Report from the Commission to the European Parliament and the Council - Evaluation of the active substances of plant protection products (submitted in accordance with Article 8(2) of Council Directive 91/414/EEC on the placing of plant protection products on the market)
Date: 2001-07-25
Institutions: European Commission
Subjects: dangerous substance, environmental policy, health policy, market approval, marketing, marketing standard, pharmaceutical product, plant health product

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 25.07.2001
COM(2001) 444 final

REPORT FROM THE COMMISSION
TO THE EUROPEAN PARLIAMENT AND THE COUNCIL

Evaluation of the active substances of plant protection products
(submitted in accordance with Article 8(2) of Council Directive 91/414/EEC on the
placing of plant protection products on the market)

1

INTRODUCTION

Council Directive 91/414/EEC1 of 15 July 1991 concerning the placing of
1.
plant protection products on the market sets out a Community harmonised
framework for authorisation, use and control of plant protection products. It is a dual-
system where the Community evaluates active substances and Member States
evaluate and authorise products containing them. A basic principle of the Directive is
the development of a positive list (Annex I) of active substances that are acceptable
for the environment, human and animal health. Substances listed in Annex I are
eligible for inclusion in plant protection products that Member States may authorise
to be placed on the market at national level.

2.
The Directive provided for a 12-year programme of evaluation of the
834 active substances already on the market at the time of its entry into force in
July 1993 (the "existing" active substances) and, pending Commission Decisions on
their inclusion in Annex I, permitted their remaining on the market until July 2003
under certain conditions. The Commission split the review programme for these
substances into four phases. All other substances presented since July 1993 are
considered as "new" substances. Both new and existing substances are evaluated in
parallel.

3.
Article 8(2) of the Directive stipulated that in July 2001 the Commission
should present to the European Parliament and to the Council a Progress Report on
the evaluation programme for existing substances. In the same article,
it was
provided that, depending on the conclusions of this report, the Commission might
decide whether, for certain substances, the deadline of 12 years should be extended.
Experience shows that it will not be possible to evaluate all 834 existing substances
before 2003, 10 years after the entry into force of the Directive. Progress at the initial
pace of the first phase would have meant finishing the review around 2015. With
new measures and resources, some of which are already in place for the first and
following phases, 2008 is a more appropriate end-date. Meeting this challenging
deadline will be contingent on these new resources and procedures being put in place
and on deadlines being respected by all stakeholders.

4.
The goal of this report is to meet the obligation of the Commission to submit a
progress report on the evaluation of existing active substances. In addition, it draws
attention to the need to extend the 12-year programme of evaluation for certain
substances. In so doing, the goal is to obtain clear confirmation from the European
Parliament and the Council that the approaches to be taken by the Commission in
deciding on such extensions are sound. The report also highlights problematic areas
where the functioning of the Directive could and should be improved, and to identify
issues to be addressed in any future amendment. In this respect, it serves as a basis to
inform the European Parliament and the Council of the current perspective of the
Commission in this area and to solicit their views on how the Commission may
proceed in the future.

1

OJ L 230, 19.8.1991, p. 1.

2

5.
The Commission emphasises that, for the sake of concision and clarity, the
content of this report is restricted to progress in the evaluation of existing active
substances and that a limited amount of information can be communicated in such a
document. Complementing this report is a technical annex2 which gives full details
of the process, procedures, measures taken, impacts, problems and possible solutions.
It also includes details of the situation for new active substances

2

THE ESTABLISHMENT AND ORGANISATION OF THE PROGRAMME

6.
Directive 91/414/EEC was a new departure for the Community in several
respects. It was one of the first major items of legislation to anticipate not only the
principle of subsidiarity, but also the precautionary principle. From the outset, it
explicitly placed protection of human health and of the environment above the needs
of
relatively
straightforward.

agricultural production. The outlines of

legislation are

the

7.
First, it provided for a positive list of acceptable substances that Member
States could authorise as plant protection products. If a substance was not on the list
then it could not be used in the Community as part of a plant protection product.

