Regulatory Affairs Cosmetics

My name is Timo Ulrichs, and I am head of the safety and regulatory affairs cosmetics department at Dermatest GmbH. From a legal point of view, placing cosmetic products on the European market is associated with a great responsibility. Fulfilling the requirements as set out in the European Cosmetic Regulation is a challenge for you as a responsible person. My team and I will be happy to support you in all regulatory issues that arise during development, manufacturing and marketing. The cooperation with Dermatest brings many advantages:

Although we cannot exempt you from the obligation to comply with the requirements of Regulation (EC) 1223/2009 on cosmetic products, we look forward to supporting you in implementing the requirements of this regulation
We take care of safety assessments, which have to be carried out by a qualified person
We issue product safety certification
Through our many years of experience and continuous training, we pursue the goal of bringing safe and legally compliant products to the market, only
Our team of state certified food chemists place their expertise entirely at the service of your product
We support you on aspects related to Cosmetic Product Safety Reports (CPSR), product information files (PIF), notifications of cosmetic products (CPNP), required labelling elements on packaging and product and even research on cosmetic products

Safety assessments

FAQ

Regulatory services

Safety assessments

In Europe, new cosmetic products are carefully evaluated even before they reach the shelves. Each manufacturer of cosmetic products is responsible for the safety of its own products. As a responsible person, you must provide the following documentation before placing the product on the European market in accordance with the requirements of the European Cosmetics Regulation (EC) 1223/2009:

Safety assessment in accordance with Art. 10 compiled in a Cosmetic Product Safety Report (CPSR)
Product information file in accordance with Art. 11
CPNP notification in accordance with Art. 13

Especially the safety assessment must be carried out by a qualified person. At Dermatest, we have a wide range of experience in this sector and will be happy to consult with you on any requirements and questions that might come up. We look forward to supporting you in topics like:

Checking the relevant labelling information and packaging requirements for cosmetic products according to Art. 19
Issuing the conformation about individual marketability for European market (provided that the Cosmetic Product Safety Report (CPSR) is available)
Consulting and research related to cosmetic products

Ask us now about cosmetics regulatory affairs or advice

We will get back to you promptly

FAQ

Why is the patch test so important for safety assessment / cosmetic product safety report (CPSR)?

A patch test provides information how well a product is tolerated by skin. This test should be carried out on at least 30 test subjects. Special groups of test subjects (e.g. sensitive skin) can be included if a product is of interest to this user group. A cosmetic product should not show any skin reaction in the simple test on 30 test subjects.

When is a test of efficacy needed?

If specific claims are made for the product (e.g. “improves skin hydration after 4 weeks”), such a claim must be proven by a scientific study. The study design should be determined to match the claim. For sun protection products, a determination of the SPF (Sun Protection Factor) and, if applicable, the UVA protection is mandatory.

When is the documentation required?

Before a cosmetic product is placed on the European market for the first time (placing on the market), all documentation must be complete.

Where should the documentation be kept?

The responsible person (manufacturer, importer or distributor, if applicable) shall keep the documents easily accessible to the national authority in electronic or analog form at the address indicated on the label. In Europe, the authorities of the Member State in which the file is kept are responsible.

Where can I find a product safety data sheet (or Material Safety Data Sheet, MSDS) and the specifications for a raw material?

The manufacturer/supplier of the raw materials must provide you with these documents.

What is an IFRA Certificate?

Perfume oils used in cosmetic products must have a so-called IFRA certificate of International Fragrance Association from the manufacturer in addition to the safety data sheet, which specifies the safe use concentration of the perfume in various cosmetic product categories. The IFRA certificate can be requested from the raw material supplier.

Regulatory services

Our mission is to support you in your responsibility for the safety of your product and to assist in placing only safe and marketable products on the market. The European Cosmetics Regulation (EG) 1223/2009 defines exactly which products are called cosmetic products:
“Cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors.”

We place our expertise in the field of safety assessments for cosmetic products at the service of your product. Make use of the extensive possibilities and individual service we offer when placing your products on the market.