Commission Regulation (EU) No 283/2013Dangos y teitl llawn

SECTION 3 Further information on the active substance

3.1. Use of the active substance

The information provided shall describe the intended purposes for which plant protection products containing the active substance are used, or are to be used and the dose and manner of their use or proposed use.

3.2. Function

The function shall be specified from among the following:

(a)

acaricide;

(b)

bactericide;

(c)

fungicide;

(d)

herbicide;

(e)

insecticide;

(f)

molluscicide;

(g)

nematicide;

(h)

plant growth regulator;

(i)

repellent;

(j)

rodenticide;

(k)

semio-chemical;

(l)

talpicide;

(m)

viricide;

(n)

other (shall be specified by the applicant).

3.3. Effects on harmful organisms

The nature of the effects on harmful organisms shall be stated:

(a)

contact action;

(b)

stomach action;

(c)

inhalation action;

(d)

fungitoxic action;

(e)

fungistatic action;

(f)

desiccant;

(g)

reproduction inhibitor;

(h)

other (shall be specified by the applicant).

It shall be stated whether or not the active substance is translocated in plants and where relevant whether such translocation is apoplastic, symplastic or both.

3.4. Field of use envisaged

The fields of use, existing and proposed, for plant protection products containing the active substance shall be specified from among the following:

(a)

field use, such as agriculture, horticulture, forestry and viticulture;

(b)

protected crops;

(c)

amenity;

(d)

weed control on non-cultivated areas;

(e)

home gardening;

(f)

house plants;

(g)

plant products storage practice;

(h)

other (shall be specified by applicant).

3.5. Harmful organisms controlled and crops or products protected or treated

Details of existing use and the intended use in terms of crops, groups of crops, plants, or plant products treated and where relevant protected shall be provided.

Where relevant, details of harmful organisms against which protection is afforded shall be provided.

Where relevant, effects achieved, such as sprout suppression, retardation of ripening, reduction in stem length, enhanced fertilisation shall be reported.

3.6. Mode of action

To the extent that it has been elucidated, a statement shall be provided as to the mode of action of the active substance in terms, where relevant, of the biochemical and physiological mechanisms and biochemical pathways involved. Where available, the results of relevant experimental studies shall be reported.

Where it is known that to exert its intended effect, the active substance has to be converted to a metabolite or breakdown product following application or use of plant protection products containing it, the following information shall be provided for active metabolite or breakdown products:

(a)

chemical name in accordance with IUPAC and CA nomenclature;

(b)

ISO common name or proposed common name;

(c)

CAS-number EC number;

(d)

molecular and structural formula; and

(e)

molar mass.

The information referred to in points (a) to (e) shall be cross referenced to and drawing on information provided under Sections 5 to 8, where relevant.

Available information relating to the formation of active metabolites and breakdown products shall be provided. Such information shall include:

• the processes, mechanisms and reactions involved,

• kinetic and other data concerning the rate of conversion and if known the rate limiting step,

• environmental and other factors effecting the rate and extent of conversion.

3.7. Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies

Where available, information on the occurrence or possible occurrence of the development of resistance or cross-resistance shall be provided.

Appropriate risk management strategies shall be addressed for national/regional areas.

3.8. Methods and precautions concerning handling, storage, transport or fire

A safety data sheet pursuant to Article 31 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(1) shall be provided for all active substances.

The studies, data and information submitted, together with other relevant studies, data and information, shall both specify and justify the methods and precautions to be followed in the event of fire. The possible products of combustion in the event of fire shall be estimated, based on the chemical structure and the chemical and physical properties of the active substance.

3.9. Procedures for destruction or decontamination

In many cases the preferred or sole means to safely dispose of active substances, contaminated materials, or contaminated packaging is through controlled incineration in a licensed incinerator. Such incineration shall be carried out in accordance with the criteria set out in Council Directive 94/67/EC(2).

Other methods to dispose of the active substance, contaminated packaging and contaminated materials, where proposed, shall be fully described. Data shall be provided for such methods, to establish their effectiveness and safety.

3.10. Emergency measures in case of an accident

Procedures for the decontamination of water and soil in case of an accident shall be provided.

The studies, data and information submitted, together with other relevant studies, data and information, shall demonstrate the suitability of measures proposed for use in emergency situations.

(1)

OJ L 396, 30.12.2006, p. 1.

(2)

OJ L 365, 31.12.1994, p. 34.