Tag Archives: Health control

African swine fever

Outline of the Community (European Union) legislation about African swine fever

Topics

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

Food safety > Animal health

African swine fever

Document or Iniciative

Council Directive 2002/60/EC of 27 June 2002 laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever [See amending acts].

Summary

The Directive lays down the minimum control measures where African swine fever is suspected or confirmed.

Any suspected or confirmed case of the disease must be notified to the competent authority. The Member State concerned informs the Commission and the other Member States of cases of swine fever, outbreaks of the disease and the results of epidemiological inquiries.

Suspected cases of African swine fever on a holding

Where a case is suspected, the Member State must immediately open an official investigation to confirm or rule out the presence of the disease. If the presence of African swine fever on a holding cannot be ruled out, the holding must be placed under official surveillance and restrictions must be placed on the movement of pigs, carcasses, and products that might spread the disease, as well as the movement of persons and vehicles to and from the holding.

An epidemiological inquiry must be carried out.

Confirmation of African swine fever on a holding

If the presence of African swine fever is officially confirmed, all the pigs on the holding are to be killed and their carcasses processed. All material (meat, semen, ova) or waste that might be contaminated must be destroyed, processed or treated to ensure destruction of the virus.

In the case of holdings consisting of two or more separate production units, derogations may be granted for healthy production units on specific, strict conditions.

In addition, all premises, vehicles and equipment that might be contaminated must be cleaned and disinfected under official supervision.

The competent authority must also establish around the outbreak site:

a protection zone with a radius of at least three kilometres, itself included in a
surveillance zone of a radius of at least 10 kilometres.

Special security measures must be implemented in these zones, in particular a census of all the holdings, a ban on the movement and transport of pigs and cleansing and disinfection measures. The competent authority may authorise, on strict conditions, the removal of pigs from a holding in the surveillance or protection zones within no less than 30 and 40 days respectively after the completion of the preliminary cleansing and disinfection, and, if necessary, disinsectisation of the infected holding.

Where African swine fever is suspected or confirmed in a slaughterhouse or means of transport

Where there is a suspicion of the disease, it must be officially confirmed or ruled out.

Where the presence of the disease is confirmed, all susceptible pigs must be killed and all material (carcases, offal and waste) from animals that might be contaminated must be processed to ensure that the virus is destroyed.

Cleansing, disinfection and, if necessary, disinsectisation of buildings and equipment, including vehicles, must take place under official supervision.

An epidemiological inquiry is carried out. The measures provided for in suspected cases are carried out on contact holdings *. The measures provided for in confirmed cases are applied on the holding of origin of the infected pigs.

Pigs may not be introduced into a holding, slaughterhouse or vehicle that has been affected by the disease until after a minimum period.

Where African swine fever is suspected or confirmed in feral pigs

Where the disease is suspected in feral pigs, the Member State must take all appropriate measures to confirm or rule out the presence of the disease.

Where African swine fever is confirmed in feral pigs, the competent authority of the Member State concerned must establish an expert group to provide assistance, which then defines the infected area and establishes the measures to be applied.

The Member State must immediately place pig holdings in the defined area under official surveillance and order that an official census be carried out of all categories of pigs on all holdings, all pigs on holdings be kept isolated from feral pigs and no pigs enter or leave holdings, except where authorised.

Within 90 days of confirmation of a case of African swine fever, Member States must submit to the Commission a plan of the measures to be taken to eradicate the disease in the infected area. When they have been approved by the Commission, these measures replace those laid down previously. 18. Every six months, the Member State concerned must send the Commission and the other Member States a report concerning the results of the eradication plan and the epidemiological situation in the defined area.

Diagnostic procedures

A diagnostic manual sets out all obligations, criteria and procedures to be applied to diagnostic tests and clinical examinations. These operations must take place exclusively in approved national laboratories.

Each Member State shall designate a national laboratory and then communicate the contact details for their laboratory to the other Member States and to the public. This laboratory is responsible for coordinating the standards and methods of diagnosis aiming at detecting the presence of African swine fever. All national laboratories shall work in cooperation with the Community Reference Laboratories located in Valdeolmos (Spain).

Vectors and vaccines

To prevent any risk of propagation, investigations and measures to eradicate the vectors of the disease (ticks) must be carried out on holdings on which it is confirmed.

The use of African swine fever vaccines is prohibited in the territory of the European Union.

