Full Compliance Pack

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Full Compliance Pack

From: Original price was: € 800.00.Current price is: € 760.00.

Full Compliance Pack

The Full Compliance Pack helps non-EU cosmetic manufacturers enter the EU market safely. It includes an EU Responsible Person, PIF review, CPSR preparation, label checks, and CPNP notification. Optional testing services are also available.

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EU Responsible Person (RP) for Cosmetics

Original price was: € 500.00.Current price is: € 475.00.
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Product Information File (PIF) Review

Original price was: € 100.00.Current price is: € 95.00.
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Cosmetic Product Safety Report – CPSR

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Cosmetic Label Review

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CPNP Notification

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Basic Physicochemical Test (Optional)

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Microbiological Test (Optional)

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Preservative Efficacy (Challenge) Test (Optional)

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Accelerated Stability and Compatibility Test (Optional)

Quantity

Info Product

SKU: FCP-01 Categories: , ,

Description

The Full Compliance Pack is designed for non-EU cosmetic manufacturers. It provides a complete, risk-free solution to enter the EU markets. Moreover, it covers all key regulatory services required under EU Cosmetic Regulation (EC) No 1223/2009.

What’s Included

  1. EU Responsible Person (RP)
    We act as your legal representative in the EU. Therefore, we handle all official communication and regulatory responsibilities.
  2. Product Information File (PIF) Review
    We check that all technical and safety documentation is complete and in the correct legal format. This ensures full compliance with EU rules.
  3. Cosmetic Product Safety Report (CPSR)
    We prepare a detailed safety assessment report. Additionally, we prove that your product is safe for human use. Pricing is flexible based on ingredients (1–10, 10–25, 25+).
  4. Label Review
    We verify that your labels, claims, warnings, and mandatory symbols meet EU requirements. As a result, your packaging is fully compliant.
  5. CPNP Notification
    We complete the Cosmetic Products Notification Portal (CPNP) registration. So, your product is legally ready for the EU market.

Optional Testing Services

If your PIF lacks tests or your company cannot perform them in-house, we also provide:

  • Basic Physicochemical Test: Checks physical and chemical properties
  • Microbiological Test: Confirms the absence of harmful microorganisms
  • Preservative Efficacy (Challenge) Test: Verifies preservative system effectiveness
  • Accelerated Stability & Compatibility Test: Ensures product stability and packaging compatibility

Why Choose the Full Compliance Pack?

With this bundle, your cosmetic products are fully compliant and safe. Furthermore, it minimizes regulatory risks and provides a single-source solution. In addition, Lexora saves you time and complexity, allowing your products to enter the EU market quickly and legally.

Additional information

Who is this bundle for?

This pack is ideal for non-EU cosmetic manufacturers or brands launching in the EU market who want complete regulatory compliance in one solution.
Can I add laboratory tests?

Yes.
Optional tests include:
Microbiological Test (Sample Amount: 100 g/ ml, Duration: 10–15 days)
Preservative Efficacy (Challenge) Test (Sample Amount: 200 g/ ml, Duration: 45–55 days)
Accelerated Stability and Compatibility Test (Sample Amount: 6 x 100 g/ ml, Duration: 90–105 days)

These can be added if your PIF does not include the data, or if your company cannot conduct them in-house.
How does this help with regulatory compliance?

This bundle ensures your products meet all core requirements of Regulation (EC) No 1223/2009, including safety assessment, proper labeling, official notification, and regulatory representation in the EU.
Can I customize the pack?

Yes. You can choose only the services you need, or add optional testing depending on your PIF and regulatory requirements.
Why should I use this bundle instead of individual services?

The Full Compliance Pack simplifies the regulatory process by combining all core services in one package. It saves time, ensures all EU requirements are met, and provides a single point of contact for all compliance needs.

EU Responsible Person (RP) for Cosmetics

What does the EU Responsible Person service fee cover?

The fee for this service is €500 per product, which covers the designation of Lexora Consultancy as your EU Responsible Person for a period of one year. During this time, we assume full legal responsibility for the product under Regulation (EC) No 1223/2009 and handle compliance oversight, CPNP notifications, and communication with competent authorities. The exact scope of our services, rights, and obligations is detailed in the mutually signed mandate, which clearly specifies all responsibilities covered by the fee. Any additional services outside this mandate can be arranged separately.
Who needs to appoint an EU Responsible Person?

