Tudástár
Scope is the sum of the products, services, and results to be provided as a project. As scope is defined, it creates the need for more requirements identification. Therefore, like requirements, scope can be well defined up front, it can evolve over time, or it can be discovered.
The Standard For Project Management And A Guide To The Project Management Body Of Knowledge (Pmbok® Guide) Seventh Edition
Propanediol is a skin-friendly, natural and petroleum-free glycol alternative for the cosmetics and personal care market. It is available as an approved by Ecocert™ and certified by the Natural Products Association (NPA), Zemea® is a 100% natural ingredient.It is the perfect glycol alternative for formulations where non-petroleum based ingredients are desired. Benefits include its high purity, lack of skin irritation or sensitization, improved humectancy, excellent aesthetics and environmentally sustainable nature. It is currently being used in many major hair and skin care brands around the world. Zemea® propanediol can be used to replace glycols such as propylene glycol (1,2-propanediol), butylene glycol (1,3-/1,4-butanediol) or glycerin. Depending on your formulation needs, it can function as: Emollient, Humectant, Solvent, Hand-feel Modifier, Viscosity Enhancer, Botanical Extraction and Dilution, as a carrier for active ingredients, Ingredient for natural esters and ethers, Ingredient in natural preservative systems.
Source: Dweck, Anthony. Handbook of Cosmetic Ingredients: - their use, safety and toxicology (Dweck Books 5)
PET is one of the most widely used resins because of its transparency, flexibility and memory (i.e. the ability to return to its original shape following deformation), and good compatibility with most cosmetic ingredients.
The good durability of PET is ideal for transparent bottles of shampoos and conditioners that may often slip from the hands and fall to the ground. The bottle will dent, without cracking, unlike other transparent resins. With the addition of pigments, PET bottles or pots become coloured, transparent or translucent. They can also be completely white by the addition of titanium dioxide or pearlescent by adding mica-based pearl luster pigments such as Iriodin®. The addition of sunscreen to the resin confers protection from light to the inner product without the loss of packaging transparency.
Source: Cosmetic Formulation Principles and Practice - Heather A.E. Benson, Michael S. Roberts, Vânia Rodrigues Leite-Silva, Kenneth A. Walters
PVC offers transparency, but is brittle and the packaging is likely to crack or break if dropped. PVC has little memory and can be coloured with pigments. It is most commonly used in bottles of shampoo, conditioner, lotions, tubes of mascara and lip gloss.
Source: Cosmetic Formulation Principles and Practice - Heather A.E. Benson, Michael S. Roberts, Vânia Rodrigues Leite-Silva, Kenneth A. Walters
PP is a translucent plastic resin used in bottles for shampoo, conditioner, jars for creams and products containing a high concentration of vegetable or mineral oil such as bath and sun tanning oils. It has lower porosity than PE, thus reducing the potential for migration of product components through the packaging.
PP is used to produce the majority of lids for containers, which can be flip top, top disc or a blind cover. The discs that are placed under the cover of a cream so that the product has no direct contact with the lid are also generally composed of PP.
Source: Cosmetic Formulation Principles and Practice - Heather A.E. Benson, Michael S. Roberts, Vânia Rodrigues Leite-Silva, Kenneth A. Walters
Piper longum fruit extract. The fruit contains 1% volatile oil, resin, alkaloids Piperin and piperlonguminine, a waxy alkaloid N-isobutyl deca-trans-2-trans-4-dienamide and a terpenoid substance. The roots have piperine, periongumine or piplartin, dihydro-stigmasterol, which have been the reason that it is popularly used in traditional practice to promote respiratory health. In a few weeks-clinical study with 20 children Piper longum extract significantly benefited respiratory function. It has been known to effectively reduce passive cutaneous anaphylaxis in rats and proteacted guinea pigs against antigen induced bronchospasm. (Dahanukar.S et.al.Indian Drugs 19:271(1982). Major chemical constituents: Essential oil. Mono and sesquiterpenes, caryophyllene (mainly), Piperine, Piperlongumine, Piperlonguminine, Pipernonaline, Piperundecalidine, Pipercide, Sesamin, B- sitosterol four aristolactams (cepharanone B. aristolactum All. Piperlactum A and piperolactam B) five 4-5 dioxoaporphines etc. The essential oil of the fruit P. longum is a complex mixture, the three major components of which are (excluding the volatile piperine) caryophyllene and pentadecane (both about 17.8%) and bisaboline (11%). Others include thujine, terpinoline, zingiberine, pcymene, p-methoxy acetophenone and dihydrocarveol. Long pepper contains less essential oil than its relatives (about 1%), which consists of sesquiterpene hydrocarbons and ethers (bisabolene, β-caryophyllene, β-caryophyllene oxide, each 10 to 20%; α-zingiberene, 5%), and saturated aliphatic hydrocarbons such as 18% pentadecane, 7% tridecane, 6% heptadecane. The essential oil of the fruits showed fungicidal activity of P. longum L. The fruit-derived materials was tested towards six phytopathogenic fungi, Pyricularia oryzae, Rhizoctonia solani, Botrytis cineria, Phytophthora infestans, Puccinia recondita, and Erysiphe graminis using a whole plant in vivo method 42-44. A piperidine alkaloid, pipernonaline, was isolated from the hexane fraction of P.longum showed a potent fungicidal activity against P. recondita with 91% and 80% control values at the concentration of 0.5 and 0.25 mg ml−1.
