Conformity Assessment — Category III PPE (EU Type-Examination + Production Conformity) — PPE / respirator (mask) (China → European Union (PPE Reg 2016/425))?

Category III PPE (all FFP respirators) require mandatory Notified Body involvement for both type-examination (Module B) and production conformity (Module C2 or D). Chinese CCC or NMPA certifications do not satisfy this requirement. Exporters must engage an EU Notified Body listed in the NANDO database for PPE (Regulation 2016/425) before placing any FFP respirator on the EU market.

Product Labelling and Marking Requirements — FFP Respirators (EN 149 + PPE Reg) — PPE / respirator (mask) (China → European Union (PPE Reg 2016/425))?

FFP respirators for the EU market require product labelling that complies with EN 149 Clause 9 (performance class, NR/R, D suffix, standard number) and PPE Regulation 2016/425 (CE mark with NB number in correct format). Instructions for use must be in the official language(s) of each destination EU member state. Chinese-language-only labelling, CCC marks, and GB 2626 standard references are not sufficient. Labelling 'KN95' on products marketed as FFP2 has been flagged by EU market surveillance authorities as misleading.

CE Marking, EU Declaration of Conformity, and EU Authorised Representative — PPE / respirator (mask) (China → European Union (PPE Reg 2016/425))?

All three elements — CE marking (with NB number), EU Declaration of Conformity (per Annex IX), and EU Authorised Representative — are mandatory before any FFP respirator is placed on the EU market. These are distinct from the technical testing requirements and must be completed even after the Notified Body certificate is obtained. Chinese CCC marks, NMPA marks, and Chinese quality certificates do not substitute for any of these requirements.

Filtering Facepiece Respirator Safety — EN 149 FFP Performance Requirements — PPE / respirator (mask) (China → European Union (PPE Reg 2016/425))?

FFP respirators are Category III PPE under Regulation (EU) 2016/425. CE marking is mandatory and requires EU type-examination (Module B) by a Notified Body plus production conformity assurance (Module C2 or D). EN 149:2001+A1:2009 is the applicable harmonised standard. Chinese GB 2626-2019 (KN95) certification does not satisfy EU requirements — full re-testing by a Notified Body is required, including the paraffin oil aerosol test and simulated workplace performance test absent from GB 2626.

Medical-Protective Respirator Safety — GB 19083 (China Only — Not a PPE Route) — PPE / respirator (mask) (China → European Union (PPE Reg 2016/425))?

GB 19083 (Chinese medical-protective mask) certification is not recognised under EU PPE or MDR pathways. Exporters must choose the correct EU route: PPE-only (EN 149 + PPE Reg) or dual PPE+MDR if medical device claims are made. See the scope fragment for the surgical mask / FFP boundary which determines which regulation applies.

CRITICAL BOUNDARY: PPE Respirator vs. Medical Device — Which EU Regulation Applies? — PPE / respirator (mask) (China → European Union (PPE Reg 2016/425))?

Surgical masks certified under EN 14683 (EU) are MEDICAL DEVICES under MDR (EU) 2017/745, NOT PPE under Regulation (EU) 2016/425. FFP respirators (EN 149) are PPE — a completely different regulatory route. The two routes must not be mixed. Products claiming both functions require dual conformity. Chinese KN95 (GB 2626) respirators exported to the EU must follow the PPE (EN 149 + PPE Reg) route — adding 'surgical' or 'medical' labelling triggers additional MDR requirements that are frequently absent, causing market surveillance withdrawals.

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

China-to-EU 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 EU requirements under PPE Regulation (EU) 2016/425, harmonised standard EN 149:2001+A1:2009 (FFP1/FFP2/FFP3), mandatory Notified Body conformity assessment, CE marking, EU Declaration of Conformity, and the critical PPE-vs-medical device boundary with MDR (EU) 2017/745.

