© Peter Lindbergh
The other sections of this website describe how L’Oréal in general evaluates the safety of all of its ingredients and products, and how it constantly monitors and examines any possible safety concern about any of its products or ingredients.
However we also understand that our consumers’ concerns are often specific to a single type of product or particular ingredient or other issue. This is why we’ve decided to offer all of the Group’s specific positions on the most commonly-mentioned questions relating to the safety of cosmetics, in the binder below.
What is it?
Phenoxyethanol is a preservative that is very widely used in numerous pharmaceutical, cosmetic and household products (detergents, disinfectants, textiles, paints, etc.). It is also used as an additive in food products to protect against microbiological contamination (bacteria, yeasts and fungi).
Why is it essential in certain cosmetic products?
Phenoxyethanol is very useful for ensuring microbiological protection of cosmetics, because it is effective against a wide spectrum of bacteria and yeasts, works in synergy with other types of preservative, and is effective for varied categories of cosmetic product. In particular, it is extremely effective against the "Pseudomonas aeruginosa" bacterium, which is very harmful to the skin.
What is the issue?
The use of phenoxyethanol in cosmetic products has been controversial since the recommendations in 2012, by the French ANSM agency for medical product safety, that European regulatory maximum concentrations be reduced for cosmetic products intended for children under 3 years old, and to prohibit its use in cosmetic products for babies' bottoms. This position has been brought before the European Commission, in order for the European Scientific Committee on Consumer Safety.to review the safety of phenoxyethanol in cosmetic products.
Why are L’Oréal products with phenoxyethanol safe?
In 2016 the European Scientific Committee on Consumer Safety re-examined all toxicological and safety data available on phenoxyethanol. The expert Committee reconfirmed that this preservative could be used in complete safety within the limits already set by European regulations, in all cosmetic products, including those for children and babies. This European opinion thus refutes the position expressed in 2012 by the ANSM in France. We never compromise on the quality and safety of our products, including protecting against microbial contamination that may be responsible for serious skin conditions. Phenoxyethanol has been present in our cosmetic products for several decades, only where it is essential to ensure effective microbiological protection. Concentrations are rigorously selected to ensure the correct level of microbiological protection for the product analysed, in strict compliance with international regulations and guaranteeing it is perfectly harmless for all of our consumers. We have also implemented a pro-active innovation strategy that aims to develop, where possible, specific packaging and new formulations that are much less vulnerable to microbial contamination, thereby limiting the use of preservatives in general and phenoxyethanol in particular.
What is it?
Methylisothiazolinone (MI) is a preservative used in numerous cosmetic and household products (detergents, cleaning products, paints, etc.) to prevent microbiological contamination. This preservative was formerly used in combination with methyl-chloro-isothiazolinone. Since the early 2000s MI on its own is much more commonly used in all of these products. The preservative is often used instead of parabens, meeting the growing demand from consumers for paraben-free cosmetics.
Why is it essential in certain cosmetic products?
MI is very useful for ensuring microbiological protection of cosmetics because it is effective against a wide spectrum of bacteria, works in synergy with other families of preservatives, and is effective for varied categories of cosmetic products.
What is the issue?
Increased use of MI (and even more, of the MCIT/MI mix) in cosmetic and non-cosmetic products is suspected to have caused a significant increase in the number of allergic reactions. For cosmetics, the role played by MI in provoking allergic reactions has only been confirmed for certain products that are not rinsed off after use. In 2013, Cosmetics Europe, the European association of cosmetics industries asked its members to voluntarily stop using the preservative for these products.
Why are L’Oréal products with MIT safe?
Experts from the European Scientific Committee on Consumer Safety have recently re-examined the safety data available for MI and confirmed at the end of 2015 that this preservative could be used safely by consumers in rinse-off products, with a recommendation for a reduction in usage concentrations. We never compromise on the quality and safety of our products, including protecting against microbiological contamination that may be responsible for serious skin conditions. We no longer use MI as a preservative in any cosmetic products that are not rinse-off. We have never used MI in products labelled "hypo-allergenic" or intended for children and babies.
We still use MI in rinse-off cosmetic products where the preservative is essential to ensure effective microbiological protection. Concentrations of the preservative are then rigorously selected to ensure the correct level of microbiological protection for the product in question, in strict compliance with international regulations while ensuring perfect safety for the consumer. We have also implemented a pro-active innovation strategy that aims to develop, where possible, specific packaging and new formulations that are much less vulnerable to microbiological contamination, thereby limiting the use of preservatives in general and MI in particular.
What is formol?
Formol is a liquid organic compound known as formaldehyde in the gaseous state. It is mainly used as a disinfectant, fixative for biological tissues and preservative in cosmetic products, in which it prevents the growth of microorganisms (bacteria, yeasts and fungi). Formol is also endowed with hardening properties.
The use of formaldehyde in cosmetic products is highly regulated. The compound is authorized, in a restricted manner, in nail hardeners and as a preservative at low concentrations. Use is prohibited in cosmetic products in aerosol or spray form. Formaldehyde has recently been incorporated, at high concentrations, in hair relaxing products. The products do not comply with the current international regulations, are associated with a risk for consumers and hairdressers and therefore should not be marketed. The products have been targeted by regulatory procedures initiated by the various international regulatory authorities.
Is formaldehyde associated with risks?
Currently, formaldehyde is considered by various international scientific organizations as being associated with the emergence of nasopharyngeal cancer after exposure by inhalation. This explains the very strict restrictions on use of the substance in cosmetics. The formaldehyde in cosmetic products is not associated with any risk for human health under normal conditions of use.
