Samples and Substances

Sample Risk Assessment and Sample Operation Instructions

Post beam time allocation a safety letter is issued to the main proposer. If requested, document your Experimental Safety Risk Assessment and Operation Instructions in the template and submit it latest one week prior to your experiment via expsaf@xfel.eu

Please contact the European XFEL biological safety officer Sigrid Kozielski or experiment safety engineer René Gertz for questions.

Template: Experimental Safety Risk Assessment and Operation Instructions
Sigrid Kozielski

Sigrid Kozielski

European XFEL GmbH
Holzkoppel 4
22869 Schenefeld
Germany

René Gertz

René Gertz

Safety Engineer

European XFEL GmbH
Holzkoppel 4
22869 Schenefeld
Germany

Samples in UPEX

Each sample or substance brought to the European XFEL must be described in the samples section. When filling out the samples section please give as much detailed information, select and tick the boxes where required.

In case the sample or substance needs to be used in a laboratory the section 5 “laboratory access” needs to be filled out.

Under Sample/Substance provide the detailed name of the substance or sample.  

Under Sample/substance description the entire composition of your sample must be given, this includes the chemical formula or CAS number if available.

Under reception and storage requirements please state how the sample arrives at European XFEL (brought by user/send to XFEL) and whether there are special requirements for reception and storage (fridge, humidity control, in the dark,…). Please order standard samples/substances on user accounts directly to European XFEL. Please get in contact with the relevant lab responsible European XFEL staff early to further discuss reception and storage options !

For storage it is mandatory that containers have to be clearly and permanently labelled with name of the owner, the name of the substance and the appropriate hazard labels according to the Globally Harmonized System of Classification and Labelling of Chemical (GHS).

Under Usage requirements describe any special requirement that you need for using the sample at the instrument.

All samples and substances must be removed by you after completion of the experiments. In case you wish to dispose samples or substances on-site the waste disposal policy of European XFEL must be followed. The disposal collection vessels and procedures of disposal are provided by the Safety Group. Please contact the Safety Group for details (expsaf@xfel.eu).

Under associated risks you should describe any danger associated with the reception of the sample or subtance, the risk associated to any used equipment and or disposal of the substance.

Biological Samples

According to the German and European biosafety legislation biological agents are

  • micro-organisms, cell cultures and endoparasites including their genetically modified forms,

  • agents associated with transmissible spongiform encephalopathy (TSE), that may constitute a hazard to humans as a result of infections, communicable diseases, toxin formation, sensitization or other effects which are harmful to human health.

The following substances are considered as equivalent to biological agents:

  • ectoparasites which may cause autonomous diseases in humans or create sensitising or toxic effects,

  • technologically produced biological entities with new properties that may pose a threat to humans in the same way as biological agents.

Micro-organisms are all cellular or non-cellular microscopically or sub-microscopically small biological entities which are capable of replicating or transferring material, in particular bacteria, viruses, protozoa and fungi.

Cell cultures are cells isolated from multicellular organisms and grown in vitro.

Toxins are metabolic products or cell components of biological substances which may have a toxic effect in humans when they are inhaled, ingested or absorbed through the skin, and may therefore result in acute or chronic damage to health or death.

A genetically modified organism (GMO) is any organism whose genetic material has been altered using genetic engineering techniques. Please specifiy Donor organism, genetic sequence, type of modification, use of vector and acceptor organism in detail.

Biological agents are classified into risk groups 1 to 4 according to the infection risk originating from them. The EU's legal classifications (Annex III to Directive 2000/54 EC), as well as additional national classifications, can be found in the technical rules of the biological substance ordinance (TRBA 460–468).

Classification of biological agents into risk groups

Risk group 1

Biological agents that are unlikely to cause human disease

Risk group 2

Biological agents that can cause human disease and might be a hazard to employees; they are unlikely to spread to the community; there is usually effective prophylaxis or treatment available,

Risk group 3

Biological agents that can cause severe human disease and present a serious hazard to employees; they may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available,

Risk group 4

Biological agents that cause severe human disease and are a serious hazard to employees; they may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment available.

 

For experiments at the beamlines, only biological samples of risk group 1 can be used.  

Biological agents of risk group 2 can only be handled in the support laboratory but not at the experimental stations. GMO samples of risk group 2 will require a notification towards the authorities prior to start of work. Therefore it is important to give as much details about the sample and sample handling in the sample section and in the laboratory support section from the beginning. The work description should include the following:

  • a brief summary of your research project that explains the purpose and the aim of the project

  • a work description with a flow diagram that explains the working steps ( e.g. production of GMO) including the maximum volume of cell culture used.

  • A list of vectors used

In case the proposal has been approved, the biological safety officer (Sigrid Kozielski, sigrid.kozielski@xfel.eu) may need further information on the GMO work that you plan carry out. The complete documentation will be sent to the genetic engineering authority of Schleswig-Holstein accompanied by a letter from the Managing Directors of the European XFEL company for approval.

Chemical Properties of Samples and Substances

In this section information about properties of chemical samples and substances must be provided. This also includes chemical substances that occur in animals, microorganisms and plants, e.g. DNA or RNA fragments, antibodies, enzymes, natural and recombinant proteins.

Indicate the type of hazard(s) of the sample, following the Globally Harmonized System of Classification and Labelling of Chemical (GHS). This information can be for example found in the material safety data sheet.

Nanomaterials

According to the COMMISSION RECOMMENDATION of 18 October 2011 (Directive 2011/696/EU) nanomaterials are defined as

“natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm.

In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.

By derogation from the above, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.”

The most important measure to protect workers’ health is to minimize (reduce or eliminate) exposures to hazardous substances in the workplace. In order to minimize exposure to nanomaterials it is important that you indicate under protective measures all engineering controls and personal protective equipment that is required to carry out the experiment under safe conditions.

In case of question please contact the Safety group under expsaf@xfel.eu.

Radioactive Samples or Substances

The use of radioactive samples/substances is not feasible in early user operation. If you intend to prepare for using radioactive substances, pieces of equipment involving radiation or sources later in steady operation, please contact radiation protection officer of the Safety group (Eric Boyd, eric.boyd@xfel.eu) well in advance in order to check about feasibility conditions.