Cosmetic Product Safety Assessment – CPSR Compliance with Regulation (EC) No 1223/2009

What is a Cosmetic Product Safety Report (CPSR)?

The Cosmetic Product Safety Report (CPSR) is a mandatory document required under Regulation (EC) No 1223/2009 for every cosmetic product placed on the EU market.

The CPSR confirms that the cosmetic product has undergone a safety assessment and that the available scientific data support the conclusion that the product is safe for human use.

The report must be prepared by a qualified Safety Assessor with appropriate expertise in toxicology, pharmacy, medicine, chemistry, or related scientific disciplines, in accordance with Article 10 of the Regulation.

The CPSR applies to all cosmetic products, including:

• skin care products,
• hair care products,
• make-up products,
• perfumes and fragrances,
• oral care products,
• baby cosmetics,
• natural and organic cosmetics,
• professional cosmetics,
• private label cosmetic products.

Is CPSR mandatory in the European Union?

Yes. A Cosmetic Product Safety Report is legally required for every cosmetic product placed on the EU market.

According to Regulation (EC) No 1223/2009:

• every cosmetic product must have a CPSR before market placement,
• the CPSR is a mandatory part of the Product Information File (PIF),
• the documentation must be available to competent authorities upon request,
• placing a cosmetic product on the market without a CPSR constitutes non-compliance with EU cosmetic legislation.

Failure to maintain compliant safety documentation may result in:

• market withdrawal of the product,
• sales restrictions,
• regulatory actions,
• financial penalties,
• legal liability of the Responsible Person.

Which regulations govern cosmetic product safety assessment?

The primary legal framework governing cosmetic products in the European Union is Regulation (EC) No 1223/2009 on cosmetic products.

The Regulation establishes requirements related to:

• cosmetic product safety assessment,
• Cosmetic Product Safety Reports (CPSR),
• Product Information File (PIF),
• Responsible Person obligations,
• ingredient restrictions and prohibited substances,
• cosmetic labeling requirements,
• Good Manufacturing Practice (GMP),
• Cosmetic Products Notification Portal (CPNP),
• undesirable effects and serious undesirable effects reporting.

The safety assessment is performed in accordance with Annex I of Regulation (EC) No 1223/2009.

What does a CPSR include?

The Cosmetic Product Safety Report consists of two mandatory sections defined in Annex I of Regulation (EC) No 1223/2009.

Part A – Cosmetic Product Safety Information

Part A includes scientific and technical information necessary to assess product safety.

This section typically includes:

• qualitative and quantitative composition of the product,
• INCI ingredient names,
• physicochemical properties and stability data,
• microbiological quality,
• impurities, traces, and packaging material information,
• normal and reasonably foreseeable use,
• exposure to the cosmetic product,
• exposure to individual substances,
• toxicological profiles of ingredients,
• undesirable effects and serious undesirable effects,
• existing data related to the cosmetic product.

Part B – Cosmetic Product Safety Assessment

Part B contains the formal safety assessment conclusion prepared by the Safety Assessor.

This section includes:

• assessment conclusion,
• scientific reasoning and justification,
• warnings and instructions for use,
• Safety Assessor credentials and qualifications.

What is evaluated during cosmetic product safety assessment?

Cosmetic safety assessment includes analysis of the cosmetic formula, ingredients, intended use, user exposure, packaging interaction, microbiological quality, and toxicological risk.

The assessment may include evaluation of:

• raw material documentation,
• Safety Data Sheets (SDS/MSDS),
• toxicological profiles of ingredients,
• ingredient concentrations and exposure calculations,
• margin of safety (MoS),
• potential interactions between substances,
• stability testing,
• packaging compatibility,
• microbiological quality,
• preservative efficacy testing (challenge test),
• target user group,
• application area and frequency of use,
• specific exposure scenarios for children or sensitive users.

What is Margin of Safety (MoS)?

Margin of Safety (MoS) is one of the key toxicological parameters used during cosmetic safety assessment.

MoS compares the level at which a substance may cause adverse effects with the estimated exposure resulting from cosmetic product use.

The calculation of MoS supports evaluation of whether the concentration of a cosmetic ingredient can be considered safe under intended conditions of use.

Who can perform a cosmetic safety assessment?

