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Ares(2019)5441154 - 28/08/2019

fieldfisher
l'Arsenal
Boulevard Louis Schmidtlaan, 29 box 15
1040 Brussels
European Commission Belgium
DG SANTE
T +32 (0)2 742 70 00
Attn of: Mr. Mark Williams
F +32 (0)2 742 71 00
Unit E4 - Pesticides and Biocides E brusselsinfo@fieldfisher.com
F101 04/90
www.fieldfisher.com
B-1049 Brussels
Belgium

European Food Safety Authority Koen Van Maldegem

Partner
Via Carlo Magno 1A +32 (0)2 742 70 62 (Direct Dial)
43126 Parma +32 (0)476 942 042 (Mobile)
Italy koen.vanmaldegem@fleldfisher.com

By Email: mark.williamsl@ec.europa.eu
Cc: cromeroc@mapa.es
l\/lalqorzata.Szlarek@minrol.qov.pl
sante-consult-e4@ec.europa.eu
tunde.molinar@efsa.europa.eu
Manuela.tiramani@efsa.europa.eu
Pesticides.peerreview@efsa.europa.eu

By registered mail and e-mail

Brussels, 23 August 2019

Dear Mr. Williams,

Re: Comments on the EFSA Statement and on the draft Renewal Report for Chlorpyrifos-
methyl

In response to your emails of 12 and 14 August 2019 respectively, we write to you on behalf of our client
Ascenza Agro S.A. (hereafter "Ascenza" or "Applicant"), in its capacity as applicant for the renewal of the
approval of the active substance Chlorpyrifos-methyl (hereafter "the Substance") within the framework of
Regulation (EC) No. 1107/2009 concerning the placing of plant protection products on the market ("the
PPPR") in order to submit comments on the EFSA Statement and the Commission's draft renewal report
on the Substance.

At the outset, we find the commenting deadlines given to our client confusing. In your 12 August e-mail,
you indeed state that comments on both documents must be given by 9 September at the latest since
"you are consulting on both documents concurrently', however your 14 August e-mail you change this
and impose a 30 August deadline "if [the Applicant] would like [Its] comments on the EFSA statement on

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chlorpyrìfos-methyl to be taken into account by the experts". Our client fails to understand the procedure
followed and the logic behind it: if both documents will be discussed concurrently surely commenting can
and should be synchronised. More importantly, however, our client fails to understand the procedure
followed at EFSA, i.e., the lacking of an ESFA Conclusion Report, the unexpected issuing of the EFSA
Statement (without involvement of the Applicant) and the untimely publication of the latter on 2 August
2019 and, despite this, the announcement that the conclusions can still be changed at an EFSA expert
meeting to be held in early September 2019. This way of proceeding is highly unusual, not to say irregular
(see also below) and the Applicant is not in the position to fully understand the procedure followed by
EFSA and ultimately by the European Commission

In any case, the 17-day deadline until 30 August (expiring on a Saturday) granted to our client to submit
comments to the EFSA Statement is extremely short, especially as it falls in the middle of the summer
season with many people being on holiday thereby making it difficult to properly consult relevant experts
and prepare a full response. Moreover, since comments on the draft renewal report can still be made until
9 September (also by Member States), and the conclusions therein could still be altered following the
expert meeting, we do not believe that there is a reason to precipitate things. We therefore hereby submit
our client's comments on a preliminary basis, with the understanding that there will be a further opportunity
to submit observations in September 2019.

1. Background

In April 2017, Spain as Rapporteur Member State (hereafter "RMS") concluded its examination of the
Substance and issued its renewal assessment report (hereafter "RAR") in which it concluded that the
approval of the Substance can be renewed. The RAR was subsequently sent to the Commission and the
European Food Safety Authority ("EFSA") on 3 July 2017. A public consultation was also organized, and
different NGO's (notably PAN Europe) submitted comments.

