ProBiocin V

SECTION 2: Hazards identification

(EC) No 1272/2008 Classification GHS / CLP Basis for Classification Based on present data no classification and labeling is required according to GHS, taking into account the national implementation (United Nations version 2011) USA

2.2 Label elements

Pictograph: No hazard symbol expected Hazard statements/Signal Word: Not applicable

Precautionary statements

P233: Keep container tightly closed P281: Use personal protective equipment as required P402: Store in a dry place P404: Store in a closed container P410: Protect from sunlight P411: Store at temperatures not exceeding 32°C

Other hazards which do not result in classification

No particular fire or explosion hazard. By mechanical effect: No particular hazards. By hydroscopic effect: No particular hazards.

Health hazards

Rating 0; Normal Material Flammability: Rating 0, Will Not Burn Reactivity: Rating 0, Stable

2.3 Other hazards

None

PBT Substances

Not applicable

vPvB Substances

Not applicable

2.1 Classification of the substance or mixture

GHS / CLP Basis for Classification: Based on present data no classification and labeling is required according to GHS, taking into account the national implementation (United Nations version 2011) USA OSHA Regulatory Status: This material is non-hazardous as defined by the American OSHA Hazard Communication Standard (29 CFR 1910.1200). Europe Basis for Classification: -According to present data no classification and labeling is required according to Reg. (EC) No 1272/2008. -This product is not classified as hazardous to health or environment according to the CLP regulation. Labeling Elements: Pictograph: No hazard symbol expected Hazard statements/Signal Word: Not applicable Precautionary statements: P233: Keep container tightly closed P281: Use personal protective equipment as required P402: Store in a dry place P404: Store in a closed container P410: Protect from sunlight P411: Store at temperatures not exceeding 32°C Other hazards which do not result in classification: No particular fire or explosion hazard. By mechanical effect: No particular hazards. By hydroscopic effect: No particular hazards. US NFPA 704 (National Fire Protection Association) Hazard Rating System: Health hazard: Rating 0; Normal Material Flammability: Rating 0, Will Not Burn Reactivity: Rating 0, Stable Other Hazard Information: None Results of PBT and vPvB assessment: -PBT: Not applicable -vPvB: Not applicable SECTION 3. COMPOSITION / INFORMATION ON INGREDIENTS Common Chemical Name: Lactobacillus Ferment Lysate Generic name: Chemical Family: Ferment Description: Substance Substance CAS Numbers EC Numbers Percentage Lactobacillus Ferment Lysate 68333-16-4 (or) N/A (or) 100.00% 92128-79-5 295-777-8 Formula: Not applicable SECTION 4. FIRST-AID MEASURES General: In all cases of doubt, or when symptoms persist, seek medical attention. Inhalation: Move to fresh air from exposure area. Get medical attention for any breathing difficulty. Skin contact: Rinse with soap and water. Get medical advice if irritation develops. Eye contact: Immediately rinse with water for at least 15 minutes, while keeping the eyes wide open. Consult with a physician. Ingestion: Consult with a physician. Protection of first-aiders: No special protection required. SECTION 5. FIRE-FIGHTING MEASURES Fire and explosion hazards: Not considered to be a fire and explosion hazard Extinguishing media: Suitable: Water, dry chemicals, foam & carbon dioxide. Not suitable: None known Fire fighting: Move container from fire area if it can be done without risk. Avoid inhalation of material or combustion by-products. Stay upwind and keep out of low area Protection for fire-fighters: Boots, gloves, goggles. SECTION 6. ACCIDENTAL RELEASE MEASURES Personal precautions: Avoid contact with eyes. Personal Protective Equipment: -Protective goggles Environmental precautions: Prevent entry into sewers and waterways. Do not allow material to contaminate ground water system Methods for cleaning up: Recovery: Pick up free liquid for recycling or disposal. Residual liquid can be absorbed on an inert material. Cleaning/Decontamination: Wash non-recoverable remainder with water. Disposal: For disposal of residues refer to sections 8 & 13. SECTION 7. HANDLING AND STORAGE Handling Technical measures: Labeling: Keep out of the reach of children. Measures: For industrial use, only as directed. Safe handling advice: Wash hands after use. Avoid storage near feed or food stuff. Storage Technical measures: Keep container closed. Recommended Storage Conditions: Store in a dry place at temperatures not exceeding 32°C. Based on stability studies, the optimum storage temperature for maximization of shelf life is 23 - 25°C. However, it may be stored at temperatures between 16 and 32°C if such specific temperature control is not available. Do not freeze. Please refer to stability data for effects heat or cold may have on the specifications of the product. Incompatible products: Avoid contact with strong oxidizers. Refer to the detailed list of incompatible materials (Section 10 Stability/Reactivity) Packaging: Product may be packaged in normal commercial packaging. Packaging materials: Recommended - Polypropylene & High Density Polyethylene SECTION 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Precautionary statements: Ensure adequate ventilation Control parameters Occupational exposure Limits: France: Not Determined ACGIH: Not Determined Korea: Not Determined UK: Not Determined Surveillance procedures: Not Determined Engineering measures: Not Determined Personal Protective Equipment: Respiratory protection: Local exhaust Hand protection: Protective gloves made of rubber or neoprene. Eye protection: Safety glasses. Collective emergency equipment: Eye fountain. Skin and Body Protection: Suitable protective clothing Hygiene measures: Handle in accordance with good industrial hygiene and safety practice. Measures related to the Environment: No particular measures. SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES Appearance: Clear to slightly hazy liquid Color: Colorless to yellow Odor: Characteristic Solids (1g/1hr/105°C): 20.0 – 25.0% pH (Direct): 4.0 - 11.0 Heavy Metals: < 20 ppm Lead: < 10 ppm Arsenic: < 2 ppm Cadmium: < 1 ppm Bacteriocins (HPLC): 5.00 – 10.00% Minimum Inhibitory Concentration Organism (ATCC#): E. coli (#8739): 0.25 – 1.00% S. aureus (#6538): 0.25 – 1.00% P. aeruginosa (#9027): 0.25 – 1.00% C. albicans (#10231): 0.25 – 1.00% A. brasiliensis (#16404): 0.25 – 1.00% Specific Gravity: 0.994 Vapor density: Not applicable Boiling Point: 100°C Freezing Point: 0°C Melting point: Not applicable Flash point: > 200°F Oxidizing properties: Non oxidizing material according to EC criteria. Solubility: In water: Soluble In organic solvents: Not determined Log P: Not determined SECTION 10. STABILITY AND REACTIVITY Stability: Stable under ordinary conditions of use and storage up to one year then re-test to full product specifications to extend shelf life Hazardous reactions: None known Conditions to avoid: No dangerous reactions known under use of normal conditions. Avoid extreme heat. Materials to avoid: No dangerous reaction known with common products. Hazardous decomposition products: None known SECTION 11. TOXICOLOGICAL INFORMATION Ingestion: Not Determined Dermal: Non-Irritant (Dermal Irritection Model) Ocular: Non-Irritant (Ocular Irritection Model) Inhalation: Not Determined Acute toxicity data: Non-Irritant, Non-Primary Sensitizer & Non-Photo Irritant Sensitization: Non-Primary Irritant & Non-Primary Sensitizers; Will not cause allergic contact dermatitis (In Chemico Skin Sensitization Direct Peptide Reactivity Assay & In Vitro Skin Sensitization ARE-Nrf2 Luciferase Test Method) Repeated dose toxicity: No known effects Subacute to chronic toxicity: Not Determined Mutagenicity: Non-Mutagenic (OECD471/ISO10993.Part 3 – Genotoxicity: Bacterial Reverse Mutation Test) Additional Toxicological Information: This product is not subject to classification according to the calculation method of the General EU Classification Guidelines for Preparations as issued in the latest version. Specific effects: Carcinogenicity: No known effects Mutagenicity: No known effects Reproductive toxicity: No known effects Neuro-toxicity: No known effects For more information: Does not present any particular risk on handling under normal conditions of good occupational hygiene practice. This product has not been tested for the following: -Primary cutaneous and corrosive irritation -Acute oral toxicity SECTION 12. ECOLOGICAL INFORMATION Ecotoxicity Effects on the aquatic environment: EC10 (Freshwater Alga): 136.55 mg/L - Not harmful to aquatic organisms EC20 (Freshwater Alga): 218.03 mg/L - Not harmful to aquatic organisms Biodegradability: Persistence: Readily Biodegradable (89.5% biodegradation after 28 days of testing) Bioaccumulation: Octanol / water partition coefficient: Not Determined Mobility: Precipitation: Expected behavior of the product: Ultimate destination of the product: Soil & sediment. Other Adverse Effects: None known SECTION 13. DISPOSAL CONSIDERATIONS Residues from product Prohibition: Do not allow the product to be released into the Environment. Destruction/Disposal: Dispose of in accordance with relevant local regulations Contaminated packaging Decontamination/cleaning: Cleaning is not required prior to disposal. Destruction/Disposal: Note: Take all necessary precautions when disposing of this product according to local regulations. SECTION 14. TRANSPORT INFORMATION UN Number: None UN Shipping Name: None Transport Hazard Class: Not classified as dangerous for transport Land (rail/road): Material is not restrictive for land transport and is not regulated by ADR/RID Sea: Material is not restrictive for sea transport and is not regulated by IMO/IMDG Air: Material is not restrictive for land transport and is not regulated by ICA/IATA Marine Pollutant: No Transport/Additional Information: Not