Easy guideline about claims for Hydro-Alcoholic Hands Gel

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!

Register your Hand Sanitizer in Europe in 1 week

Committed with the Covid-19 crisis in Europe, Cosmeservice offers 100% discount in the Express Service of the Product Information File and the Notification in the CPNP

Cosmeservice is offering the possibility to register the Hand Sanitizer in Europe as long as the registration of this product were made as a cosmetic product.

Currently, we are working in the express registration of this product with customers from Korea, Taiwan, Israel, EUA, Brasil, etc.

It is possible to consider the product as a “Sanitizer” instead of a disinfectant which would be considered as a biocidal product, would take more time (at least 6 months) and, therefore, would have to comply biocidal products REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 May 2012.).

CPNP Certificate will allow you to sell the product faster.

Take advantage of this possibility and get to market your product soon in Europe!

Our team will be pleased to revise your labellings once you accept to register your product as a cosmetic!

Collaborate with Europe against Covid-19 crisis!

Join us in helping Europe against Covid-19!

Together, we are stronger!

Cosmeservice will assume the cost of the Express Service in the registration as a way to help Europe in this complicated situation.

By this way, you will save 130€ which is the cost of the Express Service for the Product Information File and the Notification in the CPNP!By contracting the Express Service, the complete registration of your products can be done in just 1 WEEK once we receive all the documentation from your side!

rebranding cosmeservice - new logo
+34 963 21 17 17 | info@cosmeservice.com

K-beauty, the paradigm of Korean beauty

It has been the first time Cosmeservice has ventured to visit South Korea, given the boom in K-Beauty cosmetics, and we assure you that it will not be the last.

The reason for our trip has been the attendance as a visitor to one of the most important cosmetic fairs in this country, specifically, in K-Beauty Expo, in KINTEX.

The fair is positioned as a meeting place for Korean manufacturers and distributors who are leaders and innovators in the Korean cosmetics industry and which have taken advantage to present their products and the latest trends.

For Cosmeservice has been a business opportunity since it is a cosmetic fair in which we can meet with more than 10 customers of the Korean market, and in which we have contacted about 200 exhibiting companies.

This market is the one with the fastest growing among our customers. More and more companies are prescribing and recommending us, after their satisfactory experiences working with the Cosmeservice team.

What is K-Beauty?

Korean beauty products, or K-Beauty, as they are popularly known, have conquered the beauty industry, and specifically in Europe leaving consumers equally intrigued and expectant by their legendary 10-step routine: removing makeup from the eyes, cleaning the face, exfoliating the skin, toning, applying facial essences, blisters, masks, eye cream, moisturizing and, finally, putting on a cream or night mask.

The basic principles of K-Beauty cosmetics revolve around extreme skin care. The health of the dermis is the primary objective, as well as to look as natural as possible.

Proud of our work

We are pleased to note the attention paid by Korean cosmetic companies or K-Beauty to us. Also, the interest shown in our services, as more and more decide to expand their business in the European market.

Among the added values and advantages of working with Cosmeservice, highlights the power to have all services in the same company, ie the analysis of documentation, as well as conducting the necessary studies.

Our current and potential clients consider it is very important to have the peace of mind of knowing they place their trust in a consultancy that will verify their cosmetic products in accordance with current regulations and ensure that they are safe for consumers.

Another strong point they value very positively, is we are the fastest European expert consultant in Cosmetic Safety and Regulation in the market.

Finally, we would like to highlight the kindness of this country, which always receives you smiling.

feria K-beauty
feria K-beauty 01

The truth about claims

The truth about claims

When shopping for a cosmetic product, everybody looks at the advertisements. They make a product look more enticing or encourage us to try it. Given two identical products, product claims can make one more attractive than the other and beat it in terms of marketing.

