So one of the most commonly asked question is this; if i have been making natural products at home; like soap, lotions, skincare etc, how do i get KKM Notification?
now before i go further into how o get it; let's talk about what KKM Notification is first.
(p/S: Untuk melihat video dalam bahasa malaysia; sila scroll ke bawah)
What Is KKM Notification? (Apakah KKM Notification?)
KKM notification is like a 'system' where KKM NPRA created to know who is selling what cosmetics in Malaysia. Its unlike pharmaceutical registration ya. These are two different things.
Pharmaceutical registration is whereby a pharma compony registers their product; and KKM will then do tests and getting all the relevant data to determine the safety and efficacy of the products.
This can be in the form of medicine, or traditional medicine, pharmaceutical suplements and so on.
After about 6 months- 2 years of test; only then its released to public (only when its absolutely safe).
Cosmetic Notification on the other hand does not go through this process.
Notification is where you as a company who owns the brand tells KKM that; "hi, im XYZ company, i want to sell this AAA cosmetics; and heres the details about the product and this is my address bla bla.
It takes aproximately 5 mins- 48 hours for the cosmetic to be submited in the Quest 3 system and you would have uploaded the documentation, and immediately get a letter to claim you have notified NPRA.
thats it.
NPRA will not do any lab test, or any safety evaluation on these products. Its the responsibility of the product founder/ company to do this.
KKM Notification ni macam satu 'sistem' yang KKM NPRA buat untuk monitor siapa yang jual kosmetik di Malaysia. Tapi jangan salah faham, ya. Ini tak sama dengan pharmaceutical registration. Dua benda berbeza.
Pharmaceutical registration ni ialah bila syarikat farmaseutikal daftar produk mereka; lepas tu KKM akan buat ujian dan kumpul data untuk pastikan keselamatan dan keberkesanan produk tu.
Contohnya, ubat, traditional medicine, suplemen farmaseutikal, dan sebagainya.
Lepas lebih kurang 6 bulan hingga 2 tahun ujian, baru produk tu dibenarkan dijual kepada umum (bila dah betul-betul selamat).
Cosmetic Notification pula tak lalu proses ni.
Notifikasi kosmetik ni bermaksud, sebagai company yang ada brand sendiri, kita just inform KKM macam ni: "Hi, saya syarikat XYZ, saya nak jual kosmetik AAA ni, dan ni details produk saya, alamat saya bla bla."
Dalam masa 5 minit hingga 48 jam, produk tu dah boleh di-submit dalam sistem Quest 3, dan kita just upload dokumentasi yang diperlukan. Lepas tu, terus dapat surat untuk sahkan yang kita dah notify NPRA.
Simple, kan?
Tapi NPRA tak buat apa-apa lab test atau safety evaluation. Itu semua tanggungjawab founder atau company yang buat produk tu.
Who Is Responsible Of The Cosmetic Products? (Siapa Yang Bertanggungjawab ke atas Produk Kosmetik?)
Its the responsibility of the Cosmetic brand to make sure the products are safe and effective before putting it out in the market.
This is also why its very important for the founder to find a good GMP factory to make these products for you.
Without that; your product might be compromised or adultrated and if there is a problem later on; its you that the enforcement officers will come for.
Not the GMP Factory; Not your customers, Not your sales person, But its you and your company. So do your due diligence!
Basically, brand kosmetik bertanggungjawab sepenuhnya untuk pastikan produk tu selamat dan berkesan sebelum dijual kat market.
Sebab tu sangat penting untuk cari kilang GMP yang bagus untuk hasilkan produk anda.
Kalau tak, produk anda mungkin tak secure, atau worse, tercemar. Kalau ada masalah kemudian, enforcement officers akan datang cari anda. Bukan kilang GMP, bukan pelanggan anda, bukan orang sales, tapi anda dan syarikat anda. Jadi, buatlah due diligence anda dengan betul!
Why I See So Many Products That Got Banned? (Kenapa Banyak Produk Kosmetik Di Banned?)
Anyways, after a product is notified in Malaysia; its already allowed to sell publically (again KKM NOT doesnt mean its safe!).
However; over the years of selling; few or most people might get side efefct from the product.
When that happens; there will be people complaining to KKM (NPRA) about it.
So when KKM gets the complain (NPRA); they will send a post marketing surviellence team to do a spot check.
