1.10.2005   

EN

Official Journal of the European Union

L 256/1

(1)

Regulation (EC) No 3223/94 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in the Annex thereto.

(2)

In compliance with the above criteria, the standard import values must be fixed at the levels set out in the Annex to this Regulation,

1.10.2005   

EN

Official Journal of the European Union

L 256/3

(1)

Article 14(2) of Regulation (EC) No 1784/2003 provides that the export refund applicable to cereals on the day on which an application for an export licence is made must be applied on request to exports to be effected during the period of validity of the export licence. In this case, a corrective amount may be applied to the refund.

(2)

Commission Regulation (EC) No 1501/95 of 29 June 1995 laying down certain detailed rules under Council Regulation (EEC) No 1766/92 on the granting of export refunds on cereals and the cereals and the measures to be taken in the event of disturbance on the market for cereals (2), allows for the fixing of a corrective amount for the products listed in Article 1(1)(c) of Regulation (EEC) No 1766/92 (3). That corrective amount must be calculated taking account of the factors referred to in Article 1 of Regulation (EC) No 1501/95.

(3)

The world market situation or the specific requirements of certain markets may make it necessary to vary the corrective amount according to destination.

(4)

The corrective amount must be fixed at the same time as the refund and according to the same procedure; it may be altered in the period between fixings.

(5)

It follows from applying the provisions set out above that the corrective amount must be as set out in the Annex hereto.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Cereals,

1.10.2005   

EN

Official Journal of the European Union

L 256/5

(1)

Article 13 of Regulation (EC) No 1784/2003 provides that the difference between quotations or prices on the world market for the products listed in Article 1 of that Regulation and prices for those products within the Community may be covered by an export refund.

(2)

The refunds must be fixed taking into account the factors referred to in Article 1 of Commission Regulation (EC) No 1501/95 of 29 June 1995 laying down certain detailed rules under Council Regulation (EEC) No 1766/92 on the granting of export refunds on cereals and the measures to be taken in the event of disturbance on the market for cereals (2).

(3)

The refund applicable in the case of malts must be calculated with amount taken of the quantity of cereals required to manufacture the products in question. The said quantities are laid down in Regulation (EC) No 1501/95.

(4)

The world market situation or the specific requirements of certain markets may make it necessary to vary the refund for certain products according to destination.

(5)

The refund must be fixed once a month. It may be altered in the intervening period.

(6)

It follows from applying these rules to the present situation on markets in cereals, and in particular to quotations or prices for these products within the Community and on the world market, that the refunds should be as set out in the Annex hereto.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Cereals,

1.10.2005   

EN

Official Journal of the European Union

L 256/7

(1)

Article 14(2) of Regulation (EC) No 1784/2003 provides that the export refund applicable to cereals on the day on which application for an export licence is made must be applied on request to exports to be effected during the period of validity of the export licence. In this case, a corrective amount may be applied to the refund.

(2)

Commission Regulation (EC) No 1501/95 of 29 June 1995 laying down certain detailed rules under Council Regulation (EEC) No 1766/92 on the granting of export refunds on cereals and the measures to be taken in the event of disturbance on the market for cereals (2) allows for the fixing of a corrective amount for the malt referred to in Article 1(1)(c) of Regulation (EEC) No 1766/92 (3). That corrective amount must be calculated taking account of the factors referred to in Article 1 of Regulation (EC) No 1501/95.

(3)

It follows from applying the provisions set out above that the corrective amount must be as set out in the Annex hereto.

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Cereals,

1.10.2005   

EN

Official Journal of the European Union

L 256/9

(1)

Article 2 of Council Regulation (EEC) No 2681/74 of 21 October 1974 on Community financing of expenditure incurred in respect of the supply of agricultural products as food aid (3) lays down that the portion of the expenditure corresponding to the export refunds on the products in question fixed under Community rules is to be charged to the European Agricultural Guidance and Guarantee Fund, Guarantee Section.

