欧盟Eurlex法规详细信息

Article 1

Format and instructions for the annual report on the results of surveys

Article 2

Format for the multiannual survey programmes and the practical arrangements for the application of the elements concerning specific pest risks

Article 3

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

ANNEX I

Format and instructions for the annual report of surveys provided for in Article 22 of Regulation (EU) 2016/2031

PART I

General information on the results of the surveys as referred to in point (a) of Article 1(2)

The template on general information on the results of the surveys as provided for in point (a) of Article 1(2) is the following:

“General information on the results of the surveys of [year]

PART II

Format and instructions for the presentation of the results of the surveys, as referred to in point (b) of Article 1(2)

The templates and instructions on the presentation of the results of the surveys as provided for in point (b) of Article 1(2) are the following:

1.   Elements of the annual report concerning Union quarantine pests and pests subject to the measures of Articles 29 and 30 of Regulation (EU)2016/2031, in areas where those pests are not known to be present

1.1.   Template

1.2.   Instructions on how to fill in the template

For column 1: With the exception of the ‘Group 1 – Authorised places of production’, it is optional to report per group of pests. When applicable, indicate the group of pests surveyed together (e.g. citrus pests, deciduous forest pests, coniferous forest pests, cereal pests, potato pests, other (please specify)). In those cases when a pest is included in several groups, please report the information for that pest accordingly in each group.

For the ‘Group 1 – Authorised places of production’, indicate the list of pests for which surveys were carried out and the results of the surveys, using more than one row when necessary to specify different survey sites of Column 4 ‘Survey sites’. In this group, please provide the data per pest, without aggregating at the group level. Authorised places of production are those places whose operator is authorised by the competent authority to issue plant passports.

For column 2: Indicate the scientific name of the pest (as listed in Annex II of Implementing Regulation (EU) 2019/2072 or in any specific measure for a given pest), using one row per pest.

For column 3: Indicate the geographical locations where the survey took place, using preferably the lower NUTS levels available. In case of pests reported per group, it is possible to aggregate the data for all the pests in the group in one row. In case of pests not reported per groups, it is possible to aggregate the data in one row per pest. It is also possible to use as many rows as number of locations reported, if appropriate.

For column 4: Indicate the survey sites, using more than one row per pest only when required by the specific legal pest survey requirements, and indicate the number of sites surveyed. In case of pests reported per group, it is possible to aggregate the data for all pests in the group in one row, and provide the total number of survey sites. In case of pests not reported in groups, it is possible to aggregate the data in one row per pest, and provide the total number of survey sites. When using the option ‘other’, please specify what it is:

For columns 5, 6 and 7: Optional or when applicable under specific legal pest survey requirements.

For column 5: Indicate which are the risk areas identified based on the biology of the pest(s), presence of host plants, eco-climatic conditions and risk locations.

For column 6: Indicate the total area covered by the target population (ha) in the Member State.

For column 7: Indicate the proportion of the surveyed area of the target population (surveyed area/target population area) in percentage.

For column 8: Indicate plants, fruits, seeds, soil, packaging material, wood, machinery, vehicles, vector, water, other, specifying the specific case. Only when the specific legal pest survey requirement specifies the list of commodities to survey, the results shall be provided using different rows.

For column 9: Indicate the list of plant species/genera that were surveyed. Only when required by the specific legal pest survey requirement, use one row per plant species/genera.

For column 10: Indicate the months of the year when the surveys were carried out. In case of pests reported per group, it is possible to aggregate the data for all pests in the group in one row. In case of pests not reported per groups, it is possible to aggregate the data in one row per pest.

For column 11: Indicate the details of the survey, taking into account the specific legal pests survey requirements of each pest. Indicate with N/A when the information of certain column is not applicable. With the exception of the number of visual examinations, which can be reported by group, all the other data is to be provided by pest unless a justification to report per group is included in column 14 (‘Comments’). When required by the specific legal pest survey requirements, use different rows (e.g. to report different types of tests and their number).

For column 12: Indicate the number of positive results per pest. This number may differ from the number of outbreaks when several positive results are included in one outbreak notification.

For column 13: Indicate the outbreak notifications of the year when the survey took place.

For column 14: Include any other information you consider relevant and, when applicable, information about the results of the surveys of asymptomatic plants with positive findings.

2.   Elements of the annual report concerning statistically based annual results of the surveys for Union quarantine pests, in areas where the pests are not known to be present, applicable when statistically based surveys were carried out

2.1.   Template

Report of statistically based annual results of the surveys for certain Union quarantine pests and certain pests subject to the measures of Articles 29 and 30 of Regulation (EU) 2016/2031 of [year] (optional, unless specifically required by the legislation, and its use replaces the use of Template 1.1)

2.2.   Instructions on how to fill in the template

Explain the underlying assumptions for the survey design per pest. Summarise and justify:

For column 1: Indicate the scientific name of the pest (as listed in Annex II of Implementing Regulation (EU) 2019/2072 or in any specific measure for a given pest).

For column 2: Indicate the geographical locations where the survey took place, using preferably the lower NUTS levels available.

For column 3: Indicate the survey sites, using more than one row per pest when required by the specific legal pest survey requirements. Please, always report the surveys carried out in Authorised places of production, in a different row. When using the option ‘other’, please specify what it is:

For column 4: Indicate the months of the year when the surveys were carried out.

For column 5: Indicate the chosen target population providing accordingly the list of host species and area covered. The target population is defined as the ensemble of inspection units. Its size is defined typically for agricultural areas as hectares, but could be lots, fields, greenhouses etc. Please justify the choice made in the underlying assumptions. Indicate the inspection units surveyed. ‘Inspection unit’ means plants, plant parts, commodities, materials, pest vectors that had been scrutinised for identifying and detecting the pests. If the area of the target population is not available, indicate N/A and include the number of inspection units that compose the target population.

For column 6: Indicate the epidemiological units surveyed, indicating its description and unit of measurement. ‘Epidemiological unit’ means a homogeneous area where the interactions between the pest, the host plants and the abiotic and biotic factors and conditions would result into the same epidemiology, should the pest be present. The epidemiological units are a subdivision of the target population that are homogenous in terms of epidemiology with at least one host plant. In some cases the whole host plant population in a region/area/country may be defined as epidemiological unit. They could be NUTS regions, urban areas, forests, rose gardens or farms, or hectares. The choice shall be justified in the underlying assumptions.

For column 7: Indicate the methods used during the survey including the number of activities in each case, depending on the specific legal pest survey requirements of each pest. Indicate with N/A when the information of certain column is not available.

For column 8: Indicate an estimation of the sampling effectiveness. Sampling effectiveness means the probability of selecting infected plant parts from an infected plant. For vectors, it is the effectiveness of the method to capture a positive vector when it is present in the survey area. For soil, it is the effectiveness of selecting a soil sample containing the pest when the pest is present in the survey area.

For column 9: ‘Method sensitivity’ means the probability of a method to correctly detect pest presence. The method sensitivity is defined as the probability that a truly positive host is detected and confirmed as positive and it is not misidentified. It is the multiplication of the sampling effectiveness (i.e. probability of selecting infected plant parts from an infected plant) by the diagnostic sensitivity (characterised by the visual examinations and/or laboratory test used in the identification process).

For column 10: Provide the risk factors in different rows, using as many rows as necessary. For each risk factor indicate the risk level and corresponding relative risk and proportion of host plant population.

For column B: Indicate the details of the survey, depending on the specific legal pests survey requirements for each pest. Indicate with N/A when the information of certain column is not applicable. The information to be provided in these columns is related to the information included in the column 7 ‘Detection methods’.

For column 15: Indicate the number of trapping sites in case this number differs from the number of traps (Column 14) (e.g. the same trap is used in different places).

For column 18: Indicate the number of samples found positive, negative or undetermined. ‘Undetermined’ are those analysed samples for which no result was obtained due to different factors (e.g. below detection level, unprocessed sample-not identified, old, etc.).

For column 19: Indicate the outbreak notifications of the year when the survey took place.

For column 20: Indicate the sensitivity of the survey, as defined in ISPM 31. This value of the achieved confidence level of pest freedom is calculated based on the examinations (and/or samples) performed given the method sensitivity and the design prevalence.