In accordance with Article 13 of Commission Implementing Regulation (ELI) No 844/2012, EFSA initiated
the peer review of the RAR on 18 October 2017 and dispatched the RAR to the Member States and
Applicants for consultation and commenting. On 4 July 2018, EFSA requested the Applicant to provide
further information on, e.g., mammalian toxicology in accordance with Article 13(3) of Regulation (EU) No
844/2012, which was submitted, evaluated and included in an updated 2019 RAR, which still proposed
that the approval of the Substance can be renewed.. The Applicant took notice of the existing updated
RAR in the EFSA Statement, never being formally informed by RMS. The Applicant took the initiative to
contact the RMS asking for the updated RAR, which was received on 16 August 2019.

Between 1 and 5 April 2019, EFSA organised discussions between EFSA experts and Member States
(including experts from the PPR Panel) to discuss mammalian toxicology and conduct a hazard
assessment largely based on the structural similarity of the Substance with Chlorpyrifos. However, EFSA
did not conclude on the risk assessment of the Substance (in the form of an EFSA Conclusion Report
regarding the peer review of the pesticide risk assessment).

On 1 July 2019, the Commission issued a mandate to EFSA asking it to review the human health
assessment and to issue a statement as to whether the Substance can be expected to meet the human
health approval criteria laid down in Article 4 of the PPPR. On 31 July 2019, EFSA sent to the
Commission its statement, concluding in relevant part that the Substance cannot be expected to meet the
approval criteria. In relevant part, the EFSA Statement concluded that "no reference values could be set, a
fact that made it impossible to perform a risk assessment for consumers, operators, workers, bystanders
and residents". Underlying this conclusion, it was alleged that:

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 • while the available genotoxiclty dataset did not show any concern, it lacked the additional relevant
information retrieved e.g. from the literature for Chlorpyrifos and that therefore the genotoxic
potential of the Substance remains unclear, and
• while a DNT study showed no relevant effects as regards developmental neurotoxicity, this study
had some significant limitations related to the controls making a reliable statistic analysis
impossible, so that a specific DNT NOAEL could not be set.

As a result, the EFSA statement concluded that it was not possible to perform a risk assessment for
consumers, operators, workers, bystanders and residents. Because of the developmental toxicity
concerns, it was further stated that the Substance would also meet the criteria for classification as toxic for
reproduction category 1B.

Importantly, the Statement also added that the read-across to Chlorpyrifos for the hazard Identification
would be re-discussed at a later experts meeting and that the outcome of the discussions "might impact
on the assessment of the specific studies, on the possibility to identify a classification as well on the
setting of reference values for chlorpyrifos-methyľ. Despite this admission that the conclusion in the
Statement could still be changed, the latter was made public and published on the EFSA website on 2
August 2019.

By e-mail of 12 August, the Commission informed the Applicant that it had prepared a draft renewal report
on the Substance which was forwarded to the latter as an attachment. In the draft renewal report, the
overall conclusion is that:

• "The genotoxic potential of chlorpyrifos-methyl, which cannot be ruled out when taking into
account the concerns raised for chlorpyrifos concerning chromosome aberration and DNA
damage that may also apply to chlorpyrifos-methyl. Consequently, health based reference values
cannot be established for chlorpyrifos-methyl and the dietary and non-dietary risk assessments
cannot be conducted.
• Developmental neurotoxicity (DNT) - the available DNT study on chlorpyrifos-methyl did not allow
for a full assessment of effects on brain development, in particular since effects on cerebellum
height could not be evaluated due to the lack of controls in females. Since DNT effects were
observed in the available developmental neurotoxicity on chlorpyrifos (adverse effects were seen
at the lowest dose tested in rats and a no observed adverse effects level ‘NOAEU could not be
established) concerns exist also for chlorpyrifos-methyl. Moreover, epidemiological evidence
exists showing an association between exposure to chlorpyrifos-methyl during development and
adverse neurodevelopmental outcomes in in children.
• Based on the evidence for DNT, experts during the peer review suggested that classification of
chlorpyrifos-methyl as toxic for the reproduction category 1B, H360D ‘May damage the unborn
child’, in accordance with the criteria set out in Commission Regulation (EC) No 1272/2008 would
be appropriate. "

This overall conclusion is almost a word for word copy of the overall conclusions in the draft renewal
report for Chlorpyrifos. On that basis, the draft renewal report concluded that the approval of the
Substance cannot be renewed.

