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Evidence-based communications. Inform. Measure. Monitor. Succeed.
Free Webinar - 22 May 2013 -1-2pm
Please turn up your computer speakers or put on your headsetYou can ask questions in writing in the chat panel
Regulatory Affairs: What you should know about implementing and delegated acts
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Free Webinar - 22 May 2013 -1-2pm
Please turn up your computer speakers or put on your headsetYou can ask questions in writing in the chat panel
WELCOME to the 3rd FREE webinar
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ABOUT THE WEBINAR SERIES
1
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EU Lobbying, Ethics & Transparency: "Do"-s and
"Don't"-s
Risk Regulation in the EU: Sectors, Advocacy and the Precautionary
Principle
Regulatory Affairs Explained: What you
must know about implementing & delegated acts
How to Master EU Interest Representation:
The BM guide to EU lobbying best practices
7 Tips for Effective EU Public Affairs: Practical
ideas to reach the highest impact for your issue
Digital Communication in EU Affairs: How to master Twitter, Linkedin & social
media in public affairs
EU Public Affairs Forecast until June 2014: What to expect until the end of Barroso II and beyond?
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GOOD TO KNOW
2
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Turn off your Outlook, Skype and other programs
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Evidence-based communications. Inform. Measure. Monitor. Succeed.
Turn off your Outlook, Skype and other programs
Ask via chat in the bottom left chat box
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Evidence-based communications. Inform. Measure. Monitor. Succeed.
Turn off your Outlook, Skype and other programs
Ask via chat in the bottom left chat box
Questions will be answered during & after the presentation
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Evidence-based communications. Inform. Measure. Monitor. Succeed.
Turn off your Outlook, Skype and other programs
Ask via chat in the bottom left chat box
Questions will be answered during & after the presentation
Presentation will take approx. 40 mins, followed by Q&A
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Turn off your Outlook, Skype and other programs
Ask via chat in the bottom left chat box
Questions will be answered during & after the presentation
Presentation will take approx. 40 mins, followed by Q&A
The webinar is being RECORDED
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Turn off your Outlook, Skype and other programs
Ask via chat in the bottom left chat box
Questions will be answered during & after the presentation
Presentation will take approx. 40 mins, followed by Q&A
The webinar is being RECORDED
Recording & PPT will be made available within 3 days
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Evidence-based communications. Inform. Measure. Monitor. Succeed.
Turn off your Outlook, Skype and other programs
Ask via chat in the bottom left chat box
Questions will be answered during & after the presentation
Presentation will take approx. 40 mins, followed by Q&A
The webinar is being RECORDED
Recording & PPT will be made available within 3 days
Transcript will be available within 1 week
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SPEAKER & ORGANISER
3
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SPEAKERDavid O’Leary:
Director at Burson-Marsteller Brussels. He specialises in the workings of the EU institutions and in policy areas such as food, consumer goods and ICT.
Regulatory Affairs: What you should know about implementing and delegated acts
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SPEAKER MODERATORDavid O’Leary András BANETH
Director at Burson-Marsteller Brussels. He specialises Director – European Training Academyin the workings of the EU institutions and in policy areassuch as food, consumer goods and ICT.
Regulatory Affairs: What you should know about implementing and delegated acts
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THE PRESENTATION
4
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THE NEW COMITOLOGY: WHAT YOU SHOULD
KNOW ABOUT IMPLEMENTING AND DELEGATED ACTS
David O’Leary // Burson-Marsteller Brussels
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TODAY’S PRESENTATION
Part 1Comitology basics: what, who, why, when?
Part 2New comitologya) Delegated actsb) Implementing acts
Part 3Conflicts and controversies
Part 4Tips for working with the new comitology
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Evidence-based communications. Inform. Measure. Monitor. Succeed.Evidence-based communications. Inform. Measure. Monitor. Succeed.
PART 1COMITOLOGY BASICS:
WHAT, WHO, WHY, WHEN?
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WHAT IS COMITOLOGY?
• ‘Filling in the gaps’ or ‘dealing with details’• ‘An obscure system for taking important decisions’
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WHAT IS COMITOLOGY?
