Tag Archives: Community control

Bluetongue

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Bluetongue

Outline of the Community (European Union) legislation about Bluetongue

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Food safety > Animal health

Bluetongue

Document or Iniciative

Council Directive 2000/75/EC of 20 November 2000 laying down specific provisions for the control and eradication of bluetongue [See amending act(s)].

Summary

This Directive lays down measures to control and eradicate bluetongue.

Suspected or confirmed cases of the bluetongue virus must be notified to the competent authority of the Member State concerned before implementing the required measures.

Measures for suspected cases of the disease

Where the presence of the disease is suspected in a flock, the official veterinarian is to place the holding(s) concerned under surveillance and undertake a certain number of investigative measures (surveillance of the holding, inventory of the animals and the premises, epidemiological survey, etc.) and protective measures (ban on movements of animals, treatment of animals with insecticide, destruction and disposal of animal carcases, etc.).

Measures for confirmed cases of the disease

If the presence of the disease is confirmed, the official veterinarian will extend the measures introduced on suspicion to all holdings within a 20-km radius around the infected holding(s). He will also carry out an epidemiological survey and may launch a vaccination programme around the outbreaks of bluetongue.

Where the presence of the disease is confirmed, the competent authority must establish a protection zone and a surveillance zone around the holdings.

Protection zone and surveillance zone

The protection zone will extend over a radius of at least 100 kilometres around the infected holding(s). Within that zone, all holdings with animals must be identified and the animals may not leave the zone. The competent authority must establish an epidemiological surveillance programme. A vaccination programme may also be set up within the protection zone.

The surveillance zone will extend for at least 50 kilometres beyond the protection zone. Within that zone, the measures for identification, restriction of movement and epidemiological surveillance applicable within the protection zone must be implemented. However, the vaccination of animals against bluetongue is forbidden.

The protection and surveillance zones may be extended or reduced depending on the epidemiological, geographical, ecological or meteorological circumstances.

Derogations and supplementary measures

The Commission, assisted by the Standing Committee on the Food Chain and Animal Health may adopt supplementary or derogatory measures. In particular provisions may be adopted to allow animals to leave the protection and surveillance zones under certain conditions.

National laboratories

Each Member State designates a national laboratory responsible for carrying out the laboratory tests provided for by this Directive and then informs the other Member States and the public of the laboratory’s contact details. Each national laboratory must cooperate with the Community reference laboratory located at Pirbright (United Kingdom).

Context

The outbreak of bluetongue at the end of the 1990s demonstrated that the Community legislation then in force did not deal with the specific features of the disease. This Directive takes over a number of measures laid down by Directive 92/35/EEC concerning African horse sickness, which were adaptable to cover bluetongue.

References

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

Directive 2000/75/EC

22.12.2000

1.1.2002

OJ L 327 of 22.12.2000
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 2008/73/EC

12.12.2006

–

OJ L 219 of 14.8.2008

The successive amendments and corrections to Directive 2000/75/EC have been incorporated in the original text. This consolidated versionis of documentary value only.

A common legal framework for combating fraud in Community policies

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A common legal framework for combating fraud in Community policies

Outline of the Community (European Union) legislation about A common legal framework for combating fraud in Community policies

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Fight against fraud > Protecting the European Union’s financial interests

A common legal framework for combating fraud in Community policies

Document or Iniciative

Council Regulation (EC, EURATOM) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests.

Summary

This regulation establishes provisions to combat fraud against the financial interests of the European Communities. It provides for homogenous checks in all Member States and administrative measures and penalties concerning irregularities with regard to Community law.

Irregularity: an economic operator prejudices the Community budget

“Irregularity” means any infringement of a provision of Community law resulting from an act or omission by an economic operator that has, or would have, the effect of prejudicing the general budget of the Communities or budgets managed by them, either by reducing or losing revenue accruing from own resources collected directly on behalf of the Communities, or by an unjustified item of expenditure.

Economic operators are considered to be natural or legal persons and other entities on which national law confers legal capacity and to whom penalties are applied when they commit an irregularity. Penalties can also apply to those who have been involved in an irregularity, as well as those who are under a duty to take responsibility for or to ensure the non-commission of an irregularity.

