Proposal for a Council Decision concerning the non-inclusion of aldicarb in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing this active substance
Date: 2003-03-18
Institutions: European Commission
Subjects: environmental risk prevention, marketing restriction, plant health control, plant health product, protection of animal life

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 18.3.2003
COM(2003) 140 final

Proposal for a

COUNCIL DECISION

concerning the non-inclusion of aldicarb in Annex I to Council Directive 91/414/EEC
and the withdrawal of authorisations for plant protection products containing this active
substance

(presented by the Commission)

EXPLANATORY MEMORANDUM

A proposal was submitted to the Standing Committee on the Food Chain and Animal Health
on 18 October 2002. It provided for the non-inclusion of the nematicide Aldicarb in Annex I
to  Directive  91/414/EEC.  The  decision  to  withdraw  Aldicarb  was  based  largely  on  its
negative environmental impact.  It obliged  the  10  Member  States  that  have  authorisations  to
withdraw them within six months and permitted periods of grace for stock sell-out for up to
another 12 months.

No qualified majority was obtained and as a result the proposal was referred to Council. The
Council  may  react  at  any  time  until  18  March  2003.  It  will  be  discussed  again  at  the
Agriculture Council on 18 March.

Of  the  800+  substances  on  the  market,  only  10  are  nematicides  and  Member  States  are
concerned about being left with no alternatives to manage these pests in the future.

A Presidency compromise text tabled at the meeting of the Group of attachés on 13 February
2003, proposes that Aldicarb would not be included in Annex I but provides for the possibility
that for certain limited essential uses in certain Member States (specified in the Annex to the
decision),  authorisations  may remain in  place until 30  June  2007.  In  this  proposal,  Member
States will have to take the responsibility upon themselves that  authorisations are  continued
only  where  safety  for  humans, animals and the  environment  is not compromised  and  where
the  products  are  relabelled.  Member  States  also  have  to  commit  to  searching  actively  for
alternatives.

Discussions have been proceeding with Member States on this compromise. The Commission
has  been  pushing  those  Member  States  to  limit  to  the  minimum  the  essential  uses  of  this
nematicide.  These  discussions  continued  at  Coreper  on  Monday  17  March  and  a  qualified
majority in support of this amendment was indicated. In view of the moves by Member States
to limit the use of Aldicarb the Commission wishes to make a new proposal incorporating the
amendments arrived at in Council.

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Proposal for a

COUNCIL DECISION

concerning the non-inclusion of aldicarb in Annex I to Council Directive 91/414/EEC
and the withdrawal of authorisations for plant protection products containing this active
substance

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having  regard  to  Council  Directive  91/414/EEC  of  15  July  1991  concerning  the  placing  of
plant  protection  products  on  the  market1,  as  last  amended  by  Commission  Directive
2002/81/EC2, and in particular the third and fourth subparagraph of Article 8(2) thereof,

Having  regard  to  Commission  Regulation  (EEC)  No  3600/92  of  11  December  1992  laying
down  the  detailed  rules  for  the  implementation  of  the  first  stage  of  the  program  of  work
referred to in  Article  8(2) of  Council  Directive  91/414/EEC  concerning the placing of plant
protection products on the market3, as last amended by Regulation (EC) No 2266/20004, and
in particular Article 7 (3A) (b) thereof,

Having regard to the proposal from the Commission5

Whereas:

(1)

(2)

Article  8(2)  of  Directive  91/414/EEC  provided  for  the  Commission  to  carry  out  a
programme  of  work  for  the  examination  of  the  active  substances  used  in  plant
protection products which were already on the market on 25 July 1993. Detailed rules
for  the  carrying  out  of  this  programme  were  established  in  Regulation  (EEC)  No
3600/92.

Commission  Regulation  (EC)  No  933/94  of  27  April  1994  laying  down  the  active
substances of plant protection products and designating the rapporteur Member States
for  the  implementation  of  Commission  Regulation  (EEC)  No  3600/926,  as  last
amended  by  Regulation  (EC)  N°2230/957,  designated  the  active  substances  which
should be assessed  in the framework  of Regulation (EEC)  No 3600/92,  designated  a
Member State to act as rapporteur in respect of the assessment of each substance and
identified the producers of each active substance who submitted a notification in due
time.

