The PPE Directive 89/686/EEC is repealed with effect from 21 April 2018. The PPE Regulation (EU) 2016/425 shall apply from 21 April 2018. As of 21 April 2018, manufacturers can place PPE on the European market which are compliant with the PPE regulation.
The article 47 of Regulation 2016/425 foresees a specific transitional regime for PPE:
- PPE designed and manufactured in accordance with Directive 89/686/EEC can still be placed on the market until 21 April 2019, and in principle EC type-examination certificates in accordance with Directive 89/686/EEC can be issued until the end of the transitional period, unless the classification of the product and/or the essential safety requirements applicable to it have changed (in the new Regulation).
- PPE may be placed on the market after 21 April 2019 and no later than 21 April 2023 on the basis of an EC type-examination certificate and/or an approval decision in accordance with the PPE Directive. This is not applicable in the following cases:
- Higher classification in the Regulation (after 21 April 2019)
- Updated version of the Harmonized Standard may result in a non-compliance of the product with the new Regulation
- change in design and/or manufacture of the PPE
PPE Directive 89/686/EEC (Personal Protective Equipment Directive) was published on June 1995 and covers Personal Protective Equipment (PPE). It is defined as “any device to be worn or held by an individual for protection against one or more health and safety hazards”.
89/686/EEC concerning Personal Protective Equipment (PPE) has 17 Articles and 6 Annexes. Originally published in 1989, the PPE directive only has three modifications 93/95/EEC, 93/68/EEC, and 96/58/EEC.
The introduction establishes the focus of the directive as “safeguarding of public health, improving safety at work and ensuring user protection” and reinforces the European Commissions continuing efforts to create free movement of goods in the European Economic Area through the use
of harmonized standards.
The directive divides PPE into 3 categories; class 1 – simple, class 3 – complex and class 2 – neither of these. For classes 1 and 3 there are comprehensive lists of equipments covered; any equipment not included on either list are classed in the second category. There is also a comprehensive list of equipment excluded from the directive. There are general requirements for all 3 classes, including technical documentation, a CE mark and a Declaration of Conformity. For classes 2 and 3 there are additional requirements.
Awareness and communication continue to be major problems across the EU for the smooth implementation of the directive. Some of the problems identified are:
- Scope: unclear about applicability to consumer PPE for domestic use; also demarcation between PPE and other directives, e.g. Medical Devices and Toys require clarification.
- Standards: still not available for all PPE
- Product Categorization/Conformity
- Assessment Procedures: require clarification to allow an increased scope for self-certification in order to ease demands on third-party testing and reduce compliance costs
- Notified Bodies: greater transparency and uniformity is required across member states in the assessment of applicants for Notified Body status in order to increase confidence in their appointment and activities
The PPE Directive (Personal Protective Equipment Directive) covers any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.
- Equipment for protection against falls from a height
- Head protectors (helmets and other headgear for professional and private use, face protectors for ice hockey players)
- Protective clothing, gloves (chemical attack, heat)
- Protective clothing (high visibility, reflecting materials)
- Protective eyewear used in the game of floor ball
PPE Directive applies to:
- A unit constituted by several devices or appliances which have been integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous risks
- A protective device or appliance combined, reparably or inseparably, with personal non-protective equipment worn or held by an individual for the execution of a specific activity
- Interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment
However the PPED does not apply to:
- PPE designed and manufactured specifically for use by the armed forces or in the maintenance of law and order (helmets, shields, etc.)
- PPE for self-defense (aerosol canisters, personal deterrent weapons, etc.)
- PPE designed and manufactured for private use against:PPE intended for the protection or rescue of persons on vessels or aircraft, not worn all the time
- Adverse atmospheric conditions (headgear, seasonal clothing, footwear, umbrellas, etc.)
- Damp and water (dish-washing gloves, etc.)
- Heat (gloves etc.)
- Helmets and visors intended for users of two- or three wheeled motor vehicles
There are general requirements for all 3 classes, including technical documentation,
a CE mark and a Declaration of Conformity.
The manufacturer must create a technical file.
The Technical File shall consist of:
- Overall and detailed plans of the PPE accompanied, if appropriate, by calculation notes and the results of prototype tests in so far as is necessary for the verification of compliance with the basic requirements (Annex II of the PPE Directive). Personal Protective Equipment Directive FAQs 4/4
- An exhaustive list of the basic safety requirements and of the harmonized standards or other technical specifications used to demonstrate compliance with the basic requirements.
- Declaration of Conformity
Other technical documentation that should be included, although not strictly part of the ‘Technical File’ is:
- A copy of the User Information or Instructions for Use supplied with the equipment
- A description of the control and test facilities to be used in the manufacturer’s plant to check compliance of production PPE with the harmonized standards or other technical specification.
If the equipment is to be manufactured in series, an EC type-examination is required. This EC type declaration shall not be required in the case of PPE models of simple design where the designer assumes the user can himself assess the level of protection provided against the minimal risks concerning the effects of which, when they are gradual, can be safely identified by the user in good time. This category shall cover exclusively PPE intended to protect the wearer against:
- Mechanical action whose effects are superficial (gardening gloves, thimbles, etc.)
- Cleaning materials of weak action and easily reversible effects (gloves affording protection against diluted detergent solutions, etc.)
- Risks encountered in the handling of hot components which do not expose the user to a temperature exceeding 50 °C or to dangerous impacts (gloves, aprons for professional use, etc.)
- Atmospheric agents of a neither exceptional nor extreme nature (headgear, seasonal clothing, footwear, etc.)
- Minor impacts and vibrations which do not affect vital areas of the body and whose effects cannot cause irreversible lesions (light anti-scalping helmets, gloves, light footwear, etc.)
- Sunlight (sunglasses)
In the case of PPE of complex design intended to protect against mortal danger or against dangers that may seriously and irreversibly harm health, the PPE will be subject to either “EC” quality control system for the final product or system for ensuring EC quality of production by means of monitoring and to an EC Declaration of Conformity.
For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.
The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the product from the market and the revoking of the CE marking affixed on the equipment.