Are preservatives releasing formaldehyde associated with risks?
Certain preservatives have the characteristic of releasing very small quantities of formaldehyde to ensure the microbiological protection of cosmetic products. The preservatives have undergone very rigorous evaluation of their safety in cosmetic products by various international scientific expert committees, who have defined the conditions for use of the preservatives in cosmetic products. Preservatives releasing formaldehyde have thus received regulatory authorizations enabling their use without any risk for consumer health.
Why are L’Oréal products safe?
We never compromise on the quality and safety of our products for consumers and beauty-care professionals. We decided long ago not to use formaldehyde as an ingredient in our products even though the regulations authorize its use. We use, however, three ingredients releasing small quantities of formaldehyde as preservatives in some of our products at concentrations that are always less than the regulatory limits. The preservatives and their concentrations have been rigorously selected to ensure the correct level of microbiological protection of the products while ensuring the safety and quality of our products for consumers.
What are parabens?
Parabens are a series of preservatives that are very widely used to ensure the protection of foodstuffs, medicines and cosmetic products from microbiological contamination (bacteria and fungi). The parabens used in cosmetic products are of synthetic origin but they also exist naturally in certain foods such as red fruit, vanilla, carrot and onion, and in foodstuffs prepared from plants, some cheeses, products produced by bees (propolis, royal jelly) and in the human body.
Why are parabens indispensable in certain cosmetic products?
Parabens are very useful for ensuring the protection of numerous categories of cosmetic products (lotions, emulsions, creams) since they are very effective at low concentrations against bacteria and fungi, are heat-stable and act synergistically with other preservative groups.
In this group, ethyl and methyl parabens (short chains) are the most widely used, frequently in combination, while butyl and propyl parabens (long chains) are less used.
What are the potential risks?
The use of parabens in cosmetic products has been controversial for several years. Due to the ability of parabens to bind to estrogen receptors in vitro, the preservatives were suspected of a potential effect on reproduction in humans and on estrogen-dependent cancers such as breast cancer. The affinity of parabens for the estrogen receptor is, however, approximately 1 million times weaker than that of the estrogen (estradiol-17ß) present in the human body and no impact on human health has been formally demonstrated to date.
Why are L’Oréal products containing parabens safe?
The scientific experts of the various international health authorities very recently reviewed all the toxicological data available on the 4 parabens (ethyl, methyl, propyl and butyl parabens) used in cosmetic products and confirmed that they could be used in all safety by consumers, while adjusting the concentrations for use of each of the parabens.
We never compromise on the quality and safety of our products. Microbiological protection is one of the components of product quality and safety. Parabens have been used for several decades in certain categories of our cosmetic products and only when indispensable to ensure effective microbiological protection. The products then mainly contain ethyl and methyl parabens, which have a particularly positive safety profile. The concentrations of those parabens are rigorously defined in order to procure the correct level of microbiological protection for the product under study, in strict compliance with the international regulations, while ensuring perfect safety for the consumer. We have also developed an offensive innovation strategy designed to develop specific packaging systems and new formulations that are markedly less vulnerable to microbiological contamination, thus enabling limitation of the use of preservatives, including parabens.
What are preservatives? What are they used for?
Preservatives are substances of natural or synthetic origin whose principal role is to prevent physicochemical degradation and growth of microorganisms (bacteria, yeasts and fungi) in cosmetic products. Most preservatives are synthetic substances belonging to various chemical groups (halogen-containing compounds, aldehydes, parabens, glycol ethers, organic acids). Preservatives are also very widely used to prevent microorganism contamination of foodstuffs and medicines. Preservatives are absolutely indispensable for ensuring the protection of certain categories of cosmetic products (lotions, creams, etc.) since microorganism contamination may occur during manufacture (water, air, packaging materials) or repeated use by the consumer. Cosmetic products have a long shelf life (6 to 24 months after first opening) and, unlike perishable foodstuffs, are stored at room temperature. A cosmetic product that is poorly protected and contaminated may induce health risks for the consumer.
What are the potential risks?
Despite the essential role of preservatives in the protection of cosmetic products, their benefit is regularly contested. Preservatives are accused of inducing allergies and playing a role in the emergence of certain forms of cancer, and are singled out as endocrine disruptors.
The number and concentration of preservatives used in cosmetic products are very limited and strictly controlled by numerous international regulations. The safety data on those preservatives are very regularly reviewed by the scientific experts of the international health authorities in order to take the most recent studies into account. The concentrations used in cosmetic products may then be adjusted in order to prevent potential impacts on consumer health.
Why is the protection of L’Oréal cosmetic products safe?
We use a very limited number of preservatives selected for certain specific categories of cosmetic products when protection against microorganisms cannot be ensured by any other means. The preservatives and their concentrations are rigorously selected to ensure the correct level of microbiological protection of the product under study, in strict compliance with the international regulations, while ensuring perfect safety for the consumer.
We have also developed an proactive innovation strategy in the field of the microbiological protection of formulae consisting of: 1) synthesizing new preservatives endowed with an irreproachable safety profile and 2) developing specific packaging systems and new formulations that are not vulnerable to microbiological contamination.
What are siloxanes?
Siloxanes are low-molecular weight compounds widely used in numerous industrial sectors (household cleaning products, medical articles, cosmetic products, etc.). This group consists of a number of substances of which volatile cyclic siloxanes such as cyclotetrasiloxane (D4), cyclopentasiloxane (D5) and cyclohexasiloxane (D6).
