Tag Archives: Scientific research

Protection of laboratory animals

Protection of laboratory animals

Outline of the Community (European Union) legislation about Protection of laboratory animals

Topics

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

Food safety > Animal welfare

Protection of laboratory animals

Document or Iniciative

Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes.

Summary

Each year, some 12 million animals are used for scientific purposes. At present, the European Union (EU) is unable to ban the use of animals in safety tests and biomedical research. However, in order to protect laboratory animals and enable research to advance further, the EU is taking measures aimed at limiting animal testing and imposing minimal requirements concerning the housing of animals and the care they receive.

Animals

The scope of this Directive extends to animals used in basic research, education and training. It applies to all live non-human vertebrate animals and also to certain invertebrates which are likely to feel pain (cuttlefish, octopus, etc.).

The use of non-human primates is subject to restrictions and the use of great apes (chimpanzees, bonobos, gorillas and orangutans) is forbidden. Great apes may be used only in exceptional circumstances in order to ensure the survival of the species or in the case of an unexpected outbreak of a life-threatening or debilitating disease in human beings.

Fields subject to animal testing

Animal testing can be authorised only in procedures for which the purpose is:

  • basic research;
  • translational or applied research concerning:
    1. the avoidance, prevention, diagnosis or treatment of disease or abnormalities in human beings, animals or plants;
    2. the assessment, detection, regulation or modification of physiological conditions in human beings, animals or plants;
    3. the welfare of animals and the improvement of stock breeding for agricultural purposes;
  • the development, manufacture or testing of the quality, effectiveness and safety of drugs, foodstuffs and feed-stuffs, etc. for any of the aims above;
  • environmental protection and biodiversity;
  • higher education or vocational training.

Projects

The use of animals for experimental purposes is authorised in cases where no satisfactory substitute method exists, in accordance with the rule that tests on animals must be replaced, reduced and refined. Projects involving experiments on animals are assessed by the competent authority. No project may begin until it has received a positive assessment from the competent authority. This assessment must demonstrate that the use of animals is justified and that the expected advantages outweigh the harm caused to the animals.

The number of animals used in a project must be reduced to a minimum without however compromising the objectives of the project. The living conditions and methods employed in the procedures must prevent as far as possible any pain, suffering or distress to the animals.

Animal welfare

Animals used for experimental purposes must receive appropriate care and treatment. They must be housed in cages which are big enough for them and in an environment which is adapted to each species, in accordance with the standards listed in Annex III to the Directive.

The methods of killing must limit the pain, suffering and distress felt by the animals. Animals may be killed only by a person with the required skills in the establishment of the breeder, supplier or user, in accordance with the methods listed in Annex IV to the Directive.

Procedures

The only authorised procedures are those which have been approved as part of a project. They are classified according to their degree of severity in accordance with Annex VIII to the Directive. They must be carried out under anaesthetia or using another method (analgesia, etc.) except if that is not appropriate or if anaesthetia is judged to be more traumatic to the animal than the procedure itself. As far as possible, the life of the animal must be spared. The procedures are designed to result in the death of as few animals as possible and to reduce the duration and intensity of suffering.

Reusing an animal is a way of reducing the total number of laboratory animals. Before reusing an animal, the severity of the cumulated procedures, the health of the animal and the opinion of the veterinarian must be taken into account.

At the end of a procedure, the veterinarian or a competent person shall decide if the animal can be kept alive. Animals kept alive shall receive appropriate care and accommodation as defined in Annex III.

Authorisation

Breeders, suppliers and users and their establishments must be authorised by a competent authority and registered with it.

Authorised establishments must have installations and equipment adapted to the species of animals housed and the performance of the procedures (where they are carried out).

Each animal introduced into an establishment must be provided with an identification mark and registered in the animal records (including information on the number, species, origin, date of sale, date of acquisition, etc.). These records are kept for five years and made available to the public.

Furthermore, each dog, cat and non-human primate must have an individual history file containing relevant reproductive, veterinary and social information on the individual animal and the projects in which it has been used.

Inspections

The competent authorities carry out regular inspections of all breeders, suppliers and users and their establishments in order to ensure compliance with the requirements of this Directive.

The frequency of inspections is determined by the risks specific to each establishment. However, at least one third of the establishments of users are inspected each year and an appropriate proportion of the inspections shall be carried out without prior warning.

Breeders, suppliers and users of non-human primates are inspected at least once a year.

Context

This Directive replaces Directive 86/609/EC from 1 January 2013.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2010/63/EU

9.11.2010

10.11.2012

OJ L 276 of 20.10.2010

Healthy diet for a healthy life

Healthy diet for a healthy life

Outline of the Community (European Union) legislation about Healthy diet for a healthy life

Topics

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

Public health > Health determinants: lifestyle

Healthy diet for a healthy life

Document or Iniciative

Commission Recommendation No 2010/250/EU of 28 April 2010 on the research joint programming initiative “A healthy diet for a healthy life”.

Summary

Through this Recommendation, the European Commission invites Member States to develop and implement a common strategy for the prevention of diet-related diseases.

What are the risks related to poor diet?

Overweight and obesity may lead to conditions such as:

  • cardiovascular disease;
  • hypertension;
  • type 2 diabetes;
  • strokes;
  • certain cancers;
  • musculo-skeletal disorders;
  • certain mental health conditions.

However, these risks could be reduced if individuals were to adopt healthy behaviour, particularly in terms of diet. If lifestyle risk factors were eliminated, around 80 % of cases of heart disease, strokes and type 2 diabetes, and 40 % of cancers, could be avoided.

Which measures are Member States invited to put in place?

In order for research in the area of diet-related diseases to be more effective, the Commission invites Member States to develop and implement a strategic research agenda based on a common approach to the prevention of diet-related diseases.

The agenda shall contain an implementation plan establishing priorities and timelines and the action, instruments and resources required.

The strategic research agenda and implementation plan shall include the following actions in particular:

  • identifying and exchanging information on relevant national programmes and research activities;
  • identifying areas or research activities that would benefit from coordination or joint calls for proposals or pooling of resources;
  • exchanging information, resources, best practices, methods and guidelines, while establishing clinical studies;
  • exporting and disseminating knowledge, innovation and interdisciplinary approaches;
  • creating a network between existing specialised centres.

Member States shall set up a common management structure to establish common conditions, rules and procedures for cooperation and coordination. They shall also monitor implementation of the strategic research agenda.

Context

Overweight and obesity have increased greatly among European Union citizens over the past three decades. This trend is becoming more pronounced with time. The Competitiveness Council which met on 3 December 2009 recognised the need to launch a joint programming initiative to be led by Member States and facilitated by the Commission.

Research Executive Agency

Research Executive Agency

Outline of the Community (European Union) legislation about Research Executive Agency

Topics

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

Institutional affairs > The institutions bodies and agencies of the union

Research Executive Agency

Document or Iniciative

Commission Decision 2008/46/EC of 14 December 2007 setting up the ‘Research Executive Agency’ for the management of certain areas of the specific Community programmes People, Capacities and Cooperation in the field of research in application of Council Regulation (EC) No 58/2003.

Summary

This Decision establishes the ‘Research Executive Agency’ for the period 1 January 2008 – 31 December 2017. The Agency, governed by Council Regulation (EC) No 58/2003, is responsible for managing some Community activities in the field of research. The tasks of the Agency fall within the scope of the Seventh Framework Programme (FP7) of the European Community for research, technological development and demonstration activities (2007 to 2013). In particular, they correspond to specific projects implementing the People Specific Programme, the Research for the Benefit of SMEs part of the Capacities Specific Programme, and the Space and Security themes of the Cooperation Specific Programme.

The Agency’s tasks consist of the following:

  • management of parts of the specific programmes listed above;
  • execution of the relevant parts of the budget;
  • collection, analysis and communication of information to guide programme implementation;
  • provision of logistical and administrative support.

The Commission may also entrust the Agency with similar tasks for additional areas of FP7.

The Agency is managed by a Steering Committee and a Director. Both are appointed by the Commission, the first for two years and the latter for four years. The appointments may be renewed.

Financing and supervision

The Agency is financed from funds of the People, Capacities and Cooperation Specific Programmes of FP7. For any additional tasks entrusted under FP7, the financing will come from corresponding funds. The financial regulations are established by the Commission Regulation (EC) No 1653/2004.

The Commission has supervisory authority over the Agency, which is obliged to provide regular progress reports on the implementation of its programmes.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Decision 2008/46/EC

14.12.2007 – 31.12.2017

OJ L 11 of 15.1.2008

The European Research Council Executive Agency

The European Research Council Executive Agency

Outline of the Community (European Union) legislation about The European Research Council Executive Agency

Topics

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

Institutional affairs > The institutions bodies and agencies of the union

The European Research Council Executive Agency

Document or Iniciative

Commission Decision 2008/37/EC of 14 December 2007 setting up the ‘European Research Council Executive Agency’ for the management of the specific Community programme ‘Ideas’ in the field of frontier research in application of Council Regulation (EC) No 58/2003.

Summary

This Decision establishes ‘The European Research Council Executive Agency’ for the period 1 January 2008 – 31 December 2017. Governed by Council Regulation (EC) No 58/2003, the Agency is responsible for the management of Community activity in the field of frontier research.

The tasks of the Agency lie within the scope of the Seventh Framework Programme (FP7) of the European Community for research, technological development and demonstration activities (2007 to 2013). They consist of implementing the FP7 Specific Programme ‘Ideas’ according to the guidelines set by the Commission and the principles and methodology set by the ‘Ideas’ annual work programmes, as adopted from the Scientific Council proposals. In order to fulfil its delegated tasks, the Agency will do the following:

  • award contracts and grants and manage entire life-cycles of projects selected on the basis of the sole criterion of excellence of proposals;
  • adopt budget implementation tasks;
  • collect, analyse and communicate the information needed to implement the Programme.

The Agency is managed by a Steering Committee and a Director, both appointed by the Commission. The Steering Committee is appointed for two years, the Director for four years. The appointments may be renewed.

In accordance with the FP7 Specific Programme ‘Ideas’, the Agency also provides assistance to the Scientific Council of the European Research Council (ERC), as adopted by the Council Decision 2006/972/EC.

Financing and supervision

The finances for the Agency are derived from the funds for the FP7 Specific Programme ‘Ideas’ (2007-13). The operating budget is to be implemented as stipulated by Regulation (EC) No 1653/2004.

The Agency is under the supervisory authority of the Commission, to which it must report regularly on the progress made in the implementation of its programme.

Background

With its Decision 2007/134 of 2 February 2007, the Commission established the ERC to implement the FP7 Specific Programme ‘Ideas’. The ERC comprises an independent Scientific Council, which was set up simultaneously and is composed of 22 high level scientists, and a dedicated implementation structure in the form of the executive agency.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Decision 2008/37/EC

14.12.2007 – 31.12.2017

OJ L 9 of 12.1.2008