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

11-11-2019

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.

Ārējais autors

John NGANGA, Michela BISONNI and Maria CHRISTODOULOU

Endocrine disruptors: An overview of latest developments at European level in the context of plant protection products

25-04-2019

Endocrine disruptors (EDs) are chemical substances present in many products of daily life, which interact with the hormonal system and can disrupt its proper functioning. There is a growing interest in understanding EDs and progress has been made on both the scientific and regulatory side, but the topic remains of high concern at decision-making and societal levels because of the challenges it still poses. This paper provides a desk-research based overview of the key moments of the (scientific and ...

Endocrine disruptors (EDs) are chemical substances present in many products of daily life, which interact with the hormonal system and can disrupt its proper functioning. There is a growing interest in understanding EDs and progress has been made on both the scientific and regulatory side, but the topic remains of high concern at decision-making and societal levels because of the challenges it still poses. This paper provides a desk-research based overview of the key moments of the (scientific and regulatory) debate on EDs, with a focus on the latest developments at European level, namely Commission Regulation (EU) 2018/605 and the 2018 Commission communication ‘Towards a comprehensive European Union framework on endocrine disruptors’, in the particular context of plant protection products (PPPs).

Explosives precursors: Fighting the misuse of chemicals by terrorists

13-03-2019

Since 2008, in line with its action plan to enhance the security of explosives, the European Union has considered regulating chemicals that could be used to produce homemade explosives to be a priority. A first legislative act in this regard – Regulation (EU) No 98/2013 on the marketing and use of explosives precursors – was adopted in 2013. The 2015 Paris and 2016 Brussels terrorist attacks and their operating modes, which were based on the use of homemade explosives, led to an assessment of the ...

Since 2008, in line with its action plan to enhance the security of explosives, the European Union has considered regulating chemicals that could be used to produce homemade explosives to be a priority. A first legislative act in this regard – Regulation (EU) No 98/2013 on the marketing and use of explosives precursors – was adopted in 2013. The 2015 Paris and 2016 Brussels terrorist attacks and their operating modes, which were based on the use of homemade explosives, led to an assessment of the efficiency of the 2013 regulation. To take into account existing challenges, and increase stakeholders' ability to implement and enforce restrictions and controls under the regulation, the European Commission launched its revision in February 2017. On 17 April 2018, it adopted a proposal for a new regulation on explosives precursors. Following trilogue negotiations, an agreement between the European Parliament and the Council was reached on 5 February 2019. The Parliament's Committee on Civil Liberties, Justice and Home Affairs (LIBE), approved the agreed text on 19 February 2019. The vote in plenary is due to take place in April 2019. First edition. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative procedure.

Endocrine Disruptors: From Scientific Evidence to Human Health Protection

15-01-2019

This study, commissioned by the PETI Committee of the European Parliament, presents the scientific knowledge regarding the health effects of endocrine disruptors, a class of hazards recognized in EU regulation since 1999. This report reviews the scientific evidence regarding the concept of endocrine disruption, the extent of exposure, associated health effects and costs. The existing relevant EU regulations are discussed and recommendations made to better protect human health.

This study, commissioned by the PETI Committee of the European Parliament, presents the scientific knowledge regarding the health effects of endocrine disruptors, a class of hazards recognized in EU regulation since 1999. This report reviews the scientific evidence regarding the concept of endocrine disruption, the extent of exposure, associated health effects and costs. The existing relevant EU regulations are discussed and recommendations made to better protect human health.

Ārējais autors

Barbara DEMENEIX, PhD, UMR 7221 CNRS/MNHN, Muséum National d’Histoire Naturelle, Paris, France. Rémy SLAMA, PhD, Senior Investigator, INSERM (National Institute of Health and Medical Research), IAB Research Center, Team of Environmental Epidemiology, Grenoble, France.

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.

Ārējais autors

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

Revision of the Explosives Precursors Regulation

10-07-2018

Explosives precursors can be found in various chemical products used by consumers, general professional users, and industrial users, for example, in detergents, fertilisers, special fuels, lubricants and greases, water treatment chemicals. They can be used by terrorists to produce home-made explosives (HME). In April 2018 the European Commission put forward a proposal for a new regulation, accompanied by an impact assessment (IA) and an evaluation, which have been performed at the same time. The ...