These raw materials are endowed with unique physicochemical properties (no odor or color) enabling various cosmetic performances to be achieved (non-oily and silky feel, ease of product application on the skin and hair, rapid product drying). Siloxanes D4, D5 and D6 are also widely used in a large variety of cosmetic products (skin care, makeup, hair care).
What are the potential risks?
Siloxane D4 is considered by the European authorities responsible for chemicals as liable to present risks for human health due to its toxic potential with respect to reproduction. The international regulatory authorities (Canada and Europe) therefore assessed the specific risk associated with the substance in cosmetic products on several occasions and in all cases confirmed the absence of risk for consumers. The European Scientific Committee on Consumer Safety is currently reviewing the dossier on siloxane D4.
The international regulatory authorities consider that siloxane D5 may be used in its various cosmetic applications without risk for consumers. The safety assessment on siloxane D5 in cosmetic products was recently submitted to the European Scientific Committee on Consumer Safety by the cosmetics industry.
With regard to siloxane D6, the risk assessment conducted by the Canadian authorities concluded that the substance was not associated with any risk for human health.
Siloxanes D4 and D5 are also the subject of special attention insofar as they are suspected of accumulating and persisting in the aquatic environment, as defined by the European criteria. On that basis, some international regulatory authorities are considering restricting the use of siloxanes D4 and D5 to cosmetic products that are not rinsed off after use. The evaluations of siloxane D6 conducted by the international authorities did not identify any particular risk for the environment.
Why are the L’OREAL products containing siloxanes safe?
We never compromise on the quality and safety of our products. In the context of our policy of anticipation, we evaluate the intensity and pertinence of numerous weak signals relating to certain groups of ingredients such as siloxanes. In the innovation dynamic, we were able to discontinue use of siloxane D4 as a raw material in all of our products more than 10 years ago.
We monitor with particular attention all the new scientific findings relating to the human and environmental safety of siloxanes. Our knowledge is systematically incorporated in the safety assessments of products containing those substances in order to ensure that consumers can use our products in every confidence. Although there is no risk for the health of consumers, we are shortly to incorporate in our innovation dynamic the objective of only using siloxane D5 in cosmetic products that are not rinsed off after use.
What are ultraviolet filters?
The sun emits various ultraviolet (UV) rays whose wavelength and intensity vary depending on season and latitude. UVB (short wavelengths) are the most powerful. They induce immediate erythema of variable severity (redness and burning). Repeated exposure to UVB radiation is responsible for various cancers of the skin. UVA (long wavelengths) penetrate deeply into the skin and are responsible for premature skin aging and certain forms of photodermatosis.
Inorganic filters (titanium dioxide and zinc oxide) reflect light while organic filters absorb it. The various UV filters are frequently combined at variable concentrations to ensure the required level of protection (protection factor) against UVA and UVB of sunscreen product ranges and ensure everyday photo-protection of care products. These products are thus endowed with a real benefit for consumer health.
L’Oréal invented the first sunscreen oil in 1935 and remains a leader in the field of photo-protection research through the discovery of new organic filters against UVA and UVB endowed with an irreproachable safety profile.
What are UV filters suspected of?
Despite the essential role of ultraviolet filters in protection against the sun and everyday photo-protection, their benefit is regularly contested. Certain organic filters are frequently accused of inducing allergies, singled out as endocrine disruptors and suspected of a negative impact on the environment. Inorganic filters are suspected of readily crossing biological barriers (mucous membranes, skin, etc.), being distributed in the body and inducing adverse effects on health. The number and concentration of ultraviolet filters in cosmetic products are very limited and strictly controlled by numerous international regulations. Ultraviolet filters in some protection products are defined as cosmetic ingredients in numerous countries but as medicines in Australia, Canada and the USA. The safety data on ultraviolet filters are very regularly reviewed by the scientific experts of the international health authorities in order to take the most recent studies into account. In certain consumers, cases of allergy may occur. However, those cases are very rare. Current knowledge does not support the involvement of the ultraviolet filters used in cosmetic products in adverse effects for humans related to hormonal system disruption.
Why are the L’Oréal products containing UV filters safe?
We use a very limited number of inorganic and organic ultraviolet filters in our cosmetic products and they have all obtained approval from the international regulatory authorities after rigorous study by their scientific expert committees. The European Scientific Committee on Consumer Safety has recently published a favorable opinion relating to the use of titanium dioxide and zinc oxide in nanometric form in cosmetic products. The ultraviolet filters and their concentrations are rigorously selected to ensure the correct level of product performance, in strict compliance with the international regulations, while ensuring perfect safety for the consumer. The performance of our sunscreen and daily photo-protection products is most frequently ensured by our exclusive proprietary organic filters (Mexoryl SX and XL), which are endowed with an irreproachable safety profile and have not been the subject of any particular safety controversy.
What is a nanomaterial?
Nanomaterials consist of materials derived from modern nanotechnologies, nanomaterials that have been manufactured for decades for various applications and nanoparticles which may be of natural origin. Man has always lived in an atmosphere containing nanoparticles of which the great majority (over 90%) consists of natural inorganic nanoparticles deriving from wind erosion and volcanic eruptions. There is no single international definition and no harmonized and standardized analytical methods for nanomaterials. The nanomaterials used in cosmetic products are defined, in Europe, as non-soluble or non-biopersistent materials manufactured intentionally and with at least one external dimension or internal structure measuring between 1 and 100 nanometers (1 million times smaller than a millimeter). Nanomaterials have numerous applications in the healthcare, electronics, aeronautics, oil and gas, and cosmetics industries.
