Protective clothing certification for a garment sold in both the EU and India means two separate approvals. In the EU, the risk the garment protects against sets its category, and the category decides whether a notified body has to examine it. In India, the Protective Textiles (Quality Control) Order names eleven products, each tied to one Indian Standard. Since 7 October 2023 those products may be made, imported or sold only with the BIS Standard Mark under a BIS licence.
The two routes share some test methods, because India’s heat-and-flame and welding standards are ISO standards under Indian numbers. They do not share certificates. An EU type-examination certificate is not a BIS licence, and a BIS licence is not CE marking.
Protective clothing certification: the short version
- EU, Category I (minimal risks only): the manufacturer checks and declares conformity itself (Module A).
- EU, Category II (any risk not in Category I or III, which takes in high-visibility clothing): a notified body examines the type (Module B), and the factory then keeps production to that type (Module C).
- EU, Category III (risks of death or irreversible harm, including hazardous chemicals, infective agents and heat comparable to air at 100 °C or more): Module B, then either random product checks by the notified body (Module C2) or an audited quality system (Module D). The notified body’s number follows the CE mark.
- EU standards: EN ISO 11612 (heat and flame) and EN ISO 11611 (welding) are not on the EU’s list of harmonised standards for PPE. On 4 September 2026 EN ISO 24232:2025 replaced EN 343:2019 for rainwear on that list.
- India: the order was notified on 10 April 2023 and applies from 7 October 2023. One of its original twelve items, upholstered composites for non-domestic furniture, was struck out on 12 September 2024 and moved the same day into an order of its own, S.O. 3916(E), so it still needs the BIS mark. It gives small firms no later date, and it does not apply to goods made for export.
- Factories outside India, Bangladesh included, need their own BIS licence under the Foreign Manufacturers Certification Scheme and an Authorised Indian Representative.
EU: the risk sets the category, and the category decides who certifies
Under the PPE Regulation, Regulation (EU) 2016/425, which has applied since 21 April 2018 (Article 48), every item of PPE falls into one of three risk categories in Annex I, and Article 19 gives each its conformity assessment procedure. The category follows from the risk the garment is sold to protect against, not from the standard it was tested to.
| Category | Risks it covers (Annex I) | Procedure (Article 19) | Notified body |
|---|---|---|---|
| I | Minimal risks only: superficial mechanical injury; weak cleaning agents or prolonged contact with water; hot surfaces up to 50 °C; sunlight on the eyes; weather that is not extreme | Internal production control, Module A (Annex IV) | None |
| II | Any risk not listed in Category I or III | EU type-examination, Module B (Annex V), then conformity to type, Module C (Annex VI) | Examines the type; certificate valid for up to five years |
| III | Risks that can cause death or irreversible harm, among them hazardous substances and mixtures, harmful biological agents, heat comparable to air at 100 °C or more, cold of −50 °C or below, electric shock, and bullet wounds or knife stabs | Module B, then Module C2 (Annex VII) or Module D (Annex VIII) | Examines the type, then checks production at least once a year |
Applied to a garment range, the annex gives some firm answers. Chemical-protective clothing and clothing against infective agents protect against risks Category III names. Heat-and-flame clothing is Category III where the heat it is meant for is comparable to air at 100 °C or more. High-visibility clothing protects against not being seen, a risk neither Category I nor Category III lists, so it is Category II. Rainwear for weather that is not extreme can fall in Category I.
What the notified body does
- Module B, EU type-examination. The manufacturer applies to one notified body of its choice with the technical documentation and specimens representative of production. The body examines the design, tests the specimens, and issues a certificate valid for at most five years. Review is due no earlier than 12 months and no later than 6 months before expiry; if neither the garment nor the state of the art has changed, a simplified review renews it without new tests (Annex V, points 6 and 7).
- Module C2. The notified body tests a statistical sample of production against the type at least once a year, at random intervals, the first within a year of the certificate (Annex VII).
- Module D. The notified body approves the factory’s quality system for production, final inspection and testing, audits it at least once a year and may visit unannounced (Annex VIII).
Member states notify these bodies to the Commission (Article 20). For Category III, the body’s identification number follows the CE marking on the garment (Article 17(3)).
The technical file and the declaration of conformity
The technical documentation (Annex III) is the manufacturer’s evidence. It describes the garment and its intended use, and holds the risk assessment, the essential requirements that apply, drawings, the harmonised standards applied (or the other specifications used instead), test reports including the protection class, how production is controlled, and a copy of the user instructions.
