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Ares(2019)1536101-07/03/2019

- Ref.Ares(2019)3653498- 06/06/2019

EUROPEAN COMMISSION

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HEAL TH AND FOOD SAFETY DIRECTORATE -GENERAL

Director-General

Brussels ,
SANTE / E41-- ,(2019)636986

NOTE TO MR AR- NAS VI {·IONAS,

HEAD OF CABINET OF COMMISSIO ER A 0Rfllh'.AITIS

Subject: Handling of requests for import tolerances for active substances falling
under the cut-off criteria laid down in Regulation (EC) No 1107/2009

This note is to inform you or the latest developments in the discussion on the impact the or
human health related hazard-based approval criteria ("the cut-off criteria ") laid down in
Regulation (EC) No 1107/2009 on the handling of requests for import tolerances (ITs) for
pesticide residues (maximum residue levels (MRLs) of pesticides for imported products), and to
seek your approval on the way forward.

Following the last exchange on the subject 1, the Commission presented to the Standing
Committee on Plants , Animals, Food and Feed (PArF) - sect ion Pesticide Residue s on 26/27
September 2018 the revised approach fo r the hand ling of [Ts for active sub sta nces falling under
the cut-off criteria. As a reminder , this approach consists of:
1. The deletion of existing ITs for active substances falling und er the cut-off cr iter ia on the
basis of Article 17 of Regulation (EC) No 396/2005 ("the MRL Regulation ..), which ullows
for deletion of MRLs without seeking the opinion of EfSA for active substances present in
plant protection products whose authorisations have been withdrawn . Member States have to
withdraw authorisations following non-renewal or expiry of approval for active substances.
regardless of their falling under the cut-off cr iteria or not.

2. For requests to set new ITs, risk assessment in line with the MRL Regulation , and risk
management decisions taking into account the outcome of the risk assessment and other
legitimate facto rs as well as the precautionary principle.

Based on the somewhat surprising Member States' comments received , including those at and
after the PAFF meeting of 26/27 September 20 18, only four Member States (BE , FR, IT, SI}
clearly signalled their support ior this approach. FR would be prepared to go even further, by
rejecting import tolerance requests already at Member State level wit hou t proceeding with a risk
assessment. On the other hand, several Member States supported an exclusive ly risk-based

Your e-mail of 06/03/2018 , Ares(20 18) 12420 84, and furt her clarifica tion in the e-mail of the Deputy Head or
Cabinet of 12/03/2018, Arcs(2018)137171 I, both in answe r to Note Ares(2018)8 347 93, 13/02/2019 ; please
also see earlier exchange on the subject: your e-mail of2 4/03/2015 , Ares(2015 ) 13609l7 in answer to Note
Ares(2015) I O12143, 06/03/2015.
approach to the deletion of old ITs and setting of' new ITs (AT, _)E, LT. NL. PL. PT. UK), \,Vith
some of them additionally voicing concerns regarJi 11g the legal s l• 11..11ess the de let ·1 "al!
MRLs, including ITs and Codex MRLs (CXLs), on the basis orArticle 17. The pos:tion ornnc
Member State (ES) initia:ly surportive - the str·.cter ,1pproach presented by DO SANTE is
uncertain following tfa)re rece11tcomments. Acc.,ordi·1gto th,,sc that raised cvncer·1s. exist111gITs
anJ CXLs s:1iuld be maintained, 2.s fl1c risk assessment preceding their settmg concluded there
was no ··isk ·-:.r human heal~h. The UK also emphasised the lack of coherence for the hand Iing of
the ITs, as existing ones would be Gc,eted on the basis of d halard-based ar,procich, while new
ones would be evaluated following a nsk-based approach.