Why does L’Oréal use nanomaterials in cosmetic products?
We use a very small number of nanomaterials (including titanium dioxide, zinc oxide, carbon black and silica) when they contribute a consumer benefit. The benefit may consist, for example, in enhanced protection from, or prevention of, the harmful effects of sun through the incorporation of nano-titanium dioxide in sunscreen products. Nano-titanium dioxide ensures very effective filtration of ultraviolet radiation. Nano-silica enables hair color creams that are very unctuous to be obtained. The creams do not run into the eyes when they are applied.
What are the potential risks?
The very marked growth in the use of nanomaterials for numerous innovative applications has given rise to health and societal concerns. Given their particular properties (chemical and physical), nanomaterials are suspected of readily crossing biological barriers (mucous membranes, skin, meninges, placenta, etc.), being distributed in the body and inducing adverse effects on health.
The few nanomaterials used in cosmetic products are not new particulate ingredients products. They have been used in various cosmetic products for numerous years without the slightest problem for human health. The materials have all undergone a very complete specific safety assessment showing that the safety profile of nano-ingredients is not substantially different to that of non-nanometric forms. Robust scientific data show the absence of significant percutaneous penetration of nanomaterials. There is thus no particular risk for human health related to the nanometric character of the ingredients.
Why are the nanomaterials used by L’Oréal safe?
We never compromise on the quality and safety of our products. To date, there is no proven link between the few nanomaterials used in cosmetic products and any risk for human health. The European cosmetic regulations are the most advanced with respect to addressing societal concerns relating to the cosmetic use of nanomaterials. The highly rigorous regulations demand that the European Scientific Committee on Consumer Safety assess and authorize the nanomaterials used in cosmetics. The experts have already formulated a positive opinion for titanium dioxide, zinc oxide and carbon black. The few nanomaterials used in certain of our products have undergone a specific safety assessment in compliance with European standards. The regulations also require that the nano-ingredients are clearly identified in the list of ingredients on the packaging. We scrupulously comply with the regulations for all of our products.
What is gluten? Does L’Oréal use gluten?
Gluten is a mixture of substances, mainly consisting of proteins, present in the seeds of certain cereals such as wheat, barley, rye and oats. Gluten is present in numerous foods containing those cereals. It is used for its viscoelastic properties, particularly in baking.
We do not use gluten as an ingredient in our cosmetic products. Despite our high level of requirements relating to the quality of our raw materials, small traces of gluten may be present in a few of our raw materials derived from wheat, rye, barley and oats.
What are the potential risks?
Intolerance of certain protein fractions of gluten, also known as celiac disease, is relatively common in humans. The intolerance is characterized by marked impairment of the walls of the small intestine, which may interfere with the intestinal absorption of certain essential nutriments, thus resulting in serious deficiencies. The disease is induced by intake of foodstuffs derived from rye, oats, wheat or barley. Treatment necessitates life-long compliance with a gluten-free diet.
Why are L’Oréal products safe?
We decided not to use gluten as an ingredient in our cosmetic products. Traces of gluten in certain raw materials may be present in some cosmetic products in tiny proportions. The exposure of the human body to those very small quantities of gluten is not associated with a consumer health risk, even in consumers presenting with celiac disease. Ingestion, even accidental, of lipstick containing a few traces of gluten cannot induce adverse effects because the quantities of gluten are so small.
Consumers who know they have gluten intolerance rightly wish not to use cosmetic products containing ingredients derived from the incriminated cereals. Before choosing a cosmetic product, consumers may very easily verify the absence of the Latin names of the cereals involved in the list of ingredients (wheat: Triticum vulgare; barley: Hordeum distichon; oats: Avena sativa; rye: Secale cereale).
What are fragrance ingredients?
Fragrances are the constituents of olfactory compositions which create the basis of the great perfumes, eau de toilette, etc. Fragrance ingredients are also used in household fragrances, to perfume cosmetic products and in consumer products such as household cleaning products.
Since ancient times, man has made use of and traded in fragrances. The role of odors in social relations and well-being is well known. Olfactory compositions underlie the odors of cosmetics and contribute to the sensory pleasure related to their use.
Fragrance ingredients include a very large series of substances of natural origin (rose, jasmine, lavender, orange, bergamot, etc.) or synthetic origin.
Why indicate 'Fragrance' in the list of ingredients and not the names of the substances?
The creation of olfactory compositions draws on a unique experience and perfumers jealously guard the recipes of the great perfumes on which their celebrity is based. In order to comply with the confidentiality necessary for the protection of industrial know-how, the composition of the fragrance is not indicated in detail on the labeling, with the exception of the list of allergens contained in the fragrance.
What are the potential risks?
Fragrances are known by the dermatological community as being liable to induce allergies in certain consumers. In 2003, the European Union instituted, in the cosmetic regulations, the obligation of indicating, in the list of ingredients, the presence of certain substances rather than the simple statement 'fragrance'. In all, 26 substances considered the most allergenic are to be stated in the product labeling if present above a certain cutoff (0.01% for rinse-off products and 0.001% for non-rinse-off products). The consumer, who is thus better informed, is able to ensure the rational use of the cosmetic product. The European Scientific Committee on Consumer Safety recently reviewed all the scientific data on allergies related to fragrance ingredients in cosmetic products and recommended extending the list beyond the 26 substances that currently have to be stated in the labeling. The European Commission is working in close cooperation with industry to define the optimum manner of incorporating the expert opinion in new labeling provisions.