regulated for US DOT Transport in non-bulk containers This material is not dangerous or hazardous Special Precautions for User: None known The above regulatory prescriptions are those valid on the date of publication of this sheet. However, given the possible evolution of transport regulations for hazardous materials and in the event of the MSDS in your possession dating back more than 12 months, it is advisable to check their validity with your sales office. SECTION 15. REGULATORY INFORMATION Labeling: EC regulations: This product does not need to be labeled in accordance with EC Directives or respective national laws Further regulations United Kingdom: Handle in accordance with relevant British regulation: control of substance Hazardous to Health Regulations Environmental Hygiene Guidance: EH40 Workplace Exposure Limits (revised annually) Korea regulations: Industrial safety and hygiene regulation: No Hazardous material control regulation: No Fire prevention regulation: No Other regulations: EINECS inventory status: Lactobacillus Ferment Lysate: N/A (or) 295-777-8 TSCA inventory status: Exempt AICS inventory status: Not Listed: 92128-79-5 Listed: 68333-16-4 Canadian (CEPA DSL) inventory status: Not Listed: Lactobacillus Ferment Lysate (92128-79-5) Listed as Lactobacillus acidophilus (Revised ICL) Japan (MITI list): Lactobacillus Ferment Lysate Korea: Lactobacillus Ferment Lysate China inventory status: Lactobacillus Ferment Lysate Philippines inventory status: Not Listed: Lactobacillus Ferment Lysate (68333-16-4) Listed as: Lactobacillus fermentatae, lysate Note: The regulatory information given above only indicates the principal regulations specifically applicable to the products described in this sheet. The user’s attention is drawn to the possible existence of additional provision which complete these regulations. Please refer to all applicable international, national and local regulations and provisions SECTION 16. OTHER INFORMATION Prohibited uses: For specific uses, food industry, ask the manufacturer for more information. Last Revision Date: 02/11/2020 Preparation Date: 03/31/2020 MSDS summary of changes - Updated Precautionary Statement – Section 2 (Hazards Information) & Updated Recommend Storage Conditions – Section 7 (Handling & Storage) - Updated Tradename – Section 1 (Identification) - Updated Europe Basis for Classification – Section 2 (Hazards Information) The information given is based on our knowledge of this product, at the time of publication in good faith. The attention of the user is drawn to the possible risks incurred by using the product for any other purpose other than which it was intended. This is not in any way excuse the user from knowing and applying all the regulations governing their activity. It is sole responsibility of the user to take all precautions required in handling the product. The purpose of mandatory regulation mentioned is to help the user to fulfill his obligations regarding the use of products. This information is not exhaustive, this is not exonerate the user from ensuring that legal obligations other than those mentioned, relating to the use and storage. Arrival of Materials Fail Tests for Acceptance Pass Fermentation of Lactobacillus acidophilus in a Defined Media under Controlled Condition of pH, Temperature and Time Add Lysozyme* to Facilitate Controlled Cell Lysis Filtration and Concentration Make Batch Adjustments if Needed (Refiltration) Fail Sample for QC Pass Pack Material Sample for Micro Passes Micro Ship to Customer *Lysozyme is derived from Papaya (Carica papaya) Certificate of Compliance Code: M14005 INCI Name: Lactobacillus Ferment Lysate INCI Status: Conforms CAS #: 68333-16-4 [AICS, Revised ICL] (or) 92128-79-5 [PICCS] EINECS #: N/A (or) 295-777-8 The following information on regulatory clearances is believed to be accurate and is given in good faith as a guide to a global use of our ingredients in cosmetic applications. No representation or warranty as to its competences or accuracy is made. Information is offered for use in general cosmetic applications and may vary in particular applications. Users are responsible for determining the suitability of these products for their own particular use. All regulatory decisions should be made on the advice of your regulatory group or legal counsel. Country / Regulatory Body Status of Product EU (CosIng) Compliant USA (TSCA) Exempt Australia (AICS) Compliant Japan (METI) Compliant Canada (DSL) Compliant China (IECIC) Compliant Brazil (ANVISA) Compliant Korea (KECI) Compliant Philippines (PICCS) Compliant Mexico (COFEPRIS) Compliant Code: M14005 Attention must be paid to the use of ProBiocin V™ in the equivalent of OTC formulations (eg. quasi-drugs in Japan, or therapeutic goods in Australia). Some countries maintain restricted inventories of raw materials that can be used in those applications so more detailed guidance may be required. ProBiocin V™ and any components or impurities are in compliance with the rules governing