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 
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. 
£ 
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) 
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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;". 
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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 
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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. 
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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". 
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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 off ici ally checked 
and inspected to see whether they comply with the requirements of this 
Direotive and the conditions of the authorization. 
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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. " 
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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". 
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C0M(91) 87 final 
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