Key Benefits:
Spain's membership of the European Union imposes an obligation to incorporate into our national law the Community rules of application in the milk sector.
In the first phase of this process, Royal Decree 362/1992 of 10 April 1992 establishing the health and health policy rules for heat-treated milk for trade The Council Directive of 5 August 1985 on health and veterinary inspection problems in intra-Community trade in heat-treated milk and Directive 89 /384/EEC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to the Council Directive of 20 June laying down detailed rules for checking compliance with the freezing point of raw milk, set out in Annex A to Directive 85 /397/EEC.
The health rules applicable to the production and placing on the market of raw milk and milk products have been laid down in Council Directive 92/46/EEC of 16 June laying down rules (a) health conditions for the production and placing on the market of raw milk, heat-treated milk and milk-based products, having been provided for in the gradual implementation of these rules to maintain on a transitional basis, if so requested, a distinction between intra-Community trade and domestic market by means of the May 26 May 1993, laying down the conditions for the classification of establishments and the granting of temporary and limited derogations from Community health rules for the production and placing on the market of raw milk, heat-treated consumption and dairy products.
Also, in view of the risks of transmission of certain diseases to which the species of milk production are exposed, Article 8 of Council Directive 92/118/EEC of 17 December establishing the animal health and health conditions governing trade in and imports into the Community of products not subject to the specific Community rules referred to in Chapter I of this Regulation in respect of these conditions. Annex A to Directive 89 /662/EEC and, as regards pathogens, to the Directive 90 /425/EEC lays down requirements for milk and milk products when they are the subject of intra-Community trade.
For all this, the full wording of the health conditions to be met for the production and marketing of raw milk, heat-treated milk and milk products has been carried out. our right as laid down in Directive 92/46/EEC and in Article 8 of Directive 92/118/EEC, by means of this Royal Decree, in which the sectors concerned have been heard and the Interministerial Committee for Ordination has been informed. Food.
However, the criteria laid down in Articles 8 and 11 of this Royal Decree may be amended in order to adapt to the amendments introduced as a result of the existing Community procedure.
This Royal Decree is issued pursuant to Article 149.1.10 and 16 of the Constitution, and in accordance with the provisions of Article 40.2 of Law 14/1986 of 25 April, General of Health.
By virtue of the proposal of the Ministers for Health and Consumer Affairs, Trade and Tourism and Agriculture, Fisheries and Food, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 22 May. of July 1994,
D I S P O N G O:
CHAPTER I
General provisions
Article 1.
1. This Royal Decree lays down the health rules applicable to the production and placing on the market of raw milk, heat-treated drinking milk, milk intended for the production of milk products and milk products intended for consumption human.
2. This Royal Decree shall not apply to the direct sale to the consumer by the producer on his holding of:
(a) Raw milk from a herd officially free of tuberculosis and officially free or free of brucellosis.
(b) Milk products produced on their holding with such raw milk.
However, the holding in which the sale is made provided for in this paragraph shall comply with the minimum health standards laid down in regulation.
3. The application of this Royal Decree will not prevent the applicability of other more specific provisions and, in particular, the provisions of the Order of 28 March 1988 laying down the general quality standards for caseins and (a) food caseinates and Community legislation which, where appropriate, is of direct application.
Article 2.
For the purposes of this Royal Decree:
1.
2.
3.
4. Products based on milk, i.e. products derived exclusively from milk, bearing in mind that substances may be added to their preparation, provided that these substances are not used to replace them. in whole or in part, any of the constituents of milk and milk products, in which milk or a milk product is the essential part, either by its quantity or by the effect which characterises those products and in which no milk or milk product element replaces or tends to replace any component of milk.
5. : any heat treatment that, immediately after application, results in a negative reaction to the phosphatase test.
6.
7. : establishment in which one or more cows, sheep, goats or buffaloes intended for milk production are found.
8.
9. 'Centre for normalisation': establishment not linked to a collection centre, or to a treatment or processing establishment and where raw milk may be subject to a test or to a modification of the content of normal components of milk.
10.
11. : establishment and/or production operation in which processing, processing and packaging of milk and milk products are carried out.
12.
13.
14.
15. : the air-tight container, which is intended to protect the content against the penetration of microorganisms during and after heat treatment.
16. : possession or exposure for sale, sale, sale, distribution or any other form of transfer, excluding retail trade.
17.
In addition, the definitions set out in other more specific provisions, and in particular Article 2 of Royal Decree 434/1990 of 30 March 1990 laying down health conditions, will apply. applicable to intra-Community trade in live animals of the bovine and porcine species, as amended by Royal Decree 679/1993 of 7 May 1993; Article 2 of Royal Decree 2121/1993 of 3 December 1993 on animal health rules regulate intra-Community trade in and imports from third countries of animals of the the ovine and caprine species; Article 3 of Council Regulation (EEC) No 1411/71 of 29 June 1971 laying down additional rules for the common organisation of the market in milk and milk products with regard to products falling within heading 04-01 of the Common Customs Tariff, as last amended by Commission Regulation (EEC) No 323/93 of 12 February 1993; Article 2 of Council Regulation (EEC) No 1898/87 of 2 July 1993 1987, concerning the protection of the name of milk and milk products at the time of their marketing, as last amended by Regulation (EEC) No 222/88; Article 1 of Royal Decree 1114/1992 of 18 September 1992 laying down the rules for the enzootic leukosis to be complied with by bovine animals reproduction or production intended for intra-Community trade.
CHAPTER II
Provisions for Community Production
Article 3.
1. It shall only be used for the manufacture of milk products or heat-treated drinking milk which:
(a) Proceedings of animals and holdings regularly checked by the competent authority pursuant to Article 13 (1).
(b) is controlled in accordance with Article 10 (3) and Articles 14 and 15 and complies with the rules laid down in Chapter IV of Annex A.
(c) Meet the animal health conditions for raw milk laid down in Chapter I of Annex A.
(d) Proceed from holdings which comply with the hygiene conditions laid down in Chapter II of Annex A.
e) Adjustment to the hygienic requirements of milking, collection and transport of milk, as well as hygienic requirements of staff, as defined in Chapter III of Annex A.
2. Where the milk comes from healthy animals belonging to:
(a) Rebates of cows and buffaloes which, in accordance with paragraph 1 of Annex A to Royal Decree 434/1990, are not officially tuberculosis-free and free of brucellosis-free or officially free.
(b) Rebans of sheep and goats of ovine and caprine holdings which are not officially free or free of brucellosis as defined in Article 2 (4) and (5) of Royal Decree 2121/1993.
It may only be used for the manufacture of heat-treated milk or milk products after undergoing thermal treatment, under the control of the competent authority.
In the case of goat and ewe milk intended for trade, such heat treatment must be carried out on the spot.
Article 4.
Only the marketing of raw milk for direct human consumption shall be authorised if:
1. It complies with the provisions of Article 3, under heading 3 of Chapter IV of Annex A and under heading 1 of Chapter II of Chapter II of Annex C.
2. It is filtered, cooled and packaged immediately after milking in accordance with Chapter III of Annex A and Chapter III of Annex C.
3. It complies with the conditions relating to the labelling and labelling referred to in Chapter IV of Annex C.
4. It is kept, at all times, until its delivery to the consumer at a temperature not exceeding 4 grad.
C.
5. It is sold within twenty-four hours from its packaging.
Article 5.
Only heat-treated drinking milk will be marketed if:
1. It has been obtained from raw or filtered raw milk, by means of equipment referred to in paragraph (e) of Chapter V of Annex B, and which meets the following requirements:
(a) It complies with the provisions of Article 3.
(b) In the case of cow's milk, its fat content is in accordance with the provisions of Article 3 (1) (b) and Article 6 (3) of Regulation (EEC) No 1411/71.
(c) It has been passed, where appropriate, by a milk collection centre which meets the conditions laid down in Chapters I, II, III and VI of Annex B or has been transferred into tanks in good hygiene and distribution conditions.
(d) has passed, where appropriate, a milk standardisation centre which meets the conditions laid down in Chapters I, II, IV and VI of Annex B.
e) Only in the case of milk intended for the production of sterilised milk or UHT has undergone, where appropriate, an initial heat treatment in an establishment meeting the conditions laid down in paragraph 2.
2. It comes from a treatment establishment which complies with the conditions laid down in Chapters I, II, V and VI of Annex B and which is controlled in accordance with Article 10 (3) and Article 14.
3. It has been treated in accordance with Chapter I (A) of Annex C.
4. Complies with the microbiological standards referred to in Chapter II (B) of Annex C.
5. It has been labelled, in accordance with Chapter IV of Annex C, and packaged, in accordance with Chapter III of Annex C, in the treatment establishment where it has undergone the final treatment.
6. It has been stored in accordance with Chapter V of Annex C.
7. It is transported under satisfactory health conditions in accordance with Chapter V of Annex C.
8. It is accompanied, during transport, except where it is the same manufacturer that carries the milk to deliver it directly to the final consumer, of a commercial document which:
(a) It shall carry, in addition to the indications of the health marking and the labelling provided for in Chapter IV of Annex C, an indication to identify the type of heat treatment and the competent authority which is responsible for the control of the establishment of origin, in so far as it does not clearly indicate the approval number expressed in the health mark and which is not included in the compulsory labelling information.
(b) It shall be retained by the consignee for a period of at least one year, in order to present it to the competent authority.
