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 EN 
 
ANNEX  
Common 
Name IUPAC Name 
Identification Numbers Minimum degree of 
purity of the active 
substance1  Date of 
approval Expiry date 
of approval Product 
type Specific conditions2 
Bacillus 
thuringiensis subsp.  
israelensis serotype H14, strain SA3A   Not applicable 
No relevant impurities 1 July 
2016 30 June 
2026 18 The product assessment shall pay particular attention to 
the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level ri sk assessment of the active 
substance. 
For biocidal products, authorisations are subject to the 
following conditions: 
(1) For professional users, safe operational 
procedures and appropriate organisational 
measures shall be established. Where exposure cannot be reduced to an acceptable level by 
other means, products shall be used with 
appropriate personal protective equipment. 
(2) For products that may lead to residues in food or 
feed, the need to set new or to amend existing 
maximum residue levels (MRLs) in accordance 
                                                            
1 The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in a ccordance with Article 8 of Regulation (EU) 
No 528/2012. The active substance in the product placed on the market  can be of equal or different  purity if it has been proven  technically equivalent with the evaluated 
active substance. 
2 For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of ass essment reports are available on the 
Commission website: http://ec.europa.eu/environment/chemicals/biocides/index_en.htm .  
 
2 
 Common 
Name IUPAC Name 
Identification Numbers Minimum degree of 
purity of the active 
substance1  Date of 
approval Expiry date 
of approval Product 
type Specific conditions2 
with Regulation (EC) No 470/2009 of the 
European Parliament and of the Council3 or 
Regulation (EC) No 396/2005 of the European 
Parliament and of the Council4 shall be verified, 
and any appropriate risk mitigation measures 
shall be taken to ensure that the applicable MRLs 
are not exceeded. 
 
                                                                                                                                                                                                                                                                                                          
3  Regulation (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, repealing 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 European Parliament and of the Council (OJ L 152, 16.6.200 9, p. 11). 
4  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pe sticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).