EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-Feb-Doc.3.1 
[…](2013) XXX  draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
1R-trans phenothrin as an active  substance in Annex I thereto  
(Text with EEA relevance) 
 
Ref. Ares(2013)146128 - 05/02/2013 
EN 2   EN COMMISSION DIRECTIVE ../…/EU 
of XXX 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
1R-trans phenothrin 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 d-phenothrin. 
(2) Pursuant to Regulation (E C) No 1451/2007, d-phenothrin has been evaluated in 
accordance with Article 11(2) of Directiv e 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 data submitted for the purpse of the evaluation allowed conclusions to be drawn 
only regarding a certain form of d-phenothrin, i.e. a substance containing at least 89% 
w/w of 1R-trans phenothrin. In accordan ce with current pr actice for naming of 
substances3, that substance should be considered as mono-constituent and named 
1R-trans phenothrin. The eval uation did not allow conclusi ons to be drawn regarding 
any other substance complying with the definition of d-phenothrin in the 
abovementioned list of active substa nces in Regulation (EC) No 1451/2007. 
Therefore, only 1R-trans phenothrin should be included in Annex I to 
Directive 98/8/EC based on the existing evaluation.  
(4) Ireland was designated as Rapporteur Member State and submitted the competent 
authority report, together with a recomm endation, to the Commission on 29 July 2010 
in accordance with Article 14(4) a nd (6) of Regulation (EC) No 1451/2007. 
(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 
                                                 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3. 
3 See in particular Guidance for identification and naming of substances under REACH and CLP , 
ECHA-11-G-10.1-EN, p. 19 f.  
EN 3   EN findings of the review were incorporated, within the Standing Committee on Biocidal 
Products on 1 March 2013, in an assessment report. 
(6) It appears from the evaluations that biocidal products used  as insecticides, acaricides 
and products to control other arthropods a nd containing 1R-trans phenothrin may be 
expected to satisfy the requirements laid dow n in Article 5 of Dir ective 98/8/EC. It is 
therefore appropriate to incl ude 1R-trans phenothrin for use in product type 18 in 
Annex I to that Directive. 
(7) Not all potential uses  and exposure scenarios have b een evaluated at Union level. 
Certain uses and exposure scenar ios. It is therefore appropria te to require that Member 
States assess those uses or  exposure scenarios and thos e risks to human populations 
and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when gr anting product authorisations, ensure that 
appropriate measures are taken or specific conditions imposed in order to reduce the 
identified risks to acceptable levels. 
(8) In view of the risks identified for human hea lth, it is appropriate to require that safe 
operational procedures are established fo r ultra low volume (U LV) application, and 
that products are used with appropriate pers onal protective equipmen t, unless it can be 
demonstrated in the application for product au thorisation that risk s can be reduced to 
an acceptable level by other means.  
(9) In view of the risks identifie d for the environment, it is appropriate to require that 
product authorisations are su bject to appropriate risk mitigation measures for the 
protection of honey bees. 
(10) For products containing 1R-trans  phenothrin that may lead to residues in food or feed, 
Member States should verify the need to  set new or to amend existing maximum 
residue levels (MRLs) according to Regul ation (EC) No 470/2009 of the European 
Parliament and of the Council of 6 May 2009 laying down Community procedures for 
the establishment of residue limits of pharmacologically active substances in 
foodstuffs of animal origin, repeali ng Council Regulation (EEC) No 2377/90 and 
amending Directive 2001/82/EC of the European Parliament and of the Council and 
Regulation (EC) No 726/2004 of the Eur opean Parliament and of the Council
4 or 
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 am ending Council Directive 91/414/EEC5, and take any 
appropriate risk mitigation measures ensu ring that the applicable MRLs are not 
exceeded. 
(11) The provisions of this Directive should be  applied simultaneously in all Member 
States in order to ensure equal treatment on the Union market of biocidal products of 
product-type 18 containing the active substa nce 1R-trans phenothrin and also to 
facilitate the proper operation of the bi ocidal products market in general. 
(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. 
                                                 
