EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
CA-May12-Doc.3.1 
[…](2011) XXX draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX 
amending Directive 98/8/EC of the European Parliament and of the Council to extend 
the inclusion in Annex I thereto of the active substance thiamethoxam to product t ype 18
(Text with EEA relevance) 
  
EN 2   EN COMMISSION DIRECTIVE ../…/EU 
of XXX 
amending Directive 98/8/EC of the European Parliament and of the Council to extend 
the inclusion in Annex I thereto of the active  substance thiamethoxam to product type 18 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 98/8/EC of the European Parliament and of the Council of 
16 February 1998 concerning the placing of  biocidal products on the market
1, and in 
particular the second subparagraph of Article 16(2) thereof, 
Whereas: (1) Commission Regulation (EC)  No 1451/2007 of 4 December 2007 on the second phase 
of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of 
the European Parliament and of the Counc il concerning the pl acing of biocidal 
products on the market
2 establishes a list of active substances to be assessed, with a 
view to their possible inclusion in Annex I, IA or IB to Directiv e 98/8/EC. That list 
includes thiamethoxam. 
(2) Commission Directive 2008/77/EC of 25 Ju ly 2008 amending Directive 98/8/EC of 
the European Parliament and of the Counc il to include thiamethoxam as an active 
substance in Annex I thereto3 included thiamethoxam as an  active substance in Annex 
I to Directive 98/8/EC for use in productt ype 8, wood preservatives, as defined in 
Annex V to Directive 98/8/EC. 
(3) Pursuant to Regulation (EC) No 1451/2007, th iamethoxam has now been evaluated in 
accordance with Article 11(2) of Direct ive 98/8/EC for use in producttype 18, 
insecticides, acaricides and pr oducts to control other arthropods, as defined in Annex 
V to that Directive. 
(4) Spain was designated as Rapporteur Memb er State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
2 March 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. 
                                                
 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3. 
3 OJ L 198, 26.7.2008, p. 41.  
EN 3   EN (5) The competent authority report was re viewed by the Member States and the 
Commission. In accordance with Article 15 (4) of Regulation (EC) No 1451/2007, the 
findings of the review were incorporated, within the Standing Committee on Biocidal 
Products on [date of Committee meeting to be  inserted], in an assessment report. 
(6) It appears from the evaluations that biocidal products used  as insecticides, acaricides 
and products to control other arthropods  and containing thiamethoxam may be 
expected to satisfy the requirements laid dow n in Article 5 of Dir ective 98/8/EC. It is 
therefore appropriate to extend the inclusion of thia methoxam in Annex I to that 
Directive to product type 18. 
(7) Not all potential uses have b een evaluated at Union level. For example, the assessment 
only considers indoor use by professional user s. It is therefor e appropriate that 
Member States assess those uses or e xposure scenarios and those risks to human 
populations and to environmental compartmen ts that have not been representatively 
addressed in the Union level risk a ssessment and, when granting product 
authorisations, ensure that appropriate measures are ta ken or specific conditions 
imposed in order to reduce the iden tified risks to acceptable levels. 
(8) In the light of the findings in the assessm ent report that there is a possible risk of 
indirect human exposure via consumption of food as a result of those uses represented 
in the assessment, it is appropriate to requi re, where relevant, verification of the need 
to set new or to amend existing maximum residue levels in accordance with Regulation (EC) No 470/2009 of  the European Parliament and of the Council of 6 
May 2009 laying down Community procedures fo r the establishment of residue limits 
of pharmacologically active substances in foodstuffs of animal  origin, repealing 
Council Regulation (EEC) No 2377/90 and am ending Directive 2001/82/EC of the 
European Parliament and of the Council  and Regulation (EC)  No 726/2004 of the 
European Parliament and of the Council
4 or with Regulation (EC) No 396/2005 of the 
European Parliament and of the Council of 23 February 2005 on maximum residue 
levels of pesticides in or on food and feed  of plant and animal origin and amending 
Council Directive 91/414/EEC5. Measures should be adopted ensuring that the 
applicable maximum residue levels are not exceeded. 
(9) In view of the risks identifie d for the environment, it is appropriate to require that 
product authorisations are subject to appropriate risk mitigation measures. 
(10) In view of the risks identified for human h ealth, it is appropriate to require that 
products authorised for professional use mu st be used with appropriate personal 
protective equipment, unless it can be dem onstrated in the a pplication for product 
authorisation that risks to pr ofessional users can be reduced  to an acceptable level by 
other means. 
(11) The provisions of this Directive should be  applied simultaneously in all Member 
States in order to ensure equal treatmen t on the Union market of biocidal products 
containing the active substance thiamethoxa m and also to facilitate the proper 
operation of the biocidal pr oducts market in general. 
                                                 