Contingency plans

Each Member State must draw up a contingency plan specifying the national measures to be implemented in the event of an outbreak of African swine fever. The plan is to be drawn up in accordance with the criteria and requirements set out in the Directive.

Member States must ensure that a fully functional national disease control centre can be immediately set up in the event of any outbreaks of African swine fever.

Context

This Directive fills a gap in the control of the most dangerous animal diseases. It is based on the rules on classical swine fever adopted in 2001.

Key Terms of the Act
Contact holding: a holding where African swine fever may have been introduced, whether as a result of the location, movement of persons, pigs or vehicles or in any other way.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 2002/60/EC	9.8.2002	30.6.2003	OJ L 192 of 20.7.2002

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 2008/73/EC	3.9.2008	1.1.2010	OJ L 219 of 14.8.2008

Successive amendments and corrections to Directive 2002/60/EC have been incorporated into the basic text. This consolidated version is for reference purposes only.

Related Acts

Commission Decision 2003/422/CE of 26 May 2003 approving an African swine fever diagnostic manual [notified under number C(2003) 1696] [Official Journal L 143 of 11.6.2003].

This summary is for information only. It is not designed to interpret or replace the reference document, which remains the only binding legal text.

Feed hygiene

Leave a reply

Feed hygiene

Outline of the Community (European Union) legislation about Feed hygiene

Topics

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

Food safety > Animal nutrition

Feed hygiene

Document or Iniciative

Regulation 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene [See amending act(s)].

Summary

This Regulation requires feed business operators to comply with obligations relating to hygiene and traceability and the registration and approval of their establishments. The objective is to achieve a high level of protection of human and animal health, notably by ensuring that feed is safe and of good quality.

Scope

The Regulation applies to the activities of feed business operators, starting with primary production of feed * up to and including its placing on the market and imports of products intended for animal nutrition from third countries. This also includes the feeding of food-producing animals.

The following are excluded from the scope of this Regulation:

the private domestic production of feed for food-producing animals intended for private domestic consumption and for animals not intended for food production, and the feeding of these animals;
the direct supply of small quantities of primary products at local level by the producer to local farms;
the retailing of pet food.

Obligations incumbent on operators

Feed business operators responsible for the primary production of feed must take the measures necessary to prevent, eliminate or reduce feed safety hazards during the production, preparation, cleaning, packaging, storing and transport of these products (Annex I). These operators must keep records relating to measures put in place to control contamination hazards.

Feed business operators other than at the level of primary production of feed must adopt appropriate measures to guarantee the safety of the products that they manufacture, transport or use. These measures are detailed more precisely than those concerning the primary production of feed (Annex II) and chiefly concern facilities and equipment used by the operators, staff training, the organisation and monitoring of different stages of production, and the documents which the operators must keep.

Feed business operators other than at the level of primary production of feed must apply HACCP principles (hazard analysis and critical control points) and must keep documents demonstrating that they respect these principles.

These principles prescribe a certain number of requirements to be met throughout the cycle of production, processing and distribution in order to permit, via hazard analysis, identification of the critical points which need to be kept under control in order to guarantee food safety:

identify any hazards that must be prevented, eliminated or reduced to acceptable levels;
identify the critical control points at the step or steps at which control is essential;
establish critical limits beyond which intervention is necessary;
establish and implement effective monitoring procedures at critical control points;
establish corrective actions when monitoring indicates that a critical control point is not under control;
implement own-check procedures to verify whether the measures adopted are working effectively;
keep records to demonstrate the effective application of these measures and to facilitate official controls by the competent authority.

Feed business operators are responsible for any infringement of the law governing feed safety. In order to prepare an effective system of financial guarantees for operators in this sector, the Commission presents a report on financial guarantees in the feed sector to the European Parliament and the Council (see “Related Acts”).

Feed business operators (including those responsible for the primary production of feed) must register their establishments with the competent authority of their Member State. They must provide the authority with up to date information and cooperate with it in the event of controls.

Where required by national or Community legislation, businesses in the food sector must be approved by the competent authority and may not operate without such approval. The competent authority of each Member State must keep a list of approved establishments. When an approved establishment no longer complies with the requirements governing its activities, the approval may be temporarily suspended or revoked.

Operators who import products from third countries must ensure that:

the country concerned is included in a list drawn up pursuant to Regulation (EC) No 882/2004 on official controls of food and feed;
the supplier is entered in a list kept by the third country testifying to the firm’s conformity with Community hygiene standards or equivalent standards.

