COMMISSION DECISION

of 27 July 1995

providing for the specimens of the health certificate for the importation from third countries of heat-treated milk, milk-based products and raw milk for human consumption intended to be accepted at a collection centre, standardization centre, treatment establishment or processing establishment

(Text with EEA relevance)

(95/343/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products (1), as last amended by the Act of Accession of Austria, Finland and Sweden and in particular Article 23 (2) (b) thereof,

Whereas Commission Decision 95/340/EC (2) establishes a provisional list of third countries from which Member States authorize imports of raw milk, heat-treated milk and milk-based products;

Whereas the conditions applicable to the importation from third countries of raw milk, heat-treated milk and milk-based products intended for human consumption must be at least equivalent to those laid down in Chapter II of Directive 92/46/EEC for Community production;

Whereas Commission Decision 95/342/EC (3) specifies the types of treatment which are to be applied to milk and milk-based products for human consumption from third countries or parts of third countries in which there is a threat of foot-and-mouth disease;

Whereas the specimen certificate referred to in Article 23 of Directive 92/46/EEC must contain a description of the milk or milk-based product covered by the certificate, relevant references to Chapter II of Directive 92/46/EEC, a choice of language or languages in which the certificate is drawn up and a choice of rank or title of the signatory;

Whereas provision should be made first for a specimen certificate for raw milk intended to be accepted at a collection centre, standardization centre, treatment establishment or processing establishment, for a specimen certificate for heat-treated milk, milk-based products made from heat-treated milk or heat-treated milk-based products intended for human consumption from third countries or parts of third countries in which there is no threat of foot-and-mouth disease, for a specimen certificate for heat-treated milk, milk-based products made from heat-treated milk or heat-treated milk-based products intended for human consumption from third countries or parts of third countries in which there is a threat of foot-and-mouth disease, and for a specimen certificate for raw milk products for human consumption; whereas, in view of the different nature of these products, provision should be made for different specimen health certificates;

Whereas provision will be made later for a specimen health certificate for raw milk intended for direct human consumption;

Whereas the measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,

HAS ADOPTED THIS DECISION:

Article 1

The specimen certificate provided for in Article 23 (2) (b) of Directive 92/46/EEC concerning raw milk from third countries intended to be accepted at a collection centre, standardization centre, treatment establishment or processing establishment and then to be used for human consumption shall be as shown in Annex A to this Decision.

This certificate may be used only by the third countries or parts of third countries listed in column A of the Annex to Decision 95/340/EC.

Article 2

The specimen certificate provided for in Article 23 (2) (b) of Directive 92/46/EEC concerning heat-treated milk, milk-based products made from heat-treated milk or heat-treated milk-based products intended for human consumption from third countries or parts of third countries in which there is no threat of foot-and-mouth disease shall be as shown in Annex B to this Decision.

This certificate may be used only by the third countries or parts of third countries listed in column B of the Annex to Decision 95/340/EC.

Article 3

The specimen certificate provided for in Article 23 (2) (b) of Directive 92/46/EEC concerning heat-treated milk, milk-based products made from heat-treated milk or heat-treated milk-based products intended for human consumption from third countries or parts of third countries in which there is a threat of foot-and-mouth disease shall be as shown in Annex C to this Decision.

This certificate may be used by the third countries or parts of third countries listed in column C of the Annex to Decision 95/340/EC.

Article 4

The specimen certificate provided for in Article 23 (2) (b) of Directive 92/46/EEC concerning raw milk products from third countries intended for human consumption shall be as shown in Annex D to this Decision.

This certificate may be used only by the third countries or parts of third countries listed in column A of the Annex to Decision 95/340/EC.

Article 5

In order to ensure that the controls laid down in Article 4 (1) third indent of Council Directive 90/675/EEC (1) can be performed, the products detailed in Articles 2, 3 and 4 must carry the following information, in at least one of the official languages of the country of destination:

- the name of the exporting country,

- the approval number of the establishment,

- for products manufactured from raw milk and for which the method of manufacture did not include any heat treatment, the words 'from raw milk',

- for milk-based products in which there may be microbial development, the use-by date or durability limit.

