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Pesticides: MEPs propose blueprint to improve EU approval procedure | EU Parliament Press

  • Public should be granted access to studies used in the authorisation procedure 
  • EU framework should stimulate innovation and promote low-risk pesticides 
  • Scientific experts should review studies on carcinogenicity of glyphosate 
  • Data requirements for Plant Protection Products should include long-term toxicity  

Plans to boost trust in the EU approval procedure of pesticides, by making it more transparent and accountable, were put forward by Parliament on Wednesday.

MEPs agreed that the public should be granted access to the studies used in the procedure to authorise a pesticide, including all the supporting data and information relating to the applications, thus endorsing one of the many proposals put forward by the “Special committee on the European Union’s authorisation procedure for pesticides” which has been examining the issue for the past year. The Special committee report was adopted with 526 votes to 66 and 72 abstentions.

During the procedure, applicants should be required to register all regulatory studies that will be carried out in a public register, and allow for a “comment period”, during which stakeholders are able to provide additional existing data to ensure that all relevant information is taken into account before a decision is made.

Post-market evaluation and real-life impact

MEPs call on the European Commission to propose measures to protect vulnerable groups and put an end to pesticides being used over long distances in the vicinity of schools, childcare facilities, playing fields, hospitals, maternity hospitals and care homes.

Post-market evaluation should be strengthened, and the EU Commission should launch an epidemiological study on the real-life impact of pesticides on human health, MEPs say. They also propose that existing studies on carcinogenicity of glyphosate should be reviewed and maximum residue levels for soils and surface water should be set.

EU Commission should allocate the authorisation renewal

MEPs note that concerns have been raised about the right of applicants to choose a particular member state to report on the approval of an active substance to the European Food Safety Authority (EFSA), as this practice is seen as lacking in transparency and could entail a conflict of interests. They call on the EU Commission to allocate the authorisation renewal to a different member state.

Political accountability

MEPs finally stress the need to ensure political accountability when authorisation is adopted in the form of implementing acts – in the so-called “comitology procedure”. Commission and member states should publish detailed minutes and make their votes public.

Quotes

“It is crucial that the approval procedure remains science-based. On such an important issue, scientific research is the be-all and end-all. Interests or ideologies have no place here. This decision must not be dependent on daily politics or emotions”, said co-rapporteur Norbert Lins (EPP, DE) .

“ “The Special Committee has brought to light serious shortcomings in the authorisation of pesticides. The PEST report and the EP is now demanding big improvements. The overwhelming support for reform of the pesticide authorisation procedure through more transparency and independent research is a wakeup call for EU governments and the European Commission, as well as a way forward to restore citizens’ trust in EU decision-making.”, said co-rapporteur Bart Staes (Greens/EFA, BE) .

“Recent revelations about plagiarism confirm that the work of our investigative committee was necessary. We urge the European Commission to review the pesticide authorisation system in Europe and to immediately re-evaluate the authorisation of glyphosate”, said Committee Chairman Eric Andrieu (S&D, FR) .

Background

Nine years after the adoption of the Plant Protection Products Regulation (Regulation (EC) No 1107/2009) and following the controversy about the renewal of glyphosate, the European Parliament, on 6 February 2018, set up a Special committee on the European Union’s authorisation procedure for pesticides. The PEST Committee’s mandate, as laid down in Parliament’s decision of 6 February 2018, required the special committee to look into the EU’s authorisation procedure for pesticides as a whole.

CO2 emission standards for cars and vans: Council confirms agreement on stricter limits | EU Council Press

The EU is taking steps to reduce CO2 emissions of cars and vans. Under the revised rules, there will be stricter CO2 emission standards for new passenger cars and light commercial vehicles. A provisional agreement reached by the Presidency and Parliament representatives on 17 December was endorsed by member states today.

The new rules will ensure that from 2030 onwards new cars will emit on average 37.5% less CO2 and new vans will emit on average 31% less CO2 compared to 2021 levels. Between 2025 and 2029, both cars and vans will be required to emit 15% less CO2.

