Regulation (EC) no. 1223/2009 is the European standard that defines the requirements for the production and marketing of cosmetics in order to guarantee a high level of protection of human health.
This objective is guaranteed by the ingredients used in a cosmetic formulation, by the product safety assessment carried out by a competent person and which takes into consideration factors such as the product formulation, the physico-chemical and microbiological properties of the raw materials and the finished product the manufacturing method, the data on the safety assessment of the product, the evidence of the claimed effects and the existing data regarding the undesirable effects on human health caused by the cosmetic product following its use. This information must be reported in the document known as the Product Information File (PIF).
Before being placed on the market, the product must be labeled and packaged in compliance with specific requirements established by the cosmetics regulation and its formulation must be notified to the European CPNP portal.
What we offer
TECHNICAL SUPPORT AND REGULATORY CONSULTING
We identify which products you market fall within the scope of the cosmetics regulation and help you interpret and comply with the obligations
We evaluate the compliance status of the products and what procedures to undertake to improve the production and marketing of cosmetic products
Requirement for the production of cosmetic products in order to open national and international sales channels is the adaptation to GMP (Good Manufacturing Practices)
We assist you in drafting management procedures and carrying out internal audits
LABELING OF PRODUCTS AND NOTIFICATION OF FORMULATION
Whether you are a distributor or a formulator of cosmetic products, we help you to prepare the label of your products by choosing the claims, the warnings, reporting the list of ingredients, the expiry dates and the PaO as required by the standard
We send notifications to the CPNP portal for you and your customers
SECURITY ASSESSMENT AND PIF DRAFTING
Our experts with legally recognized qualifications and qualifications can assist you
in the safety assessment of your cosmetic products, draw up and sign the PIF (Product Information File) for your cosmetic product, as well as in the drafting of product and supply chain documentation
ANALYSIS AND TEST
Thanks to the collaboration with specialized laboratories on cosmetic products, we can support you in carrying out microbiological stability and tolerability tests (Challenge test, Patch test, tolerability), product efficacy, chemical determination of heavy metals, allergen tests.
ASSISTANCE IN CHOOSING A THIRD PARTY FOR DISTRIBUTORS
Choosing a good manufacturer for own-brand cosmetics is essential for the image and reputation of the brand
We assist you by carrying out audits at the subcontractor for GMP, to check the PIFs and the choice of raw materials; we check the contracts to be stipulated in order to protect the Responsible Person
Our courses cover the main obligations deriving from the cosmetics regulation: from the interpretation of the definition of a cosmetic product to the safety assessment. Trained people will have the means to recognize the elements necessary for labeling to better manage bulk (subject to regulations such as REACH, CLP, ADR) and finished products