7. 3. 90 Official Journal of the European Communities No C 56/3 
— The breakdown under point 13 should be explained 
in relationship to the table. Furthermore, statistics 
on doses must be signed by the head of the author-
Done at Brussels, 15 November 1989. 
1. Introduction 
1.1. The circulation of goods to prevent or cure 
diseases or physiological disturbances in man, animals 
and plants, falls far short of the ideal as envisaged 
by the Treaty of Rome and reinforced by the Single 
European Act. 
1.2. However, with the approach of 1993 and the 
needs for the completion of the internal market, import­
ant steps forward have already been taken towards the 
building of a genuine European human and veterinary 
pharmaceutical market. 
1.3. Up until now similar positive decisions have not 
been taken in the area of plant health and the Com­
mittee thus welcomes and notes with interest the present 
proposal for a Directive aimed at helping to fill such 
a gap and representing a first attempt towards the 
harmonization of a Community system which would 
lead to the expectation of a safe and competitive free 
circulation of phytopharmaceutical products in the 
future. ized radiation data recording centre. (By contrast, 
page 2 of the acceptability certificate is signed by 
the operator in question.) 
The Chairman 
of the Economic and Social Committee 
Alberro MASPRONE 
1.4. In 1977, the Economic and Social Committee 
was asked and gave its opinion on proposals for Council 
Directives covering both the classification, packaging 
and labelling of dangerous preparations (pesticides) (2), 
and the prohibiting of the placing on the market and 
use of plant protection products containing certain 
active substances (3). In the preamble to the former it 
was clearly stated that 'in addition it would be necessary 
to include in later Directives, special provisions con­
cerning the authorization, distribution and use of these 
(plant-protection) pesticides'. 
1.5. Subsequently a proposal for a Directive for the 
homologation/registration system entitled 'The placing 
of EEC-accepted plant-protection products on the mar­
ket' was put forward and received the endorsement of 
the Committee (4). 
1.6. The 'classification, packaging and labelling' 
proposal was subsequently adopted in Directive Opinion on the amended proposal for a Council Directive concerning the placing of EEC-
accepted plant-protection products on the market (J) 
(90/C 56/02) 
On 9 March 1989, the Council decided to consult the Economic and Social Committee, 
under Article 198 of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
The Section for Protection of the Environment, Public Health and Consumer Affairs, which 
was responsible for preparing the Committee's work on the subject, adopted its opinion on 
31 October 1989. The rapporteur was Mr Rolao Goncalves. 
At its 271st plenary session (meeting of 16 November 1989), the Economic and Social 
Committee adopted the following opinion by 34 votes to 0, with 2 abstentions. 
(!) OJ No C 89, 10. 4. 1989. (2) OJ No C 263, 17. 11. 1975, p. 64. 
(3) OJ No C 114, 11. .5. 1977, p. 16 (Special comments B). 
(4) OJ No C 114, 11. 5. 1977, p. 16 (Special comments A). 
No C 56/4 Official Journal of the European Communities 7. 3. 90 
78/631/EEC and the 'prohibition proposals' in Directive 
79/117/EEC, which was then modified by Directives 
86/355/EEC, 87/181/EEC and 89/365/EEC. 
1.7. The proposal for a 'homologation/registration 
system' was never approved by the Council, thus main­
taining very high barriers to trade in these goods 
between Member States. 
1.8. Justification for the highly protectionist attitude 
of Member States and the lack of will in achieving 
harmonization of pesticide registration was based on 
differences, between Member States, in the conditions 
affecting consumers and the environment. The approval 
of the Single European Act, and with it the development 
of Community policies on consumers and the environ­
ment, led to fresh initiatives to find the desired solution 
which would gain the acceptance of all interested par­
ties. 
1.9. It is in this context that, 12 years later, the 
Committee has now received the amended proposal for 
a Directive concerning the placing of EEC-accepted 
plant-protection products on the market and whose 
principles we will analyse, either in general or in detail 
by way of the following comments. 
2. Principles of the proposal 
2.1. Levels of registration 
2.1.1. Registration would be two-tiered (active sub­
stances and formulated pesticides at different stages). 
Submissions, via a Member State, would be considered 
by a working group of experts, which would make 
recommendations to a standing committee. If approved, 
the active substance would be added to a 'positive list' 
(Annex I of the proposed Directive). 
2.1.2. Member States would then be able to register, 
at the national level, only those pesticide formulations 
which comprised active ingredients on the 'positive list'. 
However, Member States would not be compelled to 
register plant-protection products containing such 
active ingredients, unless 'comparable conditions', as 
referred to in paragraph 2.4.1 had been established. 
2.2. Products on the market 
2.2.1. Registration of active ingredients already 
being marketed would continue for a period up to 
10 years from the date of implementation of the Direc­
tive. During this time a review of these 'existing' pestic­
ides would be initiated. For those active substances 
which failed to be included on the 'positive list' follow­
ing a review, Member States would be required to 
withdraw the respective sales authorizations for the 
corresponding plant-protection products. 2.3. Temporary authorizations 
2.3.1. Member States would be allowed to approve 
the emergency use, for a 120-day period, of products 
containing active ingredients not included on the 'posi­
tive list'. 
2.3.2. Member States may, for a period of three 
years, allow the marketing in their individual territories 
of plant-protection products containing new active sub­
stances not yet included in the 'positive list' (i.e. not on 
the market at the Directive implementation date) if 
certain defined conditions of human and environmental 
safety are proved to have been accomplished. 
2.4. Mutual recognition 
2.4.1. An attempt towards the 'mutual recognition' 
between Member States of the registration of formu­
lated pesticides is made. Thus when registration had 
been granted in one Member State, then other Member 
States must also grant registration without the need for 
additional data, unless those Member States refusing 
registration can demonstrate that agricultural, plant 
health or environmental conditions are 'not compar­
able' in the regions concerned. 
2.4.2. As a step towards the standardization of pro­
cedures within the Community it is established that the 
required tests shall be conducted in accordance with 
the methods of Annex V of Directive 79/831/EEC and 
in keeping with the rules of Directive 86/609/EEC. It 
is, also, stated that the Standing Committee on Plant 
Health shall define the uniform principles for the con­
ditions which the Member States need to follow for the 
registration of phytopharmaceutical products. 
2.5. Standing Committee on Plant Health 
2.5.1. The Standing Committee on Plant Health set 
up by Council Decision 76/894/EEC is designated as a 
steering committee for handling all technical aspects of 
the registration system, namely those concerned with 
the Annexes, including the positive list of active sub­
stances as well as the principles to be followed by 
Member States in the processing of registrations of 
phytopharmaceutical products. Such a committee con­
sists of representatives of the Member States but with­
out representation of the economic partners. 
2.6. Protection of data 
2.6.1. Some of the data submitted in support of an 
application for inclusion of an active substance on the 
'positive list' would not be accessible to alternative 
source applicants for a period of 15 years from the 
date of its first corresponding product registration in a 
Member State. A definition of data liable to be kept 
confidential is given in the proposal. 
7. 3. 90 Official Journal of the European Communities No C 56/5 
3. General observations 
3.1. Definition of principles 
3.1.1. Previous proposals by the Commission to har­
monize the registration of pesticides throughout the 
Community have failed to obtain the agreement of 
Member States. However, it is foreseeable that, as a 
result of the Single European Act, a reinforcement of 
the political will to achieve such an objective would be 
reflected in this area as has happened in other fields. 
Thus, the Committee feels that this is an opportune time 
to establish the solution needed to create conditions 
enabling the free circulation of phytopharmaceutical 
products. 
3.1.2. However, the Committee is of the opinion that 
the prime objective of any rules in this matter has to 
ensure that pesticides used by farmers and growers are 
both efficacious and safe, either for man, animals or 
the environment. 