Second,

8.
it established a dual assessment system. Active substances are
evaluated at Community level but the Member States evaluate and authorise products
containing those substances. The Directive provides a uniform set of risk assessment
principles and decision-making criteria that Member States must use when
evaluating products.

Third,

it set a new, demanding standard for safety assessments. The
9.
Commission and the Member States agreed that
if the basic principles of the
Directive were to be attained, Community evaluations would need to be
comprehensive and detailed. As a result, the data requirements that were fixed for
pesticides greatly exceed those required for any other class of substance including
pharmaceuticals,
food additives and commodity chemicals. A typical dossier
contains about 50,000 pages and takes about four and a half years to prepare.

Fourth, although the condition for inclusion of an active substance in Annex I
10.
to the Directive is the expectation that "a safe use may be demonstrated", it was
decided that all uses of all existing substances would be assessed. While this was
seen as useful to the Member States in their downstream authorisations of products,
it proved a significant drain on resources and an important source of delay.

11. Given the resources required, it was agreed that a system to share the work
between the Commission and Member States was required and that policy
development, decision-making and other progress should be by consensus. This has
since been recognised as a contributory factor to the delays encountered. Now, while
consensus in decision-making is always sought, it is accepted that it cannot always
be achieved.

2

http://europa.eu.int/comm/food/fs/ph_ps/index.htlm.

3

12.
It was recognised that, whenever possible, the procedures for existing and new
substances as well as the standards for assessments and the decision-making criteria
should be the same. In a parallel approach, extensive data requirements for dossiers
were also drawn up and agreed for the major classes of substances. For minor
categories, this work continues even today. Similarly, in many instances, the risk
assessment methodologies required for the evaluations did not exist and had to be
developed. It was necessary to develop new science, and then to ensure agreement on
its application. The numerous measures that had to be introduced are listed in the
annex.

13. The main sectors and interests involved as well as their roles and the impacts
of the programme on them are described in the annex.

14. The Commission has acted in several roles: as a co-ordinating Secretariat, as
chair of the Standing Committee on Plant Health3, as developer of new science, as
secretariat of the scientific committee on plants and as final decision-maker. Within
the Commission, DG Health and Consumer Protection and DG Environment are co-
responsible for managing Directive 91/414/EEC. Details of the coordination and
consultation mechanisms used are given in the annex.

15. The Member States have acted in four roles. First, each took the lead both in
preparing the draft assessment reports on the one or more active substances assigned
to them by the Commission and in acting as interlocutors with the notifiers of those
active substances during the process. Second, all acted as peer-reviewers of the draft
reports of the other Member States, identifying additional data needs and furnishing
critiques etc. as appropriate. Third, as members of the Standing Committee on Plant
Health, all participated in the decision-making on active substances. Fourth, they also
provided expertise and resources to develop the new scientific methodologies needed
to complete the assessments. A major contribution of the Member States in this area
was in agreeing to conduct the work relating to Community technical assessments in
one language. This imposed considerable difficulty at national level in the interest of
improving the Community procedure and the measure deserves recognition.

16. Notifiers are entities established in the Community that support the evaluation
of active substances by providing dossiers with the required data. Most are the
producers of active substances, acting as individual companies or collectively.

3

OJ L 340 of 9.12.1976, p. 25.

4

17. A list of all legal acts taken under 91/414/EEC for existing active substances is
given in the annex to this report. The general legal acts are threefold in nature. First,
a group of measures sets out data requirements and assessment and decision-making
criteria. When the Council adopted Directive 91/414/EEC, it included no detailed
provisions concerning the data requirements and criteria to be used by Member
States (Uniform Principles). The Commission defined these during 1993-1996.
Second, the practical details of the first phase of the review programme needed to be
elaborated. Commission Regulation (EC) No 3600/924 had to be amended to involve
Austria, Finland and Sweden upon their accession and to take further experience
acquired during the evaluation process into account. Third, the later phases of the
programme were established by Commission Regulation (EC) No 451/20005.

