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Biomass Action Plan

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Biomass Action Plan

Outline of the Community (European Union) legislation about Biomass Action Plan

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Environment > Tackling climate change

Biomass Action Plan

Document or Iniciative

Communication from the Commission of 7 December 2005 – Biomass Action Plan [COM(2005) 628 final – Official Journal C 49 of 28.02.2005].

Summary

To cope with the increasing dependence on imported energy, the European Union (EU) must bring into play a new energy policy, the three main objectives of which are competitiveness, sustainable development and security of supply.

It is in this wider context of an integrated and coherent energy policy and, in particular, of promoting renewable energy sources that the Commission is presenting this Biomass Action Plan.

Biomass

Biomass, i.e. all organic plant and animal products used to produce energy (or in agriculture), currently accounts for around half (44 to 65%) of all renewable energy used in the EU.

Biomass currently meets 4% of the EU’s energy needs (69 million tonnes of oil equivalent (toe)). The aim is to increase biomass use to around 150 million toe by 2010.

An increase of this magnitude could bring such benefits as:

  • diversifying Europe’s energy supply;
  • significantly reducing greenhouse gas emissions * (209 million tonnes);
  • direct employment for 250 to 300 000 people;
  • potentially lowering the price of oil as a result of lower demand.

It is important to note that these benefits can probably be obtained without additional pollution or other forms of environmental damage.

The predicted cost of expenditure linked to renewable energy is estimated at EUR 9 billion per year.

The Commission identifies three sectors in which biomass use should be prioritised, namely heat production, electricity production and transport.

Biomass for heating

Heating is without a doubt the sector which uses the most biomass, and does so simply and cheaply in terms of technology. However, paradoxically, biomass is growing slowest in this sector.

The Commission plans to use various measures to improve this situation, including:

  • adopting new specific legislation on renewable energy in heating;
  • amending the Directive on the energy performance of buildings;
  • carrying out a study of how to improve the performance of household biomass boilers and reduce pollution.

However, it appears that renewable fuels are more suited for use in district heating * than individual heating. Their use should therefore be promoted by making them more competitive, cost-effective and convenient to use.

Electricity from biomass

The Commission points out that there are many ways of generating electricity from renewable energy sources. Attention should focus on the Directive on electricity from renewable energy sources in this area.

Using biofuels in transport

As with electricity production, the transport sector is also governed by Community legislation in the form of the Directive on biofuels for transport.

In accordance with this Directive, the Commission plans to present a report in 2006 on the implementation of the Directive, with a view to a possible revision. It will address the issues of:

  • national targets for the market share of biofuels;
  • the obligation to use biofuels;
  • implementing a system to certify conformity with biofuels standards.

The Commission is set to put forward a legislative proposal for the vehicle market aimed at encouraging public procurement of clean vehicles. The future strategy on the car industry, which should be published in 2006, provides for various measures concerning:

  • the use of biofuels;
  • establishing tax incentives;
  • providing consumer information;
  • reducing congestion.

In terms of balancing domestic production and imports of biofuels, the Commission’s approach is to:

  • propose the amendment of standard EN14214 to facilitate the use of a wider range of vegetable oils for biodiesel *, to the extent feasible without significant ill-effects on fuel performance;
  • address the issue of amending the biofuels directive so that only biofuels whose cultivation complies with minimum sustainability standards count towards its targets;
  • maintain market access conditions for imported bioethanol * that are no less favourable than those provided by the trade agreements currently in force;
  • pursue a balanced approach in ongoing free trade agreement negotiations with ethanol-producing countries/regions;
  • support developing countries that wish to produce biofuels and develop their domestic markets;

In terms of standards, the Commission is currently re-examining two areas of the fuel quality directive;

  • impact on health and the environment;
  • impact on the achievement of the objectives in the biofuels directive and the cost of achieving them.

The Commission also plans to remove unjustified or discriminatory technical barriers to using biofuels.

Lastly, as Europe is better at producing bioethanol than biodiesel, the Commission will encourage the use of ethanol (in place of methanol *) to reduce demand for diesel.

Stimulating biomass supply

In terms of agriculture, the reform of the Common Agricultural Policy (CAP) introduced a special “aid for energy crops”. In 2006 the Commission will evaluate the implementation of this and, if necessary, will put forward proposals reflecting the Union’s objectives in terms of biofuels. In addition to this the Commission will fund an information campaign on the priorities for energy crops and the prospects for exploiting them.

Statistics for forestry * show that around 35% of the annual growth in EU forests remains unused. To address this, the Commission is currently preparing an action plan, which should be adopted in 2006. The plan will, in particular, examine the matter of generating electricity from wood. The Commission will also review the impact of the energy use of wood and wood residues on forest-based industries.

Waste is also an underused energy resource. For this reason the Commission is currently developing a thematic strategy on preventing and recycling waste, and is preparing a proposal on the revision of the waste framework legislation.

Animal by-products not destined for human consumption are increasingly being recovered for energy. Consequently, the Commission plans to review the regulatory framework governing such production processes, so that new sources of energy may be opened up while maintaining current levels of protection for public and animal health.

The Commission is also paying particular attention to the adoption of European standards for solid biomass fuels in order to facilitate trade, develop markets and increase consumer confidence. The European Committee for Standardisation is working to define these standards.

Regarding supply, a European trading floor for pellets and chips has been initiated with support from the EU Intelligent Energy for Europe programme (2003-2006). The Commission will also look at how the results can be improved, with a view to possibly establishing a Community-wide trading system.

Lastly, action plans making it easier to evaluate biomass at various levels (physical and economic availability, priorities for use, measures to be taken, etc.) are encouraged by the Commission both at national and regional level.

Financing biomass

Supporting the development of renewable and alternative energy sources is a key objective for the structural and cohesion funds. The EU and the Member States must therefore promote the development of renewable energy sources through regional policy.

The Commission also points out that support for biomass production and use must comply with Community state aid policy.

Biomass and research

The Commission’s proposal for the Seventh Framework Programme gives a high priority to biomass research.

The Commission plans in particular to look at how best to take forward research into the optimisation of agricultural and woody crops for energy purposes, and into conversion processes.

Lastly, through the Intelligent energy for Europe programme (2007-2013), the Commission will support the dissemination of techniques that reflect European objectives for renewable energy.

Background

This Biomass Action Plan is part of the new EU energy policy set out in the Green Paper on energy published in March 2006. Most of the recommendations it contains were supported by EU Heads of State or Government at the spring European Council of 23 and 24 March 2006. Developing safe, competitive and sustainable energy is therefore one of the EU’s priorities in relaunching the Lisbon Strategy.

Key terms used in the act
  • The main greenhouse gases are water vapour, carbon dioxide (CO2), methane (CH4), nitrous oxide and ozone (O3).
  • District heating: collective heat distribution equipment for heat generated in the form of vapour or hot water by several production units.
  • Biodiesel: fuel obtained from vegetable or animal oil which has been transformed through a chemical process called transesterification.
  • Bioethanol: biofuel for use in petrol engines. Plants which contain saccharose (beetroots, sugar cane, etc.) or starch (wheat, maize, etc.) can be transformed to produce bioethanol. This is obtained by fermenting the sugar extract of sugary plants or by distilling starch from wheat or maize.
  • Methanol: methanol is also known as methyl alcohol or wood alcohol and its chemical formula is CH3OH. It is the simplest form of alcohol and is highly toxic. It is a light, volatile, transparent and inflammable liquid which is used as anti-freeze, a solvent, as fuel (in the North American Champcar world series since 1964), and to denature ethyl alcohol.
  • Forestry: this covers all practices by which goods are produced from forests in a reasonable and sustainable way.

