# Official Journal L 90/8 Ap

| | ISSN 1725-2555 |
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| Official Journal
  of the European Union | L 90 |
| | |
| English edition | Legislation | Volume 488 April 2005 |

ISSN 1725-2555

Official Journal

of the European Union

L 90

English edition

Legislation

Volume 488 April 2005

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| Contents | | I   Acts whose publication is obligatory | page |
| --- | --- | --- | --- |
| | * | Council Directive 2005/25/EC of 14 March 2005 amending Annex VI to Directive 91/414/EEC as regards plant protection products containing micro-organisms (
  1
  ) | 1 |

Contents

I   Acts whose publication is obligatory

page

*

Council Directive 2005/25/EC of 14 March 2005 amending Annex VI to Directive 91/414/EEC as regards plant protection products containing micro-organisms (
  1
  )

1

1

| | | II   Acts whose publication is not obligatory |
| --- | --- | --- |
| | | Council |
| | * | Council Decision of 14 March 2005 on the conclusion of the bilateral agreement between the European Community and the Republic of Serbia on trade in textile products | 35 |
| Agreement between the European Community and the Republic of Serbia on trade in textile products | 36 |

II   Acts whose publication is not obligatory

Council

*

Council Decision of 14 March 2005 on the conclusion of the bilateral agreement between the European Community and the Republic of Serbia on trade in textile products

35

Agreement between the European Community and the Republic of Serbia on trade in textile products

36

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| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
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EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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I Acts whose publication is obligatory

| 8.4.2005 | EN | Official Journal of the European Union | L 90/1 |
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8.4.2005

EN

Official Journal of the European Union

L 90/1

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COUNCIL DIRECTIVE 2005/25/EC

of 14 March 2005

amending Annex VI to Directive 91/414/EEC as regards plant protection products containing micro-organisms

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 18(1) thereof,

Having regard to the proposal from the Commission,

Whereas:

| (1) | In accordance with Directive 91/414/EEC, Member States have to ensure that plant protection products are not authorised unless they comply with the requirements provided for in that Directive. |
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(1)

In accordance with Directive 91/414/EEC, Member States have to ensure that plant protection products are not authorised unless they comply with the requirements provided for in that Directive.

| (2) | Directive 91/414/EEC provides for the establishment of Uniform Principles pursuant to which the Member States have to carry out the evaluation of plant protection products with a view to their authorisation. |
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(2)

Directive 91/414/EEC provides for the establishment of Uniform Principles pursuant to which the Member States have to carry out the evaluation of plant protection products with a view to their authorisation.

| (3) | Uniform Principles have been laid down for Member States to use in the evaluation and authorisation of chemical plant protection products only. However, there are no equivalent principles for Member States to apply in the evaluation and authorisation of plant protection products containing micro-organisms. It is appropriate to lay down additional Uniform Principles for this type of plant protection product. |
| --- | --- |

(3)

Uniform Principles have been laid down for Member States to use in the evaluation and authorisation of chemical plant protection products only. However, there are no equivalent principles for Member States to apply in the evaluation and authorisation of plant protection products containing micro-organisms. It is appropriate to lay down additional Uniform Principles for this type of plant protection product.

| (4) | Requirements for the dossiers to be submitted by applicants for the authorisation of plant protection products containing micro-organisms having been included in Directive 91/414/EEC by Commission Directive 2001/36/EEC (2), it is now necessary to lay down Uniform Principles for the evaluation of a dossier concerning plant protection products containing micro-organisms based on such data requirements. |
| --- | --- |

(4)

Requirements for the dossiers to be submitted by applicants for the authorisation of plant protection products containing micro-organisms having been included in Directive 91/414/EEC by Commission Directive 2001/36/EEC (2), it is now necessary to lay down Uniform Principles for the evaluation of a dossier concerning plant protection products containing micro-organisms based on such data requirements.

| (5) | The provisions of this Directive concerning the protection of water, including the provisions related to monitoring, are without prejudice to Member States' obligations under the Directives concerned, and in particular Council Directives 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the Member States (3), 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution caused by certain dangerous substances (4), 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (5) and Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (6). |
| --- | --- |

(5)

The provisions of this Directive concerning the protection of water, including the provisions related to monitoring, are without prejudice to Member States' obligations under the Directives concerned, and in particular Council Directives 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the Member States (3), 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution caused by certain dangerous substances (4), 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (5) and Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (6).

| (6) | The provisions of this Directive concerning genetically modified organisms are without prejudice to Member States' obligations under Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (7). |
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(6)

The provisions of this Directive concerning genetically modified organisms are without prejudice to Member States' obligations under Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (7).

| (7) | The Scientific Committee on Plants has provided an opinion on this Directive, and this opinion has been taken into account. |
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(7)

The Scientific Committee on Plants has provided an opinion on this Directive, and this opinion has been taken into account.

| (8) | Directive 91/414/EEC should therefore be amended accordingly, |
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(8)

Directive 91/414/EEC should therefore be amended accordingly,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex VI to Directive 91/414/EEC is hereby amended in accordance with the Annex to this Directive.

Article 2

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 May 2006. They shall immediately forward to the Commission the text of those measures together with a correlation table between such measures and this Directive.

When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 14 March 2005.

For the Council

The President

F. BODEN

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(1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2004/99/EC (OJ L 309, 16.10.2004, p. 6).

1

(2)  OJ L 164, 20.6.2001, p. 1.

2

(3)  OJ L 194, 25.7.1975, p. 26. Directive to be repealed from 22.12.2007 by Directive 2000/60/EC (OJ L 327, 22.12.2000, p. 1).

3

(4)  OJ L 20, 26.1.1980, p. 43. Directive to be repealed from 22.12.2013 by Directive 2000/60/EC.

4

(5)  OJ L 330, 5.12.1998, p. 32. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

5

(6)  OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).

6

(7)  OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

7

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ANNEX

Annex VI is hereby amended as follows:

| (1) | The title ‘Uniform Principles for evaluation and authorisation of plant protection products’ shall be replaced by
  ‘PART I

  UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF CHEMICAL PLANT PROTECTION PRODUCTS’; |
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(1)

The title ‘Uniform Principles for evaluation and authorisation of plant protection products’ shall be replaced by

‘PART I

UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF CHEMICAL PLANT PROTECTION PRODUCTS’;

| (2) | The following Part shall be added after Part I
  ‘PART II

  UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS CONTAINING MICRO-ORGANISMS’ |
| --- | --- |

(2)

The following Part shall be added after Part I

‘PART II

UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS CONTAINING MICRO-ORGANISMS’

CONTENTS

| A. | INTRODUCTION |
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A.

| B. | EVALUATION |
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B.

| 1. | General principles |
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1.

| 2. | Specific principles |
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2.

| 2.1. | Identity |
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2.1.

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

| 2.1.2. | Identity of the plant protection product |
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2.1.2.

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

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

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

2.2.2.

| 2.3. | Further information |
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2.3.

| 2.3.1. | Quality control of the production of the micro-organism in the plant protection product |
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2.3.1.

| 2.3.2. | Quality control of the plant protection product |
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2.3.2.

| 2.4. | Efficacy |
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2.4.

| 2.5. | Identification/detection and quantification methods |
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2.5.

| 2.5.1. | Analytical methods for the plant protection product |
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2.5.1.

| 2.5.2. | Analytical methods for the determination of residues |
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2.5.2.

| 2.6. | Impact on human and animal health |
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2.6.

| 2.6.1. | Effects on human or animal health arising from the plant protection product |
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2.6.1.

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

| 2.7. | Fate and behaviour in the environment |
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2.7.

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

| 2.9. | Conclusions and proposals |
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2.9.

| C. | DECISION-MAKING |
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C.

| 1. | General principles |
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1.

| 2. | Specific principles |
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2.

| 2.1. | Identity |
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2.1.

| 2.2. | Biological and technical properties |
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2.2.

| 2.3. | Further information |
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2.3.

| 2.4. | Efficacy |
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2.4.

| 2.5. | Identification/detection and quantification methods |
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2.5.

| 2.6. | Impact on human and animal health |
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2.6.

| 2.6.1. | Effects on human or animal health arising from the plant protection product |
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2.6.1.

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

| 2.7. | Fate and behaviour in the environment |
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2.7.

| 2.8. | Effects on non-target organisms |
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2.8.

A.   INTRODUCTION

| 1. | The principles developed in Part II of this Annex aim to ensure that evaluations and decisions with regard to authorisation of plant protection products, provided they are microbial plant protection products, result in the implementation of the requirements of Article 4(1)(b), (c), (d) and (e) of this Directive by all Member States at a high level of protection of human and animal health and the environment. |
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1.

The principles developed in Part II of this Annex aim to ensure that evaluations and decisions with regard to authorisation of plant protection products, provided they are microbial plant protection products, result in the implementation of the requirements of Article 4(1)(b), (c), (d) and (e) of this Directive by all Member States at a high level of protection of human and animal health and the environment.

| 2. | In evaluating applications for granting authorisations Member States shall:






  (a) | — | ensure that dossiers on microbial plant protection products supplied are in accordance with the requirements of Annex IIIB, at the latest at the time of finalisation of the evaluation for the purpose of decision-making, without prejudice, where relevant, to the provisions of Article 13(1)(a), (4) and (6) of this Directive, |
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2.

In evaluating applications for granting authorisations Member States shall:

(a)

—

ensure that dossiers on microbial plant protection products supplied are in accordance with the requirements of Annex IIIB, at the latest at the time of finalisation of the evaluation for the purpose of decision-making, without prejudice, where relevant, to the provisions of Article 13(1)(a), (4) and (6) of this Directive,

| — | ensure that the data submitted are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier, |
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—

ensure that the data submitted are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier,

| — | evaluate, where relevant, justifications submitted by the applicant for not supplying certain data; |
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—

evaluate, where relevant, justifications submitted by the applicant for not supplying certain data;

| (b) | take into account the Annex IIB data concerning the active substance consisting of micro-organisms (including viruses) in the plant protection product, submitted for the purpose of inclusion of the micro-organism concerned in Annex I, and the results of the evaluation of those data, without prejudice, where relevant, to the provisions of Article 13(1)(b), (2), (3) and (6) of this Directive; |
| --- | --- |

(b)

take into account the Annex IIB data concerning the active substance consisting of micro-organisms (including viruses) in the plant protection product, submitted for the purpose of inclusion of the micro-organism concerned in Annex I, and the results of the evaluation of those data, without prejudice, where relevant, to the provisions of Article 13(1)(b), (2), (3) and (6) of this Directive;

| (c) | take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its metabolites/toxins. |
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(c)

take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its metabolites/toxins.

| 3. | Where, in the specific principles on evaluation, reference is made to Annex IIB data, this shall be understood as being the data referred to in point 2(b). |
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3.

Where, in the specific principles on evaluation, reference is made to Annex IIB data, this shall be understood as being the data referred to in point 2(b).

| 4. | Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, applications must be evaluated and a decision made for the proposed use.
  Taking account of justifications provided and with the benefit of any subsequent clarifications, Member States shall reject applications for granting authorisations for which the data gaps are such that it is not possible to finalise the evaluation and to make a reliable decision for at least one of the proposed uses. |
| --- | --- |

4.

Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, applications must be evaluated and a decision made for the proposed use.

Taking account of justifications provided and with the benefit of any subsequent clarifications, Member States shall reject applications for granting authorisations for which the data gaps are such that it is not possible to finalise the evaluation and to make a reliable decision for at least one of the proposed uses.

| 5. | During the process of evaluation and decision-making, the Member State shall cooperate with the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a proper evaluation of the dossier, 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 Annex or of this Directive.
  Member States shall normally come to a reasoned decision within 12 months of receiving a technically complete dossier. A technically complete dossier is one that satisfies all the requirements of Annex IIIB. |
| --- | --- |

5.

During the process of evaluation and decision-making, the Member State shall cooperate with the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a proper evaluation of the dossier, 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 Annex or of this Directive.

Member States shall normally come to a reasoned decision within 12 months of receiving a technically complete dossier. A technically complete dossier is one that satisfies all the requirements of Annex IIIB.

| 6. | The judgements made by the competent authorities of the Member States during the evaluation and decision-making process must be based on scientific principles, preferably recognised at international level, and be made with the benefit of expert advice. |
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6.

The judgements made by the competent authorities of the Member States during the evaluation and decision-making process must be based on scientific principles, preferably recognised at international level, and be made with the benefit of expert advice.

| 7. | A microbial plant protection product may contain viable and non-viable micro-organisms (including viruses) and formulation substances. It may also contain relevant metabolites/toxins produced during growth, residues from the growth medium, and microbial contaminants. The micro-organism, relevant metabolites/toxins and the plant protection product with residual growth medium and microbial contaminants present must all be evaluated. |
| --- | --- |

7.

A microbial plant protection product may contain viable and non-viable micro-organisms (including viruses) and formulation substances. It may also contain relevant metabolites/toxins produced during growth, residues from the growth medium, and microbial contaminants. The micro-organism, relevant metabolites/toxins and the plant protection product with residual growth medium and microbial contaminants present must all be evaluated.

| 8. | Member States must take into account those guidance documents taken note of in the Standing Committee on the Food Chain and Animal Health (SCFCAH). |
| --- | --- |

8.

Member States must take into account those guidance documents taken note of in the Standing Committee on the Food Chain and Animal Health (SCFCAH).

| 9. | For genetically modified micro-organisms, Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (1), must be taken into account. The evaluation completed in the framework of that Directive must be provided and taken into account. |
| --- | --- |

9.

For genetically modified micro-organisms, Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (1), must be taken into account. The evaluation completed in the framework of that Directive must be provided and taken into account.

| 10. | Definitions and explanations of microbiological terms
  Antibiosis: A relationship between two or more species in which one species is actively harmed (as by the production of toxins by the harming species).
  Antigenic: Any substance that, as a result of coming in contact with appropriate cells, induces a state of sensitivity and/or immune responsiveness after a latent period (days to weeks) and which reacts in a demonstrable way with antibodies and/or immune cells of the sensitised subject in vivo or in vitro.
  Antimicrobial: Antimicrobial agents or antimicrobial(s) refer to naturally occurring, semi-synthetic or synthetic substances that exhibit antimicrobial activity (kill or inhibit the growth of micro-organisms).The term ‘Antimicrobial(s)’ includes:





  — | antibiotics, which refer to substances produced by or derived from micro-organisms, and |
| --- | --- | --- |

10.

Definitions and explanations of microbiological terms

Antibiosis: A relationship between two or more species in which one species is actively harmed (as by the production of toxins by the harming species).

Antigenic: Any substance that, as a result of coming in contact with appropriate cells, induces a state of sensitivity and/or immune responsiveness after a latent period (days to weeks) and which reacts in a demonstrable way with antibodies and/or immune cells of the sensitised subject in vivo or in vitro.

Antimicrobial: Antimicrobial agents or antimicrobial(s) refer to naturally occurring, semi-synthetic or synthetic substances that exhibit antimicrobial activity (kill or inhibit the growth of micro-organisms).

—

antibiotics, which refer to substances produced by or derived from micro-organisms, and

| — | anticoccidials, which refer to substances that are active against coccidia, single cell protozoan parasites. |
| --- | --- |

—

anticoccidials, which refer to substances that are active against coccidia, single cell protozoan parasites.

CFU: Colony-forming unit; one or more cells that grow to form a single visible colony.

Colonisation: Proliferation and persistence of a micro-organism in an environment, such as on external (skin) or internal body surfaces (intestine, lungs). For colonisation, the micro-organism should at least persist for a longer period than expected in a specific organ. The population of micro-organisms may decline but at a slower rate than normal clearance; it may be a steady population or it may be a growing population. Colonisation can be related to harmless and functional micro-organisms as well as to pathogenic micro-organisms. The possible occurrence of effects is not indicated.

Ecological niche: Unique environmental position occupied by a particular species, perceived in terms of actual physical space occupied and function performed within the community or ecosystem.

Host: An animal (including humans) or plant that harbours or nourishes another organism (parasite).

Host specificity: The range of different host-species that can be colonised by a microbial species or strain. A host-specific micro-organism colonises or has adverse effects on one or only a small number of different host-species. A non-host-specific micro-organism might colonise or might have adverse effects on a broad range of different host-species.

Infection: The introduction or entry of a pathogenic micro-organism into a susceptible host, whether or not it causes pathological effects or disease. The organism must enter the body of the host, usually the cells, and be able to reproduce to form new infective units. Simply ingesting a pathogen does not imply infection.

Infective: Capable of transmitting an infection.

Infectivity: The characteristics of a micro-organism that allow it to infect a susceptible host.

Invasion: The entry of a micro-organism into the host body (e.g. actual penetration of the integument, gut epithelial cells, etc.). ‘Primary invasiveness’ is a property of pathogenic micro-organisms.

Multiplication: Ability of a micro-organism to reproduce and increase in numbers during an infection.

Mycotoxin: A fungal toxin.

Non-viable micro-organism: A micro-organism that is not capable of replication or of transferring genetic material.

Non-viable residue: A residue that is not capable of replication or of transferring genetic material.

Pathogenicity: The ability of a micro-organism to cause disease and/or inflict damage on the host. Many pathogens cause disease by a combination of (i) toxicity and invasiveness or (ii) toxicity and colonising ability. However, some invasive pathogens cause disease that results from an abnormal reaction of the host's defence system.

Symbiosis: A type of interaction between organisms where one organism lives in intimate association with another, which is favourable for both organisms.

Viable micro-organism: A micro-organism that is capable of replication or of transferring genetic material.

Viable residue: A residue that is capable of replication or of transferring genetic material.

Viroid: Any of a class of infectious agents consisting of a small strand of RNA not associated with any protein. The RNA does not code for proteins and is not translated; it is replicated by host cell enzymes. Viroids are known to cause several plant diseases.

Virulence: Measurement of the degree of disease producing ability of a micro-organism as indicated by the severity of the disease produced. Measure of the dosage (inoculum size) required to cause a specific degree of pathogenicity. It is measured experimentally by the median lethal dose (LD50) or median infective dose (ID50).

B.   EVALUATION

The objective of an evaluation is to identify and assess, on a scientific basis and until further experience is reached on a case-by-case basis, potential adverse effects on human and animal health and the environment of the use of a microbial plant protection product. The evaluation shall also be carried out in order to identify the need for risk management measures and to identify and recommend suitable measures.

Due to the ability of micro-organisms to replicate, there is a clear difference between chemicals and micro-organisms used as plant protection products. Hazards arising are not necessarily of the same nature as those presented by chemicals, especially in relation to the capacity of micro-organisms to persist and multiply in different environments. Moreover, micro-organisms consist of a wide range of different organisms, all with their own unique characteristics. These differences between micro-organisms should be taken into account in the evaluation.

The micro-organism in the plant protection product should ideally function as a cell factory working directly on the spot where the target organism is harmful. Thus understanding the mode of action is a crucial step in the evaluation process.

| (a) | toxicity studies, |
| --- | --- |

(a)

toxicity studies,

| (b) | biological properties of the micro-organism, |
| --- | --- |

(b)

biological properties of the micro-organism,

| (c) | relationship to known plant, animal or human pathogens, |
| --- | --- |

(c)

relationship to known plant, animal or human pathogens,

| (d) | mode of action, |
| --- | --- |

(d)

mode of action,

| (e) | analytical methods. |
| --- | --- |

(e)

analytical methods.

On the basis of this information, metabolites may be considered as possibly being relevant. Therefore potential exposure to these metabolites should be assessed, in order to decide on their relevance.

1.   General principles

| 1.1. | Having regard to current scientific and technical knowledge, Member States shall evaluate the information provided in accordance with the requirements of Annex IIB and IIIB and in particular:






  (a) | identify the hazards arising, assess their significance and make a judgement as to the likely risks to humans, animals or the environment; and |
| --- | --- | --- |

1.1.

Having regard to current scientific and technical knowledge, Member States shall evaluate the information provided in accordance with the requirements of Annex IIB and IIIB and in particular:

(a)

identify the hazards arising, assess their significance and make a judgement as to the likely risks to humans, animals or the environment; and

| (b) | assess the performance in terms of efficacy and phytotoxicity/pathogenicity of the plant protection product for each use for which authorisation is sought. |
| --- | --- |

(b)

assess the performance in terms of efficacy and phytotoxicity/pathogenicity of the plant protection product for each use for which authorisation is sought.

| 1.2. | The quality/methodology of tests, where there are no standardised test methods, must be evaluated and the following characteristics, when available, of the methods described must be assessed:
  relevance; representativeness; sensitivity; specificity; reproducibility; interlaboratory validations; predictiveness. |
| --- | --- |

1.2.

The quality/methodology of tests, where there are no standardised test methods, must be evaluated and the following characteristics, when available, of the methods described must be assessed:

relevance; representativeness; sensitivity; specificity; reproducibility; interlaboratory validations; predictiveness.

| 1.3. | In interpreting the results of evaluations, Member States shall take into consideration possible elements of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of failing to detect adverse effects or of underestimating their importance are reduced to a minimum. The decision-making process shall be examined to identify critical decision points or items of data for which uncertainties could lead to a false classification of risk.
  The first evaluation made shall be based on the best available data or estimates reflecting the realistic conditions of use of the plant protection product. This must be followed by a repeat evaluation, taking account of potential uncertainties in the critical data and of a range of use conditions that are likely to occur and resulting in a realistic worst-case approach, to determine whether it is possible that the initial evaluation could have been significantly different. |
| --- | --- |

1.3.

In interpreting the results of evaluations, Member States shall take into consideration possible elements of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of failing to detect adverse effects or of underestimating their importance are reduced to a minimum. The decision-making process shall be examined to identify critical decision points or items of data for which uncertainties could lead to a false classification of risk.

The first evaluation made shall be based on the best available data or estimates reflecting the realistic conditions of use of the plant protection product. This must be followed by a repeat evaluation, taking account of potential uncertainties in the critical data and of a range of use conditions that are likely to occur and resulting in a realistic worst-case approach, to determine whether it is possible that the initial evaluation could have been significantly different.

| 1.4. | Member States shall evaluate each microbial plant protection product for which an application for authorisation is made in that Member State — the information evaluated for the micro-organism can be taken into account. Member States must take into account the fact that any co-formulants might have an impact on the characteristics of the plant protection product compared to the micro-organism. |
| --- | --- |

1.4.

Member States shall evaluate each microbial plant protection product for which an application for authorisation is made in that Member State — the information evaluated for the micro-organism can be taken into account. Member States must take into account the fact that any co-formulants might have an impact on the characteristics of the plant protection product compared to the micro-organism.

| 1.5. | In evaluating applications and granting authorisations Member States shall consider the proposed practical conditions of use and in particular the purpose of use, the dose, the manner, frequency and timing of applications, and the nature and composition of the plant protection product. Whenever possible Member States shall also take into account the principles of integrated pest control. |
| --- | --- |

1.5.

In evaluating applications and granting authorisations Member States shall consider the proposed practical conditions of use and in particular the purpose of use, the dose, the manner, frequency and timing of applications, and the nature and composition of the plant protection product. Whenever possible Member States shall also take into account the principles of integrated pest control.

| 1.6. | In the evaluation, Member States shall consider the agricultural, plant health or environmental (including climatic) conditions in the areas of use. |
| --- | --- |

1.6.

In the evaluation, Member States shall consider the agricultural, plant health or environmental (including climatic) conditions in the areas of use.

| 1.7. | Where specific principles in Section 2 provide for the use of calculation models in the evaluation of a plant protection product, those models shall:






  (a) | make a best possible estimation of all relevant processes involved taking into account realistic parameters and assumptions, |
| --- | --- | --- |

1.7.

Where specific principles in Section 2 provide for the use of calculation models in the evaluation of a plant protection product, those models shall:

(a)

make a best possible estimation of all relevant processes involved taking into account realistic parameters and assumptions,

| (b) | be submitted to an evaluation as referred to in point 1.3., |
| --- | --- |

(b)

be submitted to an evaluation as referred to in point 1.3.,

| (c) | be reliably validated with measurements carried out under circumstances relevant for the use of the model, |
| --- | --- |

(c)

be reliably validated with measurements carried out under circumstances relevant for the use of the model,

| (d) | be relevant to the conditions in the area of use, |
| --- | --- |

(d)

be relevant to the conditions in the area of use,

| (e) | be supported with details indicating how the model calculates estimates provided, and explanations of all the inputs to the model and details of how they have been derived. |
| --- | --- |

(e)

be supported with details indicating how the model calculates estimates provided, and explanations of all the inputs to the model and details of how they have been derived.

| 1.8. | The data requirements, specified in Annex IIB and IIIB, contain guidance as to when and how certain information must be submitted and as to procedures that must be followed when preparing and evaluating a dossier. That guidance must be respected. |
| --- | --- |

1.8.

The data requirements, specified in Annex IIB and IIIB, contain guidance as to when and how certain information must be submitted and as to procedures that must be followed when preparing and evaluating a dossier. That guidance must be respected.

2.   Specific principles

Member States shall implement the following principles in the evaluation of the data and information submitted in support of applications, without prejudice to the general principles prescribed in Section 1:

2.1.   Identity

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

The identity of the micro-organism should be clearly established. It must be ensured that the appropriate data are provided to allow for checking the identity of the micro-organism at strain level in the plant protection product.

The identity of the micro-organism shall be evaluated on the strain level. Where the micro-organism is either a mutant or a genetically modified organism (2), the specific differences from other strains within the same species must be recorded. Occurrence of resting stages must be recorded.

The deposition of the strain at an internationally recognised culture collection must be checked.

2.1.2.   Identity of the plant protection product

Member States shall evaluate the detailed quantitative and qualitative information provided on the composition of the plant protection product, such as that concerning the micro-organism (see above), relevant metabolites/toxins, residual growth medium, co-formulants and microbial contaminants present.

2.2.   Biological, physical, chemical, and technical properties

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

| 2.2.1.1. | The origin of the strain, where relevant, its natural habitat including indications on the natural background level, life cycle and the possibilities for survival, colonisation, reproduction and dispersal must be evaluated. Proliferation of indigenous micro-organisms should after a short growth period level off and continue as for the background micro-organisms. |
| --- | --- |

2.2.1.1.

The origin of the strain, where relevant, its natural habitat including indications on the natural background level, life cycle and the possibilities for survival, colonisation, reproduction and dispersal must be evaluated. Proliferation of indigenous micro-organisms should after a short growth period level off and continue as for the background micro-organisms.

| 2.2.1.2. | The ability of micro-organisms to adapt to the environment must be evaluated. In particular, Member States must take account of the following principles:






  (a) | depending on the conditions (e.g. availability of substrates for growth and metabolism) micro-organisms can switch on or off the expression of given phenotypic traits; |
| --- | --- | --- |

2.2.1.2.

The ability of micro-organisms to adapt to the environment must be evaluated. In particular, Member States must take account of the following principles:

(a)

depending on the conditions (e.g. availability of substrates for growth and metabolism) micro-organisms can switch on or off the expression of given phenotypic traits;

| (b) | the microbial strains most adapted to the environment can survive and multiply better than the non-adapted strains. Adapted strains have a selective advantage and can form the majority within a population after a number of generations; |
| --- | --- |

(b)

the microbial strains most adapted to the environment can survive and multiply better than the non-adapted strains. Adapted strains have a selective advantage and can form the majority within a population after a number of generations;

| (c) | the relatively rapid multiplication of micro-organisms leads to a higher frequency of mutations. If a mutation is promoting survival in the environment, the mutant strain can become dominant; |
| --- | --- |

(c)

the relatively rapid multiplication of micro-organisms leads to a higher frequency of mutations. If a mutation is promoting survival in the environment, the mutant strain can become dominant;

| (d) | the properties of viruses, in particular, can change rapidly, including their virulence.
  Therefore, where appropriate, information on the genetic stability of the micro-organism under the environmental conditions of proposed use must be evaluated, as well as information on the micro-organism's capacity to transfer genetic material to other organisms and information on the stability of encoded traits. |
| --- | --- |

(d)

the properties of viruses, in particular, can change rapidly, including their virulence.

Therefore, where appropriate, information on the genetic stability of the micro-organism under the environmental conditions of proposed use must be evaluated, as well as information on the micro-organism's capacity to transfer genetic material to other organisms and information on the stability of encoded traits.

| 2.2.1.3. | The mode of action of the micro-organism should be evaluated in as much detail as appropriate. The possible role of metabolites/toxins for the mode of action should be evaluated and when identified, the minimal effective concentration for each active metabolite/toxin should be established. Information on mode of action can be a very valuable tool in identifying potential risks. Aspects to be considered in the evaluation, are:






  (a) | antibiosis, |
| --- | --- | --- |

2.2.1.3.

The mode of action of the micro-organism should be evaluated in as much detail as appropriate. The possible role of metabolites/toxins for the mode of action should be evaluated and when identified, the minimal effective concentration for each active metabolite/toxin should be established. Information on mode of action can be a very valuable tool in identifying potential risks. Aspects to be considered in the evaluation, are:

(a)

antibiosis,

| (b) | induction of plant resistance, |
| --- | --- |

(b)

induction of plant resistance,

| (c) | interference with the virulence of a pathogenic target organism, |
| --- | --- |

(c)

interference with the virulence of a pathogenic target organism,

| (d) | endophytic growth, |
| --- | --- |

(d)

endophytic growth,

| (e) | root colonisation, |
| --- | --- |

(e)

root colonisation,

| (f) | competition of ecological niche (e.g. nutrients, habitats), |
| --- | --- |

(f)

competition of ecological niche (e.g. nutrients, habitats),

| (g) | parasitisation, |
| --- | --- |

(g)

parasitisation,

| (h) | invertebrate pathogenicity. |
| --- | --- |

(h)

invertebrate pathogenicity.

| 2.2.1.4. | In order to evaluate possible effects on non-target organisms, information on the micro-organism's host specificity must be evaluated, taking into account the characteristics and properties described in (a) and (b).






  (a) | The ability of a micro-organism to be pathogenic for non-target organisms (humans, animals, and other non-target organisms) must be assessed. Any relationship to known plant, animal or human pathogens that are species of the genus of the active and/or contaminating micro-organisms must be assessed. |
| --- | --- | --- |

2.2.1.4.

