1. INTRODUCTION

2. WHY A SELF- CERTIFICATION  

3. RULES REQUIREMENTS 

4. GOAL OF THE SELF-CERTIFICATION

5. DEFINITION OF BIO-ECOLOGICAL COSMETIC 

6. THE LOGOTYPE 

7. DEFINITION OF NATURAL INGREDIENTS 

8. DEFINITION OF NATURAL INGREDIENT ORGANIC FARMING

9. DEFINITION OF NATURAL INGREDIENT OF NATURAL ORIGIN

10. DEFINITION OF ADDITIVE 

11. ADMITTED INGREDIENTS CATEGORIES

12. NON-ADMITTED INGREDIENTS 

13. INGREDIENTS ALLOWED BY WAY OF EXCEPTION

14. PACKAGING AND LABELING  

15. TESTS ON ANIMALS  

16. CONTROLS  

17. TRACEABILITY 

18. GOOD MANUFACTURING PRACTICES

 

1. INTRODUCTION

Our self-certification comes from the need to give a real value to our products, which distinguish themselves for the high quality and for the use of natural, bio raw materials. In order to let this extra value be concrete and verify it, we have set some standard rules to keep with the maximum attention. 

The self-certification allows us to share the quality of the products with the consumers by the utmost transparency, granting the use of selected raw materials, ruled by a set of even more strict disciplinary measures than the ones of the main private Certifying Organisms. 

In our experience with the plant cosmetics, we came in touch and related to different realities concerning the certification of the bio cosmetic products. If, on one hand, these well- known private Authorities of Certification assure the consumers, who, often, are not really experts and have not enough technical knowledge to recognize the quality of the different cosmetic products, on the other hand they represent an extra cost which affects the price of the products themselves. 

The disciplinary measures of these Certifying Organisms, are, in some way, too strict and in some cases support the use of synthesis substances. 

For all these reasons, we started to realize the idea of a self-certification that leaded us to the creation of a new brand of selection “100% Natural Bio”.

We think the self-certification to be the most evident method, able to give more guarantees to the consumer, by reminding him that those who produce a self-certification of their production method, can be more easily controlled on site by one of the main public Authorities, without any extra extra-cost for the controlled subject. 

By the self- certification the producer stakes his credibility and reputation, so it can be considered more binding than delegating any responsibility to private Certifying Organism.

The consumer can easily consult the Protocol thus having a clear idea of the content of the cosmetic products of that brand.

We want the consumers to be informed, know and get the necessary instruments to understand when a product is really obtained by a natural process, with Bio raw materials. 

2. WHY A SELF- CERTIFICATION 

The self-certification is a substitutive declaration of certification which must be taken out by the declaring company in the person of its legal representative. 

In the fulfilment of the indications of the specification, who is making the declaration must have a more correct behavior and a greater rectitude than the ones required in the ordinary certification reports.

The Specification that established the rules for the use of the trademark “xxxxxxxxxxxxxxx” is a continuous evolving indication, in fact, in case new studies will come to the knowledge of new potentially dangerous substances, it will be consequently updated and modified.  

3. RULES REQUIREMENTS 

• Regulation CE n.1223/2009 of the European Parliament and of the Council DEL dated 30^th of November 2009 on cosmetic products; 
• Decision of the Commission dated 9^th of February 2006 that modifies the decision 96/335/CE that sets up the inventory and common nomenclature of ingredients used in the cosmetic products.
• Regulation CE n.1907/2006 of the European Parliament and Council, dated 18^th of December 2006, concerning the registration, evaluation, authorization and restriction of the chemical substances (REACH)

4. GOAL OF THE SELF-CERTIFICATION

Our standard intends to promote and increase the use of ingredients coming from the organic farming plantation or spontaneous harvest avoiding the use of those raw materials at low toxic profile but not easily decomposable and questionable from an ecological point of view. 

5. DEFINITION OF BIO-ECOLOGICAL COSMETIC 

“with 100% NATURAL BIO components” we define only one category of bio-ecological cosmetics which must comply with the following requirements:

• At least 2 of the products making the product must be bio origin.
• The lavender used must be bio origin
• The rest of the components of the cosmetic product must be bio origin and certificated.
• 2% max of the extra additives admitted (see table 03) to make the cosmetic product stable, functional and pleasant (ex: preservatives, stabilizers, active ingredients)

We point out that the sum of the percentage of natural ingredients from biological plantation includes the percentage of water present in the essence but it must come from an allowed physical process; furthermore the purifying process must not involve the use of damaging methods for environment (distillation, moisturizing water, cold extraction through under pressure water etc.…)

Our cosmetic products are in any case formulated by using water for food use coming from the valleys around Brescia.

6. THE LOGOTYPE 

“with 100% NATURAL BIO components”

It is the inscription that always describes our products and identifies them as bio-ecofriendly, conform to the present protocol and to the rules of our standard.

