Regulation (EC) No 1223/2009 on cosmetic products replaces, from 11 July 2013, Directive 76/768/EEC, which until now regulated the free movement of cosmetic products. The aim of this regulation is to ensure health protection and consumer information by ensuring the composition and labelling of products. The Regulation also provides for the evaluation of product safety and prohibits animal testing.
According to Article 11 of Regulation (EC) 1223/2009, persons responsible for placing cosmetic products on the market must have sufficient documentation on their products to justify to the authorities the safety of their cosmetics. All of this documentation constitutes the Product Information File.
The European Commission has created CosIng, a database of information on substances and ingredients used in cosmetics. This list does not constitute a list of substances authorised for use in cosmetic products, as their use must always be supported by a safety assessment.
Since 11 July 2013, before a cosmetic product is placed on the market, it must have been notified to the Cosmetic Product Notification Portal (CPNP). The persons responsible for the products (manufacturers, importers or distributors) must make the notification electronically on the CPNP portal at European level, so that no further registration at national level is required.
This regulation bans the marketing in the European Union of any cosmetic product that has been tested on animals, and also extends the ban to cosmetics whose ingredients or combinations of ingredients have been tested on animals.
At Servireach e share with you all our knowledge of cosmetic product safety so that you can evaluate, notify and document your products properly, thus ensuring you market your products responsibly.
The European legal framework for cosmetic products is Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009, and Commission Regulation (EU) No 655/2013 of 10 July 2013, which establishes the common criteria that cosmetic product claims must meet.
In addition, in Spain the Real Decreto 85/2018, de 23 de febrero, which regulates cosmetic products, governs national aspects related to cosmetic products and complements the European Regulation to ensure its correct implementation.
At Servireach, we help you ensure that your cosmetic product complies with the applicable regulations.
In accordance with Article 4 of Regulation 1223/2009 on cosmetic products, the Responsible Person may be a natural or legal person, and their main role is to ensure compliance with the requirements established in the Regulation for each cosmetic product placed on the market.
For products manufactured within the Community, the Responsible Person will be the manufacturer. For imported cosmetic products, each importer will be the Responsible Person for the cosmetic product they place on the market. However, in both cases, they may designate a third party as the Responsible Person.
A distributor will be considered the Responsible Person if they place a cosmetic product on the market under their name or trademark, or if they modify an already placed product in such a way that compliance with applicable requirements may be affected.
At Servireach, we review your case and advise you to ensure compliance with the obligations applicable to your activity.
To legally market any cosmetic product in the EU, the fundamental piece is the Product Information File (PIF). This technical file must be available to the authorities and contain all product information, including the description, manufacturing method, and, most critically, the Safety Assessment. At ServiREACH, we can gather all the information and prepare this full file, certifying that your product is safe for the consumer before it reaches the market.
No, fortunately the system is centralized. Since 2013, only a single electronic notification is required in the CPNP (Cosmetic Products Notification Portal). This notification is valid for the entire European Union and is mandatory before the product being placed on the market. We execute this procedure for you, ensuring that the data entered is adequate to avoid problems with the market surveillance authorities of any member state.
Not necessarily. The CosIng database is informative, but it does not guarantee that a substance is safe in any concentration or for any use. The use of each ingredient must always be backed by a Safety Assessment for your final product. Our experts evaluate your formulas to confirm that the ingredients, their concentrations, and their combination comply with the Regulation’s restrictions and are safe for the intended use.
Labeling is not just design; it must strictly comply with Regulation 1223/2009 to protect and inform the consumer. It must include mandatory information such as the ingredient list (INCI), lot number, product function, precautions for use, and the Responsible Person’s data, among others. At ServiREACH, we review and validate your labeling to ensure it complies with the regulation and that it avoids sanctions or product withdrawal due to information defects.
No. The Regulation prohibits the marketing in the EU of cosmetic products that have been tested on animals. In principle, this prohibition also extends to ingredients or combinations of ingredients that have been tested on animals for cosmetic purposes, although there may be cases in which certain chemical ingredients (which are also used in other sectors, not just cosmetics) are subject to animal testing under other regulations (e.g., the REACH Regulation on chemicals), when alternative methods for assessing human health or environmental risks do not exist or are not feasible. In any event, we advise you properly to ensure that your entire supply chain and your safety tests comply with all ethical and legal considerations, using validated and officially accepted alternative methods.
We are willing to help if you need advice or support in launching your product on the market in a way that follows all the regulations that will apply to it. Interested?
