CROSS-STANDARD public interest · PPE / respirator (mask)

Exporting Respirators / Face Masks from China to the UK — UKCA & PPE Compliance Guide

AI-compiled from official public sources — cross-checked by multiple AI models, not human-verified. Informational only; see disclaimer. Regulatory comparison covering the key compliance gaps for filtering respirators (FFP1/2/3) exported from China to the United Kingdom under the Personal Protective Equipment Regulations 2018 (SI 2018/390) and UKCA marking requirements. Covers BS EN 149 testing, Category III Approved Body type-examination, UKCA marking, UK Responsible Person obligations, PPE-vs-medical device boundary (surgical masks), and UK labelling requirements. Chinese equivalent: GB 2626-2019.

Dataset 2026-06-11 Last verified 2026-06-12 5 rows

GAP MATRIX

Compliance Gap Matrix

Gap matrix
Compliance item Common China baseline United Kingdom (UKCA / PPE Regs) Gap / action Source + verification date
PPE Conformity Assessment — Category III (Approved Body, Type-Examination) China does not use a tiered PPE category system equivalent to EU/UK Category I–III. For filtering respirators, GB 2626-2019 testing is typically conducted at CNAS-accredited laboratories; CCC (China Compulsory Certification) by a CNCA-designated certification body is required for certain personal respiratory protective equipment sold domestically. The Chinese CCC scheme is administered by CNCA and conducted by designated certification bodies (e.g., China Quality Certification Centre, CQC). CCC certification does not satisfy the UK Approved Body requirement — a UK-designated Approved Body must independently conduct the type-examination.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (SAMR / SAC)
CNCA mandatory certification (CCC) scheme for personal protective equipment — administered by CNCA, conducted by designated bodies (e.g., CQC)		 Respirators are classified as Category III PPE under the UK PPE Regulations 2018 (SI 2018/390), which retains the framework of EU Regulation 2016/425. Category III covers PPE against mortal danger or irreversible health damage, including all filtering respirators. Conformity assessment for Cat III PPE is mandatory via an UK Approved Body (AB): (1) EU-type examination (Module B) — the AB examines the design and issues an EU-type examination certificate (now re-issued as a UK-type examination certificate for UKCA); and (2) a production-phase conformity module — either Module C2 (conformity to type based on internal production control plus supervised product checks) or Module D (production quality assurance). Self-declaration without an Approved Body is not permitted for Cat III PPE. The AB must be designated by the UK Secretary of State for the relevant PPE category.Personal Protective Equipment Regulations 2018 (SI 2018/390) — Schedule 8 (Conformity assessment procedures), Schedule 2 (Essential Safety Requirements)
Regulation (EU) 2016/425 on personal protective equipment (retained in UK law as the basis for PPE Regulations 2018)		 The conformity gap is structural: all filtering respirators are Cat III PPE in the UK, requiring mandatory Approved Body involvement. There is no self-declaration route. Chinese CCC certification (CQC or equivalent) cannot substitute for a UK Approved Body type-examination certificate. Exporters must: (1) identify a UK-designated Approved Body for PPE (list maintained by OPSS / gov.uk); (2) submit design documentation and samples for UK type-examination under BS EN 149; (3) maintain a production quality module (C2 or D) under ongoing AB surveillance; (4) hold the UK type-examination certificate and maintain it against standard revisions.[INFORMATIONAL] Filtering respirators are Category III PPE in the UK. A UK Approved Body must conduct type-examination (Module B) plus ongoing production surveillance (Module C2 or D). There is no self-declaration route. Chinese CCC/CQC certification does not satisfy this requirement. Exporters must engage a UK-designated Approved Body before UKCA marking can be applied. UK Legislation / His Majesty's Stationery Office2026-06-12 · unverified