4 OJ L 152, 16.6.2009, p. 11. 
5 OJ L 70, 16.3.2005, p. 1.  
EN 4   EN (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) In accordance with the Joint Political De claration of Member States and the 
Commission of 28 September 2011 on explanatory documents6, Member States have 
undertaken to accompany, in justified cases, the notification of their transposition 
measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition 
instruments.  
(16) 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 August 2014 at th e latest, the laws, 
regulations and administrative provisions necessary to comply with this Directive. 
They shall forthwith communicate to the Co mmission the text of those provisions. 
They shall apply those provi sions from 1 September 2015. 
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 
                                                
 
6 OJ C 369, 17.12.2011, p. 14.  
EN 5   EN ANNEX  
In Annex I to Directive 98/8/EC , the following entry is added:  
No Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance 
(*) Date of 
inclusion Deadline for 
compliance with Article 
16(3), unless one of the 
exceptions indicated in the footnote to this 
heading applies (**) Expiry date 
of inclusion Product 
type Specific provisions (***) 
"(**) 
[OPOC
E: 
please 
insert 
substance 
number] 1R-trans 
phenothr
in 1R-trans phenothrin 
IUPAC name: 3-phenoxybenzyl(1R,3S)-2,2-
dimethyl-3-(2-methylprop-1-en-
yl)cyclopropanecarboxylate 
EC No: 247-431-2 
CAS No: 26046-85-5 
 Sum of all isomers : 
IUPAC name: (3-Phenoxyphenyl)methyl 2,2-
dimethyl-3-(2-methylprop-1-enyl)cyclopropane-1-carboxylate) 
EC No: 247-404-5 
CAS No: 26002-80-2  89% w/w of 
1R-trans 
phenothrin 
 
  
 
95,5% w/w 
for the sum 
of all 
isomers 
 1 September 
2015  31August 2017 31 August 
2025 18 The Union level risk assessment did not 
address all potential uses and exposure 
scenarios. When asse ssing 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.  
Member States shall ensure that 
authorisations are subject to the following 
conditions: 
(1) safe operational procedures shall 
be established for ultra low 
volume (ULV) application, and products shall be used with 
appropriate personal protective 
equipment, unless it can be demonstrated in the application 
for product authorisation that risks 
can be reduced to an acceptable 
level by other means.  
EN 6   EN No Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance 
(*) Date of 
inclusion Deadline for 
compliance with Article 
16(3), unless one of the 
exceptions indicated in the footnote to this 
heading applies (**) Expiry date 
of inclusion Product 
type Specific provisions (***) 
(2) for products containing 1R-trans 
phenothrin 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 Regulation (EC) No 
396/2005, and take any appropriate risk mitigation 
measures ensuring that the 
applicable MRLs are not exceeded. 
(3) where appropriate, measures shall 
be taken to protect honey bees." 
 (*) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 11. The active substance 
in the product placed on  the market can be of equal or different purity if it has been proven technica lly equivalent with the e valuated substance. 
(**) For products containing more than one active substance covered by Article 16(2), the deadline for compliance with Article 16(3) is that of the last of its active substances to be 
included in this Annex. For products for which the first authorisation has been granted later than 120 days before the deadline  for compliance with Article 16(3) and a complete 
application has been submitted for mutual r ecognition in accordance wi th Article 4(1) within 60 da ys of the granting of the fir st authorisation, the deadline for compliance with 
Article 16(3) in relation to that application is extended to 120 days after the date of reception of the complete application f or mutual recognition. For products for which a Member 
State has proposed to derogate from mutu al recognition in accordance w ith Article 4(4), the deadlin e for compliance with Articl e 16(3) is extended to 30 days after the date of the 
Commission Decision adopted in acco rdance with the second subp aragraph of Article 4(4). 
(***) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are availa ble on the Commission website: 
http://ec.europa.eu/comm/environment/biocides/index.htm