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 
thiacloprid 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 20 February 2006 an application from 
Lanxess Deutschland GmbH, in accordance wi th Article 11(1) of Directive 98/8/EC, 
for the inclusion of the active substance thia cloprid in its Annex I or IA for use in 
product-type 8, wood preservatives, as de fined in Annex V to Directive 98/8/EC. 
thiacloprid was not on the market on the date referred to in Article 34(1) of Directive 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 3 July 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 used as wood 
preservatives and containing th iacloprid may be expected to satisfy the requirements 
laid down in Article 5 of Directive 98/8/EC . It is therefore a ppropriate to include 
thiacloprid 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) However, unacceptable risks were identified for the in situ  treatment of wooden 
structures near water, where direct lo sses to the aquatic compartment cannot be 
prevented. Therefore, authorisations for th ese uses should not be granted unless data 
have been submitted in order to demonstrat e that the products can be used without 
unacceptable risks to the environment. 
(6) 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 to products containing 
thiacloprid and used as wood preservatives to ensure that risks are reduced to an 
acceptable level in accordance with Article  5 of Directive 98/8/EC and Annex VI 
thereto. In particular, appropr iate measures should be ta ken to protec t the soil and 
aquatic compartments since unacceptable risks to these compartments have been identified during the evaluation. Products inte nded for industrial and/or professional 
use should be used with appr opriate protective equipment if the risk identified for 
industrial and/or profes sional users cannot be reduced by other means.  
(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 .  
EN 3   EN Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, […] 
 For the Commission 
 Stavros Dimas  Member of the Commission  
EN 4   EN ANNEX  
The following entry ‘No. 18’ 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
* 
 
 
"18 Thiacloprid (Z)-3-(6-chloro-
3-pyridylmethyl)-1,3-thiazolidin-2-
ylidenecyanamide 
EC No: n/a CAS No: n/a 
 975 g/kg 1 January 
2009 n/a 31 
December 
2018 8 Member States shall ensure that 
authorisations are subject to the following conditions: 
1. In view of the assumptions made 
during the risk assessment, products authorised for industrial and/or 
professional use, must be used with 
appropriate personal protective equipment, unless it can be 
demonstrated in the application for 
product authorisation that risks to 
industrial and/or professional users can 
be reduced to an acceptable level by other means. 
 
2. In view of the risks identified for the 
soil and aquatic compartments 
appropriate risk mitigation measures 
must be taken to protect those 
                                                 
  
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
* 
 
 
compartments. In particular, labels 
and/or safety-data sheets of products authorised for industrial use shall 
indicate that freshly treated timber 
must be stored after treatment under shelter or on impermeable hard 
standing to prevent direct losses to soil 
or water and that any losses must be collected for reuse or disposal. 
 
3. Products shall not be authorised for the 
in situ  treatment of wooden structures 
near water, where di rect losses to the 
aquatic compartment cannot be prevented, or for wood that will be in 
contact with surface water, unless data 
have been submitted to demonstrate 
that the product will meet the 
requirements of Article 5 and Annex VI, if necessary by the application of 
appropriate risk mi tigation measures." 
 
* 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