Ref. Ares(2020)4117196 - 05/08/2020
C(2019) 1063 final
Rue de la Pacification 67
DECISION OF THE EUROPEAN COMMISSION PURSUANT TO ARTICLE 4 OF THE
IMPLEMENTING RULES TO REGULATION (EC) NO 1049/20011
Your confirmatory application for access to documents under
Regulation (EC) No 1049/2001 - GESTDEM 2018/4050
I refer to your letter of 21 August 2018, registered on the same day, in which you
submitted a confirmatory application in accordance with Article 7(2) of Regulation (EC)
No 1049/2001 regarding public access to European Parliament, Council and Commission
documents2 (hereafter ‘Regulation (EC) No 1049/2001’).
SCOPE OF YOUR REQUEST
In your initial application of 25 July 2018, addressed to the Directorate-General for
Health and Food Safety, you requested access to the documents Sulfoxaflor
Nectar and Pollen of Apple_160356, reference Ares(2015)4088967 (hereafter ‘document
1') and Sulfoxaflor
Residues in Nectar and Pollen of Pumpkin_60354, reference
Ares(2015)4088967 (hereafter ’document 2’), containing confirmatory information
concerning the active substance sufloxaflor
, which the applicant had to submit by 18
August 2017 in accordance with Implementing Regulation (EU) 2015/1295 of 27 July
The Directorate-General for Health and Food Safety consulted the third party from which
the requested document originates, Dow AgroSciences
, in accordance with Article 4(4) of
Regulation (EC) No 1049/2001. Following the opposition of Dow AgroSciences
Official Journal L 345 of 29.12.2001, p. 94.
Official Journal L 145 of 31.5.2001, p. 43.
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111
disclosure of the documents, the Directorate-General for Health and Food Safety refused
access to the documents on 7 August 2018, based on Article 4(2), third indent of
Regulation (EC) No 1049/2001 (protection of commercial interests, including intellectual
In your confirmatory application, you request a review of this position. You underpin
your request with detailed arguments, which I address in the corresponding sections
ASSESSMENT AND CONCLUSIONS UNDER REGULATION NO 1049/2001
When assessing a confirmatory application for access to documents submitted pursuant
to Regulation (EC) No 1049/2001, the Secretariat-General conducts a fresh review of the
reply given by the relevant Directorate-General at the initial stage.
In this context, the Secretariat-General re-consulted Dow AgroSciences
, based on Article
4(4) of Regulation (EC) No 1049/2001, with a view to assessing whether an exception in
paragraph 1 or 2 could be applicable to the requested documents, which originate from
that third party.
While Dow AgroSciences
opposed the disclosure of the requested documents based on
Article 4(2), first indent (protection of commercial interests, including intellectual
property), it drew attention to the fact that the decision-making process relating to the
evaluation process of sulfoxaflor
was still ongoing. It specified that the requested
documents were in the process of being evaluated. It also indicated that ‘disclosing the
content of the confirmatory data before the outcome of the evaluation process risk[ed]
seriously undermining this process and preventing regulators from conducting this
process in an objective and non-politicised manner, without external pressure and undue
As to the protection of its commercial interests, Dow AgroSciences
together with its consultant, it had developed proprietary approaches, which were novel
for the conduct of the requested studies and went beyond the generic standards that
existed for only some of the individual stages of the studies.
It also stated that it had, together with its consultant, invested considerable intellectual
expertise in the methodology used, the disclosure of which would allow competitors to
follow the specific approaches, which had been developed. It explained that there were
no specific and common test methods or guidelines for the requested studies. In its view,
this was pure confidential business information –commercially crucial ‘know-how’. It
concluded that, since the requested study was entirely new and unique and had not been
published in any public forum, disclosure would seriously undermine its intellectual
property and commercial interests.
In addition, Dow AgroSciences
claimed that the disclosure of the requested documents
would undermine the confidentiality protection provided for in Article 63 of Regulation
(EC) No 1107/20093, as well as the confidentiality protection stipulated in the guidance
document on the procedures for submission and assessment of confirmatory information
following approval of an active substance in accordance with Regulation (EC) No
Consequently, Dow AgroSciences
fully opposed any disclosure of the requested
Following the confirmatory review and taking into account the reply of Dow
, I can inform you that wide partial access is granted to the requested
documents, subject only to the redactions of personal data. The partial refusal is based on
Article 4(1)(b) (protection of privacy and the integrity of the individual) of Regulation
(EC) No 1049/2001, for the reasons set out below.
