20 SGS-Personal Care Services

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COSMETICS &PERSONAL CARE PRODUCTSENSURE SAFETY, QUALITY, EFFICACY ANDREGULATORY COMPLIANCE WITH SGS SERVICES

March 2013



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COSMETICS & PERSONAL CARE INDUSTRY

YOUR CHALLENGES

Ensure compliance with applicable legislations

The safety aspect of cosmetics and personal care products havesignificant legal and commercial impacts on your brand.

Quality, safety, efficacy, and labelling requirements for these productsdiffer according to the country of distribution. Understanding theregulatory framework and your obligations is a critical success factor.

Maintain your competitiveness among international companies

Ensure that your products reach the market quickly.

Protect your brand and reduce the risk of costly legal actions.

Meet customers’ expectations

Utmost product quality, safety and stability.

Innovative product with ever greater efficacy.

Effective product claims.

Minimised environment impact (e.g. sustainable packaging).



SGS QUALITY ASSURANCE& PERFORMANCE SERVICESOVERVIEWCOSMETICS & PERSONAL CARE PRODUCTS



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PRODUCT SCOPE

SKIN CARE

• Facial Care,Moisturisers &Cleansers

• Face Masks

• Body Care• Hand Care

HAIR CARE

• Shampoos

• Conditioners• Styling Agents• Colourants

SUN CARE

• Sunscreen

• After-Sun Care

BATH & SHOWER

• Bar Soap

• Shower Gel• Liquid Soap

SGS can assist you with all varieties of Cosmetics and Personal Care products:

COLOR COSMETICS

• Facial Make-Up(Blusher, Powder, etc)

• Eye Make-Up

(Mascara, EyeShadow, Eye Liner, etc)• Lip Products (Lipstick,

Gloss)• Nail Products (Nail

Polish & Strengthener,Polish Remover)

FRAGRANCES

• Body Sprays

• Perfumes and Cologne

ORAL CARE

• Toothpaste

• Mouthwashes• Dental Floss

• Tooth Whiteners

OTHERS

• Depilatories

• Men’s Shaving• Deodorants &

Antiperspirants(Sprays, Pumps, Roll-ons, Sticks, etc)



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ONE-STOP SOLUTIONS

RAWMATERIALS /

PRODUCTFORMULATION

PACKAGING PRODUCTION DISTRIBUTION STORE

Ensure the safety, quality, efficacy and regulatory compliance of your products with:

TESTING

•Physical•Chemical•Microbiological•Product stability•Toxicity•Claim support &Performance

•Packaging

SAFETY ASSESSMENT

including Toxicological RiskAssessment (TRA) for US,

Canada, Australia &ASEAN and CosmeticProduct Safety Report

for EU

DOCUMENTATIONREVIEW

• Ingredient and PackageLabelling Review

•Material Safety DataSheet (MSDS) for rawmaterials

•Cosmetic Product SafetyReport

AUDITS

including Cosmetics GMPcompliance (ISO 22716),

EFfCI, Ethical andEnvironmental, etc.

& INSPECTIONS

SEMINARS, WEBINARSAND TRAINING



HOW COSMETICS &PERSONAL CARE PRODUCTS

ARE REGULATED?COSMETIC SAFETY IS ENSURED WORLDWIDE



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COSMETICS & PERSONAL CARE PRODUCTS

MAJOR APPLICABLE STANDARDS

Countries have different ways of regulating the cosmetic and personalcare industry. But they have one common goal: to protect the consumer

by ensuring safe ingredients and finished products.

Regulations usually include:

Product information

Product safety

Substances prohibited in cosmetics

Restrictions on ingredients

Labelling requirements

SGS can help you comply with national and international standards andregulations for cosmetics and personal care products including:

EU Cosmetic Regulation 1223/2009

U.S. Food, Drug and Cosmetics Act, CFR 21 Food and Drugs…

Canada, Australia, New Zealand, China, ASEAN, etc

Click on the leaflet



SGS QUALITY ASSURANCE& PRODUCT TESTINGCOSMETICS & PERSONAL CARE PRODUCTS



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SGS TESTING SERVICES

Physical Testing Chemical Testing

MicrobiologicalTesting

Product StabilityTesting

SafetyAssessment

Claim Support/

PerformanceTesting

Scope

Raw Materials/Ingredients

Finished Products

Packaging

Objectives

Safety

Quality

Efficacy/Performance



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COSMETICS & PERSONAL CARE CAPABILITIES

THE SGS MAIN TESTING LABORATORIES



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PHYSICAL TESTING

Evaluate key product physical characteristics:

Appearance, colour, odour

pH value

Density

Viscosity

Melting point

Flash point Moisture content

Fatty acid composition

Foam test

Etc.