Dataset 2026-06-11 Last verified 2026-06-12 6 rows

GAP MATRIX

Compliance Gap Matrix

Gap matrix
Compliance item	Common China baseline	European Union (PPE Reg 2016/425)	Gap / action	Source + verification date
Conformity Assessment — Category III PPE (EU Type-Examination + Production Conformity)	For industrial respiratory protection under GB 2626-2019 (KN95), China applies a compulsory certification (CCC) scheme administered by CNCA and third-party certification bodies (e.g., China Quality Certification Centre, CQC). The conformity assessment involves type testing by a CNAS-accredited laboratory followed by factory inspection. For medical-protective masks (GB 19083), NMPA registration is required as a medical device (Class II in most cases). Neither the CCC scheme nor the NMPA medical device registration is recognised as equivalent to a Notified Body EU type-examination (Module B) under PPE Regulation (EU) 2016/425.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (CCC mandatory certification under CNCA) GB 19083-2010 — Technical requirements for medical protective mask (NMPA Class II medical device registration)	Filtering facepiece respirators (FFP1, FFP2, FFP3) are classified as Category III PPE under Regulation (EU) 2016/425, Article 8 and Annex V — the highest risk category covering protection against mortal danger or health hazards that may cause irreversible damage. Category III conformity assessment is mandatory via a Notified Body (NB) and requires two modules: (1) Module B — EU type-examination: the manufacturer submits technical documentation and a specimen to the NB; the NB assesses design and issues an EU type-examination certificate; (2) Module C2 — Conformity to type based on internal production control plus supervised product checks at random intervals by the NB; OR Module D — Conformity to type based on a quality assurance of the production process, where the NB audits the manufacturer's QMS. The manufacturer cannot self-certify for Category III — a Notified Body is mandatory throughout.Regulation (EU) 2016/425 — PPE Regulation, Article 8 (Conformity assessment procedures), Annex V (Module B — EU type-examination), Annex VI (Module C2), Annex VII (Module D)	The entire conformity assessment must be re-run with an EU Notified Body. Specific gaps: (1) A Notified Body listed in NANDO for PPE (Regulation 2016/425) must perform the EU type-examination (Module B); (2) Chinese CCC certificates and NMPA registrations do not substitute for Module B; (3) An EU type-examination certificate must be obtained BEFORE CE marking can be applied; (4) Ongoing production must be covered by Module C2 (NB surveillance) or Module D (NB-audited QMS); (5) The EU type-examination certificate typically has a maximum validity period and must be renewed if the product design changes; (6) The technical file (including test reports, design drawings, user instructions in EU languages) must be maintained by the EU Authorised Representative.[INFORMATIONAL] Category III PPE (all FFP respirators) require mandatory Notified Body involvement for both type-examination (Module B) and production conformity (Module C2 or D). Chinese CCC or NMPA certifications do not satisfy this requirement. Exporters must engage an EU Notified Body listed in the NANDO database for PPE (Regulation 2016/425) before placing any FFP respirator on the EU market.	EUR-Lex / Official Journal of the European Union2026-06-12 · unverified
Product Labelling and Marking Requirements — FFP Respirators (EN 149 + PPE Reg)	GB 2626-2019 Clause 7 specifies Chinese marking requirements for non-powered air-purifying particle respirators. Required on the product: manufacturer name or trademark, product name, product model, standard number (GB 2626-2019), performance class (KN90 or KN95), 'NR' or 'R' designation. Required on the packaging: manufacturer name, address, and contact, production date and shelf life (or expiry date), lot number, storage conditions, instructions for use in Chinese. The CCC mark must appear on the product and packaging. Key differences from EU: Chinese markings are in Chinese only (EU requires official language of each destination member state); CCC mark replaces CE mark; no Notified Body identification number required.GB 2626-2019 — Clause 7 (Marking and packaging requirements) China CCC (3C) mark — mandatory product certification mark on product and packaging	EN 149:2001+A1:2009 Clause 9 specifies mandatory marking to be permanently and legibly applied to each filtering facepiece respirator and its packaging. Required markings