Nous ne savons pas si la réponse la plus récente à cette demande contient l'information ou non – si vous etes Vincent Harmsen veuillez vous connecter et laisser nous savoir.

Glyphosate, the European Commission and the EPA

Vincent Harmsen a fait une demande de Accès à l'information à Autorité européenne de sécurité des aliments

Automatic anti-spam measures are in place for this older request. Please let us know if a further response is expected or if you are having trouble responding.

Nous attendons Vincent Harmsen de lire les réponses récentes et mettre à jour le statut.

Vincent Harmsen

Dear European Food Safety Authority,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:

-All correspondence (including letters, emails, text messages, whatsapp messages, etc), agendas, minutes of meetings, minutes of phone calls, and/or any other reports of such communications, where the active substance glyphosate, and/or the (process of the) regulatory review (risk assessment, peer review, etc) of glyphosate in the EU and/or the US, was discussed/mentioned/referred to by representatives/officials of EFSA and representatives/officials of the following organizations:

-the United States Environmental Protection Agency (US EPA)
-the Secretariat-General of the European Commission (SG)
-the Directorate-General for Health and Food Safety of the European Commission (DG SANTE)

Timeframe of this request: Between September 2014 and February 2016.

When representatives/officials of EFSA are mentioned in this request, this includes all leadership/management positions. When representatives/officials of the EPA are mentioned in this request, this includes all leadership/management positions. When representatives/officials of DG SANTE and the SG are mentioned in this request, this includes the Commissioner, the Commission President, and their Cabinet members.

Do not hesitate to get back to me should you need any further information which could facilitate your research.

Yours faithfully,
Vincent Harmsen

Dear European Food Safety Authority,

Did you receive my email in good order?

My previous writing did not include my postal address. Also, for clarification purposes, I’ve made one minor adjustment to the text of my request for access to documents.

Could you confirm registration of the request below?

Thank you,
Vincent Harmsen
-------
-------
Dear European Food Safety Authority,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:

-All correspondence (including letters, emails, text messages, whatsapp messages, etc), agendas, minutes of meetings, minutes of phone calls, and/or any other reports of such communications, where the active substance glyphosate, and/or the (process of the) regulatory review (risk assessment, peer review, etc) of glyphosate in the EU and/or the US, was discussed/mentioned/referred to between representatives/officials of EFSA and representatives/officials of the following organizations:

-the United States Environmental Protection Agency (US EPA)
-the Secretariat-General of the European Commission (SG)
-the Directorate-General for Health and Food Safety of the European Commission (DG SANTE)

Timeframe of this request: Between September 2014 and February 2016.

When representatives/officials of EFSA are mentioned in this request, this includes all leadership/management positions. When representatives/officials of the EPA are mentioned in this request, this includes all leadership/management positions. When representatives/officials of DG SANTE and the SG are mentioned in this request, this includes the Commissioner, the Commission President, and their Cabinet members.

Do not hesitate to get back to me should you need any further information which could facilitate your research.

Yours faithfully,
Vincent Harmsen

Postal address:
[ADDRESS REDACTED]
[ADDRESS REDACTED]
[ADDRESS REDACTED]

EFSA.public.access.to.documents, Autorité européenne de sécurité des aliments

4 Attachments

Dear Mr Harmsen,

 

I hereby acknowledge receipt of your e-mail of 06 July 2020, clarifying
your e-mail of 27 June 2020, by means of which you request access to
“documents which contain the following information:

 

-All correspondence (including letters, emails, text messages, whatsapp
messages, etc), agendas, minutes of meetings, minutes of phone calls,
and/or any other reports of such communications, where the active
substance glyphosate, and/or the (process of the) regulatory review (risk
assessment, peer review, etc) of glyphosate in the EU and/or the US, was
discussed/mentioned/referred to between representatives/officials of EFSA
and representatives/officials of the following organizations:

 

-the United States Environmental Protection Agency (US EPA) -the
Secretariat-General of the European Commission (SG) -the
Directorate-General for Health and Food Safety of the European Commission
(DG SANTE)”.

 

You further specify that the timeframe of your request is “[b]etween
September 2014 and February 2016”.

 

Finally, you note that:

 

“When representatives/officials of EFSA are mentioned in this request,
this includes all leadership/management positions. When
representatives/officials of the EPA are mentioned in this request, this
includes all leadership/management positions. When
representatives/officials of DG SANTE and the SG are mentioned in this
request, this includes the Commissioner, the Commission President, and
their Cabinet members.”

 

Your request has been registered as an application for access to documents
with EFSA’s reference PAD 2020/078 on the date of receipt of your e-mail
of 06 July 2020 clarifying your e-mail of 27 June 200 and is being
processed as quickly as possible in accordance with [1]Regulation (EC) No
1049/2001 regarding public access to documents.

 

We will revert to you by 27 July 2020 at the latest.

 

 

Yours sincerely,

 

Mariama Mesnaoui

Public Access to documents Team

Legal and Assurance Services

 

Via Carlo Magno 1A

IT-43126 Parma
Italy

[2]www.efsa.europa.eu

[3]twitter.com/EFSA_EU [4]Twitter_logo_blue

[5]youtube.com/EFSAchannel [6]YouTube-logo-full_color

[7]linkedin.com/company/efsa [8][IMG]

 

This e-mail, including its attachments, is intended only for the use of
the recipient(s) named above. Unless you are a named recipient (or
authorized by a recipient), access to this e-mail message or any
disclosure or copying of its content, or any action taken in reliance on
it is unauthorized and may be unlawful.  If you are not the intended
recipient, please let the sender know immediately.

 

 

 

 

 

 

Afficher les sections citées

EFSA.public.access.to.documents, Autorité européenne de sécurité des aliments

4 Attachments

Dear Mr Harmsen,

 

Further to our e-mail of 7 July 2020, by means of which we acknowledged
receipt of your request for public access to documents with EFSA’s
reference PAD 2020/076, I would like to reiterate that your request is
being processed as quickly as possible in accordance with the provisions
of [1]Regulation (EC) No 1049/2001 regarding public access to documents.