Source: Dweck, Anthony. Handbook of Natural Ingredients (Dweck Books 4) . Dweck Data.
Polymeric materials can interact both with protein of the skin surface and with skin lipids. Parameters influencing the interaction between skin surface and the polymers are as follows:
- The positive charge density: the more cationic the character of the polymer, the better the polymer interaction with negatively charged skin surface.
- The hydrophobicity of polymer: grafting of hydrophobic moieties on the polymer backbone favor van der Waals interactions with hydrophobic areas of the keratin.
- The molecular weight of the polymer: the higher the polymer size, the more its substantivity to the skin (film-forming properties). However, very low–molecular weight polymers can easily penetrate the skin surface chinks and as such adsorb into the superficial stratum disjonctum.
- The nature of surfactants neighboring the polymer in the finished product: the polymer can interact with surfactants either through their charges or through hydrophobic interactions; also, competition between polymer and surfactants for skin anchoring sites can occur. In both cases, deposition and adsorption of polymer onto the skin surface is weakened.
Source: Handbook of Cosmetic Science and Technology - André O. Barel, Marc Paye, Howard I. Maibach
Phenoxyethanol is one of the most widely used preservatives. It is a broad-spectrum preservative, but it is slightly weaker against Gram-positive bacteria than the other species types.
Phenoxyethanol is slightly water-soluble (approximately 2.4%) and is preferably added to the product at temperatures below 40°C to reduce the possibility of evaporative loss, although this is only likely to be an issue should the manufactured batch be held at a high temperature (>80°C) for a prolonged period.
It retains its activity over a broad pH range, from pH 3 to 9. Typical use concentrations are 0.4–1.0%. Phenoxyethanol is more commonly used in combination with other preservatives and is rarely used alone. Phenoxyethanol is permitted in most territories, with restrictions.
Source: Cosmetic Formulation Principles and Practice - Heather A.E. Benson, Michael S. Roberts, Vânia Rodrigues Leite-Silva, Kenneth A. Walters
PCR stands for Post Consumer Recycled materials. These plastics are popular with customers looking to reduce the amount of virgin plastic in their product packaging.
Generally produced from discarded plastic milk and drinks bottles, PCR materials are environmentally sustainable solution for reusing single-use materials that would otherwise be disposed of landfill sites.
PCR materials can be recycled again for new manufacturing to provide genuine sustainability.
Piper Longum Fruit Extract is the extract of the fruit of the Long Pepper, Piper longum L., Piperaceae. The fruit contains 1% volatile oil, resin, alkaloids Piperin and piperlonguminine, a waxy alkaloid N-isobutyl deca-trans-2-trans-4-dienamide and a terpenoid substance. The roots have piperine, periongumine or piplartin, dihydro-stigmasterol, which have been the reason that it is popularly used in traditional practice to promote respiratory health. In a few weeks-clinical study with 20 children Piper longum extract significantly benefited respiratory function. It has been known to effectively reduce passive cutaneous anaphylaxis in rats and proteacted guinea pigs against antigen induced bronchospasm. (Dahanukar.S et.al.Indian Drugs 19:271(1982). Major chemical constituents: Essential oil. Mono and sesquiterpenes, caryophyllene (mainly), Piperine, Piperlongumine, Piperlonguminine, Pipernonaline, Piperundecalidine, Pipercide, Sesamin, B- sitosterol four aristolactams (cepharanone B. aristolactum All. Piperlactum A and piperolactam B) five 4-5 dioxoaporphines etc. The essential oil of the fruit P. longum is a complex mixture, the three major components of which are (excluding the volatile piperine) caryophyllene and pentadecane (both about 17.8%) and bisaboline (11%). Others include thujine, terpinoline, zingiberine, pcymene, p-methoxy acetophenone and dihydrocarveol. Long pepper contains less essential oil than its relatives (about 1%), which consists of sesquiterpene hydrocarbons and ethers (bisabolene, β-caryophyllene, β-caryophyllene oxide, each 10 to 20%; α-zingiberene, 5%), and saturated aliphatic hydrocarbons such as 18% pentadecane, 7% tridecane, 6% heptadecane. The essential oil of the fruits showed fungicidal activity of P. longum L. The fruit-derived materials was tested towards six phytopathogenic fungi, Pyricularia oryzae, Rhizoctonia solani, Botrytis cineria, Phytophthora infestans, Puccinia recondita, and Erysiphe graminis using a whole plant in vivo method 42-44. A piperidine alkaloid, pipernonaline, was isolated from the hexane fraction of P.longum showed a potent fungicidal activity against P. recondita with 91% and 80% control values at the concentration of 0.5 and 0.25 mg ml−1.
