Cosmetics

We offer you:

  • Cosmetics Consulting – Toxicological and Regulatory Advice with in-house Toxicologists
  • Cosmetics Safety Assessment – Creation of Safety Assessments (Safety Report) for Cosmetics according to KVO according to the Requirements of the new Cosmetics VO 1223/2009 Annex I
  • Registration of Products at the EU portal CPNP (Cosmetic Products Notification Portal)
  • Cosmetics – Creation and update of the Product Information File (PIF)
  • Cosmetics Laboratory Management (Complete Cosmetic Test and Laboratory Service – more than 80 Laboratories in the Network) / Complete Cosmetic Testing Service
  • Cosmetics – in vitro Tests and Assays under GLP
  • Cosmetics – Product and Substance Screenings – non-GLP for R&D
  • Cosmetics – Project Management and Study monitoring
  • Product Testing for contained SVHC Substances / SVHC Screening
  • MSDS (Creation and updating of Material Safety Data Sheets)
  • Outsourcing Cosmetics – Laboratory Management and Regulatory Advice -> Outsourcing Service Partner for all your Scientific Laboratory Tests and Regulatory Cosmetics Tasks
  • New in vitro Innovations for Cosmetics

 

Dear customer,

INVITRO-CONNECT GmbH offers you a full service for the registration of your cosmetic products according REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009.

Furthermore we are offering you the complete testing range of cosmetic products according to the European Directive 76/768/EEC. These tests are usually carried out under GLP (Good Laboratory Practice) in an accredited test laboratory.

Cosmetic products are exempt from the authorization requirement, but certain ingredients such as coloring agents, preservatives and UV filters are subject to approval. The European Directive 76/768/EEC regulates the marketing of cosmetics and also contains the prohibited and permitted substances for the manufacture of the products. According the legislation animal testing should be avoided, if accepted in vitro studies are available.

From the development of an excellent test strategy, over the project and laboratory coordination to study monitoring, toxicological expertise and GLP inspections at the affiliated laboratories.

Benefit from our wide range of expertise, our experienced collaborators and an international well established network of partners: thoroughly selected experts, toxicologists and more than 80 accredited testing laboratories with an over 20 years’ track record in the industry.

INVITRO-CONNECT GmbH puts together the right team for each project. Thanks to our familiarity with the laboratories and the experts, we commission those most suited for the specific service. That way we can guarantee high-quality results.

We provide final test reports including the registration dossier, of course in the format of your choice, digital as well as on paper and worldwide.

We fully advise and support you with our expertise and the expertise from our whole global in vitro cooperation network.

We offer you all tests and services with the best price-performance ratio.

We are happy to also be your service provider and support your projects reliably –as we already do for many other satisfied clients.

For further information or interest in collaboration with us please do not hesitate to contact us personally. We are pleased to be of service to you.

Laboratory Tests according GLP and for Registration

Since September 11, 2014, there has been a ban on animal experiments in Europe for cosmetic protection. In addition, the regulation prohibits the placing on the market of cosmetic products that contain ingredients that have been tested on animals.

INVITRO-CONNECT GmbH is a competent service provider in the field of safety tests for cosmetics with the exclusion of animal experiments. In doing so, we have adhered to the so-called 3R concept according to W.M.S. Russel and R.L. Burch committed. This 3R concept was introduced in 1959. It includes a complete waiver of the use of animals in research (replacement) or – if this is not possible – a reduction in the number of animals used (reduction) and a reduction in the stress or suffering to which the animals are ultimately exposed (Refinement). The application of this 3R concept by promoting the development as well as the validation of substitute methods for the evaluation of chemicals and cosmetics is one of our concerns. With a number of alternative in vitro test methods, we are able to assess all the necessary toxicological data in a GLP-compliant manner.

INVITRO-CONNECT and cooperation partners offer you a complete service for approval in accordance with Cosmetics Regulation (EC) No. 1223/2009.

