The Naturalness...2 The Naturalness for Expanscience's cosmetic products [CONTENTS]INTRODUCT ION 3D...

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The Naturalness for Expanscience's COSMETIC PRODUCTS

Transcript of The Naturalness...2 The Naturalness for Expanscience's cosmetic products [CONTENTS]INTRODUCT ION 3D...

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The Naturalness for

Expanscience's COSMETIC PRODUCTS

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[ CONTENTS ]INTRODUCTION 3

DEFINITION OF NATURALNESS FOR EXPANSCIENCE’S DERMO-COSMETIC PRODUCTS 4

AUTHORIZED INGREDIENTS

Natural ingredients or ingredients of natural origin 5

Synthetic ingredients 7

PROHIBITED INGREDIENTS 11

AUTHORIZED TRANSFORMATION PROCESSES

For obtaining a natural ingredient 12

For obtaining an ingredient of natural origin 13

For developing our own active ingredients 13

STRICTLY PROHIBITED TRANSFORMATION PROCESSES 15

CLAIMS ASSOCIATED WITH THE FINISHED PRODUCT 16

APPENDIX - Calculating the naturalness of Laboratoires Expanscience’s cosmetics products 17

GLOSSARY 18

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To ensure transparency for the public, and in the absence of binding and harmonised regulations on the definition of “naturalness” in cosmetics, Laboratoires Expanscience deemed it necessary to explain its position regarding the definition of naturalness for its cosmetic products and ingredients, and so has adopted a proactive and transparent approach.

The purpose of this document is to define the criteria that are to be met when implementing this approach which involves the sensible use of natural products. It is based on Laboratoires Expanscience’s more global approach of taking social responsibility issues into account in its operations.

This document also sets out to define the conditions under which claims that emphasise naturalness can be made, using French legislation as the main reference framework.

The idea is that information about these conditions will be added to and amended as sectorial, scientific, medical and regulatory changes are implemented.

As part of an on-going progress initiative, the Group’s position will evolve over the years ahead, factoring in more and more concepts to do with biodegradability, eco-design and viability in relation to our raw materials and products.

The Naturalness for Expanscience's

cosmetic products

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The naturalness that Laboratoires Expanscience cosmetics products are required to have can currently be summed up in an original and unique way: it is based on two ecosystems gradually converging – the planet’s nature (its plants, mainly) and human skin.

Ensuring that both of these ecosystems are protected when we develop our products is what guides and inspires the choices we make in their eco-design, in selecting their ingredients, in designing their packaging, in developing our operational processes, in assessing our products and in formulating the claims and recommendations that we make:

Ingredients will therefore be selected in accordance with 3 essential criteria, listed here in order of importance: the safety and effectiveness report,

whether they are of natural origin or not,

the economic and manufacturing benefits.

So before each one of our new raw materials can be certified, a certification dossier has to be drawn up and filled in by the supplier. Each dossier must include:

Technical and regulatory analysis,

Source of raw materials, extraction process, traceability,

Stability and storage,

Health safety, tolerance, toxicological file,

Analytical specifications.

This certification is then approved internally by a committee of scientific experts (chemist, biologist, analyst and pharmacists) and then supplemented by the approval of an independent external toxicology expert.

When a technological solution exists, priority is given to natural ingredients and ingredients of natural origin, striking a balance between safety and effectiveness, particularly in relation to the active ingredients.

As far as naturalness definitions are concerned, the work done by Laboratoires Expanscience draws inspiration from the Ecocert reference framework, approved by the Ministry of Industry. It does not, however, go so far as to actually certify these products – the reference framework is not compatible with the list of usable preservatives, perfumes or processes which are required for the safety and sensorial pleasure of the products in our brands.

[ Definition of naturalness for EXPANSCIENCE’S DERMO-COSMETIC PRODUCTS ]

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The definitions of “natural ingredient” and “ingredient of natural origin” on which we have based our approach and which are listed below are taken from the ECOCERT “Biological and Ecological Cosmetics Products” reference framework.

By “natural ingredient”, we mean any plant-based, animal-based or mineral product which has just been grown or harvested or which comes directly from a farm, and has not been transformed in any way, or which has been transformed exclusively using one of the physical processes listed in the chapter: Authorised transformation processes for natural ingredients

Water is considered a “natural ingredient”.

