PPE Regulation (EU) 2016/425
In April 2018 the PPE Regulation (EU) 2016/425 came into effect across the European Union. This
wide-ranging piece of legislation defines how personal protective equipment (PPE) is to be described,
tested and provided across the
Who the legislation applies to – the PPE Regulation applies to the following groups:
Manufacturers, who need to ensure the products and equipment they produce are compliant.
Importers, who are tasked with bringing only sufficient quality products into their home market.
Distributors, who are required to verify regulatory compliance of any products they offer for sale.
How PPE is defined – PPE is defined in the regulation as:
(a) Equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety,
(b) Interchangeable components for equipment referred to in point (a) which are essential for its protective function (e.g. filters), and
(c) Connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use.
Look for CE CertificationAnotified body gives CE certification by providing an EC certificate to PPE Cat III Gloves
To gain a CE marking, protective safety gloves for sale in Europe must meet a number of stringent European Standards, each with its own EN code.
PPE classification – in the Regulation PPE is classified into one of three categories:
1. Simple PPE (Category I) – designed to protect users against minimal risks. Products in this category include PPE designed to guard against superficial mechanical injury or prolonged contact with water.
2. Intermediate PPE (Category II) – designed to protect users against risks not specified in categories 1 and 2. Products in this category include standard safety goggles and cut resistant gloves.
3. Complex PPE (Category III) – designed to protect against risks that can cause the most serious consequences. Products in this category include equipment designed for extreme temperatures (above 100°C and below 0°C) and to guard against ionising radiation, bullet wounds or severely harmful noise.
PPE Category III:
EC certified to protect against mortal danger and irreversible harm
Complex Design Gloves
Look for a CE symbol followed by the notified body number
This means that the manufacturing facility is audited and certified and a technical file must be completed and submitted for EC type Examination by a notified body.
Also note that many products may still be covered by the PPE Directive previously in place, and it is important that you prepare for the certificates on those products to be renewed in line with the new guidance. For more information on these changes, and how the PPE Regulation might affect your business, please view our white paper
EN 420:2003+A1:2009 (EN 420) “Protective Gloves – General requirements and tests methods” is a
well-established EU-wide reference standard defining how gloves and arm protectors should be
manufactured and tested in terms of
water resistance, innocuousness and efficiency. It does not cover all aspects of protection, and
should therefore be used in conjunction with other relevant European Standards, but EN 420 does
specify the markings manufacturers
use to demonstrate compliance.
For Example, for gloves protecting against chemicals, micro-organisms, mechanical or heat and flame, the following markings will appear on the product itself or packaging:
- The primary criteria that gloves meeting EN 420 need to demonstrate are summarised as follows:
- Gloves should offer the highest level of protection and avoid causing harm to the wearer.
- If the gloves feature seams then these should not reduce performance.
- Glove pH should be as close to neutral as possible, Chromium (VII) levels should be below detectable amounts, and any other substance used in the construction of gloves that is known to cause harm, irritation or allergic reaction (such as latex) should be clearly communicated in product information.
- An agreed European-wide sizing reference standard is used to ensure consistency in sizes.
EN 374 Glove Standards
The EN 374 set of standards define how protective gloves for applications involving dangerous chemicals and micro-organisms should be manufactured, labeled and distributed. This suite of standards is arranged in five parts.
The EN 374 suite of standards specifies the protection capabilities of gloves to various chemicals and micro-organisms.
Summary of changes to EN 374
|Part 1 - Terminology and performance requirements
|Part 1 - Terminology and performance requirements for chemical risks (EN ISO 374-1:2016)|
|Part 2 - Determination of resistance to
|Part 3 - Determination of resistance to permeation
|EN ISO 16523-1:2015 Permeation by liquid chemicals under condition of continuous contact|
|Part 4 - Determination of resistance to
by chemicals (EN 374-4:2013)
|N/A||Part 5 - Terminology and performance requirements for micro-organisms risk (EN ISO 374-5:2016)|
EN ISO 374-1:2016
Terminology and performance requirements for chemical risks. Gloves will be categorised into three Types (A, B or C) based on their chemical permeation performance against an extended list of chemicals, which has increased from 12 to 18.
The new EN ISO 374-1:2016 classifications
|Min. Number of Chemicals
from the 18 listed
|Type A||Level 2 (≥30 min breakthrough)||6|
|Type B||Level 2 (≥30 min breakthrough)||3|
|Type C||Level 1 (≥10 min breakthrough)||1|
EN ISO 374-1:2016 glove permeation test list
|Code Letter||Chemical||CAS Number||CLASS|
|E||Carbon disulphate||75-15-0||Sulpher containing organic compound|
|H||THF||109-99-9||Heterocyclic and ether compound|
|K||Sodium Hydroxide 40%||1310-73-2||Inorganic base|
|L||Sulphuric Acid 96%||7664-93-9||Inorganic mineral acid|
|M||Nitric Acid 65%||7697-37-2||Inorganic acide, oxidising|
|N||Acetic Acid 99%||64-19-7||Organic acid|
|O||Ammonia 25%||1336-21-6||Organic base|
|P||Hydrogen Peroxide 30%||7722-84-1||Peroxide|
|S||Hydrogen Fluoride 40%||7664-39-3||Inorganic mineral acid, contact poison|