Our team is dedicated to the cosmetic analysis and their legalisation compliance .
One process in 5 steps
Services
Depending on the cosmetics, we tell you what kind of services you need for the quality control and legalisation.
Prepare
You will receive the documentation and/or samples we need to perform the services.
We analyse
Once we have received the samples, we will contact you for the next steps..
Results
Results
We send you the results of the analyses with our advice
Access the European market with full regulatory compliance
At Alpiguisa, we help cosmetic manufacturers and laboratories worldwide comply with European regulations through regulatory affairs services, laboratory testing, and specialized technical documentation.
Risk
Microbiological analysis of a cosmetic product is essential. Each batch produced must be tested to ensure that it's within the lower limits according to the microbiological standard UNE-EN-ISO 17516 and free of pathogens..
Stability
Ensure that the product complies with the established physical, chemical and microbiological properties.
Safety
Verify that the cosmetics preservation system fulfils its function of protecting the consumer from contamination in reasonable use..
Toxicity
We prepare the product information dossier (PID) and calculate the toxicity limits for each ingredient..
Responsibility
Any cosmetic to be placed on the European market needs a responsible person located in Europe.
We take on this responsibility.
Legality
We are in charge of the declaration on the CPNP portal of the European cosmetovigilance
Where do we come from?
1993
Establishment of Antonio Borras Laboratory
2013
Launch of the Dermohelp brand
2021
Acquisition of the laboratory by Christophe Morote (Biochemist)
2022
Laboratory renovation and implementation of Good Manufacturing Practices (GMP)
2024
Best Eco-Packaging Award
"El Berlingo"
Madrid 2024
2025
Laboratory renovation following the Valencia DANA floods
A formulation and manufacturing laboratory
¿Do you want to adapt your formulas in a professional laboratory?
We help you create YOUR formula.
Want to market your cosmetics in Europe?
To place a cosmetic product on the European Union market, it must comply with Regulation (EC) No. 1223/2009, have the required technical documentation in place, and demonstrate product safety before commercialization.
At Alpiguisa Innovación, we help international cosmetic manufacturers and laboratories gain access to the European market through comprehensive regulatory affairs services, including the preparation of the Product Information File (PIF), Cosmetic Product Safety Report (CPSR), Responsible Person services, and microbiological and physicochemical laboratory testing.
We centralize all the technical documentation, laboratory analyses, and regulatory support required under one provider, allowing you to export and market cosmetic products in Europe with full regulatory compliance.
Frequently Asked Questions
To market a cosmetic product in the European Union, it must comply with Regulation (EC) No. 1223/2009. This includes having a Product Information File (PIF), a Cosmetic Product Safety Report (CPSR), a Responsible Person established in the EU, compliant product labeling, and notification of the product through the Cosmetic Products Notification Portal (CPNP).
The Product Information File (PIF) is the technical documentation that demonstrates a cosmetic product's compliance with European legislation. It includes information on the formulation, raw materials, manufacturing process, safety assessment, studies, and all other documentation required under the European Cosmetics Regulation.
The Cosmetic Product Safety Report (CPSR) is a document prepared by a qualified safety assessor certifying that the cosmetic product is safe for consumers when used under normal or reasonably foreseeable conditions.
Yes. Every cosmetic product placed on the European Union market must have a Responsible Person established within the EU. This person is responsible for ensuring regulatory compliance and maintaining the required technical documentation.
The required tests depend on the type of product. In most cases, microbiological testing, physicochemical analyses, stability and compatibility studies, as well as other product-specific tests based on the formulation and intended use, are required.
Yes. Manufacturers from any country may place cosmetic products on the European market provided they comply with European regulations and have all the required documentation and registrations.
The Cosmetic Products Notification Portal (CPNP) is the official European Union notification system through which cosmetic products must be registered before being placed on the market.
The timeline depends on the current status of the documentation, the laboratory tests required, and the characteristics of the product. An initial assessment allows us to estimate the timeframe for each individual project.
Yes. We provide a comprehensive service that includes laboratory testing, regulatory documentation, preparation of the Product Information File (PIF), Cosmetic Product Safety Report (CPSR), Responsible Person services, and guidance throughout the entire process of accessing the European market.
Yes. We work with manufacturers, laboratories, and cosmetic brands from around the world that wish to market their cosmetic products in the European Union.
ARA EMPRESES 2025 PLAN
This investment project has been co-financed by IVACE under the ARA EMPRESES 2025 programme.
