Commission Regulation (EC) No 1095/2007 of 20 September 2007 amending Regulation (EC) No 1490/2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and Regulation (EC) No 2229/2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (Text with EEA relevance )
Date: 2007-09-20
Institutions: European Commission
Subjects: administrative formalities, dangerous substance, exchange of information, marketing standard, plant health product

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COMMISSION REGULATION (EC) No 1095/2007

of 20 September 2007

amending Regulation (EC) No 1490/2002 laying down further detailed rules for the implementation
of the third stage of the programme of work referred to in Article 8(2) of Council Directive
91/414/EEC and Regulation (EC) No 2229/2004 laying down further detailed rules for the
implementation of the fourth stage of the programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

Having regard to the Treaty
Community,

establishing the European

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 8(2) thereof,

Whereas:

(1)

(2)

Article 8(2) of Directive 91/414/EEC provides that the
Commission undertakes a programme of work for the
gradual examination of active substances on the market
two years after the date of notification of this Directive.
This programme is still ongoing.

The second and third stage of work are laid down by
Commission Regulation (EC) No 451/2000 of 28
February 2000 laying down the detailed rules for the
implementation of the second and third stages of the
work programme referred to in Article 8(2) of Council
Directive 91/414/EEC (2) and Commission Regulation
1490/2002 of 14 August 2002 laying down further
detailed rules for the implementation of the third stage
of the programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC and amending Regulation
(EC) No 451/2000 (3). The fourth stage of work is laid
down by Commission Regulation (EC) No 2229/2004 of
3 December 2004 laying down further detailed rules for
the
the
the
programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC (4).

implementation of

fourth stage of

(1) 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).
(2) OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regu-

lation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

(3) OJ L 224, 21.8.2002, p. 23. Regulation as last amended by Regu-

lation (EC) No 1744/2004 (OJ L 311, 8.10.2004, p. 23).

(4) OJ L 379, 24.12.2004, p. 13. Regulation as amended by Regulation

(EC) No 647/2007 (OJ L 151, 13.6.2007, p. 26).

(4)

(5)

(6)

(7)

Several substances in the third and fourth stages are still
in the assessment phase. It appears necessary to speed up
the examination process. Depending on whether a
substance is already under peer
for
certain aspects of
the procedure, different provisions
should apply.

review or not,

To speed up the examination process the workflow of
review and relationship between notifiers,
the peer
Member States,
the European Food Safety Authority
(EFSA) and the Commission and the obligations of
each of
the
programme should be adapted without harming the
level of safety for health and the environment.

the implementation of

the parties

for

are

the

that

clear

there

indications

The resources of the EFSA should be used efficiently.
Where
active
substance concerned meets the criteria referred to in
Article 5(1) of Directive 91/414/EEC, and in particular
does not have any harmful effects on humans or animal
health or on groundwater or any unacceptable influence
on the environment, that substance should be included in
Annex I to that Directive. Such clear cases would not
require detailed scientific advice from the EFSA before the
substance is included in Annex I. The EFSA should,
however, deliver its view on those substances later,
in
to ensure a harmonised approach when
particular
Member States apply the uniform principles at
the
evaluation of authorisations. Where, on the contrary,
there are clear indications that an active substance has
harmful affects; the Commission is not required to have
this clear situation confirmed, so it should have the
possibility to decide on non-inclusion without consulting
the EFSA.

The EFSA should focus on cases where the remaining
doubts need to be resolved before a decision on the
inclusion of the active substance concerned can be taken.

To further speed up procedures, it should be possible to
grant a longer withdrawal period in cases where there are
such remaining doubts and notifiers agree to withdraw
their support of the inclusion of the active substance.
This procedure should only apply to cases where there
are no clear indications that the substance has harmful
effects on humans or animal health or on groundwater
or any unacceptable influence on the environment.

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(8)

(9)

To identify cases where there are clear indications of
either a substance having no harmful effects or, on the
contrary, a substance having such effects, criteria should
be set out.

It shall collate the comments it receives, including available
comments
from the EFSA, and forward them to the
Commission, Member States and the notifiers.

