121. In paragraph 2 (withdrawal periods)—
(a)for sub-paragraph (2) substitute—
“(2) The withdrawal period must ensure that—
(a)where there is a maximum residue limit established for the active substance for the treated species under Regulation (EC) No 470/2009 of the European Parliament and of the Council, the level of residue of the active substance does not exceed that limit; and
(b)where there is no maximum residue limit for the treated species established under Regulation (EC) No 470/2009 of the European Parliament and of the Council but one is established for the substance itself, the level of residue of the active substance does not exceed the level determined by reference to Commission Implementing Regulation (EU) 2018/470 on detailed rules on the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated in the EU under Article 11 of Directive 2001/82/EC(1).”;
(b)in sub-paragraph (3)—
(i)for paragraph (a) substitute—
“(a)for eggs—
(i)the longest withdrawal period in the summary of product characteristics for any species multiplied by a factor of 1.5; or
(ii)14 days, if the product is not authorised for animals producing eggs for human consumption;”;
(ii)for paragraph (b) substitute—
“(b)for milk—
(i)the longest withdrawal period in the summary of product characteristics for any species multiplied by a factor of 1.5;
(ii)7 days, if the veterinary medicinal product is not authorised for animals producing milk for human consumption; or
(iii)1 day, if the medicinal product has a zero-hour withdrawal period;”;
(iii)for paragraph (c) substitute—
“(c)for meat and offal from food-producing mammals, poultry and farmed game-birds—
(i)the longest withdrawal period provided in its summary of product characteristics for meat and offal, multiplied by a factor of 1.5;
(ii)28 days if the veterinary medicinal product is not authorised for food-producing animals; or
(iii)1 day, if the veterinary medicinal product has a zero-day withdrawal period;”;
(iv)for paragraph (d) substitute—
“(d)for aquatic species producing meat for human consumption—
(i)the longest withdrawal period for any of the aquatic species in the summary of product characteristics multiplied by a factor of 1.5 and expressed as degree-days;
(ii)if the medicinal product is authorised for food-producing terrestrial animal species, the longest withdrawal period for any of the food-producing animal species in the summary of product characteristics multiplied by a factor of 50 and expressed as degree-days; or
(iii)25 degree-days if the highest withdrawal period for any animal species is zero.”;
(c)after sub-paragraph (3) insert—
“(4) For the purposes of sub-paragraph (3)—
(a)if the calculation of a withdrawal period results in a fraction of days, the withdrawal period must be rounded to the nearest number of days, with any half of a day being rounded upwards;
(b)in relation to the calculation of the withdrawal period for milk, if the calculation of the period results in a milk withdrawal period not divisible by 12, the withdrawal period must be rounded up to the nearest multiple of 12 hours.”.
EUR 2018/470.