Annexes to COM(2003)52 - Official feed and food controls

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dossier COM(2003)52 - Official feed and food controls.
document COM(2003)52 EN
date April 29, 2004
ANNEX I

TERRITORIES REFERRED TO IN ARTICLE 2(15)

1.The territory of the Kingdom of Belgium.

2.The territory of the Kingdom of Denmark with the exception of the Faroe Islands and Greenland.

3.The territory of the Federal Republic of Germany.

4.The territory of the Kingdom of Spain with the exception of Ceuta and Melilla.

5.The territory of the Hellenic Republic.

6.The territory of the French Republic.

7.The territory of Ireland.

8.The territory of the Italian Republic.

9.The territory of the Grand Duchy of Luxembourg.

10.The territory of the Kingdom of the Netherlands in Europe.

11.The territory of the Portuguese Republic.

12.The territory of the United Kingdom of Great Britain and Northern Ireland.

13.The territory of the Republic of Austria.

14.The territory of the Republic of Finland.

15.The territory of the Kingdom of Sweden.


ANNEX II

COMPETENT AUTHORITIES

Chapter I:   Subject matter for the training of staff performing official controls

1.Different control techniques, such as auditing, sampling and inspection.

2.Control procedures.

3.Feed and food law.

4.The different stages of production, processing and distribution, and the possible risks for human health, and where appropriate for the health of animals and plants and for the environment.

5.Assessment of non-compliance with feed and food law.

6.Hazards in animal, feed and food production.

7.The evaluation of the application of HACCP procedures.

8.Management systems such as quality assurance programmes that feed and food businesses operate and their assessment in so far as these are relevant for feed or food law requirements.

9.Official certification systems.

10.Contingency arrangements for emergencies, including communication between Member States and the Commission.

11.Legal proceedings and implications of official controls.

12.Examination of written, documentary material and other records, including those related to proficiency testing, accreditation and risk assessment, which may be relevant to the assessment of compliance with feed or food law; this may include financial and commercial, aspects.

13.Any other area, including animal health and animal welfare, necessary to ensure that official controls are carried out in accordance with this Regulation.

CHAPTER II:   SUBJECT AREAS FOR CONTROL PROCEDURES

1.The organisation of the competent authority and the relationship between central competent authorities and authorities to which they have delegated tasks to carry out official controls.

2.The relationship between competent authorities and control bodies to which they have delegated tasks related to official controls.

3.A statement on the objectives to be achieved.

4.Tasks, responsibilities and duties of staff.

5.Sampling procedures, control methods and techniques, interpretation of results and consequent decisions.

6.Monitoring and surveillance programmes.

7.Mutual assistance in the event that official controls require more than one Member State to take action.

8.Action to be taken following official controls.

9.Cooperation with other services or departments that may have relevant responsibilities.

10.Verification of the appropriateness of methods of sampling, methods of analysis and detection tests.

11.Any other activity or information required for the effective functioning of the official controls.


ANNEX III

CHARACTERISATION OF METHODS OF ANALYSIS

1.Methods of analysis should be characterised by the following criteria:

(a)accuracy;

(b)applicability (matrix and concentration range);

(c)limit of detection;

(d)limit of determination;

(e)precision;

(f)repeatability;

(g)reproducibility;

(h)recovery;

(i)selectivity;

(j)sensitivity;

(k)linearity;

(l)measurement uncertainty;

(m)other criteria that may be selected as required.

2.The precision values referred to in 1 (e) shall either be obtained from a collaborative trial which has been conducted in accordance with an internationally recognised protocol on collaborative trials (e.g. ISO 5725:1994 or the IUPAC International Harmonised Protocol) or, where performance criteria for analytical methods have been established, be based on criteria compliance tests. The repeatability and reproducibility values shall be expressed in an internationally recognised form (e.g. the 95% confidence intervals as defined by ISO 5725: 1994 or IUPAC). The results from the collaborative trial shall be published or freely available.

