European conformity assessment of PPE

Outlining the conformity assessment procedures that apply to personal protective equipment being placed on the European Market.

Image © Aleksandr Golubev | iStockphoto.com

This article describes the conformity assessment procedures that apply to personal protective equipment (PPE – see box 1) which is being placed on the European Market. With regard to Europe, two specific markets are considered. Firstly, we will consider the European Union and secondly, the United Kingdom (that is, England, Scotland, Wales and Northern Ireland). Since the UK is no longer a part of the EU, these two markets must now be considered separately. Nevertheless, the requirements of UK PPE legislation currently mirrors that of the EU in a large way (see box 2).

Box 1: The definition of PPE

PPE is defined by this legislation as ‘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’. This definition also includes certain associated interchangeable components and connection systems, so clearly captures a wide variety of products which include specific protective claims relating to the wearer.

Box 2: The UK, GB and BREXIT

The UK left the EU on 31st January 2020 (often called ‘BREXIT’), and was in a transition standstill phase where EU legislation still applied until the end of December 2020. Since that time, the UK has adopted its own legislation with regard to placing PPE goods onto the Great Britain (GB) market (England, Scotland and Wales).

The European PPE Regulation (EU) 2016/425 has been brought into UK law and amended to apply in GB. It is typically described as ‘Regulation 2016/425 on personal protective equipment, as amended to apply in GB’. In terms of European ‘harmonised’ standards, the UK equivalent term is a ‘designated standard’.

Harmonised standards are reviewed by the UK authorities and, if considered suitable, are adopted as designated standards. The UK equivalent of a Notified Body is an Approved Body. In this article, any reference to Regulation (EU) 2016/425, CE marking, Notified Body or harmonised standard can be taken to also equally apply to the amended UK legislation, UKCA marking, UK Approved Body and designated standard.

As part of the BREXIT agreement, Northern Ireland, while part of the UK, will not recognise the UKCA mark but instead will continue to use the CE mark or an alternative ‘UKNI’ mark.

In August 2023, the UK Government announced that it intended to introduce legislation mandating 'indefinite' acceptance of the CE mark. Hence, PPE carrying either the CE mark and/or the UKCA mark will continue to be accepted in GB.

Regulation (EU) 2016/425

Since 21st April 2018, it has been mandatory for all PPE being placed on the EU market (see box 3) to comply with Regulation (EU) 2016/425 and its transitional arrangements. This regulation repealed Directive 89/686/EEC, which had previously served a similar purpose for over 20 years. Indeed, since 1995, manufacturers of PPE were required to follow certain defined approval procedures before affixing the now familiar ‘CE’ mark (see tables 1 and 2).

Box 3: Placing and making available on the market

In very simplistic terms, ‘placing on the market’ is defined as when an individual product is made available on the EU market for the first time. Hence, the only economic operators that can ‘place product on the market’ are manufacturers. The current understanding is that an individual product is placed on the EU market as soon as it is fully manufactured and offered for sale.

The UK interpretation presently takes this a stage further and requires the ownership to have been transferred, although the physical product may still be with the manufacturer at this point in time.

‘Making available on the market’ is when an individual product, already ‘placed on the market’ is supplied on the EU market for distribution, consumption or use, so would be typically further down the supply chain. When ‘made available on the market’, products must have been in compliance with the relevant EU legislation applicable at the time of ‘placing on the market’. Please note that the published official definitions of these two terms include much greater detail, so the descriptions used in this article should not be taken as authoritative text.

Sergeyryzhov | iStockphoto.com

Before making the PPE available, distributors must verify that the product bears the correct markings and that it is accompanied by the required documents in a language that can be easily understood by the consumers

Table 2: Conformity assessment under Regulation (EU) 2016/425
PPE category	Procedure	Responsibility
Category I	Module A – internal production control	Manufacturer

Category II	Module B – EU type-examination plus	Notified Body
	Module C – conformity to type based on internal production control	Manufacturer

Category III	Module B – EU type-examination plus	Notified Body
	Module C2 – internal production control plus supervised product checks or
	Module D – production quality assurance

The scope of the regulation extends beyond that of the old directive to cover items intended to provide protection to private users from heat – for instance, domestic oven gloves. Commercial users were already covered by the original directive.

The regulation clearly defines the obligations and responsibilities of the various economic operators, such as manufacturers, authorised representatives, importers and distributors of PPE.

In general, anyone involved in the supply and distribution chain should take appropriate action to ensure that their PPE is in conformity with the regulation.

As the PPE Regulation (like the original PPE Directive before it) covers such a broad range of products, it divides them into three categories. These categories are based on the associated hazards, with exclusive lists included for two of the three categories – referred to as ‘Category I’ and ‘Category III’. Anything not on one of these two lists falls into a middle category, referred to as ‘Category II’.

