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Regulatory affairs   what you should know about implementing and delegated acts

Regulatory affairs what you should know about implementing and delegated acts



http://www.eu-academy.eu/freeresources/eu-regulatory-affairs-implementing-delegated-acts/ ...


"Comitology" demystified: how regulatory decision-making works
Who does what: the EU institutions' formal and informal roles
Timeline, planning, advocacy and impact assessment: advocacy tips



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    Regulatory affairs   what you should know about implementing and delegated acts Regulatory affairs what you should know about implementing and delegated acts Document Transcript

    • EU Regulatory Affairs: What you should know aboutimplementing and delegated actsPlease note that the following transcript has been edited to make reading easier and may slightly differfrom what was said in the webinar recording. Disclaimer: We aim to ensure a high level of accuracy, butthe webinar and the transcript are for information purposes only and they cannot be considered aslegally binding.Speaker: David O’Leary (moderator: András Baneth)Today’s topic concerns EU Regulatory Affairs and what you should know about implementing anddelegated acts or the so-called New Comitology.I would like to welcome everyone to the next in theseries of EU Public Affairs webinars. The series itself comprises of seven parts and this is the third onecovering Regulatory Affairs, what is commonly known as Comitology or at least its new form since theTreaty 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-Marstellerand he is specialist on everything that is related to consumer goods, ICT, food industry and relatedareas. As you might be familiar with Burson-Marsteller, who is kind enough to co-organise this webinarseries, 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 handdo 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 presentationThank you András and thank you for joining this presentation about the new Comitology, what youshould 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, whodoes it, why do we have it and I will explain about the history of it. Then, we have the second part whichfocuses on the new Comitology and on what happened after the Lisbon Treaty brought in thedelegatedand implementing acts. Then part three, will look at some conflicts and controversies about Comitologyand 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 justbecause it’s basically the least worst option, since other options tend to be very long winded or riskraising confusion.
    • So what is Comitology? It can be explained in a few ways. It is filling in the gaps in legislation; legislatorscannot do all of the details. It is a way of dealing with those details. It is also been called a perhapsobscure system for taking quite important decisions.Three newspaper headlines show the kind of public impact Comitology decisions may have; they are allfrom British newspapers which tend to get hot under the collar about this type of decisions taken byBrussels 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 canprevent hydration. This was another decision taken by Comitology under the health claims Regulationbased on an opinion from the European Food Safety Authority. Finally, the Daily Mail headline on bodyscanners 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. Itsimpact 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 orthe ordinary legislative procedure (as it is called after the entry into force of the Lisbon Treaty), theCommission makes a proposal, which then passes on to the Council of the EU and the EuropeanParliament, who are the two co-legislators responsible for taking decisions and developing laws. Thattakes 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 callComitology whereby the Commission takes a decision often assisted by national experts from theMember States. It will be scrutinized and networked by the European Parliament and the Council andthen it will develop these non-legislative acts. They apply with equal force to legislation and can happento have an impact. It can take at least two days to reach decision, if it is an urgent process or severalmonths. Therefore, it is a lot quicker than the legislative process.Under Comitology, the Commission proposes, consults its expert Committees and adopts an act. Then, itis the legislator who has control in some cases, sometimes the power to veto, always at least the powerof 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 differentministries, 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 differentsections and works on lots of different laws dealing with food policy. The Single Sky Committee dealswith different parts of transport legislation. And then, there are also committees that are set up forspecific pieces of legislation such as the Services Directive Committee, which deals with theimplementation of the services Directive.