Article 6

The health certificates referred to in Articles 1, 2, 3 and 4 shall be original numbered certificates consisting of a single sheet, duly completed, dated and signed by the representative of the competent authority responsible for verifying and certifying that the raw milk, heat-treated milk or milk-based products meet the requirements of Directive 92/46/EEC.

Article 7

1. The certificates referred to in Articles 1, 2, 3 and 4 shall be drawn up in at least one official language of the Member State in which the check is carried out.

2. The certificate shall bear the name, rank or title and signature of the representative of the competent authority together with the official stamp of the competent authority in a colour different from that of the other particulars shown on the certificate.

Article 8

This Decision shall apply from 2 February 1996.

Article 9

This Decision is addressed to the Member States.

Done at Brussels, 27 July 1995.

For the Commission

Franz FISCHLER

Member of the Commission

(1) OJ No L 268, 14. 9. 1992, p. 1.

(2) See page 38 of this Official Journal.

(3) See page 50 of this Official Journal.

(1) OJ No L 373, 31. 12. 1990, p. 1.

ANNEX A

HEALTH CERTIFICATE for raw milk from third countries intended to be accepted at a collection centre, standardization centre, treatment establishment or processing establishment in the European Community and then to be used for human consumption

>START OF GRAPHIC>

Reference number: .

Country (and region, where applicable) (1) of dispatch: .

Ministry: .

Department responsible for certification: .

I. Identification of products

- Raw milk from: .

(Animal species)

- Code number (as appropriate): .

- Packaging: .

- Number of packaging units: .

- Net weight: .

II. Origin of products

Name and official approval or registration number of production holding(s)/collection centre/standardization centre/(2) approved for exportation to the Community.

.

.

III. Destination of products:

The raw milk is to be sent

from: .

(Place of dispatch)

to: .

(Country and place of destination)

by the following means of transport (3): .

Seal number: .

Name and address of consignor: .

.

Name and address of consignee: .

.

(1) To be specified if the authorization to import into the Community is restricted to certain regions of the third country concerned.

(2) Delete as appropriate.

(3) Give the registration number, flight number or name of the means of goods transport. For bulk containers, include the container number.

IV. Health attestation

The official veterinarian hereby certifies that the raw milk described above has been obtained from animals, under the control of the official veterinary service:

- which were in a country or region that has been free of foot-and-mouth disease and of rinderpest for at least 12 months, and where vaccination against foot-and-mouth disease has not been carried out for at least 12 months,

- belonging to holdings which were not under restrictions due to foot-and-mouth disease or rinderpest,

- satisfying the animal health conditions laid down in Annex A, Chapter I of Directive 92/46/EEC.

The undersigned official veterinarian declares that he is familiar with the animal health requirements of Directive 92/46/EEC.

Done at . ,on .

(Place)(Date)

.

(Signature of official veterinarian (4))

.

(Name in capital letters, rank and title of the signatory)

XTB:STAMPEN400

V. Public health attestation

- The official inspector hereby certifies that the raw milk described above:

- does not, according to the findings of monitoring plans at least equivalent to those provided for in Directive 92/46/EEC, contain residues of anti-microbial substances in excess of the limits laid down in Annexes I and III to Council Regulation (EEC) No 2377/90, as amended

- does not, according to the findings of monitoring plans at least equivalent to those provided for in Directive 92/46/EEC, contain pesticide residues in excess of the maximum levels laid down in Annex II to Council Directive 86/363/EEC, as amended

- does not, according to the findings of monitoring plans at least equivalent to those provided for in Directive 92/46/EEC, contain contaminants in excess of the maximum tolerances laid down in the Community list provided for in Article 2 (3) of Council Regulation (EEC) No 315/93

- comes from registered and checked holdings meeting the conditions of hygiene laid down in Chapter II of Annex A to Directive 92/46/EEC

- was obtained, collected, cooled, stored and transported in accordance with the specific hygiene conditions laid down in Chapter III of Annex A to Directive 92/46/EEC

- was transported, where applicable, in tanks as described in Article 16 (2) of Directive 92/46/EEC

- meets the plate and somatic cell count standards laid down in Chapter IV of Annex A to Directive 92/46/EEC

- was collected and standardized, where necessary, in accordance with the hygiene conditions laid down in Chapters I, III and IV of Annex B to Directive 92/46/EEC.

