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Organ donation and transplantation in the European Union

Outline of the Community (European Union) legislation about Organ donation and transplantation in the European Union

Topics

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

Public health > Threats to health

Organ donation and transplantation in the European Union

Organ transplantation remains essential for the treatment of certain diseases. However, several factors must be taken into consideration where this therapeutic method is concerned: the risk of transmission of disease, the limited supply of organs and organ trafficking. This communication therefore aims to present the various potential options to ensure the quality and safety of organs, increase their availability and combat organ trafficking.

Document or Iniciative

Communication from the Commission to the Council and the European Parliament of 30 May 2007 entitled “Organ donation and transplantation: Policy actions at EU level” [COM(2007) 275 final – Not published in the Official Journal].

Summary

During the past decades, organ transplantation has increased and become widespread. It is a form of treatment that is indispensable for certain diseases, and the results in terms of life years gained and improvement in quality of life are often positive.

Nonetheless, organ donation and transplantation are sensitive topics, dealt with differently throughout the EU in accordance with the cultural values and legal, administrative and organisational issues of each Member State.

Moreover, these topics present three major obstacles that the Commission intends to deal with. These are the risk of transmission of disease, the limited supply of organs and organ trafficking.

The Commission therefore plans measures to improve the quality and safety of organs, increase their availability in the EU and combat organ trafficking.

Improving quality and safety

HIV, hepatitis B and C, bacteria, fungi, parasites and various types of cancer can be transmitted when an organ is transplanted. The transmission of disease by a donor organ can result in the death of the recipient.

It is therefore essential that measures be introduced into every stage of the transplant process in order to improve the quality and safety of organs. A risk-benefit analysis must be carried out so that the organs can be allocated to suitable recipients.

This entails defining the risks to which the recipient is exposed in view of his/her characteristics and the profile of the donor, and determining the consequences of not performing transplantation. Following this analysis, a rational decision will be taken concerning the transplantation.

There is also a need for effective transportation of organs to avoid their deterioration. While maintaining medical confidentiality, the organ container must be labelled and contain the necessary documentation.

It is important to ensure traceability from the donor to the recipient. Any transplantation system must also be able to highlight unexpected complications and detect serious or unexpected adverse events.

Given that an organ donor is often also a tissue donor, the quality and safety requirements for organs will be associated with the existing community system for tissues and cells.

It is essential to set up systems for the authorisation of establishments and programmes of organ donation based on common quality and safety criteria.

However, the legislation concerning quality and safety differs from one Member State to another. A high level of protection for patients must therefore be ensured throughout the EU.

Increasing the availability of organs

The Member States are facing a serious shortage of organ donors on the one hand and an increase in the demand for organs on the other.

Rates of donors differ from one Member State to another. These differences may stem from cultural, social and historical factors in each country, and the organisational characteristics of the donation system and certain aspects of their health service.

Furthermore, families are not always made aware of the possibility of making a donation, and many potential donors are lost because they are not registered as such. The establishment of an effective system making it possible to find people who can become donors after their death thus remains essential to increase the rate of donations. This system must ensure that the organs of people who wish to become donors will really be available.

Training and employing health professionals involved in organising the donation process and identifying people who could become donors after their death has resulted in an increase in organ donations in several Member States.

Another method of increasing the number of donors is to encourage donations from living donors. These have increased in recent years, particularly because the risk to donors is low and the results of the transplants have been positive.

Donors who are not ideal because of disease and a history of malignancy (“marginal donors”) can also be taken into consideration under certain circumstances.

Raising public awareness also has a role to play in increasing donations. Society still does not take a positive view of organ donations, and some families refuse to donate the organs of deceased relatives. However, messages can influence individuals’ decisions. Effective communication therefore needs to be established. The help of communication experts is important here, and the media and health professionals need to have a better knowledge of transplantation issues.

Another way of raising public awareness is the use of a European donor card stating whether the holder wishes to donate his/her organs or not.

Fighting organ trafficking

Criminal organisations have recognised the lucrative opportunity presented by the gap between the supply of and demand for organs. As a consequence, such organisations may induce poor people to sell their organs.

Several international and Community legal instruments condemn and outlaw organ trafficking, such as the European Charter on Fundamental Rights and the Oviedo Treaty on Human Rights and Biomedicine and its Additional Protocol on the Transplantation of Organs and Tissues of Human Origin.

The Commission makes frequent reference to these instruments.

Follow-up actions

The Commission aims to make transplantation systems more efficient and more accessible. It is therefore necessary to identify the most efficient systems at EU level, promote best practice and help countries with less-developed systems to improve these.

It will also encourage the Member States to work together on establishing efficient systems aimed at identifying individuals who can become donors after their death, promoting training for professionals, encouraging donations from living donors and evaluating the use of organs from “marginal donors”.

The Commission proposes two mechanisms for action: an action plan on strengthened cooperation between Member States and a legal instrument on quality and safety of organ donation and transplantation.

The action plan will enable countries to increase organ donations and to provide fair access to transplantation, as well as exchanging expertise to improve organisational aspects.

As far as the legal instrument is concerned, a European directive setting standards of quality and safety for organs could be adopted. This instrument could, among other things, include quality and safety standards for the authorisation of establishments and programmes of organ donation, ensure a complete characterisation of the organ and establish authorisation structures.

Related Acts

Proposal for a Directive of the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation [ – Not published in the Official Journal].

This Proposal for a Directive on standards of quality and safety of human organs intended for transplantation lays down rules aiming to ensure high standards of quality and safety for organs intended for transplantation into the human body.

It applies to the:

donation;
procurement;
testing;
characterisation;
preservation;
transport;
and transplantation of organs.

To achieve that objective, the Proposal plans to rely on national quality programmes which ensure the traceability of organs at each stage in the chain from donation to transplantation or disposal.

Member States shall ensure that procurement of organs takes place in specialised procurement organisations and facilities. All organs must be characterised before transplantation.

Member States shall also attend to the conditions of transport of organs, ensuring traceability from donor to recipient. Their responsibility shall also extend to the personnel and the systems for the reporting of serious adverse effects and reactions.

It is also reiterated that organ donation must be voluntary and unpaid. Member States must provide donors with all the information necessary while guaranteeing their right to anonymity.

Member States shall designate the relevant competent authorities. The latter shall be responsible in particular for controlling the procurement organisations or transplantation centres and for supervising the exchanges of organs with other countries.

Codecision procedure ()

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [Official Journal L 102, 07.04.2004].

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC [Official Journal L 33, 08.02.2003].