18. Data requirements for the conventional chemical pesticides used as active
substances in plant protection products were adopted in 1994-1996 and this work is
still ongoing for several other specific categories of active substances. Full details are
given in the annex. Due to the initial lack of consensus on criteria to assess the
conventional substances, even after harmonised data requirements had been agreed, a
significant degree of variation became apparent between review practices among
individual Rapporteur Member States. This problem had to be corrected by the
development and adoption of a series of guidance documents. Some of these required
in-depth research efforts that are still not complete. Details of guidance documents
developed or being developed are given in the annex. There were several specific
problems that arose with the first 90 substances for which individual solutions were
found. In addition, many of the lessons learned with new active substances were also
applied to existing substances. Details of these and other measures taken are given in
the annex.

3

3.1

DESCRIPTION OF THE PROGRESS MADE IN 10 YEARS

Annex I of the Directive

19. The 834 substances on the market were divided into four lists. Details of the
834 substances, as well as their current status and authorisations in the Member
States are available on the Internet6. As reported in the Table below, it is already
clear that
least 380 of the
834 substances, mainly decisions withdrawing substances from the market.

in July 2003 decisions will have been taken on at

20. The first priority list of 90 substances, established in 1992, comprised those
substances considered at that time to be the most widely used on the market as well
as those of clear concern. Details of the decision-making process flowing from
Commission Regulation No 3600/92, as amended over the years are described in the
annex. Almost all dossiers were deficient in one respect or another and, to date, there
has not been one substance that did not cause problems at some stage of the process.
This phase is not yet complete. Final decisions on all active substances on this list are
expected to have been taken by July 2003.

4

5

6

OJ L 366 of 15.12.1992, p. 10.
OJ L 55 of 29.2.2000, p. 25.
http://europa.eu.int/comm/food/fs/ph_ps/index.htlm.

5

21. The current situation is that (a) Commission Directives have been or are about
to be adopted including 13 existing substances in Annex I of the Directive,
(b) Commission Decisions have been taken not to include 16 substances in Annex I
and withdrawing them from the market, (c) 39 substances have been peer-reviewed,
and final discussions are ongoing, (d) 21 substances are undergoing or are scheduled
for peer review, and (e) one assessment report still has to be submitted to the
Commission.

22. The second list of 149 substances, established in Regulation No 451/2000,
comprised all those organophosphates and carbamates that were not on the first list
as well as other substances of concern and substances for which industry had
indicated early availability of dossiers. Commitments to support 60 of these for
Annex I inclusion were received in September 2000. Details of this list and of the
decision-making procedures foreseen are given in the annex. The outcome of the
notification procedure already implies that at
least 89 substances should be
withdrawn from the market in July 2003. On past experience, it can be expected that
the Community evaluations will be ongoing for the substances on this list during
2003-2005, even with the corrective measures provided for in the new regulation to
help speed up decision-making. Further Commission Regulations will be adopted in
the second half of 2001 containing detailed rules for evaluation of this and the third
list of substances. For the up to 60 active substances for which both a complete
dossier is available in April 2002 and for which a draft assessment report prepared by
the Rapporteur Member State will be available in 2003, a derogation to extend the
deadline of July 2003 would be necessary to allow detailed evaluation of the dossiers
submitted. About 55 active substances are expected to fall into this category.

23. The third list was also introduced by Regulation No 451/2000. It comprises the
402 remaining chemical substances, also considered 'pesticides' (as the term is
commonly understood) but not as widely used as the second list. In a first step,
notifications of interest were received in June 2000 for 192 of them. In a second step
in November 2000, detailed notifications including lists of studies and endpoints
were received for 167 of these. The institution of this list and the outcome of the
notification procedure already implies that at
least 235 substances should be
withdrawn from the market in July 2003. Details of this list and of the decision-
making procedures foreseen are given in the annex. Derogations for Member States
to continue authorising some of these substances beyond July 2003 will therefore be
necessary.
is estimated that such derogations will be required for about
150 notified substances. Derogations will not be given where there are safety
problems.