3.Methods of analysis which are applicable uniformly to various groups of commodities should be given preference over methods which apply only to individual commodities.

4.In situations where methods of analysis can only be validated within a single laboratory then they should be validated in accordance with e.g. IUPAC Harmonised Guidelines, or where performance criteria for analytical methods have been established, be based on criteria compliance tests.

5.Methods of analysis adopted under this Regulation should be edited in the standard layout for methods of analysis recommended by the ISO.


ANNEX IV

ACTIVITIES AND MINIMUM RATES FOR FEES OR CHARGES RELATED TO OFFICIAL CONTROLS IN RELATION TO COMMUNITY ESTABLISHMENTS

SECTION A:   ACTIVITIES

1.The activities covered by Directives 89/662/EEC, 90/425/EEC, 93/119/EC and 96/23/EC for which Member States are currently collecting fees under Directive 85/73/EEC.

2.The approval of feed establishments.

SECTION B:   MINIMUM RATES

Member States shall collect for controls relating to the following list of products, at least the corresponding minimum rates for fees or charges.

CHAPTER I:

MINIMUM RATES FOR FEES OR CHARGES APPLICABLE TO SLAUGHTER INSPECTION

(a)beef meat

–adult bovine animals:
5 EUR/animal
–young bovine animals:
2 EUR/animal

(b)
solipeds equidae:3 EUR/animal

(c)pigmeat: animals of a carcass weight

–of less than 25 kg:
0,5 EUR/animal
–equal to or greater than 25 kg:
1 EUR/animal

(d)sheepmeat and goatmeat: animals of a carcass weight

–of less than 12 kg:
0,15 EUR/animal
–equal to or greater than 12 kg:
0,25 EUR/animal

(e)poultry meat

–poultry of genus Gallus and guinea fowl: 0,005 EUR/animal
–ducks and geese:
0,01 EUR/animal
–turkeys:
0,025 EUR/animal
–farmed rabbit meat:
0,005 EUR/animal.

CHAPTER II

MINIMUM RATES FOR FEES OR CHARGES APPLICABLE TO CUTTING PLANTS CONTROLS

Per tonne of meat:

–beef, veal, pig, solipeds/equidae, sheep and goat meat:
EUR 2
–poultry and farmed rabbit meat:
EUR 1,5
–farmed and wild game meat:
•small game birds and ground game:
EUR 1,5
•ratites meat (ostrich, emu, nandou):
EUR 3
•boars and ruminants:
EUR 2.

CHAPTER III

MINIMUM RATES FOR FEES OR CHARGES APPLICABLE TO GAME PROCESSING HOUSES

(a)small game birds:
0,005 EUR/animal
(b)small ground game:
0,01 EUR/animal
(c)ratites:
0,5 EUR/animal
(d)land mammals:
•boar:
1,5 EUR/animal
•ruminants:
0,5 EUR/animal

CHAPTER IV

MINIMUM RATES FOR FEES OR CHARGES APPLICABLE TO MILK PRODUCTION

•EUR 1 per 30 tonnes and

•EUR 0,5 per tonne, thereafter.

CHAPTER V

MINIMUM RATES FOR FEES OR CHARGES APPLICABLE TO THE PRODUCING AND PLACING ON THE MARKET OF FISHERY PRODUCTS AND AQUACULTURE PRODUCTS

(a)first placing on the market of fishery and aquaculture products:

•1 EUR/tonne for the first 50 tonnes in the month;

•0,5 EUR/tonne thereafter.

(b)first sale in fish market

•0,5 EUR/tonne for the first 50 tonnes in the month;

•0,25 EUR/tonne thereafter.

(c)first sale in case of lack of or insufficient gradation for freshness and/or size in accordance with Regulation (EEC) No 103/76 and No 104/76:

•1 EUR/tonne for the first 50 tonnes in the month;

•0,5 EUR/tonne thereafter.

The fees collected on the species referred to in Annex II to Commission Regulation (EEC) No 3703/85 must not exceed EUR 50 per consignment.

