CROSS-STANDARD public interest · Cosmetics & personal care
China-to-EU Cosmetics 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 cosmetics compliance under CSAR 2021 and NMPA requirements against EU Regulation (EC) No 1223/2009, covering the Responsible Person, CPNP notification, safety reports, prohibited and restricted substances, positive lists, GMP, nanomaterials, labelling, and claims requirements.
Dataset 2026-06-11
Last verified 2026-06-12
13 rows
GAP MATRIX
Compliance Gap Matrix
| Compliance item | Common China baseline | European Union (Reg 1223/2009) | Gap / action | Source + verification date |
|---|---|---|---|---|
| Good Manufacturing Practice — ISO 22716:2007 (Art 8) | Under CSAR 2021 and the NMPA Cosmetic Production Quality Management Regulations (化妆品生产质量管理规范), manufacturers of cosmetics for the Chinese market must comply with GMP requirements administered by NMPA and provincial drug regulatory authorities. China's GMP framework for cosmetics aligns at a high level with ISO 22716 in terms of structure (personnel, facilities, production, quality control, records) but specific documentation requirements, facility inspection protocols, and audit trail expectations differ. GB/T 27417:2017 (Conformity assessment — Guidelines for the use of management system standards in conformity assessment) provides broader guidance. A Chinese cosmetics production licence (化妆品生产许可证) is issued after factory GMP inspection by provincial authorities.CSAR 2021, Chapter 4 — Production quality management requirements NMPA Cosmetic Production Quality Management Regulations (化妆品生产质量管理规范, effective June 2022) Chinese Cosmetics Production Licence (化妆品生产许可证) — issued by provincial drug regulatory authorities after GMP factory inspection |
Article 8 of Regulation (EC) No 1223/2009 requires that cosmetics be manufactured in compliance with Good Manufacturing Practice (GMP). Compliance with EN ISO 22716:2007 (Cosmetics — Good Manufacturing Practices — Guidelines on Good Manufacturing Practices) is voluntary, but it is the harmonised standard route that provides a presumption of conformity with the Article 8 GMP obligation; other documented GMP approaches may be used if they demonstrate compliance with the Regulation. EN ISO 22716:2007 covers personnel, premises, equipment, raw materials, packaging materials, production processes, finished products, quality control, storage, subcontracting, deviations, complaints, and recalls. GMP compliance must be documented and verifiable; the GMP documentation forms part of the Product Information File.Regulation (EC) No 1223/2009, Article 8 — Good manufacturing practice EN ISO 22716:2007 — Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices (harmonised standard for Art 8 presumption of conformity) |
Chinese manufacturers holding a Chinese cosmetics production licence and complying with NMPA GMP regulations are not automatically recognised as meeting the EU Article 8 GMP obligation. EN ISO 22716:2007 is a voluntary harmonised standard that gives a presumption of conformity, not the sole mandatory route. The EU RP is legally responsible for ensuring GMP compliance of the manufacturer and must be able to demonstrate this to EU competent authorities on request. In practice, the RP may rely on EN ISO 22716-aligned evidence or another documented GMP system that adequately demonstrates compliance. GMP compliance evidence (audit reports, quality system documentation) must be included in the Product Information File. EU distributors importing from non-EU manufacturers bear responsibility for verifying GMP.[INFORMATIONAL] Article 8 GMP compliance is mandatory for cosmetics placed on the EU market, but EN ISO 22716:2007 is a voluntary harmonised standard that gives a presumption of conformity rather than the only accepted route. Chinese manufacturers complying with NMPA GMP and holding a Chinese production licence are not automatically recognised as meeting the EU Article 8 obligation. The EU RP must ensure and document GMP compliance through EN ISO 22716-aligned evidence or another defensible documented GMP approach. | EUR-Lex / Official Journal of the European Union2026-06-12 · unverified |
| Nanomaterial Notification and Safety Assessment — Special Obligation (Art 16) | China's CSAR 2021 and NMPA regulations include provisions for new cosmetic ingredients with safety risks, which may capture some nanomaterials. NMPA has issued guidance on cosmetic ingredient safety assessment that addresses particle size considerations. However, China does not have a dedicated nanomaterial notification track equivalent to EU Article 16 with a 6-month pre-notification period and a mandatory '(nano)' label suffix requirement. Nanomaterial regulation in Chinese cosmetics is evolving and is addressed through the new ingredient registration/filing pathway for novel ingredients.CSAR 2021, Articles 11–12 — New cosmetic ingredient registration requirements (captures some nanomaterials as novel ingredients) NMPA Technical Guidelines for Cosmetic Safety Assessment (2021) — particle size and nanomaterial safety considerations |