(2)

In order to make it easier to draw up and manage the budget for Community food aid actions and to enable the Member States to know the extent of Community participation in the financing of national food aid actions, the level of the refunds granted for these actions should be determined.

(3)

The general and implementing rules provided for in Article 13 of Regulation (EC) No 1784/2003 and in Article 13 of Regulation (EC) No 3072/95 on export refunds are applicable mutatis mutandis to the abovementioned operations.

(4)

The specific criteria to be used for calculating the export refund on rice are set out in Article 13 of Regulation (EC) No 3072/95.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Cereals,

1.10.2005   

EN

Official Journal of the European Union

L 256/11

(1)

Commission Regulation (EC) No 1060/2005 (2) opened a standing invitation to tender for the export of 114 757 tonnes of common wheat held by the Slovak intervention agency.

(2)

Slovakia has informed the Commission of its intervention agency’s intention to increase by 33 192 tonnes the quantity put out to tender for export. In view of the quantities available and the market situation, the request made by Slovakia should be granted.

(3)

Regulation (EC) No 1060/2005 should therefore be amended.

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Cereals,

1.10.2005   

EN

Official Journal of the European Union

L 256/12

(1)

Article 1 of Commission Regulation (EC) No 296/96 (2) provides that the Commission is to place at the disposal of the Member States, within the framework of the budget appropriations, the funds needed to cover expenditure to be financed by the Guarantee Section of the European Agricultural and Guidance Fund.

(2)

Article 7(1) of Regulation (EC) No 296/96 provides that expenditure declared in respect of a given month must in general fall within payments and receipts effected during this month. Some exceptions to that principle are provided for.

(3)

To ensure the respect of the budget and to the extent necessary to comply with the provisions of Article 1 of Regulation (EC) No 296/96, it should be possible for Member States to adjust expenditure declarations other than those for measures covered by Council Regulation (EC) No 1257/1999 of 17 May 1999 on support for rural development from the European Agricultural Guidance and Guarantee Fund (EAGGF) (3) and to declare expenditure in respect of the following month.

(4)

Regulation (EC) No 296/96 should therefore be amended accordingly.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the European Agricultural Guidance and Guarantee Fund,

‘(d)

expenditure effected by Member States from 1 to 15 October 2005, other than for measures covered by Council Regulation (EC) No 1257/1999 (4), may, if necessary to comply with the provisions of Article 1, be declared in respect of the month following the month of payment to the beneficiary.

1.10.2005   

EN

Official Journal of the European Union

L 256/13

(1)

Article 4 of Commission Regulation (EEC) No 3149/92 (2) lays down detailed rules for invitations to tender as regards the organisation of supplies in the Member States participating in the Community measure for the distribution of food from intervention stocks for the benefit of the most deprived persons.

(2)

The products to be withdrawn from intervention stocks under the annual plan may be supplied unprocessed or processed for the manufacture of food, or withdrawn in payment for the supply or manufacture of food mobilised on the Community market. In the latter case, the products in intervention stocks which may be withdrawn in payment for the manufacture of cereal and milk products should be specified.

(3)

To respond more effectively to the needs of charitable organisations and expand the range of food products supplied, it should be laid down that products from intervention stocks may, under certain conditions, be incorporated into other products for the purposes of manufacturing food.

(4)

In accordance with Article 47, paragraph 1, of Council Regulation (EC) No 1254/1999 of 17 May 1999 on the common organisation of the market in beef and veal (3), public intervention in the beef and veal sector as a permanent market support instrument does not exist any more since 1 July 2002. The Regulation (EEC) 3149/92 should therefore be adapted to that new situation.

(5)

Regulation (EEC) No 3149/92 should therefore be amended accordingly.

(6)

The measures provided for in this Regulation are in accordance with the opinions of the Management Committees concerned,

1.

Article 4 is amended as follows:

2.

In Article 5(1), the second indent is deleted.

3.

The Annex is deleted.