Related Acts

Communication from the Commission to the Council and the European Parliament – The Renewable Energy Progress Report: Commission Report in accordance with Article 3 of Directive 2001/77/EC, Article 4(2) of Directive 2003/30/EC, and on the implementation of the EU Biomass Action Plan, COM(2005) 628 [

COM(2009) 192

final – Not published in the Official Journal].

This Report describes the progress made in the field of renewable energy. In the electricity sector, in particular, the renewable energy share has increased in some Member States. In addition, the transport sector has seen its renewable energy share increase by 1.6 points since 2004. In spite of this positive trend, the European Union is likely to fail to meet its 2010 renewable energy targets. It is therefore essential that the European Commission should continue to encourage Member States to apply the existing legislation and if necessary to initiate infringement proceedings in order to make further progress towards achieving these objectives.

Communication from the Commission of 19 October 2006 – Action Plan for Energy Efficiency: Realising the Potential [COM(2006) 545 final – Not published in the Official Journal].

Communication from the Commission of 26 May 2005 to the Council and the European Parliament, “The share of renewable energy in the EU” [COM(2004) 366 final – Not published in the Official Journal].

Biodiversity Action Plan for the Conservation of Natural Resources

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Biodiversity Action Plan for the Conservation of Natural Resources

Outline of the Community (European Union) legislation about Biodiversity Action Plan for the Conservation of Natural Resources

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Environment > Protection of nature and biodiversity

Biodiversity Action Plan for the Conservation of Natural Resources

Document or Iniciative

Commission Communication of 27 March 2001 to the Council and the European Parliament: Biodiversity Action Plan for the Conservation of Natural Resources (Volume II) [COM(2001) 162 final – Not published in the Official Journal].

Summary

This communication is the second volume of the Commission Communication of 27 March 2001 on Biodiversity Action Plans in the areas of Conservation of Natural Resources, Agriculture, Fisheries, and Development and Economic Cooperation. This volume is specifically dedicated to the conservation of natural resources.

Introduction

In recent decades, the rate of decline and even disappearance of species and related habitats, ecosystems and genes (i.e. biodiversity) has increased throughout the world. This loss of biodiversity is deplorable in itself and has adverse effects on economic development since it is the basis for the food, fibres, drink, medicines, industrial processes, agriculture and fisheries activities we rely on for our survival.

In February 1998, the Commission adopted a communication on a Community strategy for biodiversity. This strategy already provided for special action plans for the areas of activity concerned to be set up and implemented. This communication sets out the Action Plans in the areas of Conservation of Natural Resources, Agriculture, Fisheries, and Development and Economic Cooperation.

The Community Biodiversity Strategy and the Action Plans are covered by the European Union commitment to achieve sustainable development and integrate environmental concerns into other sectoral policies and other policy areas.

Indicators will be used for the long-term monitoring and benchmarking of Action Plan implementation. These indicators, which still have to be specified by the Commission with the help of the Member States, scientists and organisations concerned, will be measured locally and results compared.

The European Community clearing house mechanism (EC CHM) is an invaluable resource for exchanging information on biodiversity. It should be supported and developed further.

The Commission is currently identifying biodiversity conservation research needs so as to include them in the Sixth European Framework Programme for Research and Technological Development.

The Commission plans to set up a Committee of Experts on Biodiversity which would disseminate information and strive to ensure that European and national measures are complementary. Representatives of NGOs, industry, associations and any other interested parties would be invited to attend committee meetings as observers.

The natural resources volume of the communication stresses the following objectives: conservation of wild fauna and flora, preventing biodiversity loss related to the management of water, soil, forests and wetlands, preventing biodiversity loss throughout EU territory and conserving biodiversity worldwide. These objectives are explained in detail below.

The conservation of wild fauna and flora

The communication sets three main priorities to meet the objective of maintaining or improving the conservation status of natural habitats and wild animal and plant species: application of the Habitats and Birds Directives, establishment of networks such as Natura 2000 and financial and technical support for them, and formulating special action plans for threatened and huntable species.

The Communication highlights the objective of transposing the Habitats and Birds Directives properly into national legislation by 2002. It envisages a monitoring system with guidelines addressed to States and, moreover, the option of taking legal action against them. The annexes to both Directives will have to be amended in order to protect and take account of biodiversity in European Union candidate countries.

The communication sets the objective of adopting the list of Natura 2000 sites for all biogeographical regions, including forested areas, by the end of 2002. Guidelines will be drawn up for the administration of the network. The Commission will favour funding Natura 2000 through LIFE-Nature projects. The Commission points out the need for Community programmes to make an explicit commitment to protect the Natura 2000 network.

The Commission will finalise the Action Plans for the most threatened bird species and huntable species. Under international conventions, it will also collaborate in framing special action plans for threatened species other than birds.

Preventing biodiversity loss related to the management of water, soil, forests and wetlands

The communication proposes a three-pronged approach to reverse the current trends of biodiversity loss related to management of water, soil, forests and wetlands: using the Water Framework Directive, enhancing the ecological function of land cover and protecting wetlands.

The Water Framework Directive will be used as a tool for the conservation and sustainable use of biodiversity. For every river basin, analyses will be carried out of water quality and quantity versus demand, and also water needs for irrigation, energy generation, drinking water consumption and industrial and ecological uses.

An information base will be set up and a public awareness campaign on the need for soil protection will be launched in order to enhance the ecological function of land cover to combat erosion. It will become mandatory to check the quality of the end-products of sewage sludge and biodegradable waste treatment. A communication will be published on the proper use of pesticides. Forest biological diversity will be included in rural development plans.

The Commission will protect biodiversity in wetlands through initiatives under Natura 2000, the Water Framework Directive and the Strategy for Integrated Coastal Zone Management.

Reversing biodiversity loss across the whole territory

The communication highlights the following priority actions to develop instruments to improve the conservation and sustainable use of biodiversity on territory located outside protected areas: taking account of biodiversity in policies affecting soil such as agricultural policy, fisheries, aquaculture, Structural Funds and the urban environment, and incorporating biodiversity in cross-sectoral environmental measures.

In order to integrate biodiversity into cross-sectoral environmental measures, the objectives and actions detailed in the communication are based on the precautionary principle, environmental liability, environmental impact assessment, strategic environmental assessment, public participation and access to information, eco-labelling, eco-auditing and the strategy for EU chemicals policy.

The actions on genetic resources outlined in the communication address alien invasive species, GMOs, zoos and botanical gardens.

Conserving biodiversity worldwide

The communication sets forth objectives and actions for the conservation of biodiversity worldwide targeted at applying the EC CITES Regulation, improving coordination within international forums in the fields of climate change, ozone layer depletion and desertification, and identifying interactions between the Convention on Biological Diversity and other international agreements in order to optimise the opportunities for synergy.

Related Acts

Commission Communication of 21 December 2005: Thematic Strategy on the sustainable use of natural resources [– Not published in the Official Journal].
This strategy creates a framework for action to reduce the burden on the environment from the production and consumption of natural resources without penalising economic development. Concerns about resources will be addressed in all relevant policies and specific measures will be put into effect, notably the setting up of a centre for data and indicators, a European forum and an international expert group.

