G/SPS/GEN/1894  
 
1 April  2021 
(21-2743) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
 
RESPONSE OF THE EUROPEAN UNION TO G/SPS/GEN/1885  ON EU LEGISLATION  
ON ENDOCRINE DISRUPTORS – (CONCERN NO.  382) 
SUBMISSION BY THE EUROPEAN UNION  
The following submission , received on 26 March 2021, is being circulated at the request of the 
Delegation of the European Union . 
 
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1.   In its reply to question number 2 from Paraguay, the EU indicates tha t Article 5.7 of 
the SPS Agreement applies only to specific situations where, in the light of insufficient 
scientific evidence, the EU's risk management decisions may be based on the 
precautionary principle. Paraguay notes that a significant number of MRLs  have been 
adopted by the EU as a result of the decision not to renew certain substances found in 
plant protection products, which is based on inconclusive scientific evidence.  
(a)  Could the EU please indicate if, in these cases, it applies the precautio nary principle 
in its risk management decisions?  
(b)  If the answer is no, could the EU please specify how "insufficient scientific evidence " 
differs from "inconclusive scientific evidence "?  
The precautionary principle applies in specific circumstances where, following an assessment of 
available information, the possibility of harmful effects on health is identified but scientific 
uncertainty persists. If these conditions are fulfilled, provis ional risk management measures may be 
adopted if it is necessary to ensure the high level of health protection chosen in the European Union. 
Whether or not any decision can be referred to as "based on the precautionary principle " must be 
therefore verified  taking into account these specific circumstances.  
 
2.   In its reply to question number 4, the EU states that the protection of European 
consumers is ensured when there exists sufficient scientific certainty to establish that 
substances have no harmful effects on human health.  
(a)  Could the EU please provide a definition of when it considers that "sufficient scientific 
certainty " exists? Specific examples would be useful in order to best demonstrate this.  
There is no definition of "sufficient scientific certainty " in European Union law. In order to achieve 
the general objective of a high level of protection of human health and life, European Union food 
safety measures take into account the results of risk assessment, which is based on all available 
scientific evidence and undertaken in an independent, objectiv e and transparent manner.  
 
3.   Could the EU please confirm if environmental factors will be taken into account when 
granting emergency authorizations to member States to use substances prohibited within 
the EU?  
Yes – emergency authori zations are derogations fr om the standard requirements for authori zation, 
but do not exempt the need to consider safety. When considering whether emergency authorization s 
can be granted, member States must consider safety for human and animal health and the 
environment.  G/SPS/GEN/1894  
 
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  In January  2021, the European Commission published the Guidance on emergency authorization s 
according to Article 53 of  Regulation (EC) No 1107/2009 , which explains the process to be followed 
by applications and member States for application for emergency use as well as specifying the 
information that should be provided in such applications and their resulting authorizatio ns. 
 
Regarding substances which are not  approved in the European Union, the Guidance states:  
 
"Particular attention should be paid to the reasons underpinning the non -approval of the active 
substance when assessing applications, taking into account the most recent EFSA Conclusion 
on the substance, where available. The lack of critical endpoints  (such as health -based 
reference values)  for carrying out risk assessments is of particular importance and should be 
carefully considered, in particular when ensur ing consumer safety " (p. 6).  
 
4.   Could the EU please specify the technical criteria used when granting emergency 
authorizations to member States to use substances prohibited within the EU?  
Emergency authorization s are not granted to member States; rather, th ey are issued by the member 
States themselves – each member State is responsible individually for granting emergency 
authorization s. The Commission does not issue emergency authorization s; nor are emergency 
authorization s issued at European Union level.  
 
The Guidance referred to above in reply to question 3 provides more details on the process of 
considering emergency use of plant protection products, including product containing substances 
that are no longer approved in the European Union.  
 
Around 90% of emergency authorization s are for plant protection products containing active 
substances that are approved in the EU.  
 
5.   We note that, at the seminar of 20 January 2021 on environmental factors and setting 
MRLs, the EU stated that exports from one EU member State to another must comply with 
European MRLs and that few MRLs have been subject to emergency authorizations.  
(a)  Could the EU please indicate in which cases, for which products and in which member 
States emergency authorizations have been granted?  
There are many authorization s issued each year by member States. The vast majority (around 90%) 
of emergency authorizati ons are for plant protection products containing active substances that are 
approved in the European Union  and most comply with the EU MRL.  
 