ON THE DEVICE include: (1) Number and year of the standard (EN 149:2001+A1:2009); (2) Name or trademark of the manufacturer; (3) Type designation (manufacturer's model name); (4) Performance class (FFP1 / FFP2 / FFP3); (5) 'NR' (not re-usable) or 'R' (re-usable); (6) 'D' if the dolomite clogging test was also passed; (7) CE marking followed by the four-digit Notified Body identification number. Required on the PACKAGING: manufacturer name and address, storage conditions, lot/batch number or expiry date (if applicable), and instructions for use in the official language(s) of the destination EU member state. Instructions for use must include: donning/doffing procedure, fit-check instructions, limitations of use, storage conditions, and care/maintenance (for R types). The CE mark must meet the proportional size requirements of Regulation (EC) 765/2008, Annex II — minimum 5 mm height.EN 149:2001+A1:2009 — Clause 9 (Marking requirements) Regulation (EU) 2016/425 — PPE Regulation, Article 10 (CE marking), Article 14 (Instructions and information) Regulation (EC) 765/2008 — CE marking rules, Annex II (minimum size 5 mm)	Multiple labelling gaps are typical for Chinese manufacturers: (1) LANGUAGE: Chinese-only instructions do not satisfy EU requirements — full translation into the official language of each EU destination country is mandatory. A single product model sold across multiple EU markets typically requires 24 official EU language variants of its instructions for use. (2) CE FORMAT: The CE mark must visually comply with Regulation (EC) 765/2008, Annex II (correct graphical proportions, minimum 5 mm height). The CCC mark must be removed or covered for EU market products. (3) NB NUMBER: The four-digit Notified Body number must appear immediately after 'CE' on the product (e.g., CE 0194). (4) STANDARD CITATION: The product must reference EN 149:2001+A1:2009, not GB 2626-2019. (5) SHELF LIFE: EU market practice requires clear lot number and shelf life indication — though EN 149 does not prescribe a specific shelf life, EU Authorised Representatives typically require it for traceability purposes. (6) NO 'KN95' CLAIM: Labelling as 'KN95' on an EN 149-certified product marketed as FFP2 is misleading — the two classes have different test methodologies. EU market surveillance has flagged KN95-labelled products sold as FFP2.[INFORMATIONAL] FFP respirators for the EU market require product labelling that complies with EN 149 Clause 9 (performance class, NR/R, D suffix, standard number) and PPE Regulation 2016/425 (CE mark with NB number in correct format). Instructions for use must be in the official language(s) of each destination EU member state. Chinese-language-only labelling, CCC marks, and GB 2626 standard references are not sufficient. Labelling 'KN95' on products marketed as FFP2 has been flagged by EU market surveillance authorities as misleading.	EUR-Lex / Official Journal of the European Union2026-06-12 · unverified
CE Marking, EU Declaration of Conformity, and EU Authorised Representative	China does not require CE marking. Domestic market conformity is demonstrated via the CCC mark (mandatory for GB 2626 respirators) or NMPA registration (for GB 19083 medical masks). The CCC mark (China Compulsory Certification) is affixed after certification by a CNCA-authorised body. There is no equivalent to the EU Authorised Representative requirement — Chinese law does not mandate a domestic legal representative for the domestic market conformity pathway. The CCC mark and NMPA registration documents are not accepted by EU market surveillance authorities as evidence of CE conformity.China CCC (3C) certification — CNCA mandatory certification system for GB 2626-2019 industrial respirators NMPA medical device registration — for GB 19083 medical-protective masks under drug/device law	Before placing FFP respirators on the EU market, the manufacturer (or EU Authorised Representative) must: (1) Affix the CE marking to the product (and its packaging) — the CE mark must be followed by the four-digit identification number of the Notified Body responsible for Module C2 or D production surveillance; (2) Draw up an EU Declaration of Conformity (DoC) — a document listing the product, the applicable EU legislation, the harmonised standards applied (EN 149:2001+A1:2009), the Notified Body's name and certificate number, and the signatory; (3) Appoint an EU Authorised Representative — a legal or natural person established in the EU who acts on behalf of the manufacturer for regulatory correspondence, DoC retention (minimum 