In order to ensure that the deadlines for evaluation are
met, and to ensure equal treatment of all notifiers, the
current legislation provides that notifiers may not submit
new studies after a certain stage of
the assessment,
subject
to limited exceptions. This general principle
should be retained, but it is appropriate to clarify when
notifiers may submit new information other than studies.

3.
The EFSA shall make available at specific request or
keep available for consultation by any person the following:

(a)

the draft assessment report except the elements thereof
which have been accepted as confidential in accordance
with Article 14 of Directive 91/414/EEC;

(10)

Regulations (EC) No 1490/2002 and (EC) No 2229/2004
should therefore be amended accordingly.

(b) the list of any data required for the evaluation in view of
the possible inclusion of the active substance in Annex I
to that Directive as finalised by the EFSA where it has
finalised such a list.

(11)

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

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

Article 11a

Examination of the draft assessment report

report

The Commission shall, without delay, examine the draft
the
the
assessment
rapporteur Member State and the comments received from
other Member States, the EFSA and from the notifiers in
accordance with Article 11(2).

recommendation by

and

Amendments to Regulation (EC) No 1490/2002

Regulation (EC) No 1490/2002 is amended as follows:

Article 11b

1. Articles 11 and 12 are replaced by the following:

‘Article 11

Receipt of and access to the draft assessment report

1.
After receiving the updated summary dossier and the
draft assessment report referred to in Article 10(1) the EFSA
shall, within 30 days, acknowledge to the rapporteur
Member State receipt of that report.

fulfil

In exceptional cases where the draft assessment report clearly
does not
the requirements concerning the format
recommended by the Commission, the Commission shall
agree with the EFSA and the rapporteur Member State on
a period for resubmission of an amended report. This period
shall not exceed two months.

2.
The EFSA shall without delay communicate the draft
assessment report to the Commission, the other Member
States and the notifiers setting a time period of no more
than two months for the submission of comments by those
Member States and the notifiers.

Active substance with clear indications that they do not
have any harmful effects

If there are clear indications that it may be expected that the
active substance does not have any harmful effects on
human or animal health or on groundwater or any unac-
ceptable influence on the environment, as set out in An-
nex V, Article 12(1)(a) and (2)(a) shall apply.

Article 11c

Consultation of the EFSA

1. Where Article 11b does not apply, the Commission
may, at any time during the evaluation, ask the EFSA to
carry out a peer review of the full draft assessment report
or to focus on specific points including points related to
criteria set out in Annex VI. The EFSA shall organise a
consultation of Member States
including the
rapporteur Member State.

experts

Where the Commission requests the EFSA to carry out a full
peer review, the EFSA shall deliver its conclusion at the latest
six months after the request. Where the Commission does
not request a full peer review, but only a conclusion on
reduced to three
specific points,
months. The submission of the conclusions shall
in any
event be no later than 30 September 2008.

the period shall be

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If during the peer review there are clear indications that
2.
an active substance is expected to have harmful effects on
human or animal health or on groundwater as set out in
Annex VI, the EFSA shall inform the Commission.

substance in Annex I to Directive 91/414/EEC within two
months from receipt of the draft assessment report referred
to in Article 11(2).

The Commission may take a Decision as referred to in
Article 11f.

The Commission and the EFSA shall agree on a
3.
schedule for the delivery of
the conclusions in order to
facilitate the planning of the work. The Commission and
the EFSA shall agree on the format in which the conclusions
of the EFSA are submitted.

Article 11f

Active substance for which there are clear indications of
harmful effects

If there are clear indications that it may be expected that the
active substance has harmful effects on human or animal
health or on groundwater as set out
the
Commission shall take a Decision on the non-inclusion of
the active substance in Annex I to Directive 91/414/EEC, in
accordance with Article 12(1)(a) and (2)(b) of this Regu-
lation.

in Annex VI,

Article 11d

Submission of additional
assessment report has been submitted to the EFSA

information after the draft

Article 12

Presentation of a draft directive or draft decision

1. Without
91/414/EEC,
accepted.

prejudice

7
submission of new studies

to Article

of Directive
shall not be

The Commission shall submit to the Committee a draft

1.
review report at the latest six months after:

2. Where the EFSA considers that additional information
from the notifier is necessary to comply with a request made
by the Commission under Article 11c,
the rapporteur
Member State shall request that information. Such requests
shall be made explicitly and in writing, setting a time period
for submission of one month. They shall not concern the
submission of new studies. The rapporteur Member State
shall
such
inform the Commission and the EFSA of
requests in writing.

