What does "free from" mean?
BioNike's utmost priority when designing its product formulations is the respect for skin, also when sensitive. This very important requirement has always guided us in selecting our ingredients carefully and mainly based on their skin tolerability profile.
This special philosophy ensures that our products, besides being nickel-tested, are free from a number of substances that the dermatological literature has identified as triggers for contact allergies: preservatives, perfume, gluten.
Our “free-from philosophy” is the result of constant research work we started in the 1990s, which we carry on today and that allow us to develop innovative strategies all the time.
Cosmetics regulations in force, namely EC Regulation 1223/2009, has included nickel and its derivatives in Annex II (substances banned for cosmetic use). Article 17 of the same Regulation reads:
"The non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted... "
In short, no thresholds have been established for the technically unavoidable traces that may be found in cosmetics.
ICIM has decided to take it from there and indeed set parameters for managing nickel contamination in our manufacturing processes. This has led to implementing a test performed on each production batch to monitor the manufacturing process and any nickel traces that might end up in the finished product and possibly lead to skin allergy.
Nickel-induced allergic contact dermatitis (DAC) is the most common form of dermatitis in industrialised countries. It particularly affects the female population and certain professions because of their greater exposure to contact with products, objects or substances containing nickel.
The main therapy for nickel-induced dermatitis is based on eliminating the contact with this metal. While it is well known that primary sensitisation may be caused by contact with metal alloys or objects that contain nickel, the risk involved in the contact with products that are contaminated by nickel is less known. The latter products include cosmetics, with makeup posing the major risk.
The 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 considered safe for skin?
In the case of damaged or broken skin, as may occur often with dermatitis, absorption by skin is much higher, hence the sensitisation threshold lowers. Occlusive patch testing performed on irritated skin have shown reactions to nickel amounts as low as 0.5 ppm.
Given the aforesaid sensitisation risk, we have implemented a strategy to minimise nickel in our products, thus we guarantee for every production batch that any traces of nickel left over will be lower than 0,1 ppm (0,00001%), which is a threshold 10 times lower than the threshold the literature states an allergic reaction to nickel may occur.
Since also residual content of nickel may lead to allergic reactions or sensitisation, especially in allergy-prone skin individuals, all the products of the Triderm, Defence, Shine On, Proxera and ONails ranges are guaranteed to have a nickel content lower than 0.00001%, that is 10 times lower than the minimum threshold the literature has identified for triggering a reaction.
As for BioNike makeup ranges Defence Color and Defence Color Cover, in addition to Nickel, we also check the presence of other heavy metals such as cobalt and chromium, to ensure that cobalt and chromium content is also as low as possible.
Since the elimination of all impurities is difficult to achieve, especially in colour cosmetics, in addition to checking the content of nickel, chromium and cobalt, each makeup production batch is also checked to ensure that there is no release of these metals from the cosmetic matrix (test performed according to Regulation (EC) No. 1907/2006).
As a result Defence Color e Defence Color Cover make up ranges are developed in a manner that minimises heavy metals such as nickel, chromium and cobalt, since even residual content of these metals may lead to allergic reactions or sensitisation, especially in allergy-prone skin individuals.
Based on regulations established by the European Union, a number of preservatives are deemed safe for use in cosmetics, thus authorised for use (EC Cosmetic Regulation n° 1223/2009 – Annex V). Nonetheless, the literature reports that, in the case of individual hypersensitivity, a number of preservatives may trigger an allergic skin reaction.
Given this, BioNike has developed special formulation strategies (keeping free water content in the formula under control, osmotic systems) that has allowed to replace traditionally-used cosmetic preservatives though keeping our products effectively protected from microorganisms.
According to dermatological literature, perfume is a primary cause of allergic reactions and the cosmetic regulations, in an effort to protect end users’ health, has identified 25 substances potentially responsible for triggering a skin reaction that are used in perfumes and may also be found in vegetable extracts and derivatives. EC Regulation No. 1223/2009 has made it compulsory to state the presence of these 25 substances in the ingredient list on the cosmetic package when any of these is found in a concentration exceeding 0.001% in no-rinse products and 0,01% in rinse-off products.
BioNike products are made free from perfume to reduce the chances of skin reactions. Since a pleasant smell is key to end user appreciation of the product, though we’ve given up perfume, this has also led us to find alternative formulation strategies to improve the smell of our products by selecting ingredients also according to olfactory parameters. Nonetheless, a few of our products do carry a perfume since certain products require a fragrance to achieve the level of pleasantness end users expect. However, when perfume is indeed included in BioNike products, we use “special” perfumes, meaning that they are carefully selected to make sure they do not include any of the aforesaid sensitisers (which means we use allergen-free perfume).
Nonetheless, a few of our products include “special” perfumes to make the products more pleasant. These perfumes are carefully selected to check the content of potential allergens, meaning that we make sure that the aforesaid 25 potential sensitising allergens are, at the most, found in tiny traces that are well under the thresholds indicated in the regulations.
The scientific literature clearly shows that gluten contained in topical products may trigger forms of skin intolerance and allergic reactions in allergy-prone subjects that have an altered skin barrier or are affected by "non-celiac gluten sensitivity".
The statement indicating that products "do not contain gluten or gluten derivatives" allows subjects with non-celiac gluten sensitivity to take an informed decision.
As a result, all raw materials used in products of the Triderm, Defence, Shine On, Proxera and Gynexelle ranges are carefully selected to exclude any possible gluten source and every production batch is analysed to confirm products are free from gluten.