title: Commission Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active substances (Text with EEA relevance)

text:
               20.12.2008

               EN

               Official Journal of the European Union

               L 344/89

      COMMISSION DIRECTIVE 2008/127/EC
   of 18 December 2008
   amending Council Directive 91/414/EEC to include several active substances
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 1112/2002 (2) and (EC) No 2229/2004 (3) lay down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes the active substances listed in the Annex to this Directive.

               (2)

               By Regulation (EC) No 1095/2007 (4) a new Article 24b was inserted into Regulation (EC) No 2229/2004 to allow active substances for which there are clear indications that it may be expected that they do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, to be included in Annex I to Directive 91/414/EEC without detailed scientific advice from the European Food Safety Authority (EFSA) having been sought.

               (3)

               For the active substances listed in the Annex to this Directive the Commission examined in accordance with Article 24a of Regulation (EC) No 2229/2004 the effects on human, animal health, groundwater and the environment for a range of uses proposed by the notifiers, with the conclusion that those active substances satisfy the requirements of Article 24b of Regulation (EC) No 2229/2004.

               (4)

               In accordance with Article 25(1) of Regulation (EC) No 2229/2004 the Commission has submitted draft review reports for the active substances listed in the Annex to this Directive to the Standing Committee on the Food Chain and Animal Health, for examination. Those reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 October 2008 in the format of the Commission review reports. In accordance with Article 25a of Regulation (EC) No 2229/2004 the Commission is to request the EFSA to deliver its view on the draft review reports by 31 December 2010 at the latest.

               (5)

               It has appeared from the various examinations made that plant protection products containing the active substances listed in the Annex to this Directive may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include in Annex I to that Directive the active substances listed in the Annex to this Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

               (6)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

               (7)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing the active substances listed in the Annex to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (8)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives that have been adopted until now amending Annex I.

               (9)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (10)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 28 February 2010 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 March 2010.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing the active substances listed in the Annex as active substances by 28 February 2010.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to the active substances listed in the Annex are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holders of the authorisations have, or have access to, dossiers satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing one of the active substances listed in the Annex as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 August 2009 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning the active substances listed in the Annex. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing one of the active substances listed in the Annex as the only active substance, where necessary, amend or withdraw the authorisation by 31 August 2015 at the latest; or

               (b)

               in the case of a product containing one of the active substances listed in the Annex as one of several active substances, where necessary, amend or withdraw the authorisation by 31 August 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 September 2009.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 18 December 2008.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 168, 27.6.2002, p. 14.

      (3)  OJ L 379, 24.12.2004, p. 13.

      (4)  OJ L 246, 21.9.2007, p. 19.

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EC:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘224

                     Acetic acid
                     CAS No: 64-19-7
                     CIPAC No: not allocated

                     Acetic acid

                     ≥ 980 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on acetic acid (SANCO/2602/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     225

                     Aluminium ammonium sulphate
                     CAS No: 7784-26-1
                     CIPAC No: not allocated

                     Aluminium ammonium sulphate

                     ≥ 960 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on aluminium ammonium sulphate (SANCO/2985/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     226

                     Aluminium silicate
                     CAS No: 1332-58-7
                     CIPAC No: not allocated

                     Not available
                     Chemical name: Kaolin

                     ≥ 999,8 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on aluminium silicate (SANCO/2603/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     227

                     Ammonium acetate
                     CAS No: 631-61-8
                     CIPAC No: not allocated

                     Ammonium acetate

                     ≥ 970 g/kg
                     Relevant impurity: Heavy metals as Pb maximum 10 ppm

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as attractant may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on ammonium acetate (SANCO/2986/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     228

                     Blood meal
                     CAS No: not allocated
                     CIPAC No: not allocated

                     Not available

                     ≥ 990 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 1774/2002.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on blood meal (SANCO/2604/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     229

                     Calcium carbide
                     CAS No: 75-20-7
                     CIPAC No: not allocated

                     Calcium carbide
                     Calcium acetylide

                     ≥ 765 g/kg
                     Containing 0,08-0,52 g/kg Calcium Phosphide

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on calcium carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     230

                     Calcium carbonate
                     CAS No: 471-34-1
                     CIPAC No: not allocated

                     Calcium carbonate

                     ≥ 995 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on calcium carbonate (SANCO/2606/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     231

                     Carbon dioxide
                     CAS No: 124-38-9

                     Carbon dioxide

                     ≥ 99,9 %

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as fumigant may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on carbon dioxide (SANCO/2987/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     232

                     Denathonium benzoate
                     CAS No: 3734-33-6
                     CIPAC No: not allocated

                     Benzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate

                     ≥ 995 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on denathonium benzoate (SANCO/2607/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     233

                     Ethylene
                     CAS No: 74-85-1
                     CIPAC No: not allocated

                     Ethene

                     ≥ 99 %

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as plant growth regulator may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on ethylene (SANCO/2608/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     234

                     Extract from tea tree
                     CAS No: Tee Tree Oil 68647-73-4
                     Main components:

                                 terpinen-4-ol 562-74-3

                                 γ-terpinene 99-85-4

                                 α-terpinene 99-86-5

                                 1,8-cineol 470-82-6

                           CIPAC No: not allocated

                     Tee Tree Oil is a complex mixture of chemical substances.

