3. How to comply with cosmetics regulations

Hello and welcome to the Formula Botanica Green Beauty Conversations podcast. We are the online award winning organic and natural cosmetic science school. And you can find more information on us over@formulabotanica.com My name is Gemma and I'm the business and relationship manager at Formula Botanica. And this week I'm interviewing our director, Lorraine on global cosmetics regulations, specifically the EU cosmetics regulations. And we talk about what they are, how to be compliant, how to take the fear out of cosmetics regulations. I hope that you find this episode interesting and informative.

Hello and welcome, Lorraine.

Hi, Gemma. Thanks for having me on the podcast again.

Great. Our episode today is about global cosmetics regulations. And I thought the first question we could start with is, when we talk about global cosmetics regulations and cosmetic compliance, what are we referring to?

Good question. There isn't one set of laws that governs the whole world when it comes to cosmetics. So when we're talking about global cosmetics regulations, we're talking about the individual laws. In the EU, for instance, the U.S. australia, Canada, New Zealand, Japan, India, China, all the countries that have their own individual cosmetics regulations. I suppose that would be what summarizes the the global cosmetics regulations.

Okay. Recently we hosted a chat in our online classroom, which is where all our students and graduates gather, and we asked people to share their biggest fears about starting a business. And so many people stated, I'm so worried that my products won't be compliant with cosmetics regulations and I'll be sued for doing something illegal. And, you know, there seemed to be so much fear around the cosmetics regulations and a lot of anxiety as well. And I'm just wondering why you think there is maybe so much confusion and fear around this area.

I think when you're starting your own skincare or hair care business, it can be a bit overwhelming because there's so much going on. I mean, you're wearing every hat in the business. You're formulating, you're marketing, you're branding, you're dealing with building a team and everything that comes with that. So it's very easy to look at the regulations and, and to maybe go and have a look at them online and to feel overwhelmed because maybe they're in a language that you're not quite familiar with. Maybe there's a lot of legal wording in there. Maybe it just all sounds really, really complicated. And I think a lot of people feel overwhelmed and a bit scared by that, but they shouldn't. Because ultimately these, these regulations can easily be broken down into small actionable steps. And I think that's what we Want to really down today in this podcast as well.

Yeah, it's exactly why we wanted to cover this topic in a podcast, because I think if we can demystify some of the scary aspects of the regulations, then people will feel less panic about them. So let's dive straight in then. So this, in this podcast, we're going to be focusing mainly on the EU cosmetics regulations and we'll explain a little bit about why that is. So let's start there. The EU cosmetics regulations, what are they and what do they cover?

Well, back in 2013, the EU brought into effect a new set of regulations which superseded the directive that was in place beforehand. And there was a bit of panic at the time. I remember it well, because of course it was something new, it was more comprehensive than what we'd had in place before and it was a lot stricter. So we now have here in the EU, which applies to all 28 EU member states, a set of regulations that Govern Basically all 28 countries and how they manage cosmetics. Now, saying that some of the individual countries in the eu, just to make life that little bit more complicated, they've gone over and above what we have in place in the EU regulations, and they have their own laws on top of that, which sort of match or go over and above what the EU has set. But in general, there's this set of laws that all 28 EU member states must comply with. And anyone who makes cosmetics or sells cosmetics in the eu, so even if you don't live here, that person still has to comply with these regulations.

And we focus on these cosmetics regulations in our courses. And I just wanted to explain a little bit why we generally refer to the EU cosmetics regulations. It's because they're considered the gold standard, aren't they?

Yes, absolutely they are. And we try and get all of our students to comply with them. Because imagine you're living in the U.S. and I have to say, the regulations in the U.S. are pretty weak. They're mainly self regulating and say that you then want to come and sell your products in the eu. You then have to make sure that your products comply with the EU regulations, even if you don't live here. And a lot of our students, you know, they have plans for global domination, and rightly so. They want to build these massive global brands to sell their beautiful organic formulations. So it's better to go into the process with your eyes wide open and be prepared to comply with the highest standard there is, because that way you will be ready for anything that gets thrown at you from a legal perspective. So that's the way we approach it.

