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Our powder nail polishes give color to the nail without staining the skin and cuticles. Furthermore, it strengthens, repairing the structure of nails which tend to break.
Quality Certificates for Powder Enamels
Phthalates
What are Phthalates
Phthalates are chemicals commonly used to increase flexibility. Phthalates are most commonly used in the production of polyvinyl chloride (PVC) products. Today, PVC is the second most used type of plastic.
In general, phthalates are used in building materials, packaging materials, pipes and electrical installations, and thousands of other products. It is used in wall coverings, private floors, tablecloths, furniture floors, shower curtains, carpet floors, garden hoses, raincoats, toys, shoes, car upholstery, medical tubes and blood storage bags. Some types of phthalates are used in cosmetics, nail polish, hair products, skin care products, and even some medicines.
However, from time to time the use of certain species of phthalate is banned or banned due to safety and health concerns. For example, the use of three types of phthalates in toys and children's products at concentrations above 0 is prohibited.1 percent. Additionally, restrictions have been placed on the use of certain types of phthalates in infant and child care materials.
Today, commissions are being established and investigations are being conducted to examine the health risks of phthalate and phthalate substitutes and to determine whether bans will continue or whether any other use of phthalate will be appropriate.
Many types of phthalates pass through the human body with food. Additionally, use of personal care products and inhalation are major exposure routes for some phthalates. Phthalates in a mother's body can pass into breast milk. Infants and young children can be exposed to phthalates by absorbing plastic toys containing phthalate. In short, phthalates are widely used in various consumer products and enter the human body in many ways.
Phthalates belong to the class of synthetic chemicals and are produced in large quantities every year. By adding phthalates to PVC, this fragile plastic is made more flexible and durable.
Phthalates are defined as toxic substances with effects on reproduction and development. However, toxicity levels vary depending on the structure of the phthalate. Some phthalate species are also classified as carcinogenic.
Phthalates are not chemically bonded to the PVC polymer. Therefore, over time, products leak, especially in heat-containing conditions, and spread into air, water, food, dust, soil, living organisms and other environments.
Although six types of phthalates are currently banned in children's products manufactured in the United States and European Union countries, they are still used in toy manufacturing in many parts of the world. Additionally, children continue to be exposed to phthalates in cosmetics and personal care products such as nail polish, lotion, shampoo, soap and hairspray. Materials made from PVC such as backpacks, lunch boxes, umbrellas, raincoats, boots, bags and slippers also include phthalates.
Many other materials include phthalates such as plastic pipes, storage bags, floor tiles, automotive parts, food packaging, paint, household items, pharmaceutical coatings, electrical wires and medical devices.
The main effects of phthalates on human health are reproductive abnormalities and developmental effects. Exposure to phthalates causes male reproductive disorders, sperm damage, fertility disorders, female reproductive system diseases, precocious puberty, asthma and thyroid disorders. Adverse effects on the lungs, liver and kidneys are also observed.
Additionally, phthalates pose a risk to water and land ecosystems near businesses that use phthalate in production. Some types of phthalates are bioaccumulating and have been identified in aquatic organisms. Endocrine disrupting effects are observed in fish. Birds and mammals are affected by exposure to the food chain.
Today, the search for other chemicals to replace phthalates continues. For example, a number of substances such as alternative emollients have been introduced to replace phthalate in toys, baby care products, medical devices and some cosmetic products.
Hema
What are Hema
Many tests have shown that 2-hydroxyethyl methacrylate (2-HEMA) and ethyl cyanoacrylate (ECA) are the two allergens that most frequently and confidently allow a diagnosis of contact allergy to acrylates contained in cosmetic nails.
2-HEMA is, however, an ingredient consistently present in gel products, while it is not present in some acrylic nails.
For patients allergic to 2-HEMA, the use of nail gel should be avoided, unless preparations that do not contain them are used. However, the best alternative seems to be silk nails if the patient is not sensitive to the ECA present in all nail glues.
Clinical manifestations
Contact eczema is caused by a reaction of the skin to exogenous substances of various nature (chemical, chemical-physical, biological). There are two mechanisms that cause the onset of contact eczema. In the first case, contact with the substance causes skin irritation and cellular damage, and in this case there is irritant contact dermatitis. In the second case there is allergic sensitization towards specific substances and there is an allergic contact dermatitis. For the former, even a single skin contact is sufficient, while the latter requires a period of at least 6-10 days for the symptoms to appear. Contact dermatitis causes the appearance of erythema, edema and blisters, with the subsequent formation of crusts and, finally, desquamation. The initial lesions are localized in the area of the skin that has been exposed to the sensitizing substance, but they can also spread to other skin areas if exposure to the irritating substance continues.
Heavy Metals
What are Heavy Metals?
Heavy metals are ubiquitous substances distributed more or less uniformly in the environment, they are widespread in rocks and the earth's crust and present in food and water. Precisely due to the fact that their presence is ubiquitous in the environment, it is practically impossible to avoid daily exposure to heavy metals. Therefore, even within cosmetic products, the presence of traces of heavy metals is inevitable. However, at certain doses they could cause toxic effects on the body, therefore it is of fundamental importance to carefully evaluate their presence within each cosmetic in order to exclude any effects that could compromise the health of the consumer.
What are heavy metals?
The most frequently cited heavy metals are arsenic (As), cadmium (Cd), chromium (Cr) III and VI, lead (Pb), mercury (Hg), selenium (Se), antimony (Sb), barium ( Ba), cobalt (Co) and nickel (Ni).