Member States will collect 0,5 EUR/tonne for the processing of fishery and aquaculture products.


ANNEX V

ACTIVITIES AND MINIMUM RATES FOR FEES OR CHARGES RELATED TO THE OFFICIAL CONTROLS OF GOODS AND LIVE ANIMALS INTRODUCED INTO THE COMMUNITY

SECTION A:   ACTIVITIES OR CONTROLS

The activities covered by Directives 97/78/EC and 91/496/EEC for which Member States are currently collecting fees under Directive 85/73/EEC.

SECTION B:   FEES OR CHARGES

CHAPTER I:

Fees applicable to imported meat

The minimum fee rates for the official control on the import of a consignment of meat are fixed at:

—EUR 55 per consignment, up to 6 tonnes, and

—EUR 9 per tonne, up to 46 tonnes, thereafter, or

—EUR 420 per consignment, over 46 tonnes.

CHAPTER II

FEES APPLICABLE TO IMPORTED FISHERY PRODUCTS

1.The minimum fee for the official control on the import of a consignment of fishery products is fixed at:

—EUR 55 per consignment, up to 6 tonnes, and

—EUR 9 per tonne, up to 46 tonnes, thereafter, or

—EUR 420 per consignment, over 46 tonnes.

2.The above amount for the official control on the import of a consignment of fishery products, transported as break bulk shipment, shall be:

—EUR 600 per vessel, with a cargo of fishery products up to 500 tonnes,

—EUR 1 200 per vessel, with a cargo of fishery products up to 1000 tonnes,

—EUR 2 400 per vessel, with a cargo of fishery products up to 2000 tonnes,

—EUR 3 600 per vessel, with a cargo of fishery products of more than 2000 tonnes.

3.In the case of fishery products caught in their natural environment directly landed by a fishing vessel flying the flag of a third country, the provisions laid down in Annex IV, Section B, Chapter V, point a) shall apply.

CHAPTER III

FEES OR CHARGES APPLICABLE TO MEAT PRODUCTS, POULTRY MEAT, WILD GAME MEAT, RABBIT MEAT, FARMED GAME MEAT, BY-PRODUCTS AND FEED OF ANIMAL ORIGIN

1.The minimum fee for the official control on the import of a consignment of products of animal origin other than those mentioned in Chapters I and II or a consignment of by-products of animal origin or a consignment of feed, is fixed at:

—EUR 55 per consignment, up to 6 tonnes, and

—EUR 9 per tonne, up to 46 tonnes, thereafter, or

—EUR 420 per consignment, over 46 tonnes.

2.The above amount for the official control on the import of a consignment of products of animal origin other than those mentioned in Chapters I and II, a consignment of by-products of animal origin or a consignment of feed transported as break bulk shipment, shall be:

—EUR 600 per vessel, with a cargo of products up to 500 tonnes,

—EUR 1 200 per vessel, with a cargo of products up to 1000 tonnes,

—EUR 2 400 per vessel, with a cargo of products up to 2000 tonnes,

—EUR 3 600 per vessel, with a cargo products of more than 2000 tonnes.

CHAPTER IV

FEES APPLICABLE TO TRANSIT THROUGH THE COMMUNITY OF GOODS AND LIVE ANIMALS

The amount of fees or charges for the official control on the transit of goods and live animals through the Community is fixed at a minimum level of EUR 30, increased by EUR 20 per quarter of an hour for every member of staff involved in the controls.

CHAPTER V

FEES APPLICABLE TO IMPORTED LIVE ANIMALS

1.The fee for the official control on the import of a consignment of live animals is fixed:

(a)for bovine animals, equidae, pigs, sheep, goats, poultry, rabbits and small game birds or ground game and the following land mammals: wild boar and ruminants, at:

—EUR 55 per consignment, up to 6 tonnes, and

—EUR 9 per tonne, up to 46 tonnes, thereafter, or

—EUR 420 per consignment, over 46 tonnes,

(b)for animals of other species at the actual cost of inspection expressed either per animal or per tonne imported, at:

—EUR 55 per consignment, up to 46 tonnes, or

—EUR 420 per consignment, over 46 tonnes,

it being understood that this minimum does not apply to imports of species referred to in Commission Decision 92/432/EEC.