Guides to good practice

The Member States encourage the preparation of national guides to good practice in the feed sector and national guides on the application of HACCP principles. Member States must assess such national guides to ensure that their contents are practicable, that they have been developed taking into account the appropriate principles of the Codex Alimentarius and that all interested parties have been consulted. National guides deemed to be in conformity are forwarded to the Commission, which enters them in a register.

Standardised Community guides may be prepared if the Commission considers this advisable. The Standing Committee on the Food Chain ensures that the content of such guides is practicable, that they have been prepared taking into account the appropriate principles of the Codex Alimentarius, and that the national guides and all the interested parties have been consulted.

BACKGROUND

Regulation (EC) No 178/2002 constitutes the cornerstone of the new European legislation on food safety. Adopting the “from farm to table” approach, it aims, by drawing on the latest scientific opinions, to guarantee a high standard of health and safety throughout the food chain. This approach also covers the entire animal feed chain, including the primary production of feed (which is not covered by the old legislation), animal nutrition and the production of feed.

Following the recent health crises and the occurrences of contamination of animal feed and feed materials (bovine spongiform encephalopathy, dioxin, hormones, etc.), the European Union is equipped with an appropriate legal instrument to ensure safety of all kinds of feed, to ensure that all feed businesses operate in accordance with harmonised hygiene requirements, and to improve traceability.

The Regulation replaces Directive 95/69/EC.

Key terms used in the act
Primary production of feed: production of agricultural products, notably including cultivation, harvesting, milking, breeding (before slaughter) or fishing, terminating exclusively in products which have not been subjected to any other processing after harvesting, gathering or capture, with the exception of simple physical processing.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 183/2005	8.02.2005	–	OJ L 35 of 8.02.2005

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 219/2009	20.4.2009	–	OJ L 87 of 31.3.2009

Related Acts

Report from the Commission to the European Parliament and the Council on existing legal provisions, systems and practices in the Member States and at Community level relating to liability in the food and feed sectors and on feasible systems for financial guarantees in the feed sector at Community level in accordance with Article 8 of Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene [COM(2007) 469 – Not published in the Official Journal].

This report consitutes the basis for a system of financial guarantees for feed business operators. On the basis of Regulation (EC) No 183/2005, which assigns to operators financial liability for infringements of Community legislation on the safety of animal feed, this report analyses the different guarantee options which could ensure enforcement of this liability in the framework of an efficient system. With this aim, the report takes account of the role of compulsory and optional insurance, bank guarantees and sectoral pooling systems. The report underlines the complexity of the problem and proposes launching a wide-ranging public debate on the various options. This debate is to take place over the two years following publication of the report and will take the opinions of all stakeholders into consideration.

Intra-Community trade and imports of certain animals and their semen, ova and embryos

Leave a reply

Intra-Community trade and imports of certain animals and their semen, ova and embryos

Outline of the Community (European Union) legislation about Intra-Community trade and imports of certain animals and their semen, ova and embryos

Topics

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

Food safety > Veterinary checks animal health rules food hygiene

Intra-Community trade and imports of certain animals and their semen, ova and embryos

Document or Iniciative

Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC [See amending acts].

Summary

The Directive lays down the animal health requirements for the trade and import in the European Union (EU) of live animals, sperm, ova and embryos which are not covered by specific Community legislation (as is already the case for cattle and swine, equidae, sheep and goats, poultry and hatching eggs, certain live ungulates, as well as for aquaculture products).

Species covered by the Directive

The Directive lays down the animal health requirements applicable to trade in zoo animals, ungulates and birds which are not covered by other specific Directives, camelidae, bees, lagomorphs, minks, foxes, etc., as well as the trade in pet animals such as cats, dogs and ferrets. In order to be the subject of trade, ferrets, cats and dogs must meet the conditions provided for in Regulation (EC) No 998/2003 on the non-commercial movement of pet animals. For the latter category of animals, Finland, Ireland, Malta, the United Kingdom and Finland require additional guarantees. They may, for example, in certain cases, keep their national rules on quarantine for animals susceptible to rabies.

The Directive also lays down the animal health requirements applicable to trade in semen, ova and embryos of certain animals like equidae, sheep and goats.