Category I PPE is intended to protect against minimal risks which would tend to have gradual effects. The list includes superficial mechanical action, contact with weak cleaning solutions or hot surfaces not exceeding 50^oC, non-extreme atmospheric conditions and damage to the eyes from sunlight.

Category III PPE is intended to protect against risks that may cause very serious consequences, such as death or irreversible damage to the wearer’s health. The list includes products providing protection against falls from a height, chemicals and gases, dangerous voltages, high- or low-temperature environments, harmful noise, drowning, cutting by hand-held chainsaws, bullet wounds, knife stabs, harmful bacteria and high-pressure jets.

The procedures for demonstrating compliance, and the involvement of a Notified Body (see box 4), differ for each category (shown in table 2). Many types of PPE fall into the middle category, which requires initial examples of products and associated manufacturer’s technical documentation to be assessed by a Notified Body.

Obradovic

The PPE Regulation divides relevant products into three categories

Box 4: Notified Bodies

Notified Bodies such as SATRA Technology Europe Ltd are EU-based organisations which have been appointed by member state governments and notified to the European Commission on the basis of their ability to carry out the examinations and tests required for CE marking. To qualify, they must also be independent, impartial and subject to routine surveillance at regular intervals. It is possible to identify which Notified Body has certified the product because its name, address and unique reference number must be displayed on the accompanying user information.

Since the implementation of the original PPE Directive, SATRA has become one of the leading Notified Bodies for conformity assessment of PPE intended for supply within the EU, and has been influential in the development of PPE-related test methods and safety standards. SATRA’s testing and certification services now extend across most areas of PPE – from head protection to safety footwear, and nearly everything worn in between. Our well-equipped mechanical, thermal, chemical, optical, respiratory and acoustic laboratories are capable of testing most types of PPE.

Type-examination

‘Type-examination’ is a check on the design and documentation of a ‘model’ or initial example of an item of PPE to ensure that it satisfies the ‘Essential Health and Safety Requirement’ (EHSR) as listed in Annex II of the regulation. This process is based on the claims made about the product and is achieved by the following:

Examining the manufacturer’s technical documentation (often referred to as the ‘technical file’) in order to ensure that firstly, the product satisfies all the relevant EHSR of the PPE legislation and secondly, that the product is adequately described through the use of diagrams and lists, giving the details of all materials as well as manufacturing assembly information, and including quality procedures to ensure ongoing conformity.
Carrying out a series of tests and examinations on the products to ensure that they meet the claimed performance levels. The testing is usually specified in a harmonised European standard (see box 5). However, if necessary, the manufacturer and Notified Body can use an agreed technical specification. The test reports are then added to the technical file. If type-examination is successful, a certificate is issued by the Notified Body to prove conformity. For Category II products, this is effectively the end of the Notified Body’s involvement, and the certificate holder becomes responsible for ensuring that subsequent production remains the same as the model examined by the Notified Body.

Box 5: European harmonised standards

The PPE Regulation includes health and safety requirements that must be taken into account for all types of PPE, but it does not describe or detail how particular types of products are to be tested. To support the regulation, the EU Commission has mandated the development of various product safety standards via the European Standards agency Comité Européen de Normalisation (CEN). CEN has convened a number of technical committees (TCs) in order to develop a series of harmonised European standards to be used in the testing and certification of PPE.

The tests developed for PPE harmonised standards are designed to assess the products against the requirements of the PPE legislation for the risks of the particular activity for which the product is intended to be used. The European Commission reviews these standards and, if they are suitable, they become officially ‘harmonised’ throughout the EU, and have a ‘presumption of conformity’ for the parts of the legislation detailed in Annex ZA of each standard. The publication of the standard is also mentioned in the official journal of the EU. Hence, when starting the CE marking process, it is necessary to review Annex ZA of any harmonised standard to be used to ensure that all relevant essential health and safety requirements (EHSRs) as given in Annex II of the regulation will be addressed.

Ongoing production checks

In addition to initial type-examination of the model, Category III PPE is subject under the regulation to ongoing checks by a Notified Body to ensure that production versions of the PPE continue to comply with the regulation and are homogenous with the initial EU type-examined sample. The Notified Body that carries out the production monitoring assessment need not be the same as the Notified Body that carried out the original type approval. The manufacturer is able to choose one of two alternative methods for the Notified Body to use when checking the conformity of on-going production:

Module C2 (supervised product checks) involves the Notified Body selecting and removing a random sample of manufactured items of PPE, which are then tested to ensure continuing compliance. The test programme typically involves procedures used in the original EU type-examination, but may include other forms of testing to assess homogeneity.

Module D (quality system monitoring) involves visiting the production site and checking that the ‘factory production control systems’ used by the manufacturer are capable of enabling consistent production of the certified product.

Both Module C2 and D assessments are carried out on a regular basis, while that item of PPE remains in production.

