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General information on pigments

Allergic and inflammatory skin reactions are undesirable side effects of tattooing or permanent make-up treatments.

 

Allergic reaction to agents in the pigments:
In many cases, allergic reactions can be traced back to preservatives or metallic ingredients, especially heavy metals such as nickel, cobalt, chrome and other allergenic ingredients in the pigments.

Contamination and Azo colour components in pigments:
Contaminations in the colour mixes and certain Azo colour elements which may split into carcinogenic aromatic amines can represent another safety hazard. Such Azo components also present a risk during the removal of tattoos and permanent make-up if performed with a laser. They may be split into carcinogenic amines by the laser beam, and are then carried around the body via the bloodstream.

Laws and regulations

The Cosmetics Commission of the German Federal Risk Assessment Office (Bundesamtes für Risikobewertung) dealt with the problem of tattooing pigments in May 2000, recommending legislative action for the use of the respective pigments. Pigments that comply with the requirements provide a high degree of safety for the customers and reduce potential health risks.

 

European Council resolutions:
In recent years, the European Council has passed resolutions regarding the use of tattooing and pigmentation colours to increase consumer protection. The decisions are the result of numerous discussions, experiences and analyses by various member states.

German tattooing regulation:
As a result of the resolutions by the European Council the first German tattooing regulation came into force in May 2009. It mainly follows the resolution of the Council and refers to the German cosmetics regulations. Essential parts of the resolutions such as the determination of critical values for heavy metals or polycyclic aromatic hydrocarbons have not yet been included in the regulations. Among the 1,000+ prohibited substances and chemicals are carcinogenic Azo pigments and aromatic amines, the allergenic and sensitising paraphenylenediamine (PPD) and other ingredients that were previously permitted. They are considered dangerous to the health. The tattooing regulation is not only binding on tattooists, but also on manufacturers and distributors of pigmentats and on anyone carrying out permanent make-up treatments in Germany.

Resolution: ResAP (2003)2 

– Ban on harmful preservatives
– Ban on carcinogenic amines
– Ban of unsuitable inks
– Definition of requirements for sterility

Resolution: ResAP (2008)1

– Definition of limit values for heavy metals
– Ban on polycyclic aromatic hydrocarbons (PAHs)

German tattooing regulations:

The first German Tattoo Aid Regulation resulting from the resolutions of the Council of Europe came into force on 01.05.2009. It largely follows the Council resolutions and refers to the German Cosmetics Regulation.

The German tattooing regulations were enacted for better consumer protection. As manufacturers of pigments, we have extensively analysed the new regulations and summarised what we consider to be the most important information. The following information does not claim to be complete, and the advice given cannot be regarded as legally binding.

Our LaBina pigmentation colours

Basics and application:

• Official name: Verordnung über Mittel zum Tätowieren einschließlich vergleichbarer Stoffe und Zubereitungen
aus Stoffen (Regulation for tattooing agents including comparable substances and preparations from substances)
• Official abbreviation: Tätowiermittelverordnung (Tattooing product regulations), unofficial abbreviation: TätMVO
• Status: published in the BGBI (official list of published acts and regulations in Germany) 2008 no. 53, page
2215, published in the official gazette in November 2008. Came into force in May 2009
• The tattooing regulations are a mix of resolutions from the European Council and German cosmetics regulations,
BGB part I, no. 67 dated 13 October 1997 (2410)

The tattooing regulations concern:
• All manufacturers and distributors of tattooing and pigmentation colours
• People who carry out tattooing or permanent make-up treatments in Germany

The regulations are applicable to all tattooing and pigmentation colours and cover:
• Disclosure obligations of the manufacturers / importers
• Labeling obligations
• Manufacturer obligations
• Prohibited ingredients
• Administrative offences/criminal offence

 

Disclosure obligations:

The disclosure obligations apply to manufacturers and importers:
• Registration of the company with the local authority as a manufacturer or importer responsible for
food control
• Transmission of the following data to the Federal Office of Consumer Protection and Food Safety:
1. Trade name of the colour
2. Ingredients (if possible including the INCI name)
3. Composition of ingredients in percentages
• Electronic submission (via e-mail)

Definition: Pigment manufacturer
All companies producing pigments or having them produced for themselves. Anyone mixing and storing pigments
in their studio is a manufacturer. Definition: importers of pigments are all persons who receive pigments
from abroad (including from the EU!), regardless of the quantity imported. This also applies to people who
import pigments to use them for treatment.

