Regulations & documents
Service
Regulations & documents
Depending on the region of placing on the market, each cosmetic product requires an authorisation, notification or country-specific notification. The distributor is the 'responsible person ́ and is liable for having inspected and tested the products within the scope of his duty of care. Furthermore, product liability insurance only compensates for damage if this obligation has been met.
COSMETIC SERVICE has a qualified REGULATORY department and takes over these tasks within the framework of a delimitation of responsibility agreement, thus relieving the customer.


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The person responsible for cosmetic products (company) has to perform the following tasks, but can delegate or commission them to COSMETIC SERVICE within the framework of an agreement.
The EU Cosmetics Regulation requires that all cosmetic products with their formulation must be notified to the CPNP (Cosmetic Products Notification Portal) before they are placed on the market. The Internet portal has been operated by the European Commission since 2012 and enables uniform and central notification in all member states of the European Union. The CPNP system results from the Cosmetics Regulation (EC) No. 1223/2009 of 30 November 2009 (EU Cosmetics Ordinance). The notification is described in Articles 13 and 16 of the EU Cosmetics Ordinance.
CPNP comprises three notification obligations that a person responsible for cosmetic products (usually a manufacturer or importer, possibly also a distributor) must comply with before placing them on the market. This person is also personally liable.
- Information about the cosmetic product and its formulation, which will be made available to the poison control centresfor the purpose of providing prompt and appropriate advice in the event of health disorders.
- Information about the cosmetic product without the formulation, which is made available to the competent authorities of the federal statesfor the purpose of monitoring.
- For cosmetic products containing components in the form of nanomaterials, information on the nanomaterials must be notified 6 months before the cosmetic products are placed on the market (Art. 16 of the EU Cosmetics Ordinance). This information goes exclusively to the European Commission and, if necessary, to its Scientific Committee on Consumer Safety (SCCS) for evaluation.
The data collected via CPNP is not publicly accessible as individual data and will be treated confidentially.
The requested data is entered by the responsible person via a secure internet connection via online forms of the CPNP system and can also be corrected or updated later. The input can also be made by COSMETIC SERVICE or in the notification of cosmetic products with nanomaterials as a "delegate". In addition to the recipe, the EU Cosmetics Ordinance requires additional information, including the transmission of the label and the list of ingredients and, in the case of import, the indication of the original country of manufacture.
Furthermore, the notification is not an approval or a substantive review of the data. The person responsible for a cosmetic product, such as the manufacturer, importer or possibly also the distributor, is responsible for the products he places on the market and thus for safety and legal compliance. With regard to the assessment of security, the responsible person must appoint an expert to prepare a safety assessment. With regard to the determination of other legal conformity, the responsible person should contact an expert for the respective issue if necessary. COSMETIC SERVICE can be commissioned as a full service.
All cosmetic products made available on the market since 11 July 2013 must be notified in advance via CPNP.
This also applies to cosmetic products that were already on the market before and were already covered by national notification obligations. No data from the national notification obligations were transferred to CPNP. The notification must therefore always be made by the responsible person or an agent directly via CPNP.
LEGALLY REQUIRED DOCUMENTATION FOR ALL COSMETIC PRODUCTS:
- Preservation stress test (CBT)
- Dermatological report
- Setting up access to the CPNP (Cosmetic Products Notification Portal)
- CPNP Product Registration/Product
- Safety assessment in accordance with Regulation (EC) No. 1223/2009
- Product Information File (PID) in accordance with Article 11(EC) No.1223/2009
- Sun Screening at SPF Declaration
RECOMMENDATIONS:
- Stability test/compatibility test in the original packaging
- Leak test of packaging materials
- Preparation of the INCI declaration
- Layout text (check according to KVO/no legal advice)
- Certificate of marketability -EU- (issued when all documents are available in accordance with Regulation (EC) No. 1223/2009)
LABELLING OBLIGATION ACCORDING TO THE DANGEROUS GOODS ORDINANCE FOR BULK GOODS:
- Safety Data Sheet (SDS) (up to 25 components) for BULKWARE in an EU official language (please specify)
- Safety Data Sheet in another official EU language
- The additional component or part thereof
- Flash point determination according to Pensky Martens
OTHER TESTS:
- Documents Export (e.g. China) e.g. Free Sales Certificate, Manufacturing Certificate, Veterinary Certificate
- Detergents and cleaning agents
- Biocide Registration Germany
- Further tests (plant protection products, heavy metal determination)