cosmetic products in the European Union (Directive 76/768/ECC & Regulation No. 1223/2009). The recommended use levels for ProBiocin V™ is 2.00 – 4.00%. ProBiocin V™ is considered a non-hazardous material. All significant toxicological routes of absorption have been considered as well as the systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL). Due to the restriction placed on animal testing of cosmetic raw materials, and Active Micro Technologies, LLC’s internal non-animal testing policy, this product was not tested for NOAEL. ProBiocin V™ was tested using in vitro dermal and ocular irritation models. This product was found to be non- irritating in both models. ProBiocin V™ is in compliance with the standardized set of rules developed and approved by the NPA (Natural Products Association). To our knowledge the above material is free of CMR (*) substances, as defined according to Regulation (EC) No 1272/2008 and Cosmetic Regulation (EC) No 1223/2009 as amended. (*) Carcinogenic, Mutagenic, toxic for Reproduction Active Micro Technologies, LLC certifies that to the best of our knowledge our product does not contain any material listed on California Proposition 65. Active Micro Technologies, LLC certifies that ProBiocin V™ does not contain any materials prohibited by Halal laws. As of October 4, 2019, ProBiocin V™ does not contain any substances present on the so called “candidate list” provided by the European Chemicals Agency (ECHA). We further certify that this material has not been manufactured using any of the species listed in the CITES Appendices as of October 4, 2019. ProBiocin V™ is REACH Compliant and free of the following:  Formaldehyde or formaldehyde donors  Parabens  Glycol ethers  Paraffin/petroleum products  Gluten  Phthalates  Lactose  Polyethylene glycol (PEG)  Nanoparticles  Residual solvents  Nitrosamines  Sulfates  Palm oil/palm kernel oil (or derivatives)  Volatile organic compounds Trade Name: ProBiocin V™ (M14005) INCI Name: Lactobacillus Ferment Lysate This is to certify that ProBiocin V™ is REACH compliant. Lactobacillus Ferment Lysate falls under the polymer exemption. If you have further questions, please feel free to contact Heather Ferguson at hferguson@activeconceptsllc.com. Date Issued: February 11, 2020 ALLERGEN DECLARATION RE: ProBiocin V™ (M14005) Please be advised that this form is to certify that the above referenced product, manufactured at Active Micro Technologies, LLC, does not contain any of the allergens listed below: Eggs – or egg products Milk – or milk products (includes whey, lactose, casein, milk, cream) Peanuts – or peanut products Fish – (includes fish: surimi, cod, pollack, whitefish) Shellfish – (shrimp, lobster, crab, clams, etc.) Molluscs – or molluscs products Soybeans – or soybean products (includes soya powder, protein, oil, lecithin, tofu) Wheat – or wheat products (includes Gluten) Tree nuts – (almond, brazil nut, cashew, chestnut, hazelnut, filbert, pine nuts (pinyon, pinon), pistachio, pecan, macadamia, walnut). Palm Oil – or palm kernel oil Corn – or corn products If you have any further questions or concerns, please contact us at: 1-704-276-7100 February 11, 2020 To Whom It May Concern, This letter is to certify that ProBiocin V™ (M14005) has the following heavy metals profile: Heavy Metals: Less than 20 ppm Chromium: Less than 20 ppm Lead: Less than 10 ppm Nickel: Less than 10 ppm Antimony: Less than 5 ppm Arsenic: Less than 2 ppm Mercury: Less than 1 ppm Cadmium: Less than 1 ppm **Please note: The above levels illustrate the Maximum Limits. Values for Chromium, Nickel, Antimony and Mercury do not appear on the Specification for ProBiocin V™. Best Regards, Tomorrow's Vision... Today! ® Heather Ferguson |R&D Coordinator 107 Technology Drive | Lincolnton, NC 28092 Direct: 704.276.7083|Main: 704.276.7100|Fax: 704.276.7101 Email: hferguson@activeconceptsllc.com www.activeconceptsllc.com Version#2/02-11-20 1,00 COS-EN F363(COS)v09en Attestation n°: 1042481 Issued the: 06/05/2020 ATTESTATION OF CONFORMITY - RAW MATERIALS - COSMOS This attestation has been granted by ECOCERT Greenlife to the company: ACTIVE MICRO TECHNOLOGIES LLC 107 Technology Drive LINCOLNTON, NC 28092 UNITED STATES OF AMERICA whose non-organic raw materials (listed hereafter) have been assessed as compliant to the standard: COSMOS (v3.0 – January 2019) This attestation of conformity has been issued on the basis of the terms and conditions for the verification of raw materials according to the COSMOS standard available on the COSMOS association website: https://cosmos-standard.org/ and the conformity has been established according to the requirements related to the raw materials contained in this standard. Issued in: L'Isle Jourdain, the: 06/05/2020, Emilie CHERHAL ECOCERT Greenlife General Manager Valid until: 31/12/2020 Page 1 of 4 ECOCERT Greenlife S.A.S. - Capital 50 000 € - BP 47 - 32600 L’ISLE JOURDAIN - FRANCE TVA Intracommunautaire n° FR 55 509 534 095 Phone: +33 5 62 07 50 16 - Fax: +33 5 62 