Annexes to COM(2008)93 - Placing of plant protection products on the market - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2008)93 - Placing of plant protection products on the market. |
|---|---|
| document | COM(2008)93  |
| date | March 11, 2008 |
Definition of zones for the authorisation of plant protection products
Zone A – North
The following Member States belong to this zone:
Denmark, Estonia, Latvia, Lithuania, Finland, Sweden
Zone B – Centre
The following Member States belong to this zone:
Belgium, Czech Republic, Germany, Ireland, Luxemburg, Hungary, Netherlands, Austria, Poland, Slovenia, Slovakia, United Kingdom
Zone C – South
The following Member States belong to this zone:
Greece, Spain, France, Italy, Cyprus, Malta, Portugal
ANNEX II
Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II
1. Evaluation
1.1. During the process of evaluation and decision-making provided for in Articles 4 to 21, the rapporteur Member State and the Authority shall cooperate with applicants to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for the evaluation of the dossier, including information to eliminate the need for a restriction of the approval, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Regulation.
1.2. The evaluation by the Authority and the rapporteur Member State must be based on scientific principles and be made with the benefit of expert advice.
1.3. During the process of evaluation and decision-making provided for in Articles 4 to 21, Member States and the Authority shall take into consideration any further guidance developed in the framework of the Standing Committee on the Food Chain and Animal Health for the purposes of refining, where relevant, the risk assessments.
2. General decision-making criteria
2.1. Article 7(1) shall only be considered as complied with, where, on the basis of the dossier submitted, authorisation in at least one Member State is expected to be possible for at least one plant protection product containing that active substance for at least one of the representative uses.
2.2. Submission of further information
In principle an active substance shall only be approved where a complete dossier is submitted.
In exceptional cases an active substance may be approved even though certain information is still to be submitted where:
(a) the data requirements have been amended or refined after the submission of the dossier or;
(b) the information is considered to be confirmatory in nature, as required to increase the confidence in the decision.
In such cases the additional information shall be submitted to the rapporteur Member State for evaluation within a deadline set by the Commission. The Member State shall report to the Commission on the results of the assessment.
2.3. Restrictions on approval
Restrictions on approval, where necessary, may be linked to:
- identification of unacceptable risks under particular conditions
- gaps in the risk assessment resulting from the limited range of representative uses and preparations notified by the applicant.
Where the rapporteur Member State considers that the dossier provided lacks certain information, to the effect that the active substance could only be approved subject to restrictions, it shall contact the applicant at an early stage to obtain more information which may possibly enable these restrictions to be removed.
3. Criteria for the approval of an active substance
3.1. Dossier
The dossiers submitted pursuant to Article 7(1) shall contain the information needed to establish, where relevant, Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL) and Acute Reference Dose (ARfD).
In the case of an active substance for which the limited range of representative uses includes use on feed or food crops or leads indirectly to residues in food or feed, the dossier submitted pursuant to Article 7(1) shall contain the information necessary to carry out a risk assessment and for enforcement purposes.
The dossier shall in particular:
(a) permit any residue of concern to be defined;
(b) reliably predict the residues in food and feed, including succeeding crops;
(c) reliably predict, where relevant, the corresponding residue level reflecting the effects of processing and/or mixing;
(d) permit a Maximum Residue Level (MRL) to be defined for the commodity and, where appropriate, for products of animal origin where the commodity or parts of it is fed to animals;
(e) permit, where relevant, concentration or dilution factors due to processing and/or mixing to be defined;
The dossier submitted pursuant to Article 7(1) shall be sufficient to permit, where relevant, an estimate of the fate and distribution of the active substance in the environment, and its impact on non-target species.
3.2. Efficacy
An active substance shall only be approved where it has been established for a limited range of representative uses that the plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic normal conditions of use is sufficiently effective. This requirement shall be evaluated in the light of the uniform principles for evaluation and authorisation of plant protection products referred to in the second paragraph of Article 35.