 

However, we regret to inform you that due to the fact that EFSA is still
in the process of clarifying the confidential status of the requested
documents, we have to extend the deadline by 15 working days in accordance
with Article 7(3) of Regulation (EC) No 1049/2001. Please accept our
apologies for any inconvenience caused by this delay.

 

We will revert to you by 17 August 2020 at the latest.

 

 

Yours sincerely,

 

Mariama Mesnaoui

Public Access to documents Team

Legal and Assurance Services

 

Via Carlo Magno 1A

IT-43126 Parma
Italy

Tel. +39 0521036264 
[2][email address] 
[3]www.efsa.europa.eu

[4]twitter.com/EFSA_EU [5]Twitter_logo_blue

[6]youtube.com/EFSAchannel [7]YouTube-logo-full_color

[8]linkedin.com/company/efsa [9][IMG]

 

This e-mail, including its attachments, is intended only for the use of
the recipient(s) named above. Unless you are a named recipient (or
authorized by a recipient), access to this e-mail message or any
disclosure or copying of its content, or any action taken in reliance on
it is unauthorized and may be unlawful.  If you are not the intended
recipient, please let the sender know immediately.

 

 

 

 

From: MESNAOUI Mariama <[10][email address]> On Behalf Of
EFSA.public.access.to.documents
Sent: 07 July 2020 18:11
To: [11][FOI #8255 email]
Cc: EFSA.public.access.to.documents
<[12][email address]>
Subject: PAD 2020_076_Acknowledgement of receipt_Your request of 06 July
2020

 

Dear Mr Harmsen,

 

I hereby acknowledge receipt of your e-mail of 06 July 2020, clarifying
your e-mail of 27 June 2020, by means of which you request access to
“documents which contain the following information:

 

-All correspondence (including letters, emails, text messages, whatsapp
messages, etc), agendas, minutes of meetings, minutes of phone calls,
and/or any other reports of such communications, where the active
substance glyphosate, and/or the (process of the) regulatory review (risk
assessment, peer review, etc) of glyphosate in the EU and/or the US, was
discussed/mentioned/referred to between representatives/officials of EFSA
and representatives/officials of the following organizations:

 

-the United States Environmental Protection Agency (US EPA) -the
Secretariat-General of the European Commission (SG) -the
Directorate-General for Health and Food Safety of the European Commission
(DG SANTE)”.

 

You further specify that the timeframe of your request is “[b]etween
September 2014 and February 2016”.

 

Finally, you note that:

 

“When representatives/officials of EFSA are mentioned in this request,
this includes all leadership/management positions. When
representatives/officials of the EPA are mentioned in this request, this
includes all leadership/management positions. When
representatives/officials of DG SANTE and the SG are mentioned in this
request, this includes the Commissioner, the Commission President, and
their Cabinet members.”

 

Your request has been registered as an application for access to documents
with EFSA’s reference PAD 2020/078 on the date of receipt of your e-mail
of 06 July 2020 clarifying your e-mail of 27 June 200 and is being
processed as quickly as possible in accordance with [13]Regulation (EC) No
1049/2001 regarding public access to documents.

 

We will revert to you by 27 July 2020 at the latest.

 

 

Yours sincerely,

 

Mariama Mesnaoui

Public Access to documents Team

Legal and Assurance Services

 

Via Carlo Magno 1A

IT-43126 Parma
Italy

[14]www.efsa.europa.eu

[15]twitter.com/EFSA_EU [16]Twitter_logo_blue

[17]youtube.com/EFSAchannel [18]YouTube-logo-full_color

[19]linkedin.com/company/efsa [20][IMG]

 

This e-mail, including its attachments, is intended only for the use of
the recipient(s) named above. Unless you are a named recipient (or
authorized by a recipient), access to this e-mail message or any
disclosure or copying of its content, or any action taken in reliance on
it is unauthorized and may be unlawful.  If you are not the intended
recipient, please let the sender know immediately.

 

 

 

 

 

 

Afficher les sections citées

EFSA.public.access.to.documents, Autorité européenne de sécurité des aliments

 

Parma, 18 August 2020

Ref. DD/MH/mm (2020) - out-23704020

 

Vincent Harmsen

[ADDRESS REDACTED]

NL-[ADDRESS REDACTED]

[ADDRESS REDACTED]

 

E-mail: [1][FOI #8255 email]

 

                                                                                                                               

Re.:       Your request for public access to documents of 6 July 2020
 Ref. PAD 2020/076

 

Dear Mr Harmsen,

 

I refer to your e-mail of 6 July 2020, clarifying your e-mail of 27 June
2020, by means of which you requested access to “documents which contain
the following information:

 

“-All correspondence (including letters, emails, text messages, whatsapp
messages, etc), agendas, minutes of meetings, minutes of phone calls,
and/or any other reports of such communications, where the active
substance glyphosate, and/or the (process of the) regulatory review (risk
assessment, peer review, etc) of glyphosate in the EU and/or the US, was
discussed/mentioned/referred to between representatives/officials of EFSA
and representatives/officials of the following organizations:

 

-the United States Environmental Protection Agency (US EPA) -the
Secretariat-General of the European Commission (SG) -the
Directorate-General for Health and Food Safety of the European Commission
(DG SANTE).”

 

Moreover, as you further indicated, the timeframe concerned by your
application is between September 2014 and February 2016.

 

Your application is being processed in accordance with [2]Regulation (EC)
No 1049/2001 (hereinafter “the PAD Regulation”). In view of the very large
number of documents to which your application relates, we would like to
confer with you with a view to handling your application in successive
stages, allowing for a detailed assessment on the accessibility of each of
the documents falling within the scope of your application in accordance
with Article 6(3) of the PAD Regulation. By means of this e-mail, we are
pleased to provide you with a reply concerning the accessibility of a
first batch of documents falling within the scope of your application for
access to documents insofar as it concerns the retrieved documents “where
the active substance glyphosate, and/or the (process of the) regulatory
review (risk assessment, peer review, etc) of glyphosate in the EU and/or
the US, was discussed/mentioned/referred to between
representatives/officials of EFSA and representatives/officials of […] the
Directorate-General for Health and Food Safety of the European Commission
(DG SANTE). EFSA commits to revert to you with a complementary reply on 7
September 2020 at the latest. 