Please note, however, that the actual transmission of the documents is subject to the
absence of a request by the third party author, namely Dow AgroSciences,
measures as referred to in paragraph 4.
PROTECTION OF PRIVACY AND THE INTEGRITY OF THE INDIVIDUAL
Article 4(1)(b) of Regulation (EC) No 1049/2001 provides that ‘access to a document is
refused where disclosure would undermine the protection of […] privacy and the
integrity of the individual, in particular in accordance with Community legislation
regarding the protection of personal data’.
In its judgment in Case C-28/08 P (Bavarian Lager)
the Court of Justice ruled that
when a request is made for access to documents containing personal data, Regulation
(EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000
on the protection of individuals with regard to the processing of personal data by the
Community institutions and bodies and on the free movement of such data6
(‘hereafter Regulation (EC) No 45/2001’) becomes fully applicable.
Please note that, as from 11 December 2018, Regulation (EC) No 45/2001 has been
repealed by Regulation (EU) 2018/1725 of the European Parliament and of the Council
of 23 October 2018 on the protection of natural persons with regard to the processing of
personal data by the Union institutions, bodies, offices and agencies and on the free
movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No
1247/2002/EC7 (‘hereafter Regulation (EU) 2018/1725’).
3 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the market and repealing Council Directives
79/117/EEC and 91/414/EEC, Official Journal L 309 of 24.11.2009, p. 1–50.
4 SANCO/5634/2009 rev. 6.1, available here:
5 Judgment of 29 June 2010 in Case C-28/08 P, European Commission v The Bavarian Lager Co. Ltd
EU:C:2010:378, paragraph 59.
6 Official Journal L 8 of 12 January 2001, page 1.
7 Official Journal L 205 of 21.11.2018, p. 39.
However, the case law issued with regard to Regulation No 45/2001 remains relevant for
the interpretation of Regulation (EU) 2018/1725.
In the above-mentioned judgment, the Court stated that Article 4(1)(b) of Regulation
(EC) No 1049/2001 ‘requires that any undermining of privacy and the integrity of the
individual must always be examined and assessed in conformity with the legislation of
the Union concerning the protection of personal data, and in particular with […] [the
Data Protection] Regulation’8.
Article 3(1) of Regulation (EU) 2018/1725 provides that
personal data ‘means any
information relating to an identified or identifiable natural person […]’.
As the Court of Justice confirmed in Case C-465/00 (Rechnungshof
), ‘there is no reason
of principle to justify excluding activities of a professional […] nature from the notion of
The requested documents include names and contact details of natural persons, such as
the names of the authors of the studies or names of natural persons intervening in the
preparation or validation of studies, their signatures or their contact details.
This information clearly constitutes personal data in the sense of Article 3(1) of
Regulation (EU) 2018/1725.
Pursuant to Article 9(1)(b) of Regulation (EU) 2018/1725, ‘personal data shall only be
transmitted to recipients established in the Union other than Union institutions and bodies
if ‘[t]he recipient establishes that it is necessary to have the data transmitted for a specific
purpose in the public interest and the controller, where there is any reason to assume that
the data subject’s legitimate interests might be prejudiced, establishes that it is
proportionate to transmit the personal data for that specific purpose after having
demonstrably weighed the various competing interests’.
Only if these conditions are fulfilled and the processing constitutes lawful processing in
accordance with the requirements of Article 5 of Regulation (EU) 2018/1725, can the
transmission of personal data occur.
In Case C-615/13 P (ClientEarth
), the Court of Justice ruled that the institution does not
have to examine of its own motion the existence of a need for transferring personal
data.10 This is also clear from Article 9(1)(b) of Regulation (EU) 2018/1725, which
requires that the necessity to have the personal data transmitted must be established by
8 Quoted above, paragraph 59.
9 Judgment of 20 May 2003 in Joined Cases C-465/00, C-138/01 and C-139/01, preliminary rulings in
proceedings between Rechnungshof and Österreichischer Rundfunk
, EU:C:2003:294, paragraph 73.
10 Judgment of 16 July 2015 in Case C-615/13 P, ClientEarth v European Food Safety Agency,
EU:C:2015:489, paragraph 47.
According to Article 9(1)(b) of Regulation (EU) 2018/1725, the European Commission
has to examine the further conditions for the lawful processing of personal data only if
the first condition is fulfilled, namely if the recipient establishes that it is necessary to
have the data transmitted for a specific purpose in the public interest. It is only in this
case that the European Commission has to examine whether there is a reason to assume
that the data subject’s legitimate interests might be prejudiced and, in the affirmative,
establish the proportionality of the transmission of the personal data for that specific
purpose after having demonstrably weighed the various competing interests.