Biodiversity Action Plan for Agriculture

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Biodiversity Action Plan for Agriculture

Outline of the Community (European Union) legislation about Biodiversity Action Plan for Agriculture

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Agriculture > Environment

Biodiversity Action Plan for Agriculture

Document or Iniciative

Commission Communication of 27 March 2001 to the Council and the European Parliament: Biodiversity Action Plan for Agriculture (Volume III) [COM(2001) 162 final – not published in the Official Journal].

Summary

This communication is the third volume of the Commission Communication of 27 March 2001 on Biodiversity Action Plans in the areas of Conservation of Natural Resources, Agriculture, Fisheries, and Development and Economic Cooperation. This volume is specifically dedicated to agriculture.

Introduction

In recent decades, the rate of decline and even disappearance of species and related habitats, ecosystems and genes (i.e. biodiversity) has increased throughout the world. This loss of biodiversity is deplorable in itself and has adverse effects on economic development since it is the basis for the food, fibres, drink, medicines, industrial processes, agriculture and fisheries activities we rely on for our survival.

In February 1998, the Commission adopted a communication on a Community Biodiversity Strategy. This strategy already provided for special action plans for the areas of activity concerned to be set up and implemented. This communication sets out the Action Plans in the areas of Conservation of Natural Resources, Agriculture, Fisheries, and Development and Economic Cooperation.

The Community Biodiversity Strategy and the Action Plans are covered by the European Union commitment to achieve sustainable development and integrate environmental concerns into other sectoral policies and other policy areas.

Indicators will be used for the long-term monitoring and benchmarking of Action Plan implementation. These indicators, which still have to be specified by the Commission with the help of the Member States, scientists and organisations concerned, will be measured locally and results compared.

The European Community clearing house mechanism (EC CHM) is an invaluable resource for exchanging information on biodiversity which should be supported and developed further.

The Commission is currently identifying biodiversity conservation research needs so as to include them in the Sixth European Framework Programme for Research and Technological Development.

The Commission plans to set up a Committee of Experts on Biodiversity which would disseminate information and strive to ensure that European and national measures were complementary. Representatives of NGOs, industry, associations and any other interested parties would be invited to attend committee meetings as observers.

Priorities

The volume on agriculture begins with an analysis of the reciprocal relationship between agriculture and biodiversity stressing mutual benefits but also the pressure on biodiversity from farming. That analysis produced the following priorities for the action plan:

  • keeping intensive farming at a level which is not harmful to biodiversity: by establishing good agricultural practice, reducing the use of fertilisers, supporting non-intensive modes de production and establishing sustainable resource management;
  • ensuring that farming activities are economically viable, socially acceptable and safeguard biodiversity;
  • implementing agri-environmental measures for the sustainable use of biodiversity;
  • ensuring that the necessary ecological infrastructure exists;
  • supporting measures related to maintaining local breeds and varieties and the diversity of varieties used in agriculture;
  • preventing the spreading of non-native species.

Instruments

The communication mentions several Community instruments that can be used to implement the biodiversity action plan:

  • The Council Regulation establishing common rules for direct support schemes under the common agricultural policy;
  • agri-environmental measures in the field of rural development: these are one of the key instruments of this action plan;
  • other rural development measures;
  • the environmental components of common market organisations;
  • the Regulation (EC) No 870/2004 on genetic resources in agriculture;
  • the environmental components of market-related instruments on quality: as listed in Annex 2 of the communication;
  • plant health legislation;
  • SAPARD.

A table annexed to the communication shows these instruments, the targets and the indicative timetable for achieving the sectoral and cross-sectoral objectives pinpointed in the European Community Biodiversity Strategy, as well as the priorities of this action plan as outlined above.

The effectiveness of the action plan is dependent on the proper implementation of all these measures by Member States. Member States must submit a report by 2003 giving precise details of any obstacles to improving biodiversity in agriculture.

Related Acts

Communication from the Commission of 22 May 2006 entitled ” Halting the loss of biodiversityby 2010 and beyond – Sustaining ecosystem services for human well-being” [COM(2006) 216 final – not published in the Official Journal].

Biodiversity Action Plan for Fisheries

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Biodiversity Action Plan for Fisheries

Outline of the Community (European Union) legislation about Biodiversity Action Plan for Fisheries

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Environment > Protection of nature and biodiversity

Biodiversity Action Plan for Fisheries

1) Objective

Establishing an action plan to improve or maintain biodiversity status and preventing biodiversity loss due to fisheries and aquaculture activities.

2) Community Measure

Commission Communication of 27 March 2001 to the Council and the European Parliament: Biodiversity Action Plan for Fisheries (Volume IV).

3) Contents

This communication is the fourth volume of the Commission Communication of 27 March 2001 on Biodiversity Action Plans in the areas of Conservation of Natural Resources, Agriculture, Fisheries, and Development and Economic Cooperation. This volume is specifically dedicated to fisheries.

Introduction

In recent decades, the rate of decline and even disappearance of species and related habitats, ecosystems and genes (i.e. biodiversity) has increased throughout the world. This loss of biodiversity is deplorable in itself and has adverse effects on economic development since it is the basis for the food, fibres, drink, medicines, industrial processes, agriculture and fisheries activities we rely on for our survival.

In February 1998, the Commission adopted a communication on a Community Biodiversity Strategy. This strategy already provided for special action plans for the areas of activity concerned to be set up and implemented. This communication sets out the Action Plans in the areas of Conservation of Natural Resources, Agriculture, Fisheries, and Development and Economic Cooperation.

The Community Biodiversity Strategy and the Action Plans are covered by the European Union commitment to achieve sustainable development and integrate environmental concerns into other sectoral policies and other policy areas.

Indicators will be used for the long-term monitoring and benchmarking of Action Plan implementation. These indicators, which still have to be specified by the Commission with the help of the Member States, scientists and organisations concerned, will be measured locally and results compared.

The European Community clearing house mechanism (EC CHM) is an invaluable resource for exchanging information on biodiversity which should be supported and developed further.

The Commission is currently identifying biodiversity conservation research needs so as to include them in the Sixth European Framework Programme for Research and Technological Development.

The Commission plans to set up a Committee of Experts on Biodiversity which would disseminate information and strive to ensure that European and national measures were complementary. Representatives of NGOs, industry, associations and any other interested parties would be invited to attend committee meetings as observers.

Although the actual impact of fisheries on biodiversity has not been fully identified, the Commission Communication of 14 July 1999 on Fisheries Management and Nature Conservation in the Marine Environment [COM (1999) 363] highlights the interactions between fishing and the environment and puts forward a strategic European framework for the sustainable exploitation of fisheries resources and biodiversity.

Priorities

The plan identified the following priorities to maintain or restore biodiversity threatened by fishing or aquaculture activities:

  • promoting the conservation and sustainable use of fish stocks;
  • promoting the control of exploitation rates and the establishment of technical conservation measures to support the conservation and sustainable use of fish stocks;
  • reducing the impact of fisheries activities on non-target species and on marine and coastal ecosystems;
  • avoiding aquaculture practices that may affect habitat conservation.

