CPSR for cosmetics: What is this report and how do you get it?

What exactly is a CPSR?

A safety assessment, a cosmetic safety report, a product safety report… the CPSR is known by many different names.

A cosmetic product safety report (CPSR) is a report on a cosmetic product that describes whether the product is safe.

You can compare it to a driver’s license. Cosmetics may only be sold if they have a good ‘driver’s license’ or safety report.

The driving instructors who ultimately determine whether cosmetics are safe enough to be put on the market are called safety assessors.

They are true professionals, because they spent years in training to know enough about cosmetics, dermatology, and legislation. And that’s a good thing, because the products they approve might just be used by millions of people.

How do you get a cosmetic product safety report?

Because a CPSR may only be compiled by safety assessors, you should look for such a person first.

If you have your products produced by a (private label) factory or a contract manufacturer with its own R&D department, they may employ a safety assessor.

It’s also increasingly common that they outsource this to an external party, because it’s such a niche and usually is not within the scope of a factory’s normal business operations.

Which tests should you perform for a CPSR?

Which cosmetic tests you have to do for a CPSR depends very much on the type of cosmetic. The most common tests are shelf-life tests, because the shelf-life of each cosmetic product must be substantiated.

These types of tests are called stability tests (i.e. is the product itself stable?) and compatibility tests (i.e. is the product stable in its final packaging?).

What information should be included in the report?

The Cosmetics Regulation EC 1223/2009, Annex I, specifies the minimum requirements that a safety report must meet.

It’s useful to stick to the order of these requirements, so that local authority inspectors don’t have to search for information – because who wouldn’t want a smooth inspection by the authorities?

A CSPR consists of:

• Part A – the entire description of the product
• Part B – the safety assessor’s conclusion

Below is the structure and mandatory minimum information required for a CPSR:

Part A: the entire description of the product

Part A of the CSPR includes the following points:

1. The composition of the product

This is the recipe, both the raw materials and all the ingredients these raw materials consist of. Certain codes help to clarify the identity of the substances, such as CAS numbers, EINECS/Elincs numbers, and INCI names.

INCI stands for International Nomenclature for Cosmetic Ingredients, which regulates what the substance is called when it is used in cosmetics.

2. The physical and chemical characteristics and stability of the product

Think of color, smell, appearance (liquid, solid), viscosity, pH, flammability, and so on.

The shelf-life studies are also discussed here, as these demonstrate whether the physical and chemical characteristics remain the same (i.e. stable) over time. If the product remains stable for a long time, it has a long shelf life and expiration date.

3. Microbiological quality

Of course, you don’t want bacteria and fungi to grow in the product. That is why, usually, a challenge test is performed, in which a lot of bacteria and fungi are intentionally added to the product.

If the product doesn’t rot or become mouldy afterwards, the product has been properly preserved.

4. Contaminants, traces, information about the packaging material

The raw materials and packaging materials used must, of course, be of good quality.

If a raw material has a low quality, it can contain a lot of contaminants such as heavy metals, pesticides and other substances that can be bad for human health.

That is why it must be documented exactly which and how many contaminants are in the product, so that a safety assessor can determine whether these are safe values.

5. Normal and reasonably foreseeable use, and misuse

The safety assessor puts himself in the shoes of the consumer and determines what the normal use of the product is.

A shampoo is normally used on the hair, and reasonably expected on the rest of the body as the product flows down in the shower.

Misuse of shampoo is that it is used as a mouthwash.

In this case, if you develop a super special shampoo that may not be rinsed off the body, the safety assessor will indicate that a warning or additional instruction must be included on the packaging.

This is why sunscreen always has a lot of instructions and warnings, to remind consumers to apply the product often and properly.

6. Exposure to the cosmetic product

The safety assessor will determine what the ‘exposure of the product’ is under normal and reasonably foreseeable use, which is a technical term for ‘how does a consumer use this product’:

• In what place(s) is it applied?
• How big is that area?
• How many times a day?
• How many grams at a time?
• How long does the contact last?
• What is the expected route of exposure?
• What is the target group?

The safety assessor also looks at unintentional exposure.

Think of a lip balm that is also partly swallowed, a deodorant spray that is partly inhaled, a hand lotion that gets on the face when you touch your face.

Fun fact: in a 2015 study, Australian medical students touched their faces no less than 23 times an hour.

7. Exposure of the individual substances

After the exposure of the entire product to the consumer, the exposure is also calculated for each individual ingredient. In particular, it is examined whether an ingredient is absorbed through the skin and thus enters the body.

Some substances are easily absorbed, others remain on the skin, and some substances such as alcohol even evaporate from the skin.

8. Toxicological profile of the substances

For each substance, it’s described what it does in terms of toxicology. Think of skin irritation, eye irritation, allergy, phototoxicity (after exposure to sunlight), but also long-term effects such as carcinogenicity, mutagenicity, toxicity for reproduction, and systemic effects.

