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Council Directive 92/47/EEC of 16 June 1992 on the conditions for granting temporary and limited derogations from specific Community health rules on the production and placing on the market of milk and milk- based products Official Journal L 268 , 14/09/1992 P. 0033 - 0034 Finnish special edition: Chapter 3 Volume 45 P. 0033 Swedish special edition: Chapter 3 Volume 45 P. 0033

COUNCIL DIRECTIVE 92/47/EEC of 16 June 1992 on the conditions for granting temporary and limited derogations from specific Community health rules on the production and placing on the market of milk and milk-based products THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas milk and milk products are included on the list of products in Annex II to the Treaty; whereas production of and trade in such milk and products constitute an important source of income for the farming population; Whereas, in order to ensure the rational development of this sector, to increase its productivity and progressively to establish the conditions for an internal market, health rules applying to production and placing on the market have been laid down at Community level by Directive 92/46/EEC (4) Whereas it is possible that, because of particular circumstances, some establishments will be unable, by the date of application of the said Directive, to comply with all of the specific rules laid down; whereas, in order to take account of local situations and to prevent abrupt closures of establishments, arrangements should be made for temporary and limited derogations to be granted for establishments in operation before 1 January 1993; Whereas the granting of derogations from specific Community health rules to certain establishments must be without prejudice to the requirement that all operations connected with production and placing on the market conform to the hygiene rules laid down by the aforesaid Directive; Whereas, to forestall any risk of abuse, these derogations must be strictly controlled by the Commission; whereas to this end there should be a procedure for close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee, HAS ADOPTED THIS DIRECTIVE Article 1 Member States shall ensure that from 1 January 1998: - all establishments fulfil the requirements of Directive 92/46/EEC, - drinking milk and milk-based products from such establishments bear the health mark specified in Annex C, Chapter IV.A.3 of Directive 92/46/EEC. Article 2 1. Member States may, until 31 December 1997, authorize establishments which, on the date on which this Directive is notified, have not been judged to comply with the requirements laid down by Directive 92/46/EEC for their approval, to derogate from some of the requirements laid down in Chapters I and V of Annex B to that Directive if drinking milk and milk-based products from such establishments do not bear the health mark specified in Annex C, Chapter IV.A.3 of the said Directive and are not intended for trade. 2. Derogations as referred to in paragraph 1 may be granted only to establishments which have, before 1 April 1993, submitted an application for a derogation to the competent national authority. This application must be accompanied by a work plan and programme indicating the period within which it would be possible for the establishment to comply with the requirements referred to in paragraph 1. Where financial assistance is requested from the Community, only applications complying with the requirements of Directive 92/46/EEC can be accepted. Member States shall submit to the Commission before 1 July 1993 a list of the establishments for which it is proposed to grant a derogation. This list shall, for each individual establishment, specify the type and duration of the derogations envisaged, the nature of the products manufactured, the checks to be made on products from the establishment in question and the staff responsible for carrying out those checks. Establishments which have not submitted applications for a derogation by the date referred to in the first subparagraph or whose applications have been refused by the Member State concerned shall cease to be authorized to place drinking milk or milk-based products on the market until they have been judged to comply with the conditions of approval referred to in paragraph 1. This measure may apply to only part of the establishment and the products concerned. On receipt of the list submitted by a Member State in accordance with the fourth subparagraph, the Commission shall have two months within which to examine that list and to submit it, if necessary after amendment, to the Standing Veterinary Committee, which shall decide in accordance with the procedure laid down in Article 4. 3. The list of establishments which have been granted derogations shall be published by the Commission. Article 3 1. Member States may, until 31 December 1997, authorize establishments which are unable to obtain supplies of milk which meets the conditions laid down in Annex A, Chapter IV, of Directive 92/46/EEC to place drinking milk or milk-based products on the national market if such milk or milk-based products do not bear the health mark provided for in Annex C, Chapter IV.A.3 of that Directive and are not intended for trade. 2. Establishments approved in accordance with Article 10 or Article 11 of Directive 92/46/EEC may receive the authorization provided for in paragraph 1 for part of their production under the following conditions: - the operator or manager of the establishment must take all necessary measures, under the supervision of the competent authority, to ensure that raw milk or milk-based products which do not meet the requirements of Annex A, Chapter IV, of Directive 92/46/EEC are treated or processed in a clearly separated place or at a completely different time from milk and products which do meet these requirements and are intended for trade, - the operator or manager of the establishment must show to the satisfaction of the competent authority that the measures taken to keep a constant check on the use of the health mark ensure that it cannot be mistakenly applied to the products referred to in paragraph 1, and must keep at the disposal of the competent authority a record of raw materials and finished products which will allow the two separate circuits to be verified. Article 4 Where reference is made to the procedure provided for in this Article, the rules applicable shall be those set out in Article 31 of Directive 92/46/EEC. Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 2 (2) before 1 January 1993 and with the other provisions of this Directive before 1 January 1994. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 6 This Directive is addressed to the Member States. Done at Luxembourg, 16 June 1992. For the Council The President Arlindo MARQUES CUNHA (1) OJ No C 84, 2. 4. 1990, p. 100.(2) OJ No C 183, 15. 7. 1991, p. 60.(3) OJ No C 332, 31. 12. 1990, p. 62.(4) See page 1 of this Official Journal.

