EN EN
EUROPEAN
COMMISSION
Brussels, XXX
CA-July13-Doc.3.3
[…](2013) XXX draft
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
to approve benzoic acid as an existing active substance for use in biocidal products for 
product -types 3 and 4
(Text with EEA relevance)EN 2 ENCOMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
to approve benzoic acid as an existing active substance for use in biocidal products for 
product -types 3 and 4
(Text with EEA relevance)
THE EUROPEAN COMMI SSION,
Having regard to the Treaty on the F unctioning of the European Union ,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Counc il of 22 May 2012 concerning the making available on the market and use of biocidal 
products1, and in particular the third subparagrap h of Article 89(1) 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 market2establishes 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 benzoic a cid.
(2) Pursuant to Regulation (EC) No 1451/200 7, benzoic acidhas been evaluated in 
accordance with Article 11(2) of Directive 98/8/EC for use in product -type 3, 
veterinary hygiene biocidal products, and product -type 4, food and feed area 
disinfectants, as defin ed in Annex V to that Directive, which c orrespond respectivel y 
to product -types3 and 4 as defined in Annex V to Regulation (EU) No 528/2012.
(3) German ywas designated as Rapporteur Member State and submitted the competent 
authority report s, together with recomm endation s, to the Commission on 
3February 2011 in accordance with Article 14(4) and (6) of Regulation (EC) No 
1451/2007.
(4) The competent authority report swerereviewed by the Member States and the 
Commission. I n accordance with Article 15(4) of Regulation (EC) No 1451/2007, the 
findings of th e review were incorporated, within the Standing Committee on Biocidal 
Products on 27 September 2013 ,in twoassessment report s.
(5) It appears from the evaluations that biocidal products used for product -types 3 and 4 
and containing benzoic a cid maybe expecte d to satisfy the requirements laid down in 
Article 5 of Directive 98/8/EC . It also appears from the report sthat such biocidal 
products maybe expected to satisfy the requirements laid down in Article 19 of 
Regulation (EU) No 528/2012, provided that the co nditions specified in the Annex to 
this Regulation are satisfied.
  
1OJ L 167, 27. 6.2012, p. 1.
2OJ L 325, 11.12.2007, p. 3.EN 3 EN(6) It is therefore appropriate to approve benzoic a cid for use in biocidal products for 
product -types3and 4 .
(7) Since the evaluation sdid not a ddress nanomaterials, the approval sshould not cove r 
such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.
(8) For the use in product -type 4, t he evaluation did not adress the incorporation of
biocidal products containing benzoic aci d in materials and articles intended to come 
into contact di rectly or indirectly with food within the meaning of Article 1(1) of
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/EEC3. Such materials may require the 
establishment of specific limits on the migration into food, as referred to in 
Article 5(1)(e) ofRegulation (EC) No 1935/2004 . The approval sh ould 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 par ties, and the Commission 
where appropriate, to prepare themselves to meet the new requirements entailed .
(10) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Biocidal Products ,
HAS ADOPTED THIS REGUL ATION:
Article 1
Benzoic a cid shall be approved as an active substance for use in biocidal produ cts for product -
types3and 4 , subject to the specifications and conditions set out in the Annex to this 
Regulation.
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
  
3OJ L 338, 13.11.2004 , p.4.EN 4 ENANNEX 
Common 
Nam eIUPAC Name
Identification NumbersMinimum 
degree of 
purity of 
the active 
substance4Date of 
approvalExpiry date 
of approvalProduct 
typeSpecific condit ions5
Benzoic 
acidIUPAC Name : Benzoic a cid
EC No: 200 -618-2
CAS No: 65-85-0990 g/kg 1 July 
2015 30 June
20253The 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 l evel risk 
assessment of the active substance .
Authorisations are subject to the following 
condition s:
1)For industrial or professional 
users, safe operational procedures 
and appropriate organizational 
measures shall be established. 
Only where exposure cannot be 
reduced to an acceptable level by 
other means, products shall be 
used with appropriat e personal 
protective equipment .
2)For products that may lead to 
residues in food or feed, the need 
to set new or to am end existing 
maximum residue levels (MRLs) 
in acco rdance with Regulation 
  
4The purit y indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordanc e with Article 8 of Regulation (EU) 
No 528/2012 . The active substance in the product placed on the market can be of equal or differ ent purity if it has been proven technically equivalent with the evaluated 
active substance.
5For the implementation of the common principles of Annex VI of Regulation (EU) No 528/2012 , the content and conclusions of assessment reports are available on th e 
Commission website: http://ec.europa.eu/comm/environment/biocides/index.htmEN 5 ENCommon 
Nam eIUPAC Name
Identification NumbersMinimum 
degree of 
purity of 
the active 
substance4Date of 
approvalExpiry date 
of approvalProduct 
typeSpecific condit ions5
(EC) No 470/2009 of the 
European Parliament and of the 
Council6or Regulation (EC) No 
396/2005 of the European 
Parliament and of the Council7
shall be verified, and any 
appropriate risk mitigation 
measures shall be taken to ensure 
that the applicable MRLs are not 
exceeded.
4The 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 
condition s :
1)For industrial or professional 
users, safe operational procedures 
and appropriate organizational 
measures shall be established. 
Only where exposure cannot be 
reduced to an acceptable level by 
other means, products shall be 
used with appropriate personal 
  
6OJ L 152, 16.6.2009, p. 11.
7OJ L 70, 16.3.2005, p. 1.EN 6 ENCommon 
Nam eIUPAC Name
Identification NumbersMinimum 
degree of 
purity of 
the active 
substance4Date of 
approvalExpiry date 
of approvalProduct 
typeSpecific condit ions5
protective equipment. .
2)For products that may lead to 
residues in food or feed, the need 
to set new or to am end existing 
maximum residue levels (MRLs) 
in accordance wit h Regulation 
(EC) No 470/2009 ofthe 
European Parliament and of the 
Council or Regulation (EC) No 
396/2005 of the European 
Parliament and of the Counci l
shall be verified, and any 
appropriate risk mitigation 
measures shall be taken to ensure 
that the appli cable MRLs are not 
exceeded.
3)Products containing benzoic acid 
shall not be incorporat ed 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 
establis hed specific limits on the 
migration of benzoic acid into 
food or it has been established 
pursuant to that Regulation that 
such limits are not necessary .