What counts as PPE

In regulatory terms, PPE covers any equipment designed to be worn or held by a person to protect against one or more health or safety risks, including safety helmets, gloves, goggles, hearing protection, respiratory protection, fall‑arrest systems, protective clothing, and safety footwear. PPE is grouped into three categories based on risk level, from simple items such as gardening gloves (Category I) through to complex equipment for life‑threatening or irreversible risks such as respirators, chemical suits, and fall‑arrest systems (Category III). The intended user (worker vs consumer), environment (industrial, healthcare, domestic), and claimed protective functions determine which PPE category applies.

Core requirements, markings and information

All PPE must be designed and manufactured to meet the essential health and safety requirements in the PPE Regulation, including adequate protection against the stated risks, ergonomic design, compatibility with other PPE, and consistent performance across foreseeable conditions of use. Conformity assessment follows the risk category: Category I allows internal production control, while Categories II and III require notified‑body involvement for EU CE marking or approved body involvement for UKCA, including type‑examination and, for Category III, ongoing production surveillance. Products must be supplied with clear instructions and safety information covering the level of protection, limitations of use, fitting and adjustment, maintenance, storage, service life, and any need for training.
Materials, coatings, filters, and components used in PPE must comply with EU and UK chemical legislation, including REACH/UK REACH controls on carcinogens, mutagens, sensitizers, and other substances of very high concern that may contact skin, be inhaled, or migrate during use. For PPE incorporating electrical or electronic elements (for example, powered respirators, electronic hearing protectors, or smart helmets), RoHS restrictions and, where relevant, EMC and radio‑equipment requirements also apply alongside the PPE rules. Claims such as “latex‑free”, “nickel‑free”, or “hypoallergenic” must be supported by appropriate evidence to avoid misleading users.
PPE must bear the CE mark in the EU or UKCA/CE marking in Great Britain, together with the manufacturer’s name and postal address, product type and batch or serial number, and, where relevant, the notified or approved body number and performance levels or classes defined by the applicable standards. Each product must be accompanied by the EU or UK declaration of conformity or a web link to it, plus user instructions in the language(s) required by the destination market. Manufacturers, importers, and brand owners must maintain technical documentation for at least ten years, including design and risk assessments, test reports to harmonised EN standards, quality‑system evidence for Category III PPE, declarations of conformity, and copies of all labels and packaging.

How we can help

We help brands and employers navigate EU Regulation 2016/425, UK PPE supply and enforcement regulations, and cross‑cutting consumer‑product and chemical‑safety duties for PPE sold to workers and consumers. Support typically includes category classification and product scoping, notified/approved‑body and standards strategy, technical‑file and declaration drafting, chemical‑testing plans, and detailed review of labelling, markings, and instructions so that claimed protection levels, limitations, and safe‑use expectations are accurately and consistently communicated.

With tailored, end‑to‑end support, CERT helps you place PPE articles on the EU and UK markets that are safe, compliant and fully supported by robust documentation and expert guidance.