Questions and answers
Questions and answers
The most common questions about the safety report for cosmetics. If your question is not here, write to us via “Ask a question”.
The basics
Do I need a safety report for my cosmetic product?
Yes. Every cosmetic product sold in the EU needs a safety report before it goes on sale. This also applies to small quantities, handmade products and sales at markets or online. You also need a product information file, a correct label, the notification in the EU portal and a responsible person in the EU.
I make my own soap. Does this apply to me too?
Yes, as soon as you sell your soap. Soap for washing the skin is a cosmetic product.
I import cosmetics from Turkey or China. What do I need?
Whoever imports cosmetics from outside the EU is usually the responsible person for that product. Before it goes on sale, it needs a safety report under EU law, a product information file, a label that meets EU requirements and the notification in the EU portal. A report from the country of origin only counts if it was prepared under EU law. Your manufacturer usually has the documents needed: the recipe with quantities, data sheets for the raw materials and proof of good manufacturing practice. On request we ask the manufacturer directly. They send the documents to us in confidence.
I sell perfume. What do I need?
Perfume also needs a safety report, a product information file, a correct label and the notification in the EU portal before it goes on sale. As the recipe, alcohol, fragrance oil and water with their shares are enough. We do not need the secret formula of the fragrance oil; the allergen list and the IFRA certificate from your fragrance oil supplier are enough. Perfume is in price level 2: Report only €590, Complete €790 net. Each further fragrance on the same base costs €120 or €150.
Do I need a certificate for my cosmetics?
There is no certificate that approves cosmetics in the EU. What you need is the safety report, signed by a qualified safety assessor, plus the product information file, the label and the notification in the EU portal. Authorities and often retailers or marketplaces ask for these documents.
Can I create the safety report myself with AI?
An AI can draft texts and help you gather the documents. The assessment in the report, however, may only be carried out and signed by a person with a suitable university degree, for example in medicine, pharmacy or toxicology. A report without this assessment does not meet the legal requirement. At REGULARUS, Dr. med. Rosemarie Klotz assesses and signs it. Your AI can do the preparation: answer the questions in our questionnaire, calculate the price and gather the documents. You sign in, order and pay yourself.
Can my AI assistant do this for me?
Largely, yes. Through our interface your assistant can calculate the fixed price, list the documents needed and verify our reports. The interface is listed in the official directory of AI tools, the MCP Registry. All details are on the page "For AI assistants". You sign in, order and pay yourself.
May I do the EU notification myself?
Yes. The notification in the EU portal for cosmetics is free of charge and is done by the responsible person before the product goes on sale. With Report only you receive all the details and step-by-step instructions. With Complete we do the notification for you.
What is a responsible person, and do I need one?
Every cosmetic product in the EU needs a person or company established in the EU who is responsible for it. Usually this is the manufacturer or the importer. If your company is based outside the EU, for example in Switzerland or the UK, you need a representative in the EU. We take on this role on request.
Who can order from REGULARUS?
Businesses, including founders. REGULARUS is not intended for private individuals.
How it works
How does it work?
- You answer a few short questions and see your fixed price straight away. This takes about three minutes.
- You upload what you have. We sort it and tell you what is still missing. If something is missing, we can ask your manufacturer or supplier for it.
- You send everything for assessment. Our expert team reviews it, and Dr. med. Rosemarie Klotz assesses and signs your report.
How long does it take?
Your report is ready 10 working days after you have sent the complete documents. With express it takes 5 working days. If your product needs a stability test, the period starts with its result. The test takes 12 weeks from receipt of your samples.
When do I pay?
Preparing is free. Only when you send everything for assessment do you place a binding order. Payment is taken when we accept your order, at the latest 4 working days after you send it. If we do not accept the order, you pay nothing. You pay by card, PayPal or direct debit.
Who assesses my product?
Our expert team reviews your documents. Your report is assessed and signed by Dr. med. Rosemarie Klotz, specialist in internal medicine and safety assessor under the EU Cosmetics Regulation. A checking assistant (AI) sorts your files and tells you what is missing. It does not assess anything.
Can I call you?
We deliberately work in writing. That way every piece of information can be traced, as our documentation obligations require. Write to us via “Ask a question”; we usually reply within two working days.
Documents
Which documents do I need?
That depends on the product. After the questions, the platform shows you exactly what is missing. Usually it is:
- the recipe with all ingredients and quantities,
- a data sheet for each raw material from the supplier or manufacturer,
- for fragrance, the allergen list and the IFRA certificate for each fragrance oil, including essential oils,
- for products containing water, a stability test; if you do not have one, we carry it out,
- for contract manufacturing, proof of good manufacturing practice; if you make it yourself, two or three sentences about how,
- details of the packaging and, later, the label draft.
My manufacturer will not release the recipe. What now?
