Tag Archives: Approximation of legislation

EC type-approval system for motor vehicles

Leave a reply

EC type-approval system for motor vehicles

Outline of the Community (European Union) legislation about EC type-approval system for motor vehicles

Topics

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

Internal market > Motor vehicles > Technical implications of road safety

EC type-approval system for motor vehicles

Document or Iniciative

Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers and of systems, components and separate technical units intended for such vehicles.

Summary

The European Union (EU) is revising the system of EC type-approval for motor vehicles. The Directive retains (in revised form) the majority of the provisions of Directive 70/156/EEC and also introduces some entirely new concepts and requirements. It repeals and replaces Directive 70/156/EEC in order to have a clearer, more coherent text based on the principle of proportionality.

Scope

The requirement for EC type-approval for access to the internal market used to apply to private cars, motorcycles, mopeds and agricultural tractors. The European Union is extending this system to all categories of motor vehicles designed and constructed in one or more stages for use on the road and also to the systems, components and separate technical units designed and constructed for such vehicles. More precisely, the Directive is aimed at commercial vehicles (vans, lorries, semi-trailers, trailers), buses and coaches.

Type-approval system

The EC type-approval system is the only system in place for ensuring permanent monitoring of the conformity of output. Type-approval is based on the principle that manufacturers must issue a certificate of conformity for each vehicle manufactured, attesting that it conforms to the approved type. The manufacturer can opt for one of the following procedures: step-by-step type-approval *, single-step type-approval * or mixed type-approval *.

The Directive introduces a new EC type-approval method known as “multi-stage type-approval”. Each manufacturer involved in manufacturing a vehicle will fill in the part of the certificate relating to its own stage. The aim of this is to adapt the process to the specific nature of commercial vehicle manufacturing. The multi-stage procedure will generally involve two steps:

  • firstly, the initial manufacturer will obtain type-approval for a chassis (including the engine, wheels, shock absorbers, brakes, etc.) and a first EC type-approval certificate will be issued;
  • subsequently, the second manufacturer will assemble the bodywork and present the finished vehicle for type-approval. Where the same manufacturer is responsible for both chassis and bodywork, the vehicle may be type-approved using the time-honoured procedure for passenger cars.

The Directive is based on the principle of total harmonisation. EC type-approval procedures are compulsory and replace the national procedures with which they have co-existed up until now. The type-approval process is therefore noticeably simplified for manufacturers. It is enough for one Member State to type-approve a vehicle in order for all vehicles of that type to be registered throughout the Community solely on the basis of their certificate of conformity.

Improving road safety and environmental protection

The Directive aims to improve road safety by making a number of devices compulsory. These include ABS (anti-lock braking system), new and more effective rear-view mirrors (including the new front rear-view mirror), improved lights, side protection to prevent cyclists or pedestrians from being dragged under vehicles and anti-spray devices.

Furthermore, it lays down additional requirements for buses and coaches (emergency exits must be adapted to the number of people which the vehicle can hold, greater ease of access for persons with reduced mobility, sufficient “survival space” in the event of the vehicle rolling over etc.).

The Directive also focuses on various environmental obligations such as CO2 emissions, fuel consumption, engine power and smoke from diesel engines.

Timetable

The provisions of the proposal will be implemented from 2009 and will be phased in gradually until 2014, depending on the category of vehicle. The aim of the transition periods is to enable the industry to gradually adapt its production systems to the new requirements and enable governments to deal progressively with the increased number of requests for type-approval.

Background

Since 1970, Directive 70/156/EEC has been the main legal instrument for implementing the single market in the motor vehicle sector. It has been amended many times in order to keep pace with this sector’s constant development. It therefore seemed appropriate to increase its clarity by recasting it. Doing so also provides an opportunity to extend the scope of the established principles to new categories of motor vehicles.