10 years), and market surveillance authority contact. The Notified Body identification number (e.g., 0194 for BSI, 0086 for TÜV SÜD) must appear on the CE marking on the product.Regulation (EU) 2016/425 — PPE Regulation, Article 10 (CE marking), Article 9 (EU Declaration of Conformity), Article 5 (Obligations of manufacturers — EU Authorised Representative), Annex IX (EU Declaration of Conformity template)	Three distinct gaps must be closed: (1) CE MARKING: The CE mark with NB identification number must be physically on the product and packaging. Existing CCC or Chinese quality marks do not satisfy this. The CE mark format must comply with Regulation (EC) 765/2008. (2) EU DECLARATION OF CONFORMITY: A formal DoC per Annex IX of PPE Reg 2016/425 must be created, signed by the manufacturer or Authorised Representative, and must list the Notified Body's name, address, and certificate number. (3) EU AUTHORISED REPRESENTATIVE: A legal entity established within an EU member state must be appointed in writing. The representative's details must appear in the DoC. Chinese manufacturers commonly lack this — engaging a commercial EU Authorised Representative service is required before first shipment.[INFORMATIONAL] All three elements — CE marking (with NB number), EU Declaration of Conformity (per Annex IX), and EU Authorised Representative — are mandatory before any FFP respirator is placed on the EU market. These are distinct from the technical testing requirements and must be completed even after the Notified Body certificate is obtained. Chinese CCC marks, NMPA marks, and Chinese quality certificates do not substitute for any of these requirements.	EUR-Lex / Official Journal of the European Union2026-06-12 · unverified
Filtering Facepiece Respirator Safety — EN 149 FFP Performance Requirements	China's primary standard for non-powered air-purifying particle respirators is GB 2626-2019 (Respiratory protective equipment — Non-powered air-purifying particle respirator), with two performance classes: KN90 and KN95. GB 2626-2019 is a mandatory national standard (GB, not GB/T) enforced by SAMR. KN95 requires ≥95% filtration efficiency against NaCl particles at 85 L/min flow rate. Key differences from EN 149: GB 2626 uses sodium chloride (NaCl) aerosol only (EN 149 uses both NaCl and paraffin oil), does not require the practical performance test (simulated workplace test), and lacks the dolomite clogging resistance test. Testing by a Chinese CNAS-accredited lab to GB 2626 is not recognised under the EU PPE conformity assessment pathway.GB 2626-2019 — Respiratory protective equipment — Non-powered air-purifying particle respirator (mandatory national standard, SAMR) GB/T 32610-2016 — Technical specification of daily protective mask (voluntary, for general public use — not industrial PPE)	Filtering facepiece respirators (FFP) placed on the EU market as PPE must meet the Essential Health and Safety Requirements (EHSRs) of Regulation (EU) 2016/425 (PPE Regulation), Annex II. The harmonised standard EN 149:2001+A1:2009 specifies three performance classes: FFP1 (≥80% total inward leakage filter penetration), FFP2 (≥94% filtration, ≤8% total inward leakage), and FFP3 (≥99% filtration, ≤2% total inward leakage). Requirements cover filtration efficiency (against liquid and solid aerosols), breathing resistance (inhalation and exhalation), CO₂ content of inhaled air, practical performance tests (simulated workplace performance), dolomite clogging resistance, and flammability. Respirators may be marketed as 'without maintenance' (NR) or 'reusable' (R) and with or without exhalation valve (D = dolomite-clogged variant).Regulation (EU) 2016/425 — PPE Regulation, Annex II (Essential Health and Safety Requirements) EN 149:2001+A1:2009 — Respiratory protective devices — Filtering half masks to protect against particles — Requirements, testing, marking (harmonised standard under PPE Reg)	Exporters must obtain EN 149:2001+A1:2009 testing from an EU-recognised Notified Body laboratory. GB 2626-2019 (KN95) test reports do NOT satisfy EN 149 requirements because: (1) EN 149 requires paraffin oil aerosol testing in addition to NaCl; (2) EN 149 requires a simulated workplace performance test (total inward leakage on human subjects); (3) EN 149 requires dolomite clogging test for valve masks. Filtration efficiency thresholds differ numerically (KN95 = 95% NaCl only; FFP2 = 94% both aerosols + total inward leakage limit). A complete re-test to EN 149 by a Notified Body is required — partial bridging from GB 2626 is not accepted.[INFORMATIONAL] FFP respirators are Category III PPE under Regulation (EU) 2016/425. CE marking is mandatory and requires EU type-examination (Module B) by a Notified Body plus production conformity assurance (Module C2 or D). EN 149:2001+A1:2009 is the applicable harmonised standard. Chinese GB 2626-2019 (KN95) certification does not satisfy EU requirements — full re-testing by a Notified Body is required, including the paraffin oil aerosol test and simulated workplace performance test absent from GB 2626.	EUR-Lex / Official Journal of the European Union2026-06-12 · unverified