COUNCIL DIRECTIVE 92/47/EEC of 16 June 1992 on the conditions for granting temporary and limited derogations from specific Community health rules on the production and placing on the market of milk and milk-based products

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas milk and milk products are included on the list of products in Annex II to the Treaty; whereas production of and trade in such milk and products constitute an important source of income for the farming population;

Whereas, in order to ensure the rational development of this sector, to increase its productivity and progressively to establish the conditions for an internal market, health rules applying to production and placing on the market have been laid down at Community level by Directive 92/46/EEC (4)

Whereas it is possible that, because of particular circumstances, some establishments will be unable, by the date of application of the said Directive, to comply with all of the specific rules laid down; whereas, in order to take account of local situations and to prevent abrupt closures of establishments, arrangements should be made for temporary and limited derogations to be granted for establishments in operation before 1 January 1993;

Whereas the granting of derogations from specific Community health rules to certain establishments must be without prejudice to the requirement that all operations connected with production and placing on the market conform to the hygiene rules laid down by the aforesaid Directive;

Whereas, to forestall any risk of abuse, these derogations must be strictly controlled by the Commission; whereas to this end there should be a procedure for close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee,

HAS ADOPTED THIS DIRECTIVE

Member States shall ensure that from 1 January 1998:

- all establishments fulfil the requirements of Directive 92/46/EEC,

- drinking milk and milk-based products from such establishments bear the health mark specified in Annex C, Chapter IV.A.3 of Directive 92/46/EEC.

1. Member States may, until 31 December 1997, authorize establishments which, on the date on which this Directive is notified, have not been judged to comply with the requirements laid down by Directive 92/46/EEC for their approval, to derogate from some of the requirements laid down in Chapters I and V of Annex B to that Directive if drinking milk and milk-based products from such establishments do not bear the health mark specified in Annex C, Chapter IV.A.3 of the said Directive and are not intended for trade.

2. Derogations as referred to in paragraph 1 may be granted only to establishments which have, before 1 April 1993, submitted an application for a derogation to the competent national authority.

This application must be accompanied by a work plan and programme indicating the period within which it would be possible for the establishment to comply with the requirements referred to in paragraph 1.

Where financial assistance is requested from the Community, only applications complying with the requirements of Directive 92/46/EEC can be accepted.

Member States shall submit to the Commission before 1 July 1993 a list of the establishments for which it is proposed to grant a derogation. This list shall, for each individual establishment, specify the type and duration of the derogations envisaged, the nature of the products manufactured, the checks to be made on products from the establishment in question and the staff responsible for carrying out those checks.

Establishments which have not submitted applications for a derogation by the date referred to in the first subparagraph or whose applications have been refused by the Member State concerned shall cease to be authorized to place drinking milk or milk-based products on the market until they have been judged to comply with the conditions of approval referred to in paragraph 1. This measure may apply to only part of the establishment and the products concerned.

On receipt of the list submitted by a Member State in accordance with the fourth subparagraph, the Commission shall have two months within which to examine that list and to submit it, if necessary after amendment, to the Standing Veterinary Committee, which shall decide in accordance with the procedure laid down in Article 4.

3. The list of establishments which have been granted derogations shall be published by the Commission.

Article 3

1. Member States may, until 31 December 1997, authorize establishments which are unable to obtain supplies of milk which meets the conditions laid down in Annex A, Chapter IV, of Directive 92/46/EEC to place drinking milk or milk-based products on the national market if such milk or milk-based products do not bear the health mark provided for in Annex C, Chapter IV.A.3 of that Directive and are not intended for trade.

2. Establishments approved in accordance with Article 10 or Article 11 of Directive 92/46/EEC may receive the authorization provided for in paragraph 1 for part of their production under the following conditions:

- the operator or manager of the establishment must take all necessary measures, under the supervision of the competent authority, to ensure that raw milk or milk-based products which do not meet the requirements of Annex A, Chapter IV, of Directive 92/46/EEC are treated or processed in a clearly separated place or at a completely different time from milk and products which do meet these requirements and are intended for trade,

- the operator or manager of the establishment must show to the satisfaction of the competent authority that the measures taken to keep a constant check on the use of the health mark ensure that it cannot be mistakenly applied to the products referred to in paragraph 1, and must keep at the disposal of the competent authority a record of raw materials and finished products which will allow the two separate circuits to be verified.

Article 4

Where reference is made to the procedure provided for in this Article, the rules applicable shall be those set out in Article 31 of Directive 92/46/EEC.

Article 5

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 2 (2) before 1 January 1993 and with the other provisions of this Directive before 1 January 1994. They shall forthwith inform the Commission thereof.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 6

This Directive is addressed to the Member States.

Done at Luxembourg, 16 June 1992.

For the Council

The President

Arlindo MARQUES CUNHA

(1) OJ No C 84, 2. 4. 1990, p. 100.(2) OJ No C 183, 15. 7. 1991, p. 60.(3) OJ No C 332, 31. 12. 1990, p. 62.(4) See page 1 of this Official Journal.