New Glove standards / New EU Regulation 2016/425. Guido Van Duren - Director Regulatory Affairs

New Glove standards / New EU Regulation 2016/425 Guido Van Duren - Director Regulatory Affairs

Agenda Revision of EN standards: Protection against mechanical risks EN 388:2003 EN 388:2016 Published November 2 Protection against chemical risks EN 374-1:2003 EN ISO 374-1:2016 Protection against micro-organisms EN 374-5:2003 EN ISO 374-5:2016 Published November 23 General requirements EN 420:2003 EN ISO 21420:2018 (?) Change of EU PPE Directive 89/686 into an EU PPE Regulation 2016/425. What are the major changes and implications? 2

EN 388:2016 - Overview of main changes Abrasion: new abrasive paper introduced + procedure improvements Cut:additional ISO 13997 test method included Impact Protection: additional EN 13594 test method included New marking: 6 performance levels instead of 4, including a P code in case of Impact Protection claims 3 3

EN 388:2016 Why a revised standard? Issues with current EN 388:2003 version: Abrasion: current defined abrasive paper ( Oakey ) was not available anymore. Replacement papers used were inconsistent Cut: current test method is irreliable for high cut resistant materials which have a dulling effect on the blades As a result, different Notified Bodies have been using different methodologies and different interpretations when assigning performance levels For gloves containing impact protective pads : in absence of a standardized test method, impact protection is claimed without any substantiation 4 4

EN 388:2016 Marking requirements Performance Level Rating 1 2 3 4 5 A B C D (old marking) A B C DE F (new marking) A Abrasion resistance (cycles) B Blade cut resistance (number) C Tear resistance (newton) D Puncture resistance (newton) 100 500 2000 8000 1.2 2.5 5.0 10.0 20.0 10 25 50 75 20 60 100 150 Performance Levels A B C D E F E EN ISO cut resistance (Newton) F EN Impact protection 2 5 10 15 22 30 Pass or Fail Level X can also be applied for the above, which means not tested or not applicable 5 5

EN 388:2016 Abrasion resistance 4 circular specimens are abraded under known pressure The specimen are checked after X cycles Abrasion resistance is measured by the number of cycles required for breakthrough to occur The performance level is determined by the lowest number of cycles to abrade one of the 4 specimens 6 6

EN 388:2016 Abrasion test method New abrasive paper defined, called Klingspor PL31B New paper is more homogeneous and provides reproducible results Grains are embedded to prevent rapid wear, as opposed to Oakey defined in EN 388:2003, where the grains could be easily removed Klingspor paper is in some instances more aggressive 7 7

EN 388:2016 Blade cut test method Remains mainly unchanged A circular blade, under a force of 5N, is cycled back-and-forth until it cuts through to the test specimen. 2 samples taken from the palm are tested and the number of cycles required for cut-through is recorded. An index figure is calculated and the performance level is determined by the lowest calculated index figure obtained for the 2 test specimen 8 8

EN 388:2016 Blade cut test method The index is determined mathematically : Index = ( avg. Cn + Tn ) / avg. Cn. SEQUENCE CONTROL SPECIMEN TEST SPECIMEN CONTROL SPECIMEN INDEX 1 C1 T1 C2 I1 2 C2 T2 C3 I2 3 C3 T3 C4 I3 4 C4 T4 C5 I4 5 C5 T5 C6 I5 9 9

EN 388:2016 Blade cut test method Revisions implemented versus previous EN 388:2003: A new blade needs to be used after each 5 test sequences Test needs to be manually stopped when T (number of cycles on test specimen) reaches maximum 60 cycles First cut sequence determines if dulling occurs : this is when Cn+1 is greater than 3 times Cn If dulling found : EN ISO 13997 becomes the reference for the assessment of protection against cuts. The blade cut test can be optionally continued and the blade cut performance level optionally marked 10 1

EN 388:2016 Cut resistance (EN ISO 13997) Cut resistance is calculated at 20 mm blade displacement, using a constant blade speed of 2,5 mm/s. Load required is measured Approved test equipment = TDM (TDM-100 Tomodynamometer) test 11 1

EN 388:2016 EN ISO 13997 levels 6 levels (letters instead of figures) have been defined as follows and will become the fifth level underneath the hammer pictogram Performance Levels A B C D E F E EN ISO cut resistance (Newton) 2 5 10 15 22 30 When dulling : EN ISO levels need to be reported mandatory if cut resistance is claimed Blade cut level could be applied voluntary If no dulling : EN ISO level could be applied voluntary Blade cut level would be mandatory if cut resistance is claimed 12 1

