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Parliament rejects criteria for endocrine disruptors

12-10-2017

On 4 October 2017, the European Parliament voted to object to the European Commission's draft regulation setting out criteria for identifying endocrine disruptors in the area of plant protection products (PPPs). The vote followed the Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) backing a motion for resolution to reject the criteria. The Commission says it needs now to reflect on the next steps to take.

On 4 October 2017, the European Parliament voted to object to the European Commission's draft regulation setting out criteria for identifying endocrine disruptors in the area of plant protection products (PPPs). The vote followed the Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) backing a motion for resolution to reject the criteria. The Commission says it needs now to reflect on the next steps to take.

CE marked fertilising products

05-09-2017

Fertilising products are used to improve plant growth, mainly in agriculture, enabling higher crop yields. However, they are associated with some challenges as regards security of supply, the environment and health. Although the 2003 Fertilisers Regulation, which aimed at ensuring an internal market in fertilisers, has been effective, it mainly addresses mineral fertilisers and deters the introduction of new types of fertilisers. In March 2016, the Commission put forward a legislative proposal on ...

Fertilising products are used to improve plant growth, mainly in agriculture, enabling higher crop yields. However, they are associated with some challenges as regards security of supply, the environment and health. Although the 2003 Fertilisers Regulation, which aimed at ensuring an internal market in fertilisers, has been effective, it mainly addresses mineral fertilisers and deters the introduction of new types of fertilisers. In March 2016, the Commission put forward a legislative proposal on fertilising products, as announced in the circular economy action plan. The proposal modernises the conformity assessment and market surveillance in line with the ‘new legislative framework’ for product legislation, covers a wider range of fertilising products (including those manufactured from secondary raw materials), and sets limits for the presence of heavy metals and contaminants in fertilising products. Stakeholders’ reactions have been mixed. The European Parliament is expected to adopt its position on the proposal in October 2017. The Council is continuing to consider the proposal at working party level.

European Chemicals Agency: Role and governance

29-08-2017

The European Chemicals Agency (ECHA) is a decentralised agency of the European Union. Established in 2007, it is based in Helsinki. Its main mission is to contribute to the implementation of European chemicals legislation for the benefit of human health and the environment, as well as improving innovation and competitiveness. ECHA carries out technical, scientific and administrative tasks under four EU regulations: the regulation on registration, evaluation, authorisation and restriction of chemicals ...

The European Chemicals Agency (ECHA) is a decentralised agency of the European Union. Established in 2007, it is based in Helsinki. Its main mission is to contribute to the implementation of European chemicals legislation for the benefit of human health and the environment, as well as improving innovation and competitiveness. ECHA carries out technical, scientific and administrative tasks under four EU regulations: the regulation on registration, evaluation, authorisation and restriction of chemicals (REACH); the Classification, Labelling and Packaging (CLP) Regulation; the Biocidal Products Regulation; and the regulation on export and import of hazardous chemicals. It may also initiate regulatory processes and take limited regulatory decisions under these regulations. ECHA comprises a number of bodies active on specific aspects. These include the Member State Committee which is involved in key processes under REACH, three advisory scientific bodies (Committee for Risk Assessment, Committee for Socio-economic analysis and Biocidal Products Committee), a Forum aimed at strengthening enforcement, a Board of Appeal deciding on appeals against decisions taken by the ECHA, and a Management Board, which acts as the Agency's governing body. These bodies are supported by a secretariat employing 564 staff at the end of 2016. ECHA's annual budget, which is about €110 million, has two main sources: a subsidy from the EU budget, and fees levied on companies for services carried out under the four relevant regulations. In 2016, fees and charges accounted for 46 % of expenditure. An evaluation carried out for the European Commission in 2017 found that the ECHA carries out its work effectively and efficiently, is relevant to societal needs and brings EU added value, although the evaluation also highlighted some areas where there is room for improvement, for instance regarding IT and communication.

Agreement on criteria for endocrine disruptors

11-07-2017

On 4 July 2017, the European Commission's Standing Committee on Plants, Animals, Food and Feed (SC PAFF), made up of experts from the EU Member States, voted on the Commission's draft regulation setting out criteria for identifying endocrine disruptors in the area of plant protection products (PPPs). The vote was preceded by several meetings in which the Commission presented revised versions of its drafts. The European Parliament and the Council of the EU now have three months to examine the agreed ...

On 4 July 2017, the European Commission's Standing Committee on Plants, Animals, Food and Feed (SC PAFF), made up of experts from the EU Member States, voted on the Commission's draft regulation setting out criteria for identifying endocrine disruptors in the area of plant protection products (PPPs). The vote was preceded by several meetings in which the Commission presented revised versions of its drafts. The European Parliament and the Council of the EU now have three months to examine the agreed text.

European Medicines Agency: A look at its activities and the way ahead

10-07-2017

The European Medicines Agency (EMA) is a decentralised agency of the EU. Its mission is to foster scientific excellence in the evaluation and supervision of medicines in the Member States of the EU and the European Economic Area. The EMA began operating in London in 1995. In the context of the United Kingdom's withdrawal from the EU (Brexit), the EMA will have to move to another location that will be decided upon by common agreement among the remaining 27 Member States (EU-27). The criteria and the ...

The European Medicines Agency (EMA) is a decentralised agency of the EU. Its mission is to foster scientific excellence in the evaluation and supervision of medicines in the Member States of the EU and the European Economic Area. The EMA began operating in London in 1995. In the context of the United Kingdom's withdrawal from the EU (Brexit), the EMA will have to move to another location that will be decided upon by common agreement among the remaining 27 Member States (EU-27). The criteria and the decision-making process for selecting the new location were announced on 22 June 2017. Interested Member States have until 31 July 2017 to submit their offers. A decision is expected to be taken in November 2017. The EMA is governed by a management board and employs 897 staff (December 2016 figures). Its executive director is Guido Rasi. Around 89 % of the agency's budget comes from fees and charges levied for services rendered. Its scientific work is conducted in its scientific committees, working parties and other groups. Its main activities include: facilitating the development of and patient access to medicines; evaluating applications for marketing authorisations; monitoring the safety of medicines throughout their use in healthcare practice; and providing information to healthcare professionals, patients and the public.

