PPE regulation - Protective glove testing
On the 31st of March 2016 the new PPE Regulation (EU) 2016/425 was published in the Official Journal of the European Union. It states that all manufactures must comply with the new requirements by 21st of April 2018, when the new regulation comes into force. There will then be a one-year transition period until 21st April 2019.
At Eurofins Product Testing we offer necessary testing along with assistance and consultancy that ensures compliance for your products to the new Regulation within the specified timeframe.
- Published on 31.03.2016
- Comes into force on the 20th day following its publication in the Official Journal
- Applies from 21.04.2018
- Members States shall not impede the making available of products covered by Directive 89/686/EEC which are in conformity with that Directive and which were placed on the market before 21.04.2019
- EC Type Examination Certificates issued under Directive 89/686/EEC shall remain valid until 21.04.2023 unless they expire before that date
The newly published standard EN ISO 374-1:2016 sets the requirements for chemical protective gloves to be certified. Protective gloves are classified as Type A, B or C, depending on their performance level within permeation testing against a list of 18 chemicals. The standard now also requires chemical protective gloves to be tested for their resistance to degradation, which was not a requirement in the old version.
Table 1: The new EN ISO 374-1 classifications
Obligations for manufacturers, importers and distributors
- It is a legal requirement for all manufacturers and their supply chain to comply with the regulation
- Importers, distributors and manufacturers should take appropriate measures to ensure that PPE meets all requirements and that they only make available on the market products which comply with Regulation 2016/425
- Importers shall ensure that the PPE is accompanied by the user information. The manufacturer shall either provide the EU declaration of conformity with the PPE or include in the user information the internet address at which the EU declaration of conformity can be accessed
- Manufacturer shall detail their internal quality procedures with their technical documentation
- EU type certificates will have a validity of 5 years
- It will be the responsibility of the manufacturer to ask the notified body to review the EU type certificate either:
- In case of a modification
- In case of a change in standard, essential health and safety requirements (EHSR) or state-of-the-art
- At the latest, before the date of expiry of the certificate
(In order to allow the notified body to fulfill its tasks, the manufacturer shall submit its application at the earliest 12 months and at the latest 6 months prior to the expiry date of the EU type-examination certificate.)
How can Eurofins help you?
Eurofins Product Testing can help with all testing and guidance regarding regulations concerning 2016/425.
Our test setup and knowledge makes Eurofins Product Testing the preferred partner in the industry. If you are looking for the fastest TAT in the market together with high quality and very competitive prices you have come to the right place.
For more information please fill out the contact form or contact.