CROSS-STANDARD public interest · PPE / respirator (mask)
China-to-Armenia PPE Respirator (FFP Mask) Compliance Gap Matrix
AI-compiled from official public sources — cross-checked by multiple AI models, not human-verified. Informational only; see disclaimer. Public-interest, source-linked comparison of Chinese PPE respirator (KN95 / GB 2626) documentation against Armenia/EAEU requirements under TR CU 019/2011 (PPE safety), mandatory EAC certification via accredited EAEU conformity assessment body, EAC marking, Russian/Armenian-language labelling, and applicable GOST EN 149-type harmonised standards. TR EAEU 037/2016 (RoHS-style) applies to electrical PPE components.
Dataset 2026-06-11
Last verified 2026-06-16
6 rows
GAP MATRIX
Compliance Gap Matrix
| Compliance item | Common China baseline | Armenia (EAEU/TR CU) | Gap / action | Source + verification date |
|---|---|---|---|---|
| Conformity Assessment: EAC Certification Requirement for PPE Respirators in Armenia | Chinese industrial respirators (GB 2626-2019, KN95) require CCC (China Compulsory Certification) issued by CNCA-authorised certification bodies. Testing is conducted against GB 2626-2019 in designated laboratories. Medical-protective respirators (GB 19083-2010) require NMPA registration as a Class II medical device including clinical and technical dossier submission. Neither CCC nor NMPA registration is recognised under the EAEU EAC system. Manufacturers exporting to Armenia must undergo separate EAEU-accredited certification even if full Chinese CCC is already held.GB 2626-2019 — Non-powered air-purifying particle respirator — SAMR/CCC mandatory GB 19083-2010 — Technical requirements for medical protective mask — NMPA Class II medical device registration CNCA — China National Certification and Accreditation Administration (CCC authority) |
Under TR CU 019/2011, respiratory protective equipment (respirators) is subject to mandatory EAC CERTIFICATION — not a declaration of conformity (DoC). This is a critical distinction: unlike some EAEU product categories where a manufacturer's self-declaration is permitted, PPE including respirators requires involvement of an accredited third-party certification body. The certification body must be included in the Unified Register of Accredited Bodies of the EAEU. The conformity assessment procedure typically includes: (1) application and document review; (2) type testing of product samples against applicable GOST harmonised standards (GOST EN 149-2003 or equivalent); (3) production assessment (audit of the manufacturer's quality system or production inspection); (4) issuing the EAC certificate valid for up to 5 years; (5) periodic surveillance testing during the certificate validity period. The EAC certificate must be registered in the unified register of the Eurasian Economic Commission and is valid across all EAEU member states including Armenia. Chinese manufacturers may engage any EAEU-accredited body — Russian accredited bodies (e.g., those listed in the FGIS Akkreditatsiya register) are commonly used. Product samples must be tested in accredited test laboratories.TR CU 019/2011 — On the safety of personal protective equipment (EAEU mandatory certification scheme for PPE) GOST EN 149-2003 — Respiratory protective devices: Filtering half masks to protect against particles (test standard under TR CU 019/2011) Decision of the Eurasian Economic Commission No. 896 (2 December 2011) — Unified list of products subject to mandatory conformity assessment (includes PPE) Agreement on Mutual Recognition of Accreditation Results (EAEU) — basis for cross-member EAC certificate validity |
SIGNIFICANT GAP: Chinese CCC certification for respirators is not mutually recognised by the EAEU. Exporters must engage an EAEU-accredited certification body and have product samples tested against GOST EN 149-type standards. PPE is a certification (not declaration) category under TR CU 019/2011 — self-declaration is not available. An EAC certificate once obtained covers all EAEU member states including Armenia; exporters with existing EAEU EAC certificates (e.g., issued for Russia) need not re-certify for Armenia specifically.[INFORMATIONAL] EAC certification by an EAEU-accredited third-party body is mandatory for respiratory PPE in Armenia. Chinese CCC certificates are not recognised. Manufacturers must submit samples to GOST EN 149-type testing in an accredited EAEU laboratory. An EAC certificate covers the whole EAEU territory — a Russian-market EAC certificate is sufficient for Armenia. | EAEU / Eurasian Economic Commission — TR CU 019/20112026-06-16 · reference |