    • Why Comitology?The reason we have this slightly obscure and complicated process is actually, a very good one. It is thereason that it isused in lots of different political systems around the world. It is basically to have aprocess faster than the legislative process, thus speed. It is an efficient process because it does notblock up the Council in taking often mundane and very technical decisions. It is reactive and so you donot need to convene Ministers in 27 Member States or the entire European Parliament. In this way, youcan take a decision very quickly. And it brings the necessary expertise, given that some decisions arevery technical and you cannot really expect politicians to have general knowledge to take thesedecisions so experts are needed.Of course there are downsides to this; there are questions of democracy, accountability and oftransparency. These are to some extent being addressed by the new Comitology but there are stillconcernsabout faceless bureaucrats taking these decisions and whether they have the power but no realresponsibility for what they decide. In the end, for decisions taken in the Commission’s name, it’s theCommission who takes the blame even if it is the national experts who ultimately took the decision.A brief history of ComitologyIt grew in the 60’s when the Common Agricultural Policy (CAP)needed some implementing rules toenable its works. So the Commission set up some procedures and talked to the Member States. Thispractice developed in the 1970’s. Then in 1987, when we hada whole platter of different Committeesand different rules, the first horizontal rules on Comitology came into place. The Council took then thedecision to establish some clear procedures.By 1999, we had a new horizontal decision and for the first time the European Parliament was reallyinvolved. 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 calledRegulatory Procedurewith Scrutiny or RPS. The Parliament had a veto for the first time because itwanted a say in what was happening. It characteristically said, “Oh, we take parts in the making of theselaws, 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 thisgradually come into force over the past four years. There is a still a hangover on the collar of the RPSsystem because of all the acts contained in the old system, which are going to be updated hopefully by2014 into the new system. This is a littlepoint of controversy and I will come back to this later.New Comitology: Changes after the Lisbon TreatyThe 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 thetreaty to do with Comitology and there was one set of rules. Namely a Council decision which was takenin 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 dealtwith 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, aRegulation 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 acouple of key differencesbetween these procedures. Delegated acts are always to amend andsupplement legislation and are by nature non-essential. Hence, law can exist without these rules. In thehealth claims legislation for example, there is a part on nutrient profiles where the law has existed since2007 without these nutrientprofiles ever being established. But the law still works; there is still aRegulation of health claims. Delegated acts are just another layer so it is not an essential part, but it’s apart that supplements the basic legislation.Whereas implementing acts are also non-legislative acts but they implement the legislation, and in thatsense, they are essential. So, if we take for example thelegislation on CO2 emissions from cars, thelegislator 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 detailThereare four key features of delegated acts.In delegated acts there are no formal committees ofnational experts and this is where the confusion over the word Comitology comes in. It’s theCommission’s role to act alone and take a decision but there is now an informal consultation withnational experts. The Council really wanted to maintain a littlebit of control over what the Commissionsdoes 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 Commissionformally 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. Thelegislator can decide case by case on how it delegates by putting articles in the legislation to define thecontent, the scope and the powers given to the Commission. Again, there is a slight caveat because theinstitutions develop a ‘Common Understanding’, which is a kind of model of how these articles shouldbe 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 adecision. So, the Parliament or the Council can veto a measure, which is a very similar procedure to theRegulatory Procedure with Scrutiny. But they have an additional power; they can actually revoke thepower of delegation, so they can say to the Commission “you’re making a mess of this”,“we don’t wantto deal with this anymore” or “we consider this to be so politically important that we want to deal withit 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 andthe equal right to information. There is of course the informal consultation of national experts, stillslightly in favor of the Council, but the Parliament has to all intents and purposes parity with the Councilin 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‘CommonUnderstanding’ 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 theCommission holds this power for; it is usually 3 to 5 years that can be renewed. And how long theParliament and the Council have to scrutinize a decision that the Commission has taken; it is usually twomonths, extendable by two months. Thus,the ‘Common Understanding’ is a kind of a standard piece oftext that can go in laws to deal with delegated acts.Vetoing or Revoking PowersThen, if we look at another feature, which is the power to veto and revoke, this is very much a nuclearoption. The Parliament and the Council cannot amend the measure that comes from Commission. Butthey 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 allMEPs is needed not just those voting(376 votes out of 751) and in the Council a qualified majority (255votes out of 345) against what the Commission decides. Therefore, it is very difficult to obtain thesemajorities. The co-legislators have two months, extendable by two months, to object to an act whereasthey can use any reason whatsoever.Delegated acts example: energy labelingA Directive was passed in 2010, on the labeling of energy related products. In this law, Article 10stipulates that “the Commission shall lay down the details by means of delegated acts”whileits secondparagraph states what the aims are, so the acts“enableend-users to make better informed purchasingdecisions and enable marketing surveillance