   
  
G/SPS/GEN/1494/Rev.2  
 
2 July 2021 
(21-5296) Page: 1/4 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
 
ON-GOING REVIEW OF MAXIMUM RESIDUE LEVELS  FOR PESTICIDES  
IN THE EUROPEAN UNION  
UNDER ARTICLE 12 OF REGULATION (EC) NO . 396/2005  
COMMUNICATION FROM THE EUROPEAN UNION  
Revision  
The followi ng communication, received on 1 Ju ly 2021, is being circulated at the request of the 
Delegation of the European Union . 
 
_______________  
 
 
Purpose of the note  
This note is addressed to countries outside the European Union (EU). It explains the on -going 
process in the European Union  to review the current maximum residue levels (MRLs) for pesticides  
under Article  12 of Regulation (EC) No . 396/2005  (the MRL Regulat ion). It describes how non -EU 
countries can actively contribute to the reviewing process.  
Non-EU countries may submit additional data to the EU risk assessors, should they wish to support 
specific uses of pesticides that are no longer approved in the Europ ean Union . This note highlights 
the specific stages in the review process when non -EU countries may send such additional data.  
This note has been updated following the withdrawal of the United Kingdom  from the European 
Union . In addition, some links were n o longer valid. The revised note also includes some additional 
information as regards notifications by the European Food Safety Authority (EFSA) on the launch 
of the review procedure for specific substances.  
 
1  THE REVIEW PROCESS OF THE EXISTING EU PESTICID E MRLS  
1.1.  Article 12 of Regulation (EC) 396/20051 provides for a mechanism to review the existing 
maximum residue levels (MRLs) of all approved and certain non -approved pesticides. This review 
process has been on -going since 2008.  
1.2.  For each active substance, one member State  of the European Un ion is desig nated as 
'Rapporteur member State ' (RMS). The RMS carries out the first evaluation of the existing 
EU pesticide MRL and prepares an evaluation report recommending its amendment if necessary.  
1.3.  Subsequently, the scientific risk assessment body of the European  Union , the European Food 
Safety Authority (EFSA), is charged with delivering a reasoned opinion on each substance, based on 
the evaluation report prepared by the RMS.  
1.4.  In the reasoned opinion, if available, Codex Maximum Residue Limits (CXLs) are considere d. 
 
1 Regulation (EC) No . 396/2005 of the European Parliament and of the Council of 23 February 2005 on 
maximum residue levels of pesticides in or on food and feed of plant and animal origin , OJ L 70, 16  March 
2005, p.  1. G/SPS/GEN/1494/Rev.2  
 
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  1.5.  According to the EU legislation, where CXLs exist, they must be taken into consideration when 
setting or modifying EU MRLs, except where:  
a) they would be an ineffective or inappropriate means for the fulfilment of the legitimate 
objectives of EU food law ; 
b) there is a scientific justification ; 
c) they would result in a different level of protection from the one determined as appropriate 
in the European Union . 
1.6.  The European Union  is aligned with more than 70% of the CXLs established in the period of 
2008-2018. Th is level is comparable with the level of alignment of other major economies.  
1.7.  The opinions are published on the EFSA webpage: 
http://www.efsa.europa.eu/en/publications/efsajournal . Using the search function and the name of 
the substance, the relevant opinion can be easily retrieved.  
1.8.  The European Commission (Commi ssion) considers the opinion of EFSA and initiates a 
discussion with the EU member States about the appropriate risk management measures to be 
taken, i.e. possible modification of certain MRLs. The Commission also consults the network of the 
European Union  reference laboratories on analytical aspects and takes into account other scientific 
information available on the specific substance.  
1.9.  On this basis, the Commission prepares a draft Regulation in which amendments to the existing 
pesticide MRLs are proposed . The draft Regulation is discussed with delegates of the EU member 
States in a regulatory Committee (Standing Committee on Plants, Animals, Food and Feed, shortly 
"PAFF Committee"). The PAFF Committee meets several times a year, is chaired by the Commissi on 
and comprised of the representatives of the 27 EU member States.  
1.10.   The draft Regulation is also notified to WTO Members through the WTO/SPS Secretariat. 
WTO Members have 60 calendar days to comment on the draft Regulation.  
1.11.   The PAFF Committee takes into co nsideration all comments received and votes on the draft 
Regulation. Once endorsed by the PAFF Committee, the draft Regulation is scrutinized by the Council 
of the European Union and by the European Parliament during a two -month period. If the two 
institut ions do not object in that timeframe, the draft Regulation is finally adopted by the Commission 
as a Commission Regulation.  
1.12.   It is then translated into the official languages of the European Union and published in the 
Official Journal of the European Union2. 
2  WHEN AND HOW CAN NON -EU COUNTRIES INTERVENE IN THE REVIEW PROCESS?  
2.1.  Authorities of non -EU countries may intervene in the review process described above at two 
different stages: at an early stage (box 1) and at a later stage (box 2).  
1) At an early stage,  via the Rapporteur member State  (RMS):  
Non-EU countries which wish to submit additional supporting information or data on a specific active 
substance in which they may have a special interest, can submit such information at an early stage 
of the process, before the risk assessment is carried out by EFSA.  
 
Non-EU countries should first contact the manufacturer of the active substance concerned. They 
then need to submit the additional data through the manufacturer to the EU member State , which 
has been appoi nted as " Rapporteur member State " for that active substance. The RMSs for each 
active substance are listed in the detailed document available in the dedicated webpage of the 
European Food Safety Authority (see paragraph 4 of this note).  
 