The first stage of the revision, Directive 2001/116/EC, put in place the technical provisions needed for the practical implementation of the type-approval of commercial vehicles. This Directive marks the second stage of the revision of Directive 70/156/EEC.

Key terms of the act
  • Step-by-step type-approval: a vehicle-approval procedure consisting in the step-by-step collection of the whole set of EC type-approval certificates for the systems, components and separate technical units relating to the vehicle, and which leads, at the final stage, to the approval of the whole vehicle.
  • Single-step type-approval: a procedure consisting in the approval of a vehicle as a whole by means of a single operation.
  • Mixed type-approval: a step-by-step type-approval procedure for which one or more system approvals are achieved during the final stage of the approval of the whole vehicle, without it being necessary to issue the EC type-approval certificates for those systems.

Reference

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

Directive 2007/46/EC

29.10.2007

29.4.2009

OJ L 263, 9.10.2007

Successive amendments and corrections to Directive 2007/46/EC have been incorporated in the basic text. This consolidated version is for reference purpose only.

LAST AMENDMENTS TO THE ANNEXES

Annex IV – List of requirements for the purpose of EC type-approval of vehicles
Commission Regulation (EU) No 183/2011 [Official Journal L 53 of 26.2.2011].

Annex VI
Commission Regulation (EU) No 183/2011 [Official Journal L 53 of 26.2.2011].

Support for electricity from renewable energy sources

Leave a reply

Support for electricity from renewable energy sources

Outline of the Community (European Union) legislation about Support for electricity from renewable energy sources

Topics

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

Energy > Renewable energy

Support for electricity from renewable energy sources

Document or Iniciative

Commission Communication of 7 December 2005 “The support of electricity from renewable energy sources” [COM(2005) 627 final – Official Journal C 49 of 28 February 2006].

Summary

This communication reports on the progress made in achieving the objectives set by the Member States in the field of renewable energies, as stipulated by the previous 2001 Directive. It focuses specifically on public support allocated to assist the market penetration of electricity produced from renewable energy sources (RES-E).

The existing support schemes cover the following:

  • feed-in tariffs exist in most of the Member States. These systems are characterised by a specific price, normally set for a period of around seven years, that must be paid by electricity companies, usually distributors, to domestic producers of green electricity;
  • the green certificate system, currently in force in Sweden, the United Kingdom, Italy, Belgium and Poland. RES-E is sold at the conventional market price. In order to finance the additional cost of producing green electricity, and to ensure that it is generated in sufficient quantities, all consumers are obliged to purchase a certain number of green certificates from RES-E producers according to a fixed percentage (quota) of their total electricity consumption/generation;
  • tendering systems exist in two Member States (Ireland and France). Under this procedure, the State issues a series of invitations to tender for the supply of RES-E, which will be sold at market price. The additional cost is passed on to the final consumer in the form of a special tax;
  • tax incentives used exclusively in Malta and Finland.

To assess the performance of these support schemes, it is necessary to:

  • take into account the substantial differences between the national, regional and agricultural resources of different Member States. The wider the gap between “generation costs” and “support”, the less the cost-efficient the system is;
  • take into account the effectiveness of the different support schemes. Effectiveness refers to the ability of a support scheme to deliver green electricity;
  • compare the profits from an investor perspective and compare effectiveness so as to indicate whether the success of a particular policy results above all from substantial financial incentives or whether there are other aspects that have had a crucial impact on market distribution in the countries in question.

The different forms of renewable energy affected by this support include:

  • wind energy, for which analyses show that support is too low for any take-off in a quarter of the Member States. Another quarter of Member States provide enough support but still obtain mediocre results. Feed-in tariffs are currently the most effective systems for wind energy in Germany, Denmark and Spain;
  • biomass forestry requires the use of straw, which is taken into account in analyses of biomass forestry. Denmark is the main country using this type of biomass. In close to half of all European countries, support for this form of renewable energy is still insufficient to develop this high potential sector;
  • the biogas sector is closely linked to environmental policy for waste treatment. In nearly 70% of cases not enough support is provided for the development of this technology;
  • the other renewable energy sources to benefit from this support are hydroelectricity and photovoltaic solar energy (especially in Germany). There are several other sources of renewable energy (geothermal, wave, tidal, solar thermal, etc) which, although they receive support in some Member States, have not yet been developed on an industrial scale.