The EU declaration of conformity (Article 15, model in Annex IX) is drawn up per model under the manufacturer’s sole responsibility. It lists the standards applied with their dates, the notified body that did the type-examination and its certificate, and, for Category III, the body supervising production. It is translated into the language the member state requires, and either travels with the garment or its web address appears in the user instructions (Article 8(8)). The manufacturer keeps the declaration and the technical documentation for 10 years after the garment is placed on the market (Article 8(3)).
A maker outside the EU also needs someone inside it. PPE may be placed on the EU market only if an economic operator established there (the manufacturer, the importer, an authorised representative or, failing those, a fulfilment service provider) keeps the declaration for the authorities and can produce the technical documentation. Its name and postal address go on the product, its packaging, the parcel or an accompanying document (Regulation (EU) 2019/1020, Article 4). The importer also puts its own name and address on the garment (Article 10(3) of the PPE Regulation).
The harmonised standards garment makers meet most
A garment that meets a harmonised standard whose reference is published in the Official Journal is presumed to meet the essential requirements that standard covers (Article 14). The list now sits in Implementing Decision (EU) 2026/1279 of 12 June 2026, as amended by Implementing Decision (EU) 2026/1971 of 3 September 2026. The Commission also publishes a summary list. This table was checked against both.
| Standard | What it covers | On the EU list for PPE? |
|---|---|---|
| EN ISO 13688:2013 + A1:2021 | General requirements for all protective clothing: ergonomics, innocuousness, sizing, ageing, compatibility, marking and the information supplied. Used only with a standard for a specific hazard. | Yes, with A1:2021. The 2013 text without the amendment stopped giving presumption on 9 June 2024. |
| EN ISO 11612:2015 | Clothing of flexible materials protecting the body, except the hands, from heat and flame: limited flame spread, and convective, radiant and contact heat and molten metal splash. | No |
| EN ISO 11611:2015 | Clothing for welding and allied processes: spatter, short contact with flame, radiant heat from the arc, and less risk from brief accidental contact with live conductors up to about 100 V DC. | No |
| EN 1149-5:2018 | Electrostatic dissipative clothing worn as part of a totally earthed system, to avoid incendiary discharges in explosive atmospheres. Not for protection against mains voltage. | Yes |
| EN ISO 20471:2013 + A1:2016 | High-visibility clothing for high-risk situations: colour and retroreflection, minimum areas and placement. Medium-risk enhanced-visibility garments come under EN 17353:2020+A1:2025. | Yes |
| EN ISO 24232:2025 | Materials and made-up garments against rain, snow, fog and ground humidity. Replaces EN 343:2019. | Yes, from 4 September 2026 |
| EN 14126:2003 + AC:2004 | Reusable and limited-use clothing against infective agents. Surgical gowns and drapes are outside its scope. | Yes |
| EN 13034:2005+A1:2009 | Type 6 suits and partial-body PB[6] items: limited protection against liquid chemicals. | Yes |
| EN 14605:2005+A1:2009 | Type 3 (liquid-tight) and Type 4 (spray-tight) suits, and partial-body PB[3] and PB[4] items. | Yes |
What “No” means for heat-and-flame and welding garments. Neither EN ISO 11612 nor EN ISO 11611 appears on the Commission’s list, and the catalogue of the Estonian standards body, a CEN member, records no EU legislation against either (EN ISO 11612:2015, EN ISO 11611:2015). So meeting them gives no presumption of conformity. A notified body can still certify a garment tested to them: where a harmonised standard has not been applied, it checks that the manufacturer’s own solutions, including other technical specifications, meet the essential requirements (Annex V, point 4(f)). The declaration then cites them as other technical specifications. Ask the notified body how it will treat them before booking the tests.
Rainwear in transition. Decision 2026/1971 added EN ISO 24232:2025 to the list and struck out EN 343:2019 on 4 September 2026. Its recitals say the withdrawal of EN 343:2019 is deferred to give manufacturers time, but its annex sets no later date, and the Commission’s summary list shows EN 343:2019’s presumption ending on 4 September 2026. Until that is corrected or confirmed, plan new and renewed certificates on EN ISO 24232:2025. If the rainwear carries a fluorinated repellent finish, PFAS rules are a separate question: see PFAS in textiles: limits and dates by market.
