EUROPEAN LEGISLATION AND STANDARDS Why a PPE Regulation? Protective gloves are PPE (Personal Protective Equipment) and must comply with the European Regulation 2016/425 in order to freely circulate within the European Union. The Regulation 2016/425 contains the requirements that PPE must satisfy to guarantee the health and safety of users. That means that PPE must protect up to the required levels without compromising the user’s health. Harmonised European standards (EN 388, EN ISO 374-1…) are used in the certification process to assess conformity of the product to the requirements of the PPE Regulation in relation to the risks against which the product is intended to offer protection. The manufacturer must indicate the conformity of the product by CE marking it. He must also provide a EU declaration of conformity. PPE Regulation (EU) 2016/425 This European Regulation was implemented on 21 April 2018. It replaced the European Directive 89/686/EC, which was withdrawn on this same date. Regulation (EU) 2016/425 and Directive 89/656/EEC Regulation (EU) 2016/425 stipulates the essential health and safety requirements for designing and manufacturing PPE, as well as the responsibility of manufacturers or importers and conformity procedures to affix the CE marking on PPE. Directive 89/656/EEC is dedicated to professional users of PPE. It lays down the responsibilities of employers to supply their employees with adequate CE-marked PPE and ensure their safe use. Regulation (EU) 2016/425 Minimal risks only. The manufacturer is responsible for the conformity of its products. CAT 1 Risks other than CAT 1 and CAT 3. CE-certificate of conformity obtained from a Notified Body. CAT 2 Risks causing irreversible damage to health. CE-certificate of conformity and conformity of the production from Notified Bodies. CAT 3 CATEGORIES OF RISK AND CORRESPONDING CERTIFICATION PROCEDURE EN 407 EN 407 For gloves resistant to flame The EN 420 standard was revised in 2020 becoming standard EN ISO 21420. The revised EN ISO 21420 standard for protective gloves includes these key updates: Innocuousness: Limits on harmful substances like DMFa and PAHs in gloves. Electrostatic Properties: New EN 16350 pictogram for gloves suitable in ATEX zones, with other electrostatic standards (EN 1149) still applicable. Glove sizing: No minimum length requirement; sizes based on hand dimensions. Glove marking: Must include manufacturing and obsolescence (if applicable) dates for traceability. Instructions for use: Must provide detailed guidance on usage, hygiene, and warnings (with allergens listed upon request). EN ISO 21420 EN 407 For gloves non-resistant to flame NEW The EN 407 standard has been revised recently. The main reason for the revision is the inclusion of thermal protection articles for private use (oven gloves, potholders, etc) in the new PPE Regulation (EU) 2016/425 ➜ The performance levels remain unchanged! The major change is the integration of a new pictogram. Standards Highlights Protective gloves for pesticide operators and re-entry workers ISO 18889:2019 Protective gloves are classified into 2 categories: WHOLE HAND PROTECTION GLOVE PARTIAL HAND PROTECTION GLOVE (fingertips and palm-side) Relatively low potential risk Higher potential risk GR gloves G1 gloves G2 gloves Handling diluted pesticides. No mechanical risk. q Handling diluted or concentrated pesticides. Minimum mechanical resistance requirement. q Re-entry worker who is in contact with dry and partially dry pesticide residues that remain on the plant after pesticide application. Mechanical properties that are required for several re-entry tasks. Breathable material in the back of the hand provides comfort. q Disposable gloves Chemical gloves High dexterity mechanical gloves Protective gloves and other hand protective equipments against thermal risks STATIC ELECTRICITY Standards dealing with electrostatic properties. Working in ATEX zones or handling electronic devices both require gloves that are dissipative. Since there is no specific standard for ESD (electrostatic discharge) gloves, MAPA PROFESSIONAL follows the strict EN 16350 standard for ATEX gloves. Gloves that meet this standard are also suitable for handling electronic devices. GLOVES STANDARDS REQUIREMENT TEST METHOD PICTOGRAM ATEX environment EN 16350 Vertical resistance: <108 Ω at 25% relative humidity * The tests must be performed on 5 samples which must all pass the limit of vertical resistance EN 1149-2 Introduced in EN ISO 21420: 2020 Protection of electronic devices from ElectroStatic Discharge (ESD) No standard No test method No pictogram NEW EN 16350 5 4
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