Chris McLeod looks into the intricacies of the Product Information File within the EU Cosmetics Regulation 1223/2009/EC, in order to answer the question: how safe does a product have to be to make it fit for the marketplace?
In all areas of business in the 21st Century, we are seeing that the need for ‘health and safety’ is becoming more and more prolific, intensive and stringent in its implementation and policing. However, the increased awareness appears to have created an atmosphere of resentment and apathy towards these procedures, and “the world’s gone health and safety mad” has become a stock phrase in common conversation. In the midst of this group mentality, however, it is important that we do not lose sight of why such procedures are implemented in the first place. There is still much to be gained from health and safety regulations, particularly in the cosmetics and toiletries industries.
Legislative regulation has always had greater prominence in the pharmaceutical industry, compared to the cosmetics industry, as the health risk involved is much greater in instances of casual misuse in pharmacy than it is in cosmetics. Moreover, the hoops to jump through to get a product from conception to market are scrutinised tenfold in the pharmaceutical market: a process, if successful at all, can take ten to 15 years to complete. With the heightened need for due diligence in all industries, however, cosmetics is seeing an increasing number of countries, continents and organising bodies implementing a regulation procedure. For example, the EU Cosmetics Regulation 1223/2009/EC specifies a need to prove and provide many areas of safeguarding for both the supply chain and the consumer within the Product Information File (PIF). The buzzword throughout this regulation is ‘safety’ but, as with other areas of testing, a potentially confusing situation may arise from the definition and types of safety. We search for black and white answers – something is either safe or it isn’t – within something that is, in reality, a scale of safety management. For someone with a particular involvement in testing procedures and regulation, then, the most important and frequently used question seems to be “how safe does my product have to be?”
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