Commission Regulation (EU) No 544/2011 (repealed)Show full title

3. Further information on the active substance

(i) The information provided must describe the intended purposes for which preparations containing the active substance are used, or are to be used and the dose and manner of their use or proposed use.

(ii) The information provided must specify the normal methods and precautions to be followed, in the handling, storage and transport of the active substance.

(iii) The studies, data and information submitted, together with other relevant studies, data and information, must 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.

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

(v) The information and data referred to are required for all active substances, except where otherwise specified.

3.1. Function, e.g. fungicide, herbicide, insecticide, repellent, growth regulator

The function must be specified from among the following:

• acaricide

• bactericide

• fungicide

• herbicide

• insecticide

• molluscicide

• nematicide

• plant growth regulator

• repellent

• rodenticide

• semio-chemicals

• talpicide

• viricide

• other (must be specified).

3.2. Effects on harmful organisms, e.g. contact poison, inhalation poison, stomach poison, fungitoxic, etc. systematic or not in plants

3.2.1. The nature of the effects on harmful organisms must be stated:

• contact action

• stomach action

• inhalation action

• fungitoxic action

• fungistatic action

• desiccant

• reproduction inhibitor

• other (must be specified).

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

3.3. Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening

The field(s) of use, existing and proposed, for preparations containing the active substance must be specified from among the following:

• Field use, such as agriculture, horticulture, forestry and viticulture

• Protected crops

• Amenity

• Weed control on non-cultivated areas

• Home gardening

• House plants

• Plant products storage practice

• Other (specify).

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

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

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

3.4.3. Where relevant, effects achieved e.g. sprout suppression, retardation of ripening, reduction in stem length, enhanced fertilisation, etc. must be reported.

3.5. Mode of action

3.5.1. To the extent that is has elucidated, a statement must be provided as to the mode of action of the active substance in terms, where relevant, of the biochemical and physiological mechanism(s) and biochemical pathway(s) involved. Where available, the results of relevant experimental studies must be reported.

3.5.2. Where it is known that to exert its intended effect, the active substance must be converted to a metabolite or degradation product following application or use of preparations containing it, the following information, cross referenced to and drawing on information provided in the context of paragraphs 5.6, 5.11, 6.1, 6.2, 6.7, 7.1, 7.2 and 9, where relevant, must be provided for active metabolite or degradation product:

• chemical name in accordance with IUPAC and CA nomenclature,

• ISO common name or proposed common name,

• CAS EC-number EC (Einecs or ELINCS) number, and CIPAC number if available,

• empirical and structural formula, and

• molecular mass.

3.5.3. Available information relating to the formation of active metabolites and degradation products must be provided, to 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.

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

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

3.7. Recommended 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) must be provided for all active substances.

3.8. Procedures for destruction or decontamination

3.8.1. Controlled incineration

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.

Where the content of halogens of the active substance is greater than 60 %, the pyrolytic behaviour of the active substance under controlled conditions (including where relevant supply of oxygen and defined residence time), at 800 °C and the content of polyhalogenated dibenzo-p-dioxins and dibenzo-furans in the products of pyrolysis must be reported. The application must provide detailed instructions for safe disposal.

3.8.2. Others

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

3.9. Emergency measures in case of an accident

Procedures for the decontamination of water in case of an accident must be provided.

(1)

OJ L 396, 30.12.2006, p. 1.