- The official inspector whose signature is affixed below hereby declares that he is aware of the provisions contained in Directive 92/46/EEC, Annexes I and III to Regulation (EEC) No 2377/90, Annex II to Directive 86/363/EEC and Regulation (EEC) No 315/93.

Done at . ,on .

(Place)(Date)

.

(Signature of official inspector (4))

.

(Name in capital letters, rank and title of the signatory)

XTB:STAMPEN400

(4) The signature and seal must be in a different colour to that of the printing of the certificate.

>END OF GRAPHIC>

ANNEX B

HEALTH CERTIFICATE for heat-treated milk, milk-based products made from heat-treated milk or heat-treated milk-based products intended for human consumption from third countries or parts of third countries included in column B of the Annex to Commission Decision 95/340/EC

>START OF GRAPHIC>

Reference number: .

Country (and region, where applicable) (1) of dispatch: .

Ministry: .

Department responsible for certification: .

I. Identification of products

- Milk from: .

(Animal species)

- Description of heat-treated milk-based product made from heat-treated milk/heat-treated milk-based product (2): .

- Code number (as appropriate): .

- Type of packaging: .

- Number of packaging units: .

- Net weight: .

II. Origin of products

Name(s) and official approval number(s) of treatment and/or processing establishment(s) approved for export to the Community

.

.

.

III. Destination of products

The heat-treated milk/milk-based product made from heat-treated milk/heat-treated milk-based product (1) is to be sent from: .

(Place of dispatch)

to: .

(Country and place of destination)

by the following means of transport (3): .

Seal number: .

Name and address of consignor: .

.

Name and address of consignee: .

.

(1) To be specified if the authorization to import into the Community is restricted to certain regions of the third country concerned.

(2) Delete as appropriate.

(3) Give the registration number, flight number or name of the means of goods transport. For bulk containers, include the container number.

IV. Health attestation

- The official veterinarian hereby certifies that the heat-treated milk/milk-based product made from heat-treated milk/heat-treated milk-based product (4) described above has been obtained from animals, under the control of the official veterinary service:

- which were in a country or region that has been free of foot-and-mouth disease and of rinderpest for at least 12 months, and where vaccination against foot-and-mouth disease has not been carried out for at least 12 months

- belonging to holdings which were not under restrictions due to foot-and-mouth disease or rinderpest

- satisfying the animal health conditions laid down in Annex A, Chapter I of Council Directive 92/46/EEC, with the exception of those in paragraph 1 (a) (i) and b (i).

- The undersigned official veterinarian declares that he is familiar with the animal health requirements of Directive 92/46/EEC.

Done at . ,on .

(Place) (Date)

.

(Signature of official veterinarian (5))

.

(Name in capital letters, rank and title of the signatory)

XTB:STAMPEN500

V. Public health attestation

- The official inspector hereby certifies that the heat-treated milk/milk-based product made from heat-treated milk/heat-treated milk-based product described above:

1. was manufactured from raw milk:

- not, according to the findings of monitoring plans at least equivalent to those provided for in Directive 92/46/EEC, containing residues of anti-microbial substances in excess of the limits laid down in Annexes I and III to Regulation (EEC) No 2377/90, as amended

- not, according to the findings of monitoring plans at least equivalent to those provided for in Directive 92/46/EEC, containing pesticide residues in excess of the maximum levels laid down in Annex II to Directive 86/363/EEC, as amended

- not, according to the findings of monitoring plans at least equivalent to those provided for in Directive 92/46/EEC, containing contaminants in excess of the maximum tolerances laid down in the Community list provided for in Article 2 (3) of Regulation (EEC) No 315/93

- which comes from registered and checked holdings meeting the hygiene conditions laid down in Chapter II of Annex A to Directive 92/46/EEC

- which was obtained, collected, cooled, stored and transported in accordance with the specific hygiene conditions laid down in Chapter III of Annex A to Directive 92/46/EEC

- which meets the plate and somatic cell count standards laid down in Chapter IV of Annex A to Directive 92/46/EEC

- which was collected and standardized, where necessary, in accordance with the hygiene conditions laid down in Chapters I, III and IV of Annex B to Direcitve 92/46/EEC

(4) Delete as appropriate.