• A way of ‘filling in the gaps’ or ‘dealing with details’• An obscure system for taking big decisions
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WHAT IS COMITOLOGY?
Affects a wide range of sectors:
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Commission
EP Council
CO-DECISION
PROPOSES LEGISLATION
WHAT IS COMITOLOGY?12
to
48
mo
nth
s
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Commission
EP Counil
CO-DECISION
PROPOSES LEGISLATION
WHAT IS COMITOLOGY?
NON-LEGISLATIVE ACTS(VIA COMITOLOGY)
EP CouncilCommission(+ experts)
12 t
o 4
8 m
on
ths
2 d
ays
to s
ever
al m
on
ths
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BASIC ACT
WHO’S INVOLVED?
COMMISSION ADOPTS NON-LEGISLATIVE ACT
Consults expert committees
Commissionproposes
Legislator (EP & Council)
controls(scrutiny or
veto)
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WHO’S INVOLVED
Around 250 committees of national experts, chaired by the Commission
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WHY COMITOLOGY?
• Speed: faster than co-decision• Efficient: does not block EP/Council• Reactive: no need to convene ministers, MEPs• Expertise: technical details need specialist knowledge
But:• Democracy?• Accountability?• Transparency?
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A BRIEF HISTORY OF COMITOLOGY
60s
CAP needs rulesAd hoc procedures
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A BRIEF HISTORY OF COMITOLOGY
60s
CAP needs rulesAd hoc procedures
70s
Rapid development
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A BRIEF HISTORY OF COMITOLOGY
60s
CAP needs rulesAd hoc procedures
70s
Rapid development
1987
First horizontal rules
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A BRIEF HISTORY OF COMITOLOGY
60s
CAP needs rulesAd hoc procedures
70s
Rapid development
1987
First horizontal rules
1999
New horizontal decision + EP involved
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A BRIEF HISTORY OF COMITOLOGY
60s
CAP needs rulesAd hoc procedures
70s
Rapid development
1987
First horizontal rules
20061999
Amended rules: RPS + EP veto
New horizontal decision + EP involved
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A BRIEF HISTORY OF COMITOLOGY
60s
CAP needs rulesAd hoc procedures
70s
Rapid development
1987
First horizontal rules
2009 20061999
Lisbon: Delegated & Implementing Acts
(plus RPS ‘hangover’)
Amended rules: RPS + EP veto
New horizontal decision + EP involved
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Evidence-based communications. Inform. Measure. Monitor. Succeed.Evidence-based communications. Inform. Measure. Monitor. Succeed.
PART 2NEW COMITOLOGY :
CHANGES AFTER LISBON
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THE PRE-LISBON REGIME
• One legal basis:Article 202 EC
• One legal framework / set of rules:Comitology Decision (Council Decision 1999/468)
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THE POST-LISBON REGIME
• Two legal bases:Delegated acts (DAs): Articles 290 TFEUImplementing acts (IAs): Article 291 TFEU
• Two legal frameworks / sets of rules:DAs: Article 290IAs: Article 291 + Comitology Regulation (Council and EP Regulation 182/2011)
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CHOOSING THE RIGHT PROCEDURE
Delegated acts
Non-legislative act
Amend/supplement legislation
Non-essential
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CHOOSING THE RIGHT PROCEDURE
Delegated acts
Non-legislative act
Amend/supplement legislation
Non-essential
Implementing acts
Non-legislative act
Implement legislation
Often essential
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Evidence-based communications. Inform. Measure. Monitor. Succeed.Evidence-based communications. Inform. Measure. Monitor. Succeed.