1.10.2005   

EN

Official Journal of the European Union

L 256/15

(1)

Article 10(3) and (4) of Regulation (EC) No 1260/2001 lay down that the guaranteed quantity under production quotas should be reduced before 1 October each marketing year if the forecasts for the year in question show an exportable balance (attracting a refund) greater than the maximum laid down by the Agriculture Agreement concluded under Article 300(2) of the Treaty.

(2)

The forecasts for the 2005/06 marketing year indicate an exportable balance exceeding the maximum laid down by the Agriculture Agreement. It is therefore necessary to set the overall reduction of the guaranteed quantity and divide it up between sugar, isoglucose and inulin syrup on the one hand and the production regions concerned on the other, using the coefficients provided for in Article 10(4) of Regulation (EC) No 1260/2001.

(3)

In accordance with Article 10(5) of Regulation (EC) No 1260/2001, each Member State must then allocate the difference to which it is subject among the producer undertakings established on its territory on the basis of the existing ratio between their A and B quotas for the product in question and the basic quantity A and the basic quantity B for the Member State for this product.

(4)

Article 39(5) of Regulation (EC) No 1260/2001 lays down that a reduction in the guaranteed quantity entails a reduction in the presumed maximum raw sugar needs of Community refineries for the marketing year in question. It is therefore necessary to set the corresponding reduction for these needs and to allocate it among the Member States concerned.

(5)

The time-limits by which the Member States must establish the reductions applying to each undertaking on their territory should be set.

(6)

In view of the deadline imposed by Regulation (EC) No 1260/2001, this Regulation must enter into force on the day of its publication in the Official Journal of the European Union.

(7)

The Management Committee for Sugar has not delivered an opinion within the time-limit set by its chairman,

1.10.2005   

EN

Official Journal of the European Union

L 256/19

(1)

The intervention agencies are, pursuant to Commission Regulation (EC) No 2571/97 of 15 December 1997 on the sale of butter at reduced prices and the granting of aid for cream, butter and concentrated butter for use in the manufacture of pastry products, ice-cream and other foodstuffs (2), to sell by invitation to tender certain quantities of butter from intervention stocks that they hold and to grant aid for cream, butter and concentrated butter. Article 18 of that Regulation stipulates that in the light of the tenders received in response to each individual invitation to tender a minimum selling price shall be fixed for butter and maximum aid shall be fixed for cream, butter and concentrated butter. It is further stipulated that the price or aid may vary according to the intended use of the butter, its fat content and the incorporation procedure, and that a decision may also be taken to make no award in response to the tenders submitted. The amount(s) of the processing securities must be fixed accordingly.

(2)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Milk and Milk Products,

1.10.2005   

EN

Official Journal of the European Union

L 256/21

(1)

The intervention agencies are, pursuant to Commission Regulation (EC) No 2571/97 of 15 December 1997 on the sale of butter at reduced prices and the granting of aid for cream, butter and concentrated butter for use in the manufacture of pastry products, ice cream and other foodstuffs (2), to sell by invitation to tender certain quantities of butter of intervention stocks that they hold and to grant aid for cream, butter and concentrated butter. Article 18 of that Regulation stipulates that in the light of the tenders received in response to each individual invitation to tender a minimum selling price shall be fixed for butter and maximum aid shall be fixed for cream, butter and concentrated butter. It is further stipulated that the price or aid may vary according to the intended use of the butter, its fat content and the incorporation procedure, and that a decision may also be taken to make no award in response to the tenders submitted. The amount(s) of the processing securities must be fixed accordingly.

(2)

The Management Committee for Milk and Milk Products has not delivered an opinion within the time limit set by its chairman,

1.10.2005   

EN

Official Journal of the European Union

L 256/23

(1)

Pursuant to Article 26 of Commission Regulation (EC) No 2799/1999 of 17 December 1999 laying down detailed rules for applying Council Regulation (EC) No 1255/1999 as regards the grant of aid for skimmed milk and skimmed-milk powder intended for animal feed and the sale of such skimmed-milk powder (2), intervention agencies have put up for sale by standing invitation to tender certain quantities of skimmed-milk powder held by them.