Circulation of renewable energy on the internal market

These support schemes for RES-E cannot be separated from the internal electricity market. The compatibility of the different renewable energy support schemes with the development of the internal electricity market is essential in the medium and long term. Support for renewable sources of energy falls under the Community framework for State aid for environmental protection, whereas at the national level, the rules on State aid can influence the type of support scheme.

The Commission stresses that the market is dominated by one or several power companies that are too often vertically integrated. The existence of distribution and transport grid operators should guarantee all generators fair grid access, respecting the rules of competition. That is why the independence of these grid operators is vital to the proper functioning of the support schemes.

Governments must also ensure that consumers are informed of the way in which these support schemes for renewable energies affect consumers.

A distinction needs to be made between the physical trade in electricity and the green value of the electricity. RES-E is subject to the same restrictions as conventional electricity, including the mandatory disclosure system. This system makes it compulsory to inform consumers of the contribution of each energy source to the overall fuel mix.

The support covered by the Community framework for State aid for environmental protection may distort competition. These economic effects may however be justified and compensated for by the beneficial effects for the environment. Since the use of renewable energy sources is a priority for Community policy, the mentioned framework tends to favour support schemes. Some sixty support schemes for RES-E were already approved by the Commission during the period 2001 to 2004.

Towards a harmonisation of the rules?

Harmonisation between potential and actual development of renewable energies varies greatly among the Member States. In the short term, harmonisation seems unlikely. The Commission regards harmonisation of the rules in this sector as being desirable, as any changes to the system in the short term might disrupt some markets.

Achieving the potential benefits of harmonisation presupposes:

  • integration of renewable energies on the internal market, making the RES-E sector more competitive;
  • reduction of the forecast costs for RES-E to achieve its target share for 2010 on the basis of a harmonisation of systems such as green certificates and feed-in tariffs. These forecasts suppose the elimination of market distortions caused by support for conventional energy sources;
  • creation of a system of green certificates at the European level that would be more wide-ranging and therefore more liquid, making it possible to ensure greater price stability on national markets;
  • a common feed-in tariff system for the whole of Europe, bearing in mind the availability of resources at the local level. This could lower the cost of all RES technologies in the different Member States once installations are no longer reserved for only some of them.

Avoiding the potential disadvantages of harmonisation presupposes:

  • the absence of any significant fluctuation in the price of green certificates to avoid increasing investor uncertainty and holding back the development of RES;
  • costs linked to information on these technologies and keeping such costs low;
  • development of competitive technologies only, in the context of green certificates, as this system favours profitability above all else. Investment in other promising technologies would be insufficient.

Consideration must also be given to Member States that are importers of RES-E. There is a risk that they will not wish to pay the bill without also benefiting from the advantages at the local level to which they would have access if the renewable energy were being produced on their territory. In any case, the exporting countries may not wish to keep an excess capacity of RES if the public is opposed to building future RES installations on their territory.

Recommendations concerning administrative barriers and grid access

Such barriers appear when the project developers or investors disagree over the installation of new generation capacities or over grid access. The Commission has launched a public consultation into perceptions of these barriers and recommends that action be taken in relation to the following:

  • the large number of authorities involved (national, regional and local) and the lack of coordination between them leads to uncertainty in connection with investment. Single authorisation services should be set up;
  • it can take several years to obtain the necessary permits and this can completely freeze the development of the market. The Member States must set out clear guidelines and a precise division of responsibilities;
  • the insufficient attention given to RES in spatial planning, which must be improved by encouraging public authorities to anticipate future RES projects through the establishment of advance planning mechanisms. It is also important that the planning and authorisation process complies with European environmental legislation.

