This presentation is about the challenges of clean labelling.

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Clean Label – TiO2 free formulations

Our conclusion:

As an answer to the consumers demand BIOGRUND offers its services:

• TiO2 free formulation (white or coloured) are available.
• Formulated with alternative raw materials for whitening.
• Comparable opacity & brightness can be achieved.
• Manufacturers can meet market demand (products with or without TiO2).

BIOGRUND is Clean Label Alliance member, as well as BOSCH Packaging Technology, LONZA Inc., NATOLI Engineering Company and RIBUS Inc.

For more information about the Clean Label Alliance (click here).

Film coating users and manufacturers have to face several challenges by developing TiO2 free film coating formulations. These alternative raw materials require a higher content in a formulation compared to TiO2 but there are only limited possibilities due to necessary amounts of functional excipients!

Another challenge is the ensuring of comparable film-coating functions and film-coating properties like TiO2 containing formulations. Of course, the customer wants brightness & opacity which is not easy to reach with the decisive film-coating properties for TiO2 free film coatings.

But we always have to make sure that we ensure a similar preparation and application of TiO2 free film coatings.

Alternative raw materials for TiO2 free film coatings:

There are several possible replacements for titanium dioxide e.g.: Carbonates, Phosphates and Starches.

Definition Carbonates:
In chemistry, a carbonate is a salt of carbonic acid (H2CO3), characterized by the presence of the carbonate ion, a polyatomic ion with the formula of CO2−
3. The name may also refer to a carbonate ester, an organic compound containing the carbonate group C(=O)(O–)2.

Definition Phosphates:
A phosphate is a chemical derivative of phosphoric acid. The phosphate ion (PO3−4) is an inorganic chemical, the conjugate base that can form many different salts. In organic chemistry, a phosphate, or organophosphate, is an ester of phosphoric acid.

Definition Starches:
Starch or amylum is a polymeric carbohydrate consisting of a large number of glucose units joined by glycosidic bonds. This polysaccharide is produced by most green plants as energy storage. It is the most common carbohydrate in human diets and is contained in large amounts in staple foods like potatoes, wheat, maize (corn), rice, and cassava.

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E171 – one of the most important food additives in nutraceuticals, widely used as a whitening agent for example in tablets or tablet film coating.

Titanium dioxide – the white pigment with highest refractive index and brightness. It is an excipient with unique properties – even a low content of titanium dioxide provides a significant influence to nutraceutical products.

But why is titanium dioxide considered as critical?

Several current studies describe a potential risk of TiO2 nanoparticles (NP) to the human respiratory system.

So remember that consumers & customers know this and therefore they pay attention to the list of ingredients and are well informed!

Another aspect to pay attention is that a clearly perceived market trend in Nutraceuticals is a more natural & shortened ingredient list! (Click to learn more about the Clean Labelling movement)

As a result, the industry has to look for new alternative excipients & ingredients.

Clean label is a consumer driven movement, demanding a return to real food and transparency through authenticity. Clean Label says that nutraceuticals should contain natural, familiar, simple ingredients that are easy to recognize, understand, and pronounce.

Therefore, industry has to look for new excipients & ingredients and replace the artificial ingredients or synthetic chemicals. Here the industry can benefit from consumer-friendly labelling to the customer.

Always remember: Consumers & customers paying attention to the list of ingredients & are good informed.

There are a few accepted challenges faced by the brand owner and the contract manufacturing organization (CMO) when developing such products. The first challenge is to find natural, non-GMO ingredients. To source organic ingredients when they are available and keep products allergen/gluten-free.
Correctly manufacture products without traditional manufacturing aids (excipients/non-active ingredients) are required. Minimize use of additives and fillers.
The industry should also pay attention to changes to regulatory requirements lead to formulation adjustments.

BIOGRUND is member of the Clean Label Alliance.

Due to fast growth of clean label movement, the term natural colour was defined by “Regulation (EC) No 1333/2008” which explains the detailed rules on the use of food additives. This regulation was updated in 2010 (Commission Regulation 257/2010) and established a program for re-evaluation of approved natural colours. Natural colorants are preparations obtained from a wide range of sources like vegetables, fruits, plants, minerals and other edible natural sources by physical and/or chemical extraction resulting in a selective extraction of the pigments relative to the nutritive or aromatic constituents. The natural colorants can be divided into dyes (colour that is soluble in a medium) and pigments (finely ground particles of colour which are suspended in a medium).

BonuPrint® (BP) is a fine, homogenous, liquid pigment dispersion for solid oral dosage form which provides possibilities to print logos, brand names or barcodes onto oral dosage forms. Natural pigments can play an important role to increase the availability of the BP in different nutraceutical fields. Therefore, development of a BP with clean label approved natural pigments which provides similar characteristic like the standard BP can increase the range of its applications.

Printing inks such as BP are composed of liquid phase and solid phase. The liquid phase is used as a vehicle system to carry solid contents, adjust viscosity and drying time of the ink, whereas the solid phase is a polymer responsible for film formation, a covering agent to provide enough opacity and colour pigments to produce different colours. Depending on the used liquid phase, they can be divided into water based and solvent based inks. Generally, the water based inks are a mixture of mainly water and a small amount of alcohol as vehicle system, whereas the solvent based inks are a mixture of alcohols as vehicle system. The two types of inks have similar applications but the main difference is the easier handling and cleaning process of water based inks.

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BIOGRUND_BonuPrint®, a natural printing ink for the food and nutraceutical industries