The label is the most important element of the product from a marketing point of view. The content of the label content is regulated by law. The responsible person must ensure that the product label complies with legal requirements. We provide support in creating the correct product labeling and we verify the content of the descriptions on the unit packaging label. The purpose of verification is to ensure product compliance with legal requirements and to create the highest quality product
An element of product labeling are marketing claims related to the efficacy of the product. According to Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products Text with EEA relevance all cosmetic products should confirm common criteria: Legal compliance, Truthfulness, Evidential suport, Honesty, Fairness, Informed decision-making. We provide consultancy and professional assistance in creating unique marketing descriptions, ensuring compliance with legal requirements. We also conduct performance tests to confirm the descriptions used.
The composition of the cosmetic product is created in accordance with the INCI names – International Nomenclature of Cosmetic Ingredients. The composition of the product must be in accordance with the law and meet the safety requirements. The composition must be verified for the content of prohibited substances (Annex II) and the content of substances subject to legal regulations such as preservatives, dyes and UV filters (Annex III, IV, V, VI). All ingredients contained in the product should be included in the list of ingredients and the conventions for creating a list of ingredients are provided by law
Every company that launches a cosmetic is obliged to register in the system ECAS – EU Login. It is the European Commission Authentication System, which enables access to websites and websites maintained by the European Commission, including the Union Registry. It replaced the previously used ECAS system in November 2016 (ECAS – European Commission Authentication Service).
Each cosmetic product placed on the market must be registered in the CPNP system. Product notification in the CPNP system takes place in accordance with the requirements of art. 13 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council. Notification to the base product CPNP does not mean that the cosmetic has been approved for sale! The data contained in the CPNP database are made available to all competent authorities and poison centers or authorized units. These entities may use this information only for treatment purposes.
The cosmetic product safety report is an expert document containing the Safety Assessor conclusion in the field of safety. Raport tworzony zgodnie z aktualnymi wymaganiami prawnymi i w oparciu o wytyczne z załącznika i rozporządzenia parlamentu europejskiego i rady (we) 1223/2009. Cosmetic Product Safety Report (CPSR) is created according to requirements in Annex 1 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council and taking into account the current legal status . Based on the analysis of the qualitative documentation and the test results provided in Part A, the Safety Assessor issues opinions and determines the degree of product safety as well as the labeling and the need for additional precautions. Documentation is verified individually depending on the type of product being assessed. For each cosmetic product, the range of requirements is individually selected based on information about the composition, packaging, purpose and experience with similar products.
The cosmetic safety assessment report is created in close cooperation between the manufacturer and Safety Assessor and is subject to verification by supervisory bodies. Nadzór nad bezpieczeństwem produktów kosmetycznych w Polsce sprawuje Państwowa Inspekcja Sanitarna. The Safety Assessor’s competence is determined by law and is subject to strict control, and the qualifications of an expert performing a safety assessment should be an indispensable element of the safety report.
A graduate of Chemical Technology at the Faculty of Food Sciences and Biotechnology of the Lodz University of Technology and post-graduate studies in the “Application, production and evaluation of cosmetic products” at the College of Cosmetics and Health Care in Warsaw. Chemical technologist with laboratory expierence of cosmetic formulation. She has practical knowledge in technology, law requirements in the field of cosmetic products, detergents as well as medical devices. She works as cosmetic safety assessment specialist for five years. The knowledge gained by participating in high quality training organized by the the Vrije Universiteit Brussels „Safety Assessment of Cosmetics in the EU – Training Course” and courses conducted by the German trade associations (DGK – German Society for Scientific and Applied Cosmetics and IKW – German Cosmetic, Toiletry, Perfumery and Detergent Association). Author of publications in trade press and magazines. The author of publications in the trade press and magazines and the speaker at conference speeches and trainings on topics related to legal requirements, technical aspects related to the product implementation and creating product documentation.
Cosmetic products placed on the European Union (EU) market have high standards of safety and quality. Undesirable effects as a result of normal or reasonably foreseeable use1 of cosmetic products are rare and are typically mild in nature and completely reversible. Each company will have procedures to enable it to react appropriately to all reports of undesirable effects covering their recording and assessment and understanding their nature and future prevention. For companies, this plays an important role in the post-marketing surveillance of cosmetic products and their performance in the marketplace. The regulation provides for the immediate reporting of only serious adverse reactions (Article 23) to the competent authorities of the Member State in which the action occurred, and the reporting of any corrective measures taken by the responsible person or the distributor. Data on serious adverse reactions are included in the cosmetic product safety report and must be made public .