Definition: INCI name
INCI is short for International Nomenclature of Cosmetic Ingredients. The ingredients of beauty products
must be declared using the INCI names, as stated in the statutory regulations (§ 5a, par. 4 KVO).

Labeling obligations:

The label on the pigment flask must contain (at the bottom, in red print):
• Name of the pigmentation dye or similar unique trade name
• Batch number
• Address of the manufacturer or importer
• Ingredients – in decreasing order according to concentration
• Best-before date, if the pigments must be used within 30 months.
• Period of use after initial opening
• Colour ingredients with CI numbers (e.g.: CI 74160)

The label on the pigment flask may contain (at the bottom, in green print):
• Name of the colour
• Shade
• Item number (<ref>)
• Storage conditions
• Date of manufacture
• Time line to mark the opening date
• Symbol indicating durability after opening
• Symbol (book with an i) for additional information

Definition: Information about ingredients
Ingredients are listed in decreasing order according to their percentage/concentration in cosmetic products.

Definition: CI numbers
• The colour index (short CI) is a reference used since 1925 including all standard pigments and basic colouring
chemicals.
• Pigments included in cosmetic products are shown at the end of the list of ingredients with their CI
numbers. The colour index makes a basic distinction between colours and pigments. There is no prescribed
order for the list with regards to the amount contained in the products.

Careful analyses for the safety of your clients

The thorough inspection of our pigments exceeds the legal requirements of the German tattooingregulation. In anticipation of future regulations, the raw materials are already analysed extensively for the presence of heavy metals. This means that our pigment manufacturer complies with the more extensive requirements of the European Council recommendations which also set an upper limit for the percentage of heavy metals present in those colours. The minimal traces of heavy metals in the pigments are analysed in relation to the limits recommended by the European Council and particularly published in the analysis evaluations.

The orange bars mark to the maximum permitted maximum values ​​for heavy metals.

The green bars show to the actually found values.

No indication means that no limit has been set by the Council of Europe.

Alcohol not used as a preservative

We use highly purified water for the manufacture of LaBina® pigments, similar to that used for injections. Many allergic reactions that occur after pigmentation treatments are caused by the utilised preservatives (e.g. paraben). Infections can also be caused by germs in pigmentation colours. Due to the immune system defences of the body that are triggered by such an infection, it is possible that immediately after treatment there is an increased rejection of the pigment, which can cause a faded or patchy pigmentation. Even dead germs are still able to trigger negative reactions in the body. It is therefore particularly important to produce clean, pure and microbiologically stable colours. Our experience has shown that alcohol is solely limitedly appropriate as a preservative for pigments, because only highly concentrated alcohol such as ethanol or isopropyl can reliably kill all germs. If alcohol evaporates during storage, the proportion remaining in the pigments may even act as a nutrient for micro-organisms and even provide the basis for germs to multiply. Alcohol dries out, irritates the skin during treatment and often is perceived as extremely unpleasent on newly pigmented skin.

Our manufacturer does not use alcohol for LaBina® pigments. Nevertheless the products still offer a very good basis for meeting future microbial requirements on pigments.

Glycerine is a component of all fats and in our experience also is limitedly appropriate as a preservative, since pigments containing glycerine in a high dosage are much less suitable for pre-drwaing on the skin. However, clean and precise pre-drawing with the desired and selected pigmentation colour directly on the skin is very important since it prevents incorrect positioning and discrepancies. Even before pigmentation, customers have a precise idea of the expected result regarding the design of the lines and the colours selected.