Where a cosmetic product contains nanomaterials (other than those covered as colorants, UV filters, or preservatives in Annexes IV–VI with nano-specific entries), Article 16 of Regulation (EC) No 1223/2009 requires the Responsible Person to notify the European Commission through the CPNP six months before placing such products on the EU market. The notification must include nano-specific safety data. Nanomaterials must also be listed on the ingredient label with the suffix '(nano)' after the INCI name. 'Nanomaterial' in EU cosmetics law means an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions or internal structure on the scale of 1 to 100 nm.Regulation (EC) No 1223/2009, Article 16 — Nanomaterials Regulation (EC) No 1223/2009, Article 19(1)(g) — Labelling: nanomaterials must be listed with '(nano)' suffix |
Exporters whose products contain nanomaterials (e.g., nano titanium dioxide or nano zinc oxide in sunscreens, nano silica, nano silver) face a mandatory 6-month pre-notification period before EU market entry — a timeline gap that must be factored into export planning. The '(nano)' suffix in the EU INCI label list is a labelling change required for all nano-ingredient products. Chinese manufacturers should assess whether any ingredient in their formulation qualifies as a nanomaterial under the EU definition and flag it for the RP for the Article 16 notification process. This is an additional process distinct from the standard CPNP notification under Art 13.[INFORMATIONAL] Cosmetic products containing nanomaterials (beyond those covered by Annex IV–VI nano entries) require a separate 6-month pre-market notification under Art 16, in addition to the standard Art 13 CPNP notification. The '(nano)' label suffix is mandatory. Exporters should audit all ingredients for nanomaterial status before export planning, as the 6-month window must be factored into the market entry timeline. | EUR-Lex / Official Journal of the European Union2026-06-12 · unverified |
| INCI Ingredient Listing — Mandatory Full Disclosure (Art 19) | China's labelling standard GB 5296.3-2008 (Instructions for use of consumer products — Cosmetics) requires ingredient listing on cosmetic labels. China also uses the INCI naming system for ingredients (aligned via NMPA ingredient catalogue), and ingredients must be listed in descending order of mass, with those at or below 1% listed after higher-concentration ingredients. The INCI label requirement is broadly similar between CN and EU, but key differences exist in: which ingredients are exempt from disclosure (e.g., trade secret applications differ), the language requirement (CN requires Chinese-language labels), and specific formatting requirements.GB 5296.3-2008 — Instructions for use of consumer products — Cosmetics (SAC/NMPA — ingredient listing and general labelling) CSAR 2021, Article 35 — Cosmetic labelling obligations |
Article 19(1)(g) of Regulation (EC) No 1223/2009 requires that all cosmetic products display a list of ingredients on the label using the International Nomenclature of Cosmetic Ingredients (INCI) system. Ingredients must be listed in descending order of weight at the time of incorporation, except that ingredients present at concentrations of 1% or less may be listed in any order after ingredients present at more than 1%. The ingredient list must be preceded by the word 'Ingredients'. Perfume and aromatic compositions are listed under 'Parfum' or 'Aroma'. Nanomaterials must be followed by '(nano)' in the list. Colorants may be listed in any order after other ingredients.Regulation (EC) No 1223/2009, Article 19(1)(g) — Ingredient listing requirement Commission Decision 2006/257/EC — INCI nomenclature (now incorporated into Reg 1223/2009 framework) |
While both CN and EU require INCI ingredient listing, EU Reg 1223/2009 requires the label to be in the official language(s) of the EU member state where the product is sold — the 'Ingredients' heading and all other required label text (name and address of RP, nominal content, date of minimum durability, precautions, batch reference, function) must be in the local language. Chinese-language labels used for CN market sale are not acceptable for EU market sale. Exporters must prepare separate EU-market labels in the relevant EU language(s) including: (1) the EU RP's name and address; (2) the function of the product (if not clear from presentation); (3) precautions for use and special warnings; (4) PAO or minimum durability date; (5) the INCI ingredient list with '(nano)' where applicable.[INFORMATIONAL] INCI ingredient listing is mandatory on EU cosmetic labels and must appear in the official language(s) of the EU member state where the product is sold. Chinese-market labels are not acceptable for the EU. Exporters must prepare EU-market-specific labels including the EU RP's name and address, PAO or durability date, precautions, and full INCI list with '(nano)' suffixes as applicable. | EUR-Lex / Official Journal of the European Union2026-06-12 · unverified |