                     Main components:

                                 terpinen-4-ol ≥ 300 g/kg

                                 γ-terpinene ≥ 100 g/kg

                                 α-terpinene ≥ 50 g/kg

                                 1,8-cineol trace

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on extract from tea tree (SANCO/2609/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     235

                     Fat destilation residues
                     CAS No: not allocated
                     CIPAC No: not allocated

                     Not available

                     ≥ 40 % of cleaved fatty acids
                     Relevant impurity: Ni maximum 200 mg/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised. Fat destilation residues of animal origin must be in compliance with Regulation (EC) No 1774/2002.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fat destilation residues (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     236

                     Fatty acids C7 to C20

                     CAS No: 112-05-0 (Pelargonic Acid)
                     67701-09-1 (Fatty acids C7-C18 and C18 unsaturated potassium salts)
                     124-07-2 (Caprylic Acid)
                     334-48-5 (Capric Acid)
                     143-07-7 (Lauric Acid)
                     112-80-1 (Oleic Acid)
                     85566-26-3 (Fatty acids C8-C10 Me esters)
                     111-11-5 (Methyl octanoate)
                     110-42-9 (Methyl decanoate)
                     CIPAC No: not allocated

                     Nonanoic acid
                     Caprylic Acid, Pelargonic Acid, Capric Acid, Lauric Acid, Oleic Acid (ISO in each case)
                     Octanoic Acid, Nonanoic Acid, Decanoic Acid, Dodecanoic Acid, cis-9-Octadecenoic Acid (IUPAC in each case)
                     Fatty acids, C7-C10, Me esters

                     ≥ 889 g/kg (Pelargonic Acid)
                     ≥ 838 g/kg fatty acids
                     ≥ 99 % fatty acid methyl esters

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as insecticide, acaricide, and herbicide and plant growth regulator may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fatty acids (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     237

                     Garlic extract
                     CAS No: 8008-99-9
                     CIPAC No: not allocated

                     Food grade garlic juice concentrate

                     ≥ 99,9 %

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent, insecticide and nematicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on garlic extract (SANCO/2612/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     238

                     Gibberellic acid
                     CAS No: 77-06-5
                     CIPAC No: 307

                     (3S,3aS,4S,4aS,7S,9aR,9bR,12S)-7,12-dihydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenol(1,2-b)furan-4-carboxylic acid
                     Alt: (3S,3aR,4S,4aS,6S,8aR,8bR,11S)-6,11-dihydroxy-3-methyl-12-methylene-2-oxo-4a,6-methano-3,8b-prop-lenoperhydroindenol (1,2-b) furan-4-carboxylic acid

                     ≥ 850 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as plant growth regulator may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on gibberellic acid (SANCO/2613/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     239

                     Gibberellins
                     CAS No: GA4: 468-44-0
                     GA7: 510-75-8
                     GA4A7 mixture: 8030-53-3
                     CIPAC No: not allocated

                     GA4:
                     (3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-3,9b-propanoazuleno[1,2-b]furan-4-carboxylic acid
                     GA7:
                     (3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenoazuleno[1,2-b]furan-4-carboxylic acid

                     Review report (SANCO/2614/2008).

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as plant growth regulator may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on gibberellins (SANCO/2614/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     240

                     Hydrolised proteins
                     Beet molasses urea hydrolysate
                     Collagen protein hydrolysate
                     CAS No: not allocated
                     CIPAC No: not allocated

                     Not available

                     Beet molasses urea hydrolysate: minimum Crude Protein Equivalent: 360 g/kg (36 % w/w)
                     Collagen protein hydrolysate: organic nitrogen content > 240 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as attractant may be authorised. Hydrolised proteins of animal origin must be in compliance with Regulation (EC) No 1774/2002
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on hydrolised proteins (SANCO/2615/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     241

                     Iron sulphate
                     Iron(II)sulphate anhydrous: CAS No: 7720-78-7
                     Iron(II)sulphate monohydrate: CAS No: 17375-41-6
                     Iron(II)sulphate heptahydrate: CAS No: 7782-63-0
                     CIPAC No: not allocated

                     Iron (II) sulfate

                     Iron(II)sulphate anhydrous ≥ 367,5 g/kg
                     Iron(II)sulphate monohydrate ≥ 300 g/kg
                     Iron(II)sulphate heptahydrate ≥ 180 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on iron sulphate (SANCO/2616/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     242

                     Kieselgur (Diatomaceous earth)
                     CAS No: 61790-53-2
                     CIPAC No: 647

                     Kieselgur (diatomaceous earth)

                     920 ± 20 g SiO2/kg DE
                     Maximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.)

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as insecticide and acaricide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on kieselgur (SANCO/2617/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     243

                     Limestone
                     CAS No: 1317-65-3
                     CIPAC No: not allocated

                     not available

                     ≥ 980 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on limestone (SANCO/2618/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     244

                     Methyl nonyl ketone
                     CAS No: 112-12-9
                     CIPAC No: not allocated

                     Undecan-2-one

                     ≥ 975g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on methylnonyl ketone (SANCO/2619/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     245

                     Pepper
                     CAS No: not allocated
                     CIPAC No: not allocated

                     Black pepper — Piper nigrum

                     It is a complex mixture of chemical substances, the component piperine as marker should be minimum 4 %

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pepper (SANCO/2620/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     246

                     Plant oils/citronella oil
                     CAS No: 8000-29-1
                     CIPAC No: not allocated

                     Citronella Oil is a complex mixture of chemical substances.
                     The main components are:

                                 Citronellal (3,7-dimethyl-6-octenal).

                                 Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol).

                                 Citronellol (3,7-dimethyl-6-octan-2-ol).

                                 Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate).

                     Relevant impurities methyl eugenol and methyl-isoeugenol maximum 0,1 %.

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on citronella oil (SANCO/2621/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     247

                     Plant oils/clove oil
                     CAS No: 94961-50-2 (clove oil)
                     97-53-0 (Eugenol — main component)
                     CIPAC No: not allocated

                     Clove Oil is a complex mixture of chemical substances.
                     The main component is eugenol.

