Cosmetic Regulations – What You Need to Know
You may have started making bath and body products as a hobby with no idea that it came with a bunch of regulations! However, they aren’t there to spoil your fun, they play an important part in keeping you and your customers safe.
Don’t panic though! Cosmetic regulations aren’t as scary as they seem, but if you sell cosmetic products, you do have some legal responsibilities, and you cannot ignore them.
As a supplier of ingredients to bath, body and cosmetic makers, we want to help you understand these and keep on top of them.
1. You Are the Responsible Person
Once you sell a cosmetic product, you are legally responsible for it.
If you sell in the UK you need to be based in the UK.
If you sell in the EU you need to be based in the EU.
To sell in either of the above without living there, you need to hire someone to act as responsible person on your behalf.
Selling in other countries comes with various other regulations which can get very complicated, so when first starting we suggest selling only in your own country until you fully understand the regulations and have grown your business enough to expand.
Being a Responsible Person for your products means that you must:
✔ Keep your documents up to date
✔ Follow the limits and instructions in your CPSR
✔ Keep copies of current supplier documents (SDS, IFRA and Allergen)
✔ Make sure your labels are correct with the RP name and address (this can be a business name if you have a registered business).
✔ Check regularly for regulatory changes
✔ Update your product labels and paperwork when necessary
2. What Documents Do I Need?
For each Ingredient you should keep copies of the following (downloadable from the website):
SDS (for all ingredients)
Safety Data Sheet.
IFRA Certificate (for fragrances)
Tells you the maximum safe usage levels for different product types. Though if your CPSR states lower, you MUST follow that.
Allergen Declaration (for fragrances)
Lists allergens present in the undiluted fragrance.
CPSR
Your Cosmetic Product Safety Report / Assessment.
PIF
Your Product Information File.
3. Do I Need to Download New Documents when they come out?
Yes.
Suppliers regularly update SDS, IFRA and allergen declarations.
Having an assessment does not mean you never need new paperwork.
Good practice is to download the latest documents whenever your supplier updates them and keep them with your records.
4. How Do Allergens Work?
This is the part that causes the most confusion.
The allergen document shows what is in the undiluted fragrance oil itself.
For example:
Fragrance oil EXAMPLE
| Allergen | Amount in Fragrance |
|---|---|
| Limonene | 0.15% |
This does NOT mean Limonene must appear on your label.
Your product might only contain 1.5% fragrance.
Therefore:
Limonene at 0.15% × 1.5% = 0.00225%
This is the amount present in your finished product.
5. When Do Allergens Need To Go On The Label?
Leave-on products
Threshold = 0.001%
Examples:
- Body butter
- Lotion
- Lip balm
- Deodorant
- Perfume
Rinse-off products
Threshold = 0.01%
Examples:
- Soap
- Shampoo
- Shower gel
- Bath bombs
- Bubble bath
Example
Limonene in fragrance = 0.15%
Fragrance usage = 1.5%
Limonene in finished Bath Bomb product = 0.00225%
In this example, because 0.00225% is below the rinse-off threshold of 0.01%, it does NOT need declaring.
Therefore:
Supplier allergen document:
Limonene present
CPSR and Product label:
No Limonene declaration required
These are not contradictory. They are both correct.
However, for a leave on products such as a body butter, the declarable allergen threshold is 0.001%, therefore the final Limonene % in the above example of 0.00225% is over the leave on threshold of 0.001% and would need to be declared on the label.
EU vs UK Allergens
Currently at time of writing this (June 2026) If you sell to the UK you only need to list any of the 26 UK allergens that are declarable on your label.
If you sell in the EU, you need to list any of the 82 allergens on the EU list that are declarable on your labels.
The EU list also applies to Northern Ireland.
All Soak Assessments include all declarable EU allergens in the fragrance table.
If you are only selling in the UK, you only need to list the allergens from these that appear on the UK allergen list, but you CAN list all EU allergens if you wish.
Soak assessments include the % of that allergen present in the final product. You DO NOT put the percentage on the label, only the allergen name.
6. Do I Need A New CPSR Every Time New Documents Are Uploaded?
No.
New copies of SDS, IFRA or allergen declarations do not automatically mean you need a new assessment.
Usually, you simply need to:
✔ Keep the latest documents on file.
✔ Check that the IFRA limits and fragrance composition have not changed.
✔ Recalculate allergens if necessary.
7. When Do I Need A New Assessment?
You need a new assessment if:
– A fragrance is reformulated.
– IFRA limits change and your usage exceeds the new limit.
