PPE Regulation 2016/425 for UK sellers: risk category, EU notified body, EU type-examination, French instructions, DDPP inspections and French penalties.

Yes, but only on EU terms. Personal protective equipment sold in France must comply with Regulation (EU) 2016/425: the right risk category, the right conformity assessment procedure, an EU notified body from category II upwards, a technical file, an EU declaration of conformity and instructions in French, CE marking, and an economic operator established in the EU. A certificate from a UK Approved Body does not count.
Updated: November 2026. Key provisions: Articles 2, 3, 8 to 12, 15 to 19 and Annexes I, II, III, V and IX of Regulation (EU) 2016/425; Article 4 of Regulation (EU) 2019/1020; Article 19 of Regulation (EU) 2023/988 (GPSR); Articles L. 4311-6, L. 4314-1, R. 4314-10, R. 4314-11, R. 4314-17, L. 4746-1 and R. 4746-1 of the French Labour Code.
This guide is for directors of UK companies that sell gloves, safety glasses, high-visibility vests, knee pads and similar products to French customers, directly online or through French wholesalers, marketplaces and fulfilment centres. Victoris is a Paris law firm; UK law is mentioned only to explain your position, and nothing here is advice on English law. All examples are fictitious. The Regulation is quoted from its original text: EUR-Lex shows a consolidated version dated 29 May 2026, and the "Omnibus IV" proposal, which amends the PPE Regulation on digital documents, was still awaiting the European Parliament's first-reading vote on 12 November 2026. If a French partner has been contacted by the authorities, see our page for a lawyer for DGCCRF and DDPP inspections.
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Article 3(1) defines PPE as "equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety", together with interchangeable components essential to its protective function and certain connection systems. In practice, the claim decides. A glove sold as a fashion accessory is not PPE; the same glove sold as "cut resistant" is. If your product page, packaging or leaflet promises protection, a French inspector will treat the item as PPE.
Article 2 excludes, among others, PPE designed for the armed forces or law enforcement, PPE "designed for private use to protect against [...] atmospheric conditions that are not of an extreme nature" or "damp and water during dishwashing", PPE for exclusive use on seagoing vessels or aircraft covered by international treaties, and head, face or eye protection for motorcycle and moped riders covered by UNECE Regulation No 22. Household washing-up gloves fall outside; chemical-resistant cleaning gloves sold to a cleaning contractor do not.
"Placing on the market" means "the first making available of PPE on the Union market" (Article 3(3)), and the CE marking must be affixed before that moment (Article 17(2)). Since 1 January 2021 the UK is a third country: for a UK seller, the first making available usually takes place in France, when the goods reach a French wholesaler, a warehouse or the end customer.
Article 18 refers to Annex I. Category I "includes exclusively" minimal risks: superficial mechanical injury, weak cleaning materials or prolonged contact with water, hot surfaces not exceeding 50 °C, eye damage from sunlight, and non-extreme weather. Category III "includes exclusively" risks that may cause death or irreversible damage to health, such as hazardous substances, falls from a height, electric shock, drowning, cuts by hand-held chainsaws and harmful noise. Category II "includes risks other than those listed in Categories I and III".
Category II is therefore the default for many everyday products. On our reading of Annex I, safety glasses against flying particles, high-visibility vests and tilers' knee pads are category II: none of them targets a risk on either closed list, and the only eye risk in category I is sunlight. Take a fictitious Leeds company selling two glove ranges. Gardening gloves against scratches may be category I; handling gloves marketed as cut resistant go beyond superficial injury and, on our reading, are category II. Gloves against hazardous chemicals would be category III.
Category I PPE follows internal production control (module A, Annex IV). The manufacturer prepares the technical file, signs the EU declaration of conformity and affixes the CE marking without any third party.
Category II requires "EU type-examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C)". A notified body examines the technical file and a specimen "representative of the production envisaged". You apply to "a single notified body of [your] choice", with a written declaration that the same application has not been lodged elsewhere. The certificate's validity "shall not exceed five years", including on renewal, and it states the body's name and number, the type covered, the standards applied, the protection class and the expiry date.
Category III adds either supervised product checks at random intervals (module C2, Annex VII) or quality assurance of the production process (module D, Annex VIII). The notified body stays involved for the commercial life of the product, and its number follows the CE marking.