Medical-Protective Respirator Safety — GB 19083 (China Only — Not a PPE Route)	GB 19083-2010 (Technical requirements for medical protective mask) requires ≥95% filtration efficiency (NaCl aerosol), bacterial filtration efficiency, surface moisture resistance, and pressure differential testing. It is enforced by NMPA (National Medical Products Administration) as a medical device in China. Products certified under GB 19083 in China are regulated as medical devices domestically, not as industrial PPE under GB 2626. The EU equivalent route would require BOTH PPE Regulation (EU) 2016/425 (EN 149 type-exam by NB) AND Medical Device Regulation (EU) 2017/745 conformity — a dual-certification pathway.GB 19083-2010 — Technical requirements for medical protective mask (NMPA, medical device classification)	This row addresses the Chinese medical-protective respirator standard (GB 19083) for completeness. In the EU, medical-protective respirators that serve both a PPE function (particle filtration) and a medical device function (splash protection, sterility) fall under a dual-regulation overlap: Regulation (EU) 2016/425 (PPE) AND Regulation (EU) 2017/745 (MDR). However, the FFP respirator route covered in this comparison is the PPE-only route under EN 149. See the scope fragment (ppeeu-scope) for the critical PPE-vs-medical device boundary.GB 19083-2010 — Technical requirements for medical protective mask (China, mandatory, SAMR/NMPA) Regulation (EU) 2016/425 (PPE) and Regulation (EU) 2017/745 (MDR) — dual overlap for medical-protective respirators in the EU	GB 19083 certification is for China's domestic medical device market and has no direct EU equivalent recognition. Exporting a GB 19083-certified respirator to the EU as a PPE still requires full EN 149 type-examination by an EU Notified Body. If the product also claims medical device functionality (e.g., surgical use, sterile), it additionally requires MDR (EU) 2017/745 conformity. The dual-regulation pathway is significantly more burdensome than the PPE-only (EN 149 + PPE Reg) path.[INFORMATIONAL] GB 19083 (Chinese medical-protective mask) certification is not recognised under EU PPE or MDR pathways. Exporters must choose the correct EU route: PPE-only (EN 149 + PPE Reg) or dual PPE+MDR if medical device claims are made. See the scope fragment for the surgical mask / FFP boundary which determines which regulation applies.	EUR-Lex / Official Journal of the European Union2026-06-12 · unverified
CRITICAL BOUNDARY: PPE Respirator vs. Medical Device — Which EU Regulation Applies?	China uses a three-track classification system for respiratory masks: (1) INDUSTRIAL / NON-MEDICAL: GB 2626-2019 (KN90/KN95) — particle respirators for occupational use, mandatory CCC, administered by SAMR; (2) MEDICAL-PROTECTIVE: GB 19083-2010 (≥95% filtration, medical-grade) — for use in highly infectious environments (e.g., SARS, COVID wards), administered by NMPA as Class II medical device; (3) SURGICAL MASK: YY 0469-2011 (Medical surgical mask — Technical requirements) — for surgical use, bacterial filtration efficiency ≥95%, NMPA Class II medical device. The Chinese three-track system partially maps to the EU two-regulation system, but the mapping is not 1:1. Notably: KN95 (GB 2626) ≠ FFP2 (EN 149) because test methods differ; and China's YY 0469 surgical masks map to EU EN 14683 (MDR), not to PPE Reg 2016/425.GB 2626-2019 — Non-powered air-purifying particle respirator (KN90/KN95) — SAMR/CCC GB 19083-2010 — Technical requirements for medical protective mask — NMPA Class II YY 0469-2011 — Medical surgical mask — Technical requirements — NMPA Class II GB/T 32610-2016 — Technical specification of daily protective mask (voluntary, general public — not industrial or medical)	The PPE-vs-medical device boundary is one of the most commercially significant classification decisions for respiratory protection products entering the EU market. The determining factor is the INTENDED PURPOSE declared by the manufacturer: (A) FFP RESPIRATORS (PPE ROUTE): Products intended to protect the WEARER against airborne particles, aerosols, or hazardous environments (occupational safety, industrial, emergency use). Route: Regulation (EU) 2016/425 (PPE Regulation), Category III, harmonised standard EN 149:2001+A1:2009. Notified Body (PPE) required. (B) SURGICAL / MEDICAL MASKS (MEDICAL DEVICE ROUTE): Products intended to protect the PATIENT or ENVIRONMENT from the wearer's respiratory emissions (infection control, surgical use). Route: Regulation (EU) 2017/745 (Medical Device Regulation, MDR), typically Class I (sterile) or Class I (non-sterile with measuring function). Harmonised standard EN 14683:2019+AC:2019 (Medical face masks — Requirements and test methods). No NB required for non-sterile surgical masks (self-declaration, DoC). (C) DUAL-PURPOSE PRODUCTS: A product claiming BOTH wearer protection (PPE) AND patient/environment protection (medical device) must comply with BOTH Regulation (EU) 2016/425 AND Regulation (EU) 2017/745. This dual-regulation path is significantly more burdensome. The COMMISSION RECOMMENDATION (EU) 2020/403 issued during COVID-19 provided temporary flexibility — this is no longer in force for routine market access.Regulation (EU) 2016/425 — PPE Regulation (respirators protecting the wearer: EN 149 FFP route) Regulation (EU) 2017/745 — Medical Device Regulation (MDR) (surgical masks protecting patients/environment: EN 14683 route) EN 149:2001+A1:2009 — Filtering half masks to protect against particles (PPE harmonised standard) EN 14683:2019+AC:2019 — Medical face masks — Requirements and test methods (MDR harmonised standard)	The single most important classification decision is: what does the product label and instructions claim? (1) If the product claims WEARER PROTECTION against particles/aerosols (worker safety, industrial, emergency): → PPE Regulation (EU) 2016/425 applies → EN 149 type-exam by Notified Body (PPE) required. (2) If the product claims PATIENT/ENVIRONMENT PROTECTION from the wearer's emissions (surgical, infection control): → MDR (EU) 2017/745 applies → EN 14683 self-declaration (for non-sterile, non-measuring Class I) or NB involvement (for sterile Class Is or IIa/IIb). (3) If the product claims BOTH: → Both regulations apply. COMMON EXPORT MISTAKE: Chinese manufacturers label KN95 (GB 2626) masks with 'surgical' or 'medical' language to target multiple markets. In the EU, adding surgical/medical claims triggers MDR 2017/745 in addition to PPE 2016/425. Market surveillance authorities (MSAs) regularly detect and recall dual-claimed products that lack MDR conformity.[INFORMATIONAL — CRITICAL BOUNDARY] Surgical masks certified under EN 14683 (EU) are MEDICAL DEVICES under MDR (EU) 2017/745, NOT PPE under Regulation (EU) 2016/425. FFP respirators (EN 149) are PPE — a completely different regulatory route. The two routes must not be mixed. Products claiming both functions require dual conformity. Chinese KN95 (GB 2626) respirators exported to the EU must follow the PPE (EN 149 + PPE Reg) route — adding 'surgical' or 'medical' labelling triggers additional MDR requirements that are frequently absent, causing market surveillance withdrawals.	EUR-Lex / Official Journal of the European Union2026-06-12 · unverified

INFORMATIONAL ONLY

Informational only / not a certification conclusion

AI-compiled, not human-verified. This comparison is generated and cross-checked by multiple AI models from public official sources; it has not been reviewed by a named human expert and may contain errors or out-of-date items. Confirm every requirement directly with the official regulator or standards body and a qualified professional before relying on it. Nothing here is legal, certification, customs, or market-access advice.

This page is an informational comparison aid, not a certification decision, legal opinion, notified-body assessment, customs determination, or market-access approval. Exporters, importers, and distributors should verify current EU law, harmonised standards, notified body scope, and destination-country market surveillance practice with qualified regulatory professionals before shipment or placing products on the market. The PPE-vs-medical device boundary described herein requires case-by-case legal and regulatory analysis.

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EUR-Lex / Official Journal of the European Union · accessed 2026-06-12 · unverified · used in 5 rows
EUR-Lex / Official Journal of the European Union · accessed 2026-06-12 · unverified · used in 1 rows