CELEX: 51991PC0087
Language: en
Date: 1991-03-21
Title: SECOND AMENDMENT TO THE PROPOSAL FOR A COUNCIL DIRECTIVE CONCERNING THE PLACING OF EEC-ACCEPTED PLANT PROTECTION PRODUCTS ON THE MARKET

COMMISSION OF THE EUROPEAN COMMUNITIES
                                                    C0M(91) 87 final
                                                    Brussels, 21 March 1991
                         Second amendment to the proposal for a
                                    COUNCIL DIRECTIVE
               oonoernlqg the placing of EEC-aooepted plant protection products
                                         on the market
                (presented by the Commission pursuant to Article 149(3)
                                   of the EEC-Treaty)
grc».- .s
 ---pagebreak---                                   J
                            EHPLANATORY MEMORANDUM
At its session of 19 February 1991, the European Parliament delivered its
opinion on the Ccsnmission proposal contained in document O0M(89) 34,
cûnoerning the Amended proposal for a Council Directive concerning the
placing of EEC^accepted plant protection products on the market.
The present amended proposal takes into account these amendments suggested by
the European Parliament on which the Commission has taken a favourable
position.
 ---pagebreak---                                      £
                    Second amendment to the proposal for a
                               CQUNCIU PI RECTI YE
       conoerning the placing of EBC-aooepted plant protection products
                                  on the market
In response to the opinion delivered by the European ParliamantCD on the
amended proposal for a Directive sent by the Commission to the Council on
24 February 1989 and concerning the placing of EEC-accepted plant protection
products on the market, and in accordance with the third paragraph of
Article 149 of the Treaty establishing the European Economic Community, the
Commission has decided to amend the aforementioned proposal as follows,
1. Throughout the proposal the teiroinology "acceptance" or "accept" is
    replaced by "authorisation" and "authorise" respectively.
2.  In the 4th recital the word "animais" is introduced between the words
    "man" and "and the environment ".
3. The following recital is introduced after the 8th recital.:
    "Whereas the provisions governing authorization, must ensure a high
    standard of protection, which, in particular, must prevent the
    authorization of plant protection products whose risks to health,
    groundwater and the environment has not been adequately investigated ;
    whereas the protection of the environment and human and animal health
    should take priority over the objective of increasing plant production; ".
4. The 14th recital is amended as follows:
    "Whereas, in the interest of safety, substances on the Community list
    should be reviewed periodically to take account of scientific ard
    technological developments and of impact studies based on actual uc3 of
    the authorized, substances: ".
(1)
 ---pagebreak---                                     - 3-
5. The following recital is introduced after the 14th recital:
    "Whereas resources devoted to the conduct of tests should not be
   squandered by the unnecessary repetition of tests as a result of
   different regulations in the Member States; whereas considerations of
   public interest militate against the undue repetition of tests on
   animals;".
6. The 15th recital is completed with the following sentence:
   "whereas to this end there is a need to harmonize the methods of
   experimentation and control applied by the Member States for the purpose
   of granting authorization; ".
7. The following recital is introduced after the 18th recital:
   "Whereas it is necessary to maintain consistency between this directive
   and Community rules on the residues of plant protection products in
   agricultural products and the free movement of the latter in the
   Community;".
8. The 19th recital is amended as follows:
   "Whereas, in order to ensure that the requirements laid down are
   satisfied, Member States must make provision for appropriate control and
   inspection arrangements with regard to the marketing and use of plant
   protection products;".
9. The 20th recital is amended as follows:
   "Whereas this Directive is not adequate for the full environments! risk
   assessment necessary for release into the environment of plant protection
   products containing or composed of genetically modified organisms, Ixit
   must nonetheless be used to authorize the marketing of such products,
   provided that they have first received a clearance for release into the
   environment under Directive 90/220/EEC on deliberate release into the
   environment of genetically modified organisms;".
 ---pagebreak---                                       -4-
10. The following titles are introduced in the proposal;
    - before Article    1: "Scope"
    - before Article 2: "Definitions"
    - before Article 3: "General provisions"
    -  before Article 4: "Granting, review and withdrawal of authorizations
                           of plant protection products"
    -  before Article  5: "Inclusion of active substances in Annex I"
    - before Article   7: "Information on potentially harmful effects"
    -  before Article 8: "Transitional measures and derogations"
    - before Article 9: "Application for authorization"
    -  before Article 10: "Mutual recognition of authori^tions"
    -  before Article 11: "Exchange of information between Member States aid
                          Commission"
    - before Article 12: "Data requirements, data protection and
                          confidentiality"
    -  before Article 14: "Packaging and labelling of plant protection
                          products"
    -  before Article 16: "Control measures"
    -  before Article 17: "Atoinistrative provisions""
    - before Article 20: "Release of plant protection products for research
                          and development"
    -  before Article 21 : "Implementation of the Directive".
11. Article 1(1) is amended as follows:
    "1. This Directive concerns the authorization, placing on the market,
         use and control within the Ctamraunity of plant protection products
         put up in commercial form, and the placing on the market and control
         within the Community of active substances intended for a use as
         specified in Article 2(1). M
 ---pagebreak---                                     - 5 -
12. The following paragraphs are introduced after paragraph 2 of Article 1:
    "3. This direotive shall apply to the authorization to place on the
         market products consisting of or containing genetically modified
         organisms, provided authorization to release them into the
         environment has already been granted following assessment of the
         environmental risk under Directive 90/220/EBcCD on the deliberate
         release of genetically modified organisms into the environment.
