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CE marking PPE to EU Regulation 2016/425
Highlighting important legislation affecting all companies intending to work in the EU PPE market.
Image © SafakOguz | iStockphoto.com
A little over 20 years ago, a number of changes were made to European legislation relating to personal protective equipment (PPE) which were designed to eliminate barriers to trade and improve health and safety. These initiatives had a major effect on the testing, marketing and use of PPE in the European Union (EU).
PPE was defined by this legislation as ‘any product designed to be worn or held by an individual for protection against one or more safety or health hazards’. This definition clearly captures a wide variety of products which include specific protective claims. Subsequently, all manufacturers and suppliers of PPE placed on the market in an EU country since 30th June 1995 have been obliged to follow a defined protocol.
The document that underpinned the legislation for placing PPE on the EU market until April 2018 was Directive 89/686/EEC. This became an active part of European law in 1995. After that date, suppliers of PPE have been required to follow certain defined approval procedures before affixing the now familiar ‘CE’ mark.
Regulation (EU) 2016/425
On March 31st 2016, the European Commission published new personal protective equipment legislation which has now replaced the original Directive 89/686/EEC (see table 2). This new regulation followed an impact study in 2010 and a public consultation in 2011, which were carried out to determine if a revision was required. During this period, feedback from a number of stakeholders on proposed changes helped to influence and shape the final text. These studies were reviewed during 2013 and 2014, and changes to the PPE legislation were subsequently recommended. Work on a new regulation was then carried out, which resulted in a trialogue between representatives of the European Council, European Parliament and European Commission on final draft proposals, which were completed at the end of 2015.
The European Commission considered that experience with the original directive showed the basic principles to work well, and that they should be maintained. Therefore, the obligation to carry out the complete conformity assessment procedure remains solely that of the manufacturer. Also, the majority of core health and safety requirements and procedures remain the same, although a few specific areas have changed. One major legislative alteration is that the PPE Directive was replaced by a regulation that applies directly in all member states, without transposition into national legislation. While the practical impact on suppliers was relatively minor, a number of amendments relevant to PPE were implemented at the same time, including scope changes and certification requirements.
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. To comply with the new legislative framework, some obligations for manufacturers and authorised representatives have been extended to include importers and distributors.
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’ (previously termed ‘simple design PPE’ and ‘complex design PPE’ under the Directive). 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 with gradual effects. The list included superficial mechanical action, weak cleaning solutions, non-extreme atmospheric conditions and sunlight.
Category III PPE is intended to protect against mortal danger or risks that could seriously and irreversibly harm the wearer’s health. The list included 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 1), differ for each category (shown in table 1). Most types of PPE fall into the middle category, which requires initial examples of products and associated documentation to be tested and assessed by a Notified Body.
Box 1: Notified Bodies
Notified Bodies such as SATRA (with offices in both Ireland and the UK) 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 of PPE. 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. A network of representatives from the Notified Bodies meet on a regular basis to ensure that the standards and legislation are being applied uniformly across the EU. The groups are usually referred to as ‘Vertical Groups’ (which discuss issues related to a certain product type) and ‘Horizontal Groups’ (which discuss more general issues that relate to several product groups). As shown in table 1, Notified Bodies are involved in two main parts of the process – Module B (the ‘EU type-examination’) and Module C2 or Module D (ongoing production monitoring).
Since the implementation of the original PPE Directive, SATRA has become one of the leading Notified Bodies for CE marking 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 and acoustic laboratories are capable of testing most types of PPE.
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 ‘Basic Health and Safety Requirement’ (BHSR) of the legislation. This process is based on the claims made about the product and is achieved by:
i) Examining the design documentation (often referred to as the ‘technical file’) to ensure that firstly, the product satisfies all the relevant BHSR of the PPE legislation. Secondly, that the product is adequately described through the use of diagrams and lists, giving the source of all materials as well as manufacturing details, and including quality procedures to ensure ongoing conformity.
ii) 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 2). 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 2: European harmonised standards
Both the old directive and new regulation include health and safety requirements that must be taken into account for all types of PPE, but do not describe or detail how particular types of product need to be tested. To support the directive, the EU Commission has mandated the development of various product safety standards via the European Standards agency CEN (Comité Européen de Normalisation). 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.
What is a standard?