1 OJ L 230, 19.8.1991, p. 1.
2 OJ L 276, 12.10.2002, p. 28.
3 OJ L 366, 15.12.1992, p. 10.
4 OJ L 259, 13.10.2000, p. 27.
5 OJ C […], p. […]
6 OJ L 107, 28.4.1994, p. 8.
7 OJ L 225, 22.9.1995, p. 1.

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(3)

(4)

(5)

(6)

(7)

Aldicarb is one of the 89 active substances designated in Regulation (EC) No 933/94.

In  accordance  with  Article  7(1)(c)  of  Regulation  (EEC)  No  3600/92,  the  United
Kingdom, being the designated rapporteur Member State, submitted on 30 April 1996
to  the  Commission  the  report  of  its  assessment  of  the  information  submitted  by  the
notifiers in accordance with Article 6 (1) of that Regulation.

On receipt  of the report of  the  rapporteur  Member  State,  the  Commission  undertook
consultations  with  experts  of  the  Member  States  as  well  as  with  the  main  notifier
Rhône-Poulenc, now Bayer CropScience) as provided for in Article 7(3) of Regulation
(EEC) No 3600/92.

The  assessment  report  prepared  by  the  United  Kingdom  has  been  reviewed  by  the
Member  States  and  the  Commission  within  the  Standing  Committee  on  the  Food
Chain  and  Animal  Health.  It  appeared  that  the  information  submitted  was  not
sufficient  to  determine  whether  or  not,  under  the  proposed  conditions  of  use,  plant
protection products containing the active substance concerned would satisfy in general
the requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC. The
dossier  and  the  information  from  the  review  were  also  submitted  to  the  Scientific
Committee for Plants. The Committee was asked to comment on the ecotoxicological
risk assessment, including the risk to small birds. The  Committee noted  that the  risk
assessment  for  the  exposure  of  small  birds  to  granules  critically  depends  on  the
assumption that more than 99% of the granules are incorporated into the soil. Whilst
this  may  be  achieved  under  ideal  conditions,  the  Committee  believed  that  this  high
degree  of  incorporation  is  not  consistently  achievable  under  normal  agricultural  use
conditions and therefore advised that a re-assessment is necessary. In relation to other
non-target  organisms  the  Committee  is  not  able  to  assess  from  the  data  available
whether  the  use  of  aldicarb  should  continue  pending  the  generation,  submission  and
evaluation of further data. Therefore the Commission invited the notifier to complete
its dossier by 31 December 2001 at the latest for a limited range of representative uses.
Upon  receipt  of  the  additional  information,  the  review  was  finalised  on  18  October
2002 in the format of the Commission review report for aldicarb, in accordance with
Article 7(6) of Regulation (EEC) No 3600/92.

Assessments  made  on  the  basis  of  the  information  submitted  have  not  demonstrated
that  it  may  be  expected  that,  under  the  proposed  conditions  of  use,  plant  protection
products  containing  aldicarb  satisfy  in  general  the  requirements  laid  down  in
Article 5(1)(a)  and  (b)  of  Directive  91/414/EEC,  in  particular  with  regard  to  its
possible impact on non-target organisms. It is appropriate to take this decision in view
of the high risk of aldicarb in its present granular formulation in particular to small birds.
Data submitted by the notifier for the proposed representative uses indicate that granules
will  remain  on  the  soil  surface  after  treatment.  The  possibility  of  a  lethal  intake  of
granules by small birds cannot be excluded. A probabilistic risk assessment was prepared
by the notifier and evaluated by the rapporteur Member State who concluded that effects
on national populations would not be expected although some local impact might occur.
It  must  be  taken  into  consideration  that  agreed  criteria  for  the  interpretation  of  such  a
probabilistic risk assessment are not yet consolidated and it would not be appropriate, in
view of the possible risks, to delay decision making further until such criteria are agreed.
Moreover, the review has identified a risk to earthworms, and the available information
from field studies is still insufficient to fully resolve these concerns.

(8)

Aldicarb should therefore not be included in Annex I to Directive 91/414/EEC.

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(9)

(10)

Measures  should  be  taken  to  ensure  that  existing  authorisations  for  plant  protection
products containing aldicarb are withdrawn within a prescribed period and will not be
renewed and that no new authorisations for such products are granted.

