18 INTERVIEW
when it comes to efficacy claims, with specific testing that needs to be done in China. All this additional testing adds a lot of cost. Manufacturing is another
important issue. Whereas before they were more focused on ingredients, the formulation, the testing in China, they are focusing much more on manufacturing. The CFDA can come outside
of China to a visit a factory for inspections, and the way they expect management of microbiology can be very different from the way it is done in Europe. For example, I know of an inspection by the CFDA in France. It was a very long inspection, not for one batch but an inspection for one product. So, if you’re a brand owner that has five sub- contractors to manufacture one product, they are going to inspect the five sub-contractors. The manufacturing issues are something companies are only just starting to grasp. It’s not just a documentation and registration exercise, they will be coming and visiting factories. They may even visit raw materials sub-contractors, and it will be all in Chinese and you will have to bring your translator as well. So, in terms of the inspections, it requires a lot of organisation.
TP: What is driving this change? OS: They are taking a different approach to regulation. They’ve been inspecting a lot of local manufacturers. Local manufacturers tend to be very organised with a checklist approach. This is what the CFDA wants and they are expecting a similar way of thinking when they
PERSONAL CARE February 2024
go outside of China. So, if you don’t follow one of
the points that have stated, they may reject it unless you can prove there’s a better way to do it. That discussion can be a bit tricky sometimes. The change was expected
because China is one of the biggest cosmetics markets, and we expecting that they would change legislation to make sure products are safe. Another important point to note is that the way regulation
works in China is very different from Europe. In Europe, the responsible person is a company, if something goes wrong, they’re prosecuted. In China, the authorities are
responsible. There was a big issue in China a few years ago when they got rid of the head of the Ministry of Health. So, they have changed regulation to be more of a checklist approach that looks at the full supply chain. Another impact will be to
change the way companies act
“If I was an ingredient supplier in order to be more commercially attractive I would perform more efficacy testing of my ingredients in a base
formula” Olivia Santoni, chief executive and founder of London-based consultancy Bloom Regulatory
with their suppliers. All these initiatives will increase the amount of communication to be done.
TP: So far, we have discussed regulation in relation to safety but where does efficacy come into it? Will there have to be more evidence about claims? OS: Efficacy is the next discussion on the table about what companies are expected to supply in terms of data. I would say it’s not a change in the regulation, because regulation was already there for a long time. But I will say there are more companies that are being caught from an enforcement point of view when they don’t hold the data. The hot topic at the moment
is not so much on efficacy, it’s around green claims. In France, for instance, you cannot use the word biodegradable on products. Even if the raw material supplier has really good data on that, you may not be able to use it. They are very picky on that. In terms of data from raw
ingredient suppliers about efficacy, I would say sometimes the protocol could be improved in terms of the testing data given to customers. Customers often cannot extrapolate the data because it has been tested for efficacy at a certain level or for a certain use. If I was an ingredient supplier
in order to be more commercially attractive I would perform more efficacy testing of my ingredients in a base formula. The data could then be extrapolated directly by the customers. Of course, some already do this.
PC
www.personalcaremagazine.com
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