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1 Biological Safety Testing of Cosmetics

2 Content 01 Introduction p 3 02 Biocompatibility p 5 Cytotoxicity p 5 Genotoxicity p 5 Skin Corrosion p 6 Skin Irritation p 6 Skin Sensitization p 7 Eye Irritation p 7 Mucosal Irritation p 8 03 Microbiology p 9 Bioburden p 9 Stability Testing p 10 Stress Testing p 10 Endotoxin Testing p 11 Method Implementation and Validation p Contact p 12

3 01 Biological Safety Testing of Cosmetics As a specialized testing and analysis laboratory MicroMol offers a wide range of methods for the safety testing of cosmetics, according to the requirements of the EU Cosmetics Regulation (EC) no. 1223/2009, which is valid since July Cosmetic Directive 1223/2009 Key issue of the new Cosmetics Directive is to increase product safety and product quality before placing on the market. Manufacturers of cosmetic products have to ensure that their products do not pose any risks to human health. Accordingly, cosmetic manufacturers are required to evidence following requirements: - Proof of the effect claimed as established - Analysis of microbiological quality, including efficacy of preservation - Safety testing concerning human health, described in a safety report - Evidence of compliance with the GMP guidelines - Labelling of nanomaterials Biological Safety Service To ensure the quality and product safety of the product, our specialized laboratory offers the following biological safety services: In vitro methods according to the EU Cosmetic Regulations EC 1223/2009 Microbiological quality assurance of cosmetics and their raw materials Chemical quality assurance of cosmetics and their raw materials* Process controls, such as hygiene control, airborne germ measurement measurements, control of surfaces and staff In-house hygiene training Provision of expert reports Skin compatibility tests (patch tests) Verifications of labelling law requirements Safety assessments *In cooperation with our partner laboratory

4 01 Biological Safety Testing of Cosmetics MicroMol and its experts will assist you in the risk assessment of your cosmetic product or your manufacturing process as well as in the physical, chemical and microbiological analysis of your cosmetic product according to your specific needs and requirements. Body Contact Cosmetic Product Product Component Manufacturing Process Cytotoxicity (ISO ) x x Biocompatibility Genotoxicity (OECD TG471/476) x x Skin Irritation (OECD TG 439) x x Skin Corrosion (OECD TG 431) (x) (x) Skin Sensitization (OECD TG 429) x x Eye Irritation (OECD TG 460) x x Mucosal Irritation (OECD TG 431) x x Bioburden (ISO 11737) x x x Microbiology Stability Testing (ISO 11930:2012) Stress Testing (ISO 11930:2012) Endotoxin Testing Method Implementation x x x x Method Validation x Table 1: Biological Safety Testing Matrix. All tests are offered by MicroMol.

5 02 Biocompatibility Since 2013 the Directive 1223/2009 demands new requirements for the cosmetics industry and their manufacturers. New ingredients that are manufactured in or imported into the EU must be tested for their toxicity and general biocompatibility especially on skin and eye. MicroMol offers - as an alternative to animal experiments - validated in vitro methods for the evaluation of complex cosmetic formulations, ingredients, fragrances, stabilizers and solvents - either as single test or in specialized combination. Cytotoxicity (DIN EN ISO :2009) According to the latest requirements of DIN EN ISO cosmetic products and their ingredients, fragrances, stabilizers, detergents and solvents have to be evaluated with regard to their cytotoxic potential. MicroMol offers in addition to the standard analysis in validated mammalian cell models, the analysis on human skin keratinocytes, which imitate the physiologic skin structure. Therefore, this model is particularly interesting for the cosmetics industry. Genotoxicity (OECD TG 471/476) MicroMol provides to determine or to exclude a potentially mutagenic effect of complex cosmetic formulations, ingredients, fragrances, stabilizers and solvents with well established in vitro test systems accepted by the OECD: Ames Test (OECD TG 471) In this test the test samples are confronted with growth-limited bacterial strains, which are analyzed according to their ability to proliferate on minimal medium after substance treatment. Mammalian Cell Mutation Test (OECD 476) In this test mammalian cells are confronted with the test material. The reversion of a normally toxic metabolic pathway after substance treatment represents a measure for the mutagenic potential of the test substance. The test is

