WHAT DOES SIN PHILOSOPHY MEAN?
BioNike's top priority when designing its product formulations is respect for the skin, especially when it is sensitive skin. This very important requirement has guided BioNike to select each of the ingredients very carefully and mainly thinking based on the skin tolerability profile.
This special philosophy guarantees that BioNike products, in addition to being tested for nickel, are also free of a series of substances that dermatological literature has identified as triggering contact allergies: Preservatives, Perfumes, Gluten. This PHILOSOPHY WITHOUT is the result of constant research work that began in the 90s, which continues today and allows them to develop innovative strategies at all times.
TESTED IN NICKEL
The current cosmetics regulations, specifically EC Regulation 1223/2009, have included nickel and its derivatives in Annex II (substances prohibited for cosmetic use).
Article 17 of the same Regulation says:
"The unintentional presence of a small amount of a prohibited substance, resulting from impurities in natural or synthetic ingredients, from the manufacturing process, from storage, from migration from packaging, that is technically unavoidable in good manufacturing practices will be permitted. .. "
In short, no thresholds have been established for traces of technically unavoidable prohibited substances that can be found in cosmetics. However, BioNike has decided to take the initiative and actually establish parameters to manage nickel contamination in its manufacturing processes.
This has led to the implementation of a test carried out on each production batch to monitor the manufacturing process and any traces of nickel that could end up in the finished product and possibly cause a skin allergy.
Nickel-induced allergic contact dermatitis (CAD) is the most common form of dermatitis in industrialized countries. It especially affects the female population and certain professions due to their greater exposure to contact with products, objects or substances containing nickel. The main therapy for nickel-induced dermatitis is based on eliminating contact with this metal.
While it is true that primary sensitization can be caused by contact with metal alloys or objects containing nickel, the risk involved in contact with products contaminated with nickel is less known. These latter products include cosmetics, with makeup being the greatest risk.
BioNike products are developed to meet the needs of end users with sensitive, allergic and reactive skin.
What is the amount of nickel in cosmetics that is considered safe for the skin?
In the case of affected skin , as often occurs in the presence of irritant dermatitis, percutaneous absorption is much higher and, therefore, the sensitization threshold is lowered. Patch tests under occlusion performed on irritated skin have shown reactions up to 0.5 ppm (parts per million) of nickel .
That is why any production batch is analyzed to guarantee a nickel trace content of less than 0.1 ppm (0.00001%): a percentage 10 times lower, at a scientific level, than the threshold content that can cause an allergic reaction. .
As residual nickel content can also cause allergic reactions or sensitization, specifically in subjects who have a certain predisposition, all products from the Triderm, Defense, Shine On, Proxera and ONails have a trace nickel content of less than 0.00001%, i.e. 10 times lower than the minimum possible reaction threshold.
Since even the residual nickel content can create allergic reactions or sensitization, especially in predisposed people, all products from the Triderm, Defense, Shine On, Proxera and ONails lines guarantee a trace nickel content of less than 0.00001%, that is, 10 times lower than the minimum threshold of possible reaction .
As for the BioNike Defense Color makeup range, in addition to nickel, other heavy metals such as cobalt and chromium are also checked to ensure that the cobalt and chromium content is also as low as possible.
Since removal of all impurities is difficult to achieve, especially in color cosmetics, in addition to checking the content of nickel, chromium and cobalt, each makeup production batch is also checked to ensure that these metals are not released from the cosmetic matrix. (test carried out according to Regulation (EC) No. 1907/2006).
As a result, the Defense Color makeup range is developed in a way that minimizes heavy metals such as nickel, chromium and cobalt, as even the residual content of these metals can cause allergic reactions or sensitization, especially in people with prone skin. to allergies.
WITHOUT PRESERVATIVES / PRESERVATIVES
According to the regulations established by the European Union, several preservatives are considered safe for use in cosmetics, therefore their use is authorized (EC Regulation on Cosmetics No. 1223/2009 – Annex V).
However, according to the literature, in case of individual hypersensitivity, some preservatives can cause an allergic skin reaction.
Given this, BioNike has developed special formulation strategies (keeping the free water content in the formula under control, osmotic systems) that have made it possible to replace traditionally used cosmetic preservatives, keeping BioNike products effectively protected from microorganisms.
As a result of this strategy, all products in the Triderm, Defense, Shine On and Proxera ranges are made without preservatives listed in Annex V of EC Regulation No 1223/2009.
UNSCENTED
According to dermatological literature, perfume is the main cause of allergic reactions and cosmetic regulations, in an effort to protect the health of end users, have identified 25 substances potentially responsible for triggering a skin reaction that are used in perfumes and that They can also be found in plant extracts and derivatives. EC Regulation No. 1223/2009 has required the presence of these 25 substances to be declared in the list of ingredients on cosmetic packaging, when any of them is found in a concentration greater than 0.001% in leave-on products and 0.01% in rinse products.
BioNike products are made without perfume to reduce the chances of skin reactions. Since a pleasant smell is key for the end user to appreciate the product and although BioNike has abandoned perfume, this has also led them to look for alternative formulation strategies to improve the smell of its products, selecting the ingredients also according to the olfactory parameters. However, some of its products carry perfume, since some of them require a fragrance to reach the level of pleasure expected by end users. However, when perfume is indeed included in BioNike products, they use “special” perfumes, which means they are carefully selected to ensure that they do not include any of the sensitizers mentioned above (which means they use allergen-free perfumes).
These perfumes are carefully selected to check the content of potential allergens, which means that they ensure that the 25 potential sensitizing allergens mentioned above are found, at most, in small traces well below the thresholds indicated in the regulations.
To minimize the risk of triggering skin reactions, products in the Triderm, Defense, Shine On and Proxera ranges are unscented or include a hypoallergenic perfume.
WITHOUT GLUTEN
The scientific literature clearly shows that gluten contained in topical products can trigger forms of skin intolerance and allergic reactions in allergy-prone subjects who have an altered skin barrier or are affected by a "non-celiac gluten sensitivity."
The statement that the products "contain no gluten or gluten derivatives" allows people with non-celiac gluten sensitivity to make an informed decision.
As a result, all raw materials used in products in the Triderm, Defence, Shine On and Proxera ranges are carefully selected to exclude any possible sources of gluten and each production batch is tested to confirm that the products are gluten-free.