LAW REPUBLIC OF MOLDOVA

of December 21, 2023 No. 403

About introduction on the market of remedies of plants and modification of some regulations

The Parliament adopts this organic law.

This law is partial transposition of Regulations (EU) No. 1107/2009 of the European parliament and Council of October 21, 2009 about placement in the market of products of protection of plants and recognition voided Directives 79/117/EEC and 91/414/EEC of Council (parts (1) and (3) Articles 1, of part (1) - (3) Articles 2, Items 1-6, 8-28 and 30-33 of Article 3, of part (2) - (4) and (7) Articles 4, Article 5, of part (1) and (2) Articles 14, of part (1) and (2) Articles 20, part (1) Articles 25, part (1) and Items a) - c) and e) parts (2) Articles 28, Article 29, of part (1) and (2) Articles 30, Article 31, Article 32, part (1), Items a) - c) parts (2), Items a) - g) parts (3), parts (4) and (6) Articles 33, Article 34, Article 36, parts (1) and (2) Articles 37, Article 38-43, of part (1) and (4) Articles 44, Article 45-57, of part (1) and (2) Articles 58, Article 59, parts (2) and (3) Articles 60, Article 61, parts (1) - (4) and (6) Articles 62, Article 63-74, of part (1), (2) and (4) Articles 75, Article 77, Article 78, parts (2) and (3) Articles 81, Article 82, and also appendix I and appendix IV), CELEX: 32009R1107, European Union published in the Official magazine L 309 of November 24, 2009, with the last amendments made by Regulations (EU) 2022/1438 Commissions of August 31, 2022.

Chapter I. General provisions

Article 1. Subject and purpose of this law

(1) This law establishes the main legal base and state policy in the sphere of activity connected with remedies of plants, regulations of permission and introduction on the market of remedies of the plants provided in commodity form regulates conditions of their permission, production, transportation, warehousing, realization and harmless to human health, health of animals and for the environment of use, the relations resulting from implementation of the state supervision and control of compliance with law in the field and also determines the rights and obligations of physical persons and legal entities, powers of competent authorities in the field.

(2) the Purpose of this law is ensuring high level of health protection of people and health of animals, for environmental protection, and also growth of efficiency of functioning of the domestic market by harmonization of regulations of introduction on the market of remedies of plants in case of simultaneous improvement of agricultural products.

Article 2. The basic principles of state policy in the sphere of activity connected so by remedies of plants

The basic principles of state policy in the sphere of activity connected with remedies of plants are:

a) the precaution excluding negative impact of the active ingredients and funds entered on the market for human health, health of animals or on the environment;

b) scientific reasons for decisions on permission and introduction on the market of remedies of plants;

c) growth of efficiency of functioning of the domestic market by harmonization of regulations of introduction on the market of remedies of plants in case of simultaneous improvement of agricultural products;

d) harmlessness for human health, health of animals, for the environment of remedies of plants in case of their production, approval, permission and application on condition of observance of the requirements established by phytosanitary regulations and other regulations;

e) carrying out single state policy in the field.

Article 3. Scope

(1) This law is applied to remedies of plants which consist of active ingredients, of antidotes or synergists or contain them in the form provided to the consumer and which are intended for one of the following types of use:

a) protection of plants or vegetable products of crop production against harmful organisms or prevention of action of such organisms, except for case when it is considered that main objective of use of appropriate means is mainly hygiene, but not protection of plants or vegetable products;

b) impact on the vital processes of plants, as the substances influencing growth of plants except fertilizers;

c) preservation of vegetable products in that measure in what the corresponding substances or products do not fall under action of special regulations on preservatives;

d) destruction of plants or their undesirable parts, except seaweed, except as specified, when are applied to protection of plants of means on the soil or in water;

e) control or prevention of undesirable growth of plants, except seaweed, except as specified, when are applied to protection of plants of means on the soil or in water.

(2) This law is applied to substances, including the microorganisms making general or specific impact on harmful organisms, on plants or some of their parts or on vegetable products (further - active ingredients).

(3) This law is applied to the following substances or medicines:

a) to antidotes;

b) to synergists;

c) to koformulyanta;

d) to adjuvants.

