EN    EN EN  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
C(2009) XXX final  
  
Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
aluminium phosphide releasing phosphine as an active substance in Annex I thereto  
EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EC 
of  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
aluminium phosphide releasing phosphine 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 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 aluminium phosphide. 
(2) Commission Directive 2009/XXX/EC3 included aluminium phosphide as an active 
substance in Annex I to Dir ective 98/8/EC for use in produc t-type 14, rodenticides, as 
defined in Annex V to Directive 98/8/EC. 
(3) Pursuant to Regulation (EC) No 1451/ 2007, aluminium phosphide has now been 
evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-
type 18, insecticides, as defined in Annex V to that Directive. 
(4) Germany was designated as Rapporteur Me mber State and submitted the competent 
authority report, together  with a recommendation, to the Commission on 26 October 
2007 in accordance with Article 14(4) a nd (6) of Regulati on (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 OJ L XXX, XX.XX.2009, p. XX  
EN 3   EN findings of the review were incorporated, within the Standing Committee on Biocidal 
Products on 15 May 2009, in an assessment report. 
(6) It appears from the examinations made that biocidal products used as insecticides and 
containing aluminium phosphide may be expect ed to satisfy the requirements laid 
down in Article 5 of Directive 98/8/EC. It  is therefore appropriate to include 
aluminium phosphide in Annex I, in order to ensure that in all Member States 
authorisations for biocidal products used as insecticid es and containing aluminium 
phosphide can be granted, modified, or cancel led in accordance with Article 16(3) of 
Directive 98/8/EC.  
(7) Not all potential uses have been evaluated at the Community level. It is therefore 
appropriate that Member States assess thos e uses or exposure scenarios and those risks 
to the compartments and populations that have  not been representatively addressed in 
the Community level risk assessment and, when granting product authorisations, 
ensure that appropriate measures are taken or specific conditions imposed in order to 
reduce the identified risks to acceptable leve ls. In particular, where relevant, Member 
States should assess outdoor use, which ha s not been addressed in the Community 
level risk assessment. 
(8) In the light of the conclusions of the assessmen t report, it is approp riate to require that 
products containing aluminium pho sphide and used as insectic ides be authorised only 
for use by trained professionals in accordan ce with Article 10(2 )(i)(e) of Directive 
98/8/EC, and that specific risk mitigation measures are applied at product authorisation level to such products. Such measures should be aimed at limiting the risk of exposure of users to aluminiu m phosphide to an ac ceptable level.  
(9) Regulation (EC) 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 amending Council Directive 91/414/EEC
4 establishes 
maximum limits for aluminium phosphide residues which are present in or on food and feed as a result of use as a biocide. Member States should ensure that adequate 
residue trials are provided at product authorisation to allow consumer risk assessment 
and should also take measures such as the ad herence to waiting periods to ensure that 
maximum residue limits laid down in Regulation (EC) 396/2005 are not exceeded. 
(10) It is important that the provisions of this Directive be applied simultaneously in all the 
Member States in order to ensure equal tr eatment of biocidal products on the market 
containing the active substance aluminium phos phide and also to facilitate the proper 
operation of the biocidal pr oducts market in general. 
(11) A reasonable period should be allowed to elap se before an active substance is included 
in Annex I in order to permit Member Stat es and the interested parties to prepare 
themselves to meet the new requirements enta iled and to ensure that applicants who 
have prepared dossiers can benefit fully fr om the 10-year period of data protection, 
which, in accordance with Artic le 12(1)(c)(ii) of Directive 98/8/EC, starts from the 
date of inclusion. 
                                                
 
4 OJ L 70, 16.3.2005, p. 1.  
EN 4   EN (12) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC, and in  particular, to grant, modify or cancel 
authorisations of biocid al products in product-type  18 containing aluminium 
phosphide to ensure that they co mply with Directive 98/8/EC. 
(13) Directive 98/8/EC should therefore be amended accordingly. 
(14) 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 September 2010 at the latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive. 
They shall apply those pr ovisions from 1 October 2011. 
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 
 Stavros DIMAS  Member of the Commission  
EN 5   EN ANNEX  
The following is added to entry ‘No. 20’  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 (*)  
EN 6   EN    "830 g/kg 1 October 
2011 30 September 2013 30 
September 
2021 18 When assessing the application for au thorisation of a product in accorda n
with Article 5 and Annex VI, Member States shall assess, when relevant f
the particular product, those uses or exposure scenarios and those risks 
compartments and populations that have not been representatively address
in the Community level risk assessment. In particular, where releva n
Member States shall assess outdoor use. 
When granting product authorisation, Member States shall ensure t h
adequate residue trials are provided to  allow consumer risk assessment a n
that appropriate measures  are taken or specific c onditions imposed in order 
mitigate the identified risks.  
Member States shall ensure that aut horisations are subject to the followi n
conditions: 
(1) Products shall only be supplied to and used by specifically train
professionals in the form of ready-for-use products. 
(2) In view of the risks identified for operators, appropriate ri
mitigation measures must be applied. Those include, amon g
others, the use of appropriate personal and respiratory protecti v
equipment, the use of applicators and the presentation of t h
product in a form designed to reduce the exposure of operators 
an acceptable level. For indoor use, those include also t h
protection of operators and workers during fumigation, t h
protection of workers at re-entry  (after fumigation period) and t h
protection of bystanders against leaking of gas. 
(3) For products containing aluminium phosphide that may lead 
residues in food or feed, labels  and/or safety data sheets m u
contain instructions for use, such as the adherence to waiti n
periods, which ensure that MRLs set out in Regulation (E C
No 396/2005 of the European Parliament and of the Council(*) a
not exceeded. 
(*) OJ L 70, 16.3.2005, p. 1." 
(*) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on  the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm