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Royal Decree 1916 / 1997, Of 19 December, Which Lays Down The Health Conditions For The Production And Marketing Of Meat Preparations And Minced Meat.

Original Language Title: Real Decreto 1916/1997, de 19 de diciembre, por el que se establecen las condiciones sanitarias aplicables a la producción y comercialización de carne picada y preparados de carne.

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TEXT

Following the accession of Spain to the European Communities in 1986, it was necessary to incorporate into our national legal system the Council Directive 88 /657/EEC of 14 December 1995 on the lay down the requirements for the production and trade in minced meat of meat in pieces of less than one hundred grams and meat preparations, which in turn amended Directives 64 /433/EEC, 71 /118/EEC and 72 /462/EEC. This transposition was carried out by Royal Decree No 1436/1992 of 27 November 1992 adopting the technical and health regulations laying down the requirements relating to the production and trade in the Community. of minced meat, of meat in pieces of less than 100 grams and of meat preparations intended for direct human consumption or to the industry and amending the approved technical and health rules and regulations, respectively, by the Royal Decree 1728/1987 of 23 December 1987 and 644/1989 of 19 May.

The practical implementation of the Internal Market of the European Union meant the elimination of border controls for intra-Community trade, reinforcing guarantees at source. For this reason, the health rules governing the production and marketing of fresh meat of animals for slaughter and the other animal species and their processing into meat products were amended, with the result that the part of the meat sector to be regulated. This led to the publication of Council Directive 94 /65/EC of 14 December laying down the requirements for the production and placing on the market of minced meat and meat preparations, supplemented by the Decision of the European Parliament and of the Council Commission Decision 97 /29/EC of 17 December 1996 laying down the health conditions and the public health certificate for the importation of minced meat and meat preparations from third countries, which is to be supplemented by the and that it is necessary to move to our national legal order, replacing the norms at present, in order to have a common standard between the different Member States and with third countries and also take into account the customs of consumption of our State.

This Royal Decree, by regulating the aspects relating to the health conditions for the production and marketing of minced meat and meat preparations at national and intra-Community level, should be considered as legislation. (a) basic health care, while some of the provisions contained in these provisions, as they relate to changes with third countries, are dictated by the exclusive powers conferred by the Constitution on the State in the field of trade and External health.

Therefore, this Royal Decree is dictated by the provisions of Article 149.1.10.a and 16.a of the Constitution and by virtue of the provisions laid down in Articles 38 and 40.2 of Law 14/1986 of 25 April, General of Health. In its preparation, the sectors concerned have been heard and the Interministerial Commission for Food Management has been informed.

In its virtue, on the proposal of the Ministers of Health and Consumer Affairs, of Agriculture, Fisheries and Food, of Industry and Energy and of Economy and Finance, after the approval of the Minister of Public Administration, according to the Council of State and after deliberation by the Council of Ministers at its meeting on 19 December 1997,

D I S P O N G O:

CHAPTER I

General provisions

Article 1. Scope of application.

1. This Royal Decree lays down the health conditions for the production and placing on the market of minced meat and meat preparations for human consumption.

2. This Royal Decree shall not apply to:

(a) minced meat and meat preparations intended for human consumption produced in retail establishments or in premises adjacent to outlets for direct supply to the consumer, which shall continue to be subject to the health rules applicable to the control of retail trade.

(b) mechanically separated meat, intended for manufacture, which have undergone thermal treatment in establishments approved in accordance with the provisions of Royal Decree 1904/1993 of 29 October 1993, for which the lays down the health conditions for the production and placing on the market of meat products and certain other products of animal origin.

c) The production and marketing of minced meat intended to be used as raw material in the manufacture of meat products, which will comply with the provisions of Royal Decree 1904/1993 of 29 October.

Article 2. Definitions.

For the purposes of this Royal Decree, it is understood by:

1. Minced meat: the meat that has been subjected to a sting operation in fragments or at the passage through a continuous picker machine.

2. Meat preparations: products prepared with meat suitable for human consumption, originating in bovine species (including the species Bubalus bubalis and Bison bison), swine, sheep, goats, domestic solipeds, hens, turkeys, ducks, Guinea fowl, ocas, rabbits, farmed game and wild game, to which food products, condiments or additives have been added and/or which have undergone insufficient treatment to modify the cellular structure of the meat in the the central surface of the cutting surface and thus make the characteristics of the fresh meat disappear.

3. Condiments: salt for human consumption, mustard, spices and their aromatic extracts, aromatic herbs and their aromatic extracts.

4. Manufacture premises: any room in which minced meat or meat preparations is produced which meets the following characteristics:

(a) In the case of the manufacture of minced meat in premises attached to an approved cutting room, comply with the requirements of Chapter I of Annex I to this Royal Decree.

(b) In the case of manufacture of meat preparations in premises located in a pre-approved establishment, the latter shall satisfy the requirements of the Chapter III of Annex I to this Royal Decree.

(c) In the case of autonomous production units which the premises meet the requirements of Chapter I (2) or Chapter III (2) of Annex I to this Royal Decree.

5. Intra-Community trade: trade between Member States, in accordance with Article 9 (2) of the Treaty establishing the European Community.

6. Competent authority: the competent bodies of the Autonomous Communities in the field of intra-Community trade and the internal market, and the Ministry of Health and Consumer Affairs, in accordance with that of Agriculture, Fisheries and Food, exchanges with third countries and communications with the other Member States and the European Commission.

7. Official veterinarian: the veterinarian designated by the competent authority.

8. In addition, for the purposes of this Royal Decree, the definitions set out in Article 2 of the Royal Decree No 147/1993 of 29 January 1993 laying down health conditions for production and production shall apply mutatis mutandis. marketing of fresh meat, 1904/1993 of 29 October 1993 laying down health conditions for the production and placing on the market of meat products and certain other products of animal origin and 2087/1994 of 20 October 1994, laying down health conditions for the production and placing on the market of fresh meat of poultry.

CHAPTER II

Provisions applicable to marketing

minced meat

Article 3. Intra-Community trade.

1. Only minced meat made from fresh meat from the bovine, porcine, ovine and caprine species which meets the following requirements shall be the subject of intra-Community trade:

(a) Be obtained from the striated muscles, except for the heart, including the contiguous fatty tissues of fresh meat from approved establishments or imported from authorised third countries and has been checked in accordance with the provisions of Royal Decree 2022/1993 of 19 November 1993 laying down the veterinary checks applicable to products entering national territory from non-member countries European Community.

In the case of fresh pigmeat, the pigmeat must have been subjected to a screening test for Trichinella or cold treatment in accordance with the provisions of the Order of 17 January 1996 on the detection of Trichinella in the meat of domestic animals of the porcine and equine species.

(b) In accordance with the requirements of Chapter II of Annex I, they shall be obtained in an approved manufacturing site, which appears on the list drawn up in accordance with paragraph 1. (a) Article 8 of this Royal Decree and which complies with the provisions of Chapter I of Annex I.

(c) Be checked in accordance with the provisions of Chapter V of Annex I and Articles 7 and 8.

(d) Be marked and labelled in accordance with the provisions of Chapter VI of Annex I.

e) Be packaged, packed and stored in accordance with the provisions of Chapters VII and VIII of Annex I.

