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EU Regulatory Affairs: What you should know about
implementing and delegated acts
Please note that the following transcript has been edited to make reading easier and may slightly differ
from what was said in the webinar recording. Disclaimer: We aim to ensure a high level of accuracy, but
the webinar and the transcript are for information purposes only and they cannot be considered as
legally binding.
Speaker: David O’Leary (moderator: András Baneth)
Today’s topic concerns EU Regulatory Affairs and what you should know about implementing and
delegated acts or the so-called New Comitology.I would like to welcome everyone to the next in the
series of EU Public Affairs webinars. The series itself comprises of seven parts and this is the third one
covering Regulatory Affairs, what is commonly known as Comitology or at least its new form since the
Treaty of Lisbon entered into force in December 2009.
In terms of the speaker and in terms of us as organizers, David O’Learyis a Director at Burson-Marsteller
and he is specialist on everything that is related to consumer goods, ICT, food industry and related
areas. As you might be familiar with Burson-Marsteller, who is kind enough to co-organise this webinar
series, it is the leading Brussels consultancy on Public Affairs and corporate communications.
My name is András Baneth, I’m the Director of the European Training Academy. We, on the other hand
do training courses which are highly practical and highly focused on the real workings of EU institutions,
decision making and public affairs.
This is the point where I hand it over to David.
Overview of the presentation
Thank you András and thank you for joining this presentation about the new Comitology, what you
should learn about implementing and delegated acts.
The presentation will be based around four parts; the first is on the basics of Comitology, what is it, who
does it, why do we have it and I will explain about the history of it. Then, we have the second part which
focuses on the new Comitology and on what happened after the Lisbon Treaty brought in thedelegated
and implementing acts. Then part three, will look at some conflicts and controversies about Comitology
and finally we will provide you with some practical tips for working with new Comitology.
Comitology Basics: What, Who, Why, When?
The term Comitology doesn’t officially exist anymore but we’re using the term new Comitology just
because it’s basically the least worst option, since other options tend to be very long winded or risk
raising confusion.
So what is Comitology? It can be explained in a few ways. It is filling in the gaps in legislation; legislators
cannot do all of the details. It is a way of dealing with those details. It is also been called a perhaps
obscure system for taking quite important decisions.
Three newspaper headlines show the kind of public impact Comitology decisions may have; they are all
from British newspapers which tend to get hot under the collar about this type of decisions taken by
Brussels bureaucrats.First of all, The Guardian, “EU ridiculed for banning olive oil jugs from restaurants”.
This was a decision taken by Comitology. Then, the Daily Telegraph, “EU bans claim that water can
prevent hydration. This was another decision taken by Comitology under the health claims Regulation
based on an opinion from the European Food Safety Authority. Finally, the Daily Mail headline on body
scanners on airports was another decision taken by Comitology.
This obscure system has a real kind of public impact and affects people’s steady lives and businesses. Its
impact is felt across a whole range of sectors, so we will need to talk about food and security,
pharmaceuticals, chemicals, energy, agriculture, financial services, transport. It’s everywhere.
What is Comitology?
Now we willsee how Comitology fits into the decision making process. During the co-decision process or
the ordinary legislative procedure (as it is called after the entry into force of the Lisbon Treaty), the
Commission makes a proposal, which then passes on to the Council of the EU and the European
Parliament, who are the two co-legislators responsible for taking decisions and developing laws. That
takes between 12 and 48 months but towards the lower end now.
To give practical effect to that legislation, we then have another process which is the process we call
Comitology whereby the Commission takes a decision often assisted by national experts from the
Member States. It will be scrutinized and networked by the European Parliament and the Council and
then it will develop these non-legislative acts. They apply with equal force to legislation and can happen
to have an impact. It can take at least two days to reach decision, if it is an urgent process or several
months. Therefore, it is a lot quicker than the legislative process.
Under Comitology, the Commission proposes, consults its expert Committees and adopts an act. Then, it
is the legislator who has control in some cases, sometimes the power to veto, always at least the power
of scrutiny to oversee what the Commission does.
Who is involved?
The Comitology Committees are chaired by the Commission and there are around 250 of them.
Member States send a representative to these meetings; they are usually experts coming from different
ministries, from the national capitals of the Member States.
There are various different types of Committees, some of which work on several pieces of legislation.
There’s a Standing Committee on the Food chain and Animal Health (SCFCAH) whichhas lots of different
sections and works on lots of different laws dealing with food policy. The Single Sky Committee deals
with different parts of transport legislation. And then, there are also committees that are set up for
specific pieces of legislation such as the Services Directive Committee, which deals with the
implementation of the services Directive.
Why Comitology?
The reason we have this slightly obscure and complicated process is actually, a very good one. It is the
reason that it isused in lots of different political systems around the world. It is basically to have a
process faster than the legislative process, thus speed. It is an efficient process because it does not
block up the Council in taking often mundane and very technical decisions. It is reactive and so you do
not need to convene Ministers in 27 Member States or the entire European Parliament. In this way, you
can take a decision very quickly. And it brings the necessary expertise, given that some decisions are
very technical and you cannot really expect politicians to have general knowledge to take these
decisions so experts are needed.
Of course there are downsides to this; there are questions of democracy, accountability and of
transparency. These are to some extent being addressed by the new Comitology but there are still
concernsabout faceless bureaucrats taking these decisions and whether they have the power but no real
responsibility for what they decide. In the end, for decisions taken in the Commission’s name, it’s the
Commission who takes the blame even if it is the national experts who ultimately took the decision.
A brief history of Comitology
It grew in the 60’s when the Common Agricultural Policy (CAP)needed some implementing rules to
enable its works. So the Commission set up some procedures and talked to the Member States. This
practice developed in the 1970’s. Then in 1987, when we hada whole platter of different Committees
and different rules, the first horizontal rules on Comitology came into place. The Council took then the
decision to establish some clear procedures.
By 1999, we had a new horizontal decision and for the first time the European Parliament was really
involved. It had the power to oversee what was happening in Comitology, thus the right to information.
By 2006, the Parliament had even more power; there were new rules and a new procedure called
Regulatory Procedurewith Scrutiny or RPS. The Parliament had a veto for the first time because it
wanted a say in what was happening. It characteristically said, “Oh, we take parts in the making of these
laws, we have equal power in making them, but we do not have any power in how to implement them.”
Since 2009, when the Lisbon Treaty was passed, we have delegated and implementing acts and this
gradually come into force over the past four years. There is a still a hangover on the collar of the RPS
system because of all the acts contained in the old system, which are going to be updated hopefully by
2014 into the new system. This is a littlepoint of controversy and I will come back to this later.
New Comitology: Changes after the Lisbon Treaty
The changes in the Lisbon Treaty focus on delegated acts and implementing acts. To look to the future,
or the present, we just need to compare it with the past. Before Lisbon there was one article in the
treaty to do with Comitology and there was one set of rules. Namely a Council decision which was taken
in 1999, comprising five different systems.
Now we have two legal basis, Article 290 for delegated acts, and Article 291 for implementing acts.
These Articles constitute two separate legal frameworks so everything that is a delegated act is dealt
with solely under Article 290 and everything that is an implementing act is dealt with solely under Article
291. There is alsoa separate decision taken by the EU institutions on delegated acts, the so-called
‘Common Understanding’. Therefore, previously onlya Council decision existed, whereas now, a
Regulation adopted by the Council and the European Parliament together.
What’s the difference between these two systems? Theyboth deal with non-legislative acts but there a
couple of key differencesbetween these procedures. Delegated acts are always to amend and
supplement legislation and are by nature non-essential. Hence, law can exist without these rules. In the
health claims legislation for example, there is a part on nutrient profiles where the law has existed since
2007 without these nutrientprofiles ever being established. But the law still works; there is still a
Regulation of health claims. Delegated acts are just another layer so it is not an essential part, but it’s a
part that supplements the basic legislation.