3.3. Toxic relevance of breakdown products
Where the limited range of representative uses includes use on food or feed crops, the documentation submitted shall be sufficient to permit the establishment of the toxicological relevance of breakdown products that were not present in the animals used in the test or studies performed on the active substance but which are formed in or on treated plants, as a result of processing or are found in studies performed on livestock animals.
3.4. Composition of the active substance
3.4.1. The specification shall define the minimum degree of purity, the identity and maximum content of impurities, and where relevant of isomers / diastereo-isomers and additives, and the content of impurities of toxicological, ecotoxicological or environmental concern within acceptable limits.
3.4.2. The specification shall be in compliance with the relevant FAO specification where such specification exists. However where necessary for reasons of protection of human or animal health or the environment, stricter specifications may be adopted.
3.5. Methods of analysis
3.5.1. The methods of analysis of the active substance as manufactured and of determination of impurities of toxicological, ecotoxicological or environmental concern or which are present in quantities greater than 1 g/kg in the active substance as manufactured, shall have been validated and shown to be sufficiently specific, linear, accurate and precise.
3.5.2. The method of analysis in environmental matrices, as appropriate, shall have been validated and shown to be sufficiently sensitive with respect to the levels of concern.
3.5.3. The evaluation has been carried out in accordance with the uniform principles for evaluation and authorisation of plant protection products referred to in Article 35.
3.6. Impact on human health
3.6.1. Where relevant, an ADI, AOEL and ARfD shall be established. When establishing such values an appropriate safety margin of at least 100 shall be ensured taking into account the type and severity of effects and the vulnerability of specific groups of the population.
3.6.2. An active substance shall only be approved, if, on the basis of assessment of higher tier genotoxicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as mutagen category 1 or 2 unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use is negligible because the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the limit of determination using the most sensitive methods.
3.6.3. An active substance shall only be approved, if, on the basis of assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as carcinogen category 1 or 2 unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use is negligible because the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the limit of determination using the most sensitive methods.
3.6.4. An active substance shall only be approved, if, on the basis of assessment of reproductive toxicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as toxic for reproduction category 1 or 2 unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use is negligible because the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the limit of determination using the most sensitive methods. .
3.6.5. An active substance shall only be approved, if, on the basis of the assessment of Community or internationally agreed test guidelines it is not considered to have endocrine disrupting properties that may be of toxicological significance in humans unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use, is negligible because the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the limit of determination using the most sensitive methods. .
3.7. Fate and behaviour in the environment
3.7.1. An active substance shall only be approved where it is not considered to be a persistent organic pollutant.
A persistent organic pollutant is defined as follows:
(a) Persistence:
(i) Evidence that its DT50 in water is greater than two months, or that its DT50 in soil is greater than six months, or that its DT50 in sediment is greater than six months; and
(b) Bio-accumulation:
(i) Evidence that its bio-concentration factor or bio accumulation factor in aquatic species is greater than 5,000 or, in the absence of such data, that the log Ko/w is greater than 5;
(ii) Evidence that a chemical presents other reasons for concern, such as high bio-accumulation in other non-target species, high toxicity or ecotoxicity; and
(c) Potential for long-range environmental transport:
(i) Measured levels of the active substance in locations distant from the sources of its release that are of potential concern;
(ii) Monitoring data showing that long-range environmental transport of the active substance, with the potential for transfer to a receiving environment, may have occurred via air, water or migratory species; or
(iii) Environmental fate properties and/or model results that demonstrate that the active substance has a potential for long-range environmental transport through air, water or migratory species, with the potential for transfer to a receiving environment in locations distant from the sources of its release. For an active substance that migrates significantly through the air, its DT50 in air should be greater than two days.
3.7.2. An active substance shall only be approved if it is not considered to be a persistent, bioaccumulating and toxic (PBT) substance.
A substance that fulfils all three of the criteria of the sections below is a PBT substance.
3.7.2.1. Persistence
An active substance fulfils the persistence criterion where:
- the half-life in marine water is higher than 60 days, or
- the half-life in fresh or estuarine water is higher than 40 days, or
- the half-life in marine sediment is higher than 180 days, or
- the half-life in fresh or estuarine water sediment is higher than 120 days, or
- the half-life in soil is higher than 120 days.
