Council Directive 92/46/EEC of 16 June laying down health rules for the production and placing on the market of raw milk, heat-treated milk and milk products has been incorporated into the national legislation by means of Royal Decree 1679/1994 of 22 July 1994.

Later, Council Directive 92/46/EEC has been amended by Directive 94 /71/EC of 13 December 1994, by making it necessary to introduce into Royal Decree 1679/1994 of 22 July 1994 the amendments laid down by Directive 94 /71/EC, which is transposed into national law by means of this provision, in which the sectors concerned have been heard and the Interministerial Committee for Food Management has been informed.

In its virtue, on the proposal of the Ministers of Health and Consumer Affairs, Trade and Tourism and Agriculture, Fisheries and Food, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of Day 1 of March 1996,

D I S P O N G O:

Single item.

Royal Decree 1679/1994 of 22 July 1994 laying down health conditions for the production and placing on the market of raw milk, heat-treated milk and milk products is amended as follows:

1. The first subparagraph of Article 8 (1) shall be replaced by the following:

" 1. Establishments producing cheeses with a maturity cycle of at least 60 days may be exempted from compliance with the requirements as set out in Annex D.

2. Paragraph 1 (b) of Chapter I of Annex A is replaced by the following:

" (b) ovine and caprine animals:

1. º belonging to a ovine or caprine holding officially free or free of brucellosis ("Brucella melitensis"), as defined in Article 2 (4) and (5) of Royal Decree 2121/1993 of 3 December 1993, concerning the animal health rules governing intra-Community trade in and imports from third countries of ovine and caprine animals, except in the case of milk intended for the manufacture of cheese of a minimum maturity period of 60 days.

2. º That meet the requirements set out in heading (a), with the exception of paragraphs 1 and 6. "

3. Paragraph 5 of Chapter I of Annex A is replaced by the following:

" 5. Milk and milk products shall not come from a surveillance zone defined in accordance with Royal Decree 2223/1993 of 17 December 1993 laying down measures for the control of foot-and-mouth disease and animal health in the intra-Community trade in and imports of animals of the bovine, porcine, fresh meat or meat-based products from third countries, unless the milk has undergone initial pasteurisation (71.7 ° C); for 15 seconds), under the control of the competent authority, followed:

(a) A second heat treatment that causes a negative reaction to the peroxidase test, or

(b) A drying process that includes a heating of an effect equivalent to the heat treatment provided for in paragraph (a); or

(c) A second treatment by which the pH has decreased and has been maintained for at least one hour at a level below 6. '

4. Paragraph A. 2 of Chapter III of Annex A is replaced by the following:

" 2. Immediately after milking, the milk shall be placed in a clean and disposed place in such a way as to avoid any harmful effect in its quality.

If the milk is not collected during the two hours following the milking, it shall be cooled to a temperature of 8 ° C or less, if it is collected daily, and 6 ° C when the collection is not carried out every day. During transport to the treatment and/or processing establishments, the temperature of the chilled milk shall not exceed 10 ° C, except in the case of milk which was collected during the two hours following the milking.

For technical reasons related to the manufacture of certain milk-based products, the competent authorities may allow derogations from the temperatures provided for in the preceding paragraph, provided that the final product complies with the the rules referred to in Chapter II of Annex C. '

5. The title of Chapter IV of Annex A is replaced by the following:

"Rules to be complied with at the time of collection on the holding of production for the reception of raw milk in the treatment or processing establishment."

6. As an introductory preamble to the content of Chapter IV of Annex A, the following paragraph is added:

"For compliance with those standards, the examination of raw milk shall be carried out in a representative sample of the milk collected on each production holding separately."

7. Note (b) to paragraphs 1 and 2 of Chapter IV of Annex A is replaced by the following:

"b) Geometric mean observed over a period of three months, with a sample at least per month."

8. Paragraph B of Chapter IV of Annex A is replaced by the following:

" B. Raw milk from buffala.

Without prejudice to the compliance of the limits laid down in Annexes I and III to Regulation (EEC) 2377/90, the following rules shall be complied with:

1. If it is intended for the manufacture of heat-treated drinking milk or for the manufacture of milk-based milk products treated by heat:

From

from 1-1-1996/From

from 1-12-1999

Germ content at 30 °C (per ml)/" 3,000,000 (a)/' 1.500,000 (a)

Somatic cell content (per ml): " 500,000 (b)

(a) Geometric mean observed over a period of two months, with two samples, at least, per month.

(b) Geometric mean observed over a period of three months, with a sample at least per month.

2. If it is intended for the production of raw milk products for which the processing process does not include any heat treatment:

From

from 1-1-1996/From

from 1-12-1999

Germ content at 30 °C (per ml)/" 1,000,000 (a)/' 500,000 (a)

Somatic cell content (per ml): " 400,000 (b)

(a) Geometric mean observed over a period of two months, with two samples, at least, per month.