| Labelling Requirements for PPE Respirators in Armenia (EAEU Language and Content Rules) | Chinese GB 2626-2019 requires Chinese-language labelling on respirators, including: product name, standard number (GB 2626-2019), filtering efficiency class (KN90/KN95), manufacturer name and address, production date and shelf life, and CCC mark. Instructions for use must be in Chinese. China does not require Russian or Armenian language labelling. Chinese export packaging typically includes only Chinese and optionally English labelling — this is insufficient for the Armenian/EAEU market without additional Russian/Armenian language labels.GB 2626-2019 — Non-powered air-purifying particle respirator (labelling requirements, Section 8) GB/T 191-2008 — Packaging and storage mark (supplementary, general use) |
TR CU 019/2011 and the EAEU labelling rules require that PPE respirators placed on the Armenian market carry labelling in Russian and/or the national language (Armenian). Labelling in Chinese only is not permitted. Required label information includes: (1) product name and type designation; (2) manufacturer name and legal address; (3) country of origin; (4) protection class / filtering class (e.g., analogous to FFP1/FFP2/FFP3 or the GOST EN 149 class); (5) protection factor or intended hazard protection description; (6) date of manufacture and shelf life / expiry date (if applicable); (7) EAC mark affixed prominently; (8) instructions for use in Russian and/or Armenian (may be provided as a separate insert); (9) storage and maintenance conditions; (10) size or dimensions (if applicable). The EAC mark must appear on the product or its packaging and in accompanying documents. The EAEU does not prescribe a specific label format, but all content must be legible, durable, and present before the product leaves the point of sale to the end user.TR CU 019/2011 — On the safety of personal protective equipment (labelling requirements, Annex 3) Decision of the Eurasian Economic Commission No. 711 (15 June 2012) — Unified labelling rules for EAEU products |
Chinese export respirators typically carry Chinese (and sometimes English) labelling only. For the Armenian/EAEU market, labels must include Russian and/or Armenian language content covering all TR CU 019/2011 mandatory fields, plus the EAC mark. Relabelling in the destination country (Armenia or a Russian transit hub) is permitted under EAEU rules provided the EAC certificate holder or their authorised representative takes responsibility. The CCC mark and GB standard references on Chinese labels are irrelevant to the EAEU market and should not be presented as conformity evidence.[INFORMATIONAL] PPE respirators must carry Russian and/or Armenian language labelling and the EAC mark when sold in Armenia. Standard Chinese export labels are non-compliant. Re-labelling by the authorised EAEU representative or importer in Russia/Armenia is a common compliant approach. CCC marks and GB standard numbers on Chinese labels have no standing in the EAEU market. | EAEU / Eurasian Economic Commission — TR CU 019/2011 Annex 32026-06-16 · reference |
| EAC Mark: Mandatory Conformity Marking for PPE Respirators in Armenia | For Chinese-market industrial respirators (GB 2626-2019), the mandatory conformity mark is the CCC (China Compulsory Certification) mark, also rendered as the 「3C」 mark. CCC marks are issued after type testing and factory inspection by CNCA-authorised certification bodies. The CCC mark must be affixed to each product unit or its minimum sales packaging. For medical-grade respirators (GB 19083-2010, NMPA Class II), the equivalent is NMPA registration approval — a registration number and the medical device registration mark. The CCC mark and NMPA registration mark are entirely domestic marks with no EAEU equivalence or mutual recognition.GB 2626-2019 — CCC mark requirement for industrial respirators (China domestic market) CNCA — China National Certification and Accreditation Administration (CCC administrator) NMPA — National Medical Products Administration (medical-grade respirator registration authority) |
