Spanish competent authority publishes new instructions for the application for authorisation of personal care products

Spanish competent authority publishes new instructions for the application for authorisation of personal care products

The Spanish competent authority (AEMPS) has updated as of May 2022 its instructions for requesting authorisation for commercialising personal care products on the Spanish market.

To clarify the procedure, the Spanish competent authority newly allows the possibility to separate the information in the application process [AMORD1] depending on the type of product, among other changes.

What is a personal care product?    

In Spain, personal care products are those not falling under the legal definition of cosmetics, biocides, medical devices or medicines intended to be applied on skin, teeth or mucosa and with an aesthetic or hygiene function.

In this sense, the Spanish competent authority states several examples of what a personal care product is:

  • Toothpaste
  • Tattoo inks and permanent make-up products
  • Vaginal moisturisers
  • Sports massage products
  • Nasal cleansers or eye cleansers

How does the authorisation procedure work in Spain?

To place personal care products on the Spanish market, an AEMPS authorisation is necessary. This authorisation has a validity of five years. After the end of this validity period, should the requester wish to keep placing its product on the Spanish market, it would need to request an extension of the authorisation. This request has to be done in the last six months of validity.

Applications for authorisation, modification or extension must be made through the Spanish registry for products and installation of biocides and personal care products. Once the requestor applies for the authorisation, the Spanish competent authority will approve it within three months from the date of application. A tax is requested for modifying or extending the authorisation of commercialisation.

Finally, it is worth mentioning that for personal care products (except tattoo inks and permanent make-up), it would be necessary to provide an evaluation report on the classification, labelling and packaging according to European Union’s Regulation 1272/2008.

The Spanish national law regulating personal care products is the Real Decreto Legislativo 1/2015 on medicines and medical devices, and the Royal Decrees1559/1997 and 85/2018 on cosmetics.

Are you interested in national requirements for your products? Do you wish to know more?

Contact us!

Get in touch

Pablo de Mingo Monge

Publications Department

23.06.2022


References

AEMPS. (2022). [SVORD2] La AEMPS publica en su página web las nuevas instrucciones para la solicitud de autorización de productos de cuidado personal. Retrieved on 17/06/2022 from https://www.aemps.gob.es/informa/notasinformativas/cosmeticoshigiene/biocidas/2022-biocidas/la-aemps-publica-en-su-pagina-web-las-nuevas-instrucciones-para-la-solicitud-de-autorizacion-de-productos-de-cuidado-personal/ [SVORD3] [PDMMORD4]

AEMPS. (2022). Autorización de comercialización de productos de cuidado personal. Retreived on 17/06/2022 from https://www.aemps.gob.es/cosmeticos-cuidado-personal/productos-de-cuidado-personal/autorizacion-de-comercializacion-de-productos-de-cuidado-personal/

BOE. (2015). Real Decreto Legislativo 1/2015, de 24 de julio, por el que se aprueba el texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios. Retrieved on 17/06/2022 from https://www.boe.es/buscar/doc.php?id=BOE-A-2015-8343

BOE. (1997). Real Decreto 1599/1997,de 17 de octubre, sobre productos cosméticos. Retrieved on 17/06/2022 from https://www.boe.es/buscar/doc.php?id=BOE-A-1997-23067

BOE. (2018). Real Decreto 85/2018, de 23 de febrero, por el que se regulan los productos cosméticos. Retrieved on 17/06/2022 from https://www.boe.es/buscar/doc.php?id=BOE-A-2018-2693

EUR-Lex. (2008). Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Retrieved on 23/06/2022 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02008R1272-20220301


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