Source: Dweck, Anthony. Handbook of Cosmetic Ingredients: - their use, safety and toxicology (Dweck Books 5)
Panthenol is the biologically active alcohol analogue of pantothenic acid, a vitamin of the B-complex group, which is a normal constituent of skin and hair. Pantothenic acid, also called Vitamin B5, carries out its function in the body as an element of co-enzyme A, a molecule composed of cysteamine, ATP, and pantothenic acid. This substance is present in all living cells and serves a vital role in the metabolism of a variety of enzyme-catalyzed reactions by which energy is released from carbohydrates, fats, and proteins.
Skin manifestations of pantothenic acid deficiency are well known, and include cornification, depigmentation, and desquamation. Pantothenic acid is an unstable substance. In topical preparations such as skincare, haircare, nailcare, and derma products, pantothenic acid is used in the alcohol form, called panthenol. Its use is based on its dual role as a vitamin precursor and as an ingredient with ideal cosmetic properties. When topically applied, panthenol is absorbed by the skin and can be bioconverted into pantothenic acid. As such it exerts all functions of
vitamin B5.
Because it has a distinct humectant character, panthenol acts as a skin moisturizer. This hygroscopic substance not only provides water to the skin surface but it also penetrates deep into the epidermis and brings water to, and retains water in, the inside of the skin. Panthenol imparts a smooth, light feel to the skin without any greasiness or stickiness. Because it is well tolerated by the skin, it is an ideal and widely used ingredient in baby care products as well as in products for sensitive skin.
Topically applied panthenol stimulates epithelization as was shown by Weiser and Erlemann. Superficial wounds treated with creams containing 5% panthenol reduced the healing time by 30% compared with placebo. Favorable effects were also reported in many kinds of skin disorders accompanied by inflammatory reactions such as burns, nipple fissures, eczemas, and many others. Another application field of panthenol is, therefore, derma products for wound healing and for soothing of inflammatory disorders where it is usually incorporated in concentrations of 5%. The concentrations in cosmetics vary mainly from 0.3 to 2%.
The use of panthenol in haircare products goes back to the early 1960s, when inflammatory reactions on the scalp were treated with panthenol-containing creams. Panthenol not only showed a soothing effect but also had beneficial effects on the hair. Pantothenic acid is a natural constituent of human hair. Stuettgen applied tritium-labeled panthenol intracutaneously by injection and could show a transport of radioactive material into the hair. Stangl observed a significant increase of pantothenic
acid concentration in the hair after topical application of panthenol over longer periods.
Panthenol acts as a humectant for hair. It builds up a thin moisture film on the surface of the hair and gives hair shine without making it greasy. Panthenol also penetrates
into the hair cuticle and brings moisture to the cortex. This imparts good pliability and manageability properties to the hair, and improves its resistance to mechanical stress such as combing, brushing, and heat blowdrying.
Panthenol can also contribute to give hair more body. A thickening of the hair after 2 minutes exposure to a 2% water solution of panthenol was shown by means of scanning electron microscopy.
The main commercial forms are d-panthenol, dl-panthenol, and ethyl panthenol. All these forms are soluble in e.g., water, ethanol, and propylene glycol, but insoluble in fats and oils. Ethyl panthenol is an ether and available either as d-form or a racemic mixture of d- and l-form. Biological activity has only the d-form, because only d-pantothenic acid is incorporated into coenzyme A.