Establishing a set of legal rules for all areas covered by Community policies

More than half of Community expenditure is paid to beneficiaries via Member States. This decentralised administration and monitoring of the use of the expenditure are governed by detailed rules that are subject to specific provisions depending on the Community policy concerned. This regulation establishes a set of legal rules for all areas covered by Community policies to protect the financial interests of the European Communities, notably through checks and administrative measures and penalties.

Member States are responsible for taking the necessary measures to ensure the regularity and reality of the transactions involving the Communities’ financial interests. Measures regarding checks must be in proportion to the objectives pursued so as not to entail excessive economic constraints or administrative costs and must take account of Member States’ administrative practices and structures.

The European Commission has responsibility for checking that:

  • administrative practices conform with Community rules;
  • the necessary substantiating documents exist and that they concord with the Communities’ revenue and expenditure;
  • financial transactions are carried out and checked in appropriate circumstances.

In addition, the European Commission may carry out checks and inspections on the spot.

Withdrawal of the wrongly obtained advantage

In general, any irregularity will result in the withdrawal of the wrongly obtained advantage with, where appropriate, interest determined on a flat-rate basis. This may consist of:

  • an obligation to pay or repay the amounts due or wrongly received;
  • the total or partial loss of the security provided in support of the request for an advantage granted or at the time of the receipt of an advance.

Intentional irregularities or irregularities caused by negligence may lead to administrative penalties, such as:

  • payment of an administrative fine;
  • payment of an additional sum, which may not exceed the level strictly necessary to constitute a deterrent;
  • total or partial removal of an advantage granted, even if the operator wrongly benefited from only a part of that advantage, or exclusion from or withdrawal of the advantage for a period subsequent to that of the irregularity;
  • other penalties of a purely economic type provided for by Community law.

General principles

Administrative checks, measures and penalties must be effective, proportionate and dissuasive. They must take account of the nature and seriousness of the irregularity, the advantage granted or received and the degree of responsibility.

An administrative penalty may only be imposed if, prior to the irregularity, a Community act has made provision for it.

The limitation period for proceedings is four years, starting from the date on which the irregularity was committed. For continuous or repeated irregularities, the limitation period runs from the date on which the irregularity ceases. In the case of multiannual programmes, the limitation period runs until the programme is terminated.

References

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

Regulation (EC, EURATOM) No 2988/95

26.12.1995

–

OJ L 312, 23.12.1995

Recovery and information system for money wrongly paid in connection with the financing of the common agricultural policy

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Recovery and information system for money wrongly paid in connection with the financing of the common agricultural policy

Outline of the Community (European Union) legislation about Recovery and information system for money wrongly paid in connection with the financing of the common agricultural policy

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Agriculture > General framework

Recovery and information system for money wrongly paid in connection with the financing of the common agricultural policy

Document or Iniciative

Commission Regulation (EC) No 1848/2006 of 14 December 2006 concerning irregularities and the recovery of sums wrongly paid in connection with the financing of the common agricultural policy and the organisation of an information system in this field and repealing Council Regulation (EEC) No 595/91.

Summary

This Regulation aims to improve the Community’s response to irregular practices. It requires Member States to submit a quarterly report to the Commission listing all irregularities they have detected (and with an impact of more than EUR 10 000). Member States are required to inform the Commission of national procedures to impose administrative or criminal sanctions and – if the Commission requests them to do so – to provide details of any progress made in recovering money from beneficiaries who have committed irregularities with a detrimental effect on EAGF and EAFRD Community funding.

Quarterly report to the Commission

Within two months following the end of each quarter, Member States must report to the Commission any irregularities which have been the subject of a primary administrative or judicial finding. This report should be accompanied by information concerning the type and the amount of expenditure, the practices used to commit the irregularity, the identity of those implicated and the progress of administrative and legal proceedings. If some of this information is not available when the initial report is submitted, Member States must communicate it in subsequent quarterly reports.

