Selling imported/branded cosmetic in the EU (and US?)

[BlahBlahBlah]

Hi,
a couple of months ago I imported from China my first branded cosmetic and now I am going through the paper work to be able to sell it in the EU, I wish I never did it, the level of documentation required is absolutely ridiculous. I never planned to sell cosmetic but this was a one-off addition to my online shop that I didn't want to pass.
I was wondering whether anyone else here has imported/branded a cosmetic from outside the EU as I have a few questions. I see a lot of home-made cosmetics around and don't believe for one second that everybody actually did the required paperwork, especially in small shops where sales are very limited.

Also, I know the majority of Fastlaners here are from the US and was wondering what their experience with importing/branding/selling cosmetics there is?

Thank you for your help.

 

Dislike ads? Remove them and support the forum: Subscribe to Fastlane Insiders.

[BlahBlahBlah]

anyone?

 

[sWALK90]

What paperwork are you referring to?

 

[AllenCrawley]

I don't have an answer for you but I just wanted to caution you on importing cosmetics from China. Personally, if it goes in your body or on your body source it from the US or Europe.

 

Dislike ads? Remove them and support the forum: Subscribe to Fastlane Insiders.

[Walter Hay]

I don't have an answer for you but I just wanted to caution you on importing cosmetics from China. Personally, it it goes in your body or on your body source it from the US or Europe.

@AllenCrawley is absolutely right. Don't take the risk. I would add also don't take the risk of infringing IP rights.

Imports of big brands from sources other than ones specifically authorized by the brand owner to supply in the country to which you are importing is illegal, and can result in prosecution. It can also lead to you being sued into bankruptcy by the brand owners.

Walter

 

[AgainstAllOdds]

I don't have an answer for you but I just wanted to caution you on importing cosmetics from China. Personally, it it goes in your body or on your body source it from the US or Europe.

Another option is to spend the additional funds to have lab testing done. Not everything made in China is bad, but proper inspection is necessary.

 

[Walter Hay]

Another option is to spend the additional funds to have lab testing done. Not everything made in China is bad, but proper inspection is necessary.

Agreed, many excellent products are made in China, but every batch should be tested. A classic case some years ago involved a Japanese manufacturer of L-Tryptophan. They changed their manufacturing process and this resulted in a batch that killed (from memory) 8 people.

Small numbers considering the huge death rate for certain pharmaceutical products, but big pharma jumped on it and had L-Tryptophan from all sources banned for a number of years.

The point is, every batch is susceptible to error, so every batch should be checked. It would appear that the Japanese manufacturer didn't do that. China has a bad record for adulterated food, food supplements, pharmaceutical, and cosmetic products.

Walter

 

Dislike ads? Remove them and support the forum: Subscribe to Fastlane Insiders.

[AgainstAllOdds]

Agreed, many excellent products are made in China, but every batch should be tested. A classic case some years ago involved a Japanese manufacturer of L-Tryptophan. They changed their manufacturing process and this resulted in a batch that killed (from memory) 8 people.

Small numbers considering the huge death rate for certain pharmaceutical products, but big pharma jumped on it and had L-Tryptophan from all sources banned for a number of years.

The point is, every batch is susceptible to error, so every batch should be checked. It would appear that the Japanese manufacturer didn't do that. China has a bad record for adulterated food, food supplements, pharmaceutical, and cosmetic products.

Walter

Walter, thanks for jumping. Are there any labs you trust in Asia?

 

[AllenCrawley]

Another option is to spend the additional funds to have lab testing done. Not everything made in China is bad, but proper inspection is necessary.

Agreed but as Walter mentions... Test. Every. Single. Batch.

 

[BlahBlahBlah]

Hi Guys,

sorry I got really buy and completely forgot that I opened a thread here a couple of days ago. Basically in the EU requirements are very strict, my manufacturer provided plenty of certificates/paper work but still it is not enough. What frustrated me is that they already have customers in the UK, Germany and France who branded their product as I did, and nobody ever addressed they need for some of these documents.

These are high-level the main requirements:

· Notification of the product on the European database, Cosmetic Product Notification Portal (CPNP).