3.1.3. The Committee is conscious that differences 
throughout the Community in agronomic, environmen­
tal and plant health conditions dictate that the com­
pletely free circulation of plant-protection products is 
not easy to achieve and that innovative concepts have 
to be created, in order to achieve such free circulation 
as soon as possible without adverse effects. 
3.1.4. In this connection special attention must be 
given to protecting pesticide users against harmful 
effects to their health. The principe of the free circu­
lation of pesticides must not mean that their use 
deprives the Member States of the means to protect 
workers in the same way as they are protected against 
risks from other chemical and biological agents at the 
workplace. It should be pointed out that the framework 
Directive 80/1107/EEC empowers the Member States to 
apply legal and administrative measures which ensure 
more far-reaching protection for workers. 
3.1.5. In this context also the Committee emphasizes 
the need to enable Member States to further improve 
the protection of workers, and the need to pay adequate 
attention in the proposed Directive to safety and health 
issues. 
3.1.6. The Committee, however, recognizes that 
whereas such differences are also present in some indi­
vidual Member States due to factors such as size and 
differences in attitude and agronomic practices, these 
differences have not yet led to regional registration in 
these same Member States. Thus, there is no country 
in Europe, even where substantial regional differences in soil and climate occur, in which plant-protection 
products can be registered differently in its different 
constituent regions. In such difficult situations, sol­
utions have been achieved by the use of warnings and 
advice on product labels thus providing instructions on 
the appropriate use of the product under these different 
conditions. 
3.1.7. The Committee has doubts that the proposed 
Directive is correctly based on Article 43 of the EEC 
Treaty. Although of eventual consequences for agri­
culture, as it may also be for the environment or even 
the health of workers and consumers, the substance of 
the Directive concerns the marketing of products being 
an input of farming activity but not the agricultural 
production objective of the common agricultural pol­
icy. Thus the proposal for a Directive envisages the 
need to approach the legislations of Member States for 
the establishing and fulfilling of the internal market, a 
matter covered by Article 100a of the Treaty. 
3.2. Levels of registration 
3.2.1. The two-tiered system proposed by the Com­
mission takes account of the need to protect the 
environment and is acceptable under present con­
ditions. However, it makes the scheme more compli­
cated as it leads to registration of the active substances 
on the 'positive list' and of the plant-protection prod­
ucts in the '12 Member States'. Because effective plant 
protection is of great economic importance, either the 
Commission or the Member States should endeavour 
to avoid any unnecessary delays and complications in 
the implementation of the Directive. 
3.2.2. The introduction of a positive list should not 
preclude the acceptance in an individual Member State, 
without having to follow the procedure for inclusion 
in such list, of a plant-protection product with an active 
ingredient for solving specific problems of limited scope 
— for certain crops (e.g. bananas, pistachios or rice), 
or for uncommon pests (e.g. white fly). 
3.3. Harmonization of registrations 
3.3.1. Besides the option of harmonization chosen 
by the Commission, it would be theoretically possible 
for active substances and plant-protection products to 
be approved by a decision at Community leven (e.g. by 
a new central 'European Authority'); the current EEC 
Treaty, however, rules out this solution. The present 
Commission proposal is acceptable at least as a first 
step towards more far-reaching harmonization. Auto­
matic mutual recognition between the Member States 
of the acceptance of plant-protection products is ques­
tionable as there are as yet no harmonized testing and 
checking procedures. 
No C 56/6 Official Journal of the European Communities 7. 3. 90 
3.4. Mutual recognition 
3.4.1. The Committee considers that automatic 
mutual recognition is not possible for the reasons given 
in 3.1.3 and 3.3.1. It should, however, be possible to 
work towards more far-reaching harmonization which 
would eventually lead to a mutual recognition system. 
3.4.2. To attain such a goal the Economic and Social 
Committee is of the opinion that a 'task force', drawn 
from the Standing Committee on Plant Health should 
start at once to select a list of priorities of the tests 
covered by Annex III and considered essential for the 
appreciation of the different types of phytopharmaceu-
tical products (i.e. as envisaged in Article 17 of the 
proposed Directive) and then to proceed to the respect­
ive standardization of methods. 