This Action Plan should lead to the application of the precautionary principle as set out in the Commission Communication of December 2000 on the application of the precautionary principle and multiannual arrangements for setting TACs [COM(2000)803].

The communication proposes measures to reduce fisheries activities, technical measures and measures to intensify research and monitoring.

In the field of aquaculture, the communication proposes measures to reduce its environmental impact, to limit the introduction of alien invasive species, to protect animal health and promote further research.

Additional key elements

Education, training, raising awareness and providing information are essential complements to the effective implementation of this action plan. The communication proposes:

  • information campaigns and other awareness-raising activities;
  • a communication on applying the precautionary principle in fisheries management;
  • vocational training to improve ecosystem management;
  • improving monitoring and assessment capabilities.

The development of the new common fisheries policy for 2002 offers an excellent opportunity to review the issues raised by this plan, and to introduce new measures or enhance existing measures.

Annex II summarises the objectives, actions and instruments proposed in the communication, and gives an indicative timetable for their implementation.

4) Deadlines For The Implementation Of The Legislation In The Member States

Not required

5) Date Of Entry Into Force (If Different From The Above)

Not required

6) References

COM(2001) 162 final
Not published in the Official Journal

7) Follow-Up Work

8) Commission Implementing Measures

Biodiversity Action Plan for Economic and Development Co-operation

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Biodiversity Action Plan for Economic and Development Co-operation

Outline of the Community (European Union) legislation about Biodiversity Action Plan for Economic and Development Co-operation

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Development > Sectoral development policies

Biodiversity Action Plan for Economic and Development Co-operation

Document or Iniciative

Communication of 27 March 2001 from the Commission to the Council and the European Parliament: Biodiversity Action Plan for Economic and Development Co-operation (volume V) [COM(2001) 162 final – not published in the Official Journal].

Summary

This Communication is the fifth volume of the Commission Communication of 27 March 2001 on Biodiversity Action Plans in the areas of Conservation of Natural Resources, Agriculture, Fisheries, and Development and Economic Co-operation. This volume deals with the area of development and economic co-operation.

Introduction

In recent decades, there has been a global drop in the number of species and their habitats, ecosystems and genes (in other words biodiversity), and a higher rate of extinction. This loss of biodiversity is regrettable in itself, but it also has negative repercussions for economic development, as biodiversity provides the basis for the food, fibres, drinks, medicines, industrial processes, fishery and agriculture on which our lives depend.

In February 1998, the Commission adopted a communication on a Community Biodiversity Strategy. This strategy provided for the establishment and implementation of specific action plans for relevant areas of activity. The present communication establishes action plans for the conservation of natural resources, agriculture, fisheries and economic and development cooperation.

The Community Biodiversity Strategy and its action plans must be seen in the context of the EU commitment to achieve sustainable development and to integrate environmental concerns into other policy areas and fields of action.

The implementation of the action plans will be monitored, and their effectiveness evaluated, on the basis of indicators. These will be defined by the Commission in cooperation with Member States, scientists and relevant organisations, and will be identified at local level with a view to ensuring the comparability of results.

The Community Clearing House Mechanism (EC-CHM) constitutes an important means of sharing information on biodiversity. This resource should be strengthened and developed.

The Commission is in the process of identifying research needs for conserving biodiversity, with a view to including them in the forthcoming Sixth Framework Programme on Research and Development.

The Commission plans to establish a Biodiversity Expert Committee with responsibility for sharing information and helping to ensure the complementarity of actions taken at Community and Member State levels. Non-governmental organisations (NGOs), industry, associations and other interested parties will be invited to participate in Committee meetings as observers.

Objectives

The Biodiversity Action Plan on Economic and Development Co-operation will be implemented in the context of the International Development Targets agreed for 2015. These include reversing the trends in environmental degradation and natural resource loss, and reducing poverty. As far as poverty is concerned, the aim is to reduce the number of people living in conditions of extreme poverty by half. Biodiversity is an asset for many poor communities and can therefore be used to help reduce their poverty.

The Action Plan aims to identify actions that will:

  • address the objectives of the Community Biodiversity Strategy;
  • integrate biodiversity into the policies, programmes and projects being implemented through EC economic and development co-operation;
  • help to build the European Commission’s capacity to address biodiversity issues in the context of its economic and development co-operation.

Fields of action

The present communication establishes “guiding principles” to be followed, including the ecosystem approach, stakeholder participation, sharing the costs and benefits from biodiversity conservation and giving the public access to information.

The Action Plan sets out actions to be taken in 3 inter-linked contexts:

  • intensive production systems (agriculture, livestock, aquaculture, forestry, etc), paying attention to their importance as a source of food, the conservation of genetic diversity, and concerns regarding alien species and modified organisms;
  • production systems involving non-domesticated or non-cultivated species (natural forests and fishing grounds, wild flora and fauna, etc.), focusing on maintaining a range of ecosystems and habitats in productive landscapes;
  • protected areas, where stronger links are needed between conservation activities and sustainable development strategies.

The communication emphasises the need to improve the capacity of developing countries for biodiversity-related research, and sharing information, collections and technology. Another important field of action is education and awareness-raising to broaden acceptance of the importance of biodiversity for health and well-being.

Bilateral framework agreements for cooperation with the Mercosur countries

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Bilateral framework agreements for cooperation with the Mercosur countries

Outline of the Community (European Union) legislation about Bilateral framework agreements for cooperation with the Mercosur countries

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

External relations > Relations with third countries > Latin america

Bilateral framework agreements for cooperation with the Mercosur countries

Acts

Council Decision 95/445/EC of 30 October 1995 concerning the conclusion of the Framework Agreement for cooperation between the European Economic Community and the Federative Republic of Brazil

Council Decision 92/509/EEC of 19 October 1992 concerning the conclusion of the Framework Agreement for cooperation between the European Economic Community and the Republic of Paraguay

Council Decision 92/205/EEC of 16 March 1992 concerning the conclusion of the Framework Agreement for cooperation between the European Economic Community and the Eastern Republic of Uruguay

Council Decision 90/530/EEC of 8 October 1990 concerning the conclusion of the Framework Agreement for cooperation between the European Economic Community and the Argentine Republic

Summary

The Argentine Republic was the first of the four countries to formalise its relations with the European Union with a trade and economic cooperation agreement that entered into force in 1991. This is why the agreement covers fewer areas than the other three.

The basic principles of the agreements include respect for democracy and human rights and the strengthening of regional integration. In all four agreements, the parties grant each other most-favoured-nation treatment.

For Argentina, attention focuses on:

  • trade cooperation, to develop and diversify trade;
  • economic cooperation, excluding no field from the outset and including specifically scientific and technical cooperation, energy, protection of the environment and natural resources, regional integration and industrial standardization. The aim is to encourage the development and prosperity of industries, open up new sources of supply and new markets and promote scientific and technological progress;
  • agricultural cooperation, focusing on the development of trade in agricultural products and health measures;
  • industrial cooperation.

The second agreement to enter into force was the agreement with the Republic of Paraguay, in 1992. It covers all the points mentioned for Argentina but adapts them to the needs of the country. As regards economic cooperation, the aims are to strengthen economic links, enhance trade, promote cooperation between economic operators, improve standards of living, encourage investment flows, etc. This type of cooperation applies to services, intellectual and industrial property, the management of natural resources, environmental protection, agriculture, industry, energy and the mining sector.

