many cases, the indiscriminate and abusive use of certain products in the feeding of animals in the supply of animals poses a serious risk to the health of people, and it is therefore necessary to Article 18 (12) of Law 14/1986 of 25 April 1986 General of Health, Public Administrations carry out, in order to avoid such a risk, precise actions in the areas of food hygiene, in slaughterhouses and in the industries of their competence.

On the other hand, Directive 86 /469/EEC of 16 September 1986 on the investigation of residues in animals and fresh meat regulates the checks to be carried out on certain substances present in animals. (a) to ensure that the laws of the Member States are harmonized in the relevant field, since the existing legislative differences lead to major obstacles in the field of transport; (a) the Community trade and, secondly, in order to protect the consumer from the consequences that such substances may have for their health. In order to achieve such purposes, the Directive provides for a phased timetable for the entry into force of the provisions laid down therein, in the light of the different types of substances set out

Annex I.

As provided for in Article 4 of that Directive, Spain submitted to the Commission a programme for the detection of residues of the substances mentioned in Groups I and II of Annex I (A) to the Commission. was approved by Commission Decision No 88 /201/EEC of 18 February. This programme was extended to Groups A III and B of that Annex by Commission Decision No 89/265 of 30 March.

The purpose of this Royal Decree is to enable the correct execution of the mentioned program, in accordance with the provisions of Articles 40.12, 70.2 and 73.1 of the General Health Law.

In its virtue, on the proposal of the Ministers of Agriculture, Fisheries and Food and of Health and Consumption, with favorable report of the Inter-Ministerial Commission for Food Management, after approval of the Minister for the Public administrations, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 20 October 1989,

DISPONGO:

Article 1. °

The investigation of residues in animals, their excrement and biological liquids, as well as in the tissues and in the fresh meat, will be used according to the provisions of this Royal Decree, for the purpose of the Requirements of Directive 86 /469/EEC.

Art. 2. °

Waste research, as referred to in the previous Article, shall be implemented through a National Plan, which shall affect the substances listed in Annex I to this provision and shall be carried out in compliance with the frequencies Minimum requirements for controls, as specified in Annex II, with the effect of sampling and additional analysis which it considers to be accurate.

Art. 3. º

For the purposes of this provision,

following definitions shall apply:

Official sample: A sample taken by the competent Autonomous Community, including, in respect of the examination of the residue concerned, the indication of the species, age and sex of the animal and nature, quantity and method of taking shows, on the one hand, and the identification of the animal and the meat, as well as their origin or provenance, the taking must be carried out without warning.

Approved laboratory: A laboratory authorized by the Autonomous Community to meet the conditions to be established in general, to carry out the official sample examination, in order to investigate the presence of waste for the implementation of the Plan which is approved by this Royal Decree.

Waste: Waste of substances that have pharmacological action, of their processing products, as well as of other substances that may remain in the meat and pose a risk to human health.

Art. 4. °

As a coordinating body for the activities of the Autonomous Communities responsible for carrying out the controls for the different wastes, the Inter-Ministerial Commission for the Investigation of Waste in Animals and Carnes is hereby established. Fresh, composed of the following members:

The Director-General of Food Health and Consumer Protection.

The Director General of Food Policy.

The Director General of Agrarian Production.

High-ranking officials will be able to delegate to Deputy Directors-General of their respective Management Centers.

The Deputy Director General for Animal Health.

Deputy Director General of Veterinary Public Health.

A representative of the "Carlos III" Health Institute.

A representative of the National Consumer Institute.

The Presidency of the Commission will be the responsibility of the Director-General for Food Health and Consumer Protection; the Director-General of Agricultural Production will be Vice-President and the Secretariat will be in charge of the Deputy Director. General Animal Health. The coordination in the areas of Agriculture and Public Health with the Autonomous Communities will be carried out by the Subdirectorates General of Animal Health and Veterinary Public Health, respectively.

The following are functions of the Inter-Ministerial Commission:

1. To draw up, after consultation with the Autonomous Communities, the plans provided for in Directive 86 /469/EEC, for the purpose of lifting them up to the Ministers for Agriculture, Fisheries and Food and for Health and Consumer Affairs.

