EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/2195  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
defining data requirements for the approval of safeners and synergists and establishing 
a work programme for the gradual review of safeners and synergists on the market in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
defining data requirements for the approval of safeners and synergists and establishing 
a work programme for the gradual review of safeners and synergists on the market in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty 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 part icular 
Article  25(3) and Article  26 thereof,  
Whereas:  
(1) Article 25(1) of Regulation (EC) No 1107/2009  provides that safeners and synergists 
are to be approved when the criteria for the approval of active substances, laid down in 
Article 4 of that Regulation,  are fulfilled. Furthermore, Article  25(2) of that 
Regulation provides that the general rules applicable to the procedure for the approval 
of active substances, or the renewal thereof, set out in Articles  5 to 21 of that 
Regulation apply to safeners and sy nergists as well. In addition, Article 25(3) of that 
Regulation provides that  similar data requirements to those applicable for the approval 
of active substances should be defined for the approval of safeners and synergists .  
(2) In addition, and as required b y Article 26 of Regulation (EC) No 1107/2009 , a work 
programme for the gradual review of safeners and synergists  already on the market  
should be established. To ensure alignment with the derogation provided for in 
Article  81(1) of Regulation (EU) No 1107/2 009, these procedures should allow these 
safeners and synergists to be reviewed within five years of the adoption of that work 
programme.  
(3) In order to ensure that all safeners and synergists already on the market can be 
reviewed, it is appropriate to first  establish a list of the safeners and synergists already 
on the market and procedures for potential applicants to notify their interest in 
submitting applications for the approval of these safeners and synergists, the deadline 
for submitting such applicati ons and the procedures for the evaluation of the 
admissibility of applications.  
(4) To ensure coherence with the specific conditions for scientific assessments established 
under Regulation (EC) No 178/2002 of the European Parliament and of the Council2, 
                                                 
1 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/EEC  (OJ L 309, 24.11.2009, p. 1 ,   
ELI: http://data.europa.eu/eli/reg/2009/1107/2022 -11-21). 
2 Regulation (EC) No 178/2002 of the European  Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety  
EN 2  EN it is  appropriate to envisage similar provisions for safeners and synergists. 
Consequently, rules delineating how the precise procedures for pre -submission 
consultations with the European Food Safety Authority (‘the Authority’) pertaining to 
envisaged tests and  studies aimed at securing approval for safeners and synergists and 
for the requisite notifications regarding studies initiated or conducted by prospective 
applicants to substantiate their applications should be established.  
(5) Similar data requirements to t hose applicable for the approval of active substances 
should be defined for the approval of safeners and synergists. In addition to the data 
requirements applicable to the approval of active substances, it is in particular 
important t o require supplementar y data related to the demonstration of efficacy of the 
safeners and synergists.  
(6) In view of the substantive links between the empowerments in Article 2 5(3) of 
Regulation (EC) No  1107/2009 concerning the definition of data requirements for the 
approval of safeners and synergists  and in Article 26 of that Regulation concerning the 
establishment of a work programme for the gradual review of safeners and synergists 
already on the market , in particular the applicability of the same data requirements , it 
is appr opriate to lay down those rules  jointly  in the same act.  
(7) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
CHAPTER 1  
SUBJECT MATTER  
Article 1  
Subject matter  
This Regulation establishes : 
(a) the work programme for the gradual review of the safeners and synergists already 
used in plant protection products on [Office of Publications, please insert date of 
entry into force of this Regulation ] and procedures relating to that programme ’; 
(b) the data requirements that an application  for the approval of safener or synergist 
need s to fulfil . 
                                                                                                                                                         
Authority and laying down procedures in matters of food safety  (OJ L 31, 1.2.2002, p. 1 , ELI: 
http://da ta.europa.eu/eli/reg/2002/178/oj ).  
EN 3  EN CHAPTER 2  
ESTABLISHMENT OF THE WORK PROGRAMME FOR THE GRADUAL REVIEW OF 
SAFENERS AND SYNERGISTS ALREADY ON THE MARKET, LIST THEREOF AND 
PROCEDURES FOR THEIR GRADUAL REVIEW  
Article 2  
Establishment of the work programme  
The work programme for the gradual review of the safeners and synergists already used in 
plant protection products on  …  [Office of Publications, ple ase insert date of entry into force 
of this Regulation], set out in Annex I, is hereby established.  
Article 3 
List of safeners and synergists already on the market  
(1) By  … [Office of Publications, please insert date 1 month from the date of the entry 
into force of this Regulation] , the Commission shall publish, by electronic means and 
in a manner accessible to the general public, a list of all substances or preparations 
known to the Commission as being used as safeners or synergists contained in at 
least on e plant protection product authorised for the placing on the market in at least 
one Member State on … [Office of Publications, please insert date of entry into force 
of this Regulation] .  
(2) By … [Office of Publications, please insert date 6 months from the e ntry in force of 
this Regulation ], any interested party may submit a notification of further substances 
or preparations potentially used as safeners or synergists in plant protection products 
authorised for the placing on the market in at least one Member State on … [Office of 
Publications, please insert date of entry into force of this Regulation ].  
(3) The notification referred to in paragraph 2  shall include the information referred to in 
Sections 1.3, 1.4, 1.6 and 1.7 of Part A of the Annex to Commission Re gulation (EU) 
No 283/20133 and evidence that the notified substance or preparation is used as a 
safener or synergist in at least one plant protection product authorised in at least one 
Member State.  
The notification shall be submitted electronically to th e Commission at the following 
address:  sante -secteur -ppp@ec.europa.eu .  
(4) The Commission shall provide Member States and the Authority with a summary of 
the notifications received.  
Member States and the Authority may provide their comments to the Commission 
within two months from the date of being informed by the Commission.    
(5) The Commission shall update the list  referred to in paragraph 1 , taking into account 
the safeners and synergists contained in plant protection products authorised for the 
placing on the market in Member State s on … [Office of Publications, please insert 
                                                 