| Period After Opening (PAO) Symbol and Minimum Durability Date (Art 19) | China's GB 5296.3-2008 and CSAR 2021 require cosmetic labels to state the date of production and the shelf life (保质期) — typically expressed as a date or as a period from the date of manufacture (e.g., 'shelf life: 3 years'). CN regulations do not require the PAO symbol (open jar graphic) or distinguish between products with durability above/below 30 months in the same way as EU Reg 1223/2009. The PAO concept (post-opening safe use period) is not a mandatory labelling element under Chinese regulations, though some manufacturers voluntarily include it.GB 5296.3-2008 — Instructions for use of consumer products — Cosmetics (shelf life labelling, Section 5.1.7) CSAR 2021, Article 35(1)(iii) — Date of production and shelf life labelling requirement |
Article 19(1)(c) of Regulation (EC) No 1223/2009 sets two mutually exclusive durability labelling requirements: (1) If the minimum durability of a cosmetic product is more than 30 months, the label must display the Period After Opening (PAO) symbol — an open jar graphic — followed by the time (in months or years) during which the product can be used after opening without harm to the consumer. (2) If the minimum durability is 30 months or less, the label must display the minimum durability date preceded by the hourglass symbol or the words 'Best used before end of:'. Products that are not subject to deterioration over time (e.g., certain waterproof products where contamination is not an issue) may be exempt from durability marking but this is narrowly defined.Regulation (EC) No 1223/2009, Article 19(1)(c) — PAO and minimum durability date labelling Regulation (EC) No 1223/2009, Annex VII — PAO symbol (open jar graphic definition) |
For cosmetics with minimum durability exceeding 30 months (which covers most shampoos, conditioners, body lotions, and many skincare products), Chinese export labels must add the PAO symbol (open jar icon as defined in Annex VII) with the post-opening use period established through stability testing. Chinese labels showing only a 'shelf life: 3 years' statement and a production date do not satisfy the EU PAO requirement. For products with durability of 30 months or less (some sunscreens, eye products with shorter stability), a minimum durability date must be explicitly stated in a format compliant with EU requirements. The PAO period should be substantiated by stability and challenge testing, results of which must be in the Product Information File.[INFORMATIONAL] The PAO symbol (for products with durability over 30 months) or minimum durability date (for products with 30 months or less) is mandatory on EU cosmetic labels. Chinese shelf life labelling using production date plus shelf period does not satisfy the EU requirement. Exporters must establish PAO periods through stability testing and include the PAO symbol on EU-market labels. | EUR-Lex / Official Journal of the European Union2026-06-12 · unverified |
| Cosmetic Claims — EU Regulation 655/2013 (6 Common Criteria) | China's CSAR 2021 and the NMPA Administrative Measures for Cosmetic Labelling (化妆品标签管理办法, 2021) regulate cosmetic claims. Under CN law, cosmetic claims must not be false or misleading, must not claim medical effects (a fundamental boundary between cosmetics and drugs in China), must be within the approved scope of the product category, and must not denigrate competitors. Special claims (e.g., anti-acne, whitening, SPF) require substantiation through NMPA registration for special-use cosmetic categories. General advertising regulations administered by the State Administration for Market Regulation (SAMR) also apply. CN claims regulation addresses similar concerns to EU 655/2013 but differs in evidentiary standards, specific prohibited/permitted claim types, and the category-specific substantiation requirements.CSAR 2021, Articles 36–37 — Cosmetic labelling and claims requirements NMPA Administrative Measures for Cosmetic Labelling (化妆品标签管理办法, effective 1 May 2022) |