By a Commission e-mail of 12 August 2019, the Applicant was initially Invited to provide comments on
both the EFSA Statement and the draft renewal report for the Substance by 9 September 2019. By a
subsequent 14 August 2019 email of the Commission, the following was stated: "if you would like your

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comments on the EFSA statement on chlorpyrifos-methyl to be taken into account by the experts, please
submit your comments earlier, by 30 August, also sending directly to EFSA
(pesticides, peerreview&efsa. europa.eu) as well as to the Commission. Please note this applies only to
chlorpyrifos-methyl. Comments on the renewal report (and on the statement if you do not wish to submit in
advance for the expert discussion) can be provided by 9 September."

2. Procedural comments

As noted above, the Applicant has serious concerns regarding the procedure that was followed by EFSA
and the Commission. The Applicant provided comments in January 2018 on the final Renewal
Assessment Report ("RAR") which were also included in the so-called "reporting table" and timely
provided additional data on, e.g.t mammalian toxicology following the request made by EFSA in July 2018.
The Applicant understands that this data was included in an updated final RAR which still proposed that
the renewal of the Substance can be approved.

The Applicant was never informed of any issues which prevented the adoption of the EFSA Conclusion
Report or renewal of the approval of the Substance. After the discussions during the PRaPER meeting on
Toxicology in April 2019, the Applicant was not informed that EFSA would not peer review the other
sections of the dossier and he was also not informed of the reasons for not doing so. This is despite the
fact that under Article 13 of Regulation (ELI) No 844/2012, EFSA has an obligation to adopt a conclusion,
which it must communicate to the Applicant who should be given the possibility to request confidential
treatment of certain submitted data. The latter point too was not respected. Such approach is also contrary
to the principle of transparency, which applies to every public authority in the EU.

The Applicant was therefore legitimately and truly surprised to find out that the Commission had asked
EFSA to prepare a statement and that allegedly the approval criteria were - according to EFSA and the
Commission - not satisfied. Such a finding is contrary to the principle of legitimate expectation as
recognised by relevant case law1. The Applicant could indeed legitimately expect the Commission to be
informed and propose the renewal of the Substance, as was proposed in the RAR.

Moreover, the PPR Expert conclusions and the adverse effects which allegedly support the non-renewal
proposal are all, without any exception, based on read-across data from chlorpyrifos-ethyl, which is a
different active substance. The Applicant firmly opposes such read-across where Substance specific data
has been submitted and is available in its dossier. Flowever, in a spirit of cooperation with the EFSA
experts and the Commission, the Applicants will provide further information to EFSA which clearly
demonstrates substantial differences in the toxicity of the two substances and shows that read across of
specific adverse effects from chlorpyrifos-ethyl to chlorpyrifos-methyl is neither warranted nor justified. The
Applicant will do its best to provide this information within the 30 August 2019 deadline set in your 14
August 2019 letter, although this should not be interpreted as an agreement with or admission of validity of
this deadline.

The EFSA Statement also noted that the PPR Expert conclusions on chlorpyrifos-methyl are preliminary
and that the experts are also not sure about the read-across conclusions. Specifically, it is stated:

1 Cases T-429/13 and T-451/13, Bayer and Syngenta v. Commission, Paragraph 278: “It has consistently been held that any Individual whom an
institution of the European Union has led to entertain legitimate expectations by giving him precise assurances may rely on the principle of the
protection of legitimate expectations (judgment of 11 March 1987, Van den Bergh en Jurgens and Van Dijk Food Products (Lopik) v EEC, 265/85,
EU:C:1987:121, paragraph 44; see also judgment of 8 September 2010, Deltafma v Commission, T 29/05, EU:T:2010:355, paragraph 427 and the
case-law cited). "