This is where threshold values ​​come from, which indicate at what exposure the substance is harmful. These threshold values ​​are compared with the actual exposure described in section 7.

The difference between the real exposure and the harmful exposure is called a Margin of Safety (MoS). In cosmetics, an ingredient is safe if the actual exposure of a substance is at least 100x lower than the harmful exposure.

All ingredients in a product must have an MoS of at least 100 in order to approve the product as safe. An MoS of 100 means that the product only becomes harmful if you start using the product 100x more than you normally do.

Let’s say you use, for example, 10 liters of shampoo or 1 kilo of body lotion per day – you can imagine with such large quantities it’s indeed unsurprising if there are some harmful effects.

9. Unwanted side effects and serious unwanted side effects

Even with the safety thoroughly checked, sometimes health problems may still occur during product use, such as skin irritation or allergies. All these complaints are collected and described in this chapter. Are there too many complaints? Then the product must be adjusted.

10. Information about the cosmetic product

This describes all other relevant data, such as research on volunteers and SPF tests for sunscreen products

Part B: the safety assessment

Part B of the CSPR includes the following:

1. Conclusion: safe or not safe?
2. Label warnings and ‘instructions for use’
3. Motivation. This is the explanation for points 1 and 2. Here, the safety assessor specifically addresses details, such as when the product is intended for babies and young children, or when the product has other special requirements, or is simply a rather special product that has not yet been so common on the market (waterless toothpaste and shampoo, products that are on the borderline between cosmetics and another legislation, etc.).
4. Assessor credentials and approval of part B. Here the safety assessor proves that he/she has the right qualifications to do the safety assessment, and approves the safety assessment with date and signature.

Do I need a CPSR certificate in the EU?

It’s a legal obligation to only sell safe products. Safety is recorded in a fixed format in the CPSR. That is why in the EU it’s necessary to have a CPSR for every cosmetic product you sell, in addition to notifying your products in the CPNP.

A CPSR therefore contains a lot of information, including very sensitive, confidential information. Therefore, this report may not be shared with everyone, because the product formula is also described in it.

If you have a product made at a factory, chances are they won’t share the CPSR with you. To be able to provide that certainty, we created a SkinConsult safety certificate, which the manufacturer can share with you.

This (unofficial) safety certificate is a shorter version of Part B. This means you can see whether the product is safe, and who has assessed your product, without the manufacturer having to disclose its product formula. Then you can start selling products with confidence.

In addition to a CPSR and a safety certificate, you sometimes hear the term “free sales certificate”. This is an official certificate that you can request from authorities such as the NVWA (in the Netherlands) if you want to sell your cosmetics outside the EU. Think of countries such as Brazil, Australia, South Korea and the Middle East.

What are the costs of getting a CPSR?

Preparing a CPSR is primarily a paper exercise. The safety assessor really wants to know everything about the product.

The costs are mainly in reviewing the information that is provided, providing feedback on this, and figuring out the toxicology and safety of the ingredients.

In addition, there is also a significant difference in quality of safety reports between parties. This is tricky because it is really complicated for a non-safety assessor to see if a CPSR is of good quality.

And very annoying to only find this out during an inspection by authorities.

A first check you can do to know whether a safety assessor is good: if you have to provide a lot of documentation about the raw materials (often more than 5 documents per raw material), that is often a good sign.

Do note that an adjustment to the product also means that the CPSR must be adjusted by the safety assessor.

Suppose you also want to sell a hand lotion as a body lotion, or add an extra ingredient. The safety assessor must then assess whether the new exposure or the additional ingredient is still safe.

Even if the law changes (and it changes often!) it may happen that the product has to be adjusted so that it complies with the law again. In those cases, as well, the safety assessor must reassess the product.

Common mistakes when compiling a CPSR

The following are common mistakes when preparing a CPSR

1. Purchasing poor quality raw materials

Purchasing raw materials of poor quality, so that these raw materials cannot be used because they contain many contaminants including heavy metals such as lead and mercury.

2. Raw material suppliers who do not want to provide information

This is frustrating, because a safety assessor must have this information to approve a product safely.

3. Starting too late

If all information, including test reports, is present and correct in 1x, a safety assessment can be delivered quickly (our record is within an hour!). But if even one piece of information is missing, it can take a very long time.

4. The product must be used in a completely different way than expected

A product with the term ‘Hand’ in the name, which is then used on the entire body. Or a label from which the function is not clear (is it a body lotion or a hand lotion?).

5. Having already produced the product, and only then calling in a safety assessor

This is a major risk, because there is a chance that the safety assessor will have to reject the product if it is not safe. The product may then not be sold, and must therefore be thrown away.

6. A stability test, but no test of the product in the final packaging (i.e. compatibility test)

A stability test, but no compatibility test, which means that this test must still be used and there will be a delay of 2-6 months in the launch of the product.

Many of these errors can be easily prevented by calling in a safety assessor as soon as possible, preferably from the start. Making adjustments early means avoiding many difficulties later on.