Published: 17th Sep 2015
The aim of this article is to provide economic operators, such as manufacturers, importers and distributors, with information concerning European legal requirements of placing personal protective equipment, in particular head protection equipment, within the European Union internal market.
This article consists of two parts. Part 1 is about the general requirements of the Personal Protective Equipment (PPE) and Part 2 is about specific requirements for head protection.
Throughout this article references will be made to the PPE Directive, supported by the Guidelines on the application of the PPE Directive, which hereafter will be referred to simply as Guidelines. References will also be made to the Blue Guide on the implementation of EU product rules, which will be referred to as the Blue Guide from here on in. All of these documents can be found through the European Commission’s Enterprise and Industry website.
General PPE Directive requirements
Manufacturers bringing PPE into the European Union internal market must ensure that it complies with the European PPE Directive. The PPE Directive lays down conditions governing the placing of PPE on the European Union internal market and provides basic safety requirements, which PPE must satisfy in order to ensure the health protection and safety of users.
PPE is defined as: “Any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.” Examples of PPE product groups are equipment for hearing, eye and/or head protection, equipment for protection against falls from heights, equipment for partial or whole face protection, protective clothing, respiratory protective equipment, equipment for leg and/or foot and anti-slip protection, and equipment for hand and arm protection.
Types of equipment not covered by the PPE Directive are protective equipment for use by the armed forces, PPE for self-defence such as personal deterrent weapons, and helmets and visors intended for users of two or three wheeled motor vehicles.
In addition, presentation of PPE that is not in conformity with the provisions of the Directive is allowed at trade fairs and exhibitions, provided that an appropriate notice is displayed drawing attention to this fact.
The basic health and safety requirements (BHSRs) as laid down by Annex II of the PPE Directive cover design principles such as ergonomics, innocuousness aspects, design strength and information supplied by the manufacturer, and must be met before PPE is allowed into the European Union internal market.
Duties and obligations
The PPE Directive is currently the oldest of the so-called ‘New Approach’ legislation. As such it lacks the coherent duties and obligations of economic operators, such as manufacturers, importers, distributors and authorised representatives, as recently introduced by the New Legislative Framework for the marketing of products. This omission is to be rectified by a future PPE Regulation. Nevertheless, the current PPE Directive identifies manufacturers and authorised representatives as main actors responsible for establishing conformity with the PPE Directive.
According to European Decision No. 768/2008/EC, when referring to a common framework for the marketing of products a manufacturer is: “Any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark.”
Authorised representatives are defined as: “Any natural or legal person established within the European Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks.”
Although not defined in the PPE Directive, importers and distributors are widely recognised by national market surveillance authorities and have obligations deriving from Decision No. 768/2008/EC.
Importers are therefore defined as: “Any natural or legal person established within the European Union who places a product from a third country on the Union market.” Distributors are: “Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.”
Importers or distributors should also realise that they are considered to be manufacturers, and will be subject to the obligations of the manufacturer when placing a product on the European Union market under their own name or trademark, or if they modify a product already placed on the market in such a way that compliance with the applicable requirements may be affected.
The main obligation of a manufacturer placing its PPE on the European Union internal market is to ensure that it satisfies the BHSRs, as set out by the PPE Directive. He or she can achieve this by using European harmonised standards, the references of which are published in the Official Journal of the European Union. By using harmonised standards, the European Union Member States presume that the PPE satisfies the BHSRs.
The second main obligation of a manufacturer is to affix a CE mark and to provide an EC Declaration of Conformity. EU Member States should regard PPE bearing a CE mark that is accompanied by an EC Declaration of Conformity to be compliant with the BHSRs. It is important to realise that by affixing the CE mark, the manufacturer declares that the product not only satisfies the requirements of the PPE Directive, but that it also conforms to the provision of other applicable European Union harmonisation legislation.
Conformity assessment procedure
The PPE Directive distinguishes three groups of PPE, each covered by their own conformity assessment. It does not explicitly define these three groups, but they are commonly recognised as:
- Category I - simple design
- Category II - neither simple nor complex
- Category III - complex design
The manufacturer has the obligation to put together technical documentation, regardless of the category. The technical documentation must comprised all relevant data on the means used by the manufacturer to ensure that PPE complies with the BHSRs.
Manufacturers of simple design PPE are allowed to assess the level of protection and declare conformity by means of an EC Declaration of Conformity, without the interference of a Notified Body.
Category I exclusively covers PPE intended to protect the wearer against:
- Mechanical actions whose effects are superficial – e.g. gardening glovesCleaning materials of weak action and easily reversible effects – e.g. gloves affording protection against diluted detergent solutions
- Cleaning materials of weak action and easily reversible effects – e.g. gloves affording protection against diluted detergent solutions
- Risks encountered in the handling of hot components that do not expose the user to a temperature exceeding 50°C or to dangerous impacts – e.g. gloves and aprons for professional use
- Atmospheric agents of neither an exceptional nor extreme nature – e.g. headgear, seasonal clothing and footwear
- Minor impacts and vibrations that do not affect vital areas of the body and whose effects cannot cause irreversible lesions – e.g. light anti-scalping helmets, gloves and light footwear
- Sunlight – e.g. sunglasses and visors
Manufacturers of Category II PPE are subject to an EC type examination by a Notified Body, followed by an EC Declaration of Conformity by the manufacturer. This category covers PPE that is defined by neither Category I nor Category III.
Manufacturers of Category III PPE are subject to an EC type examination by a Notified Body and to one of the two quality assurance procedures as described in Article 11 of the PPE Directive. Upon completion, the manufacturer must compile a Declaration of Conformity.