Source: Handbook of Cosmetic Science and Technology - André O. Barel, Marc Paye, Howard I. Maibach
The main components are long-chain wax esters with chain lengths of around C60. Although it has
similar chemistry to sunflower wax, its applications are quite different. Refined rice bran wax has a very
hydrophobic character. It forms soft oil gels and is therefore highly preferred for emulsions like mascaras
and skin care products.
Source: Cosmetic Formulation Principles and Practice - Heather A.E. Benson, Michael S. Roberts, Vânia Rodrigues Leite-Silva, Kenneth A. Walters
Ozokerite wax is generally a white, crystalline, odorless and tasteless solid. It is most often made from blends of paraffin and microcrystalline waxes, and when combined offers broader functionality than the constituent ingredients. It is used extensively in personal care and cosmetic formulations. It will increase viscosity, assist in emulsion stability and enhance gel strength in liquid and semi-solid systems. It is a hard wax with a relatively high melting point. These characteristics encourage its use in lipstick and lip care products to promote structure and stick strength.
Source: Cosmetic Formulation Principles and Practice - Heather A.E. Benson, Michael S. Roberts, Vânia Rodrigues Leite-Silva, Kenneth A. Walters
Traditional use: A warming oil, it asist improvement of circulation, digestion, mental clarity and alertness. It is used to relieves muscle aches and pains and is said to assist in increasing physical endurance and energy. It may assist in reducing cellulite. In China, it is used additionally to treat itchy skin conditions. It is an ingredient of ointments and bath preparations used to alleviate rheumatism. May be used externally in baths, inhalants or poultices where an antiseptic action is required, externally as a lotion for varicose veins.
Source: Handbook Of Natural Ingredients - Anthony C. Dweck
Palmitoyl tripeptide-1 is a signal peptide that results of the conjugation of palmitic acid with tripeptide-1 which performs two functions: signal peptide and carrier peptide when complexed with copper. Palmitoyl tripeptide-1 act on the TGF-β, which is responsible for stimulating dermal fibroblasts to produce ECM proteins, which will reinforce the epidermis, but also reduce wrinkles.
Source: Journal of Drug Delivery Science and Technology - Anti-aging peptides for advanced skincare: Focus on nanodelivery systems
Oil-in-water emulsions typically contain 10 to 35% oil phase, and a lower viscosity emulsion may have an oil phase reduced to 5 to 15%. Water in the external phase of the emulsion helps hydrate the stratum corneum of the skin. This is desirable when one desires to incorporate water-soluble active ingredients in the vehicle. Oil droplets in emulsions have a lower density than the phase they are suspended in; to have a stable emulsion it is important to adjust the specific gravity of the oil and water phases as closely as possible.
Viscosity of the water phase (external phase) may be increased to impede the upward migration of the oil particles. Addition of waxes to the oil phase will increase specific gravity but have a profound effect on the appearance, texture, and feel on application to skin of the product. Increasing water-phase viscosity is one of the most common approaches.
Natural thickeners (alginates, caragenates, xanthan) and cellulosic (carboxymethyl cellulose) gums are used for this purpose.
Carbopol resin is perhaps the most popular gum thickener for contributing towards emulsion stability, especially at higher temperatures. The addition of a fatty amine to a Carbopol resin will further enhance stability by strengthening the interface of the water and oil phases through partial solubilization into the oil droplets. Electrolytes and cationic materials will have a destabilizing effect on anionic sodium carboxymethyl cellulose and should not be used together. Veegum, an inorganic aluminum silicate material, is also commonly used to thicken emulsions. Carbopol and Veegum may be used together to modify the characteristic draggy feel of Carbopol when used at the higher levels.
Emulsifier blends with HLBs ranging from 7 to 16 are used for forming o/w emulsions. In the blend, the hydrophilic emulsifier should be formulated as the predominate
emulsifier to obtain the best emulsion. A popular emulsifier, the glycerol monostearate and polyoxyethylene stearate blend is self-emulsifying and acid-stable. Emulsifiers are called self-emulsifying when an auxiliary anionic or nonionic emulsifier is added for easier emulsification of the formulation. Formulating with self-emulsifying materials containing nonionic emulsifiers permit a wide range of ingredient choice for the formulator, especially with acid systems. In alkaline formulations, polyoxyethylene ether–type emulsifiers are preferred with respect to emulsion stability.
