Notify cosmetic products (possibly with nanomaterials) before placing them on the market

Service Description

Cosmetic products are not subject to authorization. However, certain components of cosmetic products such as new preservatives, colorants and UV filters are exempt from this requirement. Regardless of which cosmetic product is involved, the safety of the product must be guaranteed. If you want to make a cosmetic product available on the European market for the first time, you as the "responsible person" (usually the manufacturer or importer, and possibly also the distributor) must provide some information about your product in advance. This is done via the notification portal for cosmetic products (Cosmetic Products Notification Portal, CPNP).

The CPNP is operated by the European Commission and enables uniform and centralized notification in all member states of the European Union.

The CPNP makes this information available electronically to

  • competent authorities (for the purposes of market surveillance, market analysis, evaluation and consumer information)
  • Poison information centers or similar bodies established by European Union countries (for the purpose of medical advice)

The CPNP is accessible to:

  • Persons responsible for cosmetic products
  • Distributors of cosmetic products
    • Notification in the CPNP does not include approval or verification of data. As a responsible person, you must ensure that the cosmetic products you place on the market are safe, that their intended use is guaranteed and that they comply with the legal provisions.
  • The CPNP is intended for manufacturers of nanomaterials in order to be able to add detailed information on nanomaterials used in a cosmetic product to the notification of the cosmetic product.

The CPNP includes 3 notification obligations that you as the responsible person must fulfill before your cosmetic product is placed on the market for the first time:

  • 1. information about the cosmetic product and its formulation, which will be made available to poison information centers for the purpose of providing prompt and appropriate advice in the event of adverse health effects.
  • 2. information on the cosmetic product without the formulation, which is made available to the competent authorities of the federal states for the purpose of monitoring.
  • 3. cosmetic products containing nanomaterials other than colorants, preservatives and UV filters must be notified 6 months before being placed on the market. This notification must be made in addition to the notification referred to in Article 13. This information is sent exclusively to the European Commission. If the European Commission has concerns about the safety of a nanomaterial, it may ask the Scientific Committee on Consumer Safety to carry out a risk assessment.
    • To fulfill this obligation, you as the responsible person can appoint a nanomaterial representative.

In cosmetic products, "nanomaterial" refers to a natural, process-derived or manufactured material consisting of solid particles that occur either independently or as recognizable constituent particles in aggregates or agglomerates, and where at least 50 percent of these particles in the number size distribution meet at least one of the following conditions:

(a) one or more external dimensions of the particles are in the size range of 1 nanometer (nm) to 100 nm;

b) the particles have an elongated shape such as a rod, fiber or tube, with two outer dimensions being less than 1 nm and the other outer dimension being greater than 100 nm

c) the particles have a platelet-like shape, where one outer dimension is less than 1 nm and the other outer dimension is greater than 100 nm.

In addition, the national Cosmetics Ordinance must be observed. Anyone who manufactures cosmetic products in Germany must notify the competent authority responsible for monitoring the place of manufacture before placing them on the market. If cosmetic products are imported into the European Union, the person responsible for the import must notify the competent authority responsible for supervision of the place where cosmetic products are brought into the scope of this Regulation (place of import) before they are imported for the first time.

Source: Zuständigkeitsfinder Thüringen (Linie6PLus)

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Competent Authority

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) Referat 113

Address
Gerichtstraße 49
13347 Berlin, Stadt

Postal address
Post office box 11 02 60
10832 Berlin, Stadt
Telephone
+49 301 8444-99999
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Remark: (Serious) undesirable effects with cosmetics (SUE)