3 guidance access Redacted.pdf.pdf

Ref. Ares(2015)4030736 - 30/09/2015
Ref. Ares(2016)5532520 - 23/09/2016
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

General Affairs
  Information systems

DG SANTE INTERNAL GUIDANCE DOCUMENT ON
ACCESS TO DOCUMENTS
IMPLEMENTATION OF REGULATION (EC) NO 1049/2001

JULY 2015

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË – Tel. +32 22991111

1.
INTRODUCTION
Responding to requests for Access to Documents must now be seen as a normal activity.
That  said,  it  is  very  difficult  for  Units  to  plan  for  these  unexpected  requests,  some  of
which  are  very  complex  and  cover  a  wide  scope  and/or  a  large  amount  of  documents.
Good  standard  administrative  practices  can  however  make  reacting  to  requests  less
burdensome and less disruptive of operational tasks.
Questions have been raised recently concerning internal documents (such as internal e-
mails exchanged within SANTE and/or with Cabinet, draft texts, and handwritten notes),
recordings  (“tapes”)  of  Committee  meetings,  the  implementation  by  the  Agencies  of
Regulation  (EC)  No  1049/20011,  and  the  relationship  between  the  Regulation  and
SANTE  sectorial  legislation  on  the  confidentiality  of  information  contained  in  certain
documents (dossiers).
Since  the  Note  to  the  Management  Team  on  this  subject  (22  September  2011,
ARES(2011)1008632),  there  has  been  some  improvement  in  SANTE  with  regard  to
respect of the procedures and the application by many Units of good practices concerning
the interpretation of the different articles of the Regulation, with a view to limit the scope
of the requests and/or to find a fair solution with the applicants. (See Chapter 4.)
Number of requests for access to documents

(figures from GESTDEM, the SG application managing requests)

2009
2010
2011
2012
2013
2014
Increase 2009-2014
SANTE
249
346
449
441
539
447
+80%

The quality control of all negative and partial access replies in 2012-2013-2014 is overall
positive, which is in line with the instructions of the Secretariat-General (SG).
SANTE  has  received  more  confirmatory  applications,  i.e.  appeals  to  the  SG  against  a
refusal to release (parts of) the documents. In such cases, the deadline to forward the full
content of (partially or totally) refused documents to the SG is 24 hours. SANTE services
replied in due time (i.e. within 24 hours) and ensured full cooperation with the SG.
This  guidance  document  focusses  on  clarification  concerning  the  above-mentioned
questions  and  further  actions  to  possibly  limit  the  workload  in  responding  to
requests in the future.
Annex 1 is a summary of the basic principles of Regulation (EC) No 1049/2001.


1   Regulation  (EC)  No  1049/2001  of  the  European  Parliament  and  of  the  Council  of  30  May  2001
regarding  public  access  to  European  Parliament,  Council  and  Commission  documents,  OJ  L  145,
31.5.2001, p. 43-48.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:145:0043:0048:EN:PDF
4

2.
CLARIFICATIONS CONCERNING DOCUMENTS
2.1.
Definition of document
The  scope  of  the  Regulation  (EC)  No  1049/2001  (hereafter  “the  Regulation”)  is  to
give the widest possible access to documents which have not already been published
or made public.
The  Regulation  gives  a  very  broad  definition  of  document.  It  does  not  provide  any
possibility to exclude certain categories of documents a priori from its scope.
Definition of document in Article 3 of the Regulation:
Article 3 – Definitions
For the purpose of this Regulation:
(a) ‘document’ shall mean any content whatever its medium (written on paper or stored in electronic
form or as a sound, visual or audio-visual recording) concerning a matter relating to the policies,
activities and decisions falling within the institution’s sphere of responsibility;

Internal documents whether they are registered or not and working documents
cannot systematically be excluded from the scope of the request.
Examples of internal documents include:
  preparatory  documents  on  Commission  policy  decisions  and  initiatives,  such  as
preliminary drafts, interim reports, draft legislative proposals or decisions;
  explanatory  documents  or  other  types  of  information,  such  as  statistics,
memorandums  or  studies,  on  which  Commission  decisions  and  policy  measures
are based;
  briefings,  minutes  of  meetings,  BTOs,  mission  reports,  internal  e-mails
saved/recorded on a computer.

In order to better define the term “document”, it is useful to refer to the definition in
Article 1 of the ‘e-Domec’ Decision 47/2002/EC:
–   document shall mean any content drawn up or received by the Commission concerning a matter
relating to the policies, activities and decisions falling within the institution’s competence and in
the framework of its official tasks, in whatever medium (written on paper or stored in electronic
form or as a sound, visual or audio-visual recording).
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:021:0023:0027:EN:PDF
Even before the migration to ARES (in May 2010) all documents (including internal
documents  and  e-mails)  which  meet  the  ‘e-Domec’  criteria  should  have  been  duly
registered. (See Point 2.3.)
ARES is not the only register, as specific types of documents are  registered in other
registers  (e-Greffe,  CIS-Net,  Basil,  MisDoc,  for  example)  and  in  other  electronic
systems or repositories (Basis, Circa web sites, Traces, Rasff, etc.).

5

The  identification  of  the  relevant  documents  whether  registered  or  not  does  not
mean that all documents will be released. The opportunity to release the documents
will  be  assessed  on  a  case  by  case  basis,  and  refusal  to  grant  access  to  (parts  of)
documents must be reasoned based on the exceptions provided for in Article 4 of the
Regulation. (See Chapter 5.)
2.2.
E-mails
2.2.1.  External e-mails (from/to outside the Commission)
All  incoming  and  outgoing  e-mails  whose  subject,  date,  sender  and  recipients  are
clearly  identified  and  whose  content  fulfills  the  ‘e-Domec’  criteria  (See  also
Point 2.3.), should be duly registered in Ares and filed in the correct file.
Any  e-mail  containing  important  information,  i.e.  which  is  not  short-lived  and
which is likely to require action, follow-up or a reply from the Commission or one
or more of its departments or to involve the responsibility of the Commission or one
or more of its departments must be registered.
Guidelines for the registration of e-mails in the framework of the electronic archiving and document
management policy of the European Commission (e-Domec), SEC(2006)353.

Documents NOT to be registered are described under Point 2.3.
2.2.2.  Internal e-mails (within Commission services)
There  is  no  obligation  to  register  an  internal  e-mail;  the  decision  is  taken  by  the
person  sending the e-mail.  A priori  internal e-mails that do not  meet the criteria for
document registration (see Point 2.3.) do not need to be registered.
However,  e-mails  may  be  saved  and  filed  in  Ares,  if  this  would  make  easier  the
comprehension of the relevant file.
Example: summary record of a meeting where a decision has been taken.
E-mails exchanged between two or several members of staff informally and in good
faith  in  the “space  to  think” should not  be registered. E-mails  exchanged between
two or several members of staff, and which constitute a major step in the procedure
of  finalising  a  document  in  the  framework  of  the  departments’  activities,  must
always be registered.
Guidelines for the registration of e-mails in the framework of the electronic archiving and document
management policy of the European Commission (e-Domec), SEC(2006)353.

2.3.
Registered documents vs. working documents
Most  applicants  who  request  access  to  documents  are  interested  in  “internal”
documents which they cannot find easily (as opposed to published ones). The files in
the Units contain both official documents and unofficial ones.
The official documents  should  be duly  registered whereas the unofficial  or  working
documents are saved and stored, usually on the P: drive or U: drive of the Units.
6

All  documents  including  e-mails  which  meet  the  criteria  of  the  provisions  on  the
document management rules must be registered.
Documents to be registered
“Documents to be registered pursuant to the provisions on document management
are all documents, regardless of medium, that:

(a)
are  received  or  formally  drawn  up  by  a  Commission  department  in  the
course of its activities; and
(b)
i) are likely to require action, follow-up or a reply from the Commission or
one or more of its departments; or

ii)  involve  the  responsibility  of  the  Commission  or  one  or  more  of  its
departments; and

(c)
contain important information which is not short-lived;”
Implementing rules for Decision 2002/47/EC, ECSC, Euratom on document management and for
Decision 2004/563/EC, Euratom on electronic and digitised documents, SEC(2009)1643
Documents NOT covered by the registration requirement
“Documents  containing  information  which  is  unimportant  and  short-lived  are,  in
contrast, documents:
•
whose  loss  would  not  prevent  the  departments  concerned  meeting  the
Commission’s administrative or evidential needs; or
•
whose value is clearly temporary and rapidly lapsing, ancillary and instrumental;

or
•
which  are  considered  or  treated  as  non-important  and  short-lived  by  a  records
schedule, a procedural regulation or routine administrative practice.”
Document registration manual, SG.B.3/MH D(2004)5794.

Commission  services  are  asked  to  follow  the  document  management  rules  and  SG
guidelines  in  the  note  from  the  Secretary-General  Ares(2015)182108  –  16/01/2015,
so as to ensure that:
  All  relevant  documents,  including  e-mails,  are  captured  and  can  be  easily
retrieved  when  needed,  in  particular  when  replying  to  a  request  for  access  to
documents.
  When processing a request for access, documents are searched only in Ares or in
another document management system.
  All colleagues are aware of their responsibilities in this regard.