For Aerosols: pressure, propellant type and content, etc.

For Cosmetics & Personal Care Accessories: weathering testsincluding humidity, heat, resistance to corrosion, leakage,functionality, etc.

Check mechanicalproperties of your products.



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COSMETICS & PERSONAL CARE

CHEMICAL TESTING

Determination of allergens (26 restricted fragrance allergens test)

Determination of preservatives (e.g. parabens)

Determination of active ingredients (e.g. UV filters, vitamins, antioxidants,aluminium salts)

Determination of restricted substances, contaminants and impurities:

Heavy metals migration (e.g. lead, mercury, arsenic)

Free formaldehyde content

Nitrosamines

Phthalates

Pesticides

1,4 Dioxane

Diethylene Glycol (DEG) Polycyclic Aromatic Hydrocarbons (PAHs)

Volatile Organic Compounds (VOCs)

Substances of Very High Concerns (SVHCs)

Etc.

Ensure all ingredients usedmeet the chemicalrestrictions and limitations of

applicable cosmeticregulations and otherrelevant legislations such asREACH, hazardoussubstances regulations, etc.

Prohibited andrestricted chemicals

PreservativesColour additivesEtc.



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COSMETICS & PERSONAL CAREMICROBIOLOGICAL TESTING (1/2)

Microbial contamination is one of the greatest concerns regarding thequality of cosmetic products. Microorganisms are everywhere and can

biodegrade (break down or feed on) most consumer products and causethem to spoil or cause chemical changes in them that may be harmful toconsumers.

Bacteria and Fungi Testing (Microbial contamination and identificationof contaminants)

Total Viable Count (TVC):

• Bacteria Count Testing (estimate of the number of bacteria)

• Yeast and Mould Count Testing (screen to check if product iscontaminated with fungi)

Absence of pathogenic germs

Examples of procedures: USP* <61> (microbial enumerations), USP*<62> (test for specified microorganisms), EP** Chapters 2.6.12 &2.6.13, ISO 21149:2009 for TVC, ISO 16212:2008 for yeast & mould,etc.

Does your product containharmful microorganisms?Evaluate the degree of

contamination of your rawmaterials and finishedproducts with bacteria,mould and yeast.

*USP: United States Pharmacopeia, ** EP: European Pharmacopeia



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COSMETICS & PERSONAL CAREMICROBIOLOGICAL TESTING (2/2)

A cosmetic or personal care product can be free from microorganisms rightafter manufacturing, but can support their growth over the course of time.

The ability of a preservative system to protect the product from microbialgrowth and degradation - during its in-use period, when it is being routinelyopened, dispensed and closed - must be established through microbialchallenge testing of the complete formulation.

Preservative Challenge Testing (Antimicrobial Effectiveness Testing)

This is a fast and easy way to learn about the efficacy of yourpreservative system.

Examples of procedures: products are evaluated using USP* <51>,EP** Chapter 5.1.3, ISO 11930:2012, etc.

Evaluate preservativeeffectiveness:figure out how long the

microbial counts will keep incheck.

*USP: United States Pharmacopeia, ** EP: European Pharmacopeia



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COSMETICS & PERSONAL CAREPRODUCT STABILITY TESTING

Real time/Accelerated Aging

Evaluate stability over time by exposing products to elevated environmental conditions for pre-

defined periods of time. Environmental Cycling (Freeze-Thaw Stability Testing)

Determine if the product will remain stable under various conditions (extreme or rapidtemperature changes) that it may encounter during transport and storage.

Photostability Testing (real time and controlled conditions)

Lighting may affect the product's colour, odour and overall appearance. Cosmetic products

whose packaging allows the product to be exposed to light should undergo photostabilitytesting: UV light resistance test.