Commission Regulation (EU) No 655/2013 establishes common criteria for claims used in relation to cosmetic products, supplementing the general prohibition on misleading claims in Reg (EC) No 1223/2009, Art 20. The six common criteria are: (1) Legal compliance — claims must not imply characteristics the product does not possess or suggest superiority not supported by evidence; (2) Truthfulness — claims must not attribute to the product effects it does not have; (3) Evidential support — claims must be supported by adequate and verifiable evidence; (4) Honesty — claims must not use results from in vitro or in vivo studies in a misleading way; (5) Fairness — claims must not denigrate competitors; (6) Informed decision-making — claims must be clear and understandable to the average user. The European Commission has also published technical documents on specific claim categories (e.g., hypoallergenic, natural, organic, anti-ageing).Commission Regulation (EU) No 655/2013 of 10 July 2013 — Common criteria for the justification of claims used in relation to cosmetic products Regulation (EC) No 1223/2009, Article 20 — Claims |
Chinese cosmetics exporters must review all claims (on pack, in accompanying literature, on websites directed at EU consumers) against EU Reg 655/2013's six common criteria. Key areas requiring attention: (1) Efficacy claims (anti-ageing, whitening, firming) must be supported by EU-acceptable evidence — consumer perception studies may be insufficient if not conducted to EU scientific standards; (2) 'Natural' and 'organic' claims have specific EU technical document guidance and must not be used loosely; (3) Claims based on NMPA registration category (e.g., '祛痘' — anti-acne) do not automatically satisfy EU evidential support criteria; (4) SPF and UVA protection claims need robust, EU-acceptable substantiation, and ISO 24444 / ISO 24443 are commonly used voluntary test-method standards rather than mandatory legal routes. Claims substantiation documents must be included in the Product Information File.[INFORMATIONAL] All cosmetic claims for EU market products must satisfy the six common criteria of Commission Regulation (EU) No 655/2013. Substantiation documents for every claim must be included in the Product Information File. Claims that rely on NMPA registration category approval or CN consumer studies not conducted to EU scientific standards may require additional substantiation or revision before EU market use. | EUR-Lex / Official Journal of the European Union2026-06-12 · unverified |
| Responsible Person — Mandatory EU-Established Entity (Art 4) | China's Cosmetics Supervision and Administration Regulation (CSAR 2021, State Council Order No. 727) requires registration or filing with NMPA before placing cosmetics on the Chinese market. For imported cosmetics, the importer or agent in China acts as the registrant/filer and bears compliance responsibility — a functional analogue to the EU RP concept, but the role is tied to NMPA registration rather than a standing legal designation. There is no direct 'Responsible Person' title in Chinese law; the NMPA registrant bears equivalent obligations.Cosmetics Supervision and Administration Regulation (CSAR 2021), Articles 11–17 — Registration and filing obligations for imported cosmetics (State Council Order No. 727, effective 1 January 2021) | Every cosmetic product placed on the EU market must have a Responsible Person (RP) established within the EU. The RP is legally accountable for compliance with Regulation (EC) No 1223/2009 and must be a natural or legal person established in the EU. The RP may be the manufacturer (if established in the EU), the importer (where the manufacturer is established outside the EU), or a designated distributor established in the EU who takes on the RP role by written mandate. The RP's name and address must appear on the product label.Regulation (EC) No 1223/2009, Article 4 — Responsible Person Regulation (EC) No 1223/2009, Article 19(1)(a) — Labelling: name and address of RP |
Chinese cosmetics manufacturers exporting to the EU have no EU-established entity by default and must appoint a Responsible Person before any product is placed on the EU market. This typically requires either establishing a legal entity in the EU, contracting with an EU-based importer willing to take on RP liability, or engaging a specialist RP service provider. The RP's name and EU address must appear on every product label — a labelling change required for all products. Failure to have an RP before market placement is a fundamental breach of Reg 1223/2009.[INFORMATIONAL] A Responsible Person established in the EU is a non-negotiable prerequisite for EU market entry under Reg (EC) No 1223/2009. Chinese manufacturers must appoint an EU RP before shipment — the Chinese NMPA registrant role does not satisfy this requirement. The RP's name and EU address must also appear on every product label. | EUR-Lex / Official Journal of the European Union2026-06-12 · unverified |