 

 1. Partial Disclosure – first batch

 

We are pleased to provide you with partial access to a first set of
documents as listed below (by chronological order):

 

+ “Glyphosate (AIR II) - additional information - call for comments” the
e-mail sent by EFSA to the Member States circulating various documents
for comments via a written procedure after EFSA identified data
requirements in relation to the physical and chemical properties,
mammalian toxicology, residues, fate and behaviour and
ecotoxicological section risk assessment;
+ “Request to consider findings by IARC”: a letter sent by EFSA to the
European Commission in reply to a letter of the European Commission
providing EFSA with a mandate to take into account in the ongoing peer
review of glyphosate the findings of IARC;
+ “Request for a technical and scientific assistance”: a letter sent by
EFSA to the European Commission containing the outcome of the
assessment of the scientific content of the technical background of
TestBiotech’s complaint on oilseed rape MON88302;
+ “FW Regulation (EC) No 10492001 - Consultation on access to”: an
e-mail exchange between EFSA and the European Commission in the
context of a consultation relating to a public access to documents
application received by the European Commission;
+ “EFSA peer review of the active substance glyphosate”: a letter sent
by EFSA to the European Commission to seek their agreement to extend
the deadline for finalising the EFSA Conclusion;
+ “PESTICIDE RISK ASSESSMENT PEER REVIEW - GLYPHOSATE ADDENDUM - CALL

FOR COMMENTS”: an e-mail sent by EFSA to Member States, the European
Commission (DG SANTE) and the European Chemicals Agency circulating the
addendum to the Renewal Assessment Report (RAR) for comments via a written
procedure;

+ “EFSA PROGRESS REPORT (01 June to 15 September 2015)”;
+ “EFSA new questions of the mandates accepted in the last trimester”: a
document containing the list of EFSA’s new questions of the mandates
with the reference period 26/5/2015-30/09/2015;
+ “EFSA Strategy 2020 - MB meeting (03 December 2015)”: a document
containing a presentation of the EFSA Strategy 2020 delivered on the
Management Board Meeting on 3 December 2015;
+ “EFSA PROGRESS REPORT (01 October to 15 November 2015)”;
+ “Forthcoming RA activities”: a document containing a list of the
forthcoming risk assessment activities with the reference period
27/09/2015-01/12/2015;
+ “RE_Glyphosate_PAN response to the EFSA open letter”: an e-mail
exchange between EFSA and the European Commission regarding an e-mail
received by the European Commission from the NGO Pesticide Action
Network (PAN) Germany in response to the EFSA open letter addressing
the open letter of Professor Cristopher Portier.

 

 2. Personal data protection and reproduction of the documents released

Please kindly note that any personal data present in the documents
released to you (i.e. names, contact details and information allowing the
direct and/or indirect identification of data subjects) have been masked
in accordance with Article 4(1)(b) of the PAD Regulation. This provision
provides that EU bodies shall refuse access to a document where the
disclosure would undermine the protection of the "privacy and the
integrity of the individual, in particular in accordance with Community
legislation regarding the protection of personal data". In accordance with
settled case-law of the Court of Justice of the European Union (CJEU),
this exception to disclosure is to be interpreted as a reference to
Regulation (EC) No 45/2001 - now repealed by [3]Regulation (EU) 2018/1725
(hereinafter "the Data Protection Regulation") - which becomes applicable
in its entirety.

As concerns the transmissions of personal data, Article 9(1)(b) of the
Data Protection Regulation provides that "personal data shall only be
transmitted to recipients established in the Union (...) if the recipient
establishes that it is necessary to have the data transmitted for a
specific purpose in the public interest". In application of this
provision, further clarified in the case law of the CJEU^6, EFSA shall
determine whether there is any reason to assume that a transmission of the
personal data might prejudice the legitimate interests of the concerned
individuals and to balance the different interests at stake, based on any
express and legitimate justification and convincing arguments you may be
able to provide in order to demonstrate that it is necessary for you to
receive these data for a specific purpose in the public interest within
the meaning of the afore-mentioned provision. Hence, only in the event
that you are interested in receiving the personal data, EFSA invites you
to submit to us your arguments as to why you consider it necessary to
receive these data in accordance with Article 9(1)(b) of the Data
Protection Regulation.

We hope you find the disclosed documents useful. I must remind you that,
in line with Article 16 of the PAD Regulation, all persons reproducing,
redistributing, exploiting or making commercial use of this information
are expected to adhere to the terms and conditions asserted by any holder
of copyright.

 3. Confirmatory application

 

To exercise your right to appeal against this decision of partial
disclosure by a confirmatory application, you may write to EFSA at the
address below. You have fifteen working days from receipt of this e-mail
to appeal. Please note that you can also exercise your right to appeal
against this decision after your request for public access to documents
has been fully addressed, i.e. after the final reply to your pending
request has been sent to you. In case you submit a confirmatory
application, EFSA will inform you of the outcome of the re-examination of
your request within fifteen working days of receipt. In case the
re-examination results in a confirmation of the present partial
disclosure, you will also be informed of any further appeal routes
available.

 

Your confirmatory application must be sent to:

 

EFSA - Bernhard Url, Executive Director

Via Carlo Magno 1/A

IT– 43126 Parma

Italy
E-mail: [4][email address]

 

 

Yours sincerely,

 

Luisa Venier

EFSA Public access to documents team

Legal and assurance services Unit

 

 

 

 

 

 

References

Visible links
1. mailto:[FOI #8255 email]
2. https://eur03.safelinks.protection.outlo...
3. https://eur03.safelinks.protection.outlo...
4. mailto:[email address]

EFSA.public.access.to.documents, Autorité européenne de sécurité des aliments

Parma, 09 December 2020

Ref. DD/MH/mm (2020) - out-24115098

 

Vincent Harmsen

[ADDRESS REDACTED]

NL-[ADDRESS REDACTED]

[ADDRESS REDACTED]

 

E-mail: [1][FOI #8255 email]

 

                                                                                                                               

Re.:       Your application for public access to documents of 09 September
2020
 Ref. PAD 2020/104

 

Dear Mr Harmsen,

 

I refer to your e-mail of 09 September 2020 by means of which you
requested access to:

 

“all correspondence (including letters, emails and text messages),
agendas, minutes of meetings, minutes of phone calls, reports and any kind
of other documents, where the German laboratory LPT (Laboratory of
Pharmacology and Toxicology) was discussed/mentioned/referred to,
especially, but not exclusively, in relation to possible fraud/forgery of
test data and/or mistreatment of test animals. Time frame of this request:
Between December 1st 2018 and September 1st 2020.”