(f) They are transported in accordance with the provisions of Chapter IX of

I.

g) Vayan accompanied during the transport of a trade accompanying document which:

1.o It will be issued by the expedition establishment.

2.o It shall bear the health mark of the approved manufacturing site and, in the case of frozen minced meat, the clear mention of the month and the year of freezing.

3.o For minced meat intended for Finland and Sweden, it shall include one of the entries provided for in the third indent of Part IV of Annex IV to Royal Decree 147/1993, and

4.o It shall be retained by the consignee in order to be submitted to the competent authority, at the request of the competent authority. In the case of computer data, the data shall be printed at the request of that authority.

At the request of the competent authority of the Member State of destination, a health certificate shall be provided when the meat is intended for export to a third country after being minced.

However, in the case of minced meat from a manufacturing establishment situated in a region or in an area subject to restriction on animal health grounds or where such consignment is intended for another State Member, after transiting through a third country, in a sealed truck, that consignment shall be accompanied by the certificate of veterinary inspection in accordance with the model set out in Annex III.

2. In addition to the provisions laid down in paragraph 1, minced meat shall meet the following requirements:

(a) Fresh meat used for the manufacture of minced meat must:

1. If it is frozen or deep-frozen meat, it has been obtained from fresh boned meat and has been stored for at most 18 months in the case of beef, 12 months in the case of meat. for sheep and six months in the case of pigmeat, from freezing or deep-freezing, in an establishment approved in accordance with Article 10 of Royal Decree 147/1993.

However, the competent authority may authorise the boning "on the spot" of pigmeat and sheep meat immediately before its minced, provided that such operation is carried out under conditions of hygiene and quality. satisfactory.

2.o If the meat is refrigerated, it shall be used within a maximum of six days after the animals have been slaughtered, or, in the case of boned and vacuum-packed beef, within a maximum period of 15 years. days after the slaughter of the animals from which it comes.

(b) minced meat shall be treated for the cold within a period of not more than one hour after the production of commercial portions and its packaging, except where recourse is made to procedures requiring a reduction in temperature of meat during its preparation.

(c) minced meat must be packaged and presented in one of the following ways:

1.a In refrigerated form, where it has been obtained from meat referred to in paragraph (a) 2 or earlier of this paragraph and has reached a temperature in the centre of + 2 oC or less within the shortest possible time.

The addition of a limited amount of frozen meat, which meets the conditions of paragraph (a) 1, or above, is authorised to speed up the cooling process and provided that this addition is mentioned on the label. In this case the time limit for reaching the temperature of + 2 oC shall be at most one hour.

2.a In an ultra-frozen form, where it has been obtained from fresh meat referred to in subparagraph (a) above and a temperature in the centre of (-18) oC has been reached in a minimum time, in accordance with the provisions of Article 2 or the general rule on deep-frozen foodstuffs intended for human consumption, approved by Royal Decree 1109/1991 of 12 July 1991.

(d) minced meat shall not be subjected to treatment by ionising radiation or ultraviolet.

(e) The names listed in Annex II (I) to this Royal Decree, which are associated with the name of the animal species from which the meat has been obtained, shall only apply in the case of packaging where the requirements laid down in that point.

3. Minced meat added up to a maximum of 1 per 100 salt shall be subject to the requirements of paragraphs 1 and 2 of this Article.

Article 4. Minced meat intended to be marketed only in the national territory.

By way of derogation from Article 3, the production and placing on the market of minced meat intended for placing on the market only on national territory shall be authorised provided that:

1. It is obtained from fresh meat from approved establishments as defined in Article 2 of the Royal Decrees 147/1993 of 29 January 1994, 1543/1994 of 8 July 1994, 14 October 1994 and 2087/1994 of 20 October 1994, without being subject to the restrictions laid down in Article 3 (2) (a), (b) and (c).

2. They shall be obtained in production establishments expressly authorised, which have the premises provided for in Chapter I of Annex I and which are registered in the General Health Register of Food.

3. Comply with the relevant provisions of Annex I, with the exception of the provisions of Chapter IX relating to the temperature of meat during transport, which in this case shall not exceed 4 oC and in respect of the mandatory thermometer recorder in the means of transport.

4. The names 'lean minced meat' and 'minced meat of other species' shall only be used if the composition requirements referred to in Annex II (I) are met.

5. The minced meat thus obtained shall in no case bear the veterinary inspection mark referred to in Chapter VI (2) of Annex I, but the veterinary inspection mark referred to in paragraph 4 of the same chapter, and shall not be the purpose of bilateral exchanges between Member States.

CHAPTER III

Provisions applicable to marketing

meat preparations

Article 5. Intra-community Trade.

1. Only meat preparations, as defined in Article 2, shall be the subject of intra-Community

:

(a) They have been prepared from or with fresh meat, other than the meat of solipeds, from establishments approved and declared fit for human consumption, of the species of slaughter, poultry, rabbits, hunting for farm or wild game.

When the meat is imported, they shall be in accordance with the provisions of Royal Decree 1728/1987 of 23 December for the meat of slaughter or of the 15 of Royal Decree 1543/1994 for domestic and domestic rabbit meat. farmed game, in Article 13 of Royal Decree 2044/1994, for wild game meat and in Article 14 of Royal Decree No 2087/1994, for fresh poultrymeat, having been checked in accordance with the provisions of the Royal Decree 2022/1993.

In the case of fresh meat of porcine animals, they must have undergone a screening test for triquine or cold treatment as provided for in the Order of the Ministry of the Presidency of 17 January 1996, on the detection of Trichinella in fresh meat from domestic animals of the porcine and equine species.

(b) They have been produced in an establishment, as described in Article 2 (4), which has been authorised in accordance with the provisions of Article 8 of this Royal Decree.

(c) Where they have been produced from deep-frozen meat, it must have been used within a maximum period of 18 months after slaughter for beef, of 12 months for sheepmeat, goatmeat, poultry, rabbit and farmed game and six months for the meat of other species.

However, the competent authority may authorise the boning "on the spot" of pigmeat and sheepmeat immediately prior to the preparation of meat preparations, provided that such operation is carried out under conditions of satisfactory hygiene and quality.

(d) If they have been packaged and are intended for marketing in refrigerated form, they must reach, in the central part of the product, at a minimum time, the temperature of + 2 oC in the case of having been obtained from minced meat, + 7 oC in the case of fresh meat, at + 4 oC in the case of poultry meat preparations and at + 3 oC in the case of preparations containing offal.

When packaged and intended for placing on the market in an ultra-frozen form, a central temperature of less than (-18) oC shall be reached in a minimum time in accordance with the provisions of Article 2 of the general rule on ultra-frozen foodstuffs intended for human consumption, approved by Royal Decree 1109/1991 of 12 July 1991.

2. In addition to the provisions of paragraph 1 above, meat preparations shall:

(a) They shall be drawn up in accordance with Chapter IV of Annex I,

(b) They shall be controlled in accordance with the provisions of Article 8 and Chapter V of Annex I,

(c) They shall be marked and labelled in compliance with the provisions of Chapter VI of Annex I,

(d) They shall be packaged and packed in accordance with the requirements of Chapter VII of Annex I, and stored in accordance with Chapter VIII of the same Annex,

e) They shall be transported in accordance with Chapter IX of Annex I, and

(f) Iran accompanied, during its transport to another Member State, of the veterinary inspection certificate referred to in Annex V, by the consignee for at least one year in order to present it to the competent authority at the request of the competent authority.