Assessment of persistency in the environment shall be based on available half-life data collected under appropriate conditions, which shall be described by the applicant.
3.7.2.2. Bioaccumulation
An active substance fulfils the bioaccumulation criterion where the bioconcentration factor (BCF) is higher than 2000.
Assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data from both freshwater and marine water species can be used.
3.7.2.3. Toxicity
An active substance fulfils the toxicity criterion where:
- the long-term no-observed effect concentration (NOEC) for marine or freshwater organisms is less than 0.01 mg/l, or
- the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2, or 3), or
- there is other evidence of chronic toxicity, as identified by the classifications: T, R48 or Xn, R48 pursuant to Directive 67/548/EEC.
3.7.3. An active substance shall not be considered as complying with Article 4 where it is very persistent, very bioaccumulating (vPvB).
A substance that fulfils both of the criteria of the sections below is a vPvB substance.
3.7.3.1. Persistence
An active substance fulfils the very persistence criterion where:
- the half-life in marine, fresh- or estuarine water is higher than 60 days, or
- the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or
- the half-life in soil is higher than 180 days.
3.7.3.2. Bioaccumulation
An active substance fulfils the very bioaccumulative criterion where the bioconcentration factor is greater than 5000.
3.8. Ecotoxicology
3.8.1. An active substance shall only be considered as complying with Article 4 if the risk assessment demonstrates risks to be acceptable in accordance with the criteria laid down in the uniform principles for evaluation and authorisation of plant protection products referred to in Article 35 under realistic proposed conditions of use of a plant protection product containing the active substance. The assessment must take into account the severity of effects, the uncertainty of the data, and the number of organism groups which the active substance is expected to affect adversely by the intended use.
3.8.2. An active substance shall only be considered as complying with Article 4 if, on the basis of the assessment of Community or internationally agreed test guidelines, it is not considered to have endocrine disrupting properties that may be of toxicological significance on non-target organisms unless the exposure of non-target organisms to that active substance in a plant protection product, under realistic proposed conditions of use is negligible.
3.9. Residue definition
An active substance shall only be approved if, where relevant, a residue definition can be established for the purposes of risk assessment and for enforcement purposes.
4. Criteria for approval as a candidate for substitution
An active substance shall be approved as a candidate for substitution pursuant to Article 24 where any of the following conditions are met :
- its ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances;
- it meets two of the criteria to be considered as a PBT substance;
- its leaching behaviour presents a high potential risk to groundwater;
- there are reasons for concern linked to the nature of the critical effects (such as neurotoxic or immunotoxic effects) which, in combination with the use/exposure patterns, amount to situations of use that could still cause concern, even with very restrictive risk management measures(such as extensive personal protective equipment or very large buffer zones);
- it contains a significant proportion of non-active isomers.
ANNEX III
List of co-formulants which are not accepted for inclusion in plant protection products
ANNEX IV
Comparative assessment pursuant to Article 48
1. Conditions for comparative assessment
A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection product containing an active substance approved as a candidate for substitution.
Where refusal or withdrawal of an authorisation of a plant protection product in favour of an alternative plant protection product is considered (hereinafter ‘substitution’), the alternative must, in the light of scientific and technical knowledge, show significantly lower risk to health or the environment. An assessment of the alternative plant protection product shall be performed to demonstrate whether it can be used with similar effect on the target organism and without significant economic and practical disadvantages to the user or not.
Further conditions for refusal or withdrawal of an authorisation are:
(a) substitution shall be applied only where the chemical diversity of the active substances, where relevant, or methods and practices of crop management and pest prevention are sufficient to minimise the occurrence of resistance in the target organism;
(b) substitution shall be applied only to active substances which, where used in authorised plant protection products, present a significantly higher level of risk to human health or the environment;
(c) substitution shall be applied only after allowing for the possibility, where necessary, of acquiring experience from use in practice, where not already available.
