EU CPNP & UK SCPN Compliance

    

Global Regulatory Affairs Consulting Agency, KGMP CORP.

U.S. FDA & MoCRA Compliance for Cosmetic

Partner with KGMP to ensure your products comply with the regulatory standards of your target market.

As a leader in cosmetic and personal care consulting, KGMP provides expert guidance to help you navigate market-specific regulations, ensuring your products meet local standards for safe export and distribution. Partner with us to ensure your products are safe, effective, and compliant with both local and global regulations.

CPNP & SCPN Compliance for Cosmetic: Essential Requirements for EU & UK Market

The Cosmetic Product Notification Portal (CPNP) is the European Union (EU)'s centralized platform for cosmetic product notification. Each cosmetic product marketed in the EU must be registered on this portal to meet European regulations, ensuring safety and compliance prior to market launch.

Similarly, the United Kingdom (UK)’s Submit Cosmetic Product Notification (SCPN) platform requires responsible persons to notify cosmetics prior to sale in Great Britain (GB), as mandated by UK cosmetics regulations. Compliance with SCPN ensures traceability, consumer protection, and industry transparency.

KGMP provides tailored strategies to meet EU and UK compliance requirements, helping to reduce risks and avoid penalties. While we handle regulatory complexities and guide you step-by-step through the cosmetic registration process for the EU and GB markets, you can focus on your core business and prepare for successful expansion.

KGMP EU CPNP & UK SCPN Notification Service

GAP Analysis	Ingredient & Label Review	Appoint EU & UK Agent	PIF & CPSR Documentation	Notification for NPNP & SCPN

EU CPNP & UK SCPN Notification Process

The EU and UK cosmetics regulations involve numerous complex laws that must be considered to determine whether cosmetics can be legally marketed. Before distribution of cosmetics in EU and GB markets, you must navigate several intricate steps and ensure compliance with the parameters set forth in the EU and UK cosmetics regulation.

STEP 1: GAP Analysis

The classification of a product as a cosmetic in Europe is determined on a case-by-case basis, taking into account all product attributes. KGMP has the expertise to evaluate whether a product qualifies as a cosmetic and to register it in the cosmetic safety database accordingly. Accurate classification is essential to the regulatory process, guiding KGMP's GAP analysis for your entry into the EU and GB markets.

Q) How is a cosmetic product defined?

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‘Cosmetic products definition’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. (EU Regulation 1223/2009, Article 2.1.a)

Cosmetic products may include:

ㆍ Cosmetic: It is defined as 'articles intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body... for cleansing, beautifying, promoting attractiveness, or altering appearance,' and as 'preparations of cosmetic ingredients with a set qualitative and quantitative composition for use in a finished product.'

ㆍSkin care product: Creams, emulsions, lotions, gels and oils for the skin, Face masks

ㆍMake-up product: Make-up powders, Make-up and products removing make-up product, Products intended for application to the lips, Tinted bases (liquids, pastes, powders)

ㆍBody care product: After-bath powders, Bath and shower preparations (salts, foams, oils, gels)

ㆍHair product: Hair colorants, Products for waving, straightening and fixing hair, Hair-setting products, Hair-cleansing products (lotions, powders, shampoos), Hair-conditioning products (lotions, creams, oils), Hairdressing products (lotions, lacquers, brilliantines)

ㆍHygienic product: Hygienic powders, Toilet soaps, For care of the teeth and the mouth, Products for external intimate hygiene

ㆍProducts for nail care and make-up

ㆍPerfumes, toilet waters and eau de Cologne

ㆍDeodorant product: Deodorant soaps, Deodorants and antiperspirants

ㆍShaving products: Creams, foams, lotions

ㆍDepilatories

ㆍSunbathing products, Products for tanning without sun

ㆍSkin-whitening products, Anti-wrinkle products, etc

Products containing substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do not come under the Cosmetic products definition.

Q) What are borderline products?

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‘Borderline products are those that are difficult to classify into a single category due to their characteristics or intended uses. These products may fall between categories such as cosmetics and medicinal products, cosmetics and biocides, or cosmetics and medical devices. Proper classification requires a case-by-case assessment, considering all product attributes and often influenced by the product claims.

STEP 2: Ingredient & Label Review

EU and UK cosmetics regulations enforce strict safety and legal standards for ingredients and labeling, including fragrance allergen controls to protect consumers. This process helps prevent non-compliant cosmetics from entering the EU and GB markets, avoiding penalties and building consumer trust. KGMP can support you in ensuring that your cosmetic ingredients and labels meet these regulatory requirements, enhancing transparency and market access in the EU and GB markets.

