It is mainly used to protect employees from serious work-related injuries or diseases caused by exposure to chemical radiation, electrical equipment, human equipment, mechanical equipment or in some dangerous workplaces. In addition to masks, safety glass, safety helmets and safety shoes, personal protective equipment includes a large number of respiratory protective equipment and protective clothing. These include safety helmets, goggles, hearing protectors, safety gloves, safety shoes, respirators and safety belts.
1. Who can help manufacturers sell PPE in the EU?
In the EU (European Union), engineering experts can help design and produce PPE that meets EU requirements and is placed on the EC market.
Foreign manufacturers can also sell PPE with the help of local private and public agencies that specialize in serving exporters.
The task of a European Notified Body is to evaluate compliance with the Directive and to provide assistance with special issues related to the assessment. Typically, the body will provide assistance and information about the standard.
In case of doubt regarding the interpretation of production, manufacturers established within the Community should contact the national competent authority responsible for PPE.
2. Is the PPE Directive mandatory for all EU member states?
The answer is yes. It has become a mandatory legal text for all EU member states since July 1995. PPE Directive 89/686/EEC was adopted on February 21, 1989 and became EC law on July 1, 1992, with a transition period lasting until June 30, 1995.
3. Will national laws regarding PPE change?
In each member state of the European Union, national laws involving PPE must be converted into the PPE Directive and adopted in accordance with the principle of "full consistency". In other words, all countries in Europe (including the European Economic Area) must convert to the PPE Directive in the same way. Therefore, PPE must comply with the health and safety requirements and related certification procedures specified in the revised PPE Directive.
4. How to know whether the protective equipment meets the requirements of the PPE Directive?
The characteristics of protective equipment, the intended protective use, and the manufacturer's statement of protection can be found in some catalogs of advertising and commercial information, as well as on the manufacturer's website and similar publications and publications. The relevant provisions of the PPE Directive are as follows.
Article 1 of the PPE Directive states:
1.2 According to the directive, PPE refers to equipment or devices worn and equipped by individuals to protect against one or more hazards to health and safety. PPE also covers the following aspects:
(a) A combination of several components or appliances put together by the manufacturer to provide individual protection against one or more possible and simultaneous hazards.
(b) detachable and inseparable protective equipment or appliances combined with individual non-protective equipment worn and carried by an individual for the performance of specific tasks.
(c) Interchangeable PPE components that essentially meet the functional requirements and are designed for use with this type of equipment.
1.3 Any external system connected to PPE is considered an integral part of the equipment even if it is worn and fitted by the user for a long period of time.
1.4 This directive is not suitable for PPE covered by other directives. This is because this directive involves the free flow and safety of goods placed on the market. In particular, the equipment-related directive 96/98/EEC used throughout the European Community.
5. How do manufacturers meet the requirements of the PPE Directive?
Personal protective equipment covered by the definition in Article 1 above must meet the corresponding essential health and safety requirements set out in Annex 2 to demonstrate that it provides appropriate health protection and safety for the user. The PPE Directive is part of the "New Approach" and these requirements are expressed in general terms.
The directive also stipulates some requirements for placing products on the market, such as certification, declaration of conformity, marking, user information, etc.
6. What are “New Approach” regulations?
The PPE Directive is part of the so-called "New Approach" directive regulations, which are generated by the same principles and common methods. The key points of the "New Approach" principle are:
Provides legal responsibility for the general principles of “essential health and safety requirements”.
Manufacturers can use harmonized standards to demonstrate compliance with essential health and safety requirements.
Products produced in accordance with the "New Approach" directive must be affixed with the CE mark.
The basic principles of the "New Approach" regulations are explained in detail in the "Guidelines based on the 2000 Approach Directives".
7. What does the CE mark mean? Is it mandatory?
The CE mark on personal protective equipment indicates compliance with the health and safety requirements of the PPE Directive and other directives. It is mandatory for PPE covered by Directive 89/686/EEC to be CE marked.
8. How to prove compliance with the PPE Directive?
Based on the declaration of conformity, the requirements placed on the manufacturer increase from relatively simple procedures for category 1 to more detailed procedures for categories 2 and 3. The definitions of PPE categories are given in Article 8 of the Directive.
Category 1 (minimum risk)
This category is sometimes referred to as "self-assurance" because the manufacturer does not need the services of a publishing agency. However, the manufacturer must meet the following conditions:
a. Ensure that its products comply with basic health and safety requirements. (Appendix 2)
b. Compilation of technical texts (Clause 8 and Appendix 3).
c. Drafting of product declaration of conformity (Clause 12 and Annex 6).
d. Affix the CE mark (Articles 12 and 13 and Annex 4).
Category 2 (standard PPE)
Measures a, b, c and d are required. Measures c and d require an EC type examination certificate, for which the manufacturer must:
e Apply to the notification body for type examination (Article 10). If the conditions are met, the notification body drafts the EC type examination certificate and the manufacturer's certificate becomes effective.
Category 3 (PPE to prevent fatal or serious and unavoidable hazards)
Requirements a, b, c, d, e provide an additional requirement for additional inspection of the production of PPE according to one or two possible procedures (clause 11A or 11B). The two procedures are as follows:
f1) Clause 11A procedure - "EC quality control system for final products". The manufacturer requires the notified body to ensure that the PPE produced actually meets the requirements of the EC type verification certificate. This is achieved by random inspections of production samples at least once a year. The notified body then issues a test report.
F2) Clause 11B procedure - "System for ensuring the quality of EC production through testing". The manufacturer should have a quality control system approved by the notified body.
9. What is a notified body?
A notified body is an institution that strengthens the directive in accordance with the EU member states. The competent authorities of the member states are authorized to be responsible for the conformity assessment of the selected institutions for testing and certification. These approved inspection bodies are notified bodies.
10. Can manufacturers choose a notified body at will?
Manufacturers can choose any notified body provided by the authorities and have no ability to conduct the necessary tests on the equipment. However, manufacturers and agents in other regions of the EU can only apply for EC type examination to one notified body.
11. PPE standards are not mandatory, if understood?
The use of PPE directives, standards, including European harmonized standards, is by no means emphasizing. On the other hand, within the scope of the implementation of the PPE directive, the European Commission has published the names, references and updated catalogs of relevant European harmonized standards that meet the requirements of Directive 89/686/EEC in the official publications of the European Community. Manufacturers who meet the requirements of such European harmonized standards and part of the standards can benefit from the assumption that they meet the basic requirements of the corresponding Directive 89/686/EEC.
12. How to adopt European unified standards?
If the relevant equipment products meet the requirements of the unified standards, they are considered to meet the EHSR requirements related to the PPE Directive (the basic health and safety requirements provided in Appendix 2), and further, they meet the standards.
Since every product and every essential requirement may not always comply with the corresponding European harmonized standards, manufacturers must be particularly careful when verifying that their personal protective equipment complies with all relevant requirements of Directive 89/686/EEC. Manufacturers must also comply with other relevant regulatory requirements, such as those for hazardous substances.
Safe, reliable and high-quality protection - this is what your customers expect. As a manufacturer of personal protective equipment, you are obliged to establish technical documents to prove that your products meet EU requirements and affix the CE mark.