                     ≥ 800 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as fungicide and bactericide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on clove oil (SANCO/2622/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     248

                     Plant oils/rape seed oil
                     CAS No: 8002-13-9
                     CIPAC No: not allocated

                     Rape seed oil

                     Rape seed oil is a complex mixture of fatty acids

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as insecticide and acaricide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on rape seed oil (SANCO/2623/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     249

                     Plant oils/spear mint oil
                     CAS No: 8008-79-5
                     CIPAC No: not allocated

                     Spearmint oil

                     ≥ 550 g/kg as L-Carvone

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as plant growth regulator may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     250

                     Potassium hydrogen carbonate
                     CAS No: 298-14-6
                     CIPAC No: not allocated

                     Potassium hydrogen carbonate

                     ≥ 99,5 %

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on potassium hydrogen carbonate (SANCO/2625/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     251

                     Putrescin (1,4-Diaminobutane)
                     CAS No: 110-60-1
                     CIPAC No: not allocated

                     Butane-1,4-diamine

                     ≥ 990 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as attractant may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on putrescin (SANCO/2626/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     252

                     Pyrethrins
                     CAS No: (A) and (B):
                     Pyrethrins: 8003-34-7
                     Extract A: extractives of Chrysanthemum cinerariaefolium: 89997-63-7
                     pyrethrin 1: CAS 121-21-1
                     pyrethrin 2: CAS 121-29-9
                     cinerin 1: CAS 25402-06-6
                     cinerin 2: CAS 121-20-0
                     jasmolin 1: CAS 4466-14-2
                     jasmolin 2: CAS 1172-63-0
                     Extract B: pyrethrin 1: CAS 121-21-1
                     pyrethrin 2: CAS 121-29-9
                     cinerin 1: CAS 25402-06-6
                     cinerin 2: CAS 121-20-0
                     jasmolin 1: CAS 4466-14-2
                     jasmolin 2: CAS 1172-63-0
                     CIPAC No 32

                     Pyrethrins are a complex mixture of chemical substances.

                     Extract A: ≥ 500 g/kg Pyrethrins
                     Extract B: ≥ 480 g/kg Pyrethrins

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pyrethrins (SANCO/2627/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     253

                     Quartz sand
                     CAS No: 14808-60-7
                     CIPAC No: not allocated

                     Quarz, Quartz, Siliciumdioxid, Silica, Silicon dioxide, SiO2

                     ≥ 915 g/kg
                     Maximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.)

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on quartz sand (SANCO/2628/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     254

                     Repellents by smell of animal or plant origin/fish oil
                     CAS No: 100085-40-3
                     CIPAC No: not allocated

                     Fish Oil

                     ≥ 99 %

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised. Fish oil must be in compliance with Regulation (EC) No 1774/2002
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fish oil (SANCO/2629/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     255

                     Repellents by smell of animal or plant origin/sheep fat
                     CAS No: 98999-15-6
                     CIPAC No: not allocated

                     Sheep Fat

                     Pure sheep fat containing a maximum of 0,18 % w/w/water.

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised. Sheep fat must be in compliance with Regulation (EC) No 1774/2002
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sheep fat (SANCO/2630/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     256

                     Repellents by smell of animal or plant origin/tall oil crude CAS No: 8002-26-4
                     CIPAC No: not allocated

                     Tall Oil Crude

                     Tall oil crude is a complex mixture of tall rosin and fatty acids

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on tall oil crude (SANCO/2631/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     257

                     Repellents by smell of animal or plant origin/tall oil pitch CAS No: 8016-81-7
                     CIPAC No: not allocated

                     Tall Oil Pitch

                     Complex mixture of esters of fatty acids, rosin and small amounts of dimers and trimers of resin acids and fatty acids.

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on tall oil pitch (SANCO/2632/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     258

                     Sea-algae extract (formerly sea algae extract and sea weeds)
                     CAS No: not allocated
                     CIPAC No: not allocated

                     See algae extract

                     See algae extract is a complex mixture. Main components as markers: mannitol, fucoidans and alginates. Review report SANCO/2634/2008

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as plant growth regulator may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sea algae extract (SANCO/2634/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     259

                     Sodium aluminium silicate
                     CAS No: 1344-00-9
                     CIPAC No: not allocated

                     Sodium aluminium silicate: Nax[(AlO2)x(SiO2)y] × zH2O

                     1 000 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as repellent may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sodium aluminium silicate (SANCO/2635/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     260

                     Sodium Hypochlorite
                     CAS No: 7681-52-9
                     CIPAC No: not allocated

                     Sodium Hypochlorite

                     10 % (w/w) expressed as chlorine

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as disinfectant may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sodium hypochlorite (SANCO/2988/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     261

                     Straight Chain Lepidopteran Pheromones

                     Acetate group:

                     Review report (SANCO/2633/2008)

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as attractants may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on straight chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     (E)-5-decen-1-yl acetate
                     CAS No: 38421-90-8
                     CIPAC No: not allocated

                     (E)-5-decen-1-yl acetate

                     (E)-8-dodecen-1-yl acetate
                     CAS No: 38363-29-0
                     CIPAC No:
                     not allocated

                     (E)-8-dodecen-1-yl acetate

                     (E/Z)-8-dodecen-1-yl acetate
                     CAS No: not available
                     CIPAC No: not avaiable

                     (E/Z)-8-dodecen-1-yl acetate as individual isomers

                     (Z)-8-dodecen-1-yl acetate
                     CAS No: 28079-04-1
                     CIPAC No: not allocated

                     (Z)-8-dodecen-1-yl acetate

                     (Z)-9-dodecen-1-yl acetate
                     CAS No: 16974-11-1
                     CIPAC No: 422

                     (Z)-9-dodecen-1-yl acetate

                     (E,Z)-7,9-dodecadien-1-yl acetate
                     CAS No: 54364-62-4
                     CIPAC No: not allocated

                     (E,Z)-7,9-dodecadien-1-yl acetate

                     (E)-11-tetradecen-1-yl acetate
                     CAS No: 33189-72-9
                     CIPAC No: not allocated