2. Significant difference in risk
A significant difference in risk, especially for health risks, shall be identified on a case-by-case basis by the competent authorities, taking into account known cumulative and synergistic effects, where the methods to assess such effects are available. The properties of the active substance, and the possibility of exposure of different population subgroups (professional or non-professional users, bystanders, workers, residents, specific vulnerable groups or consumers) directly or indirectly through food, feed, water or the environment shall be taken into account. Other factors such as the stringency of imposed restrictions on use and prescribed personal protective equipment must also be considered.
For the environment, a factor of at least 10 between the Predicted Environmental Concentration (PEC) and the Predicted No Effect Concentration (PNEC) ratios of different active substances is considered a significant difference in risk.
3. Significant practical or economic disadvantages
Significant practical or economic disadvantage to the user is defined as a major quantifiable impairment of working practices or business activity leading to inability to maintain sufficient control of the target organism. Such a major impairment might be, for example, where no technical facilities for the use of the alternative substance(s) are available or economically feasible.
Where a comparative assessment indicates that restrictions/prohibitions of use of a plant protection product could cause such disadvantage, then this will be taken into account in the decision-making process. This situation must be substantiated.
ANNEX V
Repealed Directives and their successive amendments
A. Directive 91/414/EEC
Acts amending Directive 91/414/EEC | Deadline for transposition |
Directive 93/71/EEC | 3 August 1994 |
Directive 94/37/EC | 31 July 1995 |
Directive 94/79/EC | 31 January 1996 |
Directive 95/35/EC | 30 June 1996 |
Directive 95/36/EC | 30 April 1996 |
Directive 96/12/EC | 31 March 1997 |
Directive 96/46/EC | 30 April 1997 |
Directive 96/68/EC | 30 November 1997 |
Directive 97/57/EC | 1 October 1997 |
Directive 2000/80/EC | 1 July 2002 |
Directive 2001/21/EC | 1 July 2002 |
Directive 2001/28/EC | 1 August 2001 |
Directive 2001/36/EC | 1 May 2002 |
Directive 2001/47/EC | 31 December 2001 |
Directive 2001/49/EC | 31 December 2001 |
Directive 2001/87/EC | 31 March 2002 |
Directive 2001/99/EC | 1 January 2003 |
Directive 2001/103/EC | 1 April 2003 |
Directive 2002/18/EC | 30 June 2003 |
Directive 2002/37/EC | 31 August 2003 |
Directive 2002/48/EC | 31 December 2002 |
Directive 2002/64/EC | 31 March 2003 |
Directive 2002/81/EC | 30 June 2003 |
Directive 2003/5/EC | 30 April 2004 |
Directive 2003/23/EC | 31 December 2003 |
Directive 2003/31/EC | 30 June 2004 |
Directive 2003/39/EC | 30 September 2004 |
Directive 2003/68/EC | 31 March 2004 |
Directive 2003/70/EC | 30 November 2004 |
Directive 2003/79/EC | 30 June 2004 |
Directive 2003/81/EC | 31 January 2005 |
Directive 2003/82/EC | 30 July 2004 |
Directive 2003/84/EC | 30 June 2004 |
Directive 2003/112/EC | 30 April 2005 |
Directive 2003/119/EC | 30 September 2004 |
Regulation (EC) No 806/2003 | - |
Directive 2004/20/EC | 31 July 2005 |
Directive 2004/30/EC | 30 November 2004 |
Directive 2004/58/EC | 31 August 2005 |
Directive 2004/60/EC | 28 February 2005 |
Directive 2004/62/EC | 31 March 2005 |
Directive 2004/66/EC | 1 May 2004 |
Directive 2004/71/EC | 31 March 2005 |
Directive 2004/99/EC | 30 June 2005 |
Directive 2005/2/EC | 30 September 2005 |
Directive 2005/3/EC | 30 September 2005 |
Directive 2005/25/EC | 28 May 2006 |
Directive 2005/34/EC | 30 November 2005 |
Directive 2005/53/EC | 31 August 2006 |
Directive 2005/54/EC | 31 August 2006 |
Directive 2005/57/EC | 31 October 2006 |