Information on an adverse reaction must be updated and regularly made available to the safety assessor who may need to change the safety assessment, suggest a formulation improvement, or use information to make a safety assessment for similar products.
The material safety data sheet is an information document in the supply chain, which is prepared in accordance with the requirements of Regulation (EC) 1907/2006 of the European Parliament and of the Council of December 18, 2006 on the registration, evaluation, authorization and restrictions of chemicals ( REACH). The material or mixture safety data sheet should be delivered to the recipient free of charge in paper or electronic form, no later than on the day of placing on the market. In accordance with art. 31 of Act 5 of the REACH Regulation should be delivered in the language of the country to which the product is intended (in Poland in Polish).
The claim “hypoallergenic” can only be used in cases, where the cosmetic product has been designed to minimize its allergenic potential. The responsible person should have evidence to support the claim by verifying and confirming a very low allergenic potential of the product through scientifically robust and statistically reliable data (for example reviewing postmarketing surveillance data, etc.). This assessment should be updated continuously in light of new data. If a cosmetic. The use of the claim “hypoallergenic” does not guarantee a complete absence of risk of an allergic reaction and the product should not give the impression that it does. The companies should consider whether consumers, in the respective country, understand the claim “hypoallergenic”. If necessary, further information or clarification regarding its meaning should be made available.
Natural cosmetics are a segment of cosmetic products whose composition consists entirely or mainly of raw materials of natural origin. From a legal point of view, natural cosmetics do not have a separate definition and are subject to standard law. Natural cosmetics have gained a lot of popularity but we also observe adulteration. The terms ‘natural’ or ‘organic’ are often abused when referring to cosmetics, which contain only trace amounts of raw materials of natural origin. It is possible to quantify the naturalness of a cosmetic product, which allows a fair representation of the quality of the composition. Verification of recipe compliance is based on the technical requirements contained in the standards :
- ISO: ISO 16128-1: 2016, Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients and products — Part 1: Definitions for ingredients
- ISO 16128-2: 2017 Guidelines on technical definitions and criteria for natural & organic cosmetic ingredients and products — Part 2: Criteria for ingredients and products
The quantitative determination of the amount of microorganisms in the sample tested. The test consists in the quantitative determination of the content of microorganisms in the cosmetic sample tested. Quality criteria in accordance with the requirements of the PN – EN ISO 17516: 2014 standard.
Microbiological quality study include:
- enumeration microorganisms of mesophilic aerobic bacteria
- enumeration of yeast and mold in cosmetics
- detection of pathogenic microorganisms: Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Candida albicans
Preservative challenge test
The aim of the study is to confirm the effective dose of preservatives in the initial stage of product preparation for implementation. Challenge test results are necessary for each cosmetic product and are an essential element of the safety assessment. Challenge testing involves the evaluation of antimicrobial efficacy of the preservative system in accordance with the relevant standards: International Standard ISO PN – EN ISO 11930:2012 or according to the commercial method developed by Schülke “SM 021 schülke KoKo test” Determination of the Preserving Effect of Chemical Preservatives in Cosmetic Formulations “.
Examination of the skin microbiome
The skin is the human body’s largest organ, colonized by a diverse milieu of microorganisms, most of which are harmless or even beneficial to their host. The primary role of the skin is to serve as a physical barrier, protecting our bodies from potential assault by foreign organisms or toxic substances. The skin is also an interface with the outside environment and, as such, is colonized by a diverse collection of microorganisms including bacteria, fungi and viruses, as well as mites. Many of these microorganisms are harmless and in some cases provide vital functions that the human genome has not evolved. Symbiotic microorganisms occupy a wide range of skin niches and protect against invasion by more pathogenic or harmful organismsThe pH of the skin has a significant effect on the balance of the skin’s microflora. The skin’s pH value is within 4-6, taking into account racial and anatomical differences. The acidic pH of the skin directly affects the maintenance of the dermis microbiome of the skin and ensures the proper protective functions of the skin. The increase in skin pH is associated with the pathogenesis and severity of many skin diseases. Testing the ability of recovery of the skin microbiome determines the ability of recovery of the skin or microbiome characteristic test of the body, ie. It is determined whether the skin following the symbiotic colonization / common bacteria and concomitant reduction of pathogens after application of the cosmetic product tested.