         The Commission shall, within five years of the date of
         implementation of this Directive, draw up a report for the Council
         and the European Parliament, on the basis of the experience
         acquired, on the operation of the arrangement laid down in the
         proceeding subparagraph, accompanied, where appropriate, by a
         proposal for amendment of this Directive.
     4. This direotive shall apply without prejudice no Regulation (EEC) No
         1734/88(2) of 16 June 1988 c»noerning export ftan and import into
         the Community of certain dangerous chemicals;
13. In Article 2, point 6, the word "bacteria" is introduced between the
    words "viruses" and "mycoplasma".
14. In Article 2, point 12, the word Hpiiysioal" is introduced between the
    words "chemical" and "cultural".
15. The following words are introduced in Article 4(1)(b) between "(b)" and
    the words "it is established ..." :
    "and, following application of the uniform principles provided for in
    Annex VI,".
(1)    OJ NO L 11?, 8.8.1990, p, 15.
(2)    OT NO h 155, 22.6.1988. p. 2.
 ---pagebreak---                                       -6-
16. Article 4(l)(b), points (iii) and (iv) are amended as follows:
     "(ill) it has no laarmful effect on human or animal health, directly or
             indirectly (e.g. through drinking water, food or feed),
      (iv) it has no unacceptable influence on the environment, having
             particular regard to its fate and distribution in the environment,
             particularly cxmtamination of water Including groundwater and
            drinking water, ".
17. Article 4(1 )(c) is amended as follows:
     "(c) if the nature and quantity of its active substances and, where
          appropriate, any toocLoologioally or ecotoxioologically significant
          impurities and œformulants, can be determined by appropriate
          methods harmonised according to the procedure provided in
          Article 19, or, if not, agreed by the authorities responsible for
          the authorisation. "
18. In Article 5(2), the words "at the request of the interested party, " are
     introduced after the words "in each case".
19. Article 6(3) is amended as follows:
     "3. As part of the procedure for assessing the dossier, the interested
          party may be invited by the Commission or may make a request to:
           - [unchanged]
           - [unchanged].
          The interested party shall have the right to be heard by -&e
           Committee whenever an unfavourable opinion is envisaged. "
 20. In Article 8(2) the words "for a period not exceeding three years" are
     replaced by "for a period which shall under no circumstances exceed three
     years".
 ---pagebreak---                                      - 7-
21. Article 8(3) is completed by the following subparagraph:
    "No later than two years before completion of the work programme, the
    Commission shall forward to the Council and the European Parliament a
    report on the progress achieved with the programme."
22. The provisions of Article 11(4) are introduced as a paragraph 3 in
    Artiole 4. The following sentence is added to this paragraph:
    "The interested party is immediately informed of any such decision. "
23. In Article 12(2), 2nd indent, the words "or the maintaining" are
    introduced between the words "the Inclusion" and "of the active
    substance".
24. Article 15(1 )(b) is amended as follows:
    "(b) the name and address of the holder of the authorization and the
         registration number of the plant protection product, and if
         different, the name and address of the person responsible for the
         final packaging and labelling or final labelling of the plant
         protection product; ".
25. Artiole 15(l)(k) is amended as follows:
    "(k) the uses for which the plant protection product has been authorized
         and any specific agricultural, plant health and environmental
         conditions under which the product may be used or should not be
         used;".
26. In Article 15(3) the statement "unsuitable for domestic use" is replaced
    by "reserved for agricultural use".
27. Article 16 is amended as follows:
    "Member States shall make suitable arrangements for plant protection
    products which have been placed on the market to be offici ally checked
    and inspected to see whether they comply with the requirements of this
    Direotive and the conditions of the authorization.
 ---pagebreak---                                        - 8 -
    The inspections shall also concern the proper use of the plant protection
     product, and in particular include checks on compliance with good plant
    protection practice.
    The Member States shall report annually, before the 1st of April, to
    other Member States and the Commission on the results of the inspection
    measures taken in the previous year. "
28. Artiole 17(1), third hyphen is amended as follows:
     "- Annex VI, iiWi-nHiT^g uniform principles for <^h**^g"*ng compliance with
        the requirements set out in Article 4(l)(b) and any necessary
        amendments thereto;".
29. In Annex II, part A, subpart "Further information on the active
    substance", the following point is introduced between points 3.10 and
    3.11:
     "3.10a -   Where necessary, in the light of the test results, any
                specific agricultural, plant health or environmental
                conditions under which the active substance may or may not be
                used."
30. In Annex II, part B, subpart "Further information on the organism" the
     following point is introduced between points 3.15 and 3.16:
      "3.15a -  Where necessary, in the light of the test results, any
                 specific agricultural, plant health and/or environmental
                 conditions under which the organism may or may not be used. "
 31. In Annex III, part A, subpart "Further technical information on the
     preparation" the following point is introduced between points 4.6 and
     4.7:
      "4.6a -    Where necessary in the light of the test results, any specific
                 agricultural, plant health and/or environmental conditions
                 under which the product may or may not be used. "
 ---pagebreak---                                     -9-
32. In Annex III, part B, subpart "Further technical information on the
    preparation" the following point is introduced between points 2.5 and
    2.6:
    "2.5a -    Where necessary in the light of the test results, any specific
               agricultural, plant health and/or environmental conditions
               under which the product may or may not be used".
33. A new Annex VI is included with the following title:
    "Uniform principles for the assessment of plant protection products".
 ---pagebreak---                                                                                ISSN IKM-I4/5
                                                                  C0M(91) 87 final
                                                     DOCUMENTS
EN                                                                                         03
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                                                               ISBN 92-77-70431-4
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