Given the high demand for hydroalcoholic gel due to the sanitary measures adopted in COVID-19, several products are valid to combat it, as authorized by European Health:

·         Cosmetics

·         Medical devices

·         Biocides (only antiseptics for healthy skin)

·         Medicines

Any other industrial sector would be totally prohibited.

Each one of the previous ones has a legislation and, therefore, a different labelling.

COSMETICS

In the case of cosmetics, they cannot make a direct allusion to the word "cure", "bactericidal" or "virucidal" on their labelling. The claim that it is allowed to put on a label is "sanitizer", "gel or hydroalcoholic solution", or similar and its use can be used with sanitary guarantees as long as it contains more than 60% ethanol and less than 95% ethanol with respect to the total of the formula. The highest efficiency is obtained with 70% ethanol. If not, the claim should be demonstrated as sanitizing.

9 cosmetic companies were intervened by the Spanish State in order to ensure supply in first-rate health centres, such as hospitals, health centres, or the like. These companies must ensure the supply of these first-rate health entities and also maintain the cost prices set by the Ministry of Health, exceptionally until the Spanish Government considers. These companies are:

COTY S.A.S. PARIS

INDUSTRIAL FARMACEÚTICA CANTABRIA S.A

L´ORÉAL ESPAÑA S.A

MIXER & PACK S.L.

BEIERSDORF AG 20245 HAMBURG

ANTONIO PUIG, S.A

FAES FARMA S.A.

AURIA SCCL WORKSHOP

JUSTE GROUP

The rest of the cosmetic companies that manufacture hydroalcoholic gels have free-market prices and can act freely as long as they are not required by the Spanish State.

MEDICAL DEVICES

They are those who, in order to act on the human being, must demonstrate the activity of mechanical efficiency. It is this group that includes hip prostheses, contact lens fluids or ultrasound gels used for the ultrasound. We can distinguish them by the CE marking, which sometimes if it is of a higher class, is preceded by a 4-digit numbering.

In the case of hydroalcoholic gels, they must demonstrate their effectiveness due to barrier action or the like (a glove is considered a medical device and we can see how it contains the “CE” marking on its packaging; also a mask).

BIOCIDES (ONLY ANTISEPTICS FOR HEALTHY SKIN)

All biocidal products classified as TP1, antiseptics for healthy skin, and regulated in accordance with Royal Decree 3349/1983, of November 30, which approves the Technical-Sanitary Regulation for the manufacture, marketing and use of pesticides and by Royal Decree 1054/2002, of October 11, which regulates the evaluation process for the registration, authorization and marketing of biocides, must be previously authorized and registered by the Spanish Agency for Medicines and Health Products (AEMPS) before its commercialization in the national territory.

Examples of this type of biocides are hydrogen peroxide, chlorhexidine, 96º domestic alcohol, iodized solutions, among others.

Given the health crisis situation caused by COVID-19 and the approval of Royal Decree 463/2020, of March 14, declaring the state of alarm for the management of the health crisis situation caused by COVID- 19, and the regulations adopted in its development; and by virtue of the powers established in the current legislation, the exceptional authorization of those antiseptic products for healthy skin whose active substance is Ethanol has been allowed. This exception is due to the excessive time it takes to authorize this type of products and that given COVID-19 has been exceptionally accelerated, provisionally.

The manufacture of this type of product, subject to exceptional authorization, can only be carried out by manufacturers who have previously been authorized to manufacture this type of biocidal TP1 products.

MEDICINES

For the case that covers us, they are usually antiseptics for damaged skin.

VELITURE LABORATORIES

Veliture laboratories of Fitocosmética S.L. It is a legal cosmetic laboratory since August 30, 2006 with sanitary registration number 8159CS and which was adapted to the new European Cosmetic Regulation by means of a declaration of the person in charge of manufacturing activities in June 2017.

Veliture complies with good manufacturing practices for cosmetic products according to the UNE-EN ISO 22716 standard.

Veliture has extensive experience in the development of dercosmetics for the pharmaceutical, professional cosmetics industry and in the investigation of CE class 2A medical devices for psoriasis and atopic dermatitis.Veliture realizó la declaración sanitaria ante el Ministerio de Sanidad Español de producir geles hidroalcohólicos cosméticos durante la pandemia de COVID-19, en fecha 17 de abril de 2020

.Veliture has fully legalized its hydroalcoholic gels in Europe, through the sanitary registration in the European Cosmetics Portal (CPNP).

Veliture has the registrations in the CPNP, as well as technical sheets with efficacy tests and safety sheets.

Veliture's hydroalcoholic gels and solutions all contain 70% ethanol, under the ELINNÉ and VIDAMENT brands.