Filtering Respirator Safety — FFP Performance (BS EN 149) China mandates GB 2626-2019 (Respiratory protective equipment — Non-powered air-purifying particle respirator) for non-medical filtering respirators. It defines KN90, KN95, KP100 classes based on filtration efficiency against NaCl (non-oil) and DOP (oil) aerosols. KN95 is broadly analogous to FFP2 in filtration efficiency against non-oil particles (≥95% vs. ≥94%), but the test methods, fit-test protocols, and leakage criteria differ. CCC (China Compulsory Certification) is required for certain PPE categories. A Chinese lab test report to GB 2626-2019 is not accepted as equivalent to BS EN 149:2001+A1:2009 testing for UK UKCA purposes.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (SAMR / SAC, mandatory) Filtering facepiece respirators placed on the Great Britain market must meet BS EN 149:2001+A1:2009 (Respiratory protective devices — Filtering half masks to protect against particles — Requirements, testing, marking). The standard defines three performance classes — FFP1, FFP2, FFP3 — based on total inward leakage and filter penetration limits. FFP2 is the minimum class for protection against fine particles and most biological aerosols; FFP3 provides the highest filtration (≥99% against NaCl and paraffin oil aerosols). The standard was retained in the UK National Standards body catalogue (BSI) following the UK's exit from the EU and remains the current UK technical specification for filtering respirators.BS EN 149:2001+A1:2009 — Respiratory protective devices — Filtering half masks to protect against particles — Requirements, testing, marking (BSI, retained post-Brexit)
Personal Protective Equipment Regulations 2018 (SI 2018/390) — Schedule 2, Essential Safety Requirements (UK retained law)		 Exporters must obtain fresh BS EN 149:2001+A1:2009 testing from a UKAS-accredited laboratory or an Approved Body (required for Cat III — see conformity fragment). Key technical gaps: (1) fit test and total inward leakage methodology differs from GB 2626 panel tests; (2) dolomite clogging test in BS EN 149 has no direct GB 2626 equivalent; (3) KN95 class passes the filtration efficiency threshold but may fail total inward leakage limits due to different test headform. A new test report and technical file to BS EN 149 are mandatory; existing CNAS/CQC test reports to GB 2626 cannot be cross-referenced.[INFORMATIONAL] BS EN 149:2001+A1:2009 is the mandatory UK technical standard for filtering half-mask respirators under PPE Regulations 2018. FFP2 or FFP3 class is required for protection against fine particles. Chinese GB 2626-2019 (KN95) certification does not satisfy UK UKCA conformity assessment. Independent re-testing to BS EN 149 by a UKAS-accredited or Approved Body laboratory is required before UK market entry. UK Legislation / His Majesty's Stationery Office2026-06-12 · unverified
Labelling Requirements — UK PPE Respirators China's GB 2626-2019 specifies labelling requirements for non-medical filtering respirators under Clause 7 (Marking). Mandatory markings include: product name, standard number (GB 2626-2019), product level (KN90/KN95/KP100), manufacturer name and address, production date, shelf life, and instructions for use in Mandarin Chinese. The CCC mark must appear on CCC-certified PPE. Chinese labelling does not include UKCA, UK Approved Body certificate numbers, or English-language instructions — all required for UK market entry. Product labels must be modified for UK export.GB 2626-2019 — Clause 7 (Marking) — mandatory labelling for non-medical filtering respirators
GB 2626-2019 — Clause 6 (Instructions for use) — Chinese-language user instructions		 Filtering respirators placed on the Great Britain market must be labelled in accordance with BS EN 149:2001+A1:2009 and the PPE Regulations 2018. Mandatory marking on the product (or on the smallest unit of packaging where product marking is impractical) includes: (1) UKCA mark (replacing CE mark from 1 January 2025 for new GB placements); (2) FFP class designation (FFP1, FFP2, or FFP3); (3) 'D' suffix if dolomite clogging test was passed (indicates suitability for dusty environments); (4) 'NR' (not re-use) or 'R' (re-usable) designation; (5) 'V' suffix if an exhalation valve is fitted; (6) manufacturer name or trademark; (7) product reference / model number; (8) BS EN 149:2001+A1:2009 standard reference; (9) UK Approved Body certificate number; (10) instructions for use in English (including donning/doffing, fit check, limitations, storage conditions, shelf life). Instructions must be in English for the GB market. User information must include pictograms where required by the standard.BS EN 149:2001+A1:2009 — Clause 8 (Marking) — mandatory product and packaging marking requirements
