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Commission Regulation (EU) No 546/2011Dangos y teitl llawn

Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance)

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  1. Introductory Text

  2. Article A1.Interpretation

  3. Article 1.The uniform principles for evaluation and authorisation of plant protection...

  4. Article 2.This Regulation shall enter into force on the 20th day...

  5. Signature

    1. ANNEX

      UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS, AS PROVIDED FOR IN ARTICLE 29(6)(a) OF REGULATION (EC) No 1107/2009

      1. PART I Uniform principles for evaluation and authorisation of chemical plant protection...

        1. A. INTRODUCTION

          1. 1. The principles developed in this Annex aim to ensure that...

          2. 2. In evaluating applications and granting authorisations competent authorities shall:

          3. 3. Where in the specific principles on evaluation reference is made...

          4. 4. Where the data and information provided are sufficient to permit...

          5. 5. During the process of evaluation and decision-making, competent authorities shall...

          6. 6. The judgements made by the competent authorities ... during the...

        2. B. EVALUATION

          1. 1. General principles

            1. 1.1. Having regard to current scientific and technical knowledge, competent authorities...

            2. 1.2. In accordance with the terms of Article 29 of Regulation...

            3. 1.3. In the evaluation of applications submitted, competent authorities shall have...

            4. 1.4. In interpreting the results of evaluations, competent authorities shall take...

            5. 1.5. Where specific principles of Section 2 provide for the use...

            6. 1.6. Where metabolites, degradation or reaction products are referred to in...

          2. 2. Specific principles

            1. 2.1. Efficacy

              1. 2.1.1. Where the proposed use concerns the control of or protection...

              2. 2.1.2. Where the proposed use concerns an effect other than the...

              3. 2.1.3. Competent authorities shall evaluate the efficacy data on the plant...

              4. 2.1.4. Competent Authorities shall evaluate the performance of the plant protection...

              5. 2.1.5. Where the product label includes requirements for use of the...

            2. 2.2. Absence of unacceptable effects on plants or plant products

              1. 2.2.1. Competent authorities shall evaluate the degree of adverse effects on...

              2. 2.2.2. Where the available data indicate that the active substance or...

              3. 2.2.3. Where the product label includes requirements for use of the...

            3. 2.3. Impact on vertebrates to be controlled

            4. 2.4. Impact on human or animal health

              1. 2.4.1. Impact on human or animal health arising from the plant...

                1. 2.4.1.1. Competent authorities shall evaluate operator exposure to the active substance...

                2. 2.4.1.2. Competent authorities shall examine information relating to the nature and...

                3. 2.4.1.3. Competent authorities shall examine the nature and characteristics of the...

                4. 2.4.1.4. Competent authorities shall evaluate the possibility of exposure of other...

              2. 2.4.2. Impact on human or animal health arising from residues

                1. 2.4.2.1. Competent authorities shall evaluate the specific information on toxicology as...

                2. 2.4.2.2. Prior to evaluating the residue levels in the reported trials...

                3. 2.4.2.3. On the basis of suitable statistical models competent authorities shall...

                4. 2.4.2.4. Competent authorities shall evaluate the residue levels observed in products...

                5. 2.4.2.5. Competent authorities shall estimate the potential exposure of consumers through...

                6. 2.4.2.6. Competent authorities shall, where relevant, estimate the exposure of animals,...

            5. 2.5. Influence on the environment

              1. 2.5.1. Fate and distribution in the environment

              2. 2.5.2. Impact on non-target species

                1. 2.5.2.1. Competent authorities shall evaluate the possibility of exposure of birds...

                2. 2.5.2.2 Competent authorities shall evaluate the possibility of exposure of aquatic...

                3. 2.5.2.3. Competent authorities shall evaluate the possibility of exposure of honeybees...

                4. 2.5.2.4. Competent authorities shall evaluate the possibility of exposure of beneficial...

                5. 2.5.2.5. Competent authorities shall evaluate the possibility of exposure of earthworms...

                6. 2.5.2.6. Competent authorities shall, where the evaluation carried out under point...

            6. 2.6. Analytical methods

            7. 2.7. Physical and chemical properties

              1. 2.7.1. Competent authorities shall evaluate the actual active substance content of...