(2)

According to Article 30 of the said Regulation, in the light of the tenders received in response to each individual invitation to tender a minimum selling price shall be fixed or a decision shall be taken to make no award. The amount of the processing security shall also be fixed taking account of the difference between the market price of skimmed-milk powder and the minimum selling price.

(3)

In the light of the tenders received, the minimum selling price should be fixed at the level specified below and the processing security determined accordingly.

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Milk and Milk Products,

1.10.2005   

EN

Official Journal of the European Union

L 256/24

(1)

In accordance with Commission Regulation (EEC) No 429/90 of 20 February 1990 on the granting by invitation to tender of an aid for concentrated butter intended for direct consumption in the Community (2), the intervention agencies are opening a standing invitation to tender for the granting of aid for concentrated butter. Article 6 of that Regulation provides that in the light of the tenders received in response to each special invitation to tender, a maximum amount of aid is to be fixed for concentrated butter with a minimum fat content of 96 % or a decision is to be taken to make no award; the end-use security must be fixed accordingly.

(2)

In the light of the tenders received, the maximum aid should be fixed at the level specified below and the end-use security determined accordingly.

(3)

The Management Committee for Milk and Milk Products has not delivered an opinion within the time limit set by its chairman,

1.10.2005   

EN

Official Journal of the European Union

L 256/25

(1)

Pursuant to Article 21 of Commission Regulation (EC) No 2771/1999 of 16 December 1999 laying down detailed rules for the application of Council Regulation (EC) No 1255/1999 as regards intervention on the market in butter and cream (2), intervention agencies have put up for sale by standing invitation to tender certain quantities of butter held by them.

(2)

In the light of the tenders received in response to each individual invitation to tender a minimum selling price shall be fixed or a decision shall be taken to make no award, in accordance with Article 24a of Regulation (EC) No 2771/1999.

(3)

In the light of the tenders received, a minimum selling price should be fixed.

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Milk and Milk Products,

1.10.2005   

EN

Official Journal of the European Union

L 256/26

(1)

Pursuant to Article 21 of Commission Regulation (EC) No 214/2001 of 12 January 2001 laying down detailed rules for the application of Council Regulation (EC) No 1255/1999 as regards intervention on the market in skimmed milk (2), intervention agencies have put up for sale by standing invitation to tender certain quantities of skimmed-milk powder held by them.

(2)

In the light of the tenders received in response to each individual invitation to tender a minimum selling price shall be fixed or a decision shall be taken to make no award, in accordance with Article 24a of Regulation (EC) No 214/2001.

(3)

In the light of the tenders received, a minimum selling price should be fixed.

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Milk and Milk Products,

1.10.2005   

EN

Official Journal of the European Union

L 256/27

(1)

Article 10 of Regulation (EC) No 1784/2003 provides that the rates of duty in the Common Customs Tariff are to be charged on import of the products referred to in Article 1 of that Regulation. However, in the case of the products referred to in paragraph 2 of that Article, the import duty is to be equal to the intervention price valid for such products on importation and increased by 55 %, minus the cif import price applicable to the consignment in question. However, that duty may not exceed the rate of duty in the Common Customs Tariff.

(2)

Pursuant to Article 10(3) of Regulation (EC) No 1784/2003, the cif import prices are calculated on the basis of the representative prices for the product in question on the world market.

(3)

Regulation (EC) No 1249/96 lays down detailed rules for the application of Regulation (EC) No 1784/2003 as regards import duties in the cereals sector.

(4)

The import duties are applicable until new duties are fixed and enter into force.

(5)

In order to allow the import duty system to function normally, the representative market rates recorded during a reference period should be used for calculating the duties.