An alternative to glycerol monostearate self-emulsifying emulsifier is Emulsifying Wax, National Formulary (NF). This emulsifier, when used with a fatty alcohol will form viscous liquids to creams depending on the other oil-phase ingredients used. Use levels may vary from 2 to 15%; at lower levels a secondary emulsifier such as the oleths or PEG-glycerides will give good stability. This system is good for stabilizing electrolyte emulsions or when other ionic materials are formulated into the vehicle. Polysorbates are o/w emulsifiers, wetting agents, and solubilizers often used with cetyl or stearyl alcohol at 0.5 to 5.0% to produce o/w emulsions.
Source: Handbook of Cosmetic Science and Technology - André O. Barel, Marc Paye, Howard I. Maibach
A natural is any material that is harvested, mined, or collected, and which may have subsequently been washed, decolorized, distilled, fractionated, ground, milled, separated, or concentrated, leaving a chemical or chemicals that would be available and detectable in the original source material. It is also the modification of natural material by the action of microorganisms, enzymes, or yeasts to modify or increase the yield of material by this process. Naturally derived materials are defined by the use of a natural raw material as the starting point in a chemical process that produces a new chemical or chemicals that in themselves may not be available in nature or in the starting material. Nature-identical materials are substances that have been synthetically produced, not usually from a natural starting material, in order to produce a material that is identical to that naturally occurring in nature.
Source: Dermatologic, Cosmeceutic and Cosmeticdevelopment - Kenneth A. Walters, Michael S. Roberts
When choosing your bottle you will need to decide which neck best suits your products and choice of cap. This number is the the neck finish.
The neck finish is normally signified by two numbers - for example 20/410, 20/415, 24/410 ans 24/415. These two numbers represent the outer diameter of the neck opening (mm), the thread configuration and height of the neck.
The Food and Drug Administration (FDA) includes Niacinamide and Niacin on its list of direct food substances affirmed as Generally Recognized As Safe (GRAS). Both ingredients are also GRAS as nutrients and/or dietary supplements. The safety of Niacinamide and Niacin has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the available scientific data and concluded that Niacinamide and Niacin were safe in the current practices of use and concentration in cosmetics and personal care products. Niacinamide (aka nicotinamide) and Niacin (aka nicotinic acid) are heterocyclic aromatic compounds which function in cosmetics primarily as hair and skin conditioning agents. Niacinamide is used in around 30 cosmetic formulations including shampoos, hair tonics, skin moisturizers, and cleansing formulations. Niacin is used in a few similar product types. The concentration of use of Niacinamide varies from a low of 0.0001% in night preparations to a high of 3% in body and hand creams, lotions, powders and sprays. Niacin concentrations of use range from 0.01% in body and hand creams, lotions, powders and sprays to 0.1% in paste masks (mud packs). Both ingredients are accepted for use in cosmetics in Japan and the European Union. Both are GRAS direct food additives and nutrient and/or dietary supplements. Niacinamide may be used in clinical treatment of hypercholesteremia and Niacin in prevention of pellegra and treatment of certain psychological disorders. Both ingredients are readily absorbed from skin, blood, and the intestines and widely distribute throughout the body. Metabolites include N1-methylnicotinamide and N1-methyl-4-pyridone-3-carboxamide. Excretion is primarily through the urinary tract. While Niacinamide is more toxic than Niacin in acute toxicity studies, both are relatively non-toxic. Short-term oral, parenteral, or dermal toxicity studies did not identify significant irreversible effects. Niacinamide, evaluated in an in vitro test to predict ocular irritation, was not an acute ocular hazard. Animal testing of Niacinamide in rabbits in actual formulations produced mostly non-irritant reactions, with only some marginally irritating responses. Skin irritation tests of up to 2.5% Niacinamide in rabbits produced only marginal irritation. Skin sensitization tests of Niacinamide at 5% during induction and 20% during challenge were negative in guinea pigs. Neither cosmetic ingredient was mutagenic in Ames tests, with or without metabolic activation. Niacinamide and Niacin at 2 mg/ml were negative in a chromosome aberration test in Chinese hamster ovary cells, but did produce large structural chromosome aberrations at 3 mg/ml. Niacinamide induced sister chromatid exchanges in Chinese hamster ovary cells, but Niacin did not. Under certain circumstances, Niacinamide can cause an increase in unscheduled DNA synthesis in human lymphocytes treated with UV or a nitrosoguanidine compound. Niacinamide itself was not carcinogenic when administered (1%) in the drinking water of mice. No data on the carcinogenic effect of Niacin were available. Niacinamide can moderate the induction of tumors by established carcinogens. Niacinamide in