Finished IVD’s are exempt from Biocides regulation however intermediates and raw materials are not exempt. PT 2 and 3 are regarding disinfectants, and PT 6 is regarding preservatives used in products. PT 2 & 3 can have an indirect impact on IVD’s by impacting the available disinfectants available for use to disinfect IVD’s. Companies placing products on the market which are disinfectants and are not IVD’s i.e. their main purpose is as a biocide must comply with the Biocides regulations.
Apply for active substance renewal by the deadlines to keep products on the NI market
29 March 2025
- Glutaral (glutaraldehyde) (CAS 111-30-8 EC 203-856-5) in product types 2, 3, 4, 6, 11 and 12
27 December 2025
- Biphenyl-2-ol (CAS 90-43-7 EC 201-993-5) in product types 1, 2, 4, 6 and 13
- Mixture of 5-chloro-2-methyl-2H-isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (mixture of CMIT/MIT) (CAS 55965-84-9 EC N/A) in product types 2, 4, 6, 11, 12 and 13
29 June 2026
- Amines, N-C10-16-alkyltrimethylenedi-, reaction products with chloroacetic acid (ampholyt 20) (CAS 139734-65-9 EC N/A) in product type 2,3 and 4
- Bacillus amyloliquefaciens strain ISB06 (CAS N/A EC N/A) in product type 3
- Biphenyl-2-ol (CAS 90-43-7 EC 201-993-5) in product type 3
