EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
D0xxx/01-CA-Sept11-Doc.4.1 
[…](2011) XXX draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
margosa extract as an active substance in Annex I thereto 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION DIRECTIVE ../…/EU 
of XXX 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
margosa extract 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 margosa extract. 
(2) Pursuant to Regulation (E C) No 1451/2007, margosa extrac t 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) Germany was designated as Rapporteur Me mber State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
26 November 2009 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 [date of SC meeti ng], 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 evaluations that biocidal products used  as insecticides, acaricides 
and products to control other arthropods and containing margosa extract may be 
expected to satisfy the requirements laid dow n in Article 5 of Dir ective 98/8/EC. It is 
therefore appropriate to include margosa extract in Annex I to that Directive. 
(6) Not all potential uses have been evaluated at  Union level. It is therefore appropriate 
that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartmen ts that have not been representatively 
addressed in the Union level risk a ssessment and, when granting product 
authorisations, ensure that appropriate measures are ta ken or specific conditions 
imposed in order to reduce the iden tified risks to acceptable levels. 
(7) In view of the risks identified for surface wa ter, sediment and non-target arthropods, it 
is appropriate to require that product aut horisations are subject to appropriate risk 
mitigation measures. 
(8) The provisions of this Direct ive should be applied at the same time in all Member 
States in order to ensure equal treatmen t on the Union market of biocidal products 
containing the active substanc e margosa extract and also to facilitate the proper 
operation of the biocidal pr oducts market in general. 
(9) 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. 
(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. 
Article 2 
1. Member States shall adopt and publish, by 30 April 2013 at th e latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive.  
They shall apply those provisions from 1 May 2014.  
EN 4   EN 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 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] margosa 
extract  IUPAC name: Not applicable 
CAS-No: 84696-25-3 EC No: 283-644-7 1000 g/kg 
1 May 2014 30 April 2016 30 April 2024 18 When assessing 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 su bject to appropriate 
risk mitigation measures for the protection 
of surface water, sediment and non-target arthropods." 
(*) 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