This Directive concerns the authorization, placing on the market, use and control within the Community of plant protection products in commercial form and the placing on the market and control within the Community of active substances intended for a use specified in Article 2 (1).
Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC)
Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas plant production has a very important place in the Community;
Whereas plant production yields are continually affected by harmful organisms including weeds; whereas it is absolutely essential to protect plants against these risks to prevent a decline in yields and to help to ensure security of supplies;
Whereas one of the most important ways of protecting plants and plant products and of improving agricultural production is to use plant protection products;
Whereas these plant protection products can have non-beneficial effects upon plant production; whereas their use may involve risks and hazards for humans, animals and the environment, especially if placed on the market without having been officially tested and authorized and if incorrectly used;
Whereas, in view of the hazards, there are rules in most Member States governing the authorization of plant health products; whereas these rules present differences which constitute barriers not only to trade in plant protection products but also to trade in plant products, and thereby directly affect the establishment and operation of the internal market;
Whereas it is therefore desirable to eliminate such barriers by harmonizing the provisions laid down in the Member States;
Whereas uniform rules on the conditions and procedures for the authorization of plant protection products must be applied by the Member States;
Whereas such rules should provide that plant protection products should not be put on the market or used unless they habe been officially authorized and should be used properly having regard to the principles of good plant protection practice and of integrated pest control;
Whereas the provisions governing authorization must ensure a high standard of protection, which, in particular, must prevent the authorization of plant protection products whose risks to health, groundwater and the environment and human and animal health should take priority over the objective of improving plant production;
Whereas it is necessary, at the time when plant protection products are authorized, to make sure that, when properly applied for the purpose intended, they are sufficiently effective and have no unacceptable effect on plants or plant products, no unacceptable influence on the environment in general and, in particular, no harmful effect on human or animal health or on groundwater;
Whereas authorization should be limited to plant protection products containing certain active substances specified at Community level on the basis of their toxicological and ecotoxicological properties;
Whereas it is therefore necessary to establish a Community list of authorized active substances;
Whereas a Community procedure must be laid down for assessing whether an active substance can be entered on the Community list; whereas the information that interested parties must submit with a view to admission of a substance to the list should be specified;
Whereas the Community procedure should not prevent Member States from authorizing for use in their territory for a limited period plant protection products containing an active substance not yet entered on the Community list, provided that the interested party has submitted a dossier meeting Community requirements and the Member State has concluded that the active substance and the plant protection products can be expected to satisfy the Community conditions set in regard to them;
Whereas, in the interests of safety, substances on the Community list should be reviewed periodically, to take account of developments in science and technology and of impact studies based on the actual use of plant protection products containing the said substances;
Whereas it is in the interests of free movement of plant products as well as of plant protection products that authorization granted by one Member State, and tests carried out with a view to authorization, should be recognized by other Member States, unless certain agricultural, plant health and environmental (including climatic) conditions relevant to the use of the products concerned are not comparable in the regions concerned; whereas to this end there is a need to harmonize the methods of experimentation and control applied by the Member States for the purpose of granting authorization;
Whereas it is therefore desirable that a system for the mutual supply of information should be established and that Member States should make available to each other on request the particulars and scientific documentation submitted in connection with applications for authorization of plant protection products;
Whereas, however, Member States must be enabled to authorize plant protection products not complying with the abovementioned conditions when it is necessary to do so because of an unforeseeable danger threatening plant production which cannot be countered by other means; whereas such authorization should be reviewed by the Community in close cooperation with the Member States in the framework of the Standing Committee on Plant Health;
Whereas this Directive complements Community provisions on the classification, packaging and labelling of pesticides; whereas together with these provisions it considerably improves the protection of users of plant protection products and consumers of plants and plant products; whereas it also contributes to the protection of the environment;
Whereas it is necessary to maintain consistency between this Directive and Community rules on the residues of plant protection products in agricultural products and the free movement of the latter in the Community; whereas this Directive complements Community provisions relating to maximum permissible levels for pesticide residues and will facilitate the adoption of such levels in the Commission; whereas together with the latter provisions it considerably improves the protection of consumers of plants and plant products;
Whereas resources devoted to the conduct of tests on vertebrate animals should not be dissipated as a result of the differences in the laws of the Member States and whereas considerations of public interest and Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(4) militate against needless repetition of tests on animals;
Whereas, in order to ensure that the requirements laid down are satisfied, Member States must make provision for appropriate control and inspection arrangements with regard to the marketing and use of plant protection products;
Whereas the procedures provided for by this Directive for the evaluation of the risks to the environment presented by plant protection products containing or composed of genetically modified organisms correspond in principle to those laid down in Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(5); whereas in future however the supply of data in accordance with Part B of Annexes II and III is likely to be subject to specific requirements, provision should be made to amend this Directive accordingly;
Whereas the implementation of this Directive and the adaptation of its Annexes to advances in technical and scientific knowledge necessitate close cooperation between the Commission and the Member States, and whereas the procedure of the Standing Committee on Plant Health offers a suitable basis for this cooperation,
HAS ADOPTED THIS DIRECTIVE:
Scope
Article 1
1.
2.
This Directive shall apply without prejudice to Council Directive 78/631/EEC of 26 June 1978 on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides)(6), as last amended by Directive 84/291/EEC(7) and, where active substances are concerned, without prejudice to the provisions concerning classification, packaging and labelling of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(8), as last amended by Directive 90/517/EEC(9).
3.
This Directive applies to the authorization to place on the market plant protection products containing or composed of genetically modified organisms, provided that authorization to release them into the environment has been granted after the risk to the environment has been assessed in accordance with the provisions of Parts A, B and D and the relevant provisions of Part C of Directive 90/220/EEC.
The Commission shall submit to the Council, in sufficient time for the latter to be able to act not later than two years after the date of notification of this Directive, a proposal for an amendment with a view to including in this Directive(10) a specific procedure for evaluating the risk to the environment analogous to that provided for the Directive 90/220/EEC, and enabling this Directive to be placed on the list provided for in Article 10 (3) of Directive 90/220/EEC in accordance with the procedure laid down in the said Article 10.
Within five years of the date of notification of this Directive, the Commission, on the basis of experience gained, shall provide the European Parliament and the Council with a report on the operation of the arrangements described in the first and second subparagraphs.
4.
This Directive shall apply without prejudice to Council Regulation (EEC) No 1734/88 of 16 June 1988 concerning export from and import into the Community of certain dangerous chemicals(11).
Definitions
Article 2
For the purposes of this Directive the following definitions shall apply:
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‘plant protection products’
active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:
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protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below;
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influence the life processes of plants, other than as a nutrient, (e.g. growth regulators);
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preserve plant products, in so far as such substances or products are not subject to special Council of Commission provisions on preservatives;
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destroy undesired plants; or
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destroy parts of plants, check or prevent undesired growth of plants;
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‘residues of plant protection products’
one or more substances present in or on plants or products of plant origin, edible animal products or elsewhere in the environment and resulting from the use of a plant protection product, including their metabolites and products resulting from their degradation or reaction;
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‘substances’
chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitable resulting from the manufacturing process;
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‘active substances’
substances or micro-organisms including viruses, having general or specific action:
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against harmful organisms; or
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on plants, parts of plants or plant products;
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‘preparations’
mixtures or solutions composed of two or more substances of which at least one is an active substance, intended for use as plant protection products;
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‘plants’
live plants and live parts of plants, including fresh fruit and seeds;
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‘plant products’
products in the unprocessed state or having undergone only simple preparation such as milling, drying or pressing, derived from plants, but excluding plants themselves as defined in point 6;
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‘harmful organisms’
pests of plants or plant products belonging to the animal or plant kingdom, and also viruses, bacteria and mycoplasmas and other pathogens;
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‘animals’
animals belonging to species normally fed and kept or consumed by man;
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‘placing on the market’
any supply, whether in return for payment or free of charge, other than for storage followed by consignment from the territory of the Community or disposal. Importation of a plant protection product into the territory of the Community shall be deemed to constitute placing on the market for the purposes of this Directive;
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‘authorization of a plant protection product’
administrative act by which the competent authority of a Member State authorizes, following an application submitted by an applicant, the placing on the market of a plant protection product in its territory or in a part thereof;
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‘environment’
water, air, land, wild species of fauna and flora, and any interrelationship between them, as well as any relationship with living organisms;
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‘integrated control’
the rational application of a combination of biological, biotechnological, chemical, cultural or plant-breeding measures whereby the use of chemical plant protection products is limited to the strict minimum necessary to maintain the pest population at levels below those causing economically unacceptable damage or loss.