Cosmetic Manufacturing Complexities
terribly early in the morning of July 5th, 2007Trying to establish a young company in a new country can be daunting. Of all the challenges I’m facing, getting up to speed with EU regulations in the UK governing beauty cosmetics is the most onerous.
Unfortunately, the internet is a sea of misinformation, with numerous soap making websites contradicting each other on what the EU expects. Today I discovered that much of this is scare mongering, a very good way to turn off the hobbyist or small business entrepreneur from proceeding down this avenue of work.
Whether you’re a budding soap maker or have an established micro business in the field of beauty, there are some points you need to observe.
For every product you manufacture you must create a PIF (Product Information File). It must be readily accessible to the enforcement authorities should they request it and must include the following information:
1. An ingredient list identified by INCI name, (”International Nomenclature Cosmetic Ingredients” and is a common nomenclature for use in declarations of contents for cosmetic products in the EU), CAS number and concentrations used for each type of product you will sell.
2. Method of formulation for each product. The use of a flow diagram would be ideal and should include all processes including filling and storage in accordance with GMP (Good Manufacturing Practices).
3. An MSDS (Material Safety Data Sheet) on each ingredient used.
4. Microbiological data on any creams or lotions made for sale.
5. Documented evidence of any adverse reactions, suffered by your customers, should they occur.
6. Substantiated claims if you’re going to make them. For example, claiming you have a product that has an SPF factor of x. The claim is in the value of the SPF and you must have relating data proving your claim.
7. Recorded batch or lot numbers on every fresh batch manufactured for sale.
Having founded and since sold my own food business back in Australia, I am familiar with these requirements having been HACCP (Hazard Analysis Critical Control Points) accredited, a worldwide standard of safety.
Safety Assessments.
There is a great deal of misleading information on this requirement.
The department of Trade and Industry who introduced the regulations on the back of the EU do expect you to undertake a safety assessment of ALL your products. This includes EVERY variation, which can prove to be extensive if you manufacture soap.
However, they are lenient. You are given a reasonable amount of time before undertaking a full assessment of your product line.
Lets break this down a little, for example,
a) when you have developed and are satisfied with the product range you have for sale and
b) identified and sold to a customer database you have grown; you can’t possibly expect to report on adverse reactions to products, if you haven’t sold any!
Once you are satisified with your product range, you will be expected to invest the £300 to £500 needed to comply with a comprehensive assessment. This is a once off payment and you will not be required to do this again unless you introduce new products into your range.
An assessment will involve handing over your ingredient and formulation data to a suitable person in authority. This could be an MD (Medical Doctor), qualified chemist authorised to practise in the UK or a chartered biologist.
Pre-certification.
I have seen some websites selling pre-certified DIY kits, whether that be a soap making, bath bomb or lotion making kit, in order to faciliate you making your own products and selling them without breaching EU regulations.
This is nonsense. Certification exists in the Company’s name who undertook the Safety Assessment, it most certainly is not in your name and therefore does not cover you under existing regulations.
Some other points to consider:
Ensure your labelling is accurate with ingredients listed in descending order of concentration. If your package or container is too small, include a pamphlet or tag with the item and ensure you list your ingredients on your website if you have one. You’ll gain the trust of potential customers if you operate with a full disclosure policy. I know that I won’t buy from a Company if they’re not prepared to list their ingredients, makes me wonder what they have to hide.
Ensure you include a batch number or expiry date on each product and if applicable, a description on how the product should be used.
Email me if you have any questions or if you would like me to email you the regulations. Visit my website and send me your info via our Contact Us form.
