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Analisis · 2026-10-03

PPE, set the class before the route

PPE protects a person, so the rules do not ask whether the product sells well but what happens if it fails. The EU turns that judgement into an explicit classification, and the class decides the conformity route.

Set the class first, then the route makes sense

In most categories a compliance question can be asked loosely, as in which certificate is needed. Not for PPE, because the rules are classified by risk: two products from one factory can end up with one self-declared and the other requiring a notified body.

So the first action is not to find a standard but to establish which class the product falls into. The class is not set by product name, and not by whether it is a glove or a helmet, but by which risk it protects against and how serious failure would be.

EU: three classes and the route for each

The EU basis is the Personal Protective Equipment Regulation (EU) 2016/425, published at OJ L 81/51 on 31 March 2016. It splits PPE into three classes, each with its own conformity route.

Class I covers only minimal risk, and internal production control is enough, which means the manufacturer does the work and declares conformity without a notified body.

Class II covers risks that fall outside class I and class III, and requires EU type-examination under module B, with a notified body issuing the certificate. That is the normal route for moderate risk and covers most PPE in practice.

Class III covers risks that may cause death or serious irreversible harm, including respiratory protection, chemical protection and fall protection. It requires type-examination plus an additional production-stage check, and the regulation offers one of two ways: internal production control on the basis of the type with supervised product checks, or quality assurance of the production process.

The class also changes the marking. For class III PPE, the CE mark must be followed by the identification number of the notified body involved. So a CE mark with four digits after it tells you the product went through the route requiring a notified body.

The EU is amending it, and the amendment lands in 2026

The regulation was amended in 2024. Amendment (EU) 2024/2748, published on 8 November 2024, states that it applies from 29 May 2026. Its purpose is to introduce emergency procedures for crisis-relevant goods, which creates a special channel when supply is strained rather than relaxing the ordinary requirements.

A factory selling PPE into the EU therefore has two documents to read together: the regulation itself sets the three classes and the routes, and the amendment sets the exception for crisis situations, with an application date now close at hand.

US: employer duty again

Federal PPE rules in the US sit in 29 CFR part 1910, Subpart I, with 1910.132 as the general requirements section. The point is the same as in the machinery article: this route sets out employer duties. The employer must provide PPE, assess the hazards, train workers and keep the equipment serviceable. It does not issue a product a market access certificate.

What that means in practice is that US evidence comes in two different shapes: third-party test reports and certifications for the product, such as eye and face protection, helmets, gloves and safety footwear, and the hazard assessment and training records the buyer holds as employer. Both are needed, and neither substitutes for the other.

It also explains a familiar situation. A factory can produce a test report for a piece of PPE and still be unable to answer whether the buyer will be cited when an occupational safety inspection looks at the shipment. That is not a production problem; the information simply does not sit with the factory.

China, Japan, Korea, Brazil, Gulf

China has mandatory national standards for helmets, respiratory protection and safety footwear among others, alongside an administrative regime for special labour protection products whose catalogue has been adjusted in recent years. Japan requires type inspection for protective helmets, safety belts and respirators under its industrial safety and health act. Korea works through KOSHA certification under its industrial safety and health act. Brazil has NR-6 on PPE and INMETRO certification, with an approval certificate from the labour ministry for some classes. The Gulf states regulate under the GSO PPE technical regulation, with Saudi Arabia routing through SABER.

For these markets we currently hold the regime described but no primary text, so the page states the regime and no document numbers.

Ten markets side by side

Two columns, whether classes exist and who does the assessing:

PPE shares a feature with machinery: the weight of the rules often sits at the user's end, in employer duties, hazard assessment and training, rather than at the product's end. The EU is one of the few markets that turns risk class directly into product admission classes, which makes it worth using as a reference point. Elsewhere the class judgement sits with the buyer, not in the regulation.

What to ask before you order

Ask PPE questions by class. First, which class the product falls into in the target market, and if the supplier cannot answer that, nothing later matters. Then which standard and which protection level the test report was run against, since PPE levels are finely graded and two products in the same family can suit entirely different situations. Then the notified body number, which should appear both on the marking for class III and on the report. Finally, how production consistency is assured, because class III requires more than a sample passing once; the production has to hold.

The third question is where answers most often give way. It is common to see the same notified body number quoted for a whole family of products. A number travels with a certificate, not with a factory, so a factory with several certificates has several numbers. To work through these in order, start with the free verification checklist. The previous article in this series is machinery; the next, pressure equipment, sets out another set of classes, drawn by pressure and volume. To see how certifications are recorded, look at a report sample, or get in touch.