Spain: the health products agency gives an opinion on hydroalcoholic gels marketed as cosmetics
Hydroalcoholic products marketed as cosmetics: until 30th June to comply
The Spanish agency for drugs and health products (AEMPS, Agencia Espa�ola de Medicamentos y Productos Sanitarios) published a note in December 2020 in line with a clarification from the European Commission on hydroalcoholic products.
In this note, the AEMPS returns to the criteria to be met for hydroalcoholic products marketed as cosmetics in Spain. These include the prohibition of some claims and other labelling elements.
Companies marketing hydroalcoholic products on the Spanish market have until 30th June 2021 to comply. This may mean: changing the labelling of their products to comply with these criteria, or marketing them as biocidal products..
With experts in both cosmetics and biocides regulations, EcoMundo can accompany you in all your compliance strategies for the Spanish market as well as the rest of Europe.
Claims and graphic elements to be avoided
The following claims should therefore no longer be used dans les gels hydroalcooliques:
- Antibacterial, antimicrobial, antiviral, virucidal, antifungal, antiviral properties.
- Disinfection, disinfecting, disinfect, sanitizing, sanitize.
- Antiseptic.
- Kills x% of bacteria/viruses/microbes.
- Formula recommended by the WHO.
- Anti-COVID-19, anti-coronavirus, anti-SARS.
Furthermore, references or allusions to the following elements are also to be avoided:
- Infection, pandemic, diseases.
- COVID-19, Coronavirus, SARS-CoV-2.
- Microorganisms, bacteria, viruses, pathogenic germs, fungi.
- Disinfection.
- Medical use.
- Percentage of alcohol in the product.
- Hand safety.
Finally, the following graphic elements or images must no longer appear on product packaging and labelling:
- Coronavirus, bacteria, microbes.
- Cross (red) (when it suggests a medical connotation).
- Shield (when it suggests protection against microorganisms).
- Sign of STOP (when it suggests prevention/control of the transmission of a disease, infection, or microbes).
- Any signs relating to the hospital, pharmacy, ambulance, first aid, etc.
- CLP pictograms.
As this list was given by the AEMPS, we recommend that you refer to the original list, in Spanish, for your compliance.
The context: the European Commission and borderline products
Last December, we explained how the European Commission shed light on the marketing of alcohol-based hand cleansers marketed as cosmetic products.
This technical document had been published by a sub-working group of the Commission and complemented the Manual on borderline products. In particular, it gave recommendations on claims and other packaging elements that may or may not be accepted in the context of a cosmetic product, for the specific case of hydroalcoholic hand gels without rinsing, during the Covid-19 pandemic period.
As this document is not legaly binding, companies are not obligated to comply with the recommendations. However, each country of the European Union is free to choose to follow them when checking the compliance of the hydroalcoholic gels present in their respective markets. EcoMundo therefore recommends you to be vigilant, depending on the market in which you operate, with regard to the claims and labelling of your products.
Wish to know more about the European compliance of hydroalcoholic gels?
For more information, do not hesitate to contact Nataliya Muller or one of our experts!
Hydroalcoholic products marketed as cosmetics: until 30th June to comply
The Spanish agency for drugs and health products (AEMPS, Agencia Espa�ola de Medicamentos y Productos Sanitarios) published a note in December 2020 in line with a clarification from the European Commission on hydroalcoholic products.
In this note, the AEMPS returns to the criteria to be met for hydroalcoholic products marketed as cosmetics in Spain. These include the prohibition of some claims and other labelling elements.
Companies marketing hydroalcoholic products on the Spanish market have until 30th June 2021 to comply. This may mean: changing the labelling of their products to comply with these criteria, or marketing them as biocidal products..
With experts in both cosmetics and biocides regulations, EcoMundo can accompany you in all your compliance strategies for the Spanish market as well as the rest of Europe.
Claims and graphic elements to be avoided
The following claims should therefore no longer be used dans les gels hydroalcooliques:
- Antibacterial, antimicrobial, antiviral, virucidal, antifungal, antiviral properties.
- Disinfection, disinfecting, disinfect, sanitizing, sanitize.
- Antiseptic.
- Kills x% of bacteria/viruses/microbes.
- Formula recommended by the WHO.
- Anti-COVID-19, anti-coronavirus, anti-SARS.
Furthermore, references or allusions to the following elements are also to be avoided:
- Infection, pandemic, diseases.
- COVID-19, Coronavirus, SARS-CoV-2.
- Microorganisms, bacteria, viruses, pathogenic germs, fungi.
- Disinfection.
- Medical use.
- Percentage of alcohol in the product.
- Hand safety.
Finally, the following graphic elements or images must no longer appear on product packaging and labelling:
- Coronavirus, bacteria, microbes.
- Cross (red) (when it suggests a medical connotation).
- Shield (when it suggests protection against microorganisms).
- Sign of STOP (when it suggests prevention/control of the transmission of a disease, infection, or microbes).
- Any signs relating to the hospital, pharmacy, ambulance, first aid, etc.
- CLP pictograms.
As this list was given by the AEMPS, we recommend that you refer to the original list, in Spanish, for your compliance.
The context: the European Commission and borderline products
Last December, we explained how the European Commission shed light on the marketing of alcohol-based hand cleansers marketed as cosmetic products.
This technical document had been published by a sub-working group of the Commission and complemented the Manual on borderline products. In particular, it gave recommendations on claims and other packaging elements that may or may not be accepted in the context of a cosmetic product, for the specific case of hydroalcoholic hand gels without rinsing, during the Covid-19 pandemic period.
As this document is not legaly binding, companies are not obligated to comply with the recommendations. However, each country of the European Union is free to choose to follow them when checking the compliance of the hydroalcoholic gels present in their respective markets. EcoMundo therefore recommends you to be vigilant, depending on the market in which you operate, with regard to the claims and labelling of your products.
Wish to know more about the European compliance of hydroalcoholic gels?
For more information, do not hesitate to contact Nataliya Muller or one of our experts!