· Documentation that the product is manufactured in accordance with Good Manufacturing Practice guidelines (ISO 22716).

· Preparation and maintenance of a product information file (PIF) at the address of the Responsible Person

· Preparation of a cosmetic product safety report (CPSR) consisting of a safety assessment carried out by a toxicologist or suitably qualified expert.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF

· Data on animal testing (if applicable).

· A system for documenting and reporting serious undesirable effects experienced as a result of product use.

· Appropriate labelling as per Article 19 of the Regulation (further information on this is available in Guide to Cosmetics for Responsible Persons).
· Notification of the product on the European database, Cosmetic Product Notification Portal (CPNP).

· Documentation that the product is manufactured in accordance with Good Manufacturing Practice guidelines (ISO 22716). --- my manufacturer did not have, they had the ISO 9001, now on my request they have done the ISO 22716.

· Preparation and maintenance of a product information file (PIF) at the address of the Responsible Person

· Preparation of a cosmetic product safety report (CPSR) consisting of a safety assessment carried out by a toxicologist or suitably qualified expert.

· Data on animal testing (if applicable).

· A system for documenting and reporting serious undesirable effects experienced as a result of product use.

· Appropriate labelling as per Article 19 of the Regulation (further information on this is available in Guide to Cosmetics for Responsible Persons).


I pretty much managed to get the requirements document for everything from my supplier, however the CPSR which is a key-document (in bold above) and consist in a safety assessment from a certified company includes documents such as:

Formulation of the product ---> got this
Stability testing results ----> supplier doesn't have it, can outsource testing to a company here in Europe.
Microbiology testing results ----> supplier doesn't have it, can outsource testing to a company here in Europe.
packaging specifications ----> got this
labelling ----> got this
MSDS and COA file of each raw material used in the product ---> this is where I have the problem. My manufacturer does not have these documents and they seem to be very expensive to get, and they do not intend to get them.

I am very disappointed about this, I as it is a great product (I have been using the same from another company myself for many years and my packaging look much better than the competitors on the market now and I already had my marketing strategy down in place). I basically have 500 pcs of this product here, overall the investment has been of 1.6k €, so not big money but still, I was already in love with the product! I just received the info above (that MSDS and COA file from my manufacturer won't be provided) from the manufacturer this morning, so I am trying to put down some options and what to do from here.

a) Ask for a full refund as they are not compliant for EU. I think this would be very hard to get.
b) Investigate whether it would be possible for me to sell the product in the US. I searched on the internet and it looks like it is easier to get approval in the US, but I don't even know if I can do so if I am based on the EU.
c) other suggestions?

I can't even sell the product off on eBay as it has my company name/address on it and don't want to risk any trouble for relatively low money.


Thank you all for your time and help.

 

Dislike ads? Remove them and support the forum: Subscribe to Fastlane Insiders.

[ljb7]

Hi Guys,

sorry I got really buy and completely forgot that I opened a thread here a couple of days ago. Basically in the EU requirements are very strict, my manufacturer provided plenty of certificates/paper work but still it is not enough. What frustrated me is that they already have customers in the UK, Germany and France who branded their product as I did, and nobody ever addressed they need for some of these documents.

These are high-level the main requirements:

· Notification of the product on the European database, Cosmetic Product Notification Portal (CPNP).

· Documentation that the product is manufactured in accordance with Good Manufacturing Practice guidelines (ISO 22716).

· Preparation and maintenance of a product information file (PIF) at the address of the Responsible Person

· Preparation of a cosmetic product safety report (CPSR) consisting of a safety assessment carried out by a toxicologist or suitably qualified expert.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF

· Data on animal testing (if applicable).

· A system for documenting and reporting serious undesirable effects experienced as a result of product use.

· Appropriate labelling as per Article 19 of the Regulation (further information on this is available in Guide to Cosmetics for Responsible Persons).
· Notification of the product on the European database, Cosmetic Product Notification Portal (CPNP).

· Documentation that the product is manufactured in accordance with Good Manufacturing Practice guidelines (ISO 22716). --- my manufacturer did not have, they had the ISO 9001, now on my request they have done the ISO 22716.