Directive 2005/58/EC | 31 May 2006 |
Directive 2005/72/EC | 31 December 2006 |
Directive 2006/5/EC | 31 March 2007 |
Directive 2006/6/EC | 31 March 2007 |
Directive 2006/10/EC | 30 September 2006 |
Directive 2006/16/EC | 31 January 2007 |
Directive 2006/19/EC | 30 September 2006 |
Directive 2006/39/EC | 31 July 2007 |
B. Directive 79/117/EEC
Acts amending Directive 79/117/EEC | Deadline for transposition |
Directive 83/131/EEC | 1 October 1984 |
Directive 85/298/EEC | 1 January 1986 |
Directive 86/214/EEC | - |
Directive 86/355/EEC | 1 July 1987 |
Directive 87/181/EEC | 1 January 1988 and 1 January 1989 |
Directive 87/477/EEC | 1 January 1988 |
Directive 89/365/EEC | 31 December 1989 |
Directive 90/335/EEC | 1 January 1991 |
Directive 90/533/EEC | 31 December 1990 and 30 September 1990 |
Directive 91/118/EEC | 31 March 1992 |
Regulation (EC) No 807/2003 | - |
Regulation (EC) No 850/2004 | - |
FINANCIAL STATEMENT
1. NAME OF THE PROPOSAL :
Proposal for a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market.
2. ABM / ABB FRAMEWORK
Policy Area(s) concerned: Health and Consumer Protection
Activity/Activities: Plant health, Food Safety, Animal Health, Animal Welfare and Protection of the Environment
3. BUDGET LINES
3.1. Budget lines (operational lines and related technical and administrative assistance lines (ex- B..A lines)) including headings :
17.01.04.01Plant health measures expenditure on administrative management.
3.2. Duration of the action and of the financial impact:
Open ended
3.3. Budgetary characteristics ( add rows if necessary ) :
Budget line | Type of expenditure | New | EFTA contribution | Contributions from applicant countries | Heading in financial perspective |
17.01.04.01 | Comp/ | D | NO | NO | NO | NO [2] |
4. SUMMARY OF RESOURCES
4.1. Financial Resources
4.1.1. Summary of commitment appropriations (CA) and payment appropriations (PA)
EUR million (to 3 decimal places)
Expenditure type | Section no. | Year n | n + 1 | n + 2 | n + 3 | n + 4 | n + 5 and later | Total |
Operational expenditure[15] |
Commitment Appropriations (CA) | 8.1 | a | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
Payment Appropriations (PA) | b | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
Administrative expenditure within reference amount[16] |
Technical & administrative assistance (NDA) | 8.2.4 | c | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 6.0 |
TOTAL REFERENCE AMOUNT |
Commitment Appropriations | a+c | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 6.0 |
Payment Appropriations | b+c | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 6.0 |
Administrative expenditure not included in reference amount[17] |
Human resources and associated expenditure (NDA) | 8.2.5 | d | 1.348 | 1.348 | 1.348 | 1.348 | 1.348 | 1.348 | 8.088 |
Administrative costs, other than human resources and associated costs, not included in reference amount (NDA) | 8.2.6 | e | 0.85 | 0.85 | 0.85 | 0.85 | 0.85 | 0.85 | 5.10 |
Total indicative financial cost of intervention
TOTAL CA including cost of Human Resources | a+c+d+e | 3.198 | 3.198 | 3.198 | 3.198 | 3.198 | 3.198 | 19.188 |
TOTAL PA including cost of Human Resources | b+c+d+e | 3.198 | 3.198 | 3.198 | 3.198 | 3.198 | 3.198 | 19.188 |
Co-financing details
If the proposal involves co-financing by Member States, or other bodies (please specify which), an estimate of the level of this co-financing should be indicated in the table below (additional lines may be added if different bodies are foreseen for the provision of the co-financing):
EUR million (to 3 decimal places)
Co-financing body | Year n | n + 1 | n + 2 | n + 3 | n + 4 | n + 5 and later | Total |
…………………… | f |
TOTAL CA including co-financing | a+c+d+e+f |
4.1.2. Compatibility with Financial Programming
( Proposal is compatible with existing financial programming.
