1 EN 
 
 2  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
  
Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of sulphuric  acid in Annex I to Council Directive 
91/414/EEC and the withdrawal of authorisations for plant protection products 
containing that substance  
(Text with EEA relevance) 3 Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of sulphuric  acid in Annex I to Council Directive 
91/414/EEC and the withdrawal of authorisations for plant protection products 
containing that substance  
(Text with EEA relevance)  
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
Having regard to Council Dir ective 91/414/EEC of 15 July 1991 concerning the placing of 
plant protection products on the market1, and in particular the fourth subparagraph of 
Article 8(2) thereof, 
Whereas: (1) Article 8(2) of Directive 91/414/EEC provi des that a Member State may, during a 
period of 12 years following the notification of  that Directive, authorise the placing on 
the market of plant protection products containing active substa nces not listed in 
Annex I of that Directive th at are already on the market two years after the date of 
notification, while those substances are gradually being examined within the framework of a programme of work. 
(2) Commission Regulations  (EC) No 1112/2002
2 and (EC) No 2229/20043 lay down the 
detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directiv e 91/414/EEC and estab lish a list of active 
substances to be assessed with a view to their possibl e inclusion in  Annex I to 
Directive 91/414/EEC. That li st includes sulphuric acid. 
                                                
 
1 OJ L 230, 19.8.1991, p. 1. 
2 OJ L 168, 27.6.2002, p. 14.  
3 OJ L 379, 24.12.2004, p. 13. 4 (3) For sulphuric acid the effects on human health and the environment have been 
assessed in accordance with the provisions laid down in Regulations (EC) No 1112/2002 and (EC) No 2229/2004 for a range of uses proposed by the notifier. Moreover, those Regulations designate the Rapporteur Member States which have to 
submit the relevant assessment reports a nd recommendations to the European Food 
Safety Authority (EFSA) in accordance w ith Article 20 of Regulation (EC) No 
2229/2004. For sulphuric acid the Rapporteur  Member State was France and all 
relevant information was submitted in October 2007. 
(4) The Commission examined sulphuric acid  in accordance with Article 24a of 
Regulation (EC) No 2229/2004. A draft review report for that substance was reviewed 
by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finali sed on 26 September 2008 in the format of 
the Commission review report. 
(5) During the examination of this active substance by the Committee, it was concluded, 
taking into account comments received from Member States, that the existing evidence is not sufficient to finalise the consumer risk assessment and to set a reliable Acceptable Operator Exposure Level (AOEL) and such value is necessary to conduct 
the operator risk assessment. Moreover, othe r concerns which were identified by the 
rapporteur Member States in its assessment re port are included in the review report for 
the substance. 
(6) The Commission invited the notifier to submit its comments on the results of the peer 
review and on its intention or not to fu rther support the substance. The notifier 
submitted its comments which have been carefully examined. However, despite the arguments put forwards by the notifier, the concerns identified could not be 
eliminated, and assessments made on the ba sis of the information submitted have not 
demonstrated that it may be expected that , under the proposed conditions of use, plant 
protection products containing sulphuric acid satisfy in general th e requirements laid 
down in Article 5(1)(a) and (b) of Directive 91/414/EEC. 
(7) Sulphuric acid should therefor e not be included in Annex I to Directive 91/414/EEC. 
(8) Measures should be taken to ensure that au thorisations granted for plant protection 
products containing sulphuric acid are withdraw n within a fixed period of time and are 
not renewed and that no new authorisa tions for such products are granted.  
(9) 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 pr otection products containing sulphuric acid 
should be limited to twelve months in order to allow existing stocks  to be used in one 
further growing season, which ensures that  plant protection pr oducts containing 
sulphuric acid remain available to farmers for 18 months from the adoption of this Decision. 
(10) This Decision does not prejudice the submissi on of an application for sulphuric acid in 
accordance with Article 6(2) of Direc tive 91/414/EEC and Commission Regulation 
(EC) No 33/2008 of 17 January 2008 laying dow n detailed rules for the application of 
Council Directive 91/414/EEC as  regards a regular and an accelerated procedure for 
the assessment of active substances which were part of the programme of work 5 referred to in Article 8(2) of that Directiv e but have not been included into its Annex 
I4, in view of a possible inclusion in its Annex I.  
(11) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS DECISION: 
Article 1 
Sulphuric acid shall not be incl uded as active substance in A nnex I to Directive 91/414/EEC. 
Article 2 
Member States shall ensure that: 
(a) authorisations for plant protection products  containing sulphuric acid are withdrawn by 
[INSERT DATE 6 MONTHS FROM TH E DATE OF ADOPTION OF THIS 
DECISION];  
(b) no authorisations for plant protection prod ucts containing sulphuric acid are granted or 
renewed from the date of publication of this Decision. 
Article 3 
Any period of grace granted by Member Stat es in accordance with the provisions of 
Article 4(6) of Directive 91/414/EEC, shall be as short as possible and shall expire on 
[INSERT DATA 18 MONTHS FROM ADOPTION OF THIS DECISION]  at the latest. 
                                                 
4 OJ L 15, 18.1.2008, p. 5. 6 Article 4 
This Decision is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 Androulla Vassiliou  Member of the Commission