Complife is an international group that provides consulting and testing services for different markets. With a long history dedicated to the cosmetics market, the Complife team can boast high expertise, especially in safety assessment, based on a wide range of safety tests.
According to European Cosmetics Regulation 1223/2009, a cosmetic product should be safe for human health when used under normal or reasonably foreseeable conditions of use. Consequently, the responsible person shall ensure that, before placing a cosmetic product on the market, it has undergone a safety assessment based on the relevant information and that a safety report is drawn up in accordance with Annex I of this regulation.
A full cosmetic safety assessment needs to be performed and included in a Product Information File (PIF) kept at the company. This file also includes a description of the product, the product safety report, information about the manufacturing methods, and proof of effects claimed.
The Cosmetic Product Safety Report (CPSR) is the key component of the PIF. It is divided into two sections: Part A, which contains information about the safety of the cosmetic product, and Part B, which includes the safety assessment itself. The latter, which is intended to demonstrate the product’s safety, is a requirement in the EU, and is also widely requested by different regulatory authorities.
There are various cosmetic toxicology and safety tests, tailored to evaluate specific potential hazards while adhering to the Cosmetics Regulation, which prohibits animal testing.
Although there are no enforceable industry-wide standards specifying which tests must be performed for assessments of cosmetic products, respected authorities such as the Scientific Committee on Consumer Safety (SCCS) and the Organisation for Economic Co-operation and Development (OECD) provide guidance on recommended tests and methodologies.
Our experts can assist with drafting the Product Information File (PIF) and preparing a toxicological pre-assessment report, advising on the necessary safety tests to complete the cosmetic formulation’s safety assessment.
Some of the most common tests include:
Complife can conduct these tests on individual ingredients, mixtures, and final products using in vitro or clinical methods that meet both Good Laboratory Practice (GLP) principles and compliance standards.
Ocular irritation tests are essential for evaluating the safety of products that may come into contact with the eyes. Complife offers in vitro alternative methods, including the Chorioallantoic Membrane (HET-CAM) Test and the Macromolecular Test Method (OECD 496). The latter utilizes a complex macromolecular matrix that closely mimics the composition of the cornea. But also in vitro methods based on cytotoxicity assessment, such as the Neutral Red Uptake (NRU) assay, Agarose diffusion and reconstructed human cornea-like epithelium (RhCE), which can effectively assess the potential for ocular irritation and serious eye damage while meeting regulatory requirements.
Phototoxicity and Photo-Sensitization testing are essential for products applied to sun-exposed areas. Complife’s laboratory offers the 3T3 Neutral Red Uptake (NRU) Phototoxicity Test, which evaluates cytotoxicity, as well as the Reconstructed Human Epidermis Phototoxicity Test (RhE PT), which identifies the phototoxic potential of chemicals applied topically to reconstructed human epidermis (RhE) tissue with and without simulated sunlight exposure (OECD 498). Additionally, we conduct photo-sensitization analysis which evaluates markers involved in the photosensitization response of cells, using fluorescence-based methods.
For cosmetic products that are primarily intended for skin contact, assessing their potential for skin irritation and sensitization is of paramount importance. Our laboratories provide a battery of in vitro solutions for skin sensitization testing. These include in chemico skin sensitization assays (OECD 442C), tests for keratinocyte activation (OECD 442D), and assays targeting dendritic cell activation in the Adverse Outcome Pathway for skin sensitization (OECD 442E). Additionally, we offer the Reconstructed Human Epidermis (RhE) Assay (OECD 439), which measures cell viability, providing a reliable assessment of potential skin irritation.
In addition to in vitro testing, our team also offers clinical testing services such as:
Finally, our experts could also support testing on Beauty Devices, to evaluate their safety and usability when used alone or in combination with formula(s). These tests are inspired from standard methods applied to Medical Device testing that are transposed and customized accordingly to body contact and intended use of the purposed beauty device. They ensure a high safety level to customer and study volunteer before in vivo tests.
Complife offers all its expertise’s to be the best partner to support your pre-clinical and clinical product’s development.
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