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The points of REGULATION
Identification of the Responsible Person
The Responsible Person will have
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)
New labelling layout
3) New labelling layout, with obligation to indicate the Responsible Person and the place where the safety information is kept.
A single registration
Labelling and manufacture on behalf of third parties: The name of the Responsible Person on the label
With the Regulation (EC) 1223/2009 it has been a substantial change in the labelling layout and the current supply chain “structure” for manufacture on behalf of third parties. The Regulation (EC) 1223/2009 in fact requests the name of the “Responsible Person” on the label. In other words: the entity, which appears on the label, must be fully liable and has to retain all necessary information.
This poses a serious problem in regards to manufacture on behalf of third parties: often the buyer “brand” does not want to show the third party producer (this is a private information). In this case, the designation of an “external entity” as a Responsible Person allows to meet the needs of both parties, often increases the level of compliance and safety of the group work.
Thanks to our consolidated experience gained in the market and to our constant interaction with the Trade Associations and Health Authorities, Angel Consulting can offer you all the pertinent information or assume the role of the European Responsible Person.