( Proposal will entail reprogramming of the relevant heading in the financial perspective.
( Proposal may require application of the provisions of the Interinstitutional Agreement[18] (i.e. flexibility instrument or revision of the financial perspective).
4.1.3. Financial impact on Revenue
( Proposal has no financial implications on revenue
( Proposal has financial impact – the effect on revenue is as follows:
NB: All details and observations relating to the method of calculating the effect on revenue should be shown in a separate annex.
EUR million (to one decimal place)
Prior to action [Year n-1] | Situation following action |
Total number of human resources | 13 | 13 | 13 | 13 | 13 | 13 |
5. CHARACTERISTICS AND OBJECTIVES
Details of the context of the proposal are required in the Explanatory Memorandum. This section of the Legislative Financial Statement should include the following specific complementary information:
5.1. Need to be met in the short or long term
In order to assure proportionality of the implementing measures that will be taken in the framework of the proposed regulation, the following instruments are therefore needed:
The Legislation on placing plant protection products on the market is harmonised within the EU. Decisions on active substances are taken at EU level; decisions on plant protection products (products used by the farmers) are taken by Member States, based on uniform criteria and data requirements.
Presently there are about 500 active substances under examination for approval at EU level (inclusion in a positive list). Such a list has to be managed continuously. The proposal provides for obligatory zonal mutual recognition which has to be coordinated. Reinforced control measures require continuous follow-up.
The following instruments are foreseen in the framework of the proposed Regulation:
(a) the development of a harmonised system, including an appropriate database, for gathering and storing all information concerning active substances, safeners, synergists, co-formulants, plant protection products and adjuvants and for making such information available to the competent authorities, producers and other interested parties;
(b) the performance of studies necessary for the preparation and development of further legislation on the placing on the market and use of plant protection products and adjuvants;
(c) the performance of studies necessary to harmonise procedures, decision-making criteria and data requirements;
(d) coordination, if necessary by electronic means, of the cooperation between Member States, the Authority and the Commission and measures to facilitate work sharing;
(e) the development and maintenance of a coordinated electronic submission and evaluation system aimed at promoting electronic document exchange and work sharing between the applicants, the Member States, the Authority and the Commission;
(f) development of guidance to facilitate the day-to-day implementation of this Regulation;
(g) measures to ensure the application of the control measures such as training of control staff, travel and subsistence expenses that Member States’ experts incur as a result of the Commission appointing them to assist its experts in the framework of control activities
5.2. Value-added of Community involvement and coherence of the proposal with other financial instruments and possible synergy
The data and information obtained will help in assuring:
- effective protection of plants
- protection of human health (consumers, users of plant protection products) and the environment
- a harmonised and predictable legal environment for industry
5.3. Objectives, expected results and related indicators of the proposal in the context of the ABM framework
Assure that the use of plant protection products does not lead to unacceptable risks for the user, the consumer or the environment and at the same time does not impose unnecessary burden to the industry by ensuring an appropriate functioning of the internal market for plant protection products.
5.4. Method of Implementation (indicative)
Show below the method(s)[20] chosen for the implementation of the action.
X Centralised Management
X Directly by the Commission
ٱ Indirectly by delegation to:
ٱ Executive Agencies
ٱ Bodies set up by the Communities as referred to in art. 185 of the Financial Regulation
ٱ National public-sector bodies/bodies with public-service mission
ٱ Shared or decentralised management
ٱ With Member states
ٱ With Third countries
ٱ Joint management with international organisations (please specify)
6. MONITORING AND EVALUATION
6.1. Monitoring system
The number of active substances approved, of plant protection products authorised in Member States of the same zone and the implementation of the legislation by Member States.