| CPNP Notification — Pre-Market Mandatory Submission (Art 13) | Under CSAR 2021, special-use cosmetics (hair dyes, sunscreens, freckle removal, anti-hair loss, anti-acne, deodorant, hair-perm products, and new ingredients with safety risks) require NMPA registration before market entry — a pre-market review process that may take 6–12 months. General cosmetics require a filing (备案) with NMPA, which is faster (typically 2–4 weeks online). Unlike CPNP, NMPA registration for special cosmetics involves substantive technical review. The NMPA system is not linked to or recognised by the EU CPNP.CSAR 2021, Articles 11–17 — Registration (special cosmetics) and filing (general cosmetics) requirements (State Council Order No. 727) | Before placing a cosmetic product on the EU market, the Responsible Person must submit a notification through the Cosmetic Products Notification Portal (CPNP), the EU's centralised electronic notification system managed by the European Commission. The notification must include: product category and name, the frame formulation or full list of ingredients (including INCI names, CAS numbers, and concentrations), the Product Information File (PIF) location, countries of intended sale, nanomaterial information if applicable, and the RP's contact details. CPNP notification is free of charge but must be complete before first market placement.Regulation (EC) No 1223/2009, Article 13 — Notification Commission Regulation (EU) No 655/2013 (cosmetics claims — relevant for product categorisation in CPNP) |
EU CPNP notification is separate from and additional to any NMPA registration. An RP must be in place to submit the CPNP notification, as the portal requires an EU legal entity account. The CPNP notification must reflect the exact formulation to be sold in the EU — a reformulated or relabelled product for the EU market requires a fresh CPNP notification. Chinese exporters typically have no prior CPNP account or process, and the RP service provider will often handle CPNP submission on their behalf.[INFORMATIONAL] CPNP notification is a mandatory pre-market step for all cosmetics in the EU, distinct from any Chinese NMPA filing. The notification is submitted by the EU Responsible Person. Chinese exporters must have an EU RP in place and complete CPNP submission for each product before the first EU sale or import. | European Commission — Internal Market, Industry, Entrepreneurship and SMEs2026-06-12 · unverified |
| Animal Testing Ban — Finished Products and Ingredients (Art 18) | China has historically required animal testing for imported cosmetics under the former Cosmetics Hygiene Regulations. Under CSAR 2021 and NMPA Order No. 13 (2021), China began allowing alternatives: general cosmetics produced in China no longer require animal testing for domestic market; imported general cosmetics may substitute animal tests with safety assessment reports if the manufacturer holds a quality management system certificate and the product is manufactured in a country with equivalent cosmetic safety regulation. However, as of 2024, many imported cosmetic categories, particularly 'special cosmetics' (hair dye, sunscreen, anti-acne, etc.), still require NMPA-accepted safety data that may include animal test data or data acceptable to NMPA.CSAR 2021, Article 20 and NMPA Order No. 13 (2021) — Safety assessment and animal testing exemption pathways for imported cosmetics NMPA Technical Guidelines for Cosmetic Safety Assessment (2021) |
Regulation (EC) No 1223/2009, Article 18 prohibits: (1) placing on the EU market cosmetics whose final formulation has been tested on animals; (2) placing on the EU market cosmetics containing ingredients tested on animals after the relevant marketing ban dates (most ingredient bans applied from 11 March 2013); (3) conducting animal tests within the EU for cosmetic purposes; and (4) importing cosmetics that have been animal-tested where an alternative method has been validated. There is no derogation for technical necessity or regulatory requirements in third countries.Regulation (EC) No 1223/2009, Article 18 — Animal testing Directive 2010/63/EU on the protection of animals used for scientific purposes (background framework) |
The EU's animal testing ban is absolute with no third-country derogation. Any ingredient or finished product tested on animals for cosmetic purposes after the relevant ban dates cannot legally be placed on the EU market, regardless of whether animal testing was required by the exporting country's regulations. Chinese exporters whose products contain ingredients that underwent animal testing to satisfy NMPA requirements face a direct conflict: data generated through animal testing to meet NMPA registration requirements may render the product unsaleable in the EU. Exporters should audit their ingredient safety data to confirm no post-ban animal testing has been conducted.[INFORMATIONAL] The EU ban on animal-tested cosmetics is absolute and has no third-country exemption. Chinese exporters must verify that neither the finished product nor any ingredient has been subject to animal testing for cosmetic purposes after the applicable ban dates. Products where animal testing was required for NMPA registration may face insurmountable barriers to EU market entry. | EUR-Lex / Official Journal of the European Union2026-06-12 · unverified |