Q) What are the requirements that must be met for cosmetic ingredients?

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‘A cosmetic product must not only be a suitable substance or mixture with the correct application site, purpose, and claims; it must also have an appropriate composition. Cosmetics must avoid prohibited ingredients (listed in Regulation 1223/2009, Annex II), adhere to restrictions on certain substances (Annex III), and comply with requirements for colorants (Annex IV), preservatives (Annex V), and UV filters (Annex VI).

Q) What are the requirements that must be met for cosmetic labeling?

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‘The EU Cosmetics Regulation (Regulation (EC) No 1223/2009) and UK cosmetics regulation outlines the labeling requirements for cosmetic products sold in the EU or UK. Under this regulation, all cosmetic product labels must be in a language easily understood by consumers.

ㆍProminence and conspicuousness

ㆍLanguage

ㆍFormat: Principal Display Panel, Placement of Information on Labels, Type size

ㆍMandatory requirements: Identity, Net quantity of contents, Ingredients and nanomaterials list, Directions, Warning statements, Name and place of EU RP or UK RP, Shelf-life, Batch number, etc.

ㆍOther statements for product safety responsibilities

STEP 3: Appoint the Responsible Person (RP)

To distribute a cosmetic product in the EU and GB markets, compliance with relevant regulations is essential, including appointing a Responsible Person (RP) to oversee adherence before and after market entry. While any EU or UK resident can serve as the RP, engaging a professional is highly recommended due to the specialized expertise needed to navigate complex and evolving regulations. KGMP provides experienced EU and UK RP services, providing expert legal representation, ongoing compliance support, and continuous regulatory monitoring.

Q) What is R&R of the RP?

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‘The Responsible Person (RP) is essential for ensuring product safety and regulatory compliance. These individuals or entities oversee formulation, safety assessments, and overall compliance for cosmetics on the market, ensuring adherence to legal requirements such as labeling, ingredient information, and safety testing. They manage adverse reaction reporting and maintain documentation to substantiate product claims, thereby upholding trust and safety within the industry. Furthermore, RP is accountable for product safety and must respond to regulatory authorities in their respective countries in case of any issues.

Q) What is the difference between the EU RP and the UK RP?

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‘The EU RP is based in one of the 27 EU member states and is responsible for ensuring product safety and compliance, handling CPNP notifications, and facilitating communication with EU regulatory authorities. In contrast, the UK RP must be located in UK to oversee product safety and compliance, manage SCPN notifications, and communicate with UK regulatory authorities.

Q) Who can be the RP?

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‘EU RP or UK RP can be any legal or natural person based within the EU or UK. The RP must:

ㆍBe established within the EU or UK.

ㆍBe designated through a written mandate and accept this role in writing.

ㆍBe the manufacturer (if based in the EU or UK), a distributor, an importer, or a designated professional Responsible Person.

STEP 4: Product Information File (PIF) & CPSR (Cosmetic Product Safety Report) Documentation

The Product Information File (PIF) must contain detailed descriptions, including product information, safety assessments, manufacturing methods, animal testing data, and labeling, and is essential for market entry. Before a cosmetic product can enter the EU and GB markets, it must undergo a rigorous safety assessment to confirm compliance. KGMP’s qualified Safety Assessors review all documentation for the Cosmetic Product Safety Report (CPSR), compiling all documents into the PIF with expertise in regulatory standards.

For more details about KGMP: Cosmetic PIF and CPSR services to make an adequate safety substantiation for cosmetic products ▶ Click here

STEP 5: Notification for CPNP or SCPN

Notification through the Cosmetic Products Notification Portal (CPNP) or Submit Cosmetic Product Notification (SCPN) is mandatory before releasing a product in the EU or GB markets to ensure regulatory compliance. Both the PIF and RP are essential for this process, which is why they were highlighted in the previous step. KGMP expertly compiles and submits all necessary information to meet CPNP and SCPN requirements, ensuring your product is fully prepared for the EU and UK markets.

Remember that different regulations apply in each country.

Contact us today to discover how our PIF and CPSR compliance services can benefit your business.

KGMP simplifies compliance with complex cosmetic regulations.

K-GMP supports clients in ensuring the quality, safety, and performance of their supply chains while complying with local and global regulations, from ingredients to final cosmetics.     

The Global KGMP network offers a comprehensive range of one-on-one customized consultancy support for all types of cosmetic products. We are committed to staying up-to-date with regulatory environments, trends, and industry requirements.

For detailed information about our cosmetic regulation compliance services, please contact our expert directly.

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