Alcohol dries out, irritates the skin during the treatment and is perceived as unpleasant on the freshly pigmented skin by many people.

Even today, LaBina pigmenting inks fulfill the requirements for the microbial requirements for pigmentation inks of the future


Ideal for drawing on the skin

With our pigments, lines can be pre-drawed with a fine brush, according to our proven slogan: FIRST SKETCHING – THEN STITCHING. This way the pigmentation permanently carried out has previously been seen and approvedby the client.

Germ-free thanks to novoxx® technology

Due to the use of novoxx® our colours are germ-free. It kills bacteria, yeasts and fungi and has been successfully used in pigmentation dyes since 2004.

novoxx® is a combination of minerals which have revolutionised the manufacture of safe pigmentation colours. As a micro-fine ground white powder it has various positive features. Studies certify that it is as harmless as an implant material in medicine.

 

The abilities of novoxx®
When novoxx® was first discovered our pigment manufacturer was challenged with the development of a technology for micro-biologically safe permanent make-up colours.
• novoxx® solves problems which may be related to the long-term storage and conservation of pigments after the flasks are initially opened. Since novoxx® is a solid, it cannot evaporate. With the reduction of carrier liquid, the concentration of novoxx® in the bottle increases, which in turn increases its reliable germ-eliminating effect.
• novoxx® is absorbed by the body without being detected as alien and potentially being rejected.
• We have no knowledge of any allergic reactions to novoxx® in pigments (as of July 2013).
• The minerals used for novoxx® are intended to support the healing of the wounds immediately after completion of the pigmentation process. In our daily practice we have found that itching during the healing process is reduced compared with traditional products not containing novoxx®. This results in less irritation of the skin and visibly more beautiful results.

 

novoxx® increases colour intensity

Due to additional reflective surfaces which the micro-fine ground white novoxx®-powder generates in the LaBina® pigments, brilliance and colour saturation under the skin are slightly enhanced. Free follow-up appointments after a permanent make-up treatment ensure quality and durability.

Rötlich verfärbte Augenbraue


No restrictions on MRI examinations

Modern medicine has provided us with many different ways of examining the inside of the human body. Magnetic resonance imaging (MRI) is a procedure which enables detailed and precise imaging by photographing different layers of parts of the body. It is one of the least invasive methods of examination because instead of X-rays, a magnetic field is used for imaging, which is not harmful for humans.

This examination method is used increasingly more often as a valuable tool for the best possible diagnosis. Over the course of recent years we heard about a lot of cases in which octors have cancelled planned MRI examinations after finding out that the patient in question has had a tattoo or permanent make-up with colours containing ferrous oxide.

The reason for this is that the patient’s body is exposed to very strong magnetic fields during the MRI process. Pigmentation with colours containing iron may heat up irritably during the MRI, and cause reddening and minor burns in the area where they are applied to the skin. This in turn is due to the fact that the magnetic power draws the ferrous particles in the pigments under the skin and makes them vibrate.

After a pigmentation carried out with LaBina® pigments there is absolutely no need to worry as they do not contain any pigments with ferrous oxides. In case of a medical examination you can refer to the ingredients of our pigmentation colours and quote the results of our analyses.

Benefits of our pigments

There are numerous reasons to choose LaBina pigments:
The highly viscous colour concentrates allows to insert a high amount of pigments into skin with every single needle stroke. This shortens the treatment time – and your customer will be delighted. There are official analysis documents available for every LaBina pigment that you will be working with – ready to be shown to your customers if desired. This will make them feel safe and will create trust. If performed with high quality pigments and with a suitable technique, the follow-up treatments will manly be about prolonging the durability of the pigmentation. Satisfied customers will recommend you for years to come. Our pigmentings are exeptionally resilient. Your customers will be able to enjoy their permanent make-up for a long time.

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