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“It Is noted that, after the Pesticides Peer Review Experts’ meeting held between 1 and 5 April 2019,
EFSA reconsidered the read-across approach applied for the hazard identification after a full comparison
of the available toxicological data: it was agreed to re-discuss this issue in an experts’ meeting. The
outcome of the discussions might impact on the assessment of the specific studies, on the possibility to
identify a classification as well as on the setting of reference values for chlorpyrifos-methyl. "

This mere statement raises several important procedural (and also substantial) questions:

Firstly, it seems crystal clear that the EFSA Statement is a preliminary document and that the conclusions
contained therein are not final and, indeed, could still be changed substantially. This raises the immediate
question as to why this document, which by its nature and content is commercially damaging for the
Applicant, was published on EFSA's website on 2 August 2019.

Indeed, because of the alleged developmental toxicity concerns, the EFSA Statement specifies that the
Substance would meet the criteria for classification as toxic for reproduction category 1B. It therefore puts
into question the properties of the Substance, as well as the products containing it.

The publication of such Statement is irreparably affecting the reputation of the Substance, thereby
adversely affecting the Applicant's commercial interests.

Furthermore, EFSA Statement contains unfinalised and/or partial statements. Even if EFSA were to
subsequently correct its Statement, this would not cure the damage done by incomplete and/or unfinalised
statements related to the Substance.

We herewith request that the Statement is withdrawn from this website with immediate effect.

Secondly, it follows from the first point that the Commission's draft renewal report is, to say the least,
premature and lacks scientific foundation. Therefore, our client strongly opposes that this draft renewal
report forms the basis for commenting by not only the Applicant, but more importantly also the Member
States. The risk clearly exists that Member States will comment on a flawed renewal report, so that also
their commenting risks to be vitiated by the same scientific flaws. On that basis, our client asks that the
draft renewal report be withdrawn and that any further commenting be suspended until at least EFSA has
finished its peer review and prepared a comprehensive Conclusion Report.

Thirdly, in view of the above deficiencies, the Applicant is uncertain if and to what extent the EFSA
Statement has identified any areas of concern for the Substance. In particular, as regards genotoxicity, it
is stated that "the available genotoxicity dataset submitted for chlorpyrifos-methyl did not show any
concern" and also as regards developmental neurotoxicity, it is stated that "a DNT study was available
which did not show relevant effects, however it had some significant limitations related to the controls,
making a reliable statistical analysis impossible". In both cases, the endpoints for chlorpyrifos are
conservatively read-across to chlorpyrifos-methyl, without sound justification or motivation. As regards
epidemiological data, US data was used which cannot be linked to exposure to chlorpyrifos-methyl based
products.

Fourthly, the same flawed approach is applied for classification, where "the experts conservatively applied
the same approach as for chlorpyrifos, considering that chlorpyrifos-methyl would also meet the criteria for
classification as toxic for reproduction category 1B (regarding developmental toxicity)". Here again, any
motivation or justification is lacking. More fundamentally, the Applicant is at a loss to understand how
EFSA (or its experts) can make a proposal regarding the classification of the Substance, as this is clearly

5
not within its competence during the renewal approval process; instead, this involves the exclusive
competence of the Risk Assessment Committee ("RAC") at the European Chemicals Agency (see below).

Overall, the Applicant fails to understand how these conclusions can be reconciled with the EFSA
conclusion that after the experts meeting "it reconsidered the read-across approach applied for the hazard
identification after a full comparison of the available toxicological data: it was agreed to re-discuss this
issue in an experts’ meeting. The outcome of the discussions might impact on the assessment of the
specific studies, on the possibility to identify a classification as well as on the setting of reference values
for chlorpyrifos-methyl. ”

The Applicant also submits that a concern should be distinguished from "an issue that could not be
finalised2" with respect to any decision on renewal. In addition, the Applicant refers to well established
case-law of the European Courts that the precautionary principle cannot be applied in cases where the
risk is based upon conjecture which has not been scientifically verified3. The risk cannot therefore be
hypothetical. It must be real and it must be scientifically confirmed, which is not the case here until at least
the additional data on chlorpyrifos-methyl has been assessed.