In order to evaluate possible effects on non-target organisms, information on the micro-organism's host specificity must be evaluated, taking into account the characteristics and properties described in (a) and (b).

(a)

The ability of a micro-organism to be pathogenic for non-target organisms (humans, animals, and other non-target organisms) must be assessed. Any relationship to known plant, animal or human pathogens that are species of the genus of the active and/or contaminating micro-organisms must be assessed.

| (b) | Pathogenicity as well as virulence is strongly related to the host-species (e.g. determined by body temperature, physiological environment) and to the host conditions (e.g. health condition, immune status). For example, multiplication in humans depends upon the ability of the micro-organism to grow at the body temperature of the host. Some micro-organisms can only grow and be metabolically active at temperatures far below or above human body temperature, and therefore can not be pathogenic for humans. However, the route of entry of the micro-organism into the host (oral, inhalation, skin/wound) can also be the critical factor. For example, a microbial species may cause a disease following entry via skin damage, but not via the oral route. |
| --- | --- |

(b)

Pathogenicity as well as virulence is strongly related to the host-species (e.g. determined by body temperature, physiological environment) and to the host conditions (e.g. health condition, immune status). For example, multiplication in humans depends upon the ability of the micro-organism to grow at the body temperature of the host. Some micro-organisms can only grow and be metabolically active at temperatures far below or above human body temperature, and therefore can not be pathogenic for humans. However, the route of entry of the micro-organism into the host (oral, inhalation, skin/wound) can also be the critical factor. For example, a microbial species may cause a disease following entry via skin damage, but not via the oral route.

| 2.2.1.5. | Many micro-organisms produce antibiosis substances that cause normal interferences in the microbial community. Resistance to antimicrobial agents of importance for human and veterinary medicine must be assessed. The possibility for transfer of genes that code for resistance to antimicrobial agents must be evaluated. |
| --- | --- |

2.2.1.5.

Many micro-organisms produce antibiosis substances that cause normal interferences in the microbial community. Resistance to antimicrobial agents of importance for human and veterinary medicine must be assessed. The possibility for transfer of genes that code for resistance to antimicrobial agents must be evaluated.

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

| 2.2.2.1. | Depending on the nature of the micro-organism and the formulation type, the technical properties of the plant protection product must be evaluated. |
| --- | --- |

2.2.2.1.

Depending on the nature of the micro-organism and the formulation type, the technical properties of the plant protection product must be evaluated.

| 2.2.2.2. | Shelf-life and storage stability of the preparation must be evaluated, taking into account possible changes in composition such as growth of the micro-organism or of contaminating micro-organisms, production of metabolites/toxins, etc. |
| --- | --- |

2.2.2.2.

Shelf-life and storage stability of the preparation must be evaluated, taking into account possible changes in composition such as growth of the micro-organism or of contaminating micro-organisms, production of metabolites/toxins, etc.

| 2.2.2.3. | Member States shall evaluate the physical and chemical properties of the plant protection product and the retention of these characteristics after storage and take into consideration:






  (a) | where a suitable Food and Agriculture Organisation of the United Nations (FAO) specification exists, the physical and chemical properties addressed in that specification, |
| --- | --- | --- |

2.2.2.3.

Member States shall evaluate the physical and chemical properties of the plant protection product and the retention of these characteristics after storage and take into consideration:

(a)

where a suitable Food and Agriculture Organisation of the United Nations (FAO) specification exists, the physical and chemical properties addressed in that specification,

| (b) | where no suitable FAO specification exists, all relevant physical and chemical properties for the formulation referred to in the Manual on the development and use of FAO and World Health Organisation (WHO) specifications for pesticides. |
| --- | --- |

(b)

where no suitable FAO specification exists, all relevant physical and chemical properties for the formulation referred to in the Manual on the development and use of FAO and World Health Organisation (WHO) specifications for pesticides.

| 2.2.2.4. | Where the proposed label claims include requirements or recommendations for use of the preparation with other plant protection products or adjuvants as a tank mix, and/or where the proposed label includes indications concerning the compatibility of the preparation with other plant protection products as a tank mix, those plant protection products or adjuvants must be physically and chemically compatible in the tank mix. Biological compatibility must also be demonstrated for tank-mixtures, i.e. it must be shown that each plant protection product in the mixture performs as expected and that no antagonism occurs. |
| --- | --- |

2.2.2.4.

Where the proposed label claims include requirements or recommendations for use of the preparation with other plant protection products or adjuvants as a tank mix, and/or where the proposed label includes indications concerning the compatibility of the preparation with other plant protection products as a tank mix, those plant protection products or adjuvants must be physically and chemically compatible in the tank mix. Biological compatibility must also be demonstrated for tank-mixtures, i.e. it must be shown that each plant protection product in the mixture performs as expected and that no antagonism occurs.

2.3.   Further information

2.3.1.   Quality control of the production of the micro-organism in the plant protection product

The quality assurance criteria proposed for production of the micro-organism must be evaluated. In the evaluation criteria relating to process control, good manufacturing practice, operational practices, process flows, cleaning practices, microbial monitoring and hygiene conditions should be taken into account to ensure good quality of the micro-organism. The quality, stability, purity etc., of the micro-organism must be addressed in the quality control system.

2.3.2.   Quality control of the plant protection product

The quality assurance criteria proposed must be evaluated. If the plant protection product contains metabolites/toxins produced during growth and residues from the growth medium this should be evaluated. The possibility of the occurrence of contaminating micro-organisms must be evaluated.

2.4.   Efficacy

| 2.4.1. | Where the proposed use concerns the control of or protection against an organism, Member States shall evaluate the possibility that this organism could be harmful under the agricultural, plant health and environmental (including climatic) conditions in the area of the proposed use. |
| --- | --- |

2.4.1.

Where the proposed use concerns the control of or protection against an organism, Member States shall evaluate the possibility that this organism could be harmful under the agricultural, plant health and environmental (including climatic) conditions in the area of the proposed use.

| 2.4.2. | Member States shall evaluate whether significant damage, loss or inconvenience could occur under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use if the plant protection product were not used. |
| --- | --- |

2.4.2.

Member States shall evaluate whether significant damage, loss or inconvenience could occur under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use if the plant protection product were not used.

| 2.4.3. | Member States shall evaluate the efficacy data provided for in Annex IIIB on the plant protection product having regard to the degree of control or the extent of the effect desired and having regard to relevant experimental conditions such as:






  (a) | the choice of the crop or cultivar, |
| --- | --- | --- |

2.4.3.

Member States shall evaluate the efficacy data provided for in Annex IIIB on the plant protection product having regard to the degree of control or the extent of the effect desired and having regard to relevant experimental conditions such as:

(a)

the choice of the crop or cultivar,

| (b) | the agricultural and environmental (including climatic) conditions (if necessary for acceptable efficacy such data/information should also be given for the time before and after application), |
| --- | --- |

(b)

the agricultural and environmental (including climatic) conditions (if necessary for acceptable efficacy such data/information should also be given for the time before and after application),

| (c) | the presence and density of the harmful organism, |
| --- | --- |

(c)

the presence and density of the harmful organism,

| (d) | the development stage of crop and organism, |
| --- | --- |

(d)

the development stage of crop and organism,

| (e) | the amount of the microbial plant protection product used, |
| --- | --- |

(e)

the amount of the microbial plant protection product used,

| (f) | if required on the label, the amount of adjuvant added, |
| --- | --- |

(f)

if required on the label, the amount of adjuvant added,

| (g) | the frequency and timing of the applications, |
| --- | --- |

(g)

the frequency and timing of the applications,

| (h) | the type of application equipment, |
| --- | --- |

(h)

the type of application equipment,

| (i) | the need for any special cleaning measures for the application equipment. |
| --- | --- |

(i)

the need for any special cleaning measures for the application equipment.

| 2.4.4. | Member States shall evaluate the performance of the plant protection product under the range of agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use. The effect on integrated control must be included in the evaluation. In particular, consideration should be paid to:






  (a) | the level, consistency and duration of the effect sought in relation to the dose in comparison with a suitable reference product or products, where they exist, and an untreated control; |
| --- | --- | --- |

2.4.4.

Member States shall evaluate the performance of the plant protection product under the range of agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use. The effect on integrated control must be included in the evaluation. In particular, consideration should be paid to:

(a)

the level, consistency and duration of the effect sought in relation to the dose in comparison with a suitable reference product or products, where they exist, and an untreated control;

| (b) | where relevant, the effect on yield or reduction of loss in storage, in terms of quantity and/or quality, in comparison with a suitable reference product or products, where they exist, and an untreated control.
  Where no suitable reference product exists, Member States shall evaluate the performance of the plant protection product to determine whether there is a consistent and defined benefit under the agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use. |
| --- | --- |

(b)

where relevant, the effect on yield or reduction of loss in storage, in terms of quantity and/or quality, in comparison with a suitable reference product or products, where they exist, and an untreated control.

Where no suitable reference product exists, Member States shall evaluate the performance of the plant protection product to determine whether there is a consistent and defined benefit under the agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use.

| 2.4.5. | Member States shall evaluate the degree of adverse effects on the treated crop after use of the plant protection product according to the proposed conditions of use in comparison, where relevant, with a suitable reference product or products, where they exist, and/or an untreated control.






  (a) | This evaluation will take into consideration the following information:






  (i) | efficacy data; |
| --- | --- | --- | --- |

2.4.5.

Member States shall evaluate the degree of adverse effects on the treated crop after use of the plant protection product according to the proposed conditions of use in comparison, where relevant, with a suitable reference product or products, where they exist, and/or an untreated control.

(a)

This evaluation will take into consideration the following information:

(i)

efficacy data;

| (ii) | other relevant information on the plant protection product such as nature of the plant protection product, dose, method of application, number and timing of applications, incompatibility with other crop treatments; |
| --- | --- |

(ii)

other relevant information on the plant protection product such as nature of the plant protection product, dose, method of application, number and timing of applications, incompatibility with other crop treatments;

| (iii) | all relevant information on the micro-organism, including biological properties e.g. mode of action, survival, host specificity. |
| --- | --- |

(iii)

all relevant information on the micro-organism, including biological properties e.g. mode of action, survival, host specificity.

| (b) | This evaluation will include:






  (i) | the nature, frequency, level and duration of observed phytotoxic/phytopathogenic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them; |
| --- | --- | --- |

(b)

This evaluation will include:

(i)

the nature, frequency, level and duration of observed phytotoxic/phytopathogenic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them;

| (ii) | differences between main cultivars with regard to their sensitivity to phytotoxic/phytopathogenic effects; |
| --- | --- |

(ii)

differences between main cultivars with regard to their sensitivity to phytotoxic/phytopathogenic effects;

| (iii) | the part of the treated crop or plant products where phytotoxic/phytopathogenic effects are observed; |
| --- | --- |

(iii)

the part of the treated crop or plant products where phytotoxic/phytopathogenic effects are observed;

| (iv) | adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality; |
| --- | --- |

(iv)

adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality;

| (v) | adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germination, sprouting, rooting and establishment; |
| --- | --- |

(v)

adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germination, sprouting, rooting and establishment;

| (vi) | where micro-organisms are disseminated, the adverse impact on adjacent crops. |
| --- | --- |

(vi)

where micro-organisms are disseminated, the adverse impact on adjacent crops.

| 2.4.6. | Where the plant protection product label includes requirements for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, Member States shall make the evaluations referred to in points 2.4.3 to 2.4.5 in relation to the information supplied for the tank mix.
  Where the plant protection product label includes recommendations for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, Member States shall evaluate the appropriateness of the mix and of its conditions of use. |
| --- | --- |

2.4.6.

Where the plant protection product label includes requirements for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, Member States shall make the evaluations referred to in points 2.4.3 to 2.4.5 in relation to the information supplied for the tank mix.

Where the plant protection product label includes recommendations for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, Member States shall evaluate the appropriateness of the mix and of its conditions of use.

| 2.4.7. | Where the available data indicate that the micro-organism or significant relevant metabolites/toxins, degradation and reaction products of the formulants persist in soils and/or in or on plant substances in significant quantities after use of the plant protection product according to the proposed conditions of use, Member States shall evaluate the degree of adverse effects on subsequent crops. |
| --- | --- |

2.4.7.

Where the available data indicate that the micro-organism or significant relevant metabolites/toxins, degradation and reaction products of the formulants persist in soils and/or in or on plant substances in significant quantities after use of the plant protection product according to the proposed conditions of use, Member States shall evaluate the degree of adverse effects on subsequent crops.

| 2.4.8. | Where the proposed use of a plant protection product is intended to have an effect on vertebrates, Member States shall evaluate the mechanism by which this effect is obtained and the observed effects on the behaviour and health of the target animals. When the intended effect is to kill the target animal they shall evaluate the time necessary to obtain the death of the animal and the conditions under which death occurs.This evaluation will take into consideration the following information:





  (a) | all relevant information as provided for in Annex IIB and the results of the evaluation thereof, including the toxicological studies; |
| --- | --- | --- |

2.4.8.

Where the proposed use of a plant protection product is intended to have an effect on vertebrates, Member States shall evaluate the mechanism by which this effect is obtained and the observed effects on the behaviour and health of the target animals. When the intended effect is to kill the target animal they shall evaluate the time necessary to obtain the death of the animal and the conditions under which death occurs.

(a)

all relevant information as provided for in Annex IIB and the results of the evaluation thereof, including the toxicological studies;

| (b) | all relevant information on the plant protection product as provided for in Annex IIIB, including toxicological studies and efficacy data. |
| --- | --- |

(b)

all relevant information on the plant protection product as provided for in Annex IIIB, including toxicological studies and efficacy data.

2.5.   Identification/detection and quantification methods

Member States shall evaluate the analytical methods proposed for post-registration control and monitoring purposes of the viable and non-viable components both in the formulation and as residues in or on treated crops. Sufficient validation is required for pre-authorisation methods and post-authorisation monitoring methods. Methods that are considered suitable for post-authorisation monitoring must be clearly identified.

2.5.1.   Analytical methods for the plant protection product

2.5.1.1.   Non-viable components

Member States shall evaluate the analytical methods proposed to identify and quantify the toxicologically, ecotoxicologically or environmentally significant non-viable components resulting from the micro-organism and/or present as impurity or co-formulant (including eventually resulting breakdown and/or reaction products thereof).

| (a) | the specificity and linearity of the proposed methods, |
| --- | --- |

(a)

the specificity and linearity of the proposed methods,

| (b) | the precision (repeatability) of the proposed methods, |
| --- | --- |

(b)

the precision (repeatability) of the proposed methods,

| (c) | the importance of interferences, |
| --- | --- |

(c)

the importance of interferences,

| (d) | the accuracy of the proposed methods at appropriate concentrations, |
| --- | --- |

(d)

the accuracy of the proposed methods at appropriate concentrations,

| (e) | the limit of quantification of the proposed methods. |
| --- | --- |

(e)

the limit of quantification of the proposed methods.

2.5.1.2.   Viable components

Member States shall evaluate the methods proposed to quantify and identify the specific strain concerned and especially methods that discriminate that strain from closely related strains.

| (a) | the specificity of the proposed methods, |
| --- | --- |

(a)

the specificity of the proposed methods,

| (b) | the precision (repeatability) of the proposed methods, |
| --- | --- |

(b)

the precision (repeatability) of the proposed methods,

| (c) | the importance of interferences, |
| --- | --- |

(c)

the importance of interferences,

| (d) | the quantifiability of the proposed methods. |
| --- | --- |

(d)

the quantifiability of the proposed methods.

2.5.2.   Analytical methods for the determination of residues

2.5.2.1.   Non-viable residues

Member States shall evaluate the analytical methods proposed to identify and quantify the toxicologically, ecotoxicologically or environmentally significant non-viable residues resulting from the micro-organism (including eventually resulting breakdown and/or reaction products thereof).

This evaluation will take into consideration the information on analytical methods provided for in Annex IIB and IIIB and the results of the evaluation thereof. In particular, the following information must be taken into account:

| (a) | the specificity and linearity of the proposed methods, |
| --- | --- |

(a)

the specificity and linearity of the proposed methods,

| (b) | the precision (repeatability) of the proposed methods, |
| --- | --- |

(b)

the precision (repeatability) of the proposed methods,

| (c) | the reproducibility (independent laboratory validation) of the proposed methods, |
| --- | --- |

(c)

the reproducibility (independent laboratory validation) of the proposed methods,

| (d) | the importance of interferences, |
| --- | --- |

(d)

the importance of interferences,

| (e) | the accuracy of the proposed methods at appropriate concentrations, |
| --- | --- |

(e)

the accuracy of the proposed methods at appropriate concentrations,

| (f) | the limit of quantification of the proposed methods. |
| --- | --- |

(f)

the limit of quantification of the proposed methods.

2.5.2.2.   Viable residues

Member States shall evaluate the methods proposed to identify the specific strain concerned and especially methods that discriminate that strain from closely related strains.

This evaluation will take into consideration the information on analytical methods provided for in Annex IIB and IIIB and the results of the evaluation thereof. In particular, the following information must be taken into account:

| (a) | the specificity of the proposed methods, |
| --- | --- |

(a)

the specificity of the proposed methods,

| (b) | the precision (repeatability) of the proposed methods, |
| --- | --- |

(b)

the precision (repeatability) of the proposed methods,

| (c) | the importance of interferences, |
| --- | --- |

(c)

the importance of interferences,

| (d) | the quantifiability of the proposed methods. |
| --- | --- |

(d)

the quantifiability of the proposed methods.

2.6.   Impact on human or animal health

The impact on human or animal health must be evaluated. In particular, Member States must take account of the following principles:

| (a) | due to the ability of micro-organisms to replicate, there is a clear difference between chemicals and micro-organisms used as plant protection products. Hazards arising are not necessarily of the same nature as those presented by chemicals, especially in relation to the capacity of micro-organisms to persist and multiply in different environments; |
| --- | --- |

(a)

due to the ability of micro-organisms to replicate, there is a clear difference between chemicals and micro-organisms used as plant protection products. Hazards arising are not necessarily of the same nature as those presented by chemicals, especially in relation to the capacity of micro-organisms to persist and multiply in different environments;

| (b) | the pathogenicity of the micro-organism to humans and non-target animals, the infectiveness of the micro-organism, the ability of the micro-organism to colonise, the toxicity of metabolites/toxins as well as the toxicity of the residual growth medium, contaminants and co-formulants, are important endpoints in assessing adverse effects arising from the plant protection product; |
| --- | --- |

(b)

the pathogenicity of the micro-organism to humans and non-target animals, the infectiveness of the micro-organism, the ability of the micro-organism to colonise, the toxicity of metabolites/toxins as well as the toxicity of the residual growth medium, contaminants and co-formulants, are important endpoints in assessing adverse effects arising from the plant protection product;

| (c) | colonisation, infectiveness and toxicity comprise a complex set of interactions between micro-organisms and hosts and these endpoints may not be resolved easily as independent endpoints; |
| --- | --- |

(c)

colonisation, infectiveness and toxicity comprise a complex set of interactions between micro-organisms and hosts and these endpoints may not be resolved easily as independent endpoints;

| (d) | in combining these endpoints, the most important aspects of the micro-organism that must be assessed are:






  — | ability to persist and multiply in a host (indicative of colonisation or infectivity), |
| --- | --- | --- |

(d)

in combining these endpoints, the most important aspects of the micro-organism that must be assessed are:

—

ability to persist and multiply in a host (indicative of colonisation or infectivity),

| — | ability to produce non-adverse or adverse effects in a host, indicative of infectivity, pathogenicity, and/or toxicity; |
| --- | --- |

—

ability to produce non-adverse or adverse effects in a host, indicative of infectivity, pathogenicity, and/or toxicity;

| (e) | moreover, the complexity of the biological issues should be taken into account in evaluating the hazards and risks presented by use of these plant protection products for human and animals. An assessment of pathogenicity and infectiveness is necessary even if the potential of exposure is deemed low; |
| --- | --- |

(e)

moreover, the complexity of the biological issues should be taken into account in evaluating the hazards and risks presented by use of these plant protection products for human and animals. An assessment of pathogenicity and infectiveness is necessary even if the potential of exposure is deemed low;

| (f) | for risk assessment purposes the acute toxicity studies used should, where available, include at least two doses (e.g. one very high dose and one corresponding to the expected exposure under practical conditions). |
| --- | --- |

(f)

for risk assessment purposes the acute toxicity studies used should, where available, include at least two doses (e.g. one very high dose and one corresponding to the expected exposure under practical conditions).

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

| 2.6.1.1. | Member States shall evaluate operator exposure to the micro-organism, and/or to toxicologically relevant compounds in the plant protection product (e.g. their metabolites/toxins, residual growth medium, contaminants and co-formulants), likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions). Realistic data on exposure levels must be used and, if such data are not available, a suitable, validated calculation model. When available, a European harmonised generic exposure database for plant protection products should be used.






  (a) | This evaluation will take into consideration the following information:






  (i) | the medical data and the toxicity, infectivity and pathogenicity studies as provided for in Annex IIB, and the results of the evaluation thereof. Tier 1 tests should permit an evaluation to be made of a micro-organism with respect to its ability to persist or grow in the host and its ability to cause effects/reactions in the host. Parameters that indicate the absence of ability to persist and multiply in the host, and the absence of ability to produce non-adverse or adverse effects in a host, include fast and complete clearance from the body, no activation of the immune system, no histopathological changes, and for replication temperatures far below or far above mammalian body temperatures. These parameters can in some cases be assessed using acute studies and existing human data, and sometimes can only be assessed using repeated dose studies.
  Evaluation based on relevant parameters of Tier 1 tests should lead to an assessment of the possible effects of occupational exposure, taking into account the intensity and duration of exposure including exposure due to repeated use during practical use.
  The toxicity of certain metabolites/toxins can only be assessed, if it has been demonstrated that the test animals are actually exposed to these metabolites/toxins; |
| --- | --- | --- | --- |

2.6.1.1.

Member States shall evaluate operator exposure to the micro-organism, and/or to toxicologically relevant compounds in the plant protection product (e.g. their metabolites/toxins, residual growth medium, contaminants and co-formulants), likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions). Realistic data on exposure levels must be used and, if such data are not available, a suitable, validated calculation model. When available, a European harmonised generic exposure database for plant protection products should be used.

(a)

This evaluation will take into consideration the following information:

(i)

the medical data and the toxicity, infectivity and pathogenicity studies as provided for in Annex IIB, and the results of the evaluation thereof. Tier 1 tests should permit an evaluation to be made of a micro-organism with respect to its ability to persist or grow in the host and its ability to cause effects/reactions in the host. Parameters that indicate the absence of ability to persist and multiply in the host, and the absence of ability to produce non-adverse or adverse effects in a host, include fast and complete clearance from the body, no activation of the immune system, no histopathological changes, and for replication temperatures far below or far above mammalian body temperatures. These parameters can in some cases be assessed using acute studies and existing human data, and sometimes can only be assessed using repeated dose studies.

Evaluation based on relevant parameters of Tier 1 tests should lead to an assessment of the possible effects of occupational exposure, taking into account the intensity and duration of exposure including exposure due to repeated use during practical use.

The toxicity of certain metabolites/toxins can only be assessed, if it has been demonstrated that the test animals are actually exposed to these metabolites/toxins;

| (ii) | other relevant information on the micro-organism, the metabolites/toxins, residual growth medium, contaminants and co-formulants in the plant protection product, such as their biological, physical and chemical properties (e.g. survival of the micro-organism at the body temperature of humans and animals, ecological niche, behaviour of the micro-organism and/or metabolites/toxins during application); |
| --- | --- |

(ii)

other relevant information on the micro-organism, the metabolites/toxins, residual growth medium, contaminants and co-formulants in the plant protection product, such as their biological, physical and chemical properties (e.g. survival of the micro-organism at the body temperature of humans and animals, ecological niche, behaviour of the micro-organism and/or metabolites/toxins during application);

| (iii) | the toxicological studies provided for in Annex IIIB; |
| --- | --- |

(iii)

the toxicological studies provided for in Annex IIIB;

| (iv) | other relevant information provided for in Annex IIIB such as:






  — | composition of the preparation, |
| --- | --- | --- |

(iv)

other relevant information provided for in Annex IIIB such as:

—

composition of the preparation,

| — | nature of the preparation, |
| --- | --- |

—

nature of the preparation,

| — | size, design and type of packaging, |
| --- | --- |

—

size, design and type of packaging,

| — | field of use and nature of the crop or target, |
| --- | --- |

—

field of use and nature of the crop or target,

| — | method of application including handling, loading and mixing of the plant protection product, |
| --- | --- |

—

method of application including handling, loading and mixing of the plant protection product,

| — | exposure reduction measures recommended, |
| --- | --- |

—

exposure reduction measures recommended,

| — | protective clothing recommendations, |
| --- | --- |

—

protective clothing recommendations,

| — | maximum application rate, |
| --- | --- |

—

maximum application rate,

| — | minimum spray application volume stated on the label, |
| --- | --- |

—

minimum spray application volume stated on the label,

| — | number and timing of applications. |
| --- | --- |

—

number and timing of applications.

| (b) | On the basis of the information mentioned in (a) the following overall end-points should be established for single or repeated operator exposure following the intended use:






  — | persistence or growth of the micro-organism in the host, |
| --- | --- | --- |

(b)

On the basis of the information mentioned in (a) the following overall end-points should be established for single or repeated operator exposure following the intended use:

—

persistence or growth of the micro-organism in the host,

| — | adverse effects observed, |
| --- | --- |

—

adverse effects observed,

| — | observed or expected effects of contaminants (including contaminating micro-organisms), |
| --- | --- |

—

observed or expected effects of contaminants (including contaminating micro-organisms),

| — | observed or expected effects of relevant metabolites/toxins. |
| --- | --- |

—

observed or expected effects of relevant metabolites/toxins.

If there are indications of colonisation in the host and/or if any adverse effects, indicative of toxicity/infectivity are observed, taking into account the exposure scenario (i.e. acute or repeated exposure), further testing is indicated.

| (c) | This evaluation shall be made for each type of application method and application equipment proposed for use of the plant protection product as well as for the different types and sizes of containers to be used, taking into account mixing, loading operations, application of the plant protection product and cleaning and routine maintenance of application equipment. Where relevant, other authorised uses of the plant protection product in the area of envisaged use containing the same active substance or which give rise to the same residues may also be taken into account. It should be taken into account that if replication of the micro-organism is expected, exposure assessment could be highly speculative. |
| --- | --- |

(c)

This evaluation shall be made for each type of application method and application equipment proposed for use of the plant protection product as well as for the different types and sizes of containers to be used, taking into account mixing, loading operations, application of the plant protection product and cleaning and routine maintenance of application equipment. Where relevant, other authorised uses of the plant protection product in the area of envisaged use containing the same active substance or which give rise to the same residues may also be taken into account. It should be taken into account that if replication of the micro-organism is expected, exposure assessment could be highly speculative.

| (d) | The absence or presence of the potential for colonisation or the possibility of effects in operators at the tested dose levels as provided for in Annex IIB and IIIB should be assessed with regard to measured or estimated levels of human exposure. This risk assessment, preferably quantitative, should include consideration of e.g. mode of action, biological, physical and chemical properties of the micro-organism and other substances in the formulation. |
| --- | --- |

(d)

The absence or presence of the potential for colonisation or the possibility of effects in operators at the tested dose levels as provided for in Annex IIB and IIIB should be assessed with regard to measured or estimated levels of human exposure. This risk assessment, preferably quantitative, should include consideration of e.g. mode of action, biological, physical and chemical properties of the micro-organism and other substances in the formulation.

| 2.6.1.2. | Member States shall examine information relating to the nature and characteristics of the packaging proposed with particular reference to the following aspects:






  (a) | the type of packaging, |
| --- | --- | --- |

2.6.1.2.

Member States shall examine information relating to the nature and characteristics of the packaging proposed with particular reference to the following aspects:

(a)

the type of packaging,

| (b) | its dimensions and capacity, |
| --- | --- |

(b)

its dimensions and capacity,

| (c) | the size of the opening, |
| --- | --- |

(c)

the size of the opening,

| (d) | the type of closure, |
| --- | --- |

(d)

the type of closure,

| (e) | its strength, leakproofness and resistance to normal transport and handling, |
| --- | --- |

(e)

its strength, leakproofness and resistance to normal transport and handling,

| (f) | its resistance to and compatibility with the contents. |
| --- | --- |

(f)

its resistance to and compatibility with the contents.

| 2.6.1.3. | Member States shall examine the nature and characteristics of the protective clothing and equipment proposed with particular reference to the following aspects:






  (a) | obtainability and suitability, |
| --- | --- | --- |

2.6.1.3.

Member States shall examine the nature and characteristics of the protective clothing and equipment proposed with particular reference to the following aspects:

(a)

obtainability and suitability,

| (b) | effectiveness, |
| --- | --- |

(b)

effectiveness,

| (c) | ease of wearing taking into account physical stress and climatic conditions, |
| --- | --- |

(c)

ease of wearing taking into account physical stress and climatic conditions,

| (d) | resistance to and compatibility with the plant protection product. |
| --- | --- |

(d)

resistance to and compatibility with the plant protection product.

| 2.6.1.4. | Member States shall evaluate the possibility of exposure of other humans (workers exposed after the application of the plant protection product, such as re-entering workers, or bystanders) or animals to the micro-organism and/or to other toxicologically relevant compounds in the plant protection product under the proposed conditions of use. This evaluation will take into consideration the following information:






  (a) | the medical data and the toxicity, infectivity and pathogenicity studies provided for in Annex IIB, and the results of the evaluation thereof. Tier 1 tests should permit an evaluation to be made of a micro-organism with respect to its ability to persist or grow in the host and its ability to cause effects/reactions in the host. Parameters that indicate the absence of ability to persist and multiply in the host, and the absence of ability to produce non-adverse or adverse effects in a host, include rapid and complete clearance from the body, no activation of the immune system, no histopathological changes, and inability to replicate at mammalian body temperatures. These parameters can in some cases be assessed using acute studies and existing human data, and sometimes can only be assessed using repeated dose studies.
  Evaluation based on relevant parameters of Tier 1 tests should lead to an assessment of the possible effects of occupational exposure, taking into account the intensity and duration of exposure, including exposure due to repeated use during practical use.
  The toxicity of certain metabolites/toxins can only be assessed, if it has been demonstrated that the test animals are actually exposed to these metabolites/toxins; |
| --- | --- | --- |

2.6.1.4.

