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DUSHA COMPANY COSMETIC

COSMETIC SAFETY ASSESSMENT &
EU REGULATORY COMPLIANCE

Professional Cosmetic Safety & Regulatory Consultancy

natural cosmetic products on a blue podium with a eu flag in the background and compliance

Dusha Company Cosmetic provides professional cosmetic safety assessment, regulatory compliance and technical consultancy services for cosmetic products intended to be placed on the European Union market.

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Our services are addressed to cosmetic manufacturers, brand owners, importers, distributors and companies developing or placing cosmetic products on the EU market.

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Cosmetic safety assessments and regulatory documentation are prepared in accordance with Regulation (EC) No 1223/2009 on cosmetic products and the applicable European regulatory framework.

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We work with care.

We work with passion.

We work professionally.

About Us

OUR VALUES

In a context where the cosmetics and beauty industry is undergoing continuous transformation, driven by rapidly changing consumer preferences, the constant emergence of new trends and technologies, as well as new rules and regulations governing the industry, cosmetic manufacturers need to remain permanently connected to these evolving realities.

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We provide comprehensive consultancy tailored to each client's specific needs and preferences, supporting the development and placement on the national and European markets of sustainable and innovative cosmetic products that respond to emerging trends and comply with current regulatory requirements.

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Dusha Company Cosmetics is a Romanian company specialising in consultancy and services related to placing cosmetic products on the market. Our strategy is built on the quality of the services we provide, the professionalism and extensive experience of our team and partners.

DUSHA COMPANY COSMETICS

With over three decades of experience in the field of cosmetology, we are able to provide our clients with personalised consultancy and appropriate technical assistance at every stage of the cosmetic product development process. Depending on the project and each client's specific requirements and preferences, our support can cover the entire development process, from product formulation through to industrial-scale production.

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Our company's working philosophy is based on an innovative mindset, a strong client-oriented approach, and the rapid and efficient delivery of solutions tailored to the needs of our partners.

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Working in partnership with our team provides clients with high-quality, efficient services adapted to their specific requirements, as well as the assurance that the products developed are aligned with the legislative requirements governing the European Union cosmetics market.

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Our Services

Cosmetic Product Safety Report – CPSR

Preparation of the Cosmetic Product Safety Report (CPSR) in accordance with Regulation (EC) No 1223/2009.

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  • CPSR Part A – Cosmetic Product Safety Information

  • CPSR Part B – Cosmetic Product Safety Assessment

  • Evaluation of the qualitative and quantitative composition

  • Toxicological assessment of cosmetic ingredients

  • Exposure assessment

  • Assessment of relevant impurities and traces

  • Margin of Safety (MoS) assessment, where applicable

  • Evaluation of restrictions and conditions of use

  • Assessment of warnings and precautions

  • Overall safety conclusion for the intended cosmetic use

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PRODUCT INFORMATION FILE – PIF

echnical and scientific documentation available for the cosmetic product and its ingredien

We prepare and review the Product Information File (PIF) required for cosmetic products placed on the European Union market.

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The PIF is compiled on the basis of the technical and scientific documentation available for the cosmetic product and its ingredients and includes the information required under the applicable EU cosmetic legislation.

CPNP NOTIFICATION

We provide assistance with the notification of cosmetic products through the Cosmetic Products Notification Portal (CPNP) before the product is placed on the European Union market.

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We can also assist with the review and organisation of the information required for a correct notification.

COSMETIC FORMULATION & INGREDIENT COMPLIANCE

Before the final safety assessment, the cosmetic formulation is reviewed from a regulatory and safety perspective.

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  • Verification of the INCI composition

  • Assessment of ingredient concentrations

  • Identification of restricted or prohibited substances

  • Verification of applicable conditions of use

  • Assessment of preservatives, colourants and UV filters, where applicable

  • Assessment of fragrance ingredients and allergens

  • Review of complex raw materials and ingredient blends

  • Identification of potential regulatory or toxicological concerns

RAW MATERIAL DOCUMENTATION

A reliable cosmetic safety assessment requires complete and up-to-date documentation for the raw materials used in the formulation.

