About the Personal Protective Equipment (PPE) Regulation (EU 2016/425)

Personal Protective Equipment (PPE) is defined as ‘any device to be worn or held by an individual for protection against one or more health and safety hazards’.

The PPE Directive 89/686/EEC was repealed with effect from April 2018 and the PPE Regulation (EU) 2016/425 now applies. A transition process has been outlined in Article 47 of the Regulation which states ‘without prejudice to Member States shall not impede the making available on the market of products covered by Directive 89/686/EEC which are in conformity with that Directive and which were placed on the market before 21 April 2019’ and also ‘EC type-examination certificates and approval decisions issued under Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date.

As a Notified Body for the PPE Regulation in the UK and the Netherlands choose BSI as your market access partner of choice to meet and understand the Regulation, associated testing and affix the CE marking.

Previously the PPE Directive focused on manufacturers placing products onto the EU and EEA market, but the new Regulation covers the whole supply chain. This includes importers, distributors or anyone involved in the supply and distribution of PPE. They should take appropriate measures to ensure that PPE meets standard requirements and that they make available on the market only products which comply with the Regulation as well as keep relevant documents for at least 10 years.

The PPE Regulation is mandatory - covering any type of product that falls within its scope. If you are therefore in the PPE industry, it is a legal requirement to comply.

The PPE definitions used in the Regulation are as follows:

• 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
• interchangeable components for equipment referred to in the point above which are essential for its protective function (e.g. filters)
• 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

The PPE Regulation does not apply to the following PPE:

• Equipment specifically designed for use by the armed forces or in the maintenance of law and order
• Equipment designed to be used for self-defence with the exception of PPE intended for sporting activities
• PPE use on seagoing vessels or aircraft
• Helmets and their visors for drivers and passengers of motor cycles and mopeds
• designed for private use to protect against:
  • atmospheric conditions that are not of an extreme nature,
  • damp and water during dishwashing

UKCA marking is effective in Great Britain (England, Scotland and Wales) from 1 January 2021, so if you place Personal Protective Equipment (PPE) on the market in Great Britain you will need to affix the UKCA marking (although CE marking will also be recognized for most products until the end of 2021).

BSI is an approved body (0086) to support UKCA marking services for PPE and can work with you to navigate this new regulatory landscape.

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BSI is a Notified Body for the PPE Regulation and numerous other EU Directives. We have a comprehensive scope, being able to carry out Article 10 (EC Type Examination), Article 11A (on-going surveillance through annual testing) and Article 11B (on-going surveillance through annual factory) for head protection, eye protection, clothing, gloves, respirators, footwear and life jackets as well as many other devices.

We can issue EC Type examination certificates as well as carry out on-going surveillance globally, delivered locally where at all possible.

We have a global service with world-class expertise and BSI is leader in testing and certification. With more than 270 technical experts located in over 100 countries, we provide some of the most extensive and efficient testing services, accelerating time to market and giving you a head start of the competition.