07 74 96 - Mail: mpgreenlife@ecocert.com F363(COS)v09en Attestation n°: 1042481 Issued the: 06/05/2020 ATTESTATION OF CONFORMITY - COSMOS List of the approved raw materials of: ACTIVE MICRO TECHNOLOGIES LLC PPAI: Physically Processed Agro-Ingredients CPAI: Chemically Processed Agro-Ingredients NNI: Non Natural Ingredients (Petrochemical origin) PeMo: Petrochemical Moiety CSPO: Raw material proceeding from certified sustainable palm/palm kernel oil Without animal origin: Raw material compliant to the complementary assessment « without animal origin » in force The asterisk * is used to identify the commercial name of the raw materials concerned by the appendices II and/or V of the Cosmos-standard. Unless an exception, the following references are published on the ECOCERT raw materials online database for approved raw materials available at the following link: http://ap.ecocert.com/ecoproduits. Approved Commercial name / INCI / Function %PPAI %CPAI %NNI %PeMo Restriction since AMTicide Coconut (M14003) 0 100 0 01/01/2020 Lactobacillus (and) Cocos Nucifera (Coconut) Fruit Extract Skin conditioning, Hair conditioning AMTicide® VAF (M14004) 0 100 0 01/01/2020 Bacillus Ferment (and) Saccharomyces Ferment Filtrate Skin Conditioning, Antifungal Arborcide OC (M15010) 0 50 0 01/01/2020 Leuconostoc Ferment Filtrate Skin conditioning, Antimicrobial Leucidal Advanced - Aloe (M15015) 0 18 0 01/01/2020 Water (and) Leuconostoc/Aloe Barbadensis Leaf/Sorbus Aucuparia Fruit Ferment Filtrate Moisturizing, Skin conditioning, Antimicrobial Leucidal Advanced - Rowan (M15018) 0 16 0 01/01/2020 Water (and) Leuconostoc/Sorbus Aucuparia Fruit Ferment Filtrate Emollient, Skin conditioning, Antimicrobial Valid until: 31/12/2020 WARNING: The sole purpose of the present attestation is to allow the raw material(s) to be used in finished products to be certified as compliant to the standard specified in the first page. In no event this attestation should constitute proof of the actual certification of the conformity of the raw material(s) to this standard. In that context, the raw material(s) listed in this attestation must not be qualified and / or marketed as «organic» raw material(s) certified in accordance with the abovementioned standard. The approval of the raw material (s) listed in the present attestation is personally addressed to the above-mentioned beneficiary. It is the beneficiary’s liability to ensure that its own customers are aware of the requirements and prohibitions defined in the terms and conditions and governing any reference to and use of the approval of the raw material(s) and that they abide by it. Page 2 of 4 ECOCERT Greenlife S.A.S. - Capital 50 000 € - BP 47 - 32600 L’ISLE JOURDAIN - FRANCE TVA Intracommunautaire n° FR 55 509 534 095 Phone: +33 5 62 07 50 16 - Fax: +33 5 62 07 74 96 - Mail: mpgreenlife@ecocert.com F363(COS)v09en Attestation n°: 1042481 Issued the: 06/05/2020 ATTESTATION OF CONFORMITY - COSMOS List of the approved raw materials of: ACTIVE MICRO TECHNOLOGIES LLC Approved Commercial name / INCI / Function %PPAI %CPAI %NNI %PeMo Restriction since Leucidal Liquid (M15008) 0 52 0 01/01/2020 Leuconostoc/Radish Root Ferment Filtrate Moisturizing, Skin conditioning, Antimicrobial Leucidal Liquid AE LFHC (M15008LFHC) 0 100 0 01/01/2020 Lactobacillus/Radish Root Ferment Filtrate Skin conditioning, Antimicrobial Leucidal Liquid Complete (M15024) 0 64 0 01/01/2020 Leuconostoc/Radish Root Ferment Filtrate (and) Lactobacillus (and) Cocos Nucifera (Coconut) Fruit Extract Moisturizing, Skin conditioning, Antimicrobial Leucidal Liquid PT (M15021) 0 18 0 01/01/2020 Lactobacillus Ferment Skin conditioning, Antimicrobial Leucidal Liquid SF (M15019) 0 10 0 01/01/2020 Lactobacillus Ferment Moisturizing, Skin conditioning, Antimicrobial Leucidal Liquid SF (M15019RTZJV) 0 10 0 01/01/2020 Leuconostoc/Radish Root Ferment Filtrate Skin conditioning, Antimicrobial Leucidal SF Complete (M15025) 0 32,5 0 01/01/2020 Lactobacillus Ferment (and) Lactobacillus (and) Cocos Nucifera (Coconut) Fruit Extract Moisturizing, Skin conditioning, Antimicrobial Valid until: 31/12/2020 WARNING: The sole purpose of the present attestation is to allow the raw material(s) to be used in finished products to be certified as compliant to the standard specified in the first page. In no event this attestation should constitute proof of the actual certification of the conformity of the raw material(s) to this standard. In that context, the raw material(s) listed in this attestation must not be qualified and / or marketed as «organic» raw material(s) certified in accordance with the abovementioned standard. The approval of the raw material (s) listed in the present attestation is personally addressed to the above-mentioned beneficiary. It is the beneficiary’s liability to ensure that its own customers are aware of the requirements and prohibitions defined in the terms and conditions and governing any reference to and use of the approval of the raw material(s) and that they