See Newsletter no 13 of 21/01/2015 – Document management and access to documents
(note, practical registration criteria and guidelines)

https://myintracomm.ec.europa.eu/sg/docinter/Pages/newsletter.aspx
When  processing  a  request  for  access,  documents  should  therefore  be  only
searched  for  in  Ares  or  in  another  Commission  document  management  system
(such  as  Decide,  ABAC,  etc.).  These  systems  will  be  integrated  with
Hermes/Ares/Nomcom (“IT Rationalisation” project).
7

2.4.
Sound, visual or audio-visual recording
The definition of document includes sound, visual or audio-visual recording.
The processing of the request will be the same as for paper/electronic documents. In
case of partial access, the blanking out of parts of the records should be done on the
transcription of the records.
If such processing would entail a disproportionate amount of work, the access to all
or  part  of  the  documents  requested  may  be  refused  on  the  basis  of  the  principle  of
proportionality. (See also Point 4.3.3.)
2.5.
Disclosure of information from a database
Concerning  applications  for  access  to  information  in  a  database  other  than  one
already accessible to the public, as a general rule the Commission should supply the
information  requested  on  condition  that  it  is  not  covered  by  one  of  the  exceptions
provided for in Article 4 of the Regulation and that:
  the application does not require new computer instructions to be issued in order to
retrieve the data;
  the application can be processed by routine operations.
Where  an  application  for  access  to  information  would  require  seeking  technical
assistance  in  order  to  perform  a  non-routine  operation,  access  can  be  denied  on  the
basis  that  the  application  does  not  relate  to  a  document  in  an  existing  version  and
format  (including  electronically)  and,  therefore,  falls  out  of  the  scope  of  the
Regulation.
2.6.
Confidential / sensitive documents
Under the rules applying in the Commission2, a classified document is one marked
“RESTREINT UE/EU RESTRICTED”,
“CONFIDENTIEL UE/EU CONFIDENTIAL”,
“SECRET UE/EU SECRET” or
“TRES SECRET UE/EU TOP SECRET”.
A document is classified if it contains information whose unauthorised disclosure:
– might harm the essential interests of the European Union or one of its Member
States (“top secret” – exceptional harm, “secret” – serious harm, “confidential” –
harm);

– might be prejudicial to the interests of the European Union or one of the Member
States (“restricted”).


2   Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting
EU classified information, OJ L 72, 17.3.2015, p. 53-88.
http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32015D0444&qid=1438175834535&from=EN
8

Because of the information it contains, such a document enjoys a special level of
protection within the institution itself.
A document that is classified at least as “confidential”, and falls into the area of
protection of the public interest as regards:

– public security;
– defence and military matters;
– international relations;
– the financial, monetary or economic policy of the Community or a Member State,
is referred to as a “sensitive document” (Article 9 of the Regulation).
When an application for access relates to a sensitive document or another document
classified under the Commission’s security rules, it will be examined by officials with
authority to read the document.
Any decision refusing access to all or part of a classified document must be justified
with reference to the exceptions provided for in the Regulation. (See Chapter 5.)
The agreement of the originating authority is required for granting access to a
sensitive document (Article 9 of the Regulation; Article 6 of the internal rules)3.
3.
COORDINATION ON ACCESS TO DOCUMENTS
3.1.
Coordination of initial requests at Commission level
If  a  request  covers  several  DGs,  the  coordination  should  be  ensured  by  the  natural
lead service.
If  the  request  is  addressed  to  one  or  several  DGs  and  additionally  the  SG,  the
Secretary-General,  the  (former)  President  or  one  of  the  five  Vice-Presidents
without a service and/or their respective Cabinets, and covers issues falling under the
responsibility  of  one  of  the  latter  entities,  then  the  Unit  in  SG  responsible  for  the
policy coordination will coordinate.
In  any  case,  the  SG.B.4  legal  officers  are  available  to  provide  legal  and  procedural
support.
SANTE/A4  checks  if  similar  requests  are  addressed  to  other  DGs  and  informs  the
relevant SANTE Directorate/Unit and SG. In some very specific cases, coordination
meetings  may  be  arranged  by  the  SG  in  order  to  find  a  coherent  way  to  deal  with
difficult requests.
If a request covers DG SANTE documents on a topic where the natural lead service is
another  DG,  DG  SANTE  will  prepare  the  reply  and  the  relevant  documents  and
consult the lead DG on the draft reply in order to agree on a common position.


3   2001/937/EC,  ECSC,  Euratom:  Commission  Decision  of  5  December  2001  amending  its  rules  of
procedure – Annex : Detailed rules for the application of Regulation (EC) No 1049/2001 of 30.5.2001,
OJ L 345, 29.12.2001, p. 94-98.

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:345:0094:0098:EN:PDF
9

Example: the same requests addressed to 5 different DGs concerning “A list of all
the new members added to expert groups that were referred to in the 28th February
European  Commission  State  of  Play  (‘Informal  Dialogue  on  Expert  Groups;
Initiatives Taken by Commission Services’)” and “Any applicant who has applied
to be a member of the Commission’s expert groups but been refused, including all
documents  which  give  the  justification  for  said  unsuccessful  applicants  not  being
granted  membership  to  the  applied-for  expert  group”  (GESTDEM
  and
).

The  SG  organised  a  meeting  with  the  relevant  DGs  and  the  Legal  Service.  They
collected  the  relevant  documents  from  the  different  DGs  and  the  LS  gave  its
interpretation  of  the  documents  covered  by  the  request  so  that  the  DGs  could
answer in a coherent manner.
3.2.
Coordination of requests at SANTE level
When  a  request addresses  different Units/Directorates in  SANTE,  SANTE/A4 takes
the  lead  and  will  draft  the  reply  after  consulting  all  Units/Directorates  involved.
Depending on the issue at stake, the relevant Director may be asked to sign the reply.
For requests which involve different Directorates/Units about an issue where there is
a lead Unit, then the request is assigned to the lead Unit who will then consult other
Directorates and Units on the list of documents and the draft reply in order to agree
on a common position.
Example:  35  requests  for  “documents  which  contain  the  following  information
pertaining  to  Consultation  periods  opened  regarding  Food  Safety,  specifically
copies (not summaries) of the original consultations (also described as opinions or
comments  received)  SANCO received regarding the following consultation  topics
(titles  are  listed)”:  35  different  consultations  listed  on  Europa  and  concerning  10
Units  in  4  Directorates  in  SANCO  (GESTDEM
).  SANCO/A4  had  to
take  the  lead  and  drafted  the  replies  in  different  batches.  In  this  specific  case,  a
meeting  has  been  arranged  with  the  SG  in  order  to  clarify  the  notion  of
“disproportionate amount of work”. (See also Point 4.3.3.)
3.2.1.  Role of SANTE/A2
Unit A2 is involved in the process of the assessment and validation of negative and
partial  access  replies,  as  well  as  providing  legal  advice  on  sensitive  issues  where
necessary. In particular, Unit A2 plays  an important role in checking the validity of
the exceptions used by SANTE in case of a negative reply or a partial access (when
SANTE  refuses  access  to  documents  or  parts  of  documents),  which  facilitates
defence of the SANTE position in the case of a confirmatory application.
However, Unit A2 is not involved for which concerns negative/partial access replies
-  where only personal data of individuals are redacted from the documents, i.e.
the only applicable exception is Article 4.1 (b) of the Regulation
-  or the only exception is the protection of commercial interests (Article 4.2.1st
indent), i.e. the Unit has to follow the opinion of the third party consulted.

10

3.3.
Implementation of the Regulation by the Agencies
Article  255  of  the  Treaty  establishing  the  European  Community,  implemented
through Regulation (EC) No 1049/2001 of 30 May 2001, grants a right of access to
European Parliament, Council and Commission documents.
All  SANTE  Agencies  have  either  a  specific  article  on  access  to  documents  in  their
founding  Regulation  or  specific  provisions  adopted  after  the  entry  into  force  of  the
Regulation. (See the Reference articles hereafter).
The  Agencies  should  implement  the  Regulation  in  a  similar  way  as  the  three  main
institutions and have also to take into consideration the rulings by the Court.
Best  practice  in  the  Commission  is  reciprocal  information:  the  DGs  should  inform
their Agencies when they receive requests for access to Agencies’ documents held by
the Commission, and the Agencies should inform the Commission when they receive
requests  for  access  to  Commission  documents  that  they  hold.  They  also  should
inform each other on decisions to release or not such documents, and on the relevant
exceptions  to  the  right  of  access.  While  respecting  agencies’  independence,
considering that both agencies and the Commission have to apply the same body of
rules on access to documents, the adoption of a consistent approach by both is a good
administrative  practice  that  further  facilitates  the  exercise  of  the  right  of  access
granted  by  these  rules.  There  is  still  scope  for  improved  cooperation  in  view  of  a
coherent approach on the implementation of the  principles involved in the access to
documents  (namely  transparency  versus  the  protection  of  third  parties’  legitimate
interests,  such  as  individuals’  privacy  and  integrity,  commercial  interests  and
intellectual property rights).
EFSA:  Article  41  –  Access  to  documents  in  Regulation  (EC)  No  178/2002  of  the  European
Parliament  and  of  the  Council  of  28  January  2002  laying  down  the  general  principles  and
requirements  of  food  law,  establishing  the  European  Food  Safety  Authority  and  laying  down
procedures in matters of food safety.