3 Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active 
substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council concerning th e placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 1 , ELI: 
http://data.europa.eu/eli/reg/2013/283/oj ).  
EN 4  EN date of entry into force of this Regulation] by [Office of Publications, please insert 
date 9 months from the entry into force o f this Regulation].  
Article 4 
Request for inclusion in the work programme for gradual review  
(1) Any interested party wishing to submit an application , in accordance with Article 7 
of Regulation (EC) No 1107/2009, for the approval of a safener or synergist inc luded 
in the list referred to in Article 3(1), may submit a request for inclusion of that 
safener or synergist in the work programme for gradual review by … [Office of 
Publications, please insert 12 months from  the entry into force of this Regulation] .   
The request shall be submitted electronically to the Commission at the following 
address:  sante -secteur -ppp@ec.europa.eu , and contain  the information listed in 
Annex  II. 
(2) Within one month from receipt  of a request for inclusion of a safener  or synergist in 
the work programme for the gradual review, the Commission shall indicate, in the 
list referred to in Article 3(1) of this Regulation, that a request pursuant to the 
paragraph  1 of this Article has be en made for the respective substance or preparation. 
It shall also inform those parties requesting the inclusion of a safener or synergist in 
the gradual review , of the contact details of other  parties  requesting the inclusion in 
the review of the same saf ener or synergist.  
Article 5 
Non-inclusion of a safener or a synergist in the work programme for gradual review  
Where no request for inclusion in the  work programme for  gradual review is received for a 
safener or synergist listed in the list referred to i n Article 3(1) within the deadline set out in 
Article 4(1), the Commission shall adopt a decision stating that the respective safener or 
synergist is not included in the  work programme for  gradual review.  
Article 6 
Applicants and sharing of data, establishment  of the work programme, notification of 
intended studies and pre -submission advice  
(1) From … [Office of Publication s, please insert date 13  months from the date of entry 
into force of this Regulation ], for any substance or preparation  for which t he 
Commission has indicated in the list of safeners and synergists referred to in 
Article  3(1) that a request for inclusion in the work programme for gradual review 
has been received, the person or persons requesting the inclusion of a safener or 
synergist  shall be considered individually or collectively as the applicant for the 
approval of that safener or synergist within the meaning of Articles  7 to 13 of 
Regulation (EC) No  1107/2009.  
(2) Applicants for the approval of the same safener or synergist shall und ertake all 
reasonable efforts to submit a joint application, or to share relevant scientific data .  
(3) By … [Office of Publications, please insert date 18 months from the date of entry 
into force of this Regulation] , following consultation with Member States, the 
Commission shall adopt the work programme by amending Annex I to this 
Regulation, specifying the safeners and synergists included in the work programme 
and designating for each of them a rapporteur Member St ate and co -rapporteur 
Member State .  
EN 5  EN (4) Following the amendment of Annex I of this  Regulation , in accordance with the 
previous paragraph, applicants  for the approval of a safener or a synergist shall, 
without delay, in accordance with Article  32b(2) of Regulat ion (EC) No  178/2002 
notify the Authority of the title and the scope of any study commissioned or carried 
out by them to support an application  for the approval of a safener or a synergist , as 
well as the laboratory or testing facility carrying out that st udy, and its starting and 
planned completion dates.  
(5) Applicants  for the approval of a safener or a synergist may, in accordance with 
Article 32a(1) of Regulation (EC) No  178/2002, request pre-submission advice from 
the Authority until the complete submissio n of their application. The Authority shall 
inform the rapporteur Member State of the request and they shall jointly provide 
general advice.  
Article 7 
Submission and content of the application for approval of safeners and synergists in the 
work programme for gradual review  
(1) By … [ Office of publications, please insert date 48 months from the date of entry 
into force ], applicants for the approval of a safener or a synergist shall, individually 
or collectively, submit the application for approval of the safeners and synergists to 
the rapporteur Member State.  The application shall be in standard IUCLID data 
format and be submitted via the central submission system as specified in Article 7 
of Implementing Regulation (EU)  2020/17404. 
(2) The application shall contain the data as required for safeners and synergists pursuant 
to Article  9. 
Article 8 
 Procedure for the evaluatio n of the admissibility of  applications for safeners and synergists   
(1) The rapporteur Member State shall deem an application admissible if it satisfies the 
following criteria:  
(a) it has been submitted by the date set out, in accordance with the format and 
using the central submission system referred to in Article 7(1); 
(b) it contains all the elements set out in Article 9; 
(c) it contains all studies, in full, that have been previously not ified in accordance 
with Article 32b of Regulation (EC) No 178/2002;  
(d) the relevant fee as set by the rapporteur Member State in accordance with 
Article  74 of Regulation (EC) No 1107/2009 has been paid.  
(2) The rapporteur Member State shall, within 45 days follo wing the date specified in 
Article 7(1), inform the applicant, the co -rapporteur Member State, the Commission, 
and the Authority of the date of receipt of the application and of its admissibility . 
                                                 