By “ingredient of natural origin”, we mean any plant-based, animal-based or mineral product which has been transformed using one of the authorised chemical processes listed in the chapter: Authorised transformation processes for ingredients of natural origin. Authorised transformation processes for ingredients of natural origin

[ NATURAL INGREDIENTS or INGREDIENTS OF NATURAL ORIGIN ]

AUTHORIZED INGREDIENTS

Definitions

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Fatty acids and fatty alcohols from natural substances (vegetable oils, vegetable butters, etc.); emollient properties;

Glucose derivatives (coco-glucosides, alkylpolyglucosides, etc.); emulsifying properties;

Plant-based glycerides and polyglycerols; emulsifying properties;

Plant-based gelling agents (carob, cellulose and cellulose derivatives), sea-based gelling agents (alginate, carrageenan) and biotechnological-based gelling agents (xanthan gum);

Esters made from natural substances (Glycerol esters, fatty acid esters, sorbitol esters, sucroesters, plant-based amino acid esters, lanolin-based and lecithin-based esters, natural lipoproteins, etc.);

Oil based or plant-based glycerine extracts; emollient properties;

Wax-based plant ingredients, butters, oils, lecithins, mono-, oligo-, polysaccharides, proteins, lipoproteins transformed using the physical and/or chemical processes listed in the “Authorised transformation processes for natural ingredients” and “Authorised transformation processes for ingredients of natural origin” chapters; thickening and emulsifying properties;

Animal-based products: products from the hive (beeswax, propolis, honey, royal jelly); thickening properties and active

substances; purified lanolins with emulsifying properties (sheep’s wool); milk products (active substances);

“Organic” certified ingredients in accordance with the Ecocert reference framework or another organic reference framework.

Examples of authorized natural ingredients and ingredients of natural origin which may be used:

AUTHORIZED INGREDIENTS

[ NATURAL INGREDIENTS or INGREDIENTS OF NATURAL ORIGIN ]

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There are some synthetic ingredients that are not in any way considered problematic by the public, professionals or other stakeholders in terms of people’s safety and environment. As such, they do not need to be substituted for any other ingredients.

Natural ingredients and ingredients of natural origin may therefore be combined with ingredients of synthetic origin in Expanscience products when:

no natural alternative or alternative of natural origin exists or is necessary; the safety/effectiveness profile of the natural ingredient is not satisfactory according to published studies that have been analysed by our toxicology expert;

its cost is still prohibitively high.

[ SYNTHETIC INGREDIENTS ]

AUTHORIZED INGREDIENTS

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The list of synthetic ingredients that we currently allow ourselves to use is as follows:

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Synthetic buffering agents: acetic acid, citric acid, tartaric acid, sodium bicarbonate, sodium carbonate, disodium phosphate, magnesium hydroxide, potassium hydroxide, sodium hydroxide (soda), potassium carbonate, potassium sulphate, sodium silicate, which are used in very small quantities to help regulate the product’s pH (its acid or basic properties).

Substances that exhibit antimicrobial activity (preservatives or additives that help the products keep longer) when there are no natural alternatives and when we have guarantees in relation to their harmlessness and effectiveness. However, some of the synthetic preservatives that we use are substances that are identical to substances that exist in their natural state. These include salicylic acid and its salts which are given priority for use in products for adults, sorbic acid and its salts only for use in products that are rinsed out, citric acid, etc.

Specific ingredients for use in products that provide sun protection: today, only authorised solar filters the stability/photo-stability of which have been proven are used. Their harmlessness and lack of toxicity also need to have been demonstrated (they must not contain photo-sensitizers, irritants, sensitizers or endocrine disruptors). They are used in accordance with existing published scientific data, analysed by our toxicology experts, and in accordance with assessments carried out by the community scientific bodies (SCCS).

Usable synthetic ingredients

AUTHORIZED INGREDIENTS

[ SYNTHETIC INGREDIENTS ]

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Laboratoires Expanscience uses the synthetic ingredients listed below in a more cautious and restrictive way. This is because they strike a good balance between safety and effectiveness, without there being a natural alternative that meets our selection criteria (safety/effectiveness, cost).

Fragrances (fragrance compositions): all of our fragrances are selected in accordance with specifications that meet current cosmetics and perfumery standards (Cosmetics directive 76/768/EEC / EU Regulation 1223_2009 and current IFRA standards). Furthermore, they do not contain any of the 26 allergens (identified as being potentially allergenic in Cosmetics directive 76/768/EEC – 2003 version), nor do they contain phthalates, nitromusks, terpens (camphor, eucalyptol or menthol) or any CMR substances as listed in appendix VI of the CLP regulation, or any of the endocrine disruptors which figure on the official list drawn up by EU bodies (see reference 1). When choosing our fragrances, we ascertain that they are harmless from a toxicological perspective and that they comply with our specifications. Our products are not perfumed with essential oils.

