G/SPS/GEN/1847  
21 October  2020 
(20-7298) Page: 1/4 
Committee on Sanitary and Phytosanitary Measures  Original:  Spanish  
 
  
SPECIFIC TRADE CONCERNS - EUROPEAN UNION (EU) MAXIMUM RESIDUE LEVELS 
(MRLS) FOR BUPROFEZIN, CHLOROTHALONIL, DIFLUBENZURON, ETHOXYSULFURON, 
GLUFOSINATE, IMAZALIL, IOXYNIL, IPRODIONE, MOLINATE, PICOXYSTROBIN AND 
TEPRALOXYDIM ( NO.448, SEE ALSO RELATED SPECIFIC TRADE CONCERNS NOS. 453, 
454, 457, 474, 475) 
COMMUNICATION FROM COLOMBIA, GUATEMALA AND PARAGUAY  
The following communication, received on 1 4 October  2020, is being circulated at the request of the  
delegations of Colombia, Guatemala and Paraguay.  
 
_______________  
 
 
Colombia, Guatemala and Paraguay would like to ask the European Union (EU) the following 
questions regarding specific trade concern No. 448 and the modification of MRLs.  
MODIFICATION OF EU MRLS FOR PLANT PROTECTION PRODUCTS 
(G/SPS/N/EU/264/ADD.1 , G/TBT/N/EU/625  AND G/SPS/N/EU/263/ADD.1 ) 
1.  In its replies to the questions posed in document G/SPS/GEN/1760 , the European  Union states, 
with regard to its appropriate level of protection (ALOP), that " it is necessary to ensure that pesticide 
residues are not present at levels presenting an unacceptable risk to humans . MRLs should be set 
at the lowest achievable level consist ent with good agricultural practice for each pesticide with a 
view to protecting vulnerable groups such as children and the unborn ". 
Meanwhile , paragraph 5 of Annex A to the Agreement on the Application of Sanitary and 
Phytosanitary Measures (SPS Agreement ) defines the ALOP as " [t]he level of protection deemed 
appropriate by the Member establishing a sanitary or phytosanitary measure to protect human, 
animal or plant life or health within its territory . NOTE: Many Members otherwise refer to this concept 
as the "acceptable level of risk" ." 
 
In the light of its reply, could the European Union:  
(a) Define the acceptable level of risk determined for the implementation of its policy 
regarding the determination of MRLs?  
(b) Explain how it has taken into account the objective of minimizing negative trade effects 
when determining the acceptable level of risk,  in accordance with Article 5.4 of the SPS 
Agreement.  
(c) Identify what it considers good agricultural practices (GAPs) to be.  
(d) Indicate how GAPs are taken into account when  determining the ALOP sought.  
2.  The European Union stated  that between 2012 and 2019, it adopted 1,833 of the 2,567 MRLs 
established by the Codex Alimentarius  (CXLs) and that it is therefore aligned with 70 % of Codex  
standards . It also replied that " at times, the European Union deviates from international standa rds 
when justified for the protection of public health and on the basis of EFSA's scientific advice " and 
that, in doing so, it is acting in conformity with Article 3 of the SPS Agreement.  G/SPS/GEN/1847  
- 2 - 
  In light of the foregoing, could the European Union:  
(a) Indicate how ma ny CXLs it has adopted to date since November  2017, as well the level 
of alignment between its MRLs and those established by the Codex  since the effective 
implementation  of its MRL revi ew policies linked to Regulations No. 1107/2009 and 
No. 396/2005.  
(b) Expla in the justification for its decision to deviate from the international standards of 
the Codex Alimentarius  on the basis of EFSA's scientific advice in cases where EFSA 
determines that the results of risk assessments are inconclusive or that the scientific  
evidence is insufficient .1 In this regard, we note that the EU's reply to question 11(r) 
submitted by Paraguay within the framework of the EU's Trade Policy Review (TPR), 
recalls that " MRL can be set only when there is sufficient information to support a  risk 
assessment demonstrating that the MRL is sufficiently protective for consumers ".2 
3.   The EU " allows Member States to grant emergency authorisations for PPPs that are not 
authorised for use on a specific crop ".3 There has in fact been a " rise in emergency authorisations 
[which] has been attributed by some stakeholders to the  decreasing availability of effective active 
substances and the lack of PPPs for specific uses ".4 In this light, in cases where emergency 
authorizations are granted within the  EU for the use of certain unauthorized pesticides, how does 
the EU ensure that these emergency measures do not arbitrarily or unjustifiably discriminate 
between WTO Members with identical or similar conditions as regards the use of these pesticides, 
as provided for in Article 2.3 of the SPS Agreement?5 
4.  In reply to question 6 in document G/SPS/GEN/1760 , on why Article 5.3 of the SPS Agreement6 
is not relevant in the case of the measures stipulated in paragraph 1(b)  of Annex A to  the SPS 
Agreement7, the EU stated that Article 5.3 is  not relevant because of  the second sentence of 
paragraph 4 of Annex A to the SPS Agreement8, which defines risk assessment . However, both 
paragraph 1(b) and the second sentence of paragraph 4 of Annex A to the SPS Agreement refer to 
animal health and fee dstuffs, in the same way as Regulation (EC) No. 396/2005 . We therefore 
reiterate our request that the EU elaborate on its assertion that Article 5.3 of the SPS Agreement 
 