Member States shall evaluate the possibility of exposure of other humans (workers exposed after the application of the plant protection product, such as re-entering workers, or bystanders) or animals to the micro-organism and/or to other toxicologically relevant compounds in the plant protection product under the proposed conditions of use. This evaluation will take into consideration the following information:

(a)

the medical data and the toxicity, infectivity and pathogenicity studies provided for in Annex IIB, and the results of the evaluation thereof. Tier 1 tests should permit an evaluation to be made of a micro-organism with respect to its ability to persist or grow in the host and its ability to cause effects/reactions in the host. Parameters that indicate the absence of ability to persist and multiply in the host, and the absence of ability to produce non-adverse or adverse effects in a host, include rapid and complete clearance from the body, no activation of the immune system, no histopathological changes, and inability to replicate at mammalian body temperatures. These parameters can in some cases be assessed using acute studies and existing human data, and sometimes can only be assessed using repeated dose studies.

Evaluation based on relevant parameters of Tier 1 tests should lead to an assessment of the possible effects of occupational exposure, taking into account the intensity and duration of exposure, including exposure due to repeated use during practical use.

The toxicity of certain metabolites/toxins can only be assessed, if it has been demonstrated that the test animals are actually exposed to these metabolites/toxins;

| (b) | other relevant information on the micro-organism, the metabolites/toxins, residual growth medium, contaminants and co-formulants in the plant protection product, such as their biological, physical and chemical properties (e.g. survival of the micro-organism at the body temperature of humans and animals, ecological niche, behaviour of the micro-organism and/or metabolites/toxins during application); |
| --- | --- |

(b)

other relevant information on the micro-organism, the metabolites/toxins, residual growth medium, contaminants and co-formulants in the plant protection product, such as their biological, physical and chemical properties (e.g. survival of the micro-organism at the body temperature of humans and animals, ecological niche, behaviour of the micro-organism and/or metabolites/toxins during application);

| (c) | the toxicological studies provided for in Annex IIIB; |
| --- | --- |

(c)

the toxicological studies provided for in Annex IIIB;

| (d) | other relevant information on the plant protection product as provided for in Annex IIIB such as:






  — | re-entry periods, necessary waiting periods or other precautions to protect humans and animals, |
| --- | --- | --- |

(d)

other relevant information on the plant protection product as provided for in Annex IIIB such as:

—

re-entry periods, necessary waiting periods or other precautions to protect humans and animals,

| — | method of application, in particular spraying, |
| --- | --- |

—

method of application, in particular spraying,

| — | maximum application rate, |
| --- | --- |

—

maximum application rate,

| — | minimum spray application volume, |
| --- | --- |

—

minimum spray application volume,

| — | composition of the preparation, |
| --- | --- |

—

composition of the preparation,

| — | excess remaining on plants and plant products after treatment, taking into account the influence of factors such as temperature, UV light, pH and the presence of certain substances, |
| --- | --- |

—

excess remaining on plants and plant products after treatment, taking into account the influence of factors such as temperature, UV light, pH and the presence of certain substances,

| — | further activities whereby workers are exposed. |
| --- | --- |

—

further activities whereby workers are exposed.

2.6.2.   Effects on human or animal health arising from residues

In the evaluation, non-viable and viable residues must be addressed separately. Viruses and viroids should be considered as viable residues since they are capable of transferring genetic material, although strictly speaking they are not living.

2.6.2.1.   Non-viable residues

| (a) | Member States shall evaluate the possibility of exposure of humans or animals to non-viable residues and their degradation products via the food chain due to the possible occurrence of such residues in or on edible parts of treated crops. In particular, the following information should be taken into account:






  — | the stage of development of the micro-organism at which non-viable residues are produced, |
| --- | --- | --- |

(a)

Member States shall evaluate the possibility of exposure of humans or animals to non-viable residues and their degradation products via the food chain due to the possible occurrence of such residues in or on edible parts of treated crops. In particular, the following information should be taken into account:

—

the stage of development of the micro-organism at which non-viable residues are produced,

| — | the development stages/life cycle of the micro-organism under typical environmental conditions; in particular, attention shall be paid to the assessment of the likelihood of survival and multiplication of the micro-organism in or on crops, food or feed, and, as a consequence, the likelihood of the production of non-viable residues, |
| --- | --- |

—

the development stages/life cycle of the micro-organism under typical environmental conditions; in particular, attention shall be paid to the assessment of the likelihood of survival and multiplication of the micro-organism in or on crops, food or feed, and, as a consequence, the likelihood of the production of non-viable residues,

| — | the stability of relevant non-viable residues (including the effects of factors such as temperature, UV light, pH and the presence of certain substances), |
| --- | --- |

—

the stability of relevant non-viable residues (including the effects of factors such as temperature, UV light, pH and the presence of certain substances),

| — | any experimental study showing whether or not relevant non-viable residues are translocated in plants, |
| --- | --- |

—

any experimental study showing whether or not relevant non-viable residues are translocated in plants,

| — | data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses) and additional data on application as provided for in Annex IIIB, |
| --- | --- |

—

data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses) and additional data on application as provided for in Annex IIIB,

| — | where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same residues, and |
| --- | --- |

—

where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same residues, and

| — | the natural occurrence of non-viable residues on edible plant parts as a consequence of naturally occurring micro-organisms. |
| --- | --- |

—

the natural occurrence of non-viable residues on edible plant parts as a consequence of naturally occurring micro-organisms.

| (b) | Member States shall evaluate the toxicity of non-viable residues and their degradation products having regard in particular to the specific information provided in accordance with Annex IIB and IIIB. |
| --- | --- |

(b)

Member States shall evaluate the toxicity of non-viable residues and their degradation products having regard in particular to the specific information provided in accordance with Annex IIB and IIIB.

| (c) | Where non-viable residues or their degradation products are considered toxicologically relevant for humans and/or animals and when exposure is not considered negligible, the actual levels in or on the edible parts of treated crops should be determined, taking into consideration:






  — | analytical methods for the non-viable residues, |
| --- | --- | --- |

(c)

Where non-viable residues or their degradation products are considered toxicologically relevant for humans and/or animals and when exposure is not considered negligible, the actual levels in or on the edible parts of treated crops should be determined, taking into consideration:

—

analytical methods for the non-viable residues,

| — | the growth curves of the micro-organism under optimal conditions, |
| --- | --- |

—

the growth curves of the micro-organism under optimal conditions,

| — | the production/formation of non-viable residues at relevant moments (e.g. at the anticipated harvest time). |
| --- | --- |

—

the production/formation of non-viable residues at relevant moments (e.g. at the anticipated harvest time).

2.6.2.2.   Viable residues

| (a) | Member States shall evaluate the possibility of exposure of humans or animals to viable residues via the food chain due to the possible occurrence of such residues in or on edible parts of treated crops. In particular, the following information should be taken into account:






  — | the likelihood of survival, the persistence and multiplication of the micro-organism in or on crops, food or feed. The various development stages/life cycle of the micro-organism should be addressed, |
| --- | --- | --- |

(a)

Member States shall evaluate the possibility of exposure of humans or animals to viable residues via the food chain due to the possible occurrence of such residues in or on edible parts of treated crops. In particular, the following information should be taken into account:

—

the likelihood of survival, the persistence and multiplication of the micro-organism in or on crops, food or feed. The various development stages/life cycle of the micro-organism should be addressed,

| — | information concerning its ecological niche, |
| --- | --- |

—

information concerning its ecological niche,

| — | information on fate and behaviour in the various parts of the environment, |
| --- | --- |

—

information on fate and behaviour in the various parts of the environment,

| — | the natural occurrence of the micro-organism (and/or a related micro-organism), |
| --- | --- |

—

the natural occurrence of the micro-organism (and/or a related micro-organism),

| — | data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods in the case of post-harvest uses) and additional data on application as provided for in Annex IIIB, |
| --- | --- |

—

data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods in the case of post-harvest uses) and additional data on application as provided for in Annex IIIB,

| — | where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same micro-organism or which result in the same residues. |
| --- | --- |

—

where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same micro-organism or which result in the same residues.

| (b) | Member States shall evaluate the specific information concerning the ability of viable residues to persist or grow in the host and the ability of such residues to cause effects/reactions in the host. In particular, the following information should be taken into account:






  — | the medical data and toxicity, infectivity and pathogenicity studies provided for in Annex IIB, and the results of the evaluation thereof, |
| --- | --- | --- |

(b)

Member States shall evaluate the specific information concerning the ability of viable residues to persist or grow in the host and the ability of such residues to cause effects/reactions in the host. In particular, the following information should be taken into account:

—

the medical data and toxicity, infectivity and pathogenicity studies provided for in Annex IIB, and the results of the evaluation thereof,

| — | the development stages/life cycle of the micro-organism under typical environmental conditions (e.g. in or on the treated crop), |
| --- | --- |

—

the development stages/life cycle of the micro-organism under typical environmental conditions (e.g. in or on the treated crop),

| — | the mode of action of the micro-organism, |
| --- | --- |

—

the mode of action of the micro-organism,

| — | the biological properties of the micro-organism (e.g. host specificity).
  The various development stages/life cycle of the micro-organism should be addressed. |
| --- | --- |

—

the biological properties of the micro-organism (e.g. host specificity).

The various development stages/life cycle of the micro-organism should be addressed.

| (c) | In the event that viable residues are considered to be toxicologically relevant for humans and/or animals and if exposure is not considered negligible, the actual levels in or on the edible parts of treated crops should be determined, taking into consideration:






  — | analytical methods for the viable residues, |
| --- | --- | --- |

(c)

In the event that viable residues are considered to be toxicologically relevant for humans and/or animals and if exposure is not considered negligible, the actual levels in or on the edible parts of treated crops should be determined, taking into consideration:

—

analytical methods for the viable residues,

| — | the growth curves of the micro-organism under optimal conditions, |
| --- | --- |

—

the growth curves of the micro-organism under optimal conditions,

| — | the possibilities of extrapolating data from one crop to another. |
| --- | --- |

—

the possibilities of extrapolating data from one crop to another.

2.7.   Fate and behaviour in the environment

The biocomplexity of the ecosystems and interactions in the microbial communities concerned must be taken into account.

Information on the origin and properties (e.g. specificity) of the micro-organism/its residual metabolites/toxins and its intended use forms the basis for an assessment of environmental fate and behaviour. The mode of action of the micro-organism should be taken into consideration.

An assessment shall be made of the fate and behaviour of any known relevant metabolite that is produced by the micro-organism. The assessment shall be made for each environmental compartment, and shall be triggered on the basis of the criteria specified in section 7 (iv) of Annex IIB.

In the assessment of the environmental fate and behaviour of plant protection products, Member States shall have regard to all aspects of the environment, including biota. The potential for persistence and multiplication of micro-organisms has to be assessed in all environmental compartments unless it can be justified that particular micro-organisms will not reach a specific compartment. The mobility of micro-organisms and their residual metabolites/toxins must be considered.

| 2.7.1. | Member States shall evaluate the possibility of contamination of ground water, surface water and drinking water under the proposed conditions of use of the plant protection product.
  In the overall assessment, Member States should pay particular attention to potential adverse effects on humans through groundwater contamination, when the active substance is applied in regions with vulnerable conditions, such as drinking water abstraction areas. |
| --- | --- |

2.7.1.

Member States shall evaluate the possibility of contamination of ground water, surface water and drinking water under the proposed conditions of use of the plant protection product.

In the overall assessment, Member States should pay particular attention to potential adverse effects on humans through groundwater contamination, when the active substance is applied in regions with vulnerable conditions, such as drinking water abstraction areas.

| 2.7.2. | Member States shall evaluate the risk for the aquatic compartment where the possibility of the exposure of aquatic organisms has been established. A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long-lasting or permanent impact on microbial communities or their predators.
  This evaluation will take into consideration the following information:






  (a) | the biological properties of the micro-organism, |
| --- | --- | --- |

2.7.2.

Member States shall evaluate the risk for the aquatic compartment where the possibility of the exposure of aquatic organisms has been established. A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long-lasting or permanent impact on microbial communities or their predators.

This evaluation will take into consideration the following information:

(a)

the biological properties of the micro-organism,

| (b) | the survival of the micro-organism in the environment, |
| --- | --- |

(b)

the survival of the micro-organism in the environment,

| (c) | its ecological niche, |
| --- | --- |

(c)

its ecological niche,

| (d) | the natural background level of the micro-organism, where it is indigenous, |
| --- | --- |

(d)

the natural background level of the micro-organism, where it is indigenous,

| (e) | information on fate and behaviour in the various parts of the environment, |
| --- | --- |

(e)

information on fate and behaviour in the various parts of the environment,

| (f) | where relevant, information on potential interference with analytical systems used for the control of the quality of drinking water as provided for in Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (3), |
| --- | --- |

(f)

where relevant, information on potential interference with analytical systems used for the control of the quality of drinking water as provided for in Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (3),

| (g) | where relevant, other authorised uses of plant protection products in the area of envisaged use, e.g. containing the same active substance or which gives rise to the same residues. |
| --- | --- |

(g)

where relevant, other authorised uses of plant protection products in the area of envisaged use, e.g. containing the same active substance or which gives rise to the same residues.

| 2.7.3. | Member States shall evaluate the possibility of exposure of organisms in the atmosphere to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the risk for the atmosphere. The transport, short-range and long-range, of the micro-organism in the atmosphere should be taken into account. |
| --- | --- |

2.7.3.

Member States shall evaluate the possibility of exposure of organisms in the atmosphere to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the risk for the atmosphere. The transport, short-range and long-range, of the micro-organism in the atmosphere should be taken into account.

| 2.7.4. | Member States shall evaluate the possibility of exposure of organisms in the terrestrial compartment to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the risks arising for the terrestrial compartment. A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long-lasting or permanent impact on microbial communities or their predators.
  This evaluation will take into consideration the following information:






  (a) | the biological properties of the micro-organism, |
| --- | --- | --- |

2.7.4.

Member States shall evaluate the possibility of exposure of organisms in the terrestrial compartment to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the risks arising for the terrestrial compartment. A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long-lasting or permanent impact on microbial communities or their predators.

This evaluation will take into consideration the following information:

(a)

the biological properties of the micro-organism,

| (b) | the survival of the micro-organism in the environment, |
| --- | --- |

(b)

the survival of the micro-organism in the environment,

| (c) | its ecological niche, |
| --- | --- |

(c)

its ecological niche,

| (d) | the natural background level of the micro-organism, where it is indigenous, |
| --- | --- |

(d)

the natural background level of the micro-organism, where it is indigenous,

| (e) | information on fate and behaviour in the various parts of the environment, |
| --- | --- |

(e)

information on fate and behaviour in the various parts of the environment,

| (f) | where relevant, other authorised uses of plant protection products in the area of envisaged use, e.g. containing the same active substance or which gives rise to the same residues. |
| --- | --- |

(f)

where relevant, other authorised uses of plant protection products in the area of envisaged use, e.g. containing the same active substance or which gives rise to the same residues.

2.8.   Effects on and exposure of non-target organisms

Information on the ecology of the micro-organism and effects on the environment should be assessed as well as possible exposure levels and the effects of its relevant metabolites/toxins. An overall assessment of the environmental risks that the plant protection product may cause, taking into account the normal levels of exposure to micro-organisms both in the environment as well as in the body of organisms, is necessary.

Member States shall evaluate the possibility of exposure of non-target organisms under the proposed conditions of use and if this possibility exists they shall evaluate the risks arising for the non-target organisms concerned.

Where applicable, an assessment of infectivity and pathogenicity is necessary, unless it can be justified that non-target organisms will not be exposed.

To assess the possibility of exposure the following information should also be taken into consideration:

| (a) | the survival of the micro-organism in the respective compartment, |
| --- | --- |

(a)

the survival of the micro-organism in the respective compartment,

| (b) | its ecological niche, |
| --- | --- |

(b)

its ecological niche,

| (c) | the natural background level of the micro-organism, where it is indigenous, |
| --- | --- |

(c)

the natural background level of the micro-organism, where it is indigenous,

| (d) | information on fate and behaviour in the various parts of the environment, |
| --- | --- |

(d)

information on fate and behaviour in the various parts of the environment,

| (e) | where relevant, other authorised uses of the plant protection product in the area of envisaged use containing the same active substance or which give rise to the same residues. |
| --- | --- |

(e)

where relevant, other authorised uses of the plant protection product in the area of envisaged use containing the same active substance or which give rise to the same residues.

2.8.1.   Member States shall evaluate the possibility of exposure of and effects on terrestrial wildlife (non-domestic birds, mammals and other terrestrial vertebrates).

| 2.8.1.1. | A micro-organism may give rise to risks because of its potential to infect and multiply in avian and mammalian host systems. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:






  (a) | its mode of action, |
| --- | --- | --- |

2.8.1.1.

A micro-organism may give rise to risks because of its potential to infect and multiply in avian and mammalian host systems. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:

(a)

its mode of action,

| (b) | other biological properties, |
| --- | --- |

(b)

other biological properties,

| (c) | studies on mammalian toxicity, pathogenicity and infectivity, |
| --- | --- |

(c)

studies on mammalian toxicity, pathogenicity and infectivity,

| (d) | studies on avian toxicity, pathogenicity and infectivity. |
| --- | --- |

(d)

studies on avian toxicity, pathogenicity and infectivity.

| 2.8.1.2. | A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects, the following information should be taken into consideration:






  (a) | studies on mammalian toxicity, |
| --- | --- | --- |

2.8.1.2.

A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects, the following information should be taken into consideration:

(a)

studies on mammalian toxicity,

| (b) | studies on avian toxicity, |
| --- | --- |

(b)

studies on avian toxicity,

| (c) | information on fate and behaviour in the various parts of the environment. |
| --- | --- |

(c)

information on fate and behaviour in the various parts of the environment.

If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the LD50 value and the estimated exposure expressed in mg/kg body weight.

2.8.2.   Member States shall evaluate the possibility of exposure of and effects on aquatic organisms.

| 2.8.2.1. | A micro-organism may give rise to risks because of its potential to infect and multiply in aquatic organisms. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:






  (a) | its mode of action, |
| --- | --- | --- |

2.8.2.1.

A micro-organism may give rise to risks because of its potential to infect and multiply in aquatic organisms. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:

(a)

its mode of action,

| (b) | other biological properties, |
| --- | --- |

(b)

other biological properties,

| (c) | studies on toxicity, pathogenicity and infectivity. |
| --- | --- |

(c)

studies on toxicity, pathogenicity and infectivity.

| 2.8.2.2. | A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:






  (a) | studies on toxicity to aquatic organisms, |
| --- | --- | --- |

2.8.2.2.

A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:

(a)

studies on toxicity to aquatic organisms,

| (b) | information on fate and behaviour in the various parts of the environment. |
| --- | --- |

(b)

information on fate and behaviour in the various parts of the environment.

If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the EC50 value and/or the NOEC value and the estimated exposure.

2.8.3.   Member States shall evaluate the possibility of exposure of and effects on bees.

| 2.8.3.1. | A micro-organism may give rise to risks because of its potential to infect and multiply in bees. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:






  (a) | its mode of action, |
| --- | --- | --- |

2.8.3.1.

A micro-organism may give rise to risks because of its potential to infect and multiply in bees. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:

(a)

its mode of action,

| (b) | other biological properties, |
| --- | --- |

(b)

other biological properties,

| (c) | studies on toxicity, pathogenicity and infectivity. |
| --- | --- |

(c)

studies on toxicity, pathogenicity and infectivity.

| 2.8.3.2. | A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:






  (a) | studies on toxicity to bees, |
| --- | --- | --- |

2.8.3.2.

A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:

(a)

studies on toxicity to bees,

| (b) | information on fate and behaviour in the various parts of the environment. |
| --- | --- |

(b)

information on fate and behaviour in the various parts of the environment.

If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of the hazard quotient, based on the quotient of the dose in g/ha and the LD50 value in μg/bee.

2.8.4.   Member States shall evaluate the possibility of exposure of and effects on arthropods other than bees.

| 2.8.4.1. | A micro-organism may give rise to risks because of its potential to infect and multiply in arthropods other than bees. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:






  (a) | its mode of action, |
| --- | --- | --- |

2.8.4.1.

A micro-organism may give rise to risks because of its potential to infect and multiply in arthropods other than bees. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:

(a)

its mode of action,

| (b) | other biological properties, |
| --- | --- |

(b)

other biological properties,

| (c) | studies on toxicity, pathogenicity and infectivity to honeybees and other arthropods. |
| --- | --- |

(c)

studies on toxicity, pathogenicity and infectivity to honeybees and other arthropods.

| 2.8.4.2. | A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:






  (a) | studies on toxicity to arthropods, |
| --- | --- | --- |

2.8.4.2.

A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:

(a)

studies on toxicity to arthropods,

| (b) | information on fate and behaviour in the various parts of the environment, |
| --- | --- |

(b)

information on fate and behaviour in the various parts of the environment,

| (c) | available data from biological primary screening. |
| --- | --- |

(c)

available data from biological primary screening.

If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the ER50 value (effective rate) and the estimated exposure.

2.8.5.   Member States shall evaluate the possibility of exposure of and effects on earthworms.

| 2.8.5.1. | A micro-organism may give rise to risks because of its potential to infect and multiply in earthworms. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:






  (a) | its mode of action, |
| --- | --- | --- |

2.8.5.1.

A micro-organism may give rise to risks because of its potential to infect and multiply in earthworms. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:

(a)

its mode of action,

| (b) | other biological properties, |
| --- | --- |

(b)

other biological properties,

| (c) | studies on earthworm toxicity, pathogenicity and infectivity. |
| --- | --- |

(c)

studies on earthworm toxicity, pathogenicity and infectivity.

| 2.8.5.2. | A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:






  (a) | studies on earthworm toxicity, |
| --- | --- | --- |

2.8.5.2.

A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:

(a)

studies on earthworm toxicity,

| (b) | information on fate and behaviour in the various parts of the environment. |
| --- | --- |

(b)

information on fate and behaviour in the various parts of the environment.

If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the LC50 value and the estimated exposure expressed in mg/kg dry weight soil.

2.8.6.   Member States shall evaluate the possibility of exposure of and effects on soil micro-organisms.

| 2.8.6.1. | A micro-organism may give rise to risks because of its potential to interfere with nitrogen and carbon mineralisation in the soil. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:






  (a) | its mode of action, |
| --- | --- | --- |

2.8.6.1.

A micro-organism may give rise to risks because of its potential to interfere with nitrogen and carbon mineralisation in the soil. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:

(a)

its mode of action,

| (b) | other biological properties. |
| --- | --- |

(b)

other biological properties.

Experimental data are not normally required, i.e. where it can be justified that a proper risk assessment can be performed with the available information.

| 2.8.6.2. | Member States shall evaluate the impact of exotic/non-indigenous micro-organisms on non-target micro-organisms and on their predators following use of the plant protection product according to the proposed conditions of use. Experimental data are not normally required, i.e. where it can be justified that a proper risk assessment can be performed with the available information. |
| --- | --- |

2.8.6.2.

Member States shall evaluate the impact of exotic/non-indigenous micro-organisms on non-target micro-organisms and on their predators following use of the plant protection product according to the proposed conditions of use. Experimental data are not normally required, i.e. where it can be justified that a proper risk assessment can be performed with the available information.

| 2.8.6.3. | A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:






  (a) | information on fate and behaviour in the various parts of the environment, |
| --- | --- | --- |

2.8.6.3.

A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration:

(a)

information on fate and behaviour in the various parts of the environment,

| (b) | all available information from biological primary screening. |
| --- | --- |

(b)

all available information from biological primary screening.

2.9.   Conclusions and proposals

Member States shall draw conclusions on the need for further information and/or testing and the need for measures to limit the risks arising. Member States shall justify proposals for the classification and labelling of plant protection products.

C.   DECISION-MAKING

1.   General principles

| 1.1. | Where appropriate, Member States shall impose conditions or restrictions on the authorisations they grant. The nature and severity of these conditions or restrictions must be selected on the basis of, and be appropriate to, the nature and extent of the expected advantages and the risks likely to arise. |
| --- | --- |

1.1.

Where appropriate, Member States shall impose conditions or restrictions on the authorisations they grant. The nature and severity of these conditions or restrictions must be selected on the basis of, and be appropriate to, the nature and extent of the expected advantages and the risks likely to arise.

| 1.2. | Member States shall ensure that decisions taken to grant authorisations, take account of the agricultural, plant health or environmental (including climatic) conditions in the areas of envisaged use. Such considerations may result in specific conditions and restrictions on use, and, in authorisation being granted for some but not other areas within the Member State in question. |
| --- | --- |

1.2.

Member States shall ensure that decisions taken to grant authorisations, take account of the agricultural, plant health or environmental (including climatic) conditions in the areas of envisaged use. Such considerations may result in specific conditions and restrictions on use, and, in authorisation being granted for some but not other areas within the Member State in question.

| 1.3. | Member States shall ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effect even where higher amounts would not result in unacceptable risks to human or animal health or to the environment. The authorised amounts must be differentiated according to, and be appropriate to, the agricultural, plant health or environmental (including climatic) conditions in the various areas for which an authorisation is granted. However, the rates and the number of applications may not give rise to undesirable effects such as the development of resistance. |
| --- | --- |

1.3.

Member States shall ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effect even where higher amounts would not result in unacceptable risks to human or animal health or to the environment. The authorised amounts must be differentiated according to, and be appropriate to, the agricultural, plant health or environmental (including climatic) conditions in the various areas for which an authorisation is granted. However, the rates and the number of applications may not give rise to undesirable effects such as the development of resistance.

| 1.4. | Member States shall ensure that decisions respect the principles of integrated pest control if the plant protection product is intended for use in conditions where these principles are relied on. |
| --- | --- |

1.4.

Member States shall ensure that decisions respect the principles of integrated pest control if the plant protection product is intended for use in conditions where these principles are relied on.

| 1.5. | Since the evaluation is to be based on data concerning a limited number of representative species, Member States shall ensure that use of plant protection products does not have any long-term repercussions for the abundance and diversity of non-target species. |
| --- | --- |

1.5.

Since the evaluation is to be based on data concerning a limited number of representative species, Member States shall ensure that use of plant protection products does not have any long-term repercussions for the abundance and diversity of non-target species.

| 1.6. | Before issuing an authorisation, Member States shall ensure that the label of the plant protection product:






  (a) | fulfils the requirements of Article 16 of this Directive, |
| --- | --- | --- |

1.6.

Before issuing an authorisation, Member States shall ensure that the label of the plant protection product:

(a)

fulfils the requirements of Article 16 of this Directive,

| (b) | also contains the information on protection of users required by Community legislation on worker protection, |
| --- | --- |

(b)

also contains the information on protection of users required by Community legislation on worker protection,

| (c) | specifies in particular the conditions or restrictions under which the plant protection product may or may not be used as referred to in points 1.1 to 1.5, |
| --- | --- |

(c)

specifies in particular the conditions or restrictions under which the plant protection product may or may not be used as referred to in points 1.1 to 1.5,

| (d) | The authorisation shall mention the particulars indicated in Article 16(1)(g) and (h) of this Directive and Article 10(1.2), (2.4), (2.5) and (2.6) of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (4). |
| --- | --- |

(d)

The authorisation shall mention the particulars indicated in Article 16(1)(g) and (h) of this Directive and Article 10(1.2), (2.4), (2.5) and (2.6) of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (4).

| 1.7. | Before issuing authorisations, Member States shall:






  (a) | ensure that the proposed packaging is in accordance with the provisions of Directive 1999/45/EC; |
| --- | --- | --- |

1.7.

Before issuing authorisations, Member States shall:

(a)

ensure that the proposed packaging is in accordance with the provisions of Directive 1999/45/EC;

| (b) | ensure that:






  — | the procedures for destruction of the plant protection product, |
| --- | --- | --- |

(b)

ensure that:

—

the procedures for destruction of the plant protection product,

| — | the procedures for neutralisation of any adverse effects of the plant protection product if it is accidentally dispersed, and |
| --- | --- |

—

the procedures for neutralisation of any adverse effects of the plant protection product if it is accidentally dispersed, and

| — | the procedures for the decontamination and destruction of the packaging, |
| --- | --- |

—

the procedures for the decontamination and destruction of the packaging,

are in accordance with the relevant regulatory provisions.

| 1.8. | No authorisation shall be granted unless all the requirements referred to in point 2 are satisfied. However, when one or more of the specific decision-making requirements referred to in point 2.4 are not fully satisfied, authorisations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweigh the possible adverse effects of its use. Any restrictions on use of the plant protection product relating to non-compliance with some of the requirements referred to in point 2.4 must be mentioned on the label. These advantages can be in terms of:






  (a) | advantages for and compatibility with integrated control measures or organic farming, |
| --- | --- | --- |

1.8.

No authorisation shall be granted unless all the requirements referred to in point 2 are satisfied. However, when one or more of the specific decision-making requirements referred to in point 2.4 are not fully satisfied, authorisations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweigh the possible adverse effects of its use. Any restrictions on use of the plant protection product relating to non-compliance with some of the requirements referred to in point 2.4 must be mentioned on the label. These advantages can be in terms of:

(a)

advantages for and compatibility with integrated control measures or organic farming,

| (b) | facilitating strategies to minimise the risk of development of resistance, |
| --- | --- |

(b)

facilitating strategies to minimise the risk of development of resistance,

| (c) | reduced risk for operators and consumers, |
| --- | --- |

(c)

reduced risk for operators and consumers,

| (d) | reduced contamination of the environment and reduced impact on non-target species. |
| --- | --- |

(d)

reduced contamination of the environment and reduced impact on non-target species.

| 1.9. | Where an authorisation has been granted according to the requirements provided for in this Annex, Member States may, by virtue of Article 4(6):






  (a) | define, where possible, preferably in close cooperation with the applicant, measures to improve the performance of the plant protection product, and/or |
| --- | --- | --- |

1.9.