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32002R0178&rid=1
EMA: Article 73 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
of  31  March  2004  laying  down  Community  procedures  for  the  authorisation  and  supervision  of
medicinal products for human and veterinary use and establishing a European Medicines Agency.
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32004R0726&rid=1
ECDC: Article 20 – Transparency and protection of information in Regulation (EC) No 851/2004
of the European Parliament and of the Council of 21 April 2004 establishing a European centre for
disease prevention and control.

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32004R0851&rid=1
CPVO:  Article  33(a)  of  Council  Regulation  (EC)  No  1650/2003  of  18  June  2003  amending
Regulation (EC) No 2100/94 on Community plant variety rights.

http://www.cpvo.europa.eu/main/en/home/documents-and-publications/access-to-documents
CHAFEA:  Decision  of  the  Steering  Committee  of  the  Executive  Agency  for  the  Public  Health
Programme.  Implementing  rules  for  the  application  of  Regulation  (EC)  No  1049/2001  of  the
European  Parliament  and  of  the  Council  regarding  public  access  to  documents  (SC/2006/2/03  –
PHEA(2006) D800064).
http://ec.europa.eu/chafea/documents/about/impl rules PHEA public access to documents 03
02 2006.pdf

11

4.
STEP BY STEP PROCEDURES FOR THE PROCESSING OF THE REQUESTS
Step by step procedures together with standard model letters and typical electronic
workflows are available on My SANTE at:
PROCEDURES & GUIDELINES – ACCESS TO DOCUMENTS
https://myintracomm.ec.europa.eu/dg/sante/procedures-guidelines/Pages/documents-
access.aspx
4.1.
Step 1 – Receipt and assignment
Requests  for  access  to  documents  are  received  either  directly  by  SANTE  Units  or
through  the SG  application  GESTDEM.  This  application  automatically  registers  the
requests  sent  through  the  electronic  form  available  on  Europa.  For  other  requests
received  by  mail  or  electronic  mail  at  SG,  SG.B.4  registers  the  requests.  Then
GESTDEM  automatically  sends  an  acknowledgement  of  receipt  to  the  sender  and
forwards the request to the relevant DG.
When  received  directly  by  SANTE  Units,  the  Units  must  contact  SANTE/A4  who
will  then  register  the  requests  in  GESTDEM.  (Contact  mailbox:  SANTE  ACCESS  TO
DOCUMENTS, virtual entity in ARES: ve_sante.accdoc). The Units should also send an
acknowledgement  of  receipt  to  the  applicant  as  soon  as  they  get  the  GESTDEM
registration number.
SANTE/A4  processes  directly  all  requests  for  documents  which  have  already  been
published  or  made  public  on  Europa  or  through  a  previous  request  for  access  to
documents. This represents 40% of the requests.
SANTE/A4 assigns the other requests in ARES including the deadline and a message
on the rules of procedure.
Deadline: 15 working days from date of registration (3 weeks)
All Unit secretariats should use the deadlines reports in ARES on a daily basis. Tasks
must  not  be  closed  before  the  appropriate  action  has  been  performed.  Each  Unit
needs  to  be  able  to  use  the  relevant  ARES  functionalities  for  their  tasks  and
documents received.
See  Annex  2  –  “How  to  deal  with  your  pending  assignment  tasks?”  (for
administrators),  Annex  3  –  “How  to  get  informed  about  pending  tasks  of  your
unit?”  (for assistants/secretaries),  and  Annex  4  –  “How  to  deal  with  a deadline
which has been modified/postponed?”.
Once the task is assigned in ARES to a given Unit and desk officer, the colleague in
charge  should  make  a  rapid  assessment  of  the  request.  SANTE/A4  should  be
contacted immediately in case of a problem either to meet the deadline or to identify
the documents or as regards the scope of the request.
SANTE/A4  checks  after  10  days  if  a  response  is  being  prepared  and  sends  regular
reminders to the Units and relevant colleagues in charge of the requests.
SANTE/A4 can provide full advice on the implementation of the Regulation and on
the applicable procedure.
12

4.2.
Step 2 – Scope of the request
There  is  no  immediate  relationship  between  registration  of  documents  and  their
possible  release.  Usually  the  requestors  do  not  make  a  difference  between  official
(registered)  documents  and  unofficial  (working)  documents.  They  are  interested  in
“internal” documents as opposed to published ones.
Example:  a  request  for  “the  list  of  meetings  between  the  Commissioner  and  an
organisation, minutes of meetings and all correspondence and documents relating
to these meetings”. In this specific case where the request speaks of “documents
relating to these meetings”, briefings to the Commissioner – if they exist – should
normally  be  part  of  the  list  of  relevant  documents.  However,  depending  on  the
content of the briefing, it will be released or not, or only partially, on the basis of
the exceptions provided in Regulation (EC) No 1049/2001.
4.2.1.  Request clarification
Where  the  “scope”  of  the  request  is  unclear  or  very  broad,  the  Unit  is  advised  to
contact in writing the applicant to clarify the scope of the request (Article 6.2 of the
Regulation).  The  Unit  can  ask  precisions  on  the  topic  of  the  request  and/or  a
limitation  of  the  time  span.  This  can  reduce  the  workload  (from  hundreds  of
documents in an initial request to very few documents at the end).
The  time-limit  to  answer  the  request  then  runs  from  the  date  of  the  reply  from  the
applicant.
New deadline: 15 working days from the reply by the applicant
Example:  4  vast  requests  by  an  organisation  on  8/3/2011  on  plant  protection
products and pesticide residues. A meeting of the relevant Unit with the applicant
reduced the scope of the request and the applicant agreed on an extension of the
deadline. The research of the applicant was on the impact of industry on policy as
regards bees, comparing the EU with the US. (See Annex 4.)
If the applicant does not reply to the request for clarification within 3 weeks, then the
request is closed as “devoid of purpose”.
4.3.
Step 3 – Identification of documents relevant to the request
Searches for documents by Units can be facilitated by drawing up the list of relevant
documents from the official register of documents (ARES), and then adding the other
relevant internal documents to the list as appropriate.
As  indicated  by  the  Secretary-General  in  the  note  on  “Document  management  and
access  to  documents”  (Ares(2015)182108),  when  processing  a  request  for  access,
documents are searched only in Ares or in another document management system.
In case the request covers a wide range of documents and some (parts of) documents
will not be disclosed, the SG has requested the DGs to provide the requestor with the
list  of documents  relevant  to  that  request.  The list  of documents is  therefore part of
the reply.
13

As the requestor has the right to challenge the decision taken by the DG and to send a
confirmatory request to the SG, the SG then will have to re-assess whether or not the
exceptions apply and on which documents.
For various reasons, the Unit or the desk officer may well foresee that the time-limit
cannot  be  met.  The  desk  officer  should  seek  the  advice  of  SANTE/A4  immediately
and even call SANTE/A4 for a meeting.
4.3.1.  Holding letter
In exceptional cases (for example in the event of an application relating to a very long
document  or  to  a  very  large  number  of  documents),  the  Unit  may  send  a  holding
letter which provides for an extension of the time-limit by another 15 working days.
Detailed  reasons  must  be  given  for  use  of  this  extension  (Article  7.3  of  the
Regulation).
As  DG  SANTE  receives  more  and  more  requests  with  a  wide  scope  and  which
require the consultation of third parties, the deadline of 15 working days is often too
short, thus the holding letter is used quite often.
New deadline: + 15 working days from end of first deadline (6 weeks)
4.3.2.  Fair solution with the requestor
The  Regulation  provides  for  the  possibility  to  agree  on  a  fair  solution  with  the
applicant (Article 6.3 of the Regulation). The first step is to contact the applicant (this
may be done informally by phone) and ask the applicant to reduce the timeframe or
the subject matter covered by the request, explaining the detailed reason for a delayed
reply (for instance the necessity to consult other Commission services or third parties
authors, or the need to retrieve the files from the historical archives service).
It  can  take  the  form  of  an  invitation  to  the  applicant  to  split  up  the  request  (by
explicitly withdrawing parts of it) or to agree on a calendar. Even if an agreement is
reached on the phone, the extension of the time-limit must be confirmed in writing.
Example:  4  vast  requests  by  an  organisation  on  8/3/2011  on  plant  protection
products and pesticide residues. A meeting of the relevant Unit with the applicant
reduced the scope of the request and the applicant agreed on an extension of the
deadline. (See Annex 5.)
The recent case Strack v Commission, T-392/074, revealed two new elements: First,
the  Commission  cannot  impose  unilaterally  on  an  applicant  a  “fair  solution”
according  to  Article  6,  paragraph  3,  of  Regulation  (EC)  No  1049/2001  when
confronted  with  an  application  related  to  a  large  number  of  documents;  if  such  a
solution  has  been  refused  by  the  applicant,  the  legal  deadlines  established  by
Regulation  (EC)  No  1049/2001  keep  running,  including  those  to  file  a  case  at  the
Court5.