Period After Opening (PAO) Determination - Examples of sources of information forassessing a product’s PAO:

Microbiological challenge tests

Stability data

Analytical data (e.g. preservative analysis)

Type of packaging

Experience with similar formulations and products

Consumer habits and practices

Determine if your productand its package are still ofgood quality over thedesignated use time - underdifferent conditions ofstorage, transport and use.



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PACKAGING TESTING

Packaging Stability Testing - Packaging Compatibility

Packaging can directly affect finished product stability because of possible interaction

between the product, the package, and the environment. Substances from thecontainer may leach into the product; or product ingredients may cause a chemical

reaction with the container.

Physico-chemical Testing: SVHC testing, global migration…

In-Vitro Testing: Glass, being an inert material, does not react with a cosmetic

product in any way. Testing can be performed in a glass container, as well as inthe actual packaging – to offer the most accurate results in product-to-packagecompatibility.

Environmental Conditioning: With analysis of weight loss, colour, odour,appearance, viscosity, pH and other parameters.

Packaging Leakage Testing: The packaged product is tested for leakage using a

vacuum chamber and hydrostatic pressure.

Packaging Functionality Testing: Opens, closes and dispenses appropriately.

Packaging Transit Testing: Vibration, Impact and Drop Tests are performed to

assure against breakage & leakage in transport.

Determine if the packagingintended for marketing canaffect the stability of your

finished product.Verify that the packagingchosen offers the protectionneeded for your product.



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TOXICOLOGICAL TESTING – IN VITRO TESTING

In Vitro Testing

Skin & Eye Irritation

Test to evaluate the potential of a cosmetic product or ingredient to causedermal/ocular irritation when used by the consumer.

1) Skin Irritation Tests protocols: OECD 439…

2) Eye Irritation Tests protocols: Hen’s Egg Test (HET-CAM), Red Blood Cell test(RBC) …

Skin Corrosion

Test to assess the potential of a substance/mixture to cause irreversible damageto the skin (necrosis through the epidermis and into the dermis). Extreme pH like< 2 or > 11.5 may indicate the potential to cause skin corrosion.

E.g. EST-1000 (epidermal skin test-1000) [OECD 431] …

Substances used incosmetics may causepossible skin/eye irritationand damaging effects.

Determine if your productmay be toxic or pose a riskto consumers.

HET CAM



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COSMETICS & PERSONAL CARETOXICOLOGICAL TESTING – IN VIVO TESTING

In Vivo Testing (Tolerance tests on volunteers)

Dermal irritation: patch test

Use test under medical supervision: dermatologist, ophthalmologist…

Substances used incosmetics may causepossible skin/eye irritation

and damaging effects.Determine if your productmay be toxic or pose a riskto consumers.

PATCH TEST



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COSMETICS & PERSONAL CARECLAIM SUPPORT/PERFORMANCE TESTING (1/2)

Performance tests to support your product claims:

Active ingredients

• Vitamin B5, Aloe vera…

Functional tests

• Skin care:

Creams: moisturising, firmness, elasticity, roughness, wrinklesdepth/anti-aging (effectiveness against free radicals)…

Deodorants: anti-perspirant product effectiveness (Sniff Test)

Sunscreen: SPF (Sun Protection Factor)/PA value (=UV protectiontime/strength)…

• Hair care: volumising (Shadow Method), anti-dandruff, combability of wetand dry hair, hair colour (colour fading - mechanical & light),

curling/preserving hair loops, smoothing, rinsing…

Anti-ageing or paraben-free:is your product claimmisleading?Ensure you make productefficacy claims that aresupported by scientificevidence with SGS services.



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COSMETICS & PERSONAL CARECLAIM SUPPORT/PERFORMANCE TESTING (2/2)

Consumer panel testing: product evaluation and trials duringdevelopment

Advantages• Quick product assessment

• Information on client’s behaviour, opinion, purchase intentions

• Positioning of competitive products (consumer preference)

• Verification of claims about the organoleptic criteria of a product (touch,smell, sight, etc)

Panel composition based on client’s needs• Naïve participants

• Expert panel

• Tests coordinated by a SGS cosmetics expert

• Tests conducted in our labs or at customers’ homes

Determine consumers’ levelof satisfaction with yourproducts and improve the

characteristics evaluated tomeet customer expectations.



