There are various PPE regulations and directives that apply to Personal Protective Equipment. Here we summarise the key regulations in the UK, EU and USA.
The Health and Safety Executuve
A good starting point for those individuals or organisations wanting to find out about PPE regulations is the HSE guide on the subject.
A Short Guide to the Personal Protective Equipment at Work Regulations, INDG174, is available from HSE Books. Alternatively the booklet can be downloaded from the HSE website here.
The Personal Protective Equipment at Work Regulations 1992 is based on European Council (EC) Directive 89/656/EEC requiring similar basic laws throughout the European Union on the use of PPE in the workplace.
HSE information about the UK PPE regulations
The Regulations came into force on 1 January 1993. They have subsequently been amended by the Police (Health and Safety) Regulations 1999 SI 1999/860, the Ionising Radiations Regulations 1999 SI 1999/3232 and the Health and Safety (Miscellaneous Amendments) Regulations 2002 SI 2002/2174.
The Regulations do not apply to hearing protection and to respiratory protective equipment for most work activities, as these are covered by other regulations.
Full guidance on these including selection, use and maintenance are included in the publications L108 Reducing noise at work: Guidance on the Noise at Work Regulations 1989 and HSG53 Respiratory protective equipment at work: A practical guide. Both of these publications are available from HSE Books http://books.hse.gov.uk/.
These regulations should not be confused with the Personal Protective Equipment Regulations 2002, which deal with the design, manufacture and supply of PPE. Further information on these regulations is available on the DTI website (www.berr.gov.uk/).
Gaining a clear understanding of the regulations is a necessary step in ensuring safe working practices in your workplace.
The Health and Safety Executive should be your first port of call for information on safety in the UK. Bookmark the HSE as your main source of safety information.
HSE is the national independent watchdog for work-related health, safety and illness. They are an independent regulator and act in the public interest to reduce work-related death and serious injury across Great Britain’s workplaces.
Department for Business, Innovation and Skills
The Personal Protective Equipment Regulations 2002 (SI 2002 No 1144) implements into UK law the provisions of the Council Directive 89/686/EEC. It lays down the conditions governing Personal Protective Equipment (PPE ) placed on the market. The free movement within the Community and the basic safety requirements which PPE must satisfy in order to ensure the health, safety and protection of the user.
For the purposes of the PPE Directive 89/686/EEC. PPE means any device or appliance designed for use in domestic, leisure and sports activities or for professional use. To be worn or held by an individual for protection against one or more health and safety hazards in the execution of a specific activity. The scope of the PPE Directive is wide and includes such items for protection such as clothing, footwear and headgear against adverse atmospheric conditions. Damp, water and heat. PPE also includes respiratory protective equipment and equipment intended for the rescue or protection of persons in falls from heights.
The Directive provides for three categories of PPE simple design, complex design, and PPE that is neither simple or complex, known and intermediate. Often referred to as Category one, two and three.
Am I affected?
The manufacturer or person placing the PPE on the Community market has an obligation to ensure the product is designed, manufactured and conformity assessed to the essential requirements of the PPE Directive. Products claiming to have a higher level of protection covered by categories two and three would require the manufacturer or his authorised representative to have submitted the product to a Notified Body for type examination as part of the conformity assessment process.
Although a manufacturer may not claim protective qualities for the product but by its very nature the product could be perceived by the consumer to offer protection the product should legally meet the requirements of the PPE Directive.
A list of Notified/ Approved Bodies approved by the UK and other Member States who can offer advice can be found on the NANDO database.
The CE marking symbolises the conformity of the product imposed on the manufacturer. When affixed to a product does indicate the product conforms to all applicable provisions and appropriate conformity assessment procedures.
Trading Standards are responsible for enforcing consumer related legislation under the PPE Directive working with government and stakeholders. The objective of monitoring products placed on the market is to verify that they comply with the applicable directive. The EC declaration of conformity and technical documentation relating to the a product must be made available by the person placing the product on the Community market to the market surveillance authority immediately on request.
BIS is responsible for policy advice on the PPE Regulations. However, Trading Standards should be the first point of contact for any concerns.
The European Commission is expected to make a formal proposal to amend the PPE Directive during 2011/12 taking into account the requirements of the New Legislative Framework. No exact timetable is available at present, but Member States will be informed accordingly and be required to carry out a public consultation. Comments made by the wide range of stakeholders on the proposals will be raised by the UK with the European Commission as part of the process.
Product Standards – Personal Protective Equipment – Guidance on UK Regulations (PDF 210KB)
Personal Protective Equipment Regulations 2002: guidelines on the appointment of UK approved bodies (PDF, 120 Kb)
Personal Protective Equipment (EC Directive) Regulations 1992: proposal to amend the regulations. Second consultation document (PDF, 230KB)
Personal protective equipment (EC directive) regulations 1992: proposal to amend the regulations. Consultation document (PDF, 171KB)
Personal Protective Equipment Regulations 2002: approved bodies (PDF, 162KB)
Contains public sector information published by the Health and Safety Executive and licensed under the Open Government Licence v1.0.
The United States government agency which deals with medical products and products that emit radiation is the FDA, through its branch, called CDRH. CDRH comes from Center for Devices and Radiological Health.
The role of the FDA when it comes to PPE
Personal protective equipment which is used either in the prevention or the treatment of diseases comes under the regulations of the FDA. Some of the PPE which is included in the FDA regulations includes medical gloves, N95 respirators, surgical gowns and surgical masks.
FDA has to approve any of these devices, before companies are allowed to sell them in the United States. For this purpose, FDA will analyze the product applications of the manufacturer, to insure that similar devices already exist on the market. This process is called by the FDA as product clearing for the market.
After the product is cleared, the FDA will keep a database with the products and their manufacturers, make sure that the manufacturing methods are reliable, and it will analyze and review any reports that there are problems with the medical devices. If any issues are found, the FDA can ask for a recall or recommend some changes to instructions or labels.
Other Government agencies
Another official organization that deals with PPE is OSHA. This is the organization that makes sure that companies give their workers the right type of personal protective equipment, when they are in danger of being exposed to infectious materials or blood. This organization can also ask employers to give PPE to workers that are in danger from other types of hazards.
NIOSH is yet another Governmental agency which deals with PPE, especially respiratory protection equipment. This organization tests the equipment and how well it performs, to make sure they work properly. As long as a respirator is not used for medicinal purposes, a certification from NIOSH is not required.