(5) The signature and seal must be in a different colour to that of the printing of the certificate.

2. comes from a treatment establishment and/or processing establishment offering equivalent guarantees to those laid down in Chapter II of Directive 92/46/EEC shown on the list of establishments authorized to export to the European Community and which is subject to supervision by the competent authority in accordance with the provisions of Chapter VI of Annex C to Directive 92/46/EEC

3. has undergone heat treatment during manufacture in accordance with the specific requirements of Chapter I of Annex C to Directive 92/46/EEC

4. meets the relevant microbiological criteria laid down in Chapter II of Annex C to Directive 92/46/EEC

5. has been wrapped and packaged in accordance with Chapter III of Annex C to Directive 92/46/EEC

6. was stored and transported in accordance with the requirements of Chapter V of Annex C to Directive 92/46/EEC

7. was transported, where appropriate, in tanks as described in Article 16 (2) of Directive 92/46/EEC.

- The official inspector whose signature is affixed below hereby declares that he is aware of the provisions contained in Directive 92/46/EEC, Annexes I and III of Regulation (EEC) No 2377/90, Annex II to Directive 83/363/EEC and Regulation (EEC) No 315/93.

Done at . ,on .

(Place)(Date)

.

(Signature of official inspector) (7)

.

(Name in capital letters, rank and title of the signatory)

XTB:STAMPEN700

(7) The signature and seal must be in a different colour to that of the printing of the certificate.

>END OF GRAPHIC>

ANNEX C

HEALTH CERTIFICATE for heat-treated milk, milk-based products made from heat-treated milk or heat-treated milk based products intended for human consumption from third countries or parts of third countries included in column C of the Annex to Commission Decision 95/340/EC

>START OF GRAPHIC>

Reference number: .

Country (and region, where applicable) (1) of dispatch: .

Ministry: .

Department responsible for certification: .

I. Identification of products

- Milk from: .

(Animal species)

- Description of heat-treated milk/milk-based product made from heat-treated milk / heat-treated milk-based product (2) .

- Code number (as appropriate): .

- Type of packaging: .

- Number of packaging units: .

- Net weight: .

II. Origin of products

Name(s) and official approval number(s) of treatment and/or processing establishment(s) approved for export to the Community

.

.

.

III. Destination of products

The heat-treated milk/milk-based product from heat-treated milk/heat-treated milk-based product (2) is to be sent from: .

(Place of dispatch)

to: .

(Country and place of destination)

by the following means of transport (3): .

Seal number: .

Name and address of consignor: .

.

Name and address of consignee: .

.

(1) To be specified if the authorization to import into the Community is restricted to certain regions of the third country concerned.

(2) Delete as appropriate.

(3) Give the registration number, flight number or name of the means of goods transport. For bulk containers, include the container number.

IV. Animal health attestation

- The official veterinarian hereby certifies that the heat treated milk/milk-based product made from heat-treated milk/heat-treated milk-based product (4) described above has been obtained from animals, under the control of the official veterinary service:

- belonging to holdings which were not under restrictions due to foot-and-mouth disease or rinderpest

- satisfying the animal health conditions laid down in Annex A, Chapter I of Council Directive 92/46/EEC, with the exception of those in paragraph 1 (a) (i) and b (i).

- The undersigned official veterinarian declares that he is familiar with the animal health requirements of Directive 92/46/EEC.

Dones at . ,on .

(Place) (Date)

.

(Signature of official veterinarian) (5)

.

