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 for work including work at home • PPE for sports and leisure

7. manufacturer any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark Eero Korhonen

8. market surveillance the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Community harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection Eero Korhonen

9. Obligations of manufacturers Manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements set out in directive Manufacturers shall draw up the required technical documentation and carry out the conformity assessment procedure Manufacturers shall draw up an EC declaration of conformity and affix the conformity marking. Eero Korhonen

10. Obligations of manufacturers • Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or on its packaging or in a document accompanying the product. • Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned Eero Korhonen

11. Cases in which obligations of manufacturers apply to importers and distributors An importer or distributor shall be considered a manufacturer he shall be subject to the obligations of the manufacturer, where he places a product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected Eero Korhonen

12. Harmonised standards • Application remains voluntary • Application confers a presumption of conformity with the basic health and safety requirements covered • PPE Standards give design specifications and test methods • PPE standards often define classes of protection

13. International standardisation • increasing importance of international standards as markets become globalised • obligations under the World Trade Organisation's Technical Barriers to Trade Agreement (WTO-TBT) • Vienna Agreement (between ISO and CEN) and the Dresden Agreement (between IEC and CENELEC) • withdrawing national standards which conflict with international standards, except where such international standards would be ineffective or inappropriate, for instance, because of an insufficient level of protection or fundamental climatic or geographical factors Eero Korhonen

14. Category I Minimal risk Simple design Category II Serious risk Category III Serious risk Complex design Technical documentation EC type-examination EC quality control system for the final product Production quality monitoring system EC declaration of conformity 0123

15. Market surveillance • Conformity assessment procedures aim to ensure the compliance and safety of products before they are placed on the market • Market surveillance is checking that products are in compliance with the basic requirements and are safe after they have been placed on the market

16. CE marking • CE marking should have the right format and be correctly apposed • There should not be CE marking on products not covered by the directive • Other markings should not create confusion with the CE marking • For category III PPE, CE marking includes the identification number of the Notified Body for the production phase

17. The manufacturer’s EC Declaration of Conformity provides information on • the reference of the product • the directive(s) that have been applied • the standard(s) that have been used • the Notified Body that has intervened and the number of the certificates • the person responsible for placing the product on the market (signatory)

18. Information supplied by the manufacturer • The information (instructions for use) must be supplied with the product • The information is “part of the product”, covered by basic health and safety requirement 1.4 • Information can be checked easily, and provides essential information for further investigations

19. Market surveillance and customs • It is effective to monitor products on entry to the EU • After entry, products circulate freely to other EU countries • Non-compliant products may be transferred from one market to another

20. New Legislative Framework OJEU L 218 - 13.08.08 : • Regulation 764/2008 – procedures relating to the application of certain national technical rules to products lawfully marketed in another MS (Mutual Recognition) • Regulation 765/2008 - requirements for accreditation and market surveillance relating to the marketing of products • Decision 768/2008/EC - a common framework for the marketing of products Eero Korhonen

21. Complementary legislative tools DECISION • Definitions / Obligations • Notification (criteria / process / accreditation) • Conformity Assessment Procedures • Safeguard mechanisms (& market surveillance) • marking Basis for future legislation REGULATION • Accreditation • Market Surveillance • Internal • Imported products • General principles Eero Korhonen

22. Notified Bodies • Where the Directives delegate conformity assessment to third parties, these are undertaken by ‘Notified Bodies’ • Notified Bodies are officially ‘notified’ on the basis of set criteria (EN 45000..) • National authorities justify conformity via accreditation or other evidence Eero Korhonen

23. Revision of PPE Directive • Formulating new text, Jan – Aug 2012 • Adoption of the proposal by the Commission, Oct – Dec 2012 • Council and Parliament, Dec 2012 > Eero Korhonen

24. Proposed Changes • Changes to • the scope • the conformity assessment procedures • documentary requirements • basic health and safety requirements • + alignment with the NLF Decision 768/2008 Eero Korhonen

25. Changes to the scope • Align products for private and professional use • exclude clothing for adverse atmospheric conditions for professional use • include dishwashing gloves for private use • include oven gloves for private use Clarify that motocross helmets are not excluded by referring to the UNECE Regulation Revision of the PPE Directive

26. Changes to conformity assessment procedures (1) • clarification for • custom made products • equipment for use in low/high temperature environments not limited to emergency equipment Revision of the PPE Directive

27. Changes to conformity assessment procedures (2) • move from category II to category III • life jackets (buoyancy aids to remain in cat II) • ear plugs, ear muffs protecting against noise • bullet-resistant vests, knife stab-resistant vests and needle and spike resistance vests • protection against cutting by hand held chain saws • equipment against high pressure cutting • adapt the conformity assessment procedure to the modules Revision of the PPE Directive

28. Changes to documentary requirements • limit the validity of EC type-examination certificates • require a technical file for category I PPE under discussion: • harmonise the content of EC type-examination certificates • require the Declaration of conformity to be supplied with the PPE

29. Changes to BHSR – Annex II • mechanical vibration: delete reference to limit values • protection against the harmful effects of noise: delete reference to comfort index • non-ionizing radiation: replacements of the reference to transmission curve by protection factor Revision of the PPE Directive

30. Selection and use of PPE • Risk assessment • Selection of the method to remove the risk or control it • The definition of the requirements the PPE shall fulfil • Purchasing process for PPE

31. The requirements for the selection and use of PPE • The national regulations describe; When and how to give PPE to the workers, how to organize the maintenance of PPE and rules for the selection of PPE.

32. Risk assessment • Accident risks • Exposures • The risks caused by the PPE

33. Selection of the prevention method • The technical prevention methods • removal of the risk • control of the risk • The organizational control methods • limitation of the exposure time • limitation of the number of exposed persons • If the methods mentioned above are not possible or effective enough, the use of PPE can be considered.

34. Certified management systems • ISO 9001 - Quality management systems • Total 1 109 905 • Russian Federation 62265 • ISO 14001 - Environmental management systems • Total 250972 Eero Korhonen