9. As far as cow's milk is concerned, it has a freezing point equal to or less than -0.520 grad. C and a weight equal to or greater than 1,028 grams per litre recorded in whole milk at 20 grams. C, or the equivalent per litre recorded in the milk totally defatted to 20 grad. C, and contains a minimum of 28 grams of protein per litre, obtained by multiplying the total nitrogen content of the milk expressed as a percentage by 6,38, and a dry lean extract equal to or greater than 85 grams per litre.
The application of the preceding subparagraph should be made in the light of the provisions of Chapter III of Annex C, Chapter III, Chapter III of Annex C, Chapter I of Annex C to Annex C, paragraph 1, to the freezing point. Royal Decree.
Article 6.
Dairy products will only be developed from:
1. Raw milk complying with the requirements of Article 3 and the rules and requirements referred to in Chapter I (B) of Annex C and which, where appropriate, has been passed by a milk collection or standardisation centre which meets the conditions laid down laid down in Chapters I, II, III, IV and VI of Annex B.
2. Milk intended for the manufacture of milk products, obtained from raw milk which complies with the requirements of paragraph 1 and which:
(a) Proceed from a treatment establishment that meets the conditions laid down in Chapters I, II, V and VI of Annex B.
(b) Stored and transported in accordance with Chapter V of Annex C.
Article 7.
1. Without prejudice to Article 8, only dairy products shall be placed on the market if:
(a) They have been made from milk which complies with the requirements of Article 6 or from milk products which comply with the requirements of this Article.
(b) They have been prepared in a processing establishment which complies with the rules and requirements referred to in Chapters I, II, V and VI of Annex B and is checked in accordance with Article 10 (3) and with the Article 14.
(c) Meet the microbiological standards referred to in Chapter II of Annex C.
(d) They have been packaged and packaged in accordance with Chapter III of Annex C.
e) Have been labelled in accordance with Chapter IV of Annex C.
f) They are stored and transported in accordance with Chapter V of Annex C.
g) Are controlled in accordance with Article 14 and Chapter VI of Annex C.
h) Where appropriate, they contain only substances, in addition to milk, suitable for human consumption.
i) have undergone a heat treatment during the processing process or have been manufactured with products which have undergone a heat treatment, or which comply with sufficient hygiene requirements for achieve the hygiene criteria in any finished product.
(j) A commercial document pursuant to Article 5 (8) is accompanied during transport.
2. Milk and milk products may not be subjected to ionizing radiation.
Article 8.
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.
These establishments will carry out a warehouse control so that lots can be identified, knowing and recording the length of stay of each batch of products to guarantee a minimum stay of sixty days.
2. Establishments producing dairy products with traditional characteristics may be exempted from compliance with the requirements as set out in Annex D.
To this end, the Ministry of Agriculture, Fisheries and Food and the Ministry of Health and Consumer Affairs will bring to the attention of the Commission of the European Community the list of dairy products of traditional characteristics, drawn up by the Autonomous Communities.
The milk to be used for the production of products with traditional characteristics whose maturation period is less than 60 days and does not comply with the standards set out in Chapter IV of Annex A, shall be previously pasteurized.
Article 9.
Without prejudice to the provisions of the Order of 26 May 1993 laying down the conditions for the application for the classification of establishments and the granting of temporary and limited derogations from the rules Community health services for the production and marketing of raw milk, heat-treated drinking milk and milk products:
(a) Treatment or processing establishments which receive raw milk which does not comply with the standards referred to in Chapter IV of Annex A may not be authorised in accordance with Articles 10 or 11. Products originating in such establishments shall not bear the health mark provided for in Annex C, Chapter IV, heading 3, or may be subject to trade.
(b) Products which do not comply with the rules laid down in Chapters I and II of Annex C and certain traditional products which may be determined in accordance with the Community procedure may not be traded or imported from third countries.
Article 10.
1. The competent authority, after having verified that the requirements of this Royal Decree are satisfied, shall establish the list of treatment establishments and processing establishments, other than those referred to in Article 11, as well as the collection centres and approved standardisation centres. Any establishment or approved centre shall be assigned a General Health Sanitary Register number, as set out in Royal Decree 1712/1991 of 29 November.
2. Irrespective of the penalties to which there may be, where the competent authority detects an obvious infringement, or has reasonable grounds for the failure to comply with the health rules laid down in this Royal Decree or finds In order to ensure adequate health inspection, any of the following precautionary measures may be taken, as long as the relevant file is substantiated:
a) Limit the use of equipment or premises, or even reduce the rate of production and suspend momentarily the same, until adequate sanitary conditions are restored.
(b) temporarily suspend the authorisation of the production line concerned, where the measures provided for in paragraph (a) are insufficient. The temporary suspension will also be made, in the event that an immediate public health risk has forced the withdrawal of the manufacturing batch, and the problem that caused the withdrawal remains unresolved.
c) Withdraw the authorization to the establishment where the identified deficiencies in the health conditions have not been addressed within the time limit set.
(d) In the event of repeated infringements, the control exercised by the competent authority must be strengthened, which may, where appropriate, be used by labels or supports with the health mark.
The competent authority shall take into account, in particular, the conclusions of the checks carried out in accordance with Article 14.
The withdrawal or suspension of the authorisation shall be communicated to the interested parties and to the Ministries of Agriculture, Fisheries and Food and Health and Consumer Affairs for communication to the other Member States, to the Commission The European Community and the other Autonomous Communities.
3. Any establishment or centre shall be under permanent control of the competent authority in accordance with Chapter VI of Annex C. The need for permanent or periodic presence in each establishment or centre shall depend on the size of the establishment or centre of the type. (a) of products manufactured, of the risk assessment system and of the guarantees offered in accordance with the headings (d) and (e) of the first subparagraph of Article 14 (1).
The competent authority shall have free access, at all times, to all the premises of the establishments or centres, to ensure compliance with this Royal Decree and, in case of doubt as to the origin of the milk and milk products, to the accounting documents which enable it to be traced back to the holding or establishment of origin of the raw material.
The competent authority shall regularly review the results of the checks provided for in Article 14 (1). On the basis of these analyses, additional examinations may be carried out on the various stages of production or products.
The competent authority shall inform the undertaking in writing of the outcome of its analyses and recommendations. The company shall correct the hygiene deficiencies and the observations which, where appropriate, are formulated.
Article 11.
The production establishments of dairy products whose production is limited and which have been classified within the system of permanent derogations, as provided for in the second paragraph of the Order of 26 May 1993, shall be exempt from the fulfilment of all or part of the requirements set out in Annex V to the same Order, with a view to granting the authorisation.
Within this category of establishments shall be those corresponding to the indicative classification criteria expressed in the second article of the said Order.
Article 12.
Before 1 January 1998, the competent authority shall, as provided for in Articles 10 and 11, classify all establishments, including those in the field of application of this Royal Decree, which have applied for it in accordance with the with the Order of 26 May 1993.
The establishments which, by the date of publication of this provision, are authorized for the exchange of heat treated milk in accordance with Royal Decree 362/1992, shall be automatically classified and authorised in accordance with Article 10.
Until an establishment has not been classified, it may only market its products at national level and may not be provided with the health mark referred to in Chapter IV of Annex C.
Article 13.
1. Animals from production holdings shall be subject to a periodic veterinary check with a view to verifying compliance with the requirements of Chapter I of Annex A.
Such checks may be carried out on the occasion of veterinary checks carried out in accordance with other mandatory rules.
Where the competent authority has the suspicion that the animal health requirements referred to in Annex A are not complied with, that authority shall verify the general health status of the dairy animals and, where appropriate, necessary, it shall order a supplementary examination of those animals.
2. Production holdings shall be subject to regular checks to determine whether they comply with the hygiene requirements.
3. Where the checks or controls referred to in paragraphs 1 and 2 make it possible to verify that the hygiene requirements are not met, the competent authority shall take such measures as it considers appropriate. 4. The competent authorities of the Autonomous Communities shall forward to the Ministry of Agriculture, Fisheries and Food the measures they intend to implement for the purposes of the checks provided for in paragraph 2. In turn, the Ministry shall submit them to the Commission for its opinion. The frequency of such checks shall take into account the assessment of the risks involved in the production of the production concerned.
Article 14.
1. All necessary measures shall be taken in the processing establishments and in the processing establishments to ensure that, at all stages of production, the health conditions laid down in this Royal Decree are met, owing to this meet the following requirements:
a) Establish and maintain a continuous system of control, based on the methodology of risk analysis and control of critical points.
b) Take samples to analyze the effectiveness of the cleaning and disinfection methods used in the establishments to comply with the standards set out in this Royal Decree.
(c) Keep a written or recorded record of the particulars required in accordance with paragraphs (a) and (b) above, in order to submit it to the competent authority. The results of the various checks and tests shall be kept for at least a period of two years, except in the case of milk products which cannot be kept at room temperature, for which the time limit shall be reduced to two months. from the consumer deadline or the minimum duration date.
(d) inform the competent authority when the result of the laboratory test, and other information at its disposal, show that there is a serious risk to health.
e) Withdraw from the market, in case of immediate risk to human health, the affected lots. Withdrawn products shall remain under the supervision and responsibility of the competent authority until they are destroyed, used for uses other than human consumption or, subject to the authorisation of that authority, processed in such a way as to ensure security.
f) Control the health mark, so that it appears only in the products manufactured according to the established procedures.
The system of self-control referred to in paragraph (a) of the first subparagraph shall be communicated to the competent authority, who shall regularly monitor compliance.
2. The company shall be responsible for the organisation and implementation of a programme of continuous training of staff so that the latter can meet the conditions of hygienic production, adapted to the production structure. This programme shall be carried out in collaboration with the competent authority. The staff employed shall also have the meat of food handlers, in accordance with the rules laid down in this Regulation.