6 02 Biocompatibility verified by the inclusion of international accepted control substances. In addition to the test performance, MicroMol assists to define the correct testing modules (classification of testing material according to its chemical and physical properties, extraction conditions, concentrations, etc.) for the individual test samples. Test Systems according to OECD TG 429/431/439/460 In addition to the assessment of potential toxic effects of cosmetics there is a risk, that the substances are directly irritative or corrosive against defined and exposed surfaces such as the skin or eye. MicroMol provides the testing of cosmetics and extracts for reconstituted human epidermis and on ocular cell systems, according to the OECD Guidelines 431/439 or 460 as a singular test or as a complete package. Additionally MicroMol offers the determination of influence on skin pigmentation / depigmentation (SkinEthic, RHE-system) as well as the determination of phototoxic effects (OECD 432 In vitro 3T3 NRU Phototoxicity Test). MicroMol provides following validated biocompatibility test systems: Skin Corrosion (OECD TG 431) The Skin Corrosion test of cosmetics, evaluates the potential destructive (skin corrosive) effect on human skin in accordance with the requirements of OECD TG 431 *. The test material will be analyzed directly and/or in the form of extract material under controlled conditions. The test material is applied on so-called reconstructed human epidermis (RHE). RHE shows the physiological properties of normal skin. The corrosive effect is quantified by the conversion of MTT tetrazolium dye of the viable cells. Skin Irritation (OECD TG 439) The Skin Irritation Test determines the irritative potential of cosmetics on human skin. The test replaces the Draize test with a human skin cell culture system (OECD TG 439).

7 The test is similar to the evaluation test of skin corrosion. For a defined period of time, followed by a recovery phase, the test material is applied - directly and / or as an extract- to the RHE, before the irritant effect can be quantified. Skin Sensitization (OECD TG 429) Skin Sensitization and potential allergenic effects of cosmetics are determined using the Local Lymph Node Assay (LLNA) according to OECD TG 429. MicroMol offers the possibility to evaluate medical devices according to the OECD TG 429 in cooperation with a laboratory specialized in animal studies. Eye Irritation (OECD TG 460) Destruction or irritation to ocular tissues towards direct or indirect exposure is a serious problem of cosmetics. The fluorescein leakage test (OECD TG 460) and on special request the SkinEthic HCE model excludes a potential corrosive effect of the cosmetic ingredients and preparations. Figure 1: MTT-staining 42h after treatment

8 02 Biocompatibility Determination of destructive effects on mucosal surfaces (SkinEthic) MicroMol offers the determination of a potential irritant or corrosive effect of cosmetics, ingredients, fragrances, stabilizers and solvents or their extracts in several epithelial / mucosal Skin Ethic test systems, including oral epithelium (HOE-assay), gingival epithelium (HGEassay), ocular epithelium (HOE-assay) and vaginal epithelium (HVE-assay). The following test combinations are offered by MicroMol: Complete Eye Package: The package includes three tests, that determine if cosmetics or components have a toxic (Determination of in vitro cytotoxicity according to DIN EN ISO ) or an aggressive effect on the eye (Fluorecein leakage test according to OECD 460, HET-CAM assay or SKINETHIC HCE model). *In vitro cytotoxicity test (ISO DIN /12) and skin corrosion testing (OECD 431) are accredited according to the ISO 17025, GMP and the ZLG. Complete Skin Package*: The package includes three tests, that determine if cosmetics or components have a toxic (determination of in vitro cytotoxicity according to DIN EN ISO ) or an aggressive effect on the skin (determination of skin irritation and skin corrosion according to OECD TG 431/439).

