Veterinary medicine product or not? OZOLEA's innovative approach within the new regulatory framework

Since the very beginning, OZOLEA has always had two clear goals.

The first is finding solutions to help the farmer improve health management at herd level, by addressing udder issues that could lead to milk loss, and those relating to the uterus, which are generally followed by reduced fertility in dairy cows.

The second, as important as the first, is to put the dairy farmer at the forefront of the prudent use of antimicrobials for tackling antimicrobial resistance (AMR).

The starting point was precisely the concept of resistance to active substances. Today we are aware of the fact that it is a problem for human and animal health, food safety and the environment.

In animal husbandry, the sustainable and rational way of using medicines should include the application of biosecurity strategies and a disease management plan, defined along with veterinary advice.

The dairy farmer’s ability and the availability of products such as those proposed by OZOLEA allow to avoid the use of unnecessary antibiotics and other drugs.

OZOLEA has therefore designed products capable of creating an environment, in the udder and uterus, hostile to microorganisms without acting directly against them. They belong to the product category of veterinary devices.

Let’s take a step back to the definition of a veterinary medicinal product as per Reg. (EU) n. 2019/6¹. Knowing it will help us recognize the products available on the market.

Veterinary medicinal product means any substance (of human, animal, vegetable or chemical origin) or combination of substances which fulfils at least one of the following conditions: (a) it is presented as having properties for treating or preventing disease in animals; (b) its purpose is to be used in, or administered to, animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action; (c) its purpose is to be used in animals with a view to making a medical diagnosis; (d) its purpose is to be used for euthanasia of animals;

OZOLEA products consist of bioengineered food grade vegetable oils. They do not contain substances capable of carrying out pharmacological, immunological, metabolic actions. They cannot be used for disease treatment or prevention. They do not restore, correct or modify physiological functions. They are not designed to establish a medical diagnosis and, without a doubt, are not suitable for euthanasia.

OZOLEA tested them according to ISO standards, proving that they are non-cytotoxic products.

Furthermore, we have already focused on what antimicrobials² and biocides³ mean. The concept of “direct action on microorganisms” completely excludes OZOLEA products from the markets for these two types of products.

This is why OZOLEA products are veterinary devices, the definition of which is currently derived on the basis of the legislation in force for medical devices for human use.

To date, both in Italy and at EU level, there is no specific legislation that legally defines veterinary devices. However, Italy⁴ and other EU countries recognize this type of products on the market, with or without registration specifications for marketing.

The innovative and clear OZOLEA approach is not to fall into the definitions of veterinary medicinal product, antimicrobial and biocide, with the ultimate goal of fighting AMR.

Therefore, OZOLEA products are and will continue to be legal in the EU, but also in the United States⁵. The effort will have to be towards a harmonized EU standard for veterinary devices.