EN 388:2016 Tear puncture test methods Remains unchanged: Tear: Highest peak recorded to tear a pre-cut (50 mm incision) test specimen at a specified tear speed is measured and the performance level is determined by the lowest value of the 4 results. Puncture: The force required to puncture a test specimen with a steel stylus is measured and the performance level is determined by the lowest value of the 4 results 13 1

EN 388:2016 Additional Protection Impact protection For gloves that are designed, constructed and claimed to provide specific impact attenuation; the materials shall not crack when a 2.5 kg load with an impact energy of 5 Joule drops on the tested material - peak transmitted shall also be < 7kN. Testing methodology as per EN 13594 Pass or Fail test If test passes, the indication P would apply next to the other 5 defined levels under the hammer pictogram 14 1

Overview of main changes of EN374 EN becomes EN ISO: part 1 and 5 harmonization at ISO level, EN ISO 374-1/Type C General: requirements for minimum liquid proof length will be deleted, Permeation: 18 test chemicals instead of 12, also cuff to be tested if > 40 cm. EN 374-3:2003 replaced by EN 16523-1:2015 EN ISO 374-1/Type B Degradation: new test method EN374-4:2013, change of puncture resistance after chemical contact, Micro-organisms: separate standard EN ISO 374-5:2016 with new test method ISO 16604 for virus protection claims, New marking: Beaker will be deleted, Erlenmeyer pictogramremainsbut withclassification in type A, B & C, micro-organismpictogramforvirus protection will be added. XYZ EN ISO 374-1/Type A UVWXYZ 15 15

Chemical list (18 chemicals) 6 additional test chemicals defined (Codes Mto T) 16 16

New situation EN374, Protective gloves against dangerous chemicals and micro-organisms Part 1: EN ISO 374-1:2016, Terminology and performance requirements for dangerous chemical risks (expected to become EN ISO 374-1:2016) Part 2: EN 374-2:2014 (test method), Determination of resistance to penetration. Part 3: EN 374-3:2003 (test method), permeation standard withdrawn and substituted by a general permeation test standard, revised part 1 refers to the new standard EN16523-1:2015 Part 4: EN 374:4:2013 (test method), Determination of resistance to degradation by chemicals Part 5: EN ISO 374-5:2016, Terminology and performance requirements for micro-organism risks (expected to become EN ISO 374-5:2016). 17 1

New marking requirements Protective gloves against chemical risks can be claimed, only when Type A, B or C is achieved. when the chemical protective glove is leakage proof (EN374-2:2014) When the degradation is tested for the claimed chemicals and the results available in IfU (EN374-4:2013) EN ISO 374-1/Type C EN ISO 374-1/Type B XYZ EN ISO 374-1/Type A UVWXYZ 18 1

New Marking requirements TYPE C: At least level 1 (more than 10 min) against one chemicalof the list EN ISO 374-1/Type C TYPE B: At least level 2 (more than 30 min) against at least 3 chemicals of the list EN ISO 374-1/Type B XYZ TYPE A: At least level 2 (more than 30 min) against minimum 6 chemicals of the list EN ISO 374-1/Type A UVWXYZ 19 19

EN 374-2:2014: Determination of resistance to penetration Water leak test: 1000 ml of water into the glove, glove suspended vertically After 2 minutes leak detection by water droplets on the outside Air leak test: Glove is immersed in water and its interior is pressurized with air. A leak is detected by a stream or air bubbles from the surface of the glove. 20

Permeation The process by which a chemical moves through a protective glove material on a molecular level. The former used permeation test standard EN374-3:2003 is withdrawn and substituted by a global standard for permeation which is EN16523-1:2015, Permeation test methodology remains the same as in EN 374-3:2003. 21

Permeation as per EN16523-1:2015 Breakthrough is deemed to have occurred when the calculated permeation rate reaches 1 mg/min/cm². Test conditions at 23 C ± 1 3 test specimens to be taken from the palm area. If the glove is longer or equal to 400 mm and if the cuff is claimed to protect against chemical risks, 3 additional test specimens shall be taken where the center is 80 mm from the end of the cuff. In the case of seams in the hand area this must be tested. For multilayer gloves, the layers not claiming any effect (and not bonded to the chemical layer) on the chemical protection can be removed (e.g. thermal insulation layer). 22

EN 374-4:2013 Degradation test method 2 tests methods for degradation NORMATIVE Puncture resistance test As per EN388 for puncture resistance. Measure difference between the reference material and material subjected to a continuous contact of 60 minutes with the test chemical INFORMATIVE Weight change test Measure material change of weight before and after permanent contact with challenge test chemical Vial for Puncture test Report of degradation in % Results to be mentioned in the instructions for use 23 23