abide by it. Page 3 of 4 ECOCERT Greenlife S.A.S. - Capital 50 000 € - BP 47 - 32600 L’ISLE JOURDAIN - FRANCE TVA Intracommunautaire n° FR 55 509 534 095 Phone: +33 5 62 07 50 16 - Fax: +33 5 62 07 74 96 - Mail: mpgreenlife@ecocert.com F363(COS)v09en Attestation n°: 1042481 Issued the: 06/05/2020 ATTESTATION OF CONFORMITY - COSMOS List of the approved raw materials of: ACTIVE MICRO TECHNOLOGIES LLC Approved Commercial name / INCI / Function %PPAI %CPAI %NNI %PeMo Restriction since Leucidal® Liquid J Max (M15030) 20 30 0 06/05/2020 Leuconostoc/Radish Root Ferment Filtrate (and) Salix Alba (Willow) Bark Extract Moisturization, Skin/Scalp Conditioning, Antimicrobial Leucidal® SF Max (M15019MAX) 0 25 0 01/01/2020 Lactobacillus Ferment Ferment / Skin Conditioning, Antimicrobial Myavert (M13001) 0,95 0 01/01/2020 Lactoperoxidase (and) Glucose Oxidase Skin conditioning, Hair conditioning, Antimicrobial PhytoCide Aspen Bark Extract Powder (M16002) 100 0 01/01/2020 Populus Tremuloides Bark Extract Skin conditioning, Antimicrobial PhytoCide Black Currant Powder (M16001) 100 0 01/01/2020 Ribes Nigrum (Black Currant) Fruit Extract Soothing, Skin conditioning, Antimicrobial PhytoCide Elderberry OS (M16003) 100 0 01/01/2020 Sambucus Nigra Fruit Extract Skin conditioning, Antimicrobial ProBiocin V™ (M14005) 0 100 0 06/05/2020 Lactobacillus Ferment Lysate Antimicrobial, Redness Reduction, Scalp Care Valid until: 31/12/2020 WARNING: The sole purpose of the present attestation is to allow the raw material(s) to be used in finished products to be certified as compliant to the standard specified in the first page. In no event this attestation should constitute proof of the actual certification of the conformity of the raw material(s) to this standard. In that context, the raw material(s) listed in this attestation must not be qualified and / or marketed as «organic» raw material(s) certified in accordance with the abovementioned standard. The approval of the raw material (s) listed in the present attestation is personally addressed to the above-mentioned beneficiary. It is the beneficiary’s liability to ensure that its own customers are aware of the requirements and prohibitions defined in the terms and conditions and governing any reference to and use of the approval of the raw material(s) and that they abide by it. Page 4 of 4 ECOCERT Greenlife S.A.S. - Capital 50 000 € - BP 47 - 32600 L’ISLE JOURDAIN - FRANCE TVA Intracommunautaire n° FR 55 509 534 095 Phone: +33 5 62 07 50 16 - Fax: +33 5 62 07 74 96 - Mail: mpgreenlife@ecocert.com ProBiocin V™ Vegan, Globally Compliant, Antimicrobial • Product Code: M14005 • INCI Name: Lactobacillus Ferment Lysate • Suggested Use Levels: 2.00% - 4.00% • Suggested Applications: Redness Reduction, Scalp Care, Antimicrobial • Solubility: Water Soluble Multifunctional Ingredients – Effective and Marketable • Derived from Lactobacillus acidophilus, a probiotic bacterium traditionally used to ferment milk into yogurt. Created by the fermentation of Lactobacillus in a defined growth medium, this specific manufacturing process yields a unique peptide with broad spectrum, antimicrobial and conditioning properties. • ProBiocin V™ – multifunctional balance • Antimicrobial peptide (bacteriocin) content provides antibacterial activity against pathogenic bacteria like Malassezia spp. • Implements optimal scalp care for increased moisturization and decreased erythema • Capable of reducing red areas of the face • A next generation active capable of protecting formulation integrity while simultaneously providing brand differentiation and comprehensive care for the skin the scalp. Manufacturing Process Prebiotic chicory oligosaccharide fructans are supplemented into Lactobacillus acidophilus growth media Fermentation of Lactobacillus acidophilus in a defined media under controlled conditions • Produces bacteriocins to reduce pathogens and promote a healthy skin and scalp Once fermentation is complete, lysozyme is added to facilitate cell lysis and ensure release of bacteriocins Material is filtered to remove undesired plant matter and bacteria Multitasking Beauty Multifunctional Cosmetics – Effective and Marketable • Result-driven products with characterized activity cut down on the ingredient deck in formulations. • Typical anti-aging products are losing momentum as multifunctional ingredients take center stage. • Busy lifestyles of consumers opt for convenience products – beauty products with multiple benefits and the maximum value for amount spent. • Sustainability and the conscious consumer • A rise in health consciousness among consumers push for ingredients for healthy, balanced lifestyles. • Natural probiotics, skin protection, and preventative actives with minimal environmental impact. 