2.At the request of a Member State, accompanied by appropriate supporting documents and in accordance with the procedure laid down in Article 18 of Directive 89/662/EEC, a lower level of fees may be applied to imports from certain third countries.


ANNEX VI

CRITERIA TO BE TAKEN INTO CONSIDERATION FOR THE CALCULATION OF FEES

1.the salaries of the staff involved in the official controls;

2.the costs for the staff involved in the official controls, including facilities, tools, equipment, training, travel and associated costs;

3.the laboratory analysis and sampling costs.


ANNEX VII

COMMUNITY REFERENCE LABORATORIES

I. Community reference laboratories for feed and food

1.Community reference laboratory for milk and milk products

AFSSA-LERHQA
94700 Maisons-Alfort
France

2.Community reference laboratories for the analysis and testing of zoonoses (Salmonella)

Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
3720 BA Bilthoven, The Netherlands

3.Community reference laboratory for the monitoring of marine biotoxins

Ministerio de Sanidad y Consumo, Vigo, Spain.

4.Community reference laboratory for monitoring the viral and bacteriological contamination of bivalve molluscs

The laboratory of the Centre for Environment, Fisheries and Aquaculture Science, Weymouth, United Kingdom.

5.Community reference laboratories for residues

(a)For the residues listed in Annex I, Group A 1, 2, 3, 4, Group B 2 (d) and Group B 3 (d) to Council Directive 96/23/EC

Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
NL-3720 BA Bithoven, The Netherlands

(b)For the residues listed in Annex I, Group B 1 and B 3 (e) to Council Directive 96/23/EC and carbadox and olaquidonx

Laboratoires d'études et de recherches sur les médicaments vétérinaires et les désinfectants
AFSSA - Site de Fougères
BP 90203, France

(c)For the residues listed in Annex I, Group A 5 and Group B 2 (a), (b), (e) to Council Directive 96/23/EC

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
Postfach 140162
53056 Bonn, Germany

(d)For the residues listed in Annex I, Group B 2 (c) and Group B 3 (a), (b), (c) to Council Directive 96/23/EC

Instituto Superiore di Sanità
I-00161-Roma, Italy

6.Community reference laboratory for transmissible spongiform encephalopathies (TSEs)

The laboratory referred to in Annex X, Chapter B of Regulation (EC) No 999/2001.

7.Community reference laboratory for additives for use in animal nutrition

The laboratory referred to in Annex II of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1)

8.Community reference laboratory for Genetically Modified Organisms (GMO)

The laboratory referred to in the Annex to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (2).

9.Community reference laboratory for material intended to come into contact with foodstuffs

The Joint Research Centre of the Commission

II.   Community reference laboratories for animal health

p.m.


(1) OJ L 268, 18.10.2003, p. 29.

(2) OJ L 268, 18.10.2003, p. 1.


ANNEX VIII

IMPLEMENTING RULES THAT REMAIN IN FORCE PURSUANT TO ARTICLE 61

1.Implementing rules based on Directive 70/373/EEC on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs.

(a)First Commission Directive 71/250/EEC of 15 June 1971 establishing Community methods of analysis for the official control of feedingstuffs (1);

(b)Second Commission Directive 71/393/EEC of 18 November 1971 establishing Community methods of analysis for the official control of feedingstuffs (2);

(c)Third Commission Directive 72/199/EEC of 27 April 1972 establishing Community methods of analysis for the official control of feedingstuffs (3);

(d)Fourth Commission Directive 73/46/EEC of 5 December 1972 establishing Community methods of analysis for the official control of feedingstuffs (4);

(e)First Commission Directive 76/371/EEC of 1 March 1976 establishing Community methods of sampling for the official control of feedingstuffs (5);