EN ISO 374-5:2016 New standard for micro-organism risks Protection against bacteria& fungi Testing according to EN374-2:2014 for leakage proofness Protection against bacteria, fungi& virus Testing according to EN374-2:2014 for leakage proofness Testing according to ISO16604, method B Samples to be taken in palm area & cuff area if length 40 cm 24 2

EN ISO 374:2016 Old markings vs new markings JKL EN ISO 374-1/Type C EN ISO 374-1/Type B EN ISO 374-1/Type A EN ISO 374-5 EN ISO 374-5 XYZ UVWXYZ 25 2

EN ISO 420:2018 (?) - Overview of main upcoming changes Delete total minimum glove length Alignment with REACH: No release of carcinogenic aylamines(azo dyes) : EN 14362 test method DMF (dimethylformamide content < 0.1 %) EN 16778 test method No release of nickel (metallic elements) : EN 1811 test method Marking: - marking on gloves: date of manufacturing (month.year) - instructions for use : information on donning/doffing explanation on the integrity checking of gloves before use 26 26

New PPE Regulation 2016/425 (EU-28) PPE: All equipment designed to be worn or held by an individual to protect against hazards likely to endanger his safety and health at work (both in professional as personal use) 27

Regulation versus Standards Regulations A rule that must be followed Written by Government/EU Commission Enforceable Provides rules for : -certification procedures, - conformity assessment procedures, -obligation for economic operators, certification bodies, market surveillance -information obligations : IFU s and conformity declarations -Rules and conditions for affixing ( CE/KOSHA/EAC/ ) mark - Validity of certifications Certifies (= interpretation) test data Standards A technical document approved through consensus by a standardisation body, that provides guidelines for product performances Not written by Government Provides presumption of conformity to the regulation Has no authority on its own, but may be adopted into regulations making them legal requirements No legalobligation to follow (e.g. when a standard changes) but considered state of the art Provides test data (no interpretation) 28

EU PPE Regulation. Summary of implications Recertification of all PPE required every 5 years Editorial changes required to the IfU s EU Declaration of Conformity (DoC) to be renewed and made available through web link. Ensuring having a robust traceability system in place. Further, explore the viability of printing lot numbers on our PPE products Need for a formal Risk Management Process when launching PPE in the market, to ensure a robust Quality Control system in place and to demonstrate effective compliance Need for formal Post Market Surveillance process in place. Obligations for all Economic Operators 29

EU regulatory system (PPE) 30

PPE Regulation 2016/425 - Major changes 1. Change from a Directive (89/686) to a Regulation (2016/425) = Simplification: no need of 28 national transposition acts; a single text throughout the EU for all the economic operators = Legal certainty: keep total harmonisation, avoid the risk of EU Member States to impose additional requirements 31

PPE Regulation 2016/425 - Major changes 1. Change from a Directive to a Regulation 2. Changes to the scope The scope is enlarged, including PPE designed and manufactured for private use protecting against heat (e.g. oven gloves); Distance (online) selling now also covered by the Regulation. PPE for use at trade fairs, exhibitions, demonstrations or similar events do not require compliance, provided a visible sign indicates the PPE does not comply to the Regulation 32

PPE Regulation 2016/425 - Major changes 1. Change from a Directive to a Regulation 2. Changes to the scope 3. Risk categories defined, no more PPE categories PPE intended to protect users against: o Minimal risks = Category I Superficial mechanical injury - Contact with cleaning materials of weak action - Contact with hot surfaces > 50 C - Damage to eyes due to exposure to sunlight - Atmospheric conditions of no extreme nature o Very serious risks = Category III. Substances hazardous to health - Atmospheres with oxygen deficiency - Harmful biological agents - Ionising radiation - Heat comparable to an air temperature > 100 C - Cold comparable to an air temperature < - 50 C - Falling from height Electricity - Drowning - Cuts by hand held chain-saws, highpressure jets - Bullet wounds or knife stabs - Harmful noise o Other risks than Categories I and III = Category II 33

PPE Regulation 2016/425 - Major changes 1. Change from a Directive to a Regulation 2. Changes to the scope 3. Risk categories defined, no more PPE categories 4. EU declaration of conformity (EU DoC) to be easily accessible by Market Surveillance - PPE must be accompanied by the EU DoC, or the manufacturer has to include in the Instructions for Use the internet address at which the EU DoC can be easily accessed; - Economic operators must keep the technical documentation and the EU DoC for 10 years after the PPE has been placed on the market; 34