3. Only preparations obtained from minced meat of slaughter animals which satisfy the requirements of Article 3 shall be exchanged, in addition to fresh sausages and meat for sausages.

4. Ionising or ultraviolet radiation may not be applied to meat preparations. This provision shall not affect the rules on ionisation for medical purposes.

5. Establishments with a structure and capacity of non-industrial production, which prepare meat preparations, to be authorised shall comply with the provisions of Annex VII to this Royal Decree.

They will form part of this category of establishments which, due to their structure and circuits of the establishment, flow of the products and capacities of raw materials and finished products, cannot produce more than 7.5 weekly tonnes of finished meat preparations. The competent authority shall set a maximum production limit for each of these establishments, taking into account the ceiling referred to above.

Only autonomous production units or establishments approved in accordance with Article 9 of Royal Decree 1904/1993 may be included in this category.

Article 6. Meat preparations intended to be placed on the market only in the national territory.

1. By way of derogation from Article 5, the production and placing on the market of meat preparations intended for placing on the market only on national territory shall be authorised provided that they fulfil the following conditions:

(a) They are obtained from fresh meat from approved establishments, with the exception of permanently exempted, not being subject to the restrictions provided for in paragraph 1 (c) of Article 5 (1).

(b) Be drawn up in production establishments expressly authorised, having the premises provided for in Chapter III of Annex I or Annex VII to this Royal Decree and registered in the General Register Food Health.

(c) Refreshen or ultra-freeze immediately after processing, prior to or immediately after packaging and packaging, even if, in the case of refrigeration, they may not be packaged in units of sale.

2. The transport temperatures shall be no more than 4 oC. Vehicles will not have to carry a recording thermometer.

3. The label of meat preparations thus obtained shall not be required to include the particulars provided for in the second subparagraph of Chapter VI of paragraph 5 of Annex I. 4. The meat preparations thus obtained shall not bear the veterinary inspection mark provided for in paragraph 2 of Chapter VI of Annex I, but shall bear the mark referred to in paragraph 4 of the same chapter and shall in no case be subject to trade. bilateral relations between Member States. They must be accompanied by the commercial document.

CHAPTER IV

Common Provisions

Article 7. Self-control.

1. Employers or managers of establishments producing products subject to the scope of this provision shall take the necessary measures to ensure that the provisions of this Directive are complied with at all stages of production. provided for in this Royal Decree. To this end they will establish and maintain a system of continuous self-control of production, based on the methodology of risk analysis and control of critical points (ARCPC), as provided for in Articles 3 and 5 of Royal Decree 2207/1995, of 28 of December, laying down the hygiene rules for foodstuffs, in addition to the following requirements:

(a) Control of the raw materials entering the establishment to ensure compliance with the criteria laid down in paragraph II of Annex II and Annex IV to the final product.

b) Control of cleaning and disinfection methods.

(c) Samples for analysis in laboratories recognised by the competent authority.

(d) Written or recorded recording of the checks and their results, in order to make them available to the competent authority when they so request, keeping them for at least 2 years, except in the case of products Refrigerated for which the time limit may be reduced to 6 months after the date of consumption of the product concerned.

(e) The provision of guarantees to the competent authority in respect of the management of the health marking, in particular of labels and documents bearing it.

(f) Quick information to the competent authority when the result of these checks shows that there is a health risk.

g) Withdrawal from the market, in the event of immediate public health risk, of all products obtained under technologically similar conditions and which may present the same risk. These withdrawn quantities shall remain under the supervision and responsibility of the competent authority until they are destroyed or used for uses other than human consumption or, subject to express authorisation, processed or treated in a manner adequate to ensure their safety.

2. The employer or manager of the establishment shall indicate for control purposes, in a visible and legible manner on the packaging of the product, the temperature of transport and/or storage of the product, as well as the date of minimum durability for products Frozen products or the date of expiry for refrigerated products.

3. The staff employed in the production processes must have food handling meat. The company shall establish a training programme so that such staff can meet the conditions of hygienic production, adapted to the production structure. The competent authority shall be involved in the organisation and implementation of that programme.

This training programme will not be necessary if the staff has a sufficient qualification certified by a diploma and may have a specific character for the establishments of structure and production capacity. Article 5 (1) of the Treaty

4. In the case of minced meat referred to in Article 3 and minced meat preparations referred to in Article 5, microbiological tests shall be carried out on a daily basis. In the remaining minced meat and meat preparations such examinations shall be carried out in accordance with the frequency provided for or laid down in the risk analysis and critical point control (ARCPC) programme, taking into account the microbiological criteria. referred to in Annex II and IV or at least weekly. Such analyses must be carried out at the manufacturing site, if it is recognised by the competent authority, or in an approved laboratory, in accordance with scientific methods recognised and experienced in practice and in particular those which are defined in Community legislation or in other national or international standards.

The sample to be collected for the analysis will be made up of five units and will be representative of the production of the day. For meat preparations, the samples shall be taken at the depth of the musculature, after the surface has been cauterized.

The results of these checks shall be evaluated in accordance with the interpretation criteria set out in Annex II for minced meat and minced meat preparations, except for fresh sausages and meat for sausages, or criteria in Annex IV in the case of other meat preparations.

In the event of a conflict in intra-Community trade, Member States shall recognise as reference methods methods established by European Standards (EU).

5. The requirements laid down in this Article, in the field of self-control, shall be determined in cooperation with the competent authority, which shall regularly monitor its compliance.

Article 8 Authorization of establishments and official control.

1. The competent authorities shall inform the Ministry of Health and Consumer Affairs of establishments producing minced meat and meat preparations which, in compliance with the provisions of this Royal Decree, are authorised.

This communication shall specify whether the authorisation is granted in accordance with the provisions of Articles 3 or 5 and in the case of the latter article, containing clarification as to whether the establishments concerned are whether or not they have an industrial production structure and capacity, or whether the authorisation is granted within the meaning of Articles 4 or 6, with the same clarification, and in all cases with an expression of the number assigned to them in the General Food Health Record.

With the data to receive it will be produced:

(a) A list, with establishments classified in accordance with Articles 3 and 5, which, in collaboration with the Ministry of Agriculture, Fisheries and Food, shall be communicated to the other Member States and to the European Commission

and

(b) A list, with establishments classified in accordance with Articles 4 and 6, which shall be communicated, together with the list above, to all the competent authorities of the Autonomous Communities.

2. In the case of establishments incorporated in other establishments previously approved in accordance with the provisions of the Royal Decrees 147/1993, 1904/1993, 1543/1994, 2044/1994 or 2087/1994, they shall retain the same approval number. Mention of the specific authorisation of the new activity, which may also be common to both establishments, the premises, equipment and facilities provided for the staff, as well as all the premises, in general, where there is no danger of contamination of raw materials or non-packaged products.