In detail:Delegated acts
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DELEGATED ACTS: KEY FEATURES
• No formal committees of national experts:Commission formally acts alone (but… informal consultation with national experts)
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DELEGATED ACTS: KEY FEATURES
• No formal committees of national experts:Commission formally acts alone (but… informal consultation with national experts)
• No horizontal procedure, only treaty rules:Legislator decides case-by-case on how to delegate(but… ‘common understanding’ to avoid confusion)
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DELEGATED ACTS: KEY FEATURES
• No formal committees of national experts:Commission formally acts alone (but… informal consultation with national experts)
• No horizontal procedure, only treaty rules:Legislator decides case-by-case on how to delegate(but… ‘common understanding’ to avoid confusion)
• Strong powers for legislatorEither EP or Council can veto measure or revoke power
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DELEGATED ACTS: KEY FEATURES
• No formal committees of national experts:Commission formally acts alone (but… informal consultation with national experts)
• No horizontal procedure, only treaty rules:Legislator decides case-by-case on how to delegate(but… ‘common understanding’ to avoid confusion)
• Strong powers for legislatorEither EP or Council can veto measure or revoke power
• Inter-institutional parityEP and Council have equal powers, right to information(but… informal consultation with national experts)
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Evidence-based communications. Inform. Measure. Monitor. Succeed.
DELEGATED ACTS: KEY FEATURES
• No formal committees of national experts:Commission formally acts alone (but… informal consultation with national experts)
• No horizontal procedure, only treaty rules:Legislator decides case-by-case on how to delegate(but… ‘common understanding’ to avoid confusion)
• Strong powers for legislator:Either EP or Council can veto measure or revoke power
• Inter-institutional parity:EP and Council have equal powers, right to information(but… informal consultation with national experts)
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‘COMMON UNDERSTANDING’
• No horizontal procedure, only treaty rules:Legislator decides case-by-case on how to delegate – in terms of objectives, content, duration and scope
Common understanding gives basic models:
Evidence-based communications. Inform. Measure. Monitor. Succeed.
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Evidence-based communications. Inform. Measure. Monitor. Succeed.
DELEGATED ACTS: KEY FEATURES
• No formal committees of national experts:Commission formally acts alone (but… informal consultation with national experts)
• No horizontal procedure, only treaty rules:Legislator decides case-by-case on how to delegate(but… ‘common understanding’ to avoid confusion)
• Strong powers for legislator:Either EP or Council can veto measure or revoke power
• Inter-institutional parity:EP and Council have equal powers, right to information(but… informal consultation with national experts)
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VETOING OR REVOKING POWERS
• EP and Council cannot amend draft measures • ‘Nuclear options’: veto or revoke power
• Big majorities needed to veto or revoke:– EP: absolute majority of all MEPs– Council: qualified majority
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VETOING OR REVOKING POWERS
• EP and Council cannot amend draft measures • ‘Nuclear options’: veto or revoke power
• Big majorities needed to veto or revoke:– EP: absolute majority of all MEPs– Council: qualified majority
• EP/Council have 2+2 months to object to an act• Any reason allowed for veto or revocation
• Under ‘common understanding’, EP and Council must give each other one month’s notice of intention to revoke
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Delegated acts:An example
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AN EXAMPLE: ENERGY LABELLING
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AN EXAMPLE: ENERGY LABELLING
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AN EXAMPLE: ENERGY LABELLING
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AN EXAMPLE: ENERGY LABELLING
New labels from 1 July 2013:
A +++
A ++
A +
A
B
C
D
A++
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In detail:Implementing acts
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IMPLEMENTING ACTS: KEY FEATURES
• Formal committees of national experts:Commission cannot act as it wishes
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IMPLEMENTING ACTS: KEY FEATURES
• Formal committees of national experts:Commission cannot act as it wishes
• Horizontal procedures set by EP and Council:‘Advisory’ and ‘examination’ procedures
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IMPLEMENTING ACTS: KEY FEATURES