Reporting to other Member States

Each Member State has to report to the Commission and the other Member States concerned any irregularities which it is feared may very quickly have repercussions outside its territory or which show that a new malpractice has been employed.

The Cocolaf

Once a year, the Commission provides the Advisory Committee for the Coordination of Fraud Prevention (Cocolaf) with a summary report of its work under this Regulation.

Key terms in the Act
  • Irregularity: defined in Article 1(2) of Council Regulation (EC, Euratom) No 2988/95 as any infringement of a provision of Community law resulting from an act or omission by an economic operator which has, or would have, the effect of prejudicing the general budget of the Communities either by reducing or losing revenue accruing from own resources collected directly on behalf of the Communities, or by an unjustified item of expenditure.
  • Primary administrative or judiciary finding: defined in Article 35 of Regulation (EC) No 1290/2005 as the first written assessment of a competent authority, either administrative or judicial, concluding on the basis of actual facts that an irregularity has been committed, without prejudice to the possibility that this conclusion may subsequently have to be adjusted or withdrawn as a result of developments in the course of the administrative or judicial procedure.
  • Suspected fraud: defined in Article 1a point (4) of Regulation (EC) No 1681/94 as an irregularity which has been subject of a primary administrative or judicial finding giving rise to the initiation of proceedings at national level in order to establish the presence of intentional behaviour, in particular fraud as is referred to in Article 1(1) point (a) of the Convention of 26 July 1995 on the protection of the European Communities’ financial interests drawn up on the basis of Article K.3 of the Treaty on European Union.
  • Economic operator: defined in Article 1a point (2) of Commission Regulation No 1681/94 as any natural or legal person or other entity benefiting from a financing from the EAGF or the EAFRD, with the exception of Member States exercising their prerogatives as a public authority, or receiving such assistance, or having to pay an assigned revenue within the meaning of Article 34(1) points (b) and (c) of Council Regulation (EC) No 1290/2005.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1848/2006

18.12.2006

–

OJ L 355, 15.12.2006

Regulatory agencies

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Regulatory agencies

Outline of the Community (European Union) legislation about Regulatory agencies

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Institutional affairs > The institutions bodies and agencies of the union

Regulatory agencies

Document or Iniciative

Communication from the Commission to the European Parliament and the Council of 11 March 2008: European Agencies – The way forward {SEC(2008) 323} [COM(2008) 135 final – Not published in the Official Journal].

Summary

The present Communication concerns only regulatory agencies, and not the executive agencies. It addresses the need for a common approach to the place of these agencies in European governance and the lack of clarity over their role and accountability. Currently, the Commission is responsible for proposing the establishment of agencies on a case-by-case basis, with the European Parliament and/or the Council of Ministers taking the final decision. A common view of the regulatory agencies shared by the EU institutions would promote transparency and improve working methods. This is particularly important as the agencies play an integral though highly varied part in a wide range of policy issues.

The regulatory agencies can be categorised roughly on the basis of their functions:

  • adoption of individual decisions;
  • technical or scientific advice to the Commission and the Member States;
  • responsibility for operational activities;
  • information and networking services;
  • services to other agencies and institutions.

The specific roles of each agency are set out in its own founding legal act. These agencies are independent bodies, usually governed by a Management Board. The Management Board has responsibility for overseeing the performance of the agency and for nominating the Director, who in turn is in charge of the agency’s operational aspects. Most of the agencies are funded by the EU budget, and hence the European Parliament has responsibility for their budgetary discharge. In addition, the general Financial Regulation, along with the Framework Financial Regulation, provides common rules for the agencies’ financial governance. What is lacking, however, is a general set of rules for the creation and operation of these agencies. And more importantly, there is a lack of clear rules for the accountability of their actions. Furthermore, the role and influence of the other institutions is questionable, for example with regard to the nomination and appointment of Directors and Management Boards. Consequently, with the present Communication, the Commission aims to re-launch a debate on the governance of the regulatory agencies.

A common framework

A common approach to the governance of regulatory agencies should be standardised enough to take into account the differences between the agencies. At the same time, the basic principles of accountability and sound financial management should also be respected. Therefore, the common approach should specify the following aspects of the regulatory agencies:

  • tasks;
  • structure and working methods;
  • accountability and relations with the other institutions;
  • regulatory framework;
  • establishment and termination;
  • communication strategy.