Why are L’Oréal products safe?
In our research teams, certain staff are specifically responsible for assessing the safety of fragrance ingredients. The olfactory compositions that we purchase comply with the standards of the IFRA, the international organization representing the producers of olfactory compositions, and undergo an initial safety assessment by the supplier. In addition, the compositions are required to comply with very strict in-house specifications to which the safety assessor contributes. After having checked that the composition fulfills the regulatory obligations and safety requirements, we conduct clinical tests in order to confirm the safety of the product containing the fragrance composition. The dual assessment by both the supplier and L’Oréal ensures that our products can be used in all safety.
What are aluminum salts? What are they used for?
Aluminum is a chemical element, the most abundant metal in the earth's crust and the third most abundant element after oxygen and silicon. The various aluminum salts are very widely used as adjuvants in vaccines, as coagulants in water processing, and in gastric antacid medications. Aluminum salts are also present in food and water. Some aluminum salts are very widely used in cosmetic products, in particular antiperspirant products. Aluminum salts very effectively reduce sweating and do not prevent the skin from breathing. Alum stone, which contains an aluminum salt, has long been recognized to have antiperspirant properties. Non-soluble forms of aluminum are also used in the colored pigments of lipsticks and toothpastes.
Is there a risk associated with including aluminum salts in cosmetic products?
The safety of antiperspirant products containing aluminum salts is a subject of controversy. The salts have been suspected of playing a role in the emergence of breast cancer and Alzheimer's disease. The potential risks have been evaluated by numerous international expert groups over the last 10 years (World Health Organization, US Food and Drug Administration, American Cancer Society, French Health Products Safety Agency (Afssaps)). All the expert groups confirmed that current knowledge does not provide any grounds for the involvement of aluminum salts used in cosmetic products in the emergence of breast cancer or Alzheimer's disease. These conclusions are perfectly consistent with the very limited ability of aluminum salts to penetrate the skin.
In 2011, Afssaps forwarded a report to the European Commission recommending limitation of the concentrations of aluminum salts used in antiperspirant products. The European Scientific Committee on Consumer Safety is preparing to review all the scientific data with a view to indicating the conditions under which aluminum may be used in cosmetic products. We are actively contributing to the process under the auspices of our European professional association (Cosmetics Europe) by making all our pertinent data available.
Why are L’Oréal antiperspirant products containing aluminum salts safe?
We never compromise on the quality and safety of our products. To date, there is no proven link between the use of aluminum salts in antiperspirant products and any risk for human health. This has been confirmed many times by international scientific expert groups. Aluminum salts have been used in our antiperspirant products for many years in strict compliance with the highest safety standards and the current international regulations. The safety of the products has also been confirmed by the data collected in the context of our cosmetic safety monitoring program for marketed products.
What is ammonia?
Ammonia is a colorless gas that is referred to as ammonium hydroxide in aqueous solution. Ammonium hydroxide has the characteristic and unpleasant odor of ammonia in gaseous form.
Ammonium hydroxide has a very wide variety of uses, as a fertilizer supplying nitrogen to agricultural land and as a cleaning agent in household products. Ammonium hydroxide is also used in certain hair products (perms, hair colors, hair straighteners) for its alkaline and reducing properties.
In hair coloration, oxidation and decoloration products, ammonium hydroxide facilitates colorant penetration into the hair but is also necessary for the effectiveness of hydrogen peroxide, which is only active in an alkaline medium. In hair relaxing and straightening products, ammonium hydroxide acts on the structure of the hair to induce the required shape of the hair.
Are there any risks?
Commercially available concentrated ammonium hydroxide solutions are very hazardous and may induce burns. The solutions are to be handled using appropriate individual protective measures (gloves, protection of the face and eyes). At high doses, ammonia fumes may give rise to discomfort or even irritation of the skin and respiratory tract.
These harmful properties of ammonium hydroxide have led legislators to regulate its use in cosmetic products. In Europe, the maximum concentration authorized in a cosmetic product is 6% and labeling is mandatory above 2%. Under those conditions, use of ammonium hydroxide in cosmetic products is not associated with any risk for consumers.
Why are L’Oréal products containing ammonium hydroxide safe?
We never compromise on the quality and safety of our products for consumers and hairdressers. All our raw materials and products undergo very rigorous safety assessment before marketing. In order to ensure perfect safety under normal conditions of use, we display particular precautions for use on the packaging of certain cosmetic products (glove wearing, measures to be taken in the event of accidental contact with the eyes). These particular precautions may be required by the regulations or by our safety assessors.
We regularly conduct studies targeting hairdressing professionals in order to verify the correct use of our hair products (compliance with the precautions for use, glove wearing, salon ventilation, etc.).
Compliance with the precautionary measures ensures perfectly safe use of our products containing ammonium hydroxide for both consumers and hairdressers.
What is PPD? What is it used for?
Para-phenylenediamine (PPD) is a substance used in the majority of permanent hair color products. PPD is the only product (except for para-toluenediamine (PTD), which is chemically very similar) that procures the darkest tints and covers gray hair in a lasting manner.
Permanent oxidative coloration is obtained by mixing hair colorants such as PPD with an oxidizing agent (e.g.: hydrogen peroxide solution) in appropriate proportions to obtain the required tint. The resulting mixture is then applied to the hair for an appropriate time. Permanent coloration is the most frequently used since it meets the performance expectations of hairdressers and consumers.
What are the potential risks?