Products subject to EAEU technical regulations — including PPE respirators under TR CU 019/2011 — must bear the EAC (Eurasian Conformity) mark before being placed on the market in Armenia or any other EAEU member state. The EAC mark is the EAEU equivalent of the CE mark in the EU and signals that the product has undergone the mandatory conformity assessment procedure and meets all applicable EAEU technical regulation requirements. Requirements for the EAC mark: (1) TRIGGER: The EAC mark may only be applied AFTER a valid EAC certificate has been issued by an accredited certification body under TR CU 019/2011. (2) APPEARANCE: The EAC mark consists of the letters 'E', 'A', 'C' in a specific stylised format defined by the Eurasian Economic Commission. It must not be visually confused with other marks. (3) PLACEMENT: The EAC mark must appear on the product itself (if feasible), on its packaging, and in accompanying documentation. Minimum size requirements apply — the mark must be legible and not obscured. (4) COLOUR: The EAC mark may be reproduced in any single colour that provides sufficient contrast with the background. (5) PROHIBITION: Affixing the EAC mark without a valid EAC certificate is a serious violation subject to market surveillance action, product withdrawal, and administrative penalties.TR CU 019/2011 — On the safety of personal protective equipment (EAC mark requirement) Decision of the Eurasian Economic Commission No. 711 (15 June 2012) — Procedure for application of the EAC mark Decision of the Council of the Eurasian Economic Commission No. 293 (25 December 2012) — Requirements for the unified EAC mark |
The Chinese CCC mark is not recognised in Armenia or the EAEU. Products bearing only the CCC mark (without EAC mark) cannot legally be placed on the Armenian market. The EAC mark must be applied after EAC certification is obtained — it cannot be self-applied. Products may carry both the CCC mark (for China domestic sales) and the EAC mark (for EAEU sales) simultaneously on packaging, provided both are clearly legible and not visually confused with each other.[INFORMATIONAL] The EAC mark is mandatory for PPE respirators sold in Armenia and must be applied only after a valid EAC certificate is issued under TR CU 019/2011. Chinese CCC marks are not valid in the EAEU. Dual marking (CCC + EAC) on export packaging is permitted for products sold in both markets. | Eurasian Economic Commission — Technical Regulations and EAC Mark2026-06-16 · reference |
| Performance and Safety Testing Requirements: GOST EN 149-type Standards under TR CU 019/2011 | Chinese industrial respirators (KN90/KN95) are tested under GB 2626-2019. Key parameters: filtration efficiency (NaCl aerosol only; KN95 requires 95% minimum filtration at 85 L/min), inhalation and exhalation resistance, CO2 dead space content, headband tensile strength, and flame resistance. No paraffin oil aerosol test is required under GB 2626-2019 (unlike GOST EN 149-2003 and EN 149). Testing must be conducted by a CNAS-accredited laboratory. CCC certification is issued by CNCA-authorised bodies after type testing and factory inspection.GB 2626-2019 — Non-powered air-purifying particle respirator (KN90/KN95) — SAMR/CCC mandatory GB 19083-2010 — Technical requirements for medical protective mask (NMPA Class II, filtration efficiency 95% minimum) |
Under TR CU 019/2011, filtering facepiece respirators (FFP-type) must meet the performance and safety requirements defined in the harmonised GOST standards adopted under the EAEU system. The primary harmonised standard for filtering half masks is GOST EN 149-2003 (equivalent to European EN 149:2001), which specifies three protection classes: FFP1, FFP2, and FFP3. Key test parameters include: (1) FILTRATION EFFICIENCY: Minimum penetration limits for NaCl and paraffin oil aerosols at defined flow rates — FFP1 (total inward leakage TIL 22%, penetration 20%), FFP2 (TIL 8%, penetration 6%), FFP3 (TIL 2%, penetration 1%). (2) BREATHING RESISTANCE: Maximum inhalation and exhalation resistance limits at defined flow rates. (3) CO2 CONTENT: Maximum CO2 content in inhalation air. (4) MECHANICAL STRENGTH: Head harness strength, nose clip, and body resistance tests. (5) FLAMMABILITY: Ignition resistance per test protocol. (6) DOLOMITE CLOGGING TEST (for reusable masks marked NR only): pre-clogging with dolomite dust before filtration re-test. Test protocols must be conducted by an accredited EAEU testing laboratory. Chinese KN95 test reports under GB 2626-2019 use different test aerosols (NaCl only, no paraffin oil), different flow rates, and different acceptance criteria — they are NOT equivalent to GOST EN 149-2003 and cannot substitute for EAEU conformity testing.TR CU 019/2011 — On the safety of personal protective equipment (EAEU mandatory technical regulation) GOST EN 149-2003 — Respiratory protective devices: Filtering half masks to protect against particles — Requirements, testing, marking (harmonised standard under TR CU 019/2011) |