Grid access problems play a crucial role in the increase in RES-E generation. The Member States have largely put the necessary legislative provisions in place whereby grid operators guarantee transport and distribution. In the view of the Commission, transparent rules are required in order to meet and share out the necessary cost of investment in the grid, as the absence of such rules is the source of numerous difficulties.

Denmark, Finland, Germany and the Netherlands have established rules of good practice in relation to the sharing of the cost of the various investments that have to be made in the grid. Such good practice makes it possible to implement the “shallow” cost approach, under which grid connection costs are borne by project developments or shared with grid operators. These rules should be completely transparent and non-discriminatory.

The Commission stresses the necessity of developing grid infrastructure so as to be able to absorb the future increase in RES-E generation.

Lastly, the Commission recommends the establishment of a system to guarantee the origin of electricity generated from renewable energy sources in order to facilitate trade and ensure transparency for consumers.

Preference for a coordinated approach

In the view of the Commission, harmonisation is still at an experimental stage and it consequently advocates a coordinated approach to support schemes benefiting renewable energy sources, based on the following:

  • international cooperation which would certainly contribute to the development of the different support schemes in Europe, prior to undertaking partial harmonisation;
  • optimisation of national schemes that are indicative of the ineffectiveness of such systems, resulting in a rise in prices for consumers.

In order to optimise their national schemes, the Member States should take the following action:

  • consolidate the legislative framework and limit investment risks linked to the intermittent nature of national support schemes. The system must appear stable and financially viable in the long term in the eyes of economic operators in order to contribute to greater transparency in market prices;
  • encourage technological diversity even if RES technology appears to be the most competitive at present. Better use should be made of exemptions and tax reductions offered to renewable energy sources;
  • ensure compatibility with the internal electricity market with a view to integrating these support schemes in a liberalised energy market;
  • encourage employment and local and regional benefits;
  • work in unison with national energy efficiency and demand management schemes so as to avoid cancelling out the progress achieved by RES-E with an excessive increase in consumption.

Background

The Commission will closely monitor developments concerning European renewable energy policy. It will draw up a report by the end of 2007 at the latest on the levels envisaged by the national systems for promoting electricity from renewable energy sources. It will report on the drive towards the completion of the internal electricity market and further analyse the options for and the impact of possible harmonisation.

Related Acts

of the European Parliament and of the Council of 27 September 2001 on the promotion of electricity produced from renewable energy sources in the internal electricity market [OJ L 283 of 27.10.2001]

 

Technical standards: tyre pressure gauges for motor vehicles

Leave a reply

Technical standards: tyre pressure gauges for motor vehicles

Outline of the Community (European Union) legislation about Technical standards: tyre pressure gauges for motor vehicles

Topics

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

Internal market > Motor vehicles > Technical harmonisation for motor vehicles

Technical standards: tyre pressure gauges for motor vehicles (until December 2015)

Document or Iniciative

Council Directive 86/217/EEC of 26 May 1986 on the approximation of the laws of the Member States relating to tyre pressure gauges for motor vehicles.

Summary

This Directive applies to pressure gauges intended to measure the inflation pressure of motor vehicle tyres.

To obtain an EC mark, pressure gauges are subject to EC pattern-approval and verification. Requirements that they must satisfy include:

  • the metrological characteristics specified in paragraph 2 of the annex;
  • robust and careful construction to maintain their metrological characteristics;
  • guaranteed direct and accurate reading of pressure measured;
  • the dial must specify the symbol for the quantity measured and the symbol for the unit of measurement.

More detail can be found in the technical annex.

Member States may not refuse, prohibit or restrict the marketing and use of tyre pressure gauges for reasons connected with their metrological characteristics if they bear the EC pattern-approval and verification marks.

