Community legislation on the determination of maximum residue levels for pesticides and their control in plant products is contained in Council Directive 76 /895/EEC of 23 November 1976 on the fixing of the maximum levels of pesticide residues in fruit and vegetables; in Council Directive 86 /362/EEC of 24 July 1986, as last amended by Council Directive 93 /57/EEC of 29 June 1993 on the the fixing of maximum levels for pesticide residues in and on cereals and in Council Directive 90 /642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in certain products of plant origin, including fruit and vegetables, in accordance with which they have already been (a) a number of active substances for the purposes of Council Directive 93 /58/EEC of 29 June 1993.

Directive 76 /895/EEC was transposed into our legal order by the Order of 11 March 1987 laying down the maximum limits for pesticide residues in plant products and the Order of 27 October 1989, on maximum residue limits for pesticide residues in plant products. Directive 86 /362/EEC was also transposed by the Order of 27 October 1989 and by the Order of 20 July 1990 laying down the national programme for the monitoring of residues of plant protection products at source.

Directive 90 /642/EEC has been designed to harmonise, in the area of plant health, the national legislation of the Member States on pesticide residues for the majority of plant products, which represents the the removal of a major technical obstacle to the completion of the Single Internal Market as the Council is setting the maximum residue levels for each plant-pesticide product combination. The same function fulfils, in respect of cereals, Directive 86 /362/EEC.

The harmonisation established includes two main lines: the first is the fixing of the maximum Community residue limits for each pesticide in the different products or groups of plant products and the second is the the establishment of a system for monitoring the content of pesticide residues in plant products which are put into circulation on the Community market, whether they are domestic production or imported from third countries, responsibility for each Member State to carry out inspection programmes, carried out at less by sampling, in order to prevent plant products with pesticide residues exceeding the maximum levels laid down in their territory from being put into circulation on their territory.

This provision transposes Council Directives 90 /642/EEC, 93 /57/EEC, as regards cereals; 93 /58/EEC and 79 /700/EEC, of the Commission of 24 June 1979, and also includes those previously transposed (a) in order to collect in a single provision all the rules relating to the content of pesticide residues in plant products. The ceilings already established at Community level and those which have not yet been harmonized and which have been established at national level until they are fixed by the Community are fixed. This is without prejudice to the provisions laid down in Council Directives 89 /397/EEC of 14 June 1989 on the control of foodstuffs and 74 /63/EEC of 17 December 1973 on the fixing of contents maximum levels of undesirable substances and products in food for livestock.

This Royal Decree is issued pursuant to the provisions of Article 149.1.10., 13. and 16. of the Constitution and in accordance with the provisions of Article 40 (2) of Law 14/1986 of 25 April, General of Health.

The Autonomous Communities have been consulted as well as the sectors affected.

In its virtue, on the proposal of the Ministers of Agriculture, Fisheries and Food and of Health and Consumer Affairs, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of 18 February 1994,

DISPONGO:

Article 1. Object.

This Royal Decree aims at the fixing of maximum residue limits for plant protection products in plant products, as well as the implementation of their control in relation to the content of plant protection products in the plant products, in accordance with existing Community rules.

Article 2. Definitions.

For the purposes of this provision, they are understood by:

1. Plant products: plants, or parts thereof, intended for human or livestock feed listed in the groups listed in the first column of Annex I, for which examples are given in the second column.

2. Pesticide residues: the main remains of pesticides, as well as their metabolites and degradation or reaction products, listed in the

Annex II, which are present in plant products.

3. Putting into circulation: any transmission for consideration or free of charge of the products listed in Annex I. The importation into the national territory of products from third countries shall be deemed to be put into circulation for the purposes of This Royal Decree.

Article 3. Scope of application.

1. This Royal Decree shall apply to all the plant products listed in the groups listed in the first column of Annex I, provided that the products covered by those groups or the parts thereof referred to in the third column of the This Annex may contain certain pesticide residues. Plant products will be both Community-origin and those from third countries to be marketed in the Community.

2. It shall also apply to fruit, vegetables and other products covered by Directive 90 /642/EEC where they are intended for export to third countries, except for products treated before export where it can be demonstrated Sufficient way:

(a) That the third country of destination requires such particular treatment to prevent the introduction into its territory of harmful organisms, or

(b) that the treatment is necessary to protect the products of the harmful organisms during transport to the third country of destination and the storage therein.

3. This standard shall not apply to plant products for which it is sufficiently demonstrated that they are intended to be intended:

(a) For the manufacture of products other than food and feed, or

b) To planting or planting.

Article 4. Fixing of maximum residue limits.

1. The maximum residue limits for each pesticide in plant products shall be set within the limits set out in Annex II.

2. In addition to those set out in Annex II, maximum residue limits are considered:

(a) The limit of detection of the relevant analytical method for those pesticides for plant protection not authorised in Spain which are not included in Annex II. In the case of different analytical methods, the one with the lowest detection limit shall be applied until an official method is established.

(b) Those determined in their approval, having regard to their use in good plant health practices, for pesticides of use authorised in Spain which are not covered by subparagraph (a) above, as appropriate its inclusion in Annex II.

3. In the case of dried products for which no specific ceilings have been set, the maximum applicable content shall be that provided for in the list referred to in Annex II and in paragraph 2 above, taking into account the concentration of residues due to the drying process.

Article 5. Prohibitions, responsibilities and obligations.

1. The plant products or, where appropriate, the parts of the products listed in Annex I, shall not, as soon as they are put into circulation, present the contents of pesticide residues exceeding those referred to in Annex II and in the Article 4; failure to comply with the above requirement shall be prohibited.

2. Producers and, where appropriate, those who carry out post-harvest treatments referred to in paragraph 1, are responsible for the compliance with the safety deadline and the appropriate dose of the application. the plant protection products used.

