Tuesday, November 8, 2011Focus

Cosmetics Regulation: the GMP

©L'Observatoire des Cosmétiques

The Good Manufacturing Practice (GMP) is a mandatory part of the Cosmetics Regulation, which is implemented since 11 July 2013, in lieu of the old Directive. Without any applicable text, the ISO 22716 standard is, in fact, the document, even if not named, to follow.

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A very clear reference to the ISO standard

In its Article 8.2, the Regulation states, "Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonized standards , the references of which have been published in the Official Journal of the European Union ."

In this case, it is a standard written by the International Organization for Standardization (ISO), an NGO based in Geneva, which brings together the standardization bodies of 162 countries. This standard, published in 2007, is titled: "ISO 22716. - Cosmetics. - Good manufacturing practices (GMP). - Guidelines on Good Manufacturing Practices".
Europe and France - where it has been published in the French Official Journal (JORF n°0035, 10 February 2008, page 2534 - text n°42: NF EN ISO 22716), have taken it up.
In short, this standard, though not officially called that way, is de facto THE law.

Note: in the Regulation, standards is in the plural form, as the European legislator will accept standards other than the ISO 22716, GMP from other countries or economic areas (Canada, Asean, Mercosur … for instance).

No requirements, recommendations only

The ISO standard 22716 is a  23-page document, sold for 106 Swiss …

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