India: the Protective Textiles (Quality Control) Order
The Ministry of Textiles issued the Protective Textiles (Quality Control) Order, 2022 on 10 April 2023 as S.O. 1707(E), using its powers under section 16 of the Bureau of Indian Standards Act, 2016, read with sections 17 and 25(3). As published, it was to take effect 180 days after publication; S.O. 2332(E) of 24 May 2023 fixed the date at 7 October 2023 instead. S.O. 3896(E) of 11 September 2024, in force on its publication in the Gazette on 12 September 2024, struck out item 2.
- Each listed product must conform to the Indian Standard named against it and carry the BIS Standard Mark under a BIS licence, granted under Scheme-I of the BIS (Conformity Assessment) Regulations, 2018.
- BIS is the certifying and enforcing authority, and breaches are punishable under the BIS Act. Section 17(1) of the Act reaches anyone who makes, imports, distributes, sells, hires, leases, stores or exhibits the goods for sale without the mark (India Code).
- Goods meant for export are outside the order.
- Neither the order nor its two amendments gives micro or small enterprises a later date or any other relaxation.
- The latest version of each Indian Standard applies from the date BIS publishes it. BIS has revised two of the standards since the order was made.
| No. | Product | Indian Standard in the order | Status on 3 October 2026 | Relation to ISO (BIS record) |
|---|---|---|---|---|
| 1 | Curtains and drapes | IS 15741:2007 | In force | Written in India |
| 2 | Upholstered composites used for non-domestic furniture | IS 15768:2008 | Struck out from 12 September 2024 by S.O. 3896(E) | — |
| 3 | Protective clothing for firefighters | IS 16890:2018 | In force; BIS has published a first revision, IS 16890:2024 | Written in India |
| 4 | Protective gloves for firefighters | IS 16874:2018 | In force | Written in India |
| 5 | Protective clothing for industrial workers exposed to heat | IS 15748:2022 | In force | Identical to ISO 11612:2015 (dual numbering) |
| 6 | Clothing made of limited flame spread materials and material assemblies affording protection against heat and flame | IS 15742:2007 | In force; BIS has published a first revision, IS 15742:2026 | Written in India |
| 7 | High visibility warning clothes | IS 15809:2017 | In force | Not equivalent |
| 8 | Protective clothing for use in welding and allied processes | IS 16655:2017 | In force | Identical to ISO 11611:2015 (dual numbering) |
| 9 | Tactical 3-point sling | IS 16725:2018 | In force | Written in India |
| 10 | Pouch for ammunition and grenades made of disruptive pattern nylon 6,6 | IS 16726:2018 | In force | Written in India |
| 11 | Bullet resistant jackets | IS 17051:2018 | In force | Written in India |
| 12 | Water-proof multipurpose rain poncho with convertibility as bivouac | IS 17286:2019 | In force | Written in India |
Products, standards and dates are from the three Gazette notifications. Revisions and the relation to ISO are from each standard’s page on BIS’s standards portal, linked in the table; “written in India” is the portal’s “indigenous”.
Getting the mark
A factory in India applies to BIS for a licence under Scheme-I. Under BIS’s guidelines for grant of licence of 25 February 2026, BIS visits the factory to assess its manufacturing, quality control and testing arrangements, and samples are tested in a third-party laboratory. Either BIS draws them at the visit, or, where BIS allows it for the product, the applicant files third-party test reports first and BIS draws samples again at the visit for review. Reports count only from laboratories BIS runs, recognises or has empanelled.
A factory outside India, in Bangladesh or anywhere else, applies under the Foreign Manufacturers Certification Scheme. It must be able to test the product to the Indian Standard in its own factory, with competent staff, and accept BIS’s scheme of inspection and testing; each product and each factory needs its own application (who can apply). It nominates an Authorised Indian Representative, resident in India, who answers for the licence. BIS inspects the factory and draws samples for independent testing; foreign applications always follow that route. After the grant the licensee furnishes a performance bank guarantee of USD 10,000. The licence runs for one to two years at first and can then be renewed for up to five. BIS gives about six months as the average time to grant (grant of licence).
The licensed garment carries the Standard Mark with the licence number beside it, in the form CM/L- followed by the number (BIS Standard Mark). BIS’s standards portal lists the licences granted under each Indian Standard, so a buyer can check a supplier’s.