Finally, the Commission draft renewal report on the Substance refers to a potential "classification of
chlorpyrifos-methyl as toxic for the reproduction category 1B, H360D ‘May damage the unborn child’, in
accordance with the criteria set out in Commission Regulation (EC) No 1272/2008'\

Flowever, as indicated in the draft renewal report on the Substance, this classification proposal comes
from a suggestion of experts made during the peer review.

Such statement is therefore procedural^ and legally incorrect since it is not for EFSA - or its experts - to
make a proposal regarding the classification of a substance such as chlorpyrifos-methyl while it is subject
to the renewal of approval process.

3. Substantial comments

i) Genotoxicity

As to the issue of genotoxicity, a full dataset has been submitted by the Applicant which demonstrates that
no such concerns should in fact be raised in the context of the Substance. It is strongly disputed that this
issue is one which could not be finalised due to a lack of available data, but rather seems to be a concern
based exclusively on an unjustified read across from Clorphyrifos and not on the assessment of methyl. If
further information is deemed necessary to finalize its assessment, this should be requested by EFSA to
applicant for submission within the stop-the-clock period. In a spirit of collaboration with EFSA and the
Commission (as stated above), the Applicant is willing to provide information to EFSA which clearly
demonstrates substantial differences in the toxicity of the two substances and shows that chlorpyrifos-
methyl is about significantly less toxic than chlorpyrifos and that effects of treatment are not identical. The
following examples illustrate this:

2 An issue is listed as 'could not be finalised’ if there is not enough information available to perform an assessment, even at the lowest tier level, for
the representative uses in line with the uniform principles in accordance with Article 29(6) of Regulation (EC) No 1107/2009 and as set out in
Commission Regulation (EU) No 546/20117 and if the issue is of such importance that it could, when finalised, become a concern (which would
also be listed as a critical area of concern if it is of relevance to all representative uses), (emphasis added)
3 See, e.g., Case T-13/99, Pfizer Animal Health SA v Council of the European Union, ECLI:EU:T:2002:209, paragraphs 143-146

в
 • Chlorpyrifos-oxon is a metabolite in rat of chlorpyrifos (which in itself is more toxic than
chlorpyrifos); for chlorpyrifos-methyl, however, this corresponding oxon metabolite is not found in
the rat metabolism study;
• Acute oral toxicity to the rat with chlorpyrifos-methyl is 2'500 - 5Ό00 mg/kg, whereas for
chlorpyrifos this is 66 - 223 mg/kg;
• Chlorpyrifos-methyl is a skin sensitizer, whereas chlorpyrifos is not;
• In repeated dose studies, Cholinesterase inhibition occurs at significantly lower doses of
chlorpyrifos compared to chlorpyrifos-methyl;
• The proposed ADI of chlorpyrifos-methyl is based on vacuolar changes in the adrenal cortex of
the 2-year rat study. The proposed ADI of chlorpyrifos is based on inhibition of red blood cell
cholinesterase in the 2-year rat and dog studies.

Consequently, read across of specific adverse effects from chlorpyrifos-ethyl to chlorpyrifos-methyl is

neither warranted nor justified, and certainly cannot be the basis for a suspected genotoxicity potential.
Therefore, if the genotoxicity assessment of methyl is inconclusive, this should not be the basis for a non­
renewal of the Substance, as further studies should consequently be requested to finalize the assessment
and propose specific reference values.