2. Coordinate the activities of the Autonomous Communities responsible for carrying out the controls for the various wastes. To this end:

(a) Carry out, in collaboration with the Autonomous Communities, the distribution by area of the number of samples to be taken in each case, as provided for in Chapter II of Annex II.

(b) The results of the checks carried out and the surveys to be carried out in accordance with Article 7 shall be sent by the Autonomous Communities.

(c) Facilitating the Ministries of Agriculture, Fisheries and Food and Health and Consumer Affairs and the Autonomous Communities with the periodicity that the Inter-Ministerial Commission itself establishes, information on the degree of implementation of the National Plan.

3. To draw up an annual report on the implementation of the plan and to submit the proposals for communication to the Commission of the EEC and the other States to the Ministers for Agriculture, Fisheries and Food and for Health and Consumer Affairs. members as set out in Article 12 of that Directive.

4. Make proposals at any time that you consider accurate for the best execution of the Plan.

As not provided for by this Royal Decree, the functioning of the Inter-Ministerial Commission shall be governed by the provisions of the Law on Administrative Procedure in the field of collegiate bodies.

Art. 5. °

They are designated as National Reference Laboratories to the following:

National Food and Nutrition Center of the Ministry of Health and Consumer Affairs, for hormonal substances and for the tireostatic substances in the tissues and in the fresh meat.

Animal Health and Production Laboratory of Santa Fe, for hormonal substances in the living animal.

Animal Health and Production Laboratory of Algette, for thyrostatic substances in the live animal.

Arbitration laboratory of the Ministry of Agriculture, Fisheries and Food for pesticide residues and heavy metals.

The functions of the National Reference Laboratories are as follows:

1. To establish and coordinate the standards and methods of analysis for each residue or group of waste, as long as the corresponding official methods of analysis are not established.

2. Organize Periodic Comparative Tests, on samples analyzed in authorized laboratories.

To the extent that the needs for waste research are to be increased, other National Reference Laboratories, to be designated by Order, may be authorised without prejudice to existing ones. together with the Ministries of Agriculture, Fisheries and Food and Health and Consumer Affairs, prior to the report of the Inter-Ministerial Commission for the Investigation of Waste in Animals and Fresh Meat.

Art. 6. °

The sampling will be carried out, in accordance with the provisions of Article 15 of Royal Decree 1945/1983 of 22 June 1983, which regulates infringements and penalties in the field of consumer and production defence. agri-food, by the Official Services of the Autonomous Communities, collecting the biological excrement and liquids of the animals, as well as the tissues and fresh meat, to be examined in the Authorised Laboratories for the purpose to detect the presence of residues in accordance with the provisions of Annex II.

The analysis of the samples, as provided for in the preceding paragraph, shall be carried out in accordance with the Official Analysis Methods or, failing that, with which they establish the National Reference Laboratories.

The diriment analyses shall be carried out at one of the Laboratories listed in Annex III to this provision.

Art. 7. °

1. If the examination of an official sample, taken in accordance with Annex II, reveals the presence of residues of prohibited substances or of quantities of authorised substances exceeding the maximum permitted levels, the Autonomous Communities carry out the following measures:

1. The Realization of a survey on the holding of origin to determine the reasons for the presence of residues.

2. A survey of the sources of the substances concerned, in the manufacturing, storage, transport, administration, distribution or sale phase, as the case may be.

3. The official marking and the appropriate tests on animals which, following the above surveys, may be considered as suspected of presenting the residues concerned, shall be carried out in the herd as well as on holdings of origin.

4. Ban on the placing on the market of animals for human or animal consumption, if the examination reveals the presence of prohibited substances.

5. Ban on the slaughter of animals intended for human consumption, if the conditions for the use of an authorised substance have not been respected and in particular if the examination reveals the presence of residues of authorised substances, above the levels laid down in the first subparagraph, until it can be ensured that the quantity of waste does not exceed the permissible levels. This period may in no case be less than the expected time limit for the substance concerned.

6. During the examination period, animals may not be transferred to other persons unless they are under official veterinary control.

7. However, as provided for in measure 5, animals whose slaughter has been prohibited may be slaughtered before the end of the prohibition period, provided that the competent authority is informed in advance. of the intended date of slaughter and of the place of slaughter. The animals shall be presented at the place of slaughter together with an official veterinary certificate referred to therein, expressing the limitations provided for in this Article and the date of completion of the examination period.

