16
May

In the latest communication from Cropwatch, there was mention of a Global Harmonization Act of 2008. This piqued my interest - I’m not exactly thrilled with the decisions about perfumery materials IFRA has been making, since they are founded on next to no data, and harmonizing the FDA standards with EU standards - standards that IFRA has far too much say in thanks to the chronically overburdened nature of such agencies - I am a bit concerned. My concern may be for no other reason than because I like my over the counter headache medicine to have an effect without having to take half the bottle. It could also be because yet more legislation will impact my life and livelihood while I have little or no say in the matter.

Certainly, the overarching goals of the Global Harmonization Task Force are noble: making sure every country is on the same page about pacemakers and prosthetics is pretty darned important to the people that have them and to the medical systems that support them. It says on their website,

“The purpose of the GHTF is to encourage convergence in regulatory practices related to ensuring the safety, effectiveness / performance and quality of medical devices, promoting technological innovation and facilitating international trade, and the primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices. These documents, which are developed by five (5) different GHTF Study Groups, can then be adopted/implemented by member national regulatory authorities. The relationships between the work of each Study Group can be represented schematically.”

Reasonable goals, to be sure.

Yet there is intimation that some of those goals will have a resounding impact on the cosmetics and fragrance industries.

Such regulation would have a huge impact on all our lives. Yet on a surface search, I could only find this reference on the FDA website to anything regarding the act. In the electronic access form, it sends me back to the Global Harmonization Task force page - where I can’t find a complete copy of the act or guidance referred to. I’m going to give a try to the writing or faxing method - I really want to see the data, in full detail.

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