In the event that substances do not comply with the applicable EU MRL, the treated food or feed 
must remain in the territory of the specific EU member State in which the authorization  was granted.  
 
In February 2020, the European Commission launched a publ ic database containing information on 
the notifications made by member States on emergency authorization s. Users can search to identify 
emergency authorization s granted from June 2016 onwards.   
 
Third countries can search the database to obtain informatio n on emergency authorization s. The 
notifications contain details of the use and compliance with the MRL.  
 
(b)  We note that the majority of products exported by third countries to the EU are 
unprocessed natural products (such as sugar cane, maize or beet), while those traded 
among EU member States are mainly processed products (such as sugar). In this regard, 
would  breaches of the limit of analytical determination be detected in processed products 
in the same way that they would be detected in an unprocessed raw material?  
Yes, the European Union legislation contains specific provisions for maximum residue levels fo r 
processed and composite products. EU member States include processed products in their national 
monitoring programmes and follow up on possible non -compliances in the same way as for raw 
agricultural products.  
 G/SPS/GEN/1894  
 
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  6.   We reiterate the following questions that w ere posed by the delegation of Paraguay 
at the aforementioned seminar and subsequently submitted by note to DG SANTE on 
21 January 2021:  
(a)  Could the EU please explain how it intends to incorporate environmental factors into 
import tolerances and how th is incorporation would be compatible with the obligations 
laid down for the establishment of sanitary measures under the SPS Agreement?  
The SPS Agreement applies only to measures defined in its Annex A .1 It follows from that definition 
that the SPS Agree ment covers measures aimed to protect human, animal or plant life or health 
within the territory of the Member. Measures based on other grounds, e.g. environmental, fall 
outside the scope of the SPS Agreement, even if they apply to food products.   
 
Until now, the European Union pesticides policy has been related to the protection of human health. 
Under the new approach, however, consideration may be given to issues of global environmental 
concern when setting import tolerances.  
 
(b)  Could the EU please provide a definition and list of the "environmental factors" to be 
taken into account when assessing import tolerances?  
The European Union has replied to this question in document G/SPS/GEN/1871  (point 17).  
 
(c)  In October 2020, Paraguay submitted a series of questions to the EU relating to 
specific trade concerns on MRLs and endocrine disruptors. In its replies, the EU stated 
that no amendments to Regulation No. 396/2005 are currently envisaged. Could the 
European Union please confirm whether environmental factors may constitute "other 
legitimate factors " to be taken into account when determining import tolerances?  
The European  Union has already replied to this question in document G/SPS/GEN/1872  (point 5).  
 
(d)  Can environmental factors determine the imposition of MRLs t hat are lower than 
those that would result from the application of purely sanitary factors?  
So far, the European Union has not resorted to the use of "other legitimate factors " when taking 
decisions on the setting of MRLs, including import tolerances. As already explained, environmental 
concerns of global nature may be taken into account in setting import tolerances. Measures will be 
taken on a case -by-case basis and founded on the best available scientific evidence. For those 
specific cases, this may inde ed result in lower MRLs.  
 
7.   With regard to import tolerances, could the EU please provide a list covering the period 
from November 2017 to date of all requested import tolerances, the requesting country 
and whether the requests were accepted or rejected? In cases where requests were 
rejected, could the EU please provide the reason for this rejection?  
This information is publicly available in the European Commission’s webpage: 
https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_overview -it-
table.pdf .  
 
The table reports the import tolerances requests submitted from 2009 to 2020 and the link to the 
corresponding Regulations. The table also indicates whether the import tolerances were established 
in the European Union or if they were rejected. In the latter case, a small remark on the reason for 
rejection is included. Information related to the countr y where the GAP is authori zed and the MRL 
value set for each commodity -active substance combination are also reported.  
 
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1 Any measure applied: "(a) to protect animal or plant life or health within the territory of the Member 
from risks arising from the entry, establishment or spread of pests, diseases, disease -carrying organisms or 
disease -causing organisms; (b) to protect human or animal life or health within the territory of the Member 
from risks aris ing from additives, contaminants, toxins or disease -causing organisms in foods, beverages or 
feedstuffs; (c) to protect human life or health within the territory of the Member from risks arising from 
diseases carried by animals, plants or products thereof,  or from the entry, establishment or spread of pests; or 
(d) to prevent or limit other damage within the territory of the Member from the entry, establishment or 
spread of pests ".