(b) Geometric mean observed over a period of three months, with a sample at least per month.

'' Staphylococcus aureus '': same standard as for raw cow milk. "

9. Paragraph C of Chapter IV of Annex A is replaced by the following:

" C. Raw milk of goat and sheep.

Without prejudice to the compliance of the limits laid down in Annexes I and III to Regulation (EEC) 2377/90, the following rules shall be complied with:

1. If it is intended for the production of heat-treated drinking milk or for the manufacture of heat-treated milk products:

From

from 1-1-1996/From

from 1-12-1999

Germ content at 30 °C (per ml)/" 3,000,000 (a)/' 1.500,000 (a)

(a) Geometric mean observed over a period of two months, with two samples, at least, per month.

2. If it is intended for the production of raw milk products for which the processing process does not include any heat treatment:

From

from 1-1-1996/From

from 1-12-1999

Germ content at 30 °C (per ml)/" 1,000,000 (a)/' 500,000 (a)

(a) Geometric mean observed over a period of two months, with two samples, at least, per month.

Staphylococcus aureus (per ml): same standard as for raw cow milk. '

10. Paragraph A. 3 of Chapter II of Annex B is replaced by the following:

" 3. The workplaces, the tools and the work material shall be used only for the production of products for which the authorisation has been granted. However, subject to the authorization of the competent authority, the same may or may not be used for the preparation of other foodstuffs suitable for human consumption or other milk products not intended for human consumption. the condition that these operations do not lead to the contamination of the products for which the authorisation has been granted. '

11. Paragraph (a) of Chapter V of Annex B is replaced by the following:

" (a) Where such operations are carried out in the establishment of an installation which permits the appropriate automatic filling and closing of containers intended for the packaging of drinking milk heat treated and dairy products which are in liquid state after filling. This requirement shall not apply to drums, tanks and containers of more than 4 litres.

However, in the case of limited production establishments, the competent authorities may authorise alternative methods using filling and closing means which are not automatic provided that such methods offer equivalent guarantees. "

12. Paragraph (f) of Chapter V of Annex B is replaced by the following:

" f) 1. In the case of treatment establishments, of a heat treatment equipment approved or approved by the competent authority, provided with:

1. An automatic temperature regulator.

2. º A logger thermometer.

3. An automatic security system that prevents insufficient heating.

4. A suitable safety system that prevents the mixture of heat-treated milk with insufficiently heated milk (bypass valve), and

5. º An automatic recorder of the security system referred to in paragraph 4. above or a procedure for controlling the effectiveness of such a system.

However, the competent authorities may, in the framework of the approval of establishments, authorise different equipment to ensure equivalent results with the same health guarantees.

2. In the case of processing establishments, where the operations are carried out in the establishment, a equipment and a method of heating, thermoisation or heat treatment meeting the hygienic requirements. '

13. Paragraph 3 of Chapter VI of Annex B is replaced by the following:

" 3. The material, containers and installations which, during manufacture, come into contact with milk, milk products or other perishable raw materials, shall be cleaned and, if necessary, disinfected on a regular basis a procedure in accordance with the principles referred to in Article 14 (1). "

14. Paragraph 4 of Chapter VI of Annex B is replaced by the following:

" 4. Treatment premises shall be cleaned at intervals and in accordance with a procedure in accordance with the principles referred to in Article 14 (1). "

15. Paragraph 1 (a) (1) (a) of Chapter I of Chapter I of Annex C is replaced by the following:

" 1. No raw milk which has not been treated within thirty-six hours after receipt does not exceed, immediately prior to heat treatment, a germ content of 30 ° C of 300,000 per millilitre in the case of cow's milk;. '

16. The following sentence is added to paragraph A. 4 (d) of Chapter I of Annex C:

"pasteurised milk may, under these same conditions, be produced from raw milk which has not been subjected to more than an initial thermoisation."

17. Paragraph B. 1 of Chapter I of Annex C is replaced by the following:

" 1. The employer or the manager of the processing establishment shall take the necessary measures to ensure that the raw milk is treated by heating or is used in the case of raw milk products:

1. No as soon as possible after receipt in the case of non-refrigerated milk.

2. º For thirty-six hours after reception, if the milk is stored at a temperature of less than or equal to 6 ° C.

3. º For forty-eight hours after reception, if the milk is stored at a temperature of less than or equal to 4 ° C.

4. º During the seventy-two hours following their reception for the milk of buffala, sheep and goat.

However, provided that it is due to technical reasons for the manufacture of certain milk products, the competent authorities may authorise overruns of the time and temperature referred to in paragraphs 2. 3. and 4. previous.

