Professional paper
CLASSIFICATION AND LABELLING OF PPPS BASED ON TOXICOLOGICAL STUDIES ON MAMMALS (AND ALTERNATIVE METHODS)
Zorica Vitić-Ferenc
orcid.org/0009-0002-4253-1291
; Hrvatska agencija za poljoprivredu i hranu, Centar za zaštitu bilja, Osijek
*
Edgar Kralj
orcid.org/0000-0003-1293-6378
; Hrvatska agencija za poljoprivredu i hranu, Centar za zaštitu bilja, Osijek
* Corresponding author.
Abstract
Toxicology is a scientific discipline dealing with detection, prevention and treatment of adverse health effects caused by exposure to chemicals. During the evaluation of plant protection products, the results of animal testing and calculation method or extrapolation of test results are used. The focus is on avoiding the in vivo testing and animal welfare. Toxicological studies are acute oral, dermal and inhalation toxicity, skin and eye irritation/corrosion and skin sensitisation. The final assessment is based on the assessment of the toxicological properties of the active substance and co-formulants, in line with the EFSA conclusions for active substances and safety data sheets. During authorisation, product authorisation and label of reference member state are also used. The classification and labelling process is based on the codes prescribed in the Regulation (EC) No 1272/2008 (Službeni list Europske unije, 2008.), which should be stated on the label during the placement on the market. It is also necessary to carry out the assessment of the relevance of metabolites of active substances in groundwater if they exceed the limit of 0.1 µg/L according to SANCO/221/2000-rev 11 (European Commission, 2021).
Keywords
Hrčak ID:
311295
URI
Publication date:
13.12.2023.
Visits: 218 *