Article 15.
1. The plans for the search for residues in raw milk, heat-treated milk and milk products will be governed by Royal Decree 1262/1989 of 20 October 1989 approving the National Plan for the Research of Waste in Animals and fresh meat as regards the investigation of:
(a) Waste of Group III (antibiotics, sulfamides and similar antimicrobial substances) in Annex I to Annex I to that Royal Decree.
(b) Waste of Group II (other wastes) in Annex I, paragraph B, to that Royal Decree.
2. In the field of action provided for in Article 14, the competent authority shall carry out checks to detect the existence of residues of substances having pharmacological or hormonal effects, as well as of antibiotics, pesticides, detergents and other substances which are harmful or which may alter the organoleptic characteristics of milk or milk products or make their consumption dangerous or harmful to human health, in so far as such residues exceed the permitted limits of tolerance.
If the milk or milk products examined present indications of residues exceeding the permitted tolerances, they may not be used for human consumption.
Tests for residues must be carried out in accordance with proven and scientifically recognised methods, and in particular in accordance with those defined at Community or international level.
3. The competent authority shall, by sampling, carry out checks on compliance with the requirements of paragraph 2.
Article 16.
1. The cisterns for milk and the premises, facilities and work equipment may be used for other foodstuffs provided that all appropriate measures are taken to prevent the contamination or alteration of the milk of consumption or of the dairy products.
2. The tanks used for milk shall clearly indicate that they may be used only for the transport of foodstuffs.
3. Where an establishment produces foods containing milk or milk products and other ingredients which have not undergone heat treatment or other treatment having equivalent effect, such milk, such milk products and such products raw materials must be stored separately in order to avoid contamination and must be treated or processed in premises provided for.
Article 17.
The production of the products referred to in this Royal Decree, in which a part of the milk components have been replaced by products other than dairy products, will be subject to the hygiene rules. established in this Royal Decree.
Article 18.
1. In any event, the rules laid down in Royal Decree 49/1993 of 15 January 1993 concerning veterinary checks applicable in intra-Community trade in products of animal origin, in particular as regards the the checks at destination and the safeguard measures to be taken.
2. Without prejudice to the necessary compliance with the measures provided for in this Royal Decree, in Royal Decree 49/1993, and in so many other provisions, where there are reasonable grounds for the health of the products referred to in Article 1, the competent authority
anddate how many controls you consider appropriate.
3. Experts from the Commission of the European Community may carry out
Article 19.
1. The offences provided for in the subsequent paragraphs of this Article shall give rise to the imposition of the penalties laid down in Article 36 of Law 14/1986 of 25 April of 25 April, on the instruction of the file in accordance with the provisions of Chapter VI of Title I of that Law and Title IX of Law 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure.
2. Minor infractions:
Failure to comply with the provisions of this Royal Decree, as soon as it is not considered to be serious or very serious, as required by Article 35-A-3. of the General Law of Health.
3. Serious breaches:
(a) The operation, without the corresponding health authorisation, of the establishments covered by this provision, considered as being of course provided for in Article 35.B) 1. and 2. of the General Law of Health.
b) The clandestine traffic, supply or distribution of products covered by this Royal Decree, from establishments that are not duly authorized and registered in the General Health Register, which is considered to be assumed as provided for in Article 35.B) 1. and 2. of the General Law of Health.
(c) The processing, traffic, distribution or sale of the products referred to in this provision without complying with the hygienic and sanitary requirements which are laid down, or in such a way as to involve the spread of diseases transmitted by food, epizootic diseases or zoonoses, which is considered to be the case as provided for in Article 35.B) 1. and 2. of the General Law of Health.
d) The recidivism in the commission of minor infractions, in the last three months, as required by article 35.B) 7. of the General Law of Health.
4. Very serious breaches:
(a) The manufacture, traffic or supply or distribution of products covered by this Royal Decree, from establishments which are not duly authorized and registered in the General Health Register of Food, in such a way as to generate potential risks or effective damage to public or animal health, considered as being provided for in Article 35 (C) 1. and 2. of the General Law of Health.
(b) The production, traffic, distribution or sale of the products referred to in this Royal Decree, with an infringement, in a conscious and deliberate manner, of the hygienic and sanitary requirements and conditions set out therein, provided that this involves serious risks or actual damage to public or animal health, which is considered to be the case as provided for in Article 35 (C) 1. and 2. of the General Law of Health.
(c) The manipulations aimed at masking fraud or alterations in the products referred to in this Royal Decree, which involve risks to public health, considered as supposed to be those provided for in Article 35 (C) 1. and 2. of the General Law of Health.
(d) The recidivism in the commission of serious misconduct in the last five years, in accordance with the provisions of Article 35.C) 8. of the General Law of Health.
5. The penalties imposed shall, in any event, be independent of the animal health measures which may be adopted by the competent authorities in defence of public health, whether they are those provided for in Article 10 (2) of this Regulation. Decree or any other deemed necessary.
Article 20.
1. As long as there is no general rule applicable to all the Member States of the European Union, they shall, as reference methods, be recognised as those in force in Spain and, in addition, those admitted with international validity, relating to:
(a) The requirements applicable to any product whose placing on the market is authorised in a Member State and whose composition or presentation may give rise to doubts in the other Member States.
b) The methods of control of packaging tightness.
(c) The methods of analysis and, where appropriate, the routine methods to be used to monitor compliance with the requirements of this Royal Decree, as well as the standards for sampling.
(d) The limits and methods for distinguishing between the different types of heat-treated milk as defined in Chapter I of Annex C.
(e) The methods of analysis of the standards set out in Chapter IV of Annex A and Chapters I and II of Annex C.
CHAPTER III
Provisions applicable to trade with third countries
Article 21.
Raw milk, heat-treated milk and milk products referred to in this Royal Decree, imported from third countries, must in any event comply with the conditions laid down in this Royal Decree, as well as The Ministry of Health and Consumer Affairs and the Ministries of Agriculture, Fisheries and Food, in the field of their respective powers. Under no circumstances will they be able to enjoy a regime more favourable to that established in this Royal Decree for Community products.
Article 22.
Only milk or dairy products may be imported:
(a) Processed from a third country on the list of countries from which Member States authorise the importation of raw milk, heat-treated milk and milk products into the European Union approved by the Commission and published in the
(b) Processed from an establishment approved by the Ministries of Health and Consumer Affairs and Agriculture Fisheries and Food until the Commission establishes the list of establishments authorised to export to the European Union milk and milk products.
(c) Marked in accordance with the provisions of Chapter IV of Annex C to this Royal Decree, by varying the information of the trade mark, which shall bear the name of the third-country exporter in capital letters or the (i) the number of the establishment's authorization number is at the centre of the country.
(d) Accompanied by the health certificate signed by the competent authority of the exporting third country certifying that such milk or milk products comply with the requirements of Chapter II of this Royal Decree.
The model of the health certificate shall be as set out in Annex E, until the Commission draws up a harmonised model.
The certificate shall be drawn up at least in the official language of the Spanish State and shall consist of a single sheet.
(e) Which have been checked at the time of entry into the Spanish geographical territory in accordance with the provisions of Royal Decree 2022/1993 of 19 November 1993 laying down the veterinary checks applicable products which are introduced into national territory from countries outside the European Union.
Article 23.
Products covered by this Royal Decree for export to a third country must meet the same requirements as Community products, without prejudice to any specific certifications that may be regulated by the third country of destination.
In the event that they are destined for a third country with which an Agreement has been signed, which establishes the fulfilment of requirements and conditions different from those stipulated in this Royal Decree, it will be available to you. in that Agreement. If the products are more favourable than the provisions of this Royal Decree, the products shall bear the word
CHAPTER IV
Reference Laboratories
Article 24.
They are designated as national reference laboratories as referred to in Chapter I of Annex F. These laboratories shall be responsible for:
1. To coordinate the activities of the laboratories responsible for the analysis of the control of the chemical or bacteriological standards and of the tests provided for in this Directive.
2. To assist the competent authority in the organisation of the system for the control of milk and milk products.
3. To organise regular comparative tests.
4. To ensure the transmission of the information provided by the Community reference laboratory referred to in Chapter II of Annex F and to the laboratories responsible for the analysis and testing of milk and milk products.
Additional disposition first.
This Royal Decree is issued pursuant to Article 149.1.10. and 16. of the Constitution and in accordance with the provisions of article 40.2 of Law 14/1986 of 25 April, General of Health.
Additional provision second.
Continue to apply for the purposes of this Royal Decree:
(a) Commission Decision 91 /180/EEC of 14 February adopting certain methods of analysis and testing of raw milk and heat-treated milk.
(b) Council Decision 92/608/EEC of 14 November approving certain methods of analysis and testing of heat-treated milk intended for direct human consumption.
Additional provision third.
In Annex A to Royal Decree 49/1993 of 15 January 1993 concerning veterinary checks applicable to intra-Community trade in products of animal origin, the reference to Directive 92/46/EEC is replaced by the following: number and title of this Royal Decree.
Additional provision fourth.
It is for the Autonomous Communities to regulate, by means of their own provisions, the requirements for the use of traditional milk products for purposes other than those of direct sale to the consumer, provided that such practice is rooted in the Autonomous Community and that the hygienic and sanitary conditions of the final product are sufficiently guaranteed, as provided for in the applicable European legislation and in this Royal Decree.
First transient disposition.