· Preparation and maintenance of a product information file (PIF) at the address of the Responsible Person

· Preparation of a cosmetic product safety report (CPSR) consisting of a safety assessment carried out by a toxicologist or suitably qualified expert.

· Data on animal testing (if applicable).

· A system for documenting and reporting serious undesirable effects experienced as a result of product use.

· Appropriate labelling as per Article 19 of the Regulation (further information on this is available in Guide to Cosmetics for Responsible Persons).


I pretty much managed to get the requirements document for everything from my supplier, however the CPSR which is a key-document (in bold above) and consist in a safety assessment from a certified company includes documents such as:

Formulation of the product ---> got this
Stability testing results ----> supplier doesn't have it, can outsource testing to a company here in Europe.
Microbiology testing results ----> supplier doesn't have it, can outsource testing to a company here in Europe.
packaging specifications ----> got this
labelling ----> got this
MSDS and COA file of each raw material used in the product ---> this is where I have the problem. My manufacturer does not have these documents and they seem to be very expensive to get, and they do not intend to get them.

I am very disappointed about this, I as it is a great product (I have been using the same from another company myself for many years and my packaging look much better than the competitors on the market now and I already had my marketing strategy down in place). I basically have 500 pcs of this product here, overall the investment has been of 1.6k €, so not big money but still, I was already in love with the product! I just received the info above (that MSDS and COA file from my manufacturer won't be provided) from the manufacturer this morning, so I am trying to put down some options and what to do from here.

a) Ask for a full refund as they are not compliant for EU. I think this would be very hard to get.
b) Investigate whether it would be possible for me to sell the product in the US. I searched on the internet and it looks like it is easier to get approval in the US, but I don't even know if I can do so if I am based on the EU.
c) other suggestions?

I can't even sell the product off on eBay as it has my company name/address on it and don't want to risk any trouble for relatively low money.


Thank you all for your time and help.

Ok, first things first, don't buy cosmetics from China again. I know it's been said above but I just want to drill that in.

Now, onto your issues. I have quite a bit of experience selling cosmetics in the EU. All of those requirements above are general EU requirements and you need to supply the exact same stuff regardless of where it's manufactured. I manufacture a lot in the UK and have to provide the exact same information.

The EU is incredibly strict on cosmetics and I think it's a good thing. While I've never manufactured cosmetics in China (or anywhere outside of the EU), I'm actually quite surprised that they don't want more information from you. I guess you've just got to be very careful as you can never really control what a factory in China is actually putting into your product.

Let me reiterate, this is not the manufacturers fault nor is it their obligation. They are in China, where the rules don't stand. It is you, the EU importer, who takes on all responsibility. You should have researched what was needed beforehand. Should anything go wrong, you are at fault. Before I go into the steps, let me answer your A, B, C options:

A) I assure you that you will not be able to get a refund. Again, this is not the manufacturers fault, and everybody in Europe selling cosmetics legitimately must follow the same steps
B) It's possible, but I don't know what paper work they would require for Chinese cosmetics. Yes they're laxer than the EU in general but there is likely some more paperwork required. Also shipping from UK to US after pay import duty, VAT, and another shipping fee will eat up your margins.
C) Decide whether you want to follow the steps below or chalk it up to a lesson learnt.



I'm not sure why your supplier doesn't have access to the MSDS and COA files for all the raw ingredients used, but I think that pretty much proves the point in itself. You will need to get a hold of these as they are key to your testing and final PIF reports.

I hope that your manufacturer has a file on the GMP guidelines and how they follow them. Have you asked? They may not have this as they aren't required too, but I'm sure that you and them could create something for it.

You will want to get a jump on the testing phase now.

- Stability testing takes a long time as it tests the product for up to 12 weeks, putting it under stress from different factors and seeing how it performs.
- Microbial testing I believe is used when the product contains water, and tests over a period of time to see how the product changes and if it becomes contaminated.

Both are necessary, as well as all the raw material MSDS files, to send off and get your CPSR (which you can then develop your PIF). Once you get your CPSR, it should show you what warnings, disclaimers, and other details need to be added to your label, as well as any declarable allergens.

