Should my cosmetic products be tested or approved?
For cosmetics it is a common misunderstanding that “someone”, usually an authority, should approve it. That is not the case. The manufacturer or importer is responsible and can, at his own discretion, bring a product onto the market at any time.
However, this does not mean that you as a manufacturer or importer, do not have to comply with any rules. Your cosmetics should comply with the Cosmetics Regulation (EC) 1223/2009. When sale starts, the product must be registered with the CPNP and there must be a Product Information Dossier (PIF).
What does registration with the CPNP mean?
If you introduce a cosmetic product on the European market for the first time, you must notify this product to the European Cosmetic Products Notification Portal (CPNP). This makes information about cosmetic products electronically accessible to authorities of the member states. With emphasis: a CPNP notification is not an “approval” of your product. CPNP also does not reject products. A product is signed up and ready. Nothing more, nothing less.
The idea behind CPNP is that at European level insight is gained about the products that are present on the European market. Authorities can find information about compounds if, for example, health problems occur.
What information do I need to draw up a Product Information Dossier (PIF)?
You need: the complete composition of the product as it is made in the factory.
An (M) SDS of the product or a list of INCI names that show the composition of a product is not sufficient.
You need: a description of the properties of the product, the label, the manufacturing method (you must demonstrate that the product has been manufactured according to GMP) and much more. What exactly more depends on the type of product. A powder will not go moldy but can be microbiologically contaminated; something must be done with that. For a product which claims ‘against wrinkles’, you must justify the effect. This is not necessary for a bar of soap. Everyone knows what a piece of soap does.
We can only advise you to contact specialists. Whether you want to do this with us or elsewhere, the most important thing is detailed advice, to prevent incompleteness of your file.
In which language should my PIF (product information file) be drawn up?
In Europe, The PIF must be drawn up in the language of the country OR in a language that is easy to understand for the authorities. There is consensus that English is easy to understand for all authorities. It is therefore sufficient to draw up your PIF in English, after which it can be used throughout Europe.
Is an SDS for cosmetics mandatory?
No, for cosmetics it is not obliged to have an SDS available. However, sometimes it is asked for transport properties. If desired, an SDS can then be prepared.
What do I have to comply with when importing cosmetic products from outside the EU?
As an importer, you are legally equal to a European manufacturer. This means, you are the responsible person who brings the product to the market. As a consequence of this, you have the obligation to arrange a registration with CPNP and to have a Product Information Dossier (PIF) available.
The label of a cosmetic product placed on the European market must fully comply with the requirements as laid down in Cosmetics Regulation (EC) 1223/2009. Consider, for example: the INCI list and the name and address of the person who places the product on the market.
We also hope you will be very successful and will sell large volumes. In case you bring more than 1000 kg of a single chemical on the European market per year, you will have to deal with REACH. See our FAQ on CLP & REACH for more information.
What are my obligations if I buy cosmetic products within the EU and sell them under my own name?
If you purchase cosmetic products within the EU, the responsibilities are split. The manufacturer is in fact the person who places the product on the market. In principle, the manufacturer has the obligation to provide a Product Information Dossier (PIF). On the other hand, because your brand or company name is on the product, you are the responsible person for the authorities. They expect you to have the PIF.
The most obvious solution is that the manufacturer takes care of the PIF and that you arrange the CPNP registration.
In practice it is likely that the manufacturer is not willing to provide you with the PIF. In this case you should realize that a cosmetics file, a PIF, contains such a precise description of the product that the product can be easily imitated. By giving a PIF to you, you are actually asking your supplier to give up his competitive position. You can imagine that manufacturers are not always keen on this.
I use only natural ingredients in my cosmetics. What are my obligations?
Whatever type of ingredients (raw materials) you use for your cosmetic product, your product falls under Cosmetics Regulation (EC) 1223/2009. You will have to comply with all obligations. It is a common misunderstanding that natural ingredients are safe; cosmetic products on a natural basis are not safe by definition.
We do not want to disturb anyone’s dream, but in practice it is rather complicated. Of course there are no problems with sunflower oil or olive oil, but safety is by no means guaranteed for many essential oils. Unfortunately, scientific information about the long-term health effects of many natural ingredients is not always available.
I sell my cosmetics via the internet only. What are my obligations?
If you sell your cosmetics via internet, you sell your cosmetics on the market. It does not matter whether or not you have a physical store. Therefore, you must comply with all obligations as laid down in Cosmetics Regulation (EC) 1223/2009.
CLP & REACH
I import chemical substances and mixtures from outside the EU. What are my obligations?
REACH regulation (EC) 1907/2006 applies. Next to this, it is likely you should have an SDS of your product and you might be required to register or notify your product at an Anti-Poison Center. For cosmetics other rules apply. See our Cosmetics FAQ.
When does REACH apply for my products?
If you import into the EU/EEA 1000 kg or more per year of an individual chemical substance, REACH regulation applies. 31 May 2018 was the last change to submit a REACH registration for existing substances manufactured or imported in amounts more than 1000 kg per year. If the registration obligation applied to you but you did not submit your dossier in time, as from 1 June 2018 you can no longer manufacture or import your substance legally into the EU/EEA.
If you missed the deadline, you should make yourself compliant without delay. With a pre-registration or inquiry number, you can register your substance directly. If you do not have a pre-registration or inquiry number, you need to submit an inquiry to the European Chemicals Agency (ECHA) before registering it. If a registration is submitted to ECHA after 31 May 2018, you will need to wait until you receive your registration number before resuming or starting manufacture or import of your substance.
What is the difference between an MSDS and an SDS?
There is no difference regarding the document. It is just a different name.
MSDS means Material Safety Data Sheet. This is the old name. SDS means Safety Data Sheet and is the new name which is used from now on.
Sometimes you will receive an e-SDS, which means extended Safety Data Sheet. This is a common SDS with in the attachment the Exposure Scenarios as they are REACH registered together with the substance concerned.
When do I need to have an SDS prepared for my product?
In general we advise to have an SDS prepared for all your products. The reason for this is that transporters and warehouse managers must be able to demonstrate whether or not a product is dangerous during transport or storage. Even if the product is not dangerous, they want it to be confirmed by “a paper”. Of course you can always send a letter or an email, but the alternative that everyone is happy with, is the SDS.
To whom do I have to provide an SDS?
To the professional users/buyers of your product. You do not have to provide an SDS to consumers.
In which language should my SDS be written?
The SDS must be written in the language of the country where your product is offered. Info-Care provides SDSs in 27 languages.
If you need SDSs for outside the EU, please contact us for the possibilities and requirements.
How do I know that the label of my product is correct?
Chapter 2.2 of your SDS provides guidelines for all mandatory texts and images on the label of your product. In principle, the label texts are harmonized at European level. However, Europe would not be Europe if there are no differences now and then. Sometimes, countries have drawn up special rules for specific products. In that case, consider that the label texts in the various languages and countries are deemed to be the same. So, if you have additional texts on the label in Germany because of a German regulation, then the Dutch label must be made the same. Especially if you sell the product in both countries with a multilingual label.
When should my product be registered at an Anti-Poison Center?
Unfortunately, the rules for registration at an Anti-Poison Center are not regulated at European level and therefore vary from country to country. Info-Care is aware of the different procedures and is happy to help you. In general it can be stated that if a product is classified, a notification/registration is required. For non-classified products it is not always mandatory but often recommended.