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Commission Regulation (EU) No 284/2013Show full title

Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)

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SECTION 2 U.K. Physical, chemical and technical properties of the plant protection product

The extent to which plant protection products for which authorisation is sought, comply with relevant FAO/WHO specifications, shall be stated. Divergences from these specifications shall be described in detail, and justified by the applicant.

2.1. Appearance U.K.

A description of the colour and of the physical state of the plant protection product shall be provided.

2.2. Explosive and oxidising properties U.K.

The explosive and oxidising properties of plant protection products shall be determined and reported. A theoretical estimation based on structure shall be accepted if it meets the criteria set out in Appendix 6 of the United Nations’ Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria(1).

2.3. Flammability and self-heating U.K.

The flash point of liquids which contain flammable solvents shall be determined and reported. The flammability of solid plant protection products and gases shall be determined and reported. A theoretical estimation based on structure shall be accepted if it meets the criteria set out in Appendix 6 of the United Nations’ Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria.

The self-heating shall be determined and reported.

2.4. Acidity/alkalinity and pH value U.K.

In the case of aqueous plant protection products, the pH value of the neat plant protection product shall be determined and reported.

In the case of solid and non-aqueous liquid plant protection products which are to be applied as aqueous dilutions the pH of a 1 % dilution of the plant protection product shall be determined and reported.

In the case of plant protection products which are acidic (pH < 4) or alkaline (pH > 10) the acidity or alkalinity shall be determined and reported.

2.5. Viscosity and surface tension U.K.

For liquid formulations the viscosity shall be determined at two shear rates and at 20°C and 40°C and reported together with the test conditions. The surface tension shall be determined at the highest concentration.

For liquid plant protection products containing ≥10 % hydrocarbons and for which the kinematic viscosity is less than 7 × 10– 6 m2/sec at 40 °C the surface tension of the neat formulation shall be determined at 25 °C and reported.

2.6. Relative density and bulk density U.K.

The relative density of liquid plant protection products shall be determined and reported.

The bulk density (pour and tap) of plant protection products which are powders or granules shall be determined and reported.

2.7. Storage stability and shelf-life: effects of temperature on technical characteristics of the plant protection product U.K.

The stability of the plant protection product after accelerated storage for 14 days at 54 °C shall be determined and reported. Data generated from alternative time/temperature combinations (for example 8 weeks at 40 °C, 12 weeks at 35 °C or 18 weeks at 30 °C) may be submitted as alternative accelerated storage data. Consideration shall be given to performing this test in packaging made of the same material as the commercial packaging.

If the active substance content after the heat stability test has decreased by more than 5 % from the initial value, then information on the breakdown products shall be supplied.

For liquid plant protection products, the effect of low temperatures on stability shall be determined and reported.

The shelf life of the plant protection product at ambient temperature shall be determined and reported. Where shelf life is less than two years, the shelf life in months, with appropriate temperature specifications, shall be reported. The ambient temperature stability test shall be performed in packaging made of the same material as the commercial packaging. Where appropriate, data on the content of relevant impurities, before and after storage, shall be provided.

2.8. Technical characteristics of the plant protection product U.K.

The technical characteristics of the plant protection product shall be determined and reported at appropriate concentrations.

2.8.1. Wettability U.K.

The wettability of solid plant protection products, which are diluted for use shall be determined and reported.

2.8.2. Persistent foaming U.K.

The persistence of foaming of plant protection products to be diluted with water shall be determined and reported.

2.8.3. Suspensibility, spontaneity of dispersion and dispersion stability U.K.

The suspensibility and the spontaneity of dispersion of water dispersible products shall be determined and reported.

The dispersion stability of plant protection products such as aqueous suspo-emulsions (SE), oil-based suspension concentrates (OD) or emulsifiable granules (EG) shall be determined and reported.

2.8.4. Degree of dissolution and dilution stability U.K.

The degree of dissolution and the dilution stability of water soluble products shall be determined and reported.

2.8.5. Particle size distribution, dust content, attrition and mechanical stability U.K.
2.8.5.1. Particle size distribution U.K.

In the case of water dispersible products, a wet sieve test shall be conducted and reported.

The size distribution of particles in the case of powders and suspension concentrates shall be determined and reported.

The nominal size range of granules shall be determined and reported.

2.8.5.2. Dust content U.K.

The dust content of granular plant protection products shall be determined and reported.

If results show > 1 % w/w dust then the particle size of the dust generated shall be determined and reported.

2.8.5.3. Attrition U.K.

The attrition characteristics of granules and tablets which are loose packed shall be determined and reported.

2.8.5.4. Hardness and integrity U.K.

The hardness and integrity of tablets shall be determined and reported.

2.8.6. Emulsifiability, re-emulsifiability, emulsion stability U.K.

The emulsifiability, emulsion stability and re-emulsifiability of plant protection products, which exist as emulsions in the spray tank, shall be determined and reported.

2.8.7. Flowability, pourability and dustability U.K.

The following characteristics shall be determined and reported:

  • the flowability of granular plant protection products,

  • the pourability of suspensions, and

  • the dustability of dustable powders following accelerated storage according to point 2.7.

2.9. Physical and chemical compatibility with other products including plant protection products with which its use is to be authorised U.K.

The physical and chemical compatibility of recommended tank mixes shall be determined and reported. Known non-compatibility shall be reported.

2.10. Adherence and distribution to seeds U.K.

In the case of plant protection products for seed treatment, both distribution and adhesion shall be determined and reported.

2.11. Other studies U.K.

Supplementary studies necessary for the classification of the plant protection product by hazard shall be carried out in accordance with Regulation (EC) 1272/2008.

(1)

United Nations New York and Geneva (2009) Publication ISBN 978-92-1-139135-0.

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