Ensuring safe personal protective equipment for users

KEY POINTS

• PPE may only be sold and used if it:
  • complies with the regulation, when properly maintained and used for its intended purpose, and especially with Annex II, setting out the essential health and safety requirements;
  • does not endanger the health or safety of people, pets or property.
• Manufacturers must:
  • ensure PPE items are designed and made according to the legislation;
  • subject each PPE item to the relevant conformity assessment² procedure;
  • keep relevant technical documentation and the EU conformity declaration for 10 years;
  • carry out sample testing of the PPE and, if necessary, keep a register of complaints, non-conforming PPE and PPE recalls;
  • give details, such as their registered trade name and their postal address, on PPE packaging or accompanying documents;
  • provide easily understood use and safety instructions;
  • inform national authorities immediately where the PPE presents a risk.
• Obligations are placed on importers and distributors to ensure that the PPE satisfies the EU’s standards.
• Different conformity assessment procedures are carried out by national conformity assessment bodies depending on which of the three categories of risk the PPE is intended to protect users against:
  • category I – minimal risks;
  • category II – risks not included in categories I or III;
  • category III – very serious risks such as death or irreversible damage to health.
• Evidence that PPE complies with strict safety and health requirements is signified by the CE marking on the product (under Decision No 768/2008/EC).
• EU Member States inform the European Commission of the various bodies that are authorised to carry out the conformity assessment tests.
• The Commission organises exchanges of experience between national authorities.
• The legislation does not apply to PPE used:
  • by the armed forces or for the maintenance of law and order;
  • for self-defence, except for sporting activities;
  • privately to protect against weather conditions that are not extreme, or against damp and water during dishwashing;
  • on seagoing vessels or aircraft subject to the relevant international treaties;
  • by drivers and passengers of motorcycles and mopeds (protective helmets and visors).
• Member States had to have penalties in place for any violations of the law by 21 March 2018.
• A Commission implementing act, Implementing Decision (EU) 2023/941, as amended by Implementing Decisions (EU) 2023/2752 and (EU) 2024/2599, sets out harmonised standards for PPE.

Internal market emergency mode

Amending Regulation (EU) 2024/2748 seeks to avoid disruptions to the internal market in the event of an emergency by ensuring that, once an internal market emergency mode, as set out in Regulation (EU) 2024/2747 (the Internal Market Emergency and Resilience Act), has been activated by means of an implementing act adopted by the Council of the European Union, designated crisis-relevant goods and services³ can be placed on the market as rapidly as possible.

Amending Regulation (EU) 2024/2748 adds a chapter to Regulation (EU) 2016/425 detailing how the emergency procedures apply. It also:

• requires conformity-assessment bodies to prioritise applications for PPE conformity of crisis-relevant products over those for products that are not;
• allows Member States, on an exceptional basis and where there is a duly justified request, to temporarily authorise the placing on the market of specific PPE without carrying out the normal conformity-assessment procedures, where the involvement of a notified body⁴ is mandatory and can ensure that all essential requirements are met;
• permits Member States’ competent authorities to presume that products manufactured in accordance with EU standards, relevant applicable national standards or relevant appliable international standards developed by an accredited international standardisation body, identified by the Commission as suitable to reach conformity and ensuring an equivalent level of protection to that offered by the harmonised standards, comply with the relevant applicable essential requirements;
• gives the Commission the possibility to adopt, by means of implementing acts, common specifications on which the manufacturers can rely in order to benefit from a presumption of conformity with the applicable essential requirements (implementing acts laying down such common specifications remain applicable for the duration of the internal market emergency mode).