SGS SAFETY ASSESSMENTTRA & CSACOSMETICS & PERSONAL CARE PRODUCTS



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COSMETICS & PERSONAL CARESAFETY ASSESSMENT OVERVIEW

Cosmetic products must undergo a safety assessment before they arelaunched for sale.

Different terms – we talk about:

Cosmetic Product Safety Report (CPSR) in the EU

Toxicological Risk Assessment* (TRA) in the US, Canada, Australia & ASEAN

SGS qualified safety assessors will look at:

The formulation to determine if a consumer product will pose a risk toconsumers i.e. cause adverse health effects by acute and chronic toxicity,irritation and sensitisation, under normal and reasonably foreseeable conditions

of use;

The possible interactions of ingredients in the formulation;

The potential hazards of individual ingredients;

And consider the way the product will be used by the consumers (how often…).

Every cosmetic productplaced on the market mustbe safe for use in the

intended application.

One must be in the positionto demonstrate this safetyand to provide adequateinformation to the authoritiesas well as to the consumers.

*Besides cosmetics, TRA is also conducted on toy cosmetics (face paint, tattoos), household products (detergents, diffuser oil,…)



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COSMETICS & PERSONAL CAREFOCUS ON EU COSMETIC SAFETY ASSESSMENT

The Cosmetic Regulation (EC) 1223/2009 requires a more detailed safetyassessment and is now know as a Cosmetic Product Safety Report

(CPSR). SGS can prepare the CPSR, now composed of:

Part A: Cosmetic Product Safety Information, including:

• Physical characteristics, toxicological profile of ingredients, exposure to

the product, to the ingredients, product stability, packaging suitability …

Part B: Cosmetic Product Safety Assessment.

• Expert opinion of why your product is safe. The safety assessment is not a

guarantee of product safety, it is an opinion based on the information thathas been given to the safety assessor.

Why SGS for cosmetic safety assessment?

If you don’t have the relevant data available (Part A), SGS can conduct thenecessary testing and supply data accordingly.

SGS has highly skilled safety assessors experienced in conducting Cosmetic

Safety Assessments against the new EU regulation.

After 11th July 2013, allproducts on the EU marketmust have a Cosmetic

Product Safety Report(CPSR).



SGS DOCUMENTATIONREVIEW SERVICESCOSMETICS & PERSONAL CARE PRODUCTS



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COSMETICS & PERSONAL CAREDOCUMENTATION REVIEW SERVICES (1/2)

Labelling Review, including warnings and ingredients list

SGS can help review all ingredients and package labels (completeness, format,

accuracy and correctness) based on regulatory requirements and anyprohibited and restricted materials as listed in regulations.

E.g. For the EU market, the identification of allergens must be labelled onfinished products if their concentration is over 0.001% for leave-on products or

0.01% for rinse-off products.

Ingredient Material Safety Data Sheets (MSDS) SGS can review the manufacturer’s MSDS and in the event that it is not

available, we can prepare one.

Validation of documents including claims of a certain product

SGS can review the submitted documents.

E.g. Products containing fragrances require 26 allergenic fragrancesdeclaration and IFRA (International Fragrance Association) certification. If thedocument is not available from the vendors, SGS can perform the test for the26 allergenic fragrances.

The demand fromconsumers and regulatorybodies for improved labelling

and clarity is requiringmanufacturers to includemore product information onpackaging than ever before.



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COSMETICS & PERSONAL CAREDOCUMENTATION REVIEW SERVICES (2/2)

Focus on Product Information File (PIF) according to Cosmetics ProductRegulation (EC) 1223/2009

EU Cosmetic regulation 1223/2009 (Article 11) requires that a productinformation file (PIF) is compiled for every product placed on the market.

The PIF must be kept for 10 years after the last batch of the product isplaced on the market. It includes: Product description

Product name Unique Internal formulation reference

Language variations Product function Finished product specification

Primary and secondary artwork

Cosmetic Product Safety Report (CPSR) Method of manufacture/GMP statement

Proof of the effect claimed for the cosmetic product

Animal testing data (if any) There is no reference to Material Safety Data Sheets (MSDS) in article 11 but

many PIF will contain the MSDS of the raw ingredients.