Antimicrobial efficacy test
Human skin is characterized by a constant microflora, which under normal conditions remains in natural balance. The microorganisms that inhabit it differ in their location in individual body parts depending on the temperature, humidity and pH, as well as the age and sex of human. The main representatives of the solid microflora that inhabits the skin include: staphylococci (S. epidermidis, S. capitis – occurring on the scalp, S. homnis – on the surface of arms and legs, S. aureus – on the skin of the hands, cocci (Enterococcus – on the skin of the groin, Streptococcus sp., Micrococcus sp.), bakterie z rodzaju Propionobacterium (in the deeper parts of the hair follicles and sebaceous glands), and also fungi – Candida sp. – found on the skin around the groin and armpits and around the toes.
The aim of the study is to assess the antimicrobial effect of the cosmetic product being assessed on selected bacterial strains and on a mixture of bacterial strains isolated from the skin surface of volunteers (bacteria). The antimicrobial effect of the test product was assessed on the basis of a reduction in the number of viable microorganisms after a selected time of contact with the test product compared to the control.
Tests performed in all types of cosmetic preparations and are aimed at determining the quality parameters of the product. The type of physicochemical tests performed depends on the tested product and its chemical composition and properties. Physicochemical tests are also an element of stability and compatibility tests.
Parameters of physicochemical tests:
– organoleptic evaluation (appearance, color, smell, consistency)
– determination of the pH of the solution and / or product
– density determination
– determination of viscosity
– weight loss / packaging tightness
The objective is to determine the level of water activity in the product to confirm the inclusion / exclusion capacity of proliferation of micro-organisms in the product. The effect of reduced water activity on microorganisms is well documented . Due to the fact that it is not possible for microbes to multiply in preparations with a water activity below 0.7, there is no need to carry out conservation efficacy studies in such preparations. In the absence of chemical preservatives, the low value of water activity is sufficient to maintain proper product preservation. The course of the test in accordance with PN ISO 21807: 2005
The study of water activity is dedicated to anhydrous cosmetics, oil forms, eye shadows, talcum powder and face powders.
The test aims to confirm the stability and compatibility with product packaging after long period of storage. An assessment of the stability of the cosmetic product under reasonably foreseeable storage conditions is required. Data from stability tests used to justify the indicated minimum durability.
- The test conditions and duration are selected individually for the type of product, packaging and declared conditions of use and storage.
- Compatibility tests of the finished product are carried out in the target packaging to exclude the negative impact of the packaging material on the stability of the finished product and to determine the possible interaction of the cosmetic mass with the packaging material.
- The product’s expiration date and storage conditions are determined based on the stability and compatibility tests performed..
PAO (Period After Opening) CONFIRMATION
The purpose of the test is to confirm the PAO – Period After Opening declared by the manufacturer after opening :
- Expressed in months (M) or years (Y). Contrary to the date of minimum durability, the PAO period should take into account the risk of secondary microbial infection.
The durability of the cosmetic after opening, during the period of use is much shorter than when the product is standing closed on the shelf.
Assessment of irritating and allergenic (skin tolerance) properties of a cosmetic product / household chemistry in a healthy adult volunteer by applying a patch test once and taking skin reaction readings after 48 and 72 hours. The study was conducted under the supervision of a dermatologist on a properly verified panel of people.
Assessment of features and efficacy decide of the purchase guarantee because it allows to assess consumer preferences. The test allows the assessment of sensory features such as appearance or smell, as well as the assessment of individual performance characteristics for cosmetics: efficiency, ease of distribution, durability, quality and type of packaging used, and for household chemistry products: time and effectiveness of dirt removal, or ease of application, ergonomics packaging, efficiency of use. Comparative studies also allow comparative assessment of two or more products. Research allows quantitative analysis of results, the interpretation of which is supported by statistical analysis. A wide range database of volunteers allows to match the profile of a group of volunteers with features suitable for the research project. The tests are performed ethically, taking into account the principles of the Helsinki Declaration and Good Clinical Practices. Research carried out in a modern and expertly equipped laboratory allows for monitoring of the conditions of evaluation and control environmental parameters (size, temperature and humidity rooms).