3.5. Products on the market 
The Committee suggests that Annex I should initially 
include the approximately 70 active substances which 
are acknowledged by the Commission as being cur­
rently approved in all Member States. This would facili­
tate the work required for the inclusion of the almost 
400 active substances remaining. In this regard the 
Committee fears that the 10-year period mentioned in 
Article 8 (3) is too long and could delay application 
from industry to submit the relevant dossiers. Addition­
ally it must be recognized that different manufacturers 
of the same active substance sometimes co-exist within 
the Community and, in this context, it is by no means 
clear what legal procedure would be used to decide who 
among these several producers should be the applicant. 
It must, however, be ensured that the provisional 
acceptance of an active substance is reconsidered as 
a matter of priority by the Standing Committee, in 
accordance with the provisions of Articles 6.6 and 11.4 
of the proposal, if the approval of a plant-protection 
product containing this active substance is revoked in 
a Member State for health or environmental reasons. 
3.6. Temporary authorizations 
3.6.1. The 'provisional registration' as is practised 
in some Member States (e.g. France, United Kingdom 
and Portugal) may offer a transitionary positive sol­
ution, but the Committee does not believe that the 
Commission has, in its proposal, considered this as 
offering a concrete solution. In fact the Commission, 
in contrast to those Member States adopting such a 
scheme, requires the submission of a full data package, 
including long-term toxicity studies before inclusion in 
the 'positive list' can be considered. Such a pre-requisite 
shall preclude any possibility of 'provisional regis­
tration' in this context. The Committee thinks that the 
system, as it is presently practised, is adequate, and that 
it is only necessary to harmonize its regulation in the 
12 Member States, so as to avoid distortion in competi­
tive conditions. 3.6.2. The Committee considers that the maximum 
three-year period during which Member States may 
agree to a 'provisional registration' for active substances 
being considered for inclusion in the positive list, is too 
short. If the Standing Committee subsequently takes 
longer than three years to agree to its inclusion in the 
'positive list' then the product(s) formulated with that 
ingredient must be withdrawn from the market, with 
consequent losses for the economy of the country con­
cerned in particular and for the Community in general. 
Only if serious adverse effects to either man of the 
environment are strongly suspected should the 'pro­
visional registration' given by the Member State be 
suspended before the final decision on inclusion of the 
substance in the positive list has been taken. 
3.7. Standing Committee on Plant Health 
3.7.1. The Committee does not doubt the skill and 
ability of the experts who will constitute the Standing 
Committee but is not too optimistic regarding the 
demands on their availability and time. They will live 
in 12 different Member States and will have to be aware 
of nearly 450 dossiers of the active substances currently 
existing in the market and, on average, evaluate a 
further 20 new active ingredients annually. Taking into 
consideration all the elements covered by Annex II, 
there can be no doubt regarding the enormity of the 
task if it is to be done properly, as needed. Thus, the 
Committee reinforces the hope of a fast change of 
the Standing Committee into a more pragmatic and 
efficient operational body. 
3.8. Date requirements 
3.8.1. In view of the very high level of expertise 
required to select which of the different data should be 
submitted in support of either the active substance 
or the phytopharmaceutical products, the Committee 
thinks that such selection should be left to the Standing 
Committee. The Standing Committee should thus 
establish flexible data requirements which should con­
form to the proposed applications of the product rather 
than rely on an exhaustive and detailed listing of 
requirements as is currently included in Annexes II and 
III. For the same reasons, the Committee does not 
consider itself competent to enter into a detailed analy­
sis of the data requirements currently proposed by the 
Commission in Annexes II and III. 
3.8.2. The Committee is also of the opinion that 
there should be a clearer difference in the criteria for 
data necessary to support the active substance (i.e. 
Annex II) and those for the product (i.e. Annex III). 
This is not the case in the present proposal (e.g. data 
requirements for residues appear in both Annexes) 
which demonstrate an excessive preoccupation with the 
need to submit a completed check-list of data. 