The PPD in hair color products is frequently singled out for its allergic potential. The experts of the European Scientific Committee on Consumer Safety recently reviewed all the scientific data and confirmed the safety of the substance in hair color products at a concentration not exceeding 2% in the final mixture applied to the hair. At high concentrations, PPD is, however, liable to induce rare cases of allergy in certain subjects.
Certain temporary henna tattoos available in the form of black ink contain high concentrations of PPD of up to 20%. The products remain in prolonged contact with the skin (they are not rinsed off unlike hair-color products), do not comply with current regulations and should therefore not be offered to consumers. A black henna tattoo considerably increases the risk of the consumer becoming allergic to PPD. Consumers who have become allergic to PPD following black henna tattooing will frequently trigger a cutaneous allergic reaction when they apply a hair color product containing only low concentrations of PPD.
Why are the L’Oréal hair-color products containing PPD safe?
Hair color products and the colorants they contain, including PPD, are among the cosmetic ingredients and products whose safety has been the most regularly studied. They are thus subject to very strict regulatory monitoring worldwide in order to ensure consumer safety. Our hair color products containing PPD are of course compliant with the most restrictive cosmetic regulations. We have managed to optimize the PPD concentrations in our coloration products in order to ensure that the concentrations are substantially below the regulatory limit of 2%. This provides a further assurance of safety for consumers.
In order to prevent the risk of skin allergy, we recommend systematically conducting a cutaneous allergy test 48 hours before coloration, in rigorous compliance with the instructions on the packaging and method of use of all our products. The labeling of our products also features a special warning for people having already undergone black henna tattooing. Under normal conditions of use, our hair color products containing PPD may be used by consumers in all safety.
What is a hair colorant?
Hair colorants are basic ingredients, natural or chemical, which induce coloration of the hair. Hair coloring is an age-old procedure that was already used by the ancient Egyptians, who employed henna. Depending on the result expected by the consumer, various types of hair color products may be used either directly by the consumer or applied by a professional in a hairdressing salon. Coloration may be the classic permanent oxidative coloration, permanent tone on tone coloration, or temporary or semi-permanent coloration. Permanent oxidative coloration combines various hair colorants, an oxidizing agent, generally hydrogen peroxide, and an alkaline agent (ammonium hydroxide or monoethanolamine).
L’Oréal invented the first oxidative hair color product for hairdressers in 1909 and remains a world leader in the field of innovation with the assistance of the largest hair research center worldwide, for which coloration is one of the priorities.
What are the potential risks?
Hair color products and hair dyes were the subject of considerable controversy some 10 years ago. The products were suspected of inducing an increase in the frequency of certain forms of cancer. The controversy led to numerous international scientific committees reviewing all the existing data and concluding that there was no such risk for consumers. Like very many consumer products, such as certain foods, medications and cosmetics, hair color products may induce allergic reactions. However, those reactions are very rare and in general not serious (almost exclusively contact dermatitis) and in general confined to the scalp and totally reversible on discontinuation of product use. The reactions are mainly due to the presence of certain oxidative colorants indispensable for product performance.
Why can our hair colorants be used in all safety?
Hair colorants are certainly among the ingredients that have been the most scrupulously studied with regard to human health and are highly regulated. All the hair colorants have been reviewed and their concentrations for use redefined by the European Scientific Committee on Consumer Safety over the last decade. Our hair coloration products contain colorants that have obtained regulatory approval and para-phenylenediamine (PPD) concentrations that are at least 2 times less than the maximum concentration authorized in Europe. Our products also have precautions for use and specific safety labeling in order to inform consumers that rare cases of allergic reaction may occur and that a skin allergy test is to be conducted 48 hours before applying the hair color product. The labeling also informs consumers that the risk of allergy increases after having undergone temporary tattooing with black henna containing PPD. Very clearly, the data generated by our cosmetic safety monitoring program show that the maximum frequency of non-serious cutaneous irritation and allergies is about 1 case for every million oxidative hair color product marketed. This finding is to be viewed in the light of severe food allergies: approximately 50 to 300 cases per million subjects. Our hair color products are thus not associated with any risk for consumer health under normal conditions of use.
Are there risks for babies?
Certain cosmetic products are specifically designed to meet the hygiene and skin care requirements of babies. The products are essentially hygiene products (shampoos and bath products), lotions and wipes (for the face and certain parts of the body, particularly after a diaper change), and skin care products (moisturizing creams for the face and body).
The skin of a non-premature baby is a very effective cutaneous barrier whose permeability is not markedly different from that of the adult skin. The current international cosmetic regulations therefore do not define specific measures different from those applicable to adults for the assessment of the safety of cosmetic products for babies. However, recommendations relating to the evaluation of cosmetic products for infants aged less than 3 years were formulated by the French authorities in 2010.
These cosmetic products have been the subject of particular attention and intensified vigilance of the numerous international competent authorities for many years.
Why are L’Oréal products for babies safe?
We never compromise on the quality and safety of our products for all consumers and babies are the subject of particular attention.
More than 15 years ago, we set up a specific formulation charter for products for babies. The charter very strictly controls the composition, packaging and specific safety evaluation program for ingredients and products intended for babies. The charter, which relates to products for infants aged less than 3 years, is markedly stricter than the current international regulatory requirements applicable to cosmetic products and, in addition, imposes compliance with certain formulation principles:
- The ingredients widely used for products intended for babies are always to be preferred and certain ingredients are prohibited.
- Preservatives, when absolutely indispensable to ensure the microbiological protection of products, are selected on the basis of their high tolerability from a very limited list.