“Today’s agreement gives the go-ahead to decarbonize and modernize Europe’s road transport. It represents an integrated approach to the transition towards low emission mobility, and supports the long-term competitiveness of the sector, including by facilitating innovation in clean technologies, such as batteries and recharging infrastructure. It makes sure that cars will emit on average 37.5% less CO2 in 2030 compared to the current emission standard limits and is therefore an important step to achieve our climate goals. In addition, we are improving the test procedures with stricter rules to ensure a reliable representation of the real world emissions.”
Graţiela Leocadia Gavrilescu, Romanian Vice Prime Minister and Minister of the Environment

The specific elements of the agreement

Average CO2 emissions of new cars registered in the EU will have to be 15% lower in 2025 and 37.5% lower in 2030, compared to the emission limits valid in 2021. The CO2 emissions of new vans will need to be 15% lower in 2025 and 31% lower in 2030. These are EU wide fleet targets. The CO2 reduction effort will be distributed among manufacturers on the basis of the average mass of their vehicle fleet.

A review clause provides for a possible revision of the 2030 targets and for the introduction of binding reduction targets for 2035 and 2040 onwards.

The Parliament and the Council agreed on a mechanism to encourage the sale of more zero- and low-emission vehicles such as fully electric cars or plug-in hybrid vehicles based on the approach proposed by the Commission in its original proposal. If a manufacturer meets certain benchmarks, it will be rewarded with less strict CO2 targets. The benchmark levels for 2025 will be 15% for cars and vans, and for 2030 35% for cars and 30 % for vans.

The two specific incentives for zero-and low-emission passenger cars agreed in the Council general approach were maintained with some adjustments:

  • as concerns the better weighting of low-emission vehicles a factor of 0.7 was agreed;
  • as concerns the incentive for manufacturers to sell zero- and low-emission cars in markets with a low market penetration of these vehicles, a multiplier of 1.85 was agreed. The eligibility criteria of a market share of zero and low-emission cars below 60% of the EU average was maintained but with a base year of 2017. A second eligibility criteria was introduced, namely a threshold of maximum 1000 newly registered vehicles in 2017 in the member state concerned. Finally, a cap of 5% will apply for the use of the scheme, so that if the share of zero- and low-emission vehicles in a member state exceeds 5% of newly registered cars, the incentive will no longer apply to sales into that member state.

For vans, the Parliament and Council agreed to leave the Commission proposal unchanged in respect to incentives for zero- and low-emission vehicles.

The niche derogation from the targets for those vehicle manufacturers which sell relatively few vehicles in Europe will be continued until 2028.

The effects of the transition of the automotive sector on in particular employment will be addressed via a provision on a socially fair and just transition. The Commission is to consider the possibility of allocating revenue from the excess premiums to a dedicated fund or relevant programmes aimed at ensuring a just transition and if appropriate submit a legislative proposal by 2027.

The Parliament and the Council have agreed on new rules that aim to ensure the robustness and representativeness of emissions data reported.

Firstly, stricter rules have been agreed for the transition from the old NEDC test procedure to the more accurate WLTP test procedure as the basis for calculating the specific emission targets for manufacturers.

Secondly, there will be an increased focus on monitoringreal-drive emissions”. The Commission will monitor the real world representativeness of the CO2 emission values based on data from the fuel consumption meters installed in new cars and vans. In order to prevent an increase in the emissions gap, the Commission is to assess the feasibility of developing a mechanism for the adjustment of the manufacturers’ specific targets as of 2030 and if appropriate submit a legislative proposal to this effect. The Commission must also as part of the review in 2023 assess the feasibility of developing real-world emission test procedures.

Thirdly, there are also specific provisions on in-service conformity testing and on detecting strategies which may artificially improve the CO2 performance of cars and vans.