authorities to verify when the products comply with theinformation provided.” Therefore, it becomes very clear what the Commission needs to do and what theParliament and the Council want the Commission to do.The length of the delegation isfor five years and then automatically extended unless the Parliament orCouncil decidesotherwise. What we end up with here is the Commission that goes away and talks topeople including national experts informally and develops something like this, which is a new version ofthe energy labels that I am sure you have seen on fridges and other products. Then, the measure goesback to the Parliament and the Council whohave two months plus two months to decide whethertheywant to veto it. They cannot change it or decide otherwise but they have to really take it or leave it.Implementing acts in detailThere are some features that make them very different to delegated acts. First of all, there are formalcommittees of national experts, so this is like the old Comitology. The Commission cannot simply dowhat 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 settingdown the specific procedures. You do not have specific references in the basic legislation but only anarticle 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 legislatoronly hasa right of scrutiny. It can apply to the Commission to reviewthe act, but it cannot veto it like itdoes underdelegated acts.Finally, we have inter-institutional disparity between the Parliament and Council. The Member Statesare in control in the Committees so they have a say on what the Commission does. In addition, there isan Appeal Committee, which is a second instance if it’s difficult to reach a decision whenthe memberstate representatives meet to discuss these issues. Therefore,the Member States have a lot more powerthan the Parliamentunder implementing acts. It can be argued that this is about implementation andabout a role in particular for the Member Stateswho are the ones thatin the end have to implement EUlaws. Thus, it is in some sense fair that they have more to say over those implementing rules.Implementing acts: Advisory ProcedureThe Advisory Procedure is a default procedure but a very light one, used for less important things, lesscontroversial measures, like funding decisions, etc. All the Commission has to do is take the utmostaccount of the Committees views. It does not have to do anything more and after that it can prettymuch do what it wishes. The Commission has a lot of freedom under this procedure.Implementing acts: Examination ProcedureThe Examination Procedure has a wide application and some rather vague definitions. It applies to issuesof 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 tosee what does not fall under this procedure.Under this procedure, the Committee votes on the measures and the Commission has to take account ofthe 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 theExamination Committee which votes by qualified majority. If there is a qualifiedmajority in favor, the actis adopted as the Commission drafted it. If there is a qualified majority against, the Commission has tomake a decision by either submittinga new draft actthat goes back to the Examination Committee or bysending the measureto the Appeal Committee. If there is no qualified majority either way, theCommission may adopt the proposed measure unless there is a simple majority against, unless it is saidin the legislation that the Commission cannot do this and unless it is one of these sensitive topics.Appeal Committee under the Examination ProcedureIf the Commission decides not to adopt or if there is a qualified majority against, the draft measure cango to the Appeal Committeeof deputy permanent representatives, which meets in the context of thenormal 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, theact 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 takeapproval in multilateral trade safeguardsandon these sensitive topics it must reflect the predominantview. So, if you are working in the Appeal Committee stage and you cannot get a qualified majority, it isimportant to get at least a simple majority of the Member States in order to have the predominant viewthat has bearing on what the Commission decides to do.Implementing acts: alignmentIn terms of alignment for all implementing acts, there is an automatic alignment from the oldComitology to the new Comitology from the 1stof March, 2011. For delegated acts, this has to be donecase by case and it will replace the Regulatory Procedure with Scrutiny taking place in all those acts thathave that procedure. This will go on until 2014 and is causing a bit of disputes.Implementing acts example: post-Fukushima measuresAnother aspect of the Examination Procedure is that the Commission can act urgently under thisprocedure if it needs to adopt measures like the ones taken after the Fukushima nuclear disaster, whichput controls on food and feed coming in from Japan. The Commission can do that immediately but theCommittees have an‘ex-post control’ and can take a decision afterwards in favour of the Commission’sdecision. In the case of a negative opinion by the Committees, the Commission has to repeal the act.Implementing acts example: OrphacolAnother example of an implementing decision, rather controversial in France, isabout a drug calledOrphacol, which deals with a rare leaver disease. This drug which has been used for a long time came upfor market authorisation under the new pharmaceuticals rules and was given a positive opinion by theEuropean Medicines Agency. However, the Commission, as it is free to do, decidednot to give it amarket authorisation.In the Examination Committee there was a qualified majority against the Commission’ view. Theywanted Orphacol to be licensed and thus, the draft measurewent to the Appeal Committee that alsoopposed what the Commission was doing. So the Commission came back and tabled a new draft whichwas 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 theExamination Committee on the day when there was a public holiday in one member state and so onemember state representative was absent and another member state abstained. Thus, there was noqualified majority either way. In the end, the Commission had discretion and so it stuckby its originaldecision so Orphacol did not get licensed despite the positive opinion by the Medicines Agency and thesupport of the Member States. So implementing acts, still give the Commission a fair bit of leeway to dowhat 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 toprovide the uniform conditions for implementing the law.• The scope for delegated acts is general whereas for implementing acts individual (i.e. specificproduct).