combination with streptozotocin (a nitrosourea compound) or with heliotrine (a pyrrolizidine alkaloid), produced pancreatic islet tumors. On the other hand, Niacinamide reduced the renal adenomas produced by streptozotocin; and intestinal and bladder tumors induced by a preparation of bracken fern. Niacinamide evaluated in in vitro test systems did affect development, but Niacinamide reduced the reproductive/developmental toxicity of 2-aminonicotinamide-amino-1,3,4-thiadiazole hydrochloride and urethane. Clinical testing of Niacinamide produced no stinging sensation at concentrations up to 10%, use tests produced no irritation at concentrations up to 5%, and a 21-day cumulative irritation test at concentrations up to 5% resulted in no irritancy. Niacinamide was not a sensitizer, nor was it a photosensitizer. The CIR Expert Panel considered that Niacinamide and Niacin are sufficiently similar from a toxicologic standpoint to combine the available data and reach a conclusion on the safety of both as cosmetic ingredients. Overall, these ingredients are non-toxic at levels considerably higher than would be experienced in cosmetic products. Clinical testing confirms that these ingredients are not significant skin irritants, sensitizers or photosensitizers. While certain formulations were marginal to slight ocular irritants, other formulations were not. Niacinamide, while not carcinogenic alone, can modulate the induction of tumors by certain established carcinogens. The Panel noted that the doses in these studies are high relative to the low concentrations at which Niacinamide is used in cosmetic formulations. In neither case (tumor protection or tumor promotion) are these findings considered relevant to the use of Niacinamide at its current low concentrations of use in cosmetics. Both ingredients were considered safe as used in cosmetics.
Source: Dweck, Anthony. Handbook of Cosmetic Ingredients: - their use, safety and toxicology (Dweck Books 5)
The viscosity of fluids can be modified by addition of particulates that may strictly change the viscosity index. When non-interacting buoyant particles are used in these
fluids, the viscosity of the dispersion can be predicted using the Einstein relation. Examples of such rheology-modifying substances include silica gels, fumed silica, carbon black, titanium dioxide and aluminum-magnesium-stearates when used at very small concentrations. Low molecular weight polymers also fit in this category and may be preferred if a smooth or fluid like formulation is desired.
Source: Handbook of Cosmetic Science and Technology - André O. Barel, Marc Paye, Howard I. Maibach
Unlike Newtonian fluids, non-Newtonian fluids possess shear-rate dependent viscosities. In addition to shear-rate dependent viscosities, non-Newtonian
fluids also exhibit elastic stresses when subjected to high shear rates. The usefulness of the elastic response varies with application.
At low shear rates, i.e., near at rest conditions, non-Newtonian fluids exhibit high viscosities that are relatively insensitive to shear rate and characterized by zero shear viscosity. The zero shear viscosity is known to be highly sensitive to the molecular weight and concentration of the rheological additives. The rates of deformation associated with this region include sedimentation and levelling forces, and one can tailor the zero shear viscosity to combat these forces. At moderate shear rates the decrease in viscosity versus shear rate helps when pouring and pumping these fluids. At high shear rates it is found that a second Newtonian plateau in viscosity is reached usually characterised by the so-called infinite viscosity. The shear forces in this area are close in magnitude to forces developed during rubbing and spraying exercises. The low viscosities exhibited by the rheological additives in this region imply low resistance to rubbing and thus a smooth sensation of the substance during its application.
Source: Handbook of Cosmetic Science and Technology - André O. Barel, Marc Paye, Howard I. Maibach
What is a nanomaterial?
A nanomaterial is a material in which at least one external dimension is in the nanoscale range (1-100 nanometers). Nanomaterials exhibit unique properties that are different from their bulk counterparts due to their small size. These properties arise from the increased surface area, quantum confinement, and enhanced reactivity of nanomaterials.
Despite the many potential benefits of nanomaterials, there are also some concerns about their safety. Nanomaterials can be inhaled, swallowed, or absorbed through the skin, and they may pose a risk to human health. More research is needed to assess the potential risks and benefits of nanomaterials.
Nanomaterials in cosmetics
In the context of cosmetics, a nanomaterial is defined as an intentionally manufactured material with at least one external dimension or an internal structure in the nanoscale range (1-100 nanometers). This means that the material is so small that it can only be seen with an electron microscope.
Nanomaterials are being increasingly used in cosmetics due to their unique properties, such as their ability to:
- Improve the efficacy of cosmetic products: Nanoparticles can be used to deliver active ingredients deeper into the skin, making them more effective.