A standard is a voluntary agreement on how to do something – such as defining the performance requirements of a product or the procedures of management systems such as those used by manufacturers (ISO 9001) or test laboratories (ISO 17025). A European standard is an officially recognised document that is available for use in over 30 different countries. Standards are developed by technical committees (TCs) which ideally consist of representatives of all major stakeholder groups – manufacturers, test laboratories, medical experts and end users. The technical committee helps bring these parties together and agree a solution by consensus. It is therefore important that committees have balanced representation with similar numbers of members from each area of interest.
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 basic health and safety requirements (BHSR) as given in Annex II of the regulation will be addressed.
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 initial sample previously approved by the EU type-examination. The Notified Body that carried out the production monitoring assessment need not have been 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 (product monitoring) – this involved 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) – this involves visiting the manufacturing 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 it is being abused in some way.
Obligations of manufacturers
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, keep 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 need to 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
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 PPE has been placed on the market, and to cooperate with the authorities in a language easily understood by that authority.
Obligations of importers
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 product ID and postal address where they can be contacted, as well as ensure transport and storage does not jeopardise the PPE’s conformity.
When deemed appropriate, the importer must carry out sample testing of PPE made available on the market, keep a register of complaints, and keep distributors informed of such monitoring. Importers are required to take corrective actions in case 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
When making PPE available on the market, distributors must act with due care in relation to the requirements of the regulation. Before making the PPE available, they have to verify that the PPE bears the correct markings and that it is accompanied by the required documents in a language that can be easily understood by the consumers. They 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 in case the PPE is considered to be non-compliant and inform the competent authorities if the PPE 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.
|Table 2: Comparison between Directive 89/686/EEC and Regulation 2016/425|
|PPE category||PPE Directive 89/686/EEC||PPE Regulation (EU) 2016/425|
|Category I||Manufacturer's self-declaration||Module A – internal production control|
|Category II||Article 10 – EC type-examination||Module B – EU type-examination
Module C – internal production control
|Category III||Article 10 – EC type-examination
Article 11A – ongoing surveillance through testing
Article 11B – ongoing surveillance through factory auditing
|Module B – EU type-examination
Module C2 – product verification
Module D – production quality assurance
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 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. The regulation also specifies in more detail than the directive the information that must be contained on the certificate.
The new regulation was published in the Official Journal of the EU on 31st March 2016 as (EU) 2016/425. It came into force 20 days later on 21st April and was applied on 21st April 2018, which was two years after first coming into force. There was then a one-year transition period until 21st April 2019 during which it was still possible to place on the market PPE complying with the directive.
EC type-examination certificates to the PPE Directive now become invalid at whichever date comes first – either at the stated expiry date, or five years after the application of the regulation, which will be 21st April 2023. It is still possible to make available on the market PPE certified according to the directive, but it is no longer possible to place such PPE on the market (see box 3). However, Paragraph 2 of Article 47 of the Regulation (EU) 2016/425 states that if:
i) the ‘state of the art’ has not changed (that is, the applicable standard has not been revised with significant changes on such aspects as safety clauses and withdrawal of current versions),
ii) the design and manufacturing arrangements remain the same as when the product was last subject to EC type-examination,
iii) the relevant essential health and safety requirements and product category under the regulation have not changed, then the product can be placed on the market using a PPE Directive EC type-examination certificate until 21st April 2023 (or until the expiry date of the certificate if it is earlier). However, the product itself must be in compliance with the regulation. Therefore, the product markings and user instructions must be updated as required by the regulation, and a new EU declaration of conformity must be produced.
This means that the EU declaration of conformity of the regulation can be based on a valid EC type-examination certificate produced under PPE Directive 89/686 until 21st April 2023 (or the expiry date of the certificate if earlier). This provides many current EC type-examination certificate holders with a longer timescale to fully transition.
That being said, for a number of products types, recent changes in harmonised standards will still mean EU type-examination certificates in accordance with the new regulation will be required.
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, it is transferred, with the intention of distribution, from the stage of manufacture (if production is within the EU) or transferred from the importer (if production is outside the EU). The only economic operators that can ‘place product on the market’ are therefore manufacturers or importers.
‘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 the published official definitions of these two terms include much greater detail so these descriptions should not be taken as authoritative text.
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 able to assist customers with this process.
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Please contact SATRA's PPE team (firstname.lastname@example.org) for assistance with CE marking PPE to EU Regulation 2016/425.