This Directive will be repealed by Directive 2011/17/EU on 1 December 2015.

References

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

Directive 86/217/EEC

30.05.1986

30.11.1987

OJ L 152, 6.6.1986

Tackling tax obstacles to the cross-border provision of occupational pensions

Leave a reply

Tackling tax obstacles to the cross-border provision of occupational pensions

Outline of the Community (European Union) legislation about Tackling tax obstacles to the cross-border provision of occupational pensions

Topics

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

Internal market > Single market for capital

Tackling tax obstacles to the cross-border provision of occupational pensions

Document or Iniciative

Communication from the Commission to the Council, to the European Parliament and to the European Economic and Social Committee, of 19 April 2001, entitled, “The elimination of tax obstacles to the cross-border provision of occupational pensions” [COM(2001) 214 final – Not published in the Official Journal].

Summary

Through this communication the Commission:

  • seeks a coordinated approach adapted to the diversity of Member States’ rules rather than attempting to achieve harmonisation;
  • calls for the elimination of unduly restrictive or discriminatory tax rules;
  • presents measures to safeguard Member States’ tax revenues.

To do this, the Commission proposes to monitor Member States’ national rules in this field and take the necessary steps to ensure their compliance with the EC Treaty, in particular with the rules on non-discrimination. It reserves the right to initiate legal action against any Member State failing to comply with the rules.

The Commission also proposes adopting measures to maintain the tax revenues of Member States for the cross-border provision of pensions. It further proposes a coordinated approach to eliminating the tax obstacles, in particular double taxation, which result from the different taxation systems for occupational pensions in the Member States.

Application of the EC Treaty rules

The Commission notes that the EC Treaty rules on the free movement of capital, labour and services must be applied in the area of cross-border pension provision. Member States are consequently required to eliminate all discrimination against occupational schemes established in other Member States.

Discrimination means privileged treatment of domestic schemes, in particular more favourable rules on deductibility of contributions or taxation of benefits.

The Commission accordingly intends to examine the compliance of the relevant national rules with the fundamental freedoms of the EC Treaty and, where necessary, to bring cases before the Court of Justice so as to allow the emergence of a fully functioning single market for occupational pensions.

Exchange of information

A Community legislative framework for information exchange already exists, in particular under the Directive on mutual assistance between Member States in the field of direct taxation. In the interests of better coordination between Member States on the collection of taxes applicable to cross-border pensions, the Commission recommends that Member States agree on an automatic exchange of information on occupational pensions.

The Council has already decided upon the principle of automatic information exchange in the area of taxation of savings income. The extension of that principle to pensions will help prevent distortions by ensuring the same level of information exchange for comparable products.

Mismatch of tax systems

Different Member States have different rules in terms of whether they tax or exempt pension contributions, investment income and capital gains of the pension institution, and pension benefits. These differences can create problems where employees spend their working careers in one Member State but retire to another. Pensions are sometimes taxed, for example, even though the contributions are not tax deductible or the pension is not taxed even though the contributions are deductible.

Concerning problems of double taxation and non-taxation arising from the mismatch of tax systems, the Commission recommends wider application of the “EET system” (Exempt contributions, Exempt investment income and capital gains of the pension institution, Taxed benefits) already applied in eleven Member States, entailing the deductibility of pension contributions and investment income coupled with the taxation of benefits, together with better coordination of Member States’ taxation rules.

The Commission acknowledges that completely uniform rules for occupational pensions will not be easy to achieve while the reliance on social security and occupational pension schemes varies so significantly from one Member State to another.

The Commission therefore explores how double taxation and double non-taxation problems can be addressed by better coordination of Member States’ taxation rules.

Solutions could include unilateral tax relief, bilateral agreements or a multilateral convention or coordinating measures at European Union level.

Background

Pensions are an issue of universal concern: for individual citizens who want adequate provision for their retirement; for employers who seek cost-effective pension provision for their employees and for governments who, throughout the Union, are seeking to maintain adequate pension provision in the face of ageing populations.