 

Your application is being processed in accordance with [2]Regulation (EC)
No 1049/2001 (hereinafter “the PAD Regulation”). In view of the fact that
your application relates to documents originating with multiple third
parties who have to be consulted in accordance with Article 4(4) of the
PAD Regulation, we would like to confer with you with a view to handling
your application in successive stages, allowing for a detailed assessment
on the accessibility of each of the documents falling within the scope of
your application in accordance with Article 6(3) of the PAD Regulation. By
means of this e-mail, we are pleased to provide you with a reply
concerning the accessibility of a first batch of documents held by EFSA
and identified as falling within the scope of your application for access
to documents. EFSA commits to revert to you with a complementary reply on
06 January 2021 at the latest. 

 

 1. Partial Disclosure – first batch

 

We are pleased to provide you with partial access to a first set of
documents as listed below (by chronological order):

 

* “RE: Heads-up: GLOBAL 2000 report on glyphosate” – a sequence of
EFSA-internal e-mails of 11 February 2020 anticipating and reporting on
media coverage and stakeholder statements regarding alleged violations
of GLP standards and animal welfare rules by the Laboratory of
Pharmacology and Toxicology GmbH & Co. KG (hereinafter “the LPT case”).
Please note that the attached news article “Germany’s _ death lab_ also
testing glyphosate” is not disclosed to you in application of Article
4(2), first indent, of the PAD Regulation regarding the protection of
commercial interests of a natural or legal person, including
intellectual property rights. Access to this article is reserved for
subscribers of Le Monde and you may obtain access thereto subject to the
terms and rights asserted by the copyright holder.

 

 1. “Tierschutzbestimmungen und Gute Laborpraxis: Bundesländer prüfen
mögliche Verstöße eines Tierversuchslabors“ – a statement dated 11
February 2020 from the Federal Institute for Risk Assessment in
Germany regarding the LPT case. To ease your reading, we also provide
you with a version of the statement that was electronically translated
into English.

 

 2. “Global 2000 Report LTTs” – an internal draft position paper of 16
February 2020 (i) providing background information on the LPT case,
(ii) documenting the outcome of EFSA’s own internal check regarding
the impact of the LPT case on the risk  assessment underlying the
renewal of the active substance glyphosate, (iii) detailing EFSA’s
position with regard to the concerns raised in the LPT case, and (iv)
highlighting the potential of so-called fact-finding missions
performed by the European Commission – a novel mechanism introduced
via Article 61a of Regulation (EU) 2019/1381 – to tackle incompliances
such as those allegedly committed in the LPT case.

 

 3. “AGRI_Committee_Meeting (1).mp4” – an excerpt of a video recording of
the proceedings of the European Parliament Committee on Agriculture
and Rural Development of 18 February 2020 featuring a statement of
EFSA’s Executive Director Bernhard Url on the LPT case;

 

 2. Personal data protection and reproduction of the documents released

Personal data present in the documents disclosed to you have been masked
in application of the exception to disclosure in Article 4(1)(b) of the
PAD Regulation. In accordance with settled case law of the Court of
Justice of the European Union (CJEU), this exception to disclosure is to
be interpreted with reference to Regulation (EU) 2018/1725 (hereinafter
“the EUDPR”). Article 9(1)(b) of the EUDPR deals with personal data
transmissions to recipients established in the Union. Taking account of
the case law referred to above, EFSA will only be able to balance the
interests at stake and to consider the disclosure of personal data after
you have provided an express and legitimate justification and convincing
arguments in order to demonstrate the necessity of having personal data
transmitted to you in the sense of Article 9(1)(b) (‘necessity test’).

Considering that personal data is redacted manually by EFSA, we cannot
fully exclude the possibility that certain personal data are inadvertently
disclosed to you. Should this be the case, we urge you to treat any such
residual personal data with the utmost discretion in order to avoid
undermining the privacy and integrity of the individual(s) concerned.

We hope you find the disclosed documents useful. I must remind you that,
in line with Article 16 of the PAD Regulation, all persons reproducing,
redistributing, exploiting or making commercial use of this information
are expected to adhere to the terms and conditions asserted by any holder
of copyright.

 3. Confirmatory application

 

To exercise your right to appeal against this decision of partial
disclosure by a confirmatory application, you may write to EFSA at the
address below. You have fifteen working days from receipt of this e-mail
to appeal. Please note that you can also exercise your right to appeal
against this decision after your request for public access to documents
has been fully addressed, i.e. after the final reply to your pending
request has been sent to you. In case you submit a confirmatory
application, EFSA will inform you of the outcome of the re-examination of
your request within fifteen working days of receipt. In case the
re-examination results in a confirmation of the present partial
disclosure, you will also be informed of any further appeal routes
available.

 

Your confirmatory application must be sent to:

 

EFSA - Bernhard Url, Executive Director

Via Carlo Magno 1/A

IT– 43126 Parma

Italy
E-mail: [3][email address]

 

 

Yours sincerely,

 

Luisa Venier

EFSA Public access to documents team

Legal and assurance services Unit

 

 

 

References

Visible links
1. mailto:[FOI #8255 email]
2. https://eur03.safelinks.protection.outlo...
3. mailto:[email address]

EFSA.public.access.to.documents, Autorité européenne de sécurité des aliments

Parma, 06 January 2021

Ref. DD/MH/mm (2021) – out-24272792

 

Vincent Harmsen

[ADDRESS REDACTED]

NL-[ADDRESS REDACTED]

[ADDRESS REDACTED]

 

E-mail: [1][FOI #8255 email]   

 

 

 

Re:             Your request for public access to documents of 09
September 2020

                   Our ref.: PAD 2020/104

 

 

Dear Mr Harmsen,

 

 

Further to our e-mail of 09 December 2020, by means of which we disclosed
a first batch of documents in reply to your application for public access
to documents registered at EFSA as PAD 2020/104, we would like to reassure
you that your application is being processed as quickly as possible in
accordance with the provisions of [2]Regulation (EC) No 1049/2001 on
public access to documents (hereinafter “the PAD Regulation”).