4   Judgment of 15 January 2013, EUR-Lex Document CELEX62007TJ0392.
5   Points 45-52 of the judgment.
14

As  a  lesson  of  this  ruling,  it  is  recommended  that  the  relevant  Unit  proposes  each
time  a  clear  calendar  for  the  treatment  of  the  request,  which  becomes  then  binding
for it, when agreed by the applicant.
New deadline: depends on fair agreement with the applicant
In case an agreement on a fair solution cannot be found after several attempts,
the Commission is then bound to the usual deadlines.
Only if no fair solution can be reached can the judgment be applied, by refusing, in
the final decision, those documents that cannot be handled within the 15+15 working
days deadline. In this case the applicant will need to send a new request.
4.3.3.  Disproportionate amount of work
If  the  application  really  does  involve  an  unreasonable  amount  of  work  and  no
compromise  can  be  reached,  the  Commission  may,  in  the  interest  of  sound
administration,  invoke  the  principle  of  proportionality  to  justify  a  refusal,  provided
that  the  amount  of  work  involved  in  the  concrete,  individual  examination  of  the
documents  covered  by  the  request  would  be  excessive  in  relation  to  the  interest
served by disclosure.
If only  part of the document requested is covered by one or  more of the exceptions
provided  for  in  the  Regulation,  the  other  parts  of  the  document  may  be  disclosed
(Article  4.6  of  the  Regulation).  Granting  partial  access  will  mean  concealing  or
deleting the words, sentences or paragraphs to which an exception applies. If access
can only be granted to an extract from a document, the applicant must be told what
the total volume of the document requested is. The courts6 have accepted that, in the
interests  of  sound  administration,  the  Commission  may  invoke  the  principle  of
proportionality  as  regards  the  effort  it  has  to  make  to  afford  partial  access  to  a
document.  Thus,  in  exceptional  cases,  where  the  volume  of  the  document  or  of  the
passages  to  be  censored  would  entail  a  disproportionate  amount  of  administrative
work,  the  Commission  may  apply  this  principle  to  weigh  up  the  interest  served  by
public  access  to  these  fragmentary  extracts  against  the  workload  involved  in
producing them.
Example:  35  requests  for  “documents  which  contain  the  following  information
pertaining  to  Consultation  periods  opened  regarding  Food  Safety,  specifically
copies  (not  summaries)  of  the  original  consultations  (also  described  as  opinions
or  comments  received)  SANCO  received  regarding  the  following  consultation
topics  (titles  are  listed)”:  35  different  consultations  listed  on  Europa  and
concerning  10  Units  in  4  Directorates  in  SANCO  (GESTDEM

). SANCO managed to reply in different batches but only to 23 requests. For
the  other  12  the  relevant  documents  previously  published  on  Europa  had  been
removed and the searches in SANCO archives would have been a disproportional
amount of work. (Final reply in Annex 6)
Repeated requests (more than once) from the same applicant for the same document
will be met only once.

6
Case T-2/03, Verein für Konsumenteninformation v Commission [2005] ECR II-1121, paragraphs 101
and 102, and Williams v Commission, paragraph 85.
15

4.4.
Step 4 – Assessment of the documents relevant to the request
The Regulation does not allow to exclude a specific category of documents from the
scope of the request, and moreover requires a concrete examination of the documents
one by one in order to assess whether or not the documents can be released or not and
if not, which exception would apply.
The  assessment  is  done  by  DG  SANTE  Unit  in  charge  of  the  request  for  which
concerns DG SANTE documents, but may involve the consultation of the authors of
the  documents  when  the  documents  originate  from  third  parties  and  it  is  not  clear
whether or not an exception would apply.
4.4.1.  Requests for Commissioner/Cabinet documents
The  Commissioners  and  their  Cabinets  do  not  have  correspondents  for  access  to
documents.  The  usual  practice  in  the  Commission  is  that  the  DGs  deal  with  such
requests and reply on behalf of their Commissioner.
The  DG  in  charge  of  the  request  will  contact  the  relevant  Cabinet  and  ask  them  to
provide  the  requested  documents.  As  the  DG  will  make  the  assessment  of  the
disclosure  of  the  documents,  consultation  of  the  Cabinet  may  be  needed  in  order  to
agree on a common position as to the release or not of the relevant documents.
In DG SANTE, the Unit in charge contacts the Cabinet through the Assistants of the
Director-General,  requesting  the  contribution  of  the  Cabinet  for  (1)  identifying  and
providing  the  relevant  document(s)  and  (2)  giving  a  line  to  take  for  the  possible
release  of  the  document(s)  including  details  on  the  applicable  exception(s),  if
relevant.
For  which  concerns  former  Commissioners,  their  files  have  been  transferred  to  the
historical  archives,  therefore  it  is  necessary  to  ask  them  to  make  the  search  in  the
archives,  and  in  case  they  find  relevant  documents,  request  the  documents  from  the
historical archives service, in agreement with the former Heads of Cabinet.
4.5.
Step 5 – Consultation of the authors of the documents
The authors of the documents will be consulted in case of a doubt on the opportunity
to  release  the  requested  documents,  but  not  when  it  is  clear  that  the  documents  are
published  or  have  already  been  made  public.  If  the  identified  third  party  author
(company for instance) does not exist anymore or could not be reached, DG SANTE
will have to decide alone.
The authors of the documents must always be consulted in case the request concerns
a confidential/sensitive document (See Point 2.7.).
The deadline for third parties to reply to a consultation is 5 working days. The initial
application  should  not  be  attached,  and  personal  data  of  the  applicant  cannot  be
disclosed.

16

4.5.1.  Other Commission services
There  is  a  constant  practice  to  consult  the  other  DGs/services  on  their objections  to
the  release  of  requested  documents,  especially  where  an  exception  may  apply
(protection  of  the  internal  decision-making  process,  protection  of  legal  advice,  …)
and on sensitive issues.
If a request concerns documents from the Legal Service, then the initial request must
be  split  and  a  new  request  must  be  created  and  assigned  to  the  Legal  Service  for
which concerns their own documents.
4.5.2.  Other institutions
The  Council,  the  European  Parliament  and  the  Commission  agreed  (through  a
“Memorandum of understanding” signed on 9 July  2002)  to consult  the originating
institution  automatically  in  the  case  of  an  application  for  access  to  a  document  that
the  institution  in  question  had  not  yet  made  public.  The  originating  institution  must
respond quickly, within a maximum of five working days. Clearly, the final decision
must  be  taken  by  the  institution  to  which  the  application  was  sent,  the  originating
institution of the document only having a right of veto if the application relates to a
“sensitive document” within the meaning of Article 9 of the Regulation.
Specific guidance for “Trilogue” documents has been provided by the SG (Note
Ares(2015)282423 of 23/01/2015:

https://myintracomm.ec.europa.eu/sg/docinter/Documents/Guidance note-
Trilogues.pdf
4.5.3.  Member States
Article  4.5 of  the  Regulation  says  that  “A  Member  State  may  request the  institution
not  to  disclose  a  document  originating  from  that  Member  State  without  its  prior
agreement”.  However,  this  does  not  give  the  Member  State  a  general  and
unconditional “right of veto”.
The  note  by  the  Secretariat-General  and  the  Legal  Service  provides  detailed
information  on  the  “right  to  object”  conferred  to  Member  States  following  the
Judgment of the Court of Justice of 18.12.2007 in case C-64/05 P, Sweden and IFAW
v Commission.7
It is mandatory to consult the Member State, unless the document is public. There are
model letters for Member States’ consultations. The initial application should not be
attached,  and  personal  data  of  the  applicant  cannot  be  disclosed.  The  consultations
are  done  through  the  Permanent  Representations  (the  list  of  contact  points  in
Permanent  Representations  is  regularly  updated  by  SG.B.4)  in  the  language  of  the
Member  State  concerned,  and  both  the  consultations  and  the  replies  must  be  duly
registered.