8. The meat of any animal whose slaughter has been notified, in accordance with the previous point, shall be subjected to official sampling, for the purpose of searching for the residue in question and shall be retained until the result is known. of the test.

9. The meat in which the presence of residues has been confirmed must be excluded from human consumption.

10. Subject to a reinforced check, in order to discover the substance concerned, the production establishment and breeding holdings in the same region or locality which supply the said establishment.

2. The Deputy Directorate-General for Veterinary Public Health or the Subdirectorate-General for Animal Health, as appropriate, shall be responsible for communicating the analytical results to the competent authorities of the Autonomous Communities concerned. referred to in paragraph 1 above.

Art. 8. °

Both animals and fresh meat arriving in the national territory must provide guarantees equivalent to those provided for in this provision in respect of the control of residues.

Art. 9. °

The Ministries of Agriculture, Fisheries and Food and Health and Consumer Affairs are empowered to allow, within the framework of the Community Directives and in the field of the programme for the detection of waste presented by our country, to modify, where the circumstances so advise, the groups of residues, the sampling of residues, the levels and frequency of sampling and the relationship of authorised laboratories for the performance of the analysis.

ADDITIONAL DISPOSITION

This Royal Decree is issued in accordance with the provisions of Article 149.1.1. and 16. of the Constitution.

However, it will be up to the State to compete on export restrictions and, in general, to refer to the external trade of the products covered by this rule, in accordance with the provisions of the Article 149.1.1. and 10. of the Spanish Constitution.

FINAL DISPOSITION

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given in Madrid to October 20, 1989.

JOHN CARLOS R.

The Minister of Relations with the Courts and the Government Secretariat,

VIRGILIO ZAPATERO GOMEZ

ANNEX I

Waste Group

A) Common Groups

Group I.

(a) Ethylbenes, derivatives of stilbenes, their salts and esters.

b) Tireostatic substances.

c) Other substances of estrogen, androgen or gestogen, other than those of Group II.

Group II.

Substances referred to in Article 3 of Royal Decree 1423/1987 of 22 November 1987 laying down rules on substances for the use of hormones and thyrostatic action for the use of animals (Official Journal of the European Communities). 23).

Group III.

a) Inhibitory substances. Antibiotics, sulfamides and similar antimicrobial substances.

b) Chloranfenicol.

B) Specific groups

Group I. Other medicines.

a) Substance and ectoparasitics.

b) Tranquilizers and beta-blockers.

c) Other veterinary medicinal products.

Group II. Other wastes.

a) Contaminants present in livestock feed.

b) Pollutants present in the environment.

c) Other substances.

ANNEX II

CHAPTER I

Sampling of waste

1. Sampling and maintenance conditions of the random character.

1.1 The Ministries of Agriculture, Fisheries and Food and Health and Consumer Affairs shall ensure that official samples are taken in accordance with the appropriate sampling system and taking into account the variable criteria which are mentioned below.

1.2 Variable Criteria. They will be taken into account:

1.2.1 The current legislation regarding the use of the substances mentioned in the waste groups (in particular prohibition of use or authorisation of use).

1.2.2 Factors that may encourage fraud or abuse.

1.2.3 The animal population concerned as regards:

-Total population size.

-Homogenization of population groups.

-Age of animals.

-Sex of the animals.

1.2.4 The environment of the holdings as regards:

-Regional differences.

-Relation to industrial activity.

-Relationship with agriculture.

1.2.5 Agricultural production systems included:

-Intensive agriculture units.

-fattening systems.

-Breeding systems, in particular food regime and measures taken in animal health matters.

1.2.6 Problems that may arise, taking into account known precedents and other indications.

1.2.7 The necessary degree of protection for consumers, in accordance with the nature and toxicity of the substance concerned.

2. Sampling system.

For each group of substances and depending on the level of health and the appropriate variable criteria for each territory, the different Ministries and Councils of the Autonomous Communities shall set up a system of sampling and examination of samples in accordance with the provisions of Chapter II.