Cleaner air for Europe: EU efforts to fight air pollution

23-06-2017

Air pollution knows no borders. Wind can carry pollutants over thousands of kilometres. Poor air quality impacts negatively on human health, ecosystems, crop yields and buildings. It is one of the main environmental causes of premature death, having claimed 5.5 million lives globally and over 430 000 in the EU in 2013. The European Commission estimates the cost of air pollution linked to the degradation of health in European society to amount to €330 billion to €940 billion per year. Developed since ...

Air pollution knows no borders. Wind can carry pollutants over thousands of kilometres. Poor air quality impacts negatively on human health, ecosystems, crop yields and buildings. It is one of the main environmental causes of premature death, having claimed 5.5 million lives globally and over 430 000 in the EU in 2013. The European Commission estimates the cost of air pollution linked to the degradation of health in European society to amount to €330 billion to €940 billion per year. Developed since 1970 in the wake of acid rain fall that had been destroying European forests and polluting freshwaters, EU air quality policy, in combination with technological change, has contributed to reducing air pollution substantially.

Understanding European Reference Networks: Cooperation on rare diseases across Europe

09-06-2017

European Reference Networks (ERNs) are newly established virtual platforms for voluntary cross-border collaboration between specialists in rare and complex diseases. ERNs were set up under Directive 2011/24/EU on the application of patients' rights in cross-border healthcare, and go back to a 2009 Council recommendation on an action in the field of rare diseases. Since specialist knowledge of rare diseases is both scarce and scattered across countries, the EU-level cooperation afforded by ERNs is ...

European Reference Networks (ERNs) are newly established virtual platforms for voluntary cross-border collaboration between specialists in rare and complex diseases. ERNs were set up under Directive 2011/24/EU on the application of patients' rights in cross-border healthcare, and go back to a 2009 Council recommendation on an action in the field of rare diseases. Since specialist knowledge of rare diseases is both scarce and scattered across countries, the EU-level cooperation afforded by ERNs is regarded as bringing added value through maximising synergies. Currently, 24 thematic ERNs involve more than 900 specialised healthcare teams in over 300 hospitals in 25 EU Member States plus Norway. A public consultation fed into the establishment of the ERNs, and a number of stakeholder views were presented on the occasion of their launch. The ERN initiative has generally been well received. According to stakeholders, its strengths include opportunities for carrying out research and new treatments, breaking the isolation of specialists and patients, reducing inequalities in care, and fostering patient involvement. Among the challenges that need to be addressed, stakeholders mention questions concerning reimbursement, interoperability and data confidentiality, and legal issues. The ERNs are currently in their deployment phase, and expected to reach full capacity over the next five years.

Air and noise pollution

01-06-2017

Air pollution harms our health and our environment. It mainly stems from industry, transport, energy production and agriculture. The EU air quality strategy pursues full compliance with existing air quality legislation by 2020 and sets long-term objectives for 2030. The Environmental Noise Directive helps to identify noise levels within the EU and to take the necessary measures to bring them down to acceptable levels. Separate legislation regulates noise emission from specific sources.

Air pollution harms our health and our environment. It mainly stems from industry, transport, energy production and agriculture. The EU air quality strategy pursues full compliance with existing air quality legislation by 2020 and sets long-term objectives for 2030. The Environmental Noise Directive helps to identify noise levels within the EU and to take the necessary measures to bring them down to acceptable levels. Separate legislation regulates noise emission from specific sources.

Public health

01-06-2017

The Treaty of Lisbon has enhanced the importance of health policy, stipulating that ‘a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities’. This objective is to be achieved through Community support to Member States and by fostering cooperation. Primary responsibility for health protection and, in particular, the healthcare systems continues to lie with the Member States. However, the EU has an important role to play ...

The Treaty of Lisbon has enhanced the importance of health policy, stipulating that ‘a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities’. This objective is to be achieved through Community support to Member States and by fostering cooperation. Primary responsibility for health protection and, in particular, the healthcare systems continues to lie with the Member States. However, the EU has an important role to play in improving public health, preventing and managing diseases, mitigating sources of danger to human health, and harmonising health strategies between Member States. The EU has successfully implemented a comprehensive policy, through the Health Strategy ‘Health for Growth’ and its action programme (2014-2020) and a body of secondary legislation. The current institutional set-up to support implementation includes the Commission’s Directorate-General for Health and Food Safety (DG SANTE), as well as specialised agencies, notably the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA).

Medicines and Medical Devices

01-06-2017

Medicines and medical devices are products subject to the rules of the single market, and therefore the EU holds competency for their authorisation through evaluation and supervision. In order to protect public health, before being placed on the market new pharmaceuticals for human use must be authorised under a centralised procedure by the European Medicines Agency (EMA) and/or in a decentralised manner by national agencies. Medical devices require a detailed regulatory framework for market access ...

Medicines and medical devices are products subject to the rules of the single market, and therefore the EU holds competency for their authorisation through evaluation and supervision. In order to protect public health, before being placed on the market new pharmaceuticals for human use must be authorised under a centralised procedure by the European Medicines Agency (EMA) and/or in a decentralised manner by national agencies. Medical devices require a detailed regulatory framework for market access through private-sector organisations called notified bodies; revisions are ongoing and a new legislative approach will come into force in 2017.

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