    • • Delegated acts: no formal committees, implementing acts: 250 formal committees.• Legal basis for delegated acts is in the individual legislation in the Treaty whereas forimplementing 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 toveto or revoke the delegation. Under implementing acts, the member states can block throughthe Appeal Committee but the scrutiny is more kind of sending the Commission a signal thatthey are unhappy and can formally veto.Practical insights from AndràsBefore going to the next part, I would like to add one or two points, which I myself actually dealt with atthe time when I was in the Commission’s unit dealing with these issues so as to further back upeverything that David has said so far.One thing to have very clearly in mind is the difference between voting for or against a certain proposalbecause when it comes to what we call the basic legislative acts (Regulation or a Directive), the mainrule 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 theCommission can actually have its way unless it is voted down by qualified majority. This gives theCommission very strong powers to go ahead because the goal is that it has these implementing powersin order to make sure that these Regulations or Directives are eventually adopted whether it isauthorising a new pharmaceutical product, food labeling, a health claim or body scanners at airports.Butthis also gives the Commission very, very large powers or very, very extensive powers to go ahead. So, ifyour case is not liked by the Commission, as we have seen with the Orphacol case, then it is muchharder to get it across the system. And here I give the word back to David.Conflicts and controversiesWe will now advance to the ultimate part which is conflicts and controversies. One of the majorcontroversies is about the alignment from the old Comitology to the new Comitology under the LisbonTreaty. For implementing acts, it is very simple and straightforward: under the old Comitology you hadadvisory, management and regulatory procedures, which have now become advisory and examinationprocedures with the latter taking up the management and regulatory procedures.Issue 1: Post-Lisbon alignmentUnder delegated acts there is an on-going alignment where you have to take each individual piece oflegislation and amend it in order to put it in the delegated acts rules into each individual piece oflegislation. This is becoming more difficult and controversial. On paper, it would be simple to say, thatthe Regulatory Procedure with Scrutiny, which involves a Parliament and a Council veto, should actuallybecome 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 thescope of the Examination Procedure and put as much of what was in the old RPS system in theExamination Procedure where it has more power than the Parliament. This is obviously becoming acontroversial issue. The Parliament wants to defend its interests to some extent. The Council fears that ifthere 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 issueabout the choice of procedure when developing legislation. There are three case studies that show howit is becoming a question ofpolitics versus law.Issue 2: Choice of procedureIn 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 theParliament conceded to the Council.It said “okay, you can have implementing acts which give you morepower” but it noted that “this should not be used as precedent for the future”. So the Parliament isactually 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 cameagain to a compromise. The Parliament conceded to the Council to use implementing acts rather thandelegated acts but the Commission made a protest this time and questioned whether it is legal to adoptimplementing 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 procedurebecause 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 aregoing to take this to Court, wedo not believe that the choice of implementing acts rather than delegatedacts was the right one, we fear if we take this decision it will be illegal because we used the wrongprocedure, you told us to, and so we are going to take this to court and we are going to find out whatthe 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 aquestion of trading substance for procedure so the Parliament is willing to give up its power of veto indelegated acts. Remember it has to get a very high majority to block anything so probably the MEPsmade a calculation that it is better to give away the procedure and get a bit more substance in the law interms of what the Parliament wants in the actual substance of the law. So this is where politics and thelaw conflicts in itself.Issue 3: Nuclear OptionThird issue is the idea of the nuclear option ‘take it or leave it’, a choice that can be very tricky. In thecase of food additives, the Commission proposed to authorize 20 food additives, one of which was ‘meatglue’. The Parliament was against this additive but had to veto all the measures altogether because itcould not say “we want 19 of these additives but not the last one”. Thus, it had to block everything. Youwonder whether the Commission was kind of calculating, “well, do we really think the Parliamentisgoing to veto all of these additives because it does not like one?” In the end, yes.The Parliament saidwe are so opposed tothe use of this additive that we are willing to sacrifice all of them. And that ofcourse 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 specificarea; it