Orphan medicinal products

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Orphan medicinal products

Outline of the Community (European Union) legislation about Orphan medicinal products

Topics

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

Internal market > Pharmaceutical and cosmetic products

Orphan medicinal products

Document or Iniciative

European Parliament and Council Regulation (EC) No 141/2000 of 16 December 1999 on orphan medicinal products [See amending act(s)].

Summary

As a result of the high cost of research and development, the pharmaceuticals industry is reluctant to develop medicinal products intended for the treatment of rare conditions, as well as those called ‘orphan medicinal products’, for which the market is smaller. The aim of this Regulation is to establish a Community procedure for designating orphan medicinal products and to introduce incentives for orphan medicinal products research, development and marketing, for example by granting exclusive marketing rights for a ten-year period.

Orphan medicinal product: criteria for designation

A medicinal product must be designated an orphan medicinal product:

if it is intended for the diagnosis, prevention or treatment of a condition affecting no more than five per ten thousand persons in the Community;
if it is intended for treating a serious or debilitating disease and it is unlikely that without incentives marketing it would generate sufficient return to justify the necessary investment.

Committee for Orphan Medicinal Products

A ‘Committee for Orphan Medicinal Products’, set up within the European Medicines Agency, is responsible for assessing the applications for a medicinal product to be designated an orphan medicinal product and to deliver an opinion to the Commission which makes the decision concerning the designation of a medicinal product as an orphan medicinal product. The Regulation gives the sponsor of the medicinal product the possibility of appealing against the Committee’s opinion. Medicinal products designated as orphan medicinal products are entered on the ‘Community Register of Orphan Medicinal Products’.

Marketing authorisation procedure

Orphan medicinal products are mandatorily subject to the ‘centralised’ marketing authorisation procedure provided for in Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use. The sponsor of an orphan medicinal product can be exempted from payment of the fees payable to the European Medicines Agency.

Exclusive marketing rights

Where marketing authorisation is granted in respect of an orphan medicinal product, the latter will enjoy, with certain exceptions and limitations, exclusive marketing rights for a ten-year period. However, at the request of a Member State, this period can be reduced to six years if that Member State can establish that the conditions justifying the designation as an orphan medicinal product are no longer met or that the price being charged for the medicinal product in question is excessive.

Other incentives

Orphan medicinal products can be eligible for further incentives made available by the Commission and the Member States to support the research, development and availability of orphan medicinal products. More particularly, the measures aid research in favour of small and medium sized enterprises. Member States must inform the Commission of measures taken to this end. The Commission must publish a regular inventory detailing the incentives introduced by the Community and the Member States.

Committee

The Commission shall be assisted by the Permanent Committee for Medicinal Products for Human Use established by Directive 2001/83/EC.

References

Act	Entry into force – Date of expiry	Deadline for transposition in the Member States	Official Journal
Regulation EC No 141/2000	22.1.2000	–	OJ L 18 of 22.1.2000

Amending act(s)	Entry into force – Date of expiry	Deadline for transposition in the Member States	Official Journal
Regulation EC No 596/2009	7.8.2009	–	OJ L 188 of 18.7.2009

The successive amendments and corrections to Regulation (EC) No 141/2000 have been incorporated in the original text. This consolidated version is of documentary value only.

Related Acts

of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance) [Official Journal L 136 of 30.04.2004].

This Regulation amends, improves and replaces Regulation (EEC) No 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products.

Commission Regulation (EC) No 847/2000 of 27 April 2000, laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’ [Official Journal L 103 of 28.04.2000].

Organised crime: Exchange of DNA analysis results

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Organised crime: Exchange of DNA analysis results

Outline of the Community (European Union) legislation about Organised crime: Exchange of DNA analysis results

Topics

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

Other

Organised crime: Exchange of DNA analysis results

1) Objective

To enable the results of DNA analyses carried out by Member States in the course of criminal investigations to be exchanged.

2) Union Measure

Council resolution of 9 June 1997 on the exchange of DNA analysis results.

3) Contents

To enable such results to be exchanged, Member States will have to establish compatible national DNA databases. The exchanged data will concern the non-coding part of the DNA molecule. In setting up computer systems for DNA analysis results, account will be taken of the study carried out by the DNA Working Party of the International Criminal Police Organisation (ICPO-Interpol).

From a technical point of view, the choice of the standard to be used will be determined on the basis of studies. Member States should preferably build up DNA analysis results using the same DNA markers.

From a legal standpoint, it will be for each Member State to decide under what conditions and for what offences DNA analysis results will be stored in its database. Safeguards will be introduced to ensure the physical integrity of DNA-tested individuals and the protection of personal data.

The creation of a network of national databases will be preceded by an in-depth study aimed at guaranteeing the security and protection of personal data. The exchange of information will be restricted to DNA analysis results which, when compared, can indicate whether a person already appears in a file and whether that person can be connected with traces found at the scene of a crime. In the long term, there are plans to set up a European DNA database.

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

Not applicable

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

Not applicable

6) References

Official Journal C 193, 24.6.97

7) Follow-Up Work

Council Resolution of 25 June 2001 on the exchange of DNA analysis results [Official Journal C 187, 03.07.2001.]
This Resolution provides definitions of a number of key terms such as “DNA marker”, “DNA analysis result”, “European standard set”, “ESS (European standard set) marker” and “ESS analysis result”.
The results of ESS analyses will be recorded using scientific techniques based on the studies conducted by the European Network of Forensic Science Institutes (ENFSI).
The following are included in annexes to the Resolution:

A list of DNA markers to be used by the Member States for analyses for legal purposes;
The form which is to be used to exchange results between Member States.

The provisions laid down in the Resolution shall apply without prejudice to any bilateral agreements on the use of specific DNA markers which may exist between Member States.

8) Implementing Measures

Organically grown agricultural products and foodstuffs

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Organically grown agricultural products and foodstuffs

Outline of the Community (European Union) legislation about Organically grown agricultural products and foodstuffs

Topics

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

Other

Organically grown agricultural products and foodstuffs

The Regulation establishes a harmonised framework for the production, labelling and inspection of agricultural products and foodstuffs in order to increase consumer confidence in such products and ensure fair competition between producers.

Document or Iniciative

Council Regulation (EEC) No 2092/91 of 24 June 1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs [See amending acts].

Summary

This Regulation describes the legal framework for agricultural products and foodstuffs obtained organically.

