More Simon, Bicout Dominique, Bøtner Anette, Butterworth Andrew, Calistri Paolo, Depner Klaus, Edwards Sandra, Garin-Bastuji Bruno, Good Margaret, Gortázar Schmidt Christian, Miranda Miguel Angel, Saxmose Nielsen Søren, Velarde Antonio, Thulke Hans-Hermann, Sihvonen Liisa, Spoolder Hans, Stegeman Jan Arend, Raj Mohan, Willeberg Preben, Winckler Christoph, Marano Remigio, Verdonck Frank, Candiani Denise, Michel Virginie
EFSA J. 2018 Jul 19;16(7):e05343. doi: 10.2903/j.efsa.2018.5343. eCollection 2018 Jul.
This guidance defines the process for handling applications on new or modified stunning methods and the parameters that will be assessed by the EFSA Animal Health and Welfare (AHAW) Panel. The applications, received through the European Commission, should contain administrative information, a checklist of data to be submitted and a technical dossier. The dossier should include two or more studies (in laboratory and slaughterhouse conditions) reporting all parameters and methodological aspects that are indicated in the guidance. The applications will first be scrutinised by the EFSA's Applications Desk (APDESK) Unit for verification of the completeness of the data submitted for the risk assessment of the stunning method. If the application is considered not valid, additional information may be requested from the applicant. If considered valid, it will be subjected to assessment phase 1 where the data related to parameters for the scientific evaluation of the stunning method will be examined by the AHAW Panel. Such parameters focus on the stunning method and the outcomes of interest, i.e. immediate onset of unconsciousness or the absence of avoidable pain, distress and suffering until the loss of consciousness and duration of the unconsciousness (until death). The applicant should also propose methodologies and results to assess the equivalence with existing stunning methods in terms of welfare outcomes. Applications passing assessment phase 1 will be subjected to the following phase 2 which will be carried out by the AHAW Panel and focuses on the animal welfare risk assessment. In this phase, the Panel will assess the outcomes, conclusions and discussion proposed by the applicant. The results of the assessment will be published in a scientific opinion.
本指南规定了处理新的或改良的致昏方法申请的流程以及欧洲食品安全局动物健康与福利(AHAW)专家委员会将评估的参数。通过欧盟委员会收到的申请应包含行政信息、待提交数据清单和技术档案。该档案应包括两项或更多项研究(在实验室和屠宰场条件下),报告指南中指出的所有参数和方法学方面的内容。申请将首先由欧洲食品安全局的申请受理处(APDESK)进行审查,以核实为致昏方法风险评估提交的数据的完整性。如果申请被认为无效,可能会要求申请人提供更多信息。如果被认为有效,将进入第一阶段评估,在此阶段,AHAW专家委员会将审查与致昏方法科学评估参数相关的数据。此类参数侧重于致昏方法和感兴趣的结果,即立即失去意识或在失去意识之前不存在可避免的疼痛、痛苦和折磨以及失去意识的持续时间(直至死亡)。申请人还应提出方法和结果,以评估在福利结果方面与现有致昏方法的等效性。通过第一阶段评估的申请将进入由AHAW专家委员会进行的以下第二阶段,该阶段侧重于动物福利风险评估。在这一阶段,专家委员会将评估申请人提出的结果、结论和讨论。评估结果将以科学意见的形式发布。