• Formal committees of national experts:Commission cannot act as it wishes
• Horizontal procedures set by EP and Council:‘Advisory’ and ‘examination’ procedures
• Weaker powers for legislator:Only right of scrutiny – oblige Commission to review act
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IMPLEMENTING ACTS: KEY FEATURES
• Formal committees of national experts:Commission cannot act as it wishes
• Horizontal procedures laid down by EP and Council:‘Advisory’ and ‘examination’ procedures
• Weaker powers for legislator:Only right of scrutiny – oblige Commission to review act
• Inter-institutional disparityMember states in control in committees
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IMPLEMENTING ACTS: KEY FEATURES
• Formal committees of national experts:Commission cannot act as it wishes
• Horizontal procedures set by EP and Council:‘Advisory’ and ‘examination’ procedures
• Weaker powers for legislator:Only right of scrutiny – oblige Commission to review act
• Inter-institutional disparityMember states in control in committees
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IMPLEMENTING ACTS: TWO PROCEDURES
Advisory procedure:• ‘Default’ procedure• Used for funding decisions; less controversial measures• Commission takes ‘utmost account’ of committee’s views
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IMPLEMENTING ACTS: TWO PROCEDURES
Advisory procedure:• ‘Default’ procedure• Used for funding decisions; less controversial measures• Commission takes ‘utmost account’ of committee’s views
Examination procedure:• Applies to issues of ‘general scope’ or ‘sensitive topics’ –
e.g. trade, taxation, human health, animal health, plant health, the environment, agriculture, fisheries…
• Committee votes on measures• Appeal committee (deputy perm reps) may intervene• Member states keep significant control
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IMPLEMENTING ACTS: TWO PROCEDURES
Advisory procedure:• ‘Default’ procedure• Used for funding decisions; less controversial measures• Commission takes ‘utmost account’ of committee’s views
Examination procedure:• Applies to issues of ‘general scope’ or ‘sensitive topics’ –
e.g. trade, taxation, human health, animal health, plant health, the environment, agriculture, fisheries…
• Committee votes on measures• Appeal committee (deputy perm reps) may intervene• Member states retain significant control
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EXAMINATION PROCEDURE
Commission proposes
QM +
COM may adopt unless:Simple majority against
Basic act forbids‘Sensitive topic’
EXAMINATION COMMITTEE
No QMQM - ACT ADOPTED
COM acts:(Within two months) Submits new draft act(Within one month) Send to appeal cttee
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EXAMINATION PROCEDURE
QM +
COM may adopt unless:Multilateral trade safeguard
On sensitive issues, decision must reflect predominant view
APPEAL COMMITTEE
No QMQM - ACT ADOPTEDACT NOT ADOPTED
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ACTING URGENTLY
• Commission can adopt urgent measures if needed
• Committees have ex-post control – a negative opinion means the act is repealed
• Example: post-Fukushima measures
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Implementing acts:An example
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AN EXAMPLE: ORPHACOL
• Positive EMA opinion on Orphacol - but Commission proposed not to give a market authorisation
• Examination committee: QMV opposed Commission• Appeal committee: QMV opposed Commission
• New draft tabled: no QMV either way
• Commission had discretion – and stuck by its original decision
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Overview:Delegated acts vs implementing acts
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OVERVIEW
Delegated acts Implementing actsSupplement and amend ‘non essential elements’
Role Provide uniform conditions for implementing EU acts
General application Scope General or individual application
No (not formally) Expert committees Yes
In individual legislation + ‘common
understanding’
Legal basis Horizontal EP/Council Regulation
EP/Council can veto or revoke delegation
Scrutiny Member states can block; EP/Council scrutiny
Ongoing replacement of ‘RPS’ until 2014 – and
some disputes…
Alignment Automatically replaced old comitology on 1 March 2011
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PART 3CONFLICTS AND
CONTROVERSIES
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ISSUE 1: POST-LISBON ALIGNMENT
OLD PROCEDURES NEW PROCEDURES
IMPLEMENTING ACTS (AUTOMATIC ALIGNMENT)
ADVISORY ADVISORY
MANAGEMENTEXAMINATION
REGULATORY
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ISSUE 1: POST-LISBON ALIGNMENT
OLD PROCEDURES NEW PROCEDURES
IMPLEMENTING ACTS (AUTOMATIC ALIGNMENT)
ADVISORY ADVISORY
MANAGEMENTEXAMINATION
REGULATORY
DELEGATED ACTS (ONGOING ALIGNMENT OF EACH LAW)