The logotype on the label and on the packaging of the product witnesses that all the specifications described in this protocol have been applied. 

7. DEFINITION OF NATURAL INGREDIENTS 

As in Europe the terms applied to natural origin and ecological characteristics of the cosmetic products are not legally defined, we thought it important to establish what we mean with these words: 

NATURAL INGREDIENT: 

“substance originating from the vegetal, mineral or animal world, obtained by a physical procedure that does not affect the chemical structure nor the natural origins. The allowed physical processes are described in table 01”.

Table no. 01

Physical procedures allowed for natural ingredients. They can be executed in succession but in condition that the chemical structure will be kept unchanged.

Any transformation must keep the natural functional substances contained in the original ingredients and must encourage the right management of the wastes and of the energy.

Authorized treatments on fresh plant.	Qualitative methods.
Drying	Deodorization
Crushing	Discoloration
Pounding	Purification/Detoxification
Sieving	Refinement
Cold and hot squeezing	Rectification

 

Allowed extraction solvents	Methods for separating the solute from the solvent
Water	Steam current distillation
Bio glycerin	Molecular distillation
Bio ethylic alcohol	Lyophilization
Bio vegetal oils	Atomization
Bio wine	Centrifugation
Bio vinaigrette	Filtration and ultrafiltration
Supercritical CO2	Decantation

 

Methods to obtain the extracts	Methods at controlled temperature
Infusion	Pasteurization
Decoction	Sterilization
Digestion	Roasting
Percolation
Soaking
Microwaves and ultrasounds
Hot and cold pressure
Vaporization

 

8. DEFINITION OF NATURAL INGREDIENT ORGANIC FARMING

NATURAL INGREDIENT FROM ORGANIC FARMING:

“Vegetal or of animal origin product obtained by the agricultural plantation, spontaneous and organic farming in accordance with the CEE Regulation no.2092/91, JAS (Japan), NOP (U.S.A.) or other similar regulation recognized by the European Union.

Note: it is imperative for us to have the BIO certification or the self-certification for the agricultural producer who supply the raw materials used for the cosmetic products. So, these raw materials will be certified according to a regulated and certified or voluntary control system provided that it is conform to the IFOAM standards and criteria.

9. DEFINITION OF NATURAL INGREDIENT OF NATURAL ORIGIN

 

NATURLA INGREDIENT OF NATURAL ORIGIN

“Substance originating from the vegetal, mineral or sea world transformed by an allowed technological process”

The allowed processes must take into serious account the environmental impact and human’s health, they must not be polluting nor harmful to the aquatic and earthly organisms.

In case of marine ingredients such as seaweeds (green, dark, blue and red), their extraction must not damage the marine environment where they live (see table no.02)

Table no. 02

Allowed processes for naturally derived ingredients.

All transformations must be realized in respect of the environment, must encourage reduction of wastes and provide for a proper management in compliance with current regulations concerning emissions in water, in the atmosphere and that of energy.

Alkylation	Hydration
Amidation	Hydrolysis
Condensation/Addition	Oxide/reduction
Esterification	Processes for the formation of asphoteric (betaine type)
Etherification	Saponification
Fermentation (natural/biotechnology)	Sulfating
Hydrogenation	Neutralization (to obtain salts)

10. DEFINITION OF ADDITIVE 

It is a substance needed to make a cosmetic product acceptable in terms of stability, functionality, safety and pleasantness to the use.

Our standard allows the use of even synthetic additives provided that it deals with eco-friendly chemistry with concentration below 2% of the total ingredients. 

List of the allowed additives.

Preservatives	Hair conditioners
Benzoic acid and its salts	Distearoylethyl-Hydroxyethyl monium methosulfate
Dehydroacetic acid and its Salts
Salicylic acid and its Salts
Sorbic acid
Benzyl alcohol
Phenoxyethanol

Against dandruff:

Piroctone olamine

Note:

• At present our regulation allows the use of artificial dyes, sunscreen and synthetic scents; our constant engagement in the research for natural substances will lead us to substitute gradually and definitely the artificial additives
• Some of our cosmetics still contain synthetic dyes and scents but the “not natural” origin is clearly recognizable in the certificate of conformity from the initials FC/CI followed by and identification number 

11. ADMITTED INGREDIENTS CATEGORIES

All the ingredients, being them natural or of natural origin or auxiliaries, besides responding to the European legislation for cosmetic products (CE no.1223/2009), must be conformed to the levels of biodegradability and toxicity expressed, according to the regulations on the biodegradability OECD 302A and OECD210,202,203 issued by the European Community proposal , concerning the impact for fishes, daphnia (water flea) and water weeds in fresh water.