Controls and penalties

Checks are carried out in accordance with the provisions of Council Directive 90/425/EEC applicable to intra-Community trade in live animals and their sperm, ova and embryos.

The Member States must take administrative or penal measures to penalize infringements of the Directive.

Live animals and their sperm, ova and embryos covered by this Directive and coming from third countries are subject to the minimum requirements laid down in Directive 97/78/EEC CEE concerning veterinary checks applicable to products from third countries.

Authorised imports

Imports from third countries are authorized provided they offer guarantees equivalent to those required in intra-Community trade. Conditions concerning the veterinary certificate, checks and transport are laid down, and animals must be quarantined prior to importation.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 92/65/EEC	29.7.1992	1.1.1994	OJ L 268 of 14. 9. 1992

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 998/2003	3.7.2003	–	OJ L 146 of 13. 6. 2003
Directive 2004/68/EC	20.5.2004	19.11.2005	OJ L 139 of 30.4. 2004
Directive 2008/73/EC	3.9.2008	1.1.2010	OJ L 219 of 14.8.2008

AMENDMENTS TO THE ANNEXES

Annex A – Notifiable diseases
Regulation (EC) No 1282/2002 [Official Journal L 187 of 16.7.2002];
Regulation (EC) No 1398/2003 [Official Journal L 198 of 6.8.2003].

Annex C – Conditions governing approval of bodies, institutes or centres
Decision 95/176/EC [Official Journal L 117 of 24.5.1995];
Regulation (EC) No 1282/2002 [Official Journal L 187 of 16.7.2002].

Annex D – Conditions governing semen collection and storage centres and embryo collection and production teams
Decision 95/176/EC [Official Journal L 117 of 24.5.1995];
Regulation (EU) No 176/2010 [Official Journal L 52 of 3.3.2010].

Annex E – Health certificate templates
Regulation (EC) No 1282/2002 [Official Journal L 187 of 16.7.2002];
Decision 2010/270/EU [Official Journal L 118 of 12.5.2010];
Decision 2010/684/EU [Official Journal L 293 of 11.11.2010].

Annex F – Trade and imports of animals, sperm, ova and embryos not subject to specific legislation
Directive 2004/68/EC [Official Journal L 139 of 30.4.2004].

Related Acts

Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements [Official Journal L 73 of 20.3.2010].

Commission Regulation (EC) No 1739/2005 of 21 October 2005 laying down animal health requirements for the movement of circus animals between Member States [Official Journal L 279 of 22.10.2005].

Quality and safety standards for human blood and blood components

Leave a reply

Quality and safety standards for human blood and blood components

Outline of the Community (European Union) legislation about Quality and safety standards for human blood and blood components

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

Quality and safety standards for human blood and blood components

Document or Iniciative

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 [See amending acts].

Summary

The purpose of this Directive is to set standards of quality and safety for blood * and blood components * throughout the blood transfusion chain. To this end, it applies to the collection and testing of human blood and blood components, irrespective of their final destination. It also applies to the processing, storage and distribution * of human blood and blood components intended for transfusion.

Obligations incumbent upon the authorities of the Member States

With regard to the licensing of blood establishments, Member States shall ensure that activities relating to the collection and testing of human blood and blood components are undertaken only by the blood establishments * which have been designated, authorised, accredited or licensed by the competent authority for that purpose.

All the information to be provided by blood establishments to the competent authority for the purposes of designation, authorisation, accreditation or licensing is specified in Annex I. This includes general information (identification of the blood establishment, qualifications and contact details of responsible persons, etc.) and a description of the quality system (quality manual, qualifications of personnel, hygiene provisions, details of procedures for assessment of donors, etc.).

The competent authority must organise inspections * and appropriate control measures in blood establishments at least once every two years. It must also organise appropriate measures in the event of any serious adverse event * or reaction or suspicion thereof.

Responsible person

Blood establishments must designate a person responsible for:

ensuring that every unit of blood or of blood components has been collected and tested and, when intended for transfusion, has been prepared, stored and distributed in compliance with the laws in force in the Member State;
communicating to the competent authority the information necessary for the designation, authorisation, accreditation or licensing procedure;
implementing the requirements relating to quality management in blood establishments (cf. below).

These various tasks may be delegated to other persons who possess the necessary qualifications and experience.

The Directive stipulates minimum conditions of qualification for the person responsible for the blood establishment (university-level qualification in the field of medical or biological sciences and at least two years’ post-graduate practical experience).