is actually something that deals with various different interests. The example of airport bodyscanners 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 undertheRegulatory Procedure with Scrutiny and was then sent to the Parliament for scrutiny. It went to therelevant committee first so the Transport Committee, andthe Transport Committee said, “Yes thissounds good, we are happy with this.” It was only when MEPs on the Civil Liberties Committee heardabout this measure thatthey started to object to it because of the lack of privacy safeguards. In the endthey persuaded the President of the Parliament to write to the Commission, which finally withdrew themeasure. This shows that there needs to be some way of taken into account broader interests ratherthan just a specific policy interest. And it is also worth noting that a formal veto is not the only way toblock a proposal, it can also be done informally by signaling to the Commission that the Parliament isunhappy.Comment by AndràsThe comment concerns basically the Commission’s discretionary powers, what it can do when it comesto many of these measures. For instance, in terms of the Medicines Agency or the Food Safety Authorityor any kind of scientific or expert input, these are not prejudging what the Commission can eventuallypropose as a technical measure whether it is through implementing acts or delegated ones. Because, iffor instance, the Food Safety Authority considers a certain food or a pesticide safe or unsafe, that is therisk assessor but the Commission itself is the risk manager as they call it. Thus, the Commission is theone making the policy and can apply its best judgment or even its own political consideration whetheror not it would like to propose a certain measure. Therefore,this is an interesting point to make thathaving 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 relevantministry so for example on an additive’s issue in food, somebody from the Food Standards Agency in theUK would be sent, and who specializes in additives. There may be occasions where the scope of theCommittee particularly in food law covers lots of different areas so you have to send someone with amore general knowledge of food policyissues. There is also an issue that this can create a bit of animbalance between the member states because some member states have very large administrationsand they have people whocan specialize a lot in very specific areas. Other member states may only beable to send somebody who is dealing generally with food additives and health claims and lots of otherdifferent things. So usuallythey send somebody from the ministry but it can also be somebody else. Ihave heard in some cases that even an industry representative has been sent to oneCommittee onbehalf of a member state to deal with -I think- something regarding energy labeling. Therefore, as longas 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 thesame 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 from29downwards. Obviously that will change in the Comitology committees in the same way that it willchange in the Council when the new system comes in 2014 with the weighting of the nationalpopulations.‘New Comitology’ tips
    • We will now move on to the last section which is tips for working with Comitology and I will split this upintoa few different areas. First of all impact; some of the Comitology decisions have real significantimpact on businesses and on citizens.There are around 2,000 delegated or implementing acts adoptedevery year compared to 60-70 basic legislative acts. Comitology has a huge impact on specific businessissues in particular on how you label market and on whether your product is even authorised.ProcedureIn terms of procedure, it is important that you know which one applies to your issue so that it should beclear from the initial legislation. If there is legislation being passed that affects your interests, you shouldthink about whether you need to influence the choice of procedure in that legislative phase. As we haveseen, there is a slight blur between implementing acts and delegating acts so there is a choice therewhether you want to encourage MEPs or member states to push for a particular type of Comitologyeither implementing or delegated acts.TimingIn 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 thinkingprocess about what it is going to do and how it is going to implement this law. And get in early, so talk tothe Commission while it is drafting because otherwise you could end up just calling for the nuclearoption that is a very difficult one to get MEPs to do because there is a lack of understanding, orexpertise and a lack of time due to the large number of measures. There is often too little time to vetoand the threshold is very high with the absolute majority needed in the European Parliament and thequalified majority in the Council.NetworkGet to know the Commission’s desk officer responsible that could be a source of information. Find outwhich committee is involved and who sits on it. This can often be difficult but if you talk to the nationalministries you can often find out who is involved. For delegated acts in particular, you need to thinkabout which MEPs are interested in the issue and wish to be kept informed. That was the case withinfant formula where a certain health claim oninfantformula was approved by the Commission and theanti-baby milkor pro-breast milk lobby immediately went to the Parliament to warn some