G/SPS/GEN/1872  
 
8 Decemb er 2020 
(20-8836) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
RESPONSE OF THE EUROPEAN UNION TO G/SPS/GEN/1847  ON EU MRLS FOR CERTAIN 
PLANT PROTECTION PRODUCTS  
SUBMISSION  BY THE EUROPEAN UNION  
The following document , received on 2 December  2020, is being circulated at the request of the 
Delegation of the European Union . 
 
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This document provides the EU response to the questions raised in G/SPS/GEN/1847 regarding 
STC 448. 
1.  As already explained previously, MRLs should be set at  the lowest achievable level consistent 
with good agricultural practice for each pesticide with a view to protecting vulnerable groups such 
as children and the unborn.  
EU legislation acknowledges the dual role of MRLs in consumer protection and trade facil itation. It 
provides for the possibility to set MRLs for imported products to meet the needs of international 
trade and requires the consideration of good agricultural practices authorised in third countries as 
well as of MRLs set by the Codex Alimentarius  Commission.  
In accordance with the EU legislation applicable to MRLs, 'good agricultural practice' (GAP) is the 
nationally recommended, authorised or registered safe use of plant protection products under actual 
conditions at any stage of production, stor age, transport, distribution and processing of food and 
feed. It also implies the application of the principles of integrated pest control in a given climate 
zone, as well as using the minimum quantity of pesticides and setting MRLs/temporary MRLs at the 
lowest level which allows the desired effect to be obtained. 'Critical GAP' means the GAP, where 
there is more than one GAP for an active substance/product combination, which gives rise to the 
highest acceptable level of pesticide residue in a treated crop and is the basis for establishing the 
MRL. 
Information on the toxicity and metabolism of an active substance as well as on the residue levels 
present in crops following application of plant protection products in accordance with GAP are taken 
into account, not to determine the level of protection, but to ensure that a given GAP, and in 
extension the setting of an MRL based on that GAP, is acceptable without compromising the pre -
determined level of protection.  
2.  The European Union is the only Codex mem ber openly raising reservations and communicating 
to Codex every time when not in a position to adopt a new Codex MRL. The European Union also 
provides scientific reasons for the reservations and consequent non -alignment. To increase 
transparency and predi ctability in international trade, the E uropean Union strongly encourages other 
Members to do likewise.  
In order to set a maximum residue level (MRL) a risk assessment from the European Food Safety 
Authority (EFSA) must demonstrate that the MRL is safe for consumers. This requires that a 
minimum of supporting data is provided in line with the EU data requirements allowing EFSA to reach 
a conclusion on the safety of the MRL. If such supporting evidence is lacking or insufficient, 
EFSA cannot conclude that the MRL is safe.  G/SPS/GEN/1872  
 
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  3.  The European Union ensures the absence of any discrimination by applying the same MRL for a 
given substance -commodity combination to all relevant food products on the market in the European 
Union, regardless of their origin, i.e. whether t hey were produced domestically or imported from 
third countries.  
4.  The EU prior response needs to be properly contextualised. The point we are making is that 
Article 5.3 of the SPS Agreement  applies to the assessment of risk to animal or plant life or health  
and to determining the measure to be applied for achieving the appropriate level of protection from 
such risks. Consequently, measures established to protect human health from risks, as opposed to 
risks to animal or plant life or health, fall outside the scope of this Article.  
5.  Scientific risk assessment alone cannot, in some cases, provide all the information on which a 
risk management decision should be based, and other factors relevant to the matter under 
consideration should legitimately be taken into a ccount including societal, economic, traditional, 
ethical and environmental factors and the feasibility of controls. So far, the European Union has not 
resorted to the use of "other legitimate factors" when taking decisions on the setting of MRLs, 
includin g import tolerances. Therefore, the European Union does not have any specific examples.  
6.  All the comments received in response to these notifications are duly considered and taken into 
account before a final decision is taken. Detailed replies are sent to a ll trading partners that submit 
comments. The European Union always provides a reply to all the comments submitted by another 
WTO Member on an EU notification and explains in details the planned measures and their rationale.  
7.  The European Union would like t o thank Colombia, Guatemala and Paraguay for this suggestion, 
which is being noted and will be considered in terms of feasibility.  
8.  The European Union has carefully studied all the information available and confirms that there is 
sufficient evidence to conc lude that both substances pose serious concerns for human health. 
The available regulatory studies and scientific literature, including epidemiological data, provide 
evidence of developmental neurotoxicity, leading to adverse neurological outcomes in child ren. 
In addition, a genotoxic potential cannot be excluded for the two substances, in particular concerning 
the ability of the substances to damage DNA.  
The Regulations concerning the non -renewal of approval received a favourable opinion at the 
Standing Co mmittee on Plants, Animals, Food and Feed on 6 December 2019, after being duly 
notified under the WTO/TBT procedure. The Regulations were adopted and published on 10 January 
2020.  
On 18 February 2020, member states endorsed a Commission proposal to lower t he MRLs of 
chlorpyrifos and chlorpyrifos -methyl in food and feed to the Level of Quantification, which was duly 
notified to the WTO  SPS Committee . 
Notwithstanding the serious health concerns identified by EFSA, the Regulation includes a deferral 
period for  the application of the lower MRLs - three months from the date of entry into force of the 
Regulation. Therefore, it has not led to immediate trade disruptions as the new MRLs became 
applicable on 13 November 2020 . 
It is important to note that given the co ncerns identified by EFSA, it is not possible to determine 
MRLs that are protective for consumers based on a risk assessment and therefore all MRLs must be 
lowered to the limit of analytical determination.  
For the same reason, no additional transitional me asures can be provided for products that have 
been produced in the European Union or imported into the European Union before the Regulation 
became applicable.  
Chlorpyrifos was originally evaluated by JMPR in 1972. It was evaluated for toxicology in 1982 by  
JMPR and for residues in 1995 and it was reviewed for toxicology in 1999 and for residues in 2000, 
2004 and 2006.  G/SPS/GEN/1872  
 
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  There is a 20 years' gap since chlorpyrifos was last reviewed by JMPR, as it is also indicated in 
General considerations (point 2.6) of the 2 019 Report of the extraordinary FAO/WHO Joint Meeting 
on Pesticide Residues (JMPR).  
The European Union has recently submitted a concern form to the Codex secretariat and the JMPR 
to raise awareness on its latest findings. The European Union considers that a re-evaluation for 
toxicology and residues of chlorpyrifos and all the CXLs is necessary and this task should be 
prioritised in the JMPR calendar.  
9.  It is the responsibility of the applicant to provide relevant information and data needed to carry 
out risk assessment. It is justified that the burden of providing scientific evidence is shifted onto 
applicants because they have a direct or indirect commercial interest in placing the product on the 
market and – therefore – in actively contributing to risk asses sment procedures. This is fully 
compliant with the SPS Agreement.  
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