Since the implementation of the European Personal Protective equipment (PPE) Directive in 1995, SATRA has become one of the leading Notified Bodies for CE marking of PPE intended for supply within Europe and has been influential in the development of PPE related test methods and safety standards.
SATRA’s testing and certification services now extend across all areas of PPE – from head protection to safety footwear, and everything worn in between. This article is intended to provide a background to the PPE Directive.
Virtually all activities carry an element of risk, some of which can be eliminated by common sense and safe working practices, but other hazards are inherent to the activity and these can only be reduced by the use of PPE (PPE generally being considered a last resort when the risk cannot be eliminated in some other way). PPE is defined by European legislation as any device or appliance designed to be worn or held by an individual for protection against one or more safety or health hazards in the execution of the user’s activity. It is used in a wide variety of situations.
The majority of PPE is deployed in industrial applications although the Directive also covers PPE for leisure use as well. Industrial PPE includes items such as protective clothing designed for hazardous environments such as flame retardant clothing for protecting welders and foundry operatives and chemical resistant clothing for those people involved in working with or handling chemicals.
Typical PPE also includes safety shoes and helmets which are designed to protect against crushing loads or impacts, Protection against certain atmospheric conditions such as foul weather and severe cold is also PPE, as is highly reflective clothing used by highways repair men and railway workers to aid conspicuity. A wide range of protective gloves are also available to protect against many industrial processes including protection against chemicals, chain saws, knives and cutters and general material handling tasks.
There are also many items of PPE available for use in sport and leisure activities. In team games PPE is generally worn to reduce the severity of injuries from accidental impacts with other players, the playing surface or playing equipment such as balls, sticks and bats. Football shin guards and hockey goalkeeper protection falls into this category. Other types of sports PPE are designed for outdoor pursuits where there is a risk of, for example, falling to the ground during climbing or falling overboard during sailing, impacts during racing sports (such as vehicular and equestrian) or even for protection from the elements during hiking. Typical sports PPE items include a variety of protective headwear – worn for instance in cycling, mountaineering, canoeing, horse riding, cricket and martial arts – equestrian body protectors, lifejackets and harnesses for water sports.
In Europe, one of the pieces of legislation designed to create an open single market covers a significant proportion of PPE. This legislation is formally called Council Directive 89/686/EEC, but is more commonly referred to as the “PPE Directive”. It specifies in general terms what features should be addressed in the design of PPE and how it should be tested and certified. Products meeting the requirements of the PPE directive should be marked with the ‘CE’ symbol. For some years now it has been illegal to place an item of PPE on the market in a European state unless it carries the CE mark. However, many manufacturers are only vaguely aware of the requirements and their obligations.
To support the PPE Directive, CEN (the relevant European standardisation organisation) has been mandated by the European Commission to produce technical standards which have been written specifically for each type of product. Since originally there were just a few European standards this generated a considerable amount of work activity in the standards making community. Technical committees were formed covering the main types of PPE.
These committees consist of experts from each European Union member state, representing consumers, manufacturers and other interested parties such as Notified Bodies and test houses. Whilst some national standards were used as the basis for the new ENs, many product sectors in which standards had never been adopted had to come to terms with developing and agreeing test methods and procedures suitable for the product type in a relatively tight timescale.
SATRA is a prominent member of many of the technical committees associated with these standards whose work results in the publication of many ‘European Norm’ or EN standards. The vast majority of this work was (and still is) carried out by unpaid volunteers, as traditionally only a few people receive any funding for technical committee work.
PPE Directive general safety requirements
Published EN standards describe in detail how a particular type of product should be tested and what performance is required to achieve a satisfactory pass. The tests developed for the various standards are designed to assess the products against what is known as the Basic Health & Safety Requirement (BHSR) of the PPE Directive for the hazards of the particular activity for which the product is intended to be used. The European Commission reviews standards and if they are suitable they become officially ‘harmonised’ throughout Europe, and have a ‘presumption of conformity’ such that products that are fully covered by and meet the standard requirements are deemed to satisfy the Directive general safety requirements.