As a minimum, the Applicant requests that the additional information on the differences between both
substances he will submit will be reviewed and considered by the EFSA experts during the meeting in
early September 2019. Moreover, to exclude any concerns that may be related to methyl exclusively, the
Applicant is willing to perform additional studies in coordination with RMS and EFSA either in the scope of
the current review process or as confirmatory data or during Member State product authorisation phase. If
data cannot be considered within the current stage of the process, then the reference values proposed by
RMS in its RAR should be used to derive end points for the Substance

ii) Developmental neurotoxicity

As to the issue of developmental neurotoxicity, the Applicant does not understand why this is being used
as a cut-off criterion by the Commission justifying an immediate decision not to renew the approval of
chlorpyrifos-methyl, even to the point where the EFSA Conclusion Report is deemed not necessary
anymore. The procedure and criteria for the approval of active substances are set forth in Annex II to the
PPPR, with specific focus on "Impact on human health" in point 3.6. It is clear from reading points 3.6.1 to
3.6.5 that the cut-off criteria, preventing the approval/renewal of approval of a substance relate to
substances that are a mutagen, carcinogenic, or toxic for reproduction Cat 1A or 1B, or that are endocrine
disrupters. However, developmental neurotoxicity is not listed and is not per se a cut-off criterion as it
seems to be used here. Neurotoxicity seems not to fall into the reproduction category class, as defined in
Regulation (EC) No 1272/2008 ("the Classification and Labelling or CLP Regulation") and could or should
be addressed in a complete risk assessment. This is also stated in point 3.6.1 of Annex II to the PPPR:
"When the critical effect is judged of particular significance, such as developmental neurotoxic or
immunotoxic effects, an increased margin of safety shall be considered, and applied if necessary. "

Furthermore, from the information provided to the Applicant, it would seem that the outcome of
epidemiological studies are one of the reasons for the non-renewal proposal. However, the vast majority
of the cited publications report data from the United States where chlorpyrifos-ethyl is a major insecticide
used in agriculture. On the contrary the use of chlorpyrifos-methyl is negligible in the US, and therefore
reported findings cannot be linked to exposure to this active substance. Moreover, all cited publications on
adverse effects in humans from outside US are directly linked to chlorpyrifos-ethyl and not to chlorpyrifos-

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methyl. As explained above, such read-across is not justified and does not represent realistic proposed
conditions of use. The Applicant is also not aware of any epidemiological data that can be linked to
exposure to chlorpyrifos-methyl.

Hi) Classification

As stated above, the Applicant does not understand and strongly opposes any classification proposal that
is being made by EFSA, while a legally valid harmonised classification from ECHA is already in place in
Europe.

Firstly, Article 13 of Regulation (EU) No 844/2012 Is the most relevant In terms of the assessment EFSA
can undertake within the renewal process. It states, in relevant part, "the Authority shall adopt a
conclusion in the light of current scientific and technical knowledge using guidance documents applicable
at the date of the submission of the supplementary dossiers on whether the active substance can be
expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009". The
reference to Article 4 of Regulation 1107/2009 does not, however, lead to a request for a classification
review to be undertaken by EFSA.

Secondly, the mandate that EFSA received from the European Commission to conduct its review Is
restricted; this mandate does not contain wording to the effect of permitting EFSA to make proposals on
classification of the Substance. The mandate reflects Article 12 of Regulation (EU) No 844/2012 which
states that EFSA Is limited to preparing an "EFSA Conclusion regarding the renewal of the approval of
active substances in application of Article 18 of Regulation 1107/2009 and respective work programmes
established by the Commission (Regulations 1141/2010 and 844/2012)". EFSA, or its experts, are
therefore not competent to make a proposal for the classification of the Substance.

Thirdly, the CLP Regulation also does not grant EFSA any powers in respect of substance classification.
The formal legal procedure for the proposal of a classification of a substance is based on a hazard
assessment involving only the RAC at the European Chemicals Agency. While it is true that a proposal
can be submitted by a Member State (see Article 37 of the CLP Regulation) to the European Chemicals
Agency with regard to a classification of a substance, the legislator excluded EFSA from that list of
proposers. Moreover, RMS Spain did not consider necessary to submit a new classification dossier to
ECHA related to the Substance within the remit of its scientific evaluation as it did not found grounds for a
repro-toxic category 1B reclassification for the Substance. If newly available information raises questions
about the need for a new harmonised classification for the Substance, a CLH dossier should be submitted
by RMS (or other Member State) to ECHA for a scientific assessment by the RAC.

