• • EXAMINATION OF THE MICROBIOLOGICAL PURITY The basis for the safety of the cosmetic is its microbiological purity. Each batch of cosmetic mass produced must be tested in accordance with the Regulation of the Minister of Health of 23.12.2002. (Journal of Laws No. 9 of 2003) according to ISO standards in force. 

  In order to confirm the purity of the cosmetic product, standard testing is performed:

  *Total number of microorganisms according to PN-EN ISO 21149:2009

  *Presence of Staphylococcus aureus according to PN-EN ISO 22718:2010

  *Pseudomonas aeruginosa presence according to PN-EN ISO 22717:2010

  *Presence of Candida albicans according to PN-EN ISO 18416:2009

  *Presence of Escherichia coli according to PN-EN ISO 21150:2010

  *number of moulds and yeasts according to PN-EN ISO 16212:2011

  • EFFECTIVENESS TEST / CHALLENGE TEST / LIABILITY TEST

  (PN-EN ISO 11930:2012) confirms that the used preservatives protect the cosmetic product against the development of dangerous microorganisms and also protect against the development of secondary infections during use by the consumer.

  The test consists of a controlled infection of the cosmetic product with standard strains of microorganisms (bacteria and fungi) and monitoring of the reduction of microorganisms in time.

  It is carried out at the stage of product development – in order to obtain a proper preservative system, but also during production. The tests at the production stage are performed to confirm that the technological process has no negative impact on the durability of preservatives and their effectiveness.

• The proper physical and chemical form of the cosmetics confirms their safety, stability and durability of their use properties. We offer research of:
  • Mass stability 
  • Stability of the mass and compatibility of the mass with the packaging
  • Ph measurement
  • Density measurement
  • Viscosity measurement
  • Organoleptic evaluation (appearance, color, smell)
  • Water activity
  • Determination of heavy metal content
  • Determination of concentrations of active ingredients
  • And other tests on request

Dermatological examination confirms the safety of contact of the cosmetic product with our skin. This is a so-called skin tolerance test for a given cosmetic, which is aimed at assessing its irritating potential. 

The test is carried out with the participation of a dermatologist on a group of 20 volunteers selected in accordance with the Helsinki Declaration, Polish and EU standards as well as recommendations and guidelines of Cosmetics Europe in the form of a patch or epidermal test.

We can also confirm product safety for people with particularly sensitive skin. This test is carried out on a group of people with a debilitating allergic history and a tendency to irritation. This test is performed with full control of the dermatologist over the entire course of the test.

According to current legislation, the person responsible for introducing the product to the market (manufacturer, distributor in the EU) ensures the compliance of the content of marketing statements regarding the product through documentation confirming the declared assumptions. This applies to all declared functional properties of the product, such as moisturizing, smoothing and strengthening the hydrolipid barrier of the skin. These properties must be confirmed by test reports.

We invite you to perform tests in our laboratory:

• Application tests – taking place with the participation of a group of volunteer probands in order to obtain their subjective opinion after the end of the product use period. Volunteers fill out a survey with questions and provide their own impressions of the cosmetics they use. Based on the collected surveys, statistics are created and a report is issued with the results and conclusions about the examined marketing declarations
• Special applications – intended for professional line products in order to assess the effectiveness of treatment and post-treatment cosmetics in aesthetic dermatology and cosmetology offices. In this case, the tests are similarly performed on a group of probands undergoing treatments performed by a cosmetologist or dermatologist.
• Instrumental tests – performed using specialized measuring equipment, often used as a supplement to application tests, which aim to present objective, numerical results confirming the specific effect of the cosmetic on the skin of the face or body. e.g. examining an increase in the level of hydration by x%, immediatly smoothes of wrinkles by x%.

The parameters tested are:

Hydration
Flexibility
Transepidermal water loss (TEWL)
Smoothing
Level of skin erythema/redness
Level of sebum secretion
Examination of the length and depth of wrinkles and their changes over time of product use

We take measurements with the ANTERA 3D skin analysis instrument and two measurement devices – MoistureMeterSC and ElastiMeter .

It is issued for every cosmetic product placed on the European Union market. The legal basis is the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59), which is valid from 11 July 2013. Regardless of the production process or distribution channels, cosmetic products placed on the EU market must be safe under normal and reasonably foreseeable conditions of use. The safety of these products is the responsibility of the manufacturer, who must also ensure that they undergo a specific scientific assessment for their safety before being placed on the market. Therefore, the most important document within the Product Information File (PIF) is the cosmetic product safety report documenting the safety assessment. It is a multi-stage process, requiring knowledge from different scientific disciplines: biology, chemistry, toxicology, etc.

The necessary documents for a reliable safety assessment are

• cosmetic product recipe

• • quantitative and qualitative composition (trade name, supplier name, INCI name, concentration, CAS no., einecs no., raw material function)
• documents describing raw materials:
  • safety data sheets, specifications, for raw materials that are mixtures, the exact composition % (or ranges), for nanomaterials: particle distribution curve, for fragrance compositions and essential oils: IFRA certificate and allergen form
• design of the label and/or cardboard and/or leaflet – data concerning the product name, application method, targeted group

• specification of direct packaging coming into contact with the product mass: material from which the packaging was made, manufacturer, compliance with 10/2011 and 1935/2004 or equivalent
• test reports on the finished product:
  • – finished product specification ( organoleptic/ph/ density/viscosity/storage method, expiration date etc.)
  • – report from tests of stability and compatibility of product weight with packaging
  • – microbiological purity test report (separate or as part of the analysis certificate)
  • – load test (if none – justification)
  • – dermatological examination
  • – application test
• a statement that the finished product and raw materials have not been tested for reported adverse reactions and serious effects all other data relating to the product or raw materials, test reports, not mentioned above, which may affect the quality, safety of the cosmetic product or compliance with current EU and EN law.