The ingredients of our systems are approved for food or dietary supplements and therefore do not fall under Novel Food. Also, despite their small size, our systems are not “engineered nanomaterials”, see the point: “legal situation of nanomaterials”.
Our systems are not nanomaterials according to EU regulations.
Definition of “nanomaterial” from the Cosmetics Regulation (REGULATION (EC) No. 1223/2009).
“Nanomaterial” means an insoluble or biologically stable and intentionally manufactured material with one or more external dimensions or an internal structure in the order of 1 to 100 nanometers.
Definition of “engineered nanomaterial” from the Food Information Regulation (REGULATION (EU) No. 1169/2011), which is also used in the Novel Food Regulation (REGULATION (EU) 2015/2283).
“engineered nanomaterial” means any intentionally manufactured material that has a dimension of the order of 100 nm or less in one or more dimensions, or whose internal structure or surface consists of functional compartments, many of which have a dimension of the order of 100 nm or less in one or more dimensions, including structures, agglomerates and aggregates that may be larger than 100 nm but whose properties due to nanoscale are retained.
=> Our systems are water compatible and non-biologically stable. All ingredients used are easily digestible by the body. Furthermore, the responsible EU Commission defines a “nanomaterial” by a solid character and explicitly excludes structures such as micelles*. Our systems are mixtures of liquids and consequently do not fall under the definition of a nanomaterial, regardless of their size.
*European Commission: “Questions and Answers on the Commission Recommendation on the Definition on Nanomaterial” (December 2011).
**A legal statement will be provided on request.
In principle, the alcohol content in cosmetic products does not have to be explicitly stated, as is the case for beverages, for example. There is also no maximum use concentration (corresponding regulations would be found in Annex III of the Cosmetics Regulation).
Although liquid food supplements are not considered beverages, it can nevertheless be assumed that, in accordance with the Food Information Regulation (LMIV), the alcohol content must be indicated in % by volume. Corresponding judicial decisions suggest this.
From the Food Information Regulation (LMIV) Regulation (EU) No. 1169/2011
The actual alcoholic strength by volume of beverages other than those referred to in paragraph 1 containing more than 1.2% alcohol by volume shall be indicated in accordance with Annex XII
According to the seminal standard commentary on food law Zipfel/Rathke, bioavailability claims are not yet nutrition or health claims unless they appear in the context of one. Consequently, increased bioavailability can be advertised as long as it is not associated with any unauthorized health claims related to the active ingredient. The commentary states:
“Appropriately, Meisterernst/Haber (WRP 2019, 413) point out that claims regarding bioavailability are in themselves neither nutritional nor health-related. This is also reflected in the fact that EFSA excluded some claims referring to the (enhanced) bioavailability of nutrients or other substances from the scientific evaluation in the context of the scientific review of health claims under Article 13 (e.g. blackcurrant anthocyanins (EFSA Journal 2010;8(10):1752) or mineral-enriched yeast EFSA Journal 2010; 8 (10):1743). EFSA correctly justified the exclusion of the claims by stating that the corresponding claims refer to bioavailability rather than to a relationship between a food/food ingredient and human health as required by Article 2(2)(5) for a health claim. However, bioavailability claims can be given material meaning under individual provisions of the Regulation by inclusion in nutrition or health claims. Thus, a nutrition claim about reduced or delayed bioavailability of carbohydrates from a food becomes a health claim at the latest when it is placed in relation to the resulting consequence. This also results, among other things, from the claim permitted by Regulation (EU) 432/2012 “the intake of hydroxypropylmethylcellulose as part of a meal helps to reduce the increase in blood glucose levels after the meal”; the corresponding effect results from delayed intake (influenced bioavailability).”
We can quantitatively demonstrate that our systems significantly increase the bioavailability of substances transported with them. The claim can be used truthfully accordingly. If the transported ingredient is a substance to which this applies, the claim “faster onset of action” can additionally be used in advertising.
Glycerin, water, vegetable oil, ethanol, lecithin (soy), ACTIVE INGREDIENTS.
Glycerin, water, ethanol, lecithin (soy), ACTIVE INGREDIENTS
Depending on their composition, size/size distribution, nanomaterials can have a variety of negative effects on the human organism. Hazards exist in particular when nanoscale solids enter tissue structures or cells and cause inflammation or trigger chemical reactions there, for example.
TINY Technologies’ systems consist exclusively of natural ingredients that are easy to metabolize. No solid particles are present, but liquid droplets. Comparable systems are formed by our body itself, as part of the digestive process, or are naturally present in foods such as milk.
Our experience is that customers are either enthusiastic about the term “nano” or not at all. Terms such as the combination of “high-tech” and “natural” are popular. You have a freedom of design there and can designate the technology according to your preferences / the preferences of your customers.
At least 2 years. In addition, it depends on the individual formulation according to customer requirements.
The stability of our systems is determined by warm storage tests and centrifuge tests. In this way, we ensure that no phase separation occurs during the shelf life period under specified individual storage conditions.
Our products are formulated in such a way that there is no danger to the user during intended use and also during expected inappropriate use.
Our standard products contain about 14 % ethanol by volume. Depending on the formulation and customer requirements, we also work with lower values. However, the alcohol is an important component as a preservative and to ensure stability. The amount of alcohol ingested with the intended daily dose of our products is in the order of magnitude of the alcohol content of about 50 ml of grape juice, 70 ml of “non-alcoholic” beer, 120 g of bread or 40 g of a ripe banana. With the small amounts required by TINY products, the alcohol intake does not exceed that of an ordinary diet.
Yes, we create custom formulations, which also includes the flavor of the final product.
Nanoemulsions are characterized by a higher loading capacity. Due to the presence of an almost arbitrarily selectable oil phase, the system can be optimally adapted to the desired active ingredients. This applies in particular to the dissolution behavior and stability.
Currently, we can influence the taste to a large extent. We are currently actively researching absolutely tasteless systems.
Excellent 🙂 Try it for yourself. We will be happy to provide you with a free sample.
In principle, we can process any active ingredient.
Can a basic solution of TINY be provided, which the pharmacist then only has to mix with CBD? => Prescription drug
Yes, we can do that with multiple technologies.
The PDI (polydispersity index) indicates how wide the distribution of droplet size is around the mean value, the average droplet size. A PDI of 0 means that all droplets are the same size. A small PDI (<0.3) indicates high stability.
Our systems are freely miscible with water. Beyond that, it strongly depends on the composition of the beverage. Factors influencing the stability are, for example, the pH value (due to fruit acids in juices or phosphoric acid in soft drinks) or the content of dissolved salts. By adjusting the formulation we can adapt our systems to specific environments.