COMMISSION DIRECTIVE 2011/67/EU  
of 1 July 2011  
amending Directive 98/8/EC of the European Parliament and of the Council to include abamectin 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 Council 
concerning the placing 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 Directive 98/8/EC. That list 
includes abamectin.  
(2) Pursuant to Regulation (EC) No 1451/2007, abamectin 
has been evaluated in accordance with Article 11(2) of 
Directive 98/8/EC for use in product-type 18, insec ­
ticides, acaricides and products to control other 
arthropods, as defined in Annex V to that Directive.  
(3) The Netherlands was designated as rapporteur Member 
State and submitted the competent authority report, 
together with a recommendation, to the Commission 
on 19 June 2009 in accordance with Article 14(4) and 
(6) of Regulation (EC) No 1451/2007.  
(4) The competent authority report was reviewed 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 
18 February 2011, in an assessment report.  
(5) It appears from the evaluations that biocidal products 
used as insecticides, acaricides and products to control 
other arthropods and containing abamectin may be 
expected to satisfy the requirements laid down in 
Article 5 of Directive 98/8/EC. It is therefore appropriate 
to include abamectin 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 compartments 
that have not been representatively addressed in the 
Union 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 levels.  
(7) In the light of the risks identified for sediment when 
products are used with a certain application rate and 
emitted to a sewage treatment plant, it is appropriate 
to require that products are not authorised for such 
uses, unless data are submitted demonstrating that the 
product will meet the requirements of both Article 5 of 
and Annex VI to Directive 98/8/EC, if necessary by the 
application of appropriate risk mitigation measures.  
(8) In the light of the findings of the assessment report, it is 
appropriate to require that risk mitigation measures are 
applied at product authorisation level. In particular, in 
the light of the possible risks for infants and children, 
appropriate risk mitigation measures should be taken to 
minimise the potential exposure of infants and children.  
(9) It is important that the provisions of this Directive be 
applied simultaneously in all Member States in order to 
ensure equal treatment of biocidal products on the 
market containing the active substance abamectin and 
also to facilitate the proper operation of the biocidal 
products market in general.  
(10) A reasonable period should be allowed to elapse 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 new 
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.  
(11) After inclusion, Member States should be allowed a 
reasonable period to implement Article 16(3) of 
Directive 98/8/EC.EN 2.7.2011 Official Journal of the European Union L 175/13  
( 1 ) OJ L 123, 24.4.1998, p. 1.  
( 2 ) OJ L 325, 11.12.2007, p. 3.(12) Directive 98/8/EC should therefore be amended 
accordingly.  
(13) The measures provided for in this Directive 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 accordance with 
the Annex to this Directive.  
Article 2  
Transposition  
1. Member States shall adopt and publish, by 30 June 2012 
at the latest, the laws, regulations and administrative provisions 
necessary to comply with this Directive.  
They shall apply those provisions from 1 July 2013.  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 determine 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 20th day following 
its publication in the  Official Journal of the European Union . 
Article 4  
This Directive is addressed to the Member States.  
Done at Brussels, 1 July 2011.  
For the Commission  
The President  
José Manuel BARROSOEN L 175/14 Official Journal of the European Union 2.7.2011ANNEX  
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 (*)  
‘43 Abamectin  Abamectin is a mixture of avermectin B  1a 
and avermectin B  1b 
Abamectin:  
IUPAC name: n.a. 
EC No: n.a. 
CAS No: 71751-41-2  
Avermectin B  1a: 
IUPAC name: (10E,14E,16E,22Z)- 
(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)- 
6'-[(S)-secbutyl]-21,24-dihydroxy- 
5',11,13,22-tetramethyl-2-oxo-3,7,19-trioxa ­
tetracyclo[15.6.1.14,8 .020,24  ]pentacosa- 
10,14,16,22-tetraene-6-spiro-2'-(5',6'- 
dihydro-2'H-pyran)-12-yl 2,6-dideoxy-4-O- 
(2,6-dideoxy-3-O-methyl- α-L-arabino- 
hexopyranosyl)-3-O-methyl- α-L-arabinohex ­
opyranoside 
EC No: 265-610-3 
CAS No: 65195-55-3  
Avermectin B  1b: 
IUPAC name: (10E,14E,16E,22Z)- 
(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)- 
21,24-dihydroxy-6'-isopropyl-5',11,13,22- 
tetramethyl-2-oxo-3,7,19-trioxatet ­
racyclo[15.6.1.14,8 .020,24  ]pentacosa- 
10,14,16,22-tetraene-6-spiro-2'-(5',6'- 
dihydro-2'H-pyran)-12-yl  The active 
substance shall 
comply with all the 
following purities:  
Abamectin:  
minimum 900 g/kg  
Avermectin B  1a: 
minimum 830 g/kg  
Avermectin B  1b: 
maximum 80 g/kg  1 July 2013  30 June 2015  30 June 2023  18  When assessing the application for authori ­
sation of a product in accordance with 
Article 5 and Annex VI, Member States shall 
assess, when 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. 
Products applied in such a way that emission 
to a sewage treatment plant cannot be 
prevented shall not be authorised for those 
application rates for which the Union level 
risk assessment showed unacceptable risks, 
unless data are submitted demonstrating that 
the product will meet the requirements of 
Article 5 and Annex VI, if necessary by the 
application of appropriate risk mitigation 
measures. 
Authorisations shall be subject to appropriate 
risk mitigation measures. In particular, appro ­
priate risk mitigation measures shall be taken 
to minimise the potential exposure of infants 
and children.’EN 2.7.2011 Official Journal of the European Union L 175/15No 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 (*)  
2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl- α- 
L-arabino-hexopyranosyl)-3-O-methyl- α-L- 
arabinohexopyranoside 
EC No: 265-611-9 
CAS No: 65195-56-4  
(*) 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.htmEN L 175/16 Official Journal of the European Union 2.7.2011