For column 21: Indicate the design prevalence based on a pre-survey estimate of the likely actual prevalence of the pest in the field. The design prevalence is set as a goal of the survey and corresponds to the compromise the risk managers are making between the risk of having the pest and the resources available for the survey. Typically, for a detection survey a value of 1 % is set.

PART III

Elements of the annual report concerning the summary of the results of the surveys and the update of the pest status of the surveyed pests, as referred to in point (c) of Article 1(2)

The report shall summarise the results of the surveys and update the pest status of each pest included in the annual survey, in accordance with the International Standard for Phytosanitary Measures (ISPM 8) and the following template:

ANNEX II

Format for the multiannual survey programmes provided for in Article 23 of Regulation (EU) 2016/2031, and the practical arrangements for the application of the elements set out in that Article

PART I

General information as referred to in point (a) of Article 2(2)

1.   Template

“General information for [years]

2.   Practical arrangements

PART II

Templates for the multiannual survey programmes as referred to in point (b) of Article 2(2)

1.   Elements of the multiannual survey programme concerning Union quarantine pests and pests subject to measures pursuant to Articles 29 and 30 of Regulation (EU) 2016/2031 in areas where those pests are not known to be present

1.1.   Template

1.2.   Practical arrangements

For column 2: With the exception of the ‘Group 1 – Authorised places of production’, it is optional to plan the surveys per group of pests. When applicable, indicate the group of pests that will be surveyed together (e.g. citrus pests, deciduous forest pests, coniferous forest pests, cereal pests, potato pests, other (please specify)). In those cases when a pest will be included in several groups, please include in the programme the information for that pest accordingly in each group.

For the ‘Group 1 – Authorised places of production’, indicate the list of pests for which surveys will be carried out, using more than one row when necessary to specify different survey sites of Column 5 ‘Survey sites’. In this group, please provide the data per pest, without aggregating at the group level. Authorised places of production are those places whose operator is authorised by the competent authority to issue plant passports.

For column 3: Indicate the scientific name of the pest (as listed in Annex II of Implementing Regulation (EU) 2019/2072 or in any specific measure for a given pest), using one row per pest.

For column 4: Indicate the geographical locations where the survey will take place, using preferably the lower NUTS levels available at this stage. In case of pest reported per group, it is possible to aggregate the data for all the pests in the group in one row. In case of pests not reported in groups, it is possible aggregate the data in one row per pest. It is also possible to use as many rows as number of locations reported, if appropriate.

For column 5: Indicate the survey sites, using more than one row per pest when required by the specific legal pest survey requirements, and indicate the number of sites that will be surveyed. In case of pests reported per group, it is possible to aggregate the data for all the pests in the group in one row, and provide the total number of survey sites. In case of pests not reported in groups, it is possible to aggregate the data in one row per pest, and provide the total number of survey sites. When using the option ‘other’, please specify what it is:

For column 6: Optional or when applicable under specific legal pest survey requirements. Indicate the risk areas based on the biology of the pest(s), presence of host plants, eco-climatic conditions and risk locations.

For column 7: Indicate plants, fruits, seeds, soil, packaging material, wood, machinery, vehicles, vector, water, other, specifying the specific case. When the specific legal pest survey requirement specifies the list of commodities to survey, the programme shall include the activities planned per commodity using different rows.

For column 8: Indicate the list of plant species/genera that will be surveyed. When required by the specific pest legal survey requirement, the programme shall include the list of plant species/genera using a different row per each plant species/genus.

For column 9: Indicate the months of the year when the surveys will be carried out. In case of pests reported per group, it is possible to aggregate the data for all pests in the group in one row. In case of pests not reported in groups, it is possible to aggregate the data in one row per pest.

For column 10: Indicate the survey details, taking into account the specific legal requirements of each pest. Indicate with N/A when the information of certain column will not be available. It is only possible to aggregate the data from this column at the same level of the group of pests for the number of visual examinations. When required by the specific legal pest survey requirements, use different rows (e.g. the plan of using different types of tests and their number).

