EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10093/2016 ANNEX 
(POOL/E4/2016/10093/10093-EN 
ANNEX.doc) 
[…](2016) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
approving copper flakes (coated with aliphatic acid) as an existing active substance for 
use in biocidal products of product-type 21 
  
EN 2   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 Conditions 
Copper flakes 
(coated with aliphatic acid) IUPAC Name:  
Copper  EC No: 231-159-6 CAS No: 7440-50-8 95,3% w/w 1 January 
2018 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. 
 In the event that products cont aining copper flakes (coated 
with aliphatic acid) are subsequently authorised for use by 
non-professional users, persons making products available on 
the market for non-professional users shall ensure that the 
products are supplied with appropriate gloves. 
 
For biocidal products, author isations are subject to the 
following conditions: 
1) For industrial or 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) Labels and, where provided, instructions for use shall 
indicate that children shall be kept away until treated 
surfaces are dry. 
3) 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, on an impermeable hard standing with bunding or on soil covered with an impermeable material to prevent 
                                                 
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 89(1) of Regulation 
(EU) No 528/2012. The active substance in the product placed on the market can be of equal or di fferent purity if it has been p roven technically equivalent with the 
evaluated active substance.  
EN 3   EN losses and minimise emissions to the environment, and 
that any losses or waste cont aining copper flakes (coated 
with aliphatic acid) shall be collected for reuse or disposal. 
4) 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 the Council2 
or Regulation (EC) No 396/2005 of the European 
Parliament and of the Council3 shall be verified, and any 
appropriate risk mitigation m easures shall be taken to 
ensure that the applicable  MRLs are not exceeded. 
 
 
                                                                                                                                                                                                                                                    
2 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). 
3 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).