Until the expiry of the time limit provided for in paragraph 11 of the Order of 26 May 1993, the premises, equipment and supplies used for the manufacture of heat-treated milk and milk-based milk products which comply with the requirements of the the conditions laid down in Chapter IV of Annex A to this Royal Decree may not be used for the production of heat-treated milk and milk-based milk products which do not meet the above conditions, unless expressly authorised by the competent authority, who shall ensure that the necessary measures are taken to ensure that they are at different times or at local level, in order to avoid confusion between some and other products.
Second transient disposition.
Until 31 December 1997, and in the case of heat-treated milk intended for Greece after transiting through the territory of a third country, the commercial document shall be endorsed by the competent authority of the border inspection post in which the formalities for dispatch to transit are carried out, in order to prove that it is a heat-treated milk which meets the requirements of this Royal Decree.
Transitional provision third.
The current authorizations of the establishments included in the scope of this Royal Decree will expire on 31 December 1997, unless they have been expressly classified and authorized, as disposed in the same.
Single repeal provision.
All provisions of equal or lower rank shall be repealed as opposed to the provisions of this Royal Decree, and in particular:
1) Royal Decree 2561/1982 of 24 September 1982 approving the technical-health regulation of industries, storage, transport and marketing of milk and milk products.
(2) Royal Decree 362/1992 of 10 April 1992 laying down the rules of health and animal health law relating to heat-treated milk, which are payable in respect of intra-Community trade.
Final disposition first.
The Ministers of Agriculture, Fisheries and Food and of Health and Consumer Affairs may, in the field of their respective powers, dictate the provisions necessary for the development of the provisions of this Royal Decree and for the amendment of the Annexes, where this amendment is a consequence of a provision of the European Union.
Final disposition second.
This Royal Decree shall enter into force on the day following its publication in the Official Journal of the State, except as provided for in Article 22, which shall enter into force within two months of the publication.
Given in Madrid on July 22, 1994.
JOHN CARLOS R.
The Minister of the Presidency,
ALFREDO PEREZ RUBALCABA
ANNEX A
Provisions concerning the conditions for the reception of raw milk in treatment and/or processing establishments
CHAPTER I
Animal health provisions applicable to raw milk
1. Raw milk shall proceed:
(a) Cows and buffaloes:
1. Belonging to a cabana which, under Royal Decree 434/1990, is officially free of tuberculosis; free or officially free of brucellosis.
2. Do not present symptoms of communicable diseases communicable to man by milk.
3. That they cannot transmit abnormal organoleptic characteristics to milk.
4. Do not present any visible disorder of the general health condition and do not suffer from diseases of the genital apparatus with flow, enteritis with diarrhea accompanied by fever or noticeable inflammations of the udder.
5. Do not present any wound in the udder that may alter the milk.
6. As far as cows are concerned, they give at least two litres of milk per day.
7. That they have not been treated with substances that may be transmitted to milk, which are dangerous or likely to be dangerous for human health unless the latter has been subject to the official waiting period laid down in the provisions in force.
b) Of ovine and caprine animals:
1. Belonging to an officially free or brucellosis-free ovine or caprine holding (
2. They comply with the requirements laid down in subparagraph (a), with the exception of points 1. and 6.
2. Where several animal species are cohabitable on the holding, each animal species must comply with the health conditions which would be mandatory if it were the only one.
3. If goats and cattle are cohabitated, the former must be subject to an anti-tuberculosis control in accordance with rules to be specified in accordance with the Community procedure.
4. Raw milk shall be excluded from processing, processing, selling and consumption:
(a) Where appropriate from animals which have been illegally administered substances specified in Royal Decree 1423/1987 of 22 November 1987 laying down rules on substances of hormonal action and thyrostatic use in the animals, as well as the meat from those animals.
b) Containing residues of the substances referred to in Article 15 of this Royal Decree above the level of tolerance admitted.
5. Milk for consumption and milk products shall not come from a surveillance zone defined in accordance with Royal Decree 832/1989 of 7 July 1989 laying down rules for the prevention and control of foot-and-mouth disease, unless milk is provided for. used as raw material has been subjected to a pasteurization (at least 71.7 grad). C for 15 '') under the control of the competent authority.
CHAPTER II
Hygiene of the farm
1. Raw milk shall come from holdings registered and controlled in accordance with Article 13 (1) of this Royal Decree. Where animals are not raised in the open air, the premises used shall be designed, constructed and organised in such a way as to ensure:
a) Good conditions of accommodation, hygiene, cleanliness and sanitation of animals; and
(b) satisfactory hygienic conditions for milking, handling, cooling and storage of milk.
2. The premises where the milking is carried out or where the milk is stored, handled or cooled shall be situated and constructed in such a way as to avoid any risk of contamination. They shall be easy to clean and disinfect and shall have at least:
a) Walls and easy-to-clean floors in places that can get dirty and get infected.
(b) Soils constructed in such a way as to facilitate the drainage of liquids and offer good conditions for the disposal of waste.
c) Successful ventilation and lighting systems.
(d) An appropriate and sufficient drinking water supply system, which complies with the parameters set out in Annexes D and E of the Technical-Health Regulations for the supply and quality control of drinking water public consumption, approved by Royal Decree 1138/1990 of 14 September 1990 for the milking operations, cleaning of the equipment and instruments referred to in Chapter III (B) of this Annex.
e) A proper separation of all sources of contamination, such as services and estercoleros.
f) Accessories and equipment that are easy to wash, clean and disinfect.
On the other hand, premises intended for storage of milk will have adequate cooling equipment, protected against harmful animals and clearly separated from the premises where the animals are housed. animals.
3. If a mobile milking system is used, it shall comply with the requirements of paragraphs (d) and (f) of paragraph 2. In addition, it shall:
(a) Be located on a floor free of any accumulation of excrement or other wastes.
b) Ensure the protection of milk for as long as it is used.
c) Being constructed and finished so as to keep the inner surfaces clean.
4. Where the dairy females are kept in the open air, the holding shall have a sufficiently separate zone or milking room from the stables.
5. There shall be an effective form of isolation of animals suffering, or suspected to be, suffering from one of the diseases referred to in Chapter I (1), or separation, in respect of the rest of the herd, of the animals referred to in paragraph 3 of the same chapter.
6. Animals of all species shall be kept away from the premises where the milk is stored, handled and cooled.
CHAPTER III
Hygiene of milking, collection of raw milk and its transport from the holding of production to the collection or standardisation centre or to the processing establishment or the processing establishment. Staff hygiene
A. Milking hygiene:
1. The order shall be carried out in a hygienic manner and under the conditions laid down in Royal Decree 857/1992 of 10 July 1992 laying down general conditions of hygiene for holdings of milk production for the purposes of intraCommunity trade.
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 within two hours of milking, it shall be cooled to a temperature of 8 grad or less. C, in case it is collected daily, and 6 grad. C when the collection is not done every day. During transport to treatment and/or processing establishments, the temperature of the cooled milk shall not exceed 10 grams. C.
B. Hygiene of premises, equipment and tools:
1. The material and the instruments, or their surface, which must come into contact with the milk (utensils, containers, tanks, etc., intended for milking, collection or transport) shall be made of a smooth, easy to wash material, and disinfect, resistant to corrosion and which does not release in milk a quantity of elements such that it can endanger human health, alter the composition of milk or exert a harmful influence on its organoleptic properties.
2. After use, the utensils used for milking, mechanical milking plants and containers which have been in contact with the milk shall be cleaned and disinfected. After each transport or series of transport, when the unloading and the following load only elapses for a very short period of time, and in any case at least once a day, the containers and tanks which have been used For the transport of raw milk to the collection or standardisation centre or to the treatment or processing establishment of milk, they shall be cleaned and disinfected before being re-used.
C. Staff hygiene:
1. Staff will be required to be the most perfect for cleaning. In particular the persons in charge of milking and handling of raw milk shall wear clean and proper milking clothes, wash their hands immediately before milking and keep them as clean as possible for the duration of the milking. task.
To do this, close to the place in which the milking is performed there will be appropriate facilities, so that the persons in charge of the milking and the handling of the raw milk can wash their hands and arms.
2. Employers shall take all necessary measures to prevent the handling of raw milk by persons liable to pollute them until their suitability is demonstrated to do so without any danger of contamination.
Any person in charge of the milking and handling of raw milk shall demonstrate that there are no medical contraindications to be used for such tasks.
D. Production hygiene:
1. A control system shall be established with the supervision of the competent authority to prevent the presence in the raw milk of added water. This system shall include, in particular, periodic checks of the freezing point by means of the extraction of random samples of milk at each production facility, in accordance with the following modalities:
(a) In the case of direct delivery of the milk from a single holding to the treatment or processing establishment, such sampling shall be carried out or at the time of collection on the holding, provided that precautions are taken to prevent fraud during transport, or before unloading in the treatment or processing establishment, if the milk is delivered directly by the operator of the holding.
If the results of a check induce the competent authority to suspect that water has been added, that authority shall proceed to the extraction of an official sample on the holding. The official sample shall represent the milk of a morning or afternoon milking, carried out under complete surveillance and started at least 11 hours and no later than 13 hours after the previous order.
(b) In the case of delivery from several holdings, sampling may be carried out at the time of receipt of the raw milk in the treatment or processing establishment, or at the collection centre or for standardisation, provided that control is carried out using random samples on the holding.
If the results of a check lead to the suspicion of the addition of water, the competent authority shall take samples from all holdings which have participated in the collection of the raw milk in question and if it were necessary, the competent authority shall draw up official samples in accordance with the second subparagraph of this subparagraph (a).