It

24. The fourth list, established by default, comprises the 193 remaining substances
identified as being of lower concern and to which other data requirements than those
for lists 1-3 might apply. It includes (a) microbial pesticides, (b) substances already
authorised in foodstuffs, (c) plant extracts, (d) animal products, (e) substances used
in organic farming, (f) rodenticides, (g) storage products and (h) commodity
chemicals. While these are conventionally viewed as being of lower concern, some
find wide use in the Community. 27 of these substances are no longer authorised in
any Member State. A notification procedure is envisaged in 2002 and about
69 notifications are expected. Thus, at least 124 of the substances on this list may be
expected to be withdrawn from the market in 2003 and about 69 (but the number
could be as high as 166) substances on the list will thus need to be evaluated in the
final phase during 2004-2008. For those active substances for which preliminary

6

evaluations or acceptable data are available in May 2003, a derogation to extend the
deadline of July 2003 will be considered to allow their evaluation. Such derogations
will be withdrawn where a complete dossier is not submitted.

Table: The situation in 2001 for the existing active substances to be evaluated in each
phase of the review programme (with approximate share of total market in 1993).

Phase

First
Second
Third
Fourth
TOTAL

N° substances (& %
1993 market share)

Being
examined

To be
examined

90 (30%)
149 (40%)
402 (25%)
193 (5%)
834 (100%)

61
0
0
0
61

0
60
167
166
393

Already clear
that will be
withdrawn
16
89
235
27
367

In
Annex I

13
0
0
0
13

3.2

Other Annexes of the Directive

25. Directive 91/414/EEC was adopted with Annexes II and III containing only a
skeleton list of headings. Data requirements for chemical active substances
(Annex IIA) and for products containing those substances (Annex IIIA) were
adopted, for all the headings in the original text of the Annexes to the Directive by
Commission Directives during 1994-1996. Data requirements for microbial active
substances and for products containing them were adopted by Commission Directive
in 2001.

26. Directive 91/414/EEC was adopted with Annexes IV and V empty. Work is
currently underway to fill Annex IV (Risk phrases) and V (Safety phrases) to
complement those in Council Directives 67/548/EEC7 (on dangerous substances) and
1999/45/EC8 (on dangerous preparations). The Commission intends to adopt a
Directive early in 2002 filling these annexes.

27. Directive 91/414/EEC was adopted with Annex VI empty. The Uniform
Principles for risk assessment were adopted by Council Directive 97/57/EC9. The
Commission intends to update these for microbial plant protection products early in
2002 and later for other minor categories of plant protection product.

4.

CRITIQUE OF THE ORGANISATION AND EFFICIENCY OF THE REVIEW PROCESS

28.
In looking at the programme’s achievements and the problems encountered,
consideration has to be given first and foremost to the time it took to establish the
required legislative, administrative, technical and informal structures, and to the
arduous scientific and methodological learning curve that had to be climbed.

7

8

9

OJ L 196 of 16.8.1967, p. 1.
OJ L 200 of 30.7.1999, p. 1.
OJ L 265 of 27.9.1997, p. 87.

7

29. Decision-making was slow between 1993, when the Directive entered into
force, and 1999 for the reasons already noted. An already complex piece of
legislation became progressively more complex in application as expectations
mounted on all sides, ensuring that standards and criteria were not only maintained at
a high level but were effectively raised. One particular problem relates to lack of
resources. Others include the procedures foreseen in the legislation, the need to build
confidence among Member States, the time needed to agree on data requirements and
for industry to generate the data. These problems are now largely solved and the
decision-making rate for existing substances has recently improved dramatically,
from 2 decisions per year during 1994-1999 to 13 in 2000 and 21 (projected)
in 2001. The rate for new active substances is also accelerating at the same rate.

30. The evaluation programme could be complete by end 2008, when the last
decision on an existing active substance will be taken. Review at national level of
products containing that substance would still continue for an additional two years
after the decision. During 1993-2008, there will be progressive reduction in the
market availability of substances on each of the priority lists. There will also be a
significant cut in July 2003 in the numbers of substances available. The substances in
question will be predominantly those that have limited use in agriculture. Offsetting
this, there will be a progressive increase in the availability of new active substances.