3. Users of plant protection products may not apply such products on crops or plant products for which they are not expressly authorised on the label.

4. Trade opponents and producers shall be responsible for the placing on the market, movement or sale of plant products referred to in paragraph 1 containing residues of plant protection products in excess of those mentioned above. in that paragraph.

5. The producers and traders referred to in the preceding paragraph and other natural and legal persons to whom this Royal Decree applies are obliged to provide the agents responsible for taking samples with access to plant products at any stage of their production and placing on the market, located in fields, production and handling premises, customs offices and points of sale, so that they can carry out inspections.

Article 6. Monitoring and control.

1. In order to ensure that the maximum residue levels of pesticides in plant products before they are put into circulation do not exceed the ceilings set out in Annex II and in Article 4 of this Royal Decree, the Communities Autonomous regions shall draw up annual plans for monitoring residues of plant protection products at source by sampling, in which the nature and frequency of checks shall be determined and appropriate mechanisms shall be established to prevent the the putting into circulation of plant products where the content of waste exceeds those specified in Annex II and Article 4.

2. In order to ensure that existing plant products on the national market comply with the requirements of Article 5 and to ensure the protection of the health of consumers, the Autonomous Communities shall establish the monitoring and control of residues of plant protection products in existing plant products on the market for human use and consumption.

3. The sampling methods for carrying out the checks provided for in the programmes to be established shall be those specified in Annex III.

4. The methods of analysis used for the determination of residues shall be those laid down by the Autonomous Communities in accordance with the basic standards laid down by the Ministry of Agriculture, Fisheries and Food, by the Ministry of Health and consumption or other proven and scientifically valid methods, provided that this does not constitute an obstacle to the free movement of products and that they are consistent with the rules applied in Community methods and methods. In the event of divergence of interpretation on the results, those obtained through the use of Community methods shall be decisive.

Article 7. Safeguard.

When, as a result of new information, or a reassessment of existing information, the Ministry of Health and Consumer Affairs considers that a maximum level set out in Annex II and in Article 4 is endangering health The Commission may, in accordance with the conditions laid down in the first paragraph of this paragraph, apply to the Member State concerned. In such a case, the Commission and the other Member States shall be informed immediately of the measures taken.

Article 8. Responsible authorities and competition.

1. With regard to the implementation and development of this Royal Decree, in respect of trade in plant products with third countries, the Ministry of Agriculture, Fisheries and Food is hereby entrusted to the Ministry of Agriculture, Health of Agricultural Production, the following tasks:

(a) The monitoring of plant protection product residues in plant products, in the import of third countries, without prejudice to the control which Royal Decree 1418/1986 of 13 June 1986 on the functions of the Ministry of Health and Consumption in the field of external health, attributed to the Ministry of Health and Consumer Affairs.

(b) The designation of the agents responsible for sampling at points of entry into the national territory of products from third countries.

2. They correspond to the Ministry of Agriculture, Fisheries and Food relations, through the appropriate channel, with the commission and in particular the issuing of the mandatory reports on the established programmes.

3. The Ministry of Health and Consumer Affairs, through the Directorate General of Public Health, is entrusted with the issuance of reports necessary to comply with the Community requirements. To this end, the Autonomous Communities shall provide the data required for their preparation, on the basis of the criteria to be established by public health interests.

4. It is for the Autonomous Communities to develop and implement this Royal Decree in respect of plant products of Community origin.

5. Between the Ministry of Agriculture, Fisheries and Food, the Ministry of Health and Consumer Affairs and the competent bodies of the Autonomous Communities will establish the channels of mutual information that will enable the objectives of this Royal Decree to be met with the greatest possible effectiveness.

The Ministry of Agriculture, Fisheries and Food and the Autonomous Communities shall report to the Ministry of Health and Consumer Affairs when the checks carried out will lead to the existence of possible risks to public health.

Article 9. Infringements and sanctions.

The infringements committed for violating the provisions of this Royal Decree will be sanctioned under the Royal Decree 1945/1983 of 22 June for the regulation of infringements and sanctions in the field of consumer protection. and of the agri-food production, and according to Law 14/1986, General of Health.

Single additional disposition. Regulatory competence.

The provisions of this Royal Decree are dictated by the exclusive powers on foreign trade and on external health and to regulate the bases and general coordination of health, reserved for the State by the Article 149.1.10. and 16. of the Constitution, as well as on the basis and coordination of the general planning of the economic activity attributed to it in Article 149.1.13., and pursuant to Article 40 (2) of Law 14/1986, of 25 April, General of Health.

Single repeal provision. Regulatory repeal.

As many provisions of the same or lower rank are repealed in this Royal Decree and in particular the Orders of 11 March 1987 laying down the maximum residue limits for pesticide residues in the On 27 October 1989, on maximum residue levels of pesticides in plant products, the Ministry of Relations with the Cortes and the Government Secretariat, and the Order of 20 July 1990, for which it was implements the national programme for the monitoring of residues of plant protection products at source, from the Ministry of Agriculture, Fisheries and Food.

Final disposition first. Faculty of development.

The Ministers of Agriculture, Fisheries and Food and Health and Consumer Affairs are empowered to lay down the appropriate rules for the development of the provisions of this Royal Decree and, in particular, to carry out the modification of the Annex II, in accordance with the amendments introduced by Community legislation and on the basis of a proposal from the Joint Committee on Waste of Plant Protection Products established by Order of 18 June 1985.

Final disposition second. Entry into force.

This Royal Decree will enter into force on the day following its publication in the Official Journal of the State.

Given in Madrid to February 18, 1994.

JOHN CARLOS R.

The Minister of the Presidency,

ALFREDO PEREZ RUBALCABA

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