Regulatory consultancy for cosmetic registration in the EU
Marketing a cosmetic product in the European Union is not a complicated task, but there are some important aspects to take into account when it comes to comply with the regulatory consultancy European 1935/2009 on cosmetic products. At Shapypro, we can advise you on all the stages of regulatory consultancy of your products, from the early stages of the process to the notification to the European CPNP portal.
We offer different services:
- Revision of formula, labels and claims
The labelling of a cosmetic product has to comply with Article 19 of the European Regulation 1223/2009 on cosmetic products as well as with the common criteria to which claims for cosmetic products must comply as set out in EU Regulation 655/2013.
We take care of reviewing the labelling of your cosmetic products so that they comply with the minimum requirements imposed by Article 19 of Regulation 1223/2009 and advise you on the allowed claims so that your labels comply with Regulation 655/2014.
- Product Information File (PIF)
This is the most important document containing all the most relevant information on a cosmetic product. It is generally divided into 6 sections (description of the cosmetic product, Product Safety Report Part A + Part B, manufacturing method, compliance with Good Manufacturing Practices, labelling and tests claiming the efficacy of a cosmetic product and certificate of non-animal testing).
Our experts will take care of drawing up the PIF for your cosmetic products and will advise you at all times during the compilation of the documentation.
- Cosmetic Product Safety Report (CPSR)
The cosmetic product safety report is essential to demonstrate that a cosmetic is safe and does not pose any risk to human health under normal and foreseeable conditions of use.
The safety report is divided into 2 parts:
Part A: All information on the cosmetic product is collected (quantitative and qualitative composition, physical-chemical characteristics, stability and compatibility with packaging, microbiological quality of both substances and mixtures and the finished product, impurities and traces in raw materials and finished product, information on packaging and labelling material, normal and reasonably foreseeable use, exposure to the cosmetic product, exposure to substances, description of the toxicological hazard, notification of undesirable and serious undesirable effects and other additional documents providing further information on the finished product).
Part B: This part contains the conclusion of the report, the reasoning of the safety assessor in reaching this conclusion and the credentials of the safety assessor).
- Notification to the European CPNP Portal
The last step before placing a cosmetic product on the European market is the notification to the European CPNP Portal. Notification is mandatory and has to be done before the product is first placed on the market. The use of the CPNP is mandatory since 11 July 2013.
We take care of setting up the account in the name of the Responsible Person and registering the products on the European CPNP Portal.
- Responsible Person Service
Regulation EU 1223/2009 requires the designation of a Responsible Person for any cosmetic product placed on the European market. This person acts as a point of contact with the competent health authorities, acting as a guarantor of the conformity of the cosmetic product, ensuring compliance with all relevant obligations set out in this Regulation.
International regulatory consultancy
Not all countries follow the same rules for marketing a cosmetic product. Depending on the country, cosmetics have to comply with different regulatory compliance & advisory before they can be marketed.
Our regulatory department offers tailor-made services to meet our clients’ needs in terms of regulatory compliance and technical documentation to expand their business globally.
Our experience allows us to guarantee advice for the registration of cosmetic products in the following geographical areas:
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UNITED STATES
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UNITED KINGDOM
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LATIN AMERICA
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CHINA
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INDIA
We take care of all the formalities related to the correct compliance with the legislation in force in each country.
Personalised regulatory consultancy
Our experts can attend to your needs in relation to regulatory affairs and queries related to the registration of cosmetic products.
SHAPYPRO – Shape your project Almansa street, 14 Bio-Incubator Building (Science and Technology Park) (+34) 633 596 678 |