In addition, the Commission will evaluate the possibility of developing a common EU methodology for the assessment and reporting of lifecycle emissions (life-cycle analysis) of vehicles and, where appropriate, prepare follow-up measures including legislative proposals.

The Commission will review the existing European Directive on car labelling by 2020 in order to improve information to consumers, including evaluating options for introducing a fuel economy and CO2 emission label for vans.

Background and next steps 

The Commission presented the proposal for a new regulation in November 2017 as part of the third clean mobility package. The European Parliament adopted its position on 3 October. The Council agreed its position (general approach) on 9 October.

Negotiations with the European Parliament started on 10 October and ended in a provisional agreement on 17 December, which was confirmed by EU ambassadors of the member states today.

On the European Parliament’s side, the ENVI Committee is scheduled to endorse the provisional agreement on 21 January. The formal adoption of the new rules will happen before the summer.

The overall aim of the proposal is to contribute to achieving the goals of the Paris Agreement and to reach the EU wide 30% reduction target by 2030 compared to 2005 of the non ETS (Emissions Trading System) sector set by the European Commission, which is translated into national targets in the Effort Sharing Regulation.

The proposed measures and targets are based on the 2030 climate and energy framework and the energy union strategy, which aims at a reduction in transport emissions and energy consumption. The reduced need for fossil fuels will also improve the security of energy supply in the EU and reduce our dependence on energy imports from third countries.

CO2 emission standards for cars and vans: Council agrees its position (press release, 10/10/2018)

Commission proposal

Visit the website

EU to help boost exports of generic pharmaceuticals | EU Council Press

The EU has come a step closer to adopting new rules that will boost the export of generic medicines and biosimilar products to third countries. EU ambassadors meeting today in Coreper agreed on the Council’s position on a draft regulation which introduces an exception for manufacturing for export purposes (manufacturing waiver) to the protection granted to an original medicine by a supplementary protection certificate (SPC).

Thanks to the waiver, EU-based makers of generics and biosimilars will be entitled to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the SPC if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed.

The draft regulation is expected to remove the competitive disadvantages faced by EU-based manufacturers of generics and biosimilars vis-à-vis manufacturers established outside the EU in global markets, but also in day-1 EU markets by building up production capacity.

The exception will operate only where :

  • generics or biosimilars are produced exclusively for export to third countries where protection of the original medicine does not exist or has expired;
  • the maker has provided the information required by the regulation to both the authorities of the member state of production and to the holder of the SPC at least three months in advance;
  • the maker has duly informed all those involved in the commercialisation of the product covered by the exception that the product can be put on the market only outside the EU;
  • the maker has affixed to the packaging of the product the specific logo provided for by the regulation indicating clearly that it is only for export.

Until a set date (three years from the entry into force of the regulation), the regulation will affect only SPCs that are applied for on or after the date of entry into force of the regulation. From then on , the regulation will also affect SPCs applied for before the entry into force of the regulation, but which have become effective after the entry into force of the regulation.

Next steps

Once the European Parliament agrees on a negotiating mandate, the Romanian presidency will start negotiations with the European Parliament with the aim of adopting the regulation at first reading.

Background

The EU harmonised SPC system was introduced in 1992. It sought to compensate for the loss of effective patent protection due to the time required in order to obtain marketing authorisation (including research and clinical trials).

Global demand for medicines has increased massively (reaching €1.1 trillion in 2017). Alongside this, there is a shift towards an ever-greater market share for generics and biosimilars. Assuming an annual growth rate of 6.9%, by 2020 generics and biosimilars will represent 80% of all medicines by volume, and about 28% by value.

With the expiry of industrial property protection, over €90 billion of the first generation of blockbuster biologics will become open to biosimilar competition by 2020.

The draft regulation should contribute to Europe’s competitiveness as a hub for pharmaceutical R&D and manufacturing. It will help new pharmaceutical companies start up and scale up in high growth areas, and is projected to generate, over the next 10 years, additional net annual export sales of well in excess of EUR 1 billion, which could translate into 20 000 to 25 000 new jobs over that period.