1 It should be recalled that the second sentence of Article 3.3 of the SPS Agreement reads as follows: 
"all measures which result in a level of sanitary or phytosanitary protection different from that which would be 
achieved by measures based on international standards, guidelines or recommendations shall not be 
inconsistent with  any other provision of this Agreemen t". Therefore, there must be " scientific justification " for 
any sanitary or phytosanitary measure that results in a higher level of protection than would be achieved by 
measures aligned with the relevant international s tandards.  
2 Document W/TPR/M/395/Add.1, page 395.  
3 Commission Staff Working Document Accompanying the document Report from the Commission to the 
European Parliament and the Council - Evaluation of Regulation (EC) No 1107/2009 on the placing of plant 
prote ction products on the market and of Regulation (EC) No 396/2005 on maximum residue levels of 
pesticides {COM(2020) 208 final }, page 31.  
4 Commission Staff Working Document Accompanying the document Report from the Commission to the 
European Parliament and the Council - Evaluation of Regulation (EC) No 1107/2009 on the placing of plant 
protection products on the market and of Regulation (EC) No 396/2005 on maximum residue levels of 
pesticides {COM(2020) 208 final }, page 32.  
5 Article 2.3 of the SPS Agreement : "Members shall ensure that their sanitary and phytosanitary 
measures do not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions 
prevail, including between their own territory and that of other Members. Sanitary  and phytosanitary measures 
shall not be applied in a manner which would constitute a disguised restriction on international trade. " 
6 Article 5.3 of the SPS Agreement: " In assessing the risk to animal  or plant life or health and 
determining the measure to  be applied for achieving the appropriate level of sanitary or phytosanitary 
protection from such risk, Members shall take into account as relevant economic factors: the potential damage 
in terms of loss of production or sales in the event of the entry, es tablishment or spread of a pest or disease; 
the costs of control or eradication in the territory of the importing Member; and the relative cost -effectiveness 
of alternative approaches to limiting risks. " 
7 Annex A. Definitions: " 1. Sanitary or phytosanitar y measure - Any measure applied:  [...] (b) to 
protect human or animal  life or health within the territory of the Member from risks arising from additives, 
contaminants, toxins or disease -causing organisms in foods, beverages or feedstuffs ". 
8 Annex A. Def initions: " Risk assessment - The evaluation of the likelihood of entry, establishment or 
spread of a pest or disease within the territory of an importing Member according to the sanitary or 
phytosanitary measures which might be applied, and of the associat ed potential biological and economic 
consequences; or the evaluation of the potential for adverse effects on human or animal health arising from 
the presence of additives, contaminants, toxins or disease -causing organisms in food, beverages or feedstuffs ". G/SPS/GEN/1847  
- 3 - 
  (which covers measures to protect animal health) is not relevant in the case of EU mea sures on 
MRLs.  
5.  According to the EU's reply to question 8 in document G/SPS/GEN/1760 , "[c]urrent European 
Union legislation does not provide for an exhaustive list of [other] legitimate factors " to be taken 
into account when determining risks . Could the EU please provide an indicative  list, containing 
specific examples, of what it believes these "other legitimate factors" might be?  
6.  In reply to question 9 in document G/SPS/GEN/1760 , the EU stated that it " has consistently taken 
into account comments on the revocation of authorisation on specific substances or on MRLs received 
by WTO members on measures notified under either the TBT Agreement and/or the SPS Agreement ". 
However, the EU has recently a cknowledged that, in the substance evaluation dossier, the rapporteur 
Member State does not always take into consideration comments from other EU Member States 
concerned and that this may lead to a situation where their concerns are not taken into account .9 
In light of the foregoing, could the EU:  
 