Here; they will get the products randomly from all over the place (distributor, warehouse, customers) and they will then do a test on the product.
If lets say its adultrated or has prohibited ingredients; then the product's notification will be revoked, and the owner of the company will face legal charges.
Lepas produk di-notify kepada KKM, produk tu technically dah boleh dijual kepada umum (again, Notifikasi KKM TAK bermaksud produk tu selamat, okay!).
Namun, after some time, mungkin ada pengguna yang alami side effects daripada produk tu.
Bila tu berlaku, akan ada aduan kepada KKM (NPRA).
Lepas KKM dapat aduan, mereka akan hantar pasukan pemantauan pasca pemasaran untuk buat spot check.
Mereka akan ambil produk secara rawak dari pelbagai tempat (pengedar, gudang, pelanggan), dan buat ujian ke atas produk tu.
Kalau produk didapati ada bahan terlarang, notifikasi produk tu akan dibatalkan, dan pemilik syarikat akan dikenakan tindakan undang-undang.
How To Notify Handmade Cosmetics? (Bagaimana Notify Produk Kosmetik Yang Dibuat Di Rumah?)
So now that you know already how KKM Notification works and how NPRA operates around cosmetic products; here is the important question; How do one notify handmade cosmetics?
Unfortunately; to get a product notified; you must get a GMP factory to make your products for you. and no you cant get a lab/ just do it at home and just get lab test done to say your products is notified.
Even though your product is safe, and tested; to get it notified; you must get a GMP factory to notify it for you.
and i do undertsand that most GMP factory's minimum quantity (MOQ) is too high for handmade cosmetics thats starting out but unfortunately that is how it is:-(
(Trust me; i wanted to make it low cost for handmade cosmetics since i started SoapLab but unfortunately; after operating one GMP Factory since 2021; it can get costly:-( )
For a GMP factory to operate; we have to make sure to bare the cost of auditing, the facility, the tests, the stability test etc for one product.
So it is unfortunately costly which is why a product thats is made in small quantity is very expensive. its all because of the documentation thats we have to keep incase NPRa/ auditor comes to us. So there is no two way about it:-(
Malangnya, untuk dapatkan notifikasi produk, anda mesti guna kilang GMP untuk hasilkan produk anda. Dan no, tak boleh buat kat lab atau di rumah, lepas tu buat lab test dan kata produk anda dah di-notify.
Even though produk anda selamat dan dah diuji, untuk dapatkan notifikasi, mesti melalui kilang GMP.
Saya faham, kebanyakan kilang GMP ada kuantiti minimum (MOQ) yang tinggi untuk kosmetik homemade yang baru nak bermula, but unfortunately itulah realitinya :-(
(Trust me, saya sendiri nak jadikan kos rendah untuk produk handmade sejak mula SoapLab, tapi lepas menjalankan satu kilang GMP sejak 2021, memang kos boleh jadi tinggi :-( )
Untuk kilang GMP beroperasi, kami perlu tanggung kos audit, fasiliti, ujian, ujian kestabilan, dan sebagainya untuk setiap produk.
Jadi, malangnya ia memang mahal, sebab itulah produk yang dibuat dalam kuantiti kecil jadi sangat sangat mahal. Semua ini adalah kerana dokumentasi yang perlu disimpan sekiranya NPRA atau auditor datang. Jadi, tiada jalan pintas tentang ini :-(
So what About Handmade Cosmetics? (Handmade Cosmetic Camana?)
Now this is a very grey area.
One makes handmade cosmetics because they are just starting out and have limited funds to start.
However; due to KKM requirement, they will have to go to GMP factory that charges a lot to make the products.
So what does that mean for you? Do you only sell products when you have a lot of money? Do you just 'wash' away your dreams of becoming a cosmetic 'founder'?
Well of course not!
heres the thing;
KKM Notification is the law; you have to submit notification to sell. there is no two ways to it.
However, when you are just selling to friends and family; its usually very small and in testing stage; so at this stage; you are usually just testing it out to see if the business is viable or not.
Once you are sure that your products gets good response; then you should get it made in the GMP factory to obtain the KKM Notification.
And yes it is costly initially; but it is worth it if your product is already doing well among your friends and family.