Where an authorisation has been granted according to the requirements provided for in this Annex, Member States may, by virtue of Article 4(6):

(a)

define, where possible, preferably in close cooperation with the applicant, measures to improve the performance of the plant protection product, and/or

| (b) | define, where possible, in close cooperation with the applicant, measures to reduce further the exposure that could occur during and after use of the plant protection product. |
| --- | --- |

(b)

define, where possible, in close cooperation with the applicant, measures to reduce further the exposure that could occur during and after use of the plant protection product.

Member States shall inform applicants of any measures identified under (a) or (b) and shall invite applicants to provide any supplementary data and information necessary to demonstrate performance or potential risks arising under the changed conditions.

| 1.10. | Member States shall ensure, as far as is practically possible, that for all micro-organisms that are considered for an authorisation, the applicant has taken into account all available relevant knowledge and information in literature at the time of submission. |
| --- | --- |

1.10.

Member States shall ensure, as far as is practically possible, that for all micro-organisms that are considered for an authorisation, the applicant has taken into account all available relevant knowledge and information in literature at the time of submission.

| 1.11. | Where the micro-organism has been genetically modified, as defined in Directive 2001/18/EC, no authorisation shall be granted unless the evaluation conducted in accordance with Directive 2001/18/EC has been submitted, as required under Article 1(3) of that Directive. The relevant decision taken by the competent authorities in accordance with Directive 2001/18/EC must be provided. |
| --- | --- |

1.11.

Where the micro-organism has been genetically modified, as defined in Directive 2001/18/EC, no authorisation shall be granted unless the evaluation conducted in accordance with Directive 2001/18/EC has been submitted, as required under Article 1(3) of that Directive. The relevant decision taken by the competent authorities in accordance with Directive 2001/18/EC must be provided.

| 1.12. | In accordance with Article 1(3) of this Directive, no authorisation shall be granted for a plant protection product containing a genetically modified organism unless authorisation is granted according to the provisions in Directive 2001/18/EC, part C, under which that organism can be released into the environment. |
| --- | --- |

1.12.

In accordance with Article 1(3) of this Directive, no authorisation shall be granted for a plant protection product containing a genetically modified organism unless authorisation is granted according to the provisions in Directive 2001/18/EC, part C, under which that organism can be released into the environment.

| 1.13. | No authorisation shall be granted if relevant metabolites/toxins (i.e. those expected to be of concern for human health and/or the environment) known to be formed by the micro-organism, and/or by microbial contaminants are present in the plant protection product, unless it can be shown that the amount present is at an acceptable level before and after its proposed use. |
| --- | --- |

1.13.

No authorisation shall be granted if relevant metabolites/toxins (i.e. those expected to be of concern for human health and/or the environment) known to be formed by the micro-organism, and/or by microbial contaminants are present in the plant protection product, unless it can be shown that the amount present is at an acceptable level before and after its proposed use.

| 1.14. | Member States shall ensure that adequate quality control measures are applied to ensure the identity of the micro-organism and contents of the plant protection product. Such measures must include a Hazard Analysis Critical Control Point (HACCP) system or equivalent system. |
| --- | --- |

1.14.

Member States shall ensure that adequate quality control measures are applied to ensure the identity of the micro-organism and contents of the plant protection product. Such measures must include a Hazard Analysis Critical Control Point (HACCP) system or equivalent system.

2.   Specific principles

The specific principles shall apply without prejudice to the general principles referred to in Section 1.

2.1.   Identity

For each authorisation granted the Member States shall ensure that the micro-organism concerned is deposited at an internationally recognised culture collection and has an accession number. Each micro-organism must be identified and named at the species level and characterised at the strain level. There must also be information as to whether or not the micro-organism is a wild type or a spontaneous or induced mutant, or a genetically modified organism.

2.2.   Biological and technical properties

| 2.2.1. | There must be sufficient information to permit assessment of the minimum and maximum content of the micro-organism in the material used for the manufacturing of plant protection products, as well as in the plant protection product. The content of other components and formulants in the plant protection product and contaminating micro-organisms derived from the production process must to the extent possible be defined. Member States shall ensure that the level of contaminating organisms is controlled to an acceptable level. In addition: the physical nature and state of the plant protection product must be specified, preferably according to the ‘Catalogue of pesticide formulation types and international coding system (CropLife International Technical Monograph No 2, 5th Edition, 2002)’. |
| --- | --- |

2.2.1.

There must be sufficient information to permit assessment of the minimum and maximum content of the micro-organism in the material used for the manufacturing of plant protection products, as well as in the plant protection product. The content of other components and formulants in the plant protection product and contaminating micro-organisms derived from the production process must to the extent possible be defined. Member States shall ensure that the level of contaminating organisms is controlled to an acceptable level. In addition: the physical nature and state of the plant protection product must be specified, preferably according to the ‘Catalogue of pesticide formulation types and international coding system (CropLife International Technical Monograph No 2, 5th Edition, 2002)’.

| 2.2.2. | No authorisation shall be granted if, at any stage in the development of a microbial plant protection product, it becomes apparent, on the basis of a build-up of resistance, or transfer of resistance, or other mechanism, that there may be interference with the effectiveness of an anti-microbial agent used in human or animal medicine. |
| --- | --- |

2.2.2.

No authorisation shall be granted if, at any stage in the development of a microbial plant protection product, it becomes apparent, on the basis of a build-up of resistance, or transfer of resistance, or other mechanism, that there may be interference with the effectiveness of an anti-microbial agent used in human or animal medicine.

2.3.   Further information

No authorisation shall be granted unless full information is provided on the continuous quality control of the production method, production process and plant protection product. In particular, the occurrence of spontaneous changes in major characteristics of the micro-organism and the absence/presence of contaminating organisms shall be considered. The quality assurance criteria for production and the techniques used to ensure a uniform plant protection product must to the extent possible be described and specified.

2.4.   Efficacy

2.4.1.   Performance

| 2.4.1.1. | No authorisation shall be granted where the proposed uses include recommendations for the control of or protection against organisms which are not considered to be harmful on the basis of experience acquired or scientific evidence under normal agricultural, plant health and environmental (including climatic) conditions in the areas of proposed use or where the other intended effects are not considered to be beneficial under those conditions. |
| --- | --- |

2.4.1.1.

No authorisation shall be granted where the proposed uses include recommendations for the control of or protection against organisms which are not considered to be harmful on the basis of experience acquired or scientific evidence under normal agricultural, plant health and environmental (including climatic) conditions in the areas of proposed use or where the other intended effects are not considered to be beneficial under those conditions.

| 2.4.1.2. | The level, consistency and duration of control or protection or other intended effects must be similar to those resulting from the use of suitable reference products. If no suitable reference product exists, the plant protection product must be shown to give a defined benefit in terms of the level, consistency and duration of control or protection or other intended effects under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use. |
| --- | --- |

2.4.1.2.

The level, consistency and duration of control or protection or other intended effects must be similar to those resulting from the use of suitable reference products. If no suitable reference product exists, the plant protection product must be shown to give a defined benefit in terms of the level, consistency and duration of control or protection or other intended effects under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use.

| 2.4.1.3. | Where relevant, yield response when the plant protection product is used and reduction of loss in storage must be quantitatively and/or qualitatively similar to those resulting from the use of suitable reference products. If no suitable reference product exists, the plant protection product must be shown to give a consistent and defined quantitative and/or qualitative benefit in terms of yield response and reduction of loss in storage under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use. |
| --- | --- |

2.4.1.3.

Where relevant, yield response when the plant protection product is used and reduction of loss in storage must be quantitatively and/or qualitatively similar to those resulting from the use of suitable reference products. If no suitable reference product exists, the plant protection product must be shown to give a consistent and defined quantitative and/or qualitative benefit in terms of yield response and reduction of loss in storage under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use.

| 2.4.1.4. | Conclusions as to the performance of the preparation must be valid for all areas of the Member State in which it is to be authorised, and for all conditions under which its use is proposed, except where the proposed label specifies that the preparation is intended for use in certain specified circumstances (e.g. light infestations, particular soil types or particular growing conditions). |
| --- | --- |

2.4.1.4.

Conclusions as to the performance of the preparation must be valid for all areas of the Member State in which it is to be authorised, and for all conditions under which its use is proposed, except where the proposed label specifies that the preparation is intended for use in certain specified circumstances (e.g. light infestations, particular soil types or particular growing conditions).

| 2.4.1.5. | Where proposed label claims include requirements for use of the preparation with other specified plant protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and comply with the principles referred to in points 2.4.1.1 to 2.4.1.4.
  Where proposed label claims include recommendations for use of the preparation with specified plant protection products or adjuvants as a tank mix, Member States shall not accept the recommendations unless they are justified. |
| --- | --- |

2.4.1.5.

Where proposed label claims include requirements for use of the preparation with other specified plant protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and comply with the principles referred to in points 2.4.1.1 to 2.4.1.4.

Where proposed label claims include recommendations for use of the preparation with specified plant protection products or adjuvants as a tank mix, Member States shall not accept the recommendations unless they are justified.

| 2.4.1.6. | If there is evidence of a development of resistance of pathogens towards the plant protection product, the Member State shall decide if the submitted resistance management strategy addresses this adequately and sufficiently. |
| --- | --- |

2.4.1.6.

If there is evidence of a development of resistance of pathogens towards the plant protection product, the Member State shall decide if the submitted resistance management strategy addresses this adequately and sufficiently.

| 2.4.1.7. | Only plant protection products containing non-viable micro-organisms may be authorised for use to control vertebrate species. The intended effect on vertebrates to be controlled shall be obtained without unnecessary suffering and unnecessary pain for these animals. |
| --- | --- |

2.4.1.7.

Only plant protection products containing non-viable micro-organisms may be authorised for use to control vertebrate species. The intended effect on vertebrates to be controlled shall be obtained without unnecessary suffering and unnecessary pain for these animals.

2.4.2.   Absence of unacceptable effects on plants and plant products

| 2.4.2.1. | There must be no relevant phytotoxic effects on treated plants or plant products except where the proposed label indicates appropriate limitations of use. |
| --- | --- |

2.4.2.1.

There must be no relevant phytotoxic effects on treated plants or plant products except where the proposed label indicates appropriate limitations of use.

| 2.4.2.2. | There must be no reduction of yield at harvest due to phytotoxic effects below that which could be obtained without the use of the plant protection product, unless this reduction is compensated for by other advantages such as an enhancement of the quality of the treated plants or plant products. |
| --- | --- |

2.4.2.2.

There must be no reduction of yield at harvest due to phytotoxic effects below that which could be obtained without the use of the plant protection product, unless this reduction is compensated for by other advantages such as an enhancement of the quality of the treated plants or plant products.

| 2.4.2.3. | There must be no unacceptable adverse effects on the quality of treated plants or plant products, except in the case of adverse effects on processing where proposed label claims specify that the preparation should not be applied to crops to be used for processing purposes. |
| --- | --- |

2.4.2.3.

There must be no unacceptable adverse effects on the quality of treated plants or plant products, except in the case of adverse effects on processing where proposed label claims specify that the preparation should not be applied to crops to be used for processing purposes.

| 2.4.2.4. | There must be no unacceptable adverse effects on treated plants or plant products used for propagation or reproduction, such as effects on viability, germination, sprouting, rooting and establishment, except where proposed label claims specify that the preparation should not be applied to plants or plant products to be used for propagation or reproduction. |
| --- | --- |

2.4.2.4.

There must be no unacceptable adverse effects on treated plants or plant products used for propagation or reproduction, such as effects on viability, germination, sprouting, rooting and establishment, except where proposed label claims specify that the preparation should not be applied to plants or plant products to be used for propagation or reproduction.

| 2.4.2.5. | There must be no unacceptable impact on succeeding crops, except where proposed label claims specify that particular crops, which would be affected, should not be grown following the treated crop. |
| --- | --- |

2.4.2.5.

There must be no unacceptable impact on succeeding crops, except where proposed label claims specify that particular crops, which would be affected, should not be grown following the treated crop.

| 2.4.2.6. | There must be no unacceptable impact on adjacent crops, except where proposed label claims specify that the preparation should not be applied when particular sensitive adjacent crops are present. |
| --- | --- |

2.4.2.6.

There must be no unacceptable impact on adjacent crops, except where proposed label claims specify that the preparation should not be applied when particular sensitive adjacent crops are present.

| 2.4.2.7. | Where proposed label claims include requirements for use of the preparation with other plant protection products or adjuvants, as a tank mix, the mixture must comply with the principles referred to in points 2.4.2.1 to 2.4.2.6. |
| --- | --- |

2.4.2.7.

Where proposed label claims include requirements for use of the preparation with other plant protection products or adjuvants, as a tank mix, the mixture must comply with the principles referred to in points 2.4.2.1 to 2.4.2.6.

| 2.4.2.8. | The proposed instructions for cleaning the application equipment must be both practical and effective so that they can be applied with ease so as to ensure the removal of residual traces of the plant protection product which could subsequently cause damage. |
| --- | --- |

2.4.2.8.

The proposed instructions for cleaning the application equipment must be both practical and effective so that they can be applied with ease so as to ensure the removal of residual traces of the plant protection product which could subsequently cause damage.

2.5.   Identification/detection and quantification methods

The methods proposed must reflect the latest techniques. Methods for post-authorisation monitoring should involve the use of commonly available reagents and equipment.

| 2.5.1. | No authorisation shall be granted unless there is an adequate method of sufficient quality to identify and quantify the micro-organism and non-viable components (e.g. toxins, impurities and co-formulants) in the plant protection product. In the case of a plant protection product containing more than one micro-organism, the recommended methods should be capable of identifying and determining the content of each one. |
| --- | --- |

2.5.1.

No authorisation shall be granted unless there is an adequate method of sufficient quality to identify and quantify the micro-organism and non-viable components (e.g. toxins, impurities and co-formulants) in the plant protection product. In the case of a plant protection product containing more than one micro-organism, the recommended methods should be capable of identifying and determining the content of each one.

| 2.5.2. | No authorisation shall be granted unless there are adequate methods for post-registration control and monitoring of viable and/or non-viable residues. Methods must be available for analysis of:






  (a) | plants, plant products, foodstuffs of plant and animal origin and feedingstuffs if toxicologically relevant residues occur. Residues are considered relevant if a maximum residue level (MRL) or a waiting or re-entry safety period or other such precaution is required, |
| --- | --- | --- |

2.5.2.

No authorisation shall be granted unless there are adequate methods for post-registration control and monitoring of viable and/or non-viable residues. Methods must be available for analysis of:

(a)

plants, plant products, foodstuffs of plant and animal origin and feedingstuffs if toxicologically relevant residues occur. Residues are considered relevant if a maximum residue level (MRL) or a waiting or re-entry safety period or other such precaution is required,

| (b) | soil, water, air and/or body tissues if toxicologically, ecotoxicologically or environmentally relevant residues occur. |
| --- | --- |

(b)

soil, water, air and/or body tissues if toxicologically, ecotoxicologically or environmentally relevant residues occur.

2.6.   Impact on human and animal health

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

| 2.6.1.1. | No authorisation shall be granted if on the basis of the information provided in the dossier it appears that the micro-organism is pathogenic to humans or non-target animals under the proposed conditions of use. |
| --- | --- |

2.6.1.1.

No authorisation shall be granted if on the basis of the information provided in the dossier it appears that the micro-organism is pathogenic to humans or non-target animals under the proposed conditions of use.

| 2.6.1.2. | No authorisation shall be granted if the micro-organism and/or the plant protection product containing the micro-organism might, under the recommended conditions of use, including a realistic worst case scenario, colonise or cause adverse effects in humans or animals.
  When making a decision on the authorisation of the microbial plant protection product, Member States shall consider possible effects on all human populations, namely professional users, non-professional users and humans exposed directly or indirectly though the environment and at work, and animals. |
| --- | --- |

2.6.1.2.

No authorisation shall be granted if the micro-organism and/or the plant protection product containing the micro-organism might, under the recommended conditions of use, including a realistic worst case scenario, colonise or cause adverse effects in humans or animals.

When making a decision on the authorisation of the microbial plant protection product, Member States shall consider possible effects on all human populations, namely professional users, non-professional users and humans exposed directly or indirectly though the environment and at work, and animals.

| 2.6.1.3. | All micro-organisms should be regarded as potential sensitisers, unless it is established by means of relevant information that there is no risk of sensitisation, taking into account immuno-compromised and other sensitive individuals. Authorisations granted shall therefore specify that protective clothing and suitable gloves be worn and that the plant protection product containing the micro-organism should not be inhaled. Moreover, the proposed conditions of use may require use of additional items of protective clothing and equipment.
  Where the proposed conditions of use require use of items of protective clothing, no authorisation shall be granted unless those items are effective and in accordance with relevant Community provisions, and are readily obtainable by the user and unless it is feasible to use them under the conditions of use of the plant protection product, taking into account climatic conditions in particular. |
| --- | --- |

2.6.1.3.

All micro-organisms should be regarded as potential sensitisers, unless it is established by means of relevant information that there is no risk of sensitisation, taking into account immuno-compromised and other sensitive individuals. Authorisations granted shall therefore specify that protective clothing and suitable gloves be worn and that the plant protection product containing the micro-organism should not be inhaled. Moreover, the proposed conditions of use may require use of additional items of protective clothing and equipment.

Where the proposed conditions of use require use of items of protective clothing, no authorisation shall be granted unless those items are effective and in accordance with relevant Community provisions, and are readily obtainable by the user and unless it is feasible to use them under the conditions of use of the plant protection product, taking into account climatic conditions in particular.

| 2.6.1.4. | No authorisation shall be granted if it is known that transfer of genetic material from the micro-organism to other organisms may lead to adverse effects on human and animal health, including resistance to known therapeutic substances. |
| --- | --- |

2.6.1.4.

No authorisation shall be granted if it is known that transfer of genetic material from the micro-organism to other organisms may lead to adverse effects on human and animal health, including resistance to known therapeutic substances.

| 2.6.1.5. | Plant protection products which, because of particular properties, or which, if mishandled or misused, could lead to a high degree of risk must be subject to particular restrictions such as restrictions on the size of packaging, formulation type, distribution, use or manner of use. Moreover, plant protection products which are classified as very toxic may not be authorised for use by non-professional users. |
| --- | --- |

2.6.1.5.

Plant protection products which, because of particular properties, or which, if mishandled or misused, could lead to a high degree of risk must be subject to particular restrictions such as restrictions on the size of packaging, formulation type, distribution, use or manner of use. Moreover, plant protection products which are classified as very toxic may not be authorised for use by non-professional users.

| 2.6.1.6. | Waiting and re-entry safety periods or other precautions must be established in such a way that no colonisation of or adverse effects on bystanders or workers exposed after application of the plant protection product are expected. |
| --- | --- |

2.6.1.6.

Waiting and re-entry safety periods or other precautions must be established in such a way that no colonisation of or adverse effects on bystanders or workers exposed after application of the plant protection product are expected.

| 2.6.1.7. | Waiting and re-entry safety periods or other precautions must be established in such a way that no colonisation of or adverse effects on animals are expected. |
| --- | --- |

2.6.1.7.

Waiting and re-entry safety periods or other precautions must be established in such a way that no colonisation of or adverse effects on animals are expected.

| 2.6.1.8. | Waiting and re-entry periods or other precautions to ensure that no colonisation or adverse effects are expected must be realistic; if necessary, special precautionary measures must be prescribed. |
| --- | --- |

2.6.1.8.

Waiting and re-entry periods or other precautions to ensure that no colonisation or adverse effects are expected must be realistic; if necessary, special precautionary measures must be prescribed.

| 2.6.1.9. | The conditions of authorisation shall be in compliance with Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (5), and Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (6). The experimental data and information relevant to the recognition of the symptoms of infection or pathogenicity and on the effectiveness of first aid and therapeutic measures provided shall be considered. The conditions of authorisation shall also be in compliance with Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (7). The conditions of authorisation shall also be in compliance with Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (8). |
| --- | --- |

2.6.1.9.

The conditions of authorisation shall be in compliance with Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (5), and Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (6). The experimental data and information relevant to the recognition of the symptoms of infection or pathogenicity and on the effectiveness of first aid and therapeutic measures provided shall be considered. The conditions of authorisation shall also be in compliance with Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (7). The conditions of authorisation shall also be in compliance with Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (8).

2.6.2.   Effects on human and animal health arising from residues

| 2.6.2.1. | No authorisation shall be granted unless there is sufficient information for plant protection products containing the micro-organism, to decide that there is no harmful effect on human or animal health arising from exposure to the micro-organism, its residual traces and metabolites/toxins remaining in or on plants or plant products. |
| --- | --- |

2.6.2.1.

No authorisation shall be granted unless there is sufficient information for plant protection products containing the micro-organism, to decide that there is no harmful effect on human or animal health arising from exposure to the micro-organism, its residual traces and metabolites/toxins remaining in or on plants or plant products.

| 2.6.2.2. | No authorisation shall be granted unless viable residues and/or non-viable residues occurring reflect the minimum quantities of the plant protection product necessary to achieve adequate control corresponding to good agricultural practice, applied in such a manner (including pre-harvest intervals or withholding periods or storage periods) that the viable residues and/or toxins at harvest, slaughter or after storage are reduced to a minimum. |
| --- | --- |

2.6.2.2.

No authorisation shall be granted unless viable residues and/or non-viable residues occurring reflect the minimum quantities of the plant protection product necessary to achieve adequate control corresponding to good agricultural practice, applied in such a manner (including pre-harvest intervals or withholding periods or storage periods) that the viable residues and/or toxins at harvest, slaughter or after storage are reduced to a minimum.

2.7.   Fate and behaviour in the environment

| 2.7.1. | No authorisation shall be granted if the available information indicates that there may be unacceptable adverse environmental effects due to the fate and behaviour of the plant protection product in the environment. |
| --- | --- |

2.7.1.

No authorisation shall be granted if the available information indicates that there may be unacceptable adverse environmental effects due to the fate and behaviour of the plant protection product in the environment.

| 2.7.2. | No authorisation shall be granted if contamination of ground water, surface water or drinking water expected as a result of the use of a plant protection product under the proposed conditions of use, may cause interference with the analytical systems for the control of the quality of drinking water provided for in Directive 98/83/EC. |
| --- | --- |

2.7.2.

No authorisation shall be granted if contamination of ground water, surface water or drinking water expected as a result of the use of a plant protection product under the proposed conditions of use, may cause interference with the analytical systems for the control of the quality of drinking water provided for in Directive 98/83/EC.

| 2.7.3. | No authorisation shall be granted if the contamination of groundwater expected as a result of the use of a plant protection product under the proposed conditions of use contravenes or exceeds whichever of the following is the lower:






  (a) | the parameters or maximum permissible concentrations laid down by Directive 98/83/EC, or |
| --- | --- | --- |

2.7.3.

No authorisation shall be granted if the contamination of groundwater expected as a result of the use of a plant protection product under the proposed conditions of use contravenes or exceeds whichever of the following is the lower:

(a)

the parameters or maximum permissible concentrations laid down by Directive 98/83/EC, or

| (b) | the parameters or maximum permissible concentrations laid down for components in the plant protection product such as relevant metabolites/toxins in accordance with Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (9), or |
| --- | --- |

(b)

the parameters or maximum permissible concentrations laid down for components in the plant protection product such as relevant metabolites/toxins in accordance with Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (9), or

| (c) | the parameters for the micro-organism or the maximum concentration laid down by the Commission for components in the plant protection product such as relevant metabolites/toxins when including the micro-organism in Annex I, on the basis of appropriate data, in particular, toxicological data, or, where that concentration has not been laid down, the concentration corresponding to 1/10 of the acceptable daily intake (ADI) laid down when the micro-organism was included in Annex I, |
| --- | --- |

(c)

the parameters for the micro-organism or the maximum concentration laid down by the Commission for components in the plant protection product such as relevant metabolites/toxins when including the micro-organism in Annex I, on the basis of appropriate data, in particular, toxicological data, or, where that concentration has not been laid down, the concentration corresponding to 1/10 of the acceptable daily intake (ADI) laid down when the micro-organism was included in Annex I,

unless it is scientifically demonstrated that under relevant field conditions the lower of the parameters or concentrations is not contravened or exceeded.

| 2.7.4. | No authorisation shall be granted if the contamination of surface water expected as a result of the use of a plant protection product under the proposed conditions of use:






  (a) | exceeds, where the surface water in or from the area of envisaged use is intended for the extraction of drinking water, the parameters or values established in accordance with Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the Member States (10), or |
| --- | --- | --- |

2.7.4.

No authorisation shall be granted if the contamination of surface water expected as a result of the use of a plant protection product under the proposed conditions of use:

(a)

exceeds, where the surface water in or from the area of envisaged use is intended for the extraction of drinking water, the parameters or values established in accordance with Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the Member States (10), or

| (b) | exceeds the parameters or values for components in the plant protection product, such as relevant metabolites/toxins, established in accordance with Directive 2000/60/EC or |
| --- | --- |

(b)

exceeds the parameters or values for components in the plant protection product, such as relevant metabolites/toxins, established in accordance with Directive 2000/60/EC or

| (c) | has an impact deemed unacceptable on non-target species, including animals, according to the relevant requirements provided for in point 2.8. |
| --- | --- |

(c)

has an impact deemed unacceptable on non-target species, including animals, according to the relevant requirements provided for in point 2.8.

The proposed instruction for use of the plant protection product, including procedures for cleaning application equipment, must be such that the likelihood of accidental contamination of surface water is reduced to a minimum.

| 2.7.5. | No authorisation shall be granted if it is known that transfer of genetic material from the micro-organism to other organisms, may lead to unacceptable effects on the environment. |
| --- | --- |

2.7.5.

No authorisation shall be granted if it is known that transfer of genetic material from the micro-organism to other organisms, may lead to unacceptable effects on the environment.

| 2.7.6. | No authorisation shall be granted unless there is sufficient information on the possible persistence/competitiveness of the micro-organism and relevant secondary metabolites/toxins in or on the crop under the environmental conditions prevailing at and following the intended use. |
| --- | --- |

2.7.6.

No authorisation shall be granted unless there is sufficient information on the possible persistence/competitiveness of the micro-organism and relevant secondary metabolites/toxins in or on the crop under the environmental conditions prevailing at and following the intended use.

| 2.7.7. | No authorisation shall be granted if it can be expected that the micro-organism and/or its possible relevant metabolites/toxins will persist in the environment in concentrations considerably higher than the natural background levels, taking into account repeated applications over the years, unless a robust risk assessment indicates that the risks from accumulated plateau concentrations are acceptable. |
| --- | --- |

2.7.7.

No authorisation shall be granted if it can be expected that the micro-organism and/or its possible relevant metabolites/toxins will persist in the environment in concentrations considerably higher than the natural background levels, taking into account repeated applications over the years, unless a robust risk assessment indicates that the risks from accumulated plateau concentrations are acceptable.

2.8.   Effects on non-target organisms

Member States shall ensure that the available information is sufficient to permit a decision to be taken as to whether or not there may be unacceptable effects on non-target species (flora and fauna), due to exposure to the plant protection product containing the micro-organism following its intended use.

Member States shall pay special attention to possible effects on beneficial organisms used for biological control and organisms playing an important role in integrated control.

| 2.8.1. | Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorisation shall be granted if:






  (a) | the micro-organism is pathogenic to birds and other non-target terrestrial vertebrates, |
| --- | --- | --- |

2.8.1.

Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorisation shall be granted if:

(a)

the micro-organism is pathogenic to birds and other non-target terrestrial vertebrates,

| (b) | in case of toxic effects due to components in the plant protection product, such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 10 on the basis of the acute LD50 value or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable effects occur — directly or indirectly — after use of the plant protection product according to the proposed conditions of use. |
| --- | --- |

(b)

in case of toxic effects due to components in the plant protection product, such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 10 on the basis of the acute LD50 value or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable effects occur — directly or indirectly — after use of the plant protection product according to the proposed conditions of use.

| 2.8.2. | Where there is a possibility of aquatic organisms being exposed, no authorisation shall be granted if:






  (a) | the micro-organism is pathogenic to aquatic organisms, |
| --- | --- | --- |

2.8.2.

Where there is a possibility of aquatic organisms being exposed, no authorisation shall be granted if:

(a)

the micro-organism is pathogenic to aquatic organisms,

| (b) | in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 100 in case of acute toxicity (EC50) to daphnia and fish and 10 for long-term/chronic toxicity to algae (EC50), daphnia (NOEC) and fish (NOEC), unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on the viability of exposed species occurs — directly or indirectly — after use of the plant protection product according to the proposed conditions of use. |
| --- | --- |

(b)

in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 100 in case of acute toxicity (EC50) to daphnia and fish and 10 for long-term/chronic toxicity to algae (EC50), daphnia (NOEC) and fish (NOEC), unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on the viability of exposed species occurs — directly or indirectly — after use of the plant protection product according to the proposed conditions of use.

| 2.8.3. | Where there is a possibility of bees being exposed, no authorisation shall be granted:






  (a) | if the micro-organism is pathogenic to bees, |
| --- | --- | --- |

2.8.3.

Where there is a possibility of bees being exposed, no authorisation shall be granted:

(a)

if the micro-organism is pathogenic to bees,

| (b) | in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development after use of the plant protection product according to the proposed conditions of use. |
| --- | --- |

(b)

in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development after use of the plant protection product according to the proposed conditions of use.

| 2.8.4. | Where there is a possibility of arthropods other than bees being exposed, no authorisation shall be granted if:






  (a) | the micro-organism is pathogenic to arthropods other than bees, |
| --- | --- | --- |

2.8.4.

Where there is a possibility of arthropods other than bees being exposed, no authorisation shall be granted if:

(a)

the micro-organism is pathogenic to arthropods other than bees,

| (b) | in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on those organisms after use of the plant protection product according to the proposed conditions of use. Any claims for selectivity and proposals for use in integrated pest management systems shall be substantiated by appropriate data. |
| --- | --- |

(b)

in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on those organisms after use of the plant protection product according to the proposed conditions of use. Any claims for selectivity and proposals for use in integrated pest management systems shall be substantiated by appropriate data.

| 2.8.5. | Where there is a possibility of earthworms being exposed, no authorisation shall be granted if the micro-organism is pathogenic to earthworms or in the case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the acute toxicity/exposure ratio is less than 10, or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions earthworm populations are not at risk after use of the plant protection product according to the proposed conditions of use. |
| --- | --- |

2.8.5.

Where there is a possibility of earthworms being exposed, no authorisation shall be granted if the micro-organism is pathogenic to earthworms or in the case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the acute toxicity/exposure ratio is less than 10, or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions earthworm populations are not at risk after use of the plant protection product according to the proposed conditions of use.

| 2.8.6. | Where there is a possibility of non-target soil micro-organisms being exposed, no authorisation shall be granted if the nitrogen or carbon mineralisation processes in laboratory studies are affected by more than 25 % after 100 days, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on the microbial community after use of the plant protection product according to the proposed conditions of use, taking account of the ability of micro-organisms to multiply. |
| --- | --- |

2.8.6.

Where there is a possibility of non-target soil micro-organisms being exposed, no authorisation shall be granted if the nitrogen or carbon mineralisation processes in laboratory studies are affected by more than 25 % after 100 days, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on the microbial community after use of the plant protection product according to the proposed conditions of use, taking account of the ability of micro-organisms to multiply.

---

(1)  OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

(2)  See definition of ‘genetically modified’ in Directive 2001/18/EC.

(3)  OJ L 330, 5.12.1998, p. 32. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

(4)  OJ L 200, 30.7.1999, p. 1. Directive as last amended by Directive 2004/66/EC (OJ L 168, 1.5.2004, p. 35).

(5)  OJ L 131, 5.5.1998, p. 11.

(6)  OJ L 262, 17.10.2000, p. 21.

(7)  OJ L 158, 30.4.2004 p. 50.

(8)  OJ L 393, 30.12.1989, p. 18.

(9)  OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC.

(10)  OJ L 194, 25.7.1975, p. 26. Directive to be repealed from 22.12.2007 by Directive 2000/60/EC (OJ L 327, 22.12. 2000, p. 1).

---

II Acts whose publication is not obligatory

Council

| 8.4.2005 | EN | Official Journal of the European Union | L 90/35 |
| --- | --- | --- | --- |

8.4.2005

EN

Official Journal of the European Union

L 90/35

---

COUNCIL DECISION

of 14 March 2005

on the conclusion of the bilateral agreement between the European Community and the Republic of Serbia on trade in textile products

(2005/272/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 133 in conjunction with the first sentence of the first subparagraph of Article 300(2) thereof,

Having regard to the proposal from the Commission,

Whereas:

| (1) | The Commission has negotiated on behalf of the Community a bilateral agreement on trade in textile products with the Republic of Serbia. |
| --- | --- |

(1)

The Commission has negotiated on behalf of the Community a bilateral agreement on trade in textile products with the Republic of Serbia.

| (2) | The Agreement should be approved on behalf of the Community, |
| --- | --- |

(2)

The Agreement should be approved on behalf of the Community,

HAS DECIDED AS FOLLOWS:

Article 1

The Agreement between the European Community and the Republic of Serbia on trade in textile products is hereby approved on behalf of the Community.

The text of the Agreement is attached to this Decision.

Article 2

The President of the Council is hereby authorised to designate the person(s) empowered to sign, on behalf of the Community, the Agreement in order to bind the Community.

Done at Brussels, 14 March 2005.

For the Council

The President

F. BODEN

---

AGREEMENT

between the European Community and the Republic of Serbia on trade in textile products

THE EUROPEAN COMMUNITY, hereinafter referred to as ‘the Community’,

of the one part,

and

THE REPUBLIC OF SERBIA, hereinafter referred to as ‘Serbia’,

of the other part,

DESIRING to promote, with a view to permanent cooperation and in conditions providing every security for trade, the orderly and equitable development of trade in textile products between the Community and Serbia (hereinafter referred to together as Parties), as a further step towards deeper trade and political relations including substantial trade liberalisation between the two Parties in the framework of the Stabilisation and Association process;

CONSIDERING that United Nations Security Council Resolution 1244 (1999) established an international civil presence in order to provide an interim administration for Kosovo (United Nations Interim Administration Mission in Kosovo), and it is not possible at this time to apply the obligations undertaken in this Agreement in Kosovo,

HAVE AGREED AS FOLLOWS:

Article 1

This Agreement establishes the regime applicable to trade of textile products originating in the Community and in Serbia listed in Annex I.

TITLE I

BASIC PROVISIONS

Article 2

The Parties agree that:

| 1. | the rates of customs duties applicable in Serbia to textile products originating in the Community shall be dismantled according to the schedule in Annex II; |
| --- | --- |

1.

the rates of customs duties applicable in Serbia to textile products originating in the Community shall be dismantled according to the schedule in Annex II;

| 2. | the Community will continue to grant duty free treatment to textile products originating in Serbia in accordance with the applicable Community legislation. |
| --- | --- |

2.

the Community will continue to grant duty free treatment to textile products originating in Serbia in accordance with the applicable Community legislation.

Article 3

1.   Quantitative restrictions on imports of textile products listed in Annex I into Serbia of goods originating in the Community and measures having equivalent effect, including non-tariff barriers as specified, in particular, in Annex III, shall not be maintained nor introduced from the date of application of this Agreement except as provided under Articles 5 and 7.

2.   Without prejudice to Article 4(1), quantitative restrictions on imports of textile products listed in Annex I into the Community of goods originating in Serbia shall be suspended. Measures having equivalent effect, including non-tariff barriers as specified, in particular, in Annex III, shall not be maintained nor introduced from the date of application of this Agreement, except as provided for under Articles 5, 6 and 7.

Article 4

1.   The Community will suspend the quantitative restrictions currently in force for categories listed in Annex IV, as soon as Serbia notifies to the Community that it has implemented its commitments under Article 2(1).

2.   Title II lays down the arrangements applicable to quantitative restrictions and the surveillance regime.

Article 5

1.   Either Party retains the right to suspend its obligations in Articles 2, 3 and in Article 4(1) should the other Party fail to fulfil its obligations.

2.   If the Community re-introduces quantitative restrictions, they shall be established at the year 2004 levels, increased by annual growth rates as last applied for that year.

3.   The Parties agree to consult with each other before exercising their rights, in accordance with Article 8.

Article 6

1.   With a view to ensuring the effective functioning of this Agreement, the Parties agree to cooperate fully in order to prevent, to investigate and to take any necessary legal and/or administrative action against circumvention by transhipment, re-routing, false declaration concerning the country or place of origin, falsification of documents, false declaration concerning fibre content, quantities, description or classification of merchandise and by whatever other means. Accordingly, the Parties agree to establish the necessary legal provisions and administrative procedures permitting effective action to be taken against such circumvention, which shall include the adoption of legally binding corrective measures against exporters and/or importers involved.

2.   If it appears on the basis of available information that this Agreement is circumvented, the Community will consult with Serbia in accordance with Article 8.

3.   If the Parties fail to reach a mutually satisfactory solution, the Community shall have the right:

| (a) | to introduce quantitative restrictions against the same products originating in Serbia as those involved in circumvention or to take any other appropriate measures; |
| --- | --- |

(a)

to introduce quantitative restrictions against the same products originating in Serbia as those involved in circumvention or to take any other appropriate measures;

| (b) | to set off the relevant quantities against the quantitative restrictions that are established under this Agreement. |
| --- | --- |

(b)

to set off the relevant quantities against the quantitative restrictions that are established under this Agreement.

4.   Where available information shows that false declaration concerning fibre content, quantities, description or classification of products originating in Community or in Serbia has occurred, both Parties shall have the right to refuse to import the products in question.

5.   The Parties agree to establish a system of administrative cooperation to prevent and to address effectively all problems arising from circumvention in accordance with Annex V.

Article 7

1.   Where as a direct consequence of the application of the liberalisation measures provided for in this Agreement any product is being imported in such increased quantities and under such conditions as to cause or threaten to cause:

| (a) | serious injury to domestic producers of like or directly competitive products in the territory of the importing Party, or |
| --- | --- |

(a)

serious injury to domestic producers of like or directly competitive products in the territory of the importing Party, or

| (b) | serious disturbances in any related sector of the economy or difficulties which could bring about deterioration in the economic situation of a region,
  the Party concerned may take appropriate measures after consultations are held in accordance with Article 8. In case the other Party considers the measure adopted is not justified, it shall be free to suspend the application of substantially equivalent concessions granted under this Agreement after consultations are held in accordance with Article 8. |
| --- | --- |

(b)

serious disturbances in any related sector of the economy or difficulties which could bring about deterioration in the economic situation of a region,

the Party concerned may take appropriate measures after consultations are held in accordance with Article 8. In case the other Party considers the measure adopted is not justified, it shall be free to suspend the application of substantially equivalent concessions granted under this Agreement after consultations are held in accordance with Article 8.

2.   The Parties may request consultations in accordance with Article 8 when either of them ascertains that during a particular year of application of this Agreement difficulties arise in the Community or in Serbia due to a sharp and substantial increase, by comparison to the preceding year, in imports of a given category of Group I.

Article 8

1.   The consultation procedures referred to in this Agreement shall be governed by the following provisions:

| (a) | any request for consultations shall be notified in writing to the other Party; |
| --- | --- |

(a)

any request for consultations shall be notified in writing to the other Party;

| (b) | the request for consultations shall be followed, within a reasonable period of time and in any case not later than 15 days following the notification, by a report setting out the circumstances which, in the opinion of the requesting Party, justify the submission of such a request; |
| --- | --- |

(b)

the request for consultations shall be followed, within a reasonable period of time and in any case not later than 15 days following the notification, by a report setting out the circumstances which, in the opinion of the requesting Party, justify the submission of such a request;

| (c) | the Parties shall enter into consultations within 30 days of notification of the request at the latest, with a view to reaching a mutually acceptable solution within a further 30-day period at the latest, unless this period is extended by common accord. |
| --- | --- |

(c)

the Parties shall enter into consultations within 30 days of notification of the request at the latest, with a view to reaching a mutually acceptable solution within a further 30-day period at the latest, unless this period is extended by common accord.

2.   At the request of either of the Parties, consultations shall be held on any problems arising from the application of this Agreement. Any consultations held under this Article shall take place in a spirit of cooperation and with a desire to reconcile the differences between the Parties.

TITLE II

QUANTITATIVE RESTRICTIONS AND SURVEILLANCE REGIME

Article 9

1.   The classification of the products covered by this Agreement is based on the tariff and statistical nomenclature of the Community (hereinafter referred to as the Combined Nomenclature or, in abbreviated form, CN) and any amendments thereof.

Where any decision on classification results in a change of classification practice or a change of category of any product subject to this Agreement the affected products shall follow the trade regime applicable to the practice or category they fall into after such changes.

Any amendment to the Combined Nomenclature made in accordance with the procedures in force in the Community concerning categories of products covered by this Agreement or any decision relating to the classification of goods shall not have the effect of reducing quantitative restrictions introduced pursuant to this Agreement.

2.   The origin of the products covered by this Agreement shall be determined in accordance with the non-preferential rules of origin in force in the Community.

The origin of the products subject to the tariff dismantling schedule provided for in Article 2(1), shall be determined in accordance with Community rules that apply to autonomous preferential tariff measures for certain countries or territories. Any amendment to these rules of origin shall be communicated to Serbia.

The procedures for control of the origin of the products referred to above are laid down in Annex V.

Article 10

1.   If quantitative restrictions are re-introduced in accordance with Articles 5, 6 and 7, exports of the textile products under quantitative restrictions shall be subject to a double-checking system as specified in Annex V.

2.   Following consultations in accordance with the procedures set out in Article 8, exports of products in Annex I not subject to quantitative restrictions may be subject to the double-checking system referred to in Annex V or to a prior surveillance introduced by the Community.

Article 11

1.   The Parties recognise that re-imports of textile products into the Community after processing in Serbia are a specific form of industrial and trade cooperation.

2.   Should quantitative restrictions be established under the conditions specified in this Agreement, these re-imports shall not be subject to these quantitative restrictions if they are subject to the specific arrangements laid down in Title III.

Article 12

Exports from Serbia of cottage-industry fabrics woven on hand- or foot-operated looms, garments or other made-up articles obtained manually from such fabrics and of traditional folklore handicraft products shall not be subject to the quantitative restrictions established under this Agreement, provided that these products originating in Serbia meet the conditions laid down in Annex VI.

Article 13

1.   Imports into the Community of textile products covered by this Agreement shall not be subject to any quantitative restrictions that may be established under this Agreement, provided that they are declared to be for re-export outside the Community in the same state or after processing, within the framework of the administrative system of control which exists within the Community.

However, the release into free circulation of products into the Community under the conditions referred to above shall be subject to the production of an export licence issued by the Ministry of International Economic Relations of Serbia, and to the production of a proof of origin in accordance with Annex V.

2.   Where the Community authorities ascertain that imports of textile products have been set off against quantitative restrictions that may have been established under this Agreement, but that the products have subsequently been re-exported outside the Community, the authorities shall inform the Ministry of International Economic Relations of Serbia within four weeks of the quantities involved and authorise imports of identical quantities of the same products, which shall not be set off against the quantitative restriction established under this Agreement for the current or the following year, as appropriate.

Article 14

Should quantitative restrictions be introduced under this Agreement, the following provisions shall apply:

| 1. | in any year advance use of a portion of the quantitative restriction established for the following year is authorised for each category of products up to 5 % of the quantitative restriction for the current year.
  Amounts delivered in advance shall be deducted from the corresponding quantitative restrictions established for the following year; |
| --- | --- |

1.

in any year advance use of a portion of the quantitative restriction established for the following year is authorised for each category of products up to 5 % of the quantitative restriction for the current year.

Amounts delivered in advance shall be deducted from the corresponding quantitative restrictions established for the following year;

| 2. | carryover to the corresponding quantitative restriction for the following year of the amounts not used during any year is authorised for each category of products up to 10 % of the quantitative restriction for the current year; |
| --- | --- |

2.

carryover to the corresponding quantitative restriction for the following year of the amounts not used during any year is authorised for each category of products up to 10 % of the quantitative restriction for the current year;

| 3. | transfers in respect of categories in group I shall not be made from any category except as follows:






  — | transfers between categories 1, 2 and 3 may be made up to 12 % of the quantitative restriction for the category to which the transfer is made, |
| --- | --- | --- |

3.

transfers in respect of categories in group I shall not be made from any category except as follows:

—

transfers between categories 1, 2 and 3 may be made up to 12 % of the quantitative restriction for the category to which the transfer is made,

| — | transfers between categories 4, 5, 6, 7 and 8 may be made up to 12 % of the quantitative restriction for the category to which the transfer is made. |
| --- | --- |

—

transfers between categories 4, 5, 6, 7 and 8 may be made up to 12 % of the quantitative restriction for the category to which the transfer is made.

Transfers into any category in groups II and III may be made from any category or categories in groups I, II and III up to 12 % of the quantitative restriction for the category to which the transfer is made;

| 4. | the table of equivalence applicable to the transfers referred to is given in Annex I; |
| --- | --- |

4.

the table of equivalence applicable to the transfers referred to is given in Annex I;

| 5. | the increase in any category of products resulting from the cumulative application of the provisions in paragraphs 1, 2 and 3 during a year shall not exceed 17 %; |
| --- | --- |

5.

the increase in any category of products resulting from the cumulative application of the provisions in paragraphs 1, 2 and 3 during a year shall not exceed 17 %;

| 6. | prior notification shall be given by the Ministry of International Economic Relations of Serbia in the event of recourse to the provisions of paragraphs 1, 2 and 3, at least 15 days in advance. |
| --- | --- |

6.

prior notification shall be given by the Ministry of International Economic Relations of Serbia in the event of recourse to the provisions of paragraphs 1, 2 and 3, at least 15 days in advance.

Article 15

The annual growth rate for the quantitative restrictions which may be introduced as provided for by this Agreement for the products covered by it shall be fixed by agreement between the Parties in accordance with the consultation procedures established in Article 8.

Article 16

1.   The Ministry of International Economic Relations of Serbia shall supply the Commission of the European Communities with precise statistical information on all export licences issued for categories of textile products subject to the quantitative restrictions established under this Agreement or to a double-checking system, expressed in quantities and in terms of value and broken down by Member States of the Community, as well as on all certificates issued by the Customs Administration of Serbia for products referred to in Article 12 and subject to Annex VI.

2.   The Community shall likewise transmit to the Ministry of International Economic Relations of Serbia precise statistical information on import authorisations issued by the Community authorities and import statistics for textile products.

3.   The information referred to above shall, for all categories of products, be forwarded before the end of the month following the month to which the statistics relate.

4.   Upon request by the Community, the Ministry of International Economic Relations of Serbia shall supply import statistics for all products covered by Annex I.

5.   If on the basis of the information exchanged it appears that there are significant discrepancies between the returns for exports and those for imports, consultations may be initiated in accordance with the procedure specified in Article 8.

6.   For the purpose of applying the provisions of this Agreement, the Community undertakes to provide the Ministry of International Economic Relations of Serbia before 15 April of each year with the preceding year's statistics on imports of all textile products covered by this Agreement, broken down by supplying country and Member State.

Article 17

1.   Serbia shall monitor its exports of products under restraint or surveillance into the Community. Should a sudden and prejudicial change in traditional trade flows arise, the Community will be entitled to request consultations in order to find a satisfactory solution to those problems. Such consultations shall be held within 15 working days of their being requested by the Community.

2.   Serbia shall endeavour to ensure that exports of textile products subject to quantitative restrictions, which may be established under this Agreement into the Community are spaced out as evenly as possible over the year, due account being taken in particular of seasonal factors.

Article 18

In the event of denunciation of this Agreement, the quantitative restrictions that may be established pursuant to it shall be reduced on a pro rata temporis basis unless the Parties decide otherwise by common agreement.

Article 19

The Parties undertake to refrain from discrimination in the allocation of export licences and import authorisations or documents referred to in Annexes V and VI.

TITLE III

OUTWARD PROCESS TRAFFIC (OPT)

Article 20

Re-imports into the Community, within the meaning of Article 11, shall be subject to this Agreement, unless the following special provisions provide otherwise.

| 1. | Re-imports into the Community referred to in Article 11 may be made subject to specific quantitative restrictions following consultations in accordance with the procedures set out in Article 8, provided the products concerned are subject to quantitative restrictions pursuant to this Agreement, to a double-checking system or to surveillance measures. |
| --- | --- |

1.

Re-imports into the Community referred to in Article 11 may be made subject to specific quantitative restrictions following consultations in accordance with the procedures set out in Article 8, provided the products concerned are subject to quantitative restrictions pursuant to this Agreement, to a double-checking system or to surveillance measures.

| 2. | Having regard to the interests of both Parties, the Community may at its discretion, or in response to a request under Article 8:






  (a) | examine the possibility of transferring from one category to another, using in advance or carrying over from one year to the next, portions of specific quantitative restrictions; |
| --- | --- | --- |

2.

Having regard to the interests of both Parties, the Community may at its discretion, or in response to a request under Article 8:

(a)

examine the possibility of transferring from one category to another, using in advance or carrying over from one year to the next, portions of specific quantitative restrictions;

| (b) | consider the possibility of increasing specific quantitative restrictions. |
| --- | --- |

(b)

consider the possibility of increasing specific quantitative restrictions.

| 3. | However, the Community may apply automatically the flexibility rules set out in paragraph 2 within the following restrictions:






  (a) | transfers between categories may not exceed 25 % of the quantity set for the category to which the transfer is made; |
| --- | --- | --- |

3.

However, the Community may apply automatically the flexibility rules set out in paragraph 2 within the following restrictions:

(a)

transfers between categories may not exceed 25 % of the quantity set for the category to which the transfer is made;

| (b) | carry-over of a specific quantitative restriction from one year to the next may not exceed 13,5 % of the quantity set for the year of actual utilisation; |
| --- | --- |

(b)

carry-over of a specific quantitative restriction from one year to the next may not exceed 13,5 % of the quantity set for the year of actual utilisation;

| (c) | advance use of specific quantitative restrictions from one year to another may not exceed 7,5 % of the quantity set for the year of actual utilisation. |
| --- | --- |

(c)

advance use of specific quantitative restrictions from one year to another may not exceed 7,5 % of the quantity set for the year of actual utilisation.

| 4. | The Community shall inform Serbia of any measures taken pursuant to the preceding paragraphs. |
| --- | --- |

4.

The Community shall inform Serbia of any measures taken pursuant to the preceding paragraphs.

| 5. | The competent authorities in the Community shall debit the specific quantitative restrictions referred to in paragraph 1 at the time of issue of the prior authorisation required by the relevant Community legislation which governs economic outward processing arrangements. A specific quantitative restriction shall be debited for the year in which a prior authorisation is issued. |
| --- | --- |

5.

The competent authorities in the Community shall debit the specific quantitative restrictions referred to in paragraph 1 at the time of issue of the prior authorisation required by the relevant Community legislation which governs economic outward processing arrangements. A specific quantitative restriction shall be debited for the year in which a prior authorisation is issued.

| 6. | A certificate of origin made out by the organisations authorised to do so under the law of Serbia shall be issued, in accordance with Annex V, for all products covered by this Title. This certificate shall bear a reference to the prior authorisation mentioned in paragraph 5 as evidence that the processing operation it describes has been carried out in Serbia. |
| --- | --- |

6.

A certificate of origin made out by the organisations authorised to do so under the law of Serbia shall be issued, in accordance with Annex V, for all products covered by this Title. This certificate shall bear a reference to the prior authorisation mentioned in paragraph 5 as evidence that the processing operation it describes has been carried out in Serbia.

| 7. | The Community shall provide Serbia with the names and addresses of, and specimens of the stamps used by, the competent authorities of the Community, which issue the prior authorisations referred to in paragraph 5. |
| --- | --- |

7.

The Community shall provide Serbia with the names and addresses of, and specimens of the stamps used by, the competent authorities of the Community, which issue the prior authorisations referred to in paragraph 5.

TITLE IV

FINAL PROVISIONS

Article 21

The operation of this Agreement shall be reviewed prior to the accession of Serbia to the World Trade Organisation (WTO). Should Serbia become a Member of the WTO before the expiry of this Agreement, the Agreements and rules of the WTO shall be applied from the date of Serbia's accession to the WTO.

Article 22

1.   This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the Community is applied and under the conditions laid down in that Treaty and, on the other hand, to the territory of Serbia. As regards Serbia, this Agreement shall be binding and directly applicable for all its authorities.

2.   This Agreement shall not apply in Kosovo which is at present under international administration pursuant to United Nations Security Council Resolution 1244 of 10 June 1999. This is without prejudice to the current status of Kosovo or the determination of its final status under the same Resolution.

Article 23

1.   This Agreement shall enter into force on the first day of the second month following the date on which the Parties notify each other of the completion of the procedures necessary for that purpose. The Parties agree to review this Agreement in the light of possible negotiations on a Stabilisation and Association Agreement.

2.   Either Party may at any time propose modifications to this Agreement.

3.   Either Party may at any time denounce this Agreement provided that at least 60 days' notice is given. In that event, this Agreement shall come to an end on the expiry of the period of notice.

4.   The Annexes attached to this Agreement shall form an integral part thereof.

Article 24

This Agreement shall be drawn up in duplicate in the Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Slovakian, Slovenian, Spanish, Swedish and Serbian languages, each of these texts being equally authentic.

Hecho en Bruselas, el treinta y uno de marzo del dos mil cinco.

V Bruselu dne třicátého prvního března dva tisíce pět.

Udfærdiget i Bruxelles den enogtredivte marts to tusind og fire.

Geschehen zu Brüssel am einunddreißigsten März zweitausendfünf.

Kahe tuhande viienda aasta märtsikuu kolmekümne esimesel päeval Brüsselis.

Έγινε στις Βρυξέλλες, στις τριάντα μία Μαρτίου δύο χιλιάδες πέντε.

Done at Brussels on the thirty-first day of March in the year two thousand and five.

Fait à Bruxelles, le trente-et-un mars deux mille cinq.

Fatto a Bruxelles, addi' trentuno marzo duemilacinque.

Briselē, divtūkstoš piektā gada trīsdesmit pirmajā martā.

Priimta du tūkstančiai penktų metų kovo trisdešimt pirmą dieną Briuselyje.

Kelt Brüsszelben, a kettőezer ötödik év március harmincegyedik napján.

Magħmul fi Brussel, fil-wieħed u tletin jum ta' Marzu tas-sena elfejn u ħamsa.

Gedaan te Brussel, de eenendertigste maart tweeduizend vijf.

Sporządzono w Brukseli dnia trzydziestego pierwszego marca roku dwutysięcznego piątego.

Feito em Bruxelas, em trinta e um de Março de dois mil e cinco.

V Bruselju, enaintridesetega marca leta dva tisoč pet.

V Bruseli dňa tridsiateho prvého marca dvetisícpäť.

Tehty Brysselissä kolmantenakymmenentenäensimmäisenä päivänä maaliskuuta vuonna kaksituhattaviisi.

Som skedde i Bryssel den trettioförsta mars tjugohundrafem.

Сачињено у Бриселу тридесет првог марта две хиљаде и пете године.

Por la Comunidad Europea

Za Evropské společenství

For Det Europæiske Fællesskab

Für die Europäische Gemeinschaft

Euroopa Ühenduse nimel

Για την Ευρωπαϊκή Κοινότητα

For the European Community

Pour la Communauté européenne

Per la Comunità europea

Eiropas Kopienas vārdā

Europas bendrijos vardu

az Európai Közösség részéről

Ghall-Komunità Ewropea

Voor de Europese Gemeenschap

W imieniu Wspólnoty Europejskiej

Pela Comunidade Europeia

Za Európske spoločenstvo

za Evropsko skupnost

Euroopan yhteisön puolesta

På Europeiska gemenskapens vägnar

Зa Европску заједнипу

Image

Por la República de Serbia

Za Srbskou republiku

For Republikken Serbien

Für die Republik Serbien

Serbia Vabariigi nimel

Για τη Δημοκρατία της Σερβίας

For the Republic of Serbia

Pour la République de Serbie

Per la Repubblica di Serbia

Serbijas Republikas vārdā

Serbijos Respublikos vardu

a Szerb Köztársaság részéről

Ghar-Repubblika tas-Serbja

Voor de Republiek Servië

W imieniu Republiki Serbii

Pela República da Sérvia

Za Srbskú republiku

Za Republiko Srbijo

Serbian tasavallan puolesta

För Republiken Serbien

За Републику Србију

Image

ANNEX I

TEXTILE PRODUCTS REFERRED TO IN ARTICLE 1

| 1. | Without prejudice to the rules for the interpretation of the combined nomenclature, the wording of the description of goods is considered to be of indicative value only, since the products covered by each category are determined, within this Annex, by CN codes. Where there is an ‘ex’ symbol in front of a CN code, the products covered in each category are determined by the scope of the CN code and by that of the corresponding description. |
| --- | --- |

1.

Without prejudice to the rules for the interpretation of the combined nomenclature, the wording of the description of goods is considered to be of indicative value only, since the products covered by each category are determined, within this Annex, by CN codes. Where there is an ‘ex’ symbol in front of a CN code, the products covered in each category are determined by the scope of the CN code and by that of the corresponding description.

| 2. | When the constitutive material of the products of categories 1 to 114 is not specifically mentioned, these products are to be taken to be made exclusively of wool or of fine hair, of cotton or of man-made fibres. |
| --- | --- |

2.

When the constitutive material of the products of categories 1 to 114 is not specifically mentioned, these products are to be taken to be made exclusively of wool or of fine hair, of cotton or of man-made fibres.

| 3. | Garments which are not recognisable as being garments for men or boys or as being garments for women or girls are classified with the latter. |
| --- | --- |

3.

Garments which are not recognisable as being garments for men or boys or as being garments for women or girls are classified with the latter.

| 4. | Where the expression ‘babies’ garments' is used, this is meant to cover garments up to and including commercial size 86. |
| --- | --- |

4.

