Division 1.7 Standardised guidelines for toxicity tests
United Kingdom
The applicant shall use for toxicity testing internationally agreed guidelines and test methods described by Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)f1 (see Tables 1 and 2). A non-exhaustive list of validated test methods which, where necessary, shall be used in a possibly adapted form for GMO toxicological testing is provided in Tables 1 and 2.
The performance of test methods depends on the type of genetically modified food and feed, type of the genetic modification and resulting intended and unintended alterations, intended use and exposure/intake, and the available knowledge. Some of the tests were developed for the assessment of risks at the workplace (see Sections 1.4 and 1.5).
Table 1
Non-exhaustive list of validated test methods for chemicals as provided by Regulation (EC) No 440/2008 and which may be used in a possibly adapted form for GMO toxicological testing
| Title | Reference of the method in Part B of the Annex to Regulation (EC) No 440/2008 |
|---|---|
| ACUTE TOXICITY (DERMAL) | B.3. |
| SKIN SENSITISATION | B.6. |
| REPEATED-DOSE (28 DAYS) TOXICITY (ORAL) | B.7. |
| REPEATED-DOSE (28 DAYS) TOXICITY (DERMAL) | B.9. |
| SUBCHRONIC ORAL TOXICITY TEST REPEATED-DOSE 90-DAY ORAL TOXICITY STUDY IN RODENTS | B.26. |
| CHRONIC TOXICITY TEST | B.30. |
| CARCINOGENICITY TEST | B32. |
| COMBINED CHRONIC TOXICITY/CARCINOGENICITY TEST | B.33. |
| ONE-GENERATION REPRODUCTION TOXICITY TEST | B.34. |
| TWO-GENERATION REPRODUCTION TOXICITY STUDY | B.35. |
| TOXICOKINETICS | B.36. |
| NEUROTOXICITY STUDY IN RODENTS | B.43. |
Table 2
Genotoxicity tests as provided by Regulation (EC) No 440/2008
| Title | Reference of the method in Part B of the Annex to Regulation (EC) No 440/2008 |
|---|---|
| MUTAGENICITY — IN VIVO MAMMALIAN BONE MARROW CHROMOSOME ABERRATION TEST | B.11. |
| MUTAGENICITY — IN VIVO MAMMALIAN ERYTHROCYTE MICRONUCLEUS TEST | B.12. |
| MUTAGENICITY: REVERSE MUTATION TEST USING BACTERIA | B.13/14. |
| MUTAGENICITY TESTING AND SCREENING FOR CARCINOGENICITY GENE MUTATION — SACCHAROMYCES CEREVISIAE | B.15. |
| MITOTIC RECOMBINATION — SACCHAROMYCES CEREVISIAE | B.16. |
| DNA DAMAGE AND REPAIR — UNSCHEDULED DNA SYNTHESIS — MAMMALIAN CELLS IN VITRO | B.18. |
| MUTAGENICITY — IN VITRO MAMMALIAN CELL GENE MUTATION TEST | B.17. |
| SISTER CHROMATID EXCHANGE ASSAY IN VITRO | B.19. |
| IN VITRO MAMMALIAN CELL TRANSFORMATION TESTS | B.21. |
| MAMMALIAN SPERMATOGONIAL CHROMOSOME ABERRATION TEST | B.23. |