Personal Protective Equipment (PPE) Regulations

The following note is being published on behalf of the Malta Competition and Consumer Affairs Authority (MCCAA)

The Malta Competition and Consumer Affairs Authority (MCCAA) draws attention to the draft version of the new Personal Protective Equipment (PPE) Regulations, and its corresponding Explanatory Notes.

These regulations transpose Regulation (EU) 2016/425 and shall apply as from 21st April 2018.

The new PPE Regulation (EU) 2016/425 is the result of the alignment of the previous PPE Directive 89/686/EEC to the ‘New Legislative Framework’ (NLF), as well as to the provisions of the Treaty on the Functioning of the European Union after the Treaty of Lisbon.

The main changes in Regulation (EU) 2016/425 are the following:

  • Scope is updated to include PPE designed and manufactured for private use to protect against heat
  • PPE shall provide protection against "the risks against which it is intended to protect", no longer "against all risks encountered"
  • Conformity assessment procedures are adapted to the modules of NLF
  • Definitions are aligned to the NLF
  • Obligations of Economic operators (manufacturers, authorised representatives, importers, distributors) are more in detailed descriptions
  • Economic operators acting online are subject to the same obligations as traditional economic operators
  • Requirements and procedures of notified bodies are aligned to the NLF
  • EU declaration of conformity shall be in more detail and model is aligned to the NLF
  • EC type-examination certificates issued under Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date
  • Hearing protection shifted from Category II to Category III PPE
  • Life jackets shifted from Category II to Category III PPE
  • Declaration of Conformity shall be issued with each PPE or at least an online link to where it can be obtained
  • Compulsory maximum five-year certificate validity

Members are urged to submit their comments to mark.d.formosa@mccaa.org.mt by 13th April 2018.