Whereas implementing acts are also non-legislative acts but they implement the legislation, and in that
sense, they are essential. So, if we take for example thelegislation on CO2 emissions from cars, the
legislator said that there need to be levels of emissions sets which manufacturers cannot go beyond.
Without implementing acts, which actually set those levels, the law would not have any practical effect.
So, implementing acts areoften essential.
Delegated acts in detail
Thereare four key features of delegated acts.In delegated acts there are no formal committees of
national experts and this is where the confusion over the word Comitology comes in. It’s the
Commission’s role to act alone and take a decision but there is now an informal consultation with
national experts. The Council really wanted to maintain a littlebit of control over what the Commissions
does and so they requested to have national experts involved. In its turn, the Parliamentas co-legislator,
also said “wewant to have an expert present as well”. Therefore, under delegated acts the Commission
formally acts alone but in practice there is still some involvement of national experts.
Secondly,there is no horizontal procedure anymore but only the Treaty rules and Article 290. The
legislator can decide case by case on how it delegates by putting articles in the legislation to define the
content, the scope and the powers given to the Commission. Again, there is a slight caveat because the
institutions develop a ‘Common Understanding’, which is a kind of model of how these articles should
be included in the basic legislation order to avoid confusion and lots of different procedures and timings.
Thirdly, we have a strong Council legislator in terms of its scrutiny after the Commission hastaken a
decision. So, the Parliament or the Council can veto a measure, which is a very similar procedure to the
Regulatory Procedure with Scrutiny. But they have an additional power; they can actually revoke the
power of delegation, so they can say to the Commission “you’re making a mess of this”,“we don’t want
to deal with this anymore” or “we consider this to be so politically important that we want to deal with
it ourselves”. Either the Parliament or the Council can do that.
Finally, we have inter-institutional parity, so the Parliament and the Council have equal powers now and
the equal right to information. There is of course the informal consultation of national experts, still
slightly in favor of the Council, but the Parliament has to all intents and purposes parity with the Council
in terms of scrutinizing and overseeing what the Commission does.
‘Common Understanding’ in detail
The legislator decides case by case on how it delegates but in the context of the‘Common
Understanding’ that sets down what the legislator should put in the law in terms of the objectives,
content, duration and scope of the delegation.
This is basically a text that can be copied and pasted into a piece of legislation. It sets out how long the
Commission holds this power for; it is usually 3 to 5 years that can be renewed. And how long the
Parliament and the Council have to scrutinize a decision that the Commission has taken; it is usually two
months, extendable by two months. Thus,the ‘Common Understanding’ is a kind of a standard piece of
text that can go in laws to deal with delegated acts.
Vetoing or Revoking Powers
Then, if we look at another feature, which is the power to veto and revoke, this is very much a nuclear
option. The Parliament and the Council cannot amend the measure that comes from Commission. But
they have thenuclear option of vetoing this measure or taking away the power.
Big majorities are needed to veto or revoke the power. In the Parliament, an absolute majority of all
MEPs is needed not just those voting(376 votes out of 751) and in the Council a qualified majority (255
votes out of 345) against what the Commission decides. Therefore, it is very difficult to obtain these
majorities. The co-legislators have two months, extendable by two months, to object to an act whereas
they can use any reason whatsoever.
Delegated acts example: energy labeling
A Directive was passed in 2010, on the labeling of energy related products. In this law, Article 10
stipulates that “the Commission shall lay down the details by means of delegated acts”whileits second
paragraph states what the aims are, so the acts“enableend-users to make better informed purchasing
decisions and enable marketing surveillance authorities to verify when the products comply with the
information provided.” Therefore, it becomes very clear what the Commission needs to do and what the
Parliament and the Council want the Commission to do.
The length of the delegation isfor five years and then automatically extended unless the Parliament or
Council decidesotherwise. What we end up with here is the Commission that goes away and talks to
people including national experts informally and develops something like this, which is a new version of
the energy labels that I am sure you have seen on fridges and other products. Then, the measure goes
back to the Parliament and the Council whohave two months plus two months to decide whether
theywant to veto it. They cannot change it or decide otherwise but they have to really take it or leave it.
Implementing acts in detail
There are some features that make them very different to delegated acts. First of all, there are formal
committees of national experts, so this is like the old Comitology. The Commission cannot simply do
what it wishes. It needs to act in accordance with what the national experts want.
Secondly, we have a horizontal procedure set by the Parliament and the Council via a Regulation setting
down the specific procedures. You do not have specific references in the basic legislation but only an
article saying that “it will be dealt with in the procedure referred to in the Regulation on Comitology”
(Regulation (EU) No 182/2011).
Then, we have weaker powers for the legislators, meaning the Parliament and Council, so the legislator
only hasa right of scrutiny. It can apply to the Commission to reviewthe act, but it cannot veto it like it
does underdelegated acts.
Finally, we have inter-institutional disparity between the Parliament and Council. The Member States
are in control in the Committees so they have a say on what the Commission does. In addition, there is
an Appeal Committee, which is a second instance if it’s difficult to reach a decision whenthe member
state representatives meet to discuss these issues. Therefore,the Member States have a lot more power
than the Parliamentunder implementing acts. It can be argued that this is about implementation and
about a role in particular for the Member Stateswho are the ones thatin the end have to implement EU
laws. Thus, it is in some sense fair that they have more to say over those implementing rules.
Implementing acts: Advisory Procedure
The Advisory Procedure is a default procedure but a very light one, used for less important things, less
controversial measures, like funding decisions, etc. All the Commission has to do is take the utmost
account of the Committees views. It does not have to do anything more and after that it can pretty
much do what it wishes. The Commission has a lot of freedom under this procedure.
Implementing acts: Examination Procedure
The Examination Procedure has a wide application and some rather vague definitions. It applies to issues
of general scope or sensitive topics which they helpfully outline as Trade, Taxation, Human Health,
Animal Health, Environment, Agriculture and Fisheries and many more. Therefore, it is really difficult to
see what does not fall under this procedure.
Under this procedure, the Committee votes on the measures and the Commission has to take account of
the votes by the relevant Committee. If there is a conflict, if they are unable to reach an agreement,
then the measure goes to the Appeal Committee, comprising the deputy permanent representatives. So,
the Member States keep a significant amount of control.
Under the Examination Procedure, the Commission proposes a measure that then goes to the
Examination Committee which votes by qualified majority. If there is a qualifiedmajority in favor, the act
is adopted as the Commission drafted it. If there is a qualified majority against, the Commission has to
make a decision by either submittinga new draft actthat goes back to the Examination Committee or by
sending the measureto the Appeal Committee. If there is no qualified majority either way, the
Commission may adopt the proposed measure unless there is a simple majority against, unless it is said
in the legislation that the Commission cannot do this and unless it is one of these sensitive topics.
Appeal Committee under the Examination Procedure
If the Commission decides not to adopt or if there is a qualified majority against, the draft measure can
go to the Appeal Committeeof deputy permanent representatives, which meets in the context of the
normal Comitology meetings chaired by the Commission.
If in the Appeal Committee there is a qualified majority in favor, the act is adopted. If it is against, the
act is not adopted. If there is no qualified majority, again, the Commission has a decision to make
whether it wants to adopt this measure. There are a couple of caveats:the Commissioncannot take
approval in multilateral trade safeguardsandon these sensitive topics it must reflect the predominant
view. So, if you are working in the Appeal Committee stage and you cannot get a qualified majority, it is
important to get at least a simple majority of the Member States in order to have the predominant view
that has bearing on what the Commission decides to do.
Implementing acts: alignment
In terms of alignment for all implementing acts, there is an automatic alignment from the old
Comitology to the new Comitology from the 1st
of March, 2011. For delegated acts, this has to be done
case by case and it will replace the Regulatory Procedure with Scrutiny taking place in all those acts that
have that procedure. This will go on until 2014 and is causing a bit of disputes.