(f)Seventh Commission Directive 76/372/EEC of 1 March 1976 establishing Community methods of analysis for the official control of feedingstuffs (6);

(g)Eight Commission Directive 78/633/EEC of 15 June 1978 establishing Community methods of analysis for the official control of feedingstuffs (7);

(h)Ninth Commission Directive 81/715/EEC of 31 July 1981 establishing Community methods of analysis for the official control of feedingstuffs (8);

(i)Tenth Commission Directive 84/425/EEC of 25 July 1984 establishing Community methods of analysis for the official control of feedingstuffs (9);

(j)Eleventh Commission Directive 93/70/EEC of 28 July 1993 establishing Community methods of analysis for the official control of feedingstuffs (10);

(k)Twelfth Commission Directive 93/117/EC of 17 December 1993 establishing Community methods of analysis for the official control of feedingstuffs (11);

(l)Commission Directive 98/64/EC of 3 September 1998 establishing Community methods of analysis for the determination of amino-acids, crude oils and fats, and olaquindox in feedingstuffs (12);

(m)Commission Directive 2003/126/EC of 23 December 2003 on the analytical method for the determination of constituents of animal origin for the official control of foodstuffs (13);

(n)Commission Directive 1999/27/EC of 20 April 1999 establishing Community methods of analysis for the determination of amprolium, diclazuril and carbadox in feedingstuffs (14);

(o)Commission Directive 1999/76/EC of 23 July 1999 establishing a Community method of analysis for the determination of lasalocid sodium in feedingstuffs (15);

(p)Commission Directive 2000/45/EC of 6 July 2000 establishing Community methods of analysis for the determination of vitamin A, vitamin E and tryptophan in feedingstuffs (16);

(q)Directive 2002/70/EC of 26 July 2002 establishing requirements for the determination of levels of dioxins and dioxin-like PCBs in feedingstuffs (17).

2.Implementing rules based on Directive 95/53/EC of 25 October 1995 fixing the principles governing the organisation of official inspections in the field of animal nutrition

Commission Directive 98/68/EC of 10 September 1998 laying down the standard document referred to in Article 9(1) of Council Directive 95/53/EC and certain rules for checks at the introduction into the Community of feedingstuffs from third countries (18).


(1) OJ L 155, 12.7.1971, p. 13. Directive as last amended by Commission Directive 1999/27/EC

(OJ L 118, 6.5.1999, p. 36).

(2) OJ L 279, 20.12.1971, p. 7. Directive as last amended by Commission Directive 98/64/EC

(OJ L 257, 19.9.1998, p. 14).

(3) OJ L 123, 29.05.1972, p. 6. Directive as last amended by Commission Directive 1999/79/EC

(OJ L 209, 7.8.1999, p. 23).

(4) OJ L 83, 30.3.1973, p. 21. Directive as last amended by Commission Directive 1999/27/EC.

(5) OJ L 102, 15.4.1976, p. 1.

(6) OJ L 102, 15.4.1976, p. 8. Directive as last amended by Commission Directive 94/14/EC (OJ L 94, 13.4.1994, p. 30).

(7) OJ L 206, 29.7.1978, p. 43. Directive as last amended by Commission Directive 84/4/EEC (OJ L 15, 18.1.1984, p. 28).

(8) OJ L 257, 10.9.1981, p. 38.

(9) OJ L 238, 6.9.1984, p. 34.

(10) OJ L 234, 17.9.1993, p. 17.

(11) OJ L 329, 30.12.1993, p. 54.

(12) OJ L 257, 19.9.1998, p. 14.

(13) OJ L 339, 24.12.2003, p. 78.

(14) OJ L 118, 6.5.1999, p. 36.

(15) OJ L 207, 6.8.1999, p. 13.

(16) OJ L 174, 13.7.2000, p. 32.

(17) OJ L 209, 6.8.2002, p. 15.

(18) OJ L 261, 24.9.1998, p. 32.