Legal requirements for Personal Protective Equipment (PPE)

Published on 8 March 2022 · Last updated 23 October 2026

Personal protective equipment (PPE; persoonlijke beschermingsmiddelen) sold in the Netherlands must comply with Regulation (EU) 2016/425, the PPE Regulation, which applies directly in every Member State. The manufacturer classifies the product in risk category I, II or III (Annex I), follows the matching conformity assessment procedure (Article 19), draws up an EU declaration of conformity and affixes the CE marking before placing it on the market (Article 8(2)).

Examples of PPE are FFP2 masks, safety footwear, head and hearing protection, protective gloves and protective (work) clothing. Because PPE is meant to protect the wearer against risks to health or safety, EU law sets specific requirements for its design, manufacture and marketing.

Martin Krüger, one of our Dutch lawyers specialized in Product Compliance, has already written a blog about mouth-covering masks and CE marking. In this article, Our Dutch lawyers for Product Compliance Martin Krüger and Claartje van der Marel will discuss the general legal requirements for personal protective equipment.

What does Dutch working conditions law require of employers that provide PPE?

The legislation surrounding personal protective equipment is also essential within the framework of the Working Conditions Act and the requirement for a safe working environment to be provided.

The detailed rules are in the Working Conditions Decree (Arbeidsomstandighedenbesluit). PPE that an employer provides to employees must comply with the design and manufacturing requirements of the PPE Regulation and with Directive 89/656/EEC on the use of PPE at work (Article 8.1(1) Working Conditions Decree). Before choosing PPE, the employer assesses, as part of the risk inventory and evaluation, whether the equipment is suitable (Article 8.2). Where a risk exists, sufficient PPE must be available, the employer must ensure that employees use it, and the PPE must be maintained, repaired and replaced where necessary (Article 8.3).

What does the PPE Regulation (EU) 2016/425 regulate?

The PPE Regulation lays down requirements for the design and manufacture of PPE that is made available on the market (Article 1). It has applied directly in all Member States since 21 April 2018 (Article 48(2)); no Dutch implementing act is needed. The Dutch Commodities Act Decree on Personal Protective Equipment 2018 (Warenwetbesluit persoonlijke beschermingsmiddelen 2018) only adds national rules, such as prohibitions that make the Regulation enforceable and language requirements. The CE marking must be affixed before PPE is placed on the market in the European Economic Area (‘EEA’) (Article 17(2)).

What counts as PPE under the Regulation?

The first step is to check whether a product falls under the definition of PPE in Article 3(1) of the PPE Regulation. PPE means:

equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety;
interchangeable parts for an item of equipment that are essential for the protective function;
connection systems for such equipment that are not held or worn by a person, that are designed to connect it to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use.

Not all protective equipment falls under the PPE Regulation. Article 2(2) excludes PPE:

specifically designed for use by the armed forces or in the maintenance of law and order;
designed for self-defence, except PPE for sporting activities;
designed for private use to protect against atmospheric conditions that are not of an extreme nature, or against damp and water during dishwashing;
for exclusive use on seagoing vessels or aircraft subject to the relevant international treaties;
for head, face or eye protection covered by UNECE Regulation No 22 (helmets and visors for motorcyclists and moped riders).

For these products, other rules may apply, such as the General Product Safety Regulation for consumer products (see below).

The Regulation covers PPE that is new to the EU market when it is placed on the market: new PPE made by a manufacturer established in the EU, and new or second-hand PPE imported from a third country (recital 8). It applies to all forms of supply, including distance selling (recital 9).

What are the essential health and safety requirements?

PPE must meet the essential health and safety requirements of Annex II that apply to it (Article 5). It may only be made available on the market if, when properly maintained and used for its intended purpose, it complies with the Regulation and does not endanger the health or safety of persons, domestic animals or property (Article 4). Only after the applicable conformity assessment procedure has shown compliance may the manufacturer draw up the EU declaration of conformity and affix the CE marking (Article 8(2)).

How do harmonised standards help?

To meet the essential health and safety requirements, manufacturers usually apply harmonised standards. The standards themselves can be obtained in the Netherlands from the Dutch standards institute (NEN). PPE that complies with a harmonised standard whose reference has been published in the Official Journal of the European Union is presumed to meet the essential requirements covered by that standard (Article 14). Requirements the standard does not cover must be met in another way.