Under Article 4 of Regulation (EC) No 1223/2009, every cosmetic product made available on the EU market must have a designated Responsible Person (RP) established within the European Union. The Responsible Person can be either a natural or legal person, depending on the company structure. For non-EU manufacturers, appointing an EU-based Responsible Person is mandatory. Without one, the product cannot be legally placed on the EU market. In such cases, the manufacturer must formally designate a third-party company through a written mandate. For EU-based entities, including manufacturers, importers, or distributors, the RP role can be fulfilled internally by the company itself or externally by an appointed third-party organization such as Lexora.
Can Lexora act as Responsible Person for both EU and non-EU companies?

Yes. We serve as the mandatory Responsible Person for brands outside the EU and as an independent third-party Responsible Person for EU-based manufacturers who prefer external regulatory representation. With over 5 years of regulatory expertise and know-how, our team ensures full compliance, clear communication, and smooth market access for your cosmetic products.

Product Information File (PIF) Review

How long does a PIF review take?

Typically, a complete review takes 3–5 business days once all documents are provided. If additional information or corrections are needed, we guide you through the updates.
What documents do I need to provide?

To perform the review, we need your full PIF, including CPSR, product labels, test reports, and any other supporting documentation. The more complete your submission, the faster the review.
Will the review fix errors or just point them out?

We provide a detailed report with recommendations, highlighting missing or non-compliant items. You can then update your PIF accordingly, and we can assist you in ensuring full compliance before submission to authorities.

Cosmetic Label Review

Why is label review important?

Incorrect or incomplete labels can lead to regulatory fines, product recalls, or market access delays. A compliant label is a legal requirement and ensures consumer safety.
What do you check during the label review?

We verify that all label elements are present and compliant according to Regulation (EC) No 1223/2009, Article 19, including: INCI ingredient listing and order Required warnings and precautions Marketing claims and terminology Responsible Person and manufacturer details
What documents do I need to provide?

To perform a thorough label review, please provide: Draft or final label artwork Complete formulation documentation, including quantitative/qualitative composition Raw material documents (MSDS, CoA, etc.) IFRA certificates or allergen documentation for fragrances or essential oils, if applicable INCI breakdown for blended or complex ingredients Intended claims and marketing language Any supporting documents for claims (optional but recommended) Providing these documents ensures a comprehensive, accurate review and speeds up the process, guaranteeing your label meets all EU requirements.
How long does the review take?

Label reviews typically take 1–3 business days, depending on the complexity and number of products.
Service Type

Basic, Comprehensive

CPNP Notification

What is CPNP and why is it required?

CPNP is the EU’s official system for registering cosmetic products. All products must be notified before being sold in the EU to ensure traceability and regulatory compliance.
What information is needed for CPNP submission?

We need your: Product name and category Ingredient list and function Intended use and target population Responsible Person details Product Information File (PIF) and CPSR reference
How long does the submission take?

Once all information is complete, we typically finalize CPNP notification within 1–2 business days.
Are CPNP and CPSR the same thing?

No, they are different but related. The Cosmetic Product Safety Report (CPSR) is a scientific and technical document that demonstrates that your product is safe for consumers, as required by Regulation (EC) No 1223/2009, Article 10 and Annex I. It includes the toxicological assessment, exposure evaluation, and safety conclusion for the product. The Cosmetic Products Notification Portal (CPNP) is the EU system where your cosmetic product must be officially registered before being sold in the EU, as required by Article 13. In short: the CPSR proves safety, while the CPNP notification registers the product with EU authorities. Both are necessary for legal market access.

Basic Physicochemical Test (Optional)

How much sample do I need to send for the test?

Please provide at least 200 g/ml of product, preferably in its original packaging.
How should I prepare my samples?

Send the product in sealed, clean containers, ideally in the original packaging. Handle samples carefully to avoid contamination before shipment to the lab.
Where should I send the samples?