2. If the results of the control referred to in the previous paragraph do not confirm the suspicion of water addition, raw milk may be used for the production of heat-treated milk.
3. The processing and/or processing establishment shall inform the competent authority as soon as the maximum levels laid down for the content of somatic germs and cells are reached. The competent authority shall take appropriate measures.
4. Yes, three months after the notification of the results of the checks, either of water added in accordance with paragraph 1, or of the rules referred to in Chapter IV of this Annex, for exceeding the permissible limits, from the holding in question does not satisfy those standards, the supply of raw milk shall be temporarily prohibited as long as the raw milk does not meet these standards again.
5. Milk containing residues of pharmacologically active substances shall not be used for human consumption exceeding the levels authorised for any of the substances referred to in Annexes I and III to Regulation (EEC) 2377/90, as amended Finally, by Regulation (EEC) No 895/93, the combined total of the residues of all the substances concerned cannot exceed a value to be established in accordance with the Community procedure.
CHAPTER IV
Rules to be complied with at the time of collection of the raw milk on the holding of production or at the time of receipt of the raw milk in the treatment or processing establishment
A. Raw cow milk:
Without prejudice to the compliance of the limits laid down in Annexes I and III to Regulation (EEC) 2377/90:
1. Raw cow milk intended for the production of heat-treated milk, fermented, curd, gelled or flavoured milk and cream, shall comply with the following rules:
Germ content at 30 grad. C (per ml) < o = 100,000 (a)
Somatic cell content (per ml) < o = 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, or, where production is highly variable depending on the season, the method of calculation of the results shall be adjusted according to to which the Community procedure is available.
2. Raw cow milk intended for the manufacture of milk products other than those referred to in paragraph 1 shall comply with the following rules:
From 1-1-1994/From 1-1-1998
Germ content at 30 grad. C (per ml). /< o = 400,000 (a)/< o = 100,000 (a)
Somatic cell content (per ml). /< o = 500,000 (b)/< o = 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, or, where the production is variable depending on the season, the method of calculation of the results shall be adjusted according to The Community procedure is available.
3. Raw cow milk intended for the manufacture of raw milk products, the process of which does not include any heat treatment, shall comply with the standards referred to in paragraph 1 and shall also comply with the following standard 1:
Staphylococcus aureus (per ml):
n = 5 m = 500 M = 2,000 c = 2
B. Buffala raw milk:
Without prejudice to the compliance of the limits laid down in Annexes I and III to Regulation (EEC) 2377/90:
1. The raw milk of buffala intended for the manufacture of milk products shall comply with the following rules as from 1 January 1994:
Germ content at 30 grad. C (per ml) < or = 1,000,000 (a).
Somatic cell content (per ml) < or = 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. The raw milk of buffala intended for the manufacture of raw milk-based products whose processing process does not include any heat treatment shall comply with the following rules:
Germ content at 30 grad. C (per ml) < or = 500,000.
Somatic cell content (per ml) < or = 400,000.
Staphylococcus aureus: same standard as for raw cow milk.
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:
1. Raw milk of goat or sheep for the production of goat or sheep milk for heat-treated consumption or for the manufacture of products based on heat-treated goat or sheep milk shall comply with the following rules: of 1 January 1994:
Germ content at 30 grad. C (per ml) < or = 1,000,000 (a).
(a) Geometric mean observed over a period of two months, with two samples, at least, per month.
2. Raw goat or sheep milk intended for the manufacture of raw milk products, the manufacturing process of which does not include any heat treatment, shall comply with the following rules:
Germ content at 30 grad. C (per ml): < o = 500,000 (a).
Staphylococcus aureus (per ml): same standard as for raw cow milk.
(a) Geometric mean observed over a period of two months, with two samples, at least, per month.
D. Where the maximum rules laid down in paragraphs A, B and C are exceeded and where subsequent investigations indicate a possible health hazard, the competent authority shall take appropriate measures.
E. To check whether the rules in paragraphs A, B and C are complied with, random sampling shall be carried out either on the production holding at the time of collection or on the treatment or treatment establishment. processing at the time of receipt of the raw milk
ANNEX B
CHAPTER I
General conditions for the approval of treatment establishments and processing establishments
Treatment establishments and processing establishments shall meet at least the following characteristics:
1. The workplaces will be of sufficient size so that the work activities can be carried out under appropriate hygiene conditions. Such workplaces shall be designed and designed in such a way as to prevent any contamination of the raw materials and products covered by this Royal Decree.
The production of heat-treated milk or the manufacture of lac products
Drawings that may involve a risk of contamination for the other products referred to in this Royal Decree shall be carried out in a clearly separate workplace.
2. In the places where the handling, preparation and processing of raw materials and the production of the products referred to in this Royal Decree are carried out:
a) The soil will be of impermeable and resistant materials, easy to clean and disinfect, and will be arranged in a way that facilitates the drainage of the water; it will have a device that allows to evacuate the water.
b) The walls will have smooth, easy to clean, resistant and waterproof surfaces; they will be coated with a clear coating.
(c) The ceiling shall be easy to clean at the premises where raw materials or unpacked products which can be contaminated are handled, prepared or processed.
d) The doors will be made of unalterable materials, easy to clean.
e) A suitable ventilation system and, where appropriate, vapour evacuation shall be provided.
f) There will be good natural or artificial lighting.
g) There shall be a sufficient number of facilities to wash and disinfect the hands, with cold and hot running water or warm water at a suitable temperature. In the workplace and in the toilets, the taps should not be able to operate with their hands. These facilities must be equipped with cleaning and disinfection products and hygienic means to dry the hands.
h) Devices will be provided to clean the tools, material and facilities.
3. At the premises where raw materials and products referred to in this Royal Decree are stored, the same conditions as those referred to in paragraph 2 (a) to (f), except: (a) In refrigerated storage premises, where It will be easy to clean and to disinfect, arranged so that it facilitates the drainage of the water. (b) in freezing and deep-freezing premises, in which a floor of impermeable and imputed materials is sufficient, easy to clean.
In such cases, a sufficient refrigeration power plant shall be available to ensure the preservation of the raw materials and products in the thermal conditions provided for in this Royal Decree.
The use of wood walls in the premises referred to in paragraph (b) of this paragraph and constructed before 1 January 1993 shall not constitute grounds for withdrawal of the authorisation.
The capacity of the storage rooms will guarantee the storage of the raw materials used and the products covered by this Royal Decree.
4. There shall be means for the hygienic maintenance and protection of raw materials and finished products which have not been packed or packed during loading and unloading operations.
5. Appropriate facilities for protection against undesirable animals, such as insects, rodents, birds, etc.
6. Work equipment and tools intended to come into direct contact with raw materials and products shall be made of materials resistant to corrosion and easy to clean and disinfect.
7. Special containers, watertight, of unalterable material, intended to hold raw materials or products not intended for human consumption. Where such raw materials or products are evacuated by ducts, they shall be constructed and installed in such a way as to avoid any risk of contamination of other raw materials or products.
8. They shall have appropriate facilities for the cleaning and disinfection of the material and utensils.
9. There shall be a sewage disposal device which meets the hygienic requirements.
10. They shall have an installation which supplies exclusively drinking water, in accordance with the Technical and Health Regulations for the supply and quality control of drinking water for public consumption, approved by Royal Decree 1138/1990 of 14 June 1990. September. However, the supply of non-potable water for the production of steam, fire extinguishing or refrigeration is exceptionally authorised provided that the pipes installed thereby make it impossible for this water to be used with other purposes and do not present risks of direct or indirect contamination of the products. Non-drinking water pipes will be clearly differentiated from drinking water pipes.
11. There will be a sufficient number of changing rooms with smooth, waterproof and washable walls and floors, sinks and toilets with cistern. The latter will not be able to communicate directly with the work premises. Washbasins shall be equipped with means for cleaning the hands and hygienic means for drying; the taps shall not be operated manually.
12. There shall be a properly conditioned premises with key elements, at the disposal of the competent authority if the quantity of production requires its regular or permanent presence.
13. There shall be a local or device for the storage of detergents, disinfectants or similar substances.
14. There will be a local or a cupboard for the storage of the cleaning and maintenance material.
15. There shall be adequate equipment for the cleaning and disinfection of tanks used for the transport of milk and of liquid or powdered milk products. However, such equipment shall not be compulsory where there are provisions requiring the cleaning and disinfection of means of transport in facilities officially approved by the competent authority.
CHAPTER II
General hygiene conditions in processing establishments and processing establishments
A. General hygiene conditions applicable to the premises, materials and useful work:
1. The materials and instruments used to work with the raw materials and products, the floors, the walls, the ceilings and the partitions of the premises shall be maintained in good condition of cleanliness and operation in such a way that they do not constitute a contamination focus for such raw materials or products.
2. The entry of animals into the premises reserved for the manufacture and storage of milk and milk products shall not be permitted. Any rodent, insect or other undesirable animal in the premises or in the materials shall be systematically removed. Raticides, insecticides, disinfectants and other potentially toxic substances shall be stored in premises or closets that can be locked; and shall be used in such a way that there is no risk of contamination of the products.
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, they may, at the same time or not, be used for the preparation of other foodstuffs suitable for human consumption.
4. Drinking water shall be used as defined in Royal Decree 1138/1990. However, in exceptional circumstances, the use of non-potable water may be authorized to produce steam, to combat fires or to cool the machinery, provided that the pipes installed for this purpose do not permit the use of such water with other the purpose of the Directive is not to present any risk of contamination for the raw materials or products covered by this Royal Decree.