– The formulation of the product changes.
8. Who Is Responsible?
You.
The person selling the product is legally responsible for making sure it remains compliant.
Your assessor provides a snapshot of compliance at the time the report is issued. Ongoing compliance is part of running a cosmetic business and the responsibility of the responsible person.
9. How do I write a label?
Labels need to contain certain information. To write a compliant UK label, you must include the following:
- Your Product Name and what it is if not obvious from the name.
- How to use it.
- The full ingredients list as INCI names in descending order, highest % inclusion to lowest. Anything under 1% can be listed at the end in any order. Colour CI numbers may be listed with a preceding +/- if you wish. Colour ingredients with INCI names must be before the +/- at the end of your ingredients list. You may put ingredient common names in brackets after each INCI name if you wish. The word INGREDIENTS should be in capitals.
- Allergens should be listed at the end of the ingredients but before the +/- for colours if you have this, preceded by a * and ideally in bold or italic to make them stand out a little.
- Any warnings or advisories from your CPSR.
- Your responsible person name and address.
- The weight of your product. This needs to be a minimum height (taken from the UK gov website).
| Nominal Quantity | Minimum Height of Figures |
|---|---|
| Up to 50 g or ml | 2 mm |
| Over 50 g/ml to 200 g/ml | 3 mm |
| Over 200 g/ml to 1 kg/l | 4 mm |
| Over 1 kg/l | 6 mm |
- Batch Number (this can be anything you like, it is the number – or combination of numbers and letters – you assign to your completed batch of products to identify that batch. More on this below).
Expiry information. This will be on your CPSR and will either recommend a BBE (best before end) of 6, 12 or 24 months if the product is stable for less than 30 months, which can be written as BBE and an expiry date or you can use the hourglass symbol with the Month and Year.
OR if the product is stable for 30 months or more a PAO (period after opening) whereby you’d use the open jar Symbol with either 6M, 12M or 24M inside.
If you have a particularly small product and cannot fit all information on the label then it is acceptable to use the book/refer to instructions symbol. However, the product name, weight and responsible person details and a clear way to find these instructions, such as a website address or a separate card with the product, should be viewable.
There can be slightly different or additional requirements for EAA, EU and other countries, so always check those requirements and don’t assume one label fits all.
10. How do I write a PIF?
A PIF is a compilation of information about your product. There is no right or wrong way to write one so long as you include all information required.
Luckily for you Soak CPSRs form a big part of this, but there are extra things you need to include:
- All technical data sheets available for ingredients including: SDS, IFRA and Allergen Sheets
- A description of your product, the formula and how you make it.
- All your label images
- Products images (if possible)
- A GMP statement – Good Manufacturing practice ( a statement on how you comply with GMP and your working practices in relation to safe storage and handling of ingredients, cleaning and hygiene, etc). A GMP statement does not need to be complicated. It should briefly explain how you ensure quality and safety throughout your manufacturing process. For example:
Premises and Hygiene
State that products are manufactured in a clean and hygienic environment and that equipment is cleaned and maintained appropriately.
Raw Materials
Confirm that ingredients are sourced from reputable suppliers and that supplier documentation (such as SDS, IFRA certificates, allergen declarations and specifications) is retained.
Manufacturing Procedures
Explain that products are made according to documented formulations and methods, with ingredients weighed accurately and records maintained.
Batch Records
State that each batch is assigned a batch number and that records are kept to ensure traceability. More on this below.
Packaging and Labelling
Confirm that products are packaged in suitable containers and labelled in accordance with cosmetic regulations.
Storage
Describe how raw materials and finished products are stored under appropriate conditions to maintain quality.
Complaints and Corrective Actions
State that customer complaints are recorded and investigated, and that corrective actions are taken where necessary. More on this below.
– A no animal testing declaration eg: Animal Testing Declaration
The finished product and its ingredients have not been tested on animals by or on behalf of the Responsible Person for cosmetic purposes. The product complies with the animal testing and marketing bans set out under the UK Cosmetics Regulation and Regulation (EC) No. 1223/2009.
- Information on Suppliers and Packaging – Where you purchase your ingredients and product packaging.
- Any proof of claims. If you want to say your product helps cure or prevent an issue, it required proper claims testing, otherwise it should be marketed ONLY as a cosmetic. In which case you would write something like: Claims Statement
This product is marketed solely as a cosmetic product. No medicinal, therapeutic or other non-cosmetic claims are made or implied. Any descriptions used are limited to the product’s cosmetic function.