Where the expression ‘babies’ garments' is used, this is meant to cover garments up to and including commercial size 86.

| Category | Description | Table of equivalence |
| --- | --- | --- |
| | CN code 2005 | pieces/kg | g/piece |
| (1) | (2) | (3) | (4) |
| GROUP I A |
| 1 | Cotton yarn, not put up for retail sale | | |
| | 5204 11 005204 19 005205 11 005205 12 005205 13 005205 14 005205 15 105205 15 905205 21 005205 22 005205 23 005205 24 005205 26 005205 27 005205 28 005205 31 005205 32 005205 33 005205 34 005205 35 005205 41 005205 42 005205 43 005205 44 005205 46 005205 47 005205 48 005206 11 005206 12 005206 13 005206 14 005206 15 005206 21 005206 22 005206 23 005206 24 005206 25 005206 31 005206 32 005206 33 005206 34 005206 35 005206 41 005206 42 005206 43 005206 44 005206 45 00ex 5604 90 00 | | |
| 2 | Woven fabrics of cotton, other than gauze, terry fabrics, pile fabrics, chenille fabrics, tulle and other net fabrics | | |
| | 5208 11 105208 11 905208 12 165208 12 195208 12 965208 12 995208 13 005208 19 005208 21 105208 21 905208 22 165208 22 195208 22 965208 22 995208 23 005208 29 005208 31 005208 32 165208 32 195208 32 965208 32 995208 33 005208 39 005208 41 005208 42 005208 43 005208 49 005208 51 005208 52 105208 52 905208 53 005208 59 005209 11 005209 12 005209 19 005209 21 005209 22 005209 29 005209 31 005209 32 005209 39 005209 41 005209 42 005209 43 005209 49 005209 51 005209 52 005209 59 005210 11 005210 12 005210 19 005210 21 005210 22 005210 29 005210 31 005210 32 005210 39 005210 41 005210 42 005210 49 005210 51 005210 52 005210 59 005211 11 005211 12 005211 19 005211 21 005211 22 005211 29 005211 31 005211 32 005211 39 005211 41 005211 42 005211 43 005211 49 105211 49 905211 51 005211 52 005211 59 005212 11 105212 11 905212 12 105212 12 905212 13 105212 13 905212 14 105212 14 905212 15 105212 15 905212 21 105212 21 905212 22 105212 22 905212 23 105212 23 905212 24 105212 24 905212 25 105212 25 90ex 5811 00 00ex 6308 00 00 | | |
| 2 (a) | Of which: Other than unbleached or bleached | | |
| | 5208 31 005208 32 165208 32 195208 32 965208 32 995208 33 005208 39 005208 41 005208 42 005208 43 005208 49 005208 51 005208 52 105208 52 905208 53 005208 59 005209 31 005209 32 005209 39 005209 41 005209 42 005209 43 005209 49 005209 51 005209 52 005209 59 005210 31 005210 32 005210 39 005210 41 005210 42 005210 49 005210 51 005210 52 005210 59 005211 31 005211 32 005211 39 005211 41 005211 42 005211 43 005211 49 105211 49 905211 51 005211 52 005211 59 005212 13 105212 13 905212 14 105212 14 905212 15 105212 15 905212 23 105212 23 905212 24 105212 24 905212 25 105212 25 90ex 5811 00 00ex 6308 00 00 | | |
| 3 | Woven fabrics of synthetic fibres (discontinuous or waste) other than narrow woven fabrics, pile fabrics (including terry fabrics) and chenille fabrics | | |
| | 5512 11 005512 19 105512 19 905512 21 005512 29 105512 29 905512 91 005512 99 105512 99 905513 11 205513 11 905513 12 005513 13 005513 19 005513 21 105513 21 305513 21 905513 22 005513 23 005513 29 005513 31 005513 32 005513 33 005513 39 005513 41 005513 42 005513 43 005513 49 005514 11 005514 12 005514 13 005514 19 005514 21 005514 22 005514 23 005514 29 005514 31 005514 32 005514 33 005514 39 005514 41 005514 42 005514 43 005514 49 005515 11 105515 11 305515 11 905515 12 105515 12 305515 12 905515 13 115515 13 195515 13 915515 13 995515 19 105515 19 305515 19 905515 21 105515 21 305515 21 905515 22 115515 22 195515 22 915515 22 995515 29 005515 91 105515 91 305515 91 905515 92 105515 92 905515 99 105515 99 305515 99 90ex 5803 90 40ex 5905 00 70ex 6308 00 00 | | |
| 3 (a) | Of which: Other than unbleached or bleached | | |
| | 5512 19 105512 19 905512 29 105512 29 905512 99 105512 99 905513 21 105513 21 305513 21 905513 22 005513 23 005513 29 005513 31 005513 32 005513 33 005513 39 005513 41 005513 42 005513 43 005513 49 005514 21 005514 22 005514 23 005514 29 005514 31 005514 32 005514 33 005514 39 005514 41 005514 42 005514 43 005514 49 005515 11 305515 11 905515 12 305515 12 905515 13 195515 13 995515 19 305515 19 905515 21 305515 21 905515 22 195515 22 99ex 5515 29 005515 91 305515 91 90ex 5515 92 10ex 5515 92 905515 99 305515 99 90ex 5803 90 40ex 5905 00 70ex 6308 00 00 | | |
| GROUP I B |
| 4 | Shirts, T-shirts, lightweight fine knit roll, polo or turtle necked jumpers and pullovers (other than of wool or fine animal hair), undervests and the like, knitted or crocheted | 6,48 | 154 |
| | 6105 10 006105 20 106105 20 906105 90 106109 10 006109 90 106109 90 306110 20 106110 30 10 | | |
| 5 | Jerseys, pullovers, slip-overs, waistcoats, twinsets, cardigans, bed-jackets and jumpers (others than jackets and blazers), anoraks, wind-cheaters, waister jackets and the like, knitted or crocheted | 4,53 | 221 |
| | 6101 10 906101 20 906101 30 906102 10 906102 20 906102 30 906110 11 106110 11 306110 11 906110 12 106110 12 906110 19 106110 20 906110 20 916110 20 996110 30 916110 30 99 | | |
| 6 | Men's or boys' woven breeches, shorts other than swimwear and trousers (including slacks); women's or girls' woven trousers and slacks, of wool, of cotton or of man made fibres; lower parts of track suits with lining, others than category 16 or 29, of cotton or of man-made fibres | 1,76 | 568 |
| | 6203 41 106203 41 906203 42 316203 42 336203 42 356203 42 906203 43 196203 43 906203 49 196203 49 506204 61 106204 62 316204 62 336204 62 396204 63 186204 69 186211 32 426211 33 426211 42 426211 43 42 | | |
| 7 | Women's or girls' blouses, shirts and shirt-blouses, whether or not knitted or crocheted, of wool, of cotton or man-made fibres | 5,55 | 180 |
| | 6106 10 006106 20 006106 90 106206 20 006206 30 006206 40 00 | | |
| 8 | Men's or boys' shirts, other than knitted or crocheted, of wool, cotton or man-made fibres | 4,60 | 217 |
| | 6205 10 006205 20 006205 30 00 | | |
| GROUP II A |
| 9 | Terry towelling and similar woven terry fabrics of cotton; toilet linen and kitchen linen, other than knitted or crocheted, of terry towelling and woven terry fabrics, of cotton | | |
| | 5802 11 005802 19 00ex 6302 60 00 | | |
| 20 | Bed linen, other than knitted or crocheted | | |
| | 6302 21 006302 22 906302 29 906302 31 006302 32 906302 39 90 | | |
| 22 | Yarn of staple or waste synthetic fibres, not put up for retail sale | | |
| | 5508 10 105509 11 005509 12 005509 21 005509 22 005509 31 005509 32 005509 41 005509 42 005509 51 005509 52 005509 53 005509 59 005509 61 005509 62 005509 69 005509 91 005509 92 005509 99 00 | | |
| 22 (a) | Of which acrylic | | |
| | ex 5508 10 105509 31 005509 32 005509 61 005509 62 005509 69 00 | | |
| 23 | Yarn of staple or waste artificial fibres, not put up for retail sale | | |
| | 5508 20 105510 11 005510 12 005510 20 005510 30 005510 90 00 | | |
| 32 | Woven pile fabrics and chenille fabrics (other than terry towelling or terry fabrics of cotton and narrow woven fabrics) and tufted textile surfaces, of wool, of cotton or of man-made textile fibres | | |
| | 5801 10 005801 21 005801 22 005801 23 005801 24 005801 25 005801 26 005801 31 005801 32 005801 33 005801 34 005801 35 005801 36 005802 20 005802 30 00 | | |
| 32 (a) | Of which: Cotton corduroy | | |
| | 5801 22 00 | | |
| 39 | Table linen, toilet linen and kitchen linen, other than knitted or crocheted, other than of terry towelling or a similar terry fabrics of cotton | | |
| | 6302 51 006302 53 90ex 6302 59 006302 91 006302 93 90ex 6302 99 00 | | |
| GROUP II B |
| 12 | Panty-hose and tights, stockings, understockings, socks, ankle-socks, sockettes and the like, knitted or crocheted, other than for babies, including stockings for varicose veins, other than products of category 70 | 24,3 pairs | 41 |
| | 6115 12 006115 19 006115 20 116115 20 906115 91 006115 92 006115 93 106115 93 306115 93 996115 99 00 | | |
| 13 | Men's or boys' underpants and briefs, women's or girls' knickers and briefs, knitted or crocheted, of wool, of cotton or of man-made fibres | 17 | 59 |
| | 6107 11 006107 12 006107 19 006108 21 006108 22 006108 29 00ex 6212 10 10 | | |
| 14 | Men's or boys' woven overcoats, raincoats and other coats, cloaks and capes, of wool, of cotton or of man-made textile fibres (other than parkas) (of category 21) | 0,72 | 1 389 |
| | 6201 11 00ex 6201 12 10ex 6201 12 90ex 6201 13 10ex 6201 13 906210 20 00 | | |
| 15 | Women's or girls' woven overcoats, raincoats and other coats, cloaks and capes; jackets and blazers, of wool, of cotton or of man-made textile fibres (other than parkas) (of category 21) | 0,84 | 1 190 |
| | 6202 11 00ex 6202 12 10ex 6202 12 90ex 6202 13 10ex 6202 13 906204 31 006204 32 906204 33 906204 39 196210 30 00 | | |
| 16 | Men's or boys' suits and ensembles, other than knitted or crocheted, of wool, of cotton or of man-made fibres, excluding ski suits; men's or boys' track suits with lining, with an outer shell of a single identical fabric, of cotton or of man-made fibres | 0,80 | 1 250 |
| | 6203 11 006203 12 006203 19 106203 19 306203 21 006203 22 806203 23 806203 29 186211 32 316211 33 31 | | |
| 17 | Men's or boys' jackets or blazers, other than knitted or crocheted, of wool, of cotton or of man-made fibres | 1,43 | 700 |
| | 6203 31 006203 32 906203 33 906203 39 19 | | |
| 18 | Men's or boys' singlets and other vests, underpants, briefs, nightshirts, pyjamas, bathrobes, dressing gowns and similar articles, other than knitted or crocheted | | |
| | 6207 11 006207 19 006207 21 006207 22 006207 29 006207 91 006207 92 006207 99 00 | | |
| | Women's or girls' singlets and other vests, slips, petticoats, briefs, panties, night-dresses, pyjamas, négligees, bathrobes, dressing gowns and similar articles, other than knitted or crocheted | | |
| | 6208 11 006208 19 006208 21 006208 22 006208 29 006208 91 006208 92 006208 99 00ex 6212 10 10 | | |
| 19 | Handkerchiefs, other than knitted or crocheted | 59 | 17 |
| | 6213 20 006213 90 00 | | |
| 21 | Parkas; anoraks, windcheaters, waister jackets and the like, other than knitted or crocheted, of wool, of cotton or of man-made fibres; upper parts of tracksuits with lining, other than category 16 or 29, of cotton or of man-made fibres | 2,3 | 435 |
| | ex 6201 12 10ex 6201 12 90ex 6201 13 10ex 6201 13 906201 91 006201 92 006201 93 00ex 6202 12 10ex 6202 12 90ex 6202 13 10ex 6202 13 906202 91 006202 92 006202 93 006211 32 416211 33 416211 42 416211 43 41 | | |
| 24 | Men's or boys' nightshirts, pyjamas, bathrobes, dressing gowns and similar articles, knitted or crocheted | 3,9 | 257 |
| | 6107 21 006107 22 006107 29 006107 91 006107 92 00ex 6107 99 00 | | |
| | Women's or girls' night-dresses, pyjamas, négligees, bathrobes, dressing gowns and similar articles, knitted or crocheted | | |
| | 6108 31 006108 32 006108 39 006108 91 006108 92 00ex 6108 99 00 | | |
| 26 | Women's or girls' dresses, of wool, of cotton or of man-made fibres | 3,1 | 323 |
| | 6104 41 006104 42 006104 43 006104 44 006204 41 006204 42 006204 43 006204 44 00 | | |
| 27 | Women's or girls' skirts, including divided skirts | 2,6 | 385 |
| | 6104 51 006104 52 006104 53 006104 59 006204 51 006204 52 006204 53 006204 59 10 | | |
| 28 | Trousers, bib and brace overalls, breeches and shorts (other than swimwear), knitted or crocheted, of wool, of cotton or of man-made fibres | 1,61 | 620 |
| | 6103 41 006103 42 006103 43 00ex 6103 49 0061046100610462006104 63 00ex 6104 69 00 | | |
| 29 | Women's or girls' suits and ensembles, other than knitted or crocheted, of wool, of cotton or of man-made fibres, excluding ski suits; women's or girls' track suits with lining, with an outer shell of an identical fabric, of cotton or of man-made fibres | 1,37 | 730 |
| | 6204 11 006204 12 006204 13 006204 19 106204 21 006204 22 806204 23 806204 29 186211 42 316211 43 31 | | |
| 31 | Brassières, woven, knitted or crocheted | 18,2 | 55 |
| | ex 6212 10 106212 10 90 | | |
| 68 | Babies' garments and clothing accessories, excluding babies' gloves, mittens and mitts of categories 10 and 87, and babies' stockings, socks and sockettes, other than knitted or crocheted, of category 88 | | |
| | 6111 10 906111 20 906111 30 90ex 6111 90 00ex 6209 10 00ex 6209 20 00ex 6209 30 00ex 6209 90 00 | | |
| 73 | Track suits of knitted or crocheted fabric, of wool, of cotton or of man-made textile fibres | 1,67 | 600 |
| | 6112 11 006112 12 006112 19 00 | | |
| 76 | Men's or boys' industrial or occupational clothing, other than knitted or crocheted | | |
| | 6203 22 106203 23 106203 29 116203 32 106203 33 106203 39 116203 42 116203 42 516203 43 116203 43 316203 49 116203 49 316211 32 106211 33 10 | | |
| | Women's or girls' aprons, smock overalls and other industrial or occupational clothing, other than knitted or crocheted | | |
| | 6204 22 106204 23 106204 29 116204 32 106204 33 106204 39 116204 62 116204 62 516204 63 116204 63 316204 69 116204 69 316211 42 106211 43 10 | | |
| 77 | Ski suits, other than knitted or crocheted | | |
| | ex 6211 20 00 | | |
| 78 | Garments, other than knitted or crocheted, excluding garments of categories 6, 7, 8, 14, 15, 16, 17, 18, 21, 26, 27, 29, 68, 72, 76 and 77 | | |
| | 6203 41 306203 42 596203 43 396203 49 396204 61 856204 62 596204 62 906204 63 396204 63 906204 69 396204 69 506210 40 006210 50 006211 31 006211 32 906211 33 906211 41 006211 42 906211 43 90 | | |
| 83 | Overcoats, jackets, blazers and other garments, including ski suits, knitted or crocheted, excluding garments of categories 4, 5, 7, 13, 24, 26, 27, 28, 68, 69, 72, 73, 74, 75 | | |
| | 6101 10 106101 20 106101 30 106102 10 106102 20 106102 30 106103 31 006103 32 006103 33 00ex 6103 39 006104 31 006104 32 006104 33 00ex 6104 39 006112 20 006113 00 906114 10 006114 20 006114 30 00 | | |
| GROUP III A |
| 33 | Woven fabrics of synthetic filament yarn obtained from strip or the like of polyethylene or polypropylene, less than 3 m wide | | |
| | 5407 20 11 | | |
| | Sacks and bags, of a kind used for the packing of goods, not knitted or crocheted, obtained from strip or the like | | |
| | 6305 32 816305 32 896305 33 916305 33 99 | | |
| 34 | Woven fabrics of synthetic filament yarn obtained from strip or the like of polyethylene or polypropylene, 3 m or more wide | | |
| | 5407 20 19 | | |
| 35 | Woven fabrics of synthetic fibres (continuous), other than those for tyres of category 114 | | |
| | 5407 10 005407 20 905407 30 005407 41 005407 42 005407 43 005407 44 005407 51 005407 52 005407 53 005407 54 005407 61 105407 61 305407 61 505407 61 905407 69 105407 69 905407 71 005407 72 005407 73 005407 74 005407 81 005407 82 005407 83 005407 84 005407 91 005407 92 005407 93 005407 94 00ex 5811 00 00ex 5905 00 70 | | |
| 35 (a) | Of which: Other than unbleached or bleached | | |
| | ex 5407 10 00ex 5407 20 90ex 5407 30 005407 42 005407 43 005407 44 005407 52 005407 53 00540754005407 61 305407 61 505407 61 905407 69 905407 72 005407 73 005407 74 005407 82 005407 83 005407 84 005407 92 005407 93 005407 94 00ex 5811 00 00ex 5905 00 70 | | |
| 36 | Woven fabrics of continuous artificial fibres, other than those for tyres of category 114 | | |
| | 5408 10 005408 21 005408 22 105408 22 905408 23 105408 23 905408 24 005408 31 005408 32 005408 33 005408 34 00ex 5811 00 00ex 5905 00 70 | | |
| 36 (a) | Of which: Other than unbleached or bleached | | |
| | ex 5408 10 005408 22 105408 22 905408 23 105408 23 905408 24 005408 32 005408 33 005408 34 00ex 5811 00 00ex 5905 00 70 | | |
| 37 | Woven fabrics of artificial staple fibres | | |
| | 5516 11 005516 12 005516 13 005516 14 005516 21 005516 22 005516 23 105516 23 905516 24 005516 31 005516 32 005516 33 005516 34 005516 41 005516 42 005516 43 005516 44 005516 91 005516 92 005516 93 005516 94 00ex 5803 90 40ex 5905 00 70 | | |
| 37 (a) | Of which: Other than unbleached or bleached | | |
| | 5516 12 005516 13 005516 14 005516 22 005516 23 105516 23 905516 24 005516 32 005516 33 005516 34 005516 42 005516 43 005516 44 005516 92 005516 93 005516 94 00ex 5803 90 40ex 5905 00 70 | | |
| 38 A | Knitted or crocheted synthetic curtain fabric including net curtain fabric | | |
| | 6005 31 106005 32 106005 33 106005 34 106006 31 106006 32 106006 33 106006 34 10 | | |
| 38 B | Net curtains, other than knitted or crocheted | | |
| | ex 6303 91 00ex 6303 92 90ex 6303 99 90 | | |
| 40 | Woven curtains (including drapes, interior blinds, curtain and bed valances and other furnishing articles), other than knitted or crocheted, of wool, of cotton or of man-made fibres | | |
| | ex 6303 91 00ex 6303 92 90ex 6303 99 906304 19 10ex 6304 19 906304 92 00ex 6304 93 00ex 6304 99 00 | | |
| 41 | Yarn of synthetic filament (continuous), not put up for retail sale, other than non textured single yarn untwisted or with a twist of not more than 50 turns/m | | |
| | 5401 10 125401 10 145401 10 165401 10 185402 10 105402 10 905402 20 005402 31 005402 32 005402 33 005402 39 105402 39 905402 49 105402 49 915402 49 995402 51 005402 52 005402 59 105402 59 905402 61 005402 62 005402 69 105402 69 90ex 5604 20 00ex 5604 90 00 | | |
| 42 | Yarn of continuous man-made fibres, not put up for retail sale | | |
| | 5401 20 10 | | |
| | Yarn of artificial fibres; yarn of artificial filaments, not put up for retail sale, other than single yarn of viscose rayon untwisted or with a twist of not more than 250 turns/m and single non textured yarn of cellulose acetate | | |
| | 5403 10 005403 20 00ex 5403 32 00ex 5403 33 005403 39 005403 41 005403 42 005403 49 00ex 5604 20 00 | | |
| 43 | Yarn of man-made filament, yarn of artificial staple fibres, cotton yarn, put up for retail sale | | |
| | 5204 20 005207 10 005207 90 005401 10 905401 20 905406 10 005406 20 005508 20 905511 30 00 | | |
| 46 | Carded or combed sheep's or lambs' wool or other fine animal hair | | |
| | 5105 10 005105 21 005105 29 005105 31 005105 39 105105 39 90 | | |
| 47 | Yarn of carded sheep's or lambs' wool (woollen yarn) or of carded fine animal hair, not put up for retail sale | | |
| | 5106 10 105106 10 905106 20 105106 20 915106 20 995108 10 105108 10 90 | | |
| 48 | Yarn of combed sheep's or lambs' wool (worsted yarn) or of combed fine animal hair, not put up for retail sale | | |
| | 5107 10 105107 10 905107 20 105107 20 305107 20 515107 20 595107 20 915107 20 995108 20 105108 20 90 | | |
| 49 | Yarn of sheep's or lambs' wool or of combed fine animal hair, put up for retail sale | | |
| | 5109 10 105109 10 905109 90 105109 90 90 | | |
| 50 | Woven fabrics of sheep's or lambs' wool or of fine animal hair | | |
| | 5111 11 005111 19 105111 19 905111 20 005111 30 105111 30 305111 30 905111 90 105111 90 915111 90 935111 90 995112 11 005112 19 105112 19 905112 20 005112 30 105112 30 305112 30 905112 90 105112 90 915112 90 935112 90 99 | | |
| 51 | Cotton, carded or combed | | |
| | 5203 00 00 | | |
| 53 | Cotton gauze | | |
| | 5803 10 00 | | |
| 54 | Artificial staple fibres, including waste, carded, combed or otherwise processed for spinning | | |
| | 5507 00 00 | | |
| 55 | Synthetic staple fibres, including waste, carded, combed or otherwise processed for spinning | | |
| | 5506 10 005506 20 005506 30 005506 90 105506 90 90 | | |
| 56 | Yarn of synthetic staple fibres (including waste), put up for retail sale | | |
| | 5508 10 905511 10 005511 20 00 | | |
| 58 | Carpets, carpentines and rugs, knotted (made up or not) | | |
| | 5701 10 105701 10 905701 90 105701 90 90 | | |
| 59 | Carpets and other textile floor coverings, other than the carpets of category 58 | | |
| | 5702 10 005702 31 105702 31 805702 32 105702 32 90ex 5702 39 005702 41 005702 42 00ex 5702 49 005702 51 005702 52 105702 52 90ex 5702 59 005702 91 005702 92 105702 92 90ex 5702 99 005703 10 005703 20 115703 20 195703 20 915703 20 995703 30 115703 30 195703 30 815703 30 895703 90 105703 90 905704 10 005704 90 005705 00 105705 00 30ex 5705 00 90 | | |
| 60 | Tapestries, hand-made, of the type Gobelins, Flanders, Aubusson, Beauvais and the like, and needlework tapestries (e.g. petit point and cross stitch) made in panels and the like by hand | | |
| | 5805 00 00 | | |
| 61 | Narrow woven fabrics, and narrow fabrics (bolduc) consisting of warp without weft, assembled by means of an adhesive, other than labels and similar articles of category 62
  Elastic fabrics and trimmings (not knitted or crocheted), made from textile materials assembled from rubber thread | | |
| | ex 5806 10 005806 20 005806 31 005806 32 105806 32 905806 39 005806 40 00 | | |
| 62 | Chenille yarn (including flock chenille yarn), gimped yarn (other than metallised yarn and gimped horsehair yarn) | | |
| | 5606 00 915606 00 99 | | |
| | Tulle and other net fabrics but not including woven, knitted or crocheted fabrics, hand or mechanically-made lace, in the piece, in strips or in motifs | | |
| | 5804 10 115804 10 195804 10 905804 21 105804 21 905804 29 105804 29 905804 30 00 | | |
| | Labels, badges and the like of textile materials, not embroidered, in the piece, in strips or cut to shape or size, woven | | |
| | 5807 10 105807 10 90 | | |
| | Braids and ornamental trimmings in the piece; tassels, pompons and the like | | |
| | 5808 10 005808 90 00 | | |
| | Embroidery, in the piece, in strips or in motifs | | |
| | 5810 10 105810 10 905810 91 105810 91 905810 92 105810 92 905810 99 105810 99 90 | | |
| 63 | Knitted or crocheted fabric of synthetic fibres containing by weight 5 % or more elastomeric yarn and knitted or crocheted fabrics containing by weight 5 % or more of rubber thread | | |
| | 5906 91 00ex 6002 40 006002 90 00ex 6004 10 006004 90 00 | | |
| | Raschel lace and long-pile fabric of synthetic fibres | | |
| | ex 6001 10 006003 30 106005 31 506005 32 506005 33 506005 34 50 | | |
| 65 | Knitted or crocheted fabric, other than those of categories 38 A and 63, of wool, of cotton or of man-made fibres | | |
| | 5606 00 10ex 6001 10 006001 21 006001 22 00ex 6001 29 006001 91 006001 92 00ex 6001 99 00ex 6002 40 006003 10 006003 20 006003 30 906003 40 00ex 6004 10 006005 10 006005 21 006005 22 006005 23 006005 24 006005 31 906005 32 906005 33 906005 34 906005 41 006005 42 006005 43 006005 44 006006 10 006006 21 006006 22 006006 23 006006 24 006006 31 906006 32 906006 33 906006 34 906006 41 006006 42 006006 43 006006 44 00 | | |
| 66 | Travelling rugs and blankets, other than knitted or crocheted, of wool, of cotton or of man-made fibres | | |
| | 6301 10 006301 20 906301 30 90ex 6301 40 90ex 6301 90 90 | | |
| GROUP III B |
| 10 | Gloves, mittens and mitts, knitted or crocheted | 17 | 59 |
| | 6111 10 106111 20 106111 30 10ex 6111 90 006116 10 206116 10 806116 91 006116 92 006116 93 006116 99 00 | pairs | |
| 67 | Knitted or crocheted clothing accessories other than for babies; household linen of all kinds, knitted or crocheted; curtains (including drapes) and interior blinds, curtain or bed valances and other furnishing articles knitted or crocheted; knitted or crocheted blankets and travelling rugs, other knitted or crocheted articles including parts of garments or of clothing accessories | | |
| | 5807 90 906113 00 106117 10 006117 20 006117 80 106117 80 906117 90 006301 20 106301 30 106301 40 106301 90 106302 10 006302 40 00ex 6302 60 006303 11 006303 12 006303 19 006304 11 006304 91 00ex 6305 20 006305 32 11ex 6305 32 906305 33 10ex 6305 39 00ex 6305 90 006307 10 106307 90 10 | | |
| 67 (a) | Of which: Sacks and bags of a kind used for the packing of goods, made from polyethylene or polypropylene strip | | |
| | 6305 32 116305 33 10 | | |
| 69 | Women's and girls' slips and petticoats, knitted or crocheted | 7,8 | 128 |
| | 6108 11 006108 19 00 | | |
| 70 | Panty-hose and tights of synthetic fibres, measuring per single yarn less than 67 decitex (6,7 tex) | 30,4 pairs | 33 |
| | 6115 11 006115 20 19 | | |
| | Women's full length hosiery of synthetic fibres | | |
| | 6115 93 91 | | |
| 72 | Swimwear, of wool, of cotton or of man-made fibres | 9,7 | 103 |
| | 6112 31 106112 31 906112 39 106112 39 906112 41 106112 41 906112 49 106112 49 906211 11 006211 12 00 | | |
| 74 | Women's or girls' knitted or crocheted suits and ensembles, of wool, of cotton or of man-made fibres, excluding ski suits | 1,54 | 650 |
| | 6104 11 006104 12 006104 13 00ex 6104 19 006104 21 006104 22 006104 23 00ex 6104 29 00 | | |
| 75 | Men's or boys' knitted or crocheted suits and ensembles, of wool, of cotton or of man-made fibres, excluding ski suit | 0,80 | 1 250 |
| | 6103 11 006103 12 006103 19 006103 21 006103 22 006103 23 006103 29 00 | | |
| 84 | Shawls, scarves, mufflers, mantillas, veils and the like other than knitted or crocheted, of wool, of cotton or of man-made fibres | | |
| | 6214 20 006214 30 006214 40 006214 90 10 | | |
| 85 | Ties, bow ties and cravats other than knitted or crocheted, of wool, of cotton or of man-made fibres | 17,9 | 56 |
| | 6215 20 006215 90 00 | | |
| 86 | Corsets, corset-belts, suspender belts, braces, suspenders, garters and the like, and parts thereof, whether or not knitted or crocheted | 8,8 | 114 |
| | 6212 20 006212 30 006212 90 00 | | |
| 87 | Gloves, mittens and mitts, not knitted or crocheted | | |
| | ex 6209 10 00ex 6209 20 00ex 6209 30 00ex 6209 90 006216 00 00 | | |
| 88 | Stockings, socks and sockettes, not knitted or crocheted; other clothing accessories, parts of garments or of clothing accessories other than for babies, other than knitted or crocheted | | |
| | ex 6209 10 00ex 6209 20 00ex 6209 30 00ex 6209 90 006217 10 006217 90 00 | | |
| 90 | Twine, cordage, ropes and cables of synthetic fibres, plaited or not | | |
| | 5607 41 005607 49 115607 49 195607 49 905607 50 115607 50 195607 50 305607 50 90 | | |
| 91 | Tents | | |
| | 6306 21 006306 22 006306 29 00 | | |
| 93 | Sacks and bags, of a kind used for the packing of goods of woven fabrics, other than made from polyethylene or polypropylene strip | | |
| | ex 6305 20 00ex 6305 32 90ex 6305 39 00 | | |
| 94 | Wadding of textile materials and articles thereof; textile fibres, not exceeding 5 mm in length (flock), textile dust and mill neps | | |
| | 5601 10 105601 10 905601 21 105601 21 905601 22 105601 22 915601 22 995601 29 005601 30 00 | | |
| 95 | Felt and articles thereof, whether or not impregnated or coated, other than floor coverings | | |
| | 5602 10 195602 10 315602 10 395602 10 905602 21 00ex 5602 29 005602 90 00ex 5807 90 10ex 5905 00 706210 10 106307 90 91 | | |
| 96 | Non-woven fabrics and articles of such fabrics, whether or not impregnated, coated, covered or laminated | | |
| | 5603 11 105603 11 905603 12 105603 12 905603 13 105603 13 905603 14 105603 14 905603 91 105603 91 905603 92 105603 92 905603 93 105603 93 905603 94 105603 94 90ex 5807 90 10ex 5905 00 706210 10 90ex 6301 40 90ex 6301 90 906302 22 106302 32 106302 53 106302 93 106303 92 106303 99 10ex 6304 19 90ex 6304 93 00ex 6304 99 00ex 6305 32 90ex 6305 39 006307 10 30ex 6307 90 99 | | |
| 97 | Nets and netting made of twine, cordage or rope and made up fishing nets of yarn, twine, cordage or rope | | |
| | 5608 11 115608 11 195608 11 915608 11 995608 19 115608 19 195608 19 305608 19 905608 90 00 | | |
| 98 | Other articles made from yarn, twine, cordage, cables or rope, other than textile fabrics, articles made from such fabrics and articles of category 97 | | |
| | 5609 00 005905 00 10 | | |
| 99 | Textile fabrics coated with gum or amylaceous substances, of a kind used for the outer covers of books and the like; tracing cloth; prepared painting canvas; buckram and similar stiffened textile fabrics of a kind used for hat foundations | | |
| | 5901 10 005901 90 00 | | |
| | Linoleum, whether or not cut to shape; floor coverings consisting of a coating or covering applied on a textile backing, whether or not cut to shape | | |
| | 5904 10 005904 90 00 | | |
| | Rubberised textile fabric, not knitted or crocheted, excluding those for tyres | | |
| | 5906 10 005906 99 105906 99 90 | | |
| | Textile fabrics otherwise impregnated or coated; painted canvas being theatrical scenery, studio back-cloths, other than of category 100 | | |
| | 5907 00 105907 00 90 | | |
| 100 | Textile fabrics impregnated, coated, covered or laminated with preparations of cellulose derivatives or of other artificial plastic materials | | |
| | 5903 10 105903 10 905903 20 105903 20 905903 90 105903 90 915903 90 99 | | |
| 101 | Twine, cordage, ropes and cables, plaited or not, other than of synthetic fibres | | |
| | ex 5607 90 90 | | |
| 109 | Tarpaulins, sails, awnings and sunblinds | | |
| | 6306 11 006306 12 006306 19 006306 31 006306 39 00 | | |
| 110 | Woven pneumatic mattresses | | |
| | 6306 41 006306 49 00 | | |
| 111 | Camping goods, woven, other than pneumatic mattresses and tents | | |
| | 6306 91 006306 99 00 | | |
| 112 | Other made up textile articles, woven, excluding those of categories 113 and 114 | | |
| | 6307 20 00ex 6307 90 99 | | |
| 113 | Floor cloth, dish cloth and dusters, other than knitted or crocheted | | |
| | 6307 10 90 | | |
| 114 | Woven fabrics and articles for technical uses | | |
| | 5902 10 105902 10 905902 20 105902 20 905902 90 105902 90 905908 00 005909 00 105909 00 905910 00 005911 10 00ex 5911 20 005911 31 115911 31 195911 31 905911 32 105911 32 905911 40 005911 90 105911 90 90 | | |
| GROUP IV |
| 115 | Flax or ramie yarn | | |
| | 5306 10 105306 10 305306 10 505306 10 905306 20 105306 20 905308 90 125308 90 19 | | |
| 117 | Woven fabrics of flax or of ramie | | |
| | 5309 11 105309 11 905309 19 005309 21 105309 21 905309 29 005311 00 105803 90 905905 00 30 | | |
| 118 | Table linen, toilet linen and kitchen linen of flax or ramie, other knitted or crocheted | | |
| | 6302 29 106302 39 206302 52 00ex 630259006302 92 00ex 6302 99 00 | | |
| 120 | Curtains (including drapes), interior blinds, curtain and bed valances and other furnishing articles, not knitted or crocheted, of flax or ramie | | |
| | ex 6303 99 906304 19 30ex 6304 99 00 | | |
| 121 | Twine, cordage, ropes and cables, plaited or not, of flax or ramie | | |
| | ex 5607 90 90 | | |
| 122 | Sacks and bags, of a kind used for the packing of goods, used, of flax, other than knitted or crocheted | | |
| | ex 6305 90 00 | | |
| 123 | Woven pile fabrics and chenille fabrics of flax or ramie, other than narrow woven fabrics | | |
| | 5801 90 10ex 5801 90 90 | | |
| | Shawls, scarves, mufflers, mantillas, veils and the like, of flax or ramie, other than knitted or crocheted | | |
| | 6214 90 90 | | |

