1. Zgierska 73, 91-462 Łódź POLAND Department in Kraków Zakopiańska 9, 30-418 Kraków Directive 89/656/EEC concerning Personal Protective Equipment (PPE) which defines the obligations of the manufacturer INSTITUTE OF LEATHER INDUSTRY Dr. Bogusław Woźniak

2. European Union Regulations General rule Personal protective equipment shall be used when the risks cannot be avoided or sufficiently limited by technical means of collective protection or by measures, methods or procedures of work organization.

3. PERSONAL PROTECTIVE EGUIPMENT (PPE) DIRECTIVE. General provisions Personal protective equipment must comply with the relevant Community provisions on design and manufacture with respect to safety and health.

4. Personal Protective Equipment (PPE) Definition For the purposes of this Directive, personal protective equipment shall mean all equipment designed to be worn or held by the worker to protect him against one or more hazards likely to endanger his safety and health at work, and any addition or accessory designed to meet this objective.

5. The PPE Directive sets out basic requirements, that PPE must comply with in order to be made available on the EU market. PPE must be designed and manufactured in compliance with the provisions of the Directive. Manufacturers must also affix the CE marking and provide users with instructions for storage, use, cleaning, maintenance, servicing and disinfection of the PPE. PPE Directive

6. COUNCIL DIRECTIVE of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (89/686/EEC) PPE Directive

7. Directive 89/686/EEC Directive 89/686/EEG on personal protective equipment (PPE) http://europa.eu.int/eur- lex/lex/LexUriServ/site/en/consleg/1989/L/01989L06 86-20031120-en.pdf

8. Directive 89/686/EEC on personal protective equipment1 was adopted on 21 December 1989 and became fully applicable as from 1 July 1995. Directive 89/686/EEC (PPE Directive) ensures the free movement of personal protective equipment (PPE). It has contributed considerably to the completion and operation of the Single Market with regard to PPE. It permits the free movement of PPE covered by its scope in Europe while ensuring a high level of protection for its user. Directive 89/686/EEC

9. Whereas it is necessary to harmonize these different national provisions in order to ensure the free movement of these products, without in any way reducing the valid levels of protection already required in the Member States, and to provide for any necessary increase therein; Directive 89/686/EEC

10. Whereas this Directive defines only the basic requirements to be satisfied by ppe; in order to facilitate proof of conformity with those basic requirements, it is essential that harmonized European standards be available relating, in particular, to the design and manufacture of, and the specifications and test methods applicable to, ppe, since compliance therewith confers on these products a presumption of conformity with the abovementioned basic requirements; …… Directive 89/686/EEC

11. 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 Directive 89/686/EEC

12. 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; (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; (c) interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment. PPE Directive

13. Any system placed on the market in conjunction with PPE for its connection to another external, additional device shall be regarded as an integral part of that equipment even if the system is not intended to be worn or held permanently by the user for the entire period of risk exposure. PPE Directive

14. Member States shall not prevent the presentation at trade fairs, exhibitions and the like of PPE which is not in conformity with the provisions of this Directive, provided that an appropriate notice is displayed drawing attention to this fact and the prohibition on its acquisition and/or use for any purpose whatsoever until it has been brought into conformity by the manufacturer or his representative established in the Community. PPE 89/686/EEC

15. Member States shall not prohibit, restrict or hinder the placing on the market of PPE or PPE components which satisfy the provisions of this Directive and which bear the EC mark. Member States shall not prohibit, restrict or impede the placing on the market of PPE components which do not bear the EC mark, and which are intended to be incorporated in PPE, provided that they are not essential to its satisfactory functioning. Directive 89/686/EEC

16. If PPE which is not in conformity with the relevant requirements bears the EC mark, the Member State concerned shall take the appropriate measures with regard to those responsible for affixing the mark and shall inform the Commission and the other Member States accordingly PPE 89/686/EEC

17. 1. Before placing a PPE model on the market, the manufacturer or his authorized representative established in the Community shall assemble the technical documentation referred to in Annex III so that this can, if necessary, be submitted to the competent authorities. 2. Prior to the series production of PPE other than those referred to in paragraph 3, the manufacturer or his authorized representative established in the Community shall submit a model for EC type- examination as referred to in Article 10. CERTIFICATION PROCEDURES

18. EC type-examination is the procedure whereby the approved inspection body establishes and certifies that the PPE model in question satisfies the relevant provisions of this Directive. Application for EC type-examination shall be made by the manufacturer or his authorized representative to a single approved inspection body in respect of the model in question. The authorized representative shall be established in the Community EC TYPE-EXAMINATION PROCEDURES

19. EC type-examination shall not be required in the case of PPE models of simple design where the designer assumes the user can himself assess the level of protection provided against the minimal risks concerned the effects of which, when they are gradual, can be safely identified by the user in good time. CERTIFICATION PROCEDURES

20. This category shall cover : - mechanical action whose effects are superficial (gardening gloves, thimbles, etc.), - cleaning materials of weak action and easily reversible effects - risks of hot components which do not expose the user to a temperature exceeding 50 gC - atmospheric agents of a neither exceptional nor extreme nature (headgear, seasonal clothing, footwear, etc.), sunglases - minor impacts and vibrations which do not affect vital areas of the body (helmets, gloves, light footwear, etc.), - CERTIFICATION PROCEDURES

21. The application shall comprise: - the name and address of the manufacturer or his authorized representative and of the PPE production plant in question, - the manufacturer's technical file referred to in EC TYPE-EXAMINATION PROCEDURES

22. A manufacturer shall take all steps necessary to ensure that the manufacturing process, including the final inspection of PPE and tests, ensures the homogeneity of production and the conformity of PPE with the type described in the EC type- approval certificate and with the relevant basic requirements of this Directive. 2. A body of which notification has been given, chosen by a manufacturer, shall carry out the necessary checks. Those checks shall be carried out at random, normally at intervals of at least one year. CHECKING OF PPE MANUFACTURED

23. 3. An adequate sample of PPE taken by the body of which notification has been given shall be examined and appropriate tests defined in the harmonized standards or necessary to show conformity to the basic requirements of this Directive shall be carried out to check the conformity of PPE. 4. Where a body is not the body that issued the relevant EC type-approval certificate it shall contact the body of which notification has been given in the event of difficulties in connection with the assessment of the conformity of samples. CHECKING OF PPE MANUFACTURED

24. 5. The body of which notification has been given shall provide the manufacturer with a test report. If the report concludes that production is not homogeneous or that the PPE examined do not conform to the type described in the EC type- approval certificate or the relevant basic requirements, the body shall take measures appropriate to the nature of the fault or faults recorded and inform the Member State which gave notification thereof accordingly. 6. The manufacturer must be able to present, on request, the report of the body of which notification has been given. CHECKING OF PPE MANUFACTURED

25. The EC declaration of conformity is the procedure whereby the manufacturer: 1. draws up a declaration using the form laid down in Annex VI certifying that the PPE placed on the market are in conformity with the provisions of this Directive with a view to its submission to the competent authorities; 2. affixes the EC mark of conformity provided for by Article 13 to each PPE. EC DECLARATION OF PRODUCTION CONFORMITY

26. The EC mark consists of the letters 'CE' followed by the last two figures of the year in which the mark was affixed and, in the event of the involvement of a notified body having carried out an EC examination of the type referred to in Article 10, its distinguishing number shall be added. The form of the mark to be used is shown in Annex IV. The EC mark shall be affixed to each production PPE and its packaging so as to be visible, legible and indelible throughout the foreseeable useful life of that PPE. EC MARK

27. ANNEX I EXHAUSTIVE LIST OF PPE CLASSES NOT COVERED BY THIS DIRECTIVE ANNEXES

28. ANNEX II BASIC HEALTH AND SAFETY REQUIREMENTS ANNEXES

29. ANNEX II BASIC HEALTH AND SAFETY REQUIREMENTS GENERAL REQUIREMENTS APPLICABLE TO ALL PPE ADDITIONAL REQUIREMENTS COMMON TO SEVERAL CLASSES OR TYPES OF PPE ADDITIONAL REQUIREMENTS SPECIFIC TO PARTICULAR RISKS ANNEXES

30. The example for footwear Falls 3.1.2.1. Prevention of falls due to slipping The outsoles for footwear designed to prevent slipping must be so designed, manufactured or equipped with added elements as to ensure satisfactory adhesion by grip and friction having regard to the nature or state of the surface. ANNEXES

31. ANNEX III TECHNICAL DOCUMENTATION SUPPLIED BY THE MANUFACTURER ANNEXES

32. ANNEX IV EC MARK OF CONFORMITY The EC mark of conformity consists of the symbol shown below. ANNEXES

33. ANNEX V CONDITIONS TO BE FULFILLED BY THE BODIES OF WHICH NOTIFICATION HAS BEEN GIVEN ANNEXES

34. ANNEX VI MODEL EC DECLARATION OF CONFORMITY ANNEXES

35. EN ISO 20344 Personal protective equipment — Test methods for footwear Équipement de protection individuelle — Méthodes d’essais pour les chaussures STANDARDS

36. 5.Test methods for whole footwear 5.1 Specific ergonomic features. 5.2 Determination of upper/outsole and sole interlayer bond strength 5.3 Determination of internal toecap length 5.4 Determination of impact resistance 5.5 Determination of compression resistance 5.6 Behaviour of toe caps and inserts (thermal and chemical 5.7 Determination of leakproofness 5.8 Determination of the dimensional conformity of inserts and the penetration resistance of the sole STANDARDS

