NEW PPE-REGULATION!

From April 21, 2018 the PPE “Regulation (EU) 2016/425” replaces the previous „Directive 89/686/EEC“.

The Regulation (EU) 2016/425 is a document developed over a process lasting several years, which covers requirements for the design and manufacture of personal protective equipment (PPE), the free movement of PPE in the EU and the certification process.

1. What is new? - significant changes compared to the previous PPE Directive

Legal form

The previous Directive (Directive 89/686 / EEC) became a Regulation (Regulation (EU) 2016/425) which, after entry into force, applies to all EU member states and does not have to be transposed into national law.

Scope of application

The scope of the PPE Regulation has been slightly extended. Thus, the new regulation also applies to PPE for protection against heat that is used privately (eg for grill or oven gloves)
[see Regulation (EU) 2016/425, Chapter II; Article 2]

Obligations of economic operators

By adapting to the NLF (New Legislative Framework, https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en), the Regulation contains detailed obligations for economic operators: manufacturer, authorized representative, importer / importer and trader
[see Regulation (EU) 2016/425 Chapter II]

Declaration of conformity

Declaration of conformity in accordance with a new ordinance must be issued and published for each PPE (also for Category I). These can either be attached to each PPE (analogous to the manufacturer's information) or a reference to or by the internet address at which the EU declaration of conformity can be accessed.
[see Regulation (EU) 2016/425 Annex II; Point 1.4]

Risk categories

Each PPE must (as before) be classified in one of the following risk categories

Category	Risks
Category I	minimal risks
Category II	Risks other than those listed in Categories I and III
Category III	Risks that may cause very serious consequences such as death or irreversible damage to health

As with the PPE Directive 89/686 / EEC, the definitions are purely risk-based. The risk categories are listed in detail in Annex I of the PPE Regulation (EU) 2016/425.
[see Regulation (EU) 2016/425 Annex I]

Extended risks
The list of "Category III" risks has been extended by the following:

-       Drowning

-       cuts by hand-held chainsaws

-       high-pressure jets

-       bullet wounds or knife stabs

-       harmful noise

As before, different conformity assessment procedures have to be followed depending on the category of PPE.
[see Regulation (EU) 2016/425 Annex I]

Conformity assessment procedures

The conformity assessment with the adaptation to the NLF is divided into the following modules

Category	Conformity assessment procedures
Category I	internal production control (module A) set out in Annex IV

Category II	EU type-examination (module B) set out in Annex V
	+ conformity to type based on internal production control (module C) set out in Annex VI

Category III	EU type-examination (module B) set out in Annex V
	+ conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII

	or

	EU type-examination (module B) set out in Annex V
	+ conformity to type based on quality assurance of the production process (module D) set out in Annex VIII

[see Regulation (EU) 2016/425 Chapter IV, Article 19]

2. FAQ - answers to the most common questions

When can PPE be certified under the new regulation?
From 21st April 2018 is certified according to the new regulation.

What happens after April 21st 2018 with PPE that was manufactured according to old guidelines?
The period between 21.04.2018 and 20.04.2019 is considered a transitional year. During this time, PPE produced according to old guidelines may still be placed on the market. This allows all manufacturers to sell their stock of PPE (according to the old directive) and to bring it into the market.

What happens to the valid type certificates after 21.04.2019?
Model certificates according to the old directive will remain valid after 21.04.2019, but only for commercially available products. PPE placed on the market before and during the transitional year and available on the market may be sold until the end of the validity of the relevant certificate, but no later than 20.04.2023.

What happens after 21.04.2023?
From this point on, only garments that have been manufactured and certified in accordance with the new PPE regulation may be commercially available.

3. What else is to be considered!

If you buy PPE and market it under your own label, the manufacturer's obligations will be transferred to you as a dealer. You are fully responsible for your product.

From 21.04.2018, a declaration of conformity in accordance with a new ordinance must be issued and published for each PPE (also Category I). These can either be attached to each PPE (analogous to the manufacturer's information) or a reference to where the corresponding declaration of conformity can be called up. In the case of PPE manufactured in accordance with the old directive and placed on the market during the transitional year, the declaration of conformity must contain all the relevant directives and regulations.

Certificates without expiration date are invalid from 21.04.2023. As of 21.04.2018, the same regulations apply to the certified articles as PPE, which were manufactured and certified according to old guidelines

Wir sind ein Notified body (NB 0534).

Head of
Textile Technology and Personal Protective Equipment (PPE)
Judith Pointner

Textile Technology and Personal Protective Equipment (PPE)
Marion Pfeiler

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