European Union regulations set the standard globally for the performance of personal protective equipment (PPE). These regulations form the basis of what is probably the most comprehensive and stringent PPE legislation available, and the CE marking concept is now being adopted in many other parts of the world. Peter Doughty explains the EU’s PPE Regulation and how to get safety footwear certified for placement on the European market.
The European Union and the United States of America are the world’s largest safety footwear markets. Both have comprehensive legislation covering the workplace environment and performance requirements for safety footwear. Although other parts of the world have different legislation, the industrial hazards are generally very similar. Regardless of country, PPE footwear often incorporates similar features, such as safety toecaps and under-foot protection. More specialist footwear has been developed to protect against other physical risks, such as cutting by chainsaws, or environmental hazards associated with chemicals, heat and electricity.
A little over 25 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 captured a wide variety of products which include specific protective claims. 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. Since 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.
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.
“initial examples of safety footwear and associated documentation are required to be tested and assessed by a Notified Body”
Directive was replaced by a regulation that applies directly in all member states, without requiring transposition into national legislation. While the practical impact on suppliers will be 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
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
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, extreme high or low temperature environments, harmful noise, drowning, cutting by hand-held chainsaws, bullet wounds, knife stabs, harmful bacteria and high-pressure jets. In the case of footwear, common examples of Category III products are anything protecting against chemicals, chainsaw cuts (i.e. forestry boots) or molten metal (i.e. foundry boots); or for working on live electrical installations.
The procedures for demonstrating compliance, and the involvement of a Notified Body, differ for each category. Most types of PPE such as all safety, protective or occupational footwear (other than that listed above as being category III) fall into the middle category, which requires initial examples of products and associated documentation to be tested and assessed by a Notified Body. European harmonised standards As the Regulation (like the Directive before it) is a piece of general legislation, it includes health and safety requirements that must be taken into account for all types of PPE. It does not, however, detail how particular types of product such as footwear should be tested. To support the original Directive, and now the Regulation, the European Union Commission has mandated the development of various product safety standards through the European standards agency CEN (Comité Européen de Normalisation).
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 (e.g. ISO 9001) or test laboratories (e.g. 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. CEN has convened a technical committee (referenced CEN/TC 161) to develop a series of harmonised European standards for use in testing and certification of foot and leg protection.
These European standards for foot and leg protection describe in detail how particular products should be tested and what performance is required to achieve a satisfactory pass. The tests developed for the various standards are designed to assess products against the requirements of the PPE Regulation for the risks of the particular activity for which they are to be used. The European Commission reviews these standards and, if they are found suitable, they become officially harmonised throughout Europe, and receive a ‘presumption of conformity’ for the parts of the Regulation detailed in Annex ZA of each standard. The publication of the standard is also mentioned in the official journal (OJ) 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 clauses of the Regulation are addressed.
Harmonised standards are not the only means of demonstrating compliance with the PPE Regulation. A manufacturer can use any technical specification as long as it can be shown to satisfy the relevant basic health and safety requirements (BHSR) of the PPE Regulation. However, if a harmonised standard is available for the particular product being examined, there should be a sound technical argument if it is not used. In certain areas, such as niche or leading-edge products, there may still be no harmonised standards available. In such cases a technical specification detailing how compliance is to be demonstrated must be produced and used.
Typically, the tests necessary to certify an item of PPE cover all of the following four main categories.
This is generally a subjective assessment for any parts of the product that may cause injury, such as sharp edges. It usually also includes some quantitative tests, such as measuring the quantity of trace toxic substances in the product or its raw materials.
Usually a small-scale practical wear trial which involves the wearer carrying out a range of movements typical of normal use and reporting any restrictions or discomfort caused by the PPE.
This is to ensure that the relevant parts of the wearer are being protected.
Footwear examples include the internal length of a safety toe cap, the dimensions of a perforation resistant insert or the coverage area of chainsaw cut resistant materials.
A range of physical laboratory tests to mimic accident scenarios, such as measurement of resistance to impact, perforation, cutting, burning and the flow of electricity.
During the development of CEN standards (ENs), individual EU member states are prohibited from working on their own standards (this process is formally referred to as ‘standstill’). This ensures that all new standards produced for products covered by the PPE Regulation do not differ significantly between EU member states. For instance, safety footwear designed and sold in Germany should be tested to the same standard as a similar product designed in France or Italy.
CEN standards are achieving widespread acceptance worldwide. A number of countries outside Europe have taken advantage of the progress being made under the PPE Regulation either by using the relevant ENs or modifying them slightly to meet their own requirements. Many European standards also form the basis of standards produced by the International Standards Organisation (ISO). Others are developed jointly between CEN and ISO under the ‘Vienna Agreement’, which is intended to help reduce duplication of effort. PPE footwear standards such as EN ISO 20344-7 are a good example of this.
The role of Notified Bodies
Notified Bodies 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 any 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). Notified Bodies are involved in two main parts of the process – Module B (the ‘EU typeexamination’) and Module C2 or Module D (ongoing production monitoring).
EU type examination
It is mandatory for suppliers of Category II and III PPE to have initial examples of their products assessed by an EU Notified Body. This process, called EU type examination, checks the design and documentation of a prototype or initial example of an item of PPE to ensure it is fit for its intended use and satisfies the BHSR of the Regulation. This assessment is based on the claims made about the product in the user information and is achieved by:
- Examining the manufacturer’s technical documentation (often referred to as the technical file) for the product to ensure first that it satisfies all the relevant basic health and safety requirements given in Annex II of the Regulation; and, that the product is adequately described through the use of diagrams and lists giving the source of all materials.
- Carrying out a series of tests and examinations on the products to ensure they meet the claimed performance levels. This may be carried out to harmonised European standards or, if required, the manufacturer and Notified Body can use an agreed technical specification. The test reports are then added to the technical file. If EU type examination is successful, a certificate is issued by the Notified Body to prove the item’s conformity. For Category II products, this is effectively the end of the Notified Body’s involvement and the certificate holder (i.e. the manufacturer) becomes responsible for ensuring ongoing conformity and that subsequent production remains the same as the model examined by the Notified Body.
In addition to initial type examination of the model, Category III PPE is subject to ongoing checks by a Notified Body to ensure that production versions of the item continue to comply with the sample that was approved by the EU type examination. It should be noted, however, that the Notified Body that carries out the ongoing monitoring of production need not be the same as the Notified Body that carried out the original type approval. The manufacturer can choose one of two methods for the Notified Body to use when checking the conformity of ongoing production: product monitoring or quality system 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.
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 assessment types are carried out on a regular basis, while that item of PPE remains in production.
Obligations of manufacturers
The Regulation clearly defines the obligations applicable to the manufacturer of the PPE (i.e. the holder of the Notified Body EU Type Examination certificate). 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 must ensure that their PPE meets all relevant essential health and safety requirements”
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 noncompliance 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.