In brief
The Personal Protective Equipment Regulation (2016/425/EU) divides PPE into three categories according to the severity of the risk it protects against and sets a different conformity assessment for each category. On Category III products, the four-digit identification number of the notified body must appear next to the CE mark. When purchasing, in addition to the CE mark, check the Turkish instructions for use, the EU declaration of conformity and that the notified body is genuinely authorised for that product.
Why do PPE categories matter?
When buying a mask, gloves or a safety harness for the workplace, people often look only at price and stock availability. Yet of two products on the same shelf, one may have passed a conformity assessment in line with the regulation, while the other may simply have the letters CE printed on it. The way to tell the difference is to know the PPE categories and what must appear on the product and in the documents for each category.
PPE is governed by two separate regulations:
- Personal Protective Equipment Regulation (2016/425/EU) (Official Gazette 01.05.2019, issue 30761): the design, manufacture and placing on the market of PPE. It sets out the obligations of manufacturers, importers and distributors.
- Regulation on the Use of PPE in Workplaces: the employer's obligations to select, issue and ensure the use of PPE. Under Art. 6, PPE used in the workplace must be designed and manufactured in line with the Personal Protective Equipment Regulation; products within the scope of that regulation must bear the CE mark and come with Turkish instructions for use.
So although the employer does not manufacture PPE, it is responsible for choosing a CE-marked, documented product. The 2026 basic administrative fine for not providing employees with suitable, CE-marked PPE is 8,980 TL per employee, and no increase for hazard class or headcount is applied to this per-employee fine. You can find other fines in the OHS administrative fines tool. For the employer's general PPE obligations, see our article on the Regulation on the Use of PPE.
Category I, II, III: definitions in the regulation
Art. 19 of the Personal Protective Equipment Regulation requires PPE to be classified according to the risk categories in Annex 1; Art. 20 sets the conformity assessment procedure to be followed for each category:
| Category | Definition in Annex 1 | Conformity assessment (Art. 20) | On the product |
|---|---|---|---|
| Category I | Minimal risks only: superficial mechanical injury; prolonged contact with mild cleaning materials or water; hot surfaces not exceeding 50 °C; damage to the eyes from sunlight (other than during observation of the sun); atmospheric conditions that are not extreme | Module A: internal production control (by the manufacturer itself) | CE mark |
| Category II | Risks other than those in Categories I and III | Module B (EU type examination by a notified body) + Module C (conformity to type based on internal production control) | CE mark |
| Category III | Risks that may cause very serious consequences such as death or irreversible damage to health | Module B + Module C2 (supervised product checks at random intervals) or Module D (quality assurance of the production process) | CE mark + identification number of the notified body |
Annex 1 lists the risks covered by Category III one by one: substances and mixtures hazardous to health; atmospheres with oxygen deficiency; harmful biological agents; ionising radiation; high-temperature environments with effects comparable to an air temperature of at least 100 °C; low-temperature environments with effects comparable to an air temperature of −50 °C or less; falling from a height; electric shock and live working; drowning; cuts by hand-held chainsaws; high-pressure jets; bullet wounds or knife stabs; harmful noise.
From these definitions, the following table emerges for products commonly used in the workplace:
| Product | Risk protected against | Category |
|---|---|---|
| Light gardening or dishwashing gloves | Superficial mechanical risk, mild cleaning agent | I |
| Safety helmet, safety footwear, mechanical risk gloves, impact-resistant glasses | Risks other than Categories I and III | II |
| Dust mask (FFP1–FFP3) and gas mask | Substances hazardous to health | III |
| Chemical protective gloves and clothing | Substances hazardous to health | III |
| Full-body harness and fall arrester | Falling from a height | III |
| Earplugs and earmuffs | Harmful noise | III |
| Electrical insulating gloves | Electric shock | III |
| Chainsaw protective trousers | Cuts by hand-held chainsaws | III |
The exact category depends on the risk for which the manufacturer designed the product; the same type of product may be placed on the market in a different category for different purposes. Rather than guessing the category, you should therefore check the product's declaration of conformity.
How to check the PPE CE mark and the notified body number
Art. 18 of the regulation sets the following rules for the PPE CE mark:
- The CE mark is affixed visibly, legibly and indelibly to each item of PPE; where the nature of the product does not allow this, it is affixed to the packaging or the accompanying documents.
- The CE mark is affixed before the PPE is placed on the market.
- On Category III PPE, the identification number of the notified body involved in the conformity assessment under Module C2 or Module D is placed next to the CE mark.
- After the CE mark and, where applicable, the body number, a pictogram indicating the risk the PPE protects against appears.
The notified body number has four digits. If a Category III product lacks this number, it has not been marked as the legislation requires. If there is a number, make two further checks:
- Search for the number in the European Commission's database of notified bodies (NANDO) and confirm that the body is notified under the PPE Regulation 2016/425.
