More than 100 REACH colours!

October 13, 2021

For the past year and a half, our Research & Development laboratories have been anticipating the implementation of the new REACH regulations in order to offer compliant formulas.
We welcome these new restrictions which will allow professionals to work in complete safety and serenity.

How does REACH impact us/you? Explanation of the new measures applicable from January 2022 and the measures taken by Laboratoires BIOTIC Phocea.

A new regulation for the profession.
In Europe, and contrary to cosmetic products, tattooing products were not subject to a specific regulation (whether artistic tattooing or permanent make-up). For the time being, only ResAP(2008)1 gives guidelines but does not have the value of a regulation. As a reminder, it :

- limits the presence of aromatic amines, not carcinogenic, mutagenic, reprotoxic (CMR) substances
- sets the levels of authorised impurities
- regulates the packaging: "they are sterile and supplied in a container which retains its sterility until use, preferably in a single-use packaging. In the case of multiple-use containers, the design of the containers should ensure that the contents will not be contaminated during the period of use.

REACH goes further by limiting the composition of substances contained in tattoo and permanent make-up inks. In order to ensure that safe products are placed on the market, several chemical substances have been restricted.

Thus :

- 26 organic pigments have been permanently removed
- Isopropyl alcohol is prohibited
- Certain preservatives are banned
- Impurity levels have been reduced (polycyclic aromatic hydrocarbons, carcinogenic, mutagenic and reprotoxic substances, skin corrosive agents, heavy metals)

"Our company has adapted the whole process, formulas, packaging and sterilisation to guarantee the sterility of unopened products for 5 years without using preservatives.

What BIOTIC does...for you
Since the creation of the laboratories 20 years ago, BIOTIC Phocea has made it a point of honour to manufacture "clean & safe" products that are ahead of legislation and ensure that they are used legally. As a pioneer, it is our duty to go even further than the constraints imposed by the laws. This is why we are only slightly affected by REACH. Why is that?

We have always favoured the use of mineral and some organic safe pigments which are not affected by REACH.
The alcohol used is 100% natural and organic.
BIOTIC Phocea laboratories do not use preservatives. Our company has adapted the entire process, formulas, packaging and sterilisation to guarantee the sterility of unopened products for 5 years without using preservatives thanks to our Airless Color® bottles.
Some impurity levels in our pigments were already below the 2008 ResAP(1). They have been further reduced to comply with the REACH regulation
The raw materials used are even purer and of pharmaceutical grade
BIOTIC Phocea has adapted to the new restrictions by working with different analytical laboratories to develop specific methods to measure impurities that are in trace form and therefore very difficult to measure. Despite these constraints, today we have over 100 REACH colours!

We are REACH,
we are CLEAN,
we are SAFE!

Why choose mineral pigments?

We prefer high purity mineral pigments because we believe that they do not expose either the recipient or the handler during the manufacturing cycle.

How do pigments age in the skin?

There are a multitude of factors, variables that influence the result. We have not only the nature of the pigments, their formulation, the quality and type of needle but also what we call the gesture, the technique of implantation of the ink. Finally, and perhaps most importantly, there is the skin (its nature and quality) and the post-tattoo sun exposure.

What are your obligations as a practitioner?

Systematically check the origin of your pigments: pigments manufactured outside the EU are not subject to REACH, and are therefore free to contain dangerous and/or illegal substances
Communicate on the quality of the pigments you use to raise awareness among your customers
Buy pigments that comply with the new REACH legislation to practice your "art" legally
Be aware that there is no REACH certificate issued to manufacturers for the conformity of pigments (the manufacturer is the guarantor of the conformity of his products and must himself show his analyses in case of control. Finally, all manufacturers who are not in Europe will not be controlled, so all pigments bought on the internet will be controlled at the institute, at your place, choose well!)
Do not use pigments are not REACH compliant.

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