Evaluation
6.1.1. Ex-ante evaluation
The proposed measure is an amendment of an existing Directive. An intensive stakeholder consultation has taken place. Main points which during the consultation were identified as deserving an in-depth discussion are covered by the impact assessment. Other points which bring consistency with other EU policies or optimise existing policies are included to improve the current system.
6.1.2. Measures taken following an intermediate/ex-post evaluation (lessons learned from similar experiences in the past)
6.1.3. Terms and frequency of future evaluation
The Commission will perform an ongoing evaluation to monitor the need to propose implementing measures.
Indicators include the duration of the evaluation procedure, the availability of plant protection products in different zones and the availability of low risk plant protection products. A procedure allowing to adopt implementing measures is foreseen in the Regulation.
In addition, the effectiveness, efficiency and relevance of the measure will be evaluated in accordance with a timetable, which allows the results of the evaluation to be used for the decision-making on the modification or renewal of the Regulation.
7. ANTI-FRAUD MEASURES
Full application of internal control standards No 14, 15, 16, 18, 19, 20, 21.
The Commission shall ensure that, when actions financed under the present programme are implemented, the financial interests of the Community are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and by the recovery of the amounts unduly paid and, if irregularities are detected, by effective, proportional and dissuasive penalties, in accordance with Council Regulations (EC Euratom) No 2988/95 and (Euratom, EC) No 2185/96, and with Regulation (EC) No 1073/1999 of the European Parliament and of the Council.
8. DETAILS OF RESOURCES
8.1. Objectives of the proposal in terms of their financial cost
Commitment appropriations in EUR million (to 3 decimal places)
Year n | Year n+1 | Year n+2 | Year n+3 | Year n+4 | Year n+5 |
Officials or temporary staff[21] (17 01 01) | A*/AD | 7 existing 2 new | 7 existing 2 new | 7 existing 2 new | 7 existing 2 new | 7 existing 2 new | 7 existing 2 new |
B*, C*/AST | 4 | 4 | 4 | 4 | 4 | 4 |
Staff financed[22] by art. XX 01 02 |
Other staff[23] financed by art. XX 01 04/05 |
TOTAL | 13 | 13 | 13 | 13 | 13 | 13 |
8.2.2. Description of tasks deriving from the action
Examination of technical reports from Industry, Member States, the European Food Safety Authority and preparation of decisions on substances
Control of the implementation by Member States of the measures foreseen in the Regulation
Preparation of legislation to harmonise data requirements, criteria, control measures
Examination of technical and financial reports, preparations of commitments and pass to payment
8.2.3. Sources of human resources (statutory)
(When more than one source is stated, please indicate the number of posts originating from each of the sources)
( Posts currently allocated to the management of the programme to be replaced or extended
( Posts pre-allocated within the APS/PDB exercise for year n
X Posts to be requested in the next APS/PDB procedure
( Posts to be redeployed using existing resources within the managing service (internal redeployment)
( Posts required for year n although not foreseen in the APS/PDB exercise of the year in question
8.2.4. Other Administrative expenditure included in reference amount (XX 01 04/05 – Expenditure on administrative management)
EUR million (to 3 decimal places)
Budget line (number and heading) | Year n | Year n+1 | Year n+2 | Year n+3 | Year n+4 | Year n+5 and later | TOTAL |
Other technical and administrative assistance |
intra muros |
extra muros. As mentioned in point 5.01 this will involve the development of a harmonised system, the performance of studies, coordination, control measures etc. | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 6.0 |
Total Technical and administrative assistance | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 6.0 |