31.
It is clear that the market will experience a sharp change after July 2003 - the
watershed - with the loss of up to 500 substances. There will be a smaller number of
substances, albeit of demonstrated safety, and these will be more widely used than
today. Authorisations of substances in just one or two Member States will be
uncommon and this may encourage wider co-operation among Member States for
national authorisations. By 2008, about 450 substances should be available on the
European market. Examining the numbers of substances used today without
consideration of the types of substances available, the conclusion is that this number
will be adequate. However, given that many of the existing substances being lost are
insecticides, and that insecticides account for only a small proportion of the new
actives coming onto the market, there may well be a discordance between what is
needed and what will be available. Market forces should eventually correct this
situation, but not necessarily in a time frame solving all problems. Related to this
trade due to subsequent
loss of substances,
amendments of the pesticides residues legislation. Community trading partners will
be informed through WTO procedures and developing countries through the
procedures established under the ACP-EC Partnership Agreement signed in Cotonou
in June 2000.

there may be repercussions for

5.

PLANNING OF THE WORK PROGRAM UP TO AND BEYOND 2003

32.
It is proposed to finish the first list by July 2003 with the established system
and process. The evaluation of the second list should be complete in 2005 and the
third and fourth lists in 2008, by which time re-evaluation of substances already in
Annex I will have to start. It is essential to recognise that derogations foreseen
until 2008 are contingent on the necessary resources, structures and procedures being
available. It also has to be understood that any major new area of concern for which
new data requirements might be identified could also delay dossier preparation and
evaluation.

8

33.
In spite of the recent major increase in decision-making from 2 to 20 decisions
per year, it should be noted that, if the programme is to be concluded by the end
of 2008, an average of 50 decisions per year on existing active substances (peaking at
85 in 2007) will need to be attained. This will be brought about by (i) procedural
changes for dossier examination and evaluation, (ii) increased resources in the
timelines and
(iii)
Commission and the European Food Authority,
(iv) improved dossiers and use of information technologies.

tighter

34. The evaluation process is an enormous task that cannot successfully be
managed without improving procedures for evaluation and decision-making. The
Commission together with the Member States has made a series of improvements in
the procedure in the second and later phases of the review. Some of these have also
been adopted for the remaining first list substances. For the future development of
the process and to bring it closer to the citizen, the Commission is looking at ways to
improve the participation of other stakeholders. Future activities aim at
the
harmonised development of advanced methods of risk assessment allowing better
identification of critical areas of concern and a focus on the most effective risk
mitigation measures. This next generation of tools will be developed on a global
scale with full consultation of partners in the OECD, to make sure that scientifically
valid methodology will be defined and accepted worldwide. Sizeable resources and
research will be needed to create the necessary data for this next generation of risk
assessments.

35. The evaluation of a dossier takes two to three man-years and the Commission,
and Member States have limited capacity. Decision making at Community level with
15 Member States is also very demanding of time and resources. To ensure that
Member States can carry out the necessary evaluation work, Regulation No 451/2000
provides that Rapporteur Member States request a fee from the notifiers to cover the
work they have to do. This and other measures taken recently should permit
acceleration to be maintained. One solution to the resource problem, found at the
beginning, was to share the work using the Rapporteur Member State system. Other
solutions are also being explored. Non-EU countries face the same resource
problems and the long-term strategy is to share the work of pesticide evaluation at
global level.

36. The increases in resources in the Commission and the Member States,
alongside the ascent of the long learning curve, have permitted a dramatic increase in
the last year in the rate of decision-making (up from two to about 20 per year) for
active substances. To maintain this level will require a major and additional influx of
new resources.

for a European Food Authority foresees a
37. The Commission proposal
significant increase in personnel for the assessment of active substances in the
Community but it is necessary in the planning of such increases to take note of the
recent opinion of the Scientific Steering Committee, which draws attention to a
critical lack of expertise in Europe in the field of regulatory risk assessment10. The
EFA will provide the foundation upon which to build coming phases of the

10

Conclusion 19 of the first report on the harmonisation of risk assessment procedures. Part 1: The report
of the Scientific Steering Committee's Working Group on Harmonisation of Risk Assessment
Procedures in the Scientific Committees advising the European Commission in the area of human and
environmental health 26-27.10.2000.