              2. 2.7.2. Competent authorities shall evaluate the physical and chemical properties of...

              3. 2.7.3. Where proposed label claims include requirements or recommendations for use...

        3. C. DECISION-MAKING

          1. 1. General principles

            1. 1.1. Where appropriate, competent authorities shall impose conditions or restrictions with...

            2. 1.2. Competent authorities shall ensure that, where necessary, decisions taken with...

            3. 1.3. Competent authorities shall ensure that the authorised amounts, in terms...

            4. 1.4. Competent authorities shall ensure that decisions respect the principles of...

            5. 1.5. Since the evaluation is to be based on data concerning...

            6. 1.6. Before issuing an authorisation, competent authorities shall ensure that the...

            7. 1.7. Before issuing authorisations, competent authorities shall:

            8. 1.8. No authorisation shall be granted unless all the requirements referred...

            9. 1.9. Where an authorisation has been granted in accordance with the...

          2. 2. Specific principles

            1. 2.1. Efficacy

              1. 2.1.1. Where the proposed uses include recommendations for the control of...

              2. 2.1.2. The level, consistency and duration of control or protection or...

              3. 2.1.3. Where relevant, yield response when the product is used and...

              4. 2.1.4. Conclusions as to the performance of the preparation must be...

              5. 2.1.5. Where proposed label claims include requirements for use of the...

            2. 2.2. Absence of unacceptable effects on plants or plant products

              1. 2.2.1. There must be no relevant phytotoxic effects on treated plants...

              2. 2.2.2. There must be no reduction of yield at harvest due...

              3. 2.2.3. There must be no unacceptable adverse effects on the quality...

              4. 2.2.4. There must be no unacceptable adverse effects on treated plants...

              5. 2.2.5. There must be no unacceptable impact on succeeding crops, except...

              6. 2.2.6. There must be no unacceptable impact on adjacent crops, except...

              7. 2.2.7. Where proposed label claims include requirements for use of the...

              8. 2.2.8. The proposed instructions for cleaning the application equipment must be...

            3. 2.3. Impact on vertebrates to be controlled

            4. 2.4. Impact on human or animal health

              1. 2.4.1. Impact on human or animal health arising from the plant...

                1. 2.4.1.1. No authorisation shall be granted if the extent of operator...

                2. 2.4.1.2. Where the proposed conditions of use require use of items...

                3. 2.4.1.3. Plant protection products which because of particular properties or if...

                4. 2.4.1.4. Waiting and re-entry safety periods or other precautions must be...

                5. 2.4.1.5. Waiting and re-entry safety periods or other precautions must be...

                6. 2.4.1.6. Waiting and re-entry periods or other precautions to ensure that...

              2. 2.4.2. Impact on human or animal health arising from residues

                1. 2.4.2.1. Authorisations must ensure that residues occurring reflect the minimum quantities...

                2. 2.4.2.2. Where the new circumstances under which the plant protection product...

                3. 2.4.2.3. Where a MRL exists competent authorities shall not grant an...

                4. 2.4.2.4. In the cases referred to in points 2.4.2.2, each application...

                5. 2.4.2.5. Where the nature of residues is affected during processing, a...

                6. 2.4.2.6. Where the treated plants or plant products are intended to...

            5. 2.5. Influence on the environment

              1. 2.5.1. Fate and distribution in the environment

                1. 2.5.1.1. No authorisation shall be granted if the active substance and,...

                2. 2.5.1.2. No authorisation shall be granted if the concentration of the...

                3. 2.5.1.3. No authorisation shall be granted if the concentration of the...

                4. 2.5.1.4. No authorisation shall be granted if the airborne concentration of...

              2. 2.5.2. Impact on non-target species

                1. 2.5.2.1. Where there is a possibility of birds and other non-target...

                2. 2.5.2.2. Where there is a possibility of aquatic organisms being exposed,...

                3. 2.5.2.3. Where there is a possibility of honeybees being exposed, no...

                4. 2.5.2.4. Where there is a possibility of beneficial arthropods other than...

                5. 2.5.2.5. Where there is a possibility of earthworms being exposed, no...

                6. 2.5.2.6. Where there is a possibility of non-target soil micro-organisms being...