8.2.5. Financial cost of human resources and associated costs not included in the reference amount
EUR million (to 3 decimal places)
Type of human resources | Year n | Year n+1 | Year n+2 | Year n+3 | Year n+4 | Year n+5 and later |
Officials and temporary staff (XX 01 01) | 1.188 | 1.188 | 1.188 | 1.188 | 1.188 | 1.188 |
Staff financed by Art XX 01 02 (auxiliary, END, contract staff, etc.) (specify budget line) | 0.160 | 0.160 | 0.160 | 0.160 | 0.160 | 0.160 |
Total cost of Human Resources and associated costs (NOT in reference amount) | 1.348 | 1.348 | 1.348 | 1.348 | 1.348 | 1.348 |
Calculation– Officials and Temporary agents Reference should be made to Point 8.2.1, if applicable 11 officials x 0.108 |
Calculation– Staff financed under art. XX 01 02 Reference should be made to Point 8.2.1, if applicable 2 END x 0.08 |
8.2.6 Other administrative expenditure not included in reference amount
EUR million (to 3 decimal places)
Year n | Year n+1 | Year n+2 | Year n+3 | Year n+4 | Year n+5 and later | TOTAL |
XX 01 02 11 01 – Missions | 0.20 | 0.20 | 0.20 | 0.20 | 0.20 | 0.20 | 1.2 |
XX 01 02 11 02 – Meetings & Conferences | 0.50 | 0.50 | 0.50 | 0.50 | 0.50 | 0.50 | 3.0 |
XX 01 02 11 03 – Committees[25] Standing Committee on the Food Chain and Animal Health | 0.15 | 0.15 | 0.15 | 0.15 | 0.15 | 0.15 | 0.90 |
XX 01 02 11 04 – Studies & consultations |
XX 01 02 11 05 - Information systems |
2. Total Other Management Expenditure (XX 01 02 11) |
3. Other expenditure of an administrative nature (specify including reference to budget line) |
Total Administrative expenditure, other than human resources and associated costs (NOT included in reference amount) | 0.85 | 0.85 | 0.85 | 0.85 | 0.85 | 0.85 | 5.10 |
Calculation - Other administrative expenditure not included in reference amount 100 missions with a unit cost of 2000 € are foreseen, including in particular to follow the evaluations performed by the European Food Safety Authority and to assist in the coordination of Member State activities. The organisation of meetings to prepare the necessary implementing measures and 1 conference to discuss major problems of principle. 6 Meetings of the Standing Committee (unit cost 25.000 €) are foreseen every year. |
The needs for human and administrative resources shall be covered within the allocation granted to the managing DG in the framework of the annual allocation procedure.
[1] OJ L 230, 19.8.19991, p. 1. Directive as last amended by Commission Directive 2007/xxx/EC (OJ L xxx, xx.xx.xxxx, p. xx).
[2] COM(2001) 444.
[3] OJ L 33, 8.2.1979, p. 36. Directive as last amended by Regulation (EC) No 850/2004 of the European Parliament and the Council (OJ L 158, 30.4.2005, p. 7, corrected version in OJ L 229, 29.6.2004, p. 5).
[4] OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).
[5] OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision (EC) No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).
[6] OJ L 200, 30.7.1999, p. 1. Directive as last amended by Commission Directive 2006/8/EC (OJ L 19, 24.1.2006, p. 12).
[7] OJ L 165, 30.4.2004, p. 1. Corrected version in OJ L 191, 28.5.2004, p. 1.
[8] OJ L 70, 16.3.2005, p. 1.
[9] OJ L 184, 17.7.1999, p. 23.
[10] OJ 196, 16.8.1967, p. 1.
[11] OJ L 106, 17.4.2001, p. 1.
[12] OJ L 50, 20.2.2004, p. 44.
[13] OJ L 145, 31.5.2001, p. 43.
[14] OJ L 41, 14.2.2003, p. 26.
[15] No expenditure foreseen.
[16] Expenditure within article 17 01 04 01.
[17] Expenditure within chapter 17 01 01.
[18] See points 19 and 24 of the Interinstitutional agreement.
[19] Additional columns should be added if necessary i.e. if the duration of the action exceeds 6 years.
[20] If more than one method is indicated please provide additional details in the "Relevant comments" section of this point.
[21] Cost of which is NOT covered by the reference amount.
[22] Cost of which is NOT covered by [23].8ALNef„…†‡ˆ d e | … the reference amount.
[24] Cost of which is included within the reference amount.
[25] Reference should be made to the specific legislative financial statement for the Executive Agency(ies) concerned.
[26] Specify the type of committee and the group to which it belongs.