The Autonomous Communities shall inform the Ministries of Health and Consumer Affairs and Agriculture, Fisheries and Food of those derogations, as well as of the technical reasons justifying them, for further transfer to the Commission of the European Union. '

18. Paragraph B (1) (a) of Chapter I of Chapter I of Annex C is replaced by the following:

" 1. It shall be obtained from raw milk which, if not treated within thirty-six hours after its reception at the establishment, presents, before termination, a concentration of germs at 30 ° C which does not exceed the 300,000 germs per milliliter in the case of cow's milk. "

19. In the table in Annex C, Chapter II, paragraph A. 1, in the fourth and sixth lines of the column "Standard", the two indications "absent in 25 g (b)" are replaced by "absent in 25 g".

20. The last two paragraphs of paragraph A. 2 of Chapter II of Annex C are replaced by the following:

"In addition, as regards cheese based on raw milk and on the basis of termized milk and soft paste cheeses, any overshoot of the M standard will involve the search to detect the possible presence of strains of" S. aureus "enterotoxigenic or" E. (i) 'suspected pathogens' and, if necessary, the possible presence of staphylococcal toxins in such products.

The detection of the aforementioned strains or the presence of staphylococcal enterotoxin will result in the withdrawal from the market of all the affected lots. In such a case, the competent authority shall be informed of the results obtained pursuant to Article 14 (1) (d) of this Royal Decree, as well as of the action taken to withdraw the lots in question and the corrective procedures applied within the production surveillance system. "

21. The table in paragraph A. 3 of Chapter II of Annex C shall be replaced by the following:

" 3. Germ indicators: guidelines.

Type of germs/Products/Standard (ml, g)

Coliforms 30 ° C. /Liquid dairy products. /m = 0, M = 5, n = 5,

c = 2

Milk-based butter or pasteurized cream. /m = 0, M = 10,

n = 5, c = 2

Soft paste cheese (based on heat-treated milk). /m = 10,000,

M = 100,000,

n = 5, c = 2

Dairy products powder. /m = 0, M = 10,

n = 5, c = 2

Ice cream products (including ice cream and ice cream). /m = 10, M = 100,

n = 5, c = 2

Germ content. /Liquid dairy products, heat-treated and non-fermented (a). /m = 50,000,

M = 100,000,

n = 5, c = 2

Ice cream products (including ice cream and frosty cream) (b). /m = 100,000,

M = 500,000,

n = 5, c = 2

(a) After incubation at 6 °C for five days (germ content at 21 °C).

(b) Germ content at 30 ° C. "

22. The introductory paragraph of paragraph A. 4 of Chapter II of Annex C is replaced by the following:

" In addition, dairy products that are in liquid or gelled state, which have undergone UHT treatment or sterilisation and which are to be kept at room temperature, shall, after incubation at 30 ° C for a fortnight, the following rules: "

23. The second subparagraph of Chapter III (3) of Annex C is replaced by the following:

"However, the competent authority may authorise for the case of limited production establishments the use of non-automatic filling and closing systems offering equivalent hygienic guarantees."

24. The second subparagraph of Chapter III (4) of Annex C is replaced by the following:

" In the case of drinking milk or milk products which are in liquid form, the closure shall be carried out in the establishment in which the last heat treatment is carried out, immediately after filling, and by means of a locking device which ensures the protection thereof against the harmful influences of the exterior.

The closure system shall be designed in such a way that, once opened, it is clearly and clearly opened. "

25. Paragraph 5 of Chapter III of Annex C is replaced by the following:

" 5. For the purposes of monitoring, the employer or the manager of the establishment shall make visible and legible, in the case of heat-treated milk and milk-based products, in a visible and legible manner, in addition to the particulars which are indicate in Chapter IV, the following:

1. The type of heat treatment to which the milk has been submitted.

2. No explicit or coded reference to identify the date of the last heat treatment.

3. In the case of pasteurized milk, the temperature at which the product must be stored.

However, such indications may not appear in the glass bottles intended to be used again. "

26. The last sentence of paragraph A. 1 of Chapter IV of Annex C is replaced by the following:

" However, in the case of small, individually packaged portions, in turn packaged or packaged together, even if they are sold by units to the final consumer, the health mark shall be sufficient in the second package or packaging. '

27. The following paragraph is added to Chapter IV (A) (a) of Chapter IV of Annex

:

" 3. º O:

-At the top, the word SPAIN or the letter E capital.

-In the center, a reference to the place in which the number of the General Sanitary Food Registry of the establishment is indicated.

-At the bottom, the initials CEE. "

28. Paragraph A. 3 (b) of Chapter IV of Annex C is replaced by the following:

"In the case of packages with a larger surface area of less than 10 square centimetres, the health mark shall consist only of the letter E and the number of the General Health Register of the establishment."

29. Section B. 3 of Chapter IV of Annex C is replaced by the following:

" 3. For other milk products, the type of heat treatment which they have been subjected to after the processing process. "

30. The following sentence is added to Chapter V (7) of Annex C

"However, the competent authorities may authorise a tolerance of + 2ºC during deliveries to retail and home-based businesses."

Given in Madrid on March 1, 1996.

JOHN CARLOS R.

The Minister of the Presidency,

ALFREDO PEREZ RUBALCABA