3. The establishments referred to in this Royal Decree shall be under the control of the competent authority, which shall carry out their periodic inspection and control with a frequency to depend on the size of the establishment, the type of products manufactured, the risk assessment system and the guarantees offered on the basis of Article 7 (1) of the Article 7.

However, in the case of premises attached to cutting plants, and in premises approved in accordance with Article 3, this frequency shall be at least once a day during the manufacture of the minced meat.

4. The competent authority shall have free access at any time to all the premises of the establishments in order to verify compliance with the provisions of this Royal Decree and in particular, where there is a doubt as to the origin of the meat, to the accounting records which enable it to identify the slaughterhouse or establishments of origin of the raw materials and, as regards compliance with the criteria laid down in Annexes II and IV, to the records of the results of the self-checks provided for in Article 7.

When the data is recorded in computer support, they must be printed at the request of the competent authority.

5. The competent authority shall periodically review the results of the self-checks provided for in Article 7, and shall, on the basis of the results, provide for additional examinations to be carried out at any stage of production or production. products. The results of these additional examinations shall be the subject of a report whose conclusions or recommendations shall be forwarded to the employer or manager of the establishment, who shall correct the deficiencies identified in order to improve hygiene.

In carrying out these checks, the competent authority may be assisted by inspection auxiliaries possessing the qualifications provided for in Annex VII and Annex III to the Royal Decrees 147/1993 and 2087/1994, respectively.

6. If, in accordance with the provisions of the preceding paragraph and Chapter V of Annex I, the competent authority checks a repeated non-compliance with the criteria laid down in the ARCPC system and in particular those laid down in the Annexes II and IV, or the repeated commission of infringements, shall strengthen the control measures for the production of the establishment in question, with the use of labels and other supports containing the veterinary inspection mark referred to in paragraph 1. in Chapter VI of Annex I. If, at the end of a period of 15 days, the production is not comply with the above criteria, the competent authority shall take all necessary measures to correct the deficiencies observed and, where appropriate, order that the products concerned undergo heat treatment. If these measures are not sufficient, the authorisation of such establishment shall be suspended.

7. Where the competent authority detects a clear breach of the health conditions laid down in this Royal Decree, or there are impediments to the proper conduct of the health inspection, the health inspection may:

(a) Limit the use of the premises, equipment and tools or even reduce the production rate and until momentarily suspend the production, until adequate sanitary conditions are restored.

b) Temporarily suspend the authorization of the establishment for the product concerned, where the above measures are insufficient.

(c) Withdraw the approval of the establishment where the verified breaches of the health conditions have not been fixed within the prescribed period.

The competent authority shall take into account the conclusions of the inspections carried out in accordance with Article 9.

8. The competent authorities shall notify the withdrawals or suspensions of the authorisations to the persons concerned and the Ministry of Health and Consumer for their communication to the Autonomous Communities and, in collaboration with the Ministry of Agriculture, Fisheries and Food to the other Member States and to the European Commission through the appropriate channel.

Article 9. Inspections and controls.

1. As far as is necessary for the uniform application of this provision, specialists from the European Commission, in collaboration with the competent authorities, may carry out on-the-spot inspections of a representative number of local authorities. manufacture. Representatives of the General Administration of the State may accompany the inspectors of the Commission and the Autonomous Communities carrying out these inspections.

The competent authority shall provide all necessary assistance to specialists for the performance of its tasks.

2. 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 controls in the field of animal health, shall apply. destination and the safeguard measures to be taken.

Article 10. Authorised additives.

The eventual addition of food additives to minced meat or meat preparations covered by this standard shall be made in compliance with the relevant provisions.

Article 11. Sanctioning regime.

1. The principles laid down in Law 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure shall apply to the provisions of this Royal Decree. and its implementing rules.

The sanctioning power will be exercised through the procedure established by Royal Decree 1398/1993 of 4 August, approving the Rules of Procedure for the exercise of sanctioning powers, in all those assumptions provided for by the same.

In any event, the principle of written action shall be governed by the principle of written action, unless the nature of the acts requires or permits other more appropriate forms of expression and constancy.

2. Without prejudice to other rules which may be applicable, the infringements provided for in the subsequent paragraphs shall be of a health offence in accordance with the provisions of Chapter VI of Title I of Law 14/1986 of 25 April, General of Health and will graduate and sanction in accordance with the provisions of the same, in its norms of development and in the present Royal Decree.

3. In accordance with the provisions of Article 35. (a) of Law 14/1986 of 25 April, minor infringements shall be considered as minor irregularities in compliance with the provisions of this Royal Decree, or in the provisions which develop it, without direct consequence of health public, as well as those committed for simple negligence, provided that the health risk produced is of a low nature, as long as such actions are not qualified as serious or very serious misconduct.

4. In accordance with the provisions of Article 35. (b) in Law 14/1986 of 25 April, serious infringements shall be considered as:

(a) The operation, without the corresponding health authorization, of the establishments regulated by this provision.

(b) Clandestine traffic, the supply or distribution of minced meat and meat preparations from establishments which are not authorised and registered in the General Health Register with their corresponding activity.

(c) The absence of entry of the corresponding registration identification numbers to be included, as appropriate, in packaged or packaged products or on their labels.

(d) The traffic, distribution or sale of minced meat or meat preparations exceeding the microbiological limits laid down in this standard and involving health risks.

e) Manipulations involving a substantial reduction in the nutritional capacity of the product concerned, or the addition of unauthorised additives.

(f) The lack of documentation of the consignments from the approved establishments.

g) The recidivism in the commission of minor infractions in the last three months.

5. In accordance with the provisions of Article 35. (c) of Law 14/1986, of 25 April, shall be considered as very serious infringements:

(a) The traffic, distribution or sale of minced meat or meat preparations in poor health conditions or which involve serious health risks for the spread of epizootic diseases or zoonoses or containing toxic substances which affect public health.

(b) The use of fresh meat declared unfit for human consumption.

(c) The production, distribution or clandestine sale of the products referred to in this provision which involve serious health or animal health risks.

(d) Manipulations aimed at masking fraud or alteration of products listed here, such as the use of unauthorised additives, which involve serious risks to public health.

e) The recidivism in the commission of serious infractions in the last five years.

6. The rating of the infringements shall be carried out on the basis of the health risk criteria, the amount of the possible benefit obtained, the degree of intentionality, the seriousness of the health and social change produced, the generalisation of the infringement and recidivism.

7. The penalties imposed shall, in any event, be independent of the animal health measures which may be adopted by the competent authorities in the defence of public health and animal health, whether or not they are provided for in paragraphs 4 and 5. of Article 8 of this Royal Decree or any other deemed necessary.

8. Infringements and penalties shall be prescribed within the time limits and in the form laid down in Article 132 of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure.

CHAPTER V

Provisions applicable to trade with countries

third parties

Article 12. Imports.

1. For the import of the deep-frozen minced meat referred to in Article 3 and the preparations for deep-frozen meat referred to in Article 5, they shall:

(a) Proceed from third countries or parts of third countries from which imports of fresh meat (from slaughter animals, rabbits, farmed game, wild game or poultry) are not prohibited for reasons of animal health and appearing on the lists drawn up by the European Commission and

(b) Proceed from establishments specifically approved by the Ministry of Health and Consumer Affairs in accordance with the Ministry of Agriculture, Fisheries and Food until the European Commission establishes a list of such establishments. establishments, taking into account:

1. The legislation and organization of the Veterinary Services and its Inspection Services, the privileges of the same and the control to which they are subject.

