EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10257/2018  
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) 1107/2009 of the European Parliament and of 
the Council listing co -formulants which are not accepted for inclusion in plant 
protection products  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) 1107/2009 of the European Parliament and of 
the Council listing co -formulants which are not accepted for inclusion in plant 
protection products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Tr eaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council of 21 October 2009 concerning the placing of plant protection products on the market 
and repealing Council Directives  79/117/EEC and 91/414/EEC1, and in particular 
Article  27(2) and Article 78(2) thereof,   
Whereas:  
(1) Co-formulants are described  in Article 2(3) (c) of Regulation (EC) No 1107/2009 as 
substances or preparations which are used or intended to be used in a plant protection 
product or adjuvant, but are neither active substances nor safeners nor synergists.   
(2) Co-formulants are unacceptable in plant protecti on products  if their residues, 
consequent on application  consistent with good plant protection practice, and having 
regard to  realistic conditions of use, have a harmful effect on human or animal health 
or on groundwater or an unacceptable effect on the en vironment. Co-formulants are 
also unacceptable in plant protection products if their use, consequent on application 
consistent with good plant protection practice, and having regard to realistic conditions 
of use, have a harmful effect on human or animal h ealth or have an unacceptable effect 
on plants, plant protection products or the environment. Such  unacceptable 
co-formulants are to  be listed in Annex  III to Regulation (EC) No 1107/2009.  
(3) Co-formulants are substances or preparations used together with active substances in 
plant protection products and are thus equally spread in the environment. Therefore, 
the criteria concerning human health, the environment, ecotoxicity and groundwater, 
provided for by  points  3.6, 3.7, 3.8 and 3.10 o f Annex  II to Regulation (EC) 
No 1107/2009 , should also be relevant to identify  unacceptable co -formulants .  
(4) The list of u nacceptable co -formulants thus should include substances with a 
harmoni sed classifi cation  as carcinogen s, category 1A or 1B , as cell mutagen s, 
category  1A or 1B , or as toxic to reproduction , category 1A or 1B , in accordance with  
Annex  VI to Regulation (EC) No  1272/20082.  
                                                 
1 OJ L 309, 24.11.2009, p.  1. 
2 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16  December  2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, 
p. 1).  
EN 2  EN (5) The list of u nacceptable co -formulants should  further include substances identified as 
persistent, bioaccumula tive and toxic (PBT) or very persistent and very 
bioaccumulative (vPvB) in accord ance with points (d) and (e) of Article  57 of 
Regulation (EC) No  1907/2006 of the European Parliament and of the Council3.  
(6) The list of u nacceptable co -formulants should  also include substances of very high 
concern due to endocrine disrupting properties  in accord ance with  point (f) of  
Article  57 of Regulation (EC) No  1907/2006  or substance s identified as endocrine 
disruptors under Regulation (EC) No  528/20124 concerning the making available on 
the market and use of biocidal products  or substances identified as persistent organic 
pollutants (POP) under Regulation (EC) No  850/20045. 
(7) Regulation (EC) No 1907/2006  sets out restrictions for certain dangerous substan ces 
in its Annex  XVII . Where the use of those substances is subject to restrictions  as 
co-formulants in plant protection products , they should be added to th at list of 
co-formulants in Annex  III to Regulation (EC) No  1107/2009 . 
(8) Member States have identified unacceptable co -formulants for plant protection 
products under Council Directive  91/414/EEC6 and under Article  81 of Regulation  
(EC) No  1107/2009 . Such co-formulants have been notified by Austria, Belgium, 
France, Germany, Italy, Lithuania, Spain and Norway . Amongst t hose co -formulants , 
those  with a harmonised classification as carcinogens, category 1A or 1B, as cell 
mutagens, category 1A or 1B, or as toxic to reproduction, category 1A or 1B, in 
accordance with Annex VI to Regulation (EC) No  1272 /2008, those identified as PBT 
or vPvB according to points (d) and (e) of Article  57 of Regulation (EC) 
No 1907/2006, those identified as substances of very high concern due to endocrine 
disrupting properties in accordance with point (f) of Article 57 of R egulation (EC) 
No 1907/2006, and those identified as POP under Regulation (EC) No  850/2004  
should  be listed in Annex  III to Regulation  (EC) No  1107/2009 .  
(9) The use of POE tallowamines (CAS  No 61791 -26-2) in plant protection products 
containing glyphosate was prohibited  by Commissi on Implementing Regulation 
(EU)  2016/13137, as concerns were identified in relation to the toxicity of POE 
tallowamines and their potential to negatively affect human health . Given that th ose 
concerns are due to the intrinsic prop erties of the substances  concerned  and are thus 
not limited to formulated products containing glyphosate but are equally valid for 
formulated products containing other active substances, POE tallowamines should also  
be added to that list of co -formulants in Annex  III to Regulation  (EC) No  1107/ 2009 . 
                                                 