 

Testing of Cosmetic Ingredients and Products

Cosmetic Ingredients

For the safety assessment of cosmetic ingredients, the SCCS (Scientific Committee on Consumer Safety) gives recommendations on the procedure for testing: “THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION 10TH REVISION”, SCCS / 1602/18 Final version. Animal replacement methods must be used in cosmetics wherever methods validated by the ECVAM (European Center for the Validation of Alternative Methods) are available. This is called NAMs (New Approach Methodology).

INVITRO-CONNECT GmbH can support you with the following GLP tests and studies.

NAMs for skin and eye examination:

  • Skin Corrosion
    – OECD 431, EC B.40bis, RhE Test (Reconstructed Human Epidermis) with the validated human skin model EpiDerm ™
    – OECD 435, Corrositex® (In vitro Membrane Barrier Test Method)
  • Skin Irritation
    – OECD 439, RhE Test (Reconstructed Human Epidermis) with the validated human skin model EpiDerm ™
  • Eye Corrosion
    – OECD 437, EC B.47, BCOP (Bovine Cornea Opacity Permeability) Test
  • Eye Irritation
    – OECD 492, RhT (Reconstructed human tissue) basierter Test

NAMs for the investigation of skin sensitization according to the AOP (Adverse Outcome Pathway):

  • OECD 442C / EC B.59, In chemico Skin sensitization: Direct Peptide Reactivity Assay (DPRA)
  • OECD 442D / EC B.60, In vitro skin sensitization test by determining the activation of keratinocytes, ARE-Nrf2 luciferase (LuSens) method
  • OECD 442E / EC B.72, h-CLAT (Human Cell Line Activation test)

NAM for acute oral toxicity:

  • 3T3 NRU (Neutral Red Uptake) Test

Two tests for the base level genotoxicity testing of cosmetic substances:

  • OECD 471, Bacterial Reverse Mutation Test, covering gene mutations
  • OECD 487, In vitro Micronucleus Test for structural (clastogenicity) and numerical (aneugenicity) chromosome aberrations
  • Further studies for genotoxicity are: Chromosome aberration – OECD 473 / in Vitro Mammalian Cell Gene Mutation Test or Mouse Lymphoma Assay – OECD 476 / HPRT test or Point Mutation – OECD 476 / in vitro Micronucleus assay in Human Lymphocytes Assay – OECD 487

Physicochemical data:

  • Physical state, color, odor
  • EC A.6 Solubility in water and relevant solvents
  • EC A.8, n-octanol/water partition coefficient along with pH and temperature conditions (Log Pow)
  • EC A.9, Flash point
  • EC A.2, Boiling point
  • EC A.1, Melting temperature
  • EC A.3, Relative density
  • pKa
  • Viscosity
  • EC A.4, Vapor pressure
  • UV light absorption spectrum of compounds or UV filters
  • For Nanomaterials and Nanoparticles special requirements apply. Contact us for more information.

Biodegradability

In addition, INVITRO-CONNECT GmbH is specialized in biodegradability studies for ingredients and cosmetic products. E.g., the following studies are recommended to determine if the COSMOS standards for chemically processed agro-ingredients in organic and/or natural cosmetics are met:

  • OECD 301A, percentage of degradation > 70%
  • OECD 301B, OECD 301D, OECD 301F or OECD 310 meet a percentage degradation > 60%

Based on the Cosmetics Regulation, all studies will be carried out in accordance with the principles of Good Laboratory Practice (Council Directive 87/18/EEC).

 

Testing of Cosmetic Products

Before placing cosmetic products on the market, they need to undergo a safety assessment and the competent authorities should be notified of certain information as specified in the REGULATION (EC) No 1223/2009, Annex I.

INVITRO-CONNECT GmbH can support you with the following studies to fulfill your requirements.

The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product:

  • pH
  • Viscosity

A local toxicity evaluation:

  • In vitro skin irritation
  • In vitro eye irritation
  • In vitro skin sensitization

There is a rising public awareness regarding sustainability. INVITRO-CONNECT GmbH also offers biodegradability studies for cosmetic products:

  • Ready Biodegradability, OECD 301 A, B, D, F

And we can support you with studies to assess

  • Endocrine Properties

Cosmetic products containing Nanomaterials shall be notified to the Commission including a full characterization and toxicological profile of the material. Please ask for a tailor-made testing approach.