Anyway, there's quite a few people in our discussion that were confused about why cosmetics regulations are even necessary. And there seems to be a bit of frustration. Oh, well, you know, I've got all these things to do and I've got these regulations that I have to comply with. Why do you think they're necessary and how important do you think they are?

I think they're extremely important. I understand that they can be viewed as a burden or a bureaucratic nightmare at times, but they're there to protect your customer. And more than that, they're there to protect you and they're there to protect your business. And the same goes for many regulations around the world. They're there to make life easier for you and for your customer. And it's very easy to think, oh my word, do I really have to do all of this? Do I have to have all this testing done? Why is this necessary when I know that my product is safe? But imagine that down the road there's someone who's making unpreserved water based baby shampoos. It shouldn't be possible for that person to sell those on the market. And that's where the regulations here in the EU at least come in. And that's why I get very frustrated by the US regulations, because those same checks and balances don't exist there. So it is possible for people to sell sometimes dangerous cosmetics there. So I think that the regulations, although they can be quite daunting, I do understand that. And they can feel overwhelming. They there to protect you and they're there to protect your business and they're there to protect your customer.

Great. So can you expand a little bit on actually what the cosmetic regulations are? So you're a formulator, you formulated your amazing cream, and then what are your sort of next steps to go through the process to get your product compliant?

Well, the first steps you have to go through is to make sure that you have tested your product properly. And there's a lot of testing you can do in house. We have a certificate in cosmetic stability testing and we run through 20 different types of stability tests in that course. And we tell you when you can do it yourself and when you have to outsource it, because there will be times when you have to outsource it to an accredited lab who can do something specific for you. So first of all, you make sure that your product is stable. You make sure it's ready to sell. The next step is if you Know that your product contains water, you go and have it microbially challenged, and that means you send your product in its final packaging to the lab and they introduce certain microorganisms to it and they incubate them so they speed up the normal growth that you would see. It's sort of like an accelerated shelf life. And then they tell you whether your product is going to withstand the shelf life that you'd like it to have. They also set you a shelf life and they tell you whether your product will be safe in its final packaging. So once you've got those two tests in place here in the eu, you then go to a registered safety assessor. Now, we often have people come to us and say, will your courses teach me how to assess my products myself? No, they won't, because actually, the regulations even specify that safety assessors have to have certain qualifications in, for instance, medicine or pharmacy or toxicology. So it's not just something you can do yourself. So you go to a registered safety assessor and they will ask you, where is your stability test? Where is your challenge test if your product contains or comes into contact with water? And then they'll want to complete what they call a cosmetic product safety report, a cpsr. So if you go to your safety assessor, this is what they will charge you for. And they'll use the data that you give them from the tests and they'll look at all the other information you have put together on the product, including, for instance, any cosmetic claims, the ingredients that go into it, whether you've got the right percentages of ingredients, for instance, and then they'll create this cosmetic product safety report. You then have to take that data and create a product information file, which is basically just a folder full of information that you've received from your safety assessor, imagery of the labels that you're going to create, information about you, the responsible person that you're going to have registered with that product in the eu. You then create a whole big PDF, you put it all together and you upload it to the EU central notification portal. So they have the cosmetic products notification portal, the cpnp, they love the acronyms here. You know, there will always be a big element of bureaucracy in there. So once you've uploaded that, you are then registered, they know the fact that you're selling this product, that it's had this almost stamp of approval from a registered safety assessor and. And you're ready to go, basically. And I've made that sound probably quite complicated and maybe a little bit Too fast. But there are lots of different steps involved. But as long as you break it down step by step and go through it in that way, then you'll be absolutely fine.

Yeah, I mean, it doesn't sound as bad as I think some people think it might be. Do you think that people get slightly vexed about the costs involved? I mean, let's talk a little bit about the costs of getting. Getting your products compliant.

