G/SPS/GEN/1494/Rev.1  
 
12 June 2017  
(17-3125) Page: 1/4 
Committee on Sanitary and Phytosanitary Measures    
 
ON-GOING REVIEW OF MAXI MUM RESIDUE LEVELS  
OF PESTICIDES IN THE  EUROPEAN UNION  
COMMUNICATION FROM T HE EUROPEAN UNION  
Revision  
The followi ng communication, received on 12 June 2017 , is being circulated at the request of the 
Delegation of the European Union . 
 
_______________  
 
 
This note is addressed to countries outside the European Union (EU). It explains the on -going 
process in the EU to review the current maximum residue levels (MRLs) for pesticides. It describes 
how non -EU countries can actively contribut e 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 EU. This note highlights the specific 
stages in the review process when non -EU countries may send such additional data.  
Revision 1 of this note has been updated with the reference to a dedicated page of the EFSA 
website, where the list of the active substances subject to the review process and an indicative 
time schedule of their review are provided.  
This EFSA website  page is updated quarterly. Regular consultation of the webpage is therefore 
necessary to obtain the most updated information.  
 
1  THE REVIEW PROCESS O F THE EXISTING EU PE STICIDE MRLS  
1.1.  Article 12 of Regulation (E C) 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 designated 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 EU, 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. 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.  
1.4.  The European Commission (Commission) considers the opinion of EFSA and initiates a 
discussion with the EU member State s about the appropriate risk management measures to be 
taken in case of certain substances, i.e. possible modification of certain MRLs. Th e 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 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 and amending Council 
Directive 91/414/EEC.  G/SPS/GEN/1494/Rev.1  
 
- 2 - 
 
  1.5.  On this basis the Commission prepares a draft proposal in whi ch amendments to the existing 
pesticide MRLs are proposed. The draft proposal is discussed with delegates of the EU member 
State s 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 
Commission and comprised of the representatives of the 28 EU member State s. 
1.6.  The draft proposal is also notified to WTO members through the WTO/SPS Secretariat. WTO 
Members have 60 calendar days to comment on t he Commission proposal.  
1.7.  The PAFF Committee takes into consideration all comments received and votes on the 
Commission proposal. Once endorsed by the PAFF Committee, the proposal is scrutinized by the 
Council of the European Union and by the European Parlia ment during a two month - period. If the 
two institutions do not object in that timeframe, the proposal is finally adopted by the Commission 
as a legislative act.  
1.8.  It is then translated into the official languages of the European Union and published in the 
Official Journal of the European Union.  
2  WHEN AND HOW CAN NON -EU COUNTRIES INTERVE NE IN THE REVIEW PRO CESS?  
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 informatio n 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 E U member State , which 
has been appointed 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) During the WTO/SPS consultation procedure:  
Before being submitted for a vote in the PAFF Committee, draft proposals of the Commission 
amending existing pesticide MRLs are notified under the SPS Agreement  of the World Trade 
Organisation . 
 
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 explained 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 con sult 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.  G/SPS/GEN/1494/Rev.1  
 
- 3 - 
 
  3  WHAT HAPPENS IF NON -EU COUNTRIES DO NOT INTERVENE AT ANY STA GE? 
3.1.  The review pr ocess of the existing EU pesticide MRLs proceeds as described in point 1. For 
the protection of consumers, the E uropean Union sets MRLs as low as reasonably achievable. 
Therefore, in the absence of any additional information from non -EU countries, MRLs may  in some 
cases be lowered to a level that has 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, n on-EU countries may submit a specific " import tolerance " request. The request must 
be addressed to the RMS for the active substance.  
3.3.  Import tolerance requests normally concern MRLs of active substance s approved in the 
European Union , but they may be introduced also for active substances that are not anymore 
approved in the European Union , provided that all the required data on the active substance are 
submitted. More details on the procedure of the "import tolerance" are given in Art icle 6.4 of 
Regulation (EC) No 396/2005.  
3.4.  In case of a positive evaluation of the data submitted by the non -EU country, the 
European  Union may launch a procedure to amend the MRL. It must be considered that it may 
take one to two  years from the submission o f the request until the entering into force of the 
amended MRL.  
4  WHEN AND FOR WHICH A CTIVE SUBSTANCES IS THE REVIEW PROCESS P LANNED?  
4.1.  An overview of the MRLs review progress under Article 12 of Regulation  (EU) No 396/2005 is 
available o n the dedicated page o f EFSA 's website:  
https://www.efsa.europa.eu/sites/default/files/pesticides -MRL-review -progress -report.pdf  
4.2.  It has been updated on 2 May 2017 and it wil l be further 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. Mos t 
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.  Non-EU countries that wish to submit additional information must have their data ready for 
submission to the respective RMS by the start date of the data collection.  
5  BACKGROUND: THE EU L EGISLATION ON PESTIC IDES  
5.1.  The principles of the EU legislation on pesticides are laid down in three main legislative acts:  
• Regulati on (EC) No 1107/20092, provides rules on the placing of plant protection 
products on the market;  
• Regulation (EC) No 396/2005, already mentioned, provides details on the maximum 
residue levels of pesticides (MRLs) in or on food and feed of plant and animal origin;  
• Directive 2009/128/EC3, sets 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 foresees that each active substance intended to be used in the European Uni on 
as a plant protection product (commonly called 'pesticide') first needs to be approved. The 
approval of active substances is granted at EU level. Further details can be found at:  
http://ec.europa.eu/food/plant/pesticides/approval_active_substances/index_en.htm  
                                                
2 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 Counc il Directives 79/117/EEC 
and 91/414/EEC.  
3 Directive 2009/128/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.  G/SPS/GEN/1494/Rev.1  
 
- 4 - 
 
  5.3.  Along with the first approval of the active substance, specific maximum residu e levels (MRLs) 
considered as safe for the consumers need to be established. This procedure is further described 
at: http://ec.europa.eu/food/plant/pesticides/max_res idue_levels/index_en.htm  
5.4.  The plant protection products containing EU approved active substances can only be placed 
on the EU market after prior authorisation. The authorisation of plant protection  products is 
granted by the EU m ember States. Further detail s can be found at:  
http://ec.europa.eu/food/plant/pesticides/authorisation_of_ppp/index_en.htm  
6  FURTHER INFORMATION  
6.1.  For any further information, interested parties m ay consult the section of the European 
Commission website specifically dedicated to pesticides:   
http://ec.europa.eu/food/plant/pesticides/index_en.htm  
__________