SN 3134/09  PVG/sla  
 DG B II    EN  1 
COUNCIL OF
THE EUROPEAN UNIONBrussels, 16 June 2009 
 
  SN 3134/09 
   
COUNCIL DECISION 
 
concerning the non-inclusion of  metam in Annex I to Council Directive 91/414/EEC and the 
withdrawal of authorisations for plant prot ection products containing that substance 
 
(Text with EEA relevance) 
 
THE COUNCIL OF THE EUROPEAN UNION,  Having regard to the Treaty esta blishing 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, and in particul ar the fourth subparagraph of Article 8(2) 
thereof,  Whereas:  (1) Article 8(2) of Directive 91/414/EEC provides that a Member  State may, during a period of 
12 years following the notification of that Dire ctive, authorise the placing on the market of 
plant protection products containi ng active substances not listed in  Annex I to that Directive 
that are already on the market two years after th e date of notification, while those substances 
are gradually being examined within th e framework of a programme of work. 
                                                
 
1 OJ L 230, 19.8.1991, p. 1. 
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(2) Commission Regulations (EC) No 451/20001 a nd (EC) No 1490/20022 lay down the detailed 
rules for the implementation of the third stage of  the programme of work referred to in Article 
8(2) of Directive 91/414/EEC a nd establish a list of active subs tances to be assessed with a 
view to their possible inclusion in Annex I to Directive 91/414/EEC . That list includes 
metam.  
(3) For metam the effects on human health a nd the environment have been assessed in 
accordance with the provisions laid down in  Regulations (EC) No 451/2000 and (EC) No 
1490/2002 for a range of uses proposed by the notifier. Moreover, those Regulations 
designate the rapporteur Member States which ha ve to submit the relevant assessment reports 
and recommendations to the European Food Safe ty Authority (EFSA) in accordance with 
Article 10 (1) of Regulation (EC) No 1490/2002. For metam the rapporteur Member State was 
Belgium and all relevant information was submitted on 10 September 2007. 
 (4) The assessment report has been peer reviewed  by the Member States and the EFSA within its 
Working Group Evaluation and presented to the Commission on 26 November 2008 in the 
format of the EFSA conclusion re garding the peer review of the pesticide risk assessment of 
the active substance metam3. This report has be en reviewed by the Member States and the 
Commission within the Standing Committee on the Food Chain and Animal Health and 
finalised on 26 February 2009 in the format of  the Commission review report for metam. 
                                                
 
1 OJ L 55, 29.2.2000, p. 25. 
2 OJ L 224, 21.8.2002, p. 23. 
3 EFSA Scientific Report (2008) 203, Conclusion regardi ng the peer review of the pesticide risk 
assessment of the active substance metam,( finalised 26 November 2008). SN 3134/09  PVG/sla  
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(5) During the evaluation of this active substance, a number of concerns have been identified. In 
particular, inadequate residues studies and lack of informati on on a toxicologically relevant 
impurity, N,N'-dimethylthiourea (DMTU), did not permit to demonstrate the acceptability of 
consumer exposure. Furthermore, due to the hi gh rate of applicati on, a large amount of the 
impurity DMTU is released in the environment and the lack of data with respect to its 
behaviour in the environment give rise to concern. Consequently, it  was not possible to 
conclude, on the basis of the information made available within the deadlines, that metam met 
the criteria for inclusion in Annex I to Directive 91/414/EEC. 
 (6) The Commission invited the notifier to submit its comments on the result s of the peer review 
and on its intention or not to further suppor t the substance. The notifier submitted its 
comments which have been carefully examined. However, despite the arguments put forward 
by the notifier, the concerns id entified could not be eliminate d, and assessments made on the 
basis of the information submitted and evaluated during the EFSA expert meetings have not demonstrated that it may be expected that , under the proposed conditions of use, plant 
protection products containing metam satisfy in general the requirements laid down in Article 
5(1) (a) and (b) of Directive 91/414/EEC. 
 