(6)

Application of Regulation (EC) No 1249/96 results in import duties being fixed as set out in Annex I to this Regulation,

1.10.2005   

EN

Official Journal of the European Union

L 256/30

(1)

Pursuant to Article 7(3) of Regulation (EC) No 1260/2001, production refunds may be granted on the products listed in Article 1(1)(a) and (f) of that Regulation, on syrups listed in Article 1(1)(d) thereof and on chemically pure fructose covered by CN code 1702 50 00 as an intermediate product, that are in one of the situations referred to in Article 23(2) of the Treaty and are used in the manufacture of certain products of the chemical industry.

(2)

Commission Regulation (EC) No 1265/2001 of 27 June 2001 laying down detailed rules for the application of Council Regulation (EC) No 1260/2001 as regards granting the production refund on certain sugar products used in the chemical industry (2) provides that these refunds shall be determined according to the refund fixed for white sugar.

(3)

Article 9 of Regulation (EC) No 1265/2001 provides that the production refund on white sugar is to be fixed at monthly intervals commencing on the first day of each month.

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Sugar,

1.10.2005   

EN

Official Journal of the European Union

L 256/31

(1)

In accordance with Article 4 of Regulation (EC) No 1051/2001, a world market price for unginned cotton is to be determined periodically from the price for ginned cotton recorded on the world market and by reference to the historical relationship between the price recorded for ginned cotton and that calculated for unginned cotton. That historical relationship has been established in Article 2(2) of Commission Regulation (EC) No 1591/2001 of 2 August 2001 laying down detailed rules for applying the cotton aid scheme (3). Where the world market price cannot be determined in this way, it is to be based on the most recent price determined.

(2)

In accordance with Article 5 of Regulation (EC) No 1051/2001, the world market price for unginned cotton is to be determined in respect of a product of specific characteristics and by reference to the most favourable offers and quotations on the world market among those considered representative of the real market trend. To that end, an average is to be calculated of offers and quotations recorded on one or more European exchanges for a product delivered cif to a port in the Community and coming from the various supplier countries considered the most representative in terms of international trade. However, there is provision for adjusting the criteria for determining the world market price for ginned cotton to reflect differences justified by the quality of the product delivered and the offers and quotations concerned. Those adjustments are specified in Article 3(2) of Regulation (EC) No 1591/2001.

(3)

The application of the above criteria gives the world market price for unginned cotton determined hereinafter,

1.10.2005   

EN

Official Journal of the European Union

L 256/32

(1)

Directive 2002/98/EC lays down standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and for their processing, storage and distribution when intended for transfusion so as to ensure a high level of human health protection.

(2)

In order to prevent the transmission of diseases by blood and blood components and to ensure an equivalent level of quality and safety, Directive 2002/98/EC calls for the establishment of specific technical requirements dealing with traceability, a Community procedure for notifying serious adverse reactions and events and the notification format.

(3)

Notification of suspected serious adverse reactions or serious adverse events should be submitted to the competent authority as soon as known. This Directive therefore establishes the notification format defining the minimum data needed, without prejudice to the faculty of Member States to maintain or introduce in their territory more stringent protective measures which comply with the provisions of the Treaty as provided under Article 4(2) of Directive 2002/98/EC.

(4)

This Directive lays down those technical requirements, which take account of Council Recommendation 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community (2), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (3), 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 (4), and certain recommendations of the Council of Europe.

(5)

Accordingly, blood and blood components imported from third countries, including those used as starting material or raw material for the manufacture of medicinal products derived from human blood and human plasma, intended for distribution in the Community, should meet equivalent Community standards and specifications relating to traceability and serious adverse reaction and serious adverse event notification requirements as set out in this Directive.

(6)

It is necessary to determine common definitions for technical terminology in order to ensure the consistent implementation of Directive 2002/98/EC.

