Personal Protective Equipment (PPE)

Personal Protective Equipment

We can offer an extensive range of EU Notified Body and UK Approved Body services for manufacturers of PPE who are looking to place their products onto these markets.

The approval scope covers a wide range of protection capabilities, including protection against cold, heat, electric shock, harmful biological agents, chemicals, mechanical risks, slipping, static electricity and more.

Manufacturers, suppliers and buyers of these types of PPE can leverage Eurofins’ network of companies to ensure compliant and smooth market access to both EU and GB markets with CE Marking and UKCA Marking.

Eurofins Product Testing Italy S.r.l. is accredited as a Notified Body (0477) for two major types of Personal Protective Equipment (PPE):

• Equipment providing hearing protection
• Equipment providing respiratory system protection

Eurofins Textile & Footwear Testing Spain is accredited as a Notified Body (2865) to issue CE type-certification for Category II and III PPE. Our certification covers three major PPE product types:

• General body protection equipment (protective clothing)
• Equipment that provides non-slip protection for feet and legs (safety shoes)
• Hand and arm protection equipment (protective gloves)

Eurofins E&E CML Limited is a UK Approved Body (2503) for four major types of Personal Protective Equipment (PPE):

• General body protection equipment (protective clothing)
• Equipment that provides non-slip protection for feet and legs (safety shoes)
• Hand and arm protection equipment (protective gloves)
• Respiratory system protection equipment

Placing PPE on the EU mark - Regulation (EU) 2016/425 Personal Protective Equipment

To ensure PPE products sold on the European market perform as they are expected to, the European Union has established Regulation (EU) 2016/425 that enforces stringent requirements on PPE products. It classifies PPE into three categories: 

• Category I - requiring self-declaration by manufacturers only
• Category II - requiring certification by a Notified Body in Europe
• Category III - requiring certification and on-going monitoring by a Notified Body in Europe 

To secure CE Marking for Category II and Category III PPE, manufacturers, exporters and importers are required to conduct required product testing at accredited laboratories, and submit CE Marking requests to a Notified Body. The Notified Body will review technical files provided by the applicants and evaluate whether the products meet regulatory requirements. 

For Category III PPE, suppliers need to additionally arrange for an annual review by a Notified Body through factory audit or sample testing. 

Placing PPE on the GB Market - Personal Protective Equipment Regulations (Regulation (EU) 2016/425 as brought into UK law and amended) and the Personal Protective Equipment (Enforcement) Regulations 2018

Following Brexit, the UK Conformity Assessed (UKCA) mark came into force on 1 January 2021 and is required for certain products placed on the market in Great Britain (England, Wales and Scotland). It covers most products that previously required the CE marking.

From 1 January 2023, only PPE products that carry the UKCA mark will be accepted in Great Britain.

If you currently hold a CE marking certificate issued by a EU27 notified body, you will need to get a new UKCA certificate for PPE issued by a UK approved body.

Businesses need to meet the requirements of the Personal Protective Equipment Regulations (Regulation (EU) 2016/425 as brought into UK law and amended) and the Personal Protective Equipment (Enforcement) Regulations 2018.

To secure the UKCA mark, manufacturers will have to submit a technical file containing the same information as for CE marking, aside from the product marking, user instructions and a modified declaration of conformity.

To find out how we can help you ensure your Personal Protective Equipment (PPE) and gloves are suitable and compliant and contact your local Eurofins E&E laboratory