37. 5.9 Determination of the flex resistance of penetration- resistant inserts 5.10 Determination of electrical resistance 5.11 Determination of footwear slip resistance 5.12 Determination of insulation against heat 5.13 Determination of insulation against cold 5.14 Determination of energy absorption of the seat region 5.15 Determination of resistance to water for whole footwear 5.16 Determination of impact resistance of a metatarsal protective device 5.17 Determination of the shock absorption capacity of ankle protection materials incorporated into the upper STANDARDS

38. 6. Test methods for upper, lining and tongue. 6.1 Determination of thickness of upper 6.2 Measurement of the height of the upper 6.3 Determination of tear strength of the upper, lining and/or tongue 6.4 Determination of the tensile properties of the upper material 6.5 Determination of upper flexing resistance 6.6 Determination of water vapour permeability (WVP 6.7 Determination of water vapour absorption (WVA)... STANDARDS

39. 6.8 Determination of water vapour coefficient. 6.9 Determination of pH value 6.10 Determination of resistance to hydrolysis of upper 6.11 Determination of chromium VI content 6.12 Determination of abrasion resistance of lining and insock 6.13 Determination of water penetration and water absorption for upper 6.14 Determination of resistance of upper to cutting... STANDARDS

40. 7. Test methods for insole and insock 7.1 Determination of insole thickness 7.2 Determination of water absorption and desorption of insole and insock 7.3 Determination of abrasion resistance of insole STANDARDS

41. 8.Test methods for outsole 8.1 Determination of outsole thickness 8.2 Determination of tear strength of outsole 8.3 Determination of outsole abrasion resistance 8.4 Determination of flexing resistance of outsole 8.5 Determination of resistance to hydrolysis of outsole 8.6 Determination of resistance to fuel oil 8.7 Determination of resistance to hot contact STANDARDS

42. ANNEXES Annex A (normative) Procedure for plasticine calibration Annex B (normative) Assessment of footwear by the laboratory during testing of thermal behaviou Annex C (informative) Footwear sizes Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 89/686/EEC STANDARDS

43. EN ISO 20345 Personal protective equipment — Safety footwear Équipement de protection individuelle — Chaussures de sécurité STANDARDS

44. 5. Basic requirements for safety footwear 5.1 General 5.2 Design 5.3 Whole footwear 5.4 Upper 5.5 Vamp and quarter lining 5.6 Tongue 5.7 Insole and insock 5.8 Outsole STANDARDS

45. 6. Additional requirements for safety footwear 6.1 General 6.2 Whole footwear 6.3 Upper — Water penetration and absorption 6.4 Outsole 7. Marking 8. Information to be supplied 8.1 General 8.2 Electrical properties 8.3 Insocks STANDARDS

46. INSTITUTE OF LEATHER INDUSTRY EXPERIENCE. Institute of Leather Industry is Notified Body No 1439 acc. 89/686 We have four Accredited Laboratories from 1995 and a Certificatinn Center from 1996

47. Aromatic amines benzidine - standard benzidine – standard intencionally added to the sample Graph 1. Figure of bezidine in leather sample after solvents extraction by HPLC/DAD technique benzidine - standard Absorbance time Total Ion Current Graph 2. Figure of bezidine standard by GC/MS technique

48. INSTITUTE OF LEATHER INDUSTRY our experience Graph 3. Figure of formaldehyde solution made by spectrophotomic method (UV – VIS) Formaldehyde

49. INSTITUTE OF LEATHER INDUSTRY our experience Dimethyl fumarate (DMFU) Exposition to DMFU may causing: extreme allergic reaction; skin irration; skin redness; rash; difficulties with breathing;

50. Dimethyl fumarate Graph 4. Figure of dimethyl fumarate in leather sample after solvents extraction by GC/MS technique Graph 5. Figure of dimethyl fumarate by GC/MS technique Dimethyl fumarate INSTITUTE OF LEATHER INDUSTRY Our experience

51. Heavy metals INSTITUTE OF LEATHER INDUSTRY Our experience Heavy metals are used in producting textiles,leather goods, jewellery, ferniture, cosmetics, haushold products…… The determination of heavy metals in consumer products is crucial for the safety appraisal and sources classification of human and environmental exposures.

52. Thank you for your attention Contact details Bogusław Woźniak Institute of Leather Industry e – mail: dyr-ips@ips.lodz.pl telefon: 48 42/2536107 adress: Zgierska 73 street 91-462 Łódź, Poland INSTITUTE OF LEATHER INDUSTRY