(7)

The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2002/98/EC,

(a)

‘traceability’ means the ability to trace each individual unit of blood or blood component derived thereof from the donor to its final destination, whether this is a recipient, a manufacturer of medicinal products or disposal, and vice versa;

(b)

‘reporting establishment’ means the blood establishment, the hospital blood bank or facilities where the transfusion takes place that reports serious adverse reactions and/or serious adverse events to the competent authority;

(c)

‘recipient’ means someone who has been transfused with blood or blood components;

(d)

‘issue’ means the provision of blood or blood components by a blood establishment or a hospital blood bank for transfusion to a recipient;

(e)

‘imputability’ means the likelihood that a serious adverse reaction in a recipient can be attributed to the blood or blood component transfused or that a serious adverse reaction in a donor can be attributed to the donation process;

(f)

‘facilities’ means hospitals, clinics, manufacturers, and bio-medical research institutions to which blood or blood components may be delivered.

(a)

notify to the competent authority all relevant information about serious adverse reactions of imputability level 2 or 3, as referred to in Part B of Annex II, attributable to the quality and safety of blood and blood components;

(b)

notify the competent authority of any case of transmission of infectious agents by blood and blood components as soon as known;

(c)

describe the actions taken with respect to other implicated blood components that have been distributed for transfusion or for use as plasma for fractionation;

(d)

evaluate suspected serious adverse reactions according to the imputability levels set out in Part B of Annex II;

(e)

complete the serious adverse reaction notification, upon conclusion of the investigation, using the format set out in Part C of Annex II;

(f)

submit a complete report on serious adverse reactions to the competent authority on an annual basis using the format set out in Part D of Annex II.

(a)

evaluate serious adverse events to identify preventable causes within the process;

(b)

complete the serious adverse event notification, upon conclusion of the investigation, using the format set out in Part B of Annex III;

(c)

submit a complete report on serious adverse events to the competent authority on an annual basis using the format set out in Part C of Annex III.

1.10.2005   

EN

Official Journal of the European Union

L 256/41

(1)

Directive 2002/98/EC lays down standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and for their processing, storage and distribution when intended for transfusion so as to ensure a high level of human health protection.

(2)

In order to prevent the transmission of diseases by blood and blood components and to ensure an equivalent level of quality and safety, Directive 2002/98/EC calls for the establishment of specific technical requirements including Community standards and specifications with regard to a quality system for blood establishments.

(3)

A quality system for blood establishments should embrace the principles of quality management, quality assurance, and continuous quality improvement, and should include personnel, premises and equipment, documentation, collection, testing and processing, storage and distribution, contract management, non-conformance and self-inspection, quality control, blood component recall, and external and internal auditing.

(4)

This Directive lays down those technical requirements, which take account of Council Recommendation 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community (2), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (3), Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (4), 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 (5), certain recommendations of the Council of Europe, the monographs of the European Pharmacopoeia, particularly in respect of blood or blood components as a starting material for the manufacture of proprietary medicinal products, recommendations of the World Health Organisation, as well as international experience in this field.

(5)

In order to ensure the highest quality and safety for blood and blood components, guidance on good practice should be developed to support the quality system requirements for blood establishments taking fully into account the detailed guidelines referred to in Article 47 of Directive 2001/83/EC so as to ensure that the standards required for medicinal products are maintained.

(6)

Blood and blood components imported from third countries, including those used as starting material or raw material for the manufacture of medicinal products derived from human blood and human plasma intended for distribution in the Community, should meet equivalent Community standards and specifications relating to a quality system for blood establishments as set out in this Directive.

(7)

It is necessary to specify that a quality system is to be applied for any blood and blood components circulating in the Community and that Member States therefore should ensure that for blood and blood components coming from third countries there is a quality system in place for blood establishments in the stages preceding importation equivalent to the quality system provided under this Directive.

(8)

It is necessary to determine common definitions for technical terminology in order to ensure the consistent implementation of Directive 2002/98/EC.