The rapporteur Member State shall, within one month after
the receipt of such information, evaluate the information
received and send its evaluation to the EFSA.

3.
Information submitted by the notifier but which has
not been requested, or which has not been submitted before
the end of the time period referred to in paragraph 2, shall
not be taken into account unless this information has been
submitted in accordance with Article 7 of Directive
91/414/EEC.

Where the rapporteur Member State, pursuant to paragraph
1 or to the first subparagraph of this paragraph, refuses to
take into account studies or information received from the
notifier, it shall inform the Commission and the EFSA and
indicate the reasons for such refusal.

Article 11e

Withdrawal by notifier

Where Article 11b does not apply,
withdraw his

support of

the

the notifier may
the active

inclusion of

(a) receipt of the draft assessment report where Article 11b

or Article 11f applies;

(b) receipt of the conclusion established by the EFSA where

Article 11c applies;

(c) receipt of a written withdrawal of the notifier’s support

where Article 11e applies.

Together with the draft review report the Commission

2.
shall submit to the Committee:

(a) a draft directive including the active substance in Annex I
to Directive 91/414/EEC, setting out where appropriate
the conditions,
such
inclusion; or

including the time limit,

for

(b) a draft decision addressed to the Member States requiring
them to withdraw, within six months, the authorisations
of plant protection products containing the active
substance, pursuant
to the fourth subparagraph of
Article 8(2) of Directive 91/414/EEC, whereby that
active substance is not
to that
Directive, mentioning the reasons for the non-inclusion.

included in Annex I

The Directive or Decision shall be adopted in accordance
with the procedure referred to in Article 19(2) of Directive
91/414/EEC.

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By way of derogation from paragraph 2(b), the latest
3.
date for Member States to withdraw authorisations shall be
31 December 2010 in the case referred to in paragraph 1(c)
unless the Commission has concluded that the substance
meets the criteria of Annex VI, if appropriate after having
consulted the EFSA.

Article 12a

View by the EFSA

Where an active substance is included in Annex I
to
Directive 91/414/EEC pursuant to Article 11b of this Regu-
lation, the Commission shall request the EFSA to deliver its
view on the draft review report by 31 December 2010 at the
latest. Member States and notifiers shall cooperate with the
EFSA and the Commission.

to facilitate the planning of

In order
the
Commission and the EFSA shall agree on a schedule for
the delivery of the view of the EFSA on the draft review
report and on the format in which that view is submitted.’

the work,

2. The Annexes

to Regulation (EC) No 1490/2002 are

amended in accordance with Annex I to this Regulation.

Article 2

Amendments to Regulation (EC) No 2229/2004

Regulation (EC) No 2229/2004 is amended as follows:

1. Articles 24 and 25 are replaced by the following:

‘Article 24

Receipt of and access to the draft assessment report

1.
After receiving the updated summary dossier and the
draft assessment report referred to in Article 21(1) or Article
22(1) the EFSA shall, within 30 days, acknowledge to the
rapporteur Member State receipt of that report.

fulfil

In exceptional cases where the draft assessment report clearly
does not
the requirements concerning the format
recommended by the Commission, the Commission shall
agree with the EFSA and the rapporteur Member State on
a period for resubmission of an amended report. This period
shall not exceed two months.

2.
The EFSA shall without delay communicate the draft
assessment report to the Commission, the other Member
States and the notifiers setting a time period of no more
than two months for the submission of comments by those
Member States and the notifiers.

It shall collate the comments it receives, including available
comments
from the EFSA, and forward them to the
Commission, the Member States and the notifiers.