CHAPTER II

Levels and frequency of sample takes

During the first year following the application of this Royal Decree, at least the following frequencies shall be respected:

A.I. Group

1. For young cattle for fattening (less than two years):

1.1 Initial control at least 0,15 per 100 of the bovine animals included in this category and among them, at least 0,10 per 100 of the animals slaughtered, the remainder being controlled, i.e. at least 0,05 per cent. 100 on the holding-.

1.2 Intensive Phase: If a positive case of a thousand samples is officially confirmed during a period of six months, during the sampling operations mentioned above, they will measure the amount of waste that could be present by applying a higher frequency of sampling at a minimum of 0,25 per 100 of the animals included in this category, of which at least 0,1 per 100 shall be the subject of a control of the holding.

This intensification of controls may be limited to the category of animals and the substance corresponding to the positive result.

In addition, you can refer to the production region where the positive result has been confirmed.

1.3 If after one year of application of the sampling frequency indicated in point 1.1 no positive result, officially confirmed, has been observed, the frequency corresponding to the routine phase shall be applied, that is, 300 samples per year.

These samples must be taken in such a way as to ensure at least 95 per 100 that in the absence of positive results, the proportion of bovine animals for fattening that may present residues is less than 1 per 100.

If a positive result is officially confirmed during the sampling operations referred to above, the quantity of waste that may be present shall be measured by applying a set frequency for the sampling. initial stage referred to in point 1.1.

2. For cows intended for slaughter:

2.1 Initial phase: 700 samples.

2.2 Intensive phase: 0.25 per 100 of the slaughtered cows.

2.3 Routine phase: 300 samples.

3. For the whole of the porcine, ovine, capraiy and solipeds:

3.1 Initial phase: 700 samples.

3.2 Routine phase: 300 samples.

3.3 Intensive phase: For the species in question to double the controls performed in the routine phase, with a minimum of 0,1 per 100 of the animals slaughtered.

The criteria governing the transition from one stage to another of the controls provided for in point 1 shall apply to groups 2 and 3 by analogy.

Group A. II.

1. Initial phase: 700 samples.

2. Intensive phase: 0.25 per 100 of the slaughtered cows.

3. The general criteria governing the transition from one stage to another of the checks provided for in point A. 1 above shall apply to this point by analogy.

During the initial phase, the intake must be done in a way that ensures at least 99.9 per 100, at least, that in the absence of positive results, the proportion of animals that can present residues is less than 1 per cent. 100.

Group A. III, letter a).

1. The control shall be carried out at 0,10 per 100 of the animals slaughtered; for this control it may be carried out:

-Modular your control to take into account the marketing authorization and conditions of this marketing.

-Proceed to control a group ("pool") of substances.

-Limit controls to regions of species that may be affected by such substances.

2. In the event of a positive result in the slaughterhouse, Article 7 shall apply.

Group A. III, point (b).

1. At least 300 samples per year shall be taken.

In the case where a positive result is confirmed in the slaughterhouse, Article 7 shall apply.

If for a period of one year no positive case has been confirmed, the controls will be done at least 300 samples per year.

These samples must be taken in such a way as to ensure at least 95 per 100 that in the absence of positive results, the proportion of animals that can present residues is less than 1 per 100.

2. For each positive case found, Article 7 shall apply with a reinforcement of the controls of 0,50 per 100 of the slaughtered animals of the species concerned in the region where the positive case has been discovered.

Group B.

Minimum annual frequency 700 samples.

The frequency of controls must meet the following criteria:

-The checks may be subject to regional application (region of such importance as the national result is not distorted) and of limited application to certain species representative of the production of such regions.

-Control of substances may be carried out by means of groups of substances in which each substance or groups of substances must be subject to minimum control with the possibility of alternative control.

ANNEX III

Authorized Laboratories

National Food and Nutrition Center (Ministry of Health and Consumer Affairs).

Animal Health and Production Laboratory. Santa Fe (Granada). (Ministry of Agriculture, Fisheries and Food).

Animal Health and Production Laboratory. Algete (Madrid). (Ministry of Agriculture, Fisheries and Food).

Arbitration Laboratory (Ministry of Agriculture, Fisheries and Food).

Research and Quality Control Center (Ministry of Health and Consumer Affairs).