Beauty Brand Creation, Reinvented: A Game Changer for Entrepreneurs - Lidiya Stoycheva- Biopharma

This talk explains the steps involved in launching a cosmetic brand in the European Union market. The speaker, an experienced safety assessor with a background in pharmacy, discusses the importance of understanding legal and regulatory requirements, as these can be significant barriers for new brands. They emphasize that product development must align with marketing claims and that formulations can vary based on packaging choices and claims. The talk also covers essential aspects such as Good Manufacturing Practice (GMP), the importance of proper documentation like the Product Information File (PIF), and the implications of the new EU packaging waste regulations. In addition, the speaker highlights the need for clear communication with production partners regarding pricing and intellectual property rights. Finally, resources like an academy featuring curated videos are mentioned to assist aspiring brand owners.

Hi guys, are you tired already? I'm always the last speaker. I don't know how it happens, but yes, I'm uh I will try to keep you awake. Uh because we are going to talk about uh some very interesting but a little bit uh heavy stuff. So today I'm going to explain to you how to launch a cosmetic brand on the European Union market and I hope I

will be fine with the techniques. Nope. Okay. Who we are? We are 30 years old company. Uh-huh. We are a second generation and what we do is uh we are making the the the the full process from launching a cosmetic brand from formulation to production packaging uh developing the safety assessment in the PIF making uh CPMP registration uh packing logistic everything that you can imagine connected with

uh the cosmetic business. Who am I? It's very long. I I I was already introduced but very shortly I'm a uh I have a graduated pharmacy in uh Sophia Medical University. I have a post-graduated uh in a safety assessment department. So I'm a safety assessor actually safety assessor and I'm also dealing with documentation connected with um European Union uh placing products on the market. Okay. So these

are the basic steps of what you should do to to place a cosmetic product on the market. And I have a question for you. Do you know in what of how many of those steps you need someone like us to help you? You can guess a lot, right? So those are actually the steps that that you need us. of course uh product development because yeah we are

the experts in that design branding and packaging this doesn't sounds as fun it is and I'm going to explain you why uh sort out the legal and regoratory requirements in my opinion I well I meet a lot of people who want to start a cosmetic brand but they don't know about the regulations current regulations in the European Union and this is a big problem for them when

they're launching I think uh this is the the first thing that's uh is is a huge problem for them for of them. I'm sorry I'm tired also. So then uh production and logistics this is uh of course something that every producer does. And then collect feedback. Uh this is very important and not just because customers have to tell you how you have to improve your product but

also we are the one that can help you when there is undesirable effects or or uh serious undesirable effects. We are the people who can help you deal with that. Okay. So we are going to uh talk about all those things. Uh so when we start with product development the first question that we are going to ask you is what product do you want to do? Do

you want to order and sometimes you will be very surprised to to hear that sometimes well most of the times actually people are starting to build a cosmetic brand with products that are not actually cosmetics. Yes. And this is very interesting because uh one and the same formula can be a cosmetic product or not be a cosmetic product depending on the way that you are presenting it.

So there are some claims that you cannot put on a cosmetic product. I'm going to give you an example. Uh we are having this very very thick and heavy cream that you claim that is softening the skin and nourishing the skin. This is a cosmetic product. But then if you want to claim that it helps with attopic dermatitis, it's the same formula but not a cosmetic product

anymore. Then uh what requirements do you have? We need actual cosmetic claims. Uh because when we are formulating uh we have to know what you're going to claim in order to put the right ingredients in the product. So the marketing should be done first and then the formulation happens. It's not the other way around which is again very interesting. So for instance, if you would tell us

that you want us to make for you um what um a hydrating serum that has also an anti-aging effect, we are going to prepare the ingredients to to get the ingredients that can actually defend the claims that you're making. Otherwise, we are just doing a serum and then you are claiming some things that we cannot defend and you cannot defend. then this is a problem because uh

consumers are disappointed and also the regulatory part is not okay. So uh after that we are going to ask you what are the other requirements that you have uh for the formula that we're building is it going to be natural organ and organic or organic or conventional. So if you tell us we want the product to be natural and organic, we are going to ask you according

to whom you want it to be natural and organic because in Europe there is no one standard. There are several standards and if you going to claim that we we need to know what the standard you're going to certify or you're going to use in order for us to build the formula right in order to complete the standard that you're aiming at. Then do you have a

blacklist? Because sometimes it's very funny but customers are actually telling us what ingredients to use. Please don't tell us what ingredients to use. You can tell us what ingredients not to use. So if you don't like for instance phoxyanol, you can tell us please build a formula without phoxyanol because I'm going to claim that. It's again the part of the the claiming and defense part. So what

type of packaging you're going to use? Why we need to know that from the very beginning? We don't need to know what um the the pump will be, what the color will be of the of the packaging, but we need to know are you going to put this cream in a jar or you're going to put it in the airless with a pump because the formulation is