 

However, please note that the assessment on the accessibility of the
remaining documents within the scope of your application, including via
consultations with the relevant third parties, has not been completed yet.
Accordingly, we would like to confer with you with a view to finding a
fair solution pursuant to Article 6(3) of the PAD Regulation to provide
you with a reply on the accessibility of the remaining documents within
the scope of your application as soon as possible and by 27 January 2021
at the latest. Please accept our apologies for any inconveniences caused
by this delay.

 

Should you require any information or clarification in the meantime,
please do not hesitate to contact us by writing to the following
functional mailbox: [3][Emailadresse].

 

Yours sincerely,

 

 

Luisa Venier

EFSA Public Access to Documents team

Legal & Assurance Services / Business Services Department

 

 

 

 

From: VENIER Luisa <[4][Emailadresse]> On Behalf Of
EFSA.public.access.to.documents
Sent: Wednesday 9 December 2020 18:55
To: [5][FOI #8255 email]
Cc: EFSA.public.access.to.documents
<[6][Emailadresse]>
Subject: PAD 2020/0104_Disclosure_First batch_Your application for public
access to documents of 09 September 2020

 

Parma, 09 December 2020

Ref. DD/MH/mm (2020) - out-24115098

 

Vincent Harmsen

[ADDRESS REDACTED]

NL-[ADDRESS REDACTED]

[ADDRESS REDACTED]

 

E-mail: [7][FOI #8255 email]

 

                                                                                                                               

Re.:       Your application for public access to documents of 09 September
2020
 Ref. PAD 2020/104

 

Dear Mr Harmsen,

 

I refer to your e-mail of 09 September 2020 by means of which you
requested access to:

 

“all correspondence (including letters, emails and text messages),
agendas, minutes of meetings, minutes of phone calls, reports and any kind
of other documents, where the German laboratory LPT (Laboratory of
Pharmacology and Toxicology) was discussed/mentioned/referred to,
especially, but not exclusively, in relation to possible fraud/forgery of
test data and/or mistreatment of test animals. Time frame of this request:
Between December 1st 2018 and September 1st 2020.”

 

Your application is being processed in accordance with [8]Regulation (EC)
No 1049/2001 (hereinafter “the PAD Regulation”). In view of the fact that
your application relates to documents originating with multiple third
parties who have to be consulted in accordance with Article 4(4) of the
PAD Regulation, we would like to confer with you with a view to handling
your application in successive stages, allowing for a detailed assessment
on the accessibility of each of the documents falling within the scope of
your application in accordance with Article 6(3) of the PAD Regulation. By
means of this e-mail, we are pleased to provide you with a reply
concerning the accessibility of a first batch of documents held by EFSA
and identified as falling within the scope of your application for access
to documents. EFSA commits to revert to you with a complementary reply on
06 January 2021 at the latest. 

 

 1. Partial Disclosure – first batch

 

We are pleased to provide you with partial access to a first set of
documents as listed below (by chronological order):

 

* “RE: Heads-up: GLOBAL 2000 report on glyphosate” – a sequence of
EFSA-internal e-mails of 11 February 2020 anticipating and reporting on
media coverage and stakeholder statements regarding alleged violations
of GLP standards and animal welfare rules by the Laboratory of
Pharmacology and Toxicology GmbH & Co. KG (hereinafter “the LPT case”).
Please note that the attached news article “Germany’s _ death lab_ also
testing glyphosate” is not disclosed to you in application of Article
4(2), first indent, of the PAD Regulation regarding the protection of
commercial interests of a natural or legal person, including
intellectual property rights. Access to this article is reserved for
subscribers of Le Monde and you may obtain access thereto subject to the
terms and rights asserted by the copyright holder.

 

 1. “Tierschutzbestimmungen und Gute Laborpraxis: Bundesländer prüfen
mögliche Verstöße eines Tierversuchslabors“ – a statement dated 11
February 2020 from the Federal Institute for Risk Assessment in
Germany regarding the LPT case. To ease your reading, we also provide
you with a version of the statement that was electronically translated
into English.

 

 2. “Global 2000 Report LTTs” – an internal draft position paper of 16
February 2020 (i) providing background information on the LPT case,
(ii) documenting the outcome of EFSA’s own internal check regarding
the impact of the LPT case on the risk  assessment underlying the
renewal of the active substance glyphosate, (iii) detailing EFSA’s
position with regard to the concerns raised in the LPT case, and (iv)
highlighting the potential of so-called fact-finding missions
performed by the European Commission – a novel mechanism introduced
via Article 61a of Regulation (EU) 2019/1381 – to tackle incompliances
such as those allegedly committed in the LPT case.

 

 3. “AGRI_Committee_Meeting (1).mp4” – an excerpt of a video recording of
the proceedings of the European Parliament Committee on Agriculture
and Rural Development of 18 February 2020 featuring a statement of
EFSA’s Executive Director Bernhard Url on the LPT case;

 

 2. Personal data protection and reproduction of the documents released

Personal data present in the documents disclosed to you have been masked
in application of the exception to disclosure in Article 4(1)(b) of the
PAD Regulation. In accordance with settled case law of the Court of
Justice of the European Union (CJEU), this exception to disclosure is to
be interpreted with reference to Regulation (EU) 2018/1725 (hereinafter
“the EUDPR”). Article 9(1)(b) of the EUDPR deals with personal data
transmissions to recipients established in the Union. Taking account of
the case law referred to above, EFSA will only be able to balance the
interests at stake and to consider the disclosure of personal data after
you have provided an express and legitimate justification and convincing
arguments in order to demonstrate the necessity of having personal data
transmitted to you in the sense of Article 9(1)(b) (‘necessity test’).

