Search Legislation

Advanced Search

Commission Regulation (EU) No 546/2011Show full title

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)

Help about what version

What Version

More Resources

Revised version PDFs

Close

This is a legislation item that originated from the EU

After exit day there will be three versions of this legislation to consult for different purposes. The legislation.gov.uk version is the version that applies in the UK. The EU Version currently on EUR-lex is the version that currently applies in the EU i.e you may need this if you operate a business in the EU.

The web archive version is the official version of this legislation item as it stood on exit day before being published to legislation.gov.uk and any subsequent UK changes and effects applied. The web archive also captured associated case law and other language formats from EUR-Lex.

Status:

This is the original version (as it was originally adopted).

  1. Introductory Text

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

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

  4. Signature

    1. ANNEX

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

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

        1. A. INTRODUCTION

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

          2. 2. In evaluating applications and granting authorisations Member States 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, Member States shall...

          6. 6. The judgements made by the competent authorities of the Member...

        2. B. EVALUATION

          1. 1. General principles

            1. 1.1. Having regard to current scientific and technical knowledge, Member States...

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

            3. 1.3. In the evaluation of applications submitted, Member States shall have...

            4. 1.4. In interpreting the results of evaluations, Member States 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. Member States shall evaluate the efficacy data on the plant...

              4. 2.1.4. Member States 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. Member States 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. Member States shall evaluate operator exposure to the active substance...

                2. 2.4.1.2. Member States shall examine information relating to the nature and...

                3. 2.4.1.3. Member States shall examine the nature and characteristics of the...

                4. 2.4.1.4. Member States 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. Member States 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 Member States shall...

                4. 2.4.2.4. Member States shall evaluate the residue levels observed in products...

                5. 2.4.2.5. Member States shall estimate the potential exposure of consumers through...

                6. 2.4.2.6. Member States 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. Member States shall evaluate the possibility of exposure of birds...

                2. 2.5.2.2. Member States shall evaluate the possibility of exposure of aquatic...

                3. 2.5.2.3. Member States shall evaluate the possibility of exposure of honeybees...

                4. 2.5.2.4. Member States shall evaluate the possibility of exposure of beneficial...

                5. 2.5.2.5. Member States shall evaluate the possibility of exposure of earthworms...

                6. 2.5.2.6. Member States shall, where the evaluation carried out under point...

            6. 2.6. Analytical methods

            7. 2.7. Physical and chemical properties

              1. 2.7.1. Member States shall evaluate the actual active substance content of...

              2. 2.7.2. Member States 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, Member States shall impose conditions or restrictions with...

            2. 1.2. Member States shall ensure that, where necessary, decisions taken with...

            3. 1.3. Member States shall ensure that the authorised amounts, in terms...

            4. 1.4. Member States 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, Member States shall ensure that the...

            7. 1.7. Before issuing authorisations, Member States 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 Member States 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 containing micro-organisms

        1. A. INTRODUCTION

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

          2. 2. In evaluating applications for granting authorisations Member States 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 Member State...

          6. 6. The judgements made by the competent authorities of the Member...

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

          8. 8. Member States must take into account those guidance documents taken...

          9. 9. For genetically modified micro-organisms, Directive 2001/18/EC of the European Parliament...

          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, Member States...

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

            3. 1.3. In interpreting the results of evaluations, Member States shall take...

            4. 1.4. Member States shall evaluate each microbial plant protection product for...

            5. 1.5. In evaluating applications and granting authorisations Member States shall consider...

            6. 1.6. In the evaluation, Member States 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. Member States 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. Member States shall evaluate whether significant damage, loss or inconvenience...

              3. 2.4.3. Member States shall evaluate the efficacy data provided for in...

              4. 2.4.4. Member States shall evaluate the performance of the plant protection...

              5. 2.4.5. Member States 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. Member States shall evaluate operator exposure to the micro-organism, and/or...

                2. 2.6.1.2. Member States shall examine information relating to the nature and...

                3. 2.6.1.3. Member States shall examine the nature and characteristics of the...

                4. 2.6.1.4. Member States 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) Member States shall evaluate the possibility of exposure of humans...

                  2. (b) Member States 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) Member States shall evaluate the possibility of exposure of humans...

                  2. (b) Member States 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. Member States shall evaluate the possibility of contamination of ground...

              2. 2.7.2. Member States shall evaluate the risk for the aquatic compartment...

              3. 2.7.3. Member States shall evaluate the possibility of exposure of organisms...

              4. 2.7.4. Member States shall evaluate the possibility of exposure of organisms...

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

              1. 2.8.1. Member States 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. Member States 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. Member States 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. Member States 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. Member States 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. Member States 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. Member States 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, Member States shall impose conditions or restrictions on...

            2. 1.2. Member States shall ensure that decisions taken to grant authorisations,...

            3. 1.3. Member States shall ensure that the authorised amounts, in terms...

            4. 1.4. Member States 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, Member States shall ensure that the...

            7. 1.7. Before issuing authorisations, Member States 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. Member States 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. Member States 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 Directive...

              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...

Back to top

Options/Help

Print Options

You have chosen to open the Whole Regulation

The Whole Regulation you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open Schedules only

The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the EU Official Journal
  • lists of changes made by and/or affecting this legislation item
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources