Regulations & Compliance

Comprehensive guide to EU Cosmetics Regulation 1223/2009, CPNP notification requirements, REACH directives, and global market-specific compliance frameworks

Regulatory Compliance Determines Market Access

Understanding regulatory frameworks is not optional for dermocosmetics localization—it’s foundational infrastructure. EU Regulation 1223/2009 establishes the compliance baseline for European markets, CPNP notification enables product placement, REACH directives govern ingredient restrictions, and market-specific frameworks (FDA, NMPA, MHLW) require adapted approaches. Localization teams translating regulatory documentation without regulatory literacy create the submission failures they’re trying to prevent. This resource provides the regulatory foundation essential for compliance-ready localization.

EU Cosmetics Regulation (EC) No 1223/2009

Regulatory Framework Overview

Regulation (EC) No 1223/2009 on cosmetic products establishes the legal framework for manufacturing, labeling, and marketing cosmetic products within the European Union. Effective since July 11, 2013, this regulation replaced the Cosmetics Directive 76/768/EEC and harmonizes cosmetic product requirements across all EU member states.

Scope: The regulation applies to any substance or mixture intended to be placed in contact with external parts of the human body (epidermis, hair system, nails, lips, external genital organs) or teeth and mucous membranes with a view exclusively or mainly to cleaning, perfuming, changing appearance, protecting, keeping in good condition, or correcting body odors.

Key Articles for Localization Teams

Article 4

Responsible Person

Designates the entity responsible for ensuring cosmetic product compliance. Must be established within EU. Critical for CPNP notifications and product accountability.

Article 10

Product Information File

Requires comprehensive documentation including formulation, safety assessment, manufacturing method, efficacy claims proof, and animal testing data. Core localization requirement.

Article 13

Notification (CPNP)

Mandates notification to Cosmetic Products Notification Portal before product placement on market. Includes product data, category, label, formula framework.

Article 15

Undesirable Effects

Establishes serious undesirable effect reporting system. Responsible person must report to competent authorities within 15 days of knowledge.

Article 19

Labeling Requirements

Specifies mandatory label information: name/address of responsible person, nominal content, date of minimum durability, precautions, batch number, function, ingredient list.

Article 20

Claims

Establishes that product claims must be substantiated, comply with common criteria (Regulation 655/2013), and not mislead consumers. Substantiation must be held at authorities’ disposal.

The Annexes: Substance Classifications

Regulation 1223/2009 uses six Annexes to classify substances by regulatory status. Understanding Annex classifications is essential for ingredient localization accuracy.

Annex	Description
ANNEX II Prohibited Substances	List of substances prohibited in cosmetic products. Over 1,600 substances including carcinogens, mutagens, reproductive toxicants, and substances with unacceptable safety profiles. Examples: Asbestos, Formaldehyde (above permitted concentrations), Lead acetate, Mercury compounds, Retinoic acid (Tretinoin), Hormones, Antibiotics (with exceptions)
ANNEX III Restricted Substances	Substances permitted under specific restrictions: maximum concentrations, product type limitations, usage conditions, and mandatory warnings. Requires precise adherence to specified parameters. Examples: Retinol (max 0.05% leave-on, 0.3% rinse-off), Hydrogen Peroxide (max 12% in hair products), Salicylic Acid (max 3% leave-on, 2% rinse-off), Alpha Hydroxy Acids with usage warnings
ANNEX IV Allowed Colorants	Positive list of permitted colorants with Color Index (CI) numbers, product type restrictions, and purity criteria. Any colorant not listed in Annex IV or V is prohibited. Examples: CI77891 (Titanium Dioxide), CI 77491/77492/77499 (Iron Oxides), CI 77007 (Ultramarines), with specific usage conditions per colorant
ANNEX V Allowed Preservatives	Positive list of permitted preservatives with maximum concentrations and authorized product types. Includes antimicrobial agents preventing microbial deterioration. Examples: Phenoxyethanol (max 1%), Parabens (individual max 0.4%, total max 0.8%), Benzyl Alcohol (max 1%), Sodium Benzoate (max 0.5%)
ANNEX VI Allowed UV Filters	Positive list of UV filters (sunscreen actives) with maximum concentrations and usage restrictions. Subject to regular scientific review and updates. Examples: Titanium Dioxide (max 25%), Zinc Oxide (max 25%), Avobenzone (max 5%), Octinoxate (max 10%), with nano restrictions for certain filters
Critical Localization Requirement	Always verify regulatory status against current Annexes When translating ingredient lists, safety assessments, or formulation documentation, always verify ingredient regulatory status against current Annexes. An ingredient approved in one concentration or product type may be prohibited or restricted in others. Never assume regulatory status based on previous projects—Annexes are regularly updated.

CPNP: Cosmetic Products Notification Portal

CPNP Notification Workflow

The Cosmetic Products Notification Portal (CPNP) is the electronic notification system where responsible persons submit product information before placing cosmetic products on the EU market. Notification is mandatory and must be completed before distribution begins.

Responsible Person Registration

Register responsible person entity in CPNP system. Must be natural or legal person established within EU. One-time registration enables multiple product notifications.

Product Data Submission

Submit product information: name, category, intended use, contact details for adverse effects, original labeling (images or PDF), frame formulation or full ingredient list with concentrations.

Automated Validation

CPNP system performs automated checks: ingredient name validity, format compliance, mandatory field completion. Errors must be corrected before proceeding.

Notification Confirmation

Upon successful submission, CPNP generates notification number. Product may now be placed on market. Notification number must be recorded in Product Information File.

Updates & Maintenance

Responsible person must update notification for significant formula changes, safety assessment revisions, or label modifications. Original notification remains linked to product history.

CPNP Submission Requirements

Mandatory CPNP Information:

Responsible person name, address, email, phone
Product name (as appears on label)
Product category (selecting from CPNP taxonomy)
Country or countries where product will be marketed
Contact details for adverse effects and medical information
Original label (image or PDF showing all mandatory elements)
Frame formulation OR full ingredient list with concentration ranges
Nano materials declaration (if applicable)
CMR substances declaration (Carcinogenic/Mutagenic/Reprotoxic, if applicable)
Photo of product packaging (recommended for identification)

Frame Formulation vs. Full Ingredient List

Frame Formulation: Provides ingredient categories with maximum concentrations without revealing precise formula. Sufficient for most products. Example: “Preservatives: <2%, Fragrance: <1%”

Full Ingredient List: Complete formula with specific concentrations. Required for certain product types or when requested by poison control centers for medical emergencies.

REACH: Registration, Evaluation, Authorisation, and Restriction of Chemicals

REACH Directive Implications for Cosmetics

REACH (Regulation EC 1907/2006) governs chemical substance manufacturing, importing, and use in the European Union. While cosmetics are exempt from REACH registration requirements, cosmetic manufacturers must comply with REACH restrictions on substances of very high concern (SVHC) and authorization requirements.

Key REACH-Cosmetics Interface: When REACH restricts or prohibits a substance, those restrictions apply to cosmetic use. Cosmetic regulations (1223/2009) and REACH work in parallel—both must be consulted for comprehensive ingredient compliance.

REACH Compliance for Cosmetic Ingredients

REACH Verification Steps:

Check if ingredient appears on REACH Candidate List (Substances of Very High Concern)
Verify ingredient against REACH Annex XVII (Restrictions on substances)
Confirm ingredient not on Authorization List (Annex XIV) without proper authorization
For CMR substances (Category 1A/1B), verify exemptions or specific regulations apply
Assess nanomaterial status and REACH nano-specific requirements
Document REACH compliance in safety assessment when relevant
Monitor REACH updates for newly added restrictions affecting cosmetic ingredients

REACH-Cosmetics Conflict Resolution

When REACH restrictions conflict with Cosmetics Regulation 1223/2009, the more restrictive requirement applies. If REACH bans a substance while Cosmetics Regulation permits it with restrictions, the REACH ban takes precedence. Always verify compliance with both regulatory frameworks.

Global Market-Specific Compliance Frameworks

Each major cosmetics market operates under distinct regulatory frameworks with unique requirements for product approval, ingredient compliance, and labeling. Understanding market-specific differences is essential for accurate localization and submission success.