Harmonised standards are not the only means of demonstrating compliance with the PPE Directive. A manufacturer can use any technical specification as long as it can be shown to satisfy the PPE Directive essential safety requirements. However, if a harmonised standard is available for the particular product being examined, you would need to have a sound technical argument for not using it. In certain areas, such as niche or leading edge products, there may still be no harmonised standards available, in which case 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:
- Innocuousness: Generally a subjective assessment for any parts of the product such as sharp edges that may cause injury. It may also include some quantitative tests such as measuring the pH or quantity of trace toxic substances in the product’s raw materials. pH is a measure of the inherent acidity (or alkalinity) of the extractable matter from the material. In use, liquids such as perspiration and rain can cause this extractable matter to leach out of the material onto the wearer’s skin and if the pH is too far from neutrality it may lead to skin irritation
- Ergonomics: 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
- Protective coverage: Particularly important for products such as impact protectors. The minimum dimensions are specified, usually this is dependent on the size of the intended wearers, and the area is often checked against a standard template
- Protective qualities: A range of physical laboratory tests to mimic accident scenarios, examples include impact tests often involving measuring the force transmitted through the sample, strength tests such as tear, tensile or dynamic drop tests in the case of PPE to protect against falls from a height. For clothing to be worn in cold or wet environments these tests would include waterproofness and thermal insulation
During the development of European standards, individual Member states are prohibited from working on their own standards which ensures that all new standards produced in Europe for products covered by the PPE Directive do not differ significantly between European member states. For instance, safety footwear designed and sold in Germany should have been tested to the same standard as a similar product designed in France or the UK.
European standards are also achieving widespread acceptance worldwide and a number of other countries outside Europe are also taking advantage of the progress being made under the PPE Directive by either using the European standards or modifying them slightly to meet their own requirements. Many European standards are also forming the basis of International standards produced by the International Standards Organisation (ISO).
There are three categories of PPE recognised by the Directive and these are based on the risk, consequences (type of hazard) and severity of injury likely to occur to someone not wearing adequate PPE. Each category requires a different level of involvement by a Notified Body.
- “Simple” design PPE covers products that claim to provide protection against only minimal risks with effects that are gradual and can be safely identified by the user in good time. Products considered to be ‘simple’ category are listed in the Directive. Washing up gloves are an example. This category of PPE can be ‘self certified’ by the manufacturer or European importer without the need for the product to be verified by a third party – the involvement of a Notified Body is not required. However, an enforcement authority would expect to be able to examine a technical dossier backed up by appropriate test reports and it is recommended that records of some testing carried out by an independent test centre are maintained in order to provide documentary evidence which can be used to support any claims made about the product within the scope of Directive
- “Complex” design PPE covers products that claim to provide protection against risks of mortal danger or dangers that may seriously and irreversibly harm the health of the user. Again, a list is detailed in the Directive. The product has to be certified by a Notified Body and is subject to initial type examination and ongoing (annual) production checks
- All other products fall into a third unnamed category often called “Intermediate Design” or “Category 2”. These are products that claim to provide protection against risks of severe injury. Initial examples of these products and associated documentation must be certified by a Notified Body
Notified Bodies such as SATRA are Europe-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 marking of PPE. In addition they must also be independent and impartial and have appropriate professional indemnity insurance. There are currently 114 NBs throughout Europe – 105 in EU Member States and five in EFTA (all in Switzerland and Norway), and these are all subject to routine surveillance at regular intervals. It is possible to identify which Notified Body has certified the product because their name, address and unique number has to 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 Europe.
The Role of Notified Bodies
EC Type Examination
It is a mandatory requirement for suppliers of Complex and Intermediate design PPE to have initial examples of their products assessed by a European Notified Body such as SATRA. This process is called EC type examination and is a check on the design and documentation of an item of PPE to ensure that it is fit for its intended use and satisfies the essential safety requirements of the Directive. This process is based on the claims made about the product in the user information and is achieved by:
- Examining the design documentation (referred to as the technical file) to ensure that firstly, the product satisfies all the relevant sections from the list of basic health and safety requirements given in Annex II of the PPE Directive. Secondly 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 harmonised European standards or alternatively, if required, the manufacturer and Notified Body can use an agreed technical specification. The test reports are then added to the technical file. If EC type examination is successful, a certificate is issued by the Notified Body to prove conformity. This is effectively the end of the process and the certificate holder becomes responsible for ensuring that subsequent production remains the same as the model examined by the Notified Body
In addition to initial type examination, “Complex” design PPE is subject to checks that the production items of PPE continue to comply with the initial sample previously approved under EC type-examination. These checks must be carried out by a Notified Body.
The manufacturer or authorised representative can choose one of two alternative methods for the Notified Body to use when checking the conformity of ongoing production:
- Article 11A (Product Monitoring) – The first involves the Notified Body selecting and removing a random sample of manufactured items of PPE which are then tested by methods used in the original EC type- examination to ensure continuing compliance
- Article 11B (Quality System Monitoring) – The second involves visiting the manufacturing site and checking that the quality systems used by the manufacturer are capable of enabling consistent production of the certified product. SATRA uses qualified IRCA (International Register of Certified Auditors) registered quality management system auditors for this work
Both Article 11A and 11B assessments are carried out on a regular basis while that item of PPE remains in production.