As regards trade cooperation, the parties undertake, beyond diversifying trade, to examine ways of eliminating barriers and exchanging information. The agreement also contains an article on the arrangements applicable to this type of cooperation. Moreover, temporarily imported goods are exempt from duties and taxes, in the same way as for Uruguay and Brazil.

The objectives of agricultural cooperation are the same as for Argentina. As regards trade cooperation, the need to examine ways of eliminating non-tariff barriers was added. In the industrial field, the aim is to diversify the country’s productive base.

Cooperation on the environment aims at resolving problems linked to water, soil and air pollution, erosion, desertification, deforestation and overexploitation of natural resources. The parties therefore encourage the productive conservation of flora and fauna, and the conservation of tropical forests and national parks.

Another area of interest is science and technology; the parties want to boost Paraguay’s technological capabilities by fostering broad cooperation between the two parties.

Regional integration is another aim of the agreement which, without excluding any sphere of action, gives express consideration to environmental cooperation at regional level, the development of intra-regional trade, the strengthening of regional institutions, support for the development of common policies and activities and regional communications.

Development cooperation aims at strengthening and speeding up Paraguay’s economic and social development, attaching particular importance to rural development.

The fight against drugs, training, public health, investment, tourism, government service and information, communication and culture are other areas of EU-Paraguay cooperation.

The agreement with Uruguay entered into force in 1994 and comprises all the areas of cooperation listed in the agreement with Paraguay, except for the fight against drugs and development cooperation. It does, however, include an article on cooperation on social development.

Economic cooperation does not exclude any area from the outset and aims at diversifying economic ties, boosting economies and standards of living, creating new jobs, encouraging rural development, promoting depressed border areas, supporting the Mercosur integration process, etc.

The objectives of cooperation in the fields of trade, agriculture, the environment and industry are the same as for Paraguay. As regards cooperation on regional integration, health matters and the transfer of experience were added to the areas already mentioned for Paraguay.

Cooperation on science and technology focuses on facilitating the mobility and exchange of scientists, establishing permanent links, fostering the transfer of technology, creating links between research centres, stimulating innovation and creating economic cooperation opportunities.

Cooperation on social development aims to improve the standard of living and quality of life of the most underprivileged sections of the population, and includes technical assistance.

The framework agreement with Brazil entered into force in 1995. Cooperation is strengthened particularly in the areas of trade, investment, finance and technology. The agreement with Brazil adds the following to the cooperation areas covered by the agreements signed with the other countries: standards, information technology, telecommunications and space technology, transport, energy, the mining, forestry and rural sectors, fisheries, technological development and intellectual property.

The areas covered by economic cooperation are industry, the use of natural resources against a background of sustainable development, industrial property, health and plant health regulations, services in general and information on monetary matters.

Cooperation on standards aims to reduce existing differences in respect of weights and measures, standardisation and certification by promoting the use of available systems of standards and certification.

Cooperation in the area of air, road and rail transport centres on the interchange of information, training programmes and technical assistance.

Several areas of common interest are highlighted in the article on information technology, telecommunications and the use of space technology. The article covers, inter alia, earth and space-based telecommunications, electronics and microelectronics, computerisation and automation, and high-definition television.

As regards the environment, the aim is to reconcile the need for economic and social development with need for due protection of nature, devoting particular attention to the most disadvantaged sections of the population, urban environmental problems and the protection of ecosystems.

In order to contribute to regional integration and cooperation, measures must be taken with regard to technical assistance, the promotion of inter-regional trade, support for regional institutions and the preparation of studies. Certain areas, such as telecommunications and the environment, can be opened up for participation by other countries in the region.

Joint Cooperation Committee and duration

The four agreements establish a Joint Cooperation Committee consisting of representatives from both parties. The Committee ensures the proper functioning of the agreement and makes recommendations. Things are a little different in the case of Brazil, since the Joint Committee already existed and the agreement merely retained it.

The agreements are concluded for an initial period of five years and are renewed tacitly thereafter unless one of the parties denounces them in writing six months before the date of expiry. The agreements all include a future developments clause, enabling the parties to expand the content of the agreements.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Council Decision 95/445/EC (Brazil) [adoption: consultation CNS/1992/1204] 01.11.1995 – Official Journal L 262 of 1.11.1995
Council Decision 92/509/EEC (Paraguay) 01.11.1992 – Official Journal L 313 of 30.10.1992
Council Decision 92/205/EEC (Uruguay) 01.11.1994 – Official Journal L 94 of 8.4.1992
Council Decision 90/530/EEC (Argentina) 01.08.1991 – Official Journal L 295 of 26.10.1990

Related Acts

On 22 March 1999, the Council concluded in the name of the European Community the Interregional Framework Cooperation Agreement between the European Community and its Member States, of the one part, and the Southern Common Market and its Party States, of the other part.

Biodiversity strategy for 2020

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Biodiversity strategy for 2020

Outline of the Community (European Union) legislation about Biodiversity strategy for 2020

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Environment > Protection of nature and biodiversity

Biodiversity strategy for 2020

Document or Iniciative

Communication from the Commission of 3 June 2011, entitled: “Our life insurance, our natural capital: an EU biodiversity strategy to 2020” [COM(2011) 244 final – Not published in the Official Journal].

Summary

This strategy aims to halt the loss of biodiversity and the degradation of ecosystems in the European Union (EU) by 2020, by identifying six priority targets.. This strategy is an integral part of the Europe 2020 strategy, and, in particular, of the flagship initiative entitled “A resource-efficient Europe”.

Target 1: conserving and restoring nature

The EU must ensure better application of Directives “Birds” and “Habitats”. These two Directives constitute the backbone of EU biodiversity policy. They have achieved some good results so far, such as the creation of Natura 2000, the world’s largest network of protected areas, covering over 750 000 km2.. However, progress is still insufficient in terms of reaching a favourable conservation status of all habitats and species of European importance. In order to achieve the first target of this strategy, Member Sates must ensure better application of existing legislation. In particular, they must manage and restore the Natura 2000 sites by investing the necessary resources. These actions would contribute towards halting biodiversity loss and restoring biodiversity by 2020.

Target 2: maintaining and enhancing ecosystems and their services

The integration of a green infrastructure, restoring at least 15 % of the degraded ecosystems by 2020, and the development of an initiative aimed at preventing any net loss of ecosystems and their services by 2015, will be essential measures for maintaining and improving ecosystem services (for example the pollination of crops by bees).

Target 3: ensuring the sustainability of agriculture and forestry

The instruments provided under the CAP should contribute towards maximising areas under agriculture across grasslands, arable land, and permanent crops that are covered by biodiversity measures, by 2020.

Forest Management Plans or equivalent instruments will be put in place for all forests that are publicly owned and for forest holdings above a certain size, by 2020. The plans must ensure sustainable management of forests in order to receive funding under the EU’s Rural Development Policy.

Measures adopted to ensure sustainable management must also contribute towards achieving targets 1 and 2 of the strategy.

Target 4: ensuring sustainable use of fisheries resources

The measures adopted as part of the Common Fisheries Policy must enable the Maximum Sustainable Yield (MSY) to be achieved by 2015. In order to achieve this, it is essential to achieve a population by age and by size distribution indicative of a healthy stock. Through fisheries management with no significant adverse impacts on other stocks, species and ecosystems, it will be possible to achieve Good Environmental Status by 2020, in accordance with the “Marine Strategy Framework-Directive”..