You'll then have to develop your label so that it conforms to EU reg, including but not limited to: Ingredient list (using correct ingredient names), size, description, usage, POA, warnings, and anything else that may be applicable.

After that, you're nearly there. After all the testing is done, the CPSR and COA have been generated, and labelling is up to EU reg, then you will upload your product to the CPNP portal. This is very simple to do (guide here:

). After that, you're legally sound and your products can be sold.

Feel free to ask me any questions if you need some clarification. I didn't have a lot of time to spend on this post.

 

[BlahBlahBlah]

Hi!
First of all thank you very much for taking the time for this long and comprehensive answer.
I agree I should have done more research beforehand, I paid the inexperience in this field, I wasn't really planning to get into cosmetics, this was really a one-off thing. I will give a try with the FDA in the US and see what they say. I am not VAT registered and shipping of the product to the US cost me the same as sending it to pretty much anywhere in Europe, so that wouldn't be an issue. I am just surprised that none of their other EU-own-branded customers requested this documentation, so I guess they are just selling illegally, which I have no intention of doingdo as I am trying to build a proper business and not trying to just make some quick money.
Worst case scenario as I am a user of the product myself and I have 500 pcs of it now, I should have enough until I turn 90 saving myself 10k that I would spend over the years buying it from competitors (just kidding obv, kind of...)

Yes, the manufacturer have GMP guidelines and also got the ISO 22716 certificate after I requested it to them.

I won't go on with Stability and Microbiology testing as those would cost me 480€ (+350€ for CPSR) and at this stage they would be of no use anyway as the MSDS and COA files are not available anyway. Unless of course FDA in the US says that these are not required there (which I doubt).

Regarding the product label I don't worry too much, I know at the moment the product label is not 100% compliant (ingredients not listed in INCI format and "Made in China" not included), but over-labelling is allowed, so that would have been relatively easy to sort for the first batch and then I would have had it re-printed properly in the second shipment.

One thing I wonder about though, and maybe you have an idea, I see many small companies selling their own branded creams, oils, etc. etc. and for sure their sales are very limited. I wonder, did they really all went through this? It seems to be really an expensive investment for them to get all the required paperwork done, especially because often have no marketing behind or anything that suggest heavy sales.

Thank you again for your help!!!

 

[ljb7]

Hi!
First of all thank you very much for taking the time for this long and comprehensive answer.
I agree I should have done more research beforehand, I paid the inexperience in this field, I wasn't really planning to get into cosmetics, this was really a one-off thing. I will give a try with the FDA in the US and see what they say. I am not VAT registered and shipping of the product to the US cost me the same as sending it to pretty much anywhere in Europe, so that wouldn't be an issue. I am just surprised that none of their other EU-own-branded customers requested this documentation, so I guess they are just selling illegally, which I have no intention of doingdo as I am trying to build a proper business and not trying to just make some quick money.
Worst case scenario as I am a user of the product myself and I have 500 pcs of it now, I should have enough until I turn 90 saving myself 10k that I would spend over the years buying it from competitors (just kidding obv, kind of...)

Yes, the manufacturer have GMP guidelines and also got the ISO 22716 certificate after I requested it to them.

I won't go on with Stability and Microbiology testing as those would cost me 480€ (+350€ for CPSR) and at this stage they would be of no use anyway as the MSDS and COA files are not available anyway. Unless of course FDA in the US says that these are not required there (which I doubt).

Regarding the product label I don't worry too much, I know at the moment the product label is not 100% compliant (ingredients not listed in INCI format and "Made in China" not included), but over-labelling is allowed, so that would have been relatively easy to sort for the first batch and then I would have had it re-printed properly in the second shipment.

One thing I wonder about though, and maybe you have an idea, I see many small companies selling their own branded creams, oils, etc. etc. and for sure their sales are very limited. I wonder, did they really all went through this? It seems to be really an expensive investment for them to get all the required paperwork done, especially because often have no marketing behind or anything that suggest heavy sales.

Thank you again for your help!!!