Pedro Sánchez: We must protect Europe, so Europe can protect its citizens | EU Parliament Press

The EU needs to be defended in the face of new challenges and against those who want to destroy it, said Pedro Sánchez on Wednesday to the European Parliament.

In a plenary debate on the future of the EU, the President of the Spanish Government underlined that “we must protect Europe, so Europe can protect its citizens”. This should be done through a rights-based Union that gives shelter to the most vulnerable, offers opportunities to youth and the unemployed, ensures citizens’ safety, reaffirms its commitment against climate change and completes the Economic and Monetary Union.

Ahead of the European elections in May, Mr Sánchez said that the main priority should be harnessing globalisation to guarantee the survival of the European social model. He demanded an end to the austerity approach adopted after the financial crisis that caused a split in the European Union. “It is time to close that phase”, and make Europe valid again to Europeans. He refused, in that context, to cut the EU budget, because it would imply accepting the idea of a “retreating Europe”.

Speaking about extremist and anti-European discourses, he warned that “peace, democracy and freedom can never be taken for granted” and insisted we should all defend EU values. In this context, Sánchez emphasized that his main concern is “not the far-right itself, but how the far-right is shaping the agenda and discourse of political parties that previously had a strong commitment to the European project”.

Brexit

The Spanish Prime Minister noted that the deal rejected by the UK Parliament was “the best deal possible”, offering the highest level of protection to both sides, including citizens’ rights and economic actors, and aimed at an orderly exit. Brexit is a “disgrace” in which everyone loses, he said, hoping there will be a compromise for the closest relationship possible.

Women’s rights

Noting that his government has the highest number of women in the world, Mr Sánchez called on the EU to adopt a binding strategy for gender equality, focused on reducing the gender gap and the higher rate of unemployment and lack of security that affects women. He also proposed establishing a children’s guarantee to prevent social exclusion from early stages.

Global challenges

The EU should move towards creating a truly European army and become a credible power on the world stage, advocating a global order based on the rule of law and common rules, said Mr Sánchez. We must show the world the European Union “is a soft power by choice, not due to weakness”.

Regarding migration, the President of the Spanish Government called for cooperation with countries of origin (particularly in Africa), transit and destination, while supporting the global approach developed within the UN. Responsibility and solidarity should be the guiding principles in the reform of the asylum system, he added.

Catalonia

Replying to MEPs, Sánchez explained that in Catalonia, despite the parliamentary majority enjoyed by pro-independence forces, there is no social majority supporting independence. “They cannot impose a political project on a majority that has repeatedly stated that it does not share that direction”. He urged the pro-independence forces to open up a process of dialogue within Catalan society, with the support of the Spanish government, which is determined to solve the situation through dialogue and respect to the Constitution.

“In Catalonia, the problem is not independence, but coexistence”, he concluded.

You can watch the plenary debate via EP Live and EbS+.

Speakers’ interventions are available by clicking on the links below.

Brexit: the time has come for the UK to clarify its position | EU Parliament Press

n the debate following the UK House of Commons’ meaningful vote, MEPs underlined that Europeans will remain united and that citizens’ rights are still the EP’s priority.

Following the rejection of the Withdrawal Agreement and the Political Declaration in the UK’s House of Commons yesterday evening, it is now up to the UK government and UK Parliament to let the EU know where a positive majority lies and what type of relationship they want with the European Union, MEPs stressed.

The Withdrawal agreement is the best and only compromise possible within the red lines established by the UK government, underlined the EU`s Brexit chief negotiator, Michel Barnier. It allows for legal certainty where Brexit creates uncertainty. The EU will not accept established guidelines to be watered down, including the peace process and the border on the island of Ireland or on citizens’ rights, added Frans Timmermans for the European Commission.

EP Brexit coordinator, Guy Verhofstadt (ALDE, BE) called for a cross-party dialogue in the UK in order to build a positive majority to break the deadlock and possibly redefine the UK’s red lines. He underlined that changes in the UK’s position might allow a deeper future relationship between the UK and the EU to be considered.