-For products intended for the buttocks, which remain confined and in contact with the skin over a long period, even more stringent safety precautions and restrictions on the choice and concentrations of the ingredients that may be used are imposed.
Application of the in-house charter, which incorporates a very complete safety assessment program, consisting of several stages in adults and then infants aged less than 3 years, ensures a very high safety level for young consumers under normal conditions of use.
What are heavy metals?
'Heavy metals' are metal trace elements associated with human or environmental toxicity. While there is no technical or scientific definition or any precise list, trace elements such as lead, arsenic, cadmium, mercury, chrome, nickel, selenium, antimony, barium and cobalt are considered heavy metals. Heavy metals are present in the earth's crust. Some are present in the water, air and food and are the subject of particular monitoring. Some metal trace elements (selenium, copper, chrome III) are essential at low concentrations to the functions of living organisms, including humans. A deficiency in certain trace elements may also induce serious health problems.
Why are heavy metal traces found in cosmetic products?
Heavy metals are not used as ingredients in cosmetic products. Certain metal trace elements are prohibited by current international regulations. The presence of very small quantities or traces of heavy metals is nonetheless tolerated in cosmetic products insofar as they are not harmful to human health. The traces often derive from impurities in certain synthetic or natural raw materials (colorants, pigments, opalescent materials) or from the product manufacturing, storage or packaging process. The presence of those traces is considered inevitable at technical level. The presence of lead traces in lipsticks is frequently the subject of particular attention.
What are the potential risks?
When heavy metals are absorbed continuously via the diet and water or by breathing highly polluted air, the heavy metals may gradually accumulate in the human body, inducing serious poisoning and various chronic diseases. Thus, excess lead intake gives rise to lead poisoning while cadmium may induce lesions of the kidneys and liver. Form VI of chrome is highly carcinogenic while form III is an essential trace element.
How are the heavy metal levels in our cosmetic products controlled?
We do not use heavy metals as ingredients in our cosmetic products. In order to control the presence of inevitable traces of heavy metals in certain products, a large-scale program for the selection and analytical characterization of our susceptible raw materials has been set up. We also control our manufacturing processes. We also ask our raw material suppliers to comply with very strict standards for the principal heavy metals liable to be present. Obviously, we comply with the current international regulations, which define the maximum concentrations of certain heavy metals, which are not to be exceeded in cosmetic products. We always use lower limits than those defined by the regulations.
By way of an example, the lead traces that may subsist in some of our lipsticks are extremely small and not associated with any consumer health hazard. The lead traces related to application of a lipstick constitute a quantity 500 to 1000 times lower than the quantity deriving from daily intake of drinking water.
Are there risks for the mother or child?
No scientific study has demonstrated any particular risk for pregnant women or infants related to the use of cosmetic products.
The current international cosmetic regulations thus do not define specific measures different from those applicable to all consumers with regard to evaluating the safety of cosmetic products that may be used by pregnant women. The products and their ingredients undergo very rigorous safety assessment ensuring a high level of safety for consumers and their infants.
In pregnant women, the transformation of the body may induce changes in the skin, which sometimes becomes more reactive, more sensitive and subject to the emergence of stretch marks. Exposure to the sun may also induce emergence of pigmented areas on the facial skin giving rise to a 'pregnancy mask'. It is therefore particularly recommended to moisturize the skin during pregnancy, avoid exposure to the sun and use an appropriate sunscreen product when necessary.
Why are L’Oréal products safe?
We never compromise on the quality and safety of our products for all consumers. Our products and ingredients undergo a safety assessment implemented in compliance with the highest international standards before marketing. Assessment of the potential impact of cosmetic product ingredients on reproduction is an integral component of the assessment. We also analyze the suitability of the product category relative to target consumers. In exceptional cases, we may advise against use of a product by a pregnant woman, using specific labeling, when our analysis requires it (slimming products).
We monitor scientific developments and the position of the health authorities very closely when particular ingredients give rise to questions.
By way of an example, excessive dietary intake of vitamin A during pregnancy may be prejudicial to the correct development of the fetus. Certain regulatory agencies (France and Germany) thus rightly questioned the safety in use of vitamin A derivatives (retinol, retinyl palmitate, retinyl acetate) in facial care products for pregnant women. On the basis of all the data compiled by the cosmetic industry, the regulatory authorities concluded that the vitamin A exposure associated with use of cosmetic products containing vitamin A derivatives at the usual concentrations was not associated with any risk for pregnant women.
We market cosmetic products that may be use in all safety by pregnant women with no particular hazard for the infant.
We always advise our consumers with specific questions relating to use of our products during pregnancy to consult their physician or gynecologist for advice.
What are endocrine disruptors?
The World Health Organization (WHO) defines endocrine disruptors as 'chemical substances of natural or artificial origin foreign to the body which may interfere with the functions of the endocrine system and consequently cause adverse health effects in an intact organism or its progeny'. An endocrine disruptor is thus a substance or mixture of substances that interacts with the hormone system and induces, by that mechanism, adverse effects on health. In contrast, substances that interact with the endocrine system without the interaction inducing any adverse effect on health should not be considered endocrine disruptors. The study of endocrine disruption and its impact on human health has been the subject of very great scientific research interest as over 4000 scientific articles have been published since 1990. The subject remains highly controversial today. The parties involved (NGO, media and consumer associations) insistently demand that the substances which only interact with endocrine systems, with no proven impact on human health, should be the subject of regulatory prohibition pursuant to the principle of precaution. None of the substances targeted fulfill the WHO definition however.
Are there endocrine disruptors in our products?