(a) Explain how it ensures that comments from non -EU trading partners are taken into 
consideration, when comments from EU Member States themselves are sometimes not 
taken into consideration during the peer review.  
(b) Provide concrete examples of specific cases in which comments from non -EU trading 
partners have been taken into consideration.  
7.  We thank the EU for offering to once again provide the link to the EFSA website where details 
concerning the state of the  review of MRLs are published . We note that the EU previously provided 
the SPS Committee with the link to this website in June 2016 in document G/SPS/GEN/1494 . 
Members are aware of the various websites and the information they contain . 
However, as the EU itself expressly points out r egarding its database, "[s]imply having information 
publicly available does not necessarily translate into a better informed public if the information is 
difficult to find".10 
For example, the EFSA website https://www.efsa.europa.eu/sites/default/files/pesticides -MRL-review -
progress -report.pdf  refers only to substances that are under review. However, once the review process 
is complete, substances that are not to be renewed are removed from this portal and moved to the 
pesticides database on another website: https://ec.europa.eu/food/plant/pesticides/eu -pesticides -
database/public/?event=homepage&language=EN . 
The fact that available information does not appear on one sole website  that provides an overview 
of the progress of a substance evaluation , from when  a substance is included on the list through to 
when new MRLs are notified, makes holistic and systemic monitoring of the substances evaluated 
by the EU extremely difficult, parti cularly for developing countries with limited resources.  
We therefore reiterate the request that we made to the EU in paragraph 10 of document 
G/SPS/GEN/1760  for a single list that clearly indicates all the substances that have already been 
reviewed and the processes related to, and status of, those for which reviews are ongoing.  
 
8.  In the statement made by the EU concerning the specific trade concern (STC) raised by the 
delegations of Colombia and Ecuador regarding chlorpyrifos and chlorpyrifos -methyl , the EU noted 
 
9 Commission Staff Working Document Accompanying the document Report from the Commission to the 
European Parliament and the Council - Evaluation of Regulation (EC) No 1107/2009 on the placing of plant 
protection products on the market and of Regulation (E C) No 396/2005 on maximum residue levels of 
pesticides {COM(2020) 208 final }, page 48.  
10 Commission Staff Working Document Accompanying the document Report from the Commission to 
the European Parliament and the Council Evaluation of Regulation (EC) No 1107/2009 on the placing of plant 
protection products on the market and of Regulation (EC) No 396/2005 on maximum residue levels of 
pesticides {COM(2020) 208 final }, page 61.  G/SPS/GEN/1847  
- 4 - 
  that " given the conc erns identified by EFSA, it is not possible to determine MRLs based on a risk 
assessment and therefore all MRLs must be lowered to the limit of determination ".11 
Could the EU confirm that the MRLs for both substances will be lowered to the limit of detecti on 
(LOD) without a risk assessment?  
 
9.  In the same statement, the EU also said that " European Union legislation prescribes that it is the 
responsibility of the industry to demonstrate that substances and products they contain do not have 
any harmful effects on human and animal health or unacceptable effects on the environment ".12 The 
EU had already stated this in its replies to questions 8(j) and (k) and 11(q) submitted by Paraguay 
within the framework of the TPR of the European Union.13 
According to the European Union, the burden of proof regarding the safety of products falls on the 
industry . Could the EU explain how this assertion is consistent with its obligations under Articles 2.2 
and 5.1 of the SPS Agreement, which require WTO Members  to base th eir measures on scientific 
evidence?  
 
__________  
 
11 EU statement on the STC regarding MRLs  for chlorpyrifos and chlorpyrifos -methyl.  
12 EU statement on the STC regarding MRLs for chlorpyrifos and chlorpyrifos -methyl.  
13 Document W/TPR/M/395/Add.1, pages 392 -395.