Furthermore, in the numerous interventions on this topic in the WTO-SPS C._mmittee and
bilateral correspondence anJ meetings. practicdll)' all third countries have strnng!y criticiseG the
deletion of all MRLs for cut-off substances as not being in l111ewith the WTO-SPS Agrccrnc 1t2•
wh;ch requires a risk-based approach. This issue remams also a particularly difficult point i11the
EU-US re:Jtions

We therefore seek your advice on the way forward, co·1sidenng the two followir.g options 1~,r
MRL action follC'wmg non-renewal or expiry orapprcval for active substances foiling, ndcr the
cut-off criteria Please note that the options differ only in the first step (ddetion f' existing
MRLs including ITs), while the second step (requests for new ITs) is identical:

Option 1: Continuing with the approach:

First step: after non-renewal or expiry of approval or the active substance, and the end ol all
grace periods for plant protection products contain n6 ··, all MRLs arc deleted. i.e. MRLs
that were set based C'l1<1Jt11orisations in EU Mi:n1bu St«tes. MRLs tlic1twere set baseJ on
specific IT requests, and MRLs that were set based on CXLs.
Second step: if subsequently requests for new import t lerances arc submitted, a Member
State and thereafter EFSA carry out a full risk assessme 1t Tl1e Commission proposes a risk
management decision on the import tolerance request that takes into account the outcome of
the risk assessment, other legitimate factors, and the precautionary principle. It is expected.
in the light of the hazards at stake for which safe exposure thresholds can only seldom be
determined, that the outcome of the risk assessment would often lead to the rejection o!'
impo1i tolerance requests. However, for some requests the outcome might confirm the
absence of risk so thdt the ITs can be granted.
Pros: this strict approach w0Lld ClHTespondto a large extent to the wishes t 1t- Europe:"'
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Parliament (as voiced among others in the rep0rt from the PEST Commit ee1 and the ~U
farrt1ing community, to treat imported commodities equally strict as those prouuccd in the
EU
Cons: this approach carries the risk of insufficient support from Member States (e.g. when
""ting in the PAFF Committee on dratt Regulations lowering all MRLs including ITs and
CXLs for cut-off substances). Moreover, third countries will continue to forcefully unpose
this approach, with a strong risk of formal WTO disputes. This may also impact the ::;:u-us
dialogue.
Option 2: Changing the approach·

The .VTO Agree1·1e1ton the Application of Sanitary and Phytosanitary Measures.

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 First step: substances falling under the cut-off criteria would be treated in the same way as
any other n0n-approvcd s"Jbstal'.Ce,i.e. atkr non-renew<.!:or expiry 11fapp··oval L'f. the active
substance, and the end L>fall grace periods 1t'r plant protection products containing it, only
those MRLs that were set based on autilC'risations in EU Member States will be proposed for
deletion, whereas those MRLs that were set based on specific IT re(, cs~s,>rMRLs that ,vere
set based o 1 cx=--.,swould be maintained - except for cases where ccsA identified pokntial
risks during e ;>receding assessmcnt 3 , and providca that the assessment look accou 1t of the
hazard that led to the conclusion that the substance meets the cut-off criteri,1. Moreover,
following specific requests from interested parties and firm Cllmin;tmcnts to generate
necessary data and sul"tllit imro·'l tokrancc requests, MRLs that ¼ere sd bc1sedon EU uses
would be maintainec 1, r a limited penod until a Jecision on that :P,p1"1 tolerance request is
taken. Furthermore, CXLS can replace MR.Ls that were set based o 1 EU c1scs.Both measures
(temporary maintena L:e of MR.Ls following request , and setting ,~f M'{Ls baseJ on CXLs)
likewise require t:1at EFSA did not identify potential risks during the preceding assessment,
and provided that the assessment took account of the hazard that led to the conclusion that
the substance meets the cut-off criteria. Both measures arc in l111ewith current practice and
help addressing the e0ncerns .:,f trad•ng r1rtners, as for their exports 1(' th-: E!J hey olten
rely on MRLs that were set based o, [0 uses and that wc•uld otherwise 11< f-)e iaint1 ned
alter non-renewal,"· expiry of appn)"a I 1c~ivesubstan.:es (falling under the cut-off cnteria
or not).
Second step: if subsequently requests for new imoort tolera11ces, re submitted, a Member
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State and thereafter EFSA carry out a full risk assessment. The C •11missionproposes a risk
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management decision on the import tnlerance request that takes i1', account tbe outcome of
the risk assessment, other legitimate fact,,rs, and the precautionary principle. It is expected,
in the light of the hazaras at stake for which safe exposure thresholds can ()nly sel-::om he
determined, that the Oi.ltcome0f the risk assessment would 0ften lead 10 the rejection of
import tolerance requests However, for some requests the outcome might confirm the
absence of risk so that the ITs can be granted.
Pros: this approach e1~joys more backing than option I, based on views expressed by
Member States so far, although it d0es also 110tguarantee sufficient support fr,m Member
States, when the Commission presents proposals to amend MRLs in the P/ FF. r loreovcr, it
addresses the concerns of third countncs who mstst that ITs should be estab1ished t'11 the
basis of a risk assessmt:nt, thus reduc111gthe likelihooJ of formal WTO dispL;tes.
Cons: this approach would ct1 rrespond less to the wishes of the EL. 1pean Parliament (as
voiced among others 111 the report from the PEST Commit 1.ee) a11d the EU farming
community, to treat imrorteJ commodities equally strict as those pr0duccd in the EU.
Overall, it can be expeckJ that many decisions on MRLs for substances faJling under the cut-oft
criteria would in actual fact be identical for both options, due to an untc1vourablec-r inconclusive
risk assessment during the pr(ccding ev~luat1on.