9 03 Microbiology Microbiological Analysis of Cosmetics To ensure the quality and product safety of cosmetics it is necessary to evaluate the product or its components with defined microbiological tests, according to the EU regulations Notes of Guidance for the Testing of Cosmetic Substances and their Safety Evaluation of the SCCS (Scientific Committee on Consumer Safety) before placing on the market. MicroMol offers the most important test systems to the cosmetic industry or rather to the manufacturers of cosmetics. Determination of the Bioburden (TAMC, ISO 11737) Bioburden or bacterial burden defines the total aerobic microbial count (TAMC) of bacteria and yeast that are present in or on the product before sterilization. Cosmetic products may be contaminated in two ways: either by contamination in the production process or by the consumer during usage. By routine microbiological controls during production and bottling batches are checked for impurities. The germ load when using the product is restricted by a preservative. MicroMols microbiological methods identify the number of colony building units (cfu) on solid culture media. The counted results are compared with the limits of the two categories of cosmetic products: - Category 1: Cosmetic products applied on areas around the eye and of mucosal membranes of children < 3years(<10 2 cfu/ml or g)* - Category 2: All other products (< 10 3 cfu/ml or g)* *Pseudomonas aeruginosa, Staphylococcus aureus and Candida albicans shall not be detectable in 1 g or 1 ml of a compound/product from category 1 and in 100 mg or 100 μl in a compound/product from category 2. In this regard the determination of pathogenic germs can be specifically determined by differential plating technologies.

10 03 Microbiology Stability Testing (DIN EN ISO 11930:2012) In addition to the health safety the stability of the product is an important aspect for all cosmetic preparations. The purpose of stability testing is to determine the changes of a cosmetic product or its ingredients under certain conditions (temperature, humidity, light) for a specified period of time. The results are used - inter alia - to derive the durability and the recommended storage conditions of the cosmetic product. MicroMols services include the advising of stability studies, the stability plan including protocol, storage, method development and validation, the analysis of cosmetic products, the implementation of microbiological tests as well as the stability report. Testing of Efficacy of Preservation (DIN EN ISO 11930:2012, CTFA or Ph Eur (GMP)) Both the EU Cosmetics Regulation (EC) and the guidelines of the SCCS (Scientific Committee on Consumer Safety) requires the testing of efficacy of preservation for cosmetics, but without specifications for implementation and evaluation of tests. In the testing of efficacy of preservation MicroMol complies with the recommendation of DIN EN ISP 11930: 2012 "Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product". In the test cosmetics are inoculated with germs. The microbial reduction is checked at regular intervals over a period of time, to verify the germreducing and accordingly preservative effect of the preservative agent. Furthermore MicroMol offers the recommended "proof of the effectiveness of the neutralizing agent" as a pre-test. The test verifies the growth of various cultures of microorganisms in the presence and absence of the test product and the possible neutralization of preservatives.

11 Endotoxin Testing Endotoxin is a component of the outer cell membrane of gram-negative bacteria or cyanobacteria. Chemically, it is lipopolysaccharide (LPS). Endotoxins are heat stable and even survive the sterilization. Contamination of cosmetics with bacterial endotoxins, can lead to physiological reactions and cellular defence mechanisms in humans, depending on the portal of entry, site of action and concentration. For prevention MicroMol examines cosmetics using Ph. Eur. Chapter methods. MicroMol offers limit and quantitative tests to rule out contamination with bacterial lipopolysaccharide (endotoxin). Method Implementation and Validation In addition to the several cosmetic testing methods, MicroMol offers as a GMP accredited laboratory the possibility of method implementation and validation for cosmetic manufacturers.

12 04 For further information or to place an order please contact us: Hedwigstr. 2-8 D Karlsruhe Contact: Dr. Wolfgang Rudy Phone: / Fax: / Mail: Web:

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