(7) Metam should therefore not be includ ed in Annex I to Directive 91/414/EEC. 
 (8) Measures should be taken to ensure that au thorisations granted for plant protection products 
containing metam are withdrawn w ithin a fixed period of time and are not renewed and that 
no new authorisations for such products are granted. SN 3134/09  PVG/sla  
 DG B II    EN  4 
(9) In the light of the information before the C ouncil it appears that, in the absence of efficient 
alternatives for certain limited uses in certain Me mber States, there is a need for further use of 
the active substance so as to enable the developmen t of alternatives. It is therefore justified in 
the present circumstances to prescribe under strict conditions  aimed at minimising risk a 
longer period for the withdrawal of existing auth orisations for the limite d uses considered as 
essential for which no efficient alternatives appear  currently to be available for the control of 
harmful organisms. 
 (10) Any period of grace granted by a Member St ate for the disposal, storage, placing on the 
market and use of existing stocks of plant protection products contai ning metam should be 
limited to twelve months in order to allow exis ting stocks to be used in one further growing 
season, which ensures that plan t protection products containing  metam remain available to 
farmers for 18 months from the adoption of this Decision. 
 (11) This Decision does not prejudice the submi ssion of an application for metam according to the 
provisions of Article 6 (2) of Directive 91/ 414/EEC, the detailed im plementation rules of 
which have been laid down in Commissi on Regulation (EC) No 33/2008 of 17 January 2008 
laying down detailed rules for the application of Council Directive 91/ 414/EEC as regards a 
regular and an accelerated procedure for the asse ssment of active substances which were part 
of the programme of work referred to in Arti cle 8(2) of that Direct ive but have not been 
included into its Annex I1 in view of a po ssible inclusion in its Annex I.  
 (12) In the absence of a favourable opinion of the Standing Committee on the Food Chain and 
Animal Health, the Commission has been unabl e to adopt the provisi ons it envisaged under 
the procedure laid down in Article 19 of Council Directive 91/414/EEC. 
 HAS ADOPTED THIS DECISION: 
                                                
 
1 OJ L 15, 18.1.2009, p. 5.  SN 3134/09  PVG/sla  
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Article 1 
 
Metam shall not be included as an active s ubstance in Annex I to  Directive 91/414/EEC. 
 
Article 2 
Member States shall ensure that: 
 1. authorisations for plant pr otection products containing metam are withdrawn by [… INSERT 
DATE 6 MONTHS FROM THE DATE OF ADOPTION OF THIS DECISION]; 
 2. no authorisations for plant protection products containing metam are granted or renewed from 
the date of publication of this Decision.  
Article 3 
 
1. By way of derogation from Article 2, a Memb er State listed in column A of Annex I may 
maintain authorisations for plant protection pr oducts containing metam for the uses listed in 
column B of that Annex until 31 December 2014, provided that it complies with the following 
conditions: 
 
(a) it ensures that no harmful effects to hu man and animal health and no unacceptable 
influence to the environment are caused; 
 
(b) it ensures that such plant protection products  remaining on the market are relabelled in 
order to match the restricted use conditions; SN 3134/09  PVG/sla  
 DG B II    EN  6 
(c) it imposes all appropriate risk mitigation measures to reduce any possible risks in order 
to ensure the protection of human an d animal health and the environment; 
 
(d) it ensures that alte rnative products or methods for such  uses are being seriously sought, 
in particular, by means of action plans. 
 2. The Member State making use of the derogation  provided for in paragraph 1, shall inform the 
Commission about the measures taken under paragraph 1, and, in particular, under points (a) 
to (d) by 31 December of each year and provide on  a yearly basis estimates of the amounts of 
metam used for essential uses pursuant to this Article. 
 