Yeah. It can feel overwhelming again. And obviously prices will vary between countries, they will vary between assessors, they will vary between labs. I can have a microbial challenge test in the UK here, done for £250 plus VAT, which is about $350, but there are labs that might charge three or four times that all around the world, maybe even more. So you have to shop around to find a reputable lab that meets the right standards, but that can also give you value for money. And the same goes for safety assessors. Some of them will charge more than others, some of them will give you economies of scale. So if you go to them and say, look, I've got four different facial oils or four different facial emulsions, can you give me a discount? Because actually, they don't vary much, then invariably they will be able to do that. But it depends on who you work with. And the same goes for any consultant, really. You have to shop around and do your homework, but it doesn't have to break the bank. And I think that's the thing you have to remember, you will have to budget for this. Absolutely. You're not going to do this for free. And there will probably be at least a 500 to 1,000 pound cost per product involved, depending on where you are in the world and depending on how cost efficient you're doing this. But it doesn't have to break the bank.

And we think that this is such a worthwhile investment, because it doesn't matter if you're based in the eu, if you were based in another country, it's probably worthwhile doing this because of the fact that if you wanted to scale and work with larger retailers, you need to have these regulations in place. I mean, what do you think about that?

Yes, absolutely. And this is also what we've heard from the big retailers that we've worked with over the last few years, and we've worked with some of the biggest retailers here in the uk and they all say the same, you know, they want to see that you have the paperwork in place to demonstrate that your products are compliant. Because imagine that you're Selling your serum to one of the largest department stores in your country and they're selling it on your behalf, and all of a sudden the whole batch goes off. And it turns out that you never had it challenge tested, they never asked you for it. They open themselves up for potential lawsuits as well. And obviously no big retailer wants that. So if you're going to be working with retailers generally, they will expect you to have all the paperwork in place to know the regulations and to be confident in how you're handling them.

When I asked you previously about the process that someone would go through to become compliant, you mentioned this thing about a responsible person. Can you just expand on that a little bit?

Yes. A responsible person is the person who's registered with your product that you place on the market. So you have someone who's designated for your product, and that person has to ensure compliance of the product with your regulations, particularly in terms of human health, safety and consumer information. And that person has to be responsible for the product information file that goes to the authorities. So here's the big catch. And this is something that's a problem for businesses that are located outside of the eu. That responsible person has to be located in one of the 28 EU member states. So if you're a brand in Canada or in Australia or in India or in Brazil, and you want to come to the UK or to Italy or to France or wherever in the EU you want to sell, and you want to have your products regulated according to the EU Cosmetics regulations, you need a responsible person. So practically speaking, you're probably not going to jump on a plane and move to the UK or France or Italy or wherever in the EU we're going. So you're going to have to find someone who can be registered as your responsible person. Now, there are companies that do that. It can be the manufacturer of your cosmetic item, it can be your agent, it can be someone who ordered the product, so maybe a retail store. It can be whoever supplies your product in the country where you're selling. But they have to have the experience, the qualifications, and they have to be able to be responsible for your product. Now, not a lot of people will step forward and do that for free, as you can probably imagine. So there will generally be a cost associated with that because you're effectively putting your name to that particular product and saying, I will make sure that it's safe for sale. And in the country I'm in, some consultancies will say, I'll be the responsible person for you, but I'm going to charge you either a flat rate or I'm going to ask you to pay a percentage of all the sales on the product that I'm responsible for. And I get that, but it can be a little overwhelming when you're. You're an indie brand and you're thinking, I'm going to crack this new market and all of a sudden here's another cost that you're presented with. So I do get that. That can feel quite frustrating.

Yeah, I can imagine. Just looking at what we teach at Formula Botanica. So we cover global cosmetics regulations in our diploma in organic skincare formulation. And we cover. I think I'm right in Lorraine, in saying there's 48 countries.

Yes. And that includes obviously the 28 EU member states. So what we've done is we've looked at the majority of regulations that we could easily get our hands on and we've looked at how they differ. And in the course materials we give you, we actually tell you where the main differences are. So for instance, if we look at labelling, that's always a good one. In the EU and in most countries around the world, you have to label the weight of your product in metric measurements.

Okay.

I'm a big fan of metric measurements. In fact, imperial measurements drive me insane. But dual labeling is allowed, for instance, in the euro. In Canada, it's okay to have both ounces and milligrams on your product, for instance. But in some countries, in fact, only in one country in the us, imperial measurements have to come first on the label rather than metric measurements, whereas here it's the other way around. So we show you in our courses where the differences lie. And that's a very small example, but a very important example. If you're having your labels printed for global sales, for instance, these are little things that you have to think about.