A no-deal exit would be in nobody’s interests, MEPs underlined. The EU will intensify its preparation and contingency work with the member states and the EP, added Melania Ciot, on behalf of the Romanian Council Presidency.

Live replays :

Romanian Presidency of the Council: debate with Prime Minister Viorica Dăncilă | EU Parliament Press

Competitiveness, digitization, protection and the safety of citizens will be the focus of the Romanian presidency of the Council, said Prime Minister Dăncilă.

During the next six months, the Romanian presidency will aim for better political and economic cohesion between member states and will commit to work towards reducing development gaps between regions, supporting economic growth and digitization, especially for European industry.

Coherent management of migration flows, strengthening the EU’s external borders and a better protection of citizens in virtual space will also be work priorities in the first semester of 2019. Setting up and even extending the mandate of the European Prosecutor’s Office to include terrorist offenses and better cooperation between countries of origin and transit countries on migration issues will also be on the agenda.

The Prime Minister underlined the Romanian government’s commitment to move forward on EU enlargement matters, with particular attention paid to the Western Balkans and a focus on common European values.

MEPs of all political groups underlined that they stood ready to work hand in hand with the presidency to move forward on European legislative matters in priority areas, pointing out that the Romanian government must do more to promote European values by being more politically stable and consistent.

To watch videos of speakers’ statements, click on the names:

Antonio TAJANI, EP President and Viorica DANCILA, Romanian Prime Minister

Andrus ANSIP, Vice-President of the European Commission

Theodor Dumitru STOLOJAN (EPP, RO)

Udo BULLMANN (S&D, DE)

Helga STEVENS (ECR, BE)

Guy VERHOFSTADT (ALDE, BE)

Ska KELLER (Greens/EFA, DE)

Neoklis SYLIKIOTIS (GUE/NGL, CY)

Rolandas PAKSAS (EFDD, LT)

Georg MAYER (ENF, AT)

Andrus ANSIP, closing statement

Viorica DANCILA , closing statement

MEPs to debate Brexit at 8.30 on Wednesday | EU Parliament Press

From 8.30 on Wednesday, Parliament will debate the state of play of the UK’s withdrawal from the EU, one day after the UK House of Commons meaningful vote on 15 January.

The debate is scheduled to last ninety minutes, with one MEP speaking for each political group and interventions from the members of the European Parliament’s Brexit Steering Group.

You can follow the debate live on EP Live and EbS+.

COLLEGE MEETING: Commission launches debate on a gradual transition to more efficient and democratic decision-making in EU tax policy | EU Commission Press

The Commission has today kick-started the debate on reforming decision-making for areas of EU taxation policy, which currently requires unanimity among Member States. The Communication published today suggests a roadmap for a progressive and targeted transition to qualified majority voting (QMV) under the ordinary legislative procedure in certain areas of shared EU taxation policy, as is already the case with most other EU policy areas.

This possibility is envisaged by the EU Treaties. It would allow Member States to reach quicker, more effective and more democratic compromises on taxation matters, unleashing the full potential of this policy area. Commission President Jean-Claude Juncker, who had called for a move to qualified majority voting in taxation in his recent State of the Union addresses, said: “Our increasingly globalised economies need modern and ambitious tax systems. I remain strongly in favour of moving to qualified majority voting and a stronger voice for the European Parliament on the common future of taxation in our Union.” Commissioner for Economic and Financial Affairs, Taxation and Customs Pierre Moscovici said: “The EU has had a role in taxation policy since the origins of the Community six decades ago. Yet if unanimity in this area made sense in the 1950s, with six Member States, it no longer makes sense today. The unanimity rule in taxation increasingly appears as politically anachronistic, legally problematic and economically counterproductive.” The Commission is not proposing any change in EU competences in the field of taxation, or to the rights of Member States to set personal or corporate tax rates as they see fit. Instead, the aim is to allow Member States to exercise more efficiently their already pooled sovereignty so that shared challenges can be addressed more swiftly. A press release, memo and factsheet are available online.