GB 2626-2019 (KN95) test reports do NOT satisfy GOST EN 149-2003 requirements for EAEU/Armenian market certification because: (1) GB 2626-2019 uses NaCl aerosol only — GOST EN 149-2003 also requires paraffin oil aerosol testing; (2) flow rate protocols differ; (3) total inward leakage (TIL) measurement with human subjects is required under GOST EN 149 but the Chinese standard uses a different fit-test methodology; (4) FFP2 (GOST EN 149) is NOT the same as KN95 (GB 2626) — the test protocols are not harmonised. Chinese exporters must have products re-tested under GOST EN 149-2003 by an EAEU-accredited laboratory and certified by an EAEU-accredited certification body before the EAC certificate can be issued.[INFORMATIONAL] Chinese KN95 (GB 2626-2019) test reports do not satisfy GOST EN 149-2003 requirements under TR CU 019/2011. Products must be re-tested by an EAEU-accredited laboratory using GOST EN 149-2003 protocols (including paraffin oil aerosol, total inward leakage with human subjects) before an EAC certificate can be issued for the Armenian market. | EAEU / Eurasian Economic Commission — TR CU 019/20112026-06-16 · reference |
| Hazardous Substances in Electrical PPE Components: TR EAEU 037/2016 (RoHS-style) — Present in Armenia | China regulates hazardous substances in electrical and electronic equipment under SJ/T 11363-2006 (now substantially superseded by GB/T 26572-2011 on concentration limits) and the Management Methods for Restriction of Use of Hazardous Substances in Electrical and Electronic Products (Order No. 32, 2016, effective 1 July 2016), which aligns with EU RoHS categories. The six restricted substances and concentration thresholds are the same as TR EAEU 037/2016 and EU RoHS 2. China requires the China RoHS 'hazardous substance' disclosure label on covered products. For non-powered passive FFP masks, no RoHS-equivalent obligation applies in China either — the regulation targets products with electrical/electronic components.GB/T 26572-2011 — Requirements of concentration limits for certain restricted hazardous substances in electrical and electronic products (China RoHS concentration limits) Management Methods for Restriction of Use of Hazardous Substances in Electrical and Electronic Products (Order No. 32, 2016) — China RoHS mandatory requirements |
TR EAEU 037/2016 'On restriction of the use of hazardous substances in electrical and electronic equipment' is the EAEU RoHS-equivalent technical regulation. It restricts the same six hazardous substances as EU RoHS 2 (Directive 2011/65/EU): lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (Cr VI), polybrominated biphenyls (PBB), and polybrominated diphenyl ethers (PBDE), with the same maximum concentration values (lead and others: 0.1 wt% homogeneous material; cadmium: 0.01 wt%). TR EAEU 037/2016 applies to electrical and electronic equipment placed on the EAEU market. For PPE respirators, this regulation is PRESENT if the respirator contains electrical or electronic components — for example, powered air-purifying respirators (PAPR), respirators with battery-powered fans, electronic fit-check indicators, or electronic communication systems integrated into the mask. For PASSIVE (non-powered) filtering half masks (FFP1/FFP2/FFP3) that contain no electrical components, TR EAEU 037/2016 does NOT apply. Exporters should confirm the scope applicability based on product design.TR EAEU 037/2016 — On restriction of the use of hazardous substances in electrical and electronic equipment (EAEU RoHS-equivalent, in force 1 March 2018) | TR EAEU 037/2016 is PRESENT for electrical PPE components (powered/battery respirators) exported to Armenia. For passive FFP masks (no electrical components), this regulation does NOT apply — no gap. Where TR EAEU 037/2016 does apply, Chinese exporters who already comply with China RoHS (GB/T 26572-2011, Order No. 32) will find the substance restrictions and thresholds are identical — the primary additional requirement is the documentation and declaration format required under the EAEU system rather than a different technical limit. An EAEU Declaration of Conformity under TR EAEU 037/2016 must be prepared separately from the China RoHS disclosure label.[INFORMATIONAL] TR EAEU 037/2016 (RoHS-style hazardous substance restrictions) is PRESENT for electrical PPE components in Armenia. Passive non-powered FFP respirators are out of scope. For powered/battery-equipped respirators, the six restricted substances and concentration thresholds are identical to China RoHS — the primary compliance gap is the EAEU-format Declaration of Conformity documentation, not different technical limits. | Eurasian Economic Commission — TR EAEU 037/20162026-06-16 · reference |