Category

Description

Table of equivalence

CN code 2005

pieces/kg

g/piece

(1)

(2)

(3)

(4)

GROUP I A

1

Cotton yarn, not put up for retail sale

5204 11 005204 19 005205 11 005205 12 005205 13 005205 14 005205 15 105205 15 905205 21 005205 22 005205 23 005205 24 005205 26 005205 27 005205 28 005205 31 005205 32 005205 33 005205 34 005205 35 005205 41 005205 42 005205 43 005205 44 005205 46 005205 47 005205 48 005206 11 005206 12 005206 13 005206 14 005206 15 005206 21 005206 22 005206 23 005206 24 005206 25 005206 31 005206 32 005206 33 005206 34 005206 35 005206 41 005206 42 005206 43 005206 44 005206 45 00ex 5604 90 00

2

Woven fabrics of cotton, other than gauze, terry fabrics, pile fabrics, chenille fabrics, tulle and other net fabrics

5208 11 105208 11 905208 12 165208 12 195208 12 965208 12 995208 13 005208 19 005208 21 105208 21 905208 22 165208 22 195208 22 965208 22 995208 23 005208 29 005208 31 005208 32 165208 32 195208 32 965208 32 995208 33 005208 39 005208 41 005208 42 005208 43 005208 49 005208 51 005208 52 105208 52 905208 53 005208 59 005209 11 005209 12 005209 19 005209 21 005209 22 005209 29 005209 31 005209 32 005209 39 005209 41 005209 42 005209 43 005209 49 005209 51 005209 52 005209 59 005210 11 005210 12 005210 19 005210 21 005210 22 005210 29 005210 31 005210 32 005210 39 005210 41 005210 42 005210 49 005210 51 005210 52 005210 59 005211 11 005211 12 005211 19 005211 21 005211 22 005211 29 005211 31 005211 32 005211 39 005211 41 005211 42 005211 43 005211 49 105211 49 905211 51 005211 52 005211 59 005212 11 105212 11 905212 12 105212 12 905212 13 105212 13 905212 14 105212 14 905212 15 105212 15 905212 21 105212 21 905212 22 105212 22 905212 23 105212 23 905212 24 105212 24 905212 25 105212 25 90ex 5811 00 00ex 6308 00 00

2 (a)

Of which: Other than unbleached or bleached

5208 31 005208 32 165208 32 195208 32 965208 32 995208 33 005208 39 005208 41 005208 42 005208 43 005208 49 005208 51 005208 52 105208 52 905208 53 005208 59 005209 31 005209 32 005209 39 005209 41 005209 42 005209 43 005209 49 005209 51 005209 52 005209 59 005210 31 005210 32 005210 39 005210 41 005210 42 005210 49 005210 51 005210 52 005210 59 005211 31 005211 32 005211 39 005211 41 005211 42 005211 43 005211 49 105211 49 905211 51 005211 52 005211 59 005212 13 105212 13 905212 14 105212 14 905212 15 105212 15 905212 23 105212 23 905212 24 105212 24 905212 25 105212 25 90ex 5811 00 00ex 6308 00 00

3

Woven fabrics of synthetic fibres (discontinuous or waste) other than narrow woven fabrics, pile fabrics (including terry fabrics) and chenille fabrics

5512 11 005512 19 105512 19 905512 21 005512 29 105512 29 905512 91 005512 99 105512 99 905513 11 205513 11 905513 12 005513 13 005513 19 005513 21 105513 21 305513 21 905513 22 005513 23 005513 29 005513 31 005513 32 005513 33 005513 39 005513 41 005513 42 005513 43 005513 49 005514 11 005514 12 005514 13 005514 19 005514 21 005514 22 005514 23 005514 29 005514 31 005514 32 005514 33 005514 39 005514 41 005514 42 005514 43 005514 49 005515 11 105515 11 305515 11 905515 12 105515 12 305515 12 905515 13 115515 13 195515 13 915515 13 995515 19 105515 19 305515 19 905515 21 105515 21 305515 21 905515 22 115515 22 195515 22 915515 22 995515 29 005515 91 105515 91 305515 91 905515 92 105515 92 905515 99 105515 99 305515 99 90ex 5803 90 40ex 5905 00 70ex 6308 00 00

3 (a)

Of which: Other than unbleached or bleached

5512 19 105512 19 905512 29 105512 29 905512 99 105512 99 905513 21 105513 21 305513 21 905513 22 005513 23 005513 29 005513 31 005513 32 005513 33 005513 39 005513 41 005513 42 005513 43 005513 49 005514 21 005514 22 005514 23 005514 29 005514 31 005514 32 005514 33 005514 39 005514 41 005514 42 005514 43 005514 49 005515 11 305515 11 905515 12 305515 12 905515 13 195515 13 995515 19 305515 19 905515 21 305515 21 905515 22 195515 22 99ex 5515 29 005515 91 305515 91 90ex 5515 92 10ex 5515 92 905515 99 305515 99 90ex 5803 90 40ex 5905 00 70ex 6308 00 00

GROUP I B

4

Shirts, T-shirts, lightweight fine knit roll, polo or turtle necked jumpers and pullovers (other than of wool or fine animal hair), undervests and the like, knitted or crocheted

6,48

154

6105 10 006105 20 106105 20 906105 90 106109 10 006109 90 106109 90 306110 20 106110 30 10

5

Jerseys, pullovers, slip-overs, waistcoats, twinsets, cardigans, bed-jackets and jumpers (others than jackets and blazers), anoraks, wind-cheaters, waister jackets and the like, knitted or crocheted

4,53

221

6101 10 906101 20 906101 30 906102 10 906102 20 906102 30 906110 11 106110 11 306110 11 906110 12 106110 12 906110 19 106110 20 906110 20 916110 20 996110 30 916110 30 99

6

Men's or boys' woven breeches, shorts other than swimwear and trousers (including slacks); women's or girls' woven trousers and slacks, of wool, of cotton or of man made fibres; lower parts of track suits with lining, others than category 16 or 29, of cotton or of man-made fibres

1,76

568

6203 41 106203 41 906203 42 316203 42 336203 42 356203 42 906203 43 196203 43 906203 49 196203 49 506204 61 106204 62 316204 62 336204 62 396204 63 186204 69 186211 32 426211 33 426211 42 426211 43 42

7

Women's or girls' blouses, shirts and shirt-blouses, whether or not knitted or crocheted, of wool, of cotton or man-made fibres

5,55

180

6106 10 006106 20 006106 90 106206 20 006206 30 006206 40 00

8

Men's or boys' shirts, other than knitted or crocheted, of wool, cotton or man-made fibres

4,60

217

6205 10 006205 20 006205 30 00

GROUP II A

9

Terry towelling and similar woven terry fabrics of cotton; toilet linen and kitchen linen, other than knitted or crocheted, of terry towelling and woven terry fabrics, of cotton

5802 11 005802 19 00ex 6302 60 00

20

Bed linen, other than knitted or crocheted

6302 21 006302 22 906302 29 906302 31 006302 32 906302 39 90

22

Yarn of staple or waste synthetic fibres, not put up for retail sale

5508 10 105509 11 005509 12 005509 21 005509 22 005509 31 005509 32 005509 41 005509 42 005509 51 005509 52 005509 53 005509 59 005509 61 005509 62 005509 69 005509 91 005509 92 005509 99 00

22 (a)

Of which acrylic

ex 5508 10 105509 31 005509 32 005509 61 005509 62 005509 69 00

23

Yarn of staple or waste artificial fibres, not put up for retail sale

5508 20 105510 11 005510 12 005510 20 005510 30 005510 90 00

32

Woven pile fabrics and chenille fabrics (other than terry towelling or terry fabrics of cotton and narrow woven fabrics) and tufted textile surfaces, of wool, of cotton or of man-made textile fibres

5801 10 005801 21 005801 22 005801 23 005801 24 005801 25 005801 26 005801 31 005801 32 005801 33 005801 34 005801 35 005801 36 005802 20 005802 30 00

32 (a)

Of which: Cotton corduroy

5801 22 00

39

Table linen, toilet linen and kitchen linen, other than knitted or crocheted, other than of terry towelling or a similar terry fabrics of cotton

6302 51 006302 53 90ex 6302 59 006302 91 006302 93 90ex 6302 99 00

GROUP II B

12

Panty-hose and tights, stockings, understockings, socks, ankle-socks, sockettes and the like, knitted or crocheted, other than for babies, including stockings for varicose veins, other than products of category 70

24,3 pairs

41

6115 12 006115 19 006115 20 116115 20 906115 91 006115 92 006115 93 106115 93 306115 93 996115 99 00

13

Men's or boys' underpants and briefs, women's or girls' knickers and briefs, knitted or crocheted, of wool, of cotton or of man-made fibres

17

59

6107 11 006107 12 006107 19 006108 21 006108 22 006108 29 00ex 6212 10 10

14

Men's or boys' woven overcoats, raincoats and other coats, cloaks and capes, of wool, of cotton or of man-made textile fibres (other than parkas) (of category 21)

0,72

1 389

6201 11 00ex 6201 12 10ex 6201 12 90ex 6201 13 10ex 6201 13 906210 20 00

15

Women's or girls' woven overcoats, raincoats and other coats, cloaks and capes; jackets and blazers, of wool, of cotton or of man-made textile fibres (other than parkas) (of category 21)

0,84

1 190

6202 11 00ex 6202 12 10ex 6202 12 90ex 6202 13 10ex 6202 13 906204 31 006204 32 906204 33 906204 39 196210 30 00

16

Men's or boys' suits and ensembles, other than knitted or crocheted, of wool, of cotton or of man-made fibres, excluding ski suits; men's or boys' track suits with lining, with an outer shell of a single identical fabric, of cotton or of man-made fibres

0,80

1 250

6203 11 006203 12 006203 19 106203 19 306203 21 006203 22 806203 23 806203 29 186211 32 316211 33 31

17

Men's or boys' jackets or blazers, other than knitted or crocheted, of wool, of cotton or of man-made fibres

1,43

700

6203 31 006203 32 906203 33 906203 39 19

18

Men's or boys' singlets and other vests, underpants, briefs, nightshirts, pyjamas, bathrobes, dressing gowns and similar articles, other than knitted or crocheted

6207 11 006207 19 006207 21 006207 22 006207 29 006207 91 006207 92 006207 99 00

Women's or girls' singlets and other vests, slips, petticoats, briefs, panties, night-dresses, pyjamas, négligees, bathrobes, dressing gowns and similar articles, other than knitted or crocheted

6208 11 006208 19 006208 21 006208 22 006208 29 006208 91 006208 92 006208 99 00ex 6212 10 10

19

Handkerchiefs, other than knitted or crocheted

59

17

6213 20 006213 90 00

21

Parkas; anoraks, windcheaters, waister jackets and the like, other than knitted or crocheted, of wool, of cotton or of man-made fibres; upper parts of tracksuits with lining, other than category 16 or 29, of cotton or of man-made fibres

2,3

435

ex 6201 12 10ex 6201 12 90ex 6201 13 10ex 6201 13 906201 91 006201 92 006201 93 00ex 6202 12 10ex 6202 12 90ex 6202 13 10ex 6202 13 906202 91 006202 92 006202 93 006211 32 416211 33 416211 42 416211 43 41

24

Men's or boys' nightshirts, pyjamas, bathrobes, dressing gowns and similar articles, knitted or crocheted

3,9

257

6107 21 006107 22 006107 29 006107 91 006107 92 00ex 6107 99 00

Women's or girls' night-dresses, pyjamas, négligees, bathrobes, dressing gowns and similar articles, knitted or crocheted

6108 31 006108 32 006108 39 006108 91 006108 92 00ex 6108 99 00

26

Women's or girls' dresses, of wool, of cotton or of man-made fibres

3,1

323

6104 41 006104 42 006104 43 006104 44 006204 41 006204 42 006204 43 006204 44 00

27

Women's or girls' skirts, including divided skirts

2,6

385

6104 51 006104 52 006104 53 006104 59 006204 51 006204 52 006204 53 006204 59 10

28

Trousers, bib and brace overalls, breeches and shorts (other than swimwear), knitted or crocheted, of wool, of cotton or of man-made fibres

1,61

620

6103 41 006103 42 006103 43 00ex 6103 49 0061046100610462006104 63 00ex 6104 69 00

29

Women's or girls' suits and ensembles, other than knitted or crocheted, of wool, of cotton or of man-made fibres, excluding ski suits; women's or girls' track suits with lining, with an outer shell of an identical fabric, of cotton or of man-made fibres

1,37

730

6204 11 006204 12 006204 13 006204 19 106204 21 006204 22 806204 23 806204 29 186211 42 316211 43 31

31

Brassières, woven, knitted or crocheted

18,2

55

ex 6212 10 106212 10 90

68

Babies' garments and clothing accessories, excluding babies' gloves, mittens and mitts of categories 10 and 87, and babies' stockings, socks and sockettes, other than knitted or crocheted, of category 88

6111 10 906111 20 906111 30 90ex 6111 90 00ex 6209 10 00ex 6209 20 00ex 6209 30 00ex 6209 90 00

73

Track suits of knitted or crocheted fabric, of wool, of cotton or of man-made textile fibres

1,67

600

6112 11 006112 12 006112 19 00

76

Men's or boys' industrial or occupational clothing, other than knitted or crocheted

6203 22 106203 23 106203 29 116203 32 106203 33 106203 39 116203 42 116203 42 516203 43 116203 43 316203 49 116203 49 316211 32 106211 33 10

Women's or girls' aprons, smock overalls and other industrial or occupational clothing, other than knitted or crocheted

6204 22 106204 23 106204 29 116204 32 106204 33 106204 39 116204 62 116204 62 516204 63 116204 63 316204 69 116204 69 316211 42 106211 43 10

77

Ski suits, other than knitted or crocheted

ex 6211 20 00

78

Garments, other than knitted or crocheted, excluding garments of categories 6, 7, 8, 14, 15, 16, 17, 18, 21, 26, 27, 29, 68, 72, 76 and 77

6203 41 306203 42 596203 43 396203 49 396204 61 856204 62 596204 62 906204 63 396204 63 906204 69 396204 69 506210 40 006210 50 006211 31 006211 32 906211 33 906211 41 006211 42 906211 43 90

83

Overcoats, jackets, blazers and other garments, including ski suits, knitted or crocheted, excluding garments of categories 4, 5, 7, 13, 24, 26, 27, 28, 68, 69, 72, 73, 74, 75

6101 10 106101 20 106101 30 106102 10 106102 20 106102 30 106103 31 006103 32 006103 33 00ex 6103 39 006104 31 006104 32 006104 33 00ex 6104 39 006112 20 006113 00 906114 10 006114 20 006114 30 00

GROUP III A

33

Woven fabrics of synthetic filament yarn obtained from strip or the like of polyethylene or polypropylene, less than 3 m wide

5407 20 11

Sacks and bags, of a kind used for the packing of goods, not knitted or crocheted, obtained from strip or the like

6305 32 816305 32 896305 33 916305 33 99

34

Woven fabrics of synthetic filament yarn obtained from strip or the like of polyethylene or polypropylene, 3 m or more wide

5407 20 19

35

Woven fabrics of synthetic fibres (continuous), other than those for tyres of category 114

5407 10 005407 20 905407 30 005407 41 005407 42 005407 43 005407 44 005407 51 005407 52 005407 53 005407 54 005407 61 105407 61 305407 61 505407 61 905407 69 105407 69 905407 71 005407 72 005407 73 005407 74 005407 81 005407 82 005407 83 005407 84 005407 91 005407 92 005407 93 005407 94 00ex 5811 00 00ex 5905 00 70

35 (a)

Of which: Other than unbleached or bleached

ex 5407 10 00ex 5407 20 90ex 5407 30 005407 42 005407 43 005407 44 005407 52 005407 53 00540754005407 61 305407 61 505407 61 905407 69 905407 72 005407 73 005407 74 005407 82 005407 83 005407 84 005407 92 005407 93 005407 94 00ex 5811 00 00ex 5905 00 70

36

Woven fabrics of continuous artificial fibres, other than those for tyres of category 114

5408 10 005408 21 005408 22 105408 22 905408 23 105408 23 905408 24 005408 31 005408 32 005408 33 005408 34 00ex 5811 00 00ex 5905 00 70

36 (a)

Of which: Other than unbleached or bleached

ex 5408 10 005408 22 105408 22 905408 23 105408 23 905408 24 005408 32 005408 33 005408 34 00ex 5811 00 00ex 5905 00 70

37

Woven fabrics of artificial staple fibres

5516 11 005516 12 005516 13 005516 14 005516 21 005516 22 005516 23 105516 23 905516 24 005516 31 005516 32 005516 33 005516 34 005516 41 005516 42 005516 43 005516 44 005516 91 005516 92 005516 93 005516 94 00ex 5803 90 40ex 5905 00 70

37 (a)

Of which: Other than unbleached or bleached

5516 12 005516 13 005516 14 005516 22 005516 23 105516 23 905516 24 005516 32 005516 33 005516 34 005516 42 005516 43 005516 44 005516 92 005516 93 005516 94 00ex 5803 90 40ex 5905 00 70

38 A

Knitted or crocheted synthetic curtain fabric including net curtain fabric

6005 31 106005 32 106005 33 106005 34 106006 31 106006 32 106006 33 106006 34 10

38 B

Net curtains, other than knitted or crocheted

ex 6303 91 00ex 6303 92 90ex 6303 99 90

40

Woven curtains (including drapes, interior blinds, curtain and bed valances and other furnishing articles), other than knitted or crocheted, of wool, of cotton or of man-made fibres

ex 6303 91 00ex 6303 92 90ex 6303 99 906304 19 10ex 6304 19 906304 92 00ex 6304 93 00ex 6304 99 00

41

Yarn of synthetic filament (continuous), not put up for retail sale, other than non textured single yarn untwisted or with a twist of not more than 50 turns/m

5401 10 125401 10 145401 10 165401 10 185402 10 105402 10 905402 20 005402 31 005402 32 005402 33 005402 39 105402 39 905402 49 105402 49 915402 49 995402 51 005402 52 005402 59 105402 59 905402 61 005402 62 005402 69 105402 69 90ex 5604 20 00ex 5604 90 00

42

Yarn of continuous man-made fibres, not put up for retail sale

5401 20 10

Yarn of artificial fibres; yarn of artificial filaments, not put up for retail sale, other than single yarn of viscose rayon untwisted or with a twist of not more than 250 turns/m and single non textured yarn of cellulose acetate

5403 10 005403 20 00ex 5403 32 00ex 5403 33 005403 39 005403 41 005403 42 005403 49 00ex 5604 20 00

43

Yarn of man-made filament, yarn of artificial staple fibres, cotton yarn, put up for retail sale

5204 20 005207 10 005207 90 005401 10 905401 20 905406 10 005406 20 005508 20 905511 30 00

46

Carded or combed sheep's or lambs' wool or other fine animal hair

5105 10 005105 21 005105 29 005105 31 005105 39 105105 39 90

47

Yarn of carded sheep's or lambs' wool (woollen yarn) or of carded fine animal hair, not put up for retail sale

5106 10 105106 10 905106 20 105106 20 915106 20 995108 10 105108 10 90

48

Yarn of combed sheep's or lambs' wool (worsted yarn) or of combed fine animal hair, not put up for retail sale

5107 10 105107 10 905107 20 105107 20 305107 20 515107 20 595107 20 915107 20 995108 20 105108 20 90

49

Yarn of sheep's or lambs' wool or of combed fine animal hair, put up for retail sale

5109 10 105109 10 905109 90 105109 90 90

50

Woven fabrics of sheep's or lambs' wool or of fine animal hair

5111 11 005111 19 105111 19 905111 20 005111 30 105111 30 305111 30 905111 90 105111 90 915111 90 935111 90 995112 11 005112 19 105112 19 905112 20 005112 30 105112 30 305112 30 905112 90 105112 90 915112 90 935112 90 99

51

Cotton, carded or combed

5203 00 00

53

Cotton gauze

5803 10 00

54

Artificial staple fibres, including waste, carded, combed or otherwise processed for spinning

5507 00 00

55

Synthetic staple fibres, including waste, carded, combed or otherwise processed for spinning

5506 10 005506 20 005506 30 005506 90 105506 90 90

56

Yarn of synthetic staple fibres (including waste), put up for retail sale

5508 10 905511 10 005511 20 00

58

Carpets, carpentines and rugs, knotted (made up or not)

5701 10 105701 10 905701 90 105701 90 90

59

Carpets and other textile floor coverings, other than the carpets of category 58

5702 10 005702 31 105702 31 805702 32 105702 32 90ex 5702 39 005702 41 005702 42 00ex 5702 49 005702 51 005702 52 105702 52 90ex 5702 59 005702 91 005702 92 105702 92 90ex 5702 99 005703 10 005703 20 115703 20 195703 20 915703 20 995703 30 115703 30 195703 30 815703 30 895703 90 105703 90 905704 10 005704 90 005705 00 105705 00 30ex 5705 00 90

60

Tapestries, hand-made, of the type Gobelins, Flanders, Aubusson, Beauvais and the like, and needlework tapestries (e.g. petit point and cross stitch) made in panels and the like by hand

5805 00 00

61

Narrow woven fabrics, and narrow fabrics (bolduc) consisting of warp without weft, assembled by means of an adhesive, other than labels and similar articles of category 62

Elastic fabrics and trimmings (not knitted or crocheted), made from textile materials assembled from rubber thread

ex 5806 10 005806 20 005806 31 005806 32 105806 32 905806 39 005806 40 00

62

Chenille yarn (including flock chenille yarn), gimped yarn (other than metallised yarn and gimped horsehair yarn)

5606 00 915606 00 99

Tulle and other net fabrics but not including woven, knitted or crocheted fabrics, hand or mechanically-made lace, in the piece, in strips or in motifs

5804 10 115804 10 195804 10 905804 21 105804 21 905804 29 105804 29 905804 30 00

Labels, badges and the like of textile materials, not embroidered, in the piece, in strips or cut to shape or size, woven

5807 10 105807 10 90

Braids and ornamental trimmings in the piece; tassels, pompons and the like

5808 10 005808 90 00

Embroidery, in the piece, in strips or in motifs

5810 10 105810 10 905810 91 105810 91 905810 92 105810 92 905810 99 105810 99 90

63

Knitted or crocheted fabric of synthetic fibres containing by weight 5 % or more elastomeric yarn and knitted or crocheted fabrics containing by weight 5 % or more of rubber thread

5906 91 00ex 6002 40 006002 90 00ex 6004 10 006004 90 00

Raschel lace and long-pile fabric of synthetic fibres

ex 6001 10 006003 30 106005 31 506005 32 506005 33 506005 34 50

65

Knitted or crocheted fabric, other than those of categories 38 A and 63, of wool, of cotton or of man-made fibres

5606 00 10ex 6001 10 006001 21 006001 22 00ex 6001 29 006001 91 006001 92 00ex 6001 99 00ex 6002 40 006003 10 006003 20 006003 30 906003 40 00ex 6004 10 006005 10 006005 21 006005 22 006005 23 006005 24 006005 31 906005 32 906005 33 906005 34 906005 41 006005 42 006005 43 006005 44 006006 10 006006 21 006006 22 006006 23 006006 24 006006 31 906006 32 906006 33 906006 34 906006 41 006006 42 006006 43 006006 44 00

66

Travelling rugs and blankets, other than knitted or crocheted, of wool, of cotton or of man-made fibres

6301 10 006301 20 906301 30 90ex 6301 40 90ex 6301 90 90

GROUP III B

10

Gloves, mittens and mitts, knitted or crocheted

17

59

6111 10 106111 20 106111 30 10ex 6111 90 006116 10 206116 10 806116 91 006116 92 006116 93 006116 99 00

pairs

67

Knitted or crocheted clothing accessories other than for babies; household linen of all kinds, knitted or crocheted; curtains (including drapes) and interior blinds, curtain or bed valances and other furnishing articles knitted or crocheted; knitted or crocheted blankets and travelling rugs, other knitted or crocheted articles including parts of garments or of clothing accessories

5807 90 906113 00 106117 10 006117 20 006117 80 106117 80 906117 90 006301 20 106301 30 106301 40 106301 90 106302 10 006302 40 00ex 6302 60 006303 11 006303 12 006303 19 006304 11 006304 91 00ex 6305 20 006305 32 11ex 6305 32 906305 33 10ex 6305 39 00ex 6305 90 006307 10 106307 90 10

67 (a)

Of which: Sacks and bags of a kind used for the packing of goods, made from polyethylene or polypropylene strip

6305 32 116305 33 10

69

Women's and girls' slips and petticoats, knitted or crocheted

7,8

128

6108 11 006108 19 00

70

Panty-hose and tights of synthetic fibres, measuring per single yarn less than 67 decitex (6,7 tex)

30,4 pairs

33

6115 11 006115 20 19

Women's full length hosiery of synthetic fibres

6115 93 91

72

Swimwear, of wool, of cotton or of man-made fibres

9,7

103

6112 31 106112 31 906112 39 106112 39 906112 41 106112 41 906112 49 106112 49 906211 11 006211 12 00

74

Women's or girls' knitted or crocheted suits and ensembles, of wool, of cotton or of man-made fibres, excluding ski suits

1,54

650

6104 11 006104 12 006104 13 00ex 6104 19 006104 21 006104 22 006104 23 00ex 6104 29 00

75

Men's or boys' knitted or crocheted suits and ensembles, of wool, of cotton or of man-made fibres, excluding ski suit

0,80

1 250

6103 11 006103 12 006103 19 006103 21 006103 22 006103 23 006103 29 00

84

Shawls, scarves, mufflers, mantillas, veils and the like other than knitted or crocheted, of wool, of cotton or of man-made fibres

6214 20 006214 30 006214 40 006214 90 10

85

Ties, bow ties and cravats other than knitted or crocheted, of wool, of cotton or of man-made fibres

17,9

56

6215 20 006215 90 00

86

Corsets, corset-belts, suspender belts, braces, suspenders, garters and the like, and parts thereof, whether or not knitted or crocheted

8,8

114

6212 20 006212 30 006212 90 00

87

Gloves, mittens and mitts, not knitted or crocheted

ex 6209 10 00ex 6209 20 00ex 6209 30 00ex 6209 90 006216 00 00

88

Stockings, socks and sockettes, not knitted or crocheted; other clothing accessories, parts of garments or of clothing accessories other than for babies, other than knitted or crocheted

ex 6209 10 00ex 6209 20 00ex 6209 30 00ex 6209 90 006217 10 006217 90 00

90

Twine, cordage, ropes and cables of synthetic fibres, plaited or not

5607 41 005607 49 115607 49 195607 49 905607 50 115607 50 195607 50 305607 50 90

91

Tents

6306 21 006306 22 006306 29 00

93

Sacks and bags, of a kind used for the packing of goods of woven fabrics, other than made from polyethylene or polypropylene strip

ex 6305 20 00ex 6305 32 90ex 6305 39 00

94

Wadding of textile materials and articles thereof; textile fibres, not exceeding 5 mm in length (flock), textile dust and mill neps