2.o The guarantees offered by the Veterinary Service for the fulfilment of the health requirements of this Royal Decree.

2. The importation of minced meat shall comply with the following conditions:

(a) It must have been drawn up in accordance with the requirements laid down in Articles 3 and 7 of this Royal Decree.

b) You must proceed from an establishment or establishments offering the guarantees set out in Annex I to this Royal Decree.

(c) It must have been deep-frozen in the production establishment or in the establishments of origin.

3. The importation of meat preparations shall be in accordance with the following conditions:

(a) They must have been manufactured in accordance with the requirements set out in Articles 5 and 7 of this Royal Decree.

b) You must proceed from an establishment or establishments offering the guarantees set out in Annex I to this Royal Decree.

(c) They must have been deep-frozen in the production establishment or in the establishments of origin.

4. Each consignment of minced meat must be accompanied by the original, numbered, completed, signed and dated public health certificate, consisting of a single page and in accordance with the model set out in Annex VI-A.

5. Each consignment of meat preparations shall be accompanied by the original, numbered, completed, signed and dated public health certificate, consisting of a single page and in accordance with the model set out in Annex VI-B.

6. Certificates must be drawn up, at least, in the Spanish language.

7. The consignments shall be checked in accordance with the provisions of Royal Decree 2022/1993 of 19 November 1993 laying down the veterinary checks applicable to products entering national territory from non-member countries. belonging to the European Community.

Article 13. Exports.

1. Minced meat and meat preparations intended for export must comply with the rules laid down in this Royal Decree and shall be accompanied, if necessary, and where the country of destination has established it in its rules of procedure. internal, of the health certificate for the export of foodstuffs, as referred to in the Order of the Ministry of Health and Consumer Affairs of 12 May 1993, or, where appropriate, of specific certificates which are regulated by the third country of destination.

2. In the case of minced meat or meat preparations intended for a third country with which an Agreement establishing the fulfilment of requirements and conditions other than those laid down in this Royal Decree has been concluded, shall be subject to the provisions of that Agreement. If they are more favourable than those referred to in this Royal Decree, they must bear the word 'EXPORT' on the packaging and packaging in clearly visible and indelible characters and may not be placed on the market or consumed on the national territory of the other of the Member States of the European Union.

Additional disposition first. Character of basic health standard.

This Royal Decree is applicable throughout the national territory, having the character of a basic health standard, in accordance with the powers conferred on the State in Article 149.1.16.a of the Constitution and in the Article 40.2 of Law 14/1986 of 25 April 1986, General of Health; except as provided for in Chapter V, which is given on the basis of exclusive competence in the field of Health and Foreign Trade, which confers on the State Article 149.1.10.a and 16.a of the Constitution and Article 38 of Law 14/1986 of 25 April, General of Health.

Additional provision second. Amendments to the Royal Decrees 1543/1994 of 8 July 1994 and 2087/1994 of 20 October 1994.

1. Article 6 of Royal Decree 1543/1994 of 8 July 1994 laying down the health and animal health requirements applicable to the production and placing on the market of domestic rabbit meat and farmed game meat, paragraph 4 replaces with the following text:

" 4. Mechanically separated meat may be placed on the market only if it has been previously subjected to a heat treatment in accordance with the provisions of Royal Decree 1904/1993 of 29 October 1993 in the establishment of origin or in another establishment as determined by the competent authority. '

2. In Article 5 of Royal Decree 2087/1994 of 20 October 1994 laying down the health conditions for the production and marketing of fresh poultrymeat, a new paragraph 3 is added, the wording of which is as follows:

" 3. Mechanically separated meat may be placed on the market only if it has been previously subjected to a heat treatment in accordance with the provisions of Royal Decree 1904/1993 of 29 October 1993, either in the establishment of origin or in the another establishment determined by the competent authority. '

Additional provision third. Regulatory reference substitution.

In Annex A, paragraph 8, of Royal Decree 49/1993 of 15 January, the reference to Royal Decree No 1436/1992 of 27 November 1992 is replaced by the number, date and title of this Royal Decree.

Single repeal provision. Provisions to be repealed.

As from the entry into force of this Royal Decree, all provisions of the same or lower rank shall be repealed with respect to the provisions of the present Royal Decree, and in particular the following:

1. Royal Decree 1436/1992 of 27 November 1992 on the technical and health regulations laying down the requirements for the production and trade in intra-Community trade in minced meat of meat in pieces less than 100 grams and prepared meat intended for direct human consumption or to industry and for which the technical-health rules and the technical-health regulations adopted, respectively, by the Royal Decrees 1728/1987 of 23 December 1989 and 644/1989 of 19 May, as well as its amendment to the Royal Decree 2275/1993 of 22 December 1993.

2. Royal Decree 379/1984 of 25 January 1984 on the technical and health regulations of industries, wholesale warehouses and packers of processed meat products and derivatives and of retail trade establishments meat and processed products, in all those parts thereof, relating to minced meat and meat preparations, except where they relate to minced meat and meat preparations being drawn up in retail establishments, or in premises adjacent to the points of sale, in order to sell them directly to the final consumer.

3. The Order of 14 January 1986 approving the quality standard for minced meat of bovine animals, sheep and pigs intended for the internal market, with the exception of those paragraphs of the same reference to minced meat produced in the retail establishment, or in premises adjacent to the outlets, to be sold directly to the final consumer.

Final disposition first. Faculty of development.

The Ministers of Agriculture, Fisheries and Food and of Health and Consumer Affairs may, in the field of their powers, dictate the provisions necessary for the development of the provisions of this Royal Decree and for the updating of the annexes, when this update is the result of a provision by the European Community.

Final disposition second. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State", with the exception of the provisions of Chapter V which shall enter into force within two months of its publication.

Given in Madrid to December 19, 1997.

JOHN CARLOS R.

The President of the Government,

JOSÉ MARÍA AZNAR LÓPEZ

ANNEX I

CHAPTER I

Special technical-health conditions

authorization for the establishments

minced meat production

Establishments will have:

1. In the case of manufacturing premises, as defined in Article 2 (4), in addition to the conditions laid down in Chapter I and III of Annex I to Royal Decree 147/1993, at least:

(a) A local, separate from the cutting room, for the operations of chopping and packing, provided with a thermometer or a register-thermometer.

However, the competent authority may authorise the meat to be minced in the cutting room, provided that the operation is carried out at a specific location, clearly separated and without danger of contamination.

(b) A packing place, unless the conditions laid down in paragraph 63 of the Chapter XII of Annex I to Royal Decree 147/1993 are met.

c) A local or closets for salt storage.

d) Refrigeration equipment that will allow the temperatures foreseen in this Royal Decree to be respected.

2. In the autonomous production units, in addition to the general conditions of Chapter I of Annex A to Royal Decree 1904/1993, at least:

(a) The premises described in paragraph 1 of the Chapter I of Annex B to Royal Decree 1904/1993, and

(b) A local which is in accordance with paragraph 1 (a) of this Chapter.