To achieve consistency, the common approach may necessitate amending the founding legal act of an existing agency.

Next steps

The Commission calls for the creation of an inter-institutional working group to form a political assessment of the regulatory agencies. This could be followed-up with an instrument, legally binding or otherwise, that would provide form and transparency to the results of the assessment. The objective is to achieve a common political understanding about the agencies.

Simultaneously, the Commission will launch an evaluation of the existing regulatory agencies, with the results to be communicated by 2009-10. In the meantime, no new agencies will be proposed so that the evaluation may be carried out in a constant setting. The Commission will also launch a review of its own internal systems with regard to its relations to agencies and its methodology for conducting impact assessment of the regulatory agencies.

Related Acts

Draft Interinsitutional Agreement of 25 February 2005 on the operating framework for the European regulatory agencies [COM(2005) 59 final – Not published in the Official Journal].

Communication from the Commission to the Council of 20 December 1999: Participation of candidate countries in Community programmes, agencies and committees [COM(1999) 710 final – Not published in the Official Journal].

Compliance work plan and scoreboard

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Compliance work plan and scoreboard

Outline of the Community (European Union) legislation about Compliance work plan and scoreboard

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Maritime Affairs And Fisheries > Management of fisheries resources and the environment

Compliance work plan and scoreboard

Document or Iniciative

Communication from the Commission – Compliance with the rules of the Common Fisheries Policy “Compliance work plan and scoreboard” [COM(2003) 344 final – Not published in the Official Journal].

Summary

Before presenting its compliance work plan, the Commission first assessed the degree of compliance in the application of the CFP. The assessment shows that the Member States have made progress. This is borne out by the introduction of vessel monitoring systems (VMS’s); more direct participation by the fisheries sector in the CFP; the progress made in terms of the means of control allocated and the implementation of comprehensive control systems by some Member States.

Deficiencies in the application of the CFP

However, some shortcomings continue to exist. These can be attributed in particular to the following:

  • delays in national authorities implementing of Community requirements concerning fisheries controls;
  • deficient application of restrictions on catches (TACs and quotas) and the fishing effort (number of days at sea);
  • the fact that the capacity of the Member States’ fishing fleet is not adapted to fishing opportunities (contrary to Article 11 of Regulation (EC) No 2371/2002);
  • shortcomings in the national control systems and irregularities in the collection of the data communicated to the Commission;
  • shortcomings in the data sent to the Community fleet register (engine power).

Continuing to fish after quotas have been exhausted generates fishing mortality for the stocks concerned throughout the year at a level much higher than allowed. This explains why the mortality rate for some stocks (cod, hake, etc.) has not fallen in proportion to these restrictions. In addition, inspection and monitoring by the Member States is inadequate and the collection of data is unsatisfactory. These have to be improved.

Compliance work plan

In order solve these deficiencies, the Commission is proposing a compliance work plan intended to achieve a more effective, uniform and equitable application of the rules of the CFP by all the Member States. It focuses on three areas:

FIRST AREA

Cooperation with and between Member States

Cooperation with the Member States within the Management Committee for Fisheries and Aquaculture and the fisheries control expert group should be enhanced. In particular, the rules on the fishing fleet should be examined and deficiencies observed in the Member States’ inspection and control systems should be raised. These forums are also responsible for monitoring the implementation of joint inspection programmes. The Commission will take responsibility for coordinating its activities with those of the Member States.

Cooperation with the sector

The work plan is also intended to provide support for the fisheries sector. The economic viability of the sector depends on the health of fish stocks and on compliance with rules. However, fishermen are unwilling to apply them for fear of unfair competition from other market participants who are not complying with the rules. For this reason, it is not only essential that a more level playing field in terms of control is guaranteed, but also that the sector is informed on the degrees of compliance achieved.

