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Limits on exposure to carcinogens and mutagens at work: Third proposal

18-02-2019

The European Commission has proposed to amend Directive 2004/37/EC by expanding its scope and by including and/or revising occupational exposure limit values for a number of cancer- or mutation-causing substances. The initiative is proceeding in steps. The first proposal of May 2016 covered 13 priority chemical agents, the second, of January 2017, a further seven. The current (third) proposal addresses an additional five. Broad discussions with scientists and the social partners fed into all three ...

The European Commission has proposed to amend Directive 2004/37/EC by expanding its scope and by including and/or revising occupational exposure limit values for a number of cancer- or mutation-causing substances. The initiative is proceeding in steps. The first proposal of May 2016 covered 13 priority chemical agents, the second, of January 2017, a further seven. The current (third) proposal addresses an additional five. Broad discussions with scientists and the social partners fed into all three proposals. Reacting to the Commission’s set of measures as a whole, trade unions have acknowledged the importance of further improving the existing framework. Actors on the employers’ side have underlined the need to ensure that values are proportionate and feasible in terms of technical implementation. Parliament’s Employment and Social Affairs Committee voted its report on 20 November 2018. It includes the call to bring cytotoxic medicines, which are used in the treatment of cancer, within the scope of the directive, as well as to grant incentives to businesses that comply. Council agreed on its position on 6 December 2018. Trilogue negotiations gave rise to a provisional agreement in January 2019. Once endorsed by the Council, it will be voted in Parliament’s plenary. Second edition. The ‘EU Legislation in Progress’ briefings are updated at key stages throughout the legislative procedure.

Protection of workers from exposure to carcinogens or mutagens: Third proposal

17-12-2018

This detailed appraisal focuses on the process and evidence base used in the IA for setting the limit values for cadmium and beryllium, notably in light of some knowledge gaps and methodological challenges identified in the IA in relation to the number of workers exposed and the estimation of the burden of disease. The appraisal concludes that the IA has relied on a vast and updated amount of information, including scientific journals, guidelines, manuals, surveys, published by authoritative research ...

This detailed appraisal focuses on the process and evidence base used in the IA for setting the limit values for cadmium and beryllium, notably in light of some knowledge gaps and methodological challenges identified in the IA in relation to the number of workers exposed and the estimation of the burden of disease. The appraisal concludes that the IA has relied on a vast and updated amount of information, including scientific journals, guidelines, manuals, surveys, published by authoritative research centres, publishers and international organisations, making the overall analysis sufficiently convincing and robust. As regards the limitations of the analysis, which are transparently acknowledged, the analysis carried out by the external contractors and endorsed in the IA recognises that the full current and future disease burden deriving from historic exposures to cadmium and beryllium is not captured; consequently, the disease burdens may be underestimated. As regards the estimated number of workers exposed to cadmium, the value of 10 000 workers considered by the external contractors for their modelling (in addition to a higher value of 30 000), and taken over in the IA, is coherently justified in light of the recognised wide divergences among the different estimates. This value appears to be reasonable, based on the availability of data at national and EU level, and the way some of them were gathered. As regards the estimated number of workers exposed to beryllium, the figure of 54 071 workers exposed in the EU 28 (excluding the construction sector) identified by the external contractor and used in the IA appears to be plausible, based on the justifications provided. However, it is acknowledged that higher exposure levels would imply higher costs and benefits at all target OEL values.

Directive 2009/128/EC on the sustainable use of pesticides

19-10-2018

The study presents the results of evaluation of the implementation of the Directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides. The study was outsourced and prepared by a consortium led by ÖIR GmbH, in collaboration with Arcadia International, t33 and external experts. The study covers the implementation of the directive as a whole. Furthermore, it concentrates on the implementation of the integrated pest management principles in the individual ...

The study presents the results of evaluation of the implementation of the Directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides. The study was outsourced and prepared by a consortium led by ÖIR GmbH, in collaboration with Arcadia International, t33 and external experts. The study covers the implementation of the directive as a whole. Furthermore, it concentrates on the implementation of the integrated pest management principles in the individual Member States. In addition, it also provides an analysis concerning of a the development of harmonised risk indicators, the imposition of limitation and bans of on the usage of pesticides in sensitive specific sensitive areas, and the impacts that of the use of pesticides has on drinking water. The analysis is accompanied by recommendations on how to improve the implementation processes.