Same method, separate certificate
BIS records IS 15748:2022 as identical to ISO 11612:2015 and IS 16655:2017 as identical to ISO 11611:2015. EN ISO 11612:2015 and EN ISO 11611:2015 are the same ISO texts adopted in Europe. A fabric and garment developed for EU heat-and-flame or welding work is therefore developed to the requirements India sets for items 5 and 8. The paperwork does not carry over: BIS tests samples in laboratories it runs, recognises or empanels, and an EU type-examination certificate is not one of the routes to a licence.
High-visibility clothing is the opposite case. BIS records IS 15809:2017 as not equivalent to an international standard, so an EN ISO 20471 report is not evidence for item 7.
Which garment goes where
| Garment | EU standard | India: item in this order |
|---|---|---|
| FR and heat-and-flame workwear | EN ISO 11612:2015 with EN ISO 13688 (not on the EU list) | Item 5, IS 15748:2022; clothing of limited flame spread materials is item 6, IS 15742 |
| Welding clothing | EN ISO 11611:2015 with EN ISO 13688 (not on the EU list) | Item 8, IS 16655:2017 |
| High-visibility clothing | EN ISO 20471:2013 + A1:2016 | Item 7, IS 15809:2017 |
| Firefighters’ clothing and gloves | Not covered on this page | Items 3 and 4, IS 16890 and IS 16874:2018 |
| Rainwear | EN ISO 24232:2025 | Only the multipurpose poncho convertible to a bivouac, item 12, IS 17286:2019 |
| Anti-static clothing | EN 1149-5:2018 | Not in this order |
| Chemical suits, Types 6, 4 and 3 | EN 13034:2005+A1:2009; EN 14605:2005+A1:2009 | Not in this order |
| Clothing against infective agents | EN 14126:2003 | Not in this order |
| Bullet resistant jackets | Not covered on this page | Item 11, IS 17051:2018 |
“Not in this order” means only that. Another Indian order may cover the product, so check BIS’s list of products under compulsory certification before shipping.
Tools for the work
- Flame retardant LOI predictor: estimates limiting oxygen index from flame-retardant add-on, and the add-on needed for a target LOI. Use it to plan a finish before the fabric goes to the laboratory; it does not stand in for the tests in EN ISO 11612 or IS 15748.
- Gown hydrostatic head and seam failure predictor: compares fabric and seam hydrostatic head with a required level and shows which one limits the garment. It is built for surgical gowns, but the arithmetic carries to rainwear, because EN ISO 24232 assesses made-up garments as well as materials, and a seam that holds less than the fabric decides the result.
- Built into the fibre or applied to the cloth (Pro): compares flame retardancy built into the fibre with a finish applied to the cloth, costed per wash of protection actually delivered over the garment’s life rather than on the garment price.
EU route and India route, side by side
| EU (Regulation (EU) 2016/425) | India (Protective Textiles QCO) | |
|---|---|---|
| What is covered | Any garment sold as PPE; category set by the risk | Eleven named products, one Indian Standard each |
| Mark | CE; for Category III followed by the notified body’s number | BIS Standard Mark with the licence number (CM/L-) |
| Who certifies | Category I: the manufacturer. Categories II and III: a notified body the manufacturer chooses | BIS, the certifying and enforcing authority |
| What is tested | Specimens of the type, against the essential requirements, usually through harmonised standards; for Category III, production samples each year (C2) or an audited quality system (D) | Samples tested against the Indian Standard in a laboratory BIS runs, recognises or empanels; factory inspection; in-house testing to BIS’s scheme |
| How long it lasts | EU type-examination certificate: up to five years | Foreign factories: one to two years at first, renewable for up to five |
| Paperwork the buyer or authorities ask for | EU declaration of conformity per model; user instructions in the local language; type-examination certificate (Categories II and III); the EU economic operator’s name on the product or packaging; technical documentation on request, kept 10 years | A valid BIS licence for that product and factory; the mark and licence number on the goods; for a foreign factory, its Authorised Indian Representative |
| Goods for export | Not applicable | Outside the order |
How this page is kept
Last verified: 3 October 2026. Built from the Official Journal texts of Regulation (EU) 2016/425, Regulation (EU) 2019/1020 and Implementing Decisions (EU) 2026/1279 and 2026/1971; the Commission’s summary list of harmonised standards (generated 4 September 2026); the Gazette of India notifications S.O. 1707(E), S.O. 2332(E) and S.O. 3896(E); the BIS Act on India Code; and BIS’s standards portal, FMCS pages and licensing guidelines, each linked where it is used. The dated records sit in the regulation register. This page describes what the instruments say; it is not legal advice for a particular product. Corrections are welcome through the contact page.