            6. 2.6. Analytical methods

            7. 2.7. Physical and chemical properties

              1. 2.7.1. Where an appropriate FAO specification exists, that specification must be...

              2. 2.7.2. Where no appropriate FAO specification exists, the physical and chemical...

              3. 2.7.3. Where the proposed label claims include requirements or recommendations for...

      2. PART II Uniform principles for evaluation and authorisation of plant protection products...

        1. A. INTRODUCTION

          1. 1. The principles developed in Part II aim to ensure that...

          2. 2. In evaluating applications for granting authorisations competent authorities shall:

          3. 3. Where, in the specific principles on evaluation, reference is made...

          4. 4. Where the data and information provided are sufficient to permit...

          5. 5. During the process of evaluation and decision-making, the competent authority...

          6. 6. The judgements made by the competent authorities ... during the...

          7. 7. A microbial plant protection product may contain viable and non-viable...

          8. 8. Competent authorities must take into account those guidance documents issued...

          9. 9. For genetically modified micro-organisms, the EU-derived domestic legislation which transposed...

          10. 10. Definitions and explanations of microbiological terms

        2. B. EVALUATION

          1. 1. General principles

            1. 1.1. Having regard to current scientific and technical knowledge, competent authorities...

            2. 1.2. The quality/methodology of tests, where there are no standardised test...

            3. 1.3. In interpreting the results of evaluations, competent authorities shall take...

            4. 1.4. Competent authorities shall evaluate each microbial plant protection product for...

            5. 1.5. In evaluating applications and granting authorisations competent authorities shall consider...

            6. 1.6. In the evaluation, competent authorities shall consider the agricultural, plant...

            7. 1.7. Where specific principles in Section 2 provide for the use...

            8. 1.8. The data requirements, specified in part B of the Annex...

          2. 2. Specific principles

            1. 2.1. Identity

              1. 2.1.1. Identity of the micro-organism in the plant protection product

              2. 2.1.2. Identity of the plant protection product

            2. 2.2. Biological, physical, chemical, and technical properties

              1. 2.2.1. Biological properties of the micro-organism in the plant protection product...

                1. 2.2.1.1. The origin of the strain, where relevant, its natural habitat...

                2. 2.2.1.2. The ability of micro-organisms to adapt to the environment must...

                3. 2.2.1.3. The mode of action of the micro-organism shall be evaluated...

                4. 2.2.1.4. In order to evaluate possible effects on non-target organisms, information...

                5. 2.2.1.5. Many micro-organisms produce antibiosis substances that cause normal interferences in...

              2. 2.2.2. Physical, chemical and technical properties of the plant protection product...

                1. 2.2.2.1. Depending on the nature of the micro-organism and the formulation...

                2. 2.2.2.2. Shelf-life and storage stability of the preparation must be evaluated,...

                3. 2.2.2.3. Competent authorities shall evaluate the physical and chemical properties of...

                4. 2.2.2.4. Where the proposed label claims include requirements or recommendations for...

            3. 2.3. Further information

              1. 2.3.1. Quality control of the production of the micro-organism in the...

              2. 2.3.2. Quality control of the plant protection product

            4. 2.4. Efficacy

              1. 2.4.1. Where the proposed use concerns the control of or protection...

              2. 2.4.2. Competent authorities shall evaluate whether significant damage, loss or inconvenience...

              3. 2.4.3. Competent authorities shall evaluate the efficacy data provided for in...

              4. 2.4.4. Competent authorities shall evaluate the performance of the plant protection...

              5. 2.4.5. Competent authorities shall evaluate the degree of adverse effects on...

              6. 2.4.6. Where the label of the plant protection product includes requirements...

              7. 2.4.7. Where the available data indicate that the micro-organism or significant...

              8. 2.4.8. Where the proposed use of a plant protection product is...

            5. 2.5. Identification/detection and quantification methods

              1. 2.5.1. Analytical methods for the plant protection product

                1. 2.5.1.1. Non-viable components

                2. 2.5.1.2. Viable components

              2. 2.5.2. Analytical methods for the determination of residues

                1. 2.5.2.1. Non-viable residues

                2. 2.5.2.2. Viable residues

            6. 2.6. Impact on human or animal health

              1. 2.6.1. Effects on human or animal health arising from the plant...

