To launch your products on the European market, you must comply with European Cosmetic Regulation no 1223/2009. EcoMundo handles every step, from registering your products to CPNP notification, enabling you to sell your products in the 31 countries covered by the regulation.

 
  
1

VERIFYING COMPOSITION, LABELS & CLAIMS

Validating the composition of your formula

EcoMundo checks the composition of each product in relation to the annexes of the Cosmetic Regulation (prohibited/restricted ingredients, allowed ingredients such as preservatives, colourants and UV-filters).

Our teams provide you with a dashboard for checking all the products and their associated regulatory requirements.

Checking labels

The labelling and packaging of your products is also regulated by Cosmetic Regulation no. 1223/2009. The appearance of your labels and packaging is essential, and it is important, from a marketing point of view, to create a successful design which also precisely meets the strict rules set out by the Regulation. You must also comply with various regulatory requirements concerning translation depending on the country in which you wish to market your products.

EcoMundo takes over the checking of all your labels and provides you with a checklist of regulatory requirements that apply to you in order to ensure that your labels and packaging are compliant without affecting the original design.

Reviewing claims

Claims are efficient tools for marketing your products. They are strictly controlled by European legislation, particularly by article 20 of Regulation no. 1223/2009 and by Regulation EC 655/2013. Their aim is to ensure that the information communicated to the end user by the claims is useful, comprehensible and reliable.

Our regulation experts are specialists in reviewing claims, and their involvement will save you time and money. They make sure that you avoid errors and suggest alternative claims while taking your marketing strategy into account.

Lead time: 2 to 3 weeks

2

PRODUCT INFORMATION FILE

A Product Information File (PIF) is mandatory for all cosmetic products. EcoMundo draws up the PIF based on the information submitted

ONE FILE MADE UP OF FIVE PARTS

  1. 1. Description of the cosmetic product based on the information provided
  2. 2. Product Safety Report : Part A + Part B
  3. 3. Good Manufacturing Practices : EcoMundo validates the description of manufacturing methods used, and archives the Declaration of Conformity with the GMP.
  4. 4. Proof of the effect claimed : EcoMundo validates the proof provided from scientific tests and/or consumer perception tests.
  5. 5. Animal testing : EcoMundo validates the dates of tests carried out by the manufacturer, its agents or suppliers based on the information submitted.

Lead time : 2 to 3 weeks

3

COSMETIC PRODUCT SAFETY REPORT

The Cosmetic Product Safety Report (CPSR) is the main part of the Product Information File (PIF). It is divided into two parts and is a regulatory requirement in its own right, forming part of Cosmetic Regulation no. 1223/2009.

Part A

The aim of part A of the CPSR is to gather all the information required for the safety assessment. It consists of 10 sections.

The safety assessor is required to have an official qualification (for example, a pharmacy or toxicology diploma) recognized by a Member State. Our experts can assist you and are used to drafting Product Safety Reports from all sectors on a daily basis. Ensure the safety and compliance of your products by placing your trust in EcoMundo!

Part B

Part B contains the safety assessor’s conclusion on the safety of the cosmetic product. It is divided into four sections:

  • Safety assessment conclusion
  • Labelled warnings and instructions for use
  • Scientific reasoning
  • Assessor's credentials and approval of part B

As set out by the International Cooperation on Cosmetics Regulation (ICCR), “the safety assessment of cosmetic ingredients is not a standardized procedure but should be performed on a case-by-case basis using the best science. [...] The safety assessment must involve a systematic stepwise approach that starts from conservative assumptions and includes refined approaches, as required and/or appropriate. [...]” The safety assessment forms Part B of the Cosmetic Product Safety Report and is mandatory. Its aim is to prove that the cosmetic product does not pose a threat to human health.

EcoMundo’s expert pharmacists and toxicologists will assist you in carrying out this Safety Assessment.

Lead time : 2 to 3 weeks

4

CPNP NOTIFICATION

Cosmetic Regulation no. 1223/2009 demands that any organization wishing to place a cosmetic product on the European market must notify it online via the Cosmetic Products Notification Portal (CPNP) before doing so.

The CPNP is a website that only Responsible Persons and competent authorities may use to access product information.

EcoMundo will take care of the whole notification process and register your products on the CPNP portal.

Lead time : 2 to 3 weeks

 

Responsible Person

Since Regulation 1223/2009 on cosmetic products came into force in July 2013, a Responsible Person (RP) must be designated for each cosmetic product placed on the European market. The Responsible Person guarantees the compliance of the cosmetic product in line with articles 4 and 5 of the Cosmetic Regulation.

The Responsible Person must be a legal or natural person based in the European Union. The RP has a strategic role :

  • Ensure compliance of products placed on the European market
  • Assist with the fulfilment of all the obligations described in the Regulation
  • Act as the point of contact for the competent European authorities

With its three offices (Paris, Montreal in Canada and Seoul in South Korea), EcoMundo can act as your Responsible Person in French or in English. Our Responsible Person services cover the 31 countries of the European Economic Area (EEA) and enable you to sell your cosmetic products throughout the European market.

EcoMundo guarantees the compliance of your products before the European authorities, and makes sure that your products do not pose a threat to human health.