(Name in capital letters, rank and title of the signatory)

XTB:STAMPEN500

V. Public health attestation

- The official inspector hereby certifies that the heat-treated milk/milk-based product made from heat-treated milk/heat-treated milk-based product (4) described above:

1. was manufactured from raw milk:

- not, according to the findings of monitoring plans at least equivalent to those provided for in Directive 92/46/EEC, containing residues of anti-microbial substances in excess of the limits laid down in Annexes I and III to Regulation (EEC) No 2377/90, as amended

- not, according to the findings of monitoring plans at least equivalent to those provided for in Directive 92/46/EEC, containing pesticide residues in excess of the maximum levels laid down in Annex II to Directive 86/363/EEC, as amended

- not, according to the findings of monitoring plans at least equivalent to those provided for in Directive 92/46/EEC, containing contaminants in excess of the maximum tolerances laid down in the Community list provided for in Article 2 (3) of Regulation (EEC) No 315/93

- which comes from registered and checked holdings meeting the hygiene conditions laid down in Chapter II of Annex A to Directive 92/46/EEC

- which was obtained, collected, cooled, stored and transported in accordance with the specific hygiene conditions laid down in Chapter III of Annex A to Directive 92/46/EEC

- which meets the plate and somatic cell count standards laid down in Chapter IV of Annex A to Directive 92/46/EEC

- which was collected and standardized, where necessary, in accordance with the hygiene conditions laid down in Chapters I, III and IV of Annex B to Direcitve 92/46/EEC

(4) Delete as appropriate.

(5) The signature and the seal must be in a different colour to that of the printing of the certificate.

2. comes from a treatment establishment and/or processing establishment offering equivalent guarantees to those laid down in Chapter II of Directive 92/46/EEC shown on the list of establishments authorized to export to the European Community and which is subject to supervision by the competent authority in accordance with the provisions of Chapter VI of Annex C to Directive 92/46/EEC

3. has undergone, prior to import into the territory of the Community:

(a) a sterilization process, whereby an Fo value equal to or greater than 3 was achieved

or

(b) an initial heat treatment having an effect at least equivalent to that achieved by pasteurization at a temperature of at least 72 °C for at least 15 seconds, so as to produce a negative reaction to the phosphates test, followed by:

(i) a second heat treatment involving high-temperature pasteurization, UHT or sterilization, so as to produce a negative reaction to the perixidase test

or

(ii) in the case of milk powder or a dry milk-based product, a second heat treatment having an effect at least equivalent to that achieved by the first heat treatment, so as to produce a negative reaction to the phosphatase test, followed by a drying process

or

(iii) an acidification process such that the pH value is lowered and kept below 6 for at least one hour

4. meets the relevant microbiological criteria laid down in Chapter II of Annex C to Directive 92/46/EEC

5. has been wrapped and packaged in accordance with Chapter III of Annex C to Directive 92/46/EEC

6. was stored and transported in accordance with the requirements of Chapter V of Annex C to Directive 92/46/EEC

7. was transported, where appropriate, in tanks as described in Article 16 (2) of Directive 92/46/EEC.

- The official inspector whose signature is affixed below hereby declares that he is aware of the provisions contained in Directive 92/46/EEC, Annexes I and III of Regulation (EEC) No 2377/90, Annex II to Directive 86/363/EEC and Regulation (EEC) No 315/93.

Done at . ,on .

(Place) (Date)

.

(Signature of official inspector (7))

.

(Name in capital letters, rank and title of signatory)

XTB:STAMPEN700

(7) The signature and the seal must be in a different colour to that of the printing of the certificate.

>END OF GRAPHIC>

ANNEX D

HEALTH CERTIFICATE for raw milk products from third countries intended for human consumption

>START OF GRAPHIC>

Reference number: .

Country (and region, where applicable (1)) of dispatch: .

Ministry: .

Department responsible for certification: .

I. Identification of products

- Milk from: .

(Animal species)

- Description of raw milk product: .

- Code number (as appropriate): .

- Type of packaging: .

- Number of packaging units: .

- Net weight: .

II. Origin of products

Name(s) and official approval number(s) of processing establishment(s) approved for export to the Community

.