9

programme. The switch from the current system to a new arrangement that is both
sustainable and efficient in the long term can only be achieved via close co-operation
with the Member State institutions in this field. Existing procedures in similar fields
(medicines, veterinary drugs, food or feed additives) could be used as models. Based
on current work procedures, about 25 qualified evaluators are going to be required at
the level of the European Food Authority for active substances, complemented by
additional staff to fix MRLs for residues in food and agricultural commodities.

impact of a significantly reduced number of substances is
38. The potential
described in the annex. Regulation No 451/2000 provides for the eventuality that, if
the Commission may take temporary
necessary, and on a case by case basis,
measures for uses for which additional
technical evidence has been provided
demonstrating (i) no safety concerns, (ii) the essential need for further use of the
active substance and (iii) that there is no efficient alternative. The Commission will
be sparing in granting such derogations.

39. Article 9 of Directive 91/414/EEC provides that Member States can, at
national level, apply a relatively flexible system for extensions of authorisations of
plant protection products for minor uses. A guidance document on voluntary mutual
recognition of authorisations for minor uses has been developed together with
Member States and stakeholders. Member States are invited to define at national
level minor uses and minor crops and to apply the system proposed in the guidance
document to facilitate authorisations for minor uses.

40. The July 2003 deadline would only be extended for active substances for
which sufficient information concerning their impact on health and the environment
has been submitted and for which there is a clear commitment by industry to
demonstrate that there are acceptable uses in the sense of the Directive. As explained
above, the Commission aims to finalise the review programme in 2008 and therefore
an extension of the deadline until end of 2008 is proposed. The measure extending
the deadline would be adopted in June 2003 and follow the approaches outlined
below.

41.
First list: For all remaining active substances, a full dossier has to be available
in May 2002. In exceptional cases this deadline might be later because the evaluation
and the setting of specific additional data requirements for individual substances is
not yet finalised. The number of active substances for which no final decision can be
made will be very limited and known by early 2003.

42.
Second List: The completeness checks will be finalised by end 2002. Decisions
on extending the deadline can be taken early in 2003 for those active substances for
which there is a complete dossier.

43. Third list: It
is expected that a full data package will be submitted by
May 2003 for about 150 of the 402 active substances. Since this deadline is very
close to the overall deadline of 25 July 2003, it will not be possible to exclude that
for some of the active substances a decision on extension will have to be repealed in
autumn 2003. The number should be rather limited, since industry has already made
its selection of substances for which it still has an interest.

Fourth list: Only for

44.
notification has been received would prolongation of the deadline be proposed.

those active substances for which an acceptable

10

6.

CONCLUSIONS

In presenting this progress report,

45.
requirement to report under Article 8(2) of the Directive is fulfilled.

the Commission considers that

the

46. Although progress, in terms of the numbers of evaluations that have been
finalised, has not been as good as was originally anticipated, a solid foundation has
been laid in legislation, in organisation and collaboration, and in learning from
experience and in planning. This has now started to yield dividends. The next few
years will see a tremendous change in the marketing and use of plant protection
products and the high safety standards set in the Directive will be realised, albeit at a
cost.

47. With the new measures provided for in the second and third phases of the
programme, combined with the infrastructures and expertise developed in the
Member States, and the resources proposed for this area in the European Food
Authority, evaluation and decision-making on existing active substances will
increase significantly in the future; barring unforeseen surprises the current
programme should be complete by end 2008. The Commission notes the need to
recognise that the derogations foreseen until 2008 are contingent on the necessary
resources, structures and procedures being made available at all levels. It is crucial,
however, if the deadlines are to be met that all partners in the process recognise and
meet their responsibilities in this regard.

48. The deadline of July 2003 needs to be extended, as provided for by the
Directive, for certain specific substances. Specific derogations will only be proposed
for substances that meet agreed criteria, and where there is sufficient data and no
identified concerns. In addition, derogations will take into account essential uses to
be identified as soon as possible to facilitate the planning of appropriate national
measures.

Finally, although the Commission recognises the need to amend Directive
49.
91/414/EEC, it will await the reactions of Parliament and Council to this report
before bringing forward proposals for amendment in 2002.

11