What happens if the contract manufacturer does not have FDA approved facility?
2 күн бұрын
You need a better marketing team ! For a better video, lower bg music, less stock video :/ very distracting
@annayah_khan_mua_3 ай бұрын
Hi. Thanks for great information. Please would you kindly tell me where i can get this template for PIF? & CPNS? I'm a new small cosmetics business & im really stuck in this area. Thanks for your reply in advance.
@CewayEu3 ай бұрын
Hi, there is no template for PIF
@annayah_khan_mua_3 ай бұрын
Does this need to be created by myself or my supplie?
@CewayEu3 ай бұрын
@@annayah_khan_mua_ either, or a third party consultant, most documents need to be provided by the product producer though
@annayah_khan_mua_3 ай бұрын
@@CewayEu Thank you so much.
@ocacionskjll6734 ай бұрын
Hello, how are you, I have a question. I need a license if I make hair cosmetics at home to market.
@CewayEu4 ай бұрын
Yes, of course
@rsh17_WR6 ай бұрын
do you have consulting services about cosmetic regulations in Europe and the United States? i just created a bath soap brand in Indonesia, and i am interested in selling my bath soap to Europe/United States.
@CewayEu6 ай бұрын
Yes, we cover Europe (EU and UK) as well as USA and Canada. You can contact us for more info to [email protected]
@rsh17_WR5 ай бұрын
What if I want to get a certificate of cosmetic regulation in Europe and America even though I don't sell it there for now. the main reason is because of the budget and I want my liquid soap to be completely safe in the lab test of these 2 institutions. I want to have 2 certificates so that I can sell liquid soap at a higher price in Indonesia. because in Indonesia the cosmetics supervision agency is not very strict, even some who get a distribution permit when retested the results are not up to standard and there are many, even some only need to pay money.@@CewayEu
@ashwinshetty15986 ай бұрын
Hello, could you please shed some light on whether the address of the manufacturing facility based outside the USA is supposed to be mentioned along with the distributor's address on the product label, as the final guidance document doesnt clearly specify whether either one of the addresses or both of them are supposed to be mentioned
@CewayEu6 ай бұрын
No, that is not necessary. The label has to include the name and address of the manufacturer, packer OR distributor.
@ashwinshetty15986 ай бұрын
Thank you for getting back on such short notice! Although I have another concern! Now that it's established that our manufacturing facility is located overseas and our distributor is US based (they're both part of the same company), can the manufacturing facility handle product listings, while the distributor handles adverse event recording? As they can both be Responsible Persons in this case, can only either one of the addresses be included in the product label even then?
@CewayEu6 ай бұрын
For adverse events, you need to have one of the following on the labels: - US address (this can be your distributor's address if they are the RP and will deal with adverse event reporting) - US phone number (the same as above) - electronic information (eg. website or email) But this is in addition to the name and address of the manufacturer, distributor or packer, that should appear on the labels. Foreign facilities require a US agent, who needs to handle facility registration and communication with the FDA. This can be handled by your US distributor if that is your agreement. The RP is usually the brand owner, but according to the definition it is either the manufacturer, distributor or packer. So it is up to you to define who the RP is in your organization and then that company has the RP responsibilities. You can also share the responsibilities but there has to be one official known RP, who the FDA will contact in case of any inspections.@@ashwinshetty1598
@ashwinshetty15984 ай бұрын
@@CewayEu And lastly, should we designate our US based distributor as "Responsible Person" on the label outright, or will the contact information and the mail address provided suffice for the General consumer?
@CewayEu4 ай бұрын
@@ashwinshetty1598 RP can't be outsourced in USA, it has to be the brand owner, so a distributor can't be the RP
@manish.shukla7 ай бұрын
Hi, how much do you charge for consultation in developing label?
We never buy EU cosmetics. Poor quality, because we know how they produce it 😂
@KasperCDK8 ай бұрын
I know there are some exceptions regarding registration of all products (Beside the 24h rule) if the sales are lower than $1m pr. year. Is these sales looked at as a the sales inside the US or as in our case we are based in Europe and sell to a wholeseller in the US, so the amount we sell for to this wholeseller? Hope it makes sense...
@CewayEu8 ай бұрын
MoCRA defines small business as facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation. Our interpretation is that the sales apply to products that are sold in the US. In your case, you would need to consider the sales of cosmetic products you sell in the US through your wholesaler.
@seangommier86526 ай бұрын
@@CewayEu if there are multiple locations representing a single brand, is the $1M applied to each location or in aggregate?
@CewayEu6 ай бұрын
@@seangommier8652 the legislation says per business. I would presume that this would mean in aggregate, but it's not really clear
@seangommier86526 ай бұрын
@@CewayEu glad you're in agreement on the ambiguity. It's quite frustrating that this legislation has been passed without more clear guidance.
@matinaris10 ай бұрын
I wish they cared about the 1500 toxic chemicals in our tap water. Pesticides, fluorides , VOC’s, PFAS, Arsenic, lead…. It goes on and on. These chemicals are deadly and they approve. Let’s not forget how they approved of making baby powder from talc for the last 50 years. Major cancer. In order to pass lab approval they will have to add preservatives and phalates add synthetic material to our cosmetics and lotion . Look at deadly flouride toothpaste, lotion and deodorant filled with aluminum, cancer causing sunscreen, talc eyeshadows, lead lipstick, toxic mascara. It’s ALL bad for you! I think they don’t want us to have natural anything. Let’s get rid of the little guy making unadulterated natural products so we can buy more pharmaceuticals.