| Cosmetic Product Safety Report (CPSR) — Mandatory Safety Assessment (Annex I) | Under CSAR 2021 and the NMPA Technical Guidelines for Cosmetic Safety Assessment (2021), cosmetics placed on the Chinese market must undergo safety assessment. However, the NMPA process involves review by NMPA assessors (for special-use cosmetics under registration) or a self-declaration by the registrant/filer (for general cosmetics). There is no requirement for a named independent safety assessor with specified academic credentials equivalent to the EU CPSR Part B. The NMPA safety review against China's Cosmetic Safety Technical Standards (化妆品安全技术规范) 2015 edition covers prohibited/restricted substances and microbiological limits but does not require an Annex I-equivalent structured dossier.CSAR 2021, Article 18 — Safety assessment obligations NMPA Technical Guidelines for Cosmetic Safety Assessment (2021) — assessment requirements for CN market Cosmetic Safety Technical Standards (化妆品安全技术规范) 2015 edition (NMPA) — substance and microbiological limits |
Every cosmetic product placed on the EU market must have a Cosmetic Product Safety Report (CPSR) as defined in Annex I of Regulation (EC) No 1223/2009. The CPSR has two mandatory parts: Part A (Cosmetic Product Safety Information) containing qualitative and quantitative composition, physical and chemical characteristics, microbiological quality, impurities and traces, packaging material information, normal and reasonably foreseeable use, exposure to the cosmetic product, exposure to the substances, toxicological profile of the substances, undesirable effects and serious undesirable effects, and other information; and Part B (Cosmetic Product Safety Assessment) which is the safety assessor's conclusions, labelling warnings, reasoning, and credentials. The safety assessment in Part B must be carried out by a person holding at minimum a degree in pharmacy, toxicology, medicine, or similar discipline.Regulation (EC) No 1223/2009, Article 10 — Safety assessment Regulation (EC) No 1223/2009, Annex I — Cosmetic Product Safety Report (Part A and Part B) |
The EU CPSR is a structured, two-part dossier that must be signed by a qualified safety assessor with specific academic credentials — a role that does not exist in the Chinese regulatory pathway. Chinese cosmetics manufacturers typically have safety data compiled for NMPA submission, but this data is usually not structured to satisfy Annex I of Reg 1223/2009. A qualified EU safety assessor (typically a toxicologist or pharmacologist) must review all formulation data, toxicological profiles, and exposure assessments, then prepare and sign Part B. The cost and lead time of commissioning a CPSR from an EU-qualified assessor is a significant barrier for first-time EU market entrants.[INFORMATIONAL] A CPSR prepared by a qualified safety assessor (holding at minimum a pharmacy, toxicology, or medicine degree) is mandatory for every EU cosmetic product. Chinese NMPA safety submissions do not satisfy the Annex I structure. Exporters must commission a fresh CPSR from an EU-qualified assessor, providing full formulation and toxicological data in the required format. | EUR-Lex / Official Journal of the European Union2026-06-12 · unverified |
| Product Information File (PIF) — 10-Year Retention Obligation (Art 11) | CSAR 2021 requires registrants and filers to maintain product quality files and safety data, and to cooperate with NMPA inspections. Record-keeping obligations under CSAR 2021 include production and quality records to be retained for specified periods. However, the specific structure of a PIF (as a single, access-ready dossier covering CPSR, GMP conformity, efficacy evidence, and adverse events in a prescribed format) does not have a direct equivalent in Chinese regulations. NMPA inspection documents and registration dossiers serve a similar function but differ in format, content requirements, and access protocols.CSAR 2021, Articles 25–28 — Quality management, record keeping, and inspection cooperation obligations | The Responsible Person must maintain a Product Information File (PIF) for each cosmetic product and make it available to competent authorities on request. The PIF must be kept for 10 years after the last batch of the cosmetic product is placed on the market. The PIF must be kept at the address of the RP in the EU (or the address notified to the competent authorities of the relevant member state). Required PIF content includes: the CPSR (Annex I), a description of manufacturing method and conformity with GMP, proof of effect claimed, data on animal testing, and adverse event data. The PIF must be in the language(s) of the EU member state where it is held.Regulation (EC) No 1223/2009, Article 11 — Product Information File Regulation (EC) No 1223/2009, Article 11(3) — 10-year retention period |
