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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Animal testing is a big subject of discussion both among the consumers and among cosmetics manufacturers. As you may know, animal testing has been banned in the EU. Let’s see some more details about this.
The ban on animal testing has already been announced in the 7th Amendment of the Cosmetics Directive 76/768/EEC. Animal tests have been prohibited on finished cosmetic products and on cosmetic ingredients (testing ban). Furthermore, the sales of finished cosmetic products and ingredients included in cosmetic products, which were tested on animals, have been prohibited (marketing ban). The prohibition is also extended to all beauty and hygiene products tested on animals outside the EU, which may not be sold inside the EU. Application dates for the ban of animal testing are as following:
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.
When conducting the notification to CPNP, the Responsible person needs to upload the product formula as well.
The formula can be uploaded either in exact concentrations, in concentration ranges or as a predefined frame formulation. ‘Frame formulation’ means a formulation which lists the category or function of ingredients and their maximum concentration in the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation. New frame formulations are now available. They will be integrated in the CPNP system as from January 2014. Once the Frame Formulations 2013 will be in the system, the Frame Formulations 2011 will not be available any more for new notifications. Please note that old notifications for which Frame Formulations 2011 were used remain valid. You can find Frame Formulations 2013 here: https://webgate.ec.europa.eu/cpnp/resources/ff/FF-2013-EN-TRA-00.pdf As mentioned the last time, products which are difficult to classify i.e. could be put in one or the other category of products, are called borderline products.
Cosmetic products can be borderline with different other products. Some can be borderline with medicinal products, some with biocides, some with medical devices etc. Whether a product belongs to one product group or the other has to be determined on case-by-case basis. The classification of a borderline product can often depend on the claims of the product – what product claims it does. Find a link to the guidance documents published by the European Commission here: http://www.ceway.eu/INFO_Cosmetics_5_Is_it_cosmetics.html Determining what is a cosmetic product and what isn't sometimes isn't as easy as one would think. Certain products that general public would classify as cosmetics actually aren't, and there are also a lot of so called borderline products.
In the EU cosmetic products are defined in the regulation 1223/2009: “‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.” (EU Regulation 1223/2009, Article 2.1.a) A cosmetic product has to be a substance or a mixture, so cotton buds, combs, hair dryers etc. are not cosmetic products, and nor are products which are intended to be ingested, inhaled, injected or implanted into the human body. Cosmetic products also shouldn’t claim that they heal or treat any diseases. Products which are difficult to classify i.e. could be put in one or the other category of products, are called borderline products. We’ll say more about them next time. Broad categories of cosmetic product, which contain multiple subcategories, are: skin products, hair and scalp products, nail and cuticle products and oral hygiene products. To find out more about them, or to confirm the classification of your products, contact our official partner CE.way Regulatory Consultants Ltd www.ceway.eu |
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