Article 4 
 
Any period of grace granted by Member States in acco rdance with the provisions  of Article 4(6) of 
Directive 91/414/EEC, shall be  as short as possible.  
 For authorisations which are withdrawn in accord ance with Article 2, that period shall expire on 
INSERT DATE 18 MONTHS FROM ADOPTION OF THIS DECISION] at the latest.  
 For authorisations which are withdrawn in accordance with Article 3, it shall expire on 
31 December 2014.  SN 3134/09  PVG/sla  
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Article 5 
 
This Decision is addressed to the Member States.  Done at Brussels,   For the Council  The President  
ANNEX 
 
List of authorisations re ferred to in Article 3(2) 
Column A Column B 
Member State 
 Use 
Limited to professional users with appropriate protective equipment under specific authorised c onditions including 
those laid down in Article 3.  
  SN 3134/09  PVG/sla  
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REV 3 
 
ANNEX 
 
List of authorisations re ferred to in Article 3(2) 
Column A Column B 
Member State 
 Use 
Soil disinfection and weed control before planting/sowing, limited to professional users with appropriate protective equipment under specific authorised condi tions as laid down in 
Article 3 and subject to the following restrictions per Member State: 
Belgium Potting Soil (all crops). 
Potatoes (seed, ware and starch potatoes), sugar and fodder beets, onions, vegetables, fruit crops, herbs, orchards (replanting), ornamentals.  
Bulgaria Glass house use (tom atoes, cucumbers, lettuce, 
carrots, peppers, aubergines and tobacco).  
Cyprus Nurseries, vegetables, potatoes, ornamentals, 
deciduous fruits, citrus  fruits, and grapes. 
France Vegetable and fruit crops and mainly 
lamb's lettuce, carrots, tomatoes, strawberries, asparagus, ornamental plants, trees and shrubs. 
Greece Potting soil and soil co mpost (for all crops), 
Indoor use for soil treatment (for vegetable and ornamental crops), Tobacco nurseries SN 3134/09  PVG/sla  
 DG B II    EN  9 
Hungary Field use: potatoes, carrots, celeriac, parsley 
root, ornamentals, berries, apples, pears, tobacco, wine grapes, stone fruits, fruit and grapevine nurseries. Glasshouse use: green peppers, tomatoes, cucumbers, carrots, celeriac, parsley root, tobacco, berries, ornamentals.  
Italy Rice, Lettuce and similar, Tomatoes, Peppers 
and Aubergines, Cucurbits, Carrots, Bulb vegetables, Stem vegetables, Potatoes, Tobacco, Re-establishing vineyards and orchards, Floreals. 
Ireland Glasshouse uses:  Tomatoes, Carnations, 
Cucumbers, Ornamentals, Chrysanthemum and Lettuce.  Field uses: Potatoes, Bulbs, Hardy nursery stock, Cane Fruit, Tu rf, Strawberries and 
Forestry Plantations.  
Malta Tomatoes, aubergines, peppers, melons, 
watermelons, squash, cucumbers and strawberries 
The Netherlands Potatoes (Seed, ware and starch potatoes), 
sugar and fodder beets, onions, vegetables, strawberries, orchards (replanting), ornamentals (including growing of bulbs), 
yellow nutsedge in all crops.  SN 3134/09  PVG/sla  
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Poland Field uses: strawberries, cabbages, carrots, 
lettuce, onions, garlic. Greenhouses: tomatoes, cucumbers, peppers, aubergines. 
Portugal Potatoes, onions, carrots, melons, 
strawberries, cucumbers, peppers, tomatoes, citrus fruits, orname ntals, greenhouse soil 
fumigation, nursery soil fumigation.  
Romania Vegetables and ornamental plants.  
Spain Nurseries, Seedbeds, Vegetables, Tobacco, 
Flowers, Strawberries, Seed potatoes, vineyards. 
UK Glasshouse soils, nurser y soils, outdoor soils 
and potting soils prior to planting of fruit crops, vegetable crops, potatoes, herbs, flowers, bulbs, ornamental plants, perennial plants.