7 https://myintracomm.ec.europa.eu/dg/sante/procedures-guidelines/Documents/doc-access note sg-sj.pdf
17

4.5.4.  Third parties
Commission  services must consult the third party author of a document, unless it is
clear  that  the  requested  document  can  be  disclosed  or  that  an  exception  applies.
Article 4.4 of the Regulation: “As regards third-party documents, the institution shall
consult the third party with a view to assessing whether an exception in paragraph 1
or 2 is applicable, unless it is clear that the document shall or shall not be disclosed”.
There are model letters for third parties’ consultations. The initial application should
not  be  attached,  and  personal  data  of  the  applicant  cannot  be  disclosed.  Both  the
consultation and the reply must be duly registered.
The  third  party  author  who  is  consulted  is  given  a  period  of  5  working  days  for  its
reply, so that it allows the Commission to meet its own deadline for replying to the
application.  In  the  absence  of  any  reply  within  the  stated  period,  or  if  the  author
cannot be found or identified, the Commission will decide according to the system of
exceptions  provided  for  in  the  Regulation,  taking  account of  the  legitimate  interests
of the third party on the basis of the information at its disposal.
4.6.
Step 6 – Reply to the applicant
The Unit will prepare the reply following the assessment of the documents. The reply
may be positive, negative, partially negative or devoid of purpose.
Positive replies shall include the requested document(s) and are signed by the Head
of Unit.
Negative  or  partially  negative  replies  shall  include  the  reference  of  the  requested
document or the list of relevant documents, the relevant exception in Article 4 of the
Regulation, and the concrete explanation why the exception applies to the (parts of)
document(s), and are signed by the Director-General.
Partially  negative  replies  where  only  personal  data  are  redacted  from  the
document(s) may be signed by the Head of Unit (Note SG Ares(2014)3950212).
Negative or partially negative replies may be challenged by the applicant who has the
right  to  send  a  confirmatory  application  to  the  Secretariat-General.  Therefore,  they
should be signed by the Director-General.
Devoid  of  purpose  replies  (document  not  found,  documents  do  not  exist,  etc.)  may
also  be  challenged  by  the  applicant  following  a  recent  Court  case  (Strack  v
Commission, C-127/13 P8). Contrary to negative or partially negative replies, devoid
of purpose replies can be signed by the Head of Unit.
Standard  model  letters  and  typical  electronic  workflows  are  available  on
IntraComm (SG Access to documents web page):

https://myintracomm.ec.europa.eu/sg/docinter/Pages/tools.aspx
and  on  My  SANTE  (Procedures  &  guidelines  –  Access  to  documents):
https://myintracomm.ec.europa.eu/dg/sante/procedures-
guidelines/Pages/documents-access.aspx.

8 Judgment of 2 October 2014, EUR-Lex Document CELEX62013CJ0127.
18

The Secretariat-General has introduced this year the obligation to send all negative or
partially  negative  replies  and  devoid  of  purpose  replies  by  registered  post  with
acknowledgement  of  receipt  (Note  SG  Ares(2014)801872)  and  meeting  Access  to
documents coordinators with SG on 17.03.2015).
4.6.1.  Charges
No charge is made if the documents are consulted on the spot, if the number of copies
requested is no more than 20 A4 pages, or if the document(s) can be accessed directly
in electronic form or via the register.
A system of invoicing may be applied to applications relating to documents of  over
20  pages.  The  rate  charged  is  €0.10  per  page  plus  postage,  i.e.  the  normal  cost  of
photocopying.  The  invoicing  system  is  optional.  You  are  advised  to  invoice  costs
only  in  the  case  of  applications  for  voluminous  documents  or  repetitive  requests.
Departments  can  therefore decide whether or  not  to  invoice costs on a  case by case
basis.
The  charges  for  information  supplied  on  other  media  (computer  data,  audio  tapes,
etc.) will be decided  by the DGs and Services case by case, subject to  the principle
that charges must be reasonable (Article 10 of the Regulation).
See Annex 7 – Procedure for payment through OP
5.
EXCEPTIONS TO THE RIGHT OF ACCESS
The  exceptions  to  the right  of  access  are  listed  in  Article  4  “Exceptions”  of  Regulation
(EC) No 1049/2001. These exceptions are to be interpreted and applied as restrictively as
possible.  A  specific  exception  relates  to  the  protection  of  the  environment  (Aarhus
Convention) and another one to confidential information.
5.1.
Protection of the public interest – Article 4.1 (a)
This  exception  covers  public  security,  defence  and  military  matters,  international
relations, the financial, monetary or economic policy of the Community or a Member
State.  It  can  be  invoked  if  it  is  clear  that  disclosure  would  harm  the  EU’s
international relations with third countries and international organisations, complicate
international  negotiations,  undermine  its  position  in  international  negotiations,
endanger international cooperation in matters like the fight on terrorism, etc.
Examples:
Documents  containing  information  about  plans  to  combat  terrorism  at
Community or Member-State level.
Documents containing information about the positions the Commission intends to
adopt at multilateral negotiations.
This  exception  has  been  used  by  DG  SANTE  for  the  protection  of  international
relations  in  the  context  of  EU-
  discussions  on  GMO’s  and  recently  for  the
protection of international relations with
(Example 1 of Annex 8).
19

In  the  case  in  ’t  Veld  v  Commission,  T-301/109,  access  to  documents  regarding  the
negotiations of the Anti-Counterfeiting Trade Agreement (ACTA) was refused on the
basis of the exception  for protection of the  public interests as regards international
relations in Article 4, paragraph 1 (a), third indent. The General Court confirmed that
a  “certain  level  of  discretion  to  allow  mutual  trust  between  negotiators  and  the
development  of  a  free  and  effective  discussion”  was  necessary  in  the  framework  of
negotiations  of  an  international  agreement.  The  General  Court  also  confirmed  its
previous  jurisprudence  that  “initiating  and  conducting  negotiations  in  order  to
conclude  an  international  agreement  fall,  in  principle,  within  the  domain  of  the
executive”10.

5.2.
The protection of privacy and integrity of the individual – Article 4.1 (b)
This exception prevents the institutions to disclose the identity of third parties and of
some  staff,  i.e.  to  disclose  their  personal  data,  in  order  to  protect  their  privacy  and
integrity.
Examples:
Officials’ personal files, including their medical records
Consultants’ CVs
This  exception  to  the  right  of  access  should  be  interpreted  in  accordance  with
Regulation (EC) No 45/2001 on the protection of personal data.11
(Example 2 of Annex 8)
The  Commission  follows  the  doctrine  that  there  is  no  general  presumption  that
documents  containing  personal  data  are  by  definition  exempted  from  disclosure.
Rather,  every  document  has  to  be  analysed  on  its  own  merits  and  an  overall
assessment has to be made, taking into account:
– any prejudice to the (natural) persons exposed;
– the loyalty [“loyauté”] of processing the personal data; and
– the identity/function of the persons exposed and the implications of the file.
When it comes to the names of Commission staff in documents which are subject to
an access to documents request, the SG has adopted specific guidance:
This approach consists of granting, in principle, access to the names and functions
of  Commissioners  and  their  cabinet  members,  and  staff  in  senior  management
positions  (Secretary-General,  Director-General,  Directors,  Members  of  Cabinet).
This access is exceptionally extended to the names and functions of non-managerial
staff  if  the  need  thereto  has  been  clearly  substantiated  and  there  are  no  reasons  to

9   Judgment of 19 March 2013, EUR-Lex Document CELEX62010TJ0301.
10   Points 119 and 120 of the judgment.
11   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  data,  OJ  L  8,  12.1.2001,  p.  1-22.
http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1439898222939&uri=CELEX:32001R0045

20

assume that the legitimate rights of the individuals concerned might be prejudiced (as
required by Article 8(b) of Regulation EC No 45/2001).
Both at the initial and at confirmatory stage, no access should, in principle, be granted
to  the  names  and  functions  of  non-managerial  staff,  unless  a  clear  need  thereto  is
established  and  there  are  no  reasons  to  assume  that  the  legitimate  rights  of  the
individuals concerned might be prejudiced.
Reference: Note SG Ares(2015)1350426

These first two exceptions in Articles 4.1 (a) and 4.1 (b) apply directly without any other
consideration, whilst the following exceptions apply unless there is an overriding public
interest in disclosure of the documents. To apply these exceptions there is a need to
balance the overriding public interest with the specific interest to be protected.

In reference to the Aarhus Convention an overriding public interest in disclosure shall be
deemed to exist where the information requested related to emissions into the
environment.

5.3.
The protection of commercial interests, including intellectual property –
Article 4.2 1st indent
This exception applies to incoming documents or parts of these documents containing
sensitive  information  whose  release  would  harm  the  commercial  interests  of  the
sender,  documents  bearing  a  marking  like  “business  confidential”  and  (parts  of)
documents subject to confidentiality clauses in the legal basis.
Examples in SANTE:
Some parts of applications from companies in the food additives area.

Some  part  of  information  on  costs  and  tenders  (including  other  commercial  and
industrial  secrets)  provided  by  tenderers  in  connection  with  an  invitation  to
tender.
(Example 3 of Annex 8)

5.4.
The  protection  of  Court  proceedings  and  legal  advice  –  Article  4.2  2nd
indent
As  regards  the  types  of  documents  covered  by  Court  proceedings,  the  Court  has
adopted  a  restrictive  interpretation.  Only  “documents  drawn  up  by  an  institution
solely for the purposes of specific court proceedings” will be covered. These include
pleadings  and  other  documents  lodged,  internal  documents  concerning  the
investigation  of  the  case  at  hand,  correspondence  concerning  the  case  between  the
Directorate-General involved and the Legal Service or a lawyers’ office. Documents
drawn  up  in  connection  with  a  purely  administrative  matter  are,  however,  not
covered.
As regards legal advice, it covers legal advice given in the framework of legislative
and administrative processes and aims at protecting legal advice to the institution’s
interest in receiving frank, objective and comprehensive legal advice.
Examples:
Opinions given by the Legal Unit on a draft legislative proposal.