Scope

This Regulation applies to the following products, where they bear or are intended to bear indications referring to organic production:

non-processed agricultural crop and livestock products;
farmed livestock;
agricultural crop and livestock products intended for human consumption, processed and constituted mainly from one or more agricultural crop or livestock ingredients;
animal feeds, compound feedingstuffs for animals and raw materials for animal feed that meet the conditions laid down in Regulation (EC) No 223/2003.

Pet foods, feed for animals raised for their fur and feed for use in aquaculture are not covered by this Regulation.

Rules of production

A product, its ingredients or raw materials for animal feed are considered to bear indications referring to organic production if the labelling, advertising or trade documents for them describe them by means of the indications used in the Member State concerned, thus suggesting to purchasers that they have been obtained in accordance with the rules of production set out in the Regulation.

Annex I to the Regulation specifies the principles of organic production for plants, livestock (cattle, pigs, sheep, goats, horses and poultry) and bees, and all products thereof. It sets out criteria for the management of certain key aspects of farming those animals, in particular the choice of breeds, feed and veterinary treatment in accordance with the principles of organic production. Annex II explains which substances may be used as pesticides, soil fertilisers, feed and detergents for animals, along with any exceptions. The Regulation also establishes the conditions for expanding the lists of permitted substances.

The Regulation states that organic production may be referred to only where the product in question has been obtained and tested in accordance with the rules established therein, and in particular that it contains only substances listed in the Annexes, has not been subjected to treatments involving the use of ionising radiation and has not been made using genetically modified organisms (GMOs) or products derived from these organisms, as this would be incompatible with organic production (Regulation (EC) No 1804/1999).

Inspection and indications of conformity

In order to guarantee respect for the rules of production, the Regulation provides for an inspection system to ensure that operators who produce, prepare or store organic products or import them from third countries notify the competent private and public authorities in the Member States of their activities. These inspection authorities must, at the very least, ensure application of the minimum inspection and precautionary measures laid down in Annex III to the Regulation. For the production of meat, the Regulation states that the Member States must guarantee the traceability of products throughout the production, processing and preparation chain.

Annex V to the Regulation lists the indications showing that a product is covered by the inspection scheme implemented by that Regulation. It also shows the various versions of the Community organic farming logo which may be combined with those indications. Under the new legal framework which will soon be implemented this logo will have to be used on all organic products. It may be accompanied by national and private logos.

The Regulation also provides for a system to ensure that products imported from third countries have been produced and marketed under production and inspection conditions equivalent to those applicable to Community products. These third countries are entered in a list laid down by a Commission Decision.

The Member States may not prohibit or restrict the sale of products that meet the provisions of the Regulation.

Implementation

In implementing the Regulation the Commission is assisted by a regulatory committee made up of representatives of the Member States and chaired by a representative of the Commission.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EEC) No 2092/91	22.7.1991	–	OJ L198, 22.7.1991

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EEC) No 2083/92	24.7.1992	–	OJ L 208, 24.7.1992
Regulation (EEC) No 3713/92	1.1.1993	–	OJ L 378, 23.12.1992
Regulation (EC) No 1468/94	28.6.1994	–	OJ L 159, 28.6.1994
Regulation (EC) No 529/95	1.3.1995	–	OJ L 54, 10.3.1995
Regulation (EC) No 1935/95	12.8.1995	–	OJ L 186, 5.8.1995
Regulation (EC) No 1804/99	24.8.1999	–	OJ L 222, 24.8.1999
Regulation (EC) No 806/2003	5.6.2003	–	OJ L 122, 16.5.2003
Regulation (EC) No 223/2003	26.2.2003	–	OJ L 3, 6.2.2003
Regulation (EC) No 392/2004	10.3.2004	–	OJ L 65, 3.3.2004
Regulation (EC) No 746/2004	24.4.2004	–	OJ L 122, 26.4.2004
Regulation (EC) No 1567/2005	6.10.2005	–	OJ L 252, 28.9.2005
Regulation (EC) No 1791/2006	1.1.2007	–	OJ L 363, 20.12.2006
Regulation (EC) No 1991/2006	6.1.2007	–	OJ L 411, 30.12.2006
Regulation (EC) No 1997/2006	4.1.2007	–	OJ L 379, 28.12.2006

AMENDMENT OF ANNEXES

Annex I – Principles of organic production at farm level:

Regulation (EEC) No 1535/92 [Official Journal L 162 of 16.6.1992];
Regulation (EEC) No 2608/93 [Official Journal L 239 of 24.9.1993];
Regulation (EC) No 1202/95 [Official Journal L 119 of 30.5.1995];
Regulation (EC) No 1900/98 [Official Journal L 247 of 5.9.1998];
Regulation (EC) No 1804/1999 [Official Journal L 222 of 24.8.1999];
Regulation (EC) No 1073/2000 [Official Journal L 119 of 20.5.2000];
Regulation (EC) No 473/2002 [Official Journal L 75 of 15.3.2002];
Regulation (EC) No 223/2003 [Official Journal L 31 of 6.2.2003];
Regulation (EC) No 599/2003 [Official Journal L 85 of 2.4.2003];
Regulation (EC) No 2277/2003 [Official Journal L 336 of 23.12.2003];
Regulation (EC) No 2254/2004 [Official Journal L 385 of 29.12.2004];
Regulation (EC) No 1294/2005 [Official Journal L 205 of 6.8.2005];
Regulation (EC) No 699/2006 [Official Journal L 121 of 6.5.2006];
Regulation (EC) No 1851/2006 [Official Journal L 355 of 15.12.2006];
Regulation (EC) No 394/2007 [Official Journal L 98 of 13.4.2007];
Regulation (EC) No 1319/2007 [Official Journal L 293 of 10.11.2007].

Annex II – Products authorised for use in soil conditioning and fertilisation:

Regulation (EEC) No 1535/92 [Official Journal L 162 of 16.6.1992];
Regulation (EEC) No 2608/93 [Official Journal L 239 of 24.9.1993];
Regulation (EC) No 2381/94 [Official Journal L 255 of 1.10.1994];
Regulation (EC) No 1488/97 [Official Journal L 202 of 30.7.1997];
Regulation (EC) No 1804/1999 [Official Journal L 222 of 24.8.1999];
Regulation (EC) No 1073/2000 [Official Journal L 119 of 20.5.2000];
Regulation (EC) No 436/2001 [Official Journal L 63 of 3.3.2001];
Regulation (EC) No 473/2002 [Official Journal L 75 of 15.3.2002];
Regulation (EC) No 599/2003 [Official Journal L 85 of 2.4.2003];
Regulation (EC) No 2277/2003 [Official Journal L 336 of 23.12.2003];
Regulation (EC) No 1318/2005 [Official Journal L 210 of 12.8.2005];
Regulation (EC) No 1916/2005 [Official Journal L 307 of 25.11.2005];
Regulation (EC) No 592/2006 [Official Journal L 104 of 13.4.2006];
Regulation (EC) No 807/2007 [Official Journal L 181 of 11.7.2007];
Regulation (EC) No 404/2008 [Official Journal L 120 of 7.5.2008].

