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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.

Externí autor

John NGANGA, Michela BISONNI and Maria CHRISTODOULOU

Strengthening market surveillance of harmonised industrial products

29-07-2019

Harmonised products represent 69 % of the overall value of industrial products in the internal market. However, a significant part of these products does not comply with harmonised EU rules. This has negative effects on the health and safety of consumers, and on fair competition between businesses. To remedy the situation, in 2017 the Commission proposed to strengthen market surveillance rules for non-food products harmonised by EU legislation. Parliament and Council reached a provisional agreement ...

Harmonised products represent 69 % of the overall value of industrial products in the internal market. However, a significant part of these products does not comply with harmonised EU rules. This has negative effects on the health and safety of consumers, and on fair competition between businesses. To remedy the situation, in 2017 the Commission proposed to strengthen market surveillance rules for non-food products harmonised by EU legislation. Parliament and Council reached a provisional agreement on the proposal in February 2019. The new regulation was signed on 20 June and published in the Official Journal on 25 June 2019, applying in full from July 2021. It aims to increase EU-level coordination of market surveillance and clarify the procedures for the mutual assistance mechanism. Non-EU manufacturers of products that could cause an elevated level of risk to public interest will have to designate an importer, an authorised representative or a fulfilment service provider established in the EU. Fifth edition. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative procedure.

What if we didn't need cows for our beef?

12-07-2019

With the help of cells from a single cow, scientists can produce 175 million hamburgers. What if we didn’t need cows for our beef? Technologies for producing cultured meat and dairy products will help feeding the world in a sustainable way. What if we could produce meat without farming? New technology within reach to produce meat with a very low eco-footprint

With the help of cells from a single cow, scientists can produce 175 million hamburgers. What if we didn’t need cows for our beef? Technologies for producing cultured meat and dairy products will help feeding the world in a sustainable way. What if we could produce meat without farming? New technology within reach to produce meat with a very low eco-footprint

EU certification of aviation security screening equipment

07-07-2019

In 2016, the European Commission adopted a proposal for a regulation establishing a certification system for aviation security screening equipment. The proposal sought ‘to contribute to the proper functioning of the EU internal market and to increase the global competitiveness of the EU industry by establishing an EU certification system for aviation security equipment’. This system was to be based on EU type-approval and issuance of a certificate of conformity by manufacturers, which would have ...

In 2016, the European Commission adopted a proposal for a regulation establishing a certification system for aviation security screening equipment. The proposal sought ‘to contribute to the proper functioning of the EU internal market and to increase the global competitiveness of the EU industry by establishing an EU certification system for aviation security equipment’. This system was to be based on EU type-approval and issuance of a certificate of conformity by manufacturers, which would have been valid in all Member States, according to the principle of mutual recognition. Progress on the proposal rapidly reached a stalemate. Consequently, in its 2019 work programme, the Commission announced its intention to withdraw the proposal, noting that there was a common understanding that an EU certification system would be better reached by amending existing implementing legislation based on Regulation (EC) No 300/2008 on common rules in the field of civil aviation security. The proposal was formally withdrawn on 21 June 2019. Second edition. The ‘EU Legislation in Progress’ briefings are updated at key stages throughout the legislative procedure.

EU fertilising products

26-06-2019

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. After completion of the legislative procedure, the final act was signed on 5 June 2019. The regulation will apply in full from 16 July 2022. Fifth edition of a briefing originally drafted by Didier Bourguignon. The ‘EU Legislation in Progress’ briefings are updated at key stages throughout the legislative procedure. Please note this document has been designed for on-line viewing.

Mutual recognition of goods

25-04-2019

The revision of the regulation on mutual recognition of goods was announced in the 2015 Single Market Strategy. The Commission adopted its proposal in December 2017, which aimed to revise previous rules dating from 2008. This regulation aims to improve the rules governing the trade of goods in the single market. Intra-EU trade remains twice as big as extra-EU trade, and is rising constantly. This is, in large part, due to free movement of goods in the EU, which is based on either harmonised product ...

The revision of the regulation on mutual recognition of goods was announced in the 2015 Single Market Strategy. The Commission adopted its proposal in December 2017, which aimed to revise previous rules dating from 2008. This regulation aims to improve the rules governing the trade of goods in the single market. Intra-EU trade remains twice as big as extra-EU trade, and is rising constantly. This is, in large part, due to free movement of goods in the EU, which is based on either harmonised product rules at the EU level or, where there are no harmonised rules, the principle of mutual recognition under which goods lawfully marketed in one Member State may be sold in another Member State. The proposal addressed a number of shortcomings in the application of the mutual recognition principle. A provisional agreement between the co-legislators was reached on 22 November 2018. The text was adopted in plenary in February 2019. The new rules will improve collaboration among national authoritites and enhance the role of national product contact points. They will introduce a faster problem-solving procedure for disputes between companies and national authorities, as well as a new voluntary declaration to be filled in by economic operators to prove lawful marketing in an EU Member State. The new rules will apply from 19 April 2020. Fourth edition. The ‘EU Legislation in Progress’ briefings are updated at key stages throughout the legislative procedure. Please note this document has been designed for on-line viewing.

CE-marked fertilising products

20-03-2019

In March 2016, the European Commission presented a proposal on fertilising products, which would extend the scope of existing legislation, notably to cover organic and waste-based fertilisers, and set limits on heavy metals and contaminants in fertilising products. At its March II 2019 plenary session, the European Parliament is expected to vote on the agreement reached on the file after trilogue negotiations.

In March 2016, the European Commission presented a proposal on fertilising products, which would extend the scope of existing legislation, notably to cover organic and waste-based fertilisers, and set limits on heavy metals and contaminants in fertilising products. At its March II 2019 plenary session, the European Parliament is expected to vote on the agreement reached on the file after trilogue negotiations.

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 (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.

Externí autor

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)

Approval and market surveillance of vehicles

11-04-2018

In 2016, following work in previous years but also in response to the Volkswagen (VW) case, the European Commission made a proposal to strengthen type-approval and market surveillance for motor vehicles. First-reading negotiations with the Council delivered a compromise, which now awaits a vote during the April plenary.

In 2016, following work in previous years but also in response to the Volkswagen (VW) case, the European Commission made a proposal to strengthen type-approval and market surveillance for motor vehicles. First-reading negotiations with the Council delivered a compromise, which now awaits a vote during the April plenary.

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