Month: December 2020

As of now, some labeling elements will be forbidden in the context of the Covid-19 pandemic. Claims, references, and pictures will be affected by this Technical Document.

Introduction to the previously published legislation

Following the spread of the Coronavirus (COVID-19) disease, many actions have been carried out in EU to prevent and reduce the transmission of the virus. This includes enhanced hygiene practices. As preventive measure against the spread of Coronavirus (COVID-19) disease, the European Centre for Disease Prevention and Control recommends “Washing of hands with soap and water for at least 20 seconds, or cleaning hands with alcohol-based solutions, gels or tissues is recommended in all settings”.

The use of hand cleaners and hand disinfectants in forms of gels, hand wipes or other leave-on products has increased dramatically across most EU countries, and a lot of companies are investing in the production of Hand cleaners and Hand disinfectants to respond to the additional needs.

A steep increase in the submission to the Cosmetics Product Notification Portal under the Cosmetics Regulation of hydroalcoholic gels was noticed, and clear guidance for manufacturers on the applicable legislation and related requirements was published on 30th March 2020. In particular, while normally soap is a cosmetic product, other products such as alcohol-based solutions, gels, hand-cleaners, hand-disinfectants, etc. might require further clarification.

Sometimes it may be unclear whether a particular product is a cosmetic product, falling under cosmetics legislation or whether it falls under other sectorial legislation. In the case of Hydroalcoholic gel, this product can be classified as a cosmetic product or as a biocidal one, depending on the intended use.

The decision on a product’s classification must be taken at first stage of production, to evaluate the safety of the product properly, to perform the different tests needed, and to select the claims that will be placed at the label.

These products can be subject either to Cosmetic Products Regulation or Biocidal Products Regulation (normally only one legislation should be applicable to a product). This depends first of all on the presence of an active substance and the main purpose of the product:

• Products supplied with a main or exclusive cosmetic purpose (i.e. cleaning or cleansing the skin notably in absence of water rinsing) are covered by the Cosmetics Regulation.
• Products containing an active substance and supplied with a primary biocidal purpose (i.e. intended to control harmful organisms) are not covered by the cosmetics legislation and therefore fall within the scope of the biocides legislation.

Practical examples

Although the claims themselves are not the only decisive factor whether the product should be considered as covered by the Cosmetics Regulation or the Biocidal Products Regulation, they are a relevant indication of the purpose of the product. However, if the product is presented with a claim stating a biocidal action, it could be considered as biocidal.

Examples include products containing an active substance and making a claim to improve public health through the control of infectious organisms, such as “disinfecting”, “kill viruses”, “kill bacteria”, which would go beyond the general perception of personal hygiene and can include antibacterial hand gels.

It is therefore important to look at all the characteristics of the product, and in particular its composition, the purpose and the function of the product. If it is clear that the product is mainly intended to protect public health through biocidal action (e.g. disinfecting, antimicrobial/virus function), which would go beyond the general perception of personal hygiene, and the objective criteria for considering such a product as “biocidal product” are fulfilled, the product cannot be considered as a cosmetic product and will have to comply with the Biocidal Products Regulation.

The European Commission has drawn up a technical document on the legislation that applies to cleaners and disinfectants that do not require a hand rinse. These changes affect the labeling elements that would not support the main cosmetic function of these leave-on gels.

We want to help you have everything under control! Because of this, we have created this quick table to answer your questions in just a moment. You can find listed the claims, references or pictures that cannot be used at cosmetic products, at leave-on hydroalcoholic hand gels.

The recently published technical document should be read taking into account the Borderline Manual and the “Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants”, as it aims to complement these documents.

Even if the classification of each product shall be conducted on a case-by-case basis, taking into consideration all characteristics, product claims (to be intended as text, names, trademarks, pictures and figurative or other signs) can, nevertheless, be a strong indication of the main purpose of a product.

If you have any questions or concerns about this, contact us. We will be glad to help!