3 Regulation (EC) No  1907/2006 of the European Parliament and of the Council of 18  December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing a European Chemicals Agency, amending Directive 1999/45 /EC and repealing Council 
Regulation (EEC) No  793/93 and Commission Regulation (EC) No  1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p.  1). 
4 Regulation (EU)  No 528/2012 of the European Parliament and of the Council of 22  May 2012 
concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p.  1). 
5 Regulation (EC) No 850/2004 of the European Parliament and of the Council of  29 April 2004 on 
persistent organic pollutants and amending Directive 79/117/EEC ( OJ L 158, 30.4.2004, p.  7). 
6 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on 
the market (OJ L 230, 19.8.1991, p.  1). 
7 Commission Implementing Regulation (EU) 2016/1313 of 1 August 2016 amending Implementation 
Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance glyphosate 
(OJ L 208, 2.8.2016, p.  1).  
EN 3  EN (10) The use of PHMB (1600; 1.8) , CAS number 27083 -27-8 and 32289 -58-0, and PHMB 
(1415; 4.7) , CAS number 32289 -58-0 and 1802181 -67-4, as in -can preservatives in 
plant protection products would lead to unacceptable e ffects on human health and in 
the environment. Commission Implementing Decisions (EU) 2016/1098 and 2018/6199 
did not approve them as existing active substance s for use in biocidal products for 
product -type 6  (in-can preservatives),  amongst other product t ypes due to unacceptable 
risks for human health and the environment . The refore PHMB (1600; 1.8) and PHMB 
(1415;  4.7) should  also be added to  Annex  III to Regulation  (EC) No 1107/2009 . 
(11) Co-formulants to be listed in Annex III to Regulation (EC) No  1107/2009 may also be 
contained in adjuvants placed on the market. As d etailed rules for the authorisation of 
adjuvants , in accordance with Article  58(2) of Regulation (EC) No  1107/2009,  have 
not yet been established , Member States may continue to apply na tional provisions as 
regards adjuvants in accordance with Article  81(3) of that Regulation . As Regulation 
(EC) No  1107/2009 aims to prevent the placing on the market or use of adjuvants 
containing prohibited co -formulants,  it is necessary to ensure th at also adjuvants , to be 
mixed with plant protection products, do not contain any of those unacceptable 
co-formulants .  
(12) Member States should be provided with sufficient time  to review the composition of 
the plant protection products and adjuvants currently authorised in their territor y, in 
order to assess whether they contain co -formulants listed in Annex  III to Regulation 
(EC) No  1107/2009 and to withdraw or amend authorisations for plant protection 
products and adjuvants containing those co -formu lants .  
(13) For plant protection products or adjuvants containing a co-formulant listed in 
Annex  III to Regulation  (EC) No  1107/2009 , where  Member States grant any grace 
period in accordance with Article  46 of th at Regulation  or in accordance with national 
provisions for authorisation of adjuvants , respectively , that period should expire  for 
the sale and distribution  at the latest 3 months and for the disposal, storage and use 
additional 9  months after the amendment  or withdrawal of the authorisations.  
(14) Co-formulants to be listed in Annex III to Regulation (EC) No 1107/2009 may be 
present as unintentional impurities  in other co -formulants, which as such are 
acceptable for use in plant protection products or adjuvants. Therefore, the individual 
concentration of  the unacceptable co -formulants in the finished plant protection 
product or adjuvant should be less than 0,01  % weight by weight (w/w) in order to be 
considered as acceptable unintentional impurity, unless a different limit is provided 
due to technical lim itations of relevant analytical methods . 
(15) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
                                                 
8 Commission Implementing Decision (EU) 2016/109 of 27 January 2016 not to approve PHMB 
(1600;  1.8) as an existing active substance for use in biocidal products for product -types 1, 6 and 9 
(OJ L 21, 28.1.2016, p.  84). 
9 Commission Implementing Decision (EU)  2018/619 of 20 April 2018 not approving PHMB (1415; 4.7) 
as an existing active substance for use in biocidal products of product -types 1, 5 and 6 ( OJ L 102, 
23.4.2018, p.  21).  
EN 4  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annex III to Regulation (EC) No 1107/2009 is amended in accordance with the Annex to this 
Regulation.  
Article 2  
Member States wh ich ha ve granted authorisations for  plant protection products containing 
co-formulants listed in Annex III to Regulation (EC) No  1107/2009 , as amended  by this 
Regulation , shall amend  or withdraw those authorisations  as soon as possible but no later than  
[Office of Publications please insert date corresponding to 2 years  from the date of the Entry 
into Force ].  
Article 3 
Member States shall  not authori se the placing on the market or use of adjuvants  containing 
co-formulants listed in Annex III to Regulation (EC) No 1107/2009 , as amended by this 
Regulation .  
Member States which have authorised  adjuvants containing co -formulants listed  in Annex  III 
to Regu lation (EC) No  1107/2009 , as amended by this Regulation , shall amend or withdraw 
those authorisations as soon as possible and no later than [Office of Publications please insert 
date corresponding to 2 years  from the date of the Entry into Force ]. 
Article 4 
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) 
No 1107/2009 or national provisions for authorisation of adjuvants shall be as short as 
possible and shall expire for sale and distribution at the latest 3 months and for disposal, 
storage and use additional 9  months  after the date of withdrawal or amendment of the 
authorisation  referred to  in Article s 2 and 3 . 
Article 5 
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  
 Ursula VON DER LEYEN