2.   Elements of the multiannual survey programme concerning statistically based surveys for Union quarantine pests, and pests subject to measures pursuant to Articles 29 and 30 of Regulation (EU) 2016/2031, in areas where those pests are not known to be present, applicable when statistically based surveys will be carried out

The multiannual survey programme shall summarise and justify the survey, including its input parameters, and the planned sampling effort

2.1.   Template

2.2.   Practical arrangements

Explain the underlying assumptions for the survey design per pest. Summarise and justify:

For column 2: Indicate the scientific name of the pest (as listed in Annex II of Implementing Regulation (EU) 2019/2072 or in any specific measure for a given pest).

For column 3: Indicate the geographical locations where the survey will take place, using preferably the lower NUTS levels available.

For column 4: Indicate the survey sites, using more than one row per pest when required by the specific legal pest survey requirements. Please, always plan the surveys to be carried out in Authorised places of production, in a different row. When using the option ‘other’, please specify what it is:

For column 5: Indicate the months of the year when the surveys will be carried out.

For column 6: Indicate the chosen target population providing accordingly the list of host species and area covered. The target population is defined as the ensemble of inspection units. Its size is defined typically for agricultural areas as hectares, but could be lots, fields, greenhouses etc. Please justify the choice made in the underlying assumptions in column 21 (‘Comments’). Indicate the inspection units surveyed. ‘Inspection unit’ means plants, plant parts, commodities, materials, pest vectors that will be scrutinised for identifying and detecting the pests. If the area of the target population is not available, indicate N/A and include the number of inspection units that compose the target population.

For column 7: Indicate the epidemiological units to be surveyed, indicating its description and unit of measurement. Epidemiological unit is defined as a homogeneous area where the interactions between the pest, the host plants and the abiotic and biotic factors and conditions would result into the same epidemiology, should the pest be present. The epidemiological units are a subdivision of the target population that are homogenous in terms of epidemiology with at least one host plant. In some cases the whole host plant population in a region/area/country might be defined as epidemiological unit. They could be NUTS regions, urban areas, forests, rose gardens or farms, or hectares. The choice shall be justified in the underlying assumptions.

For column 8: Indicate the methods that will be used during the survey, including the number of activities in each case, depending on the specific legal pest survey requirements of each pest. Indicate with N/A when the information of certain column is not available. Indicate yes/no in Visual examinations and provide details of the methods for Trapping, Testing and Other measures.

For column 9: Indicate an estimation of the sampling effectiveness. Sampling effectiveness means the probability of selecting infected plant parts from an infected plant. For vectors, it is the effectiveness of the method to capture a positive vector when it is present in the survey area. For soil, it is the effectiveness of selecting a soil sample containing the pest when the pest is present in the survey area.

For column 10: ‘Method sensitivity’ is defined as the probability of a method to correctly detect pest presence. The method sensitivity is defined as the probability that a truly positive host is detected and confirmed positive and it is not misidentified. It is the multiplication of the sampling effectiveness (i.e. probability of selecting infected plant parts from an infected plant) by the diagnostic sensitivity (characterised by the visual examination and/or laboratory test used in the identification process).

For column 11: Provide the risk factors in different rows, using as many rows as necessary. For each risk factor indicate the risk level and corresponding relative risk and proportion of host plant population.

For column B: Indicate the number of activities planned, specifying the type of activity. Indicate with N/A when the information of certain column is not available. The information to be provided in these columns is related to the information included in the column 8 ‘Detection methods planned’.

For column 16: Indicate the number of trapping sites in case this number differs from the number of traps (Column 15) (e.g. the same trap is used in different places).

For column 20: Indicate the sensitivity of the survey, as defined in ISPM 31. This value of the achieved confidence level of pest freedom is calculated based on the examinations (and/or samples) performed given the method sensitivity and the design prevalence.

For column 21: Indicate the design prevalence based on a pre-survey estimate of the likely actual prevalence of the pest in the field. The design prevalence is set as a goal of the survey and corresponds to the compromise the risk managers are making between the risk of having the pest and the resources available for the survey. Typically, for a detection survey a value of 1 % is set.