This category exclusively covers:
- Filtering respiratory devices for protection against solid and liquid aerosols or irritant, dangerous, toxic or radiotoxic gases
- Respiratory protection devices providing full insulation from the atmosphere, including those for use in diving
- PPE providing only limited protection against chemical attack or against ionising radiation
- Emergency equipment for use in high temperature environments, the effects of which are comparable to those of an air temperature of 100°C or more and which may or may not be characterised by the presence of infrared radiation, flames or the projection of large amounts of molten material
- Emergency equipment for use in low temperature environments, the effects of which are comparable to those of an air temperature of -50°C or less
- PPE to protect against falls from height
- PPE to protect against electrical risks and dangerous voltages
- PPE used as insulation in high-tension work
Head protection requirements
Now that we have covered the basic definitions, main obligations and legal classifications of the PPE Directive, it’s time to look at more specific requirements for head protection PPE.
Classification of head protection equipment
Head protection is classified under Category II of the PPE Directive, with the exception of following:
- Helmets designed and manufactured for use in high temperature environments, the effects of which are comparable to those of an air temperature of 100°C or more and which may or may not be characterised by the presence of infra-red radiation, flames or the projection of large amounts of molten material
- Helmets designed and manufactured to provide protection against electrical risks
- Light headgear designed and manufactured to provide scalp protection
As mentioned previously, certain head protection is excluded from the PPE Directive:
- Helmets designed and manufactured specifically for use by the armed forces or in the maintenance of law and order
- Helmets designed and manufactured for riders of two or three wheeled motor vehicles, including racing helmets. Car racing helmets are not excluded and fall within Category II
There are a total of 15 harmonised standards under the PPE Directive, covering a wide range of helmets and head protection. These are:
- EN 397:2012+A1:2012 - Industrial safety helmets
- EN 14052:2012+A1:2012 - High performance industrial helmets
- EN 443:2008 – Helmets for fire fighting in buildings and other structures
- EN 960:2006 – Headforms for use in the testing of protective helmets
- EN 966:2012+A1:2012 – Helmets for airborne sports
- EN 1077:2007 – Helmets for alpine skiers and snowboarders
- EN 1078:2012+A1:2012 – Helmets for pedal cyclists and for users of skateboards and roller skates
- EN 1080:2013 – Impact protection helmets for young children
- EN 1385:2012 – Helmets for canoeing and white water sports
- EN 12492:2012 – Mountaineering equipment – Helmets for mountaineers – Safety requirements and test methods
- EN-ISO 10256:2003 – Head and face protection for use in ice hockey
- EN 13484:2012 – Helmets for users of luges
- EN 13781:2012 – Protective helmets for drivers and passengers of snowmobiles and bobsleighs
- EN 13277-4:2001 – Protective equipment for martial arts – Additional requirements and test methods for head protectors
- EN 50365:2002 – Electrically insulating helmets for use on low voltage installation
In addition, EN 13087, which is also a European harmonised standard, covers a wide range of standardised European test methods, used by test laboratories and/or Notified Bodies during their assessments.
Risks covered by this standard are:
- Conditions and conditioning of helmets
- Shock absorption
- Resistance to penetration
- Retention system effectiveness
- Retention system strength • Field of vision • Flame resistance • Electrical properties • Resistance to radiant heat
- Field of vision • Flame resistance • Electrical properties • Resistance to radiant heat
- Flame resistance
- Electrical properties • Resistance to radiant heat
- Resistance to radiant heat
Taking a closer look at these standards, there are many different requirements to consider. All of which depend on the intended use, the user and the environment in which the head protection will be used. Overall construction and field of vision are obviously main characteristics that should be considered by (potential) manufacturers. Furthermore, criteria like chinstraps, fastening devices, head mobility, eye protection, shock absorbing capacity, durability, and ease of release are to be considered.
It’s important that (potential) manufacturers outline the intended use, the level of protection, the end users (i.e. consumers or professionals) and the environment (i.e. general or industrial) of the PPE, before proceeding with the manufacturing process. As much PPE is manufactured outside the European Union, importers should be very careful when choosing a third-party to buy from or to have manufacture their PPE. They should take into consideration that once they import their PPE into the European Union, they themselves are considered to be manufacturers and take the full responsibility and (product) liability of the products they bring into the European Union. Naturally the importance of head protection is not something anyone would like to take lightly. Unfit head protection can lead to severe head traumas and even fatal injuries.
In order to properly inform the end-user of the considerations taken by the manufacturer, it’s important to stay in line with marking requirements as stipulated by the harmonised standards. Some general markings that should be applied to the PPE are the number of standards used, name and trademark of the manufacturer, designation of the model, designation of the intended use, size or size range of the helmet, its weight and year of manufacture.
The same applies to information supplied by the manufacturer. It should include more detailed information on how to use the head protection. Information to be considered:
- The head protection only protects if it fits well
- The head protection should be adjusted to fit the user
- Positioning of the head protection on the helmet to ensure the intended protection is provided
- Clear indications that a piece of head protection does not always provide protection against injury
- Head protection that is subject to severe impact should be discarded
- Head protection should never be modified in any way or form
This article outlined the general legal obligations by the PPE Directive in Part 1. The second part of this article aimed to provide an introduction into the appropriate classification, the available European standards and important considerations to be considered by the manufacturer. Whereas most head protection falls within Category II, meaning an involvement of a Notified Body is required, the manufacturer must consider carefully which Notified Body he or she is willing to work with. It’s advisable to consider a Regulatory Compliance Affairs consultant if there is insufficient know-how on the subject of legal obligations, technical specifications and conformity assessments procedures.
Finally, to conclude this article, economic operators should be on the lookout for a new European Regulation on PPE, which will replace the current European Directive. It’s unclear at this point when the Regulation will enter into force. The Regulation will apply two years after entering into force and as such is expected to become applicable somewhere in 2017/18.
Published: 17th Sep 2015 in Health and Safety International