Defence pleas.
(Example 4 of Annex 8)
21

5.5.
The protection of inspections, investigations and audits – Article 4.2 3rd
indent
To rely  on  this  exception, the institutions need to  show, not only  that the document
concerns an inspection or investigation, but, more importantly, that its disclosure will
endanger  the  purpose  and  outcome  of  the  inspections,  investigations  or  audit.  In
general, the exception can be invoked as long as the investigations or inspections are
on-going.
Examples:
Audit report drawn up by a Commission department following an alleged fraud.
Documents drawn up by a department or received from a Member State as part of
an on-going investigation into a possible failure to comply with Community law.
(Example 5 of Annex 8)
5.6.
The protection of the institutions decision-making process – Article 4.3
This article is meant for the protection of the “space to think” in the context of  the
internal and inter-institutional decision-making process, i.e.:

–  the protection of internal deliberations before (1st paragraph) the decision has
taken place; and
–  the protection of internal deliberations even after (2nd paragraph) the decision has
taken place.
This  provision  explicitly  requires  there  to  be  a  serious  undermining  of  the
institution’s  decision-making  process.  It  is  also  subject  to  a  balancing  test  requiring
the  protected  interest  to  be  weighed  off  against  any  potential  overriding  public
interest in disclosure.
Documents refused on the ground of this exception include:
Before the decision (Article 4.3 1st paragraph):

Successive  versions  of  a  draft  legislative  proposal  and  the  various  contributions
from  third  parties,  before  adoption  of  the  instrument  by  the  institution.
Annual  activity  reports  before  the  adoption  of  the  summary  report  by  the
Commission.
(Example 6 of Annex 8)

After the decision (Article 4.3 2nd paragraph):

Special  Commission  Minutes  (which  contain  the  Members’  individual  views
expressed during the discussions).

Opinions given as part of inter-service consultations on sensitive topics.

Briefing notes for Members of the Commission.

Individual  opinions  of  members  of  a  selection  board  or  assessors  in  a  tendering
procedure.
(Example 7 of Annex 8)
22

5.7.
The  protection  of  the  environment  –  Exception  in  Article  6.2  of
Regulation (EC) No 1367/2006 on the Aarhus Convention
This  exception  concerns  the  access  to  environment  information  where  disclosure  of
the information would adversely affect the protection of the environment to which the
information relates, such as the breeding sites of rare species.
5.8.
Confidentiality clauses
Some  specific  legislative  acts  contain  confidentiality  clauses  setting  out  the
conditions  in  which  certain  documents  or  information  may  be  disclosed.  A  detailed
analysis of over 120 specific provisions in Community legislation in force shows that
they tend to fall into two categories.
Some  specific  rules  should  be  regarded  as  special  cases  falling  within  one  of  the
general  exceptions  set  out  in  Article  4  of  Regulation  (EC)  No  1049/2001.  An
examination of these  rules  has  not  shown any incompatibility with  the principles  of
the Regulation. The interests they protect correspond to those that constitute grounds
for refusing access under the exceptions provided for by the Regulation. Accordingly,
any refusal to grant access to a document must be justified on the basis of one of the
exceptions  provided  for  in  Regulation  (EC)  No  1049/2001,  the  reference  to  the
specific legal instrument serving merely to support the justification.
Other  clauses  grant  interested  parties  specific  rights  of  access  going  beyond  the
public  right  of  access.  The  more  favourable  specific  provisions  which  relate  to
transparency, and provide for greater access for certain categories of person in view
of their status as “parties” to a procedure, should be considered to be “lex specialis”
in  relation  to  the  Regulation.  Under  these  rules,  certain  people  will  therefore  be
granted  access  to  documents  which  would  not  be  accessible  to  the  public  under  the
system of exceptions provided for by Article 4 of the Regulation.

Contact persons in SANTE/A4:
, tel.


, tel.

Mailbox:

SANTE ACCESS TO DOCUMENTS

Contact persons in SANTE/A2
for negative and partial access replies:
, tel.


, tel.

23

ANNEX 1 – Basic principles of Regulation (EC) No 1049/2001

Regulation (EC)
The  public  has  the  right  to  access  all  documents  of  the
No 1049/2001
institutions,  unless  there  is  an  exception  (protection  of  private
or public interests).
Who gives access?
The  Council,  The  European  Parliament,  the  Commission  and  its
agencies
Who is the public?
Any citizen and any natural or legal person in the world
Which documents?
All documents drawn up by an institution OR received by it and in
its  possession  (documents  from  third  parties  or  from  Member
States),  which  are  not  published  (by  EUR-OP  for  example)  or
which  are  not  made  available  to  the  public  (through  Europa  for
example).
Written requests
Regular mail or
Addressed
Fax or
to DG SANTE or
E-mail or
directly to the competent Unit or
Electronic form posted
via the Secretariat-General or
on Europa
via another Directorate-General

3 basic principles :
For
holding
reply   15  working  days  from  the  day  after  the
and for reply
date of registering of the request
  Strict deadlines
No reply within the deadline = refusal without a reason
  Reasoned refusal  The decision to refuse to grant access to a document or to part(s) of
a  document  MUST  be  given  a  REASON  based  on  one  of  the
exceptions  provided  for  in  Article  4  of  Regulation  (EC)  No
1049/2001.
  Means of redress  In  case  of  refusal  OR  Confirmatory  application  to  the
partial access
Secretary-General  against  the  decision  of
the DG
If refusal is confirmed
– Complaint to the Ombudsman (EU
citizens only)
– Court of First Instance Proceedings
(Court of Justice)

24

ANNEX 2 – ARES tip on how to deal with pending assignment tasks
Dear Ares users,
We  would  like  to  inform  you  that  there  are  a  lot  of  attribution  tasks  with  a  passed
deadline (especially CF/ASOC/INFO) and which are not closed although, in general, the
necessary work has been done.
Why do we have this situation?
1.  The  work  is  not  done,  the  deadline  has  passed  and  consequently  the  task  is  not
closed
Please  check  your  Ares  profile  regularly  to  see  if  you  have  received  any  tasks  with  or
without an associated deadline (the “Notis” configuration may also facilitate your work).
You  should  treat  your  task  before  its  deadline  or  in  a  reasonable  time  if  no  deadline  is
specified.
Sometimes the deadline for a CF task can be modified. In order to modify it in Ares, and
thus  avoiding  false  reports  concerning  the  deadline  (obtained  under  “Deadlines”  menu
corresponding  to  secretaries  and  managers),  please  take  into  account  the  indications
given in the document:
How to deal with a deadline which has been modified/postponed (See Annex 3)
2. The work is done, but the person who received the task has forgotten to close it
Please  keep  in  mind  that  the  tasks  have  to  be  closed  manually  after  having  done  the
necessary  work  (you  do  this  by  clicking  on  the  “Finish”  or  “Finish  with  comments”
buttons from the “Assignment” tab of your document). For example:
a) If you receive a CF or ASOC task for a document, you should create a draft reply and
when it is registered (in other words, finalised) you should close your CF or ASOC task
in  Ares.  This  will  ensure  that  your  work  has  been  completed.  If  you  leave  your  task
unclosed, the report with the deadlines/unclosed tasks will be affected, even if the work
itself was done.
b) If you receive an INFO task for a document, you should read the document and then
close  your  task  (by  clicking  on  “Finish”  or  “Finish  with  comments”  buttons  from  the
“Assignment” tab of your document).
c)  If  you  receive  a  CLASS  task,  you  should  file  the  document  into  the  corresponding
folder and your task will be closed automatically by Ares.
Attention!!! CLASS is the only task closed automatically by Ares after doing the work
indicated by the task code.

25

ANNEX 3 – Deadlines/Open tasks reports – How to check not-finished tasks
How to be informed about pending tasks of your Unit?
If you are secretary or manager, the option from your Ares vertical menu enables you to
see what the pending tasks of your Unit are.

Important!  As  secretary,  you  need  to  check  this  option  under  the  virtual  entity  profile
(using “Change role”).
The report includes tasks received by all Unit members (i.e. desk officers, HoU/Director)
and by Unit virtual entity (i.e. secretaries).
How does it work?
1.  Clicking  on  Deadline  List  TAB
  you  can  see  open  tasks
received by your Unit, where a deadline is specified by the sender of the task.
By pointing to the cards from the report
, you can quickly see how much time is
left until your deadlines expire.
2.  Open  tasks  TAB
  shows  all  non-closed  tasks  of  your  Unit,
with and without a deadline. So, if you want to see the whole situation of your Unit tasks,
here is where you need to check.
If  you  click  on  arrows  from  the  top,  you  can  sort  the  data.  Both  reports  can  be  also
exported as an Excel sheet.
When  a  task  displayed  in  the  reports  is  closed  by  its  recipient,  the  task  will  disappear
from the reports.
We recommend that a secretary from the virtual entity checks at least once a week
the above reports and:
– reminds people concerned about non-closed tasks;
– deals with CLASS tasks.

26

ANNEX 4 – How to deal with a deadline which has been changed?

The
following
scenario
(when
deadline
for
assignment
task
has
been
modified/postponed) can be applied to CF and ASOC tasks.
Let’s say that the  secretary or CAD  launches a CF task with a deadline of 15 days and
thereafter  the  deadline  is  postponed  by  5  days  (initial  deadline  +  5  days).  In  order  to
apply this in Ares:
– the secretaries from the Unit (or CAD) assign another CF with the new deadline
(Important:  in  the  comments  field  of  the  new  task  the  secretaries  (or  CAD)
should specify that the deadline was changed)
and
– the person who received the first CF task (the desk officer or the virtual entity) should
close it with comments indicating that a new deadline was added.