Implementing acts example: post-Fukushima measures
Another aspect of the Examination Procedure is that the Commission can act urgently under this
procedure if it needs to adopt measures like the ones taken after the Fukushima nuclear disaster, which
put controls on food and feed coming in from Japan. The Commission can do that immediately but the
Committees have an‘ex-post control’ and can take a decision afterwards in favour of the Commission’s
decision. In the case of a negative opinion by the Committees, the Commission has to repeal the act.
Implementing acts example: Orphacol
Another example of an implementing decision, rather controversial in France, isabout a drug called
Orphacol, which deals with a rare leaver disease. This drug which has been used for a long time came up
for market authorisation under the new pharmaceuticals rules and was given a positive opinion by the
European Medicines Agency. However, the Commission, as it is free to do, decidednot to give it a
market authorisation.
In the Examination Committee there was a qualified majority against the Commission’ view. They
wanted Orphacol to be licensed and thus, the draft measurewent to the Appeal Committee that also
opposed what the Commission was doing. So the Commission came back and tabled a new draft which
was very similar or maybe even identical to the original measure.
A little bit of underhand tactics of the Commission, it tabled these documents to be voted in the
Examination Committee on the day when there was a public holiday in one member state and so one
member state representative was absent and another member state abstained. Thus, there was no
qualified majority either way. In the end, the Commission had discretion and so it stuckby its original
decision so Orphacol did not get licensed despite the positive opinion by the Medicines Agency and the
support of the Member States. So implementing acts, still give the Commission a fair bit of leeway to do
what it wishes.
Delegated acts vs. implementing acts: an overview
• The role of delegated acts is to supplement and amend. The role of implementing acts is to
provide the uniform conditions for implementing the law.
• The scope for delegated acts is general whereas for implementing acts individual (i.e. specific
product).
• Delegated acts: no formal committees, implementing acts: 250 formal committees.
• Legal basis for delegated acts is in the individual legislation in the Treaty whereas for
implementing acts there’s a horizontal Regulation that deals with the different procedures.
• In terms of scrutiny, under delegated acts, the Parliament and the Council have the power to
veto or revoke the delegation. Under implementing acts, the member states can block through
the Appeal Committee but the scrutiny is more kind of sending the Commission a signal that
they are unhappy and can formally veto.
Practical insights from Andràs
Before going to the next part, I would like to add one or two points, which I myself actually dealt with at
the time when I was in the Commission’s unit dealing with these issues so as to further back up
everything that David has said so far.
One thing to have very clearly in mind is the difference between voting for or against a certain proposal
because when it comes to what we call the basic legislative acts (Regulation or a Directive), the main
rule is that the Parliament and the Council need to have a qualified majority for in order to adopt those.
Whereas for implementing measures, whichever procedure is being used, the rule is that the
Commission can actually have its way unless it is voted down by qualified majority. This gives the
Commission very strong powers to go ahead because the goal is that it has these implementing powers
in order to make sure that these Regulations or Directives are eventually adopted whether it is
authorising a new pharmaceutical product, food labeling, a health claim or body scanners at airports.But
this also gives the Commission very, very large powers or very, very extensive powers to go ahead. So, if
your case is not liked by the Commission, as we have seen with the Orphacol case, then it is much
harder to get it across the system. And here I give the word back to David.
Conflicts and controversies
We will now advance to the ultimate part which is conflicts and controversies. One of the major
controversies is about the alignment from the old Comitology to the new Comitology under the Lisbon
Treaty. For implementing acts, it is very simple and straightforward: under the old Comitology you had
advisory, management and regulatory procedures, which have now become advisory and examination
procedures with the latter taking up the management and regulatory procedures.
Issue 1: Post-Lisbon alignment
Under delegated acts there is an on-going alignment where you have to take each individual piece of
legislation and amend it in order to put it in the delegated acts rules into each individual piece of
legislation. This is becoming more difficult and controversial. On paper, it would be simple to say, that
the Regulatory Procedure with Scrutiny, which involves a Parliament and a Council veto, should actually
become delegated acts to give the same powers to the Parliament and Council to veto a measure.
What the Council is actually trying to do is move as much as possible into the Examination Procedure,
that big long list of areas of sensitive topics, etc. This is an attempt by the Council to really broaden the
scope of the Examination Procedure and put as much of what was in the old RPS system in the
Examination Procedure where it has more power than the Parliament. This is obviously becoming a
controversial issue. The Parliament wants to defend its interests to some extent. The Council fears that if
there is too much that goes under delegated acts, the Parliament will be more susceptible to lobbying
and pressure and it will veto more measures.To link to this issue of alignment, there is also an issue
about the choice of procedure when developing legislation. There are three case studies that show how
it is becoming a question ofpolitics versus law.
Issue 2: Choice of procedure
In the WEEE Directive (waste electrical and electronic equipment), the Parliament is against the Council.
They were lock into disputes whether to use implementing acts or delegated acts, and in the end the
Parliament conceded to the Council.It said “okay, you can have implementing acts which give you more
power” but it noted that “this should not be used as precedent for the future”. So the Parliament is
actually saying here, “we give you what you want this time but not necessarily in the future”.
Then we have another case, which iscross borderhealthcare where the Parliament and the Council came
again to a compromise. The Parliament conceded to the Council to use implementing acts rather than
delegated acts but the Commission made a protest this time and questioned whether it is legal to adopt
implementing acts because they should actually be delegated acts. So, the Commission was sitting there,
saying it was afraid that they would be challenged in Court for having used the wrong procedure
because the Parliament and the Council told it to. So, this is a new type of dispute.
A similar thing happened in the Biocides Directive where the Commission basically said that “we are
going to take this to Court, wedo not believe that the choice of implementing acts rather than delegated
acts was the right one, we fear if we take this decision it will be illegal because we used the wrong
procedure, you told us to, and so we are going to take this to court and we are going to find out what
the legality is in this case and it may also be instructive for the future.”
You may ask why on earth the Parliament gave away its power like this. Well, I think it is really a
question of trading substance for procedure so the Parliament is willing to give up its power of veto in
delegated acts. Remember it has to get a very high majority to block anything so probably the MEPs
made a calculation that it is better to give away the procedure and get a bit more substance in the law in
terms of what the Parliament wants in the actual substance of the law. So this is where politics and the
law conflicts in itself.
Issue 3: Nuclear Option
Third issue is the idea of the nuclear option ‘take it or leave it’, a choice that can be very tricky. In the
case of food additives, the Commission proposed to authorize 20 food additives, one of which was ‘meat
glue’. The Parliament was against this additive but had to veto all the measures altogether because it
could not say “we want 19 of these additives but not the last one”. Thus, it had to block everything. You
wonder whether the Commission was kind of calculating, “well, do we really think the Parliament
isgoing to veto all of these additives because it does not like one?” In the end, yes.The Parliament said
we are so opposed tothe use of this additive that we are willing to sacrifice all of them. And that of
course had a big impact on those companies that were using those other additives.
Issue 4: Putting policy in ‘silos’
The fourth issue is putting policy in ‘silos’. Sometimesan issue is not just black and white in one specific
area; it is actually something that deals with various different interests. The example of airport body
scanners is a good one, where the Commission drafted an act on the installation of body scanners in
airports. This was adopted by the Committee of Transport Experts under
theRegulatory Procedure with Scrutiny and was then sent to the Parliament for scrutiny. It went to the
relevant committee first so the Transport Committee, andthe Transport Committee said, “Yes this
sounds good, we are happy with this.” It was only when MEPs on the Civil Liberties Committee heard
about this measure thatthey started to object to it because of the lack of privacy safeguards. In the end
they persuaded the President of the Parliament to write to the Commission, which finally withdrew the
measure. This shows that there needs to be some way of taken into account broader interests rather
than just a specific policy interest. And it is also worth noting that a formal veto is not the only way to
block a proposal, it can also be done informally by signaling to the Commission that the Parliament is
unhappy.