The personnel of the establishment must also possess the necessary qualifications and receive relevant and regular training.

Quality management

A quality system based on the principles of good practice must be introduced by each blood establishment and hospital blood banks *. The Commission is responsible for establishing the Community standards and specifications relating to this system.

With regard to documentation and record-keeping, the blood establishments must keep the following up to date:

documentation on operational procedures, guidelines, training and reference manuals, and reporting forms;
records of the information required in Annexes II (report concerning the preceding year’s activity) and IV (basic testing requirements for whole blood and plasma donations).

The competent authority must keep records of applications made by establishments for accreditation, provisions relating to existing establishments and notifications of any serious adverse reactions or events.

Haemovigilance *

The traceability of blood and blood components, from donor to recipient and vice versa, must be guaranteed. In order to ensure full traceability, blood establishments and hospital blood banks must implement a system permitting unmistakable identification of each single blood donation and each unit of blood and components thereof.

A system permitting an equivalent level of traceability must be operated with regard to blood and blood components imported from third countries.

Product labelling must match the requirements listed in Annex III.

Any serious adverse events must be notified to the competent authority. Blood establishments and hospital blood banks must have in place a procedure for the efficient withdrawal from distribution of blood or blood components associated with a serious adverse event.

Conditions relating to donations and donors in order to ensure the quality and safety of blood and blood components

Donors must be provided with certain information when giving blood. This includes information on the characteristics of blood and blood products, and an undertaking by the blood collection centre to contact the donor if the results of the tests reveal any form of pathology.

Certain information must be obtained from donors, for example their identification, their state of health and medical history, and a signature confirming that the donor has read and understood the information provided.

The donor is subject to an evaluation procedure and must satisfy the criteria concerning physical suitability, such as age, and donation criteria, such as the time interval between donations. Permanent deferral criteria are also drawn up in order to protect both the donor and the recipient (for example in case of diseases that could place either the donor or the recipient in danger).

An examination of the donor, including an interview, shall be carried out before any donation of blood or blood components.

Measures must be taken to encourage voluntary and unpaid blood donations, with a view to ensuring that blood and blood components are as far as possible provided from such donations.

Each donation of blood or blood components must undergo certain tests (listed in Annex IV). The same applies to blood or blood components imported into the Community.

Data protection and confidentiality

All data, including genetic information, must be rendered anonymous so that the donor is no longer identifiable.

Community code relating to medicinal products for human use

This Directive amends the Community code relating to medicinal products for human use in order to ensure that the safety and quality standards are the same whatever the intended purpose of blood or blood components, including their use as raw materials in the production of medicinal products.

Background

The purpose of this Directive is to set standards of quality and safety for blood and blood components throughout the blood transfusion chain in the European Union (EU). It is a response not only to the need to protect public health but also to the need to ensure that the internal market functions properly by facilitating the movement of these products within the EU.

Key terms used in the act
Blood component: a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods (centrifugation, filtration and freezing). Hospital blood bank: a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities. Distribution: the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusion. Blood establishment: any structure or body that is involved in any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion. Haemovigilance: a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors. Serious adverse event: any untoward occurrence associated with the collection, testing, processing, storage and distribution of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity. Inspection: formal and objective control according to adopted standards to assess compliance with this Directive and other relevant legislation and to identify problems. Blood product: any therapeutic product derived from human blood or plasma. Blood: whole blood collected from a donor and processed either for transfusion or for further manufacturing. Autologous transfusion: a transfusion in which the donor and the recipient are the same person and in which pre-deposited blood and blood components are used.

Key terms used in the act

Blood component: a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods (centrifugation, filtration and freezing).
Hospital blood bank: a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities.
Distribution: the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusion.
Blood establishment: any structure or body that is involved in any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion.
Haemovigilance: a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors.
Serious adverse event: any untoward occurrence associated with the collection, testing, processing, storage and distribution of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity.
Inspection: formal and objective control according to adopted standards to assess compliance with this Directive and other relevant legislation and to identify problems.
Blood product: any therapeutic product derived from human blood or plasma.
Blood: whole blood collected from a donor and processed either for transfusion or for further manufacturing.
Autologous transfusion: a transfusion in which the donor and the recipient are the same person and in which pre-deposited blood and blood components are used.