Annex III – Minimum inspection requirements and precautionary measures:

Regulation (EEC) No 1535/92 [Official Journal L 162, 16.6.1992];
Regulation (EEC) No 2608/93 [Official Journal L 239, 24.9.1993];
Regulation (EC) No 1202/95 [Official Journal L 119 of 30.5.1995];
Regulation (EC) No 1804/1999 [Official Journal L 222 of 24.8.1999];
Regulation (EC) No 2491/2001 [Official Journal L 337 of 20.12.2001];
Regulation (EC) No 223/2003 [Official Journal L 31 of 6.2.2003];
Regulation (EC) No 2277/2003 [Official Journal L 336 of 23.12.2003];
Regulation (EC) No 1336/2005 [Official Journal L 211 of 13.8.2005];
Regulation (EC) No 1991/2006 [Official Journal L 411 of 30.12.2006];
Regulation (EC) No 1997/2006 [Official Journal L 379 of 28.12.2006];
Regulation (EC) No 1517/2007 [Official Journal L 335 of 20.12.2007].

Annex V – Indication that products are covered by the inspection scheme:Â

Regulation (EC) No 331/2000 [Official Journal L 48 of 19.2.2000];
Regulation (EC) No 746/2004 [Official Journal L 122 of 26.4.2004];
Regulation (EC) No 1481/2004 [Official Journal L 272 of 20.8.2004];
Regulation (EC) No 1791/2006 [Official Journal L 363 of 20.12.2006].

Annex VI – Ingredients of agricultural and non-agricultural origin which may be used in preparation:Â

Regulation (EEC) No 207/93 [Official Journal L 25, 2.2.1993];
Regulation (EC) No 468/94 [Official Journal L 59 of 3.3.1994];
Regulation (EC) No 1201/95 [Official Journal L 119 of 30.5.1995];
Regulation (EC) No 418/96 [Official Journal L 59 of 8.3.1996];
Regulation (EC) No 1488/97 [Official Journal L 202 of 30.7.1997];
Regulation (EC) No 330/1999 [Official Journal L 40 of 13.2.1999];
Regulation (EC) No 1804/1999 [Official Journal L 222 of 24.8.1999];
Regulation (EC) No 1073/2000 [Official Journal L 119 of 20.5.2000];
Regulation (EC) No 1437/2000 [Official Journal L 161 of 1.7.2000];
Regulation (EC) No 2020/2000 [Official Journal L 241 of 26.9.2000];
Regulation (EC) No 473/2002 [Official Journal L 75 of 15.3.2002];
Regulation (EC) No 1481/2004 [Official Journal L 272 of 20.8.2004];
Regulation (EC) No 780/2006 [Official Journal L 137 of 25.5.2006];
Regulation (EC) No 123/2008 [Official Journal L 38 of 13.2.2008].

Annex VII – Maximum number of animals per hectare:

Regulation (EC) No 1804/1999 [Official Journal L 222 of 24.8.1999].

Annex VIII – Characteristics of housing for the different species:

Regulation (EC) No 1804/1999 [Official Journal L 222 of 24.8.1999].

Successive amendments and corrections to Regulation (EEC) No 2092/91 have been incorporated in the basic text. This consolidated version (pdf ) is for reference purposes only.

Related Acts

New legal framework:

Council Regulation (EC) No 834/2007Â (FR)of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) NoÂ [Official Journal L 189 of 20.7.2007].Â
This Regulation establishes a new legal framework for organic products. It lays down the objectives and principles applicable to this type of production and illustrates the rules on production, labelling, inspection and trade with third countries. The new Regulation will apply from 1 January 2009.

Use of non-organic agricultural ingredients:

Regulation (EC) No 207/93 [Official Journal L 25 of 2.2.1993].

This Commission Regulation of 29 January 1993 specifies certain ingredients which may be contained in organic products (particularly ingredients of non-agricultural origin and ingredients of agricultural origin which are not produced organically in sufficient quantity in the Community) and products which may be used for the processing of ingredients of agricultural origin obtained by organic production.
Successive amendments and corrections have been incorporated in the basic text. This consolidated version (pdf ) is for reference purposes only.

Imports from third countries (implementing rules):

Regulation (EC) No 3457/92 [Official Journal L 350 of 1.12.1992].

Commission Regulation of 30 November 1992 laying down detailed rules concerning the inspection certificate for imports from third countries into the Community provided for in Regulation NoÂ 2092/91/EECÂ on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs.

Regulation (EC) No 529/95 [Official Journal L 54 of 10.3.1995].
Commission Regulation of 9 March 1995 deferring for imports from certain third countries the date of application of Article 11(1) of Council Regulation (EEC) NoÂ 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs.

Regulation (EC) No 1788/2001 [Official Journal L 243 of 13.9.2001].
Commission Regulation of 7 September 2001 laying down detailed rules for implementing the provisions concerning the certificate of inspection for imports from third countries.
Successive amendments and corrections have been incorporated in the basic text.This consolidated version (pdf ) is for reference purposes only.

Regulation (EC) No 345/2008 [Official Journal L 108 of 18.4.2008].
Commission Regulation of 17 April 2008 laying down detailed rules for implementing the arrangements for imports from third countries. It contains the list of third countries which are authorised to import organic products into the Community, including:Â Â Argentina, Australia, Costa Rica, India, Israel, Switzerland and New Zealand. For each of these countries, the Regulation lays down certain specifications and the inspection bodies which certify that the imported product are to be registered as organically produced.Â The Regulation also lays down the rules on the procedure to be followed for including a third country in the list of importers.

Organisation of working time

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Organisation of working time

Outline of the Community (European Union) legislation about Organisation of working time

Topics

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

Other

Organisation of working time (basic Directive)

1) Objective

To adopt minimum requirements covering certain aspects of the organisation of working time connected with workers’ health and safety.

2) Community Measures

Council Directive 93/104/EC, of 23 November 1993, concerning certain aspects of the organisation of working time.

Amended by Directive 2000/34/EC of 22 June 2000 of the European Parliament and of the Council.