 
2 https://eur -lex.europa.eu/homepage.html . G/SPS/GEN/1494/Rev.2  
 
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  2) During the WTO/SPS consultation procedure:  
Before being submitted for a vote in the PAFF Committee, draft proposals amending existing 
pesticide MRLs are notified under the WTO SPS Agreement . 
 
WTO Members have 60 calendar days to send their comments to the SPS contact  point of the 
European Union . Received comments are considered by the Commission before the vote takes place 
at the PAFF Committee.  
 
2.2.  Non-EU countries which have a special interest in a particular active substance may intervene 
at one or both stages explain ed above. It is however strongly advised and in the interest of the 
country to intervene at the early stage of the procedure.  
2.3.  Non-EU countries are therefore invited to consult the lists of active substances for which the 
review process is already planned ( see paragraph 4) and to provide as soon as possible the additional 
data to the RMS in charge.  
3  WHAT HAPPENS IF NON -EU COUNTRIES DO NOT INTERVENE AT ANY STAGE?  
3.1.  The review process of the existing EU pesticide MRLs proceeds as described in point 1. For the 
protection of consumers, the European Union  sets MRLs as low as reasonably achievable and 
supporting data are needed to support the MRL. If such data are lacking or insufficient, the MRL is 
lowered to the limit of quantification (LOQ). This may in some cases have a negative impact on 
exports of the relevant commodity from non -EU countries into the European Union . 
3.2.  If deemed necessary for ensuring the continuity of international trade, after the publication of 
new MRLs, non -EU countries may submit a specific "im port tolerance" request. The request must be 
addressed to the RMS for the active substance. Import tolerance requests normally concern MRLs of 
active substance approved in the European Union , but they may also be introduced for active 
substances that are n ot approved in the European Union , provided that all the required data on the 
active substance are submitted. More details on the procedure for "import tolerances" are given in 
Article 6(4) of Regulation (EC) No 396/2005 and in the most recent version of t he Technical 
Guidelines on the MRL Setting Procedure  (SANTE/2015/10595).  
3.3.  In case of a favourable evaluation by EFSA, the European Union  may launch a procedure to 
amend the respective MRL. To be noted that it takes on average around two years from the 
submission of the request until the entering into force of the amended MRL.  
4  WHEN AND FOR WHICH ACTIVE SUBSTANCES IS THE REVIEW PROCESS PLANN ED? 
4.1.  An overview of the MRLs review progress under Article 12 of Regulation  (EU) No 396/2005 is 
available in the dedicated page of EFSA website:  
https:/ /www.efsa.europa.eu/sites/default/files/pesticides -MRL-review -progress -report.pdf . 
4.2.  It is updated by EFSA  on a quarterly basis. It is therefore recommended to consult this webpage 
on a regular basis to have the most updated information available.  
4.3.  The overview contains information on the indicative schedule for the MRLs review. Most 
important information for non-EU countries is the list of substances for which the review is planned, 
the start date of data collection  and the Rapporteur member State (RMS) for each substance.  
4.4.  In addition, it is possible to subscribe to a notification system managed by EFSA, which  informs 
about the launch of the review procedure for a specific substance. Requests for inclusion in the 
distribution list for such notifications can be made to the following e -mail address: 
pesticides.mrl@efsa.europa.eu . 
4.5.  Non-EU countries that wish to submit additional information for the Article 12 MRL review 
process must have their data ready for submission to the respective RMS by the start date of the 
data collection.  G/SPS/GEN/1494/Rev.2  
 
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  5  BACKGROUND: THE EU LE GISLATION ON PESTICIDES  
5.1.  The principles of the EU legislation on pesticides are laid down in three main legislative acts:  
• Regulation (EC) No 1107/20093, provid ing rules on the placing of plant protection products 
on the market;  
• Regulation (EC) No 396/2005, already mentioned, provid ing details on the maximum 
residue levels of pesticides (MRLs) in or on food and feed of plant and animal origin;  and 
• Directive 2009/128/EC4, setting rules for the sustainable use of pesticides to reduce the 
risks and impacts of their use on people's health and the environment.  
5.2.  EU legislation envisages that each  active substance intended to be used in the European Union  
as a plant protection product (commonly called 'pesticide') first needs to be approved. The approval 
of active substances is granted at the EU level. Further details can be found at:  
https://ec.europa.eu/food/plants/pesticides/approval -active -substances_en . 
5.3.  Along with the first approval of the active substance, specific maximum residue levels (MRLs) 
considered  as safe for the consumers need to be established. This procedure is further described at:  
https://ec.europa.eu/food/plants/pesticides/maximum -residue -levels_en . 
5.4.  The plan t protection products containing EU approved active substances can only be placed on 
the EU market following prior authorisation. The authorisation of plant protection products is granted 
by the EU member States. Further details can be found at:  
https://ec.europa.eu/food/plants/pesticides/authorisation -plant-protection -products_en . 
6  FURTHER INFORMATION  
6.1.  For any further information, interested parties may con sult the section of the European 
Commission website specifically dedicated to pesticides:   
https://ec.europa.eu/food/plants/pesticides_en . 
__________  
 
3 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, OJ L 309, 24  November 2009, p. 1.  
4 Directive 2009/12 8/EC of the European Parliament and of the Council of 21 October 2009, establishing 
a framework for Community action to achieve the sustainable use of pesticides, OJ L 309, 24  November 2009, 
p. 71.  