3. The rules laid down in Chapter V of Annex I to Royal Decree 147/1993 shall apply in respect of the hygiene of staff, premises and equipment in establishments.

In case of manual preparation, the personnel responsible for the production of minced meat must also wear a buconasal mask. The competent authority may also impose the use of smooth, waterproof and disposable gloves, or similar ones that can be cleaned and disinfected.

CHAPTER II

Health conditions for the production of minced meat

1. Meat must be inspected before the meat is minced or cut in accordance with Article 7. Before the stung will be removed, all the parts stained or in doubt will be discarded.

2. Minced meat may not be obtained from debris

cutting or cutting and cleaning meat or mechanically separated meat.

In particular, it may not be prepared from meat declared unfit for human consumption, as provided for in the health rules governing the production and placing on the market of fresh meat, or from meat from the following parts of bovine animals, swine, sheep, goats, solipeds and game (wild or wild) game: meat of the head, excluding maseteros, non-muscular part of the alba line, carp and tarsus region; and waste of meat scraped from the bones. The muscles of the diaphragm, after separation of the serous membranes, and the masseters may only be used after the screening test for cisticercosis. Fresh meat must not contain any fragment of bones.

When the operations performed between the time the meat is placed in the premises referred to in Chapter I and the time when the finished product is subjected to the refrigeration or ultra-freezing process, The temperature at the centre of the meat must be at the maximum of one hour at the maximum of + 7 .oC and the temperature of the manufacturing premises of +12 .oC at the latest. The competent authority may authorise higher time limits in special cases where the addition of salt is justified for technological reasons, provided that such derogation does not affect the health rules.

When such operations last more than one hour or more than the time allowed by the competent authority in accordance with the preceding subparagraph, fresh meat may only be used once its core temperature has been reduced to + 4 oC maximum.

3. Minced meat shall only be subjected to a single deep-freeze.

4. Immediately after production, the minced meat must be packaged in a hygienic manner, placed before being packed, at the temperatures referred to in Article 3 (2) (c) and stored at such temperatures.

CHAPTER III

Technical and health conditions

for the manufacture of meat preparations

1. Manufacturing premises, as defined in Article 2 (4), shall, at least, have rooms which meet the requirements of:

(a) Chapters I and III of Annex I to Royal Decree No 147/1993,

(b) Chapters I and III of Annex I to Royal Decree No 2087/1994, or

(c) Chapter I, paragraph A and Chapter 1 of Chapter IV of Annex I to Royal Decree 2044/1994,

and have the following items:

1. A local separate from the cutting room for the production operations of meat preparations, for the addition of other food and packaging products, provided with a thermometer or a register-thermometer.

However, the competent authority may authorise the production of meat preparations in the cutting room provided that the production takes place at a specific location clearly separated. The addition of condiments to whole poultry carcases may be authorised at a specific site which is clearly separate from the slaughter site.

2.o A packing place, unless the conditions laid down in paragraph 63 of the Chapter XII of Annex I to Royal Decree 147/1993 are met, in Chapter XIV of Annex I to Royal Decree No 2087/1993 or of the paragraph 5 of Chapter VIII of Annex I to Royal Decree 2044/1993.

3.o A local for storage of condiments and other clean food products and ready for use.

4.o Local fridges for storage of fresh meat, as referred to in paragraph (a) of Article 5 (1) (a) or meat preparations;

5.o Refrigeration equipment to ensure compliance with the temperatures provided for in this Royal Decree.

2. The autonomous manufacturing units shall comply with the requirements of Chapter I of Annex A and Chapter I of Annex B to Royal Decree 1904/1993.

3. The rules laid down in Chapter V of Annex I to Royal Decree 147/1993 and/or Royal Decree No 2087/1994 or those of Chapter II of Annex I to Royal Decree No 2044/1994 shall apply by analogy with regard to the hygiene of personnel, local and material in the establishments.

In the case of manual preparation, the personnel responsible for the production of meat preparations must also wear a buconasal mask. The competent authority may require such staff to use smooth, waterproof and disposable gloves or similar gloves which can be cleaned and disinfected.

CHAPTER IV

Special requirements for manufacturing

meat preparations

In addition to compliance with the general conditions set out in Chapter III, and depending on the type of production concerned:

1. The production of meat preparations must be carried out at a controlled temperature and the raw materials referred to in Chapter III (4) of Annex B to Royal Decree 1904/1993 of 29 October 1993 cannot be used.

2. Meat preparations must be packed in dispatch units in such a way as to avoid any risk of contamination.

3. Meat preparations may be frozen only once and may only be placed on the market within a period of not more than 18 months.

4. Immediately after the production process, the meat preparations must be packaged in accordance with Chapter VII and must be placed, before being packed, at the temperatures referred to in Article 5 (1) (d).

CHAPTER V

Controls

1. The premises for the manufacture of minced meat and meat preparations shall be subject to a check by the competent authority, which shall ensure that the requirements of this Royal Decree are met and in particular:

a) Control:

1. Cleaning of premises, facilities and instruments and staff hygiene.

2.o The effectiveness of the checks carried out by the establishment in accordance with Article 7 of this Royal Decree, in particular by examining the results and sampling.

3.o The microbiological and hygienic conditions of minced meat and meat preparations.

4.The appropriate veterinary inspection marking for minced meat and meat preparations.

5.o The storage and transport conditions.

(b) Take, within the framework of the official controls, the samples required for laboratory tests to confirm the results of the self-control.

(c) Proceed to any other control it deems necessary to ensure compliance with the requirements of this Royal Decree, with the understanding that the competent authority shall assess the results of the checks microbiological according to the criteria laid down in Annex II in the case of minced meat and in Annex IV in the case of meat preparations.

2. The competent authority shall have free access at all times to cold stores and to all working premises in order to verify the strict compliance with these provisions.

CHAPTER VI

Marking and tagging

1. The health mark for veterinary inspection shall be included in the package or packaging of minced meat and meat preparations.

2. The Community veterinary inspection mark may be affixed only to minced meat obtained in accordance with Article 3 and to meat preparations obtained in accordance with Article 5 at a manufacturing site approved in accordance with the Article 8; the veterinary inspection mark shall comply with the following except as regards the dimensions:

(a) In the case of minced meat, the provisions of paragraph 50 of Chapter XI of Annex I to Royal Decree No 147/1993.

b) In the case of meat preparations:

1. Obtained from fresh meat of animals for slaughter or farmed game, as provided for in paragraph 50 of Chapter XI of Annex I to Royal Decree No 147/1993.

2.o Obtained from poultrymeat and meat of farmed feathered or hair farmed game, as provided for in Chapter XII of Annex I to Royal Decree 2087/1994.

3.o Obtained from wild game the provisions of Chapter VII (3) of Annex I to Royal Decree 2044/1994.

3. Where the manufacture of minced meat or meat preparations takes place in autonomous production units, the veterinary inspection mark shall bear the approval number assigned by the competent authority in accordance with the provisions of the Article 8 (1).

4. Minced meat and meat preparations obtained in accordance with the provisions of Article 4 and 6 shall be marked with a round seal, containing the following legend inside the circle: at the top of the table: "NATIONAL" in capital letters and at the bottom of the General Health Sanitary Register number.