3.
The EFSA shall make available at specific request or
keep available for consultation by any person the following:

(a)

the draft assessment report except the elements thereof
which have been accepted as confidential in accordance
with Article 14 of Directive 91/414/EEC;

(b) the list of any data required for the evaluation in view of
the possible inclusion of the active substance in Annex I
to that Directive as finalised by the EFSA where it has
finalised such a list.

Article 24a

Evaluation of the draft assessment report

report

The Commission shall, without delay, examine the draft
the
the
assessment
rapporteur Member State and the comments received from
other Member States, the EFSA and from the notifiers in
accordance with Article 24(2).

recommendation by

and

Article 24b

Active substances with clear indications that they do
not have any harmful effects

If there are clear indications that it may be expected that the
active substance does not have any harmful effects on
human or animal health or on groundwater or any
unacceptable influence on the environment, as set out in
Annex VI, Article 25(1)(a) and (2)(a) shall apply.

Article 24c

Consultation of the EFSA

1. Where Article 24b does not apply, the Commission
may, at any time during the evaluation, ask the EFSA to
carry out a peer review of the full draft assessment report,
or to focus on specific points including points related to
criteria set out in Annex VII. The EFSA shall organise a
consultation of Member States
including the
rapporteur Member State.

experts

Where the Commission requests the EFSA to carry out a full
peer review, the EFSA shall deliver its conclusion at the latest
six months after the request. Where the Commission does
not request a full peer review, but only a conclusion on
reduced to three
specific points,
months. The submission of the conclusions shall
in any
event be no later than 30 September 2008.

the period shall be

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If during the peer review there are clear indications that
2.
an active substance is expected to have harmful effects on
human or animal health or on groundwater as set out in
Annex VII, the EFSA shall inform the Commission.

substance in Annex I to Directive 91/414/EEC within two
months from receipt of the draft assessment report referred
to in Article 24(2).

The Commission may take a Decision as referred to in
Article 24f.

The Commission and the EFSA shall agree on a
3.
schedule for the delivery of
the conclusions in order to
facilitate the planning of the work. The Commission and
the EFSA shall agree on the format in which the conclusions
of the EFSA are submitted.

Article 24f

Active substance for which there are clear indications of
harmful effects

If there are clear indications that it may be expected that the
active substance has harmful effects on human or animal
health or on groundwater as set out
the
Commission shall take a Decision on the non-inclusion of
the active substance in Annex I to Directive 91/414/EEC, in
accordance with Article 25(1)(a) and (2)(b) of this Regu-
lation.

in Annex VII

Article 24d

Article 25

Submission of additional
assessment report has been submitted to the EFSA

information after the draft

Presentation of a draft directive or draft decision

1. Without prejudice to Article 7 of Directive 91/414/EEC
submission of new studies shall not be accepted.

The Commission shall submit to the Committee a draft

1.
review report at the latest six months after:

2. Where the EFSA considers that additional information
from the notifier is necessary to comply with a request made
by the Commission under Article 24c,
the rapporteur
Member State shall request that information. Such requests
shall be made explicitly and in writing, setting a time period
for submission of one month. They shall not concern the
submission of new studies. The rapporteur Member State
shall
such
inform the Commission and the EFSA of
requests in writing.

The rapporteur Member State shall, within one month after
the receipt of such information, evaluate the information
received and send its evaluation to the EFSA.

3.
Information submitted by the notifier but which has
not been requested, or which has not been submitted before
the end of the time period referred to in paragraph 2, shall
not be taken into account unless this information has been
submitted in accordance with Article 7 of Directive
91/414/EEC.

Where the rapporteur Member State, pursuant to paragraph
1 or to the first subparagraph of this paragraph, refuses to
take into account studies or information received from the
notifier, it shall inform the Commission and the EFSA and
indicate the reasons for such refusal.

Article 24e

Withdrawal by notifier

Where Article 24b does not apply,
withdraw his

support of

the

the notifier may
the active

inclusion of

(a) receipt of the draft assessment report where Article 24b

or Article 24f applies;

(b) receipt of the conclusion by the EFSA where Article 24c

applies;

(c) receipt of a written withdrawal of the notifier’s support

where Article 24e applies.