The potential benefits of better cross-border pension provision are substantial. At present citizens who take up employment or residence outside their home State are often unable to remain in their existing occupational pension schemes. The number of European citizens aged 15 years and over residing in a Member State other than their Member State of origin is increasing, and enlargement of the Union will contribute further to this trend. Impediments to cross-border pension provision may also prevent European businesses from choosing the most efficient way of providing pensions for their employees by centralising their pension provision.

At the Stockholm European Council of 23 and 24 March 2001, as part of the new strategy to open up pan-European labour markets, the Commission promised an initiative in the tax field to complement the Directive on occupational retirement provision that would facilitate cross-border pension provision and investment.

 

Deliberate release of genetically modified organisms

Leave a reply

Deliberate release of genetically modified organisms

Outline of the Community (European Union) legislation about Deliberate release of genetically modified organisms

Topics

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

Food safety > Specific themes

Deliberate release of genetically modified organisms (GMOs)

Document or Iniciative

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. [See amending act(s)].

Summary

The main aim of this Directive is to make the procedure for granting consent for the deliberate release and placing on the market of genetically modified organisms (GMOs) more efficient and more transparent, to limit such consent to a period of ten years (renewable) and to introduce compulsory monitoring after GMOs have been placed on the market.

It also provides for a common methodology to assess case-by-case the risks for the environment associated with the release of GMOs (the principles applying to environmental risk assessment are set out in Annex II to the Directive), common objectives for the monitoring of GMOs after their deliberate release or placing on the market, and a mechanism allowing the release of the GMOs to be modified, suspended or terminated where new information becomes available on the risks of such release.

Public consultation and GMO labelling are made compulsory under the new Directive. The system of exchange of information contained in notifications, set up under Directive 90/220/EEC, is maintained. The Commission is obliged to consult the competent scientific committees on any question which may affect human health and/or the environment. It may also consult ethical committees. The Directive requires registers to be established for the purpose of recording information on genetic modifications in GMOs and on the location of GMOs. Rules on the operation of these registers are laid down in Decision 2004/204/EC (see related acts).

Every three years, the Commission must publish a summary of the measures taken in the Member States to implement the Directive, and a report on experience with GMOs placed on the market. This report should include a separate chapter on the socio-economic advantages and disadvantages of each type of GMO authorised to be placed on the market, taking due account of the interests of farmers and consumers (the first report was due to be published in 2003). An annual report on ethical issues will also be published. The Directive invited the Commission to present a proposal for implementing the Cartagena Protocol on biosafety, which led to the adoption of Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms.

Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms will be repealed by the present Directive from 17 October 2002.

References

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

Directive 2001/18/EC

17.4.2001

17.10.2002

OJ L 106 of 17.4.2001
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1829/2003

07.11.2003

–

OJ L 268 of 18.10.2003

Regulation (EC) No 1830/2003

07.11.2003

–

OJ L 268 of 18.10.2003

Directive 2008/27/EC

21.3.2008

–

OJ L 81 of 20.3.2008

The successive amendments and corrections to Directive 2001/18/EC have been incorporated into the basic text. This consolidated version  is for information only.

Related Acts

GMOs placed on the market in accordance with Directive 2001/18/EC
Decision 2010/135/EU – potato product EH92-527-1 [Official Journal L 53 of 4.3.2010];
Decision 2009/244/EC – carnation 123.8.12 [Official Journal L 72 of 18.3.2009];
Decision 2007/364/EC – carnation 123.2.38 [Official Journal L 138 of 30.5.2007];
Decision 2007/232/EC – oilseed rape products Ms8, Rf3 and Ms8xRf3 [Official Journal L 100 of 17.4.2007];
Decision 2006/47/EC – maize product MON863 x MON810 [Official Journal L 26 of 31.1.2006];
Decision 2005/772/EC – maize product 1507 [Official Journal L 291 of 5.11.2005].
Decision 2005/635/EC – oilseed rape product GT73 [Official Journal L 228 of 3.9.2005];
Decision 2005/608/EC – maize product MON 863 [Official Journal L 207 of 10.8.2005];
Decision 2004/643/EC – maize product NK603 [Official Journal L 295 of 18.9.2004].

