The New PPE Regulation

Regulation (EU) 2016/425 of 9 March 2016 on personal protective equipment

Personal Protective Equipment (PPE) are products that the user can carry or hold to be protected from hazards either at home, at work or in connection with recreational activities.

Accidents and major accidents statistics emphasize the importance of protection and prevention, so personal protection equipment plays an important role.

The EU Commission has issued a number of directives for improving health and safety at work and for ensuring high quality PPE.

The EPP Directive 89/686 / EEC covers the manufacture and marketing of personal protective equipment. It defines legal obligations to ensure that the PPE on the European market provides the highest level of protection against hazards. PPE is CE-marked to emphasize this.

The PPE Guidelines - Version 24/2017 aims to facilitate a common interpretation and application of the PPE Directive. However, it should be noted that only the national implementation of the Directive is legally binding.

The guidelines can be read here PPE Guidelines - Version 24 August 2017

New PPE regulation As of 21 April 2018, Directive 89/686 / EEC is repealed and replaced by a new PPE Regulation (EU 2016/425) on personal protective equipment.

The aim is to establish new common requirements for the design and manufacture of personal protective equipment (PVs) to be made available on the market in order to ensure the protection of the health and safety of users, as well as the free movement of PVs in the Union.

Personal protective equipment that is not covered is eg. equipment specially designed for the military, for self-defense - but not for sports activities, equipment for "not extreme weather", humidity and water under dishwashing and the like.

The new EPP regulation is adapted to the new legislative framework policy (New Legislative Framework). In addition, it slightly changes in relation to the scope and risk categorization of products and clarifies the economic actors' documentary obligations.

The Commission organized a workshop on the transition from Directive 89/686 / EEC to the new EPP Regulation. The workshop took place in November 2016 and resulted in a FAQ document, which you will find here: FAQ document Also read more on the Commission's website: http://ec.europa.eu/growth/sectors/mechanical-engineering/personal-protective-equipment/

Manufacturer's responsibility The manufacturer shall ensure that, when placing the PVs on the market, they are designed and manufactured in accordance with the applicable essential health and safety requirements set out in Annex II.

The regulation states that the manufacturer must produce the technical documentation ('technical documentation, Annex III') and implement or have it carried out in accordance with the applicable conformity assessment procedure (Article 19).

The manufacturer must ensure that a PV is accompanied by a number of information, such as type, batch or serial number or any other form of identification on the packaging or a document accompanying that PV.

Manufacturers specify their name and registered business name or registered trademark and the postal address at which they can be contacted on that PV or, if that is not possible, on its packaging or in a document accompanying the PV.

The address must indicate one single place where the manufacturer can be contacted.

the inactivity information is given in an easy-to-understand language for end-users and market surveillance authorities.

Manufacturers shall ensure that the relevant PV is accompanied by a user manual and information as set out in Annex II, point 1.4, in a language easily understood by consumers and other end-users as determined by that Member State.

The importer's responsibility Importers may only market PVs that meet the requirements.

Importers must ensure, before placing on the market, that the manufacturer has implemented the relevant conformity assessment procedure (Article 19).

The importer must also ensure that the manufacturer has drawn up the technical documentation that the PV concerned has CE marking and is accompanied by the required documents and that the manufacturer has complied with the requirements of Article 8 (1). 5 and 6.

Importers indicate their name and registered business name or registered trademark and the postal address where they can be contacted on that PV or, if that is not possible, on its packaging or in a document accompanying the PV.

The contact information is given in an easy-to-understand language for end-users and market surveillance authorities. Importers shall ensure that the relevant PV is accompanied by instructions and information as set out in point 1.4 of Annex II, in a language easily understood by consumers and other end-users, as determined by that Member State.


Distributors' responsibility Distributors must check, prior to making a PV available on the market, that they bear the CE marking, are accompanied by the required documents and an instruction manual and information as set out in Annex II, point 1.4, in an easily understandable language for consumers and other end-users in the Member State where the PV in question must be made available on the market and that the manufacturer and importer have complied with the requirements of Article 8 (1) respectively; 5 and 6, and Article 10 (1). Third

If a distributor finds or has reason to believe that a PV does not meet the applicable essential health and safety requirements as set out in Annex II, it must first make that PV available on the market once it has been brought into conformity.

In addition, if the PV concerned constitutes a risk, the distributor shall inform the manufacturer or importer and the market surveillance authorities thereof. The distributor must ensure that the storage and transport conditions of a PV for which they are responsible do not jeopardize its compliance with the applicable essential health and safety requirements set out in Annex II.

What obligations?