The forums intended to deal with these issues are the Advisory Committee for Fisheries and Aquaculture(ACFA) and the Regional Advisory Councils (RACs). They make it possible to improve understanding of the CFP in the fisheries sector, to seek the opinion of the sector on drafts of legislative proposals, to present compliance scoreboards (see below) and to examine any complaints from the sectors concerning unfair competition resulting from the lack of a level playing field in the application of the rules by the Member States.

SECOND AREA

Compliance scoreboard

To improve transparency, the Commission has drawn up a compliance scoreboard, which it publishes each year. The scoreboard, which is published on the internet, makes it possible to compare the Member States’ compliance with their obligations under the CFP, in particular as regards:

  • conservation of fisheries resources;
  • fleet management;
  • structural policy;
  • control and enforcement.

The compliance scoreboard also provides an overview of the infringement procedures launched by the Commission and the number and subject matter of missions carried out by its inspectors.

THIRD AREA

Priorities

It is proposed that the Commission and the Member States adopt the same priorities in terms of inspection and control. The first priority relates to stocks that exceed the biological limits in certain ICES divisions. For such stocks, recovery plans will be drawn up, accompanied by specific monitoring programmes, coordinated and enhanced by the Member States. The Commission will carry out inspections, possibly without the aid of national inspectors, in order to monitor implementation of the programmes.

Secondly, the Commission inspectors will verify the Member States’ compliance concerning:

  • the application of restrictions on fishing effort in the North Sea, the west of Scotland and Rockall ICES divisions;
  • the application of conservation measures for highly migratory species;
  • compliance with the requirements for keeping a log book in the Mediterranean Sea;
  • the effectiveness of the measures taken to monitor engine power.

Thirdly, the Commission will cooperate with third countries:

  • via bilateral agreements;
  • within regional fisheries organisations;
  • within the Food and Agriculture Organisation of the United Nations as regards illicit fishing. This cooperation also requires coordination of measures at Community level.

Lastly, the Commission will aid in extending VMS to include small vessels and will improve its implementing provisions. It also intends to provide support for pilot projects relating to remote sensing and the electronic logbook.

Transfer of tasks

The Commission has decided to delegate other tasks to the Member States in order to devote more time to the priorities mentioned above. This is the case for the monitoring of compliance with the rules in the NAFO and NEAFC zones, which come under the responsibility of the Member States in accordance with the basic regulation.

Enforcement measures

In accordance with the basic regulation, the Member States must deprive those responsible for committing infringements of any economic benefit thus gained and also deter them from committing any further infringements of this kind in the future. To obtain compliance with the rules, the Commission makes use of the means granted to it under the CFP. It may in particular:

  • take preventative measures if fishing activities constitute a serious threat to the conservation of resources, particularly owing to landings that exceed quotas;
  • carry out deductions from a Member State’s future fishing opportunities if it has exceeded the fishing opportunities granted to it;
  • suspend financial aid under structural measures, with the exception of funds intended for the dismantling of vessels, if a Member State’s fleet capacity exceeds the limits imposed on it;
  • launch formal infringement procedures where deficiencies are identified in the national control and enforcement systems jeopardising certain vulnerable stocks.

In general terms, the Commission acts in accordance with the following guidelines:

  • to facilitate compliance with the rules by actively supporting the Member States and by ensuring cooperation between them;
  • to increase transparency as regards compliance with the rules, particularly through the publication of a compliance scoreboard;
  • to give priority to inspections concerning the Member States’ application of the rules of the CFP for certain vulnerable stocks (particularly as regards inspections carried out without the assistance of national inspectors);
  • to request that the Member States carry out an administrative inquiry into the illegal landings of cod and hake;
  • to limit the number of referrals to the Court of Justice in the event of non-compliance with conservation and control measures and of deficiencies in the national control and enforcement systems that fundamentally affect the effectiveness of these measures;
  • to make use of the commercial, trade and tax data to identify such illegal landings.

Background

The compliance work plan and scoreboard form part of the monitoring of the reform of the CFP.

They form part of a convergence process initiated by the action plan for cooperation in enforcement which ultimately led to the creation of a joint inspection structure: the Community Fisheries Control Agency. Even though the Community Agency has been set up in the meantime, the compliance scoreboard continues to be published every year. It makes it possible to improve transparency, thereby encouraging all the Member States to enforce the rules of the CFP.

