# Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance), Division 2.5.1: Fate and distribution in the environment

Extent: E+W+S+N.I.

In the evaluation of the fate and distribution of the plant protection product in the environment, competent authorities shall have regard to all aspects of the environment, including biota, and in particular to the following:
2.5.1.1.Competent authorities shall evaluate the possibility of the plant protection product reaching the soil under the proposed conditions of use; if this possibility exists they shall estimate the rate and the route of degradation in the soil, the mobility in the soil and the change in the total concentration (extractable and non-extractable of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the soil in the area of envisaged use after use of the plant protection product in accordance with the proposed conditions of use.
This evaluation shall take into consideration the following information:
(i)the specific information on fate and behaviour in soil as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof;
(ii)other relevant information on the active substance such as:
molecular weight,
solubility in water,
octanol/water partition coefficient,
vapour pressure,
volatilisation rate,
dissociation constant,
photodegradation rate and identity of breakdown products,
hydrolysis rate in relation to pH and identity of breakdown products;
(iii)all information on the plant protection product as provided for in the Annex to Regulation (EU) No 545/2011, including the information on distribution and dissipation in soil;
(iv)where relevant, other authorised uses of plant protection products in the area of proposed use containing the same active substance or which give rise to the same residues.
2.5.1.2.Competent authorities shall evaluate the possibility of the plant protection product reaching the groundwater under the proposed conditions of use; if this possibility exists, they shall estimate, using a suitable validated calculation model, the concentration of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the groundwater in the area of envisaged use after use of the plant protection product in accordance with the proposed conditions of use.
As long as there is no validated ... calculation model, competent authorities shall base their evaluation especially on the results of mobility and persistence in soil studies as provided for in the Annex to Regulation (EU) No 544/2011 and Regulation (EU) No 545/2011.
This evaluation shall also take into consideration the following information:
(i)the specific information on fate and behaviour in soil and water as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof;
(ii)other relevant information on the active substance such as:
molecular weight,
solubility in water,
octanol/water partition coefficient,
vapour pressure,
volatilisation rate,
hydrolysis rate in relation to pH and identity of breakdown products,
dissociation constant;
(iii)all information on the plant protection product as provided for in the Annex to Regulation (EU) No 545/2011, including the information on distribution and dissipation in soil and water;
(iv)where relevant, other authorised uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues;
(v)where relevant, data on dissipation including transformation and sorption in the saturated zone;
(vi)where relevant, data on the procedures for drinking water abstraction and treatment in the area of envisaged use;
(vii)where relevant, monitoring data on the presence or absence of the active substance and relevant metabolites, degradation or reaction products in groundwater as a result of previous use of plant protection products containing the same active substance or which give rise to the same residues; such monitoring data shall be interpreted in a consistent scientific way.
2.5.1.3.Competent authorities shall evaluate the possibility of the plant protection product reaching surface water under the proposed conditions of use; if this possibility exists they shall estimate, using a suitable validated calculation model, the short-term and long-term predicted concentration of the active substance and of metabolites, degradation and reaction products that could be expected in the surface water in the area of envisaged use after use of the plant protection product in accordance with the proposed conditions of use.
If there is no validated ... calculation model, competent authorities shall base their evaluation especially on the results of mobility and persistence in soil studies and the information on run-off and drift as provided for in the Annex to Regulation (EU) No 544/2011 and to Regulation (EU) No 545/2011.
This evaluation shall also take into consideration the following information:
(i)the specific information on fate and behaviour in soil and water as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof;
(ii)other relevant information on the active substance such as:
molecular weight,
solubility in water,
octanol/water partition coefficient,
vapour pressure,
volatilisation rate,
hydrolysis rate in relation to pH and identity of breakdown products,
dissociation constant;
(iii)all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 545/2011, including the information on distribution and dissipation in soil and water;
(iv)possible routes of exposure:
drift,
run-off,
overspray,
discharge via drains,
leaching,
deposit in the atmosphere;
(v)where relevant, other authorised uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues;
(vi)where relevant, data on the procedures for drinking water abstraction and treatment in the area of envisaged use.
2.5.1.4.Competent authorities shall evaluate the possibility of the plant protection product being dissipated in the air under the proposed conditions of use; if this possibility exists they shall make the best possible estimation, using where appropriate a suitable, validated calculation model, of the concentration of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the air after use of the plant protection product in accordance with the proposed conditions of use.
This evaluation shall take into consideration the following information:
(i)the specific information on fate and behaviour in soil, water and air as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof;
(ii)other relevant information on the active substance such as:
vapour pressure,
solubility in water,
hydrolysis rate in relation to pH and identity of breakdown products,
photochemical degradation in water and air and identity of breakdown products,
octanol/water partition coefficient;
(iii)all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 545/2011, including the information on distribution and dissipation in air.
2.5.1.5.Competent authorities shall evaluate the procedures for destruction or decontamination of the plant protection product and its packaging.

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Source: https://www.legislation.gov.uk/eur/2011/546/annex/part/I/division/B/division/2/division/2.5/division/2.5.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-546/annex/part-I/division-B/division-2/division-2.5/division-2.5.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.