Our products do not contain endocrine disruptors as officially defined by the WHO. Numerous substances used in various industrial sectors, such as the chemical, agrochemical, food and consumer product industries, have been singled out as endocrine disruptors. The substances are frequently accused of inducing disorders of metabolism, growth and reproduction, and hormone-dependent cancers due to their interactions with the hormone systems. Certain substances present in cosmetic products such as phthalates, triclosan and parabens have been the target of repeated attacks on the simple basis of a known interaction with various hormone receptors in cell culture models. However, no valid scientific study has yet confirmed that the hormone interactions give rise to adverse effects on human health.
How can the safety of ingredients be ensured in this context?
We have incorporated the issue of endocrine disruptors in the innovation dynamics through our policy of anticipation. The substances used in our products have a safety assessment evidencing that they do not have the characteristics of endocrine disruptors as defined by the WHO. On the basis of the intensity and pertinence of the weak scientific and societal signals for certain ingredients, we may nonetheless decide to no longer use them in our products, restrict their use, or restrict them to particular product categories even though the current international regulations authorize their widespread use. In parallel, we have set up, for the selection of our new ingredients, a considerable platform of predictive tests, not using laboratory animals, enabling detection of the ability of ingredients to interact with certain hormone receptors we wish to avoid. Our innovation dynamic thus incorporates the fundamental principle of anticipation in which any risk that is not yet scientifically proven or is only perceived by society is not neglected in the safety assessment. This ensures that our consumers can use our products with every confidence.
The duration of cosmetic product use is based on two complementary factors: the date of minimum durability of a cosmetic product or expiry date and the maximum duration of product use after opening or Period After Opening (PAO).
Date of minimum durability (expiry date)
The expiry date is the limit date until which the cosmetic product, stored under appropriate conditions, fulfills its function. Beyond that date, the use is no longer guaranteed. The date is preceded by the statement 'Best before ...' and followed by either the date itself or a statement of where the date can be found on the labeling. The date is written in the form of the month followed by the year (e.g.: 06/2014) or by the day followed by the month and year (e.g.: 01/06/2014). The European regulations do not require the date when the minimum durability is greater than 30 months. For that reason, the date is not indicated on a large number of our cosmetic product labels. When the minimum durability of our cosmetic products is less than 30 months, the date is shown on the product labeling in strict compliance with the regulations.
Maximum duration of use after opening (Period After Opening - PAO)
The period after opening is the maximum duration over which the cosmetic product may be used by the consumer after product opening. During that period, the cosmetic product remains compliant with the general safety requirements and does not undergo any deterioration under normal conditions of use. The PAO is represented by an explicit symbol showing an open pot of cream followed by the duration of use expressed in months.
The symbol opposite indicates a PAO of 12 months
Indication of the duration and hence display of the symbol on the product labeling is mandatory only when the expiry date is greater than 30 months. In contrast, the duration is not mandatory for certain categories whose compositions are such that there is no risk of deterioration liable to affect the safety of the product (fragrance, aerosol, spray, etc.) or for single-use products.
Obviously, the PAO varies depending on cosmetic product category, composition, texture and type of packaging, which may or may not promote exposure to the air. Packaging a cosmetic product in a tube enables a longer PAO relative to a pot. The PAO is generally 6 months for mascaras and eyeliners, 12 months for moisturizing creams, sunscreen products and lipsticks and 24 months for nail varnish, fragrances, eye shadows and powders.
We recommend not using a cosmetic product after its expiry date or when its period after opening has expired.
What is an allergen?
Allergens are substances that are foreign to the body and that may induce, in certain subjects, after several contacts, an exaggerated response of the immune system known as an 'allergy'. Allergens are naturally present in our environment and diet. For example, pollen or the mites in dust may give rise to asthma; peanuts, shrimp and strawberries are known to induce allergic reactions that may potentially be very serious. Lastly, synthetic ingredients may have allergic potential. This is the case with certain medications, colorants, fragrances, etc.
Several types of allergy are to be distinguished, among which the best known are immediate allergies, mainly food allergies, which may be very severe, and delayed contact allergies, which gives rise to cutaneous symptoms (redness, itching, etc.) that may be extensive to a greater or lesser degree.
What are the risks with cosmetics?
Cosmetic products may occasionally give rise to allergic reactions, mainly contact allergies. The reactions are due to the presence of ingredients such as certain hair colorants, preservatives and fragrances (cf. datasheets). The reactions are rare, generally confined to the product application site and totally reversible on discontinuation of product use. The reactions may necessitate dermatological consultation and an appropriate treatment.
Why are L’Oréal products safe?
The ingredients that we use in our products have all undergone rigorous evaluation of their allergenic potential. When we evaluate cosmetic product safety prior to marketing, we verify that the ingredients constituting the product are used under conditions in which they will not induce allergies in consumers. Lastly, we verify the absence of allergic reactions by conducting appropriate clinical trials on our products.
This rigorous approach covers all the products that we develop.
In rare cases and for very specific products, when an allergic risk is known and cannot be totally eradicated with the current state of scientific and technical knowledge, we inform the consumers of the risk incurred via the product labeling and we propose a method of detecting allergic potential before product use. This is the case for hair color products, for which we recommend systematically conducting a cutaneous allergy test 48 hours before coloration (see hair colorants). It is to be noted that we pioneered the recommendation of this test.
In general, we recommend that consumers who know themselves to be allergic read the list of ingredients in the labeling of all cosmetic products attentively in order to avoid use of products that contain the ingredient(s) responsible.