Together with the draft review report the Commission

2.
shall submit to the Committee:

(a) a draft directive including the active substance in Annex I
to Directive 91/414/EEC, setting out where appropriate
the conditions,
such
inclusion; or

including the time limit,

for

(b) a draft decision addressed to the Member States requiring
them to withdraw, within six months, the authorisations
of plant protection products containing the active
substance, pursuant
to the fourth subparagraph of
Article 8(2) of Directive 91/414/EEC, whereby that
active substance is not
to that
Directive, mentioning the reasons for the non-inclusion.

included in Annex I

The Directive or Decision shall be adopted in accordance
with the procedure referred to in Article 19(2) of Directive
91/414/EEC.

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By way of derogation from point (b) of paragraph 2,
3.
the latest date for Member States to withdraw authorisations
shall be 31 December 2010 in the case referred to in point
(c) of paragraph 1 unless the Commission concluded that the
substance meets the criteria of Annex VII, if appropriate after
having consulted the EFSA.

(i) the active substance is not expected to meet the criteria

of Annex VI of that Regulation;

(ii) upon being consulted by the Commission, the EFSA has
concluded that the active substance does not meet the
criteria to Annex VI of that Regulation; and

Article 25a

View by the EFSA

Where an active substance is included in Annex I
to
Directive 91/414/EEC pursuant to Article 24b of this Regu-
lation, the Commission shall request the EFSA to deliver its
view on the draft review report by 31 December 2010 at the
latest. Member States and notifiers shall cooperate with the
EFSA and the Commission.

to facilitate the planning of

the
In order
Commission and the EFSA shall agree on a schedule for
the delivery of the view of the EFSA on the draft review
report and on the format in which that view is submitted.’

the work,

2. The Annexes

to Regulation (EC) No 2229/2004 are

amended in accordance with Annex II to this Regulation.

Article 3

Transitional provisions for Regulation (EC) No 1490/2002

1.
As regards active substances for which at the date of entry
into force of
this Regulation the EFSA had submitted its
(EC) No
conclusions
1490/2002, as it stood before its amendment by this Regu-
lation, shall continue to apply.

the Commission, Regulation

to

As regards active substances for which, at the date of
2.
entry into force of this Regulation, the draft assessment report
by the rapporteur Member State had been sent to the EFSA but
for which the EFSA had not submitted its conclusions to the
Commission, by way of derogation from Article 11e of Regu-
lation (EC) No 1490/2002, Article 12(3) of that Regulation
shall apply if both of the following conditions are satisfied:

(b) the notifier informs the Commission of the withdrawal of
the active substance in
to Directive 91/414/EEC within two months

his support of
Annex I
from the entry into force of this Regulation.

the inclusion of

Article 4

Transitional provisions for Regulation (EC) No 2229/2004

As regards active substances for which, at the date of entry into
force of this Regulation, the draft assessment report by the
rapporteur Member State had been sent to the EFSA but for
which the EFSA had not submitted its conclusions to the
Commission, by way of derogation from Article 24e of Regu-
lation (EC) No 2229/2004, Article 25(3) of that Regulation
shall apply if both of the following conditions are satisfied:

(a) Article 24b does not apply and one of the following cases is

present:

(i) the active substance is not expected to meet the criteria

of Annex VII of that Regulation;

(ii) upon being consulted by the Commission, the EFSA has
concluded that the active substance does not meet the
criteria to Annex VII of that Regulation; and

(b) the notifier informs the Commission of the withdrawal of
the active substance in
to Directive 91/414/EEC within two months

his support of
Annex I
from the entry into force of this Regulation.

the inclusion of

Article 5

(a) Article 11b does not apply and one of the following cases is

present:

This Regulation shall enter into force on the seventh day
following its publication in the Official Journal of the European
Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 September 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX I

Amendments to the Annexes to Regulation (EC) No 1490/2002

After Annex IV to Regulation (EC) No 1490/2002 the following Annexes are added as Annexes V and VI:

‘ANNEX V

Criteria for clear indications of no harmful effects

An active substance shall be considered as fulfilling the requirement, as referred to in Article 11b, of there being clear
indications that it may be expected that it does not have any harmful effects on human or animal health or on
groundwater or any unacceptable influence on the environment if all the criteria set out in points 1 and 2 are met.