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For the recent case of I nuron. the non-approval was based on the class,ficat1011as toxic for reprod.ict.011
category I Band endocrme disrupting properties, but also other concerns identified and relev,lllt for protection
of consumers, including that the co'lsumer risk assessment could not be finalised due to a number of serious
deficiencies n the data package. Subsequently <lllMR Ls were deleted.

Likewise, for the recc11t case ol iprodione, the lh.>11-uppro,dlwas based on the proposec, (by ErSA)
c ass1fjcat on as carcinogen categoi-y I Band endocrine L1isruptingnnmcrties. bu' also oll·er cencerns 1Cl<.::nt1licd
,rnd releh,nt for pr, tett10n of c~,nsumers, 1nc.luding c ,r cerns on t 1e genot<'x1c p 'knt ,11cf , 11. 'lbol te.
SubseqLently, all MRLs were deletec..

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 Conclusion: in the light of the rather negative feedback from a significant number of Memher
States on option 1 at the PAFF meeting in September 2018, and the need to obtain a qualified
majority on dratl acts amending MRLs, as wel1 as taking mto account the positions of practically
all third countries, DG SANTE considers that the second option is the preferred one.

It is not clear lww the )ther DGs wlw were involveJ in the 1..1iscusSllll' ,,·Klagreea tu the Cl rrcnt
app1oach woulu pos,ll n tnemselvcs with regaru to the sec nd opt, n ' 1..- 1 be expected thut
DG TRADE will strongly support it, whereas it is less clea1 for the '"'t11e1 DGs, espec1<1ly ll>I'DG
AGRI who might raise the issue of Jiscrimination between EU cmJ third c rnntry far111ers.
However, this would equally apply for substances not falling unuer the cut-off criteria, where
DG AGRI has never opposed the approach so far

Our position, when agreed internally in the Commission, should first be shared w;tl, Member
States. If sutficient support is obtained 1 11 the PAFF Committee, the position should be carefully
communicated to third countries aPd stakeholJers , not least in view of earlier cornn'1111ic<1t1on
on
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this t0pic T h1s enJ, an infc rn attt .1 note coulu be d1stnbuted to L,h.img partners t!"oc1gh tl e
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WTO-SPS CL Y mittee. and lo stakeholders tlv·ough the Advisory Groc1pon the FoJL: C'L"."nanJ
Animal a u P,unt Health. Moreover, the procedura! guidance published on the SAN' 'E \vcbsite
should be updated accordingly.

I would appreciate to receive your agreement on the pr0posed approach in order to discuss it
with the other services,

Anne Bucher

Cc: Ms N. Chaze, Cab Andriukaitis Cad (ve

Note ofDG SANTE to other DGs, Ares(2017)3458667, 10/07/2017; letter of Commissioner Andriukaitis to
ambassadors of third courtres, Ares(20 8)3670816. 10/07/20 8, Note of DG SANTE to other DGs,
Ares(2018)3984036, 27/07 /2C 8

- Electronically signed on 06/06/2019 16:27 (UTC+02)in accordance with article 4.2 (Validity of electronic documents) of Commission Decision 2004/563
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