Ok -- just make sure to exercise extreme caution if you decide to send it to the US. Just imagine if something did go wrong over there, I think you'd be in a lot more trouble than if something went wrong in the UK. You have no protection, no insurance, no testing, no company. It seems very risky to me to be selling a cosmetic from China like that.

I wouldn't be so quick to assume that your competitors are selling illegally. Does the rep that you're in talks with really know? Are they just trying to get you off their back? Are they really the only rep at that company? C'mon, this is common sense. I would expect any established brand to be selling cosmetics they import from China legitimately. Yes, it requires a small upfront investment, but if they have a sales history, it's a no-brainer.

At least they manufacture under GMP guidelines.

Yes, like I said, you would need to get the MSDS and COA files first. I think it's a little sketch that the manufacturer can't provide those. Red flag for sure. At the very least you should be getting the label right. If it means sitting and relabelling 500 units, so be it.

The short answer is some do and some don't. You can't be comparing yourself to them though because I don't think it's at all the same situation. Most of these small companies products are handmade by them, domestically. It's easy to find good quality domestic sources for ingredients for simple cosmetic products. This goes for most oil based products.

Once you start getting into creams and products containing water, the whole process gets a lot more complicated. I don't believe that most small companies make these by hand, instead they partner up with small private label manufacturers who have already done the majority of testing, and have the certificates.

Another thing to remember is that even if you're making oil based products, let's say you're creating a range, the cost of testing and certificates becomes more affordable when you're getting multiple products tested at once.

I began with making products by hand, strictly for cash flow and margin. I didn't register from the get-go (out of naivety more than anything), but made sure once I started selling volume I got everything legit quick.

If you were making a simple product by hand (with ingredients that you have MSDS data on) and didn't have the time or money to do the testing yet, I would tell you to sell these, test the market, and then get the testing done during.

However, in your situation I can't in good faith tell you to sell these and worry about things later.

 

Dislike ads? Remove them and support the forum: Subscribe to Fastlane Insiders.

[Walter Hay]

Walter, thanks for jumping. Are there any labs you trust in Asia?

My preference would be to go to SGS who have some of the most extensive chemical testing facilities you will find, and they are totally reliable.

This is what they say about their chemical testing service:
Cosmetics and personal care testing services from SGS – meet regulatory requirements and ensure product safety.

Over the past ten years the cosmetics and personal care products industry has expanded beyond a market solely for women, to include men and children. Many products are regulated due to concerns over health and performance.


Equipped with proven expertise in cosmetics testing, auditing and certification worldwide, we offer a broad range of services to help you check the safety, quality and performance of your products and systems and to protect your brand. We help you verify your cosmetic and personal care products’ compliance against the requirements of applicable cosmetic regulations and other relevant legislation, including REACH, GMP, CMRs, aerosol, hazardous substances, etc. We can also verify the compliance of your products and manufacturing processes against various social and environmental standards.

You might have to have batch samples delivered to a laboratory outside of China, depending on the nature of the product. Perfumes are relatively simple, but can hide dangerous solvents. Other excipients, such as fillers, colors, thickeners, preservatives etc., also need to be checked for safety.
They will all be found in normal analytical procedures.

Some of these additives can be highly allergenic, and thus dangerous to susceptible people. A very common preservative, Sulphur Dioxide, usually identified as E220, is approved for use in the EU, but in some countries, manufacturers declare it because of the known allergy hazard. You don't want your customers to die from anaphylactic shock! Even some natural colors and flavors can cause problems. Annatto, (160b) used to produce yellow or orange/yellow color has been found in a clinical trial to produce more reactions than synthetic dyes. (see below my sig.)

In short, there are many risks involved in importing food, food supplements, cosmetics, and pharmaceuticals. I would never do it, but if you must, then a very strict testing regime is essential.

The information and advice provided by @ljb7 is excellent. I would just add that if you know the names of the ingredients and can find suppliers of those ingredients, they should have Material Safety Data Sheets available.

Walter

Annatto study: Mikkelsen H and others Hypersensitivity reactions to food colours with special reference to the natural colour annatto extract (butter colour). Arch Toxicol Suppl 1978;(1):141-3

 

[BlahBlahBlah]

Thank you all for the replies.
I won't be selling in the EU - I learned a lot from this experience, especially that in the EU there PLENTY of small companies selling cosmetics without the proper approvals (and I also got the confirmation on this by the person looking into the documentation requirements for the CPRS).