- Increase the stability of cosmetic products: Nanoparticles can help to stabilize active ingredients and protect them from degradation.
- Enhance the aesthetic properties of cosmetic products: Nanoparticles can be used to improve the texture, color, and fragrance of cosmetic products.
Definition of nanomaterials:
Regulation (EC) No 1223/2009 specifically covers the use of nanomaterials in cosmetic products. The Regulation provides a definition of nanomaterial, as well as a mechanism for notification, labelling, and safety evaluation of cosmetic products containing nanomaterials. Under Article 2 (1) (k), “nanomaterial” means an insoluble or bio persistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm”. In view of the EU Chemicals Strategy for Sustainability (Ares, 2021), it is likely that the definition for a nanomaterial in the Cosmetic Regulation will be aligned with the recently published 2022/C 229/01 Commission Recommendation of 10 June 2022 on the definition of nanomaterial. The Regulation therefore mainly covers those nanomaterials that are intentionally produced and are insoluble/poorly-soluble or bio persistent (e.g., metals, metal oxides, carbon materials, etc.), and not those that are either completely soluble or degraded and are not persistent in biological systems (e.g., liposomes, oil/water emulsions, etc.). When dealing with the question of solubility, as provided in the current definition, it is important to note that any nano-specific risk may change (even diminish) when a nanomaterial is dissolved. But it is the time period during which the dissolution happens that determines the considerations for risk assessment based on either particle risk or soluble substance risk. Partial dissolution over a long period of time may lead to the mistaken claim that the material is 'soluble', and therefore not a nanomaterial under the scope of the current definition provided in the Cosmetic Regulation (EC) No 1223/2009.
Potential safety issues of nanomaterials
The use of nanomaterials in cosmetics is subject to a high level of protection of human health under the EU Cosmetics Regulation. This is because nano forms of some substances may differ from their conventional (bulk) forms in terms of physicochemical properties, biokinetic behaviour, and/or biological effects. Any intended use of nanomaterials (other than colourants, preservatives and UV filters and not otherwise restricted by the EUCosmetics Regulation) in cosmetic products must be notified to the Commission by the RP through the Cosmetic Product Notification Portal (CPNP) at least six months prior to placing them on the market, except if they were already on the market before 11 January 2013.In case of a safety concern over a nanomaterial, the Commission shall request the SCCSfor a scientific Opinion on the safety of the nanomaterial for use in relevant categories of cosmetic products in consideration of the reasonably foreseeable consumer exposure.The SCCS was recently mandated by the Commission to provide scientific advice to facilitate the identification of any safety concerns relating to the nanomaterials intended for use in cosmetic products, so that they can be prioritised for safety assessment. The advice has recently been published (SCCS/1618/2020), which provides the key scientific aspects of a nanomaterial that should trigger consumer safety concerns, and therefore the need for further evidence-based safety assessment.Although there are currently no hard and fast rules for identifying the safety concerns for nanomaterials, as a general principle, each of the following attributes should add a further degree of safety concern. For example, where:
i. The nanomaterial has constituent particles that have sizes in the lower range of the nanoscale.
ii. The nanomaterial is insoluble, or only partially soluble.
iii. The chemical nature of the nanomaterial suggests the potential for a toxicological hazard.
iv. The nanomaterial has certain physical/morphological features (e.g. needle shape, rigidlong fibres) that are associated with a higher potential for harmful effects. The nanomaterial has surface reactivity in terms of catalytic (including photocatalytic)activity, potential for radical formation, or other surface properties (e.g. potential allergenicity due to proteinaceous surface).
v. The nanomaterial has a different bio kinetic behaviour than the conventional equivalent.For example, a surface modification/coating (e.g. hydrophobic coatings, encapsulation)has been applied to core nanoparticles to alter their ADME properties and as a result make them more accessible systemically, compared to the neat nanoparticles and/or their conventional chemical forms.
vi. The nanomaterial is used as vehicle to carry other substances that have not been assessed for safety as individual components, or together in the form of nano-scale entity.
vii. There is a likelihood of systemic exposure of the consumer to nanoparticles through the use of final products. The frequency of use, and/or the amounts of the relevant consumer product are relatively high.
viii.There is evidence for persistence/accumulation of nanoparticles in the body.
ix. Nanoparticles have other distinctive properties not present in conventional form of the same material, or have a new activity/function (e.g. a smart/functional nanomaterial).
x. The nanomaterial is so novel that it does not have a conventional comparator to allow assessment of changes in properties, behaviour or effects.
xi. The nanomaterial is used in a product that is inhalable (taken up by inhalation into respiratory tract and lung), and the particles are respirable (can reach respiratory epithelium i.e. alveoli).
xii. The assessment of genotoxicity is performed inadequately, e.g. in vitro studies are without information on stability of the test suspension, or evidence of cell exposure(internalisation).