27

ANNEX 6 – Disproportionate amount of work
Initial request concerning 35 different consultations:
Dear Health and Consumers (SANCO),
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
pertaining  to  Consultation  periods  opened  regarding  Food  Safety.  I  am  specifically
requesting  copies  (not  summaries)  of  the  original  consultations  (also  described  as
opinions  or  comments  received)  SANCO  received  regarding  the  following  consultation
topics (titles are listed):
1.  Consultation  on  administrative  burden,  administrative  costs  and  compliance  costs
related to current Animal Health legislation and the new possible elements of the Animal
Health Law.
2.  On  line  consultation  on  a  staff  working  paper  of  the  services  of  the  Commission  on
antimicrobial resistance
3. On-line consultation on the protection of animals during transport
[……….]
35. Consultation on the Opinion of the Scientific Steering Committee on Oral exposure of
Humans to the BSE agent: infective dose and species barrier.
The consultations listed above can be re-listed here:
http://ec.europa.eu/food/consultations/index en.htm
Gestdem
to

Final reply:
Concerning  the  remaining  requests  (GestDem  No.
  -
  -
  -
  -
-
-
-
-
-
-
-
numbers 1, 2, 3, 5, 17, 22, 23,
25,  28,  29  and  30  in  the  attached  table,  I  regret  to  inform  you  that  my  services  are  no
longer able to retrieve the relevant documents.
The  received  opinions,  if  any,  may  not  have  been  registered  in  our  electronic
repositories,  while  the  persons  involved  are  no  longer  in  the  Directorate-General.  The
retrieval  in  paper  archives  would  mean  days  of  searches  for  many  different  Units,
without  knowing  exactly  what  result  to  expect.  According  to  the  ruling  of  the  Court  of
First  Instance  in  Verein  für  Konsumenteninformation  v.  Commission1  (VKI)  when  a
request  relates  to  a  very  large  number  of  documents  and  so  imposes  a  volume  of  work
which is likely to undermine the work of its services, the Commission retains the right to
balance the interest in public access to documents with that of good administration.
In  light  of  the  circumstances  set  out  above,  I  consider  that  the  handling  of  those
remaining  requests  would  entail  a  disproportionate  administrative  burden  for  my
services and, therefore, cannot be carried out.

Ref.
–

29

ANNEX 7 – Charges
If the DG or Service intends to invoice costs, it must notify the applicant before sending
the document.
If the requestor agrees to the charge, the department will send a second letter, using the
model hereafter. This covering letter must always specify the number of pages, to enable
EUR-OP to calculate the charge.
A  copy  of  this  letter  must  be  sent  immediately  to  EUR-OP  to  enable  it  to  produce  the
invoice and follow up the payment. The copy should be sent to
(EUR-
OP, Distribution Department).
If necessary a document should be attached to the copy intended for EUR-OP setting out
the various details required for billing:

–  DG,  department,  official  responsible  for  the  file,  administrative  address,  telephone
number;

–  requester’s name and address for invoice;
–  description  of  the  documents  sent,  exact  number  of  pages,  date  of  dispatch;
–  cost of post and packaging;

–  list of people who should be sent a copy of the confirmation of dispatch of the invoice.
SENDING A DOCUMENT OF MORE THAN 20 PAGES
for which the DG or department intends to make a charge
Dear Mr/Mrs/Ms ....,
Thank you for your letter/e-mail/fax of XXX, which we received on XXX, in which
you apply for access to documents in accordance with Regulation (EC)
No 1049/2001 regarding public access to European Parliament, Council and
Commission documents.
I would draw your attention to the fact that you will be asked to pay €0.10 per page
plus €.... postage for this ... page copy in order to cover the costs of reproduction.
Please would you confirm that you wish to proceed with your application, by letter
or by fax (32/2/29 ......), as soon as possible.
Yours sincerely,
IF THE REQUESTER REPLIES THAT HE WISHES TO PROCEED WITH
HIS APPLICATION
Dear Mr/Mrs/Ms ....,
Thank you for your letter/e-mail/fax of ...., which we received on ...., in which you
apply for access to documents in accordance with Regulation (EC) No 1049/2001
regarding public access to European Parliament, Council and Commission
documents.
Please find enclosed a copy of the document(s) which I hope you will find useful.
You will shortly be receiving an invoice, with an indication of the payment
arrangements, for the delivery of this copy of ... pages. I would remind you that the
document(s) may not be copied for commercial purposes without prior permission
from the Commission.
Yours sincerely,
Copy:
(EUR-OP, Distribution Department)

30

ANNEX 8 – Examples of the use of the exceptions in SANTE
-----------------------------------------------------------------------------
Example 1
Exception “protection of international relations” – Article 4.1 (a) 3rd indent

“We refer to your letter to  Commissioner Dalli of
in  which you ask for a
copy of the letter from
to the European Commission concerning
the presence of non-authorised GMO in basmati rice. This is a follow-up request to your
application  registered  as  GestDem
  under  Regulation  No  1049/200112
regarding public access to European Parliament, Council and Commission documents.
As  indicated  in  our  letter  of
  (
),  the

sent  an  official  letter  to  the  European  Commission  on
.  Given  that  the  letter
originates from a third party, we have consulted the
on your request
in accordance with Article 4 (4) of Regulation 1049/2001/EC which states: "As regards
third-party  documents,  the  institution  shall  consult  the  third  party  with  a  view  to
assessing whether an exception in paragraph 1 or 2 is applicable, unless it is clear that
the document shall or shall not be disclosed".


12   OJ  L145, 31.05.2001, page 43.
13   That  provision  reads:  "The  institutions  shall  refuse  access  to  a  document  where  disclosure  would
undermine the protection of international relations".
31

Example 2
Exception “protection of privacy” – Article 4.1 (b)

Model letter for EU or EEA recipients14
“[Some of the documents] [The] document/documents to which you have requested access
contains/contain personal data [, in particular: (specify if necessary)].
Pursuant to Article 4(1) (b) of Regulation (EC) No 1049/2001, access to a document has to
be refused if its 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. The applicable legislation in this field is  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 data15.

When  access  is  requested  to  documents  containing  personal  data,  Regulation  (EC)  No
45/2001 becomes fully applicable16.
According  to  Article  8(b)  of  this  Regulation,  personal  data  shall  only  be  transferred  to
recipients if they establish the necessity of having the data transferred to them and if there is
no reason to assume that the legitimate rights of the persons concerned might be prejudiced.
We  consider  that,  with  the  information  available,  the  necessity  of  disclosing  the
aforementioned  personal  data  to  you  has  not  been  established  and/or  that  it  cannot  be
assumed  that  such  disclosure  would  not  prejudice  the  legitimate  rights  of  the  persons
concerned.  Therefore,  we  are  disclosing  the  documents  requested  expunged  from  this
personal data.
In  case  you  would  disagree  with  the  assessment  that  the  expunged  data  are  personal  data
which can only be disclosed if such disclosure is legitimate under the rules of personal data
protection,  you  are  entitled,  in  accordance  with  Article  7(2)  of  Regulation  1049/2001,  to
make a confirmatory application requesting the Commission to review this position.
Such a confirmatory application should be addressed within 15 working days upon receipt
of this letter to the Secretary-General of the Commission at the following address:
European Commission
Secretary-General
Transparency unit SG-B-4
BERL 5/327
B-1049 Bruxelles
or by email to: xxxxxxxxxx@xx.xxxxxx.xx
Yours faithfully,”

14  Another model to be used when the recipients are from Third countries or International organisations is
available. In case of doubt, please contact SANTE/A4.
15  OJ L 8 of 12.1.2001, p. 1
16  Judgment of the Court of Justice of the EU of 29 June 2010 in case 28/08 P, Commission/The Bavarian
Lager Co. Ltd, ECR 2010 I-06055.
32

Example 3
Exception “protection of commercial interests” – Article 4.2 1st indent

“I  understand  your  request  to  refer  to  all  documents  containing  data  on  the  approval  of
L-selenomethionine as a source of selenium in food supplements.

We believe that the following documents fall under the scope of your request:
1.  Technical  dossier  for  the  use  of  L-selenomethionine  in  foods  for  particular
nutritional  uses  (PARNUTS)  and  supplements.
.  Submitted  by

on behalf of the petitioner,
,
.
2.  Technical  dossier  on  L-selenomethionine  for  use  in  the  manufacture  of  foods
supplements.
.  Submitted  by

,

3.  Technical  dossier  on  L-selenomethionine  for  adding  to  Directive  2002/46/EC
Annex II. December,

,
.
4.  Technical  dossier  for  safety  evaluation  of  selenomethionine  for  use  in  the
manufacture  of  foods  supplements.
.  Submitted  by

5.  Technical  dossier  on  selenomethionine.

.  Submitted  by

You have been informed by letter on
and on
that the documents
you  have  requested  originate  from  third  parties  and,  in  accordance  with  Article  4(4)  of
Regulation  (EC)  No  1049/2001,  it  was  necessary  that  these  third  parties  were  consulted
before taking a decision on their disclosure.