Comment by Andràs
The comment concerns basically the Commission’s discretionary powers, what it can do when it comes
to many of these measures. For instance, in terms of the Medicines Agency or the Food Safety Authority
or any kind of scientific or expert input, these are not prejudging what the Commission can eventually
propose as a technical measure whether it is through implementing acts or delegated ones. Because, if
for instance, the Food Safety Authority considers a certain food or a pesticide safe or unsafe, that is the
risk assessor but the Commission itself is the risk manager as they call it. Thus, the Commission is the
one making the policy and can apply its best judgment or even its own political consideration whether
or not it would like to propose a certain measure. Therefore,this is an interesting point to make that
having science on your side does not necessarily mean that it is going to turn into legislation in the end.
Question: Who can member states delegate into the implementing committees to represent them?
This is a very good question. They can send anybody they like. Usually it is an expert from a relevant
ministry so for example on an additive’s issue in food, somebody from the Food Standards Agency in the
UK would be sent, and who specializes in additives. There may be occasions where the scope of the
Committee particularly in food law covers lots of different areas so you have to send someone with a
more general knowledge of food policyissues. There is also an issue that this can create a bit of an
imbalance between the member states because some member states have very large administrations
and they have people whocan specialize a lot in very specific areas. Other member states may only be
able to send somebody who is dealing generally with food additives and health claims and lots of other
different things. So usuallythey send somebody from the ministry but it can also be somebody else. I
have heard in some cases that even an industry representative has been sent to oneCommittee on
behalf of a member state to deal with -I think- something regarding energy labeling. Therefore, as long
as that person can commit the member state in that Committee, then they can attend.
Question: Is the qualified majority being used in the examination committee, the same majority or the
same type of vote as the one used in normal Council working groups or even on ministerial level?
Yes, it is the same qualified majority that applies at the moment with the votes going from
29downwards. Obviously that will change in the Comitology committees in the same way that it will
change in the Council when the new system comes in 2014 with the weighting of the national
populations.
‘New Comitology’ tips
We will now move on to the last section which is tips for working with Comitology and I will split this up
intoa few different areas. First of all impact; some of the Comitology decisions have real significant
impact on businesses and on citizens.There are around 2,000 delegated or implementing acts adopted
every year compared to 60-70 basic legislative acts. Comitology has a huge impact on specific business
issues in particular on how you label market and on whether your product is even authorised.
Procedure
In terms of procedure, it is important that you know which one applies to your issue so that it should be
clear from the initial legislation. If there is legislation being passed that affects your interests, you should
think about whether you need to influence the choice of procedure in that legislative phase. As we have
seen, there is a slight blur between implementing acts and delegating acts so there is a choice there
whether you want to encourage MEPs or member states to push for a particular type of Comitology
either implementing or delegated acts.
Timing
In terms of timing, think about Comitology from the legislative phase so especially on delegated acts,
think about what type of powers should be delegated so you can talk to MEPs and member states. Then,
focus on Comitology as soon as the law is passed because the Commission will already start thinking
process about what it is going to do and how it is going to implement this law. And get in early, so talk to
the Commission while it is drafting because otherwise you could end up just calling for the nuclear
option that is a very difficult one to get MEPs to do because there is a lack of understanding, or
expertise and a lack of time due to the large number of measures. There is often too little time to veto
and the threshold is very high with the absolute majority needed in the European Parliament and the
qualified majority in the Council.
Network
Get to know the Commission’s desk officer responsible that could be a source of information. Find out
which committee is involved and who sits on it. This can often be difficult but if you talk to the national
ministries you can often find out who is involved. For delegated acts in particular, you need to think
about which MEPs are interested in the issue and wish to be kept informed. That was the case with
infant formula where a certain health claim oninfantformula was approved by the Commission and the
anti-baby milkor pro-breast milk lobby immediately went to the Parliament to warn some supportive
MEPs that this decision was coming up and that they needed to keep an eye out for it and that they
needed to start building an alliance to block this claim. They achieved partial success and they got a
majority of the MEPs voting but they did not manage toget the absolute majority needed in the
Parliament. So there are people watching where these rules come from. Finally, consultations may
include experts from the Parliament or non-institutional actors so they may be online consultations or
people from industry or civil society may be brought in to discuss with the Commission.
Stay informed
And then the last tip is to stay informed. Talk to the Commission desk officer and keep in mind that the
Parliament’s Committee secretariats now have people who specialise in Comitology, who manage the
process, or who edit newsletters for MEPs that are available on the Parliament’s website. You could also
talk to permanent representations and ministry officials too. Finally there is a Comitology register that is
online. This is a great step forward in transparency that was probably unthinkable maybe a decade ago
but there is a lot of information about the types of decisions that are being taken and the types of
committees that exist.
Question:Why can the Commission and its agencies take decisions since it is a non-elected body and
even taken into account the consultations, this does not look good from a democracy and
transparency point of view?
(Andras) It isabsolutely not my task to defend the Commission but in terms of the governance nature of
the EU, it makes sense that there is an administrative and executive body just like any government
agency which with sufficient and unbiased scientific input from neutral experts such as in the EFSA or in
the Medicines Agency or any other EU agency eventually it makes policy under the necessary
safeguards. Now, where the system can certainly be criticized is whether the safeguards are sufficient.
Because it is the eternal dilemma between efficiency and democracy and when it comes to these
technical measures, efficiency is very important. Whereas the democratic element comes in especially in
the implementing measures where committees take part and member states experts participate. For
delegated acts, it can be heavily criticized because ithappens in-house. Essentially, the Commission has
an enormous large power to do as it pleases it even if it is asks various experts or member states
representatives or others. It is the Commission and the Commission only that passes those delegated
acts. And the scrutiny is mostly of political nature and just as we saw with the food additive issue for
instance, it is either everything or nothing so that is why it is called ‘a nuclear option’. For delegated
acts, there is a much less democratic element in it and that is why the choice between the two
procedures is so important. Because who has the upper hand? Who has more influence? Is it the
Commission, is it the member states, is it the Parliament? Maybe David you want to share a few
thoughts yourself.
(David) Just to add, I think it is also a question more fundamentally about the legitimacy of the
Commission and all that it does. In that it does not have any direct elections to it and therefore, there is
a question over its legitimacy. Sometimes it is handy for the member states to actually have this kind of
system because if we take the olive oil example, you would probably not find any member states who
wouldsay“we really think this is a great idea” but what they can do is only blame the Commission.
Whereas they actually sat inthe Committee and either voted for it or did not vote against it anyway. So it
can be helpful for the member states to do something they want to do but nothing unpopular and in
that case they can blame it on the Commission and complain about the lack of legitimacy. It is just one
of those political games, I think.
Comment: Whether influencing the Commission, am I the only one who worries?Generally speaking,
the Commission has no transparency register where EU citizens can have avision of which lobbyists it
meets.
(Andràs) I think the term influencing the Commission is often limited to corporate lobbyists and private
businesses but just like any member state diplomat, external country and NGO, everyone tries to
influence the Commission. So, the concept of influencing the Commission is not to be understood as a
negative one. Certainly there is a point to be made in terms of itstransparency but there is a
transparency register online, which isbeing currently revised.
Question: Has the Parliament so far under the new rules used the opportunity to actually veto a
certain measure that the Commission has proposed. Have they achieved the necessary, absolute
majority and if so, in which area or policy?
You kind of caught me out there on that question. I do notthink they do, I do not think they have
actually. I have certainly not seen one. There were several times in the previous Parliament under RPS
thatthe Parliament has vetoed a Commission measure. I think the closest they came in this
Parliamentunder the new rules was actually with this baby milk claim where they got a majority of MEPs
but not an absolute majority. But there weresome cases in the previous Parliament on issues to do with
energy labeling where an absolute majority was reached. In fact, on the energy labeling issue, there
were two questions, one on the refrigerators and one on televisions, on which they actuallyvetoed one
and they did not manage to veto the other because some people went to lunch.