REGULATORY PROCEDURE WITH SCRUTINY
DELEGATED ACTS
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ISSUE 1: POST-LISBON ALIGNMENT
OLD PROCEDURES NEW PROCEDURES
IMPLEMENTING ACTS (AUTOMATIC ALIGNMENT)
ADVISORY ADVISORY
MANAGEMENTEXAMINATION
REGULATORY
DELEGATED ACTS (ONGOING ALIGNMENT OF EACH LAW)
REGULATORY PROCEDURE WITH SCRUTINY
DELEGATED ACTS
COUNCIL PRESSURE
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ISSUE 2: CHOICE OF PROCEDURE
WEEE – EP vs Council• EP concedes to Council – IAs chosen over DAs• Notes than “shall not be used as a precedent”
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ISSUE 2: CHOICE OF PROCEDURE
WEEE – EP vs Council• EP concedes to Council – IAs chosen over DAs• Notes than “shall not be used as a precedent”
Cross-border healthcare – EP/Council vs Commission• EP concedes to Council – IAs chosen over DAs• Commission notes that legality of IAs may be questioned
– says they should be DAs
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ISSUE 2: CHOICE OF PROCEDURE
WEEE – EP vs Council• EP concedes to Council – IAs chosen over DAs• Notes than “shall not be used as a precedent”
Cross-border healthcare – EP/Council vs Commission• EP concedes to Council – IAs chosen over DAs• Commission notes that legality of IAs may be questioned
– says they should be DAs
Biocides – EP/Council vs Commission, the ECJ rules• EP concedes to Council – IAs chosen over DAs• Commission takes EP/Council to Court to challenge use
of IAs
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ISSUE 2: CHOICE OF PROCEDURE
‘Procedure’ becoming part of the negotiation between EP and Council
• EP seems willing to trade ‘substance’ for ‘procedure’
• Biocides case should give clearer indication of line between DAs and IAs
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ISSUE 3: THE ‘NUCLEAR OPTION’
‘Take it or leave it’ choice can be tricky…
Food additives:• Commission included a ‘meat glue’ in a list of 20 food
additives• EP vetoed, blocking all 20 additives• Did Commission think EP would not veto all additives
because it disliked one additive?
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ISSUE 4: PUTTING POLICY IN ‘SILOS’
Some issues encompass wider interests that can be missed in policy-specific comitology procedures
Airport body scanners:• Commission draft act adopted by transport experts• EP Transport Committee signalled its approval• MEPs on Civil Liberties Committee heard about plan and
objected to lack of privacy safeguards• EP President wrote to Commission, which withdrew
measure
NB: a formal veto is not the only way to block a proposal…
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Evidence-based communications. Inform. Measure. Monitor. Succeed.Evidence-based communications. Inform. Measure. Monitor. Succeed.
PART 4TIPS FOR WORKING WITH THE NEW COMITOLOGY
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‘NEW COMITOLOGY’ TIPS
Impact:• Don’t forget the impact of comitology:
– 60-70 legislative acts per year– > 2,000 delegated or implementing acts per year
• It can affect key business issues – labelling, marketing, authorisations…
Procedure:• Ensure you know which one applies to your issue• In the legislative phase, think about whether you can
affect the choice in your favour (including for texts that need to be aligned)
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‘NEW COMITOLOGY’ TIPS
Timing:• Think about comitology impact from legislative phase so
that ‘objective, scope, duration, content’ suit your needs• Focus on comitology measures as soon as the law is
passed – the Commission will be thinking about them!• Get in early – influence the content while the
Commission is drafting to avoid calling for a ‘nuclear option’
• Remember, the nuclear option is difficult to achieve:– Lack of expertise/understanding in EP/Council– Too many measures– Too little time (2+2 months)– Thresholds are very high (absolute majority / QMV)
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‘NEW COMITOLOGY’ TIPS
Network:• For DAs and IAs, know the Commission desk officer
responsible• For IAs in particular, find out the committee involved and
who sits on it – often officials in national capitals• For DAs in particular, consider which MEPs are
interested and wish to be kept informed… you may need them in the scrutiny phase (Baby milk health claim case)
• Consultations may include experts from Parliament or non-institutional actors - another chance to influence
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‘NEW COMITOLOGY’ TIPS
Stay informed:• Commission desk officer• EP committee secretariats• Perm Reps• Comitology register
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Evidence-based communications. Inform. Measure. Monitor. Succeed.Evidence-based communications. Inform. Measure. Monitor. Succeed.
ANY QUESTIONS?
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Thank you for your attention
…and see you on 12 June!