ANALYSIS USE:

Microbiological control of cosmetic products at all stages of production, including raw materials, bulk and finished products, in order to ensure compliance with current legislation, and therefore consumer safety.

LEGISLATION-REFERENCE STANDARDS:

• Regulation 1223/2009 of the European Parliament and the Council of November 30, 2009, on CosmeticProducts.

TESTS:

ANALYSIS USE:

Production batches compliance with product specifications, as well as evaluation of these specifications in time.

LEGISLATION-REFERENCE STANDARDS:

• Regulation 1223/2009 of the European Parliament and the Council of November 30, 2009, on Cosmetic Products.

PARAMETERS:

CHALLENGE TEST:

Challenge test is carried out to evaluate the preservative system efficacy incosmetic products. To achieve it, cosmetic product faces exponential cultures of different pathogens, which are monitored over a period of one month, in order to detect expecteddecrease due to preservative activity.

Cosmetics are monitored at the following times:

The assay, based on customer's requirements can be performed against the following pathogens:

LEGISLATIÓN-REFERENCE STANDARDS:

• ISO 11930:2012.
• European pharmacopeia.

UTILIDAD DEL ANÁLISIS:

ESTUDIO DE ESTABILIDAD INTRINSECA:

• Ciclos térmicos bruscos para emulsiones y suspensiones, que permiten ascelerar la aparición de posibles señales de inestabilidad prototipos en desarrollo, así como variantes del mismo.

ESTUDIO DE ESTABILIDAD A CORTO PLAZO PARA ESTIMACIÓN DE VIDA ÚTIL:

• La valoración del producto cosmético en condiciones de estrés térmico durante tres meses, permite anticipar la vida útil teórica del producto.

ESTUDIO DE ESTABILIDAD A LARGO PLAZO O "SHELF LIFE":

• Se comprobará la estabilidad del producto cosmético durante el periodo de vida útil establecido de manera predictiva.

LEGISLACIÓN-NORMAS DE REFERENCIA:

• Reglamento 1223/2009 del Parlamento Europeo y del Consejo de 30 de noviembre de 2009, sobre los Productos Cosméticos.
• Real Decreto 1599/1997 sobre Productos Cosméticos.
• The Stability Testing of Cosmetics - Cosmetics Europe - Personal Care Products Council - 2011
• Guía de Estabilidad de Productos cosméticos - ANVISA - 2005
• ICH Q1A - Stability testing. International Conference on Harmonisation - 2003
• ISO TR 13097 - Guidelines for the characterization of dispersion stability

ENSAYOS:

Se realizarán distintos ensayos en función de la naturaleza del producto, en diferentes condiciones según el estudio en cuestión.

ANALYSIS USE:

INTRINSIC STABILITY STUDY:

• Abrupt thermal cycling for emulsions and suspensions, will speed up the emergence of possible signs of instability, when developing prototypes or compairing them.

SHORT TERM STABILITY TEST FOR SHELF LIFE ESTIMATION:

• The assessment of the cosmetic product in heat stress conditions for three months, anticipates theoretical lifetime of the product.

LONG TERM STABILITY - SHELF LIFE:

• Cosmetic product predicted shelf life will be confirmed during lifetime.

LEGISLATION-REFERENCE STANDARDS:

• Regulation 1223/2009 of the European Parliament and the Council of November 30, 2009, on Cosmetic Products.
• The Stability Testing of Cosmetics - Cosmetics Europe - Personal Care Products Council - 2011
• Guía de Estabilidad de Productos cosméticos - ANVISA - 2005
• ICH Q1A - Stability testing. International Conference on Harmonisation - 2003
• ISO TR 13097 - Guidelines for the characterization of dispersion stability

TEST:

Different test will be performed according to the nature of the product, under different conditions.

ANALYSIS USE:

This test should be performed over final product and packaging, as complementary to Stability test, in order to detect interactions between the packaging and the product itself, that might alter product nature, or composite product safety.

Final product is analyzed over a period of three months within its final packaging, under different light and temperature conditions, in order to detect alterations.

LEGISLATION-REFERENCE STANDARDS:

• Regulation 1223/2009 of the European Parliament and the Council of November 30, 2009, on Cosmetic Products.

TESTS:

Different test will be performed according to the nature of the product, under different conditions.

• Test conditions: 5ºC (±3ºC) / 45ºC (±2ºC) / Light / Darkness
• Test period: 3 months
• Product analysis: Color, odour, aspect, product migration (Ftalatos, heavy metals)...
• Packaging analysis: Color, deformation, cracking...
• Funcionality: Colapse, pieces link...

ANALYSIS USE:

• In vitro safety evaluation of ingredients, complex ingredients or mixtures for the preparation of their Toxicology File.
• In vitro efficacy testing of the ingredient or product to claim certain efficacy.
• In vitro efficacy testing of the ingredient or product as a preliminary assessment prior to in vivo studies.
• Developing innovative protocols adapted to the needs of each ingredient mixture or by means of specialized tests.

TESTS:

Tests made by Invitrotecnia, member along with Dr Goya Análisis of the group of companies Lab&Clin Alliance.

ANALYSIS USE:

• Assessment of tolerance and skin compatibility of a cosmetic product, by means of studies performed under occlusion (Patch Test) or without occlusion (Open Test), with unique application or repeated applications (HRIPT), in extreme conditions.
• Verification of product acceptability,by means of a In-Use Test, under normal conditions of use. This Test allows enables the product to be classified as "Tested under dematologist control".
• Demonstration of a specific Efficacy of a cosmetic product by means of Efficacy studies, using objectve measurements with different scientific analyzers.

LEGISLATION-REFERENCE STANDARDS:

• Regulation 1223/2009 of the European Parliament and the Council of November 30, 2009, on Cosmetic Products.

ENSAYOS:

Tests made by Anmar Clinical Services, member along with Dr Goya Análisis of the group of companies Lab&Clin Alliance.

USE:

• Support in the legal aspects of the cosmetic company.
• Register of manufacturers and importers
• Technical support with independent professionals who may integrate into the company, as needed.
• Development of cosmetic products.

LEGISLATION-REFERENCE STANDARDS:

• Regulation 1223/2009 of the European Parliament and the Council of November 30, 2009, on Cosmetic Products.

APPLICATIONS:

REGULATORY: Follow-up of new regulations and adaption of companies for their compliance, both in processes as well as in documentation. MANAGEMENT OF AUTHORIZATIONS FOR MANUFACTURING AND/OR IMPORT ACTIVITIES OF COSMETIC PRODUCTS: Procurement or Renewal of Authorization for Manufacturing and/or Import Activities of cosmetic product, adapting facilities and all the necessary documentation required by the regulations in force in the country. PRODUCT INFORMATION FILE -PIF- AND SAFETY ASSESSMENT OF COSMETIC PRODUCTS: Elaboration of Product Information File and Safety Assessment of Cosmetic Products by qualified Safety Assesors, according to EU Regulation 1223/2009 on Cosmetics. RESPONSIBLE PERSON: Outsourcing of Responsible Person, qualified and with experience in the supervision of Manufacturing and Import Activities related to Cosmetic Products.