Exactly. So would you say that there is harmony between regulations? Because obviously 48 countries mean 26 of those. 28. So we've still got like a balance of 20 odd other countries. I mean, is there quite a lot then? Is there any harmony between those? Or. I mean, are there some, you know, groups that say, well, we'll just, we'll just take the EU regulations and use them as our standard.

Yes. And that is happening more and more. So Southeast Asian countries, the ASEAN countries, they are generally mirroring EU COSM regulations, or New Zealand has started to bring their regulations in line with the eu. Certain South American countries are doing the same. So it is good to see that there is a very gradual move towards Harmonization. But I would say that in general, no, there isn't that much. And it's particularly frustrating to look at some of the very weak regulations around the world in the US and see how they do allow people to effectively sell unpreserved cosmetics on the market, because those checks and balances don't exist. Obviously the regulations say that your product has to be safe for sale, but if no one's checking it, then how do you make sure that that is happening? So I would like to see a lot more harmonisation in the future and there is a push for that, but it will be very gradual and I'm sure there won't be much harmonisation, at least for the next decade.

Do you want to talk a little bit about what makes you so angry about the US regulations? And I know that we've talked about this before and maybe you feel like it lets down the indie brands a bit by not having strong enough regulations. Can you expand on that a little bit?

I think the main issue is that the FDA is very understaffed and probably very underfunded, so they can only put their resources into the area that they can. And I get that. I think that's the same for many government branches around the world at the moment. But they seem to put a lot of their efforts into cosmetic flames. And I would actually like to see them, rather than looking at, rather than cracking down on indie brands, saying, you can't call your lavender extract anti inflammatory because that suggests it's a drug. I would rather that they do spot checks on cosmetics to make sure that they're properly preserved and that they're actually safe for use. And they do sometimes do that, but it is so ad hoc that it can't really be seen as them really enforcing their regulations. So I would like to see far more emphasis on the safety and preservation of products rather than on what goes on the label. Whilst I understand that claims are something that do need to be looked at, I think that preservation and safety is a bigger issue. And I mean, I mentioned water based, unpreserved baby shampoos before and I have seen this. You know, I've spoken to brands in the US who happily sell these unpreserved, particularly infant products that contain water. And it really makes me angry, particularly as a mother, the idea that someone might go out there and buy this really dangerous product that might be teeming with microbes could really harm their families. That really upsets me. And I would like to see a lot more checks and balances in place to try and prevent that.

Okay. And I know when we were having our little pre podcast chat, we talked about some of our other courses that cover aspects of the regulations and things that go over and above that. Can you chat about that a bit more? I think it was some of our certificate programs.

Yeah, we have two certificates. I mentioned our certificate in cosmetic stability testing earlier already, and I think that's a good course for anyone to take who wants to start formulating and manufacturing seriously, because you need to know how to make sure that your product is safe and stable. And these are not things that you can skimp on. You can. You can't outsource it. It has to become something that becomes embedded in your formulation culture, in your brand. So we teach that and we teach you what you can do in house and how to set up a stability testing regime for your business and how to really bring it into the heart of your business. That's something that's very, very important. And I would like to see a lot more formulators thinking about stability testing. The second course we have is our certificate in Natural Cosmetic preservation, which is a very popular course that we run where we teach you how to choose the right preservative for your needs. And I see a lot of people come into our groups, particularly our free groups, and say, hey, what's your favorite preservative? Or, hey, I'm making this cream. Which preservative should I use? But it isn't as simple as that because you have to go through a whole variety of checklists to make sure that you know what ph your formulation has or what sort of packaging you're using and what's suitable with the ingredients you use and whether your preservatives are actually legal in the country that you're working in, or whether there are maximum permitted concentrations. So these are all things that we teach you and we help you choose the right naturally derived and natural preservatives for the job.

Great. One other thing I wanted to ask you is you mentioned that you had a checklist that we could go through that might be helpful for people.