(Andràs) There was the famous issue of the novel foods Regulation, which was proposed by the
Commission and which contained a number of implementing measures and delegated acts in terms of
which, issues are to be decided by which procedure. But this was a primary legislation that would lay
down the framework rules and not about any specific food claim or any specific authorisation
procedure. It essentially failed because of the inability of members of Parliament, of member states, and
the Commission to come to an agreement on which procedure is to be used. So, in terms of looking at
the importance of these procedures, I think we can say that the devil is always in the details.
I thank you very much David for being here with us and I am very glad that we managed to cover this
very complex topic and hopefully we shed some light on how it works in practice with various examples.
Have a nice day and thanks once again.

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Regulatory affairs what you should know about implementing and delegated acts

  • 1. EU Regulatory Affairs: What you should know about implementing and delegated acts Please note that the following transcript has been edited to make reading easier and may slightly differ from what was said in the webinar recording. Disclaimer: We aim to ensure a high level of accuracy, but the webinar and the transcript are for information purposes only and they cannot be considered as legally binding. Speaker: David O’Leary (moderator: András Baneth) Today’s topic concerns EU Regulatory Affairs and what you should know about implementing and delegated acts or the so-called New Comitology.I would like to welcome everyone to the next in the series of EU Public Affairs webinars. The series itself comprises of seven parts and this is the third one covering Regulatory Affairs, what is commonly known as Comitology or at least its new form since the Treaty of Lisbon entered into force in December 2009. In terms of the speaker and in terms of us as organizers, David O’Learyis a Director at Burson-Marsteller and he is specialist on everything that is related to consumer goods, ICT, food industry and related areas. As you might be familiar with Burson-Marsteller, who is kind enough to co-organise this webinar series, it is the leading Brussels consultancy on Public Affairs and corporate communications. My name is András Baneth, I’m the Director of the European Training Academy. We, on the other hand do training courses which are highly practical and highly focused on the real workings of EU institutions, decision making and public affairs. This is the point where I hand it over to David. Overview of the presentation Thank you András and thank you for joining this presentation about the new Comitology, what you should learn about implementing and delegated acts. The presentation will be based around four parts; the first is on the basics of Comitology, what is it, who does it, why do we have it and I will explain about the history of it. Then, we have the second part which focuses on the new Comitology and on what happened after the Lisbon Treaty brought in thedelegated and implementing acts. Then part three, will look at some conflicts and controversies about Comitology and finally we will provide you with some practical tips for working with new Comitology. Comitology Basics: What, Who, Why, When? The term Comitology doesn’t officially exist anymore but we’re using the term new Comitology just because it’s basically the least worst option, since other options tend to be very long winded or risk raising confusion.
  • 2. So what is Comitology? It can be explained in a few ways. It is filling in the gaps in legislation; legislators cannot do all of the details. It is a way of dealing with those details. It is also been called a perhaps obscure system for taking quite important decisions. Three newspaper headlines show the kind of public impact Comitology decisions may have; they are all from British newspapers which tend to get hot under the collar about this type of decisions taken by Brussels bureaucrats.First of all, The Guardian, “EU ridiculed for banning olive oil jugs from restaurants”. This was a decision taken by Comitology. Then, the Daily Telegraph, “EU bans claim that water can prevent hydration. This was another decision taken by Comitology under the health claims Regulation based on an opinion from the European Food Safety Authority. Finally, the Daily Mail headline on body scanners on airports was another decision taken by Comitology. This obscure system has a real kind of public impact and affects people’s steady lives and businesses. Its impact is felt across a whole range of sectors, so we will need to talk about food and security, pharmaceuticals, chemicals, energy, agriculture, financial services, transport. It’s everywhere. What is Comitology? Now we willsee how Comitology fits into the decision making process. During the co-decision process or the ordinary legislative procedure (as it is called after the entry into force of the Lisbon Treaty), the Commission makes a proposal, which then passes on to the Council of the EU and the European Parliament, who are the two co-legislators responsible for taking decisions and developing laws. That takes between 12 and 48 months but towards the lower end now. To give practical effect to that legislation, we then have another process which is the process we call Comitology whereby the Commission takes a decision often assisted by national experts from the Member States. It will be scrutinized and networked by the European Parliament and the Council and then it will develop these non-legislative acts. They apply with equal force to legislation and can happen to have an impact. It can take at least two days to reach decision, if it is an urgent process or several months. Therefore, it is a lot quicker than the legislative process. Under Comitology, the Commission proposes, consults its expert Committees and adopts an act. Then, it is the legislator who has control in some cases, sometimes the power to veto, always at least the power of scrutiny to oversee what the Commission does. Who is involved? The Comitology Committees are chaired by the Commission and there are around 250 of them. Member States send a representative to these meetings; they are usually experts coming from different ministries, from the national capitals of the Member States. There are various different types of Committees, some of which work on several pieces of legislation. There’s a Standing Committee on the Food chain and Animal Health (SCFCAH) whichhas lots of different sections and works on lots of different laws dealing with food policy. The Single Sky Committee deals with different parts of transport legislation. And then, there are also committees that are set up for specific pieces of legislation such as the Services Directive Committee, which deals with the implementation of the services Directive.
  • 3. Why Comitology? The reason we have this slightly obscure and complicated process is actually, a very good one. It is the reason that it isused in lots of different political systems around the world. It is basically to have a process faster than the legislative process, thus speed. It is an efficient process because it does not block up the Council in taking often mundane and very technical decisions. It is reactive and so you do not need to convene Ministers in 27 Member States or the entire European Parliament. In this way, you can take a decision very quickly. And it brings the necessary expertise, given that some decisions are very technical and you cannot really expect politicians to have general knowledge to take these decisions so experts are needed. Of course there are downsides to this; there are questions of democracy, accountability and of transparency. These are to some extent being addressed by the new Comitology but there are still concernsabout faceless bureaucrats taking these decisions and whether they have the power but no real responsibility for what they decide. In the end, for decisions taken in the Commission’s name, it’s the Commission who takes the blame even if it is the national experts who ultimately took the decision. A brief history of Comitology It grew in the 60’s when the Common Agricultural Policy (CAP)needed some implementing rules to enable its works. So the Commission set up some procedures and talked to the Member States. This practice developed in the 1970’s. Then in 1987, when we hada whole platter of different Committees and different rules, the first horizontal rules on Comitology came into place. The Council took then the decision to establish some clear procedures. By 1999, we had a new horizontal decision and for the first time the European Parliament was really involved. It had the power to oversee what was happening in Comitology, thus the right to information. By 2006, the Parliament had even more power; there were new rules and a new procedure called Regulatory Procedurewith Scrutiny or RPS. The Parliament had a veto for the first time because it wanted a say in what was happening. It characteristically said, “Oh, we take parts in the making of these laws, we have equal power in making them, but we do not have any power in how to implement them.” Since 2009, when the Lisbon Treaty was passed, we have delegated and implementing acts and this gradually come into force over the past four years. There is a still a hangover on the collar of the RPS system because of all the acts contained in the old system, which are going to be updated hopefully by 2014 into the new system. This is a littlepoint of controversy and I will come back to this later. New Comitology: Changes after the Lisbon Treaty The changes in the Lisbon Treaty focus on delegated acts and implementing acts. To look to the future, or the present, we just need to compare it with the past. Before Lisbon there was one article in the treaty to do with Comitology and there was one set of rules. Namely a Council decision which was taken in 1999, comprising five different systems. Now we have two legal basis, Article 290 for delegated acts, and Article 291 for implementing acts. These Articles constitute two separate legal frameworks so everything that is a delegated act is dealt with solely under Article 290 and everything that is an implementing act is dealt with solely under Article