Therefore, until any classification of the Substance as repro-toxic category 1B has been formally adopted,
the existing classification of the substance is the only one which is legally applicable and relevant within
the framework of the renewal process. The EFSA Statement therefore cannot and should not be used for
concluding on a non-renewal of the Substance under the PPPR.

4. Conclusion

The Applicant disagrees with the conclusions reached in both the EFSA Statement and in the Commission
draft renewal report for the reasons discussed in this letter.

Because of the procedural and scientific concerns, we respectfully but urgently request the Commission to
suspend the decision-making process related to the Substance until the issues raised in this letter have

8
been fully discussed and addressed with the Commission. Doing otherwise would render the final decision
flawed, both from a legal and scientific point of view.

Furthermore, the classification proposal made by EFSA during the peer review may not and should not be
used for concluding on a non-renewal of the Substance under PPPR.

It is important to highlight the fact that the renewal process of the Substance is “an administrative
procedure entailing complex technical evaluations" in which “the respect for the rights guaranteed by the
Community legal order ... is of even more fundamental importance”4. Accordingly, “those guarantees
include ... the right of the person concerned to make his views known"5. Specifically, “the right to be
heard in such an administrative procedure requires that the person concerned should be able, during the
actual procedure before the Commission, to put his own case and properly make his views known on the
relevant circumstances..."6 The principle of fair hearing requires that any legal entity who may be
adversely affected by the adoption of a decision should be placed In a position In which he may effectively
make known his views on the evidence against him which the Commission has taken as the basis for the
decision at Issue.

The Applicant Is requesting a thorough review of all data submitted as part of the renewal process before
a final conclusion can be made. It is therefore particularly important that EFSA and the Commission
assess all the available data, including the possibility to submit confirmatory data, before concluding on
the non-renewal of the Substance. Such an approach is necessary to meet the requirements of the
principle of proportionality.

It is indeed settled case-law that the “principle of proportionality, which is one of the general principles of
European Union law, requires that acts adopted by Community institutions do not exceed the limits of
what is appropriate and necessary in order to attain the legitimate objective pursued by the legislation in
question; where there is a choice between several appropriate measures, recourse must be had to the
least onerous, and the disadvantages caused must not be disproportionate to the aims pursued."7

Finally, we request a meeting with DG Santé in the coming week in order to discuss the above issues. In
that regard, we hope that such a meeting may be facilitated during the first week of September 2019,
when the technical expert will be available to attend and discuss these matters further.

We thank you for your urgent consideration of the points raised in this letter and for a reply at your earliest
convenience.

Yours sincerely,

Koen Van Maldegem

Partner

4 Case C-269/90 Technische Universität München ECLI:EU:C:1991:438 at paragraphs 13 and 14.

5 Case C-269/90 ibid at paragraph 14.
6 Case C-269/90 ibid at paragraph 25.
7 Case C-137/85 Maizena and others [1987] ECR 4587, paragraph 15; Judgment of 3 September 2009 in Case T-326/07 Cheminova and others
paragraph 194 (unreported); Case C-15/10, Etimine SA v Secretary of State for Work and Pensions, EU:C:2011:504, paragraph 124 and the case-
law cited and Case A-005-2011, Honeywell Belgium N.V., Decision of the Board of Appeal of 29 April 2013, paragraphs 115 to 117.

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 BELGIQUE^
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fieldfisher G
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Collect & Stamp

European Commission
DG SANTE
Attn of: Mr. Mark Williams
Unit E4 - Pesticides and Biocides
F101 04/90
B-1049 Brussels
Belgium

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