Following consultation, we are happy to grant you full access to documents number 2 and 5
and partial access to document number 1. I must remind you that these documents cannot
be reproduced or disseminated for commercial purposes unless the Commission or their
author has first been consulted and has agreed to the publication.

The author of the dossier identified by number 1 agrees that the Commission discloses the
dossier  only  after  protecting  information  relating  to  its  commercial  interests  and  which
includes  a  description  of  the  composition  of  specific  finished  products,  as  well  as  their
manufacturing  process.  Such  information  (included  in  Annexes  4,  5A,  5B  and  6  of  the
dossier) is to be protected in accordance with Article 4(2) first indent of Regulation (EC)
No 1049/2001217 by being blackened out.

In  relation  to  the  dossiers  identified  by  number  3  and  number  4,  my  services  consulted
  and
  on  your  request.


17   The  institutions  shall  refuse  access  to  a  document  where  disclosure  would  undermine  the  protection  of
commercial interests of a natural or legal person, including intellectual property…unless there is an overriding
public interest in disclosing.
33

Article  4(2)  first  indent  of  Regulation  (EC)  No  1049/20012  applies  "unless  there  is  an
overriding public interest in disclosing."

  In  these
circumstances,  I  have  to  conclude  that  there  is  no  evidence  of  an  overriding  public
interest in disclosure, in the sense of Regulation (EC) No 1049/2001. The public interest
in this case is rather to protect the Commission's decision-making process.”

34

Example 4
Exception “protection of court proceedings and legal advice” –
Article 4.2 2nd indent

“Thank  you  for  your  email  dated
  and  registered
  (No
GESTDEM
)  requesting  access  to  documents  under  Regulation  (EC)  No
1049/2001,  regarding  public  access  to  European  Parliament,  Council  and  Commission
documents.
We understood your request as covering all communication between the Commission and
the European Food Safety Authority (EFSA) and all internal Commission documents as
of 1st May 2010 relating to the implementation of Regulation (EC) No 1924/2006 with
regard to botanical substances.
[…]
A list of all relevant communication exchanged between the Commission and EFSA, as
well as a list of internal registered communications of the Commission are enclosed.
[…]
The  two  internal  registered  documents  entitled  'Regulation  1924/2006:  Adoption  of  the
permitted  list  -  consideration  of  claims  for  botanical  ingredients'  and  'Reply  from  the
Legal Service to the consultation Ares (2010)798888 launched by DG SANCO', also aim
at  exploring  the  possible  options  for  the  treatment  of  botanicals.  They  contain  a  legal
analysis on such options.
Having carefully examined their content, we consider that they cannot be disclosed since
they  are  covered  by  the  exceptions  provided  for  in  Article  4(2)  second  indent  and  in
Article 4(3) first paragraph of Regulation (EC) No 1049/2001.
35

Ref.
–

36

Example 5
Exception “protection of investigations, inspections an audit” –
Article 4.2 3rd indent

“In  particular,  you  would  like  to  have  access  to:  correspondence  between  the
Commission and public and/or private entities or associations on the subject of Spanish
breeders of German shepherd dogs.
We understand your request refers to correspondence between the Commission and

.  Please  note  that  so  far  such
correspondence  includes  Commission  request  for  information  of
  on  the
manner in which
implements Directive 91/174/EEC  laying down zootechnical and
pedigree requirements for the marketing of pure-bred animals concerning recognition of
animal pedigrees.
I  regret  to  inform  you  that  this  document  is  exempted  from  access  according  to  Article
4(2)  third  indent  of  the  Regulation.  This  provision  does  not  allow  for  disclosure  of
documents  on  a  matter  under  examination  by  the  Commission,  unless  there  is  an
overriding public interest.
Partial  access  to  the  requested  document  in  accordance  with  Article  4(6)  of  Regulation
(EC) No 1049/2001 is not possible since the document in question is covered entirely by
the exception in Article 4(2) third indent.
According to Article 4(2), access shall be granted if there is an overriding public interest
in  disclosure.  In  your  application  you  did  not  submit  any  grounds  concerning  a public
interest  on  the  basis  of  which  the  interests  protected  in  the  Regulation  (EC)  No
1049/2001 would have to be overridden.”

37

Example 6
Exception “internal decision-making process before decision” – Article 4.3 1st par.

“Your application concerns the following document:
Draft Commission Implementing Regulation laying down lists of third countries, territories
or  parts  thereof  authorised  for  the  introduction  into  the  European  Union  of  frogs'  legs,
snails,  gelatine,  collagen,  material  for  the  production  of  collagen  and  gelatine  and  honey,
royal  jelly  and  other  products  of  apiculture  for  human  consumption  and  the  health
certificates requirements, amending Regulation (EC) No 2074/2005 and repealing Decision
2003/812/EC.
Having  examined  the  document  requested  under  the  provisions  of  Regulation  (EC)  No
1049/2001  regarding  public  access  to  documents,  I  regret  to  inform  you  that  your
application  cannot  be  granted,  as  disclosure  is  prevented  by  an  exception  to  the  right  of
access laid down in Article 4 of this Regulation.
Therefore the exception laid down in Article 4(3) first subparagraph of Regulation (EC) No
1049/2001 applies to this document19.
We have considered whether partial access could be granted to the document requested.
The document is entirely covered by the exceptions.
The  exception  laid  down  in  Article  4(3)  first  subparagraph  applies  "unless  there  is  an
overriding public interest."

In these circumstances, I have to conclude that
there  is  no  evidence  of  an  overriding  public  interest  in  disclosure,  in  the  sense  of
Regulation  (EC)  No  1049/2001.  The  public  interest  in  this  case  is  rather  to  protect  the
Commission's decision-making process.”


18 For more information on  SCFCAH  meetings:
http://ec.europa.eu/dgs/health consumer/dgs consultations/regulatory committees en htm
19 Article 4(3) first subparagraph reads as follows: "Access to a document, drawn up by an institution for
internal use or received by an institution, which relates to a matter where the decision has not been taken
by the institution, shall be refused if disclosure of the document would seriously undermine the institution's
decision-making process, unless there is an overriding public interest in disclosure."
38

Example 7
Exception “internal decision-making process after decision” – Article 4.3 2nd par.
[Reply to confirmatory application]
“I refer to your letter of
, registered on
, in which you lodge a
confirmatory  application,  pursuant  to  Regulation  1049/2001  regarding  public  access  to
European Parliament, Council and Commission documents, for a review of a reply from the
Directorate-General for Health and Consumers to your request for access to draft versions of
the  Impact  Assessment  Report  regarding  the  possible  revision  of  the  Tobacco  Products
Directive 2001/37/EC.
I refer further to the Commission's letters of
and of
, extending
the time-limit for handling your above application. I apologise for the time it took us to reply,
which was due to the need to carry out a full analysis of your request.
1. SCOPE OF YOUR REQUEST
You request access to the following Commission documents:
(i)  The  version  of  the  Impact  Assessment  Report  as  submitted  by  the  Commission  to  the
Impact Assessment Board on 21 March 2012 ;
(ii)  The  version  of  the  Impact  Assessment  Report  as  submitted  by  the  Commission  to  the
Impact Assessment Board on 11 June 2012 ;
(iii) Any marked-up versions of the Impact Assessment Report submitted by the Commission
to  the  Impact  Assessment  Board  on  21  March  2012,  drafted  by  the  Commission  following
submission of the version of the Impact Assessment Report to the Impact Assessment Board
on 21 March 2012 and between submission of the version of the Impact Assessment Report
to the Impact Assessment Board on 11 June 2012;
(iv) Any marked-up versions of the Impact Assessment Report submitted by the Commission
to  the  Impact  Assessment  Board  on  11  June  2012,  drafted  by  the  Commission  following
submission of the version of the Impact Assessment Report to the Impact Assessment Board
on 11 June 2012 and between the publication of the final Impact Assessment Report on 19
December 2012 (SWD(2012)425 final).
After having examined the scope of your request, we understand that points (iii) and (iv) of
your  request  are  limited  to  track-changed  versions  of  the  Impact  Assessment  Report.  We
have not been able to identify any track-changed versions of the Impact Assessment Report
that would correspond to your original requests under (iii) and (iv) above and fall within the
scope  of  Regulation  1049/2001.  Therefore  the  only  documents  at  our  disposal  are  those
mentioned  under  (i)  and  (ii)  of  your  request,  i.e.  the  versions  submitted  to  the  Impact
Assessment board on 21 March and 11 June 2012. Your requests under (iii) and (iv)  above
are hence devoid of purpose.
2.  ASSESSMENT  OF  YOUR  REQUEST  AND  CONCLUSIONS  UNDER
REGULATION 1049/2001
39

3. MEANS OF REDRESS
Finally,  I  draw  your  attention  to  the  means  of  redress  available  against  this  decision.  You
may, under the conditions of Article 263 TFEU, bring proceedings before the General Court
or,  under  the  conditions  of  Article  228  TFEU,  file  a  complaint  with  the  European
Ombudsman.
Yours faithfully,”
Ref.
–

41