References

Act	Entry into force – Date of expiry	Deadline for transposition in the Member States	Official Journal
Directive 2002/98/EC	8.2.2003	8.2.2005	OJ L 33 of 8.2.2003

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

Related Acts

Implementing measures

Commission Directive 2009/135/EC of 3 November 2009 allowing temporary derogations to certain eligibility criteria for whole blood and blood components donors laid down in Annex III to Directive 2004/33/EC in the context of a risk of shortage caused by the Influenza A(H1N1) pandemic [Official Journal L 288 of 4.11.2009].
This implementing Directive, applicable until 30 June 2009, gave Member States the possibility to derogate exceptionally and conditionally from certain eligibility criteria for blood donors in order to guarantee blood supply in the case of an Influenza A(H1N1) pandemic, whilst ensuring the health of blood and blood component donors and recipients is protected.

Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments [Official Journal L 256 of 1.10.2005].

This implementing Directive lays down the specific technical requirements for a quality system for blood establishments.
Member States must ensure that the quality system in place in all blood establishments and hospital blood banks complies with the Community standards and specifications set out in the Annex to the Directive.

Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events [Official Journal L 256 of 1.10.2005].

This implementing Directive lays down the technical requirements to ensure traceability of blood and blood components from the donor to the recipient, and the procedures.
Member States must ensure that the systems and procedures for traceability and notification of serious adverse reactions in place at national level and in all blood establishments and hospital blood banks comply with the Community standards and specifications set out in the Annex to the Directive.

Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components [Official Journal L 91 of 30.3.2004].
In application of Directive 2002/98/EC, this text provides more detailed information, criteria and requirements relating to donations and donors, storage, transport and distribution of blood and blood components and to the quality and safety of blood and blood components.

Implementation reports

Communication from the Commission of 19 January 2010 to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2002/98/EC 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 [COM(2010) 3 final – Not published in the Official Journal].

This Communication reports a satisfactory implementation of Directive 2002/98/EC. Member States have now successfully designated and set up their competent authorities, as well as inspection systems, control measures and haemovigilance systems.
However, Member States must pursue the finalisation of the accreditation/designation/authorisation/licensing process for all blood establishments.
The Commission encourages the good practice of collecting reports on blood establishments in the preceding year. These reports could be a valuable source of information for both regulators and citizens.

Report from the Commission of 19 June 2006 – First report on the application of the Blood Directive [COM(2006) 313 final – Not published in the Official Journal].
This report sets out the measures adopted by the Member States in application of the Blood Directive. It covers the 15 Member States which belonged to the EU on 31 December 2003.
The report points out that ten Member States adopted more stringent protective measures than those provided for in the Directive, particularly with regard to donor selection, biological control of donations and haemovigilance.
The document describes the application, at national level, of the Directive’s provisions relating to:

the obligations of the competent national authorities, in particular those relating to inspection and control;
blood establishments and the obligation to designate a responsible person with at least the minimum qualifications;
quality management in each blood establishment;
haemovigilance;
the quality and safety of blood and blood components;
data protection.

Report from the Commission of 17 May 2006 on the promotion by Member States of voluntary unpaid blood donations [COM(2006) 217 final – Not published in the Official Journal].
This report summarises the measures taken by Member States to encourage voluntary unpaid donations (allowances, possibility of time off work, information campaigns, awareness programmes, etc.).
It also presents the measures the Commission intends to take in order to promote self-sufficiency in human blood and human plasma in the European Community. Such measures include:

a Europe-wide study to identify best practices with a view to developing a methodology and basic set of principles for awareness campaigns;
continuation of the discussion on self-sufficiency in the Community with an examination of the question of the optimal use of blood.

Executive Agency for Health and Consumers

Leave a reply

Executive Agency for Health and Consumers

Outline of the Community (European Union) legislation about Executive Agency for Health and Consumers

Topics

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

Food safety > Food safety: general provisions

Executive Agency for Health and Consumers

Document or Iniciative

Commission Decision 2008/544/EC of 20 June 2008 amending Decision 2004/858/EC in order to transform the “Executive Agency for the Public Health Programme” into the “Executive Agency for Health and Consumers”.

Summary

The Executive Agency for Health and Consumers was established on 20 June 2008 under Regulation 58/2003 laying down the statute for European Union executive agencies. It replaces the Executive Agency for the Public Health Programme (PHEA). It was established in Luxembourg for the period 1 January 2005 until 21 December 2015.