5. Without prejudice to the provisions of Royal Decree No 212/1992 of 6 March 1992 on the general rule on the labelling, presentation and advertising of foodstuffs, the packaging must appear in a visible and legible manner for the purposes of control, in cases where it is not clear from the name of sale of the product or the list of ingredients in accordance with Royal Decree 212/1992, the following information: the species or species from which the meat has been obtained, in the case of a mixture, the percentage of each species, and where the product is contained in a packaging intended for the final consumer, the date of manufacture.

For minced meat and meat preparations obtained from minced meat of slaughter animals, excluding fresh sausages and meat for sausages, bearing the veterinary inspection mark provided for in this Annex Chapter, the label shall also contain the following indications: the indication "percentage of fat less than ..."; the indication "collagen/protein ratio of less than ...".

CHAPTER VII

Packaging and Packaging

1. Packaging and packaging, whatever the material used in their preparation, must satisfy all the hygiene rules, and in particular:

(a) They must not be able to alter the organoleptic characteristics of minced meat or meat preparations.

(b) They must not be able to transmit to minced meat or meat preparations harmful substances to human health, and

(c) They shall be of sufficient strength to ensure the effective protection of minced meat or meat preparations during transport and handling.

2. Packaging and packaging shall not be reused for the packaging of minced meat or meat preparations unless they are made of easy-to-clean corrosion-resistant materials, and if they have been cleaned and disinfected in advance.

3. Minced meat or packaged meat preparations must be packaged.

4. However, if the package meets all the conditions for the protection of the packaging, it must not be clear and colourless and it shall not be necessary to place it in a second package, provided that the other conditions of paragraph 1 are met. previous.

CHAPTER VIII

Storage

1. Minced meat and meat preparations must be refrigerated immediately after packaging and/or packaging, and stored at the temperature specified in Article 3 (2) (c) in the case of minced meat, and in paragraph (d) Article 5 (1) in the case of meat preparations.

2. The deep-freezing of minced meat and meat preparations may only be carried out at the premises of the premises of manufacture or of the autonomous production units or in approved cold stores.

3. In cold stores, minced meat and meat preparations may only be stored with other foodstuffs if the packaging ensures that any detrimental effect on minced meat and meat preparations is excluded.

CHAPTER IX

Transport

1. Minced meat and meat preparations must be issued in such a way that, in the course of transport, they remain protected from agents liable to contaminate or alter them, taking into account the duration and conditions of the transport, and the means of transport. used transport. In particular, vehicles used for the transport of minced meat and meat preparations shall be equipped so as not to exceed the temperatures laid down in this Royal Decree during transport and must be fitted with a a recording thermometer to record compliance with it.

2. By way of derogation from paragraph 1, the transport of meat preparations from the establishments referred to in Article 5 (5) from a manufacturing site or an autonomous production unit to establishments Retail or local collectivities nearby may be carried out at a temperature not exceeding + 4 .oC for meat preparations obtained from minced meat and for preparations containing offal, provided that such transport does not last longer of one hour.

3. In the case of transit through a third country, or where the manufacturing site is situated in an area subject to restrictions for animal health reasons, the means of transport shall remain sealed.

ANNEX II

Composition criteria and microbiological criteria for minced meat

I. Daily controlled composition criteria:

Relationship

collagen/protein

Meat/Percent of

fat matter

Lean/lean meat 7/' 12

Beef minced meat/ 20/' 15

Minced meat containing pork/ 30/' 18

Minced meat of other species/ 25/' 15

II. Microbiological criteria:

Manufacturing premises or autonomous production units must ensure that in the checks provided for in Article 7 (4), according to the methods of interpretation below, the minced meat is to the following criteria:

M a/m

Mesophilic aerobic germs

n = 5; c = 2/5 x 10 /g/5 x 10 /g

Escherichia coli

n = 5; c = 2/5 x 10 /g/50 /g

Salmonella

n = 5; c = 0/absence in 10 g

Staphylococcus aureus

n = 5; c = 2/10 /g/10 /g

(a) M = limit of acceptability, above which the results are no longer considered satisfactory. M is equal to "10 x m" when the count is performed on a solid medium and equal to "30 x m" when the count is carried out in a liquid medium.

(b) m = limit below which all results are considered satisfactory.

(c) rn = Number of units that make up the sample.

(d) rc = Number of units in the sample that manifest values between m and M.

Interpretation of results:

The results of microbiological analyses should be interpreted as follows:

A. A plan of three classes of contamination for the aerobic mesophilos, "Escherichia coli and Staphylococcus aureus", namely: a class less than or equal to the criterion m, a class between criterion m and threshold M, a class higher than threshold M.

The quality of departure will be considered:

a) Satisfactory: when all the observed values are less than or equal to 3 x m, when a solid medium is used, or 10 x m, when a liquid medium is used;

b) Acceptable: when the observed values are between: 3 x m and 10 x m (= M) in solid medium, or 10 x m and 30 x m (= M) in liquid medium, and when c/n is less than or equal to 2/5 with the plan [n = 5 and c = 2] or any other the equivalent or higher efficiency plan to be recognised by the Council, acting in accordance with the envisaged Community procedure.

c) Insatisfactory: in all cases where values greater than M are observed, or when c/n is greater than 2/5.

However, where the latter threshold is exceeded in the aerobic micro-organisms at + 30 oC, provided that the other criteria are met, this threshold overrun shall be the subject of a further interpretation, in particular in the case of raw products.

In any case, the product must be considered toxic or corrupted when the contamination reaches the limit microbial value S which is usually set to m x 10.

For the "Staphylococcus aureus" this value S can never exceed the amount of 5 x 10.

The tolerances linked to the analysis techniques shall not apply to the values of M or S.

B. A plan of two classes for the Salmonella, without any tolerance, which corresponds to the expressions: "Absence in": the result will be considered satisfactory; "Presence in": the result will be considered unsatisfactory.

ANNEX III

Veterinary inspection certificate concerning minced meat (1)

Num.

Shipper country:

Ministry: Service:

Reference (2):

I. Identification of minced meat:

Products prepared from meat:

(animal species)

Nature of products (3):

Nature of packaging:

Number of parts or packing units:

Storage and storage temperature:

Conservation time:

Net weight:

II. Origin of the minced meat:

Address (s) and authorization number (s) of the authorized meat (s) industry (s):

If necessary:

Address and authorization number (s) of the authorized cold store (s):

III. Destination of minced meat:

Minced meat is issued from:

(place of dispatch)

to:

(recipient country)

by the following means of transport (4):

Shipper name and address:

Recipient Name and Address:

IV. Certificate of veterinary inspection:

I, the undersigned, certify that the minced meat above is designated

(a) has been prepared with meat under the specific conditions laid down in

94 /65/EC;

(b) is intended for the Hellenic Republic (5)

Made in, the ........ of ............

(place) (date)

(Seal and signature of the official veterinarian)

(Name and name in uppercase)

------------------

(1) Pursuant to Article 2 of Directive 94 /65/EC.

(2) Optional.

(3) To be completed with the particulars provided for in Article 3 (2) (e) of Directive 94 /65/EC.