You already have the confirmation there. So its a risk that is worth taking. You are not going in blind:-)
Ramai yang buat kosmetik handmade sebab mereka baru nak mula dan ada limited funds untuk memulakan.
Tapi, disebabkan keperluan KKM, anda perlu pergi ke kilang GMP yang mengenakan caj tinggi untuk buat produk tersebut.
Jadi, apa maksudnya untuk anda? Adakah anda hanya boleh jual produk bila anda ada banyak duit? Adakah anda perlu 'buang' impian anda untuk jadi founder kosmetik?
Of course not!
Here’s the thing:
Notifikasi KKM adalah undang-undang; anda kena submit notifikasi untuk menjual. Tak ada cara lain.
Namun, kalau anda cuma jual kepada kawan-kawan dan keluarga, biasanya ia sangat kecil dan di peringkat testing. Jadi, pada peringkat ni, anda biasanya hanya uji untuk tengok sama ada bisnes ni viable atau tak.
Once produk anda dah dapat good response, barulah anda patut pergi ke kilang GMP untuk dapatkan Notifikasi KKM.
And yes, memang kos awalnya tinggi; tapi berbaloi jika produk anda dah diterima baik di kalangan kawan-kawan dan keluarga.
You already have the confirmation there, so it’s a risk worth taking. You’re not going in blind. :-)
But how about GMP Factory's MOQ? (Apa MOQ Kilang GMP?)
Now i dont know about other GMP factories; but if you were to employ our GMP factory to make your products; we have quite small MOQ.
It starts with 100pcs for products that are using our existing bases, or 1000 pcs for those that are made from scratch,
Truthfully, saya tak pasti tentang kilang GMP lain, tapi kalau guna kilang GMP kami, MOQ kami agak kecil.
Kami mula dengan 100 pcs untuk produk yang guna existing cosmetic bases kami, atau 1000 pcs untuk produk yang dibuat dari scratch.
What Is Cosmetic Bases? (Apakah Itu Base Kosmetik?)
Cosmetic Bases are products that are 'half done'.
Its like instant noodle; just add water nd 'perencah' and its done.
Similarly our cosmetic bases like soap base, shampoo base, lotion baseserum base etc are bases where he product is done.
You just have to add your own extracts and scents to make it uniquely yours.
Cosmetic Bases ni adalah produk yang 'half done.'
Macam mee segera; just tambah air dan 'perencah', dah siap!
Begitu juga dengan cosmetic bases kami seperti soap base, shampoo base, lotion base, serum base, dan sebagainya. Produk tu dah siap, anda cuma perlu tambah extracts dan essential oil sendiri untuk jadikannya unik kepada anda.
Why Cosmetic Bases MOQ are low? (Kenapa MOQ Base Kosmetik Rendah Pula?)
The reason its low is because we usually make it in bulk. We buy the ingredients in bulk, and we have already done lab test and NOtify the bases as well.
So when you come to us to make products using these bases; we dont have to do those 'expensive' tests anymore.
Plus its already Pre notified where the ingredinets base is already 'approved'. Adding additional ingredients in it will usually have higher chances of approval since the base ingredients are already approved (provided you only use ingredients that are approved for cosmetic usage) Click here to see what is not allowed
If you were to make products formulation from scratch, we will have to source for the ingredient (not wholesale price coz we are not buying a lot), we will have to do stability test, and microbial test for it, create new trail of documentation for it, and do a lot of samples for efficacy for it; causing it to be quite high cost; which will translate to the products becoming more expensive.
To make it more 'worthwhile' our MOQ is 1000 pcs for that.
The reason MOQ for cosmetic bases is low is because we usually buat dalam kuantiti besar. Kami beli bahan dalam jumlah yang banyak, dan lab test serta Notifikasi untuk bases ni pun dah diapprove sebagai Base.
Jadi, bila anda datang kepada kami untuk buat produk guna cosmetic bases ni, kita tak perlu buat lagi 'expensive' tests tu.
Plus, semua base ingredients ni dah pre-notified, maksudnya ingredients dia dah approved. Jadi bila anda tambah bahan lain, chances untuk dapat approval lebih tinggi, asalkan anda guna bahan yang memang dibenarkan untuk kosmetik (click sini untuk tengok apa yang tak dibenarkan).