Said this I know that my manufacturer is FDA approved (they provided the certification). Does this mean that I am actually allowed to sell in the US without further requirements, or should I still contact the FDA? I know is a bit weird to be based in the EU and sell outside the EU only, but I don't want to close doors to these options, even though I will probably be limited to selling on eBay/Amazon rather than on my website.
Any suggestion?

 

[Walter Hay]

Thank you all for the replies.
I won't be selling in the EU - I learned a lot from this experience, especially that in the EU there PLENTY of small companies selling cosmetics without the proper approvals (and I also got the confirmation on this by the person looking into the documentation requirements for the CPRS).

Said this I know that my manufacturer is FDA approved (they provided the certification). Does this mean that I am actually allowed to sell in the US without further requirements, or should I still contact the FDA? I know is a bit weird to be based in the EU and sell outside the EU only, but I don't want to close doors to these options, even though I will probably be limited to selling on eBay/Amazon rather than on my website.
Any suggestion?

If the FDA approval is genuine that will certainly make your entry to the US market easier.

There is no reason you can't sell via your own website, but you will need to set up a US entity to simplify your duty and tax obligations. I will PM a link for a course that can provide the help you need in that regard.

Walter

 

Dislike ads? Remove them and support the forum: Subscribe to Fastlane Insiders.

[hughjasle]

Test. Every. Single. Batch.

Been going thru this for simple "coloring" in my products. Lesson learned. Never again.

 

[BlahBlahBlah]

Thank you again Walter!

 

[Rsimmons016]

If the FDA approval is genuine that will certainly make your entry to the US market easier.

There is no reason you can't sell via your own website, but you will need to set up a US entity to simplify your duty and tax obligations. I will PM a link for a course that can provide the help you need in that regard.

Walter

Hello Blah, Blah, Blah,

Walter is correct if your FDA approval (FYI is a voluntary submission with cosmetics) is legit, you should not have any issues getting through customs and FDA importing requirements and ultimately selling in the U.S. I also agree with Walter that if you intend to import and sell into the states that you should set up a U.S. entity and import under that company. The only real work around to this will be distribution and storage in the states, but there are many options to work around this.

If you have any questions on US customs import rules and regulations don't hesitate to ask

 

Dislike ads? Remove them and support the forum: Subscribe to Fastlane Insiders.

[Noj]

Hey Walter,

I purchased your book. Thought it was full of great information. I'd like to contact you with a quick questions regarding sourcing. Whats the best way to go about this?

Thanks.

 

[Walter Hay]

Hey Walter,

I purchased your book. Thought it was full of great information. I'd like to contact you with a quick questions regarding sourcing. Whats the best way to go about this?

Thanks.

I will PM you so that you can contact me via the reply function.

Walter

 

[Walter Hay]

Hello Blah, Blah, Blah,

Walter is correct if your FDA approval (FYI is a voluntary submission with cosmetics) is legit, you should not have any issues getting through customs and FDA importing requirements and ultimately selling in the U.S. I also agree with Walter that if you intend to import and sell into the states that you should set up a U.S. entity and import under that company. The only real work around to this will be distribution and storage in the states, but there are many options to work around this.

If you have any questions on US customs import rules and regulations don't hesitate to ask

@Rsimmons016 I value your expert contributions to the Fastlane forum, and hope members will take up your offer to get answers to questions about US import rules and regulations, and maybe use your services when importing.

Although I have worked in the field of international shipping and knew the rules and regulations, when I started importing I used the services of freight forwarders and customs brokers. I needed to get suppliers to ship to the 4 countries where my franchisees were, and it was far more cost effective to pay experts whose job was to keep up to date on the ever-changing rules than to do it myself.

Walter

 

Dislike ads? Remove them and support the forum: Subscribe to Fastlane Insiders.

[GregK]

Maybe I am wrong but Msds and coa shouldn't be tough to get. Especially if you are dealing with the manufacturer that buys these things. These are pretty standard for any chemical...