Frequently Asked Questions & Guides

CEN/ISO 22716:2007 – Presumption of Conformity with Cosmetic GMP in Europe

in CEN/ISO 22716:2007, Frequently Asked Questions & Guides

Prepared between 2002 and 2006 by ISO Technical Committee 217, Working Group 6, the ISO standard 22716:2007 was published in November 2007.

While being an international standard, ISO 22716:2007 was adopted by the European Committee for Standardization (CEN) to become also a European Harmonized Standard (as published in the Official Journal of the European Union on April 21st 2011 – 2011/C 123/04) in reference to the implementation of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.

ISO 22716:2007 provides guidelines for the production, control, storage and shipment of finished cosmetic products. However, it is not aimed at covering the quality aspects of the product, the personnel engaged in the manufacturing site or the protection of the environment. Read more

Cosmetics with small packaging space

in Frequently Asked Questions & Guides, News

As the NEW Cosmetic Regulation EC 1223/2009 on Cosmetic products implies, a correct label is the gateway to placing your product on the European market. The Label is one of the core elements within a cosmetic Product Information File (PIF).

As presented in our article on Official EU Languages & Labeling Requirements, labels shall be eligible, visible and contain certain obligatory mentions;

However, how to apply adequate labeling when facing impossibilities due to practical reasons?

For instance; how will all the necessary labeling information be presented in case of mascaras or eye pencils, where the packaging space, is simply too small? 

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What is a Product Information File?

in Frequently Asked Questions & Guides

One of the main activities of the Responsible Person is the overview of the compiled Product Information File (PIF). This includes all necessary elements according to the EU Cosmetic Regulation 1223/2009. The PIF contains a number of files including a description of the product, method of manufacture, Good Manufacturing Practice (GMP), labels and a cosmetic product Safety Report. This report includes important Safety Information of the physic-chemical and microbiological specifications of raw materials and finished products, as well as the Safety Assessment of the finished product. Additional information in the PIF includes proof of effect claimed, data on animal testing, labeling, data on undesirable effects, and more.

The PIF is kept by the Responsible Person at the address on the label for 10 years after the last batch is manufactured. The document should be held in a safe storage location, readily accessible in electronic or other format. The RP also ensures the language of the PIF is easily understood by Competent Authorities and updates the document when necessary.a

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Evidence of Good Manufacturing Practice

in Frequently Asked Questions & Guides, News

Evidence on Good Manufacturing Practice (GMP) is one of the essential requirements of the EU Cosmetic Regulation in Europe (EC 1223/2009) in light of product placement onto the European market. The GMP is only in reference to the entity which actually produces the product (the Producer). However, any entity placing cosmetic products onto the EU market under its name is required to have evidence of GMP (in reference to its Producers) as part of their Product Information File (PIF).

The producer may show evidence of GMP by obtaining a third-party certificate in reference to an on-site audit or they may issue a signed declaration which states they meet the criteria for Good Manufacturing Practices. One specific way to ensure the producer provides sufficient evidence is through the ISO 22716 standard which was adopted as a CEN standard (a European Standard). European regulation directs that the CEN/ISO Norm 22716 serves as presumption of conformity towards GMP.

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Cosmetic products vs. Medicinal products – Classification guidelines

in Frequently Asked Questions & Guides, News

Summary of the Guidance Document:

The “Guidance Document of the Demarcation between the Cosmetic Products Directive 76/768/EEC and the Medicinal Products Directive 2001/83 as agreed between the Commission Services and the Competent Authorities of the EU Member States” document attempts to provide guidance for the classification of products that may simultaneously fulfill the definition of a cosmetic product (as per the 76/768 Directive) as well as the definition of a medicinal product (as per the 2001/83 Directive).

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EU Market, Timeline & Harmonization

in Frequently Asked Questions & Guides, News


EU Market Timeline:

1. The European Community (1957)
2. Schengen Visa area (1985)
3. Unified European Market (1992)
4. “New Approach” (1985,1989,1993 & 2010)
5. The Euro born (2002)

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