Definitions and legal framework to be observed when working with cosmetic products
According to the Regulation, the main terms to be considered are as follows:
- Cosmetic product: any substance or mixture intended to be placed in contact with the superficial parts of the human body (i.e., epidermis, hair and capillary system, nails, lips, and external genitalia) or with the teeth and oral mucous membranes for the sole or primary purpose of cleaning, perfuming, modifying their appearance, protecting, maintaining them in good condition, or regulating body odour.
- Manufacturer: any natural or legal person who manufactures a product or orders the design or manufacture of a product and markets that product under their name or trademark.
- Distributor: any natural or legal person in the supply chain, other than the manufacturer or importer, who places a cosmetic product on the EU market.
- Importer: any natural or legal person based in the EU who places a cosmetic product from a third country on the EU market.
There are currently several regulations that affect cosmetic products. The legal framework governing cosmetic products must be observed to market cosmetic products correctly:
- Commission Regulation (EU) No. 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products.
- COMMISSION IMPLEMENTING DECISION of 25 November 2013 clarifying the guidelines for the safety report, which appears in Annex I of the Regulation.
- ROYAL LEGISLATIVE DECREE 1/2015, of 24 July 2015, which stipulates that a statement of compliance must be provided for manufacturing and importing activities.
- ROYAL DECREE 85/2018 of 23 February 2019, which is the national implementation of Regulation 1223 of 2009.
- And finally, and most importantly, REGULATION (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 regulating all cosmetic products in Europe. This Regulation establishes the requirements that must be met by cosmetic products to be sold within the European Union.
The main body of this Regulation comprises Articles 1 to 40 followed by ten annexes, the most important of which are Annexes I to VI:
- Annex I contains the guidelines for the safety report to be included in the product information file.
- Annex II provides a list of banned substances.
- Annex III lists the substances that must comply with the restrictions indicated therein to be used.
- Finally, Annexes IV, V and VI list the colourants, preservatives and ultraviolet filters that can be used in cosmetics.
Azierta’s experts in cosmetic products can provide personalised advice on your products, answer any questions you may have and help to guarantee the success of your project. Please contact us!