The New EU 2016/425 Standard for PPE Regulation

The initial PPE Regulations was revoked by The New European Union 2016/425 Standard for PPE Regulation on 21st April 2018. The main aim of this new regulation is to regulate and set guidelines for various products divisions and their products in the European Market.

This New EU Regulation comes with a number of specifications that should be adhered by all the product manufacturers. Only then the new products which follow new approach directives can be suitably put in the European markets.

The directives are about common safety and health objectives that are explicit for each and every product. The directives also demand that every product should carry a CE mark.

Though CE marking is not a quality assurance code and it shouldn’t be mixed with any independent certification label that’s given by European or international notified test bodies. 

The EU PPE Regulation for the Personal Protective Equipment

After revoking the initial PPE Regulation on 21st April 2018, this EU PPE Regulation 2016/425 aims to ensure common standards for PPE in terms of protection of health and safety of the users in all member states. This also allows free movement of PPE within the union.

These regulations are applicable for all kinds of PPE with some exclusions like – the PPE used by armed forces, certain private uses of PPE and the ones who are subject to other rules and regulations (motorcycle helmet).

The terms that are defined in the regulation include PPE, manufacturer, distributor, technical specification, accreditation, national accreditation body, authorized representative, importer, economic operators, harmonized standard, conformity assessment, conformity assessment body, CE Marking, withdrawal, recall.

Contents of the Regulation Are:

All PPE should follow the regulations and should not risk the safety of person and properties. All PPE should meet the Annex II, that’s health and safety requirements specified in the PPE’s EU declaration of conformity. Free movement of the PPE on the market should be ensured. Though the member states may lay down special requirements for the use of hearing protection PPE.

The manufacturer is under obligation to conduct the conformity assessment. This is applicable on imported PPE too. PPE should be provided with instructions and contact detail’s in the user’s language.

Specific rules related to CE mark on PPEs are mentioned in this regulation and these rules must be followed by the manufacturers.

There are three risk categories mentioned in the regulations that require differing assessment conformity procedures.

The provisions of the regulation are:

  • Notification of conformity assessment bodies.
  • Market surveillance, Control of PPE entering the market.
  • Union safeguard procedure.
  • Transitional and final provisions.


  • Risk Categories.
  • Health and safety requirements.
  • PPE technical documentation.
  • Production control.
  • EU type- examination.
  • Conformity to type on the basis of production control.
  • Conformity to type on the basis of random supervised product checks.
  • Conformity to type on the basis of quality assurance.
  • EU declaration of conformity.
  • Correlation table.