Regulatory reference
The use of metals as ingredients is explicitly prohibited by Regulation (EC) 1223/2009 which includes them in Annex II, i.e. in the list of substances whose use is prohibited in the composition of cosmetic products. However, precisely in consideration of their ubiquity, article 17 of Regulation (EC) 1223/2009 indicates the following:
" The unintentional presence of a small quantity of a prohibited substance, resulting from impurities in the natural or synthetic ingredients, the manufacturing process, storage, migration from the packaging and which is technically unavoidable despite the observance of good manufacturing practices, is permitted provided that such presence is in compliance with Article 3."
So essentially the Regulation tolerates the presence of heavy metals in finished products in small quantities when they are a residue of the cosmetic production and conservation process or when present as impurities of other cosmetic ingredients (such as dyes).
This presence is accepted only if:
-Heavy metals are present at technically unavoidable trace levels;
-If the presence occurs despite the observance of good manufacturing practices;
-The cosmetic product has been assessed as safe by the Safety Assessor Safety under normal or reasonably foreseeable conditions of use.
Therefore the Regulation underlines the concept of involuntary presence of prohibited substances (such as heavy metals) and therefore of tolerability, in any case the presence of heavy metals and impurities must be carefully evaluated and examined on a case by case basis case at the time of the Safety Assessment.
Is there a limit for heavy metals?
As previously indicated, Regulation (EC) 1223/2009 essentially indicates that the presence of heavy metals, in technically unavoidable traces, is permitted but in fact no global maximum limit has been defined for heavy metals in cosmetics nor an individual limit for each of the heavy metals, therefore there is no reference value for the term "reduced quantity of prohibited substance" in Article 17. Therefore, in the absence of limit values for heavy metals, a case-by-case assessment is necessary.
There are also no standardized methods for determining the total content of heavy metals and methods for determining chemical species (for example Cr VI or Chromium III). The absence of quantitative limits has led some Member State authorities to establish indicative values to be respected.
Therefore, in the absence of limits harmonized by the Regulation, reference limits have been defined by:
Federal Office of Consumer Protection and Food Safety (BVL). The German Federal Government, following tests conducted on cosmetic products, has defined the following values as limits:
-Pb: 2 mg/kg (or 5 in certain make-up products);
-As: 0.5 mg/kg (for carnival or theater tricks 2.5 mg/kg);
-Cd: 0.1 mg/kg;
-Hg: 0.1 mg/kg;
-Sb: 0.5 mg/kg
Health Canada. A similar initiative was taken in Canada by Health Canada, technically unavoidable impurities are considered when heavy metals are lower than the following levels:
-Pb: 10 mg/kg;
-As: 3 mg/kg ;
-Cd: 3 mg/kg;
-Hg: 1 mg/kg;
-Sb: 5 mg/kg
Italy. the Istituto Superiore di Sanità (ISS) has indicated the maximum limits that can be considered as technically unavoidable traces (for toothpastes the values are reported in brackets, if different)
Challenge test
What does the Challenge Test consist of?
The challenge test, literally "challenge test", is one of the most important cosmetological tests applied in the laboratory to verify any microbiological aggression that a cosmetic product may undergo, both during the manufacturing or storage phase and during period of consumer use.
This test is mandatory for all cosmetic products which, under normal conditions of storage and use, may present the risk of bacteriological contamination.
Only products with a low microbiological risk (alcohol-based products, products with very basic pH such as soaps, for example) are exempt from these tests, but their absence must still be justified.
This type of cosmetological test is used to verify the efficiency of the preservative system used in the formulation.
The challenge test on cosmetics is carried out by inoculating microorganisms into a cosmetic product to verify their survival over time.
Of considerable importance is the application of official protocols by the microbiologist, even if the most used methodology is the ISO one, which indicates not only the type of analysis to be carried out, but also how to interpret the results.
What microorganisms are tested for?
The microorganisms inoculated during the challenge test analysis are:
-Escherichia coli, bacterium found mainly in contaminated faeces
-Pseudomonas aeruginosa, ubiquitous bacterium pathogenic for humans
-Candida albicans, saprophytic yeast for humans, normally found in the oral cavity, in the gastrointestinal tract and at the vaginal level
-Aspergillus brasilensis
-Staphilococcus aureus, skin saprophyte and potential pathogen
How is the challenge test carried out?
The test is monitored during a period called verification time, for each sample inoculated with the pathogen on a Petri dish. The verification times are divided into:
T0: zero time immediately after inoculation
T1: after 24 hours
T2 : after 48 hours
T7: after the seventh day
T14: after 14 days
T28: after the twenty-eighth day to verify the total lack of the initial microbiological load
How are the results interpreted? The results can converge in 3 typical situations:
Compliance with criterion A: acceptable microbiological risk, the cosmetic product is considered protected against microbial proliferation. No other factors except those of the formulation are taken into consideration.
Compliance with criterion B: acceptable microbiological risk, in this case the control factors must also be taken into consideration, i.e. the characteristics of the packaging to reduce the risk of contamination.
Non-compliance: does not meet any of the above criteria. There must be a progressive decrease in the microbiological load until the twenty-eighth day without an increase in the count compared to the previous counting time. Slow reduction or further development during the testing phase results in an inadequate preservative system. In this case the product did not pass this test, therefore the preservative system in question has failed and it is not possible to use it in new preparations.