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New plant-breeding techniques: Applicability of EU GMO rules

13-11-2020

New plant genetic modification techniques, referred to as 'gene editing' or 'genome editing', have evolved rapidly in recent years, allowing much faster and more precise results than conventional plant-breeding techniques. They are seen as a promising innovative field for the agri-food industry, offering great technical potential. Consumers could benefit from enhanced nutritional quality or reduced allergenicity of food, for example, such as gluten-reduced wheat. There is, however, considerable debate ...

New plant genetic modification techniques, referred to as 'gene editing' or 'genome editing', have evolved rapidly in recent years, allowing much faster and more precise results than conventional plant-breeding techniques. They are seen as a promising innovative field for the agri-food industry, offering great technical potential. Consumers could benefit from enhanced nutritional quality or reduced allergenicity of food, for example, such as gluten-reduced wheat. There is, however, considerable debate as to how these new techniques should be regulated, and whether some or all of them should fall within the scope of EU legislation on genetically modified organisms (GMOs). Those who take the view that the new techniques should be exempt from GMO legislation generally argue that the end product is very similar to products generated using conventional breeding techniques, or that similar changes could also occur naturally. Those who consider that the new techniques should fall within the scope of GMO legislation contend that the processes used mean that plants bred using the new techniques are in fact genetically modified. In July 2018, the Court of Justice of the European Union ruled that genome-edited organisms fall under the scope of European GMO legislation. While welcomed by some, the judgment also sparked criticism and calls for the new European Commission to amend EU GMO legislation. In November 2019, the Council requested that the Commission submit a study in light of the Court of Justice judgment regarding the status of novel genomic techniques (NGTs), by 30 April 2021. This is an updated edition of an October 2019 Briefing.

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.

Autor externo

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