7. 3. 90 Official Journal of the European Communities No C 56/7 
3.9. Tests using animals 
Within the same context of these extensive data require­
ments listed in Annexes II and III, the Committee feels 
obliged to express its concern regarding the multiplicity 
of data requirements which are derived from tests using 
animals. This is in contradiction with opinions pre­
viously expressed by both the European Parliament and 
by this Committee, that the use of animals for testing 
should not proceed, if alternative in vitro test pro­
cedures are available. 
3.10. Protection of data 
3.10.1. The Committee is aware of the high cost of 
pesticide research, necessitating substantial investments 
on the part of firms in connection with examining and 
developing a plant-protection product, and is pleased 
to note that the Commission proposal adequately 
protects the proprietary data rights of industry as set 
out in the relevant dossiers. Under the proposed rules, 
it would appear that firms operating within the Com­
munity will be able to develop their activities and to 
safeguard and enlarge their share of the market, in face 
of the very aggressive competition from third country 
manufacturers. 
3.10.2. The Committee considers it to be of utmost 
importance to ensure free competition in this area of 
activity, but this has to be maintained within fair limits 
and, in particular, must take into consideration those 
firms developing new active substances as against the 
economic interest of the competing 'me-too' producers. 
3.11. Right to be heard 
3.11.1. Within the same degree of fairness, the Com­
mittee thinks that the provision whereby the Standing 
Committee may hear the views of the interested party 
on his own dossier should not be one-sided. Thus the 
applicant under Article 9 must have the right of being 
heard, if he so wishes, by the same procedure. 
3.12. Right of appeal 
3.12.1. Additionally, the Committee considers that a 
'right of appeal mechanism' has to be considered as 
one of the most elementary rights in a democratic 
society and also for the good of the transparency of the 
system, which has been overlooked in the proposal for 
the Directive. 
4. Particular observations 
4.1. Article 2 (2) 
The presented definition of 'residues' is not in accord­
ance with that given by the FAO or the WHO, it being 
so broad as to encompass everything. 
The Committee would prefer to adopt the classic defi­
nition of the WHO or, if the Commission insists on maintaining this definition, suggests the inclusion of 
'active' between 'more' and 'substances'. 
4.2. Article 3 (3) 
In accordance with Article 15 (subparagraph (1) (k)), 
plant-protection products are registered for the specific 
uses for which they have been accepted. The principles 
of integrated pest control, although deserving the sup­
port of the Committee, have nothing to do with the 
registration of the pesticides. Its application is com­
pletely out of the scope of the proposed Directive system 
and taking into consideration its importance should be 
subject to a specialized document of the Commission, 
harmonizing principles and procedures in the Com­
munity. Its mention at this point minimizes its rel­
evance. 
The Committee thus considers that the last phrase of 
the article must be deleted. 
4.3. Article 4 (1) (b) (w) 
The Commission should define more clearly the 
expression 'unacceptable adverse influence'. 
4.4. Article 4 (1) (c) 
One of the aims of the Community must be the harmon­
ization of methods and testing procedures. That is the 
way foreseen in many different technical areas and will 
certainly be one of the goals to be pursued by the 
appropriate technical committee. The expression 
'methods in general use', particularly when covering 
very delicate and difficult analysis, such as those of the 
organic active substances, its isomers and metabolites, 
has no scientific meaning. 
The Committee suggests its replacement by 'methods 
accepted by the registration authorities, harmonized in 
accordance with the process foreseen in Article 18' (and 
fulfilling the objective detailed in Article 17). 
4.5. Article 5(1) and (2) 
The Committee considers that both the initial period 
of inclusion in the 'positive list' and the respective 
renewals must be fixed at 10 years. The Committee 
therefore advises changing the renewable periods from 
'5' up to '10' years. 
The reasons for this comment are included in para­
graphs 3.10.1 and 3.10.2 dealing with the similar prob­
lem of 'data protection rights'. 