Samples are shipped directly to our partner laboratories in Istanbul/Türkiye. The labs are fully accredited and operate according to EU standards. After purchase, our team will provide the exact lab and shipping address based on the type of test.
How long does the test take?

Testing typically takes 10–15 days after the samples are delivered to the laboratory.
Why test in Türkiye?

Our Türkiye-based labs offer a cost-effective solution without compromising quality. They provide accurate, reliable, and EU-compliant results, with state-of-the-art equipment and experienced staff, making them a smart choice for small and medium cosmetic manufacturers.

Microbiological Test (Optional)

How much sample do I need to send for the test?

Please provide at least 100 g/ml of product, preferably in its original packaging.
How should I prepare my samples?

Send the product in sealed, clean containers, ideally in the original packaging. Handle samples carefully to avoid contamination and ensure accurate test results.
Where should I send the samples?

Samples are shipped directly to our partner laboratories in Istanbul/Türkiye. The labs are fully accredited and operate according to EU standards. After purchase, our team will provide the exact lab and shipping address based on the type of test.
How long does the microbiological test take?

Testing typically takes 5-10 days after the samples are delivered to the laboratory.
Why test in Türkiye?

Our Türkiye-based labs offer a cost-effective solution without compromising quality. They provide accurate, reliable, and EU-compliant results, with state-of-the-art equipment and experienced staff, making them a smart choice for small and medium cosmetic manufacturers.

Preservative Efficacy (Challenge) Test (Optional)

How much sample is required for the challenge test?

The minimum amount required is 200 g or 200 ml, ideally in the original packaging to reflect real product conditions.
How should I prepare my samples?

Samples should be sealed and clean, preferably in the original packaging. Handle carefully to avoid contamination before shipment to the lab.
Where should I send the samples?

Samples are shipped directly to our partner laboratories in Istanbul/Türkiye. The labs are fully accredited and operate according to EU standards. After purchase, our team will provide the exact lab and shipping address based on the type of test.
How long does the challenge test take?

The test usually takes 40–45 days after the samples arrive at the laboratory.
Why test in Türkiye?

Our Türkiye-based labs offer a cost-effective solution without compromising quality. They provide accurate, reliable, and EU-compliant results, with state-of-the-art equipment and experienced staff, making them a smart choice for small and medium cosmetic manufacturers.
Are any products exHow can I tell if my product is exempt from the challenge test?empt from the challenge test?

Some cosmetic products may not require a preservative efficacy (challenge) test, depending on their formulation and microbial risk. Common exemptions include: Completely anhydrous products (contain no water) or those with very low water activity. Single-use or contamination-proof packaging, such as sealed ampoules or sachets. Alcohol-based products with sufficiently high antimicrobial content. Even if your product may qualify for an exemption, microbiological testing is still recommended to confirm its initial microbial quality and support your Product Information File (PIF). Any exemptions and the rationale should be documented in the CPSR, in accordance with Annex I, Part B of Regulation (EC) No 1223/2009.

Accelerated Stability and Compatibility Test (Optional)

Why is stability and compatibility testing important?

These tests ensure your product maintains its quality, safety, and intended function under different storage and environmental conditions. Stability data is required for the PIF and helps prevent product complaints or regulatory issues.
What does the test cover?

Physical characteristics (appearance, color, texture) Chemical parameters (pH, viscosity, phase separation) Packaging compatibility (interaction between product and container) Performance under accelerated conditions (temperature, humidity, light)
How should I prepare and send samples?

Send the product in its final packaging with at least 6 x 100 g/ml per sample, depending on product type. Ensure samples are sealed and uncontaminated before shipment.
Where should I send the samples?

Samples are shipped directly to our partner laboratories in Istanbul/Türkiye, which are fully accredited and aligned with EU standards. After purchase, our team will provide the exact lab and shipping instructions based on the product and test type.
How long does the test take?

The accelerated stability and compatibility test typically takes 100-105 days.
Why test in Türkiye?

Our Türkiye-based labs offer a cost-effective solution without compromising quality. They provide accurate, reliable, and EU-compliant results, with state-of-the-art equipment and experienced staff, making them a smart choice for small and medium cosmetic manufacturers.

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