Explosives precursors can be found in various chemical products used by consumers, general professional users, and industrial users, for example, in detergents, fertilisers, special fuels, lubricants and greases, water treatment chemicals. They can be used by terrorists to produce home-made explosives (HME). In April 2018 the European Commission put forward a proposal for a new regulation, accompanied by an impact assessment (IA) and an evaluation, which have been performed at the same time. The IA has attempted to provide a rather detailed, albeit mainly qualitative, analysis of the various types of impacts, disregarding some limitations to obtain data, such as a risk of exposing vulnerabilities in Member States and of jeopardising ongoing investigations and prosecutions. The IA notes that many SMEs are not part of the EU level industry associations, which have been consulted while drafting the ex-post evaluation. A question arises if the SMEs have been targeted at the stakeholder consultation in any other way, which appears not to be the case. The public consultation took less than 12 weeks, which is not in line with the Better Regulation Guidelines.

Regulation 98/2013 on the marketing and use of explosives precursors: Implementation Appraisal

29-05-2018

Explosives precursors are chemical substances that can be (and have been) misused to manufacture homemade explosives (HMEs). Regulation 98/2013 on the marketing and use of explosives precursors, applicable since September 2014, has two general aims: to increase public security through a reduced risk of misuse of explosives precursors for the manufacture of HMEs and, at the same time, to enable the free movement of explosives precursor substances in the EU internal market, given their many legitimate ...

Explosives precursors are chemical substances that can be (and have been) misused to manufacture homemade explosives (HMEs). Regulation 98/2013 on the marketing and use of explosives precursors, applicable since September 2014, has two general aims: to increase public security through a reduced risk of misuse of explosives precursors for the manufacture of HMEs and, at the same time, to enable the free movement of explosives precursor substances in the EU internal market, given their many legitimate uses. The regulation establishes a system of restrictions and controls on a number of explosives precursors with the aim of limiting the general public's access to these substances. The regulation also establishes an obligation for economic operators to report suspicious transactions, disappearances and thefts of explosives precursors. Evidence collected through the Commission's evaluation and stakeholder consultation confirms the existence of significant challenges related to the application of the regulation. These include a fragmented landscape of restrictions and controls across Member States (which apply an outright ban, a licensing or a registration regime, or a combination of these); insufficient awareness along the supply chain about rules and obligations arising from the regulation; and a lack of clarity about certain provisions that focus particularly on the identification of products that fall within the scope of the regulation and the identification of legitimate/professional users. Lack of clarity as to the application of the regulation to online marketplaces is yet another problem, given the absence of an explicit reference to e-commerce in the regulation. Non-inclusion of all threat substances in the list of restricted explosives precursors is seen as yet another important challenge, and so is the perceived inflexibility of the procedure for adding new threat substances to the list, especially in view of the need to react quickly to new and evolving threats. In light of the above, in April 2018 the European Commission put forward a proposal for a new regulation, accompanied by an impact assessment and an evaluation.

Chemicals and the circular economy: Dealing with substances of concern

02-10-2017

Unlike the traditional linear economic model based on a 'take-make-consume-throw away' pattern, the circular economy is an economic model based on sharing, leasing, reuse, repair, refurbishment and recycling, in an (almost) closed loop. One of the challenges associated with this model is the presence of substances of concern in products, which risk being passed on to waste and subsequently recycled. A large number of European Union (EU) legal acts are relevant to the theme of substances of concern ...

Unlike the traditional linear economic model based on a 'take-make-consume-throw away' pattern, the circular economy is an economic model based on sharing, leasing, reuse, repair, refurbishment and recycling, in an (almost) closed loop. One of the challenges associated with this model is the presence of substances of concern in products, which risk being passed on to waste and subsequently recycled. A large number of European Union (EU) legal acts are relevant to the theme of substances of concern in material cycles. They relate to three broad areas: chemicals, products and waste. The European Commission is expected to publish a communication on the interface between these policy areas by the end of 2017. The main challenge in relation to chemicals and the circular economy is increasing recycling and reuse, while making sure consumers are not at risk from exposure to substances of concern that may be present in products and passed on to waste. More specific challenges relate, among other things, to long-term exposure, lack of information, trade aspects and implementation of EU law. Increased policy coherence in the current regulatory framework could help the situation. More specifically, elements of possible remedies include: disseminating information about the presence of substances of concern in products, reducing and substituting them, and improving the management of substances of concern that cannot be substituted. However, there may be some difficulties in implementing these solutions, in particular regarding the administrative burden and costs. The European Parliament supports the development of non-toxic material cycles so that recycled waste can be used as a major, reliable source of raw materials. Stakeholders' views on the topic are mixed.

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.

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