We do. The first thing I want you to do, if you're starting out and you want to sell skincare or hair care or makeup or any other type of cosmetic, any is, you need to have a batch recording system set up. So make sure that you know what a batch recording system is. If you don't know, come and take our diploma in organic skincare formulation and we'll teach you. But you basically need to make sure that every single batch formulation you make has its own code and that you can follow that code through in your artisan lab. The second point is you need to make sure that you've correctly listed every single ingredient on the label, using the right terminology. Again, ingredient labelling isn't rocket science, but there are just certain things you have to keep in mind. For instance, the ingredient with the highest percentage in the formula comes first. The ingredients with the lowest percentage come last on the label. That's a very simplistic way of putting it. There are a few more other things you have to consider, but these are things you have to know when you're putting together your label and you have to use the right language as well. So we use Inkey International Nomenclature of Cosmetic Ingredients. The third thing is, have you complied with labelling requirements in the countries where you'll be selling your products? I used my example earlier of imperial versus metric weight measurements. That is just one small example of what you need to consider when you're creating your cosmetic labels. The fourth one is, have you complied with the legislation on cosmetic claims? So here in the eu, they're not that keen on free from claims. In the us, for instance, they're not that keen on you actually telling them what's in the product because they don't want any drug claims coming through. So you have to make sure that you comply with the cosmetics claims regulations in the countries where you're going to sell.

And just to interrupt you really quickly, we're going to be doing a podcast on cosmetic claims.

We are, we are, absolutely. The fifth one is, have you implemented good manufacturing practice gmp in your artisan lab? Now, GMP is not mandatory in many countries, such as the us, but it is mandatory here in the eu. In fact, they even have an ISO standard which we've tried to summarize into some very helpful checklists for you in our Advanced Diploma in Organic Cosmetic Science and our Foundation Diploma as well, because you need to make sure that you comply with that ISO standard. It's part of the regulations and you will be expected to sign off to say, I am in compliance. Everyone, as an absolute minimum baseline, should be in compliance with this standard. And we can't provide you with the standard, unfortunately, you have to buy it from the International Organization for Standardisation in Switzerland. The sixth point is, have you tested your products adequately? So, have you done stability testing? Have you done microbial challenge testing if your product contains water or comes into contact with water? The seventh one is, have you undertaken final safety checks on your product? So, have you gone to a registered safety assessor, and make sure that they have actually signed off on your product and given you that cpsr, that cosmetic product safety report. And then the eighth step, the final step, is do you have all the right paperwork in place? Have you created a product information file which contains everything that you've done and turned that into one big file that you keep in your artisan lab? And again, we give out templates for product information files and in our Diploma in Organic Skincare formulation. So if you follow those eight steps, then you will generally be well on your way to complying with the EU cosmetics regulations and probably also most regulations in your country. The one final thing I would say is one of the most empowering things that you can do as a formulator, as a business owner, is to download the regulations in your country, print them out, grab hold of a highlighter, get yourself a nice big, bright yellow highlighter and sit down and read it. And I did that when I first started out in the industry and I spent probably a couple of hours just sat at the table reading through these regulations, highlighting the bits that I found most relevant and the bits that surprised me the most, making notes. And it was one of the most empowering things I've ever done. And now when someone says, what do the regulations say? I just open them up and I know where to go because. Because I dedicated my time to reading them and that's the one thing I don't see people do. So if you feel overwhelmed or scared, read the regulations. Yes, it's going to take you a few hours. Yes, it might make your head hurt at times, but don't be overwhelmed by it because they're there to support you and they're there to make your business better.

Thank you so much, Lorraine. This has been so informative. I've learned a lot myself and. And I hope that all our listeners will learn a lot as well. So thank you so much for all the information and thank you so much for joining us.

Thank you.

I hope that you really enjoyed this episode. I found it very informative myself. If you would like more information about us, you can check out our website, formulabotanica.com you can also check out all of our social media handles, Facebook, Twitter and Instagram. Formula Botanica. If you want to join in on the conversation, check us out on Facebook at. Our Skincare Entrepreneur Mastermind Group is a really large group full of wonderful cosmetic formulators, and there's always interesting discussions and debates. Thanks for your time and we hope to hear from you. Thank you.