.

.

III. Destination of products

The raw milk product is to be sent from: .

(Place of dispatch)

to: .

(Country and place of destination)

by the following means of transport (2): .

Seal number: .

Name and address of consignor: .

.

Name and address of consignee: .

.

(1) To be specified if the authorization to import into the Community is restricted to certain regions of the third country concerned.

(2) Give the registration number, flight number of name of the means of goods transport. For bulk containers, include the container number.

IV. Animal health attestation

- The official veterinarian hereby certifies that the raw milk product described above has been manufactured from raw milk obtained from animals, under the control of the official veterinary service:

- which were in a country or region that has been free of foot-and-mouth disease and of rinderpest for at least 12 months, and where vaccination against foot-and-mouth disease has not been carried out for at least 12 months

- belonging to holdings which were not under restrictions due to foot-and-mouth disease or rinderpest

- satisfying the animal health conditions laid down in Annex A, Chapter I of Council Directive 92/46/EEC.

- The undersigned official veterinarian declares that he is familiar with the animal health requirements of Directive 92/46/EEC.

Done at . ,on .

(Place)(Date)

.

(Signature of official veterinarian) (3)

.

(Name in capital letters, rank and title of the signatory)

XTB:STAMPEN300

V. Public health attestation

- The official inspector hereby certifies that the raw milk product described above:

1. was manufactured from raw milk:

- not, according to the findings of monitoring plans at least equivalent to those provided for in Directive 92/46/EEC, containing residues of anti-microbial substances in excess of the limits laid down in Annexes I and III to Regulation (EEC) No 2377/90, as amended

- not, according to the findings of monitoring plans at least equivalent to those provided for in Directive 92/46/EEC, containing pesticide residues in excess of the maximum levels laid down in Annex II to Directive 86/363/EEC, as amended

- not, according to the findings of monitoring plans at least equivalent to those provided for in Directive 92/46/EEC, containing contaminants in excess of the maximum tolerances laid down in the Community list provided for in Article 2 (3) of Regulation (EEC) No 315/93

- which comes from registered and checked holdings meeting the hygiene conditions laid down in Chapter II of Annex A to Directive 92/46/EEC

- which was obtained, collected, cooled, stored and transported in accordance with the specific hygiene conditions laid down in Chapter III of Annex A to Directive 92/46/EEC

- which meets the plate and somatic cell count standards laid down in Directive 92/46/EEC, Annex A, Chapter IV, paragraph A, point 3 as regards cow's milk, paragraph B, point 2 as regards buffalo milk, and paragraph C, point 2 as regards goat's and sheep's milk

- which, where necessary, was collected and standardized in accordance with the hygiene conditions laid down in Chapters I, III and IV of Annex B to Directive 92/46/EEC

2. comes from a processing establishment offering equivalent guarantees to those laid down in Chapter II of Directive 92/46/EEC shown on the list of establishments authorized to export to the European Community and which is subject to supervision by the competent authority in accordance with the provisions of Chapter VI of Annex C to Directive 92/46/EEC

(3) The signature and the stamp must be in a different colour to that of the printing of the certificate.

3. has not undergone any heat treatment during its manufacture from raw milk

4. meets the relevant microbiological criteria laid down in Chapter II of Annex C to Directive 92/46/EEC

5. has been wrapped and packaged in accordance with Chapter III of Annex C to Directive 92/46/EEC

6. was stored and transported in accordance with the requirements of Chapter V of Annex C to Directive 92/46/EEC

- The official inspector whose signature is affixed below hereby declares that he is aware of the provisions contained in Directive 92/46/EEC, Annexes I and III of Regulation (EEC) No 2377/90, Annex II to Directive 86/363/EEC and Regulation (EEC) No 315/93.

Done at . ,on .

(Place)(Date)

.

(Signature of official inspector) (4)

.

(Name in capital letters, rank and title of signatory)

XTB:STAMPEN400

(4) The signature and the stamp must be in a different colour to that of the printing of the certificate.

>END OF GRAPHIC>