How is PPE classified into risk categories I, II and III?

PPE is classified according to the risks against which it is intended to protect (Article 18 and Annex I). There are three risk categories:

minimal risks;
risks other than those mentioned in I and III;
risks that may cause very serious consequences such as death or irreversible damage to health.

The classification determines which conformity assessment procedure applies. Category I covers exclusively the following minimal risks: superficial mechanical injury; contact with cleaning materials of weak action or prolonged contact with water; contact with hot surfaces not exceeding 50 °C; damage to the eyes due to exposure to sunlight (other than during observation of the sun); and atmospheric conditions that are not of an extreme nature. Examples are sunglasses and simple gardening gloves. Rainwear for professional use can also be Category I; rainwear designed for private use falls outside the Regulation (Article 2(2)(c)).

Category II covers all risks other than those listed in Categories I and III (Annex I). Many safety shoes and safety helmets fall into this category, unless they are intended to protect against a Category III risk.

Category III covers exclusively the risks that may cause very serious consequences such as death or irreversible damage to health, relating to: substances and mixtures hazardous to health; atmospheres with oxygen deficiency; harmful biological agents; ionising radiation; high-temperature environments comparable to an air temperature of at least 100 °C; low-temperature environments 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; and harmful noise (Annex I).

Which conformity assessment procedure applies, and how is the CE marking affixed?

The CE marking must be affixed visibly, legibly and indelibly to the PPE. Only where that is not possible or not warranted on account of the nature of the PPE may it be affixed to the packaging and the accompanying documents (Article 17(1)). For Category III PPE, the CE marking is followed by the identification number of the notified body involved in the production control (Article 17(3)). In the Netherlands, acting contrary to these rules is prohibited by Article 2(1) of the Commodities Act Decree on Personal Protective Equipment 2018.

The procedure depends on the risk category (Article 19):

Category I: internal production control (module A). The manufacturer assesses conformity itself.
Category II: EU type-examination by a notified body (module B), followed by conformity to type based on internal production control (module C).
Category III: EU type-examination (module B), followed by either supervised product checks at random intervals (module C2) or quality assurance of the production process (module D), both involving a notified body. Category III PPE produced as a single unit to fit an individual user may follow the Category II procedure.

A notified body is a conformity assessment body that a Member State has notified to the European Commission and the other Member States (Article 20). The Commission publishes the notified bodies per Union act in the NANDO database.

What obligations do manufacturers, importers and distributors have?

The PPE Regulation spreads responsibility across the supply chain:

Manufacturers ensure that the PPE meets Annex II, draw up the technical documentation, carry out the conformity assessment, draw up the EU declaration of conformity, affix the CE marking and keep the documentation for 10 years after the PPE has been placed on the market (Article 8). They also provide identification and contact details and instructions in a language easily understood by users.
Importers place only compliant PPE on the market. They check that the conformity assessment was carried out, that the PPE bears the CE marking and is accompanied by the required documents, and they add their own name and address (Article 10).
Distributors act with due care. Before making PPE available they check the CE marking, the documents and the instructions (Article 11).
An importer or distributor that markets PPE under its own name or trademark, or modifies it in a way that may affect compliance, takes on the obligations of the manufacturer (Article 12).

For the Dutch market, the instructions and safety information must in any case be in Dutch; the EU declaration of conformity must in any case be in Dutch or English (Article 3(2) and (3), Article 5(2) and Article 6(2) of the Commodities Act Decree on Personal Protective Equipment 2018). In addition, PPE may only be placed on the EU market if an economic operator established in the EU (manufacturer, importer, authorised representative or fulfilment service provider) is responsible for the tasks in Article 4 of Regulation (EU) 2019/1020, such as keeping the declaration of conformity available and cooperating with the authorities.

How does the PPE Regulation relate to the General Product Safety Regulation (GPSR)?

