Bellisai Giulia, Bernasconi Giovanni, Cabrera Luis Carrasco, Castellan Irene, Del Aguila Monica, Ferreira Lucien, Santonja German Giner, Greco Luna, Jarrah Samira, Leuschner Renata, Miron Ileana, Nave Stefanie, Pedersen Ragnor, Reich Hermine, Ruocco Silvia, Santos Miguel, Scarlato Alessia Pia, Szot Marta, Theobald Anne, Tiramani Manuela, Verani Alessia
EFSA J. 2024 Jan 9;22(1):e8446. doi: 10.2903/j.efsa.2024.8446. eCollection 2024 Jan.
The applicant Detia Freyberg GmbH submitted to the competent national authority in Germany two requests to evaluate the confirmatory data that were identified for tree nuts, oilseeds, cereals and commodities of animal origin in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available and two requests in accordance with Article 6 of Regulation (EC) No 396/2005 to increase the existing MRL for the active substance aluminium phosphide in peanuts, barley, oat, rye, rice and wheat, roots of herbal infusions, cocoa beans and seed spices and for the active substance magnesium phosphide in oilseeds (except peanuts) and pistachios. The four applications were combined by EFSA under the current assessment. To address the data gaps, validation data for the method of analysis for enforcement of phosphide in high-oil content commodities and new residue trials were submitted. The data gaps on additional residue trials supporting authorisations on oilseeds and cereal grains, on clarifications regarding the discrepancies observed in the residue trial results for pistachios, and on data confirming the negligible occurrence of phosphane and its oxidation products in livestock products were considered addressed. The data gap on independent laboratory validation (ILV) and a confirmatory method for monitoring of phosphide in high-oil content commodities was considered not fully addressed. The information provided justified a lowering of the current tentative MRLs for the whole group of cereals (except rice and 'others'), an increase of the current tentative MRLs for pistachios, the whole group of oilseeds, rice and 'other' cereals, herbal infusions from roots, cocoa beans and seed spices, and a revision of the risk assessment performed for phosphane and its phosphide salts. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of AlP and MgP according to the reported agricultural practices is unlikely to present a risk to consumer health. Further risk management considerations are required.
申请人Detia Freyberg GmbH向德国国家主管当局提交了两项请求，以评估在根据欧盟第396/2005号法规第12条进行的最大残留限量（MRL）审查框架下，被认定为无法获得的坚果、油籽、谷物和动物源性商品的确认数据；以及两项根据欧盟第396/2005号法规第6条提出的请求，以提高花生、大麦、燕麦、黑麦、大米和小麦、草药浸膏根、可可豆和种子香料中活性物质磷化铝，以及油籽（花生除外）和开心果中活性物质磷化镁的现有最大残留限量。欧洲食品安全局（EFSA）在当前评估中将这四项申请合并处理。为解决数据缺口问题，提交了高油含量商品中磷化物分析方法的验证数据以及新的残留试验数据。关于支持油籽和谷物授权的额外残留试验的数据缺口、关于开心果残留试验结果中观察到的差异的澄清，以及关于确认畜产品中磷化氢及其氧化产物出现极少的数据缺口，均被视为已得到解决。关于独立实验室验证（ILV）以及高油含量商品中磷化物监测的确认方法的数据缺口，被认为未得到充分解决。所提供的信息表明有理由降低整个谷物组（大米和“其他”谷物除外）的当前暂定最大残留限量，提高开心果、整个油籽组、大米和“其他”谷物、根类草药浸膏、可可豆和种子香料的当前暂定最大残留限量，并对磷化氢及其磷化物盐类进行的风险评估进行修订。基于风险评估结果，EFSA得出结论，按照报告的农业操作使用AlP和MgP产生的残留物的短期和长期摄入量不太可能对消费者健康构成风险。还需要进一步进行风险管理考量。