Guidelines for submission and evaluation of applications for the approval of active substances in pesticides

21-09-2018

Active substances are an essential element of pesticides. The approval of active substance occurs at EU level, and guidance documents and guidelines for this procedure exist. They aim to clarify, harmonise and standardise the complex approval process. This study examines the guidance and guidelines which exist for active substance approval; the level of harmonisation among them; the connection to the good laboratory practice (GLP) principles; and provides an overview of the studies which are required ...

Active substances are an essential element of pesticides. The approval of active substance occurs at EU level, and guidance documents and guidelines for this procedure exist. They aim to clarify, harmonise and standardise the complex approval process. This study examines the guidance and guidelines which exist for active substance approval; the level of harmonisation among them; the connection to the good laboratory practice (GLP) principles; and provides an overview of the studies which are required for active substance approval.

Външен автор

John NGANGA, Michela BISONNI and Maria CHRISTODOULOU, Agra CEAS Consulting IEG

Protection of workers from exposure to carcinogens or mutagens: third proposal

27-06-2018

The impact assessment (IA) accompanying the proposal for a third revision of the carcinogens and mutagens Directive 2004/37/EC clearly defines the problem to be addressed. However, it would have benefited from providing more comprehensive explanations of its evolution without EU action. The objectives appear to be relevant, sufficiently measurable, achievable, though not time-bound. The IA considers a wide range of options, and those retained for further assessment appear to be reasonable, and consistent ...

The impact assessment (IA) accompanying the proposal for a third revision of the carcinogens and mutagens Directive 2004/37/EC clearly defines the problem to be addressed. However, it would have benefited from providing more comprehensive explanations of its evolution without EU action. The objectives appear to be relevant, sufficiently measurable, achievable, though not time-bound. The IA considers a wide range of options, and those retained for further assessment appear to be reasonable, and consistent with the approach followed in two previous amendments of the directive. The analysis of impacts focuses on the economic and social dimension, mainly health, consistently with the manner in which the problem has been defined. Environmental impacts are assessed to be broadly negligible: considering that the IA is dealing with carcinogenic chemical substances, this would have perhaps required further justification. The IA acknowledges a general issue regarding, inter alia, the availability of data on the number of workers exposed, and the scarce and not always sufficiently robust epidemiological evidence. The methodological annex does not provide information regarding how the multi criteria analysis has been performed. Finally, the IA appears to have addressed most of the RSB's recommendations and the legislative proposal appears to be consistent with the analysis carried out in the IA.

Regulation (EC) 1107/2009 on the Placing of Plant Protection Products on the Market

24-04-2018

Regulation (EC) 1107/2009 lays down the main instruments for placing effective plant protection products (using pesticide substances) on the market that are safe for humans, animals and the environment, while at the same time ensuring effective functioning of the internal market and improved agricultural production. This European Implementation Assessment found that the above objectives, while largely relevant to real needs, are not being achieved in practice. In particular, implementation of the ...

Regulation (EC) 1107/2009 lays down the main instruments for placing effective plant protection products (using pesticide substances) on the market that are safe for humans, animals and the environment, while at the same time ensuring effective functioning of the internal market and improved agricultural production. This European Implementation Assessment found that the above objectives, while largely relevant to real needs, are not being achieved in practice. In particular, implementation of the main instruments of the regulation – substance approval, plant protection products authorisation and enforcement of the regulatory decisions taken in the frame of the approvals and authorisations, is problematic, which also affect other related EU policies. Nevertheless, despite the implementation challenges observed, stakeholders – including national competent authorities, health/environment NGOs, manufacturers of substances and plant protection products and their users (farmers) – agree that the EU is the appropriate level at which regulatory action in the field of pesticides (used in plant protection products) should continue to take place.

Външен автор

Annex I written by Florent PELSY and Lise OULÈS from Milieu Ltd (Belgium) and Evelyn UNDERWOOD (Institute for European Environmental Policy, IEEP). Annex II written by Dr Emanuela BOZZINI (University of Trento, Italy). Annex III written by Dr Olivia HAMLYN (University of Leicester, United Kingdom). Annex IV written by Dr Dovilė RIMKUTĖ (University of Leiden, The Netherlands)

Authorisation of pesticides in the EU: With a focus on glyphosate

01-02-2018

In the European Union, plant protection products, often referred to as 'pesticides', are subject to a dual approval process: active substances are approved at European Union (EU) level, provided they meet a number of criteria. Commercial plant protection products containing one or more active substances are subsequently authorised at Member State level if they satisfy certain conditions. A controversy has emerged since 2015 over the renewal of the approval of glyphosate. One of the active substances ...