Target 5: combating invasive alien species

With the exception of the legislation on the use of alien and locally absent species in aquaculture, there is currently no comprehensive EU policy on combating invasive alien species. However, these species pose a significant threat to European biodiversity. It is therefore necessary to identify them, isolate or eradicate them, and to control their introduction in order to prevent the appearance of new species. To this end, the Commission will fill policy gaps in combating invasive alien species with a dedicated legislative instrument..

Target 6: addressing the global biodiversity crisis

The EU must step up its contribution to averting global biodiversity loss by meeting the commitments made at the 10th Conference of Parties (COP10) to the United Nations Convention on Biological Diversity, which took place in Nagoya in 2010. During this conference, the EU committed to:

  • achieving the goals set by the global strategic plan for biodiversity 2011-2020;
  • implementing the Nagoya protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their use (ABS Protocol); and
  • mobilising additional resources to finance the challenge of protecting biodiversity world-wide.

Context

The strategy responds to two major commitments made by EU officials in March 2010, namely halting biodiversity loss in the EU by 2020 and protecting, assessing and restoring biodiversity and ecosystem services in the EU by 2050.

Biocides

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Biocides

Outline of the Community (European Union) legislation about Biocides

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Biocides (until 1 September 2013)

Document or Iniciative

Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market [See amending act(s)].

Summary

Scope

The Directive concerns:

  • the authorisation and placing on the market of biocidal products in the Member States;
  • the mutual recognition of authorisations within the Community;
  • the establishment at Community level of a list of active substances which may be used in biocidal products.

The Directive applies to biocidal products, i.e. non-agricultural pesticides as defined in Article 2 of the Directive. An exhaustive list of the products covered by this Directive is annexed below.

The Directive does not apply to products falling within the scope of the following legislative acts:

  • Directive 2001/83/EC (medicinal products for human use);
  • Directive 2001/82/EC (veterinary medicinal products);
  • Regulation (EC) No 726/2004 (European Medicines Agency);
  • Directive 90/385/EEC (active implantable medical devices)
  • Directive 93/42/EEC (medical devices);
  • Directive 98/79/EC (in vitro diagnostic medical devices);
  • Regulation (EC) No 1333/2008 (food additives)
  • Regulation (EC) No 1334/2008 (flavourings in foodstuffs);
  • Regulation (EC) No 1935/2004 (materials and articles intended to come into contact with foodstuffs);
  • Directive 90/167/EEC (medicated feedingstuffs);
  • Regulation (EC) No 767/2009 (feed);
  • Regulation (EC) No 1831/2003 (use of additives in animal nutrition);
  • Regulation (EC) No 1223/2009 (cosmetic products);
  • Regulation (EC) No 1107/2009 (plant protection products).

Obligations of the Member States

Member States must ensure the authorisation, classification, labelling, packaging and proper use of the biocidal products in line with this Directive. Proper use includes measures necessary to keep the use of biocidal products to a minimum as well as an obligation to ensure that their use in the workplace is in compliance with the directives on health and safety protection for workers. Member States must appoint one or more competent authorities responsible for complying with the obligations imposed on them under this Directive, including granting authorisations and receiving information relating to biocidal products so as to be able to meet any medical demand.

Each quarter Member States must inform the other Member States and the Commission of any biocidal products which have been registered and authorised within their territory or for which an authorisation or registration has been refused, modified, renewed or cancelled.

Every three years since 2003, Member States have submitted reports to the Commission in which they provide information on any poisonings involving biocidal products.

Principle of mutual recognition of authorisations

The authorisation system is based on the principle of mutual recognition of authorisations. Under this principle, a biocidal product that has already been authorised or registered in one Member State must be authorised in another Member State within 120 days or registered within 60 days of an application being received by the other Member State.

However, there are a number of derogations from mutual recognition:

  • The Member State may request that certain conditions relating to the classification, labelling and packaging of biocidal products be adapted under certain circumstances. These involve the quantity of the target species in the territory of the Member State, the degree of resistance of the target organism to the biocidal product and the circumstances under which it is used;
  • Where a Member State believes that a low-risk biocidal product which has been registered in another Member State does not comply with the definition set out in the Directive it may provisionally refuse to register it. In such cases it must notify the competent authority responsible for verifying the dossier;
  • Where a Member State believes a biocidal product authorised by another Member State does not meet the conditions for granting the authorisation and proposes to refuse the authorisation or registration it must notify the Commission, the other Member States and the applicant. The case will then be referred to the Standing Committee on Biocidal Products for a final decision which must be unanimously accepted;
  • Unless otherwise stated in the Treaty, Member States may refuse to grant mutual recognition of authorisations issued for types of products used against vermin, fish and birds, provided that such action is justifiable and does not frustrate the objectives of the Directive.

Conditions governing the granting of authorisations

It is compulsory to issue product marketing authorisation, subject to certain derogations in the case of low-risk products. The Member States may authorise a biocidal product only if:

  • its active substances are listed in the Annexes to the Directive and the requirements set out in the Annexes are met;
  • it is established that:
    • the biocidal product is sufficiently effective,
    • it has no unacceptable effects on the target organisms,
    • it has no unacceptable effects on human health or animal health or on surface water or groundwater,
    • it has no unacceptable effect on the environment;
  • the nature and quantity of its active substances can be determined according to the requirements listed in the Annexes to the Directive;
  • its physical and chemical properties have been deemed acceptable for purposes of appropriate use, storage and transport of the product.

A biocidal product classified as toxic, carcinogenic and mutagenic or toxic for reproduction is not authorised for marketing to the general public.

Authorisations may be reviewed at any time during the period for which they have been granted.

Placing on the market of active substances

An active substance for use in biocidal products may be placed on the market if:

  • a dossier has been submitted to a Member State accompanied by a declaration that the active substance is intended for inclusion in a biocidal product. This condition applies to active substances which did not have an authorisation to be placed on the market before 14 May 2000;
  • the active substance is classified, packaged and labelled in accordance with Directive 67/548/EEC which is applicable until 1 June 2015.

All active substances approved for inclusion in biocidal products are listed in Annex I or IA to the Directive. The maximum period during which a substance may be listed in the Annex is ten years.

Inclusion of a new active substance in the Annex

With a view to listing a new active substance in Annex I, IA or IB to the Directive, the Commission presents a proposal to the Standing Committee. The proposal is based on an evaluation of the substance carried out with the help of data supplied by the applicant.

Cancellation of an authorisation

An authorisation is cancelled if:

  • the active substance is no longer included in Annex I or IA to the Directive;
  • the conditions for obtaining the authorisation are no longer satisfied;
  • false particulars were supplied with the application for authorisation;
  • at the request of the authorisation holder.

Modification of an authorisation

An authorisation may be modified:

  • where a Member State considers that this is necessary to protect health and the environment;
  • at the request of the holder.

It is the responsibility of the holder of an authorisation for a biocidal product to pass on immediately to the competent authority any information of which he is aware concerning an active substance or a biocidal product containing it and which may affect continuing authorisation.