1. The active substance satisfies the following criteria:

(a)

it is not classified or proposed for classification as C (carcinogenic effects) M (mutagenic effects) R (toxic to
reproduction) in categories 1, 2 or 3 in accordance with Directive 67/548/EEC;

(b) either not requested or, if required, an ADI (Acceptable Daily Intake), AOEL (Acceptable Operator Exposure Level)
and ARfD (Acute Reference Dose) can be established on the basis of the standard assessment factor of 100;

(c)

it is not considered to have the potential to meet the criteria of a persistent organic pollutant set out in Regulation
(EC) No 850/2004 of the European Parliament and of the Council (*);

(d) it is not considered to have the potential to meet the criteria set out in Annex XIII to the Regulation (EC) No

1907/2006 of the European Parliament and of the Council (**).

2. At least one supported representative use of the active substance satisfies all of the following criteria:

(a) operator exposure is less than or equal to 75 % of the AOEL in modelled scenarios, considered relevant for the
intended use and where the use of such modelling is appropriate to the supported use and at maximum using
gloves as personal protective equipment (PPE);

(b) bystander exposure and worker exposure is less than or equal to 75 % AOEL in modelled scenarios, considered
relevant for the intended use and where the use of such modelling is appropriate to the supported use and without
the use of PPE;

(c) consumer exposure is less than or equal to 75 % of the ADI or ARfD (where such a value is necessarily established)
in all available EU consumer diets on the basis of the MRLs (Maximum Residues Level) proposed for the active
substance (without special refinements);

(d) leaching to groundwater is below 0,1 μg/l in at least half of the scenarios considered relevant for the intended use,

or in relevant lysimeter/field studies, for both the parent substance and relevant metabolites;

(e) buffer zones for the protection of the environment do not exceed 30m without any further risk mitigation

measures (e.g. drift reducing nozzles);

(f)

the risk to non-target organisms is acceptable based on standard refinements.

(*) OJ L 158, 30.4.2004, p. 7; corrected by OJ L 229, 29.6.2004, p. 5.
(**) OJ L 396, 30.12.2006, p. 1; corrected by OJ L 136, 29.5.2007, p. 3.

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ANNEX VI

Criteria for clear indications of harmful effects

An active substance shall be considered as fulfilling the requirement, as referred to in Article 11f, of there being clear
indications that on the basis on the available data, and which are evaluated in accordance with the provisions of Article
11d, it may be expected that it has harmful effects on human or animal health or on groundwater if either the criterion in
point 1 or one of the criteria in point 2 is met.

1. As regards the active substance, the existing evidence is not sufficient to allow the establishment of an ADI, ARfD or

an AOEL and such values are necessary to conduct a consumer and operator risk assessment.

2. As regards each supported representative use, at least one of the following criteria is met:

(a) operator exposure is greater than 100 % AOEL in all modelled scenarios with the use of PPE/RPE (Personal
Protective Equipment/Respiratory Protective Equipment), where the use of such modelling is appropriate to the
supported use, and where actual exposure data, if available, also indicate that the AOEL will be exceeded under
normal conditions of use;

(b) bystander exposure and worker exposure is greater than 100 % AOEL in modelled scenarios, where the use of such
modelling is appropriate to the supported use, and where actual exposure data, if available, indicate that the AOEL
will be exceeded for these groups under normal conditions of use;

(c) consumer exposure is greater than 100 % of the ADI or ARfD (where such a value is required) in at least one of
the available EU consumer diets on the basis of the MRLs (Maximum Residues Level) proposed for the active
substance;

(d) leaching to groundwater is equal to or above 0,1 μg/l in all modelled scenarios either for the parent substance or

for relevant metabolites.’