Any change to the approved type or technical file that may affect conformity must be reported and approved as an addition to the certificate. Review must be requested between 12 and 6 months before expiry. If the certificate is withdrawn, "the manufacturer shall cease the placing on the market of the PPE concerned" (Annex V, points 7.2, 7.4 and 7.7).
No, if it was issued by a UK Approved Body. UK government guidance states that UK Approved Bodies "can only be used to certify products for UKCA marking", and the Office for Product Safety and Standards states that they "are not recognised by the EU (unless they have a presence in the EU) and cannot approve CE marking". Great Britain still accepts CE marked PPE, but that recognition runs one way only.
Northern Ireland is a separate case. UK bodies that remain notified for the Northern Ireland market issue certificates that require the CE marking plus the UKNI indication, and UK guidance is clear that such products cannot be placed on the market in the European Economic Area. Safety glasses marked "CE UKNI" cannot be sold in France on that basis.
Check the body in NANDO, the Commission's database of notified bodies, now part of the Single Market Compliance Space: it must be notified under Regulation (EU) 2016/425 for the relevant product type. A UK manufacturer may choose any EU notified body. Where the existing certificate is British, a new EU type-examination is needed; existing test reports can go into the technical file, and the notified body decides what it can rely on. Stock already in France then becomes an immediate question.
A manufacturer is anyone who "manufactures PPE or has it designed or manufactured, and markets it under his name or trademark" (Article 3(4)). A UK company selling under its own brand remains the manufacturer even though it is outside the EU. Article 8 makes it responsible for compliance with Annex II, the technical file, the Article 19 procedure, the EU declaration, the CE marking, ten-year record keeping and corrective action.
An authorised representative is established in the EU and acts under a written mandate. Article 9 bars the mandate from covering compliant design and drafting of the technical file; the representative keeps the documents for ten years, answers reasoned requests and cooperates with the authorities.
An importer is a person "established within the Union who places PPE from a third country on the Union market" (Article 3(6)). Before placing on the market, it checks that the procedure was carried out, the technical file exists, the CE marking is affixed and the instructions are in the required language, and it adds its own name and postal address (Article 10). A distributor, such as a French wholesaler, must "act with due care" and verify the CE marking, the documents, the instructions in French and the manufacturer's and importer's details before selling (Article 11).
Under Article 12, an importer or distributor "shall be considered a manufacturer" where it "places PPE on the market under his name or trademark or modifies PPE already placed on the market in such a way that compliance with this Regulation may be affected". Where several companies in one group are involved, the answer depends on facts: who first makes the product available in the EU, under whose name, who owns the stock, who changes the product or its documents. These points are checked on documents, case by case, and are worth reviewing with a lawyer before the authorities do it for you.
The PPE Regulation is listed in Article 4(5) of Regulation (EU) 2019/1020. Since 16 July 2021, PPE "may be placed on the market only if there is an economic operator established in the Union" (an EU manufacturer, an importer, an authorised representative or, failing those, a fulfilment service provider) responsible for keeping the declaration available and cooperating with the authorities, with its details on the product, packaging, parcel or an accompanying document. The Commission's guidelines add that where goods are shipped directly from outside the EU to an end user and no authorised representative has been appointed, "the product may not be offered for sale to EU end-users".
Annex III lists the minimum contents of the technical file: a complete description and intended use, the risk assessment, the applicable essential requirements, drawings, the harmonised standards or other specifications applied, calculations and test reports, the production controls and a copy of the instructions. A file built for the UK market, citing UK rules and a UK body, must be reworked around EU law.
The EU declaration of conformity follows the model in Annex IX and "shall be translated into the language or languages required by the Member State" (Article 15(2)). You either ship it with the product or give its web address in the instructions (Article 8(8)). For France, Article R. 4746-1 of the French Labour Code makes it an offence to supply PPE without the declaration or a secure link to it, or with a declaration that is incomplete or "non rédigée en français" (not written in French). The same article covers instructions that are missing, incomplete or not in French.