Considering that personal data is redacted manually by EFSA, we cannot
fully exclude the possibility that certain personal data are inadvertently
disclosed to you. Should this be the case, we urge you to treat any such
residual personal data with the utmost discretion in order to avoid
undermining the privacy and integrity of the individual(s) concerned.

We hope you find the disclosed documents useful. I must remind you that,
in line with Article 16 of the PAD Regulation, all persons reproducing,
redistributing, exploiting or making commercial use of this information
are expected to adhere to the terms and conditions asserted by any holder
of copyright.

 3. Confirmatory application

 

To exercise your right to appeal against this decision of partial
disclosure by a confirmatory application, you may write to EFSA at the
address below. You have fifteen working days from receipt of this e-mail
to appeal. Please note that you can also exercise your right to appeal
against this decision after your request for public access to documents
has been fully addressed, i.e. after the final reply to your pending
request has been sent to you. In case you submit a confirmatory
application, EFSA will inform you of the outcome of the re-examination of
your request within fifteen working days of receipt. In case the
re-examination results in a confirmation of the present partial
disclosure, you will also be informed of any further appeal routes
available.

 

Your confirmatory application must be sent to:

 

EFSA - Bernhard Url, Executive Director

Via Carlo Magno 1/A

IT– 43126 Parma

Italy
E-mail: [9][Emailadresse]

 

 

Yours sincerely,

 

Luisa Venier

EFSA Public access to documents team

Legal and assurance services Unit

 

 

 

References

Visible links
1. mailto:[FOI #8255 email]
2. https://eur03.safelinks.protection.outlo...
3. mailto:[Emailadresse]
4. mailto:[Emailadresse]
5. mailto:[FOI #8255 email]
6. mailto:[Emailadresse]
7. mailto:[FOI #8255 email]
8. https://eur03.safelinks.protection.outlo...
9. mailto:[Emailadresse]

EFSA.public.access.to.documents, Autorité européenne de sécurité des aliments

Parma, 13 January 2021

Ref. DD/MH/mm (2021) - out-24302987

 

Vincent Harmsen

[ADDRESS REDACTED]

NL-[ADDRESS REDACTED]

[ADDRESS REDACTED]

 

E-mail: [1][FOI #8255 email]

 

 

Re.:      Your request for public access to documents of 6 July 2020
Ref. PAD 2020/076

 

Dear Mr Harmsen,

 

I refer to your e-mail of 6 July 2020, clarifying your e-mail of 27 June
2020, by means of which you requested access to “documents which contain
the following information:

 

“-All correspondence (including letters, emails, text messages, whatsapp
messages, etc), agendas, minutes of meetings, minutes of phone calls,
and/or any other reports of such communications, where the active
substance glyphosate, and/or the (process of the) regulatory review (risk
assessment, peer review, etc) of glyphosate in the EU and/or the US, was
discussed/mentioned/referred to between representatives/officials of EFSA
and representatives/officials of the following organizations:

 

-the United States Environmental Protection Agency (US EPA) -the
Secretariat-General of the European Commission (SG) -the
Directorate-General for Health and Food Safety of the European Commission
(DG SANTE).”

 

You further indicate that the timeframe concerned by your application is
“[b]etween September 2014 and February 2016”.

 

Finally, you note that:

 

“When representatives/officials of EFSA are mentioned in this request,
this includes all leadership/management positions. When
representatives/officials of the EPA are mentioned in this request, this
includes all leadership/management positions. When
representatives/officials of DG SANTE and the SG are mentioned in this
request, this includes the Commissioner, the Commission President, and
their Cabinet members.”

 

 1. Partial Disclosure – third and final batch

 

Your application was processed in accordance with [2]Regulation (EC) No
1049/2001 (hereinafter “the PAD Regulation”). We are pleased to provide
you with partial access to a third and final set of documents held by EFSA
within the scope of your application as listed below (by chronological
order):

 

+ “RE  Glyphosate IARC classification (2)”: an e-mail exchange between
the European Commission and EFSA as regards the IARC assessment of
glyphosate;
+ “Ares(2015)1823991-29.04.2015”: a letter sent by the European
Commission to EFSA requesting EFSA to consider the findings by IARC as
regards the potential carcinogenicity of glyphosate or glyphosate
containing plant protection products in the ongoing peer review of the
active substance;
+ “10 EFSA peer review of the active substance glyphosate”: a letter
sent by the European Commission to EFSA in reply to EFSA’s request for
extension of the target date to consider the findings by IARC as
regards the potential carcinogenicity;
+ “Glyphosate (AIR II) – draft EFSA conclusion call for comments”: an
e-mail sent by EFSA to collect comments before finalising the EFSA
Conclusions in relation to the application for renewal of the approval
of the active substance glyphosate;
+ “Glyphosate (AIRII) EFSA Conclusion on the peer review of the risk
assessment”: an e-mail sent by EFSA informing about the finalisation
of the EFSA Conclusion in relation to the application for renewal of
the approval of the active substance glyphosate;
+ “letter_EC to EFSA_30-10-2015”: a letter sent by the European
Commission to EFSA requesting EFSA to develop appropriate answers to
the questions raised in relation to the assessment of genotoxicity and
carcinogenicity of glyphosate in the open letters received by the
European Commission from the [3]German and European Parliaments as
well as [4]47 NGOs;
+ “6. Letter to EFSA_11 Dec 2015_Ares(2015)5765726 (1) (002)”: a letter
sent by the European Commission to EFSA requesting EFSA to develop
appropriate answers to the questions raised in relation to the
assessment of genotoxicity and carcinogenicity of glyphosate in an
[5]open letter received by the European Commission from 96 scientists
(lead author – Prof. Portier);
+ “PRAS_Glyphosate_mandate_animal_health_135275”: a letter sent by the
European Commission to EFSA requesting EFSA to consider the impact of
glyphosate residues on feed on animal health.

