Regulation 1223/2009: Changes

Cosmetics under EU 1223/2009: What to do

• 1 Put in charge EU Responsible Person :
    heavy, full technical responsibility
    keep a continuously updated Dossier,
    the name of RP on the label of product 
• 2 Edit and keep updated Cosmetic Dossier  – Product Information File (kept by RP)
• 3 Notification of products to EU database (by January 2012)
• 4 Compulsory appliance of Cosmetic Good Manufacturing Practice (ISO 22716)

How can we help you?

We can:
Notify the products, Assume the role of RP, or: Help you on keeping the role of RP under a safe way, edit and keep updated Cosmetic PIF, and more…

For any free information CONTACT US or call us on  +39 3405180274, Dr. Matteo Zanotti Russo

Need More details? See below:

Even though it acknowledges the validity of the structuring of the 78/768 directive, the new Regulation No. 1223/2009, carries out a number of implementations and clarifications based on the  experiences of the past years, focusing attention on some keywords which have been further elaborated on and defined: in particular, the appointment of the Responsible Person, the implementation (important) of the cosmetic dossier and the application of the Good Manufacturing Practice according to ISO 22716:2007.

1. Identification of the Person Responsible for the introduction to the EU market. The Person Responsible effectively takes on full technical and health responsibility for the products introduced on the market. Moreover, he is not just guarantor of the compliance but also of the realisation and management of all safety documentation   (Regulation 1223/2009, art. 25: Non Compliance by the Responsible Person).
2. The Responsible Person will have to draft and retain (at the address specified on the label) and keep updated:
a. Informational Documentation (art.11)
b. Safety Report (Annex I)
c. Safety Assessment (art. 10)

3. New labelling layout, with the obligation to indicate the Person Responsible and the place where the safety information is kept.
4. Identification and responsibilities of the distributors (obliged to notify)
5. Identification and management of the nanomaterials (with separate notification)
6. A single registration valid for all the EU countries with dispatch of the packaging images to the EU Commission
7. Verification of the sustainability of advertising claims
8. CMR substances (Cancerous, Mutagenic, Toxic for the reproduction) can be allowed only under prior verification by SCCS (Scientific Committee for Consumer Safety)
9. The Person Responsible has to organise and manage the Cosmetic Survey and inform Health Authorities of possible undesirable effects: Reinforcement  of controls on the market 
10. Good Manufacturing Practice (GMP) such as by ISO EN 22716:2007
11. INCI inventory: Glossary
12. Immediate application in EU countries (it must not be taken in: it is immediately operational)

Labelling and production on behalf of third parties: The name of the Person Responsible on the label 

With the new Regulation no. 1223/2009 there will be a substantial change in the labelling layout and the current supply chain “structure” for production on behalf of third parties. The new Regulation  no.1223/2009 in fact entails that the name of the “Person Responsible” is displayed on the label who takes on  full responsibilities and charges (retention and updating of the Informational Documentation and of the Safety Report, the “old” Dossier). In other words: The entity which appears on the label must be fully liable and will have to retain all  the necessary information.

This will pose a serious problem as regards to production on behalf of third parties: often the buyer “brand” does not want to display to everyone who the third party producer is (this is very private information).  In this case as well,  the appointment of an “external entity” as a Person Responsible allows to meet the needs of both parties, often increasing the level of compliance and safety of the work group.

Thanks to its long experience and to its constant interaction with Trade Associations and the Health Authorities, Angel Consulting can offer you all the pertaining information or take on the position of European Person Responsible, as it meets the requirements needed.

For any free information contact us or call +39 3405180274, Dr. Matteo Zanotti Russo
Skype address: angelconsultingsas