supportiveMEPs that this decision was coming up and that they needed to keep an eye out for it and that theyneeded to start building an alliance to block this claim. They achieved partial success and they got amajority of the MEPs voting but they did not manage toget the absolute majority needed in theParliament. So there are people watching where these rules come from. Finally, consultations mayinclude experts from the Parliament or non-institutional actors so they may be online consultations orpeople from industry or civil society may be brought in to discuss with the Commission.Stay informedAnd then the last tip is to stay informed. Talk to the Commission desk officer and keep in mind that theParliament’s Committee secretariats now have people who specialise in Comitology, who manage theprocess, or who edit newsletters for MEPs that are available on the Parliament’s website. You could alsotalk 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 agobut there is a lot of information about the types of decisions that are being taken and the types ofcommittees that exist.Question:Why can the Commission and its agencies take decisions since it is a non-elected body andeven taken into account the consultations, this does not look good from a democracy andtransparency point of view?(Andras) It isabsolutely not my task to defend the Commission but in terms of the governance nature ofthe EU, it makes sense that there is an administrative and executive body just like any governmentagency which with sufficient and unbiased scientific input from neutral experts such as in the EFSA or inthe Medicines Agency or any other EU agency eventually it makes policy under the necessarysafeguards. 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 thesetechnical measures, efficiency is very important. Whereas the democratic element comes in especially inthe implementing measures where committees take part and member states experts participate. Fordelegated acts, it can be heavily criticized because ithappens in-house. Essentially, the Commission hasan enormous large power to do as it pleases it even if it is asks various experts or member statesrepresentatives or others. It is the Commission and the Commission only that passes those delegatedacts. And the scrutiny is mostly of political nature and just as we saw with the food additive issue forinstance, it is either everything or nothing so that is why it is called ‘a nuclear option’. For delegatedacts, there is a much less democratic element in it and that is why the choice between the twoprocedures is so important. Because who has the upper hand? Who has more influence? Is it theCommission, is it the member states, is it the Parliament? Maybe David you want to share a fewthoughts yourself.(David) Just to add, I think it is also a question more fundamentally about the legitimacy of theCommission and all that it does. In that it does not have any direct elections to it and therefore, there isa question over its legitimacy. Sometimes it is handy for the member states to actually have this kind ofsystem because if we take the olive oil example, you would probably not find any member states whowouldsay“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 itcan be helpful for the member states to do something they want to do but nothing unpopular and inthat case they can blame it on the Commission and complain about the lack of legitimacy. It is just oneof 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 itmeets.(Andràs) I think the term influencing the Commission is often limited to corporate lobbyists and privatebusinesses but just like any member state diplomat, external country and NGO, everyone tries toinfluence the Commission. So, the concept of influencing the Commission is not to be understood as anegative one. Certainly there is a point to be made in terms of itstransparency but there is atransparency register online, which isbeing currently revised.
    • Question: Has the Parliament so far under the new rules used the opportunity to actually veto acertain measure that the Commission has proposed. Have they achieved the necessary, absolutemajority 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 haveactually. I have certainly not seen one. There were several times in the previous Parliament under RPSthatthe Parliament has vetoed a Commission measure. I think the closest they came in thisParliamentunder the new rules was actually with this baby milk claim where they got a majority of MEPsbut not an absolute majority. But there weresome cases in the previous Parliament on issues to do withenergy labeling where an absolute majority was reached. In fact, on the energy labeling issue, therewere two questions, one on the refrigerators and one on televisions, on which they actuallyvetoed oneand 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 theCommission and which contained a number of implementing measures and delegated acts in terms ofwhich, issues are to be decided by which procedure. But this was a primary legislation that would laydown the framework rules and not about any specific food claim or any specific authorisationprocedure. It essentially failed because of the inability of members of Parliament, of member states, andthe Commission to come to an agreement on which procedure is to be used. So, in terms of looking atthe 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 thisvery 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.