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What is chemicals risk assessment?



Assessment of chemicals risk is crucial if we want to prevent undesired and harmful effects on human and animal health and the environment when manufacturing or using chemicals. Chemicals risk assessment means determining and, if appropriate, quantifying any risk stemming from exposure to a certain substance and preparation, including identifying a relationship between a dose and its effect as well as target populations. Generally speaking, this is a procedure aiming at


  • Determining hazardous properties of chemicals, 
  • Impact assessment, 
  • Exposure assessment, 
  • Risk identification.

Legislation and guidelines governing risk assessments in areas falling under the remit of the National Chemicals Bureau.








In Slovenia, the Biocidal Products Act (OJ RS, No. 61/06) governs placing on the market of biocidal products. The EU enacted the Biocidal Products Directive 98/8/EC in 2004; and in doing so started to implement a systematic programme of biocidal active substances assessment.


Risk Assessment under REACH (1906/2007/EEC) 


Preparing a  chemical safety assessment  (CSR-"Chemical Safety Report")


A chemical safety assessment (CSA) is under REACH required, when a substance is manufactured or imported at 10 tonnes or more per year. This assessment shall be documented in a chemical safety report (CSR) to be submitted as part of a registration dossier. Annex 1 sets out the general provision for assessing the substances and preparing CSRs. One of the primary aims of carrying out a chemical safety assessment is to define the conditions of use (operational conditions and risk management) under which the risks can be controlled.



Overall process of preparing chemical safety assessment:

  • Collection and generation of available and required information on intrinsic properties
  • Human health hazard assessment; including classification and derivation of derived no effect levels (DNELs) 
  • Physicochemical hazard assessment; including classification 
  • Environmental hazard assessment; including classification and derivation of predicted no effect concentrations (PNECs)
  • PBT (Persistant, Bioaccumulative, Toxic) and vPvB (very Persistant, very Bioaccumulative) assessment

If as a result of the hazard assessment, it is found that a substance meets the criteria for classification as dangerous according to criteria of Directive 67/548/EEC or 1999/45/EC, or is a PBT or vPvB substance, then exposure assessment and subsequent risk characterisation is required:


  • Exposure assessment (covering development of exposure scenarios and exposure  estimation)
  • Risk characterization

CSA iterations might be needed to be able to document that risks are controlled:


  • Potential CSA iterations.

It is important also, that exposure scenario is added as an attachment to the Safety Data Sheet.   

General principles for risk assessment of biocidal products (active substances and products) are defined in Annex VI of Directive 98/8/EC, while more detailed guidelines are laid down in: "Technical Notes for Guidance", "Technical Guidance Document - TGD.



Plant Protection Products



It is the Pyhitosanitary Administration of the RS within the Ministry of Agriculture, Forestry and Food that is responsible for drawing up risk assessments for plant protection products. In compliance with Article 13 of the Plant Protection Products Act, and Article 49. a of the Chemicals Act (OJ RS No. 110/03 – official consolidated text, 47/04 - ZdZPZ), the Chemicals Office of the Republic of Slovenia takes part in the procedure for issuing decisions on plant protection products registration by approving such decision that is based on a plant protection product assessment on human health and the environment. In addition to accounting for general principles, this assessment needs to heed geographical, environmental and health characteristics of the Slovene territory, as well as plant protection product’s intended use and method of application.

More information of chemicals risk assessment is available at: 


Contact Points: Simona Fajfar and Petra Čebašek