EN    EN  
 
 
 
EN  
EN 1   EN  
 
 
Draft 
COMMISSION DIRECTIVE .../…/EC 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
indoxacarb as an active substance in Annex I thereto 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
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 market1, and in 
particular Article 11(4) thereof, 
Whereas: (1) The United Kingdom (UK) has received on 12 December 2005 an application from 
DuPont de Nemours S.A., in accordance with  Article 11(1) of Directive 98/8/EC, for 
the inclusion of the active substance indoxacarb in its Annex I or IA for use in 
product-type 18, insecticides, acaricides and products to control other arthropods, as 
defined in Annex V to Directive 98/8/EC. Indoxacarb was not on the market on the date referred to in Article 34(1) of Dir ective 98/8/EC as an active substance of a 
biocidal product. 
(2) After carrying out an evaluation, the UK submitted a competent authority report, 
together with a recommendation, to the Commission on 5 March 2007. 
(3) The competent authority report was re viewed by the Member States and the 
Commission within the Sta nding Committee on Biocidal Products on 28 May 2008, 
and the findings of the review were in corporated in an assessment report. 
(4) It appears from the examinations made that  biocidal products us ed as insecticides, 
acaricides or to control other arthropods and containing indoxacarb may be expected 
to satisfy the requirements laid down in Artic le 5 of Directive 98/8/ EC. It is therefore 
appropriate to include indoxacarb in Annex I.  
                                                
 
1 OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission Directive 2007/70/EC (OJ L 312, 
30.11.2007, p. 26).  
EN 2   EN (5) In the light of the findings of the assessment report, it is also appropriate to require 
that risk mitigation measures are applied at product authorisation level to products 
containing indoxacarb and used as insect icides, acaricides or to control other 
arthropods. 
(6) Such measures should be aimed at limiting the risks to non-target species and the 
aquatic environment. To this end, certain c onditions such as ensuring that products are 
not placed in areas accessible to infants,  children and compani on animals and do not 
enter into contact with water should be imposed. 
(7) A reasonable period should be allowed to elap se before an active substance is included 
in Annex I in order to permit Member States  to bring into force the laws, regulations 
and administrative provisions necessary to comply with this Directive. 
(8) Directive 98/8/EC should therefore be amended accordingly. 
(9) 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 the laws, regulations and administrative 
provisions necessary to comply with this Di rective not later than 6 months after its 
entry into force. They shall forthwith co mmunicate to the Commission the text of 
those provisions and a correlation table betw een those provisions and this Directive. 
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 3   EN Done at Brussels, […] 
 For the Commission 
 Stavros Dimas  Member of the Commission  
EN 4   EN ANNEX  
The following entry ‘No. 19’ is insert ed in Annex I to Directive 98/8/EC:  
  
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
* 
 
 
"19 Indoxacarb Reaction mass of 
methyl (S)- and methyl(R)-7-chloro-
2,3,4a,5-tetrahydro-2-
[methoxycarbonyl-(4-trifluoromethoxyphenyl) 
carbamoyl]indeno[1,2-
e][1,3,4]oxadiazine-4a-carboxylate (This entry 
covers the 75:25 
reaction mass of the S 
and R enantiomers) 
EC No: n/a CAS No: 173584-44-6 
 467 g/kg 1 January 
2009 n/a 31 
December 
2018 18 Member States shall ensure that 
authorisations are subject to the following conditions: 
Appropriate risk mitigation 
measures must be taken to minimise the potential exposure of humans, of 
non-target species and of the aquatic 
environment. In particular, labels and/or safety-data sheets of products 
authorised shall indicate that: 
(1) Products shall not be placed in 
areas accessible to infants, 
children and companion animals. 
(2) Products shall be positioned 
away from external drains.
 
(3) Unused products shall be 
disposed of properly and not 
washed down the drain.  
                                                 
  
EN 5   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
* 
 
 
For amateur uses, only ready-to-use 
products shall be authorised." 
 
* For the implementation of the common principles of Annex VI, the content and conclusions of asse ssment reports are available on  the Commission website: http://ec.europa.eu/comm/envir onment/biocides/index.htm