1. https://www.cosmeticsdesign.com/Article/2013/07/22/What-do-consumers-want-Mintel-reveals-US-facial-skin-care-trends. Skin & Scalp Care “Health is Wealth” • Scalp care is a prevalent branch of hair care. A healthy scalp means healthy hair growth! • Dandruff has been shown to effect approximately 50% of the population, regardless of gender or ethnicity1, driving consumer’s interests in products that can restore balance to an “unhealthy” scalp. • Malassezia spp. has been shown to play a key role in the pathogenesis of dandruff. • A study performed on a group of dandruff patients resulted in 84% of participants having a species of Malassezia present on the scalp2. • Inspired by dandruff related irritation, research has driven product development to address Malassezia and balance the scalp microbiome. 1. Ranganathan, S., and T. Mukhopadhyay. “Dandruff: The most commercially exploited skin disease.” Indian journal of dermatology 55.2 (2010): 130. 2. Rudramurthy, Shivaprakash M., et al. “Association of Malassezia species with dandruff.” The Indian journal of medical research 139.3 (2014): 431. Probiotic Trend The Rise of Probiotics in Wellness and Skin Care • In recent years, awareness has been growing around the key role probiotics play in digestive health. • The global market for probiotic ingredients in 2017 was valued at 36.6 billion USD and predicted to exceed 64 billion USD by 20234. • Oral probiotic supplements and fermented dairy products are well recognized for balancing and protecting the gut’s microflora and supporting the body’s immune system. • Research is emerging to support the notion that topical probiotics are beneficial for skin. • The topical use of probiotics will confer similar protective balance to the skin, and therefore help keep skin strong, healthy and age resistant. 4. 2018 Wellness Trends, from Global Market Insights Inc. Our Innovative Probiotic Approach Bacterial Lysates for Probiotic Benefit • Probiotics are defined by the Food and Agriculture Organization of the World Health Organization as live microorganisms that, when administered in adequate amounts, confer a health benefit to the host. • Within cosmetics, there are restrictions placed on the microbial content of a product as indicated in the US FDA’S Guidelines. In order for probiotics to deliver the desired benefit they must be present in billions of colony forming units (CFU). This level of probiotic incorporated into a cosmetic product would exceed the microbial limit as designated by the FDA. • Active Micro Technologies has taken an innovative approach through the use of bacterial lysates for probiotic benefit. The bacterial lysate has all the beneficial active components of live bacteria, without the live bacteria. • Through the specific technique of supplementing growth media with prebiotics to stimulate the probiotic attributes of Lactobacillus acidophilus, Active Micro Technologies is able to isolate and extract novel postbiotic active compounds for a powerful probiotic active! Veganism Trend Moving Forward • Veganism is a popular trend in the cosmetic industry. As consumers are making lifestyle choices that make them feel healthier, the same logic applies to the products they use. • Although you do not have to be vegan to use vegan products, consumers are beginning to pay more attention to what goes into the products they use and how these products will benefit them long-term. • While shifting towards animal alternatives and away from ethical concerns, sacrificing the quality of ingredients is not an option when it comes to treating common cosmetic concerns such as moisturization and redness. Preservative Systems Choosing the Right One • Consumer concerns often pertain to the use of synthetic preservatives such as parabens, formaldehyde donors and phenoxyethanol in their products5. Consumers often perceive traditional preservative systems as being associated with sensitization6. • Traditional preservatives have been shown to be detrimental to both commensal and pathogenic bacteria living on the skin. • ProBiocin V™ is a technology able to diminish these concerns, while providing efficacious benefits against scalp irritation. These peptides are also capable of providing broad spectrum antimicrobial protection in order to maintain the integrity of the formulation. 5. Lee, Eun-Young, et al. “A Study of Influencing Factors for Sensory Irritation Due to Preservatives of Cosmetics.” Journal of the Society of Cosmetic Scientists of Korea, Society of Cosmetic Scientists of Korea, www.koreascience.or.kr/article/JAKO200616419600251.page. 6. Kabara, Jon J., and Donald S. Orth. Preservative-Free and Self-Preserving Cosmetics and Drugs: Principles and Practices. Marcel Dekker, 1997. Available Efficacy Data • In-vivo Efficacy Studies • Safety Information • VISIA® Analysis • in-vitro Dermal and Ocular Irritation Tests • Scalp Care Study • Bacterial Reverse Mutation Test • Phototoxicity Test • In-vitro Efficacy Studies • OECD 442D TG in-vitro Skin Sensitization • Minimum Inhibition Concentration (MIC) Data • OECD 201 Freshwater Alga Growth • E. Coli, P. aeruginosa, S. aureus, A. brasiliensis, Inhibition Test C. albicans, M. furfur. • OECD 301B Ready Biogradability Assay • Cream Formula