                     (E)-11-tetradecen-1-yl acetate

                     (Z)-9-tetradecen-1-yl acetate
                     CAS No: 16725-53-4
                     CIPAC No: not allocated

                     (Z)-9-tetradecen-1-yl acetate

                     (Z)-11-tetradecen-1-yl acetate
                     CAS No: 20711-10-8
                     CIPAC No: not allocated

                     (Z)-11-tetradecen-1-yl acetate

                     (Z, E)-9, 12-tetradecadien-1-yl acetate
                     CAS No: 31654-77-0
                     CIPAC No: not allocated

                     (Z, E)-9, 12-tetradecadien-1-yl acetate

                     Z-11-hexadecen-1-yl acetate
                     CAS No: 34010-21-4
                     CIPAC No: not allocated

                     Z-11-hexadecen-1-yl acetate

                     (Z, E)-7, 11-hexadecadien-1-yl acetate
                     CAS No: 51606-94-4
                     CIPAC No: not allocated

                     Z, E)-7, 11-hexadecadien-1-yl acetate

                     (E, Z)-2, 13-octadecadien-1-yl acetate.
                     CAS No: 86252-65-5
                     CIPAC No: not allocated

                     (E, Z)-2, 13-octadecadien-1-yl acetate.

                     Alcohol group:

                     Alcohol group:

                     (E)-5-decen-1-ol
                     CAS No: 56578-18-8
                     CIPAC No: not allocated

                     (E)-5-decen-1-ol

                     (Z)-8-dodecen-1-ol
                     CAS No: 40642-40-8
                     CIPAC No: not allocated

                     (Z)-8-dodecen-1-ol

                     (E,E)-8,10-dodecadien-1-ol
                     CAS No: 33956-49-9
                     CIPAC No: not allocated

                     (E,E)-8,10-dodecadien-1-ol

                     tetradecan-1-ol
                     CAS No: 112-72-1
                     CIPAC No: not allocated

                     tetradecan-1-ol

                     (Z)-11-hexadecen-1-ol
                     CAS No: 56683-54-6
                     CIPAC No: not allocated

                     (Z)-11-hexadecen-1-ol

                     Aldehyde group:

                     Aldehyde group:

                     (Z)-7-tetradecenal
                     CAS No: 65128-96-3
                     CIPAC No: not allocated

                     (Z)-7-tetradecenal

                     (Z)-9-hexadecenal
                     CAS No: 56219-04-6
                     CIPAC No: not allocated

                     (Z)-9-hexadecenal

                     (Z)-11-hexadecenal
                     CAS No: 53939-28-9
                     CIPAC No: not allocated

                     (Z)-11-hexadecenal

                     (Z)-13-octadecenal
                     CAS No: 58594-45-9
                     CIPAC No: not allocated

                     (Z)-13-octadecenal

                     Blends acetates:

                     Blends acetates:

                                 i)

                                 (Z)-8-dodecen-1-yl acetate
                                 CAS No: 28079-04-1
                                 CIPAC No: not allocated

                                 i)

                                 (Z)-8-dodecen-1-yl acetate

                     and ii) Dodecyl acetate
                     CAS No: 112-66-3
                     CIPAC No: not allocated;

                     and ii) Dodecyl acetate;

                                 i)

                                 (Z)-9-dodecen-1-yl acetate
                                 CAS No: 16974-11-1
                                 CIPAC No: 422
                                 and

                                 i)

                                 (Z)-9-dodecen-1-yl acetate
                                 and

                                 ii)

                                 Dodecyl acetate
                                 CAS No: 112-66-3
                                 CIPAC No: 422;

                                 ii)

                                 Dodecyl acetate;

                                 i)

                                 (E,Z)-7,9-dodecadien-1-yl acetate
                                 CAS No: 55774-32-8
                                 CIPAC No: not allocated
                                 and

                                 i)

                                 (E,Z)-7,9-dodecadien-1-yl acetate,
                                 and

                                 ii)

                                 (E,E)-7,9-dodecadien-1-yl acetate
                                 CAS No: 54364-63-5
                                 CIPAC No: not allocated;

                                 ii)

                                 (E,E)-7,9-dodecadien-1-yl acetate;

                                 i)

                                 (Z,Z)-7,11-hexadecadien-1-yl acetate
                                 and

                                 i)

                                 (Z,Z)-7,11-hexadecadien-1-yl acetate
                                 and

                                 ii)

                                 (Z,E)-7,11-hexadecadien-1-yl acetate
                                 CAS No: i) & ii) 53042-79-8
                                 CAS No: i) 52207-99-5
                                 CAS No: ii) 51606-94-4
                                 CIPAC No: not allocated;

                                 ii)

                                 (Z,E)-7,11-hexadecadien-1-yl acetate;

                     Blends aldehydes:

                     Blends aldehydes:

                                 i)

                                 (Z)-9-hexadecenal
                                 CAS No: 56219-04-6
                                 CIPAC No: not allocated
                                 and

                                 i)

                                 (Z)-9-hexadecenal
                                 and

                                 ii)

                                 (Z)-11-hexadecenal
                                 CAS No: 53939-28-9
                                 CIPAC: not allocated
                                 and

                                 ii)

                                 (Z)-11-hexadecenal
                                 and

                                 iii)

                                 (Z)-13-octadecenal
                                 CAS No: 58594-45-9
                                 CIPAC No: not allocated;

                                 iii)

                                 (Z)-13-octadecenal;

                     Blends mixtures:

                     Blends mixtures:

                                 i)

                                 (E)-5-decen-1-yl acetate
                                 CAS No: 38421-90-8
                                 CIPAC No: not allocated
                                 and

                                 i)

                                 (E)-5-decen-1-yl acetate and

                                 ii)