| Scope and Applicable EAEU Technical Regulation for Respiratory PPE Exported to Armenia | China regulates industrial/non-medical respirators under GB 2626-2019 (Non-powered air-purifying particle respirator — KN90/KN95). Compliance is mandatory and enforced via the CCC (China Compulsory Certification) system administered by SAMR (State Administration for Market Regulation). Medical-protective respirators are additionally regulated as Class II medical devices under GB 19083-2010 by NMPA. The Chinese system and the EAEU TR CU 019/2011 system are structurally parallel (both mandatory, both require third-party certification for PPE), but the specific technical standards, test methods, and certification bodies are entirely distinct — GB 2626 / KN95 compliance does not satisfy TR CU 019/2011 requirements.GB 2626-2019 — Non-powered air-purifying particle respirator (KN90/KN95) — SAMR/CCC mandatory GB 19083-2010 — Technical requirements for medical protective mask — NMPA Class II medical device |
Armenia is a full member of the Eurasian Economic Union (EAEU) and the Customs Union (CU). All PPE placed on the Armenian market — including filtering facepiece respirators (FFP-type) — must comply with the EAEU technical regulation TR CU 019/2011 'On the safety of personal protective equipment'. This TR CU came into force on 1 June 2012 and establishes mandatory safety requirements for PPE. Respirators fall under the scope as respiratory protective equipment. The regulation is directly applicable in Armenia without transposition; SARM (the Standards, Metrology and Certification Unit under the National Institute of Standards of the Republic of Armenia) is the national standards body. Accredited EAC certification bodies (located anywhere within the EAEU) are authorised to issue EAC certificates for the Armenian market. Products already certified under TR CU 019/2011 for another EAEU member state (e.g., Russia, Kazakhstan) are valid for Armenia without re-certification — the EAC certificate covers the whole EAEU territory.TR CU 019/2011 — On the safety of personal protective equipment (EAEU/Customs Union technical regulation) GOST EN 149-2003 — Respiratory protective devices: Filtering half masks to protect against particles (harmonised standard under TR CU 019/2011) Treaty on the Eurasian Economic Union (29 May 2014) — Armenia accession treaty 2 January 2015 |
Chinese exporters must obtain a separate EAC certificate under TR CU 019/2011 from an EAEU-accredited certification body before exporting respirators to Armenia. GB 2626 (KN95) certification from Chinese authorities (CCC, SAMR) is not recognised in Armenia or any EAEU member state. An EAC certificate issued for one EAEU member state covers the whole EAEU territory including Armenia — exporters who already hold a valid TR CU 019/2011 EAC certificate for Russia or Kazakhstan need not re-certify specifically for Armenia.[INFORMATIONAL] Respiratory PPE (FFP respirators) exported to Armenia must comply with TR CU 019/2011 and carry the EAC mark. Chinese GB 2626/KN95 certification is not transferable to the EAEU system. Exporters must engage an EAEU-accredited certification body and conduct GOST EN 149-type conformity testing. A valid EAC certificate from any EAEU member state covers the whole union including Armenia. | EAEU / Eurasian Economic Commission — TR CU 019/20112026-06-16 · reference |
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SOURCES
Official-source register.
- EAEU / Eurasian Economic Commission — TR CU 019/2011 · accessed 2026-06-16 · reference · used in 3 rows
- EAEU / Eurasian Economic Commission — TR CU 019/2011 Annex 3 · accessed 2026-06-16 · reference · used in 1 rows
- Eurasian Economic Commission — Technical Regulations and EAC Mark · accessed 2026-06-16 · reference · used in 1 rows
- Eurasian Economic Commission — TR EAEU 037/2016 · accessed 2026-06-16 · reference · used in 1 rows