Exposure scenario
Exposure Scenario (English exposure scenario ) is a term from the hazardous substances . First of all, it is the documentation of the processes associated with the production, further processing and use of a substance, and secondly of the way and to what extent people and the environment come into contact with the substance.
Exposure scenarios are of great importance in European chemicals law and are regulated by Regulation (EC) No. 1907/2006 (REACh, EU Chemicals Regulation). They are a core element of the chemical safety assessment and thus the mandatory registration of hazardous substances that are placed on the market by a manufacturer or importer in quantities of more than ten tons per year. Exposure scenarios must be created by the manufacturer or importer (natural or legal person based in the EU who is responsible for the import) of substances and summarized in an appendix to the safety data sheet.
An exposure scenario is then mandatory
- if at least 10 tonnes of the substance are imported or produced per year because they are subject to registration; Furthermore
- when a fabric as persistent , bio-accumulative and toxic ( PBT ), or as much ( v persistent and bioaccumulative strong (ery) vPvB ) holds.
Structure of the exposure scenario
The first part usually consists of a short title and a summary of the uses or activities covered by the exposure scenario. They are mostly divided into individual scenarios, e.g. B. Mass transfer, sampling, filling of containers and devices. This is followed by the operating conditions and the associated risk management measures , which are intended to ensure safe use.
Identification of the uses of a substance
The exact uses of a substance must be specified in the exposure scenario. Uses that are considered dangerous must be marked as “use advised against”. An identified use can belong to several exposure scenarios, an exposure scenario can contain several identified uses.
The uses mentioned in the scenario can be standardized with a so-called use descriptor from ECHA . The system of use descriptors groups substance characteristics into five categories which, in combination with one another, enable a short and standardized description of the use:
- Sector ( Sector of use SU)
- Indicates the industry in which a substance is used.
- Product Category ( Product Category , PC)
- Describes the product type in which a substance reaches its end use.
- Process Category ( Process Category , PROC)
- Describes manufacturing and application processes under occupational safety aspects.
- Release to the environment ( Environmental Release Category , ERC)
- Describes manufacturing and application processes under environmental aspects.
- Article category ( ArticleCategory , AC)
- Describes the type of article into which a substance is processed.
In many cases the usage descriptor is insufficient to describe the exact application. It can be difficult for the user to determine from this alone whether his use is covered by the exposure scenario. The manufacturers / importers who describe the uses must therefore also list the relevant further uses for the product .
Passing on the information along the supply chain
The exposure scenario to be created by the manufacturer / importer is passed on as an attachment to the safety data sheet (E-SDS). The REACH regulation does not prescribe a clear format. The template contained in the guidelines of the European Chemicals Agency (ECHA) on information requirements and chemical safety assessments can be used in general, but is not mandatory. A uniform format would further simplify clear and understandable communication along the supply chain .
Every member of the supply chain is obliged to share this information.
The recipient is obliged
- to check whether its use is described in the exposure scenario,
- to design its operational conditions in such a way that they comply with the risk management measures ,
- to communicate the information to its consumers.
Registration number
It happens that users supplied with the substance do not receive a registration number for the dangerous substance or that the last four company-specific digits are missing, which do not have to be communicated to the users. On the other hand, the complete registration number (with all digits) must be disclosed to the authorities during an inspection. In this case, the user must ask the manufacturer / importer to provide the authorities with the complete registration number no later than seven days after the request.
Absence of the exposure scenario
There are various reasons why there is no exposure scenario in the annex to the safety data sheet:
- Not every registrant has the right to assess a chemical safety and to prepare a chemical safety report.
- Substances that are manufactured or imported in quantities of less than 10 tonnes per year, or substances that are stored or transported in isolation in accordance with Articles 17 or 18, do not need an exposure scenario.
- Not all registrants are required to carry out a chemical safety assessment and create the exposure scenario:
- Users to whom Article 14 of REACH does not apply
- Other reasons not explained by the registrant
- It may be that the substance belongs to a category for which the registration requirement according to REACH regulation does not apply (e.g. polymer ). It is also possible that the substance has already been pre-registered and the manufacturer / importer has not yet given the registration number.
Even if the supplier / manufacturer is not obliged, he can provide his users with safety data sheets at his own discretion .
If a substance is considered an exception to the registration requirement, it is recommended that the manufacturer / importer leave a comment in point 15.2 (or in the appendix if he adds a new sheet).
Quantification (exposure assessment)
Wherever hazardous substances are used, the risk must be assessed (Section 6, Hazardous Substances Ordinance, GefStoffV). This also includes assessing the “type and extent of exposure”. Because the hazard (like the risk) is a function of the dangerous properties of a substance and the current concentration - or: “the dose makes the poison” ( Paracelsus ).
Because chemical analysis is expensive, the employer can choose other suitable - i. H. statistical - choose methods. Such freeware calculation models use the many exposure measurements that have already been carried out from databases and transfer the values to comparable substances and scenarios:
- The ' Technical Rules for Hazardous Substances' (TRGS) No. 400 names the simple concept of measures for hazardous substances (EMKG),
- Another example is the GESTIS fabric manager .
Both estimate the airborne (inhalative) and skin (dermal) pollutant load, as is common in professional situations. For the private, domestic use of chemicals z. B. the ConsExpo program, which is only available in English, is suitable. Also in approval procedures for chemical substances and products (e.g. of particularly questionable everyday and industrial chemicals according to Regulation (EC) No. 1907/2006 (REACH) , products according to Regulation (EC) No. 1107/2009 (Plant Protection Products Regulation) or Regulation (EU) No. 528/2012 (Biocide Regulation) ) such u. Ä. Exposure models used.
Individual evidence
- ↑ ECHA: Guidelines on information requirements and chemical safety assessment - Chapter R.12: System of use descriptors , 2015.
- ↑ ECHA: Guidelines on information requirements and chemical safety assessment .
- ↑ Simple concept of measures for hazardous substances , EMKG 2.2 software, Federal Institute for Occupational Safety and Health (BAuA).
- ↑ GESTIS-Stoffmanager / Stoffenmanager - Assistance with risk assessment and assessment of inhalation exposure ( memento of the original from October 21, 2015 in the Internet Archive ) Info: The archive link has been inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice.
- ↑ Krause M., Baron M., Kahl A .: Statistics as a component in hazard assessment and risk assessment , in: Hazardous substances - clean air , 74 (2014), No. 6, pp. 227-234.
- ↑ ConsExpo , Rijksinstituut voor Volksgezondheid en Milieu (RIVM), Netherlands.
