Legislation
Our objective is to help our valued clients achieve seamless protection in every process and situation –
and this includes regulatory protection. In order to achieve this we not only provide a range of
high-quality compliant products
but we
also look for opportunities to share our advice, insights and support to help your applications and
facilities keep pace with current legislation.
On this page we have collected a variety of information and resources on three important areas of
regulatory compliance that relate to our product portfolio.
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
region.
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 Certification
Anotified body gives CE certification by providing an EC certificate to PPE Cat III GlovesTo 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:
Complex Design Gloves
EC certified to protect against mortal danger and irreversible harmLook 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 420:2003+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
comfort,
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
should
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
| OLD | NEW |
|---|---|
| Part 1 - Terminology and performance requirements (EN 374-1:2003) |
Part 1 - Terminology and performance requirements for chemical risks (EN ISO 374-1:2016) |
| Part 2 - Determination of resistance to
penetration (EN 374-2:2014) |
No Change |
| Part 3 - Determination of resistance to permeation (EN 374-3:2003) |
EN ISO 16523-1:2015 Permeation by liquid chemicals under condition of continuous contact |
| Part 4 - Determination of resistance to
degradation by chemicals (EN 374-4:2013) |
Becomes mandatory |
| 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
| New classification |
Min. Performance Level Required |
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 |
|---|---|---|---|
| A | Methanol | 67-56-1 | Primary alcohol |
| B | Acetone | 67-64-1 | Ketone |
| C | Acetonitirle | 75-05-8 | Nitrile Compound |
| D | Dichloromethane | 75-09-2 | Chlorinated paraffin |
| E | Carbon disulphate | 75-15-0 | Sulpher containing organic compound |
| F | Toluene | 108-88-3 | Aromatic hydrocarbon |
| G | Diethylamine | 109-89-7 | Amine |
| H | THF | 109-99-9 | Heterocyclic and ether compound |
| I | Ethyl Acetate | 141-78-6 | Ester |
| J | N-Heptane | 142-82-5 | Saturated hydrocarbon |
| 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 |
| T | Formaldehyde 37% | 50-00-0 | Aldehyde |
EN ISO 374-1:2016
Terminology and performance requirements for chemical risks.
The most visible change will be new icons on glove packaging to reflect the new standard
The beaker pictogram currently used for EN374-1:2003
for chemical splash risk, will no
longer be used.
Chemical permeation performance levels will be standardised with the erlenmeyer flask pictogram
and information booklet pictogram.
Type A, B or C will be differentiated with the letters associated with the tested chemicals:
The letters in the first column of the glove permeation test list detail the tested chemicals.
EN374-2:2014
Determination of resistance to penetration.
Example of watertightness test according to EN374-2.
This standard replaced EN 374-2:2003 with no major technical changes.
Continues to specify the air and water leak test method for the penetration resistance of
protective gloves.
Notable changes include:
Reference to EN 374-3:2003 has changed to EN
ISO 16523-1:2015
EN374-3:2003 withdrawn
Determination of resistance to permeation by chemicals.
EN 374-3 has been superseded by EN ISO 16523-1:2015.
Easier to understand testing procedures
across a wide range of PPE.
Very similar to EN 374-3:2003.
Minor changes to apparatus dimensions.
Higher level of specificity for analytical
techniques.
Not expecting major differences in results.
All data to EN374-3 remains valid.
All new chemical permeation tests to use new
standard.
EN374-4:2013
Determination of resistance to degradation by chemicals.
To become mandatory for each chemical tested for permeation as stated in EN ISO
374-1:2016.
No changes planned.
The degradation test includes.
test principles and methods.
mandatory puncture resistance test for
natural or synthetic gloves.
non-mandatory weight change test for lined
gloves.
experimental equipment and reporting of
results as % degradation.
EN ISO 374-5:2016
Terminology and performance requirements for micro-organisms risks.
For protection against bacteria and fungi a penetration test is required using EN 374-2:2014:
air-leak/water-leak tests.
For protection against viruses, compliance to ISO 16604:2004 (method B) standard is
necessary.
New marking on packaging for gloves protecting against bacteria and fungi, and for gloves
protecting against bacteria, fungi and viruses:
For more information on the EN 374 standards please view our white paper
Maintaining regulatory compliance
In order to ensure that your facilities, personnel and product portfolios remain compliant with all
relevant legislation on an ongoing basis, and in an efficient manner, the following steps are
recommended:
1. Keep all existing certificates and documentation organised and easily accessible to relevant
staff. Records should be kept for at least 10 years and may include compliance certificates,
examination certificates, and declarations
of conformity.
2. Log the expiry dates of all documents to ensure that updates and obsolescence are carefully
planned to a schedule that better suits your operations. Note that certificate validity dates do not
always correspond directly to the
date that new legislation comes into force. For example, products governed with certificates from the
PPE Directive are valid until 2023, although this legislation was replaced by the PPE Regulation in
2018.
3. Ensure that all relevant user instructions are in the correct language. Protective products can
only perform effectively when they are used correctly, so customers need to understand instructions.
4. Develop an approach to continuously monitoring the certification and compliance status of your
product portfolio. This process can integrate with other timelines and systems used in your company
to assess and monitor operations.
5. Finally, engagement with your suppliers and providers can help ensure that all parties are
committed to the same level of customer/user protection and adherence to legislation.
When you work with expert partners and high-quality equipment manufacturers, regulatory compliance
should be a given. However, it is your responsibility to ensure this, along with protection for all
other aspects of processes and
equipment use that relate to your operations.
Familiarisation with the important aspects of relevant legislation will simplify this process – and
if you need any additional help or advice please feel free to contact us today in order to discuss
your needs