Related Acts

Communication from the Commission, of 21 March 2003, ‘Towards uniform and effective implementation of the Common Fisheries Policy’. [COM(2003) 130 final – Not published in the Official Journal].

Communication from the Commission, of 28 May 2002, on the reform of the Common Fisheries Policy – Roadmap. [COM(2002) 181 final – Not published in the Official Journal].

Insurance undertakings: supervision

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Insurance undertakings: supervision

Outline of the Community (European Union) legislation about Insurance undertakings: supervision

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Internal market > Single market for services > Financial services: insurance

Insurance undertakings: supervision

Document or Iniciative

Directive 98/78/EC of the European Parliament and of the Council of 27 October 1998 on the supplementary supervision of insurance undertakings in an insurance group [See amending acts].

Summary

The Directive applies to insurance undertakings * with their registered office in the European Union (EU).

The Directive requires Member States to extend supervision (“supplementary supervision”) to all other entities that could have a bearing on the financial and operating position of a supervised insurance undertaking, including undertakings related to * or participating in * the insurance undertaking. Its scope extends to the following enterprises with which an insurer may have a parent/subsidiary relationship, or in which a participation * exists:

  • reinsurance undertakings *;
  • holding companies * (a distinction is made between financial holding companies with subsidiaries operating principally or exclusively in the insurance sector and mixed-activity holding companies with a broader range of activity);
  • non-member-country insurance and reinsurance undertakings *.

The Member States or the competent authorities * responsible for exercising supplementary supervision may waive supervision if it is deemed inappropriate or if the undertaking is of negligible interest.

Adequate internal mechanisms must exist for the production of relevant information in each insurance undertaking subject to supplementary supervision.

The competent authorities may carry out within their territory, themselves or through the intermediary of persons whom they appoint for that purpose, on-the-spot verification of information received by them.

Should the competent authorities of a Member State wish to verify information concerning an insurance undertaking situated in another Member State, they must ask the competent authorities of that other Member State to have that verification carried out.

Intra-group transactions must not jeopardise the solvency of the insurance undertaking. This applies to transactions between an insurance undertaking and its parent or subsidiaries as well as to transactions with an enterprise in which an insurance undertaking holds a participation.

The competent authorities are informed of intra-group transactions by way of an annual reporting requirement. Only significant transactions (loans, investments, etc) must be notified. The competent authorities must take appropriate measures at the level of the insurance undertaking when its solvency cannot be adequately guaranteed.

The Member States must ensure that an adjusted solvency calculation is carried out in compliance with Annex I to the Directive.

Directive 2002/87/EC amends the Directive in order to establish common standards for the prudential supervision of financial conglomerates and to create a level playing field and legal certainty for the financial institutions concerned.

The aim of Directive 2005/1/EC is to ensure institutional and legal coherence with the approach taken in the financial services industry. As of its entry into force, the European Insurance and Occupational Pensions Committee, established by Decision 2004/9/EC, replaces the Insurance Committee as the advisory body responsible for supporting the Commission in this area.

This Directive is repealed by the Directive on the taking-up and pursuit of the business of insurance and reinsurance as of 1 November 2012.

Key terms used in the act
  • Insurance undertaking: an undertaking which has received official authorisation in accordance with Article 6 of Directive 73/239/EEC.
  • Related undertaking: an undertaking which is either a subsidiary or another undertaking in which a participation is held.
  • Participating undertaking: either a parent undertaking or another undertaking which holds a participation.
  • Participation: participation within the meaning of Article 17, first sentence, of Directive 78/660/EEC or the holding, directly or indirectly, of 20 % or more of the voting rights or capital of an undertaking.
  • Reinsurance undertaking: an undertaking, other than an insurance undertaking or a non-member-country insurance undertaking, the main business of which consists in accepting risks ceded by an insurance undertaking, a non-member-country insurance undertaking or other reinsurance undertakings.
  • Insurance Holding Company: a parent undertaking the main business of which is to acquire and hold participations in subsidiary undertakings, where those subsidiary undertakings are exclusively or mainly insurance undertakings, reinsurance undertakings or non-member-country insurance undertakings, one at least of such subsidiary undertakings being an insurance undertaking.
  • Non-member-country insurance undertaking: an undertaking which would require authorisation in accordance with Article 6 of Directive 73/239/EEC if it had its registered office in the Community.
  • Competent authorities: the national authorities which are empowered by law or regulation to supervise insurance undertakings.