very different for for for different packaging. And if you tell us in the very beginning, we are going to place this product in a jar and then you change your mind and it has to be in a pump. This is not just fix it. We are starting from the very beginning and this is something that slows you down and it's very expensive and it it doesn't make

sense. Then we are when we are talking about branding and packaging I told you it's not a well a fun thing from our part because when we are talking about packaging um we are interested in uh packaging compatibility. So we have to test if the product is actually compatible with your packaging. And of course uh the the cosmetic packaging is made of materials that are made to

be into contact with cosmetic product. But I'm going to give you a very uh very nice example when we are talking about how the product actually works. Imagine that you are giving us the well we have to do what um a styling spray and then you are giving us a pump that is too small and we know that when you pump it three times then the styling

spray will stick to the pump and it's not usable anymore. This is what I'm talking about for the other compatibility part. here I have to mention something that is very dear to me. This is the new packaging waste regulation in the EU that is right now applying and it will be applied first in uh 2030. So according to it, you have to until 2030, you have to

have fully recyclable packaging and then you have to have at least 30% already recycled plastic inside the the packaging. So why I'm telling you that because if you launch today a cosmetic brand, you have to think of that because otherwise in like four years or three years, you will have to change the packaging which is again a huge cost and it's super risky. And when we are

talking about packaging, you have to also think about the supply chain. I very much um very much like Chinese packaging because they can be really really high quality. However, think when we go into the production when you plan a production if you want to get something from China that means at least 3 months delivery. That means that if you are going to source something uh from very

far away, you have to think about the deliveries, the delivery times and and everything. I'm getting good at that. So EU cosmetic legislation currently we are under regulation 1223 2009 regulation 655 2013 and the new packaging waste regulation. The first one those regulations are actually very very short. If you want to go into the cosmetic business please read them. And uh the first regulation is the main

regulation that is um uh putting all the rules that has to uh every every European uh company and every cosmetic product place on the market has to um be according to this regulation. The second regulation is actually a regulation about cosmetic claims. So over there there is a special regulated uh regulation that deals with the um the things that you say to your clients. As I told

you, you can say that it is nourishing but you cannot say that it helps with autotopic dermatitis. And furthermore, I have uh been asked like a thousand times why can not uh can I not say that my product is not tested on animals because it's not tested on animals, right? But this is uh uh this is something that is banned because it is against regulation 655 um

article one because testing in on animals in Europe is banned from 2013. That means that you you cannot claim something that you are obliged not to do. Right? Uh that is why uh testing on animals written on the packaging or in in the uh marketing is it's absolutely banned. What is a responsible person? You are the responsible person. Responsible person is every entity that is either producing

either placing on the mark market and delivering the the products from a third country or uh it is a distributor under which brand it the product is produced. This mean that if you have a your own cosmetic brand and somebody produces for you, you are the responsible person. That means that you have to oblige with the regulations and we can just help you with that. But at

the end of the day uh in front of the authorities and in front of the clients, it's it's your responsibility to follow What are the mandatory tests? This is also very very commonly asked question. There are no mandatory tests. So every product has tests on itself. So for instance, if you have a product that is uh that contains water and does not contain alcohol uh above a

certain level. So it it has doesn't have a low microbiological risk then you have to make a challenge test. Challenge test is a test for microbiology and it has to prove that your um preservative system will keep your product stable microbiologically stable during the minimum durability of the product. This is just an example. Every product has different tests. If you have an emotion, you have to do

a stability but it is not mandatory for gels for instance. So if somebody tells you did have you done the mandatory tests, you can ask which ones and who is going to tell you what the mandatory tests are? The formulator and the safety assessor because there are also claims that has to be proven. There are also things um connected with um uh safety that has to be

proven with the test. So it's decided really product by And my favorite question, what is PIF and what is CPMP? PIF is the documentation that you cannot go without. So please remember that if you are placing a product on the market and here there is a very good distinction. So placing a product on the market is when you place the product in the hands of the final

consumer. It doesn't matter if you are selling it or not. You can give it for free. it's still placing on the market. In order to place on the market a product, you have to have a PIF. So, it's a a full documentation. It's actually a photo docu documental photo of your product. In this uh PIF, you will have um u a production dossier. You will have the

MSDS and and all the uh documents of the ingredients. Then you you have to have a safety assessment which is done from somebody like me for instance that has a degree from pharmacy uh toxicology dermat uh dermatology and other such professions. So uh make sure that you have these documents and when you have them then you have to notify the European Union so the the authorities that

you're placing this product on the market. This is done by by making a registration in uh CPMP. This is a cosmetic product notification portal. Please remember that you first do do the PIF then you made the notification and then you can place it. Without notification it is legal to illegal to place the product on the and then when you're choosing a producer be careful for them they

have to have a GMP. What is GMP? This is good manufacturing practice. But there is something important here also. It is not mandatory for the producer to have an ISO or third party certification. In the regulation, it says that the producer has to follow the rules of the good manufacturing practice. So when you're choosing a producer, remember that it's not mandatory for them to have a certificate.