The General Product Safety Regulation (EU) 2023/988 (GPSR) applies from 13 December 2024 to consumer products, but only insofar as no specific EU rules with the same objective apply (Article 2(1)). For consumer PPE this means: the PPE Regulation governs the risks it covers, and the GPSR safety requirements apply only to aspects and risks not covered by it. Some GPSR chapters do not apply to PPE at all, such as the obligations of economic operators in Chapter III, Section 1. Other GPSR rules do apply to consumer PPE, for example the information requirements for distance sales (Article 19), the reporting of accidents (Article 20), the obligations of online marketplaces (Chapter IV) and the rules on recalls and remedies (Chapter VIII).

Who supervises PPE in the Netherlands?

In the Netherlands, two authorities share market surveillance of PPE. The Dutch Food and Consumer Product Safety Authority (‘NVWA’) supervises PPE intended for consumers. The Netherlands Labour Authority (Nederlandse Arbeidsinspectie, formerly the Inspectorate SZW) supervises PPE for professional users. Both enforce the PPE Regulation together with the Commodities Act Decree on Personal Protective Equipment 2018, which makes acting contrary to the Regulation a prohibited act under Dutch law.

Frequently asked questions about the legal requirements for PPE

Does the PPE Regulation also apply to PPE for private use?

Yes, in principle. The Regulation excludes only PPE designed for private use against atmospheric conditions that are not of an extreme nature or against damp and water during dishwashing (Article 2(2)(c) of Regulation (EU) 2016/425). Bicycle helmets for consumers, for example, are covered.

How do I know which risk category my PPE falls into?

Check Annex I of the PPE Regulation. Category I and Category III are exhaustive lists of risks; every other risk falls under Category II. The classification depends on the risk against which the PPE is intended to protect (Article 18), so check the intended use and the manufacturer’s risk assessment (Annex II, preliminary remark 4).

Does Category II PPE need a notified body?

Yes. Category II PPE requires an EU type-examination by a notified body (module B), followed by conformity to type based on internal production control (module C) (Article 19(b)). Only for Category III does the identification number of the notified body follow the CE marking (Article 17(3)).

In which language must PPE instructions be when sold in the Netherlands?

The instructions and safety information must in any case be in Dutch. The EU declaration of conformity must in any case be in Dutch or English (Article 3(2) and (3), Article 5(2) and Article 6(2) of the Commodities Act Decree on Personal Protective Equipment 2018).

Does the General Product Safety Regulation also apply to PPE?

Only to consumer PPE and only for aspects and risks that the PPE Regulation does not cover (Article 2(1) GPSR). Rules such as accident reporting (Article 20 GPSR), distance-sales information (Article 19), online marketplaces (Chapter IV) and recalls (Chapter VIII) do apply.

Primary sources

Regulation (EU) 2016/425 on personal protective equipment: Articles 1-5, 8, 10-12, 14, 17-20 and 48, recitals 8 and 9, Annexes I and II
Regulation (EU) 2023/988 (General Product Safety Regulation): Articles 2, 19, 20 and 52
Regulation (EU) 2019/1020 on market surveillance: Article 4
Working Conditions Decree (Arbeidsomstandighedenbesluit): Articles 8.1, 8.2 and 8.3
Commodities Act Decree on Personal Protective Equipment 2018 (Warenwetbesluit persoonlijke beschermingsmiddelen 2018): Articles 2, 3, 5 and 6

Do you need a lawyer for PPE compliance in the Netherlands?

Our Product Compliance lawyers at MAAK Advocaten in Amsterdam will be happy to advise and support you in determining which legal requirements for Personal Protective Equipment (PPE) apply in your case and how you can meet them, but also in disputes with competitors or discussions with regulators. Our lawyers are regularly confronted with legal issues concerning the legal requirements for personal protective equipment and have extensive knowledge and experience in this matter.

Dispute or advice in the Netherlands on Personal Protective Equipment

The Dutch lawyers at MAAK Advocaten in Amsterdam have extensive experience in assisting companies in the manufacturing industry with various Product Compliance issues. Would you like to get legal advice on the applicability of the PPE Regulation or on the obligations for personal protective equipment? Does your company have to deal with an enforcement issue by the NVWA or the Netherlands Labour Authority? Or do you need support in a dispute with another market participant? Please contact Martin Krüger or Claartje van der Marel or one of our other Product Compliance lawyers.