 2. Personal data protection and reproduction of the documents released

Please kindly note that any personal data present in the documents
released to you (i.e. names, contact details and information allowing the
direct and/or indirect identification of data subjects) have been masked
in accordance with Article 4(1)(b) of the PAD Regulation. This provision
provides that EU bodies shall refuse access to a document where the
disclosure would undermine the protection of the "privacy and the
integrity of the individual, in particular in accordance with Community
legislation regarding the protection of personal data". In accordance with
settled case-law of the Court of Justice of the European Union (CJEU),
this exception to disclosure is to be interpreted as a reference to
Regulation (EC) No 45/2001 - now repealed by [6]Regulation (EU) 2018/1725
(hereinafter "the Data Protection Regulation") - which becomes applicable
in its entirety.

As concerns the transmissions of personal data, Article 9(1)(b) of the
Data Protection Regulation provides that "personal data shall only be
transmitted to recipients established in the Union (...) if the recipient
establishes that it is necessary to have the data transmitted for a
specific purpose in the public interest". In application of this
provision, further clarified in the case law of the CJEU^6, EFSA shall
determine whether there is any reason to assume that a transmission of the
personal data might prejudice the legitimate interests of the concerned
individuals and to balance the different interests at stake, based on any
express and legitimate justification and convincing arguments you may be
able to provide in order to demonstrate that it is necessary for you to
receive these data for a specific purpose in the public interest within
the meaning of the afore-mentioned provision. Hence, only in the event
that you are interested in receiving the personal data, EFSA invites you
to submit to us your arguments as to why you consider it necessary to
receive these data in accordance with Article 9(1)(b) of the Data
Protection Regulation.

It should be pointed out that personal data contained in these documents
were redacted manually. Therefore, EFSA cannot fully exclude the
possibility that certain personal data are inadvertently disclosed to you.
Should this be the case, we urge you to treat any such residual personal
data with the utmost discretion in order to avoid undermining the privacy
and integrity of the individual(s) concerned.

We hope you find the disclosed documents useful. I must remind you that,
in line with Article 16 of the PAD Regulation, all persons reproducing,
redistributing, exploiting or making commercial use of this information
are expected to adhere to the terms and conditions asserted by any holder
of copyright.

 3. Confirmatory application

 

To exercise your right to appeal against this decision of partial
disclosure by a confirmatory application, you may write to EFSA at the
address below. You have fifteen working days from receipt of this e-mail
to appeal. In case you submit a confirmatory application, EFSA will inform
you of the outcome of the re-examination of your request within fifteen
working days of receipt. In case the re-examination results in a
confirmation of the present partial disclosure, you will also be informed
of any further appeal routes available.

 

Your confirmatory application must be sent to:

 

EFSA - Bernhard Url, Executive Director

Via Carlo Magno 1/A

IT– 43126 Parma

Italy
E-mail: [7][email address]

 

 

Yours sincerely,

 

 

Luisa Venier

EFSA Public Access to Documents team

Legal & Assurance Services / Business Services Department

 

 

 

CC: M. Tiramani (EFSA)

 

Encl. 8

References

Visible links
1. mailto:[FOI #8255 email]
2. https://eur03.safelinks.protection.outlo...
3. https://eur03.safelinks.protection.outlo...
4. https://eur03.safelinks.protection.outlo...
5. https://eur03.safelinks.protection.outlo...
6. https://eur03.safelinks.protection.outlo...
7. mailto:[email address]

VENIER Luisa, Autorité européenne de sécurité des aliments

Parma, 28 January 2021

Ref. DD/MH/mm (2021) - out-24373506

 

Vincent Harmsen

[ADDRESS REDACTED]

NL-[ADDRESS REDACTED]

[ADDRESS REDACTED]

 

E-mail: [1][FOI #8255 email]

 

                                                                                                                               

Re.:       Your application for public access to documents of 09 September
2020
 Ref. PAD 2020/104

 

Dear Mr Harmsen,

 

I refer to your e-mail of 09 September 2020 by means of which you
requested access to:

 

“all correspondence (including letters, emails and text messages),
agendas, minutes of meetings, minutes of phone calls, reports and any kind
of other documents, where the German laboratory LPT (Laboratory of
Pharmacology and Toxicology) was discussed/mentioned/referred to,
especially, but not exclusively, in relation to possible fraud/forgery of
test data and/or mistreatment of test animals. Time frame of this request:
Between December 1st 2018 and September 1st 2020.”

 

Your application is being processed in accordance with [2]Regulation (EC)
No 1049/2001 (hereinafter “the PAD Regulation”). As proposed in our e-mail
of 09 December 2020 providing you with a reply concerning the
accessibility of a first batch of documents in relation to your
application for access to documents (hereinafter “your application”), your
application was handled in successive stages, allowing for a detailed
assessment on the accessibility of each of the documents falling within
the scope of your application in accordance with Article 6(3) of the PAD
Regulation. By means of this e-mail, we are pleased to provide you with a
reply concerning the accessibility of a second and final batch of
documents held by EFSA[3][1] and identified as falling within the scope
of your application[4][2]. 

 

 1. Partial Disclosure

 

We are pleased to provide you with partial access to a second and final
set of documents as listed below (by chronological order):

 

* “Heads-up_ GLOBAL 2000 report on glyphosate (8)” – an e-mail of 11
February 2020 from EFSA addressed to the European Commission reporting
on the imminent release of the AT NGO Global2000 report regarding
alleged violations of GLP standards and animal welfare rules by the
Laboratory of Pharmacology and Toxicology GmbH & Co. KG (hereinafter
“the LPT case”) and pending (media) inquiries in relation thereto.

 

 1. “FW_ germany glyfosaat” – a thread of e-mails starting with an e-mail
of 11 February 2020 from the Belgian daily De Standaard to EFSA
inquiring as to whether EFSA knew about the LPT case and whether the
reliability of studies impacted by the LPT case was checked in
relation to the renewal of the approval of glyphosate resulting in a
follow-up e-mail from EFSA to the German Federal Institute for Risk
Assessment (hereinafter “the BfR”) seeking information as to whether
the BfR is aware of the findings of the investigative ARD news
magazine FAKT regarding the LPT case or had been confronted with that
issue in the past.