Step by step guide to CE marking
Step 1 It is essential that manufacturers have access to copies of the standards associated with their particular products and familiarise themselves with the requirements otherwise it will be more difficult to manufacture anything that is likely to be immediately suitable. We also recommend that you obtain a copy of the European PPE Directive as this is the legislation that controls the placing on the European Market of PPE.
Step 2 We recommend that products are designed taking into account the requirements of the product standard(s). This sounds obvious but we still see many instances where product has been made first and then legislative requirements considered later! With many standards there will be a number of optional properties, it is important at this stage to decide what category of protection is required. Manufacturers may also wish to commission some limited experimental tests to identify any potential design problems.
Step 3 Where the involvement of a Notified Body is required, the manufacturer or authorised representative needs to make a formal application for EC type examination. Amongst other things, this will confirm the organisation the certificate should be issued to, the product identifiers and the product test specification. Ideally the application form should be accompanied by the technical file and product samples.
Step 4 The Notified Body assessor will need to confirm that appropriate tests have been carried out. However, SATRA also has some of the most extensive testing facilities in the world and many clients also require us to test the product.
Step 5 In addition to performance testing against the specific product standard, EC Type Examination against the PPE Directive also requires an assessment of ‘innocuousness’, i.e. confirmation that the product does not cause any harm to those who come into contact with it including the wearer. At its simplest this may be a check for the absence of sharp edges and points. However, European legislation also covers a number of restricted chemical substances and therefore SATRA also needs to confirm these are absent from the product before a certificate can be issued. Restricted substance legislation includes:
- EC Directive 2002/61/EC – Azo Colourants (Dyes)
- EC Directive 1999/51/EC – Pentachlorophenol (PCP)
- EC Directive 94/27/EC – Nickel
- Products also need to be assessed against EN340: 2003 General requirements for clothing
Step 6 In addition to confirmation of the products physical attributes, EC type examination also includes assessment of a technical dossier – called the ‘technical file’ which should include:
- Name & address of the manufacturer
- EU Authorised representative (if relevant)
- Product specifications (drawings & construction details)
- Raw material specifications (including the full postal address of the supplier)
- Quality control and test facilities to be used at the manufacturing plant
- Product marking (artwork of the information to be affixed to the product)
- Copy of user information sheet
- Details of how the product complies with Annex II of EC Directive 89/686
- Details of how the certificate holder intends to comply with Article 11 of EC Directive 89/686* – * Complex design products only
- Test reports (especially those being used to support the EC Type Examination)
Step 7 SATRA will assess the technical file and if necessary request any additional information required to satisfy our minimum requirements. When the file is considered to be satisfactory, an EC Type Examination certificate will be produced.
Step 8 SATRA returns the technical file (but keeps a copy) together with the EC Type Examination certificate, and it is recommended these are kept in a safe place (ideally in a European office) as the relevant European enforcement authorities may require to see them as part of any investigations if there is any future problem.
Step 9 The certificate holder is also required to draw up an ‘EC Declaration of conformity’ which is effectively a written commitment to manufacture the products in exactly the same way as the model that was type approved. Any changes to subsequent production should be discussed with and reviewed by the Notified Body otherwise the certificate may no longer be valid.
Step 10 Products can now be manufactured and placed on the European Market provided that:
- The design remains unchanged
- The products are marked in accordance with the technical file
- The products are supplied with user information as detailed in the technical file
Step 11 In the case of complex design products, maintain ongoing compliance in accordance with one of the two Article 11 routes.
It is important to remember that the EC type Examination certificate remains the property of the Notified Body, and whilst we cannot prevent organisations supplying product into the market place, we can withdraw the certificate if we have sufficient grounds to consider it is being abused in someway.
To conclude, Notified Bodies carry out a crucial role in assessing PPE products – facilitating European trade by ensuring safety and consistency of application through harmonised European standards and the PPE Directive requirements. This in turn provides consumers with a measure of confidence that supplier’s products have been assessed against recognised standards or other specifications by an independent third party who are themselves assessed for competence. However, it is important to remember that with the exception of complex category products, where the Notified Body has additional responsibilities to periodically assess on going production, a Notified Body does not see the vast majority of PPE produced after initial type examination. The responsibility for ensuring consistent production in accordance with the initial type examination is the certificate holders.
Published: 10th Oct 2006 in Health and Safety International