Personal Protective Equipment Regulations 2018 (SI 2018/390) — Schedule 2, Essential Safety Requirements, paragraph 1.4 (information for users)		 Multiple labelling gaps exist between Chinese domestic requirements and UK market requirements: (1) Language — Chinese GB 2626 labels are in Mandarin; UK requires English-language instructions; (2) Mark — Chinese labels carry CCC or no conformity mark; UK requires UKCA mark; (3) Standard reference — Chinese labels cite GB 2626-2019; UK labels must cite BS EN 149:2001+A1:2009; (4) AB certificate number — not present on Chinese labels; mandatory on UK labels; (5) Classification designators — GB 2626 uses KN/KP system; BS EN 149 uses FFP1/2/3 with NR/R/D/V suffixes; Chinese labels typically omit these designators; (6) Shelf life and storage — both standards require this, but format and content differ; (7) Fit-check instructions — BS EN 149 mandates specific fit-check procedure pictogram; often absent from Chinese domestic packaging. All these elements must be on the product or primary packaging — not solely in a separate insert.[INFORMATIONAL] UK labelling for filtering respirators requires UKCA mark, BS EN 149:2001+A1:2009 reference, UK Approved Body certificate number, FFP class (FFP1/2/3) with applicable suffixes (NR/R/D/V), and English-language instructions for use including fit-check pictograms. Chinese domestic labels (GB 2626-2019, CCC mark, Mandarin-only) do not satisfy UK requirements. Separate UK-market packaging and labelling must be produced for all products exported to Great Britain. Health and Safety Executive (HSE) — UK Government2026-06-12 · unverified
PPE vs. Medical Device Boundary — Surgical Masks (UK MDR 2002 / MHRA + BS EN 14683) China separates the PPE and medical mask regulatory regimes analogously. Non-medical filtering respirators are governed by GB 2626-2019 under SAMR. Medical surgical masks (医用外科口罩) are governed by YY 0469-2011 (Medical surgical mask — Technical requirements) under the National Medical Products Administration (NMPA, formerly CFDA), which is China's medical device regulator. Medical masks in China require registration with NMPA as Class II medical devices (Class II for medical surgical masks under China MDR). Medical protective masks (医用防护口罩) — the highest-grade medical respiratory protection — are governed by GB 19083-2010 (Technical requirements for medical protective mask) and also require NMPA Class II registration.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (SAMR, non-medical PPE)
YY 0469-2011 — Medical surgical mask — Technical requirements (NMPA, Class II medical device)
GB 19083-2010 — Technical requirements for medical protective mask (NMPA, Class II medical device)		 In the UK, the regulatory classification of a mask depends on its intended purpose. Filtering respirators (FFP1/2/3) intended to protect the wearer from airborne particles are regulated as PPE under the Personal Protective Equipment Regulations 2018 (SI 2018/390). Surgical masks — also called medical face masks — intended to prevent transmission from the wearer to the patient/environment are regulated as Class I medical devices under the UK Medical Devices Regulations 2002 (SI 2002/618) (UK MDR 2002), administered by the MHRA. Some products are dual-use and must comply with both regimes: for example, a mask tested to both BS EN 149 (respiratory protection) and BS EN 14683 (medical face mask bacterial filtration efficiency) must satisfy both PPE Regulations 2018 and UK MDR 2002. BS EN 14683:2019+AC:2019 is the relevant standard for surgical mask bacterial filtration efficiency (BFE) Type I / Type II / Type IIR.Personal Protective Equipment Regulations 2018 (SI 2018/390) — for PPE respirators
UK Medical Devices Regulations 2002 (SI 2002/618) (UK MDR 2002) — for surgical / medical face masks, administered by MHRA
BS EN 14683:2019+AC:2019 — Medical face masks — Requirements and test methods (surgical mask BFE Type I / II / IIR)		 ⚠️ BOUNDARY FLAG — This row identifies a dual-regulation risk zone. The classification of a mask product under UK law depends on its intended use as labelled and marketed, not solely its physical construction. Key gaps for Chinese exporters: (1) A mask marketed as a 'surgical mask' or making medical claims in the UK requires MHRA registration as a medical device under UK MDR 2002, in addition to or instead of UKCA/PPE marking; (2) A KN95 mask marketed in the UK as a filtering respirator (no medical claims) is regulated purely under PPE Regulations 2018 and requires UKCA — it does NOT require MHRA registration; (3) Dual-use products (e.g., a mask claiming both FFP2 protection and BFE ≥98% surgical performance) must satisfy both regimes — UKCA (PPE AB type-exam to BS EN 149) AND UK MDR 2002 MHRA registration (BS EN 14683 testing); (4) As of 2026, UK MDR 2002 is under reform — the Medicines and Medical Devices Act 2021 grants powers to update the UK MDR framework; check MHRA guidance for current registration timelines. IMPORTANT: This dataset covers PPE respirators under PPE Regulations 2018. Surgical masks as standalone medical devices are outside the primary scope of this comparison but are flagged here because Chinese manufacturers often produce both categories from the same facility and risk misclassification.