Article 4. Basic concepts

In this law the following concepts are used:

adjuvants - the substances or medicines consisting of the koformulyant or medicines containing one or several koformulyant in type in which they are delivered to the user and are entered on the market for subsequent their mixing by the user with remedy of plants and which increase efficiency or other properties of appropriate means;

antidotes - the substances or medicines added to remedy of plants for the purpose of elimination or decrease in the phytotoxic effect which had by remedy of plants on some plants;

synergists - substances or medicines which, though have insignificant or zero action in the field of application can strengthen effect of substance or active ingredients as a part of remedy of plants;

competent authority on development the politician - the central industry body to which development function the politician in the field of protection of plants is assigned;

competent authority on issue of permission - the state body operating in the mode of the public power for the purpose of accomplishment of the tasks established according to this law on issue of permissions for remedies of plants;

competent authority on realization the politician - the central administrative authority to which function of implementation of state policy in the field of protection of plants is assigned;

provision of permissions for remedies of plants - administrative process by means of which the competent authority on issue of permission provides permission to placement of remedy of plants in the market in the territory of the Republic of Moldova;

proper laboratory practice - the practice creating the quality system which determines procedure for the organization and condition of planning, carrying out, check, registration, archiving of not clinical trials regarding safety for health and for the environment and the reporting under them for the purpose of the allowing procedure;

proper experimental practice - the practice corresponding to the guidelines 152 and 181 of the European and Mediterranean organization for protection of plants which the Republic of Moldova joined based on the Law No. 16/2006;

proper phytosanitary practice - practice in case of which processing by the remedies of plants applied to specific plants or vegetable products in accordance with the terms of provision of permission to their use gets out, dosed and established on time for ensuring optimum efficiency in case of minimum necessary quantity taking into account local conditions and opportunities for agrotechnical and biological control of cultures and biological material;

category of danger - the Section of criteria in each class of danger (physical nature, for health or for the environment) with indication of its degree;

koformulyanta - substances or medicines which are used or are held for use as a part of remedy of plants or adjuvant, but are not either active ingredients, or antidotes, or synergists;

vulnerable group - the group of persons requiring special attention in case of assessment of serious and chronic consequences of remedies of plants for health. The corresponding group includes in need of pregnant women and the feeding women, children who are not given birth yet, chest and minor children, elderly people, and also persons who work and/or live nearby and are exposed to high and long impact of pesticides;

impurity - the component other than net active ingredient and/or its net option which is present at technical material (including the components formed in the course of production or as a result of decomposition during storage period);

introduction on the market - ownership for the purpose of realization, including the offer for sale or any other form of transfer, for a fee or gratuitously, and also sale, distribution or any other form of transfer as such, except for return to the previous seller. For the purposes of this law release in free circulation is one of introduction forms on the market;

the environment - waters (including underground, superficial, transitional, coastal and sea), ground deposits, the soil, air, lands, wild fauna and flora, and also interrelations between them and the relations with other live organisms;

metabolite - the product of degradation of active ingredient, antidote or synergist which is formed in organisms or in the environment. The metabolite is considered significant if there are bases to assume that properties inherent in it are comparable to properties of initial substance from the point of view of its biological target activities or that it represents for organisms risk which exceeds or is comparable to risk which represents initial substance or that it has certain toxicological properties which are considered as unacceptable. Such metabolite matters for the decision on approval or for determination of measures for decrease in risks;

not chemical methods - the alternative methods for remedies of plants of the chemical nature applied to protection of plants and fight against harmful organisms, based on agrotechnical acceptances or by physical, mechanical or biological methods of fight against harmful organisms;

microorganism - microbiological education, including the lowest mushroom or virus, cellular or noncellular, capable to reproduction or transfer of genetic material;

harmful organism - the type, strain or biotype belonging to fauna or flora or the pathogenic agent making harmful effects on plants or vegetable products;

the genetically modified organism - concept is used in the value determined by article 4 of the Law on regulation and control of genetically modified organisms No. 152/2022;

plants - live plants and parts of live plants, including fresh fruit, vegetables and seeds;

medicines - mixes or solutions which consist of two or more substances and held for use as remedies of plants or adjuvants;

the producer - person who makes remedies of plants, antidotes, synergists, koformulyanta or adjuvants independently or under the agreement signed with other party; person designated by the producer as his exclusive representative for the purpose of observance of this law;

vegetable products - products of plant origin which were not exposed to conversion or were exposed only to simple processing, such as crushing, drying or pressing, except for plants;

data protection - the temporary right of the owner of the report on testing or the report on researches on prevention of its use for the benefit of other applicant;

advertizing - the information on realization or use of remedies of plants distributed through printing or electronic mass media, intended for persons, others than the owner of permission, person entering on the market means of phytosanitary appointment and their agents;

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