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Regulation (EC) 1223/2009

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The points of REGULATION

Identification of the Responsible Person

1) Identification of the Responsible Person for the placing on the EU market of the cosmetic product. The Responsible Person takes full technical and safety responsibility concerning the health of the consumers about the products placement. Moreover, he is not only considered to be the guarantor of the compliance but of the realization and management of all safety documentation as well (Regulation (EC) 1223/2009, art. 25: Non-compliance by the responsible person).

The Responsible Person will have

2) The Responsible Person shall draft and retain (at the address specified on the label) and update:

a. Informational Documentation (art.11)
b. Safety Report (Annex I)
c. Safety Assessment (art. 10)

Labelling layout

3) New labelling layout, you have to make sure to insert the name or registered name of the Responsible Person and the place where the safety information is kept.

Identification

4) Identification and responsibilities of the distributors (whom shall provide to send a notification in case of translation into a language more suitable for the labelling).

Management

5) Identification and management of the nanomaterials (with a separate notification at least 6 months before placing on the market).

A single registration

6) A single registration valid for all the EU countries with the dispatch of the packaging images to the EU Commission.

Check

7) Verification of the sustainability of advertising claims.

CMR

8) CMR (Carcinogenic, Mutagenic and Reprotoxic) substances can be allowed only after prior verification by SCCS (Scientific Committee on Consumer Safety).

Cosmetic Surveillance

9) The Responsible Person shall organize and manage the Cosmetic Surveillance in such a way to inform the competent authorities about possible undesirable effects: Reinforcement of the market controls.

GMP

10) Cosmetic Good Manufacturing Practice (GMP): ISO EN 22716:2007.

Glossary

11) INCI inventory: Glossary

Application

12) Immediate application in all EU countries

LABELLING AND MANUFACTURE ON TOLL MANUFACTURING: THE NAME OF THE RESPONSIBLE PERSON ON THE LABEL

The Regulation (EC) 1223/2009 has basically changed the labelling layout and the current supply chain “structure” for toll manufacturing. The Regulation (EC) 1223/2009 in fact requires the name and the address of the “Responsible Person” on the label. In other words: the entity, which appears on the label, must be fully traceable as the holder of all necessary information about the product.

This is a serious problem for the toll manufacturing: often the buyer “brand” doesn’t want to show the third-party producer publicly (this could rightly be a private information). In this case, the designation of an “external entity” as Responsible Person allows to satisfy the needs of both parties, often increasing the level of compliance and safety of the working group.

Thanks to our consolidated gained experience in the market and to our direct interaction with the Trade Associations and Health Authorities, Angel Consulting offers you all the pertinent information or it can fulfill itself the role of the European Responsible Person.