Synthetic waxes (ceresin, ozokerite) and mineral oils (vaseline, paraffin, etc.): still very often necessary for specific dosage forms which require a high melting point and high levels of stability in heat: sticks.

Synthetic colouring agents: still used in order to compensate for the variable composition of natural colouring agents.

Alkylether sulphate derivatives (sodium laureth sulphate,etc.): used in order to obtain special dosage forms that are economically viable.

List of restricted synthetic ingredients

AUTHORIZED INGREDIENTS

[ SYNTHETIC INGREDIENTS ]

1http://ec.europa.eu/environment/endocrine/strategy/short_en.htm

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EDTA: biodegradable chelating agents, such as tetrasodium glutamate diacetate, are used in preference to this.

Octyldodecyl neopentanoate, isodecylpentanoate, isononyl isonanoate, neopentyl glycol diheptanoate type esters: these are still used to give the dosage form a specific feel and rendering.

Ethylene, propylene and butylene glycol (although it is not technically possible to avoid these solvents, butylene glycol is used whenever possible): certain processes do not yet allow for the substitution of glycols of natural origin, or when they do, the cost is not economically viable.

Ethoxylated derivatives (PEG, -eth, polysorbate, etc.): in the absence of any available substitutes, still used to stabilise certain emulsions that contain high concentrates of active ingredients, and for reasons of texture.

Silicones: some silicones (non-CMR) may be used in sensible quantities, particularly in sun protection products, to provide the texture and level of safety and protection that this type of products requires (mainly to ensure effective solubilisation of the UV filters, provide good resistance to water, and so provide effective, stable sun protection over time).

AUTHORIZED INGREDIENTS

[ SYNTHETIC INGREDIENTS ]

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Formaldehyde and formol-releasing ingredients (kathon CG MIT/MCIT, diazolidinyl urea, imidazolidinylurea, DMDM hydantoin, quaternium 15, sodium hydroxymethylglycinate for the new products being developed): because formaldehyde is classified as a CMR.

Essential oils: in light of the substantial toxicology, irritation and allergen risks, particularly for our sensitive targets, as well as the variable composition of these oils.

Terpenes (camphor, menthol, eucalyptol) for products intended for babies, in accordance with the recommendations formulated by France’s national agency for the safety of medical products (ANSM): in light of our specific target population and how sensitive young children can be to this type of ingredient.

All classifications of CMR-classified substances, in accordance with appendix VI of the CLP regulations and ethanol in light of its classification and the sensitive skin of our target populations.

Endocrine disruptors on the official list drawn up by the EU bodies.

Parabens.

Glycol ethers, including phenoxyethanol.

Alkyl sulphate derivatives (e.g.: SLS).

Phtalates.

All plant extracts derived from genetically modified plants.

Cyclotetrasiloxane (silicone) prohibited in all types of product.

BHA and BHT used in their basic state.

Aluminium chlorohydrate.

Benzoic acid.

Any ingredient from the animal kingdom, except for the following ingredients: honey, beeswax, propolis, royal jelly, purified lanolins, milk products.

Any ingredient derived from one of the protected species that appears on the list drawn up for the CITES Convention (except for candelilla wax).

PROHIBITED INGREDIENTS

List of natural ingredients, ingredients of natural origin and synthetic ingredients that we abstain from using in light of the real or perceived risks, other than those which are prohibited by cosmetics regulations:

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1

2

3

1 Atomization: Drying process that involves transforming a liquid, which is sprayed in the form of tiny droplets and brought into contact with a hot gas, into a powder.

2 leaching: Extraction process which involves slowly passing the extraction solvent over a powdered solid.

3 Zeodratation: Innovative drying process that uses zeolites (mineral belonging to the aluminosilicate family). This technique is based on using a vacuum (100 bars,

-20°C to 60°C) to extract the water, which is then absorbed by the zeolites. Chlorinated refrigeration gases may not be used with these zeolites.

