Explanations of the EU claims regulation 655/2013 / Elisabeth Bumberger in SOFW JOURNAL, Vol. 142, N° 11 (11/2016)  

[article]  inSOFW JOURNAL > Vol. 142, N° 11 (11/2016) . - p. 38-42 Titre : Explanations of the EU claims regulation 655/2013 Type de document : texte imprimé Auteurs : Elisabeth Bumberger, Auteur ; Anne-Marie Burkhard, Auteur ; Andrea Keck-Wilhelm, Auteur ; Birgit Huber, Auteur Année de publication : 2016 Article en page(s) : p. 38-42 Note générale : Bibliogr. Langues : Anglais (eng) Catégories : Assurance qualité Cosmétiques Industrie cosmétique -- Législation -- Pays de l'Union Européenne Tests d'efficacité Index. décimale : 668.5 Parfums et cosmétiques Résumé : These explanations are to support cosmetics manufacturers at the implementation of the provisions of the European Cosmetics Regulation (EC) No. 1223/2009 and Regulation (EU) No. 655/2013 laying clown common criteria for the justification of claims used in relation to cosmetic products adopted on its basis. They supplement the guidelines to Regulation (EU) No. 655/2013 which must likewise be observed. Furthermore, it must be taken into account that there are other advertising provisions bath on the level of the EU and on the national level to protect consumers. More detailed explanations on the "Evaluation of the efficacy of cosmetic products" can be found in the Colipa Guidelines of the same narine dating back to the year 2001. All the considerations on this topic focus on the consumer and his justified expectations concerning the effect and the properties of the respective products. For the competent authorities it matters above all, that the evidence of the advertising daims made on the products or in other advertising forms — as far as necessary in accordante with Article 11 para 2 d) EC Cosmetics Regulation — is documented in an understandable manner in the product information file. In order to ensure this, a good communication between the manufacturers of cosmetic products and their raw material producers is required in nnany cases. It may also be necessary to take into account, for instance, the selection of a qualified external test institute, if studies with a view to a planned advertising daim are to be carried out there. The requirements described here apply of course also to cosmetic products imported from third countries. If the manufacturer in the third country is not able to provide the responsible persan within the EU with reliable data on the claimed efficacy, the latter must himself take tare of the production of corresponding evidence. Note de contenu : - Objective of these explanations - Advertising claims within the meaning of article 20 EC cosmetics regulation - Misleading and consumer expectation - Form of the proof of efficacy - General principles for all tests En ligne : https://drive.google.com/file/d/1WqfocYloTvM4UkwwGnMATBxoKp4PjRtK/view?usp=drive [...] Format de la ressource électronique : Pdf Permalink : https://e-campus.itech.fr/pmb/opac_css/index.php?lvl=notice_display&id=27861 [article]

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Substantiation of antibacterial/antimicrobial claims for cosmetic products / Barbara Tyralla in SOFW JOURNAL, Vol. 144, N° 5 (05/2018)  

[article]  inSOFW JOURNAL > Vol. 144, N° 5 (05/2018) . - p. 24-27 Titre : Substantiation of antibacterial/antimicrobial claims for cosmetic products Type de document : texte imprimé Auteurs : Barbara Tyralla, Auteur ; Andrea Keck-Wilhelm, Auteur ; Anne-Marie Burkhard, Auteur ; Bernhard Fellenberg, Auteur ; Otto Sponheimer, Auteur ; Jürgen Rabenhorst, Auteur ; Joelle Nussbaum, Auteur Année de publication : 2018 Article en page(s) : p. 24-27 Note générale : Bibliogr. Langues : Anglais (eng) Catégories : Antimicrobiens Cosmétiques -- Normalisation Essais (technologie) Industrie cosmétique -- Législation -- Pays de l'Union Européenne Index. décimale : 668.5 Parfums et cosmétiques Résumé : A product applied on external parts of the human body, which is claimed as antibacterial or antimicrobial, can, from the legal point of view, be classified as either biocidal or as a cosmetic product. If, however, the claim or advertising explicitly refers to the treatment or the relief of an illness caused by bacteria/microorganisms the product has to be classified as a drug. It is of critical significance to differentiate between a cosmetic product and a biocidal product that claims for the antimicrobial efficacy can be judged as secondary compared to the main cosmetic purposes in the sense of Art. 2, 1(a) of the Regulation (EC) No 1223/2009. If the product is classified as cosmetic product, adequate and verifiable proof of the claimed antimicrobial efficacy has to be provided with regard to the provisions made in Annex I, 3 of the VO (EC) 655/2013. Detailed legal requirements or binding normative standards regarding the kind and extent of such proof is, however, missing for cosmetic products. This position paper shall give proposals and assistance for choosing appropriate proof. Note de contenu : - Requirements and standards of other areas - Recommendations for testing cosmetic products for which a microbicidal, microbiostatic or antibacterial resp. antimicrobial efficacy is claimed - Table 1 : Requirements and norms in non-cosmetic areas - Table 2 : Recommendations for the selection of test-methods and relevant test-organisms of specific products or application areas and recommended contact-times En ligne : https://drive.google.com/file/d/1f563ycn7Junqz80JYff8OT2eTjSMs54w/view?usp=drive [...] Format de la ressource électronique : Pdf Permalink : https://e-campus.itech.fr/pmb/opac_css/index.php?lvl=notice_display&id=30682 [article]

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