Cosmetic and personal care products are ranging from creams, lotions, soaps, bath and shower preparations, to deodorants, shaving products, make-up, hair colorants, toothpaste and sunscreen.

They are categorized in rinse-off and leave-on product as well as by intended area of application, e. g. skin, lip, face, nail, hair products.

If you need to rise experimental data for your ingredient or cosmetic product, don’t hesitate to contact the experts from INVITRO-CONNECT GmbH.

 

Evaluation of the Potential for Mutagenicity of Cosmetic Substances within the EU

In April 2014 the 8th Revision of the Addendum to the SCC`s Notes of Guidance (NoG) for the Testing of Cosmetic Ingredients was adopted, which includes a general recommendation for the evaluation of the potential for mutagenicity of cosmetic substances within the EU:

Addendum to the SCCS`s Notes of Guidance (NoG) for the Testing of Cosmetic Ingredients and their Safety Evaluation, 8th Revision, SCCS/1501/12, 9. April 2014.

According to the document two different genotoxic endpoints should be tested:

  • Mutagenicity (Gene mutation)
    Bacterial Reverse Mutation Test – Ames Test [OECD 471]
  • Structural and numerical chromosome aberrations (clastogenicity and aneuploidy)
    in vitro Micronucleus Test [OECD 487]

If the results of both studies should differ the performance of an in vitro Comet Assay is recommended.

In case of biocidal compounds, antibiotics or nanomaterials instead of a bacterial reverse mutation test a gene mutation test in mammalian cells should be performed like the HPRT Test or the Mouse Lymphoma Assay.

The following figure shows four different possible scenarios for testing the mutagenicity:

Ames Test
I
Negativ oder Positiv
I
Negativ = in vitro Micronucleus Test ———- Positiv = in vitro Micronucleus Test
I
Negativ oder Positiv ———- Negativ oder Positiv
I
Negativ = Keine weitere Testung oder Positiv = in vitro Comet Assay ———-  Negativ = in vitro Comet Assay oder Positiv = Keine weitere Testung
INVITRO-CONNECT GmbH offers an extensive service portfolio for the implementation of further studies and tests for the safety determination of the ingredients of cosmetics:
  • Endocrine active substances
    • Steroidogenesis ttest (OECD 456)
    • Androgen receptor binding assay (OPPTS 890,1150)
    • Estrogen receptor binding assay (OPPTS 1250)
    • Aromatase assay (OPPTS 890,1200)
    • Estrogen receptor binding assay (OPPTS 890,1300)
  • Reproduction toxicity
    • Embryonic stem cell test
  • Carcinogenicity
    • Cell transformation test (Bhas42)
    • Syrian Ham­ster Embryo (SHE)

Definitions

According to Regulation (EC) No. 1223/2009, a cosmetic is defined as follows:

“Cosmetic products are substances or mixtures that are intended to come into contact with the various parts of the human body (skin, hair system, nails, lips and intimate regions) or with the teeth and the mucous membranes of the oral cavity, namely for the exclusive or predominant purpose of cleaning them, scenting them, changing their appearance and / or influencing body odor and / or to protect them or to keep them in good condition. ”

This definition includes, for example, face and body care products, sun protection products, skin cleansing products, depilatories, deodorants and antiperspirants, shaving products, make-up, perfume, self-tanning products, hair and scalp care products, hair styling products and dental care products.

Demarcation

Since the legal provisions are very specific, a clear distinction between a cosmetic and other product categories, e.g. B. biocides, tattoo inks, drugs, medical products or food are particularly important.

Cosmetics Safety Assessment Contents

According to European regulations, a safety assessment of cosmetic products is mandatory, which ensures that the product does not pose any risk to the consumer.

Depending on the product category, how it remains on the skin and how it is absorbed through it varies, as does the amount and frequency of use. In addition, there are user groups whose special protection must be taken into account, such as children, pregnant women and breastfeeding women. Therefore, the choice of raw materials, also with regard to their impurities, can be decisive.