5601 10 105601 10 905601 21 105601 21 905601 22 105601 22 915601 22 995601 29 005601 30 00

95

Felt and articles thereof, whether or not impregnated or coated, other than floor coverings

5602 10 195602 10 315602 10 395602 10 905602 21 00ex 5602 29 005602 90 00ex 5807 90 10ex 5905 00 706210 10 106307 90 91

96

Non-woven fabrics and articles of such fabrics, whether or not impregnated, coated, covered or laminated

5603 11 105603 11 905603 12 105603 12 905603 13 105603 13 905603 14 105603 14 905603 91 105603 91 905603 92 105603 92 905603 93 105603 93 905603 94 105603 94 90ex 5807 90 10ex 5905 00 706210 10 90ex 6301 40 90ex 6301 90 906302 22 106302 32 106302 53 106302 93 106303 92 106303 99 10ex 6304 19 90ex 6304 93 00ex 6304 99 00ex 6305 32 90ex 6305 39 006307 10 30ex 6307 90 99

97

Nets and netting made of twine, cordage or rope and made up fishing nets of yarn, twine, cordage or rope

5608 11 115608 11 195608 11 915608 11 995608 19 115608 19 195608 19 305608 19 905608 90 00

98

Other articles made from yarn, twine, cordage, cables or rope, other than textile fabrics, articles made from such fabrics and articles of category 97

5609 00 005905 00 10

99

Textile fabrics coated with gum or amylaceous substances, of a kind used for the outer covers of books and the like; tracing cloth; prepared painting canvas; buckram and similar stiffened textile fabrics of a kind used for hat foundations

5901 10 005901 90 00

Linoleum, whether or not cut to shape; floor coverings consisting of a coating or covering applied on a textile backing, whether or not cut to shape

5904 10 005904 90 00

Rubberised textile fabric, not knitted or crocheted, excluding those for tyres

5906 10 005906 99 105906 99 90

Textile fabrics otherwise impregnated or coated; painted canvas being theatrical scenery, studio back-cloths, other than of category 100

5907 00 105907 00 90

100

Textile fabrics impregnated, coated, covered or laminated with preparations of cellulose derivatives or of other artificial plastic materials

5903 10 105903 10 905903 20 105903 20 905903 90 105903 90 915903 90 99

101

Twine, cordage, ropes and cables, plaited or not, other than of synthetic fibres

ex 5607 90 90

109

Tarpaulins, sails, awnings and sunblinds

6306 11 006306 12 006306 19 006306 31 006306 39 00

110

Woven pneumatic mattresses

6306 41 006306 49 00

111

Camping goods, woven, other than pneumatic mattresses and tents

6306 91 006306 99 00

112

Other made up textile articles, woven, excluding those of categories 113 and 114

6307 20 00ex 6307 90 99

113

Floor cloth, dish cloth and dusters, other than knitted or crocheted

6307 10 90

114

Woven fabrics and articles for technical uses

5902 10 105902 10 905902 20 105902 20 905902 90 105902 90 905908 00 005909 00 105909 00 905910 00 005911 10 00ex 5911 20 005911 31 115911 31 195911 31 905911 32 105911 32 905911 40 005911 90 105911 90 90

GROUP IV

115

Flax or ramie yarn

5306 10 105306 10 305306 10 505306 10 905306 20 105306 20 905308 90 125308 90 19

117

Woven fabrics of flax or of ramie

5309 11 105309 11 905309 19 005309 21 105309 21 905309 29 005311 00 105803 90 905905 00 30

118

Table linen, toilet linen and kitchen linen of flax or ramie, other knitted or crocheted

6302 29 106302 39 206302 52 00ex 630259006302 92 00ex 6302 99 00

120

Curtains (including drapes), interior blinds, curtain and bed valances and other furnishing articles, not knitted or crocheted, of flax or ramie

ex 6303 99 906304 19 30ex 6304 99 00

121

Twine, cordage, ropes and cables, plaited or not, of flax or ramie

ex 5607 90 90

122

Sacks and bags, of a kind used for the packing of goods, used, of flax, other than knitted or crocheted

ex 6305 90 00

123

Woven pile fabrics and chenille fabrics of flax or ramie, other than narrow woven fabrics

5801 90 10ex 5801 90 90

Shawls, scarves, mufflers, mantillas, veils and the like, of flax or ramie, other than knitted or crocheted

6214 90 90

ANNEX II

TARIFFS DISMANTLING SCHEDULE

| DISMANTLING TABLE |
| --- |
| | Tariffs (2004) | 2005 | 2006 | 2007 | 2008 and subsequent years |
| Raw materials | 0 | 0 | 0 | 0 | 0 |
| 1 | 0,5 | 0 | 0 | 0 |
| 10 | 7 | 5 | 3 | 0 |
| Yarn/fibres | 0 | 0 | 0 | 0 | 0 |
| 1 | 1 | 1 | 1 | 0 |
| 5 | 4 | 4 | 3 | 0 |
| 10 | 7 | 5 | 2 | 0 |
| Fabrics | 1 | 1 | 1 | 1 | 0 |
| 5 | 4 | 4 | 2 | 0 |
| 10 | 7 | 5 | 2 | 0 |
| 15 | 12 | 9 | 5 | 0 |
| Apparel | 5 | 5 | 4 | 3 | 0 |
| 10 | 7 | 5 | 2 | 0 |
| 18 | 14 | 10 | 7 | 0 |
| 22 | 16 | 12 | 8 | 0 |

DISMANTLING TABLE

Tariffs (2004)

2005

2006

2007

2008 and subsequent years

Raw materials

0

0

0

0

0

1

0,5

0

0

0

10

7

5

3

0

Yarn/fibres

0

0

0

0

0

1

1

1

1

0

5

4

4

3

0

10

7

5

2

0

Fabrics

1

1

1

1

0

5

4

4

2

0

10

7

5

2

0

15

12

9

5

0

Apparel

5

5

4

3

0

10

7

5

2

0

18

14

10

7

0

22

16

12

8

0

ANNEX III

AGREED MINUTE ON MARKET ACCESS

The Parties recorded their understanding that non-tariff barriers related to all forms of hindrance to trade in the sector are not to be applied by either of the Parties. The Parties agree these non-tariff barriers include but are not limited to matters such as:

| — | any additional customs duties on the import or sale of products of Community or Serbian origin in excess of those set out in this Agreement, or any fees and charges in connection with importation or exportation in excess of the approximate cost of services rendered, |
| --- | --- |

—

any additional customs duties on the import or sale of products of Community or Serbian origin in excess of those set out in this Agreement, or any fees and charges in connection with importation or exportation in excess of the approximate cost of services rendered,

| — | any taxes which are higher than any such taxes imposed on the production or sale of equivalent domestic goods, |
| --- | --- |

—

any taxes which are higher than any such taxes imposed on the production or sale of equivalent domestic goods,

| — | technical regulations or standards, or conformity assessment or certification rules, procedures or practices going beyond the purposes for which they are required, |
| --- | --- |

—

technical regulations or standards, or conformity assessment or certification rules, procedures or practices going beyond the purposes for which they are required,

| — | any further barriers and controls within the territory of each Party hampering the free movement of goods after customs clearance and their release into free circulation, |
| --- | --- |

—

any further barriers and controls within the territory of each Party hampering the free movement of goods after customs clearance and their release into free circulation,

| — | any indicative values resulting in effective application of minimum prices or arbitrary and fictitious prices or any customs valuation rules, procedures or practices giving rise to barriers to trade, |
| --- | --- |

—

any indicative values resulting in effective application of minimum prices or arbitrary and fictitious prices or any customs valuation rules, procedures or practices giving rise to barriers to trade,

| — | rules, procedures or practices for pre-shipment inspection that are discriminatory, non-transparent, excessively lengthy or burdensome, and the imposition of customs controls for the clearance of goods to shipments that have already been subject of pre-shipment inspection, |
| --- | --- |

—

rules, procedures or practices for pre-shipment inspection that are discriminatory, non-transparent, excessively lengthy or burdensome, and the imposition of customs controls for the clearance of goods to shipments that have already been subject of pre-shipment inspection,

| — | excessively burdensome, costly or arbitrary rules, procedures or practices concerning the certification of the origin of products or requiring direct shipment of goods from the country of origin to the country of destination, |
| --- | --- |

—

excessively burdensome, costly or arbitrary rules, procedures or practices concerning the certification of the origin of products or requiring direct shipment of goods from the country of origin to the country of destination,

| — | any non-automatic, discretionary or other licensing requirements, rules, procedures or practices imposing disproportionate burdens or having restrictive effects on imports. In particular application for automatic licenses submitted in an appropriate and complete form should be approved immediately on receipt, to the extent administratively feasible, but within a maximum of 10 working days, |
| --- | --- |

—

any non-automatic, discretionary or other licensing requirements, rules, procedures or practices imposing disproportionate burdens or having restrictive effects on imports. In particular application for automatic licenses submitted in an appropriate and complete form should be approved immediately on receipt, to the extent administratively feasible, but within a maximum of 10 working days,

| — | requirements or practices concerning marking, labelling, the description of composition of the product or the description of the manufacturing of products which, either in their formulation or in their application, are in any form discriminatory as compared with domestic products and no more trade restrictive than necessary to fulfil a legitimate objective, |
| --- | --- |

—

requirements or practices concerning marking, labelling, the description of composition of the product or the description of the manufacturing of products which, either in their formulation or in their application, are in any form discriminatory as compared with domestic products and no more trade restrictive than necessary to fulfil a legitimate objective,

| — | unduly long customs clearance delays or excessively burdensome, non-transparent or costly customs procedures, including inspection requirements, which have an unnecessary restrictive effect on imports, |
| --- | --- |

—

unduly long customs clearance delays or excessively burdensome, non-transparent or costly customs procedures, including inspection requirements, which have an unnecessary restrictive effect on imports,

| — | subsidies causing injury to the textiles and clothing industry of the other Party. |
| --- | --- |

—

subsidies causing injury to the textiles and clothing industry of the other Party.

In order to facilitate legitimate trade, notwithstanding the need of effective control, the Parties undertake to:

| — | cooperate and exchange information on all issues concerning customs legislation and procedures, and in particular to deal promptly with problems faced by operators arising from measures covered by this Agreement, |
| --- | --- |

—

cooperate and exchange information on all issues concerning customs legislation and procedures, and in particular to deal promptly with problems faced by operators arising from measures covered by this Agreement,

| — | provide effective, non-discriminatory and prompt procedures enabling the right of appeal against customs and other agency administrative actions, ruling and decisions affecting import or export of goods, |
| --- | --- |

—

provide effective, non-discriminatory and prompt procedures enabling the right of appeal against customs and other agency administrative actions, ruling and decisions affecting import or export of goods,

| — | establish an appropriate consultation mechanism between customs administrations and traders on customs regulations and procedures, |
| --- | --- |

—

establish an appropriate consultation mechanism between customs administrations and traders on customs regulations and procedures,

| — | publish, as far as possible through electronic means, and publicise new legislation and general procedures related to customs, as well as any modification, no later than the entry into force of any such legislation and procedures, |
| --- | --- |

—

publish, as far as possible through electronic means, and publicise new legislation and general procedures related to customs, as well as any modification, no later than the entry into force of any such legislation and procedures,

| — | cooperate with a view to reaching a common approach to issues relating to customs valuation, in particular the elaboration of a ‘code of good practices’ in relation to working methods and operational aspects, the use of indicative or reference indices, appropriate documentation to certify the accuracy of the customs value and the use of securities. The Parties agree to open negotiations on the ‘code of good practices’ upon application of this Agreement and to conclude them as soon as possible. |
| --- | --- |

—

cooperate with a view to reaching a common approach to issues relating to customs valuation, in particular the elaboration of a ‘code of good practices’ in relation to working methods and operational aspects, the use of indicative or reference indices, appropriate documentation to certify the accuracy of the customs value and the use of securities. The Parties agree to open negotiations on the ‘code of good practices’ upon application of this Agreement and to conclude them as soon as possible.

ANNEX IV

Products subject to the suspension of the quantitative restrictions as referred to in Article 4(1) of this Agreement.

(The full product descriptions of the categories listed in this Annex are to be found in Annex I).

Categories:

1

2

2a

3

5

6

7

8

9

15

16

67

ANNEX V

TITLE I

CLASSIFICATION

Article 1

1.   The competent authorities of the Community undertake to inform Serbia of any changes in the Combined Nomenclature (CN) before the date of their entry into force in the Community.

2.   The competent authorities of the Community undertake to inform the competent authorities of Serbia of any decisions relating to the classification of products subject to the present Agreement, within one month of their adoption at the latest. Such communication shall include:

| (a) | a description of the products concerned; |
| --- | --- |

(a)

a description of the products concerned;

| (b) | the relevant category and the related CN codes; |
| --- | --- |

(b)

the relevant category and the related CN codes;

| (c) | the reasons which have led to the decision. |
| --- | --- |

(c)

the reasons which have led to the decision.

3.   Where a decision on classification results in a change of classification practice or a change of category of any product subject to this Agreement, the competent authorities of the Community shall provide 30 days' notice, from the date of the Community's communication, before the decision is put into effect.

Products shipped before the date of entry into effect of the decision shall remain subject to the earlier classification practice, provided that the goods in question are presented for importation into the Community within 60 days of that date.

4.   Where a Community decision on classification resulting in a change of classification practice or a change of categorisation of any product subject to this Agreement affects a category subject to quantitative restrictions, the Parties agree to enter into consultation in accordance with the procedures described in Article 8 of this Agreement with a view to honouring the obligation under the third subparagraph of Article 9(1) of this Agreement.

5.   In case of divergent opinions between Serbia and the competent Community authorities at the point of entry into the Community on the classification of products covered by this Agreement, classification shall provisionally be based on indications provided by the Community, pending consultations in accordance with Article 8 of this Agreement with a view to reaching agreement on definitive classification of the product concerned.

TITLE II

ORIGIN

Article 2

1.   Products originating in Serbia for export to the Community in accordance with the arrangements set out in this Agreement shall be accompanied by a certificate of origin issued by the Customs Administration of Serbia conforming to the model annexed to this Annex.

2.   The certificate of origin shall be certified by the Customs Administration of Serbia, if the products in question can be considered products originating in Serbia within the meaning of the relevant rules in force in the Community.

3.   However, the products in Group III may be imported into the Community in accordance with the arrangements established by this Agreement on production of a declaration by the exporter on the invoice or other commercial document relating to the products to the effect that the products in question originate in Serbia within the meaning of the relevant rules in force in the Community.

4.   The certificate of origin referred to in paragraph 1 shall not be required for imports of goods covered by a movement certificate EUR. 1 issued in accordance with the relevant provisions of the autonomous tariff regime granted to Serbia by the Community.

Article 3

The certificate of origin shall be issued only on application having been made in writing by the exporter or, under the exporter's responsibility, by his authorised representative. The Customs Administration of Serbia shall ensure that the certificate of origin is properly completed and for this purpose they shall call for any necessary documentary evidence or carry out any check which they consider appropriate.

Article 4

Where different criteria for determining origin are laid down for products falling within the same category, the certificates or declarations of origin must contain a sufficiently detailed description of the goods on the basis of which the certificate was issued or the declaration drawn up.

Article 5

The discovery of slight discrepancies between the statements made in the certificate of origin and those made in the documents produced to the Customs Administration of Serbia for the purpose of carrying out the formalities for importing the products shall not, ipso facto, cast doubt upon the statements in the certificate.

TITLE III

DOUBLE-CHECKING SYSTEM

SECTION I

Exportation

Article 6

The Ministry of International Economic Relations of Serbia shall issue an export licence in respect of all consignments from Serbia of textile products subject to any definitive or provisional quantitative restrictions established under this Agreement, up to the relevant quantitative restrictions as may be modified by this Agreement, as well as of all consignments of textile products subject to a double-checking system without quantitative restrictions as provided for in it.

Article 7

1.   For products subject to quantitative restrictions under this Agreement the export licence shall conform to the Model 1 annexed to this Annex and it shall be valid for exports throughout the customs territory to which the Treaty establishing the European Community applies.

2.   Where quantitative restrictions have been introduced pursuant to this Agreement, each export licence must certify, inter alia, that the quantity of the product in question has been set off against the quantitative restriction established for the category of the products concerned and shall only cover one category of products subject to quantitative restrictions. It may be used for one or more consignments of the products in question.

3.   For products subject to a double-checking system without quantitative restrictions the export licence shall conform to the Model 2 annexed to this Annex. It shall only cover one category of products and may be used for one or more consignments of the products in question.

Article 8

The competent authorities of the Community must be informed immediately of the withdrawal or modification of any export licence already issued.

Article 9

1.   Exports of textile products subject to quantitative restrictions pursuant this Agreement shall be set off against the quantitative restrictions established for the year in which the shipment of the goods has been effected even if the export licence is issued after such shipment.

2.   For the purpose of applying paragraph 1, shipment of goods is considered to have taken place on the date of their loading onto the exporting aircraft, vehicle or vessel.

Article 10

The presentation of an export licence, in application of Article 12 of this Annex, shall be effected not later than 31 March of the year following that in which the goods covered by the licence have been shipped.

SECTION II

Importation

Article 11

Importation into the Community of textile products subject to quantitative restrictions or to a double-checking system pursuant to this Agreement shall be subject to the presentation of an import authorisation.

Article 12

1.   The competent authorities of the Community shall issue the import authorisation referred to in Article 11 of this Annex, within five working days of the presentation by the importer of the original of the corresponding export licence.

2.   The import authorisations concerning products subject to quantitative restrictions under this Agreement shall be valid for six months from the date of their issue for imports throughout the customs territory to which the Treaty establishing the European Community is applicable.

3.   The import authorisations for products subject to a double-checking system without quantitative restrictions shall be valid for six months from the date of issue for imports throughout the customs territory to which the Treaty establishing the European Community is applicable.

4.   The competent authorities of the Community shall cancel the import authorisation already issued whenever the corresponding export licence has been withdrawn.

However, if the competent authorities of the Community are notified of the withdrawal or the cancellation of the export licence only after the importation of the products into the Community, the relevant quantities shall be set off against the quantitative restrictions established for the category and the quota year concerned.

Article 13

1.   If the competent authorities of the Community find that the total quantities covered by export licences issued by the Ministry of International Economic Relations of Serbia for a particular category in any year exceed the quantitative restriction that may be established in accordance with the provisions of this Agreement for that category, as may be modified by the relevant provisions thereof, the said authorities may suspend the further issue of import authorisations. In this event, the competent authorities of the Community shall immediately inform the Ministry for International Economic Relations of Serbia and the special consultation procedure set out in Article 8 of this Agreement shall be initiated forthwith.

2.   Exports of products of Serbian origin subject to quantitative restrictions or double-checking system and not covered by export licences of Serbia issued in accordance with the provisions of this Annex may be refused an import authorisation by the competent Community authorities.

However, without prejudice to Article 6 of this Agreement, if the import of such products is allowed into the Community by the competent authorities of the Community, the quantities involved shall not be set off against the appropriate quantitative restrictions established pursuant to this Agreement, without the express agreement of the Ministry for International Economic Relations of Serbia.

TITLE IV

FORM AND PRODUCTION OF EXPORT CERTIFICATES AND CERTIFICATES OF ORIGIN, AND COMMON PROVISIONS CONCERNING EXPORTS TO THE COMMUNITY

Article 14

1.   The export licence and the certificate of origin may comprise additional copies duly indicated as such. They shall be made out in English or French. If they are completed by hand, entries must be in ink and in printed script.

These documents shall measure 210 x 297 mm. The paper used shall be white writing paper, sized, not containing mechanical pulp, and weighing not less than 25 g/m2. If the documents have several copies only the top copy, which is the original, shall be printed with the guilloche pattern background. This copy shall be clearly marked as ‘original’ and the other copies as ‘copies’. Only the original shall be accepted by the competent authorities of the Community as being valid for the purpose of export to the Community in accordance with the provisions of this Agreement.

2.   Each document shall bear a standardised serial number, whether or not printed, by which it can be identified.

This number shall be composed of the following elements:

| — | a two-digit number identifying the exporting entity as follows: XS, |
| --- | --- |

—

a two-digit number identifying the exporting entity as follows: XS,

| — | two digits identifying the intended Member State of customs clearance as follows:





  — | AT = Austria |
| --- | --- | --- |

—

—

AT = Austria

| — | BL = Benelux |
| --- | --- |

—

BL = Benelux

| — | CY = Cyprus |
| --- | --- |

—

CY = Cyprus

| — | CZ = Czech Republic |
| --- | --- |

—

CZ = Czech Republic

| — | DE = Germany |
| --- | --- |

—

DE = Germany

| — | DK = Denmark |
| --- | --- |

—

DK = Denmark

| — | EE = Estonia |
| --- | --- |

—

EE = Estonia

| — | EL = Greece |
| --- | --- |

—

EL = Greece

| — | ES = Spain |
| --- | --- |

—

ES = Spain

| — | FI = Finland |
| --- | --- |

—

FI = Finland

| — | FR = France |
| --- | --- |

—

FR = France

| — | GB = United Kingdom |
| --- | --- |

—

GB = United Kingdom

| — | HU = Hungary |
| --- | --- |

—

HU = Hungary

| — | IE = Ireland |
| --- | --- |

—

IE = Ireland

| — | IT = Italy |
| --- | --- |

—

IT = Italy

| — | LT = Lithuania |
| --- | --- |

—

LT = Lithuania

| — | LV = Latvia |
| --- | --- |

—

LV = Latvia

| — | MT = Malta |
| --- | --- |

—

MT = Malta

| — | PL = Poland |
| --- | --- |

—

PL = Poland

| — | PT = Portugal |
| --- | --- |

—

PT = Portugal

| — | SE = Sweden |
| --- | --- |

—

SE = Sweden

| — | SI = Slovenia |
| --- | --- |

—

SI = Slovenia

| — | SK = Slovakia, |
| --- | --- |

—

SK = Slovakia,

| — | a one-digit number identifying quota year, corresponding to the last figure in the respective year, e.g. 4 for 2004, 5 for 2005, 6 for 2006 and 7 for 2007, |
| --- | --- |

—

a one-digit number identifying quota year, corresponding to the last figure in the respective year, e.g. 4 for 2004, 5 for 2005, 6 for 2006 and 7 for 2007,

| — | a two-digit number from 01 to 99, identifying the particular issuing office concerned in exporting entity, |
| --- | --- |

—

a two-digit number from 01 to 99, identifying the particular issuing office concerned in exporting entity,

| — | a five-digit number running consecutively from 00001 to 99999 allocated to the intended Member State of customs clearance. |
| --- | --- |

—

a five-digit number running consecutively from 00001 to 99999 allocated to the intended Member State of customs clearance.

Article 15

The export licence and the certificate of origin may be issued after the shipment of the products to which they relate. In such cases they must bear the endorsement ‘délivré à posteriori’ or the endorsement ‘issued retrospectively’.

Article 16

1.   In the event of a theft, loss or destruction of an export licence or a certificate of origin, the exporter may apply to the Ministry of International Economic Relations of Serbia in case of an export licence, or the Customs Administration of Serbia, in case of a certificate of origin, which issued the document for a duplicate to be made out on the basis of the export documents in his possession. The duplicate of any such certificate or licence so issued shall bear the endorsement ‘duplicata’ or ‘duplicate’.

2.   The duplicate shall bear the date of the original export licence or certificate of origin.

TITLE V

ADMINISTRATIVE COOPERATION

Article 17

The Parties shall cooperate closely in the implementation of the provisions of this Annex. To this end, contacts and exchanges of views, including on technical matters, shall be facilitated by both Parties.

Article 18

In order to ensure the correct application of this Annex, the Parties offer mutual assistance for the checking of the authenticity and the accuracy of export licences and certificates of origin issued or of any declarations made within the terms of this Annex.

Article 19

Serbia shall transmit to the Community the names and addresses of the authorities competent to issue and verify the export licences and the certificates of origin, together with specimens of the stamps used by these authorities and specimen signatures of officials responsible for signing the export licences and the certificates of origin. Serbia shall also notify the Community of any change in this information.

Article 20

1.   Subsequent verification of certificates of origin or export licences shall be carried out at random, or whenever the competent Community authorities have reasonable doubt as to the authenticity of the certificate or licence or as to the accuracy of the information regarding the true origin of the products in question.

2.   In such cases, the competent authorities in the Community shall return the certificate of origin or the export licence or a copy thereof to the Ministry for International Economic Relations of Serbia in case of an export licence, or to the Customs Administration of Serbia, in case of a certificate of origin, giving, where appropriate, the reasons of form or substance which justify an enquiry. If the invoice has been submitted, such invoice or a copy thereof shall be attached to the certificate or to the licence or their copies. The authorities shall also forward any information that has been obtained suggesting that the particulars given on the said certificate or licence are inaccurate.

3.   The provisions of paragraph 1 shall also apply to subsequent verifications of the declarations of origin provided for in Article 2 of this Annex.

4.   The results of the subsequent verifications carried out in accordance with paragraphs 1 and 2 shall be communicated to the competent authorities of the Community within three months at the latest. The information communicated shall indicate whether the disputed certificate, licence or declaration applies to the goods actually exported and whether these goods are eligible for export under the arrangements established by this Agreement. The information shall also include at the request of the Community, copies of all the documentation necessary to fully determine the facts, and in particular the true origin of the goods.

5.   Should such verifications reveal systematic irregularities in the use of declarations of origin, the Community may subject imports of the products in question to Article 2(1) of this Annex. For the purpose of subsequent verification of certificates of origin, copies of the certificates as well as any export documents referring to them shall be kept for at least two years by the issuing authority.

6.   Recourse to the random verification procedure specified in this Article must not constitute an obstacle to the release into free circulation of the products in question.

Article 21

1.   Where the verification procedure referred to in Article 20 of this Annex or where information available to the competent authorities of the Community or of Serbia indicates or appears to indicate that the provisions of this Agreement are being circumvented or infringed, the two Parties shall cooperate closely and with the appropriate urgency in order to prevent any such circumvention or infringement.

2.   To this end, the Ministry for International Economic Relations of Serbia in case of an export licence, or the Customs Administration of Serbia, in case of a certificate of origin, shall, on their own initiative or at the request of the Community, carry out appropriate inquiries, or arrange for such inquiries to be carried out, concerning operations which are, or appear to the Community to be, in circumvention or infringement of this Annex. Serbia shall communicate the results of these inquiries to the Community, including any other pertinent information enabling the cause of the circumvention or infringement, including the true origin of the goods to be determined.

3.   By agreement between the Parties, officials designated by the Community may be present at the inquiries referred to in paragraph 2.

4.   In pursuance of the cooperation referred to in paragraph 1, the competent authorities of the Parties shall exchange any information considered by either of them to be of use in preventing circumvention or infringement of the provisions of this Agreement. These exchanges may include information on the production of textile products in Serbia and on the trade in the type of products covered by this Agreement between Serbia and third countries, particularly where the Community has reasonable grounds to consider that the products in question may be in transit across the territory of Serbia prior to their importation into the Community. This information may include at the request of the Community copies of all available relevant documentation.

5.   Where the provisions of this Annex have not been applied correctly, the Community may take the measures set out in Article 6(3) of this Agreement, or any other appropriate measure.

Specimen of Certificate of Origin referred to in Article 2(1) of Annex V

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Specimen of Export Licence referred to in Article 7(1) of Annex V, Model 1

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Specimen of Export Licence referred to in Article 7(3) of Annex V, Model 2

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ANNEX VI

COTTAGE INDUSTRY AND FOLKLORE PRODUCTS ORIGINATING IN SERBIA

| 1. | The exemption provided for in Article 12 of this Agreement in respect of cottage industry products shall apply to the following types of product only:






  (a) | fabrics woven on looms operated solely by hand or foot, being fabrics of a kind traditionally made in the cottage industry of Serbia; |
| --- | --- | --- |

1.

The exemption provided for in Article 12 of this Agreement in respect of cottage industry products shall apply to the following types of product only:

(a)

fabrics woven on looms operated solely by hand or foot, being fabrics of a kind traditionally made in the cottage industry of Serbia;

| (b) | garments or other textile articles of a kind traditionally made in the cottage industry of Serbia obtained manually from the fabrics referred to above and sewn exclusively by hand without the aid of any machine; |
| --- | --- |

(b)

garments or other textile articles of a kind traditionally made in the cottage industry of Serbia obtained manually from the fabrics referred to above and sewn exclusively by hand without the aid of any machine;

| (c) | traditional folklore products of Serbia made by hand, in a list to be agreed between the Parties. |
| --- | --- |

(c)

traditional folklore products of Serbia made by hand, in a list to be agreed between the Parties.

Exemption shall be granted in respect only of products covered by a certificate conforming to the specimen annexed to this Annex and issued by the Customs Administration of Serbia. These certificates must indicate the reasons justifying their issuance. The competent authorities of the Community will accept them after having checked that the products concerned have fulfilled the conditions established in this Annex. The certificates concerning the products envisaged in point (c) above must bear a stamp ‘FOLKLORE’ marked clearly. In the case of a difference of opinion between the Parties concerning the nature of these products, consultations shall be held within one month in order to resolve these differences.

Should imports of any product covered by this Annex reach proportions liable to cause problems within the Community, consultations with Serbia shall be initiated as soon as possible, with a view to resolving the situation by the adoption if necessary of a quantitative restriction, in accordance with the procedure laid down in Article 8 of this Agreement.

| 2. | Titles IV and V of Annex V shall apply mutatis mutandis to the products covered by paragraph 1 of this Annex. |
| --- | --- |

2.

Titles IV and V of Annex V shall apply mutatis mutandis to the products covered by paragraph 1 of this Annex.

Appendix to Annex VI

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ANNEX VII

DECLARATION BY THE COMMUNITY

The Community undertakes to assist Serbia with questions which may arise from the application of the provisions of this Agreement in the context of Serbia's accession to the WTO.

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