5. Disinfectants and similar substances shall be products authorised by the competent authority, packed in such a way as to be clearly identified and labelled indicating the mode of use. These products will be used in such a way that the equipment, material, raw materials and products covered by this Royal Decree are not affected by them.
After their use, such equipment and work instruments will be completely cleared with drinking water.
B. General hygiene conditions applicable to staff:
1. The staff will be required to be the most perfect for cleaning, especially in the case of persons handling raw materials and products covered by this Royal Decree without packaging and which can be contaminated. In particular:
a) You will wear proper, clean workwear and a clean cap that fully covers the hair.
b) The hands will be washed at least every time the work resumes and/or in case of contamination; the wounds on the skin will be covered with a watertight bandage.
It will be forbidden to smoke, spit, drink and eat in the working and storage premises of raw materials and products covered by this Royal Decree.
2. Employers shall take all necessary measures to prevent them from handling the products referred to in this Royal Decree by persons liable to pollute them until their ability to do so is demonstrated without danger of contamination.
At the time of the start of the employment relationship, any person who is going to work and manipulate raw materials and products must, by means of a medical certificate, prove that there is no health impediment to the are assigned those tasks.
CHAPTER III
Special conditions for authorization of collection centers
Regardless of the general conditions of Chapter I, collection centres must have at least:
(a) A device or means suitable for the cooling of milk and, in so far as milk is stored in that centre, of a cold storage facility.
(b) centrifuge or any other apparatus suitable for the physical purification of milk, when it is purified in this establishment.
CHAPTER IV
Special conditions for authorization of normalization centers
In addition to the general conditions laid down in Chapter I, the standardisation centres shall have at least:
(a) Of containers for cold storage of raw milk, of an installation for the normalization and of containers for the storage of the normalized milk.
b) Of centrifuges or any other apparatus suitable for the physical purification of milk.
CHAPTER V
Special conditions for the approval of processing establishments and processing establishments
In addition to the general conditions laid down in Chapter I, treatment establishments and processing establishments shall have at least:
(a) Where such operations are carried out in the establishment, of a facility which permits the appropriate automatic filling and closing of containers intended for the packaging of drinking milk heat-treated and liquid milk products, after filling, excluding drums and tanks.
(b) Where such operations are carried out in the establishment, equipment for cooling and cold storage of heat-treated milk, liquid milk products and, in the cases provided for in Chapters III and IV of this Annex, of raw milk. Storage facilities shall be equipped with properly graduated temperature-measuring equipment.
(c) In the case of packaging in single-use containers, of a location for storage, as well as for the storage of the raw materials intended for the manufacture of those, and in the case of packaging in containers reusable, of a special location for storage, as well as of a facility that allows the cleaning and disinfection to be carried out mechanically.
(d) of containers for the storage of raw milk, of an installation for the normalization and of containers for the storage of the standardized milk.
e) Where appropriate, of centrifuges or any other apparatus suitable for the purification of milk.
(f) Provided that in the manufacturing process heat products are treated, a heat treatment equipment approved or approved by the competent authority, provided with an automatic temperature regulator, a a recording thermometer, an automatic safety system which prevents insufficient heating, an appropriate safety system which prevents the mixing of pasteurised or sterilised milk with unheated milk (diversion valve); and a procedure for verifying the efficiency of the security system to which it is made reference in the previous indent.
(g) Where such operations are carried out in the establishment, installation and equipment for the cooling, packaging and storage of frozen milk products.
(h) Where such operations are carried out in the establishment, installation and equipment to enable the drying and packaging of milk powder products to be carried out.
CHAPTER VI
Conditions of hygiene of the premises, material and staff of processing establishments and processing establishments
Regardless of the general conditions laid down in Chapter II, treatment establishments and processing establishments shall comply with the following conditions:
1. Cross-contamination, between operations, by material, aeration or personnel shall be avoided. Where appropriate, and in the light of the risk analysis referred to in Article 14 of this Royal Decree, the premises intended for production operations shall be divided into wet areas and dry areas, each with their own conditions of operation.
2. As soon as possible, after each transport or series of transport, when the unloading and the following load only elapses a very short period of time, but in any case at least once per day of work, the containers and the Tanks which have been used for the transport of raw milk to the collection or standardisation centre or to the treatment or processing establishment of milk shall be cleaned and disinfected before they are re-used.
3. At the end of each working phase and at least once per day of work, the material, containers and facilities which come into contact with milk or milk products or other perishable raw materials shall be cleaned and disinfected.
4. In principle, treatment rooms shall be cleaned at least once per day of work.
5. For the cleaning of other equipment, containers and installations which come into contact with microbiologically stable dairy products, as well as the premises in which such materials are located, the employer or the manager of the establishment establish a cleaning programme based on the risk analysis referred to in Article 14 of this Royal Decree and which complies with paragraph 1 of this Chapter. In no case shall inadequate cleaning methods which represent a health risk for the products referred to in this Royal Decree be used.
ANNEX C
CHAPTER I
Requirements for the manufacture of heat-treated milk and milk products
A. Requirements for the preparation of heat-treated milk intended for consumption:
1. Heat-treated drinking milk shall be obtained from raw milk which complies with the standards set out in Chapter IV of Annex A.
2. When the milk received in a treatment establishment is not treated within four hours of receipt, it shall be cooled to a temperature not exceeding + 6 grad. C and shall be maintained at such temperature hastasu heat treatment.
When raw cow milk is not treated within thirty-six hours after receipt, a supplementary check shall be carried out on the cow's milk before the heat treatment. When it is found, according to a direct or indirect method, that the germ content is 30 grad. C of that milk exceeds 300,000 per ml, the milk in question shall not be used for the production of heat-treated drinking milk.
3. In the manufacture of heat-treated drinking milk, all necessary measures shall be taken, in particular by means of random checks, in respect of:
a) The germ content, to make sure that:
1. Raw milk which has not been treated within thirty-six hours after its receipt does not exceed, immediately before the heat treatment, a germ content of 30 grams. C of 300,000 per ml.
2. The milk subjected to a prior pasteurisation must, immediately before the second heat treatment, contain a germ content of 30 C not exceeding 100,000 per ml.
b) The presence in the milk of water from the outside, mainly by checking the freezing point. To this end, a monitoring system shall be established under the supervision of the competent authority who, in positive cases, shall take appropriate measures.
When establishing a control system, the competent authority shall take into account:
1. The results of the checks carried out on raw milk referred to in Annex A, Chapter III, Section 1, heading 1, and in particular their variation and average.
2. The effect of storage and treatment on the freezing point of milk obtained in accordance with the correct manufacturing standards.
The heat-treated drinking milk may be subjected to any test that allows the microbiological status of the milk to be known before the heat treatment.
4. Compliance with requirements:
a) Pasterized milk will meet the following requirements:
1. Have been obtained by a treatment using a high temperature for a short period of time (at least 71.7 grad. C for fifteen seconds) or a pasteurization procedure using different combinations of time and temperature to achieve an equivalent effect.
2. React negatively to the phosphatase test and positively to the peroxidase test. However, it shall be authorised to manufacture pasteurised milk which will react negatively to the peroxidase test provided that it bears a label with an indication of the type 'high pasteurisation'.
3. Cool down immediately after pasteurisation and reach a temperature not exceeding 6 grad as soon as possible. C.
b) UHT milk will meet the following requirements:
1. Have been obtained by continuous flow heating of the raw milk at a high temperature for a short period of time (at least + 135 grad). C during at least one second)-in order to destroy all the residual micro-organisms of decomposition and their spores-and subsequent aseptic packaging in an opaque container, or which the packaging converts into opaque, so as to be reduced to a minimum chemical, physical and organoleptic transformations.
2. Have a conservability such that, in the case of random checks, it is not noticeable any alteration after 15 days, kept in a closed container at a temperature of + 30 grad. C, where necessary, it may also be possible to provide for a stay of seven days in a closed container at a temperature of + 55 grad. C.
In case the milk treatment procedure called
c) sterilized milk will meet the following requirements:
1. Have been heated and sterilized in hermetically sealed containers or containers, the closing device remaining intact.
2. Have, in the case of random checks, a conservability such that no alteration is noticeable after a fortnight in a closed container at a temperature of + 30 grad. C, provided that it is necessary, it may also be provided for a stay of seven days in a closed container at a temperature of + 55 grad. C.
(d) The production of pasteurised milk subjected to high pasturization>, UHT milk and sterilised milk may be carried out from raw milk which has been subjected, in another establishment, to a thermization or a heat treatment. In this case, the ratio
e) Warming procedures, temperatures and duration of heating for pasteurized, UHT and sterilized milk, types of heating devices, bypass valve, types of devices Regulation and registration of the temperature shall be approved or approved by the competent authority in accordance with national, Community or international standards.
(f) Data on the registered thermometers shall be dated and stored for two years so that they can be submitted upon request by the officials appointed by the competent authority to control the establishment, except for microbiologically perishable products, for which the time limit may be fixed within two months of the expiry date.
5. Heat-treated drinking milk in addition:
(a) Meet the microbiological standards set out in Chapter II.
(b) It shall not contain pharmacologically active substances in quantities exceeding the limits laid down in Annexes I and III to Regulation (EEC) 2377/90.
The combined total of the residues of all substances shall not exceed the value to be fixed in accordance with the Community procedure provided for in the same Regulation.
B. Requirements relating to milk intended for the manufacture of milk products:
1. The employer or the manager of the processing establishment shall take the necessary measures to ensure that the raw milk is heat treated, or used in the case of raw milk products, in the thirties and six hours. following reception if the milk has been kept at a temperature not exceeding 6 grad. C, or within forty-eight hours following receipt thereof, if it has been kept at a temperature of 4 grad or less. C.
2. Milk treated by heating and intended for the manufacture of milk products shall be obtained from raw milk which complies with the standards set out in Chapter IV of Annex A.
3. Milk treated by heating shall meet the following requirements:
a) Thermized milk:
1. It shall be obtained in the case of cow's milk, from raw milk which, if not treated in the thirties and six hours following its receipt in the establishment, shall present, before thermization, a concentration of germs at 30 grad. C do not exceed 300,000 germs per ml.
2. It shall have been obtained by treatment as defined in Article 2 (6) of this Royal Decree.
3. If it is intended for the production of pasteurised milk, UHT or sterilised milk, intended for the manufacture of milk products, it shall not exceed, before treatment, its germ content at 30 grad. C, the limit of 100,000 germs per ml.
b) pasteurized milk:
1. It shall have been obtained by heating at a high temperature for a short period of time (at least 71,7 grad. C for fifteen seconds) or a pasteurization procedure using different combinations of time and temperature to achieve an equivalent effect.
2. It will react negatively to the phosphatase test and positively to the peroxidase. However, it shall be authorised to manufacture pasteurised milk which will react negatively to the peroxidase test provided that the accompanying commercial document indicates the type .
c) UHT milk shall be obtained by continuous flow heating at a high temperature for a short period of time (at least + 135 grad. C for at least one second)-in order to destroy all the residual micro-organisms of decomposition and their spores, so as to reduce to a minimum the chemical, physical and organoleptic transformations.
CHAPTER II
Microbiological criteria for dairy products and for drinking milk
A. Microbiological criteria to be met by certain milk products upon exit from the processing establishment:
1. Mandatory criteria: pathogenic germs:
Germs/Products Type/Standard (ml, g) 1
Listeria monocytogenes. /Cheeses, other than those of hard paste. /Absent in 25 g (b) n = 5, c = 0.
/Other products (a). /Absent in 1 g.
Salmonella spp. /All, except milk powder. /Absent in 25 g (b) n = 5, c = 0.
/Milk powder. /Absent in 25 g (b) n = 10, c = 0.
(a) The search shall not be mandatory for the preserved lecha and the heat-treated dairy products after and during packaging and packaging.
(b) The 25 grams will be obtained by five 5 grams in the same sample of products at different points.
On the other hand, they will not contain any pathogenic micro-organisms or their toxins in an amount that affects the health of consumers.
To be exceeded, products shall be withdrawn from the market and excluded from human consumption, in accordance with the provisions of Article 14 (1) (d) and (e) of this Royal Decree.
The sampling programs will be established according to the nature of the products and the risk analysis.
2. Analytical criteria: germs for lack of hygiene:
Germ/Product Type/Standard (ml, g) 1
Staphylococcus aureus. /Cheese based on raw milk and on the basis of termized milk. /m = 1,000
M = 10,000
n = 5
c = 2
/Soft paste cheese (thermally treated milk base). /m = 100
M = 1,000
n = 5
c = 2
Fresh cheese.
Milk powder.
Ice cream products (including ice cream and ice cream).
m = 10
M = 100
n = 5
c = 2
Escherichia coli. /Cheese based on raw milk and on the basis of termized milk. /m = 10,000
M = 100,000
n = 5
c = 2
/Soft paste cheese (thermally treated milk base). /m = 100
M = 1,000
n = 5
c = 2
The overshoot of these rules will inevitably imply the revision of the application, in the establishment of transformation, in accordance with Article 14 of this Royal Decree, of the methods of surveillance and control of the critical points. The competent authority shall be informed of the corrective procedures applied to the production surveillance system in order to avoid any repetition of such overruns.
In addition, as regards the cheese based on raw milk and on the basis of termized milk and soft paste cheese, any overshoot of the M standard will involve the search to detect the possible presence of toxins in the said cheese. products.
The detection of strains of Staphylococcus aureus enterotoxigenes or strains of pathogenic Escherichia coli will involve the withdrawal of the market from all the lots concerned. 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 to the production surveillance system.
3. Germ indicators: guidelines.
Germ/Product Type/Standard (ml, g) 1
30 Grad Coliforms. C/Liquid dairy products. /m = 0
M = 5
n = 5
c = 2
/Milk-based butter or pasteurized cream. /m = 0
M = 0
n = 5
c = 2
/Soft paste cheese (thermally treated milk base). /m = 10,000
M = 100,000
n = 5
c = 2
/Dairy products powder. /m = 0
M = 10
n = 5
c = 2
Germ content. /Ice cream products (including ice cream and frosty cream). /m = 10
M = 100
n = 5
c = 2
/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 = 10,000
M = 500,000
n = 5
c = 2
(a) After incubation at 6 Grad. C for five days (germ content to 21 Grad. C).
(b) Germ content at 30 Grad. C.
These guidelines should help producers to judge the proper functioning of their establishment and to implement the system and the procedure for self-monitoring of their production.
4. In addition, sterilised dairy products will, after incubation at 30 C for a fortnight, comply with the following rules:
a) Germ content at 30 Grad. C (per 0.1 ml): < o = 10.
b) Organoleptic control: normal.
B. Microbiological criteria for drinking milk:
1. Raw cow milk intended for direct consumption shall, after packaging, comply with the following rules (1):
a) Germ content at 30 Grad. C (per ml): < or = 50,000 (a).
b) Staphylococcus aureus (per ml): m = 100, M = 500, n = 5, c = 2.
c) Salmonella: absent in 25 g, n = 5, c = 0.
(a) Geometric mean observed over a period of two months, with two samples, at least, per month. In addition, pathogenic micro-organisms and their toxins shall not be present in quantities which affect the health of consumers.
2. Pasteurised milk shall also comply with the following microbiological standards in the random checks carried out on the treatment establishment:
Pathogenic germs: absent in 25 g, n = 5, c = 0, m = 0, M = 0.
Coliforms (per ml): n = 5, c = 1, m = 0, M = 5.
After incubation at 6 Grad. C for five days:
Germ content to 21 Grad. C (per ml): n = 5, c = 1, m = 5 x 10 raised to 4, M = 5 x 10 raised to 5.
3. Sterilised milk and UHT milk shall, at the time of the random checks carried out at the treatment establishment, comply with the following rules after incubation at 30 Grad. C for a fortnight:
a) Germ content at 30 Grad. C (per 0.1 ml): < o = 10.
b) Organoleptic control: normal.
(c) pharmacologically active substances: they must not exceed the limits laid down in Annexes I and III to Regulation (EEC) 2377/90.
The combined total of residues of all substances may not exceed a value to be fixed in accordance with the procedure laid down in Regulation (EEC) 2377/90.
4. Where the maximum rules and the mandatory criteria are exceeded and where subsequent investigations indicate a possible danger to health, the competent authority shall take the measures necessary.
CHAPTER III
Packaging and Packaging
1. Packaging and packaging shall be carried out at premises provided for this purpose and in satisfactory hygienic conditions.
2. Without prejudice to the provisions of Royal Decree No 397/1990 of 16 March 1990 laying down general conditions for food-use materials other than polymeric materials, the packaging and packaging shall comply with all the rules laid down in this Regulation. hygiene and shall be sufficiently strong to ensure the effective protection of the products referred to in this Royal Decree.
3. The bottling operations, filling the heat-treated milk and liquid milk products, as well as the closing operations of containers and containers, shall be carried out automatically.
However, the competent authority may authorise the use of non-automatic filling and closing systems for the case of limited production establishments.
4. Packaging or packaging may not be used for products covered by this Royal Decree, except for certain containers which may be re-used after being effectively cleaned and disinfected.
The closure shall be carried out in the establishment in which the heat treatment is carried out, immediately after filling, by means of a closing device to ensure the protection of milk against harmful influences. from the outside on the characteristics of the milk. The closure system shall be designed in such a way that, once opened, it is clearly and clearly opened.
5. The employer or the manager of the establishment shall, for the purposes of checking, in a visible and legible manner, appear on the packaging of heat-treated milk and milk products, in addition to the particulars provided for in Chapter IV:
(a) The nature of the heat treatment to which the raw milk has been subjected.
(b) Any clear or code indication to identify the date of heat treatment and, for pasteurised milk, the temperature at which the product must be stored.
6. The manufacture of packaging products and operations may, by way of derogation from paragraph 1, be carried out in the same premises if the packaging has the characteristics referred to in paragraph 2 and if the following conditions are met: conditions:
a) The local is large enough and is conditioned to ensure the hygiene of the operations.
(b) The packaging and packaging are transported to the treatment or processing establishment in a wrapper in which they have been introduced immediately after their manufacture and which protects them against any damage during the course of the process. transport to the establishment, and are stored in hygienic conditions at a premises intended for this purpose.
(c) The storage premises of the packaging material are devoid of any harmful dust and animals and separated from the premises containing substances which may contaminate the products. The packaging must not be stored in contact with the soil.
d) Packaging is assembled in hygienic conditions before being introduced into the premises, this requirement can be avoided when packaging is automatically assembled whenever there is no danger of contamination of the packaging. products.
e) Packaging is introduced in hygienic conditions at the premises, used immediately and are not handled by the staff responsible for handling the products without packaging.
f) Immediately after the packaging, the products are deposited in the storage premises provided for this purpose.
CHAPTER IV
Conditions regarding health marking and labeling
A. Conditions for the marking of healthiness:
1. The products referred to in this Royal Decree shall bear the health mark. The marking shall be carried out at the time of its preparation or immediately after it has been drawn up in the establishment, in a clearly visible place, in a perfectly legible, indelible and easily decipherable character. The health mark may be reflected either in the product itself or in the package if the product carries an individual package, or on a label attached to this package. However, in the case of a product packed and packed individually, the health mark must be placed on the packaging.
2. In the case of products bearing the health mark in accordance with paragraph 1, which are then packaged, the health mark shall also be affixed to the packaging.
3. Indications of the health mark:
a) The health mark shall include the following entries within an oval:
1. or: at the top: the letter E, followed by the number of the General Health Register of the establishment, at the bottom: the following initials: EEC.
2. or: at the top, the word Spain in capital letters, in the centre, the number of the General Health Record of the establishment, at the bottom, the following initials: EEC.
(b) The health mark may be affixed by an ink or fire stamp on the product, packaging or packaging, or printed or placed on a label. For products contained in hermetically sealed containers, the marking shall be applied indelibly on the lid or on the can;
(c) The health marking may also consist of the immovable attachment of a resistant material plate which meets all hygienic requirements and which includes the particulars specified in subparagraph (a).
B. Conditions for labelling:
Without prejudice to the provisions of Royal Decree 212/1992, of 6 March, approving the General Standard for Labelling, Presentation and Advertising of Foodstuffs and to facilitate control, they will be clearly displayed. indicated on the label:
1. For raw milk intended for direct human consumption, the mention
2. For dairy products made from raw milk whose processing process does not include any heat treatment by heating, including thermization, the mention .
3. For other dairy products, the type of heat treatment which they have been subjected to in the process of preparation.
4. For milk products where a microbial development may occur, the date of expiry or the date of minimum durability.
CHAPTER V
Storage and transport requirements
1. The products referred to in this Royal Decree which cannot be stored at room temperature shall be kept at the temperature indicated by the manufacturer to ensure its duration. This temperature shall be equal to or less than that laid down in regulations for the various products. In particular, the maximum temperature at which the pasteurised milk will be kept until it leaves the establishment and during transport shall be 6 Grad. C.
In case of cooling storage, storage temperatures will be recorded and the cooling rate will allow the products to reach the required temperature as quickly as possible.
2. Tanks, drums and other containers to be used for the transport of pasteurised milk shall comply with all hygienic standards and in particular the following requirements:
(a) Its internal walls or any other party which may come into contact with milk shall be made of a smooth, easy to wash, clean and disinfect material, resistant to corrosion and which does not release in milk a quantity of substances such as to endanger human health, to alter the composition of milk or to have harmful consequences for its organoleptic properties.
(b) They shall be designed in such a way as to allow the total output of milk; when they are fitted with taps, they shall be removable in order to be easily washed, cleaned and disinfected.
(c) They shall be washed, cleaned and disinfected immediately after each use and, to the extent necessary, prior to each new use, cleaning and disinfection shall be carried out in accordance with paragraphs 2 and 3 of this Regulation. Chapter VI of Annex B.
(d) They shall be hermetically closed, prior to and during transport, by means of a watertight sealing device.
3. Vehicles and containers intended for the transport of the perishable products referred to in this Royal Decree shall be designed and equipped in such a way that the required temperature can be maintained throughout the transport period.
4. Vehicles used to transport heat-treated milk and packaged milk in small containers or in drums shall be in good condition. They may not be used for the transport of any other product or object which may alter milk. Its inner lining will be smooth and easy to wash, clean and disinfect. The interior of the vehicles intended for the transport of milk shall be subject to all hygiene rules. Vehicles intended for the transport of heat-treated treated milk in small containers or in drums shall be designed in such a way as to sufficiently protect the containers and drums of any stain and any atmospheric influence and may not be used for the transport of animals.
5. The competent authority shall, for this purpose, regularly check that the means of transport, as well as the loading conditions, comply with the hygiene conditions laid down in this Chapter.
6. The consignment of the products referred to in this Royal Decree shall be carried out in such a way that they are properly protected during the transport of everything that could contaminate or alter them, taking into account the duration and the conditions transport and the means of transport used.
7. During transport, the temperature of the pasteurized milk transported in tank or packaged in small containers and in drums shall not exceed 6 Grad. C.
CHAPTER VI
Health control and surveillance of productions
1. The establishments shall be subject to a check carried out by the competent authority, which shall ensure compliance with the requirements of this Royal Decree, and in particular:
a) Control:
1. The cleaning of the premises, the facilities and the instruments and the hygiene of the staff.
2. The effectiveness of the checks carried out by the establishment, in accordance with Article 14 of this Royal Decree, mainly by examining the results and sampling.
3. The microbiological and hygienic conditions of dairy products.
4. The effectiveness of heat treatment in dairy products and in drinking milk.
5. The containers are hermetically closed by random sampling.
6. The proper health marking of dairy products.
7. The conditions of storage and transport.
b) Take the necessary samples for laboratory tests.
c) It shall proceed to any other control it deems necessary for the fulfilment of the requirements of this Royal Decree.
2. The competent authority shall have free access at all times to the cold stores and to all working premises in order to verify the strict compliance with these provisions.
ANNEX D
Conditions for establishments producing cheeses with a minimum maturation period of sixty days or traditional feature products
Cheese making establishments with a minimum maturity period of 60 days or of dairy products with traditional characteristics, shall comply with this Royal Decree, with the exception of the following: requirements:
1. The use of milk which complies with the rules set out in Chapter IV of Annex A applicable to raw milk at the time of collection on the holding of production or at the time of reception in the processing establishment, provided that the milk used in that preparation complies with the requirements of Chapter I of Annex A.
2. Only for those establishments of limited production, according to the second paragraph of the Order of 26 May 1993, the following requirements:
1. Soil of impermeable and resistant materials, provided that it is easy to clean and disinfect, and arranged in such a way as to facilitate the outlet of the water and a device for its evacuation.
2. The requirement that the taps for washing and disinfecting the existing hands in the toilets and working premises be non-manual.
3. Devices for cleaning useful and materials in the premises where raw materials and dairy products are stored.
4. The requirement to have a sufficient number of changing rooms with smooth, waterproof and washable walls and floors, provided that the number and capacity of the robuts is sufficient, with toilets with washbasin and hygienic means for cleaning. and drying of the hands and toilet with cistern that does not communicate directly with the work place.
5. Loading and unloading springs.
6. Local correctly conditioned, at the exclusive disposal of the competent authority.
7. Installations for the standardisation of raw milk and containers for the storage of standardised milk.
8. The requirement that the heat treatment equipment, where necessary, meet the following requirements:
a) An automatic temperature regulator.
b) A logger thermometer.
c) An automatic security system that prevents insufficient heating.
(d) A suitable safety system to prevent the mixing of pasteurised or sterilised milk with insufficiently heated milk (diversion valve).
e) A procedure for verifying the efficiency of the security system referred to in paragraph (d).
As long as the resulting heat treatment equipment is approved or approved by the competent authority.
9. The control referred to in Article 14 (1), provided that the competent authority considers that the hygiene of the establishment is the optimum for the wholesomeness of the products being produced.
10. The existence of an independent premises for packaging and packaging, provided that such operations are carried out under hygienic conditions.
ANNEX E
Certificate of health-related to milk and dairy products imported from third countries destined for Spain
Shipper country ...
Ministry ...
Competent service ...
Reference (1) ...
Product identification
Nature of milk/milk product ...
The product has been/has not been (2) obtained from a raw milk subjected to a first heat treatment whose relationship
Nature of heat treatment ... (temperature/time) Nature of the container ...
Number of packages ...
Quantity of the product by volume or by weight (in litres or in kilograms) ...
Manufacturing batch number ..
Date of freezing.
Deadline for conservation.
II. Origin of the products
Place of expedition ...
Name, address, and authorization number of the source establishment ...
Shipper name and address ...
III. Target of products
Place and country of destination ...
Recipient name and address ...
Transport medium (3) ...
IV. Health-related data
The undersigned (first and last name) ..
Official health inspector of the establishment of origin.
CERTIFICATE:
That the milk/milk product previously designated has been obtained and stored in accordance with Council Directive 92/46/EEC of 16 June 1992 laying down the health rules applicable to production and marketing of raw milk, heat-treated milk and dairy products.
That are fit for human consumption.
Signed on ...., on .... of .... from 199 ..
(Official Seal)
Signature,
(1) Optional.
(2) Strike out what does not apply.
(3) For wagons and trucks, indicate the registration number; for the aircraft, the flight number, and for the ships, the name and the container number.
ANNEX F
CHAPTER I
National Reference Laboratories
Carlos III Health Institute.
Ministry of Health and Consumer Affairs.
Sinesio Delgado, number 6.
28071 Madrid.
Santander Agro-Food Laboratory.
Directorate General for Food Policy.
Ministry of Agriculture, Fisheries and Food.
Marques de la Hermida, no number.
39080 Santander.
CHAPTER II
Community Reference Laboratory
43 rue de Dantzig.
75015 Paris.
Final Note: The notations (1) used in Annexes A and C will mean the following:
n = number of units the sample is composed of;
m = threshold value for the number of bacteria; the result is considered satisfactory if all the units in which the sample is composed have a number of bacteria equal to or less than m;
M = limit value for the number of bacteria; the result will be considered to be unsatisfactory if one or more units of which make up the sample have a number of bacteria equal to or greater than M;
c = number of units in the sample whose number of bacteria may be between m and M; the sample shall remain acceptable if the other units of which it is composed have a number of bacteria less than or equal to m.
