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EN ISO 22716 Cosmetics – Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices


By July 2013, the new EU Regulation 1223/2009 calls for manufacturers of cosmetic products to produce "Good Manufacturing Practices - GMP". In Austria this has already been stated in Federal Law Gazette No. 92/2005 § 1 para. 1 no. 2 lit. C.


Manufacturers are therefore well advised to adapt to this regulation. But, how can an organization prove that the production meets the requirements of GMP? The ISO 22716 standard particularly, as it has been designed for this purpose. In this standard, the main areas of personnel, equipment, manufacturing and complaints are recorded in 15 chapters and are specifically questioned. A certification according to this standard not only proves that the legal requirements are adhered to/are complied with, but also provides the possibility of an intensive analysis of the hygienic status of the company.

This International Standard includes guidelines for the production, control, storage and shipment of cosmetic products. These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment. These guidelines are not applicable to research and development activities and distribution of finished products.

ISO 22716 is intended to provide guidance regarding Good Manufacturing Practices for cosmetic products. These guidelines have been prepared for consideration by the cosmetic industry and take the specific needs of this sector into account.

ISO 22716 offers organizational and practical advice on the management of the human, technical and administrative factors affecting product quality. These guidelines have been established in order to be used during the entire product cycle from receipt to shipment. Additionally, in order to clarify the way this document reaches its objectives, a ‘principle’ is added to each major section.

Good Manufacturing Practices constitute the practical development of the quality assurance concept through the description of the plant activities that are based on sound scientific judgement and risk assessments. The objective of these GMP guidelines is to define the activities that enables the client to obtain a product that meets defined characteristics.

Documentation is an integral part of Good Manufacturing Practices.

ISO 9001, ISO 22000, BRC Packaging, BRC – Global Markets Programs, IFS PACsecure, EN 15593, FEFCO GMP


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Mr. Wolfgang Leger-Hillebrand

Executive Vice President Sector Management Food Safety

Mr. Dr. Johannes Bergmair

Network partner, Product Expert Packaging