And also remember that it's a it's a very bad example, but I'm going to share it. there are producers that actually have the the certificate but don't follow the rules of the good manufacturing practice. So make sure that they actually follow the rules. Then you have to ask them of course what is the MOQ? What is the minimum order quantity? Every producer has a minimum order quantity.

But this is also very important to ask them can you produce more? Because imagine that you're going to launch this brand. Everybody will love the brand and then you have to produce more and more and more and then if the producer sorry if the producer if they don't have the equipment to do larger batches that means that you either have to produce very often very small batches

which is not good for you because it's still very expensive and very slow or you have to change a producer and trust me changing a producer is super hard takes super many times and also it's It's very expensive because every producer works with certain ingredients. If you change a producer and the new producer doesn't have these ingredients, you have to buy them and they are not small

quantities. What about logistics? Every producer, well, the producer that you're choosing, they have to have a logistic base. At least they have to have a warehouse. I'm telling you that because there are actually producers that does not have a warehouse. So why you need that is uh because you have to uh when you're producing your own product with them first of all you have to deliver the

packaging right and the packaging have to deliver be delivered in advance then maybe they have to keep your goods for certain time certain period before uh you arrange the shipping and everything and if they don't have a logistics that is um absolutely impossible and then be careful where the producer is situated especially in Bulgaria because you know the quality of our infrastructure and imagine that you're going

to send um a 30ft truck to a small village somewhere in the mountains to load your goods. You can do it once but after that you have to change the logistic companies many times because they will they will crash the trucks and very important also they can they prepare my goods for shipments and with specific requirements so many of you know Amazon many of you know the

the big chains like Crossman like DM all those guys everybody has a specific requirements of shipment so the folio has to be this by there. There should be a sticker on the pallet which says that that and that. The the boxes has to be arranged in certain way and a certain order. Make sure that your producer can do that before because otherwise you're going to ship your

goods to a third party warehouse where they can prepare it and this is a waste of money actually when we are talking about the pricing also something very interesting the pricing of the product is actually up to you how well when when you are in the development phase, in the very beginning, you should be the one that you're telling your producer how much you're willing to pay

for this product. This is a very interesting concept because normally people are asking how much will it cost. No, you're going to tell us how much will it cost because you you know your customers, you know how to how you're going to sell this product. So you know how much it will cost then deduct everything and tell us how much the the product should cost from us.

Uh stop thinking like uh final users. You're not final users anymore. You're producers. You're brand owners. So you should be ready to to set the boundaries and pricing is uh something um connected with that. Cheap is always more expensive. I think you know that because well cheap is always more expensive because first in the first case you're choosing somebody who gives you lower prices but cannot provide

the service that you need. Then you have uh god forbids defect products or or recall or or something and then you at the final stage you will go to the more expensive producer because they are the best but you you will just waste some money in in the steps to there two minutes. Two minutes. Yes. Okay. Intellectual property is something very important in in the first meeting

with your producer and the the people who are going to make the formula. Ask them who is the owner of my intellectual property. If they say we are, then you say no, I'm going to buy it. Simply communicate. If you communicate enough with those people, they will do everything that you require them to do. High volumes are always cheaper. This is connected with the thing that I

told you before. Don't judge only on the moqs. Judge o um about the producer of the overall capacity that they have. Try to plan in advance. This is super hard for everybody. I know. But if you plan in advance, you can order more goods and then the price will be lower. And yes, I here I'm talking about annual plans. But I think that you know that what

um what what if there is something wrong with your product. This is why you have to be the owner of the intellectual property because otherwise you say my my products does my product doesn't have the same viscosity as the sample. How are you going to prove that if you don't have the the the actual documentation and the the actual intellectual property and every um information connected with

your product? And two more slides I promise what we can do minutes for commercial what we can do we can actually do everything for you. First of all second of all if you have already chosen a different partner you should know that we are also consulting. You can meet with us and ask us about every face or every problem that you've met. uh we will try to

help you and to answer your questions. We have a new partnership model. So if somebody is interested in that, please visit us on our stand. We will be there there for I think half an hour more. And also because I'm giving this lecture for like a thousandth time for the last uh 10 years uh we have made an academy. There are uh 18 highly curated videos made

for people like you who wants to launch their own cosmetic brand. In these videos, we are explaining everything from the very beginning to the very end. Even we are giving information about uh exhibitions and and trading and everything. So if you're interested in that, you can join us. Sadly, it's only available in Bulgarian for now, but we are working about that.