4 Commission Implementing Regulation (EU) 2020/1740 of 20 November 202 0 setting out the provisions 
necessary for the implementation of the renewal procedure for active substances, as provided for in 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and repealing 
Commission Implementing Regulation (E U) No 844/2012  (OJ L 392, 23.11.2020, p. 20 , ELI: 
http://data.europa.eu/eli/reg_impl/2020/1740/oj ).  
EN 6  EN (3) If the application is not submitted by the date set out in Article 7(1), the rapporteur 
Member State shall promptly inform the applicant, the co‑rapporteur Member State, 
the Commission, the other Member States and the Authority that the application is 
deemed inadmissible due to a missed deadline . 
(4) If an application  is submitted by the date set out in Article 7(1), but does not satisfy 
the criteria set out in paragraph 1, point (b) or (d), the rapporteur Member State shall 
notify the applicant within one month from the date of receipt of the application of 
the specif ic elements that are missing and set a 14 -day period for the submission of 
the missing elements via the central submission system referred to in Article  7(1).  
(5) If an application is submitted by the date set out in Article 7(1), but the application 
does not  satisfy the criteria set out in paragraph 1, point (c), the rapporteur Member 
State shall, in cooperation with the Authority, inform the applicant within one month 
from the date of receipt of the application. The applicant shall be given a 14 -day 
period t o provide a valid justification for this non -compliance.  
(6) If the missing elements referred to in paragraph 4 or the valid justification referred to 
in paragraph 5 are not provided within the 14 -day period, the application shall be 
deemed inadmissible and Ar ticle 32b(5) of Regulation (EC) No 178/2002 shall 
apply.  
(7) In case of such inadmissibility, the rapporteur Member State shall promptly inform 
the applicant, the co -rapporteur Member State, the Commission, the other Member 
States, and the Authority that the a pplication is deemed inadmissible and of the 
reasons for the inadmissibility.  
(8) The assessment of the admissibility of a resubmitted application shall only 
commence after the six -month period mentioned in Article 32b(5) of Regulation 
(EC) No 178/2002 has ela psed following the notification of the necessary studies 
and/or submission of studies, as applicable .  
CHAPTER 3  
DEFINITION OF DATA REQUIREMEN TS FOR SAFENERS AND SYNERGISTS  
Article 9 
Data requirements for safeners and synergists  
(1) In addition to the data requirements set out in  Article 8 of Regulation (EC)  
No 1107/2009, a n application for the approval of a safeners or synergist shall  
include : 
(a) the data as require d for active substances pursuant to  Regulation (EU) 
No 283/2013, and the supplementary data listed in Annex III to this 
Regulation;  
(b) the data as requir ed for plant protection products  pursuant to Regulation (EU) 
No 284/2013 , and the supplementary data listed  in Annex I II to this 
Regulation;  
(c) where relevant, the identification and proposal of a residue definition for the 
purposes of risk assessment and for enforcement purposes;   
EN 7  EN (d) where relevant, a proposal for classification in one or more hazard classes in 
accordance with Regulation (EC) No 1272/2008 of the Europe an Parliament 
and of the Council5;  
(e) where relevant, a justification for any IUCLID Validation Assistant check 
failures;  
(f) the summaries and results of scientific peer -reviewed open literature, as 
referred in Article 8(5) of Regulation (EC) No 1107/2009;  
(g) an assessment according to the current scientific and technical knowledge of all 
information submitted;  
(h) the identification and proposal for any necessary and appropriate risk 
mitigation measures;  
(i) all relevant information related to the notification of the stu dies as required in 
accordance with Article 32b of Regulation (EC) No 178/2002.  
(2) When obtaining an authorisation for a plant protection product containing a safener 
or a synergist, the applicants may submit a request, pursuant to Article  59 of 
Regulation ( EC) No 1107/2009, aimed at obtaining data protection for their test and 
study reports.  
(3) When submitting the application  for the approval of a safener or a synergist , the 
applicants may submit a request, pursuant to Article  63 of Regulation (EC) 
No 1107/200 9, to treat certain information, including certain parts of the dossier, as 
confidential and shall identify the confidential and non -confidential versions of the 
information submitted . 
CHAPTER 4  
FINAL PROVISIONS  
Article 10 
Entry into force   
This Regulatio n 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 L EYEN  
                                                 
5 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, ELI: http://data.europa.eu/eli/reg/2008/1272/o ).