SGS can help check andreview data for the PIF.



SGS INSPECTION & AUDITINGSERVICESCOSMETICS & PERSONAL CARE PRODUCTS



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COSMETICS & PERSONAL CARE PRODUCTSSGS AUDITING SERVICES

• GMP ISO 22716 audits

• EFfCI Guide

FACTORY AUDITS

• Respect of ethical and social code of the company by the supplier

• Covers child labour, forced labour, discrimination, working hours, etc.

SOCIAL AUDITS

• Evaluate the environmental compliance level of factories and identifyimprovement opportunities.

• Covers water, waste, energy, etc.

ENVIRONMENTAL AUDITS

Demonstrate yourenvironmentalcommitment.

Demonstrate your socialcommitment.

Ensure production is doneaccording to GMP.



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COSMETICS & PERSONAL CARE PRODUCTSFOCUS ON GMP ISO 22716 AUDITING

Good Manufacturing Practice (GMP) ISO 22716

Standard that describes the Cosmetics GMP, and was written in collaboration

with cosmetics industry professionals to promote best-in-class methods. Set of guidelines focused on human, technical, and administrative factors to

control the product quality throughout the supply chain. The scope of ISO22716 is not limited to manufacturing, but also applies to control, storage, andexpedition of the product.

Benefits: GMP is worldwide reference, ensuring compliant products,

manufactured in a controlled environment.

SGS has the capabilities to perform GMP ISO 22716 audits.

COUNTRY GUIDELINES

EU As per regulation (EC) No 1223/2009 (Article 8), which will take full effect from 11 July2013, ISO 22716:2007 is the only recognized standard for GMP audits for cosmetics.

USA US are considering a voluntary program to assess suppliers against a uniform standardwhich would be based on ISO 22716.

Canada Canada has adopted ISO 22716 on May 29th, 2010.

Japan Japan has adopted ISO 22716 as voluntary guidelines.



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COSMETICS & PERSONAL CARE PRODUCTSSGS INSPECTIONS

• Raw Materials and Componentry• Pre-Production check

• Initial Production check (IPC)• During Production check (DUPRO)

• Final Random Inspection (FRI)

RAW MATERIALS/PRODUCT INSPECTIONS

• Check of the container and its seal• Quantitative control

LOADING SUPERVISION

• Visual control in store• Picking, usage tests, laboratory tests

• Assessment of merchandising : visual aspect, price,• Temperature of store shelves…

• Discount verification• Benchmarking…

RETAIL STORE CHECK/MYSTERY SHOPPING

Ensure the product qualityis maintained throughoutthe supply chain.

Last check before dispatch.

Increase consumers’purchasing decisions.



TO GO FURTHER:SUSTAINABILITY SERVICESCOSMETICS & PERSONAL CARE PRODUCTS



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COSMETICS & PERSONAL CARE PRODUCTSSGS SUSTAINABILITY SERVICES

Addressing the environmental impact by controlling the rawmaterials in your packaging

Eco-Labelling (European Ecolabel for Cosmetics and Detergents)

SGS can conduct biodegradability tests (cosmetic formula andpackaging), eco-toxicology and performance tests

Eco-Design Diagnosis

Life Cycle Assessment (LCA)

Product Carbon Footprint Analysis and Certification Marks

Natural/Organic Product Services

Packaging Eco-Assessment Rating



WHY SGS?




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COSMETICS & PERSONAL CARE PRODUCTSSGS COMPETITIVE ADVANTAGES

SGS offers a wide range of services including testing, audits,inspections, training and consultancy services for all varieties of

Cosmetics and Personal Care products. SGS has a global network of testing labs (ISO 17025 accredited)

in Europe, Asia & the USA.

SGS has a global network of skilled inspectors and auditors

covering most countries.

SGS has technical experts with experience in internationalmarkets. We offer consultancy services on problem solving bychemists, toxicologists and microbiologists.

SGS has highly skilled cosmetic safety assessors.

Added-value services to your suppliers (e.g. supplier training,regulatory updates).



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20 SGS-Personal Care Services