The Agency is responsible for implementing the programmes of Community action in the field of health 2003-2008 and 2008-2013, the programme of Community action in the field of Consumer policy for 2007-2013 and food safety training measures, with regard to the legislation on foodstuffs, animal feeds, animal health and animal welfare, as well as plant health rules.

The detailed tasks of the Agency were defined in the Commission decision delegating authority to the Agency adopted on 9 September 2008. Its general mission is to:

manage and supervise the life cycle of the projects;
adopt the instruments of budget implementation and implement the programmes and measures;
produce reports to help the Commission evaluate the programmes and measures.

Function and management

Management of the Agency is provided by a Steering Committee of 5 members and a director. The Commission shall appoint them for a renewable term of office for two years and four years respectively. The Agency is accountable to the Commission for the programmes’ performance.

Finance

For its running costs the Agency receives subsidies entered in the general budget of the European Communities. They are distributed from the funds allocated to the Public Health Programme 2008-2013, the Consumer Programme 2007-2014 and the food safety training measures.

References

Act	Entry into force	Transposition into the Member States	Official Journal
Decision 2008/544/EC	20.6.2008	–	OJ L 173 of 3.7.2008

Pesticides

Leave a reply

Pesticides

Outline of the Community (European Union) legislation about Pesticides

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

Pesticides

Document or Iniciative

Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides.

Summary

Pesticides are used in agriculture, to regulate the growth of plants on non-agricultural land, or for other purposes (for example, biocide products used to preserve wood, as disinfectants, and for some domestic uses). They are also used to kill or combat pests.

Scope

This Framework Directive covers only pesticides which are plant protection products. It does not apply to biocide products.

Member States may apply the precautionary principle to restrict or prohibit the use of pesticides in specific circumstances or areas.

National Action Plans

National Action Plans shall contain objectives, measures and timetables to reduce risks of pesticide use on human health and the environment. They should also foster the use of alternative ecological approaches or techniques.

National Action Plans shall also include indicators to monitor the use of plant protection products containing active substances of particular concern.

Training, sales of pesticides, and information

Member States shall set up systems of training for professional users, distributors and advisors. This training shall be sanctioned by the obtaining of a certificate. These certificates shall attest that professional users, distributors and advisors have acquired sufficient knowledge regarding: the legislation in force, the dangers and risks associated with pesticides, means of detection and monitoring, procedures for preparing equipment, emergency action in case of accident, etc.

Persons selling pesticides for professional use must hold the aforementioned certificate.

Member States shall inform the public and promote information and awareness-raising programmes regarding the risks for human health, non-target organisms and the environment arising from pesticide use.

Inspection of pesticide application equipment

Pesticide application equipment used by professionals must be inspected every five years by bodies designated by Member States. From 2020, the frequency of inspections will increase to once every three years. The purpose of these inspections is to check that equipment functions reliably and that it is used properly for its intended purpose, ensuring that pesticides can be accurately dosed and distributed.

These inspections concern the following equipment: power transmission parts, pumps, agitation devices, tanks, measuring systems, control and regulation systems, pipes and hoses, filters, etc.

Aerial spraying of pesticides

The aerial spraying of pesticides is prohibited. Derogations are nevertheless possible where there is no viable alternative, or where aerial spraying has advantages in terms of reduced impacts on human health and the environment as compared with land-based application. If a derogation is granted, measures must be taken as regards information and protection.

Protection of the aquatic environment and drinking water

Member States shall adopt specific measures to protect the aquatic environment and drinking water supplies. These measures give priority to the use of the least toxic products, the most effective techniques, equipment limiting drift of products, and the establishment of buffer zones along surface waters. These measures also aim at reducing or prohibiting spraying near roads or railways, or surfaces likely to be contaminated by the seepage or run-off of surface water or groundwater.

Protection of sensitive areas

In certain sensitive areas, the use of pesticides is prohibited or strictly limited. This measure aims at protecting areas covered by the “Birds” and “Habitats” Directives, and areas used by the general public or by sensitive groups of the population (parks, public gardens, sports grounds, recreation grounds, etc.).

Integrated pest management

Integrated pest management prioritises the least dangerous solutions for health and the environment. Professionals must therefore take into consideration all plant protection methods in order to eradicate pests. They must in particular give priority to those which cause the least disruption to agricultural ecosystems and encourage natural pest control mechanisms. These general principles for integrated pest management will become obligatory from 1 January 2014.