(4) For wagons and lorries, indicate the registration number; for aeroplanes, the flight number, and for the ships, the name, indications to be updated in case of transhipment.

(5) In your case.

ANNEX IV

Microbiological criteria for meat preparations

Manufacturing premises or autonomous production units shall ensure that the checks provided for in Article 7 (4), and in accordance with the methods of interpretation specified in Annex II, provide for: Meat preparations comply with the following criteria:

Meat/M/m preparations

Escherichia coli

n = 5; c = 2/5 x 10 /g/5 x 10 /g

Staphylococcus aureus

n = 5; c = 0/5 x 10 /g/5 x 10 /g

Salmonella

n = 5; c = 0/absence in 1 g

M = limit of acceptability, above which the results are no longer considered satisfactory. M is equal to "10 x m" when the count is done in a solid medium and equal to "30 x m" when the count is carried out in liquid medium.

m = limit below which all results are considered satisfactory.

ANNEX V

Veterinary inspection certificate concerning meat preparations (1)

Num.

Shipper country:

Ministry:

Service:

Reference (2):

I. Identification of meat preparations:

Products prepared from meat:

(animal species)

Nature of products (3):

Number of parts or packing units:

Storage and storage temperature:

Conservation time:

Net weight:

II. Provenance of meat preparations:

Address (s) and authorization number (s) of the authorized meat (s) industry (s):

If necessary:

Address and authorization number (s) of the authorized cold store (s):

III. Destination of meat preparations:

Products are issued from:

(place of dispatch)

to:

(recipient country)

by the following means of transport (4):

Shipper name and address:

Recipient Name and Address:

IV. Certificate of veterinary inspection:

I, the undersigned, certify that the meat preparations above are designated

(a) have been prepared with fresh meat under the specific conditions laid down in the Directi-va 94 /65/EC;

(b) is intended for the Hellenic Republic (5).

Made in, the ........ of ............

(place) (date)

(Seal and signature of the official veterinarian)

(Name and name in uppercase)

(1) Pursuant to Article 2 of Directive 94 /65/EC.

(2) Optional.

(3) To be completed with the particulars provided for in Article 3 (2) (e) of Directive 94 /65/EC.

(4) For wagons and lorries, indicate the registration number; for aeroplanes, the flight number, and for the ships, the name, indications to be updated in case of transhipment.

(5) In your case.

ANNEX VI-A

Public health certificate concerning minced meat (1)

Num.

Shipper country:

Ministry:

Service:

Reference (2):

I. Identification of minced meat:

Products prepared from meat:

(animal species)

Nature of products (3):

Number of parts or packing units:

Storage and storage temperature:

Conservation time:

Net weight:

II. Origin of the minced meat:

Address (s) and authorization number (s) of the authorized meat (s) industry (s):

If necessary:

Address and authorization number (s) of the authorized cold store (s):

III. Destination of minced meat:

Minced meat is issued from:

(place of dispatch)

to:

(country and place of destination)

by the following means of transport (4):

Shipper name and address:

Recipient Name and Address:

IV. Health certification:

I, the undersigned, certify that I have read and understood Directive 94 /65/EC and that the minced meat described above

(a) has been prepared in accordance with the provisions laid down in Articles 3 and 7 of

94 /65/EC;

(b) comes from an establishment or establishments offering the guarantees laid down in Annex I to

94 /65/EC;

(c) has been deep-frozen in the production establishment or in the establishments of origin.

En, a ........ de de ............

(place) (date)

(Seal and signature of the official veterinarian) (5)

(Name and name in uppercase)

------------------

(1) Pursuant to Article 2 of Directive 94 /65/EC.

(2) Optional.

(3) To be completed with the particulars provided for in Article 3 (2) (e) of Directive 94 /65/EC.

(4) For wagons and lorries, indicate the registration number; for aeroplanes, the flight number, and for the ships, the name, indications to be updated in case of transhipment.

(5) The signature and the stamp must be of a different colour from the ink of the printed text.

ANNEX VI-B

Public health certificate concerning meat preparations (1)

Num.

Shipper country:

Ministry:

Service:

Reference (2):

I. Identification of meat preparations:

Products prepared from meat:

(animal species)

Nature of products (3):

Number of parts or packing units:

Storage and storage temperature:

Conservation time:

Net weight:

II. Provenance of meat preparations:

Address (s) and authorization number (s) of the authorized meat (s) industry (s):

If necessary:

Address and authorization number (s) of the authorized cold store (s):

III. Destination of meat preparations:

Products are issued from:

(place of dispatch)

to:

(country and place of destination)

by the following means of transport (4):

Shipper name and address:

Recipient Name and Address:

IV. Health certification:

I, the undersigned, certify that you have read and understood Directive 94 /65/EC and that you prepare them-two of the meat described above

(a) have been prepared in accordance with the provisions laid down in Articles 5 and 7 of

94 /65/EC;

(b) come from an establishment or establishments offering the guarantees laid down in Annex I to

94 /65/EC;

(c) have been deep-frozen in the production establishment or in the establishments of origin.

En, a ........ de de ............

(place) (date)

(Seal and signature of the official veterinarian) (5)

(Name and name in uppercase)

------------------

(1) Pursuant to Article 2 of Directive 94 /65/EC.

(2) Optional.

(3) To be completed with the particulars provided for in Article 3 (2) (e) of Directive 94 /65/EC.

(4) For wagons and lorries, indicate the registration number; for aeroplanes, the flight number, and for the ships, the name, indications to be updated in case of transhipment.

(5) The signature and the stamp must be of a different colour from the ink of the printed text.

ANNEX VII

Conditions for Structure Establishments

and non-industrial capacity

The establishments referred to in Article 5 shall meet the following requirements:

1. The technical and health conditions of Annex A to Royal Decree 1904/1993, except for the following paragraphs of Chapter I:

(a) 2.g), as regards the actuation of the taps, which may be manual.

b) The 11, as regards changing rooms, which may be replaced by closets.

2. The special conditions of Annex B to Royal Decree 1904/1993, except Chapter I, which is replaced by the following:

" 1. All establishments shall have:

(a) Where the raw materials, a local or a device, in their case refrigerated, are stored, and when the preparations, a local or a device are stored, in their case refrigerated.

(b) Sufficiently large premises for the manufacture and packaging of meat preparations. Such operations may be carried out in a local area where the design and dimensions are appropriate and the process is carried out continuously and hygienically.

c) A local or device for storing food additives.

(d) A premises for packing and dispatch operations, unless the conditions laid down in Chapter V (3) of Annex B are met.

e) A local for storage of packaging and packaging materials.

f) A site for cleaning useful such as hooks and containers.

2. Depending on the type of product concerned, they shall have:

a) A suitable location to remove the packaging.

b) A site for defrosting raw materials.

(c) A site for the prior cleaning of non-meat raw materials, if necessary.

(d) A site for the prior cleaning, if appropriate, of meat preparations which are to be cut or sliced for subsequent packaging.

(e) A local provided, if necessary, of an air conditioning device for the cutting, cutting and packaging of meat preparations intended for marketing in prepackaged form.

The operations of boning, chopping, desalting, soaking or any other treatment of natural guts and similar products may be carried out at the premises referred to in paragraph 1 (b). '