General information on PPE

In the section on personal protective equipment (PPE), we will explain the requirements for PPE, as well as their markings and instructions. We will also tell you about the obligations of businesses in relation to conformity assessment, the documentation and labelling of PPE and the sale of PPE in a store/online store. Welcome to the PPE section!

What is PPE?

Personal protective equipment (PPE) refers to equipment (such as protective clothing) designed for protection against risks to their user’s health or safety. Examples of PPE:

• Reflective vests and pedestrian safety reflectors
• Life jackets
• Respiratory protective equipment
• Hearing protectors
• Helmets
• Safety goggles
• Motorcyclists’ protective equipment such as protective clothing against abrasion and impacts, back and limb joint protectors, gloves and footwear
• Oven gloves and potholders

Legislation on personal protective equipment

PPE is subject to the Personal Protective Equipment Regulation (EU) 2016/425. PPE requirements can be roughly divided into two categories: one for the PPE and one for you as an entrepreneur. The PPE legislation includes the essential health and safety requirements for PPE and the assessment methods to assess their conformity. The technical details required for PPE are specified in European harmonised standards.

Nationally, PPE intended for consumer use is regulated by the Act on personal protective equipment intended for consumer use (218/2018) and in the Act on the Conformity of Certain Technical Devices to Relevant Requirements (1016/2004). National legislation lays down language requirements for protective equipment, for example.

What other directives/regulations might apply to PPE?

Legislation lays down requirements on products in order to ensure various aspects of safety, health, environmental protection and consumer protection. All products must be safe and reliable to use, or they must comply with certain minimum requirements. Provisions on these requirements are laid down in EU directives, regulations and decisions, and in national legislation. Often, regulation concerns only one characteristic of a product, so a single product is often subject to several regulations. The CE marking indicates that the product complies with all the relevant regulations.

In this learning material, we will go through the regulations that apply to PPE. However, PPE can also be subject to many other regulations, depending on the characteristics of the PPE, and where it is used.

For example:

• The REACH Regulation also applies to chemical substances on objects, so the requirements of REACH should be considered with PPE as well. In the case of PPE, particular attention must be given to substances of very high concern and restricted substances. You can read more about these on the Tukes website. Learn more about the REACH Regulation.

•  If the PPE has been treated with a substance intended as a chemical deterrent to organisms such as bacteria, the requirements of the EU Biocidal Products Regulation (528/2012) must be observed. For more information on biocidal products and treated articles, see the Tukes website.

• Pressure equipment means a tank, pipework or other technical unit which includes or might form overpressure, as well as the protective devices of the pressure equipment. Pressure equipment is used in industrial applications, workplaces and households. You can find more information on pressure equipment on the Tukes website.

• If the PPE needs electric power or fields to operate (including battery operated equipment), it is an electrical appliance. You can find more information on electrical appliances in the electrical products section on this website and on the Tukes website.

• When a device is used for the prevention, monitoring or treatment of illness or injury, the device is a medical device. Fimea monitors the conformity of medical devices in Finland. Certain products may be a combination of products, i.e. they are both PPE and medical devices.