3) Contents

Scope: Initially, all sectors of activity except transport, activities at sea and the activities of doctors undergoing training. Since the amendment of June 2000, workers belonging to these three categories have been covered by certain provisions governing rest periods, breaks, working hours, paid holidays and night work. Certain articles of the initial directive do not apply to these categories, but ad hoc measures have been adopted, such as the establishment of a maximum number of working hours or, alternatively, a minimum number of rest hours for workers on board shipping vessels at sea.

Definition of the terms “working time”, “rest period”, “night work”: any period of not less than seven hours, as defined by national legislation and including in all cases the period from 12 midnight to 5 a.m.; “night worker”: any worker who performs at least three hours of his daily work or a part of his annual work (as defined by the Member States) during the night work period; “shift work”: any method of organising work whereby workers succeed each other in the same tasks in accordance with a given time schedule at different times over a given period of days or weeks.
Directive 2000/34/EC amending Directive 93/104/EC adds the terms “adequate rest”; “mobile worker”: any worker employed as a member of travelling or flying personnel by an undertaking which operates transport services for passengers or goods by road, air, or inland waterway; “offshore work”: work performed mainly on or from offshore installations.

Member States shall take measures to ensure that workers enjoy:

the minimum daily rest period of 11 consecutive hours per period of 24 hours;
the minimum period of one rest day on average immediately following the daily rest period in every seven-day period;
for a daily period of work of more than six hours, a break as defined by the provisions of collective agreements, agreements concluded between social partners or national legislation;
not less than four weeks’ annual paid holiday, qualification for which shall be determined by reference to national practice/legislation;
an average weekly working period of not more than 48 hours, including the overtime for each seven-day period.

Normal hours of work for night workers must not exceed an average of eight hours in any 24-hour period. Workers shall be entitled to a free health check-up before being employed on night work and at regular intervals thereafter. Anyone suffering from health problems connected with night work must be transferred, wherever possible, to day work.

Employers who regularly use night workers must duly inform the authorities responsible for health and safety matters.

Night workers must enjoy a level of health and safety protection commensurate with the nature of their work. Protection and prevention facilities must be equivalent to those of other workers and must be available at all times.

Employers who organise work in accordance with a certain time schedule must abide by the general principle of adapting the work to man, especially in the case of monotonous tasks required to be performed in quick succession.

Member States may stipulate reference periods:

not exceeding 14 days for the weekly rest period;
not exceeding four months for the maximum weekly working period;
and for the duration of night work.

Derogations are permitted:

on condition that the general principles of the protection of workers’ health and safety are complied with, where the duration of work is not measured and/or predetermined by the worker himself;
in the case of activities where the worker’s place of work and his place of residence are distant from one another;
in the case of security and surveillance activities in order to protect property and persons;
in the case of activities involving the need for continuity of service or production, such as treatment and/or care provided by hospitals; agriculture; or again press and information services;
where there is a foreseeable surge of activity, particularly in agriculture, tourism and the postal services; in the case of persons working in railway transport.
provided that equivalent compensatory rest periods are granted to the workers concerned:

– in accordance with the criteria listed in the directive, for example in the case of activities where the service or production has to be continuous;
– by means of collective agreements or agreements concluded between social partners.

A transitional period of five years from 1 August 2004 has been laid down for doctors in training. During the first three years of the transitional period, the number of weekly working hours may not exceed an average of 58. Subsequently, in the two following years, it may not exceed an average of 56. A sixth transitional year may be granted to certain Member States. In this case, the ceiling is 52 weekly working hours.
At the end of this transitional period, the ceiling will be 48 hours weekly.

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

Directive 93/104/EC: 23.11.1996
Directive 2000/34/EC: 01.08.2003 (for doctors in training: 01.08.2004)

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

Directive 2000/34/EC: 01.08.2000.

6) References

Official Journal L 307, 13.12.1993
Official Journal L 195, 01.08.2000

7) Follow-Up Work

Directives (EC) No 104/1993 and (EC) No 34/2000 were repealed by Directive (EC) Noof the European Parliament and the Council of 4 November 2003 on certain aspects of the organisation of working time.

Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions concerning the re-exam of Directive 93/104/EC concerning certain aspects of the organisation of working time [COM(2003) 843 final – Not published in the Official Journal].

Report from the Commission – State of implementation of Council Directive 93/104/EC of 23 November 1993 concerning certain aspects of the organisation of working time (“Working Time Directive”) [COM(2000) 787 final – Not published in the Official Journal].

On 18 November 1998 the Commission presented a Communication to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions on the organisation of working time in the sectors and activities excluded from Directive 93/104/EC of 23 November 1993 [COM(98) 662 final – Not published in the Official Journal].

The Communication presents the measures proposed by the Commission to protect workers whose sectors were excluded from the scope of the Directive on working time 93/104/EC (air, rail, road, sea, inland waterway and lake transport, sea fishing, other work at sea and activities of doctors in training).

The Commission has always held that workers in these sectors should benefit from minimum standards in order to protect their own health and safety (excessive working time, inadequate rest). During the process of adopting Directive 93/104/EC the Commission gave the European Parliament an undertaking that it would take initiatives concerning the excluded sectors. Besides, in the medium-term action programme for 1995-1997, it declared that it wanted to continue the discussions with the social partners on this issue.

On 15 July 1997 the Commission adopted a White Paper on the sectors and activities excluded from the Directive on working time [COM(97) 334 final – not published in the Official Journal], in which it presented the characteristics of each sector and the various possible approaches. A second consultation phase was launched on 31 March 1998 [SEC(1998) 537 final – not published in the Official Journal].

The professional organisations consulted supported the differentiated approach proposed by the Commission. Most of the bodies approved including non-mobile workers within the scope of Directive 93/104/EC. Subsequently, the discussions were stepped up within the joint committees concerned and formal agreements on working time were signed in the sea and rail transport sectors. However, the negotiations on road transport did not lead to the signature of an agreement.

In this Communication the Commission explains the approach selected, which takes account of the particular constraints that affect these sectors and activities and also ensures overall consistency with the other legislative texts on transport safety. In effect the Community action must allow firms to remain flexible, take into account any impact on employment, avoid imposing unreasonable constraints on firms and notably small businesses and, finally, cater for the specific features of each sector (heterogeneity of sea fishing, for example).

This approach consists of:

– horizontal measures: the Commission proposes amending Directive 93/104/EC to extend its application to:

all non-mobile workers, including doctors in training and workers at sea;
all mobile railway workers;
mobile workers in the road, air, inland and sea transport sectors and sea fishing.