EU leaders past and present pay homage to the Euro | EU Parliament Press

During a ceremony in the plenary to commemorate 20 years of the Euro, the currency’s popularity and its role in strengthening the EU’s stance in the world were regularly highlighted.

Opening the ceremony, European Parliament President Antonio Tajani pointed out that 75% of citizens approve of the Euro, the highest popularity rating ever. He underlined that it has made life easier in many ways and provided protection during the financial crisis.

Jean-Claude Trichet, former President of the European Central Bank, praised the Euro for the credibility and stability it has delivered and also for its resilience during the financial crisis. The Euro, Mr Trichet pointed out, allowed growth rates to be comparable to those in the United States over the last two decades.

Current European Central Bank President Mario Draghi underlined that the Euro was an important tool in “being stronger together”. It was because numerous EU member states founded a common currency that they kept their voice on the global financial stage. Mr Draghi also praised the price stability brought about by the Euro, “even in countries where this was a long-lost memory”.

European Commission President Jean-Claude Juncker reminded the plenary that “two decades ago we were considered mad by many. We hear these critics little today”. Mr Juncker also told the audience that the hardship experienced in recent years was caused by long-overdue structural reforms, and not the Euro currency.

The President of the Eurogroup, Mário Centeno, said that the last few years had not been easy, but the Euro emerged from the crisis a stronger currency. He pointed out that the Euro is not an end in itself, but rather a tool with which to achieve a more inclusive society.

Roberto Gualtieri, the Chair of the European Parliament’s economic and monetary affairs committee, praised the Euro for making the deepening of the single market possible, allowing member states to recover sovereignty in the global order, and underpinning the peace project that is at the heart of the EU’s origin.

All speakers also recognised that the Euro was not perfect. Notably, the progress towards economic union needed to pick up pace. In the words of President Tajani, “We need to conclude the economic and monetary union. We cannot remain exposed in the middle of the road”.

MEPs call for safety and liability rules for driverless cars | EU Parliament Press

  • EU needs to act faster to the developments in the sector 
  • More funding for research, safety and liability rules needed 
  • Focus also on other modes of transport, not only road 

MEPs welcome focus on automated mobility, but call for further efforts to ensure road safety and support for EU industry.

Europe has to be innovative, but faster. China and the USA are not waiting,” said rapporteur Wim Van de Camp (EPP, NL). Several countries around the world are moving rapidly towards making both connected and automated mobility available on the market and the EU needs to respond much faster to the developments in the sector, MEPs say in a non-binding resolution adopted with 585 in favour, 85 against, 26 abstentions.

They welcome the European Commission’s communication “On the road to automated mobility” as an important milestone in the EU strategy for connected and automated mobility, but stress that further efforts are needed to ensure that there is sufficient funding to support the sector and that there are appropriate safety and liability rules.

MEPs urge the Commission and EU countries to work to maintain a leading role in the international technical harmonisation of automated vehicles within the framework of the United Nations Economic Commission for Europe (UNECE) and the Vienna Convention.

Safeguard systems to allow automated vehicles and vehicles which are neither connected nor automated to co-exist also need to be developed, they stress.

Rules on automation for other modes of transport

MEPs also want the Commission to present detailed rules for automated aircraft and to define the levels of automation for both inland and sea navigation in order to stimulate the uptake of autonomous vessels. Standards should also be developed to enable autonomous train and light-rail systems, they say.

A joint partnership (Joint Undertaking), along similar lines to Shift2Rail for rail transport and CleanSky for the aeronautics industry, to create an industry-driven strategic initiative on autonomous transport should be set up, MEPs add.

Research should focus also on the long-term effects of autonomous transport on issues such as consumer adaptation, societal acceptance, physiological reactions, physical responses and reducing accidents.