                                 (E)-5-decen-1-ol
                                 CAS No: 56578-18-8
                                 CIPAC No: not allocated;

                                 ii)

                                 (E)-5-decen-1-ol;

                                 i)

                                 (E/Z)-8-dodecen-1-yl acetate
                                 CAS No: as individual isomers
                                 CIPAC No: not allocated;
                                 and

                                 i)

                                 (E/Z)-8-dodecen-1-yl acetate
                                 and

                                 i)

                                 (E)-8-dodecen-1-yl acetate
                                 CAS No: (E) 38363-29-0
                                 CIPAC No: not allocated
                                 and

                                 i)

                                 (E)-8-dodecen-1-yl acetate
                                 and

                                 i)

                                 (Z)-8-dodecen-1-yl acetate
                                 CAS No: (Z) 28079-04-1
                                 CIPAC No: not allocated
                                 and

                                 i)

                                 (Z)-8-dodecen-1-yl acetate
                                 and

                                 ii)

                                 (Z)-8-dodecen-1-ol
                                 CAS No: ii) 40642-40-8
                                 CIPAC No: not allocated;

                                 ii)

                                 (Z)-8-dodecen-1-ol;

                                 i)

                                 (Z)-11-hexadecenal
                                 CAS No: 53939-28-9
                                 CIPAC No: not allocated
                                 and

                                 i)

                                 (Z)-11-hexadecenal
                                 and

                                 ii)

                                 (Z)-11-hexadecen-1-yl acetate
                                 CAS No: 34010-21-4
                                 CIPAC No: not allocated

                                 ii)

                                 (Z)-11-hexadecen-1-yl acetate

                     262

                     Trimethylamine hydrochloride
                     CAS No: 593-81-7
                     CIPAC No: not allocated

                     Trimethylamine hydrochloride

                     ≥ 988 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as attractant may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on trimethylamine hydrochloride (SANCO/2636/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     263

                     Urea
                     CAS No: 57-13-6
                     CIPAC No: 8352

                     Urea

                     ≥ 98 % w/w

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as attractant and fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on urea (SANCO/2637/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     264

                     Z-13-hexadecen-11-yn-1-yl acetate
                     CAS No: 78617-58-0
                     CIPAC: not allocated

                     Z-13-hexadecen-11-yn-1-yl acetate

                     ≥ 75 %

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as attractant may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Z-13-hexadecen-11-yn-1-yl acetate (SANCO/2649/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.

                     265

                     Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate
                     CAS No: 135459-81-3
                     CIPAC: not allocated

                     Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate

                     ≥ 90 %

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as attractant may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate (SANCO/2650/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


title: Commission Directive 2007/62/EC of 4 October 2007 amending certain Annexes to Council Directives 86/362/EEC and 90/642/EEC as regards maximum residue levels for bifenazate, pethoxamid, pyrimethanil and rimsulfuron (Text with EEA relevance)

text:
               5.10.2007

               EN

               Official Journal of the European Union

               L 260/4

      COMMISSION DIRECTIVE 2007/62/EC
   of 4 October 2007
   amending certain Annexes to Council Directives 86/362/EEC and 90/642/EEC as regards maximum residue levels for bifenazate, pethoxamid, pyrimethanil and rimsulfuron
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), and in particular Article 10 thereof,
   Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (2), and in particular Article 7 thereof,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3), and in particular Article 4(1)(f) thereof,
   Whereas:

               (1)

               The following active substances have been included in Annex I to Directive 91/414/EEC: pyrimethanil, pethoxamid, bifenazate and rimsulfuron by Commission Directives 2006/74/EC (4), 2006/41/EC (5), 2005/58/EC (6), and 2006/39/EC (7) respectively.

               (2)

               The inclusion in Annex I to Directive 91/414/EEC of the active substances concerned was based on the assessment of the information submitted concerning the proposed use. Information relating to that use has been submitted by certain Member States in accordance with Article 4(1)(f) of that Directive. The information available has been reviewed and is sufficient to allow certain maximum residue levels (MRLs) to be fixed.

               (3)

               Where no Community MRL or provisional MRL exists, Member States are to establish a national provisional MRL in accordance with Article 4(1)(f) of Directive 91/414/EEC before plant protection products containing these active substances may be authorised.

               (4)

               Community MRLs and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are a number of Codex MRLs for bifenazate. The MRLs based on Codex MRLs have been evaluated in the light of the risks for the consumers. No risk was established when using the toxicological end points based on the studies available to the Commission.

               (5)

               The Commission review reports which were prepared for the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned, fixed the Acceptable Daily Intake (ADI) and, if necessary, the Acute Reference Dose (ARfD) for those substances. The exposure of consumers of food products treated with the active substance concerned has been assessed in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation (8) and the opinion of the Scientific Committee for Plants (9) on the methodology employed. It is concluded that MRLs proposed will not lead to those ADIs or ARfD being exceeded.

               (6)

               In order to ensure that the consumer is adequately protected from exposure to residues resulting from unauthorised uses of plant protection products, provisional MRLs should be set for the relevant product/pesticide combinations at the lower limit of analytical determination.

               (7)

               The setting at Community level of such provisional MRLs does not prevent the Member States from establishing provisional MRLs for the substances concerned in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI to that Directive. It is considered that a period of four years is sufficient to permit further uses of the active substance concerned. The provisional MRLs should then become definitive.

               (8)

               It is therefore necessary to modify the MRLs set out in the Annexes to Directives 86/362/EEC and 90/642/EEC, to allow for proper surveillance and control of the prohibition of their uses and to protect the consumer.

               (9)

               Directives 86/362/EEC and 90/642/EEC should therefore be amended accordingly.