They do not have to give it to you. They can send it directly to us in confidence. Without a recipe with quantities, a safety report is not possible; the law requires it. If your manufacturer refuses altogether, write to us. You will not have to pay anything in that case.
Do I need laboratory tests, and will I know the cost in advance?
Products containing water need a stability test. If you have no report, we run it in our own laboratory for €290 per recipe in 12 weeks. No stability test is planned for solid soaps, oils, balms, ointments and butters without water, for lip care or for perfume. Whether your product needs further evidence becomes clear when we check your documents, before we accept your order and before you pay. If further evidence is needed, we tell you its fixed price before you pay, and you decide.
Do I get the ingredient list and the allergen information for my label?
Yes, in the Complete package. The label specification contains, for each product, the list of ingredients with INCI names in the correct order and the fragrance allergens that must be declared. We review your label draft once before the notification. You or your designer take care of the design.
My manufacturer has no IFRA certificates or allergen lists. What now?
With the Complete with service package we request missing documents from your manufacturer, and through them from the fragrance supplier, and follow up, for €190 per variety. If your manufacturer obtains the documents, simply upload them in the portal. For each fragrance we need at least the IFRA certificate and the allergen list. Without them the fragrance cannot be assessed; the supplier then has to provide them or the fragrance has to be replaced.
What happens to my data and my recipe?
Your files are transferred encrypted and stored in the EU. Only our expert team and the safety assessor can see them. We do not train AI with your data. We use your recipe and supplier data only for your order.
Prices and packages
How much does a safety report cost?
The price depends on the product type and the package. Per recipe, net: Report only €390 to €890, Complete €590 to €1,090. Each further variety on the same recipe costs €120 or €150. Volume discounts start at 5 varieties per order. Calculate your exact fixed price in three minutes; it is valid for 30 days.
Which price level does my product have?
- Level 1: solid soap, liquid soap, shower gel and shampoo, balm, ointment or butter without water, body and hair oil.
- Level 2: cream, lotion or serum with water, lip care, perfume, deodorant, products for the eye area.
- Level 3: eyelash and eyebrow serum, aerosol spray, oral and dental care, sun protection, hair dye.
Nanomaterials and novel active ingredients move a product to level 3. If our review shows a different level, we tell you before accepting the order, and you decide again.
What is the difference between the packages?
- Report only: the safety report. You handle the product information file and the EU notification yourself, with our templates and instructions.
- Complete: everything you need to sell. Safety report, product information file, label specification and the EU notification by us.
- Complete with service: like Complete. In addition, we take care of missing documents from your manufacturer and suppliers.
What is included in the price, and what can cost extra?
The Complete package includes, per product: the safety report (Part A and B) signed by the safety assessor, the product information file, the label specification with all mandatory particulars, one review of your label draft and the notification in the EU portal. Only services you book yourself cost extra: stability test €290 per recipe (products containing water only), review of advertising claims €150 per variety, requesting documents from your manufacturer €190 per variety, documents for Great Britain €760 per variety, express +35%, EU representative from €590 per year. Products for children under three and wipes or pads carry €290 per product; this is already included in your calculated fixed price. Nothing is added without your consent.
Are there any other mandatory costs?
No. You pay the fixed price of your package and the extras you book yourself. The notification in the EU portal is free of charge. Recurring costs only arise if you book the EU representative.
What is a variety?
A variety is a variation of the same recipe, for example with a different fragrance or colour. The recipe is assessed once; each variety is added at a low price.
Is there a discount for several products?
Yes. From 5 varieties per order 10%, from 10 varieties 15%, from 20 varieties 20% on package and varieties. Every variety counts, including the first one of each recipe: one recipe with five fragrances already gets 10%.
How much does the EU representative cost?
For companies in the EU €590 per year for the first recipe, €180 for each further recipe and €60 for each further variety. For companies outside the EU €690 per year for the first recipe, €240 for each further recipe and €60 for each further variety. All prices net. We act as representative for products whose safety report and product information file we prepared. It includes our name and address on your label; we act as contact for the authorities, report serious undesirable effects and keep your product information file up to date. If a new assessment becomes necessary, you receive a fixed price for it in advance.
Can I pay by invoice?
On the platform you pay by card, PayPal or direct debit. With a custom quote we invoice you.
Is the report also valid for the UK and Switzerland?
The report follows EU law. For the UK we provide the adapted documents as an add-on, €760 per variety. You will also need a responsible person in the UK. For Switzerland, please write to us.
My product is changing. What then?
If you change the recipe, packaging, use or target market, the report must be updated. Write to us and you will receive a fixed price for it. A further variety on a recipe we have already assessed costs €150 in the Complete package and €120 with Report only.
Many products
I have many products or launch new ones regularly.
Then we will gladly prepare a custom quote with fixed prices for your whole range, invoiced. Request it on the “Custom quote” page. We reply in writing, usually within two working days.