  • 4. 291. There is alsoa separate decision taken by the EU institutions on delegated acts, the so-called ‘Common Understanding’. Therefore, previously onlya Council decision existed, whereas now, a Regulation adopted by the Council and the European Parliament together. What’s the difference between these two systems? Theyboth deal with non-legislative acts but there a couple of key differencesbetween these procedures. Delegated acts are always to amend and supplement legislation and are by nature non-essential. Hence, law can exist without these rules. In the health claims legislation for example, there is a part on nutrient profiles where the law has existed since 2007 without these nutrientprofiles ever being established. But the law still works; there is still a Regulation of health claims. Delegated acts are just another layer so it is not an essential part, but it’s a part that supplements the basic legislation. Whereas implementing acts are also non-legislative acts but they implement the legislation, and in that sense, they are essential. So, if we take for example thelegislation on CO2 emissions from cars, the legislator said that there need to be levels of emissions sets which manufacturers cannot go beyond. Without implementing acts, which actually set those levels, the law would not have any practical effect. So, implementing acts areoften essential. Delegated acts in detail Thereare four key features of delegated acts.In delegated acts there are no formal committees of national experts and this is where the confusion over the word Comitology comes in. It’s the Commission’s role to act alone and take a decision but there is now an informal consultation with national experts. The Council really wanted to maintain a littlebit of control over what the Commissions does and so they requested to have national experts involved. In its turn, the Parliamentas co-legislator, also said “wewant to have an expert present as well”. Therefore, under delegated acts the Commission formally acts alone but in practice there is still some involvement of national experts. Secondly,there is no horizontal procedure anymore but only the Treaty rules and Article 290. The legislator can decide case by case on how it delegates by putting articles in the legislation to define the content, the scope and the powers given to the Commission. Again, there is a slight caveat because the institutions develop a ‘Common Understanding’, which is a kind of model of how these articles should be included in the basic legislation order to avoid confusion and lots of different procedures and timings. Thirdly, we have a strong Council legislator in terms of its scrutiny after the Commission hastaken a decision. So, the Parliament or the Council can veto a measure, which is a very similar procedure to the Regulatory Procedure with Scrutiny. But they have an additional power; they can actually revoke the power of delegation, so they can say to the Commission “you’re making a mess of this”,“we don’t want to deal with this anymore” or “we consider this to be so politically important that we want to deal with it ourselves”. Either the Parliament or the Council can do that. Finally, we have inter-institutional parity, so the Parliament and the Council have equal powers now and the equal right to information. There is of course the informal consultation of national experts, still slightly in favor of the Council, but the Parliament has to all intents and purposes parity with the Council in terms of scrutinizing and overseeing what the Commission does. ‘Common Understanding’ in detail
  • 5. The legislator decides case by case on how it delegates but in the context of the‘Common Understanding’ that sets down what the legislator should put in the law in terms of the objectives, content, duration and scope of the delegation. This is basically a text that can be copied and pasted into a piece of legislation. It sets out how long the Commission holds this power for; it is usually 3 to 5 years that can be renewed. And how long the Parliament and the Council have to scrutinize a decision that the Commission has taken; it is usually two months, extendable by two months. Thus,the ‘Common Understanding’ is a kind of a standard piece of text that can go in laws to deal with delegated acts. Vetoing or Revoking Powers Then, if we look at another feature, which is the power to veto and revoke, this is very much a nuclear option. The Parliament and the Council cannot amend the measure that comes from Commission. But they have thenuclear option of vetoing this measure or taking away the power. Big majorities are needed to veto or revoke the power. In the Parliament, an absolute majority of all MEPs is needed not just those voting(376 votes out of 751) and in the Council a qualified majority (255 votes out of 345) against what the Commission decides. Therefore, it is very difficult to obtain these majorities. The co-legislators have two months, extendable by two months, to object to an act whereas they can use any reason whatsoever. Delegated acts example: energy labeling A Directive was passed in 2010, on the labeling of energy related products. In this law, Article 10 stipulates that “the Commission shall lay down the details by means of delegated acts”whileits second paragraph states what the aims are, so the acts“enableend-users to make better informed purchasing decisions and enable marketing surveillance authorities to verify when the products comply with the information provided.” Therefore, it becomes very clear what the Commission needs to do and what the Parliament and the Council want the Commission to do. The length of the delegation isfor five years and then automatically extended unless the Parliament or Council decidesotherwise. What we end up with here is the Commission that goes away and talks to people including national experts informally and develops something like this, which is a new version of the energy labels that I am sure you have seen on fridges and other products. Then, the measure goes back to the Parliament and the Council whohave two months plus two months to decide whether theywant to veto it. They cannot change it or decide otherwise but they have to really take it or leave it. Implementing acts in detail There are some features that make them very different to delegated acts. First of all, there are formal committees of national experts, so this is like the old Comitology. The Commission cannot simply do what it wishes. It needs to act in accordance with what the national experts want. Secondly, we have a horizontal procedure set by the Parliament and the Council via a Regulation setting down the specific procedures. You do not have specific references in the basic legislation but only an article saying that “it will be dealt with in the procedure referred to in the Regulation on Comitology” (Regulation (EU) No 182/2011).
  • 6. Then, we have weaker powers for the legislators, meaning the Parliament and Council, so the legislator only hasa right of scrutiny. It can apply to the Commission to reviewthe act, but it cannot veto it like it does underdelegated acts. Finally, we have inter-institutional disparity between the Parliament and Council. The Member States are in control in the Committees so they have a say on what the Commission does. In addition, there is an Appeal Committee, which is a second instance if it’s difficult to reach a decision whenthe member state representatives meet to discuss these issues. Therefore,the Member States have a lot more power than the Parliamentunder implementing acts. It can be argued that this is about implementation and about a role in particular for the Member Stateswho are the ones thatin the end have to implement EU laws. Thus, it is in some sense fair that they have more to say over those implementing rules. Implementing acts: Advisory Procedure The Advisory Procedure is a default procedure but a very light one, used for less important things, less controversial measures, like funding decisions, etc. All the Commission has to do is take the utmost account of the Committees views. It does not have to do anything more and after that it can pretty much do what it wishes. The Commission has a lot of freedom under this procedure. Implementing acts: Examination Procedure The Examination Procedure has a wide application and some rather vague definitions. It applies to issues of general scope or sensitive topics which they helpfully outline as Trade, Taxation, Human Health, Animal Health, Environment, Agriculture and Fisheries and many more. Therefore, it is really difficult to see what does not fall under this procedure. Under this procedure, the Committee votes on the measures and the Commission has to take account of the votes by the relevant Committee. If there is a conflict, if they are unable to reach an agreement, then the measure goes to the Appeal Committee, comprising the deputy permanent representatives. So, the Member States keep a significant amount of control. Under the Examination Procedure, the Commission proposes a measure that then goes to the Examination Committee which votes by qualified majority. If there is a qualifiedmajority in favor, the act is adopted as the Commission drafted it. If there is a qualified majority against, the Commission has to make a decision by either submittinga new draft actthat goes back to the Examination Committee or by sending the measureto the Appeal Committee. If there is no qualified majority either way, the Commission may adopt the proposed measure unless there is a simple majority against, unless it is said in the legislation that the Commission cannot do this and unless it is one of these sensitive topics. Appeal Committee under the Examination Procedure If the Commission decides not to adopt or if there is a qualified majority against, the draft measure can go to the Appeal Committeeof deputy permanent representatives, which meets in the context of the normal Comitology meetings chaired by the Commission. If in the Appeal Committee there is a qualified majority in favor, the act is adopted. If it is against, the act is not adopted. If there is no qualified majority, again, the Commission has a decision to make
  • 7. whether it wants to adopt this measure. There are a couple of caveats:the Commissioncannot take approval in multilateral trade safeguardsandon these sensitive topics it must reflect the predominant view. So, if you are working in the Appeal Committee stage and you cannot get a qualified majority, it is important to get at least a simple majority of the Member States in order to have the predominant view that has bearing on what the Commission decides to do. Implementing acts: alignment In terms of alignment for all implementing acts, there is an automatic alignment from the old Comitology to the new Comitology from the 1st of March, 2011. For delegated acts, this has to be done case by case and it will replace the Regulatory Procedure with Scrutiny taking place in all those acts that have that procedure. This will go on until 2014 and is causing a bit of disputes. Implementing acts example: post-Fukushima measures Another aspect of the Examination Procedure is that the Commission can act urgently under this procedure if it needs to adopt measures like the ones taken after the Fukushima nuclear disaster, which put controls on food and feed coming in from Japan. The Commission can do that immediately but the Committees have an‘ex-post control’ and can take a decision afterwards in favour of the Commission’s decision. In the case of a negative opinion by the Committees, the Commission has to repeal the act. Implementing acts example: Orphacol Another example of an implementing decision, rather controversial in France, isabout a drug called Orphacol, which deals with a rare leaver disease. This drug which has been used for a long time came up for market authorisation under the new pharmaceuticals rules and was given a positive opinion by the European Medicines Agency. However, the Commission, as it is free to do, decidednot to give it a market authorisation. In the Examination Committee there was a qualified majority against the Commission’ view. They wanted Orphacol to be licensed and thus, the draft measurewent to the Appeal Committee that also opposed what the Commission was doing. So the Commission came back and tabled a new draft which was very similar or maybe even identical to the original measure. A little bit of underhand tactics of the Commission, it tabled these documents to be voted in the Examination Committee on the day when there was a public holiday in one member state and so one member state representative was absent and another member state abstained. Thus, there was no qualified majority either way. In the end, the Commission had discretion and so it stuckby its original decision so Orphacol did not get licensed despite the positive opinion by the Medicines Agency and the support of the Member States. So implementing acts, still give the Commission a fair bit of leeway to do what it wishes. Delegated acts vs. implementing acts: an overview • The role of delegated acts is to supplement and amend. The role of implementing acts is to provide the uniform conditions for implementing the law. • The scope for delegated acts is general whereas for implementing acts individual (i.e. specific product).
