EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(2010) yyy final D/008218/01 
CA May10-Doc.3.  
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
spinosad as an active substance in Annex I thereto  
EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EU 
of  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
spinosad as an active substance in Annex I thereto 
(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 spinosad. 
(2) Pursuant to Regulation (EC) No 1451/ 2007, spinosad has been evaluated in 
accordance with Article 11(2)  of Directive 98/8/EC for use in product-type 18, 
insecticides, acaricides and products to control other arthropods, as defined in 
Annex V to that Directive. 
(3) The Netherlands were designated as Ra pporteur Member State and submitted the 
competent authority report, together with a recommendation, to the Commission on 
1 April 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. 
(4) 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 27 May 2010, in an assessment report. 
                                                
 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3.  
EN 3   EN (5) It appears from the examinations made that  biocidal products us ed as insecticides, 
acaricides or to control other arthropods a nd containing spinosad may be expected to 
satisfy the requirements laid down in Articl e 5 of Directive 98/8/ EC. It is therefore 
appropriate to include spinosad in Annex I to that Directive. 
(6) Not all potential uses have been evaluated at the Community level. It is therefore 
appropriate that Member States assess thos e uses or exposure scenarios and those risks 
to the compartments and populations that have  not been representatively addressed in 
the Community level risk assessment and, when granting product authorisations, 
ensure that appropriate measures are taken or specific conditions imposed in order to 
reduce the identified risks to acceptable levels. 
(7) In the light of the findings of the assessment report, it is appropriate to require that risk 
mitigation measures are applied at product au thorisation level. In particular, in the 
light of the identified adverse health e ffects for the unprotected professional user 
during application by spraying of biocid al products containing spinosad, it is 
appropriate to require at product author isation level that products intended for 
professional use by spraying be used with a ppropriate personal protective equipment, 
unless it can be demonstrated that risks fo r industrial or profe ssional users can be 
reduced by other means. Furthermore, in the light of the findings relating to possible 
indirect human exposure via consumption of  food, it is appropriate to require, where 
relevant, verification of the need to se t new or amended existing maximum residue 
levels (MRLs) and adoption of measures en suring that the applicable MRLs are not 
exceeded. 
(8) It is important that the provisions of this Directive be applied simultaneously in all the 
Member States in order to ensure equal tr eatment of biocidal products on the market 
containing the active substance spinosad and also to facilitate the proper operation of the biocidal products market in general. 
(9) A reasonable period should be allowed to elap se before an active substance is included 
in Annex I in order to permit Member Stat es and the interested parties to prepare 
themselves to meet the new requirements enta iled and to ensure that applicants who 
have prepared dossiers can benefit fully fr om the 10-year period of data protection, 
which, in accordance with Artic le 12(1)(c)(ii) of Directive 98/8/EC, starts from the 
date of inclusion. 
(10) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC. 
(11) Directive 98/8/EC should therefore be amended accordingly. 
(12) 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.  
EN 4   EN Article 2 
 
Transposition 
1. Member States shall adopt and publish, by 31 October 2011 at the latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive.  
They shall apply those provi sions from 1 November 2012. 
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. 
Done at Brussels,  
 For the Commission 
 The President  José Manuel BARROSO  
EN 5   EN ANNEX  
In Annex I to Directive 98/8/EC, the following entry for the substance spinosad is added:  
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 (*) 
"(**) 
[OPOC
E: please 
insert 
substance 
number] Spinosad EC No: 434-300-1  
CAS No: 168316-95-8 
Spinosad is a mixture of 50-95 % spinosyn A 
and 5-50 % spinosyn D. 
Spinosyn A: 
(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-
[(6-deoxy-2,3,4-tri-O-methyl- α-L-
mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2H-
pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-
tetradecahydro-14-methyl-1H-as-
indaceno[3,2-d]oxacyclododecin-7,15-dione  CAS No: 131929-60-7 
Spinosyn D: 
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-
[(6-deoxy-2,3,4-tri-O-methyl- α-L-
mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-850 g/kg 
1 November 
2012 31 October 2014 31 October 
2022 18 When assessing the application for 
authorisation of a product in accordance 
with Article 5 and Annex VI, Member States shall assess, when relevant for the 
particular product, those uses or exposure 
scenarios and those risks to compartments and populations that have not been 
representatively addressed in the 
Community level risk assessment. 
Member States shall ensure that 
authorisations are subject to the following conditions: 
• Authorisations shall be subject to 
appropriate risk mitigation measures. In particular, products authorised for 
professional use by spraying shall be 
used with appropriate personal protective equipment, unless it can be  
EN 6   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 (*) 
(dimethylamino)tetrahydro-6-methyl-2H-
pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-
indaceno[3,2-d]oxacyclododecin-7,15-dione  
CAS No: 131929-63-0 demonstrated in the application for 
product authorisation that risks to 
professional users can be reduced to an acceptable level by others means. 
• For products containing spinosad that 
may lead to residues in food or feed, Member States shall verify the need to 
set new and/or amended existing 
maximum residue levels (MRLs) 
according to Regulation (EC) 
No 470/2009 and/or Regulation (EC) No 396/2005, and take any appropriate 
risk mitigation measures ensuring that 
the applicable MRLs are not exceeded." 
(*) 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