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The 1223/2009/EC
Regulatory Changes
The new regulation implies greater risk for the “responsible person” (Authorized Representative) in terms of product safety. It gives clear requirements for generating, keeping and updating information. Hence, the major responsibility in regard to the safety of a cosmetic product will rely on the “responsible person” (Authorized Representative).
The “responsible person” will carry out the legal obligations of the cosmetic manufacturer or importer in regard to the new regulation, including but not limited to registration, maintenance of product files, safety assessments, etc.
Furthermore, in regard to product safety, the Regulation underlines strict requirements for the content of the Safety Assessment and that of the Product Information File (Annex I), as well as the responsibilities of the “responsible person” (Authorized Representative) and the Safety Assessor.
The process of registration is changed by the notification of sales and compositional information being delivered to the Commission, who will circulate the information to Poison Centres and Member States.
The new regulation introduces changes in regard to the notification, evaluation and labeling requirements for all cosmetic products that contain nanomaterials. Furthermore, additional safety assessment provisions related to nanomaterials have also been incorporated in the regulation.
Moreover, the regulation will allow the use of Carcinogenic, Mutagenic or Reprotoxic Substances if they have been evaluated and found safe by the SCCS (Scientific Committee for Consumer Products) for use in cosmetic products.
Last, in line with the REACH Regulation, the new legislation stresses the need to make information available to the public and to the consumers.
Market Surveillance
There will be a section provided by the regulation (Chapter VII and Chapter VIII) in regard to Market Surveillance, Communication of Effects and Action to be taken if problems occur in the marketplace or if there are situations of non-compliance with the regulation.
The new regulation implies greater risk for the “responsible person” (Authorized Representative) in terms of product safety. It gives clear requirements for generating, keeping and updating information. Hence, the major responsibility in regard to the safety of a cosmetic product will rely on the “responsible person” (Authorized Representative).
The “responsible person” will carry out the legal obligations of the cosmetic manufacturer or importer in regard to the new regulation, including but not limited to registration, maintenance of product files, safety assessments, etc.
Furthermore, in regard to product safety, the Regulation underlines strict requirements for the content of the Safety Assessment and that of the Product Information File (Annex I), as well as the responsibilities of the “responsible person” (Authorized Representative) and the Safety Assessor.
The process of registration is changed by the notification of sales and compositional information being delivered to the Commission, who will circulate the information to Poison Centres and Member States.
The new regulation introduces changes in regard to the notification, evaluation and labeling requirements for all cosmetic products that contain nanomaterials. Furthermore, additional safety assessment provisions related to nanomaterials have also been incorporated in the regulation.
Moreover, the regulation will allow the use of Carcinogenic, Mutagenic or Reprotoxic Substances if they have been evaluated and found safe by the SCCS (Scientific Committee for Consumer Products) for use in cosmetic products.
Last, in line with the REACH Regulation, the new legislation stresses the need to make information available to the public and to the consumers.
Market Surveillance
There will be a section provided by the regulation (Chapter VII and Chapter VIII) in regard to Market Surveillance, Communication of Effects and Action to be taken if problems occur in the marketplace or if there are situations of non-compliance with the regulation.
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