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Permissions / RestrictionsGenehmigungen / Beschränkungen

Permissions and Restrictions

The supply of cell lines might be subject to restrictions. Pertinent risk codings are indicated in the information sheets provided for each cell line.

A

In accordance with German law (Biostoffverordnung), the DSMZ has carried out biological risk assessments for every cell line in the collection. Uncontaminated cell lines are generally allocated to Risk Group 1 (RG1) (TRBA 468). Only virally / microbially infected cell lines are deemed potential hazards and may be graded Biosafety Level (Schutzstufe) 2 or higher.
According to §6 and §7 of the Biostoffverordnung, each employer is obliged to perform risk assessments for the protection of employees. The DSMZ biosafety level classification does not provide any exemption from this responsibility. Helpful tips may be found in: Technische Regeln für Biologische Arbeitsstoffe (TRBA): Liste der Zelllinien und Tätigkeiten mit Zellkulturen (TRBA 468), Einstufung von Bakterien in Risikogruppen (TRBA 466), Einstufung von Viren in Risikogruppen (TRBA 462) and Schutzmaßnahmen für gezielte und nicht-gezielte Tätigkeiten mit biologischen Arbeitsstoffen in Laboratorien (TRBA 100), Einstufungskriterien für Biologische Arbeitsstoffe (TRBA 450).

B

Restrictions are placed on the distribution of Biosafety Level 2 cell lines. Cell lines infected with human pathogenic microorganisms, or known to release human pathogenic viruses may be distributed only to customers who provide evidence that they have the necessary authorization to work with pathogens. In Germany, a permit according to §44 Infektionsschutzgesetz (IfSG) must be provided. For exceptions, see §45 IfSG. Customers from outside Germany must show a valid permit provided by their competent authorities. The DSMZ reserves the right to decide on shipment of Biosafety Level 2 cell lines.

C

Cell lines infected with microorganisms or viruses pathogenic to animals may only be released to customers providing evidence that they have been granted the necessary authorization. In Germany, a permit according to §2, §3 Tierseuchenerregerverordnung is mandatory. Customers outside Germany must possess a valid permit provided by their competent authorities. The DSMZ reserves the right to deny shipment of Biosafety Level 2 cell lines without further explanation.

D

According to German and European legislation (Gentechnikgesetz, EU-Directive 2001/18 EG), risk assessments must be performed before starting work with genetically modified organisms (GMO). Risk assessment demands knowledge about the potential hazards arising from the cloned sequences, the vector and from the organism to be modified (host organism). GMOs may be transferred only to parties possessing appropriate permits from competent authorities. The DSMZ requires the name of the issuing authority, the name of the project manager and the reference number of the official permit, all information to be given on the MTA. GMOs will be sent to the project manager only.

E

Monkey cell lines require import and export permits according to the Convention on International Trade in Endangered Species (CITES). Therefore, shipment may be restricted to EU countries only. Please inquire beforehand to Dr. Klaus Steube kst@dsmz.de.