  • 8. • Delegated acts: no formal committees, implementing acts: 250 formal committees. • Legal basis for delegated acts is in the individual legislation in the Treaty whereas for implementing acts there’s a horizontal Regulation that deals with the different procedures. • In terms of scrutiny, under delegated acts, the Parliament and the Council have the power to veto or revoke the delegation. Under implementing acts, the member states can block through the Appeal Committee but the scrutiny is more kind of sending the Commission a signal that they are unhappy and can formally veto. Practical insights from Andràs Before going to the next part, I would like to add one or two points, which I myself actually dealt with at the time when I was in the Commission’s unit dealing with these issues so as to further back up everything that David has said so far. One thing to have very clearly in mind is the difference between voting for or against a certain proposal because when it comes to what we call the basic legislative acts (Regulation or a Directive), the main rule is that the Parliament and the Council need to have a qualified majority for in order to adopt those. Whereas for implementing measures, whichever procedure is being used, the rule is that the Commission can actually have its way unless it is voted down by qualified majority. This gives the Commission very strong powers to go ahead because the goal is that it has these implementing powers in order to make sure that these Regulations or Directives are eventually adopted whether it is authorising a new pharmaceutical product, food labeling, a health claim or body scanners at airports.But this also gives the Commission very, very large powers or very, very extensive powers to go ahead. So, if your case is not liked by the Commission, as we have seen with the Orphacol case, then it is much harder to get it across the system. And here I give the word back to David. Conflicts and controversies We will now advance to the ultimate part which is conflicts and controversies. One of the major controversies is about the alignment from the old Comitology to the new Comitology under the Lisbon Treaty. For implementing acts, it is very simple and straightforward: under the old Comitology you had advisory, management and regulatory procedures, which have now become advisory and examination procedures with the latter taking up the management and regulatory procedures. Issue 1: Post-Lisbon alignment Under delegated acts there is an on-going alignment where you have to take each individual piece of legislation and amend it in order to put it in the delegated acts rules into each individual piece of legislation. This is becoming more difficult and controversial. On paper, it would be simple to say, that the Regulatory Procedure with Scrutiny, which involves a Parliament and a Council veto, should actually become delegated acts to give the same powers to the Parliament and Council to veto a measure. What the Council is actually trying to do is move as much as possible into the Examination Procedure, that big long list of areas of sensitive topics, etc. This is an attempt by the Council to really broaden the scope of the Examination Procedure and put as much of what was in the old RPS system in the Examination Procedure where it has more power than the Parliament. This is obviously becoming a controversial issue. The Parliament wants to defend its interests to some extent. The Council fears that if there is too much that goes under delegated acts, the Parliament will be more susceptible to lobbying
  • 9. and pressure and it will veto more measures.To link to this issue of alignment, there is also an issue about the choice of procedure when developing legislation. There are three case studies that show how it is becoming a question ofpolitics versus law. Issue 2: Choice of procedure In the WEEE Directive (waste electrical and electronic equipment), the Parliament is against the Council. They were lock into disputes whether to use implementing acts or delegated acts, and in the end the Parliament conceded to the Council.It said “okay, you can have implementing acts which give you more power” but it noted that “this should not be used as precedent for the future”. So the Parliament is actually saying here, “we give you what you want this time but not necessarily in the future”. Then we have another case, which iscross borderhealthcare where the Parliament and the Council came again to a compromise. The Parliament conceded to the Council to use implementing acts rather than delegated acts but the Commission made a protest this time and questioned whether it is legal to adopt implementing acts because they should actually be delegated acts. So, the Commission was sitting there, saying it was afraid that they would be challenged in Court for having used the wrong procedure because the Parliament and the Council told it to. So, this is a new type of dispute. A similar thing happened in the Biocides Directive where the Commission basically said that “we are going to take this to Court, wedo not believe that the choice of implementing acts rather than delegated acts was the right one, we fear if we take this decision it will be illegal because we used the wrong procedure, you told us to, and so we are going to take this to court and we are going to find out what the legality is in this case and it may also be instructive for the future.” You may ask why on earth the Parliament gave away its power like this. Well, I think it is really a question of trading substance for procedure so the Parliament is willing to give up its power of veto in delegated acts. Remember it has to get a very high majority to block anything so probably the MEPs made a calculation that it is better to give away the procedure and get a bit more substance in the law in terms of what the Parliament wants in the actual substance of the law. So this is where politics and the law conflicts in itself. Issue 3: Nuclear Option Third issue is the idea of the nuclear option ‘take it or leave it’, a choice that can be very tricky. In the case of food additives, the Commission proposed to authorize 20 food additives, one of which was ‘meat glue’. The Parliament was against this additive but had to veto all the measures altogether because it could not say “we want 19 of these additives but not the last one”. Thus, it had to block everything. You wonder whether the Commission was kind of calculating, “well, do we really think the Parliament isgoing to veto all of these additives because it does not like one?” In the end, yes.The Parliament said we are so opposed tothe use of this additive that we are willing to sacrifice all of them. And that of course had a big impact on those companies that were using those other additives. Issue 4: Putting policy in ‘silos’ The fourth issue is putting policy in ‘silos’. Sometimesan issue is not just black and white in one specific area; it is actually something that deals with various different interests. The example of airport body scanners is a good one, where the Commission drafted an act on the installation of body scanners in
  • 10. airports. This was adopted by the Committee of Transport Experts under theRegulatory Procedure with Scrutiny and was then sent to the Parliament for scrutiny. It went to the relevant committee first so the Transport Committee, andthe Transport Committee said, “Yes this sounds good, we are happy with this.” It was only when MEPs on the Civil Liberties Committee heard about this measure thatthey started to object to it because of the lack of privacy safeguards. In the end they persuaded the President of the Parliament to write to the Commission, which finally withdrew the measure. This shows that there needs to be some way of taken into account broader interests rather than just a specific policy interest. And it is also worth noting that a formal veto is not the only way to block a proposal, it can also be done informally by signaling to the Commission that the Parliament is unhappy. Comment by Andràs The comment concerns basically the Commission’s discretionary powers, what it can do when it comes to many of these measures. For instance, in terms of the Medicines Agency or the Food Safety Authority or any kind of scientific or expert input, these are not prejudging what the Commission can eventually propose as a technical measure whether it is through implementing acts or delegated ones. Because, if for instance, the Food Safety Authority considers a certain food or a pesticide safe or unsafe, that is the risk assessor but the Commission itself is the risk manager as they call it. Thus, the Commission is the one making the policy and can apply its best judgment or even its own political consideration whether or not it would like to propose a certain measure. Therefore,this is an interesting point to make that having science on your side does not necessarily mean that it is going to turn into legislation in the end. Question: Who can member states delegate into the implementing committees to represent them? This is a very good question. They can send anybody they like. Usually it is an expert from a relevant ministry so for example on an additive’s issue in food, somebody from the Food Standards Agency in the UK would be sent, and who specializes in additives. There may be occasions where the scope of the Committee particularly in food law covers lots of different areas so you have to send someone with a more general knowledge of food policyissues. There is also an issue that this can create a bit of an imbalance between the member states because some member states have very large administrations and they have people whocan specialize a lot in very specific areas. Other member states may only be able to send somebody who is dealing generally with food additives and health claims and lots of other different things. So usuallythey send somebody from the ministry but it can also be somebody else. I have heard in some cases that even an industry representative has been sent to oneCommittee on behalf of a member state to deal with -I think- something regarding energy labeling. Therefore, as long as that person can commit the member state in that Committee, then they can attend. Question: Is the qualified majority being used in the examination committee, the same majority or the same type of vote as the one used in normal Council working groups or even on ministerial level? Yes, it is the same qualified majority that applies at the moment with the votes going from 29downwards. Obviously that will change in the Comitology committees in the same way that it will change in the Council when the new system comes in 2014 with the weighting of the national populations. ‘New Comitology’ tips