Water

Water can be used limitless, provided that it comes from:

• Sourcing water
• Purified water through ions exchange resins
• Osmotic water
• Distilled water

Ingredients of vegetal origin

All plants and their derivatives are allowed provided that they are not:

• Included in the international list of the protected species
• At extinction risk (eco-friendly)
• Obtained through out the child exploitation or the unfair treatment of local populations (fair trade)
• Genetically modified

Ingredients of mineral origin

The following ingredients of mineral origin are allowed:

• Clay
• NaCl (Sodium Cloride)
• Zinc Oxide 
• Zinc Sulfate
• Sodium Hydroxide
• Potassium Hydroxide
• Sodium bicarbonate
• Titanium dioxide (TiO2)
• Magnesium sulfate (MgSo4) 
• Silica
• Sulfur

Ingredients of animal origin

Only ingredients coming from animal production achieved without compromising their well-being, nor caused their suffering or killing are admitted. Among them there are:

• Honey
• Bees wax
• Propolis extract
• Royal jelly

Ingredients of biotechnological origin

Only ingredients coming from bacterial fermentation, not GMO nor obtained on vegetal cultivations soils

12. NON-ADMITTED INGREDIENTS 

Our standard forbids the use of the raw materials listed in Enclosure A, among which:

• SLS (sodium lauryl sulfate) and derivatives
• SLES (sodium laureth sulfate) and derivatives 
• Glycol and derivatives (ex. Polyethylenglycol (PEG) and polypropylenglycol (PGG)
• Silicone and derivatives
• Petrolatum and derivatives
• Lanoline and derivatives
• Mineral oils and derivatives
• Genetically modified organisms (GMO)
• Carbomer
• Triethanolamine 
• Ethylenediaminetetraacetic acid (EDTA) and derivatives 
• Parabens and derivatives
• *Dyes 
• Formaldehyde donors (ex: preservatives)
• Acrylic polymers
• Aluminum and Silicon derivatives of synthetic origin
• Compounds that can give rise to nitrosamine (ex. Ethoxylate)
• Glycerin of synthetic or animal origin
• *chemical sun screens

 

*continuous research

 

13. INGREDIENTS ALLOWED BY WAY OF EXCEPTION 

Our standard allows the use of those substances in the product only deriving from the use of essential natural oils (natural allergens of essential oils) that we list below:

 

ALPHA-ISOMETHYL IONONE

AMYL CINNAMAL

AMYLCINNAMYL ALCOHOL

ANISE ALCOHOL

BENZYL ALCOHOL

BENZYL BENZOATE

BENZYL CINNAMATE

BENZYL SALICYLATE

BUTYLPHENYL METHYLPROPIONAL

CINNAMAL

CINNAMYL ALCOHOL

CITRAL

CITRONELLOL

COUMARIN

EUGENOL

EVERINA PRUNASTRI

EVERINA FUFURACEA

FARNESOL

GERANIOL

HEXYL CINNAMAL

HYDROXYCITRONELLAL

HYDROXY ISOHEXYL – 3 CYCLOHEXENE CARBOXALDEHYDE

ISOEUGENOL

LIMONENE

LINALOOL

METHYL 2 OCTYNOATE

 

14. PACKAGING AND LABELING  

For packaging products such as jars and bottles, recyclable material with low energy consumption must be used. Packaging materials containing PVC or polystyrene resins cannot be used. For labels and cases, materials that are readily biodegradable, such as paper or cardboard are to be preferred in the minimum quantity required. For the packaging of the finished boxes, readily biodegradable materials such as recycled newspapers or Materbi, a bio-plastic derived from the raw materials of agricultural origin and from non-genetically modified starch should be used.

15. TESTS ON ANIMALS  

As required also by the actual legislation, all tests on animals are forbidden either on the finished product and on each of its ingredients.

16. CONTROLS  

Once a year the company agrees to be audited by an independent qualified inspector who will verify the application of the requirements of this production protocol. The auditor will carry out random spot checks based on his experience by verifying the methods of production of cosmetics chosen randomly.

17. TRACEABILITY 

During the inspection, the production company will also leave its paper archives for the traceability of the ingredients from organic farming while purchasing and using them to witness their use of the requested percentages. 

18. GOOD MANUFACTURING PRACTICES

The whole cycle of the cosmetics production is realized through the use of good manufacturing practices.

These procedures regulate the production and the bottling of the cosmetics products. The respect of the rules described, is directly done by the Company Direction throughout the daily controls of the production activities and the audits done by an external third party.

The audits have the goal to find evidences of the use of the correct application of the rules here described.

As examples, the procedures describe the specifications both for the raw materials coming from organic farming and the certified finished cosmetic products. Besides the GMP describes the storage methods in separate and differentiated areas, the cleaning of the machinery and of the production and packaging environments (daily practiced with the use of readily biodegradable detergents and disinfectants and not harmful to health)