Frequently Asked Questions

What are cosmetic products and which products are included?

Cosmetic products are substances or mixtures that are intended to be applied externally on parts of the human body (skin, hair system, nails, lips and external intimate regions) or with the teeth and mucous membranes of the oral cavity for the sole or predominant purpose of predominant purpose of cleaning, perfuming or changing their appearance, protect them, keep them in good condition or influence body odour. ¹. Products that are not applied to the body (externally) or not applied to humans (e.g. room fragrances or dog shampoo) are not cosmetics. If you unsure whether your product falls under the category of cosmetics, please contact us.
¹ _{REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products}

What legal requirements must be observed when manufacturing and selling cosmetic products in particular?

The most important requirements for cosmetics are set out in EU Regulation (EC) No. 1223/2009 on cosmetic products. It primarily regulates aspects of product safety for human health, e.g. which ingredients are not permitted, which restrictions apply and how the products must be correctly labelled.

In which countries does the Cosmetics Regulation apply?

The EU Cosmetics Regulation applies directly in every EU member state and does not have to be converted into national law, thus ensuring a uniform standard within Europe. However, the language requirements for labelling are country-specific and there may be additional reporting or labelling obligations in various member states.

Who is responsible for compliance with the legal provisions?

If a cosmetic product is placed on the market within the European Union, a Responsible Person must be designated. In practice, this is often the manufacturer of the product, but it can also be an importer or a distributor if the product is placed on the market under their name or trade mark. The most important obligations of the Responsible Person are listed in Article 5 of the Cosmetics Regulation.

What must be observed when importing cosmetic products into the EU?

For every product that is imported into the EU and placed on the market, the importer is initially the Responsible Person – with all the resulting obligations. However, he can also transfer this responsibility via a mandate to a legal or natural person established in the Community, who accepts this mandate in writing. Upon import, the products must comply with the provisions of the Cosmetics Regulation and be labelled with the address of the Responsible Person.

What must be observed when exporting, e.g. to Great Britain?

When exporting, the legal provisions of the destination country must always be observed and complied with. We can advise you on the legal requirements for cosmetic products in the UK.

What is a Product Information File and are there requirements for its format?

A product information file (PIF) must be created for every cosmetic product that is placed on the market in the European Union and, in accordance with Article 11, contains all information that ensures that the product complies with the requirements of Regulation (EC) No. 1223/2009. There are no specific requirements for the format of the PIF. However, the information should be presented in a clear and structured manner to enable efficient verification by the competent authorities. The PIF can be in electronic or printed form, but must be available at all times at the address of the Responsible Person within the EU.

What information do we need to prepare a safety report or a PIF and in what format?

The content requirements for a safety report are listed in Annex I of the Cosmetics Regulation. When you enquire about a safety report or a PIF, we will send you a detailed questionnaire in which you provide us with the basic information. We may ask you for any further product-specific information, test results, etc. in advance of the safety report.
Flexibility is very important to us and we are happy to customise our solutions to your individual requirements and needs.

If certain test results are requested, can/must they be carried out by COSICHEM?

No, we do not have our own laboratory equipment.
You can send us test results from your preferred service providers and in various formats without having to make any adjustments.
However, we can also provide you with the names of independent test laboratories.

How long is a safety report valid?

There is no fixed period of time after which a safety report automatically becomes invalid.
A safety report summarises the basic information on the properties of the product and takes into account legal requirements and current knowledge of the substances contained and their properties. The possible health hazards are considered and assessments for the safe use of the product are derived from this.
The safety report remains valid as long as no safety-relevant changes are made to the product or new scientific findings or legal changes require a review.
It is therefore advisable to review the report regularly and update it as necessary to ensure that all safety requirements continue to be met. In our personal experience, this makes sense at least every 4 years.

What costs should I expect?

We can offer you various types of support based on your needs and the planned budget. From specific answers to individual questions, through the preparation of reports and assessments, to comprehensive overall packages, we can provide customised solutions to suit your needs.

We will be happy to provide you with a customised quote for the final costs.