- Use test for household chemistry products
- Detergent usage tests in accordance with ECOLABEL methodology
- Evaluation of cleaning efficiency of dishwasher detergents
- Hypoallergenic assessment of fabric softeners
- Use test for cosmetic products
- Use test for animals care products
- Comparative study
- Application studies for skin care cosmetics
- Application studies for hair cosmetics
- Application studies for cosmetics for oral hygiene
- Application studies for cleansing cosmetics
- Application studies for antiperspirants
- Evaluation of soothing
- Assessment of anti-dandruff effect
- Evaluation of the effectiveness of intimate hygiene products
- Evaluation of the effectiveness of oral hygiene products
- Evaluation of the effectiveness of slimming and anti-cellulite cosmetics
- Evaluation of the effectiveness of nail polishes and conditioners
- Tests under the supervision of a doctor or a qualified specialist: dermatologist, ophthalmologist, podologist, trichologist, cosmetologist, beautician
Examination of parameters determining the condition of skin, hair and nails using non-invasive research techniques. The tests are performed ethically, taking into account the principles of the Helsinki Declaration and Good Clinical Practices. We have specialized laboratory facilities. The modern laboratory surface and high-quality research equipment of well-known and reputable manufacturers allow for high-quality testsMonitoring of laboratory conditions allows conducting tests in a standardized and controlled manner. Tests carried out in controlled ambient conditions using specialized research equipment allowing for a reliable and credible assessment of the effectiveness of preparations used on the skin. Quantitatively presented test results allow for precise determination of the impact of the tested product on skin parameters.
INSTRUMENTAL TESTS FOR THE EVALUATION OF SKIN CONDITION
- Measure of skin hydration
- pH measurement
- transepidermalna utrata wody (TEWL)
- elasticity / firmness
- level of erythema / redness of the skin
- sebum level
- wrinkle surface
- skin tone
- full-size 2D / 3D face photography
- ultrasonic measurement of skin thickness and density
- measuring the gloss of hair, teeth and skin
INSTRUMENTAL TESTS FOR EVALUATION OF HAIR AND NAIL CONDITION
- Hair loss measure
- Assessment of scalp
- Hair density and thickness
- Sensitivity of the scalpTłustość włosów
- The condition of hair follicle
- Hair cuticle
- Trichoscopic analysis of hair thickness and density: assessment of the effectiveness of preparations stimulating hair and eyelash growth
- Testing the length and thickness of the nail plate
Sunscreen products, as defined, are preparations intended to come into contact with human skin, exclusively or primarily to protect against UV radiation. The efficacy of sunscreen products, and the basis on which this efficacy is claimed are important public health-issues. The Recommendation on the efficacy of sunscreen products and the claims made relating to them, adopted in 2006, addresses these issues and sets out the:
- claims which should not be made in relation to sunscreen products
- precautions to be observed including application instructions
- minimum efficacy standard for sunscreen products in order to ensure a high level of protection of public health
- simple and understandable labelling to assist in choosing the appropriate product.
The degree of protection should be provided by specifying numerical category and protection against UVB (SPF value specified). The effectiveness of sunscreen products is divided into categories: “low”, “medium”, “high” and “very high”. Each category should correspond to the degree of protection against UVB radiation and UVA should constitute at least 1/3 of the declared UVB protection. Keep in mind that the SPF factor of this declaration, which refers only to protection against UVB. The appropriate SPF is selected depending on the results obtained (SPF 6, 10, 15, 25, 30, 50 and 50+). There are appropriate research methods to assess the degree of protection against UVA and UVB rays. The testing methods referred to in this recommendation are currently subject to standardisation by the European Committee for Standardization CEN.
