MoCRA – Problem and Opportunity

If you haven’t heard about it yet, MoCRA or the Modernization of Cosmetics Regulation Act of 2022 is going to be big and it is going to be with us soon.

The essence of it is that the US is adopting a set of rules that match quite closely those of the EU. US companies will now need to work to good cosmetic manufacturing practice (GMP), register their products, track adverse events and notify serious ones. And they need to list a responsible person on the pack. (Like in the EU the responsible person usually means a legal entity like a company rather than a human being.)

These requirements will also apply to suppliers of goods to the US. This should not be too much of a problem given that none of this is really anything that companies in Europe aren’t already doing, but it will probably involve doing more of it. So

But the US hasn’t simply copied and pasted – there are some differences. Manufacturing facilities will now need to be registered. People who don’t know the business are often surprised that this isn’t already the case. Well it now is for stuff sold on the American market. There is also no requiremennt for safety assessments carried out by a qualified person. This role is to be carried out by the manufacturer by someone with appropriate qualifications and experience. This is obviously a much better way of ensuring the safety of cosmetic products. In fact, the MoCRA approach here is what I think was the original intention of the European cosmetic regulations. I was around when they first came in and it wasn’t at all obvious at that stage that a formal signed off report was what was needed. The safety assessments we are used to today were originally created by the big regulatory consulting companies and have taken on something of a life of their own.

So overall I think MoCRA brings EU and US regulations more closely into alignment, and where there are differences those differences are an improvement on European practices. I don’t think European brands and manufacturers are going to find meeting the new requirements particularly difficult, but there is some work that will need to be done. My biggest criticism is that they are bringing in the rules at breakneck speed – less than a year isn’t much time for implementing something that has such wide implications. There are some obvious questions about practicalities the FDA is yet to answer .

I think the obvious next step is for the EU to bring their regulations more closely in line with MoCRA. The two approaches are clearly very similar already and further harmonisation is to everyone’s benefit. The EU regulations haven’t been updated for around 15 years now, so change is due. I’m very optimistic in the medium term.

In the short term, this is a change that will require a lot of action on the part of many of us in the business. I’m going to be covering developments via my newsletter, so please sign up to it. I’m also going to launch a more detailed paid for newsletter with more in depth coverage of regulations in general, so please consider if that is something you need.

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