 

 2. “WG_Anfrage_ ORF konkret_ GL- Überwachung: Wie sicher sind Studien
für die

Zulassung von Chemikalien/Medikamenten“ – an e-mail of 11 February 2020
from the Austrian Agency for Health and Food Safety (hereinafter “AGES”)
to EFSA informing EFSA on the lack of updates on the LPT case from the
Austria media landscape, pending media queries with AGES and the BfR and
the coordination of replies between the BfR and AGES.

 

 3. “FW_ Coalition Open letter_ Fraud at GLP-certified laboratories” – an
e-mail exchange between the European Commission and EFSA dated 04
March 2020. This exchange includes (i) an e-mail from the European
Commission inquiring as to whether EFSA conducted any analysis further
to that of the BfR regarding the relevance of the studies affected by
the LPT case in relation to the renewal of the approval of glyphosate
and requesting access to that analysis as well as (ii) an e-mail from
EFSA providing the European Commission with the requested analysis.

 

 4. “RE Official Invitation EFSA Sounding Board - 1st Meeting – 23032020”
– an e-mail dated 16 March 2020 from a member of the EFSA Sounding
Board (hereinafter “the Sounding Board member”) suggesting to include
a discussion on the LPT case in the EFSA Sounding Board meeting of 23
March 2020.

 

 5. “FW_ Greetings and a request (1)” – a thread of e-mails containing an
e-mail exchange between EFSA and the Sounding Board member (24 March
to 06 April 2020) in follow-up to the EFSA Sounding Board meeting of
23 March 2020 as concerns the LPT case and, more specifically, EFSA’s
actions in relation thereto and an internal e-mail exchange within
EFSA (24 April – 29 April 2020) considering engagement with relevant
German authorities as concerns the LPT case.

 

 6. “FW_Greetings and a request (2)” – an e-mail exchange between EFSA and
the Sounding Board member (26 May to 30 June 2020) complementing and
clarifying the exchange referred to under the preceding bullet point
with regard to the question as to whether EFSA intends to take any
further action regarding the LPT case pending the outcome of the
investigation of the German authorities into this matter.

 

 7. “EFSA Ref. 23388832 Ermittlungen zu möglichen Verstößen des LPT gegen
Tierschutzbestimmungen und der GLP-Grundsätze“ – a letter from EFSA to
the BfR dated 04 June 2020 inquiring about the latest information
available to the BfR in relation to the ongoing investigations into
the LPT case and asking the BfR to inform EFSA in good time about
novel developments pertaining to the investigations which are of
relevance to EFSA.

 

 8. “200714_an EFSA_Ermittlungen zu mögl Verstößen des LPT“ – a letter
from the BfR to EFSA dated 14 July 2020 in reply to the EFSA letter
mentioned under the preceding bullet point detailing (i) that, as
communicated over the phone, the Hamburg Authority for Justice and
Consumer Protection (hereinafter “the BJV”) is in charge of overseeing
compliance with animal welfare rules and GLP standards, (ii) that,
while according to the GLP supervisory authority the investigation has
not been completed, intermediate results thereof are to be transmitted
to the BfR soon which, in turn, will be conveyed to EFSA and other
authorities shortly, and (iii) that there are no new insights, i.e.
insights in addition to those communicated via BfR-notice 010/2020
dated 11 February 2020, as to the impact of the LPT case on study
reports used in the context of the procedure underlying the renewal of
the approval of glyphosate.

 2. Personal data protection and reproduction of the documents released

Personal data present in the documents disclosed to you have been masked
in application of the exception to disclosure in Article 4(1)(b) of the
PAD Regulation. In accordance with settled case law of the Court of
Justice of the European Union (CJEU), this exception to disclosure is to
be interpreted with reference to Regulation (EU) 2018/1725 (hereinafter
“the EUDPR”). Article 9(1)(b) of the EUDPR deals with personal data
transmissions to recipients established in the Union. Taking account of
the case law referred to above, EFSA will only be able to balance the
interests at stake and to consider the disclosure of personal data after
you have provided an express and legitimate justification and convincing
arguments in order to demonstrate the necessity of having personal data
transmitted to you in the sense of Article 9(1)(b) (‘necessity test’).

Considering that personal data is redacted manually by EFSA, we cannot
fully exclude the possibility that certain personal data are inadvertently
disclosed to you. Should this be the case, we urge you to treat any such
residual personal data with the utmost discretion in order to avoid
undermining the privacy and integrity of the individual(s) concerned.

We hope you find the disclosed documents useful. I must remind you that,
in line with Article 16 of the PAD Regulation, all persons reproducing,
redistributing, exploiting or making commercial use of this information
are expected to adhere to the terms and conditions asserted by any holder
of copyright.

 3. Confirmatory application

 

To exercise your right to appeal against this decision of partial
disclosure by a confirmatory application, you may write to EFSA at the
address below. You have fifteen working days from receipt of this e-mail
to appeal. In case you submit a confirmatory application, EFSA will inform
you of the outcome of the re-examination of your request within fifteen
working days of receipt. In case the re-examination results in a
confirmation of the present partial disclosure, you will also be informed
of any further appeal routes available.

 

Your confirmatory application must be sent to:

 

EFSA - Bernhard Url, Executive Director

Via Carlo Magno 1/A

IT– 43126 Parma

Italy
E-mail: [5][email address]

 

 

Yours sincerely,

 

 

Luisa Venier

EFSA Public access to documents team

Legal and assurance services Unit

 

 

 

 

 

 

 

------------------------

------------------------

[6][1]     Documents held by EFSA are documents registered in accordance
with EFSA’s Records Management Policy.

[7][2]     Where documents disclosed to you contain information beyond the
scope of your application such information has been removed.

References

Visible links
1. mailto:[FOI #8255 email]
2. https://eur03.safelinks.protection.outlo...
3. file:///tmp/foiextract20210128-29871-1ksf5ob#_ftn1
4. file:///tmp/foiextract20210128-29871-1ksf5ob#_ftn2
5. mailto:[email address]
6. file:///tmp/foiextract20210128-29871-1ksf5ob#_ftnref1
7. file:///tmp/foiextract20210128-29871-1ksf5ob#_ftnref2

Nous ne savons pas si la réponse la plus récente à cette demande contient l'information ou non – si vous etes Vincent Harmsen veuillez vous connecter et laisser nous savoir.