11. What else do I need to do?
Portal
For every product you put on the market you need to notify the Government Cosmetics Portal.
In the UK this is the SCPN (Submit Cosmetic Product Notification) Portal.
In the EU and Northern Ireland this is the CPNP (Cosmetic Product Notification Portal).
In the UK This involves signing up for an account here https://submit.cosmetic-product-notifications.service.gov.uk and going through a set of tick box questions about your product. You will also need to upload label images and your product formulation and percentages.
You only need to do this once for each product unless something about it changes.
Batch Records
You need to keep batch records.
To do this create a sheet with the following headings: Below is shown as an example only, these are not real batch numbers.
| Product Name | Date Made | Ingredient/Supplier/Batch Number | Assigned Batch Number |
|---|---|---|---|
| Bath Bomb | 12/06/2026 | Bicarbonate of Soda/Soak/00000001 Citric Acid/Soak/00000002 SLSa/Soak/00000045 |
SRBB0626 |
Then fill in similar to above.
Each time you go to make a batch of products, before you make, get out all of your ingredients and write down supplier name and batch numbers on your batch record.
Once you’ve done this, assign a batch number of your choice to your finished product. This can be just numbers, a combination of numbers and letters, whatever you like.
This identifies your product incase of a recall or customer issue.
12. Complaints and Reporting Undesirable Effects and Serious Undesirable Effects
If a customer reports an undesirable effect, such as skin irritation, redness, itching, swelling or another adverse reaction, details of the complaint should be recorded and investigated. Information such as the batch number, date of manufacture, product used, and details of the reaction should be recorded by you and kept in your PIF.
If the effect is minor, corrective actions should be considered where appropriate, such as reviewing ingredients, labels, instructions for use, or manufacturing procedures.
If a Serious Undesirable Effect (SUE) occurs (for example, temporary or permanent functional incapacity, disability, hospitalisation, immediate vital risk or death), the Responsible Person is legally required to notify the relevant competent authority without delay and cooperate with any investigation.
Records of all complaints, investigations and any actions taken should be retained as part of the Product Information File (PIF).
This is unlikely, but you should have a complaints spreadsheet ready to record any incidents no matter how minor, as this will be expected by authorities, even if it’s blank.
13. Get appropriate Insurance
Selling Online
At a minimum, most cosmetic businesses should have:
– Product Liability Insurance – protects you if a customer claims that one of your products caused injury, irritation or damage.
– Public Liability Insurance – covers claims for injury or property damage involving members of the public.
– Professional Indemnity Insurance (if offering advice or services) – can help protect against claims arising from professional advice or recommendations.
Selling at Markets, Fairs and Events
Most event organisers and market operators will require:
– Public Liability Insurance (typically £2 million to £5 million cover).
– Product Liability Insurance.
– Employers’ Liability Insurance if you have staff or volunteers working for you.
Other Insurance Worth Considering
– Stock and equipment cover.
– Business contents insurance.
– Cyber insurance if you sell through a website or hold customer information.
– Legal expenses cover.
A Few Things to Remember
- Insurance does not replace your legal responsibilities under cosmetic regulations.
- Insurers will usually expect products to be correctly assessed, labelled and manufactured.
- Keep your CPSRs, PIFs, batch records and supplier documentation up to date.
- Always check your policy wording carefully to ensure your specific products and activities are covered.
No single policy suits every business, so it is worth discussing your needs with an insurance broker or provider experienced in cosmetic and handmade businesses.
You can ask in the Soak Facebook Group for recommendations from others.
Advice on staying compliant
- Work on a computer. Don’t try and do everything from a phone. The cosmetics industry involves a lot of paperwork and regulations to keep on top of and you need to stay organised. You will find it extremely difficult without a computer. You need to keep track of ingredients stock as well as product stock, so a spreadsheet will help, or there is various software out there that can help you.
- If you struggle with the legal side, get help. Find someone who can take over this side of the business for you, as it’s not optional and you need to stay on top of it.
- Sign up to supplier/Soaks email list. This is the best way to keep up to date with regulation updates, as they will let you know whenever something changes, updates or discontinues.
- Create a checklist and every couple of month set a little time aside to check for regulation updates and new documents to download, check your allergens and labels are up to date, if anything needs updating act on it. Do a stock take and ensure all ingredients are in date and batch numbers recorded.
- The legal side is non-negotiable, but doesn’t have to be complicated if you take the time to understand it and make it part of your routine.
- If you are still stuck, then our safety assessor partners www.revega.co.uk offer not only our CPSRs, but also compliance services.