                1. 2.6.1.1. Competent authorities shall evaluate operator exposure to the micro-organism, and/or...

                2. 2.6.1.2. Competent authorities shall examine information relating to the nature and...

                3. 2.6.1.3. Competent authorities shall examine the nature and characteristics of the...

                4. 2.6.1.4. Competent authorities shall evaluate the possibility of exposure of other...

              2. 2.6.2. Effects on human or animal health arising from residues

                1. 2.6.2.1. Non-viable residues

                  1. (a) Competent authorities shall evaluate the possibility of exposure of humans...

                  2. (b) Competent authorities shall evaluate the toxicity of non-viable residues and...

                  3. (c) Where non-viable residues or their degradation products are considered toxicologically...

                2. 2.6.2.2. Viable residues

                  1. (a) Competent authorities shall evaluate the possibility of exposure of humans...

                  2. (b) Competent authorities shall evaluate the specific information concerning the ability...

                  3. (c) In the event that viable residues are considered to be...

            7. 2.7. Fate and behaviour in the environment

              1. 2.7.1. Competent authorities shall evaluate the possibility of contamination of ground...

              2. 2.7.2. Competent authorities shall evaluate the risk for the aquatic compartment...

              3. 2.7.3. Competent authorities shall evaluate the possibility of exposure of organisms...

              4. 2.7.4. Competent authorities shall evaluate the possibility of exposure of organisms...

            8. 2.8. Effects on and exposure of non-target organisms

              1. 2.8.1. Competent authorities shall evaluate the possibility of exposure of and...

                1. 2.8.1.1. A micro-organism may give rise to risks because of its...

                2. 2.8.1.2. A plant protection product may give rise to toxic effects...

              2. 2.8.2. Competent authorities shall evaluate the possibility of exposure of and...

                1. 2.8.2.1. A micro-organism may give rise to risks because of its...

                2. 2.8.2.2. A plant protection product may give rise to toxic effects...

              3. 2.8.3. Competent authorities shall evaluate the possibility of exposure of and...

                1. 2.8.3.1. A micro-organism may give rise to risks because of its...

                2. 2.8.3.2. A plant protection product may give rise to toxic effects...

              4. 2.8.4. Competent authorities shall evaluate the possibility of exposure of and...

                1. 2.8.4.1. A micro-organism may give rise to risks because of its...

                2. 2.8.4.2. A plant protection product may give rise to toxic effects...

              5. 2.8.5. Competent authorities shall evaluate the possibility of exposure of and...

                1. 2.8.5.1. A micro-organism may give rise to risks because of its...

                2. 2.8.5.2. A plant protection product may give rise to toxic effects...

              6. 2.8.6. Competent authorities shall evaluate the possibility of exposure of and...

                1. 2.8.6.1. A micro-organism may give rise to risks because of its...

                2. 2.8.6.2. Competent authorities shall evaluate the impact of exotic/non-indigenous micro-organisms on...

                3. 2.8.6.3. A plant protection product may give rise to toxic effects...

            9. 2.9. Conclusions and proposals

        3. C. DECISION-MAKING

          1. 1. General principles

            1. 1.1. Where appropriate, competent authorities shall impose conditions or restrictions on...

            2. 1.2. Competent authorities shall ensure that decisions taken to grant authorisations,...

            3. 1.3. Competent authorities shall ensure that the authorised amounts, in terms...

            4. 1.4. Competent authorities shall ensure that decisions respect the principles of...

            5. 1.5. Since the evaluation is to be based on data concerning...

            6. 1.6. Before issuing an authorisation, competent authorities shall ensure that the...

            7. 1.7. Before issuing authorisations, competent authorities shall:

            8. 1.8. No authorisation shall be granted unless all the requirements referred...

            9. 1.9. Where an authorisation has been granted in accordance with the...

            10. 1.10. Competent authorities shall ensure, as far as is practically possible,...

            11. 1.11. Where the micro-organism has been genetically modified, as defined in...

            12. 1.12. In accordance with Article 53(4) of Regulation (EC) No 1107/2009,...

            13. 1.13. No authorisation shall be granted if relevant metabolites/toxins (i.e. those...

            14. 1.14. Competent authorities shall ensure that adequate quality control measures are...