Risk indicators

The Commission establishes harmonised indicators according to statistics collected by the Member States. These indicators allow trends in risks from pesticide use to be estimated.

Member States may use their own national indicators in addition to the indicators harmonised at Community level.

Context

The Framework Directive was originally one of two legislative proposals accompanying the 2006 Communication – A thematic strategy on the sustainable use of pesticides. The other legislative proposal led to the adoption of Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 2009/128/EC	25.11.2009	14.12.2011	OJ L 309 of 24.11.2009

This summary is for information only. It is not designed to interpret or replace the reference document, which remains the only binding legal text.

Good laboratory practice: tests on chemical substances

Leave a reply

Good laboratory practice: tests on chemical substances

Outline of the Community (European Union) legislation about Good laboratory practice: tests on chemical substances

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

Good laboratory practice: tests on chemical substances

Document or Iniciative

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) [See amending act(s)].

Summary

This directive substantially amends and repeals Directive 87/18/EEC on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice (GLP) and the verification of their applications for tests on chemical substances.

The Directive requires Member States to take all measures necessary to ensure that laboratories carrying out tests on chemical products, in accordance with Directive 67/548/EEC, comply with the principles of good laboratory practice (GLP) as laid down in Annex I to this Directive.

It also applies where other Community provisions provide for the application of the principles of GLP to tests on chemical products to evaluate their safety for man and/or the environment.

The tests conducted on these different elements seek to obtain data on their properties and their safety with regard to human health and the environment.

When submitting results, laboratories must certify that the tests were carried out in accordance with the principles of good laboratory practice.

Member States must adopt the measures necessary for verification of compliance with the principles of good laboratory practice including, in particular, inspections and checks conducted in accordance with the recommendations of the Organisation for Economic Cooperation and Development (OECD) in this area.

Member States may not, on grounds relating to the principles of GLP, prohibit, restrict or impede the placing on the market of chemical products if the principles applied are in conformity with this directive.

Should a Member State establish that the application of the principles of GLP and the verification of their application for tests on chemical substances show that, although a chemical substance has been examined in accordance with the requirements of this Directive, it presents a danger to man or the environment, the Member State may provisionally prohibit or make subject to special conditions the marketing of that product on its territory.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 2004/10/EC	11.03.2004	–	OJ L 50 of 20.02.2004

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 219/2009	20.4.2009	–	OJ L 87 of 31.3.2009

Related Acts

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [Official Journal L 396 of 30.12.2006].

Good laboratory practice: inspection and verification of laboratory studies on all chemicals

Leave a reply

Good laboratory practice: inspection and verification of laboratory studies on all chemicals

Outline of the Community (European Union) legislation about Good laboratory practice: inspection and verification of laboratory studies on all chemicals

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

Good laboratory practice: inspection and verification of laboratory studies on all chemicals

Document or Iniciative

Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) [See amending act(s)].

Summary

This Directive amends and repeals Directive 88/320/EEC on the inspection and verification of Good Laboratory Practice.

It applies to the inspection and verification of the organisational processes and the conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing, carried out in accordance with the rules and regulations, of all chemicals (e.g. cosmetics, industrial chemicals, medicinal products, food additives, animal feed additives, pesticides) in order to assess the effect of such products on man, animals and the environment.

Each Member State designates the authorities responsible for the inspection of laboratories within its territory.

Each year, the Member States forward to the Commission and to a Committee set up by the Directive a report listing the laboratories inspected, the date of the inspection and the conclusions of the inspection.

If the inspection is positive, the Member State is the guarantor that the laboratory is GLP-compliant and this decision is binding in the other Member States.

If a Member State considers that a laboratory within its territory claiming GLP compliance does not in fact comply, it shall inform the Commission, which shall inform the other Member States. Similarly, a Member State may also request a study audit, possibly in conjunction with a new inspection, of laboratories located in another Member State.

The Annexes to the Directive include a detailed description of the procedures to be followed in monitoring GLP compliance in order to ensure that these are internationally acceptable.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 2004/9/EC	11.03.2004	–	OJ L 50 of 20.02.2004

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 219/2009	20.4.2009	–	OJ L 87 of 31.3.2009

Successive amendments and corrections to Directive 219/2009 have been incorporated in the basic text. This consolidated version is for reference purpose only.