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
Legislation and guidelines governing risk assessments in areas falling under the remit of the National Chemicals Bureau.
New substances
When registering new substances, risk assessments for human health and the environment have to be devised. Ways of assessing new substances are defined by the Rules on Notification and Risk Assessment of Notified Substances (Official Gazette RS, No. 73/02, 51/04). Risk assessment principles for new substances are determined in Directive 93/67/EEC, while more detailed guidelines are laid down in "Technical Guidance Document - TGD".
Existing substances
At present, there is ongoing assessment of existing substances based on priority lists published in the Official Journal of the European Union. Ways of The Rules on Evaluation and Control of Existing Substances (Official Gazette RS, No. 74/02) and Council Regulation (EEC) 793/93 lay down methods for risk assessment concerning existing substances. Risk assessment principles for existing substances are laid down in Commission Regulation (EC) 1488/94, while more detailed guidelines are identified in Technical Guidance Document - TGD".
Biocides
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.
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 National Chemicals Bureau 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:
http://ecb.jrc.it/
http://europa.eu.int/comm/environment/biocides/index.htm#Furtherguidance
http://europa.eu.int/comm/food/plant/protection/evaluation/index_en.htm
Contact Points: Simona Fajfar and Petra Čebašek
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