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Depending on the nature of the ingredient, the documentation may include:

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  • SDS / MSDS – Safety Data Sheet

  • TDS – Technical Data Sheet / Technical Specification

  • COA – Certificate of Analysis

  • Complete INCI composition

  • Quantitative composition of blends or complex raw materials, where required for the safety assessment

  • Purity and impurity information

  • Relevant toxicological information

  • Additional technical documentation necessary for regulatory and safety evaluation

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FRAGRANCES & PERFUME COMPOSITIONS

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Fragrance compositions require specific documentation for both safety assessment and labelling purposes.

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Depending on the product and fragrance, documentation may include:

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  • SDS / MSDS

  • Technical specification / TDS

  • Current IFRA Certificate of Conformity applicable to the intended cosmetic product category

  • Fragrance allergen declaration

  • Relevant composition information necessary for toxicological and regulatory assessment

FINISHED PRODUCT DOCUMENTATION

Depending on the type, composition and intended use of the cosmetic product, appropriate finished-product documentation may be required, including:

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  • Finished Product Specification

  • Certificate of Analysis (COA) for the finished product or representative production batch

  • Microbiological test results, where applicable

  • Stability testing or stability assessment

  • Product–packaging compatibility testing or supporting compatibility documentation

  • Other relevant test reports according to the characteristics and intended use of the cosmetic product

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PRIMARY PACKAGING ASSESSMENT

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The primary packaging is an important part of the cosmetic product safety evaluation because it is in direct contact with the formulation.

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Relevant documentation may include:

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  • Technical specification of the packaging

  • Identification and type/composition of the packaging material

  • Supplier declaration or Certificate of Conformity, where applicable

  • Relevant information concerning substances of concern, impurities or potential migration

  • Product–packaging compatibility information or test results, where applicable

COSMETIC LABEL COMPLIANCE

We review cosmetic product labels for compliance with the applicable European cosmetic legislation.

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The review may include:

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  • INCI ingredient list

  • Mandatory product information

  • Warnings and precautions for use

  • Nominal content

  • Durability / PAO information

  • Responsible Person information

  • Country of origin, where applicable

  • Batch identification

  • Product function

  • Fragrance allergens and other mandatory labelling requirements

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TECHNICAL & REGULATORY CONSULTANCY

Dusha Company Cosmetic also provides specialised consultancy for companies developing new cosmetic products or reviewing existing product portfolios.

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Services may include:

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  • Cosmetic formulation review

  • Technical assessment of raw materials

  • Regulatory assessment of cosmetic ingredients

  • Toxicological documentation review

  • Assistance with reformulation where regulatory or safety concerns are identified

  • Technical review of supplier documentation

  • Support in preparing documentation for imported cosmetic products

  • Regulatory guidance before placing cosmetic products on the European Union market

SERVICES FOR COSMETIC PRODUCTS

IMPORTED INTO THE EU

Cosmetic products manufactured outside the European Union require particular attention to technical documentation and regulatory compliance before being placed on the EU market.

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We can review documentation provided by non-EU manufacturers and identify missing, incomplete or insufficient information required for the European safety assessment.

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Where necessary, we provide a structured list of documentation and clarifications that should be requested from the manufacturer before the CPSR and PIF can be completed.

UNITED KINGDOM

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Dusha Company Cosmetic can also provide support for cosmetic products intended for the Great Britain market – England, Scotland and Wales.

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Depending on the project, services may include:

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  • Cosmetic safety assessment

  • CPSR and technical documentation

  • Product Information File support

  • UK cosmetic label compliance review

  • Support regarding SCPN notification

  • Guidance regarding the UK Responsible Person

  • Assessment of raw material, fragrance, finished product and primary packaging documentation for UK market requirements

WHO WE WORK WITH

Our services are suitable for cosmetic manufacturers, brand owners, private-label companies, importers, distributors, start-ups, laboratories and international cosmetic companies.

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Whether you are developing a new cosmetic product, importing an existing product into the European Union or reviewing the compliance of an established cosmetic range, we can provide the scientific and regulatory support required throughout the process.

Our Professional Principle

Cosmetic safety begins with reliable documentation.

ASSESSMENT​

INGREDIENTS

EVALUATION

PACKAGING

DOCUMENTATION

For this reason, every assessment is based on the formulation and on the technical, toxicological and regulatory documentation available for the ingredients, finished product and relevant packaging.

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Where information is insufficient to support a scientifically sound safety assessment, additional documentation or clarification will be requested before the assessment is finalised.

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Contact

DUSHA COMPANY COSMETIC SRL
Cluj-Napoca, Romania

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