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ANNEX II

Amendments to the Annexes to Regulation (EC) No 2229/2004

After Annex V to Regulation (EC) No 2229/2004 the following Annexes are added as Annexes VI and VII:

‘ANNEX VI

Criteria for clear indications of no harmful effects

An active substance shall be considered as fulfilling the requirement, as referred to in Article 24b, of there being clear
indications that it may be expected that it does not have any harmful effects on human or animal health or on
groundwater or any unacceptable influence on the environment if all the criteria set out in points 1 and 2 are met.

1. The active substance satisfies the following criteria:

(a)

it is not classified or proposed for classification as C (carcinogenic effects) M (mutagenic effects) R (toxic to
reproduction) in categories 1, 2 or 3 in accordance with Directive 67/548/EEC;

(b) either not requested or, if required, an ADI (Acceptable Daily Intake), AOEL (Acceptable Operator Exposure Level)
and ARfD (Acute Reference Dose) can be established on the basis of the standard assessment factor of 100;

(c)

it is not considered to have the potential to meet the criteria of a persistent organic pollutant set out in Regulation
(EC) No 850/2004 of the European Parliament and of the Council (*);

(d) it is not considered to have the potential to meet the criteria set out in Annex XIII to the Regulation (EC)

No 1907/2006 of the European Parliament and of the Council (**).

2. At least one supported representative use of the active substance satisfies all of the following criteria:

(a) operator exposure is less than or equal to 75 % of the AOEL in modelled scenarios, considered relevant for the
intended use and where the use of such modelling is appropriate to the supported use and at maximum using
gloves as personal protective equipment (PPE);

(b) bystander exposure and worker exposure is less than or equal to 75 % AOEL in modelled scenarios, considered
relevant for the intended use and where the use of such modelling is appropriate to the supported use and without
the use of PPE;

(c) consumer exposure is less than or equal to 75 % of the ADI or ARfD (where such a value is necessarily established)
in all available EU consumer diets on the basis of the MRLs (Maximum Residues Level) proposed for the active
substance (without special refinements);

(d) leaching to groundwater is below 0,1 μg/l in at least half of the scenarios considered relevant for the intended use,

or in relevant lysimeter/field studies, for both the parent substance and relevant metabolites;

(e) Buffer zones for the protection of the environment do not exceed 30m without any further risk mitigation

measures (e.g. drift reducing nozzles);

(f)

the risk to non-target organisms is acceptable based on standard refinements.

(*) OJ L 158, 30.4.2004, p. 7; corrected by OJ L 229, 29.6.2004, p. 5.
(**) OJ L 396, 30.12.2006, p. 1; corrected by OJ L 136, 29.5.2007, p. 3.

L 246/28

EN

Official Journal of the European Union

21.9.2007

ANNEX VII

Criteria for clear indications of harmful effects

An active substance shall be considered as fulfilling the requirement, as referred to in Article 24f, of there being clear
indications that on the basis on the available data, and which have been evaluated in accordance with the provisions of
Article 24d, it may be expected that it has harmful effects on human or animal health or on groundwater if either the
criterion in point 1 or one of the criteria in point 2 is met.

1. As regards the active substance, the existing evidence is not sufficient to allow the establishment of an ADI, ARfD or

an AOEL and such values are necessary to conduct a consumer and operator risk assessment.

2. As regards each supported representative use, at least one of the following criteria is met:

(a) operator exposure is greater than 100 % AOEL in all modelled scenarios with the use of PPE/RPE (Personal
Protective Equipment/Respiratory Protective Equipment), where the use of such modelling is appropriate to the
supported use, and where actual exposure data, if available, also indicate that the AOEL will be exceeded under
normal conditions of use;

(b) bystander exposure and worker exposure is greater than 100 % AOEL in modelled scenarios, where the use of such
modelling is appropriate to the supported use, and where actual exposure data, if available, indicate that the AOEL
will be exceeded for these groups under normal conditions of use;

(c) consumer exposure is greater than 100 % of the ADI or ARfD (where such a value is required) in at least one of
the available EU consumer diets on the basis of the MRLs (Maximum Residues Level) proposed for the active
substance;

(d) leaching to groundwater is equal to or above 0,1 μg/l in all modelled scenarios either for the parent substance or

for relevant metabolites.’