               (10)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex II to Directive 86/362/EEC is amended in accordance with Annex I to this Directive.
   Article 2
   Annex II to Directive 90/642/EEC is amended in accordance with Annex II to this Directive.
   Article 3
   Member States shall adopt and publish, by 5 April 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 6 April 2008.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 4
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 4 October 2007.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2007/57/EC (OJ L 243, 18.9.2007, p. 61).

      (2)  OJ L 350, 14.12.1990, p. 71. Directive as last amended by Directive 2007/57/EC.

      (3)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/52/EC (OJ L 214, 17.8.2007, p. 3).

      (4)  OJ L 235, 30.8.2006, p. 17.

      (5)  OJ L 187, 8.7.2006, p. 24.

      (6)  OJ L 246, 22.9.2005, p. 17.

      (7)  OJ L 104, 13.4.2006, p. 30.

      (8)  Guidelines for predicting dietary intake of pesticide residues (revised), prepared by the GEMS/Food Programme in collaboration with the Codex Committee on Pesticide Residues, published by the World Health Organisation 1997 (WHO/FSF/FOS/97.7).

      (9)  Opinion of the Scientific Committee on Plants regarding questions relating to amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC (Opinion expressed by the Scientific Committee on Plants, 14 July 1998) (http://europa.eu.int/comm/food/fs/sc/index_en.html).

      ANNEX I
      In Part A of Annex II to Directive 86/362/EEC, the following lines for bifenazate, pethoxamid, pyrimethanil and rimsulfuron are added:

                     ‘Pesticide residues

                     Maximum levels in mg/kg

                     Bifenazate

                     0,01 (1)
                         (2)

                     CEREALS

                     Pethoxamid

                     0,01 (1)
                         (2)

                     CEREALS

                     Pyrimethanil

                     0,05 (1)
                         (2)

                     CEREALS

                     Rimsulfuron

                     0,05 (1)
                         (2)

                     CEREALS

         (1)  Indicates lower limit of analytical determination.

         (2)  Indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless amended, this level will become definitive with effect from 25 October 2011.’

      ANNEX II
      In Part A of Annex II to Directive 90/642/EEC, the following columns for bifenazate, pethoxamid, pyrimethanil and rimsulfuron are added:

                     ‘Pesticide residues and maximum residue levels (mg/kg)

                     Groups and examples of individual products to which the MRLs apply

                     Bifenazate

                     Pethoxamid

                     Pyrimethanil

                     Rimsulfuron

                                 1.

                                 Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts

                     0,01 (1)
                         (2)

                     0,05 (1)
                         (2)

                                 (i)

                                 CITRUS FRUIT

                     0,01 (1)
                         (2)

                     10 (2)

                     Grapefruit

                     Lemons

                     Limes

                     Mandarins (including clementines and other hybrids)

                     Oranges

                     Pomelos

                     Others

                                 (ii)

                                 TREE NUTS (shelled or unshelled)

                     0,01 (1)
                         (2)

                     Almonds

                     0,2 (2)

                     Brazil nuts

                     Cashew nuts

                     Chestnuts

                     Coconuts

                     Hazelnuts

                     Macadamia

                     Pecans

                     Pine nuts

                     Pistachios

                     0,2 (2)

                     Walnuts

                     Others

                     0,05 (1)
                         (2)

                                 (iii)

                                 POME FRUIT

                     0,01 (1)
                         (2)

                     5 (2)

                     Apples

                     Pears

                     Quinces

                     Others

                                 (iv)

                                 STONE FRUIT

                     0,01 (1)
                         (2)

                     Apricots

                     3 (2)

                     Cherries

                     Peaches (including nectarines and similar hybrids)

                     10 (2)

                     Plums

                     3 (2)

                     Others

                     0,05 (1)
                         (2)

                                 (v)

                                 BERRIES AND SMALL FRUIT

                                 (a)

                                 Table and wine grapes

                     0,01 (1)
                         (2)

                     5 (2)

                     Table grapes

                     Wine grapes

                                 (b)

                                 Strawberries (other than wild)

                     2 (2)

                     5 (2)

                                 (c)

                                 Cane fruit (other than wild)

                     0,01 (1)
                         (2)

                     Blackberries

                     10 (2)

                     Dewberries

                     Loganberries

                     Raspberries

                     10 (2)

                     Others

                     0,05 (1)
                         (2)

                                 (d)

                                 Other small fruit & berries (other than wild)

                     0,01 (1)
                         (2)

                     5 (2)

                     Bilberries

                     Cranberries

                     Currants (red, black and white)

                     Gooseberries

                     Others

                                 (e)

                                 Wild berries and wild fruit

                     0,01 (1)
                         (2)

                     0,05 (1)
                         (2)

                                 (vi)

                                 MISCELLANEOUS

                     0,01 (1)
                         (2)

                     Avocados

                     Bananas

                     0,1 (2)

                     Dates

                     Figs

                     Kiwi

                     Kumquats

                     Litchis

                     Mangoes

                     Olives (table consumption)

                     Olives (oil extraction)

                     Papaya

                     Passion fruit

                     Pineapples

                     Pomegranate

                     Others

                     0,05 (1)
                         (2)

                                 2.