References

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

Directive 98/78/EC

5.12.1998

5.6.2000

OJ L 330 of 5.12.1998
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 2002/87/EC

11.2.2003

10.8.2004

OJ L 35 of 11.2.2003

Directive 2005/1/EC

13.4.2005

13.5.2005

OJ L 79 of 24.3.2005

Directive 2005/68/EC

10.12.2005

10.12.2007

OJ L 323 of 9.12.2005

Successive amendments and corrections to Directive 98/78/EC have been incorporated in the basic text. This consolidated version  is for reference purpose only.

Related Acts

Council Directive 2005/68/EC of 16 November 2005 on reinsurance and amending Council Directives 73/239/EEC, 92/49/EEC as well as Directives 98/78/EC and 2002/83/EC [Official Journal L 323 of 9.12.2005].

This Directive specifically mentions Directive 98/78/EC in Article 59 and provides for specific amendments in the fields of “supplementary supervision of insurance and reinsurance undertakings” (application, scope and competent authorities). Specific rules are laid down for access to information, cooperation between competent authorities and intra-group transactions.

Biocides

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Biocides

Outline of the Community (European Union) legislation about Biocides

Topics

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

Food safety > Contamination and environmental factors

Biocides (until 1 September 2013)

Document or Iniciative

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

Summary

Scope

The Directive concerns:

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

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

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

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

Obligations of the Member States

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

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

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

Principle of mutual recognition of authorisations

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

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

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

Conditions governing the granting of authorisations

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

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

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

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

Placing on the market of active substances

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

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

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

Inclusion of a new active substance in the Annex

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

Cancellation of an authorisation

An authorisation is cancelled if:

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

Modification of an authorisation

An authorisation may be modified:

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

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

Procedure for requesting authorisation

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

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

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

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

Provisions applicable to a biocidal product that has already been authorised

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

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

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

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

Exemptions

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

Role of the Commission

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

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

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

Research and development

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

Classification, packaging and labelling

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

Safety measures

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

Confidentiality

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

Safeguard clause

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

Advertising

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

Comitology

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

References

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

Directive 98/8/EC

14.5.1998

13.5.2000

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

Regulation (EC) No 1882/2003

20.11.2003

–

OJ L 284 of 31.10.2003

Directive 2007/47/EC

11.10.2007

21.12.2008

OJ L 247 of 21.9.2007

Directive 2008/31/EC

21.3.2008

–

OJ L 81 of 20.3.2008

Directive 2009/107/EC

26.10.2009

14.5.2010

JO L 262 du 6.10.2009

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

LAST AMENDMENTS TO THE ANNEXES

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

Related Acts

Evaluation of active substances

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

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

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

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

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

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

Application of the legislation

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

Another Normative about Biocides

Topics

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

Food safety > Plant health checks

Biocides

Document or Iniciative

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

Summary

This Regulation applies to:

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

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

Conditions for authorisation of biocidal products

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

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

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

National authorisation and mutual recognition

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

Union authorisation

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

Simplified authorisation procedure

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

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

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

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

Treated articles

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

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

References

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

Regulation (EC) No 528/2012

17.7.2012

–

OJ L 167 of 27.6.2012

Another Normative about Biocides

Topics

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

Food safety > Contamination and environmental factors

Biocides

Document or Iniciative

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

Summary

This Regulation applies to:

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

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

Conditions for authorisation of biocidal products

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

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

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

National authorisation and mutual recognition

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

Union authorisation

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

Simplified authorisation procedure

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

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

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

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

Treated articles

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

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

References

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

Regulation (EC) No 528/2012

17.7.2012

–

OJ L 167 of 27.6.2012