[INFORMATIONAL] ⚠️ PPE-VS-MEDICAL BOUNDARY FLAGGED. Filtering respirators (FFP1/2/3, no medical claims) → PPE Regulations 2018, UKCA, Approved Body Cat III. Surgical masks (medical claims or intended to protect patients) → UK MDR 2002, MHRA registration, BS EN 14683. Dual-use products must satisfy both regimes. Chinese YY 0469 or GB 19083 medical device registration does not satisfy UK MDR 2002 / MHRA requirements. Misclassification carries enforcement and market withdrawal risk. Manufacturers should seek MHRA borderline product guidance if intent-of-use is ambiguous. UK Government / MHRA2026-06-12 · unverified
UKCA Marking, UK Responsible Person, and Declaration of Conformity China does not have a UKCA equivalent. The Chinese mandatory certification mark for eligible PPE is the CCC mark (China Compulsory Certification, 3C). For non-CCC PPE categories, a manufacturer's declaration is common practice. There is no UK Responsible Person concept in the Chinese regulatory framework. Chinese manufacturers exporting to the UK must appoint a UK-established UKRP to hold the DoC and act as the UK legal contact — this is a new structural obligation with no Chinese domestic parallel.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (SAMR / SAC, reference only)
CNCA mandatory certification (CCC) scheme — administered by CNCA for eligible PPE categories		 Filtering respirators placed on the Great Britain market (England, Scotland, Wales) must bear the UKCA mark. The UKCA mark replaced the CE mark for GB market access; CE marking alone is no longer sufficient for GB after 31 December 2024 (the transitional period having ended). The UKCA mark must be affixed by or on behalf of the manufacturer and indicates conformity with UK PPE Regulations 2018. A UK Responsible Person (UKRP) — a natural or legal person established in the UK — must be designated by any manufacturer not established in the UK. The UKRP holds the UK Declaration of Conformity (DoC) and is legally responsible for product compliance. The UK DoC must reference the applicable UK legislation (PPE Regulations 2018) and the UK type-examination certificate number issued by the UK Approved Body. Northern Ireland retains separate rules (CE/UKNI marking) under the Windsor Framework.Personal Protective Equipment Regulations 2018 (SI 2018/390) — Regulations 15–17 (UKCA marking), Regulation 7 (UK Responsible Person obligations)
Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019/696) — transitional provisions
UK Conformity Assessed (UKCA) marking guidance — OPSS / gov.uk		 Three structural gaps: (1) UKCA mark — CE marking is no longer accepted for GB market access (transitional period ended 31 December 2024); UKCA must be physically affixed to the product or packaging; (2) UK Responsible Person — Chinese manufacturers must legally appoint a UK-established UKRP before placing products on the GB market; the UKRP must hold the technical file and DoC, register with OPSS if required, and is jointly liable for product safety; (3) UK Declaration of Conformity — must be drafted in English, reference PPE Regulations 2018 (not the EU Regulation), and cite the UK type-examination certificate number. Note on CE transition: as of 1 January 2025, CE-marked PPE is no longer accepted for new GB market placements; existing CE stock placed on the GB market before this date may be sold through (check OPSS guidance for current stock rules).[INFORMATIONAL] UKCA marking is mandatory for filtering respirators placed on the Great Britain market as of 1 January 2025 (CE transitional period ended). Chinese manufacturers must appoint a UK Responsible Person (UKRP) and hold a UK Declaration of Conformity referencing PPE Regulations 2018 and the UK Approved Body type-examination certificate. CE marking alone is no longer sufficient for new GB market placements. Northern Ireland requires CE or UKNI marking under the Windsor Framework — separate rules apply. UK Government / Office for Product Safety and Standards (OPSS)2026-06-12 · unverified

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