                                 Vegetables, fresh or uncooked, frozen or dry

                     0,01 (1)
                         (2)

                     0,05 (1)
                         (2)

                                 (i)

                                 ROOT AND TUBER VEGETABLES

                     0,01 (1)
                         (2)

                     Beetroot

                     Carrots

                     1 (2)

                     Cassava

                     Celeriac

                     Horseradish

                     Jerusalem artichokes

                     Parsnips

                     Parsley root

                     Radishes

                     Salsify

                     Sweet potatoes

                     Swedes

                     Turnips

                     Yam

                     Others

                     0,05 (1)
                         (2)

                                 (ii)

                                 BULB VEGETABLES

                     0,01 (1)
                         (2)

                     Garlic

                     Onions

                     0,1 (2)

                     Shallots

                     Spring onions

                     Others

                     0,05 (1)
                         (2)

                                 (iii)

                                 FRUITING VEGETABLES

                                 (a)

                                 Solanacea

                     Tomatoes

                     0,5 (2)

                     1 (2)

                     Peppers

                     2 (2)

                     2 (2)

                     Aubergines

                     0,5 (2)

                     1 (2)

                     Okra

                     Others

                     0,01 (1)
                         (2)

                     0,05 (1)
                         (2)

                                 (b)

                                 Cucurbits — edible peel

                     0,3 (2)

                     1 (2)

                     Cucumbers

                     Gherkins

                     Courgettes

                     Others

                                 (c)

                                 Cucurbits — inedible peel

                     0,01 (1)
                         (2)

                     0,05 (1)
                         (2)

                     Melons

                     Squashes

                     Watermelons

                     Others

                                 (d)

                                 Sweetcorn

                     0,01 (1)
                         (2)

                     0,05 (1)
                         (2)

                                 (iv)

                                 BRASSICA VEGETABLES

                     0,01 (1)
                         (2)

                     0,05 (1)
                         (2)

                                 (a)

                                 Flowering brassica

                     Broccoli (including Calabrese)

                     Cauliflower

                     Others

                                 (b)

                                 Head brassica

                     Brussels sprouts

                     Head cabbage

                     Others

                                 (c)

                                 Leafy brassica

                     Chinese cabbage

                     Kale

                     Others

                                 (d)

                                 Kohlrabi

                                 (v)

                                 LEAF VEGETABLES AND FRESH HERBS

                     0,01 (1)
                         (2)

                                 (a)

                                 Lettuce and similar

                     Cress

                     Lamb's lettuce

                     Lettuce

                     10 (2)

                     Scarole (broad-leaf endive)

                     Rocket

                     Leaves and stems of brassica, including turnip greens

                     Others

                     0,05 (1)
                         (2)

                                 (b)

                                 Spinach and similar

                     0,05 (1)
                         (2)

                     Spinach

                     Beet leaves (chard)

                     Others

                                 (c)

                                 Watercress

                     0,05 (1)
                         (2)

                                 (d)

                                 Witloof

                     0,05 (1)
                         (2)

                                 (e)

                                 Herbs

                     3 (2)

                     Chervil

                     Chives

                     Parsley

                     Celery leaves

                     Others

                                 (vi)

                                 LEGUME VEGETABLES (fresh)

                     0,01 (1)
                         (2)

                     Beans (with pods)

                     2 (2)

                     Beans (without pods)

                     Peas (with pods)

                     Peas (without pods)

                     0,2 (2)

                     Others

                     0,05 (1)
                         (2)

                                 (vii)

                                 STEM VEGETABLES (fresh)

                     0,01 (1)
                         (2)

                     Asparagus

                     Cardoons

                     Celery

                     Fennel

                     Globe artichokes

                     Leeks

                     1 (2)

                     Rhubarb

                     Others

                     0,05 (1)
                         (2)

                                 (viii)

                                 FUNGI

                     0,01 (1)
                         (2)

                     0,05 (1)
                         (2)

                                 (a)

                                 Cultivated mushrooms

                                 (b)

                                 Wild mushrooms

                                 3.

                                 Pulses

                     0,01 (1)
                         (2)

                     0,01 (1)
                         (2)

                     0,5 (2)

                     0,05 (1)
                         (2)

                     Beans

                     Lentils

                     Peas

                     Lupines

                     Others

                                 4.

                                 Oilseeds

                     0,02 (1)
                         (2)

                     0,01 (1)
                         (2)

                     0,1 (1)
                         (2)

                     0,05 (1)
                         (2)

                     Linseed

                     Peanuts

                     Poppy seed

                     Sesame seed

                     Sunflower seed

                     Rape seed

                     Soya bean

                     Mustard seed

                     Cotton seed

                     Hemp seed

                     Pumpkin seed

                     Others

                                 5.

                                 Potatoes

                     0,01 (1)
                         (2)

                     0,01 (1)
                         (2)

                     0,05 (1)
                         (2)

                     0,05 (1)
                         (2)

                     Early potatoes

                     Ware potatoes

                                 6.

                                 Tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis)

                     0,02 (1)
                         (2)

                     0,02 (1)
                         (2)

                     0,1 (1)
                         (2)

                     0,1 (2)

                                 7.

                                 Hops (dried), including hop pellets and unconcentrated powder

                     0,02 (1)
                         (2)

                     0,02 (1)
                         (2)

                     0,1 (1)
                         (2)

                     0,1 (1)
                         (2)

         (1)  Indicates lower limit of analytical determination.

         (2)  Indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless amended, this level will become definitive with effect from 25 October 2011.’


Avis juridique important

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31987L0403

Council Directive 87/403/EEC of 25 June 1987 supplementing Annex I to Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers

Official Journal L 220 , 08/08/1987 P. 0044 - 0047 Finnish special edition: Chapter 13 Volume 16 P. 0196  Swedish special edition: Chapter 13 Volume 16 P. 0196