@balasahebmukhekarpatil6516 Жыл бұрын
excellent👌
@EmelyBriones Жыл бұрын
Thank you, precise and straightforward.
@gabrielefejza1761 Жыл бұрын
Hi there, are these video information updated with the 2022 law? Thank you!
@HB-sk5bc Жыл бұрын
Other players in the market sell goods with English text, I got a little confused. Do you still need other language as labeling on the product that shows content measure (19.1b) Durability labeling (19.1c) Precautions for use, if indicated (19.1d) Function/purpose of the product (19.1f). Why others have english text on their product and why would i translate my product to countries language?
@HB-sk5bc Жыл бұрын
Other players in the market sell goods with English text, I got a little confused. Do you still need other language as labeling on the product that shows content measure (19.1b) Durability labeling (19.1c) Precautions for use, if indicated (19.1d) Function/purpose of the product (19.1f). Why others have english text on their product and why would i translate my product to countries language?
@HB-sk5bc Жыл бұрын
i know noone will answer but anyway who knows... I want to buy a cosmetic product from a country outside the EU/EEA and resell it on the Swedish market, but the product is already available in the EU and registered in CPNP. How can i register myself or my company as a distributor in RP located in the Netherlands. And is it ok to buy products directly from the manufacturer which is outside the EU/EEA .
@horalqa0073 ай бұрын
also wondering about the same thing.....
@Sami-id3oy Жыл бұрын
Thanks
@samialsati8054 Жыл бұрын
Thank you
@dmitrimaksimov2 жыл бұрын
Thank you very much for such useful summary of the cosmetics regulation. I just don't understand, if possible a situation when one Importer A designate the RP who register product on CPNP. After that another Importer B can simply use this CPNP registration and RP and import this product.
@3dmonkeybizz2 жыл бұрын
I don't want to take over the world, or flood it with chemicals, but once I finish these processes I should damn well be allowed to!!! 🤣😂🤣😂 Thanks so much for the excellent video and information!
@choppalamounika15392 жыл бұрын
Wonderful explanation in short and simple way,thank you
@vipankumar73262 жыл бұрын
Great Information :) is it very long process ? and very Expensive for each product ?
@lene58942 жыл бұрын
thank you for this! Is it possible for the primary packaging label to stay in English as long as the secondary packaging has the translations?
@AS-ps7uq3 жыл бұрын
Hi, thank you, this is useful. I have a question and not sure if I would get a respond but on labelling the weight, if I have 100ml bottle but due to rosebuds, the total volume of the product is actually 90ml. Do I write 90ml on the label?
@ntuschiev3 жыл бұрын
Thanks for the video! Do I need to submit notifications if I buy products from wholesaler in one EU state member and sell in another? Thank you!
@RicardoMartinez-zx5ji3 жыл бұрын
Nice information! Many Thanks!
@itsnaomipatricia3 жыл бұрын
Hi there! Does the responsible person have to be a professional person? Can I be the responsible person for my own products?
@itsnaomipatricia3 жыл бұрын
I am the distributor
@CewayEu3 жыл бұрын
Hi Naome, the responsible person can be any natural or legal person, so if you're based in the EU or UK, you can act as the responsible person yourself.
@itsnaomipatricia3 жыл бұрын
@@CewayEu Great thank you for the quick reply!
@jongriffin1983 жыл бұрын
Hi!! Liked the video, good job. Have you thought about using smzeus . c o m to get your video higher in the search??
@marieoket53923 жыл бұрын
We are looking to import makeup products from CHINA. The supplier has FDA and MSDS certificates. Do we need to follow the steps mentioned in your video before start selling these products online? Do we need to perform product testing to check if the ingredients are safe? Please help. Thank you
@CewayEu3 жыл бұрын
Yes, all products sold in the EU, also those sold online, have to follow these steps
@marieoket53923 жыл бұрын
@@CewayEu Thank you very much for your quick answer. Much appreciated!
@Ali-tp8gr3 жыл бұрын
@@CewayEu Is it necessary to perform product testing, even if the manufacturer can provide PIF?
@cosmeticgmp4 жыл бұрын
good, solid content. thanks for sharing!
@kaiserandkaisercc67264 жыл бұрын
Does it mean i also have to include the formula of the product?
@jimsouthsea3 жыл бұрын
No that's already covered in the CSPR
@svetlanagorodin91214 жыл бұрын
It's a very informative and useful video. Thanks a lot for keeping us updated.
@sangloklee30364 жыл бұрын
Great Information. Thanks :D
@sallanagesh83475 жыл бұрын
Good performance
@atlantisfae11116 жыл бұрын
does less than 5g include when it hits 5grams?
@lochuynh72826 жыл бұрын
What about the requirement for listing any of the 26 allergens over certain thresholds? The video does not mention this.
@CewayEu11 жыл бұрын
Hi Robert! All the information requested in the video is mandatory, although depending on the formulation of the product, certain tests might not be needed. PIF has to be in a language that is understandable to the competent authority of the country where your EU Responsible person is based (in most countries English is acceptable), so it doesn't have to be multilingual. Certain things on the label have to be translated though. Please contact us via email for more info.
@RobertMihoc11 жыл бұрын
Hello and thank you for uploading this usefull video. However, I have a question regarding GMP compliance. Ne need to make PIF's to all our products in order to obtain GMP certification. That being said, all the information requested in your video is mandatory, or only if available? Also, does it needs to be made multilingual if the product is sold in more than 1 EU country, or english is enough, regardless of the marketplace (EU)?
@martinduggan138611 жыл бұрын
good video. Good to know there are other people that can look after this for us