          2. 2. Specific principles

            1. 2.1. Identity

            2. 2.2. Biological and technical properties

              1. 2.2.1. There must be sufficient information to permit assessment of the...

              2. 2.2.2. No authorisation shall be granted if, at any stage in...

            3. 2.3. Further information

            4. 2.4. Efficacy

              1. 2.4.1. Performance

                1. 2.4.1.1. No authorisation shall be granted where the proposed uses include...

                2. 2.4.1.2. The level, consistency and duration of control or protection or...

                3. 2.4.1.3. Where relevant, yield response when the plant protection product is...

                4. 2.4.1.4. Conclusions as to the performance of the preparation must be...

                5. 2.4.1.5. Where proposed label claims include requirements for use of the...

                6. 2.4.1.6. If there is evidence of a development of resistance of...

                7. 2.4.1.7. Only plant protection products containing non-viable micro-organisms may be authorised...

              2. 2.4.2. Absence of unacceptable effects on plants and plant products

                1. 2.4.2.1. There must be no relevant phytotoxic effects on treated plants...

                2. 2.4.2.2. There must be no reduction of yield at harvest due...

                3. 2.4.2.3. There must be no unacceptable adverse effects on the quality...

                4. 2.4.2.4. There must be no unacceptable adverse effects on treated plants...

                5. 2.4.2.5. There must be no unacceptable impact on succeeding crops, except...

                6. 2.4.2.6. There must be no unacceptable impact on adjacent crops, except...

                7. 2.4.2.7. Where proposed label claims include requirements for use of the...

                8. 2.4.2.8. The proposed instructions for cleaning the application equipment must be...

            5. 2.5. Identification/detection and quantification methods

              1. 2.5.1. No authorisation shall be granted unless there is an adequate...

              2. 2.5.2. No authorisation shall be granted unless there are adequate methods...

            6. 2.6. Impact on human and animal health

              1. 2.6.1. Effects on human and animal health arising from the plant...

                1. 2.6.1.1. No authorisation shall be granted if on the basis of...

                2. 2.6.1.2. No authorisation shall be granted if the micro-organism and/or the...

                3. 2.6.1.3. All micro-organisms shall be regarded as potential sensitisers, unless it...

                4. 2.6.1.4. No authorisation shall be granted if it is known that...

                5. 2.6.1.5. Plant protection products which, because of particular properties, or which,...

                6. 2.6.1.6. Waiting and re-entry safety periods or other precautions must be...

                7. 2.6.1.7. Waiting and re-entry safety periods or other precautions must be...

                8. 2.6.1.8. Waiting and re-entry periods or other precautions to ensure that...

                9. 2.6.1.9. The conditions of authorisation shall be in compliance with the...

              2. 2.6.2. Effects on human and animal health arising from residues

                1. 2.6.2.1. No authorisation shall be granted unless there is sufficient information...

                2. 2.6.2.2. No authorisation shall be granted unless viable residues and/or non-viable...

            7. 2.7. Fate and behaviour in the environment

              1. 2.7.1. No authorisation shall be granted if the available information indicates...

              2. 2.7.2. No authorisation shall be granted if contamination of ground water,...

              3. 2.7.3. No authorisation shall be granted if the contamination of groundwater...

              4. 2.7.4. No authorisation shall be granted if the contamination of surface...

              5. 2.7.5. No authorisation shall be granted if it is known that...

              6. 2.7.6. No authorisation shall be granted unless there is sufficient information...

              7. 2.7.7. No authorisation shall be granted if it can be expected...

            8. 2.8. Effects on non-target organisms

              1. 2.8.1. Where there is a possibility of birds and other non-target...

              2. 2.8.2. Where there is a possibility of aquatic organisms being exposed,...

              3. 2.8.3. Where there is a possibility of bees being exposed, no...

              4. 2.8.4. Where there is a possibility of arthropods other than bees...

              5. 2.8.5. Where there is a possibility of earthworms being exposed, no...

              6. 2.8.6. Where there is a possibility of non-target soil micro-organisms being...

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  • rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
  • manylion rhoi grym a newid cyffredinol
  • pob fformat o’r holl ddogfennau cysylltiedig
  • dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill