Mapping of Regulation (EU) 2016/425

To implement the requirements of Regulation (EU) 2016/425 in a transparent and structured manner, the regulatory assessment process can be represented through a Structured Assessment Logic (SAL). This logic ensures that all technical and regulatory requirements are systematically evaluated and that compliance is supported by documented evidence.

The SAL comprises the following steps:

1. Product qualification – Does the product qualify as Personal Protective Equipment (PPE) under the Regulation?

2. PPE classification – Category I, II or III

   PPE must be classified according to the severity of the risks against which it is intended to protect the user. This classification forms the basis for selecting the applicable conformity assessment procedure.

3. Selection of the conformity assessment procedure – Internal production control or Notified Body involvement.

4. Risk assessment – Identification of the relevant Essential Health and Safety Requirements (EHSR) of Annex II

5. Harmonised standards and gap analysis – Which standards cover the requirements, and where are there gaps?

6. Technical documentation – Which records demonstrate compliance?

7. Series Production – How is ongoing conformity ensured?

8. EU Declaration of Conformity & CE marking – Official confirmation of compliance, ready for the EU market.

Note: SAL is not an end in itself. It provides a repeatable methodology that translates regulatory principles into a clear, structured assessment logic.

Parallel applicability of legislation / Norm hierarchy and conflict of laws

Other Union harmonisation legislation may need to be taken into account. As part of the applicability assessment, it must be determined whether such acts apply in parallel or whether, due to rules of precedence and lex specialis principles, individual requirements or an entire harmonisation act is displaced in favour of another. Where no normative conflict exists, the respective requirements apply in parallel and cumulatively.

This diagram illustrates the SAL workflow visually:

Product qualification

↓

PPE classification (Category I–III)

↓

Conformity assessment procedure

↓

Identification of relevant requirements listed in Annex II

↓

Harmonised standards / other means of fulfilment

↓

Technical documentation

↓

Series Production

↓

CE marking & Declaration of Conformity

Overview: Regulation (EU) 2016/425

• Number: (EU) 2016/425

• Title: Regulation on personal protective equipment

• Publication: OJ L 81, 31.3.2016, p. 51

• Summary: The Regulation (EU) 2016/425 lays down requirements for the design and manufacture of personal protective equipment (PPE) in order to ensure protection of the health and safety of users.

• Public interest: Product safety

• Guidance: PPE Regulation Guidelines

Scope

The provisions of Regulation (EU) 2016/425 apply to Personal Protective Equipment (PPE), defined as any 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.

This includes equipment whose primary function is protective in nature, regardless of whether it is used in professional, industrial or private contexts.

The Regulation does not apply to PPE used:

• by the armed forces or for the maintenance of law and order;

• for self-defence purposes, except where intended for sporting activities;

• privately to protect against weather conditions that are not extreme, or against damp and water during activities such as dishwashing;

• on seagoing vessels or aircraft, where equipment is subject to specific international treaties;

• for head, face or eye protection used by drivers and passengers of motorcycles and mopeds (including protective helmets and visors).

Classification

PPE must be classified according to the severity of the risks against which it is intended to protect the user. This classification forms the basis for selecting the applicable conformity assessment procedure.

The categories are:

• Category I – PPE protecting against minimal risks;

• Category II – PPE protecting against risks other than those covered by Categories I and III;

• Category III – PPE protecting against risks that may cause very serious consequences such as death or irreversible damage to health.

Conformity Assessment Procedures

Manufacturers must select the appropriate procedure according to Article 19 and Annexes IV–VIII.

The applicable conformity assessment procedure depends directly on the PPE category:

• Category I: Internal production control (Module A);

• Category II: EU type-examination (Module B) followed by conformity to type based on internal production control (Module C);

• Category III: EU type-examination (Module B) combined with either:

  • conformity to type based on internal production control plus supervised product checks at random intervals (Module C2), or

  • conformity to type based on quality assurance of the production process (Module D).

    
    

Essential Requirements under Annex II │ Risks assessment

The risk assessment is required not only to evaluate and mitigate hazards, but also to determine which of the Essential Health and Safety Requirements set out in Annex II are relevant to the specific PPE, taking into account its intended use, foreseeable conditions of use, and the risks against which protection is intended to be provided.

Harmonised Standards

• Technical specifications facilitating compliance

• Use provides a presumption of conformity

• Developed by recognised European standardisation organisations

• Referenced in the Official Journal of the EU

• Summary list of references of harmonised standards

Technical documentation

Manufacturers must compile and maintain technical documentation demonstrating conformity with the applicable Essential Health and Safety Requirements and supporting the selected conformity assessment procedure.

Series Production

The requirement for ongoing conformity is implemented in practice by ensuring that manufacturers identify and keep under control those product and process characteristics whose deviation could jeopardize compliance with the legal requirements.

This requires a systematic management of safety- and compliance-critical characteristics, defining how these characteristics are identified, monitored, controlled, and protected against unintended change.

CE marking

• Mandatory before placing the product on the EU market

• Must be visible, legible, and permanent

• Notified Body number required if involved

Conclusion

With SAL, the mapping as a roadmap, it becomes clear how Regulation (EU) 2016/425 is systematically applied. The final workflow logically follows from scope through requirements, standards, and assessment procedures to CE marking – providing a clear orientation for manufacturers, assessors, and all stakeholders seeking regulatory clarity.