– sectoral measures, specifically:

proposal for a Council Directive on the organisation of working time for mobile workers performing road transport activities and for self-employed drivers;
Council Directive concerning the agreement on the organisation of working time of seafarers concluded by the European Community Shipowners’ Association (ECSA) and the Federation of Transport Workers’ Unions in the European Union (FST), adopted by the Council on 21 June 1999 (Directive 1999/63/EC);
Directive of the European Parliament and of the Council concerning the enforcement of seafarers’ hours of work onboard ship using Community ports;
Commission Recommendation inviting Member States to ratify ILO Convention 180 concerning seafarers’ hours of work and the manning of ships and the 1996 Protocol to the 1976 Merchant Shipping (Minimum Standards) Convention.

8) Commission Implementing Measures

Organisation and management of the internet

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Organisation and management of the internet

Outline of the Community (European Union) legislation about Organisation and management of the internet

Topics

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

Information society > Internet Online activities and ICT standards

Organisation and management of the internet

Document or Iniciative

Communication from the Commission of 11 April 2000 to the Council and the European Parliament “The organisation and management of the internet. International and European policy issues 1998-2000” [COM(2000) 202 final – Not published in the Official Journal].

Summary

The Internet is a communications network that should be universally accessible. The IANA (Internet Assigned Numbers Authority), a body under contract with the United States Government, was set up in order to administer the central coordinating functions of the global Internet for the pubic good. The US Government has furthermore recognised that the global Internet user community should have a voice in the coordination of the Internet.

The new structure of the management body

In October 1998, ICANN (the Internet Corporation for Assigned Numbers and Names) was set up on the basis of a US Government White Paper. ICANN is incorporated as a non-profit public-benefit corporation in the county of Los Angeles, California. It will be responsible for coordinating the management of the Domain Name System (DNS), the allocation of Internet protocol address spaces, the coordination of new Internet coordination parameters and the management of the Internet’s root name server system. All these functions are due to be transferred to ICANN by October 2000.

ICANN began its work in autumn 1998. Its Board currently consists of nine temporary members appointed by the IANA, and nine members elected by the technical (naming, addressing, standardisation) organisations. The intention is that by 2002, nine members will be elected by on-line voting to replace the temporary members.

ICANN’s budget comes from contributions from:

domain name registries;
domain name registrars and;
IP address registries.

ICANN is assisted in its work by a Governmental Advisory Committee (GAC) which is open to all governments and a number of international organisations with a direct interest in ICANN policy, including ITU, WIPO, OECD etc.

The Commission urges the Member States and the European Parliament to facilitate the participation of all Internet user categories within this management body.

Internet protocols

Internet protocols allow the different entities on the Internet to work together to transport data between machines and present it in the applications that the users actually see. The development of new protocols is fundamental to the development of new services on the Internet.

Recognising the importance of the protocols, the Commission will take them into account in its approach to IT standardisation, including EU research projects.

Internet addressing

The Internet addresses which are used to route data from one host computer to another are numerical. This numerical system is currently based on numbers that are 32 bits long (IPv4). All Internet applications, both current and future, rely on these addresses, and the Ipv4 address space has been coming under increasing pressure because of the growth of the use of the Internet.

The Commission therefore considers that it should closely monitor developments in ICANN and its policies with regard to the allocation of IP addresses. It is important that IP addresses are autonomously and neutrally managed. The rapid development of the Internet necessitates the transition to a new generation of Ipv6 addresses based on 128 bit numbers, which will multiply the number of addresses available to users. Internet search and directory services will also need to be developed.

Domain names

Domain names are names by which Internet hosts may be easily identified, as opposed to the numerical IP addressing system used for network communication. Two types of registry are in current use:

a number of generic top-level domains (gTLDs), such as “.COM”, “.NET”, are used worldwide;
about 240 national or territorial registries maintain similar systems of names under a country code (ccTLD registries), such as “.GR”, “.BE”.

ICANN (taking over from the IANA) will be responsible for the attribution of registries. One of its main functions is to introduce competition into the registration market for gTLD domain names and increase the number of TLDs available.

ICANN has already accredited a number of registrars in order to encourage competition.

The “.EU” top-level domain

Given the rapid expansion of the Internet, the Commission considers it vital to create an ” .EU ” European top-level TLD registry, in order to give the Internet domain space in Europe an additional dimension for identification and growth.

Intellectual property rights (IPR)

The main IPR questions arising from domain names are currently trademark-related. Domain names have been an easy target for abuses of intellectual property rights, given that the principal open generic domains have been allocated on a “first come, first (only) served” basis.

The Commission will continue discussions with WIPO (he World Intellectual Property Organisation) and the US authorities on dispute resolution and the implementation of international dispute resolution mechanisms. It also intends to submit a proposal for a code of conduct to restrict current abuses of intellectual property rights. This will include identification of the categories of names to be protected and the treatment of trademarks and other recognised marks.

Data protection

Under the Registrars Accreditation Agreement, anyone applying to register a domain name must provide information to the registry and the WHOIS database. Personal data is covered by Directive 95/46/EC (protection of personal data). Neither the Registrars, nor the registries, nor ICANN can claim any rights over this type of information.

Transparency and access to WHOIS data are fundamental for Internet users. Transparency can help to reduce disputes concerning trademarks and even prevent fraud. However, there is also a need for data security and confidentiality.

The Commission will continue discussions with ICANN and the US authorities regarding data protection and may also recommend that ICANN and the GAC adopt policies limiting the collection, processing and use of personal registration data.

Competition policy

The Commission will closely monitor developments regarding the organisation and management of the Internet, and will ascertain whether agreements and business registration practices fall under EU competition rules.

In the case of generic top-level domain (gTLD) registries, registrars have to submit their registration requests to NSI (Network Solutions Incorporated). ICANN regards this as being a factor for uncertainty, and wishes to upgrade the US-based monopolistic infrastructure towards a more balanced international environment.

Internet infrastructure

If Europe is to be able to rise to the international challenges where the Internet is concerned, it is necessary that the current disparities in terms of access, use, content and cost can be rapidly reduced through: less expensive access, availability of European websites, more extensive use of all European languages, availability of efficient backbone infrastructure, and security of commercial transactions.

The Commission has set out its objectives with regard to the development of the information society in its ” eEurope ” communication. It also invites the Member States to act as expeditiously as possible to implement its recommendations on leased-line pricing and unbundling of the local loop in order to accelerate affordable Internet access.

Related Acts

Communication of 28 May 2002 from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions – eEurope 2005: An information society for all [COM(2002) 263 final – Not published in the Official Journal].

The eEurope 2005 Action Plan is designed to foster the development of services, applications and content, while at the same time speeding up the deployment of secure broadband access to the Internet.