The natural ingredients must be obtained using physical processes that comply with the list below (that has its roots in the Ecocert reference framework):

Atomization1;

Grinding, centrifugation, mixing;

Freezing – Vacuum packing;

Deterpenation using steam;

Molecular distillation;

Extraction using supercritical fluids;

Traditional extraction (digestion, maceration, distillation, pressing, evaporation, leaching2 or percolation);

Authorized extraction solvents: water, CO2, vegetable glycerin, vegetable oils, ethanol if completely evaporated

at the end of the process. Glycolated solvents are to be avoided;

Clarifying and sterilizing filtrations (ultrafiltration, nanofiltration, dialysis, electrolysis, etc.);

Lyophilization – Zeodratation3;

Cold and hot pressing;

Physical chemical refining of fatty bodies;

Drying, desiccation (gradual or otherwise, by evaporation or naturally in the sun);

Roasting;

Sterilization using thermal treatments (the temperatures of which respect the active ingredients), flash pasteurisation.

This list may be updated on a case-by-case basis, given that recent environmentally friendly extraction techniques are being developed.

A process is considered acceptable if it can guarantee that the ingredient it uses is harmless, that the active ingredient retains its integrity and that it is not dangerous to people or the environment.

[ For obtaining a NATURAL INGREDIENT ]

AUTHORIZED TRANSFORMATION PROCESSES

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The ingredients of natural origin must be obtained using chemical or biochemical processes that comply with the list below (that has its roots in the Ecocert reference framework):

Alkylation;

Amide formation;

Plant carbonization and calcination;

Condensation, addition;

Esterification and etherification;

Natural or biotechnological fermentation;

Hydration;

Hydrogenation;

Hydrolysis;

Neutralization (obtaining Na, Ca, Mg or K salts);

Oxidation/Reduction;

Processes for producing amphoterics: amide formation and quaternisation;

Enzymatic reactions;

Saponification;

Sulfatation.

This list may be updated on a case-by-case basis, given that recent environmentally friendly extraction techniques are being developed. A process is considered acceptable if it can guarantee that the ingredient it uses is harmless, that the active ingredient retains its integrity and that it is not dangerous to people or the environment.

Our expertise in using ingredients of plant origin has always been oriented towards minimising the impact that our processes have on people and the environment. This has been the case particularly over the last 3 years.

For a long time now, our understanding of the plant kingdom has helped us minimise our impact on the environment – we have been able to adopt industrial processes that use so-called “green” technologies that do not damage the environment.

[ For obtaining an INGREDIENT OF NATURAL ORIGIN ]

[ For developing our own ACTIVE INGREDIENTS ]

AUTHORIZED TRANSFORMATION PROCESSES

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For physical processes, we use: molecular distillation;

pressing;

extraction with supercritical CO2;

deodistillation;

grinding.

For chemical processes, we use: Extraction using so-called "clean" solvents, including water and fruit ethanol;

Green chemicals without solvents, or with solvents that have a very low impact on people and the environment;

Enzymatic engineering using non-GMO enzymes.

Today, these guidelines for industrial sustainability – a concept that is associated with naturalness – are applied at every stage of a project: From the plant source:

The focus is on seeking out organic raw materials whenever possible, in addition to other components that are associated with sustainable development (FSC, fair trade, preserving biodiversity, limiting carbon consumption, etc.), as well as on pre-transformation of these materials where they are harvested, if relevant, and on streamlining our supply to improve the carbon footprint involved in transporting them. We are also moving gradually closer to a product life-cycle approach.

To the final, stable active ingredient: by eliminating non-natural chemical substances and risky natural chemical substances;

by eliminating water (physical processes) to reduce AW, thus naturally ensuring health safety (by preventing microbiological development) and chemical safety (limited chemical degradation in the absence of water) for active ingredients.

The ultimate objective of these various initiatives is (ideally) to obtain active ingredients that are in compliance with the Ecocert reference framework or equivalent.

More specific examples include:

AUTHORIZED TRANSFORMATION PROCESSES

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The following processes are prohibited for all ingredients:

Debacterization treatments using ethylene oxide;

Deterpenation, except using steam;

Decoloration and deodorization using a medium of animal origin4;

Treatments using mercury (mercurial sodium and potassium);

Techniques requiring genetic manipulations;

Sulphonation;

Halogen chemistry (chemical processes that result in a halogenated raw material).

This list is not exhaustive.

We ban manufacturing processes that are excessively polluting, consume too much energy, require the use of organic solvents or generate residues that are toxic to people or the environment.

NOTE: all of these processes also apply to finished products.

44Consequently, diatomaceous earth (fossils of seaweed and single-celled marine plants) is authorized as a medium for decoloration, deodorisation, filtration and clarification.

