32016R0425

WHAT IS THE AIM OF THE REGULATION?

• Regulation (EU) 2016/425 lays down requirements for the design and manufacture of personal protective equipment¹ (PPE) that aim to ensure the health and safety of users and to allow the equipment to be sold and used throughout the European Union (EU).
• The regulation replaces earlier legislation (Council Directive 89/686/EEC).

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).

FROM WHEN DOES THE REGULATION APPLY?

Regulation (EU) 2016/425 has applied since 21 April 2018, apart from articles mainly dealing with notification bodies and procedures. The latter articles have applied since 21 October 2016.

Amending Regulation (EU) 2024/2748 applies from 29 May 2026.

BACKGROUND

For further information, see:

• Personal protective equipment (PPE) (European Commission)
• New legislative framework (European Commission).

KEY TERMS

1. Personal protective equipment. Equipment designed and manufactured to be worn or held by a person to protect them against one or more risks to their health and safety.
2. Conformity assessment. The process confirming that a product satisfies the necessary process, service, system, person or body requirements.
3. Crisis-relevant goods and services. Goods or services that are non-substitutable, non-diversifiable or indispensable in the maintenance of vital societal functions or economic activities in order to ensure the proper functioning of the internal market and its supply chains, that are considered essential for responding to a crisis and that are listed in an implementing act adopted by the Council.
4. Notified body. A body that assesses conformity under the conditions laid down by EU regulations. This is a service offered to manufacturers in the public interest.

MAIN DOCUMENT

Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, pp. 51–98).

RELATED DOCUMENTS

Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) (OJ L, 2024/2747, 8.11.2024).

Regulation (EU) 2024/2748 of the European Parliament and of the Council of 9 October 2024 amending Regulations (EU) No 305/2011, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2023/988 and (EU) 2023/1230 as regards emergency procedures for the conformity assessment, presumption of conformity, adoption of common specifications and market surveillance due to an internal market emergency (OJ L, 2024/2748, 8.11.2024).

Commission Implementing Decision (EU) 2023/941 of 2 May 2023 on harmonised standards for personal protective equipment drafted in support of Regulation (EU) 2016/425 of the European Parliament and of the Council (OJ L 125, 11.5.2023, pp. 37–58).

Successive amendments to Decision (EU) 2023/941 have been incorporated into the original text. This consolidated version is of documentary value only.

Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, pp. 1–44).

See consolidated version.

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, pp. 82–128).