Pharmanager Development, provider of services and tools to guarantee the conformity and effectiveness of your products

Cosmetics

At Pharmanager Development, we leverage our expertise in cosmetics to support our clients in meeting regulatory requirements throughout the entire product lifecycle. With a comprehensive approach, we help ensure the compliance of your products, from development to market launch.

Which Regulations Apply?

1223/2009/EC

This regulation establishes the general rules applicable to the safety of cosmetic products within the European Union. It notably requires the creation of a Product Information File (PIF) and the mandatory notification of products through the Cosmetic Products Notification Portal (CPNP) before being placed on the market, thus ensuring their compliance with regulatory requirements.

655/2013/EC

It sets precise and common criteria for regulating the justification of cosmetic claims, ensuring they are clear, verifiable, and not misleading. This framework helps provide greater transparency and prevents any information that could mislead consumers, thereby strengthening confidence in the products offered on the market.

1545/2023/EU

This regulation amends Regulation (EC) No 1223/2009 on cosmetic products by strengthening labeling requirements for allergenic fragrance substances. It aims to enhance consumer protection by increasing the number of allergenic substances that must be listed on the label of cosmetic products.

Cosmetic Compliance Verification

We analyze your formulations, labels, and claims to ensure compliance with current cosmetic regulations and European standards.

Safety of Your Cosmetic Formulations

We assess the safety and efficacy of your cosmetic formulations, considering the latest regulatory developments and consumer expectations.

Cosmetic Product Safety Report (CPSR)

We prepare a comprehensive report assessing the safety of your products in accordance with Regulation (EC) No 1223/2009.

Product Information File (PIF) & CPNP Notification

We compile your PIF, including safety, quality, and compliance data, and ensure product notification on the CPNP, a mandatory step for market placement.

Label and Claim Verification

We review your labels and communications to ensure that your cosmetic claims are compliant, relevant, and compelling.

Pharmanager Development Assists You in

We guide you through every stage of your cosmetic products’ lifecycle, from conception to market launch. From ingredient selection to the preparation of the Product Information File (PIF), we ensure regulatory compliance and market success.

Our services include claim validation, labeling verification, and regulatory monitoring. We help you anticipate market requirements, meet consumer expectations, and enhance the competitiveness of your products.

Laboratoire cosmétique avec flacons et main versant un liquide doré, illustrant l'expertise de Pharmanager Development en conformité réglementaire des cosmétiques.

Our Experts Guide You in Exporting Your Cosmetic Products

Pharmanager Development assists you in bringing your cosmetic products to market in Europe and third countries, considering local regulatory specificities. We analyze the requirements of each region, compile compliant regulatory dossiers, and oversee the entire process.

With our expertise and rigorous monitoring of regulatory developments, we ensure the success of your international launches while guaranteeing product compliance.

Our answers to your questions

What are the key regulatory requirements for cosmetic products in the European Union (EU)?

In the EU, cosmetic products are regulated under Regulation (EC) No 1223/2009, which sets comprehensive standards for product safety, labeling, and marketing. Manufacturers must ensure that products are safe for human health, provide a Product Information File (PIF), and designate a Responsible Person within the EU to oversee compliance. Additionally, the regulation enforces strict rules on the use of certain substances and mandates that animal testing for cosmetic products and their ingredients is prohibited.

How does the EU assess the safety of cosmetic ingredients, especially concerning nanomaterials?

 

The Scientific Committee on Consumer Safety (SCCS) provides independent scientific assessments of cosmetic ingredient safety in the EU. When it comes to nanomaterials, the SCCS evaluates aspects such as particle size, solubility, chemical nature, and potential toxicity to ensure consumer safety. Their assessments guide regulatory decisions and updates, ensuring that only safe ingredients are used in cosmetic products.

What are the implications of the EU’s ban on animal testing for cosmetics?

The EU has implemented a complete ban on animal testing for cosmetic products and their ingredients, as well as a prohibition on marketing cosmetics tested on animals. This has led to increased investment in alternative testing methods and a push for global acceptance of non-animal approaches. Companies must now rely on validated alternative methods to demonstrate product safety, aligning with ethical considerations and consumer demand for cruelty-free products.

How can cosmetic manufacturers ensure compliance with Good Manufacturing Practices (GMP)?

Compliance with GMP is essential to ensure the quality and safety of cosmetic products. Manufacturers should adhere to harmonized standards, maintain clean and controlled production environments, and implement robust quality management systems. Regular audits, thorough documentation, and staff training are also crucial components of GMP compliance, helping to prevent contamination and ensure product consistency.

Need advice or have a question in this evolving and increasingly demanding regulatory context? looking for expert guidance?