- Check that the body is authorised for the product type and module you are buying. The number of a body authorised only for safety helmets is meaningless on a safety harness.
The shape of the CE mark is also a clue. The proportions of the mark and the spacing between the letters are defined in the Regulation on the "CE" Marking; a mark with letters very close together or distorted proportions should be examined carefully.
PPE declaration of conformity and instructions for use
The mark on the product is incomplete unless it is backed by documents. Under Art. 9 of the regulation, the manufacturer:
- Makes the product identifiable by type, batch or serial number and shows its name, registered trade name or trade mark and contact address on the product, packaging or accompanying document.
- Prepares the instructions for use in Turkish and supplies them with the PPE.
- Supplies the EU Declaration of Conformity with the PPE or states in the instructions for use the internet address where the declaration can be accessed.
- Keeps the technical file and the declaration of conformity for 10 years after the PPE is placed on the market.
For imported products, the importer must also show its name, registered trade name or trade mark and address on the product, packaging or accompanying document and supply Turkish instructions for use with the product (Art. 11). The distributor verifies the CE mark, required documents and Turkish instructions before selling the product (Art. 12).
The content of the PPE declaration of conformity is set out in Annex 9. Look for the following in the declaration:
| Heading in Annex 9 | What to check |
|---|---|
| Description of the PPE | Do the product, type/model and batch or serial number match the product you bought? |
| Name and address of the manufacturer | Is it consistent with the product and packaging? |
| Legislation complied with | Does it refer to 2016/425, or is it a declaration based on the old 89/686/EEC? |
| Harmonised standards | Does it state the appropriate standard and its date for the product? |
| EU Type Examination Certificate (Category II and III) | Are the notified body's name, number and certificate number given? |
| Module C2 or D (Category III) | Are the name and number of the notified body at the production stage given? |
| Signature | Are the place, date and the signatory's name and title given? |
Fake PPE: what to watch for when purchasing
Fake PPE does not always look bad; the packaging and price may be convincing. Even one of the following signs is enough reason to stop and examine the product before use:
- There is no four-digit body number next to the CE mark on a Category III product (mask, harness, chemical gloves, hearing protector).
- There is a number, but it does not belong to a body notified for PPE in NANDO, or it does not cover that product type.
- There are no Turkish instructions for use; the product is labelled only in a foreign language.
- The declaration of conformity is not provided on request, or the model number in the declaration does not match the product.
- The standard number on the product (e.g. filter class and standard on a mask) is missing or inconsistent with the product type.
- The documents consist only of papers called a "test report" or "certificate of conformity" whose issuer is unclear.
- The price is far below market prices for products of the same class.
To build these checks into your purchasing process, ask the supplier for the declaration of conformity for each product line and, where required, a copy of the EU Type Examination Certificate; compare the markings on the product with the documents when receiving the first batch; and keep these documents in your PPE file. You can report a product you believe to be non-compliant to the ministry responsible for market surveillance; the institution referred to as "the Ministry" in the regulation is today the Ministry of Labour and Social Security.
For product-specific markings, you can read our articles on dust masks FFP1, FFP2, FFP3, work glove selection and the full-body safety harness. Our article on PPE issue and replacement tracking explains how to record the PPE issued. We link PPE selection to the risk assessment and check the documents of purchased products as part of our OHS specialist service.
Frequently Asked Questions
What does Category 3 PPE mean?
It is PPE that protects against risks with very serious consequences such as death or irreversible damage to health. Respiratory protective equipment, chemical gloves, fall protection harnesses, hearing protectors and electrical insulating gloves are in this group. On these products, the four-digit number of the notified body appears next to the CE mark.
Why is there no body number on a Category II product?
In Category II, the notified body carries out the EU type examination at the design stage; production control rests with the manufacturer. The regulation requires the body number to be placed next to the CE mark only for Category III. Information on the type examination certificate of a Category II product appears in the declaration of conformity.
Can PPE without Turkish instructions for use be used?
It should not be used. The Regulation on the Use of PPE requires products within the scope of the Personal Protective Equipment Regulation to bear the CE mark and come with Turkish instructions for use; manufacturers and importers are also obliged to supply the instructions in Turkish with the product.
Is PPE certified under the old regulation still valid?
The new regulation does not prevent products placed on the market before 21.04.2019 in line with the old regulation (89/686/EEC) from being made available; however, EC type examination certificates and approval decisions issued under the old regulation were valid until 21.04.2023 at the latest. Today, the documents of a newly purchased product should refer to 2016/425.
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Bursa SİSTEMER OSGB Technical Team — written from the field experience of our OHS specialists and workplace physicians. Legal information is valid as of the publication/update date; contact us for an assessment specific to your business.