The legal requirement for the cosmetic safety assessment is divided into two parts:

A) The product information file

The product information file contains the following data in an easily understandable language (German or English):

  • the description of the cosmetic product
  • the intended use
  • the safety report
  • the manufacturing method
  • Good Manufacturing Practice Statement
  • Proof of the advertised effect
  • Data on animal experiments carried out

The responsible person shall make the product information file easily accessible to the competent authority in electronic or other format at the address indicated on the label.

The product information file must be created and kept up-to-date for each individual cosmetic product that is made available for the market.

It is kept for a period of ten years after the last batch of the cosmetic product was placed on the market.

B) The safety report

1) The safety information covers all essential characteristics of the cosmetic product and its ingredients that may be relevant for the safety of the product:

  • Composition of the product
  • physical / chemical properties and stability
  • microbiological quality / conservation
  • Contamination, traces and packaging material
  • normal and reasonably foreseeable use
  • Exposure to the product and the substances used
  • toxicological profile of the substances
  • unwanted effects
  • Evaluation result
  • Information on effectiveness studies
  • Complaint statistics
  • Validity, date, signature
  • Proof of competence of the safety assessors for cosmetics

2) In the safety assessment for cosmetics, the safety of the cosmetic product is justified on the basis of the data in the safety report – possibly with the addition of certain warning notices.

Place and period of availability:

The product information file must be kept for a period of ten years after the date on which the last batch of the cosmetic product was placed on the market. The place of availability is the address of the responsible person, which is also given on the label of the product.

Definition of the responsible person

According to Article 4 of the EU Cosmetics Regulation:

  • The person responsible for a cosmetic product manufactured within the Community that is not subsequently exported and re-imported into the Community is the manufacturer established in the Community. The manufacturer can use a written mandate to designate a person resident in the community as the responsible person who accepts the mandate in writing.
  • If the manufacturer of a cosmetic product manufactured within the Community that is subsequently not exported and re-imported into the Community is located outside the Community, he shall designate a person resident in the Community as the responsible person who accepts the mandate in writing by means of a written mandate.
  • In any case, for an imported cosmetic product, the importer is the person responsible for the specific cosmetic product that he places on the market. The importer can, by means of a written mandate, designate a person resident within the community as the responsible person who accepts the mandate in writing.
  • The retailer is the responsible person if he puts a cosmetic product on the market under his own name and brand or changes a product that is already on the market in such a way that compliance with the applicable requirements may be affected.

Reference is made to the additional definitions in Art. 2 of the EU Cosmetics Regulation.

The obligations of the responsible persons and the dealers are set out in Art. 5 and 6 of the EU Cosmetics Regulation.

Required documents for the product information file including safety report

  1. the (exact) recipe of the preparation, if necessary nondisclosure agreement
  2. Safety data sheets and specification, certificate of analysis, microbiological status of each of the ingredients
  3. Physical, chemical data of the preparation, if applicable (PH, viscosity, color, important particle size for nanomaterial, excessive grease)
  4. Description of the product including application quantities (including labeling)
  5. Product stability (e.g. 3 months at 40 ° C)
  6. Preservation load test / germ load test
  7. If necessary, skin compatibility tests (e.g. human patch test)
  8. if necessary, effectiveness tests
  9. If applicable, INCI declaration, IFRA certificates, if perfume oil is available. (without an IFRA certificate, additional costs may arise)
  10. Packaging documents (EC declaration of conformity according to 1935/2004 and (EU) 10/2011 and SVHC declaration)
  11. Information on the microbiological contamination of the product (e.g. bioburden tests of the last 3 batches)
  12. if applicable, GMP certificate (or confirmation of good manufacturing practice)
  13. if necessary, statistical evaluation of complaints
  14. possibly product information file without a safety report
  15. Information on animal experiments with regard to the raw materials and product (confirmation “no animal experimentation”)
  16. Information on the manufacturing process
  17. if necessary, toxicological profiles of the raw materials from the manufacturer
  18. Others

Your direct contact

Dr. Ute Hassmann

+ 49 7223 806 932 2
hassmann@invitro-connect.com
INVITRO CONNECT GmbH