COUNCIL DIRECTIVE of 25 June 1987 supplementing Annex  I to Directive 70/156/EEC on the approximation of the laws of the Member States relating to the  type-approval of motor vehicles and their trailers (87/403/EEC)THE COUNCIL OF THE  EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article  100 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Whereas Directive 70/156/EEC(3), as last amended by Directive 87/358/EEC(4), laid down, in the  N°tes to Annex I, the classification of motor vehicles and their trailers; Whereas it is now necessary to define off-road vehicles at Community level with a view in  particular to the application of Directive 84/424/EEC(5), Article 1 of which lays down exceptions  for these vehicles and more generally for the application of any other Directive in the motor  vehicle sector that might need such definition; Whereas off-road vehicles are defined differently in each Member State and whereas, in order not to  hinder intra-Community trade, a common definition, within the international categories set out in  the notes to Annex I to Directive 70/156/EEC, is necessary, HAS ADOPTED THIS DIRECTIVE: Article 1 Annex I to Directive 70/156/EEC is hereby supplemented as set out in the Annex hereto. Article 2 Member States shall take the measures necessary to comply with this Directive by 1  October 1988. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States. Done at Luxembourg, 25 June 1987. For the CouncilThe PresidentH. DE CROO (1)OJ N° C 108, 23. 4. 1987, p. 9.  (2)Opinion delivered on 19 June 1987 (not yet published in the Official Journal).  (3)OJ N° L 42, 23. 2. 1970, p. 1.  (4)OJ N° L 192, 11. 7. 1987, p. 51.  (5)OJ N° L 238, 6. 9. 1984, p. 31.   ANNEX In the N°tes to Annex I the following shall be added at the end of (b): '4.Vehicles in categories M and N, above, considered to be off-road vehicles under the load and  checking conditions set out in point 4.4 and pursuant to the definitions and sketches of point  4.5. 4.1.Vehicles in category N1 with a maximum mass not exceeding two tonnes and motor vehicles in  category M1 are considered to be off-road vehicles if they have: at least one front axle and at least one rear axle designed to be driven simultaneously including  vehicles where the drive to one axle can be disengaged, at least one differential locking mechanism or at least one mechanism having a similar effect and if they can climb a 30 % gradient calculated for a solo vehicle. In addition, they must satisfy at least five of the following six requirements: -the front incidence angle must be at least 25°, -the rear incidence angle must be at least 20°, -the ramp angle must be at least 20°, -the ground clearance under the front axle must be at least 180 mm, -the ground clearance under the rear axle must be at least 180 mm, -the ground clearance between the axles must be at least 200 mm. 4.2.Vehicles in category N1 with a maximum mass exceeding two tonnes or in category N2, M2 or M3  with a maximum mass not exceeding 12 tonnes are considered to be off-road vehicles either if all  their wheels are designed to be driven simultaneously, including vehicles where the drive to one  axle can be disengaged, or if the following three requirements are satisfied: -at least one front axle and at least one rear axle are designed to be driven simultaneously,  including vehicles where the drive to one axle can be disengaged, -there is at least one differential locking mechanism or at least one mechanism having a similar  effect, -they can climb a 25 % gradient calculated for a solo vehicle. 4.3.Vehicles in category M3 with a maximum mass exceeding 12 tonnes or in category N3 are  considered to be off-road either if the wheels are designed to be driven simultaneously, including  vehicles where the drive to one axle can be disengaged, or if the following requirements are  satisfied: -at least half the wheels are driven, -there is at least one differential locking mechanism or at least one mechanism having a similar  effect, -they can climb a 25 % gradient calculated for a solo vehicle, -at least four of the following six requirements are satisfied: -the front incidence angle must be at least 25°, -the rear incidence angle must be at least 25°, -the ramp angle must be at least 25°, -the ground clearance under the front axle must be at least 250 mm, -the ground clearance between the axles must be at least 300 mm, -the ground clearance under the rear axle must be at least 250 mm. 4.4.Load and checking conditions 4.4.1.Vehicles in category N1 with a maximum mass not exceeding two tonnes and vehicles in category  M1 must be in running order, namely with coolant fluid, lubricants, fuel, tools, spare-wheel and a  driver considered to weigh a standard 75 kilograms. 4.4.2.Motor vehicles other than those referred to in 4.4.1 must be loaded to the technically  permissible maximum mass stated by the manufacturer. 4.4.3.The ability to climb the required gradients (25 % and 30 %) is verified by simple  calculation. In exceptional cases, however, the technical services may ask for a vehicle of the  type concerned to be submitted to it for an actual test. 4.4.4.When measuring front and rear incidence angles and ramp angles, no account is taken of  underrun protective devices. 4.5.Definitions and sketches of front and rear incidences angles, ramp angle and ground clearance 4.5.1.'Front incidence angle' means the maximum angle between the ground plane and planes  tangential to the tyres of the front wheels, under a static load, such that no point of the vehicle  ahead of the front axle is situated below these planes and no rigid part of the vehicle, with the  exception of any steps, is situated below these planes. >START OF GRAPHIC>1>END OF GRAPHIC>4.5.2.'Rear incidence angle' means the maximum angle between  the ground plane and planes tangential to the tyres of the rear wheels, under a static load, such  that no point of the vehicle behind the rearmost axle is situated below these planes and no rigid  part of the vehicle is situated below these planes. >START OF GRAPHIC>2>END OF GRAPHIC>4.5.3.'Ramp angle' means the minimum acute angle between two  planes, perpendicular to the median longitudinal plane of the vehicle, tangential to the tyres of  the front wheels and to the tyres of the rear wheels respectively, under a static load, the  intersection of which touches the rigid underside of the vehicle apart from the wheels. This angle  defines the steepest ramp over which the vehicle can pass. >START OF GRAPHIC>3>END OF GRAPHIC>4.5.4.'Ground clearance between the axles' means the shortest  distance between the ground plane and the lowest fixed point of the vehicle. Multi-axle bogies are considered to be a single axle. >START OF GRAPHIC>4>END OF GRAPHIC>-'Ground clearance beneath one axle' means the distance  beneath the highest point of the arc of a circle passing through the centre of the tyre footprint  of the wheels on one axle (the inner wheels in the case of twin tyres) and touching the lowest  fixed point of the vehicle between the wheels. N° rigid part of the vehicle may project into the  shaded area of the diagram. Where appropriate, the ground clearance of several axles is indicated  in accordance with their arrangement, for example 280/250/250. >START OF GRAPHIC>5>END OF GRAPHIC>