ANNEX IISupplementary provisions
ANNEX II In Part B of the Annex to Implementing Regulation (EU) No 540/2011, row 28 on phosphane is replaced by the following: No Common Name, Identification Numbers IUPAC Name Purity ( 1 ) Date of approval Expiration of approval Specific provisions ‘28 Phosphine/Phosphane (no ISO common name allocated) CAS No: 7803-51-2 CIPAC No: 127 Phosphine 970 g/kg 1 October 2026 30 September 2041 For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on phosphine, and in particular Appendices I and II thereto, shall be taken into account. When granting authorisations for plant protection products containing phosphine, Member States shall pay particular attention to eliminate any exposure of humans, animals and the environment to phosphine. For that purpose, when authorising plant protection products, the following conditions and restrictions shall be imposed: — application of products shall only be carried out by well-trained authorised personnel, possessing the corresponding certificate of competence and fumigation licences according to the respective national legislation, — application of products shall only be carried out in gas-tight chambers or rooms and gas tightness of the chamber or room is tested, and the fumigation is initiated by supplying phosphine into the chamber or room from outside, — a safety zone shall be established from which all persons must be evacuated and it must be monitored with appropriate certified detection devices that a concentration of 0,01 ppm for PH3 in the air at the border of the zone is not exceeded, to ensure protection of bystanders and residents, — entering the treated chambers or rooms shall be prohibited. However in case of emergency personal protective equipment must be worn by operators and workers entering treated chambers, for example self-contained breathing apparatus (SCBA), — it must be ensured that, following fumigation, remaining phosphine is pumped off by special filter technology suitable for capturing phosphine to ensure that no phosphine is emitted into the environment, — fumigation shall only be considered fully complete once the phosphine level in the air of the treated chamber or room is below the limit of detection (0,01 ppm of PH3), — products present in the chamber or room during treatment shall only be removed after ventilation if phosphine residue concentrations in these products are at or below LOQ levels, — treated containers shall not be transported until fumigation is fully completed. The applicant shall submit to the Commission, the Member States and the Authority the following confirmatory information about the potential genotoxicity of phosphine: (1) either information confirming, on the basis of existing studies or scientific literature, that genotoxicity testing of phosphine in vivo is not appropriate because: (a) the observed severe clinical symptoms or the mortality resulting from exposure to phosphine are expected to prevent a clear interpretation of the results as regards specifically genotoxicity; and (b) positive genotoxicity results are only observed close to high toxicity concentrations, based on dose-response or mode of action analysis; (2) or, if the information in point (1) cannot be provided, a new in vivo Micronucleus test by inhalation following short-term exposure according to the OECD Test Guidelines 474. The applicant shall submit to the Commission, the Member States and the Authority the requested confirmatory information by 28 September 2028.’ ( 1 ) Further details on the identity and specification of the active substance are provided in the renewal report.