In your confirmatory application, you assert that ‘[t]he functioning of ecosystems we all
depend on is a public interest’ and that there is ‘an overriding public interest in the
process of approval of new insecticides such as sufloxaflor
and the data it is based on’.
However, you do not refer in any way to the personal data included in the requested
studies, nor do you put forward any arguments to establish the necessity to have the
personal data included in the documents transmitted for a specific purpose in the public
interest. Therefore, the European Commission does not have to examine whether there is
a reason to assume that the data subject’s legitimate interests might be prejudiced.
Notwithstanding the above, there are reasons to assume that the legitimate interests of the
data subjects concerned would be prejudiced by the disclosure of the personal data
reflected in the documents, as there is a real and non-hypothetical risk that such public
disclosure would harm their privacy and subject them to unsolicited external contacts.
As to the handwritten signatures appearing in the requested studies, which constitute
biometric data, there is a risk that their disclosure would prejudice the legitimate interests
of the persons concerned.
Consequently, I conclude that, pursuant to Article 4(1)(b) of Regulation (EC) No
1049/2001, access cannot be granted to the personal data, as the need to obtain access
thereto for a purpose in the public interest has not been substantiated and there is no
reason to think that the legitimate interests of the individuals concerned would not be
prejudiced by the disclosure of the personal data concerned.
I would also like to point out that Article 4(1)(b) has an absolute character and does not
envisage the possibility of demonstrating the existence of an overriding public interest.
DISCLOSURE AGAINST THE EXPLICIT OPINION OF THE AUTHOR
According to Article 5(5) and (6) of Commission Decision of 5 December 2001
amending its rules of procedure11, ‘[t]he third-party author consulted shall have a
deadline for reply which shall be no shorter than five working days but must enable the
Commission to abide by its own deadlines for reply. In the absence of an answer within
the prescribed period, or if the third party is untraceable or not identifiable, the
11 Commission Decision of 5 December 2001 amending its rules of procedure (notified under document
number C(2001) 3714), Official Journal of 29.12.2001, L 345, p. 94.
Commission shall decide in accordance with the rules on exceptions in Article 4 of
Regulation (EC) No 1049/2001, taking into account the legitimate interests of the third
party on the basis of the information at its disposal. If the Commission intends to give
access to a document against the explicit opinion of the author, it shall inform the author
of its intention to disclose the document after a ten-working day period and shall draw his
attention to the remedies available to him to oppose disclosure.’
At initial and confirmatory level, Dow AgroSciences
objected to the disclosure of the
requested documents on the grounds that it would undermine the protection of its
commercial interests, including intellectual property and the decision-making process.
The European Commission informed the applicant that, according to Article 4(4) of
Regulation (EC) No 1049/2001, a third party, other than a Member State, is consulted
with a view to assessing whether an exception in paragraph 1 or 2 is applicable. The
exception of Article 4(3) of Regulation (EC) No 1049/2001 cannot be invoked by a third
party other than a Member State. Furthermore, the European Commission does not
consider that its decision-making process would be seriously undermined by the
disclosure of the requested studies. As to the exception relating to the protection of the
commercial interests, including intellectual property, of Dow AgroSciences,
detailed examination of the requested studies, the European Commission concluded that
these interests would not be undermined by disclosure at this stage. It also concluded
that, even if it could be considered that public disclosure at this stage would undermine
the protection of the commercial interests, including intellectual property, of Dow
, such disclosure is justified, as there is an overriding public interest in its
Since the decision to grant wide access is taken against the objection of the third party
author expressed at initial and confirmatory level, the European Commission will inform
the third-party author of its decision to give wide partial access to the documents
requested. The European Commission will not grant such partial disclosure until a period
of ten working days has elapsed from the formal notification of this decision to the third
party author, in accordance with the provisions mentioned above.
This time period will allow the third party author to inform the European Commission of
whether it will object to the partial disclosure using the remedies available to it, i.e. an
application for annulment and an application for interim measures before the General
Court. Once this period has elapsed, and if the third party author has not signalled its
intention to avail itself of the remedies at its disposal, the European Commission will
forward the redacted documents to you.
MEANS OF REDRESS
Finally, I draw your attention to the means of redress available against this decision. You
may either bring proceedings before the General Court or file a complaint with the
European Ombudsman under the conditions specified respectively in Articles 263 and
228 of the Treaty on the Functioning of the European Union.
For the Commission