Division 5.9.2 Data collected on humans
United Kingdom
Where available, reports from studies with humans, such as tests on toxicokinetics and metabolism, or tests on skin irritation or skin sensitisation, shall be submitted.
In general, the reference values shall be based on animal studies, but if appropriate scientifically valid and ethically generated human data are available and show that humans are more sensitive and lead to lower regulatory limit values, these data shall take precedence over animal data.
Notes on Division 5.9
Textual amendments
- F1
Words in Annex Pt. A point 5.9 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 21(5)(b)(vi); 2020 c. 1, Sch. 5 para. 1(1)