Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, 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) (c. 283)

ANNEX U.K.

PART A U.K. CHEMICAL ACTIVE SUBSTANCES

SECTION 7 U.K. Fate and behaviour in the environment

7.1. Fate and behaviour in soil U.K.

7.1.3. Adsorption and desorption in soil U.K.

7.1.3.1. Adsorption and desorption U.K.

The information provided, together with other relevant data, shall be sufficient to establish the adsorption coefficient of the active substance and of its metabolites, breakdown and reaction products.

7.1.3.1.1. Adsorption and desorption of the active substance U.K.

Circumstances in which required U.K.

Studies on adsorption and desorption of the active substance shall be provided, except where the nature and manner of use of plant protection products containing the active substance preclude soil contamination such as indoor uses on stored products or brush applied wound healing treatments for trees.

Test conditions U.K.

Studies on the active substance shall be reported for at least four soils.

Where the batch equilibrium method cannot be applied due to fast degradation, methods such as studies with short equilibration times, QSPR (Quantitative Structure Property Relationship) or the HPLC (High-Performance Liquid Chromatography) method shall be considered as possible alternatives. Where the batch equilibrium method cannot be applied due to weak adsorption, column leaching studies (see point 7.1.4.1) shall be considered as an alternative.

7.1.3.1.2. Adsorption and desorption of metabolites, breakdown and reaction products U.K.

Circumstances in which required U.K.

Studies on adsorption and desorption shall be provided for all metabolites, breakdown and reaction products, for which in soil degradation studies one of the following conditions is fulfilled:

(a)

they account for more than 10 % of the amount of active substance added, at any time during the studies;

(b)

they account for more than 5 % of the amount of active substance added in at least two sequential measurements;

(c)

the maximum of formation is not reached at the end of the study but accounts for at least 5 % of the active substance at the final measurement;

(d)

all metabolites found in lysimeter studies at annual average concentrations exceeding 0,1 μg/L in the leachate.

Test conditions U.K.

Studies on metabolites, breakdown and reaction products shall be provided for at least three soils.

Where the batch equilibrium method cannot be applied due to fast degradation, methods such as studies with short equilibration times, QSPR or the HPLC method shall be considered as an alternative. Where the batch equilibrium method cannot be applied due to weak adsorption, column leaching studies (see point 7.1.4.1) shall be considered as an alternative.

7.1.3.2. Aged sorption U.K.

As a higher tier option, information on aged sorption may be provided.

Circumstances in which required U.K.

The need to carry out a study on aged sorption shall be discussed with the national competent authorities.

Test conditions U.K.

In absence of guidance being included in the list referred to under point 6 of the introduction, the type and conditions of the study to be performed shall be discussed with the national competent authorities. The influence on the rate of degradation shall also be considered. Aged sorption data shall be compatible with the model in which those values will be used.