While this section only provides a brief guidance on nanomaterials in cosmetics, the SCCS has published a more detailed specific Guidance on Risk Assessment of Nanomaterials( SCCS/1611/19, under revision), which is an update of a previous guidance published in2012 (SCCS/1484/12), a Memorandum on the Relevance, Adequacy and Quality of theData Expected in Safety Dossiers on Nanomaterials (SCCS/1524/13), and a checklist for the applicants submitting dossiers on nanomaterials as cosmetic ingredients(SCCS/1588/17). Safety assessors need to consult these documents to ensure that any testing to generate evidence on the safety of nanomaterials is carried out with special considerations of the nano-size related characteristics of the materials, and in compliance with the ban on animal testing of cosmetic ingredients. In this regard, it is important to note that, as indicated in the memorandum (SCCS/1524/13), the SCCS will only consider data that are relevant to the nanomaterial(s) under evaluation, are sufficiently complete, and are of appropriate quality to support the safety assessment. The SCCS has also published a number of scientific Opinions in the past few years on the nano-form of different materials. Each of the Opinions can be consulted via the EuropeanCommission website. SCCS Opinions can provide further information on the type o fscientific evidence needed in a safety dossier on nanomaterials intended for use as cosmetic ingredients.In general, a number of reviews have concluded that the existing risk assessment paradigm, in use for conventional chemicals, should in principle be also applicable to engineered nanomaterials. However, it has also been pointed out that the current testing methods may need certain adaptations to take account of the special features of nanomaterials (Rocks et al., 2008; SCENIHR, 2009; SCCS, 2012; EC, 2012; ECHA, 2017; EFSA, 2018;EFSA, 2021a, EFSA 2021b, EC 2022).
Special features of nanomaterials:
- Due to high surface energies, nanoparticles have a tendency to stick together to form agglomerates and aggregates, and/or bind with other moieties on the particle surface.This particle behaviour can change in the presence of certain stabilising/dispersing agents. Characterisation of nanomaterials, prior to and during a test, is therefore a key to ensuring that results obtained are valid.
- Most of the currently available test methods were developed for conventional substances that can be solubilised. In contrast, nanomaterials generally comprise insoluble or poorly soluble nanoparticles that are dispersed in a test medium in the form of a nano-suspension rather than a solution. The applied concentration of a nanomaterial may therefore drop during the test due to particle agglomeration, sedimentation, binding with other moieties in the medium, or sticking to the sides ofthe glass/plastic ware. This could lead to only a partial or no exposure of the test systems during the test. Nanomaterials are known to adsorb or bind different substances on their surfaces, including proteins (Šimon and Joner, 2008; Lynch andDawson, 2008; Monopoli et al., 2012; Moore et al., 2015). They may also bind other substances in the test medium and carry them into the exposed test systems, leading to artefacts in the results.
- The toxicological hazards of chemical substances are currently measured and expressed in terms of weight or volume units (such as mg/kg, or mg/l). These conventionalmetrics may not be fully adequate to account for nanomaterial toxicity. It is thereforeimportant that tests on nanomaterials are not only evaluated in terms of weight/volume concentration, but that results are also expressed in other dose-describing metrics, such as particle number concentration, surface area etc.
- Due to the insoluble particulate nature, and the nano-dimensions, nanomaterials may show an altered uptake and bio kinetic profile in a biological system compared to equivalent conventional forms, e.g. transport of insoluble particles across biological membrane barriers is not driven by concentration-gradient based diffusion partitioning, but by other mechanisms such as endocytosis and/or active (energy-driven) uptake and transport.
- Currently, there are uncertainties in regard to whether the endpoints identified by the current testing methods will be sufficient to identify and characterise all the hazards that may be associated with a nanomaterial.
Source: SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation
MSDS stands for Material Safety Datasheet. This document provides detailed information about the properties, hazards, handling, storage, and emergency measures related to a chemical product or substance. MSDSs are typically created by manufacturers, suppliers, or distributors of chemicals to ensure that users, such as workers, emergency responders, and consumers, have access to important safety information.