4 OJ L 152, 16.6.2009, p. 11. 
5 OJ L 70, 16.3.2005, p. 1.  
EN 4   EN (12) A reasonable period should be allowed to elap se before an active substance is included 
in Annex I to Directive 98/8/EC, in order to permit Member States and interested 
parties to prepare themselves to meet the ne w requirements entailed and to ensure that 
applicants who have prepared  dossiers can benefit fully from the 10-year period of 
data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, 
starts from the date of inclusion. 
(13) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC. 
(14) Directive 98/8/EC should therefore be amended accordingly. 
(15) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex I to Directive 98/8/EC is amended in a ccordance with the Annex to this Directive. 
Article 2 
1. Member States shall adopt and publish, by 31 July 2013 at the latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive.  
They shall apply those provisions from 1 August 2014. 
When Member States adopt those provisions,  they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determin e how such reference is to be made. 
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 3 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 4 
This Directive is addressed to the Member States.  
EN 5   EN Done at Brussels,  
 For the Commission 
 The President  José Manuel BARROSO  
EN 6   EN ANNEX  
In Annex I to Directive 98/8/EC, th e following is added to entry n° 14:  
No Common 
Name IUPAC Name 
Identification Numbers Minimum 
purity of 
the active 
substance in the biocidal 
product as 
placed on the market Date of 
inclusion Deadline for 
compliance with Article 
16(3) (except for 
products containing more than one active 
substance, for which the 
deadline to comply with Article 16(3) shall be 
the one set out in the 
last of the inclusion 
decisions relating to its 
active substances) Expiry date 
of inclusion Product 
type Specific provisions (*) 
   "980 g/kg 1 August 
2014 31 July 2016 31 July 2024 18 The Union level risk assessment did not 
address all potential uses, but concerned, 
for example, only indoor application by 
professionals. When assessing the 
application for authorisation of a product in 
accordance with Article 5 and Annex VI, Member States shall assess, where relevant 
for the particular product, those uses or 
exposure scenarios and those risks to 
human populations and to environmental 
compartments that have not been representatively addressed in the Union 
level risk assessment. 
For products containing thiametoxam that 
may lead to residues in food or feed, 
Member States shall verify the need to set 
new or to amend existing maximum residue levels (MRLs) according to 
Regulation (EC) No 470/2009 or  
EN 7   EN No Common 
Name IUPAC Name 
Identification Numbers Minimum 
purity of 
the active 
substance in the biocidal 
product as 
placed on the market Date of 
inclusion Deadline for 
compliance with Article 
16(3) (except for 
products containing more than one active 
substance, for which the 
deadline to comply with Article 16(3) shall be 
the one set out in the 
last of the inclusion decisions relating to its 
active substances) Expiry date 
of inclusion Product 
type Specific provisions (*) 
Regulation (EC) No 396/2005, and take 
any appropriate risk mitigation measures 
ensuring that the app licable MRLs are not 
exceeded. 
Member States shall ensure that 
authorisations are subject to the following conditions: 
Where relevant, appropriate risk 
mitigation measures shall be taken 
for the protection of the environment. 
Products authorised for professional 
use shall be used with appropriate 
personal protective equipment, 
unless it can be demonstrated in the application for product authorisation 
that risks to professional users can be 
reduced to an acceptable level by other means. " 
(*) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are availabl e on the Commission website: 
http://ec.europa.eu/comm/environment/biocides/index.htm