TYPE OF TEST:
- Determination of the SPF sun protection factor in vivo by EN ISO 24444
- Determination of the level of UVA sunscreen in vitro according to EN ISO 24443
- Water resistance/ high water resistance testing in vivo by EN ISO 24444 and Cosmetics Europe guidelines
Adverse reactions of cosmetic products related to light exposure include phototoxic and photoallergic reactions. Substances with phototoxic potential are widely used in cosmetic products, often as active substances having a positive effect on the skin. The negative effect only manifests as a result of skin sun exposure. To exclude the occurrence of allergic or toxic changes after exposure to UV radiation, phototoxicity and photoallergy assessment is performed.
TYPE OF TEST:
- Determination of photoallergic properties according to Cosmetics Europe guidelines
- Determination of phototoxic properties according to Cosmetics Europe guidelines
ELABORATION OF COSMETIC RECIPES
- FULL ADAPTATION OF THE RECIPE TO THE EXPECTATIONS
Before starting the formulation, the customer can specify all product parameters: from efficacy/active ingredients, through raw materials, to consistency or the final price of the cosmetic. This service is fully profiled to meet customer expectations.
- WORKING TOGETHER ON COSMETIC FORMULATION
After accepting the product concept, including the proposed composition, marketing declarations and estimated batch price, samples of cosmetic products are prepared and sent. As part of recipe design, customers can receive subsequent versions of the cosmetic product so that the final recipe fully meets their expectations.
- COMPLETE DATA TO START PRODUCTION
- The developed recipe contains qualitative and quantitative composition, general production technology, basic physico-chemical data, proposed raw material suppliers, contact details for them, estimated time of waiting for the raw material and the calculated price of the raw material for the smallest available packaging.
- EXCLUSION AND PROPERTY COPYRIGHT
The designed recipe becomes the exclusive property of the customer.
- MODIFICATION OF EXISTING RECIPES
Modification of recipes entrusted by the customer in accordance with his expectations and requirements
IMPLEMENTATION OF THE GMP COSMETIC STANDARD
Article 8 of Regulation (EC) No 1223/2009 / EC of the European Parliament and of the Council on cosmetic products imposes the obligation to produce cosmetics in accordance with the principles of Good Manufacturing Practices (GMPThe PN-EN ISO 22716: 2009 standard, which is a guide to Good Cosmetics Production Practices, includes guidelines for the production, control, storage and transport of cosmetic products, and covers product quality aspects.
Benefits of implementing Good Manufacturing Practices in accordance with ISO 22716:
- FULFILLMENT OF LEGAL REQUIREMENTS
Production of cosmetics in accordance with Good Production Practices ISO 22716 is a legal condition for placing the cosmetic product on the market
- IMPROVEMENT AND ORDERING THE ORGANIZATION FUNCTIONING AS A WHOLE
A clear and transparent documentation system specifying the procedures to be followed, defining the forms for keeping the necessary entries and specifying the tasks, rights and responsibilities of individual employees. A perceptible increase in the awareness and responsibility of employees and the extension of the service life of equipment through their proper use and regular maintenance.
- IMPROVEMENT THE QUALITY OF THE FINISHED PRODUCT
Compliance with the requirements of the GMP guide guarantees quick detection of non-compliance and responding to the possibility of their occurrence by introducing appropriate controls, ensures the production of a safe cosmetic product and minimizes the risk associated with placing a dangerous product on the market.
- GROWTH OF CUSTOMERS`S TRUST
The increase in the competitiveness of the entity and its brand associated with the increase in customer confidence
We guarantee high guality of wide range of trainings. In our offer you can find:
- Labelling and correct claims comminucation for cosmetics according to law requirements
- Toxicological assessment of substances as key parameter of cosmetic safety assessment
- Law requirements for chemical substances used as cosmetic raw materials
- Cosmetic product`s documentation – law requirements
- Borderline products – Regulatory issues related to proper product classification
- Actual law requirements for detergents
- Cosmetics for animals – Legal requirements
- Micropigmentation preparations used in tattoo and permanent makeup
In our offer you can find interna trainings which are suitable for individual needs of company of cosmetic, household and medical devices industry. Schedule is creating based on the required range of thematic issues. Individual training offer organized at the place and time indicated by the client, adapted to the subject, duration and number of participants. The training offer also includes paper or electronic training materials and course completion certificates. We also offer free post-training consultations.
We offer free post-training consultations !