In the European Union, plant protection products, often referred to as 'pesticides', are subject to a dual approval process: active substances are approved at European Union (EU) level, provided they meet a number of criteria. Commercial plant protection products containing one or more active substances are subsequently authorised at Member State level if they satisfy certain conditions. A controversy has emerged since 2015 over the renewal of the approval of glyphosate. One of the active substances most commonly found in broad-spectrum herbicides in the world, glyphosate is mainly used in agriculture. The controversy started as a result of diverging assessments of its carcinogenicity: the International Agency for Research on Cancer, a branch of the World Health Organization, classified glyphosate as probably carcinogenic to humans, while the European Food Safety Authority found it unlikely to pose a carcinogenic hazard to humans. The European Chemicals Agency later concluded that glyphosate did not classify as a carcinogen. Several national authorities outside the EU also came to the same conclusion. The European Commission eventually renewed the approval of glyphosate for five years in December 2017. The views of stakeholders and Member States on the topic have been strongly divided. The European Parliament has called for phasing out all uses of glyphosate by the end of 2022. Parliament is expected to vote, in February 2018, on the creation of a special committee on the Union's authorisation procedure for pesticides.

Химични вещества и пестициди

01-02-2018

Законодателството на ЕС в областта на химичните вещества и пестицидите има за цел да защити човешкото здраве и околната среда и да предотврати препятствията пред търговията. То се състои от правила, които уреждат предлагането на пазара и употребата на определени категории химически продукти, набор от хармонизирани ограничения относно пускането на пазара и употребата на конкретни опасни вещества и препарати, и правила в случай на големи аварии и износ на опасни вещества. Терминът „пестициди“ се използва ...

Законодателството на ЕС в областта на химичните вещества и пестицидите има за цел да защити човешкото здраве и околната среда и да предотврати препятствията пред търговията. То се състои от правила, които уреждат предлагането на пазара и употребата на определени категории химически продукти, набор от хармонизирани ограничения относно пускането на пазара и употребата на конкретни опасни вещества и препарати, и правила в случай на големи аварии и износ на опасни вещества. Терминът „пестициди“ се използва за група вещества, използвани за потискане на развитието, премахване и предотвратяване на появата на организми, които се считат за вредни. Те включват биоцидните продукти и продуктите за растителна защита (ПРЗ). Най-голямото постижение на равнището на ЕС е регламентът REACH, който урежда регистрацията, оценката и разрешаването на опасни вещества, както и приложимите към тях ограничения.

Limits on exposure to carcinogens and mutagens at work

22-01-2018

The European Commission proposes to amend Directive 2004/37/EC by expanding its scope and by including and/or revising occupational exposure limit values for a number of cancer-causing chemical agents. According to the Commission, this would improve workers' health protection, increase the effectiveness of the EU framework and promote clarity for economic operators. Overall, the proposal received a broad welcome from stakeholders. After completion of the legislative procedure at first reading in ...

The European Commission proposes to amend Directive 2004/37/EC by expanding its scope and by including and/or revising occupational exposure limit values for a number of cancer-causing chemical agents. According to the Commission, this would improve workers' health protection, increase the effectiveness of the EU framework and promote clarity for economic operators. Overall, the proposal received a broad welcome from stakeholders. After completion of the legislative procedure at first reading in the European Parliament and the Council, the presidents of the co-legislators signed the final act on 12 December 2017. The directive applies as from 16 January 2018.

Approval of glyphosate: Latest developments

10-11-2017

Glyphosate, one of the world's most widely used active substances in herbicides, has become the subject of controversy. A proposal by the European Commission to renew its approval for five years failed to gather a qualified majority of Member States and is to be submitted to an appeal body. The European Parliament has called for glyphosate to be phased out by 2022.

Glyphosate, one of the world's most widely used active substances in herbicides, has become the subject of controversy. A proposal by the European Commission to renew its approval for five years failed to gather a qualified majority of Member States and is to be submitted to an appeal body. The European Parliament has called for glyphosate to be phased out by 2022.

Предстоящи събития

01-10-2019
Health threats from climate change: Scientific evidence for policy-making
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