4.6. Article 6(1) 
The Committee has already expressed in paragraph 
3.7.1, its doubts regarding the ability of the Standing 
No C 56/8 Official Journal of the European Communities 7. 3. 90 
Committee and the Commission, to accomplish, in a 
reasonable time, their obligations in view of such a 
complicated procedure, and in the light of limited 
human resources. 
In any event, the Committee thinks it most useful to 
insert the expression 'without delay' between 'refer' 
and 'the dossier'. 
4.7. Article 6 (3) 
As expressed in paragraph 3.11.1, the Committee con­
siders that, for the prestige of the Community and its 
executive arms, the applicants must have the right of 
free access to the Commission and to the Standing 
Committee and thus suggests that the words 'invited 
by the Commission to:' be replaced by 'invited by the 
Commission to take the initiative and may request the 
Commission for an opportunity to:'. 
4.8. Article 8(1) 
The Committee suggests the inclusion of stored prod­
ucts protection pesticides in the same scheme and the 
insertion between 'production' and 'which' of the 
expression 'or storage'. The Committee also advises the 
extension of the referred period from 120 days to one 
year as the Committee does not think it feasible that 
the procedure laid down in Article 18 allows sufficient 
time for the continuation, if so agreed, of the process 
initiated by the Member State. 
4.9. Article 8 (2) 
As previously mentioned in paragraph 3.6.2 the Com­
mittee feels the need for true 'provisional registration' 
as practised in a number of Member States like the 
United Kingdom, France and Portugal and recommends 
that the Commission should study means by which such 
a procedure could be introduced into the Registration 
system, thus permitting a trial marketing during a mini­
mal period of five years (possibly renewable). 
The Committee considers that the process proposed by 
the Commission, particularly in cases where inclusion 
of the active ingredient in the positive list is subject to 
delay, is likely to fail particularly in view of such a trial 
marketing period being so short as that proposed (three 
years). 
4.10. Article 8 (3) 
The Committee considers it important that the essential 
outline for the gradual examination of active substances 
should already be laid down in the Directive. 
The Committee strongly recommends, as in 3.5, that 
Annex I should initially include those 70 or so active 
substances already accepted by all Member States. 4.11. Article 9(1) 
The Committee considers that the remaining text after 
'distributor' has to be deleted. In accordance with the 
rules of free competition that constitute one of the 
major principles of the Community, the application for 
acceptance should not be restricted in any instance, or 
discriminate any class of economic agents. 
4.12. Article 9 (4) 
The Committee never agrees with vague expressions 
or unlimited periods such as mentioned here—i.e. 'a 
reasonable period'. The Committee suggests that such 
an expression be replaced by '60 days'). 
4.13. Article 10 
The Committee recommends the Commission to 
implement, via this Article, a provision according to 
which the protection of data accorded in Article 12 
(2) shall also be applied when registering in another 
Member State, under the same conditions as for the 
first country registration. 
4.14. Article 10(1) 
As mentioned in 3.3.1, the Committee accepts that 
mutual recognition is difficult to achieve before com­
plete harmonization of testing and checking procedures, 
and the establishment of criteria and principles to evalu­
ate the application dossiers. 
' So, the Committee agrees with the principle of Article 
10 (1) of the proposal but strongly recommends the 
Commission to remove the vague concept of 'compara­
bility' (mentioned but not clearly defined) in the text 
of the Article in question, replacing it by objective 
criteria. 
Otherwise conditions are being created for a possible 
new system of 'temporary non-tariff barriers' on the 
basis of controversial arguments over 'comparability', 
thereby hindering the free circulation of goods, contrary 
to the objectives of the 'internal market'. 
4.15. Article 11 (2) 
The Committee suggests that the Commission, with 
the lists received from Member States, promote the 
publication of an annual summary covering the ter­
ritories of the Community, and made available to all 
interested parties. Such a publication should also con­
tain a yearly report of the Standing Committee's activity 
and decisions. 