PPE Regulation 2016/425 - Major changes 1. Change from a Directive to a Regulation 2. Changes to the scope 3. Risk categories defined, no more PPE categories 4. EU declaration of conformity (EU DoC) to be easily accessible by Market Surveillance 5. Traceability requirements 6. Conformity assessment procedure more elaborate: - Technical file required for all products - Claims substantiation : need for a Risk Management process (incl. reasonably foreseen conditions of end use) + more robust Quality System (procedures in place for series of production to remain in conformity) + Post Market Surveillance (carry out sample testing, complaint handling & recall procedures, active participation with market Control) - 5 year validity of certification : renewal of certifications required every 5 years 36

PPE Regulation 2016/425 Conformity assessment procedures adapted Cat I -> Module A (internal production control) Cat II -> Module B (EU type-examination) + Module C (internal production control) Cat III -> - Module B + C2 (C + supervised product checks) or, - Module B + D (QA system) 37

PPE Regulation 2016/425 - Major changes 1. Change from a Directive to a Regulation 2. Changes to the scope 3. Risk categories defined, no more PPE categories 4. EU declaration of conformity to be easily accessible by Market Surveillance 5. Traceability requirements 6. Conformity assessment procedure more elaborate 7. Obligations of Economic Operators / Distributor Due Diligence All (manufacturer, distributor, importer), intervening in the supply and distribution chain, should take appropriate actions to ensure the PPE is in conformity with the Regulations 41

Manufacturers / importers (1/2) PPE needs to be safe + safe for the intended purpose Place only compliant products in the market Technical documentation needs to be available, carry out the conformity assessment, apply the CE mark and draw up the EU declaration of conformity (EU DoC) Shall keep technical file + EU DoC available for 10 years after PPE is placed on the market Shall ensure that procedures are in place for series production to remain in conformity with the PPE Regulation. If necessary, carry out sample testing of PPE made available in the market, keep a register of complaints and keep distributors informed of such monitoring Shall ensure PPE bears a type, batch or serial number 42

Manufacturers / importers (2/2) Shall indicate on the PPE their name and postal address Shall ensure the PPE is accompanied with the Instructions for Use (IfU) Shall provide the EU DoC with the PPE or add the internet address to the IfU where the EU DoC can be accessed Shall take corrective actions in case of non compliance and inform the competent authorities where PPE presents a risk Shall cooperate with authorities in a language which can be easily understood by that authority 43

Distributors Shall act with due care Shall verify that the PPE bears the correct markings and is accompanied by the required documents in a language that can be easily understood by the consumers Shall not make PPE available in the market if the PPE is considered not to meet the essential health & safety requirements Shall ensure transport and storage does not jeopardize the PPE s conformity Shall take corrective actions in case PPE is considered to be non compliant and inform the competent authorities in case PPE presents a risk Shall cooperate with authorities and provide all the information necessary to demonstrate compliance 44

PPE Regulation 2016/425 - Major changes 1. Change from a Directive to a Regulation 2. Changes to the scope 3. Risk categories defined, no more PPE categories 4. EU declaration of conformity to be easily accessible by Market Surveillance 5. Traceability requirements 6. Conformity assessment procedure more elaborate 7. Obligations of Economic Operators / Distributor Due Diligence 8. Market Surveillance Stricter : - Programmes to be installed to ensure effective measures are taken and continuously assessed - Commission to be informed periodically together with proof of areas of competence - Establish adequate procedures to follow up complaints & verify if corrective actions are taken - Improve cooperation between authorities, manufacturers and notified bodies 45

PPE Regulation 2016/425 - Major changes 1. Change from a Directive to a Regulation 2. Changes to the scope 3. Risk categories defined, no more PPE categories 4. EU declaration of conformity to be easily accessible by Market Surveillance 5. Traceability requirements 6. Conformity assessment procedure more elaborate 7. Obligations of Economic Operators / Distributor Due Diligence 8. Market Surveillance Stricter 9. Stricter requirements for Notified Bodies - Attendance of Coordination meetings - Active participation in round robin tests - Participation in standardisation activities - Mandatory application of Recommendations for Use - NB s shall take full responsibilty for the tasks performed by subcontractors, with agreement of the client 46

Market : What will change in a nutshell? Make it easier to remove dangerous products from the market Defining clearer responsibilities Improved traceability Reinforced controls More collaborative system for market surveillance 47

PPE Regulation 2016/425. Transition - Regulation applies from 21 April 2018 with one year transition. - All new products must comply latest after 21 Apr 2019 (PPE Directive is repealed as of that date) - Certificates based on old PPE Directive remain valid until 21 April 2023 or sooner. 48 48

Questions? 49