Only biological material which can be handled under containment level 1 and 2 can be processed by the DSMZ. Highly pathogenic microorganisms of Risk Group 3 and 4 are not handled by the DSMZ. Risk Groups as defined by the European Parliament (2000) Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work.
The supply of certain strains may fall under one or several of the following restrictions. Which of the respective categories (A-F) applies for an individual strain is given in our catalogues. The categories are explained in the following.
Each microorganism of the DSMZ collection is classified according to German legislation (Biostoff-Verordnung*). If a strain is allocated to Risk Group 2 (= Hazard Group or Biological Safety Level) or Risk Group 3**, this information is given on the delivery note. The culture is marked with the bio-hazard label. Distributing cultures of Risk Group 2 and Risk Group 3** is restricted according to "Infektionsschutzgesetz" (Act dealing with the prevention and control of infectious diseases in man, IfSG). These restrictions apply to orders within Germany. A complete copy of the "Erlaubnis zum Arbeiten mit Krankheitserregern", §44 IfSG, must be provided. Outside Germany delivery may be restricted according to respective national laws. It is the sole responsibility of customers to work in conformity with their national regulations. The DSMZ asks for the respective permit/registration of the laboratory.
*see Council Directive 2000/54/EEC on the protection of workers from risks related to exposure to biological agents at work, and TRBA (Technische Regeln für Biologische Arbeitsstoffe): 'Einstufung von Prokaryonten (Bacteria und Archaea) in Risikogruppen' (TRBA 466) and 'Einstufung von Pilzen in Risikogruppen' (TRBA 460). In rare cases, the allocation in Risk Groups during genetic engineering by the ZKBS is deviating from that of the TRBA, more at FAQ. Council Directive 2000/54/EEC on the protection of workers from risks related to exposure to biological agents at work.
Restriction A1 applies and additionally distribution is restricted to customers using the strain for diagnostic or clinical purposes in Germany only.
According to the „Gesetz über die Kontrolle von Kriegswaffen" (German war weapons control act) and to the EU Council Directive EC/428/2009 “setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use items”, restrictions are placed on the distribution of certain microorganisms (see respective Annex, export list positions 1C351-1C354). Up-to-date information and appropriate forms including end-user certificates will be provided by the DSMZ. It is the sole responsibility of customers to familiarise themselves with their national regulations. Applies also to organisms of the Australia Group Warning List. The same legal restriction applies to genomic DNA.
These strains are not exported outside Germany according to the regulations cited under B1. The same legal restriction applies to genomic DNA.
According to the “Gentechnikgesetz” (German law regulating genetic engineering), all orders for genetically modified organisms (GMO) must be accompanied by a complete copy of the permit issued by the local regulatory authority responsible for overseeing work with genetically engineered organisms. In the case of orders of S2 organisms according to § 7 of the German Law Regulating Genetic Engineering (of Class 2 GMOs according to Article 4 of EU-Directive 2009/41/EC, respectively) restriction A1 applies in addition. The grouping of organisms into Risk Groups for genetic engineering in Germany are listed on the website of the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL), search for "Organismenliste". Outside Germany, it is the responsibility of customers to work in conformity with their national regulations.
For these organisms an agreement ("Material Transfer Agreement", provided by the DSMZ) has to be signed stating that these organisms, their genes, enzymes or metabolites will be used for specific purposes only and that they will not be distributed to third parties.
Restrictions are placed on the distribution of certain plant pathogenic species. Within the European Community, the European Parliament Council Directive 2000/29/EC "on protective measures against the introduction …of organisms harmful to plants …. and against their spread …” is in force. Orders from within the EU must be accompanied by aLetter of Authority according to Commission Directive 2008/61/EC (“...conditions under which certain harmful organisms...may be...moved within the Community...”). Intra-European shipment will then be released by the German authority on the basis of this Letter of Authority. Orders from countries outside the EU have to be accompanied by the import permit of the respective nation, which can usually be applied at the local plant protection service. This Import Permit or Letter of Authority (alternatively Certificate of Exemption) will be checked by the German authority and Export Permit will be issued on the basis of this documentation. It is the responsibility of customers of non-EU countries to familiarize themselves with their own national regulations.
The distribution of these organisms is restricted within Germany by the "Tiergesundheitsgesetz", the "Tierseuchenerregerverordnung", the "Verordnung über meldepflichtige Tierkrankheiten" and the "Verordnung über anzeigepflichtige Tierseuchen". A copy of the permit to work with animal pathogenic organisms according to § 2 "Tierseuchenerregerverordnung" must be provided. The export of these microorganisms is restricted, see "Tierseuchenerreger-Einfuhrverordnung".
Strains appearing in the DSMZ Catalogue of Strains with reference to a patent are mentioned in that patent. It is the sole responsibility of the customer to check whether the intended use of the strain may infringe that patent. Strains listed in the DSMZ Catalogue of Strains may also have been used in patents of which the DSMZ is not aware.