Kalau anda buat produk dari scratch, kita kena cari bahan (bukan wholesale price sebab kita tak beli banyak), lepas tu kena buat stability test, microbial test, dan create documentation baru. Semua ni akan naikkan kos produk dan akhirnya produk jadi lebih mahal.
Sebab tu, MOQ untuk produk yang dibuat dari scratch adalah 1000 pcs.
Can I Start Using The Cosmetic Bases At Home? (Boleh Ke Saya Guna Kosmetik Bases Kat Rumah?
Yes. if you were just starting out and want to test the market with friends and family before getting the whole cosmetic notification done; you can get the cosmetic bases from us to try out.
We sell in bulk in different sizes (100g, 500g, 1kg, 25kg). you can find out more about what cosmetic bases we have here (click here)
As for the extra ingredients that you are adding in; make sure that you have all the COA and MSDS for it.
Do not ever use Fresh Ingredients in your product (click here to find out why).
For a product to be made in GMP Factory later on; we will need the COA and MSDS for the ingredients that you added in.
So make sure that whatever extracts/ scents you are adding in has all these documentation so that the application of notification process will be smooth.
Yes, kalau anda baru nak mula dan nak test market sebelum dapatkan notifikasi penuh, anda boleh dapatkan cosmetic bases dari kami untuk cuba.
Kami jual dalam kuantiti besar dengan pelbagai saiz (100g, 500g, 1kg, 25kg). Anda boleh tengok lebih lanjut tentang cosmetic bases kami di sini (click here).
Bagi bahan tambahan yang anda nak masukkan, pastikan anda ada COA dan MSDS untuk setiap bahan tersebut.
Jangan guna Fresh Ingredients dalam produk anda (click sini untuk tahu kenapa).
Untuk produk yang akan dibuat di kilang GMP nanti, kami perlukan COA dan MSDS untuk bahan-bahan yang anda tambah. Jadi pastikan apa saja extracts atau wangian yang anda masukkan mempunyai dokumentasi lengkap supaya proses notifikasi berjalan lancar.
Can I Use Fresh Herbs In My Handmade Products? (Boleh Ke Guna Fresh Ingredients Dalam Handmade Produk Saya?)
No. First of all its not safe to use fresh ingredients in your products because it will spoil fast causing bacteria and moulds to contaminate your products (even if you cant see this its there).
Secondly; to get a product to be made in GMP factory; one will need to have COA & MSDS which most fresh ingredients doesn't have.
So always use cosmetic extracts, or if you really want to put your fresh herbs; get it extracted by labs like SIRIM who offers these services. (price range RM 10'000-Rm 15'000).
For me personally; these extracts are already available so just get it from reputable sources so its not so mahal.
No. Pertama sekali, it's not safe untuk guna fresh ingredients dalam produk anda sebab ia akan cepat rosak, menyebabkan bacteria dan kulat mencemari produk (even kalau tak nampak, ia tetap ada).
Kedua, untuk produk yang akan dibuat di kilang GMP, kita perlu ada COA & MSDS, dan kebanyakan fresh ingredients tak ada dokumen-dokumen ni.
Jadi, selalu gunakan cosmetic extracts. Kalau anda betul-betul nak guna fresh herbs, anda kena hantar ke lab macam SIRIM yang tawarkan servis untuk extract bahan-bahan tersebut (harga dalam RM 10,000 – RM 15,000).
Personally, saya rasa extracts ni dah banyak tersedia, jadi just beli dari sumber yang reputable supaya tak terlalu mahal.
Who Should I Contact If I Wanted More Information About SoapLab's GMP Service?
If you would need help from Soaplab to make your products for you; you may whatsapp us at 0126643817 (monday-Fri 9-4.30pm)
I hope this article helps in clarifying your doubt about The KKM Notification for handmade products. If at all you need any help; please dont hesitate to contact us.
Kalau anda perlukan bantuan dari SoapLab untuk buat produk anda, anda boleh WhatsApp kami di 0126643817 (Isnin-Jumaat 9-4.30 petang).
Saya harap artikel ini membantu menjelaskan keraguan anda tentang Notifikasi KKM untuk produk buatan tangan. Kalau anda perlukan sebarang bantuan, boleh hubungi kami.
Video
Nisha;
Pharmacist & Formulator.
*used to work in NPRA & KKM for 7 years.
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