The commitments depend on how the PPE should be classified according to the risk categories in Annex I to the Regulation and after increasing risk categories 1, 2 and 3.

If a PPE is a Category 1 product, there must be an internal production control (Module A) as set out in Annex IV, whereas it is a Category 2 product, there must be EU type examination (Module B) as set out in Annex V, followed by type conformity based on internal production control (Module C) as set out in Annex VI.

Category 1 products are typically those products that must protect against minimal risks such as superficial cuts, contact with non-active cleaners, contact with hot surfaces or protection from exposure to sunlight. It may be sunglasses or work gloves. It is typically PPE for consumers listed here.

Category 2 products are subject to risks other than those listed in categories I and III. These are typically products for both consumers and professional use listed here.

Category 3 products include only risks that can have very serious consequences, such as death or irreversible health damage, related to substances and mixtures that are harmful to health, to protect against atmosphere with lack of oxygen, harmful radiation, hot and cold environments above 100 degrees Celsius and below minus 50 falls from heights, drowning, cuts from chain saws, significant noise. Typically, it is PPE for professional use which is listed here, but parachutes can e.g. also used by consumers.

The transitional Regulation (EU) 2016/425 on personal protection equipment (PPE - personal protection equipment) came into force in March 2016, but does not apply fully until April 21, 2018.

However, the Regulation provides for a transitional period for products marketed before 21 April 2019.

Article 47 (1) of the Regulation Paragraph 1 provides that 'Member States shall not prevent products covered by Directive 89/686 / EEC from being available on the market which comply with that Directive and which were placed on the market before 21 April 2019. Article 47 (1) Paragraph 2 provides that 'EC type-approval certificates and approval decisions issued under Directive 89/686 / EEC shall remain valid until 21 April 2023 unless they expire before that date'.

The regulation's transitional regime for personal protective equipment is hereby 1 year (21 April 2018 to 20 April 2019), where both the old directive and the new regulation apply.

In accordance with Article 47 (1). 1, PPE designed and manufactured in accordance with Directive 89/686 / EEC can thus still be marketed until 21 April 2019.

EC type-examination certificates may be issued in accordance with Directive 89/686 / EEC until the end of the transitional period, ie. April 20, 2019. As the Regulation applies from 21 April 2018, manufacturers can from that date start to market the PPE in accordance with the Regulation.

From 21 April 2019, all personal protective equipment placed on the market must comply with the requirements of the PPE Regulation, accompanied by the EU Declaration of Conformity (Article 15, Annex IX) and instructions for use set out in Annex II, point 1.4, for categories II and III products, on the EU type examination certificate (Annex V) and, where appropriate, on quality assurance approval decisions in accordance with the relevant conformity assessment procedures (Article 19, Annexes V, VII and VIII).

In general, certificates and approval decisions issued after the date of application of a revised law must comply with the new legislation.


However, the legislation can specifically foresee that certificates and approval decisions issued under the repealed legislation are also valid under the new legislation until a due date. Such a provision is usually inserted when the essential security requirements remain largely the same in the revised legislation.

According to the PPE Regulation, Article 47 (1) provides that 2, before 21 April 2019, EC type-approval certificates and approval decisions issued under Directive 89/686 / EEC shall remain valid until 21 April 2023 unless they expire before that date.

This provision was the subject of various interpretations, in particular whether it was applicable to all EC type-approval certificates issued under Directive 89/686 / EEC or only those issued during the transitional period.

It is important to note that this issue concerns only the validity of the certificate. It should be clear that any PPE marketed must comply with the requirements of the Regulation. April 21, 2019.

The question here is whether economic operators are allowed to base their EU declaration of conformity (which must also comply with the requirements of the new regulation) on a certificate issued under Directive 89/686 / EEC by 21 April 2019.

As a general rule, the PPE can be marketed under the PPE Regulation (21 March 2019) fully apply on the basis of an EC type-examination certificate and / or an approval decision under the EPP Directive until 21 April 2023. After that date, the validity of certificate / approval decision in any case and a new certificate / approval decision is required in accordance with the regulation.

However, this approach is not applicable in the following cases:

One or more applicable essential health and safety requirements in the Regulation have been amended to require a higher level of protection than the Directive provides. In this case, a certificate issued under the PPE Directive cannot be used to demonstrate compliance with the Regulation and an EU type-examination certificate must be issued in accordance with the Regulation.

Design and / or manufacture of PPE has changed since the last EC type test The generally recognized technology reflected in European harmonized standards has been modified (updated versions with significant changes to security clauses, revocation of current versions, etc.). It may therefore mean that the product may not be in conformity.