Simply bringing cosmetic products to the EU market isn’t allowed. Every product must firstly comply with European legislation. One requirement is the presence of a product information file.
Just putting cosmetic products on the EU market isn’t allowed. Every product must firstly comply with European legislation. The most important aspect of this law is that a cosmetic product is safe for use. Sounds logical, but what does this look like?
All cosmetics sold in the EU require a report that exactly describes what the product is, where it comes from and if it is indeed safe for use. A kind of cosmetic passport.
Such cosmetics passport is called a Product Information File, or PIF. This file contains all sorts of information about the product, to allow competent authorities such as the Dutch NVWA to easily read and check this.
This not only allows them to check whether the product complies with all legislative rules, but also whether the product is safe. Because consumers must be able to trust that all cosmetics in the EU are safe for use.
A PIF basically has three parts: a safety assessment, a CPNP notification and an administrative part. But that’s not the whole story.
Besides the actual product safety assessment, the most important information in the dossier is who the Responsible Person is. This is the company who carries the final responsibility for the cosmetic product.
Often this is the brand owner, but it can be any party in the EU.
The Responsible Person must also be stated on the product packaging, to make it clear to everybody that this company guarantees the safety of that particular product.
It is important for each product to have a Responsible Person, because this party not only is obligated to prove the safety of their products, but also must ensure that customer complaints are followed-up correctly.
Or in the worst-case, when a product must be recalled from market due to a product defect or risk to consumer health, then the Responsible Person must ensure that this is done.
The PIF obviously has a product description, so what the product looks like, how it is used and by whom. This gives clarity on which product this dossier belongs to. Comparable to a photo in your passport.
The PIF also contains the more technical details provided by the manufacturer. The product formulation for example, but also a description of the manufacturing process.
When something goes awry during manufacturing, this description immediately paints a clear picture to both authorities and safety assessors what the causes and effects of this problem are.
Furthermore, the manufacturer must prove that they manufacture their products according to standardized processes and protocols – also called Good Manufacturing Practices (GMP).
Many cosmetic products contain exciting marketing claims, to promote their sale to consumers. Obviously you can’t just claim whatever you’d like, the claim must be correct.
That’s why is it crucial to provide adequate claim substantiation. That not only goes for claims such as “anti-wrinkling”, but also claims about Sun Protection Factors (SPF), or that a product is made specifically for baby’s, or a sensitive skin.
A lot of work is spent in the PIF to prove that the product is free from animal testing.
Animal tests, are they even still done for cosmetics? Well, no, since the EU has forbidden animal testing for cosmetics decades ago.
But you still need to prove that this is the case, especially for products and raw materials from non-EU countries. That’s why (non-)animal testing is still a part of the product information file.
A PIF is really an EU-passport for cosmetic products containing all of the important information about the product, including its safety.
The Responsible Person is the company stated in the PIF as the party that ensures that the product is safe and will remain safe, going full-circle on its safety.
The good news: everybody can make a PIF! You don’t need a special education nor a certificate. The only thing you need is a lot of information on the product.
This information often comes from multiple parties, including the manufacturer, raw material suppliers, packaging suppliers and brand owner.
Much of the information that is stated in the administrative part of the PIF, is also part of the safety assessment. This safety assessment can only be done by a specialized safety assessor.
So when you’re compiling a PIF, it is highly recommended to collaborate as much (and as early) as possible with such safety assessor, because of the overlap in information.
What also happens often, is that the safety assessor creates both the safety assessment and the administrative PIF, because this saves a lot of time. And the faster the full PIF is completed, the earlier the product can go to market.
For a product information dossier, a lot of information is needed. Most of the work for compiling a PIF actually goes to obtaining the information from all stakeholders, and processing this information.
To give you an example, for demonstrating that your product is free from animal testing, you not only need a statement from the product manufacturer, but also from all of the raw material suppliers.
For a complex product like a cream this can easily be 20-30 different suppliers who all need to send such statement.
Talking about complex, claim substantiation is another part of the PIF that can bring hidden extra costs with them.
Some claims are easy to substantiate because they aren’t very ‘strong’ claims (like ‘nourishes the skin’). But other claims dó need very thorough evidential claim support.
The claim ‘dermatologically tested’ must be done by an actual dermatologist. These clinical studies cost more money to do, which is fair because they feel stronger and more convincing than a claim like ‘feels great on your skin’.
Other claims are even obligatory to test, like the SPF sun protection factor, but also for demonstrating the minimum durability or shelf-life for your product (which is also a claim, since you claim that this product ‘is at least durable for X amount of time’).
So keep these additional costs into account during product development.
To compile a PIF, there are various parts that may include costs:
For the administrative part of a PIF, the costs are usually quite okay (a few hundred euros), it is especially the clinical testing that may cost a few thousands of euros.
Which sounds fair, because a lot of people are involved in these types of tests, but it is good to realise beforehand. We highly recommend to check which tests are needed before you start to produce and sell your products.
The legislation on cosmetics and cosmetic safety is the Cosmetics Regulation EC 1223/2009. A Regulation is a type of legislation that is directly applicable to all member states.
With other words: the cosmetics law is the same in all EU countries. For example, a PIF in the Netherlands is also accepted in France and vice versa.
A product information file or PIF is the passport for cosmetic products. It is obligatory in the EU that each cosmetic product put on market has a PIF. The Responsible Person is the company carrying the final responsibility for the product, and for the PIF.
The PIF consists of a safety assessment, a CPNP notification and an administrative part. Authorities like the Dutch NVWA use the PIF to check whether the product complies with the Cosmetics Regulation.
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