Procedure for requesting authorisation

An application for authorisation should come from the person initially responsible for placing a biocidal product on the market in a Member State and should be addressed to the competent authority in that Member State. In order to obtain the authorisation, the applicant must provide the following:

  • a dossier or letter of access concerning the biocidal product and containing the information specified in Annex IIB, IIIB or IVB depending on the type of biocidal product. The required information will contain, for example: the applicant’s name and address, the name and composition of the product, proposed uses, protective measures to be taken, among others. Dossiers for low-risk biocidal products are less detailed;
  • a dossier or letter of access for each active substance contained in the biocidal product and containing the information specified in Annexes IIA, IIIA and IVA.

The authorisation to place biocidal products on the market and entries of substances in Annex I, IA or IB are subject to the payment of a charge.

Member States may only use the information contained in the dossier accompanying the application for authorisation for the benefit of another applicant on certain conditions, one of which stipulates that the written agreement of the first applicant must be obtained.

Provisions applicable to a biocidal product that has already been authorised

Applicants for authorisation to place products on the market may use information provided by a previous applicant, in so far as the subsequent applicant can provide evidence that the product is similar and its active substances are the same as in the product previously authorised.

Before carrying out experiments involving vertebrate animals, an applicant for authorisation of a biocidal product must enquire of the competent authority of the Member State to which they intend to submit their application:

  • whether the biocidal product in question is similar to a biocidal product already authorised;
  • as to the name and address of the holder of the authorisation.

The applicant and holder or holders of former authorisations are encouraged to come to an agreement on the shared use of information to avoid duplicating the testing on vertebrate animals.

Exemptions

The Directive provides for the possibility of exemption from the requirements for placing biocidal products on the market. A Member State may temporarily authorise placing biocidal products on the market which do not comply with the provisions of the Directive for limited and controlled use if such measures appear necessary due to unforeseen danger not able to be contained by other means.

Role of the Commission

Following the adoption of the Directive, the Commission is to embark on a programme of work, systematically examining the risks associated with all active substances authorised for inclusion in biocidal products. The programme has been set up under a Regulation adopted by the Standing Committee on Biocidal Products, and will run for ten years. Its task is to examine all active substances already available on the market as of 14 May 2000 in the form of active substances for a biocidal product, with the exception of products used for purposes of research, science and product development.

Not more than two years prior to the completion of the programme of work, the Commission will send a progress report on the implementation of the programme to the European Parliament and the Council.

To further improve implementation of the Directive, the Commission must prepare technical guidelines which are to be published in the Official Journal of the European Communities.

Research and development

Experiments or tests carried out for the purposes of research or development involving the placing on the market of an unauthorised biocidal product or an active substance intended exclusively for use in a biocidal product are subject to several conditions, including an obligation to obtain authorisation from the competent authority if the tests are likely to have harmful effects on human or animal health or on the environment.

Classification, packaging and labelling

Biocidal products are classified, packaged and labelled in accordance with Directive 1999/45/EC on the classification, packaging and labelling of dangerous preparations which is applicable until 1 June 2015. However, in order to avoid any misunderstandings (confusion with foodstuffs or drinks, for example), the Directive lays down additional requirements with regard to the packaging and labelling of such products.

Safety measures

A system of specific information is introduced in order to enable professional and industrial users of biocidal products to take the necessary measures for the protection of the environment and health. This system must take the form of a data safety sheet provided by those responsible for placing the product on the market.

Confidentiality

The Directive allows the applicant to ask for certain sensitive information to be kept confidential from all persons other than the competent authorities and the Commission. Some information, however, (such as the name and address of the applicant, the physical and chemical properties of the biocidal product, etc.), cannot be included in this confidentiality clause.

Safeguard clause

The Directive allows the applicant to ask for certain sensitive information to be kept confidential from all persons other than the competent authorities and the Commission. Some information, however, (such as the name and address of the applicant, the physical and chemical properties of the biocidal product, etc.), cannot be included in this confidentiality clause.

Advertising

Marketing biocidal products is subject to certain conditions and must be in particular accompanied by wording which makes clear that the product should be used with care.

Comitology

The Commission is assisted by a Standing Committee on Biocidal Products. The Committee operates according to a regulatory procedure in the case of certain tasks, such as taking decisions to grant or withhold a prohibition (safeguard clause) or according to a management procedure in other cases, such as the listing of an active substance in the Annex and granting confidentiality.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Directive 98/8/EC

14.5.1998

13.5.2000

OJ L 123 of 24.4.1998
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1882/2003

20.11.2003

–

OJ L 284 of 31.10.2003

Directive 2007/47/EC

11.10.2007

21.12.2008

OJ L 247 of 21.9.2007

Directive 2008/31/EC

21.3.2008

–

OJ L 81 of 20.3.2008

Directive 2009/107/EC

26.10.2009

14.5.2010

JO L 262 du 6.10.2009

The successive amendments and corrections to Directive 98/8/EC have been incorporated into the basic text. This consolidated version  is for reference purpose only.

LAST AMENDMENTS TO THE ANNEXES

Annex I – List of active substances with requirements agreed at community level for inclusion in biocidal products
Directive 2011/10/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/11/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/12/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/13/EU [Official Journal L 34 of 9.2.2011].

Related Acts

Evaluation of active substances

Directive 98/8/EC provides for an evaluation of all active substances already on the market as at 14 May 2000 in the form of active substances in biocidal products. The ten-year programme is divided into two phases: the first, which began in 2000, is concerned with the identification of the substances, and the second, which began in 2003, with their evaluation.

Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products [Official Journal L 228 of 8.9.2000].
The first phase of this Regulation adopted on 7 September 2000 aims to:

  • identify the relevant substances and specify which need to be evaluated with a view to their possible listing in Annex I, IA or IB to Directive 98/8/EC (active substances authorised for use in biocidal products);
  • identify the first priority list of active substances to be evaluated during the second phase of the programme (the existing active substances used in biocidal products of type 8 (wood preservatives) and type 14 (rodenticides)).

Producers should identify the active substances to the Commission not later than 18 months after the entry into force of this Regulation using the special software provided free of charge by the Commission. Should the producer or formulator wish to request the listing of an active substance in Annex I or IA to the Directive, notification rather than identification will be necessary. The producer or formulator is required to provide the Commission with the information specified in Annex II to the Regulation, using the special Commission software, within 18-months of the Regulation’s date of entry into force. The Commission, in cooperation with the Member States, will then decide whether to accept or reject the notification. If it is accepted, the notifier must provide all the data and information necessary evaluating the active substance with a view to its possible inclusion in the Annex to the Directive during the second phase of the review programme.

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market [Official Journal L 325 of 11.12.2007].
This Regulation replaces and repeals Regulation (EC) No 2032/2003 of 4 November 2003, which had been subject to successive amendments. These various amendments made it difficult to read, particularly the Annexes concerning lists of identified active substances (Annexes I and VII to Regulation EC No 2032/2003), notified substances (Annexes II, V and VIII), and identified but not notified active substances (Annex III).
Regulation (EC) No 1451/2007 thus rationalises these lists and consolidates their successive amendments:

  • by creating an Annexe I, corresponding to the list of existing active substances, i.e. substances that are known to have been placed on the market as active biocidal substances before 14 May 2000 (consolidation of Annexes I and VII to the previous Regulation);
  • by creating an Annexe II, corresponding to the list of active substances currently notified to the review programme, updated, indicating the name of the reporting Member State (consolidation of Annexes II, V and VIII to the previous Regulation);
  • by deleting the former Annex III to the previous Regulation EC No 2032/2003, since it was no longer of use.

