(b)

the following Section 3.3 is added: ‘3.3. Sampling rules for sprouts For the purposes of this Section, the definition of batch in Article 2(b) of Implementing Regulation (EU) No 208/2013 will apply. A. General rules for sampling and testing 1. Preliminary testing of the batch of seeds Food business operators producing sprouts shall carry out a preliminary testing of a representative sample of all batches of seeds. A representative sample shall include at least 0,5 % of the weight of the batch of seeds in sub samples of 50 g or be selected based on a structured statistically equivalent sampling strategy verified by the competent authority. For the purposes of performing the preliminary testing, the food business operator must sprout the seeds in the representative sample under the same conditions as the rest of the batch of seeds to be sprouted. 2. Sampling and testing of the sprouts and the spent irrigation water Food business operators producing sprouts shall take samples for microbiological testing at the stage where the probability of finding Shiga toxin producing E. coli (STEC) and Salmonella spp. is the highest, in any case not before 48 hours after the start of the sprouting process. Samples of sprouts shall be analysed according to the requirements in rows 1.18 and 1.29 of Chapter 1. However, if a food business operator producing sprouts has a sampling plan, including sampling procedures and sampling points of the spent irrigation water, they may replace the sampling requirement under the sampling plans set out in rows 1.18 and 1.29 of Chapter 1 with the analysis of 5 samples of 200 ml of the water that was used for the irrigation of the sprouts. In that case requirements set out in rows 1.18 and 1.29 of Chapter 1 shall apply to the analysis of the water that was used for the irrigation of the sprouts, with the limit of absence in 200 ml. When testing a batch of seeds for the first time, food business operators may only place sprouts on the market if the results of the microbiological analysis comply with rows 1.18 and 1.29 of Chapter 1, or the limit of absence in 200 ml if they analyse spent irrigation water. 3. Sampling frequency Food business operators producing sprouts shall take samples for microbiological analysis at least once a month at the stage where the probability of finding Shiga toxin producing E. coli (STEC) and Salmonella spp. is the highest, in any case not before 48 hours after the start of the sprouting process. B. Derogation from the preliminary testing of all batches of seeds set out in point A.1 of this Section When justified on the basis of the following conditions and authorised by the competent authority, food business operators producing sprouts may be exempted from the sampling set out in point A.1 of this Section: (a) the competent authority is satisfied that the food business operator implements a food safety management system in that establishment, which may include steps in the production process, which reduces the microbiological risk; and, (b) historical data confirms that during at least 6 consecutive months prior to granting the authorisation, all batches of the different types of sprouts produced in the establishment comply with the food safety criteria set out in rows 1.18 and 1.29 of Chapter 1.’