[mikethair]

Thanks.

[mikethair]

Yes, inconsistent advice. I would raise the question/s with the EU regulation consultant. And you should get an answer. If not, find another consultant.

[mikethair]

ketchito said:

@akrep Have you tried with Candelilla or Carnauba waxes?

I have used Candelilla in various applications. It works well. But some work is required in arriving at the hardness you require.

[mikethair]

And if possible, can the template be posted here?

[mikethair]

Rockstargirl said:

As a manufacturer or formulator - do you stick to your own style or ethos?

Yes, absolutely. I enjoy what I do, and prefer not to engage with formulations I’m not comfortable with.

[mikethair]

As a formulator and manufacturer, we have placed products in the EU market.

Check  European Regulation EC 1223/2009 (Article 4.1), “Only
cosmetic products for which a legal or natural person is designated
within the community as ‘the responsible person shall be placed on the
market.”

We appointed a Safety Assessor who was the European Responsible Person. This person will guide you on the PIF. This file must be in the possession of the Safety Assessor / Responsible Person located in the European Union.

We found it all very straightforward.

[mikethair]

ledude said:

mikethair said:

We use Mikrocount Duo kits and have test results periodically validated by a registered external lab. Our production facility is GMP Certified, and this approach is acceptable to the GMP Auditors.

We were looking at those kits as well. Just curious, how often are you testing?

We buy RO water from a local supplier in 19 Kg containers. Plus we have a RO unit in our production facility.

We take a sample from every Batch # of the 19 Kg containers of RO water and do a microbial test.

 

With the RO unit in our production facility, the QC Manager tests every two months.

Finished products are microbial tested.

[mikethair]

We use Mikrocount Duo kits and have test results periodically validated by a registered external lab. Our production facility is GMP Certified, and this approach is acceptable to the GMP Auditors.

[mikethair]

In our experience, at a pH of 10, a preservative is not required. We always do a microbial test and continue regular microbial testing beyond the shelf life. In 10 years have never had any positive microbial results.

[mikethair]

Microformulation said:

We looked at multiple software packages as well. I agree 100% with Formulator in that you have to add multiple modules. Others have different issues. We work with multiple (>30) contract manufacturers with differing systems as there is no one Industry leader. In the end, we settled on Excel as well. We have even found ways to import our excel data into the other systems as well. Simply there is no appeal to purchase.

Our experience as well. In the end, I wrote our own QMS, and yes, we rely on  Excel. It works.

[mikethair]

Yes, I’d be willing to have a look at this for you.

[mikethair]

ozgirl said:

Are you certain it is cocoa butter. Cocoa butter should be a solid at room temperature. Melting point 34-38 C.

OK, you have nailed the problem. The so-called Cocoa Butter has a melting point of 62 C. And once melted it won’t solidify on cooling in my AC formulating room (24 C).

Have just spoken to the local supplier. He has no explanation.

[mikethair]

Squinny said:

If other brands ae making what you are trying to emulate I don’t know why you are bothering unless it is to make same product for yourself but cheaper. Cheers.

We don’t produce “cheap products” and target the lower end of the marketplace.

The fact is that good quality Lotion Bars are not produced in our country, and we are hoping to target this sector with locally produced Lotion Bars.

[mikethair]

We aim to not have excess product from production runs. We calculate our BMRs very carefully, ensuring that the product containers have been calibrated for volume.

In cases where we have ‘extras” which is usually <10, our customers are usually happy to purchase these.

[mikethair]

Squinny said:

Hi Mike - While I personally dont see the point of such a product maybe try a type of body butter bar and play around with percentages. I think you need to add something like Cetyl Alcohol , Stearic Acid? Anyway something like:this may be what you are after (or not) - 
Cocoa Butter 60%, Mango Butter 10% (OR 70% Cocoa butter) Oils like coconut or sunflower as cheap about 10%, Cetyl Alcohol 9% and Stearic Acid 8%, Beeswax (or Vegan sub if thats what you are after? around 3%. Play around with such ingredients until you get the consistency you want. Just do a small batch like 50g to start. Assume you have a procedure for making these and a silicone mould? 

I’m not quite sure what I would achieve by adding Cetyl Alcohol and Stearic Acid. Other brands in this space certainly do not use these ingredients, and the ingredients I have quoted in my original post comes from one of the biggest and most popular brands.

Yes, I do have an appropriate silicon mould. I was previously getting good results by adding a small percentage of Candelilla Wax. However, it tended to make the bars feel “sticky.”

[mikethair]

ozgirl said:

Are you certain it is cocoa butter. Cocoa butter should be a solid at room temperature. Melting point 34-38 C.

I know you are in SE Asia. Is your lab too hot?

Always a good point…is it Cocoa Butter. To the best of my knowledge, it is. And yes, it is solid at room temperature.

Our formulation space has AC.

[mikethair]

We opt for good quality stainless steel pots. I find them a lot more robust and easier to use.

[mikethair]

I’m currently working with Cocoa Butter and having good results. But of course, it needs to be formulated with oils to produce a softer end product.

[mikethair]

As the co-founder of a skincare manufacturing company located outside of the EU, I think you have made a number of erroneous assumptions.

First, ‘a manufacturer outside the EU there may be problems with the regulatory issues’ is not correct. We operate a GMP-certified facility in Malaysia, and conforming to EU standards is not a challenge for us.

Second. ‘cost of transport’ can be offset by lower manufacturing costs.

Third, ‘low MOQ - 5000 pcs or below’ is not an issue for a small manufacturer like ourselves. We specialise in small indie startups that we support and watch grow larger.

Fourth, ‘possibility of transfer of IP rights,’ is always on the table. But I question what protection this provides you.

Fifth, the purchase of ingredients. We never require customers to purchase ingredients. This is our function and role.

We are probably not the right manufacturer for you. And to answer your question ‘I’m a bit stuck with making a decision, so I want to ask what you think
about it. Maybe there are other factors I should consider?’ …..my suggestion is to keep looking for a manufacturer, cast your net wider, and engage in meaningful dialogue without having too many misconceptions,

[mikethair]

A workaround that you might like to try. I discovered this when I was upgrading labs at an Indonesian University campus. A lot of it was advanced analytical equipment (mass spectrometers, chromatographs  spectrometers (AAS, and fluorescence),

The water from the airconditioners tested pure. The trick was to pipe it directly into a clean container. As they were running 24/7, and there were a few AC,s the water they produced was adequate.

[mikethair]

We have been using Mikrocount
kits from Schulke for our water and product microbial testing for years. We have test results validated by external labs periodically.

In our experience, the results from the Schulke  Mikrocount
kits are OK.

[mikethair]

Dazed said:

What about a non-compete clause or what if they sell their 30% to another party a few years from now, a few things to consider, partnerships are unpredictable.

Yes indeed….. and when the partner has its own brand, it would be easy to grab all the IP and transfer before the deal is completed.

[mikethair]

MarkBroussard said:

@mikethair

Let them tell you what they want disclosed is generally how it works.

Good luck.

OK, but what if they want everything at the 30% stage?

I’m thinking that the stage disclosure process and limits should be stipulated as part of a legal agreement.

[mikethair]

I’ll chip in my experience. I’m not here to convince others one way or the other.

We have been making liquid soap for more than 10 years. We saponify coconut oil to make a shampoo. Each batch we make produces around 300 x 250 mL bottles. And it’s one of our best sellers.

To learn more you can check out this link:  https://indochinenatural.com/product/tropical-sunrise-natural-shampoo-250ml/

[mikethair]

We produce a lot of cold process soap in our GMP certified facility, and the stability requirements are fairly much the same as for other cosmetic products.