Challenge Test at 4.0% use • Allergen Statement level at pH 3, 5, & 7 • Shampoo Formula Challenge Test at 4.0% • Time Kill Test VISIA® Complexion Analysis: Average Red Area Feature Counts Protocol • An in-vivo VISIA® Complexion Analysis study was conducted using 10 M/F participants between the ages of 23-55 • Each participant was instructed to apply 2.0 mg of lotion to their entire face twice a day for a four week period. Participants were instructed to continue their usual skin care routine and to apply the lotion once their everyday skin care routine is finished • Half of the participant population used 4% ProBiocin™ Cetaphil Daily Facial Moisturizer for all skin types, while the other half used the Cetaphil Daily Facial Moisturizer alone as a control Figure 1: Average red area feature count • Feature counts provide a count of the number of discrete instances of the feature being evaluated • ProBiocin™ V in base lotion displayed a reduced number of red areas when compared to the control VISIA® Complexion Analysis: Average Red Area Feature Counts Figure 2: Panelist #3 treated with 4.0% ProBiocin™ V in Base Lotion displays a reduction (25.8%) in feature counts for red areas from beginning of treatment (T=0) to T=4 Weeks via VISIA Image Analysis. Images on the left are panelist #3 with image enhancement, through VISIA, which provides higher visualization of feature changes. Images on the right are natural photos of panelist #3. Figure 3: Panelist #3 treated with 4.0% ProBiocin™ V in Base Lotion displays a increase (31.6%) in feature counts for red areas (due to the halted use of product) from 4 weeks to -2 weeks (regression) via VISIA Image Analysis. Images on the left are panelist #3 with image enhancement, through VISIA, which provides higher visualization of feature changes. Images on the right are natural photos of panelist #3. Scalp Care Study Protocol • An in-vivo Scalp Care Study was conducted using 10 M/F participants between the ages of 23-55 • Panelist’s heads were treated with either the base shampoo and conditioner or the experimental containing 4.0% ProBiocin V™ in the base shampoo and base conditioner • After the application and rinse of the experimental and control applications, each panelist’s hair was blown dry using a round brush • Each panelist had his or her head washed three times per week for a two week period • After the third wash of the week, panelists had scalp moisturization and pigmentation values recorded Figure 4: Images of Panelist #4 treated with 4.0% ProBiocin V™ in Base Shampoo and Conditioner display an increase in overall scalp moisturization (front, middle, back averages) by 88.26% and decrease in overall scalp erythema (front, middle, back averages) by 55.31% from beginning of treatment (T=0) to T=2 Weeks via DermaLab analysis. Challenge Test Protocol • Samples were inoculated with microorganisms 1.00E+07 (cfu/ml) C. albicans. - E. Coli, P. aeruginosa, S. aureus, A. brasiliensis, 1.00E+06 1.00E+05 Concentration for the presence of these microorganisms. 1.00E+04 • During the first 28-day incubation period, 1.00E+03 A. brasiliensis samples were periodically collected and tested C. albicans 1.00E+02 Inoculum E. coli S. aureus cream samples were then re-inoculated with 1.00E+01 P. aeruginosa • Following this initial 28 days of incubation, the 1.00E+00 0 7 the cultures and sampled over an additional 28- 14 21 7 14 21 28 day period. Days M14005 ProBiocin V™ Figure 6: Challenge Test Results for Generic Cream Formula pH 5 with 4.0% ProBiocin V™ inoculated on demonstrated successful Day 0 and re-inoculated on Day 28. Results show % reduction in viable organisms. antimicrobial protection Challenge Test Protocol • Samples were inoculated with Malassezia furfur. 4.0% ProBiocin™ V in Shampoo Formula Challenge Test • During the first 28-day incubation period, samples were periodically collected and tested for the presence of these microorganisms. • Following this initial 28 days of incubation, the cream samples were then re-inoculated with the cultures and sampled over an additional 28-day period. Figure 5: Challenge Test Results for Generic Shampoo Formula with 4.0% ProBiocin V™ inoculated on Day 0 and re-inoculated on Day 28. Results show % reduction in viable organisms. M14005 ProBiocin V™ demonstrated successful antimicrobial protection Marketable and Effective • Moisturizing, Redness Reduction, Scalp Care • Natural, multifunctional product – fits any application • Effective and marketable • Multifunctional active • Probiotic & prebiotic provenance • Deployed postbiotic technology • COSMOS compliant • Vegan compliant Vegan, Globally Compliant, Antimicrobial • Product Code: M14005 • INCI Name: Lactobacillus Ferment Lysate • Suggested Use Levels: 2.00% - 4.00% • Suggested Applications: Redness Reduction, Scalp Care, Antimicrobial • Solubility: Water Soluble Active Micro Technologies, LLC Lincolnton, NC. USA www. activemicrotechnologies.com Office: +1 704 276 7100 info@activemicrotechnologies.com ProBiocin V™