EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-July13-Doc.4.7 
[…](2013) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving zineb as an existing active substa nce for use in biocidal products for product-
type 21 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving zineb as an existing active substa nce for use in biocidal products for product-
type 21 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Council of 22 May 2012 concerning the making av ailable on the market and use of biocidal 
products
1, and in particular the third subpa ragraph of Article 89(1) thereof, 
Whereas: (1) Commission Regulati on (EC) No 1451/2007
2 establishes a list of active substances to 
be assessed, with a view to their possibl e inclusion in Annex I, IA or IB to 
Directive 98/8/EC of the European  Parliament and of the Council3. That list includes 
zineb. 
(2) Zineb has been evaluated in accordance with  Article 11(2) of Di rective 98/8/EC for 
use in product-type 21, antifouling products, as defined in Annex V to that Directive, 
which corresponds to product-type 21 as de fined in Annex V to Regulation (EU) 
No 528/2012. 
(3) Ireland was designated as Rapporteur Member State and submitted the competent 
authority report, together  with a recommendation, to the Commission on 29 March 
2011 in accordance with Article 14(4) a nd (6) of Regulati on (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 SCB], in an assessment report. 
(5) It appears from that repor t that biocidal products used for product-type 21 and 
containing zineb may be expected to satisfy the requirements laid down in Article 5 of 
Directive 98/8/EC, provided that the c onditions specified in the Annex to this 
Regulation are satisfied.It is therefore appropriate to approve zineb for use in biocidal 
products for product-type 21. 
(6) Since the evaluation did not a ddress nanomaterials, the appr oval should not cover such 
materials pursuant to Article 4( 4) of Regulation (EU) No 528/2012. 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Regulation (EC) No 1 451/2007of 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 (OJ L 325, 11.12.2007, p. 3). 
3 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 (OJ L 123, 24.4.1998, p. 1) .  
EN 3   EN (7) A reasonable period should be allowed to elapse before an active substance is 
approved, in order to permit Member States, interested parties, and the Commission 
where appropriate, to prepare themselves to meet the new requirements entailed.  
(8) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products,  
HAS ADOPTED THIS REGULATION: 
Article 1 
Zineb shall be approved as an active substa nce for use in biocidal products for product-
type 21, subject to the sp ecifications and condition s set out in the Annex. 
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  José Manuel BARROSO   
EN 4   EN ANNEX  
Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
4 Date of 
approval Expiry date 
of approval Product 
type Specific conditions5 
Zineb 
 IUPAC Name :  
Zinc ethylenebis(dithiocarbamate) (polymeric) EC n° : 12122-67-7  CAS n° : 235-180-1 
 940 g/kg 1 January 
2016  31 
December 
2025
 21 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 risk 
assessment of the active substance. 
Authorisations are subject to the following 
conditions: 
(1) For industrial or professional 
users, safe operational procedures and appropriate 
organizational 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) Products authorised for non-
professional users shall be 
sold with the appropriate 
                                                 
4 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. 
5 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/comm/environment/biocides/index.htm .  
EN 5   EN Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
4 Date of 
approval Expiry date 
of approval Product 
type Specific conditions5 
protective gloves. Labels and, 
where provided, instructions for use shall indicate whether 
other personal protective 
equipments shall be used.Labels and, where 
provided, safety data sheets 
of products authorised shall 
indicate that application, 
maintenance and repair activities shall be conducted 
within a contained area and 
on impermeable hard standing with bunding to 
prevent direct losses and 
minimize emissions to the environment, and that any 
losses or waste containing 
zineb shall be collected for reuse or disposal.. 
(3) 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 with Regulation (EC) No 
                                                                                                                                                                                                                                                    
6 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for t he 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). 
7 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pes ticides 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).  
EN 6   EN Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
4 Date of 
approval Expiry date 
of approval Product 
type Specific conditions5 
470/2009 of the European 
Parliament and of the Council
6 or Regulation (EC) 
No 396/2005 of the European 
Parliament and of the Council
7 shall be verified, and 
any appropriate risk 
mitigation measures shall be 
taken to ensure that the 
applicable MRLs are not exceeded. 
 
Where a treated article has been treated 
with or intentionally incorporates zineb, 
and where necessary due to the possibility 
of skin contact as well as the release of zineb under normal conditions of use, the 
person responsible for placing the treated 
article on the market shall ensure that the label provides information on the risk of 
skin sensitisation, as well as the 
information referred to in the second subparagraph of Article 58(3) of 
Regulation (EU) No 528/2012