Compliance with this standard can be shown either by the ISO 22716 certificate, or by a declaration stating that the products are produced according to ISO 22716. ISO 22716 is an international standard that gives guidance for the production, control, storage and shipment of cosmetic products. It deals with all aspects of the supply chain of cosmetic products. The guidelines cover the quality and safety of the product, and they affect manufacturers, as well as suppliers, retailers, brand holders and retailers of cosmetic products. It does not, however, cover safety aspects for the personnel engaged in the plant, or the protection of the environment.
Cosmetics Good Manufacturing Practices (GMP) is one of the pillars of the New European Regulation for Cosmetics. This Regulation sets very high requirements to ensure consumers’ safety, and is concerning all the participants in the cosmetics products chain, European and non-European. Amongst these new legal requirements, all cosmetics products circulating in the European Market will have to be produced according to the Cosmetics Good Manufacturing Practices described by the ISO 22716 standard.
Compliance with this standard can be shown either by the ISO 22716 certificate, or by a declaration stating that the products are produced according to ISO 22716. ISO 22716 is an international standard that gives guidance for the production, control, storage and shipment of cosmetic products. It deals with all aspects of the supply chain of cosmetic products. The guidelines cover the quality and safety of the product, and they affect manufacturers, as well as suppliers, retailers, brand holders and retailers of cosmetic products. It does not, however, cover safety aspects for the personnel engaged in the plant, or the protection of the environment.
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The Responsible Person for cosmetic products placed on the EU market has to keep a Product Information File (PIF) for each of these cosmetic products. A complete Product Information File is a basis for the Responsible Person to be able to perform the “Notification”. The requirements for the PIF are described in Article 11 and Annex I of the EU Cosmetics Regulation 1223/2009/EC, while there are some additional requirements described in the other articles as well. Responsible Person has to keep the PIF readily accessible in electronic or other format at his address, which is indicated on the product label, for the competent authority of the Member State in which the File is kept. The PIF has to be kept at one single address within the Community by the Responsible Person, and has to be kept updated at all times. The information contained in the PIF shall be made available in a language which can be easily understood by the competent authority of the Member State, and the File has to be kept for a period of ten years following the date on which the last batch of the product was placed on the market. Furthermore, where the cosmetic product presents a risk to human health, the Responsible Person shall immediately inform the competent national authorities of the Member States in which they made the product available and of the Member State in which the File is readily accessible, giving details, in particular, of the non-compliance and of the corrective measures to be taken.
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