4.16. Article 12 (2) 
The Committee is of the opinion that the moment of 
initiation of the data protection period should not be 
7. 3. 90 Official Journal of the European Communities No C 56/9 
from the first acceptance in a Member State but from 
the date of publication or communication of inclusion 
on the positive list as is the usual practice. 
Also the Committee considers that additional demands 
have to be protected as well. Practical experience con­
firms that the registration of plant-protection products 
is an on-going process, so the protection should not be 
limited to the first registration but bound to the first 
assessment of any subsequent data by the competent 
authority. 
4.17. Article 13 
After 'plant-protection product', add: 'or its extension 
of use or "review"'. 
In this connection, however, the Committee would refer 
to its opinion on the proposal for a Directive on the 
freedom of access to information on the environment (') 
in which it proposed that the Commission also be 
required to provide information within the limits set. 
4.18. Article 1.5 (1) 
The labelling of plant-protection products is an import­
ant instrument for the Member States for protecting 
the users of such products against exposure hazards {cf. 
3.1.4). The Committee welcomes the provisions in this 
Article extending the requirements of Directive 78/631/ 
EEC to include labelling provisions for all pesticides 
and not only these classified as dangerous under the 
said Directive. 
4.19. Article 15 (3) 
The Committee, although agreeing with the principle 
expressed here, thinks that the expression 'unsuitable 
for' is likely to mislead the consumer and suggests its 
replacement by 'not for'. 
(') OJNoC 139,5.6. 1989. 
Done at Brussels, 16 November 1989. 4.20. Article 17(1) 
As mentioned in 4.4, there is a need to include the 
harmonization of testing methods to respond to the 
needs of Annex III. 
4.21. Article 21 
The Committee considers possible and necessary the 
entry into force of the Directive within a period not 
exceeding 12 months of the date on which it is adopted. 
5. Conclusion 
5.1. Aware of the importance of the regulation of 
the marketing of phytopharmaceutical products, in 
accordance with the principles of the Single European 
Act, and conscious of the existing implications of differ­
ent orders, the Committee welcomes the proposal for 
a Directive but considers that if the aims of the proposal 
are to be achieved, some basic changes are necessary, 
as suggested in the foregoing text, with particular 
emphasis on the following points: 
— the need to bypass the bureaucracy which could 
well result from the proposed two-tier system by 
simplifying the procedures, 
— the urgent need to standardize in all Member States 
the principles and criteria used to prepare and evalu­
ate the dossiers needed to support the registration 
of plant-protection products, as well as the corre­
sponding test methods used to obtain these data, 
— the harmonization of provisional registrations for 
existing and new products, 
— re-examination of the procedure for including active 
substances in the positive list in Annex I, 
— consideration of the implementation of a multi-State 
procedure for the registration of plant-protection 
products, once the necessary standardization is 
obtained by the principles and criteria used to pre­
pare and evaluate the application dossiers. 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE 
No C 56/10 Official Journal of the European Communities 7. 3. 90 
APPENDIX 
to the opinion of the Economic and Social Committee 
The following amendments, which were supported by at least a quarter of the votes cast, were rejected 
during the debate: 
Point 3.6.2 
Delete this paragraph. 
Reasons 
This proposal refers to Article 8 (2) of the Commission proposal. The 'provisional registration' provided 
for in the Commission proposal takes minimum health and environmental protection requirements into 
consideration in so far as it is linked to a provisional examination of the registration documents submitted. 
To dispense with this as the Section does in its proposal means deferring initially the harmonization which 
the Commission is seeking to achieve. 
Voting 
For: 13. Against: 22. Abstentions: 4. 
Point 4.9 
Delete this paragraph. 
Reasons 
This proposal refers to Article 8 (2) of the Commission proposal. The 'provisional registration' provided 
for in the Commission proposal takes minimum health and environmental protection requirements into 
consideration in so far as it is linked to a provisional examination of the registration documents submitted. 
To dispense with this as the Section does in its proposal means deferring initially the harmonization which 
the Commission is seeking to achieve. 
Voting 
For: 12. Against: 20. Abstention: 1.