In  the  light  of  the  information  before  the  Council  it  appears  that,  in  the  absence  of
efficient alternatives for certain limited uses in certain Member States, there is a need
for further use of the active substance so as to enable the development of alternatives.
It is therefore justified in the present circumstances to prescribe under strict conditions
aimed  at minimising  risk (for  example  stewardship  programmes)  a  longer  period  for
the  withdrawal  of  existing  authorisations  for  the  limited  uses  considered  as  essential
for which no  efficient  alternatives  appear  currently  to  be  available  for  the  control  of
harmful organisms.

(11) Any period  of  grace  for  disposal,  storage,  placing  on  the  market  and  use  of  existing
stocks of plant protection products containing aldicarb allowed by Member States, in
accordance  with  Article  4(6)  of  Directive  91/414/EEC  should  be  limited  to  a  short
period to allow existing stocks to be used in no more than one further growing season.

(12)

(13)

This Decision does not prejudice any action the Commission may undertake at a later
stage for this active substance within the framework of Council Directive 79/117/EEC
of 21 December 1978 prohibiting the placing on the market and use of plant protection
products  containing  certain  active  substances8,  as  last  amended  by  the  Act  of
Accession of Austria, Finland and Sweden.

In the absence of a favourable opinion of the Standing Committee on the Food Chain
and  Animal  Health,  the  Commission  has  been  unable  to  adopt  the  provisions  it
envisaged  under  the  procedure  laid  down  in  Article  19  of  Council  Directive
91/414/EEC,

HAS ADOPTED THIS DECISION:

Aldicarb is not included as active substance in Annex I to Directive 91/414/EEC.

Article 1

Member States shall ensure that:

Article 2

(1)

(2)

authorisations  for  plant  protection  products  containing  aldicarb  are  withdrawn  by
(cid:1)
..........

;

from  **  no  authorisations  for  plant  protection  products  containing  aldicarb  are
granted  or  renewed  under  the  derogation  provided  for  in  Article  8  (2)  of  Directive
91/414/EEC.

8 OJ L 33, 8.2.1979, p. 36.
(cid:1) Six months from the date of adoption of this Decision.

**

the date of adoption of this Decision

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(3)

In relation to the uses listed in column B of the Annex, a Member State specified in
column  A  may  maintain  in  force  authorisations  for  plant  protection  products
containing aldicarb until 30 June 2007 provided that it:

(a)

(b)

ensures  that  such  plant  protection  products  remaining  on  the  market  are
relabelled in order to match the restricted use conditions,

imposes  all  appropriate  risk  mitigation  measures  to  reduce  any  possible  risks
and to ensure the protection of human and animal health and the environment,
and

(c)

ensures that alternative products or methods for such uses are being seriously
sought, in particular, by means of action plans.

The Member State concerned shall inform the Commission on 31 December 2004 at the latest
on the application of this paragraph and in particular on the actions taken pursuant to points
(a) to (c) and provide on a yearly basis estimates of the amounts of aldicarb used for essential
uses pursuant to this article.

Article 3

Any period of grace granted by Member States in accordance with the provisions of Article
4(6) of Directive 91/414/EEC, shall be as short as possible and:

(a)

(b)

(cid:1)
for the uses for which the authorisation is to be withdrawn ..........
later than ............

(cid:1)(cid:1)

, shall expire not

for  the  uses  for  which  the  authorisation  is  to  be  withdrawn  by  30  June  2007,  shall
expire not later than 31 December 2007.

Article 4

This Decision is addressed to the Member States.

Done at Brussels,

For the Council
The President

(cid:1) Six months from the date of adoption of this Decision.
(cid:1)(cid:1) Eighteen months from the date of adoption of this Decision.

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List of authorisations referred to in Article 2 (3)

ANNEX

Column A

Member State

BELGIUM

FRANCE

GREECE

NETHERLANDS

ITALY

PORTUGAL

SPAIN

Column B

Use

BEET

BEET,

VINEYARD

POTATOES,

TOBACCO,

ORNAMENTALS

SUGAR BEET

POTATOES (seed and starch)

SUGAR BEET

TOBACCO

NURSERIES

CITRUS,

FLORICULTURE,

VINE YARDS

COTTON,

CITRUS (young plantations),

WOODY NURSERIES

UNITED KINGDOM

POTATOES

CARROTS (including parsnips)

ONIONS

ORNAMENTALS

7