Division SECTION E Specific conditions applicable to the production, placing on the market and use of milk replacers containing fishmeal for the feeding of unweaned ruminantsF1

The following specific conditions shall apply to the production, placing on the market and use of milk replacers containing fishmeal in the feeding of unweaned farmed animals of the ruminant species:

1. (a)

   F2the fishmeal used in milk replacers shall be produced in processing plants dedicated exclusively to the production of products derived from:

   1. (i)

      aquatic animals, except sea mammals;

   2. (ii)

      farmed aquatic invertebrates other than those that fall within the definition of ‘ aquatic animals ’ provided for in Article 3(1)(e) of Directive 2006/88/EC; or

   3. (iii)

      starfish of the species Asterias rubens which are harvested in a production area as defined in Annex I point 2.5 of Regulation (EC) No 853/2004 and classified accordingly.

   The fishmeal used in milk replacers shall comply with general conditions laid set out in Chapter III.

2. (b)

   F3the words ‘ fishmeal — shall not be used in feed for ruminants except unweaned ruminants ’ shall be clearly indicated on the accompanying commercial document or health certificate referred to in Article 21(2) of Regulation (EC) No 1069/2009, as appropriate, as well as the label of fishmeal intended to be used in milk replacers;

3. (c)

   the use of fishmeal for unweaned farmed animals of the ruminant species shall only be authorised for the production of milk replacers, distributed in dry form and administered after dilution in a given quantity of liquid, intended for the feeding of unweaned ruminants as a supplement to, or substitute for, post-colostral milk before weaning is complete;

4. (d)

   milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species shall be produced in establishments which do not produce other compound feed for ruminants and which are authorised for this purpose by the competent authority.

   By way of derogation from that special condition, the production of other compound feed for ruminants in establishments which also produce milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species may be authorised by the competent authority, following an on-site inspection, subject to compliance with the following conditions:

   1. (i)

      other compound feed destined for ruminants must be kept in facilities that are physically separate from those used for bulk fishmeal and bulk milk replacers containing fishmeal during storage, transport and packaging;

   2. (ii)

      other compound feed destined for ruminants must be manufactured in facilities that are physically separate from facilities where milk replacers containing fishmeal are manufactured;

   3. (iii)

      records detailing the purchases and uses of fishmeal and the sales of milk replacers containing fishmeal must be kept available to the competent authority for a period of at least five years;

   4. (iv)

      regular sampling and analysis of the other compound feed destined for ruminants must be carried out in order to verify the absence of unauthorised constituents of animal origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of such sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles; the results must be kept available to the competent authority for a period of at least five years;

5. (e)

   before release F4..., importers shall ensure that each consignment of imported milk replacers containing fishmeal is analysed in accordance with methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009 in order to verify the absence of unauthorised constituents of animal origin;

6. (f)

   The label of milk replacers containing fishmeal, intended for unweaned farmed animals of the ruminant species, must be clearly marked with the words ‘ contains fishmeal — shall not be fed to ruminants except unweaned ruminants ’ ;

7. (g)

   bulk milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively for the transport or storage of other feed intended for ruminants.

   By way of derogation from that special condition, vehicles, containers and storage facilities which will be subsequently used for the transport or storage of other bulk feed intended for ruminants may be used for the transport or storage of bulk milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species provided that they have been cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented record of such use shall be kept available to the competent authority for a period of at least two years;

8. (h)

   on farms where ruminants are kept, on-farm measures shall be in place to prevent milk replacers containing fishmeal being fed to other ruminants than unweaned ruminants. The competent authority shall establish a list of farms where milk replacers containing fishmeal are used through a system of prior notification by the farm or another system thereby ensuring compliance with this specific condition.