EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-Sept13-Doc.3.5 
[…](2013) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving iodine as an existing active s ubstance for use in biocidal products for 
product-types 1, 3, 4 and 22 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving iodine as an existing active s ubstance for use in biocidal products for 
product-types 1, 3, 4 and 22 
(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 possible in clusion in Annex I, IA or IB to Directive 
98/8/EC of the European Parliament and of the Council3. That list includes iodine. 
(2) Iodine has been evaluated in accordance with  Article 11(2) of Directive 98/8/EC for 
use in product-type 1, human hygiene bioc idal products, product- type 3, veterinary 
hygiene biocidal products, product-type 4, food and feed area disinfectants, and 
product-type 22, embalming and taxidermist fluids, as defined in Annex V to that Directive, which correspond respectively to  product-types 1, 3, 4 and 22 as defined in 
Annex V to Regulati on (EU) No 528/2012.  
(3) Sweden was designated as Rapporteur Member State and submitted the competent 
authority report, together with recomme ndations, to the Commission on 20 April 2011 
in accordance with Article 14(4) a nd (6) of Regulation (EC) No 1451/2007. 
(4) The competent authority reports were 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 report that biocidal products used for product-types 1, 3, 4 and 22 
and containing iodine may be expected to sa tisfy the requirements laid down in Article 
5 of Directive 98/8/EC, provide d that the conditions specified in the Annex to this 
Regulation are satisfied.  
(6) It is therefore appropriate to approve iodi ne for use in biocidal products for product-
type 1, 3, 4 and 22. 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Regulation (EC) No 1451/2007 of 4 Decem ber 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) Since the evaluations did not address nanom aterials, the approvals should not cover 
such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012. 
(8) The evaluation did not address the incorpor ation of biocidal products containing 
iodine in materials and articles intended to come into contact directly or indirectly 
with food within the meaning of Article 1( 1) of Regulation (EC)  No 1935/2004 of the 
European Parliament and of the Council4. Such materials may require the 
establishment of specific limits on the mi gration into food, as referred to in 
Article 5(1)(e) of Regulation (EC) No 1935/2004. The approval should therefore not 
cover such use unless the Commission has established such limits or it has been established pursuant to that Regulation that such limits are not necessary.  
(9) 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.  
(10) 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 
Iodine shall be approved as an  active substance for use in bi ocidal products for product-types 
1, 3, 4 and 22, subject to the specifications and conditi ons 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
                                                
 
4 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact  with food and repealing Directives 80/590/EEC and 
89/109/EEC (OJ L 338, 13.11.2004, p. 4).  
EN 4   EN ANNEX  
Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
5 Date of 
approval Expiry date 
of approval Product 
type Specific conditions6 
1 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.
 Iodine 
  
 
 
 
  
 
  
 
  
 
  
 IUPAC Name :  
Iodine EC No : 231-442-4 CAS No : 7553-56-2 
 
 
 
  
 
  
 
  995 g/kg 
 
 
  
 
 
 
  
 
  
 
 1 
September 
2015  
  
 
 
 
  
 
  
 
  31 August 
2025 
 
  
 
 
 
  
 
  
 
 3 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 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 470/2009 of 
                                                 
5 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 
6 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
5 Date of 
approval Expiry date 
of approval Product 
type Specific conditions6 
the European Parliament and of 
the Council7 or Regulation (EC) 
No 396/2005 of the European 
Parliament and of the Council8 
shall be verified, and any 
appropriate risk mitigation 
measures shall be taken to 
ensure that the applicable MRLs 
are not exceeded.  
  
 
  
 
 
 
  
 
  
  
 
  
 
 
 
  
  
  
 
  
 
 
 
   
  
 
  
  
  
 
 
4 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: 
(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 with 
Regulation (EC) No 470/2009 of the European Parliament and of 
                                                 
7 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). 
8 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
5 Date of 
approval Expiry date 
of approval Product 
type Specific conditions6 
the Council or Regulation (EC) 
No 396/2005 of the European Parliament and of the Council
 
shall be verified, and any appropriate risk mitigation measures shall be taken to 
ensure that the applicable MRLs 
are not exceeded. 
(3) Products containing iodine shall 
not be incorporated in materials and articles intended to come 
into contact with food within the 
meaning of Article 1(1) of Regulation (EC) No 1935/2004, 
unless the Commission has 
established specific limits on the migration of iodine into food or 
it has been established pursuant 
to that Regulation that such limits are not necessary . 
22 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 
adressed in the Union level risk assessment 
of the active substance. 
Authorisations are subject to the following 
condition: 
For professional users, safe operational 
procedures and appropriate organizational  
EN 7   EN Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
5 Date of 
approval Expiry date 
of approval Product 
type Specific conditions6 
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.