Regulatory Element	EUEC 1223/2009	USAFDA	ChinaNMPA	JapanMHLW	KoreaMFDS
Pre-Market Approval	Notification required (CPNP). No pre-market approval for standard cosmetics.	No pre-market approval. Voluntary registration via VCRP.	Registration required for general cosmetics. Approval required for special-use cosmetics.	No pre-market approval for cosmetics. Notification for quasi-drugs.	Notification required via K-REACH and CPNP-equivalent system.
Ingredient Lists	Positive lists for preservatives (Annex V), UV filters (Annex VI), colorants (Annex IV). Negative list (Annex II).	No positive list. Prohibited ingredients list maintained by FDA.	Positive list: Inventory of Existing Cosmetic Ingredients in China (IECIC). New ingredients require approval.	Positive list for quasi-drugs. Negative list for cosmetics. Standards for specific ingredients.	Positive list approach. Korea Existing Cosmetic Ingredients (KECI) inventory.
Safety Assessment	Mandatory. Must be conducted by qualified professional (pharmacist, toxicologist, physician).	Not mandatory. Manufacturer responsible for safety substantiation.	Mandatory for special-use cosmetics. Toxicological assessment required.	Not explicitly required for cosmetics. Required for quasi-drugs.	Safety assessment required. Must demonstrate safety for intended use.
Claims Regulation	Regulation 655/2013. Claims must be substantiated, truthful, and meet common criteria.	FTC regulations. Claims must be truthful, not misleading. Substantiation required.	Strict claims regulation. Efficacy claims require substantiation. “Special-use” claims trigger approval pathway.	Efficacy claims allowed for quasi-drugs only. Cosmetics limited to sensorial/appearance claims.	Functional claims regulated. Substantiation required. “Functional cosmetics” category for specific claims.
Labeling Language	Language of member state where marketed. Multilingual permitted.	English. Spanish may be added.	Mandatory Mandarin Chinese. English as supplementary.	Japanese required. English supplementary allowed.	Korean required. English as supplementary.
Ingredient Nomenclature	INCI names mandatory (Aqua, Sodium Chloride, etc.)	INCI names or common names acceptable (Water, Salt, etc.)	IECIC names (Chinese) mandatory. INCI may be supplementary.	Japanese nomenclature. INCI not sufficient alone.	Korean nomenclature. INCI may supplement.
Animal Testing	Prohibited for cosmetics and ingredients since 2013.	Not prohibited but discouraged. Alternative methods accepted.	Required for special-use cosmetics unless exempted. General cosmetics: recent regulatory changes reducing requirements.	Not required but accepted as safety evidence.	Alternative methods accepted. Animal testing discouraged.
GMP Requirements	Mandatory. ISO 22716 standard reference.	Recommended but not legally mandatory.	Mandatory. China-specific GMP standards.	Mandatory GMP compliance for manufacturing facilities.	GMP compliance required. Regular inspections.

Market-Specific Localization Considerations

United States (FDA)

Key Difference: Cosmetics vs. drugs determined by claims, not ingredients. Product claiming therapeutic benefits becomes drug requiring FDA approval. Localization must carefully adapt claim language to avoid drug classification.

China (NMPA)

Key Difference: Dual-track system: general cosmetics (notification) vs. special-use cosmetics (approval required for whitening, sunscreen, anti-hair loss, etc.). New ingredients require separate approval process.

Japan (MHLW)

Key Difference: Three categories: cosmetics, quasi-drugs (medicated cosmetics with specific approved claims), and pharmaceuticals. Categorization affects allowed claims and regulatory pathway.

Korea (MFDS)

Key Difference: “Functional cosmetics” category for products with specific functions (whitening, anti-wrinkle, sun protection). These require functional testing and approval before marketing.

Pre-Submission Compliance Verification

Multi-Market Compliance Checklist

• All ingredients verified against target market approved lists (CosIng/IECIC/KECI/Japan Standards)
• Restricted substances compliance confirmed (concentrations, usage conditions, warnings)
• REACH restrictions checked for EU markets (SVHC, Authorization List, Annex XVII)
• Claims language appropriate for market regulatory framework (cosmetic vs. drug classification)
• Ingredient nomenclature follows market requirements (INCI vs. common names vs. local language)
• Mandatory label elements present per market (warnings, symbols, responsible person)
• Safety assessment completed by qualified professional (where required)
• Product category classification correct for intended claims and formulation
• GMP compliance documented (where mandatory)
• Notification or registration requirements completed before market placement
• Claims substantiation aligned with market-specific evidence standards
• Language requirements met (mandatory language, supplementary language rules)

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