Exporters must compile a PIF in the format required by Reg 1223/2009, Art 11, maintained at the EU RP's address in the relevant EU language(s), and retained for 10 years after the last batch. Chinese regulatory dossiers compiled for NMPA do not satisfy the EU PIF structure. The PIF must include the CPSR (Annex I), GMP conformity declaration, efficacy substantiation data, and a log of adverse events — elements that may not be compiled in a single dossier in the exporter's current documentation system. The 10-year retention obligation starts from the last batch, which creates an ongoing compliance obligation even after a product is discontinued.[INFORMATIONAL] The PIF is a mandatory EU dossier retained for 10 years at the EU RP's address. Chinese NMPA registration dossiers do not satisfy the EU PIF requirement. Exporters must build a compliant PIF incorporating the CPSR (Annex I), GMP proof, efficacy data, and adverse event records in the required format and language. | EUR-Lex / Official Journal of the European Union2026-06-12 · unverified |
| Prohibited Substances — Annex II Negative List (~1,400 entries) | China's Cosmetic Safety Technical Standards (化妆品安全技术规范, CSTS) 2015 edition, maintained by NMPA, contains a list of prohibited substances in cosmetics (Table 1 and associated tables). The CN prohibited list covers a substantial number of substances but differs in scope, specific entries, and threshold levels from EU Annex II. Some substances prohibited in the EU are permitted or not explicitly addressed in China, and vice versa. The CSTS is updated periodically by NMPA announcements.Cosmetic Safety Technical Standards (化妆品安全技术规范) 2015 edition, Table 1 — Prohibited substances in cosmetics (NMPA) | Annex II of Regulation (EC) No 1223/2009 lists substances prohibited in cosmetic products. The list contains approximately 1,400 entries including specific substances and substance categories (e.g., carcinogenic, mutagenic, or reprotoxic — CMR — substances of category 1A and 1B under CLP Regulation (EC) No 1272/2008 are prohibited by default under Art 15, subject to exceptions where safe use is demonstrated to the SCCS). The Responsible Person must ensure no cosmetic product contains a substance listed in Annex II, including substances that appear only as impurities, traces, or decomposition products in concentrations above technically unavoidable limits.Regulation (EC) No 1223/2009, Article 14 and Annex II — Prohibited substances Regulation (EC) No 1223/2009, Article 15 — CMR substances (default prohibition of CLP 1A/1B CMR substances) |
Chinese exporters must screen all formulation ingredients against EU Annex II, not just the Chinese CSTS prohibited list. The lists are not identical — a substance permitted or not addressed in China may be prohibited in the EU. This requires ingredient-by-ingredient verification against the current Annex II (which is updated by Commission Delegated Regulations). Additionally, impurities and trace contaminants must also be assessed against Annex II, including unintended decomposition products. A qualified formulation chemist or toxicologist should conduct the screen using the current consolidated Annex II text.[INFORMATIONAL] All cosmetic formulations must be screened against the current EU Annex II prohibited substances list before EU market entry. Chinese CSTS compliance does not ensure EU Annex II compliance — the lists differ. Exporters should engage a qualified formulation toxicologist to conduct a full Annex II screen including trace impurities and decomposition products. | EUR-Lex / Official Journal of the European Union2026-06-12 · unverified |
| Restricted Substances — Annex III Conditions of Use | China's CSTS 2015 contains a list of restricted substances (Table 2 — conditional use substances) with specified maximum concentrations, applicable product types, and use restrictions. The CN restricted list covers many of the same chemical families as EU Annex III but the specific concentration limits, product-type permissions, and label warning requirements differ. For example, some preservatives (including specific parabens) are permitted at higher concentrations in China than in the EU, and the labelling warnings required by CN differ from those mandated by EU Annex III.Cosmetic Safety Technical Standards (化妆品安全技术规范) 2015 edition, Table 2 — Restricted (conditional-use) substances in cosmetics (NMPA) | Annex III of Regulation (EC) No 1223/2009 lists substances that may only be used in cosmetics under specified conditions, including maximum concentrations, product types permitted (e.g., rinse-off only), areas of application, and mandatory label warnings. The list includes, for example, specific parabens at defined maximum concentrations and product-type restrictions, hydrogen peroxide at set maximum percentages for different product categories, fluoride compounds with concentration limits, and alpha-hydroxy acids (AHAs) with pH and concentration restrictions. The Responsible Person must ensure restricted substances are only used within their Annex III permitted conditions.Regulation (EC) No 1223/2009, Article 14 and Annex III — Restricted substances: substances subject to conditions of use Commission Delegated Regulations amending Annex III (periodic updates, e.g., on parabens: Commission Regulation (EU) No 1004/2014) |
