COMMISSION DIRECTIVE 2010/72/EU  
of 4 November 2010  
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 Council 
concerning the placing 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 Directive 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, insec ­
ticides, acaricides and products to control other 
arthropods, as defined in Annex V to that Directive.  
(3) The Netherlands were designated as Rapporteur 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 reviewed 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.  
(5) It appears from the examinations made that biocidal 
products used as insecticides, acaricides or to control 
other arthropods and containing spinosad may be 
expected to satisfy the requirements laid down in 
Article 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 EU level. It 
is therefore appropriate that Member States assess those 
uses or exposure scenarios and those risks to the 
compartments and populations that have not been repre ­
sentatively addressed in the EU level risk assessment and, 
when granting product authorisations, ensure that appro ­
priate 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 authorisation level. In particular, in 
the light of the identified adverse health effects for the 
unprotected professional user during application by 
spraying of biocidal products containing spinosad, it is 
appropriate to require at product authorisation level that 
products intended for professional use by spraying be 
used with appropriate personal protective equipment, 
unless it can be demonstrated that risks for industrial 
or professional 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, verifi ­
cation of the need to set new or amended existing 
maximum residue levels (MRLs) and adoption of 
measures ensuring 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 treatment 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 elapse before 
an active substance is included in Annex I in order to 
permit Member States and the interested parties to 
prepare themselves to meet the new 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.  
(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.EN L 288/20 Official Journal of the European Union 5.11.2010  
( 1 ) OJ L 123, 24.4.1998, p. 1.  
( 2 ) OJ L 325, 11.12.2007, p. 3.(12) The measures provided for in this Directive 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 accordance with 
the Annex to this Directive.  
Article 2  
Transposition  
1. Member States shall adopt and publish, by 31 October 
2011 at the latest, the laws, regulations and administrative 
provisions necessary to comply with this Directive.  
They shall apply those provisions 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 determine 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 20th day following 
its publication in the  Official Journal of the European Union . 
Article 4  
This Directive is addressed to the Member States.  
Done at Brussels, 4 November 2010.  
For the Commission  
The President  
José Manuel BARROSOEN 5.11.2010 Official Journal of the European Union L 288/21ANNEX  
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 (*)  
‘37 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,6,9,10,11,12,13,14,1 ­
6a,16b-tetradecahydro-14-methyl- 
1H-as-indaceno[3,2-d]oxacyclo ­
dodecin-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- 
(dimethylamino)tetrahydro-6- 
methyl-2H-pyran-2-yl]oxy]-9-ethyl- 
2,3,3a,5a,5b,6,9,10,11,12,13,14,1 ­
6a,16b-tetradecahydro-4,14- 
dimethyl-1H-as-indaceno[3,2- 
d]oxacyclododecin-7,15-dione 
CAS No: 131929-63-0  850 g/kg  1 November 2012  31 October 2014  31 October 2022  18  When assessing the application for author- 
isation 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 popu ­
lations that have not been representatively 
addressed in the EU level risk assessment. 
Member States shall ensure that author- 
isations are subject to the following 
conditions: 
— Authorisations shall be subject to appro ­
priate risk mitigation measures. In 
particular, products authorised for 
professional use by spraying 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 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.htmEN L 288/22 Official Journal of the European Union 5.11.2010