It is important to remember that the type-examination certificate remains the property of the Notified Body and, while this body cannot prevent manufacturers supplying products into the market place, it can withdraw the certificate if it has sufficient grounds to consider that it is being abused in some way.

Obligations of manufacturers

In line with Article 8 of Regulation (EU) 2016/425, manufacturers must ensure that their PPE meets all relevant essential health and safety requirements (Annex II of the regulation), and must draw up and make available the technical documentation as listed in Annex III. They are also obliged to carry out the conformity assessment, apply the CE mark and draw up an EU declaration of conformity (‘EU DoC’). The technical file and EU DoC are to be kept for ten years after the last item of that PPE is placed on the market.

Manufacturers are also required to ensure that procedures are in place for series production to remain in conformity with the PPE Regulation. If necessary, they must also carry out sample testing of PPE made available in the market, retain a register of complaints and keep distributors informed of such monitoring. It is also the manufacturer’s responsibility to ensure that PPE bears a type, batch or serial number, is accompanied with the instructions for use and has a single (postal address) point of contact.

To ensure easy access to the declaration of conformity, manufacturers must ensure that when PPE is supplied to an end user, it is accompanied by either a full hard copy of the declaration or the internet/website address where the declaration can be accessed. Manufacturers are also obliged to take corrective actions in case of non-compliance and inform the competent authorities where PPE presents a risk. In addition, it is their duty to cooperate with authorities in a language which can be easily understood by that authority.

Obligations of authorised representatives

As outlined in Article 9 of Regulation (EU) 2016/425, a manufacturer may, by written mandate, appoint an authorised representative. If this is done, the mandate allows the representatives to at a minimum keep the technical file and EU DoC available for the authorities for a minimum of ten years after the last item of that PPE has been placed on the market, and to cooperate with the authorities in a language easily understood by that authority.

Obligations of importers

Article 10 of Regulation (EU) 2016/425 indicates that importers can only place compliant PPE on the market. They must also ensure that the PPE has technical documentation available, the conformity assessment has been carried out, the PPE is correctly marked and that it is accompanied by the required documents. Importers need to indicate on the PPE their company identification and postal address where they can be contacted, as well as ensure that transport and storage do not jeopardise the PPE’s conformity.

When deemed appropriate, the importer must carry out sample testing of PPE made available on the market, retain a register of complaints and keep distributors informed of such monitoring. Importers are required to take corrective action in cases of non-compliance and inform the competent authorities where PPE presents a risk. They must cooperate with authorities and provide all the information necessary to demonstrate compliance, in a language that can be easily understood by the authority. The importer needs to keep the EU DoC available for ten years after the last item of that PPE is placed on the market, and ensure that the technical documentation can be made available upon request from the authorities.

Obligations of distributors

According to Article 11 of Regulation (EU) 2016/425, distributors must, when making PPE available on the market, act with due care in relation to the requirements of the regulation. Before making the PPE available, they have to verify that the product bears the correct markings and that it is accompanied by the required documents in a language that can be easily understood by the consumers. Distributors cannot make PPE available on the market if it is not considered to meet the essential health and safety requirements.

Distributors must ensure that transport and storage does not jeopardise the PPE’s conformity. They need to take corrective action if the PPE is considered to be non-compliant and inform the competent authorities if the product is considered to present a risk. Distributors are required to cooperate with authorities and provide all the information necessary to demonstrate compliance.

The regulation also introduces definitions and adapted conformity assessment procedures for made-to-measure and individually-adapted PPE. This will be of particular interest to manufacturers of products such as mouth-formed mouthguards or orthopaedic safety footwear.

State-of-the-art

In order to ensure that PPE is examined on the basis of the being state-of-the-art, the regulation requires time-limited EU type-examination certificates. These will be valid for a maximum of five years, after which they will need to undergo a revalidation procedure in order to be extended. To ensure sufficient time for any required renewal, the regulation specifies that the application must be submitted to the Notified Body at least six months (and no more than one year) prior to the certificate’s expiry date. A simplified renewal procedure is applied when there has been no change to the product, the harmonised standard or associated guidance.

Testing respiratory equipment in one of SATRA's laboratories

In summary

To conclude, products that are designed to be worn or held and provide a specific type of protection fall within the scope of the EU PPE Regulation and so require CE marking before being placed on the EU market. To help with this certification process, there are a number of European standards that describe in detail how various types of PPE should be tested and what performance requirements should be met.

SATRA is world-renowned for its testing and certification services in the field of personal protective equipment. Manufacturers can certify their products for sale in the European Union (EU) by working with SATRA’s Notified Body in Ireland (an EU 27 member state), thus enabling affixation of the CE mark. SATRA is also able to conduct conformity assessment work for manufacturers who require ‘United Kingdom Conformity Assessed’ (UKCA) certification.