Exporters must verify that every restricted substance in their formulation is used within EU Annex III conditions — not merely within Chinese CSTS Table 2 limits. Key divergences include: (1) parabens: EU has stricter concentration caps and prohibits certain parabens (propylparaben and butylparaben) in rinse-off products for children under 3 and leave-on products on the nappy area; (2) AHAs: EU Annex III Entry 73 sets a maximum 10% concentration and a pH of 3.5 minimum with specific labelling; (3) hydrogen peroxide: EU sets specific limits per product type. Where a Chinese formulation uses a restricted substance at a concentration or in a product type not permitted under EU Annex III, reformulation is required.[INFORMATIONAL] EU Annex III conditions of use must be verified for every restricted substance in the formulation. Chinese CSTS Table 2 compliance does not guarantee EU Annex III compliance. Key areas to check include preservative concentrations, AHA concentrations and pH, and hydrogen peroxide levels by product type. Where limits diverge, reformulation may be required before EU market entry. | EUR-Lex / Official Journal of the European Union2026-06-12 · unverified |
| Positive Lists — Colorants (Annex IV), Preservatives (Annex V), UV Filters (Annex VI) | China's CSTS 2015 likewise uses positive lists for colorants (Table 5 — permitted colorants in cosmetics), preservatives (Table 4 — permitted preservatives), and UV filters (Table 6 — permitted UV filters). The Chinese lists cover many of the same substances as the EU annexes but differ in specific entries, permitted product types, maximum concentrations, and conditions of use. Some UV filters and colorants widely used in Chinese cosmetics products are not included on the EU positive lists; conversely, some EU-listed UV filters have not been approved for use in the Chinese market.Cosmetic Safety Technical Standards (化妆品安全技术规范) 2015 edition, Tables 4, 5, and 6 — Permitted preservatives, colorants, and UV filters (NMPA) | Regulation (EC) No 1223/2009 establishes three positive lists for specific ingredient categories: Annex IV (permitted colorants — only listed colorants may be used, with specific conditions on product type, e.g., 'rinse-off only', and maximum concentrations); Annex V (permitted preservatives — only listed preservatives may be used, with maximum concentrations and other conditions); and Annex VI (permitted UV filters — only listed UV filters may be used in cosmetics intended for sun protection or UV absorption, with maximum concentrations). An ingredient that falls into one of these three functional categories but does not appear on the relevant positive list may not be used in EU cosmetics regardless of its safety profile.Regulation (EC) No 1223/2009, Article 14 and Annex IV — Permitted colorants Regulation (EC) No 1223/2009, Article 14 and Annex V — Permitted preservatives Regulation (EC) No 1223/2009, Article 14 and Annex VI — Permitted UV filters |
Exporters must verify every colorant, preservative, and UV filter in their formulation against the relevant EU positive list (Annexes IV, V, VI respectively). Any ingredient in these categories not on the EU positive list must be removed or substituted before EU market entry — regardless of whether it appears on the Chinese positive list. Particular attention should be paid to: (1) UV filters — several UV filters used in Chinese sunscreen formulations (e.g., some benzophenone derivatives and newer organic filters) are not on the EU Annex VI list, requiring reformulation for sunscreens; (2) preservatives — concentration limits for overlapping substances may differ; (3) colorants — hair dye colorants and cosmetic colorants have separate regulatory pathways in both systems; hair dyes in particular require careful mapping.[INFORMATIONAL] EU Annexes IV, V, and VI are closed positive lists — only listed colorants, preservatives, and UV filters may be used for those functions in EU cosmetics. Chinese formulations using colorants, preservatives, or UV filters not on the EU positive lists require reformulation before EU market entry. Sunscreen products are particularly affected due to divergent UV filter approval lists. | EUR-Lex / Official Journal of the European Union2026-06-12 · unverified |
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