(9)

The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2002/98/EC,

(a)

‘standard’ means the requirements that serve as the basis for comparison;

(b)

‘specification’ means a description of the criteria that must be fulfilled in order to achieve the required quality standard;

(c)

‘quality system’ means the organisational structure, responsibilities, procedures, processes, and resources for implementing quality management;

(d)

‘quality management’ means the co-ordinated activities to direct and control an organisation with regard to quality at all levels within the blood establishment;

(e)

‘quality control’ means part of a quality system focussed on fulfilling quality requirements;

(f)

‘quality assurance’ means all the activities from blood collection to distribution made with the object of ensuring that blood and blood components are of the quality required for their intended use;

(g)

‘trace-back’ means the process of investigating a report of a suspected transfusion-associated adverse reaction in a recipient in order to identify a potentially implicated donor;

(h)

‘written procedures’ means controlled documents that describe how specified operations are to be carried out;

(i)

‘mobile site’ means a temporary or movable place used for the collection of blood and blood components which is in a location outside of but under the control of the blood establishment;

(j)

‘processing’ means any step in the preparation of a blood component that is carried out between the collection of blood and the issuing of a blood component;

(k)

‘good practice’ means all elements in established practice that collectively will lead to final blood or blood components that consistently meet predefined specifications and compliance with defined regulations;

(l)

‘quarantine’ means the physical isolation of blood components or incoming materials/reagents over a variable period of time while awaiting acceptance, issuance or rejection of the blood components or incoming materials/reagents;

(m)

‘validation’ means the establishment of documented and objective evidence that the pre-defined requirements for a specific procedure or process can be consistently fulfilled;

(n)

‘qualification’, as part of validation, means the action of verifying that any personnel, premises, equipment or material works correctly and delivers the expected results;

(o)

‘computerised system’ means a system including the input of data, electronic processing and the output of information to be used either for reporting, automatic control or documentation.

1.10.2005   

EN

Official Journal of the European Union

L 256/49

(1)

On 22 January 2002 the Council adopted Decision 2002/60/EC (1) appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2002 to 25 January 2006.

(2)

Two members’ seats on the Committee of the Regions have become vacant following the resignations of Ms Annette McNAMARA and of Mr Royston BRADY; four alternate members’ seats on the Committee of the Regions have become vacant following the resignations of Ms Angela LUPTON, Ms Vivian O’CALLAGHAN, Mr P.J. COGHILL and Ms Catherine MURPHY,

(a)

as members:

(b)

as alternate members:

1.10.2005   

EN

Official Journal of the European Union

L 256/51

(1)

On 22 January 2002 the Council adopted Decision 2002/60/EC appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2002 to 25 January 2006 (1).

(2)

Three members’ seats on the Committee of the Regions have become vacant following expiry of the mandates of Mr Francesco STORACE, Mr Vito d’AMBROSIO and Mr Raffaele FITTO; one alternate member’s seat on the Committee of the Regions has become vacant following the resignation of Mr Giuseppe CHIARAVALLOTI and four alternate members’ seats following expiry of the mandates of Mr Giovanni PACE, Mr Filippo BUBBICO, Mr Giandomenico BARCI and Mr Enzo GHIGO,

(a)

as members:

(b)

as alternate members:

1.10.2005   

EN

Official Journal of the European Union

L 256/53

(1)

On 22 January 2002 the Council adopted Decision 2002/60/EC appointing the members and alternate members of the Committee of the Regions for the period 26 January 2002 to 25 January 2006 (1).

(2)

A seat as an alternate member of the Committee of the Regions has become vacant following the resignation of Mr Ivan ŽAGAR,

1.10.2005   

EN

Official Journal of the European Union

L 256/54

1.10.2005   

EN

Official Journal of the European Union

L 256/55

(1)

On 22 January 2002 the Council adopted Decision 2002/60/EC appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2002 to 25 January 2006 (1).

(2)

Two seats as members of the Committee of the Regions have become vacant following the resignations of Mr Andrus ANSIP and Mr Edgar SAVISAAR and one seat as an alternate member of the Committee of the Regions has become vacant following the nomination of Mr Väino HALLIKMÄGI as a member,

(a)

as members:

(b)

as alternate member:

Ms Laine JÄNES

Mayor of Tartu

in place of Mr Väino HALLIKMÄGI