  • 11. We will now move on to the last section which is tips for working with Comitology and I will split this up intoa few different areas. First of all impact; some of the Comitology decisions have real significant impact on businesses and on citizens.There are around 2,000 delegated or implementing acts adopted every year compared to 60-70 basic legislative acts. Comitology has a huge impact on specific business issues in particular on how you label market and on whether your product is even authorised. Procedure In terms of procedure, it is important that you know which one applies to your issue so that it should be clear from the initial legislation. If there is legislation being passed that affects your interests, you should think about whether you need to influence the choice of procedure in that legislative phase. As we have seen, there is a slight blur between implementing acts and delegating acts so there is a choice there whether you want to encourage MEPs or member states to push for a particular type of Comitology either implementing or delegated acts. Timing In terms of timing, think about Comitology from the legislative phase so especially on delegated acts, think about what type of powers should be delegated so you can talk to MEPs and member states. Then, focus on Comitology as soon as the law is passed because the Commission will already start thinking process about what it is going to do and how it is going to implement this law. And get in early, so talk to the Commission while it is drafting because otherwise you could end up just calling for the nuclear option that is a very difficult one to get MEPs to do because there is a lack of understanding, or expertise and a lack of time due to the large number of measures. There is often too little time to veto and the threshold is very high with the absolute majority needed in the European Parliament and the qualified majority in the Council. Network Get to know the Commission’s desk officer responsible that could be a source of information. Find out which committee is involved and who sits on it. This can often be difficult but if you talk to the national ministries you can often find out who is involved. For delegated acts in particular, you need to think about which MEPs are interested in the issue and wish to be kept informed. That was the case with infant formula where a certain health claim oninfantformula was approved by the Commission and the anti-baby milkor pro-breast milk lobby immediately went to the Parliament to warn some supportive MEPs that this decision was coming up and that they needed to keep an eye out for it and that they needed to start building an alliance to block this claim. They achieved partial success and they got a majority of the MEPs voting but they did not manage toget the absolute majority needed in the Parliament. So there are people watching where these rules come from. Finally, consultations may include experts from the Parliament or non-institutional actors so they may be online consultations or people from industry or civil society may be brought in to discuss with the Commission. Stay informed And then the last tip is to stay informed. Talk to the Commission desk officer and keep in mind that the Parliament’s Committee secretariats now have people who specialise in Comitology, who manage the process, or who edit newsletters for MEPs that are available on the Parliament’s website. You could also talk to permanent representations and ministry officials too. Finally there is a Comitology register that is
  • 12. online. This is a great step forward in transparency that was probably unthinkable maybe a decade ago but there is a lot of information about the types of decisions that are being taken and the types of committees that exist. Question:Why can the Commission and its agencies take decisions since it is a non-elected body and even taken into account the consultations, this does not look good from a democracy and transparency point of view? (Andras) It isabsolutely not my task to defend the Commission but in terms of the governance nature of the EU, it makes sense that there is an administrative and executive body just like any government agency which with sufficient and unbiased scientific input from neutral experts such as in the EFSA or in the Medicines Agency or any other EU agency eventually it makes policy under the necessary safeguards. Now, where the system can certainly be criticized is whether the safeguards are sufficient. Because it is the eternal dilemma between efficiency and democracy and when it comes to these technical measures, efficiency is very important. Whereas the democratic element comes in especially in the implementing measures where committees take part and member states experts participate. For delegated acts, it can be heavily criticized because ithappens in-house. Essentially, the Commission has an enormous large power to do as it pleases it even if it is asks various experts or member states representatives or others. It is the Commission and the Commission only that passes those delegated acts. And the scrutiny is mostly of political nature and just as we saw with the food additive issue for instance, it is either everything or nothing so that is why it is called ‘a nuclear option’. For delegated acts, there is a much less democratic element in it and that is why the choice between the two procedures is so important. Because who has the upper hand? Who has more influence? Is it the Commission, is it the member states, is it the Parliament? Maybe David you want to share a few thoughts yourself. (David) Just to add, I think it is also a question more fundamentally about the legitimacy of the Commission and all that it does. In that it does not have any direct elections to it and therefore, there is a question over its legitimacy. Sometimes it is handy for the member states to actually have this kind of system because if we take the olive oil example, you would probably not find any member states who wouldsay“we really think this is a great idea” but what they can do is only blame the Commission. Whereas they actually sat inthe Committee and either voted for it or did not vote against it anyway. So it can be helpful for the member states to do something they want to do but nothing unpopular and in that case they can blame it on the Commission and complain about the lack of legitimacy. It is just one of those political games, I think. Comment: Whether influencing the Commission, am I the only one who worries?Generally speaking, the Commission has no transparency register where EU citizens can have avision of which lobbyists it meets. (Andràs) I think the term influencing the Commission is often limited to corporate lobbyists and private businesses but just like any member state diplomat, external country and NGO, everyone tries to influence the Commission. So, the concept of influencing the Commission is not to be understood as a negative one. Certainly there is a point to be made in terms of itstransparency but there is a transparency register online, which isbeing currently revised.
  • 13. Question: Has the Parliament so far under the new rules used the opportunity to actually veto a certain measure that the Commission has proposed. Have they achieved the necessary, absolute majority and if so, in which area or policy? You kind of caught me out there on that question. I do notthink they do, I do not think they have actually. I have certainly not seen one. There were several times in the previous Parliament under RPS thatthe Parliament has vetoed a Commission measure. I think the closest they came in this Parliamentunder the new rules was actually with this baby milk claim where they got a majority of MEPs but not an absolute majority. But there weresome cases in the previous Parliament on issues to do with energy labeling where an absolute majority was reached. In fact, on the energy labeling issue, there were two questions, one on the refrigerators and one on televisions, on which they actuallyvetoed one and they did not manage to veto the other because some people went to lunch. (Andràs) There was the famous issue of the novel foods Regulation, which was proposed by the Commission and which contained a number of implementing measures and delegated acts in terms of which, issues are to be decided by which procedure. But this was a primary legislation that would lay down the framework rules and not about any specific food claim or any specific authorisation procedure. It essentially failed because of the inability of members of Parliament, of member states, and the Commission to come to an agreement on which procedure is to be used. So, in terms of looking at the importance of these procedures, I think we can say that the devil is always in the details. I thank you very much David for being here with us and I am very glad that we managed to cover this very complex topic and hopefully we shed some light on how it works in practice with various examples. Have a nice day and thanks once again.