Application of the legislation

Report from the Commission to the Council and the European Parliament of 8 October 2008 – Evaluation of the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market (submitted in accordance with Article 18 (5) of the Directive) and progress Report on the work programme referred to in Article 16(2) of the same Directive [COM(2008) 620 – Not published in the Official Journal].
The Directive set the foundations for improving the level of environmental and public health protection which is offered to European Union citizens in relation to biocidal products. During the five years prior to the effective start of the active substance review in 2004, the Commission, in cooperation with the Member States and industry, inventoried biocidal products on the market and put into place a structured procedure for the assessment and evaluation of the existing active substances.
The review programme will not be finalised by the date originally set, 14 May 2010, which also happens to be the date by which national rules for the placing on the market of biocidal products will cease to apply. Allowing the transitional period to elapse without completing the review programme for biocidal products,would mean that the harmonised rules of the Directive about product authorisation could not apply for all the biocidal products already on the market. If neither set of rules – harmonised or national – could apply, there would be a legal void with regard to the placing on the market of biocidal products. This could have negative effects on public health (if important biocidal products were withdrawn from the market) and would have severe adverse economic effects on all companies operating in the biocides sector.
Therefore, this Communication is accompanied by a proposal for the revision of the Directive which would extend the review programme, the transitional period, and certain provisions on data protection that accompany this period for an additional three years.

Another Normative about Biocides

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic

Food safety > Plant health checks

Biocides

Document or Iniciative

Regulation (EC) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.

Summary

This Regulation applies to:

  • biocidal products *;
  • articles and materials treated * with biocidal products;
  • active substances.

A list of the products concerned can be found in Annex V to the Regulation.

Conditions for authorisation of biocidal products

For biocidal products, the following conditions must be met for authorisation:

  • the active substance are approved for the relevant product-type;
  • the biocidal product, when used as authorised, is sufficiently effective, has no unacceptable effects on the target organisms, on the health of humans or animals, or on the environment;
  • the physical and chemical properties of the product are considered acceptable with regard to the use and transport of the product;
  • where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product;
  • where nanomaterials are used in the product, the risk to human health, animal health and the environment has been assessed separately.

An active substance shall be approved for a maximum initial period of 10 years if at least one biocidal product containing that active substance may be expected to meet the above criteria.

National authorisation and mutual recognition

The Regulation provides for harmonised procedures for the authorisation of biocidal products in the EU. Once a first authorisation is granted by an EU country, the applicant can ask for the recognition of that authorisation by other EU countries. The authorisation shall be granted under identical terms and conditions.

Union authorisation

The centralised authorisation procedure will result in a Union authorisation which allows the industry to place biocidal products directly on the entire EU market without the need to obtain separate national authorisations or go through the mutual recognition procedure. This centralised authorisation is voluntary and if, for whatever reason, the applicant is not interested in a Union authorisation, he can instead apply for a national authorisation and, if appropriate, mutual recognition of that authorisation in other EU countries.

Simplified authorisation procedure

Certain biocidal products may be eligible for a simplified authorisation procedure, if the following conditions are met:

  • all the active substances contained in the biocide appear in and satisfy any restrictions in Annex I to this regulation;
  • the biocide does not contain any substance of concern or any nanomaterials;
  • the biocide is sufficiently effective;
  • the handling of the biocidal product and its intended use do not require personal protective equipment.

If the above conditions are met, applicants must submit applications to the European Chemicals Agency (ECHA), designating a competent authority to evaluate its application.

A biocidal product authorised by the above simplified procedure may be made available on the market in all EU countries without the need for mutual recognition. However, the authorisation holder must notify each EU country no later than 30 days before placing the product on the market within that country. The official language or languages of that country must be used on the product’s labelling, unless the country provides otherwise.

Treated articles

This Regulation extends the scope from previous legislation on biocides to now also cover articles which have been treated or which incorporate a biocidal product. Articles can only be treated with active substances which have been approved in the EU for that purpose. Manufacturers and importers of treated articles are required to label products when:

  • a claim is made that the treated article has biocidal properties;
  • the conditions of the approval of the active substance used to treat the article require specific labelling provisions to protect public health or the environment.
KEY TERMS USED IN THE ACT
  • Biocidal products: any substance or mixture to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
  • Treated article: any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 528/2012

17.7.2012

–

OJ L 167 of 27.6.2012

Another Normative about Biocides

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic

Food safety > Contamination and environmental factors

Biocides

Document or Iniciative

Regulation (EC) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.

Summary

This Regulation applies to:

  • biocidal products *;
  • articles and materials treated * with biocidal products;
  • active substances.

A list of the products concerned can be found in Annex V to the Regulation.

Conditions for authorisation of biocidal products

For biocidal products, the following conditions must be met for authorisation:

  • the active substance are approved for the relevant product-type;
  • the biocidal product, when used as authorised, is sufficiently effective, has no unacceptable effects on the target organisms, on the health of humans or animals, or on the environment;
  • the physical and chemical properties of the product are considered acceptable with regard to the use and transport of the product;
  • where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product;
  • where nanomaterials are used in the product, the risk to human health, animal health and the environment has been assessed separately.

An active substance shall be approved for a maximum initial period of 10 years if at least one biocidal product containing that active substance may be expected to meet the above criteria.

National authorisation and mutual recognition

The Regulation provides for harmonised procedures for the authorisation of biocidal products in the EU. Once a first authorisation is granted by an EU country, the applicant can ask for the recognition of that authorisation by other EU countries. The authorisation shall be granted under identical terms and conditions.

Union authorisation

The centralised authorisation procedure will result in a Union authorisation which allows the industry to place biocidal products directly on the entire EU market without the need to obtain separate national authorisations or go through the mutual recognition procedure. This centralised authorisation is voluntary and if, for whatever reason, the applicant is not interested in a Union authorisation, he can instead apply for a national authorisation and, if appropriate, mutual recognition of that authorisation in other EU countries.

Simplified authorisation procedure

Certain biocidal products may be eligible for a simplified authorisation procedure, if the following conditions are met:

  • all the active substances contained in the biocide appear in and satisfy any restrictions in Annex I to this regulation;
  • the biocide does not contain any substance of concern or any nanomaterials;
  • the biocide is sufficiently effective;
  • the handling of the biocidal product and its intended use do not require personal protective equipment.

If the above conditions are met, applicants must submit applications to the European Chemicals Agency (ECHA), designating a competent authority to evaluate its application.

A biocidal product authorised by the above simplified procedure may be made available on the market in all EU countries without the need for mutual recognition. However, the authorisation holder must notify each EU country no later than 30 days before placing the product on the market within that country. The official language or languages of that country must be used on the product’s labelling, unless the country provides otherwise.

Treated articles

This Regulation extends the scope from previous legislation on biocides to now also cover articles which have been treated or which incorporate a biocidal product. Articles can only be treated with active substances which have been approved in the EU for that purpose. Manufacturers and importers of treated articles are required to label products when:

  • a claim is made that the treated article has biocidal properties;
  • the conditions of the approval of the active substance used to treat the article require specific labelling provisions to protect public health or the environment.
KEY TERMS USED IN THE ACT
  • Biocidal products: any substance or mixture to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
  • Treated article: any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 528/2012

17.7.2012

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OJ L 167 of 27.6.2012