Information gathering and dissemination

Commission Decision 2005/463/EC of 21 June 2005 establishing a network group for the exchange and coordination of information concerning coexistence of genetically modified, conventional and organic crops [Official Journal L 164 of 24.6.2005].

Commission Decision 2004/204/EC of 23 February 2004 laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council [Official Journal L 65 of 3.3.2004].
Pursuant to Directive 2001/18/EC, the Commission must establish one or more registers recording information on genetic modifications in GMOs. The Decision specifies that the registers will contain information accessible to the public, and information accessible only to the Member States, the Commission and the European Food Safety Authority. The information which must be recorded includes:

  • detailed information on the person responsible for the deliberate release or the placing on the market;
  • general information concerning the GMO(s) (the commercial and scientific names, the Member State concerned, the decision to authorise the GMO, etc.);
  • information on the DNA inserted into the GMO;
  • information on detection and identification tools;
  • information on the lodging, storage and supply of samples.

Commission Decision 2003/701/EC of 29 September 2003 establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market Official Journal L 254 of 8.10.2003.

Summary notification format

Council Decision 2002/813/EC of 3 October 2002 establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market Official Journal L 280 of 18.10.2002.

Council Decision 2002/812/EC of 3 October 2002 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products Official Journal L 280 of 18.10.2002.

Explanatory notes on the annexes

Council Decision 2002/811/EC of 3 October 2002 establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC Official Journal L 280 of 18.10.2002.

Commission Decision 2002/623/EC of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC Official Journal L 200 of 30.7.2002.

Reports

Second report from the Commission to the Council and the European Parliament of 5 March 2007 on the experience of Member States with GMOs placed on the market under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms [COM(2007) 81 final – Not published in the Official Journal].
Between October 2002 and October 2005, 13 applications to place genetically modified plants on the market were submitted in 8 Member States and led to the authorisation of 5 products:

  • NK603 maize from Monsanto Europe S.A;
  • MON863 maize from Monsanto Europe S.A;
  • GT73 oilseed rape from Monsanto Europe S.A;
  • 1507 maize from Pioneer Hi-Bred International INC and Mycogen Seeds;
  • MON863 x MON810 maize from Monsanto Europe S.A.

Moreover, in the same period, 245 applications for the release of GMOs for purposes other than for placing on the market (e.g. for research purposes) submitted to 13 Member States led to 191 authorisations (with 23 applications pending in October 2005).
Those Member States which have handled applications are generally positive about their experience with the implementation of the Directive, despite a number of technical issues which have yet to be adequately addressed. Other stakeholders have tended to be less positive in their assessment of the Directive. Some Member States have called for more guidance on specific aspects of environmental risk assessment and increased harmonisation of the process of release for research purposes. The majority of Member States has emphasised the need for a legal instrument establishing seeds’ thresholds.

Report from the Commission to the Council and the European Parliament of 31 August 2004 on the experience of Member States with GMOs placed on the market under Directive 2001/18/EC and incorporating a specific report on the operation of parts B and C of the Directive [COM(2004) 575 – not published in the Official Journal].
This report concerns only 15 Member States as the reference period for this report ended before the accession of the new Member States (1 May 2004). The vast majority of GMOs that have been developed for deliberate release are transgenic crop plants, modified for tolerance to certain herbicides or resistance to certain insect pests. Despite the fairly limited experience gained since this Directive entered into force, the report stresses that the Directive and the relevant Regulations (see below) help to increase confidence in the legislative framework and to increase the predictability of the decision-making process.