According to Regulation (EC) No 1223/2009, cosmetic product safety assessment must be performed by a qualified Safety Assessor.

The Safety Assessor should hold a formal qualification in fields such as:

• toxicology,
• pharmacy,
• medicine,
• chemistry,
• or equivalent scientific disciplines.

The qualifications of the Safety Assessor must be documented within the CPSR.

When does a CPSR need to be updated?

The Cosmetic Product Safety Report must remain current throughout the entire period during which the product is available on the market.

CPSR updates may be necessary in cases such as:

• formula modification,
• change of raw material supplier,
• new toxicological data,
• change of packaging material,
• changes in product claims or intended use,
• changes in exposure scenarios,
• new regulatory requirements,
• reported undesirable effects.

Failure to maintain updated documentation may create regulatory non-compliance risks.

CPSR for natural and organic cosmetics

Natural and organic cosmetics are subject to the same safety assessment requirements as conventional cosmetic products.

“Natural” or “organic” claims do not exempt cosmetic products from the obligation to maintain a compliant CPSR and complete PIF documentation.

Natural formulations may require particular attention regarding:

• essential oils and allergens,
• microbiological stability,
• preservation systems,
• plant extract variability,
• raw material purity.

CPSR for private label cosmetics

Private label cosmetic products also require a Cosmetic Product Safety Report compliant with Regulation (EC) No 1223/2009.

The Responsible Person placing the product on the EU market remains responsible for maintaining compliant documentation regardless of the manufacturing model.

Private label products frequently require verification of:

• ingredient documentation,
• manufacturing data,
• packaging compatibility,
• product claims,
• traceability within the supply chain.

Most common cosmetic safety documentation issues

Incomplete or outdated cosmetic documentation is one of the most common compliance issues identified within the cosmetics sector.

Typical non-conformities may include:

• missing raw material documentation,
• outdated Safety Data Sheets,
• incomplete toxicological data,
• incorrect ingredient concentrations,
• lack of microbiological testing,
• missing stability studies,
• lack of packaging compatibility assessment,
• outdated CPSR after formula modification,
• inconsistencies between CPSR and PIF documentation,
• non-compliant product labeling.

CPSR and Product Information File (PIF)

The CPSR forms an integral part of the Product Information File (PIF).

The PIF must be maintained by the Responsible Person and made accessible to competent authorities upon request.

The Product Information File generally includes:

• product description,
• Cosmetic Product Safety Report (CPSR),
• manufacturing method description,
• GMP compliance statement,
• supporting efficacy data for product claims,
• animal testing information, where applicable.

CPSR and CPNP notification

Before placing a cosmetic product on the EU market, the product must be notified through the Cosmetic Products Notification Portal (CPNP).

Safety assessment and complete product documentation are essential elements supporting the CPNP notification process.

Information included within the CPSR is connected with data submitted during CPNP notification.

Cosmetic safety assessment and ISO 22716 GMP

Cosmetic product safety assessment is closely linked to manufacturing quality systems and production documentation.

Many cosmetic manufacturers implement ISO 22716 Good Manufacturing Practices (GMP) in order to maintain control over:

• manufacturing processes,
• production hygiene,
• quality documentation,
• raw material traceability,
• change control,
• storage and transportation conditions.

A structured quality management approach supports regulatory compliance with Regulation (EC) No 1223/2009.

Safety assessment as a foundation of cosmetic compliance

Cosmetic product safety assessment is one of the core elements of cosmetic regulatory compliance within the European Union.

Maintaining a complete and up-to-date CPSR supports:

• legal market placement,
• compliance with EU cosmetic legislation,
• maintenance of complete PIF documentation,
• product risk management,
• preparation for regulatory inspections,
• cooperation with distributors and retail partners,
• market access within the European Union.

GCB – support in cosmetic documentation conformity assessment

GCB operates in the field of conformity assessment and quality systems for regulated industries, including the cosmetics sector.

GCB activities include verification of cosmetic documentation conformity with applicable regulatory requirements and assessment of the completeness of safety-related cosmetic product documentation.

Experience in regulatory compliance, technical documentation, quality systems, and regulated environments supports organizations operating within the cosmetics sector in meeting requirements related to cosmetic product safety and documentation compliance.