The instructions must cover the points in Annex II, point 1.4: storage, use, cleaning and maintenance; test performance and protection classes; limits of use; obsolescence where relevant; the meaning of markings; the risk covered; and, unless the declaration accompanies the product, the notified body, the standards and the declaration's web address. On the product itself: CE marking "visibly, legibly and indelibly" (Article 17), a type, batch or serial number (Article 8(5)), the manufacturer's name and postal address (Article 8(6)), the importer's details (Article 10(3)) and, where ageing affects performance, the month and year of manufacture or obsolescence (Annex II, point 2.4). Words in safety markings must be in the language set by the Member State (point 2.12): a high-visibility vest with an English-only sewn label raises a compliance question even if the leaflet is translated.
When PPE is sold to French consumers, Article L. 111-1 of the French Consumer Code requires the essential characteristics of the goods, the price, the delivery date and the seller's identity and contact details before the contract is concluded; for PPE, the risk covered, the protection class and the limits of use belong there. Article 19 of the General Product Safety Regulation (EU) 2023/988, which applies since 13 December 2024, also applies to harmonised products such as PPE sold at a distance: the offer must show the manufacturer's name, postal and email address, the EU economic operator's details where the manufacturer is outside the EU, product identification including a picture, and safety warnings in the local language. A product page claiming a higher cut level than the certificate can also be pursued as a misleading commercial practice (Article L. 121-2 of the French Consumer Code).
Article L. 4311-6 of the French Labour Code empowers labour inspectors, customs officers, mining and industry engineers and officers of the DGCCRF (the French authority for competition, consumer affairs and fraud control) to investigate breaches of Regulation (EU) 2016/425. DGCCRF officers usually work within the DDPP (the local departmental directorate for consumer protection), which is the authority most UK online sellers meet. Market surveillance officers may enter business premises between 8 am and 8 pm, and the cost of tests and storage may be charged to the operator once non-compliance is established (Article L. 4314-1).
Before any measure, the authority sets out the evidence of non-compliance and gives the operator a deadline to comment and describe corrective action, including timing, user information and who pays (Article R. 4314-10). It may require the manufacturer or authorised representative to have the corrections checked, at its own cost, by an accredited body other than the one used for the original assessment, allowing at least one month for the results. If nothing adequate follows, it may order compliance, a sales stop including removal of online listings, withdrawal, recall, destruction or warnings (Article R. 4314-11). The operator must have at least ten working days to submit observations before a measure is taken, except in urgent cases (Article R. 4314-17). What you write at this stage will be read again if the case goes to the prosecutor, which is why it should be prepared with counsel. Our guide on why a DGCCRF, DDPP or DREETS interview is not a formality explains the next step when officers ask to hear a representative.
The French distributor is an economic operator too, and the easiest one for the authorities to reach. A category II product sold on the strength of a UK Approved Body certificate raises the first offence directly, because the Article 19 procedure was not followed with an EU notified body.
Yes, whenever PPE is made available on the EU market. A UK company selling under its own brand is the manufacturer and carries the Article 8 obligations, and an economic operator must be established in the EU.
No. UK Approved Bodies certify for UKCA only and cannot approve CE marking. Category II and III PPE needs an EU type-examination certificate from an EU notified body.
Yes: module B by a notified body, followed by module C (conformity to type based on internal production control). The certificate lasts five years at most.
Yes. Article R. 4746-1 of the French Labour Code penalises instructions and EU declarations that are incomplete or not written in French.
Only for category III PPE (Article 17(3)). For category II, the body appears in the instructions and the declaration.
Up to EUR 50,000, 100,000 or 200,000 for individuals under Article L. 4746-1 of the French Labour Code, five times more for companies, plus fifth-class petty offences for documentary breaches.
Selling PPE into France from the UK means working entirely under EU law: the Annex I category, an EU notified body from category II upwards, a complete technical file, a declaration and instructions in French, correct CE marking and an EU economic operator. A UK certificate serves the British market, not the French one, and your French partners have their own duties to check. If you or your French distributor receive a document request, a notice of non-compliance or a draft order about PPE, Victoris can review your certificates, declarations, instructions and contracts and assist you with the French authorities. For labelling rules more generally, see our guide to product and price labelling obligations in France.
Article written by Guillaume Leclerc, lawyer at the Paris Bar, 34 avenue des Champs-Élysées, Paris. Working languages: French and English.