STRICTLY PROHIBITED TRANSFORMATION PROCESSES

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In light of the general approach described in this document, it will be possible to use the following tagline on any communications media: “priority given to ingredients of natural origin”.

This concept of “priority given to ingredients of natural origin” is the result of a global company approach which sets out to showcase our ingredients selection approach based on the expertise we have in our understanding of plants in particular.

This illustrates the fact that for each formulation or reformulation, we are committed to using naturalness as a selection and prioritising criterion, while at the same time meeting our other fundamental commitments: safety, effectiveness and economic impact.

Additionally, in accordance with the recommendations set out by the certifying entities (Ecocert) and those formulated by the ARPP (French advertising authority) on natural products, we consider that, in order to bear a “natural product” or “product of natural origin” claim, our cosmetics products must comply with these rules:When the product contains at least 95% natural ingredients or ingredients of natural origin, we will be able to advertise:

“natural product”, insofar as this designation may be accepted in the various countries in which the product is sold;

The claims mentioned below.

When the product contains more than 75% but less than 95% natural ingredients or ingredients of natural origin, we will be able to advertise:

"product of natural origin"; "product based on natural ingredients or ingredients of natural origin"*; "product composed of x% natural ingredients or ingredients of natural origin"; of the percentage of ingredients of natural origin.

In both cases, the percentage of remaining ingredients must be composed solely of ingredients that are authorised in this document.

Ifhese claims are present on the products or advertising tools, they must include a reference to the brand website that can be used to link to this document.

For organic claims, a number of references exist.

Any “organic” type claim will be based on a specific reference framework (for example: Cosmebio, Cosmos, Natrue, etc.) and on having our relevant ingredients and products certified by the certifying body (Ecocert or other).

* In reference to the recommendations of the BVP in 1998 specifying that the term "based on" can be used only if the substance in question is responsible for the main property of the product or if it makes up more than 50% of its composition.

"Natural" claims:

"Organic" claims

CLAIMS ASSOCIATED WITH THE FINISHED PRODUCT

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APPENDIX

Calculating the naturalness of Laboratoires Expanscience’s cosmetics productsThe percentage level of a given formula’s naturalness is defined as the sum of the naturalness percentages of its constituent Raw Materials taken individually and then weighted by the share that they represent in the formula as a percentage.

A Raw Material is classified as natural or of natural origin or synthetic, in accordance with the information given in the previous chapters.

A naturalness percentage (percentage of natural origin) is given to each Raw Material, based on its INCI composition.

Examples:

Hexanediol (INCI: 100% 1.2-hexanediol): chemically synthesised ingredient. It is therefore classified as a 100% synthetic ingredient, and so of 0% natural origin;

Sophora Japonica extract (INCI: 55% Butylene Glycol + 42% water + 3% Sophora Japonica Extract) is classified as an ingredient of 45% natural origin. Its natural properties are derived from water (42%) + Sophora Japonica Extract (3%), Butylene Glycol being completely synthetic;

Citric acid (INCI: 100% citric acid) is made by fermenting sugar (beetroot), a manufacturing process that is on the list of authorised processes (in the information given in the previous chapters). Its Raw Material is of plant origin, and so it is classified as a product of 100% natural origin.

The formula’s naturalness percentage is calculated by adding together the naturalness percentages of each Raw Material weighted by their share in the product as a percentage.

Example:

Using the Raw Materials defined above and defining the formula as a blend of 90% hexanediol + 9% citric acid + 1% Sophora Japonica extract, we get:

90%x0 + 9%x100 + 1%x45 = 9,45% naturalness percentage for this formula

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GLOSSARY

ANSM ______________ Agence Nationale de Sécurité du Médicament, France’s national agency for the safety of medicines

ARPP _______________ Autorité de Régulation de la Publicité Professionnelle Française, France’s advertising regulation authority

BVP _______________ Bureau de Vérification de la Publicité, France’s advertising standards authority

CMR _______________ Carcinogenic, Mutagenic, Reprotoxic

CLP _______________ Classification, Labelling, Packaging

FSC _______________ Forest Stewardship Council

IFRA _______________ International Fragrance Association

RP _______________ Raw material

GMO _______________ Genetically Modified Organism

Stakeholders: ______ all people/bodies/institutions that are involved in the economic aspects of the company (employees, clients, suppliers, shareholders), who observe it (unions, NGOs) and on which it has a more or less direct influence (civil society, local authority, etc.)

SCCS ______________ Scientific Committee on Consumer Safety