Commission Regulation No. 665/2013 sets out common criteria applicable to claims made for cosmetic products, and puts limits on the claims we can use to make our product a marketing superstar. The Regulation provides guidelines regarding points to take into account when making claims for a cosmetic product. Compliance with Regulation No. 1223/2009 on cosmetic products is obligatory for all products, and therefore does not need to be restated. Neither should it be claimed that that a product does not contain ingredients which are not permitted, as they are prohibited and the product could not pass the safety assessment process.

Veracity is another important point, as if a product claims that it contains an ingredient then it must be included in the formula. For example, for the claim “Contains Lavender” the product must include the lavender plant as an extract, oil or a specific part of the plant like leaves, not a perfume that imitates the smell of lavender. Likewise, if a product says that it lasts for 24 hours then there must have been a study that confirmed this is true. Doing otherwise is to mislead the consumer.

Another guideline to take into account is that the data must support these marketing tools. In other words, explicit or implicit claims must be justified by tests that demonstrate the truth of what is stated. The previously mentioned claim “lasts for 24 hours” is an example. The Responsible Person must make sure that all claims are proven. With the tests out of the way, claims should focus on the effects of the product, and go no further than that. This point relates to honesty regarding the product and competitors.

The next point is impartiality, that is to say that claims should be objective and not go against similar products of other brands on the market. It is not impartial to denigrate the use of ingredients by other manufacturers when these are permitted on the market. Examples are “parabens free”, “alcohol free”, “free of silcones”, “free of preservatives”, “free of colourants”.

Finally, consumers should be presented with claims that are clear, and comprehensible, and that cannot be misunderstood. They should not be mislead into believing that the product has properties or effects that it does not.

At Cosmeservice, we recommend thinking about claims at the very beginning of producing a formula. Raw materials, with their bibliography, can be another tool for justifying a claim. The labelling should be designed as the product is being developed, and cannot be finalised until the Safety Assessment has been carried out.


Ana María Hernández


Are parabens safe?

Are parabens safe?

Lately, products free of parabens can be found in any shop that sells cosmetics. Society has a poor view of parabens, as everyone has heard that they are bad for the skin, can cause cancer, can affect growth hormones, etc. To better understand them, we will look at their origins.

These preservatives were discovered in 1924, and were immediately used in all kinds of cosmetic products. The concentrations used varied from enormous to tiny quantities. They were not regulated and everybody used them. There was no risk in using them.

Parabens are used topically and orally. Several studies found that ingested parabens are absorbed well by the intestines and fully removed through urine, but when applied topically their metabolisation is not as simple and quick.

From the beginning, parabens were known to be an anti-fungal and work as a preservative for products. They are widely used in all kinds of cosmetics to preserve and protect the safety of products. They are usually employed as a combination of different parabens with other anti-microbial agents, aiming to achieve a synergistic effect. One of the main advantages, compared to other preservatives that only work in acid conditions, is that they work in neutral conditions (pH 7) and are also cheap to produce.

Around 1940 the first irritation and sensitisation reactions began to appear in the population, but it was not until the 60s that the first cases of serious and long-term eczema were seen. In 1984 it was decided that their use was safe up to 25%.

Based on these facts countless studies have been carried out to test the toxicity or non-toxicity of parabens in cosmetic products. Alarm bells started ringing when, in 2004, a study found a relationship between breast cancer and traces of parabens found in tissue. Later studies have tried to produce conclusive evidence regarding this finding, but nothing has been proven.

Even so, the alarm had been sounded, and based on these studies the case for the safety of parabens was re-opened, and new limits  were established. This was not so good for all the manufacturers that had developed a large number products that included them. Now, as well as having to reformulate existing products, they would have to find new preservatives that were as effective and cheap as parabens.

Currently, parabens are allowed to be used as long as this is within the permitted concentration (0.4%  for methyl and ethyl paraben, and 0.14% for propyl and butyl paraben, and the mixture of various parabens cannot exceed 0.8%), which is established in European Regulation 1223/2009 on cosmetic products. These ingredients are not bad, they are needed in order to preserve products.


Ana María Herández