Regulation (EC) No 733/2002 of the European Parliament and of the Council of 22 April 2002 on the implementation of the .eu Top Level Domain [Official Journal L 113 of 30.04.2002].

This Regulation lays down the conditions for implementation of the .eu top level domain (TLD) and establishes the general policy framework within which the Registry will function.
In May 2003 the Commission decided to entrust the operation of the .eu TLD to EURID (European Registry for Internet Domains).

Communication of 13 March 2001 from the Commission: eEurope 2002: Impact and Priorities. A communication to the Spring European Council in Stockholm, 23-24 March 2001 [COM(2001) 140 final – Not published in the Official Journal].

The main objectives of eEurope 2002 are to extend Internet connectivity in Europe, open up all communication networks to competition and encourage use of the Internet by laying emphasis on consumer protection and training.

Organisation and financing of the fisheries sector

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Organisation and financing of the fisheries sector

Outline of the Community (European Union) legislation about Organisation and financing of the fisheries sector

Topics

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

Organisation and financing of the fisheries sector

The common fisheries policy (CFP) has been based on a common organisation of the markets (CMO) since October 1970. This CMO aims to find the right balance between supply and demand in the interests of European fishers and consumers. It introduces marketing standards, a price stabilisation system and rules for trade with third countries. A European Fisheries Fund (EFF) enables solutions to be found to surplus fleet capacity, overindebtedness of enterprises, technical restrictions, and adaptations regarding hygiene, health, product quality and safety on board vessels.

GENERAL FRAMEWORK

Common Fisheries Policy (CFP)

Reform of the Common Fisheries Policy
Reform of the Common Fisheries Policy (Green Paper)
Improving decision-making in Community fisheries management

Markets

Common organisation of the market in fishery products

Social standards

Organisation of seafarers’ working time
Organisation of hours of work on board ships using Community ports
Fishing vessels
Improved medical treatment on board vessels

Institutional aspects

Advisory committee on fisheries and aquaculture
Regional Advisory Councils
Scientific, Technical and Economic Committee for Fisheries
Community Fisheries Control Agency

STRUCTURAL MEASURES AND FINANCING

Improving the financial measures relating to the common fisheries policy

2007-2013

Interinstitutional Agreement on cooperation in budgetary matters
European Fisheries Fund
Detailed rules for the implementation of the EFF Regulation

2007-2013

Detailed rules and arrangements regarding Community structural assistance in the fisheries sector
Emergency measures for scrapping fishing vessels
FIFG: Financial Instrument for Fisheries Guidance

STATE AID

State Aid: Guidelines
De minimis aid for the fisheries sector
State aid for SMEs in the fisheries sector
Improving the economic situation in the fishing industry
State aid for rescuing and restructuring firms in difficulty

Organised crime: crime prevention in the European Union

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Organised crime: crime prevention in the European Union

Outline of the Community (European Union) legislation about Organised crime: crime prevention in the European Union

Topics

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

Justice freedom and security > Fight against organised crime

Organised crime: crime prevention in the European Union

Document or Iniciative

Communication from the Commission to the Council and the European Parliament. The prevention of crime in the European Union. Reflection on common guidelines and proposals for Community financial support [COM(2000) 786 final – Not published in the Official Journal].

Summary

The Commission has approached crime prevention under specific headings: sexual exploitation of children, trafficking in human beings and fraud against the Community budget. Following the Treaty of Amsterdam and the Tampere European Council, the Commission proposes to put the experience acquired at European and international levels to work as part of an overall strategy to fight crime.

The communication defines crime as “punishable conduct by individuals and by spontaneous associations of persons”. However, this concept covers a number of aspects:

crime in the strict sense;
less serious offences that are actually more frequent;
violence in various contexts;
anti-social conduct, which includes behaviour that is not a criminal offence.

Organised crime is defined, in accordance with Joint Action 98/733/JHA of 21 December 1998, as “a structured association, established over a period of time, of more than two persons, acting in concert with a view to committing offences which are punishable by deprivation of liberty … of a maximum of at least four years or a more serious penalty”.

Prevention is defined as “all activities which contribute to halting or reducing crime as a social phenomenon, both quantitatively and qualitatively, either through permanent and structured cooperation measures or through ad hoc initiatives”. Crime prevention measures may be aimed at:

reducing the opportunities that make crime easier;
improving the social factors that foster crime;
informing and protecting victims.

Characteristics of the European strategy

Preventive measures should complement enforcement and should develop a multidisciplinary approach. Action taken by the Union is based on the subsidiarity principle and is therefore not intended to take the place of national, regional or local initiatives. Furthermore, close attention must be paid to the fundamental principles of law and public freedoms.

A list of priority actions should be drawn up, with a view to the fact that crime prevention is a new Union policy. As regards general crime, priorities were set by the Tampere European Council: the fight against urban, juvenile and drug-related crime. As regards organised crime, priority will be given to combating trafficking in human beings, the exploitation of children and counterfeiting of the euro.

The Union’s strategy could be focused on three points:

improve understanding of the phenomena of crime by sharing national experience and practices;
develop cooperation and the networking of those involved in prevention at all levels;
strengthen the multidisciplinary approach to projects.

Instruments of the prevention strategy

The Union’s approach to crime prevention must primarily be comprehensive. The 1998 Council Resolution on the prevention of organised crime invited the Commission to assess Community policies in terms of their contribution to crime prevention. In the light of that assessment, the Commission concludes that it should strengthen and structure its preventive measures.

Economic and financial policy (fraud, corruption and money laundering), social policy (the fight against all forms of discrimination), external policy and environmental policy are all areas where action could be taken.

The Commission is committed to assessing the possible impact of its legislative proposals in terms of crime prevention. A similar study should also be carried out by Member States of their national initiatives. The analysis should not be limited to proposals for new laws and regulations but should include existing legislation.

The Commission encourages all measures aimed at the collection of data on crime. It notes in this respect that the identification of objective and relevant indicators is essential to the study of crime. A lack of comparable data is a serious obstacle to cooperation and prevention at the European level.

European Forum for the prevention of crime

The Commission believes that one of the effective means of setting up a coordinated strategy is to network those involved in prevention. For that reason it supports the initiative of the French Presidency and Sweden for the creation of a European Network for the prevention of urban, juvenile and drug-related crime. In addition, the Commission suggests setting up a European Forum for the prevention of organised crime which will be able to deal with various aspects of prevention such as economic and financial crime, lawful and unlawful dealings in goods, trafficking in human beings and corruption. The Forum will consist of representatives of the institutions, national and local authorities and the business circles and associations most concerned by crime. The Commission also proposes that national coordination structures be set up at national level.

The activities of the Forum will essentially consist in:

assisting the European institutions and the Member States in crime prevention matters;
contributing to the identification of crime trends;
facilitating the exchange of information;
contributing to the setting-up and operation of the expertise centres on specific topics;
identifying fields of research and training.

The Commission also plans to set up an Internet site on crime prevention.

At the request of the Heads of State or Government at the Tampere European Council (paragraphs 41 and 42 of the conclusions), the Commission proposed in its communication that a new financial instrument be adopted to support the European crime prevention measures. The programme, known as Hippocrates, should cover the prevention of all forms of crime and provide support for the measures listed in the communication.

The financial instrument will consist of two parts: cross-frontier organised crime and general crime. The projects supported will be:

meetings and seminars;
studies and research work;
pilot projects;
exchange of good practices.

The Commission asks the European Parliament, the Council, the Committee of the Regions and the Economic and Social Committee, as well as the professional organisations representing industry and services and the associations representing civil society, to make their views known on the communication.

Related Acts

Council Decision 2009/902/JHA of 30 November 2009 setting up a European Crime Prevention Network (EUCPN) and repealing Decision 2001/427/JHA.

The prevention and control of organised crime: a strategy for the beginning of the new millennium [Official Journal C 124 of 03.05.2000].

on the prevention of organised crime with reference to the establishment of a comprehensive strategy for combating it [Official Journal C 408 of 29.12.1998].

Organised crime: contact points to combat high-tech crime

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Organised crime: contact points to combat high-tech crime

Outline of the Community (European Union) legislation about Organised crime: contact points to combat high-tech crime

Topics

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

Justice freedom and security > Fight against organised crime

Organised crime: contact points to combat high-tech crime

Document or Iniciative

Council Recommendation of 25 June 2001 on contact points maintaining a 24-hour service for combating high-tech crime.

Summary

On 19 March 1998 the Council invited the Member States to join the G8 24-hour information network for combating high-tech crime. This network will provide the countries which join it with an overview of computer network crime, given that it often occurs simultaneously at different locations in different countries.

At a meeting held in Washington on 9 and 10 December 1997, the justice and home affairs ministers of the G8 adopted the network’s basic principles. An action plan was also adopted which made provision for countries from outside the G8 circle to join the network. The network was established between 1998 and 2000.

Those EU Member States which do not form part of the G8 network have joined Interpol’s “National Central Reference Point System” (NCRP). However, Interpol’s national central reference points do not always provide 24-readiness. The two networks will work together in a spirit of cooperation. In addition, those Member States which are not represented in the G8 network should be able to link a 24-hour function to their specialist units that form part of the Interpol network.

The Council therefore recommends that those Member States that have not yet joined the G8 network of contact points do so, and that the national units designated as contact points specialise in combating high-tech crime. The Council also recommends that those units should be able to take operational measures.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Council Recommendation of 25 June 2001	–	–	OJ C 187 of 3.07.2001

Related Acts

Council Frameworkof 24 February 2005 on attacks against information systems

Organised crime: strategy for the prevention and control of organised crime

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Organised crime: strategy for the prevention and control of organised crime

Outline of the Community (European Union) legislation about Organised crime: strategy for the prevention and control of organised crime

Topics

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

Justice freedom and security > Fight against organised crime

Organised crime: strategy for the prevention and control of organised crime

Document or Iniciative

The prevention and control of organised crime: a strategy for the beginning of the new millennium [Official Journal C 124 of 3.5.2000].

Summary

The contributions of Member States to the annual report on organised crime show that it is on the increase in the European Union. Criminal groups have managed to infiltrate all sections of society, taking advantage of the free movement of capital, goods, persons and services within the European Union and exploiting differences in the legal systems of the Member States.

In view of the threat from organised crime at national and international level, a coordinated response is necessary in which the Member States, the Council, the Commission, Europol and the European Judicial Network all have a role to play.

Following up its action plan to combat organised crime of June 1997, the Vienna European Council, meeting in December 1998, called for EU action on organised crime to be strengthened in the light of the new possibilities opened up by the Amsterdam Treaty. That objective was restated by the European Council at its Tampere meeting in October 1999.

By adopting its strategy for the prevention and control of organised crime, the Council has responded to the need for action.

The document spells out the actions which must be taken at European level to combat organised crime and provides details of priorities, the bodies responsible for implementation and target dates.

The political guidelines and thirty-nine detailed recommendations which make up the strategy reflect eleven objectives:

to strengthen the collection and analysis of data on organised crime;
to prevent penetration of organised crime in the public and the legitimate private sector;
to strengthen the prevention of organised crime and strengthen partnerships between the criminal justice system and civil society;
to review and improve legislation and control and regulatory policies at national and European Union level;
to strengthen the investigation of organised crime;
to strengthen Europol;
to trace, freeze, seize and confiscate the proceeds of crime;
to strengthen cooperation between law enforcement and judicial authorities nationally and within the European Union;
to strengthen cooperation with the applicant countries;
to strengthen cooperation with third countries and other international organisations;
to monitor the strengthening of the implementation of measures for the prevention and control of organised crime within the European Union.

For each objective, details are also given of the initiatives taken in the relevant field and an assessment is made of the specific mandate for the development of future actions which can be deduced from the 1997 Action Plan, the December 1998 Action Plan for the establishment of an area of freedom, security and justice, the Council Resolution of 21 December 1998 on the prevention of organised crime and the conclusions of the Tampere European Council.

The Multidisciplinary Group on Organised Crime will report at regular intervals to the Council and the European Council on the implementation of strategy. The Council will take the appropriate measures.

The Commission and Council will submit to the European Council, by 30 June 2005 at the latest, a general report on implementation of the EU strategy to combat organised crime. The European Council will provide guidelines on further measures to be taken.

On 29 May 2000, the Council adopted a report on the state of organised crime in the European Union in 1998.

References

Act	Entry into force – Date of expiry	Deadline for transposition in the Member States	Official Journal
Prevention and control of organised crime: a strategy for the beginning of the new millennium	–	–	OJ C 124, 03.05.2000

Related Acts

Council Decision 2009/902/JHA of 30 November 2009 setting up a European Crime Prevention Network (EUCPN) and repealing Decision 2001/427/JHA.

of 21 December 1998 on the prevention of organised crime with reference to the establishment of a comprehensive strategy for combating it [Official Journal C 408 of 29.12.1998].