Annex I to Directive 2008/38/EC is amended as follows:
In Part A, the following point is added:
10.
When a feed intended for particular nutritional purposes is placed on the market in the form of a bolus, being a feed material or complementary feed intended for individual oral administration by forced feeding, the label of the feed shall, if applicable, mention the maximum period of continuously release of the bolus and the daily release rate for each additive for which a maximum content in complete feed is fixed. At the request of the competent authority the feed business operator which is placing a bolus on the market shall provide proof that the daily available additive level in the digestive tract will not exceed, if applicable, the maximum content of the additive established per kg complete feed during the whole feeding period (slow release effect). It is recommended that feed in form of bolus is administered by a veterinarian or any other competent person.
Part B is amended as follows:
| Particular nutritional purpose | Essential nutritional characteristics | Species or category of animal | Labelling declarations | Recommended length of time | Other provisions |
|---|
The following row is inserted between the row of the particular nutritional purpose ‘Regulation of lipid metabolism in the case of hyperlipidaemia’ and the row of the particular nutritional purpose ‘Reduction of copper in the liver’:
| Reduction of iodine levels in feed in case of hyperthyroidism | Restricted level of iodine: maximum 0,26 mg/kg complete pet food with a moisture content of 12 % | Cats | Total iodine | Initially up to 3 months | Indicate on the labelling: “It is recommended that advice from a veterinarian be sought before use and before extending the period of use” |
The row of the particular nutritional purpose ‘Nutritional restoration, convalescence’, species or category of animals: ‘dogs and cats’, is replaced by the following:
|
The manufacturer may complete the particular nutritional purpose with a reference to “Feline hepatic lipidosis”.’
|
| ‘Nutritional restoration, convalescence
| High energy density, high concentrations of essential nutrients and highly digestible ingredients | Dogs and cats |
Highly digestible ingredients, including their treatment if appropriate
Energy value
Content of n-3 and n-6 fatty acids (if added)
| Until restoration is achieved | In the case of feed specially presented to be given via tubing, indicate on the labelling: “Administration under veterinary supervision.” |
|
Enterococcus faecium DSM 10663 / NCIMB 10415 (E1707)
The complementary feed may contain feed additives of the functional group of “gut flora stabilisers” in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
| Dogs | Name and added amount of the gut flora stabiliser | 10 to 15 days |
The instructions for use of the feed shall ensure that the legal maximum content of the gut flora stabiliser for complete feed is respected.
Indicate on the labelling: “It is recommended that advice from a veterinarian be sought before use and before extending the period of use.”
|
The row of the particular nutritional purpose ‘Stabilisation of physiological digestion’ is replaced by the following:
| Stabilisation of physiological digestion | Low buffering capacity, and highly digestible ingredients | Piglets |
Highly digestible ingredients including their treatment if appropriate
Buffering capacity
Source(s) of astringent substances (if added)
Source(s) of mucilaginous substances (if added)
| 2 to 4 weeks |
Indicate on the labelling:
“In case of risk of, during periods of, or recovery from, digestive disturbance.”
|
| Highly digestible ingredients | Pigs |
Highly digestible ingredients including their treatment if appropriate
Source(s) of astringent substances (if added)
Source(s) of mucilaginous substances (if added)
|
|
Feed additives of the functional group “Gut flora stabiliser” of the category “zootechnical additives” as referred to in Annex I to Regulation (EC) No 1831/2003.
The complementary feed may contain feed additives of the functional group of “gut flora stabilisers” in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
| Animal species for which the gut flora stabiliser is authorised | Name and added amount of the gut flora stabiliser | Up to 4 weeks |
Indicate on the labelling of the feed:
“In case of risk of, during periods of, or recovery from digestive disturbance.”
If applicable: “The feed contains a gut flora stabiliser in a concentration above 100 times the authorised maximum content in complete feed.”
The instructions for use of the feed shall ensure that the legal maximum content of the gut flora stabiliser for complete feed is respected.
|
The following rows are inserted between the row of the particular nutritional purpose ‘Reduction of the risk of acidosis’ and the row for the particular nutritional purpose ‘Stabilisation of water and electrolyte balance’:
| Long-term supply of grazing animals with trace elements and/or vitamins |
High level of
Trace elements
and/or
vitamins, provitamins and chemically well-defined substances having similar effects.
The complementary feed may contain feed additives in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
| Ruminants with a functional rumen |
Names and total amounts of each added trace element, vitamin, provitamin and chemically well-defined substance having similar effects.
Daily release rate for each trace element and/or vitamin if a bolus is used;
Maximum period of continuously release of the trace element or vitamin if a bolus is used.
| Up to 12 months |
Application in the form of bolus is allowed. A bolus may contain up to 20 % iron in an inert, non-bioavailable form, in order to increase its density.
Indicate on the labelling of the feed:
Simultaneous supplementation of additives with a maximum content from other sources to those incorporated in a bolus, if applicable, shall be avoided.
Before using, it is recommended to have advice from a veterinarian or nutritionist concerning:
the balance of trace elements in the daily ration;
the trace elements status of the herd
The bolus contains x % inert iron in order to increase its density, if applicable.
|
| Compensation for insufficient iron availability after birth |
High level of iron compounds authorised under the functional group “compounds of trace elements” of the category “nutritional additives” as referred to in Annex I to Regulation (EC) No 1831/2003.
The complementary feed may contain iron in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
| Suckling piglets and calves | Total iron content | After birth up to 3 weeks | The instructions for use for the feed shall ensure that the legal maximum contents of iron for complete feed are respected. |
| Support the regeneration of hooves, trotters and skin |
High level of zinc.
The complementary feed may contain zinc in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
| Horses, ruminants and pigs |
Total amount of
zinc
methionine
| Up to 8 weeks | The instructions of use for the feed shall ensure that the legal maximum contents of zinc for complete feed are respected. |
| Support the preparation for oestrus and reproduction |
High level of selenium and
a minimum content of vitamin E per kg complete feed with a moisture content of 12 % for pigs of 53 mg, rabbits of 35 mg, for dogs, cats, mink of 88 mg;
a minimum content of vitamin E per animal and day for ovines of 100 mg, cattle of 300 mg, horses of 1 100 mg
or
High level(s) of vitamins A
and/or vitamin D and/or a
minimum content of beta- carotene of 300 mg per animal and day.
The complementary feed may contain selenium, vitamin A and D in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
| Mammals | Names and total amounts of each added trace element and vitamin. |
Cows: 2 weeks before the end of gestation until the next gestation is confirmed.
Sows: 7 days before until 3 days after parturition and 7 days before until 3 days mating.
Other female mammals: from the last part of gestation until the next gestation is confirmed.
Males: during periods of reproductive activity.
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The instructions of use for the feed shall ensure that the respective legal maximum contents for complete feed are respected.
Indicate on the labelling of the feed:
“Guidance on the situations in which the use of the feed is appropriate.”
|
|
High level(s) of vitamin A and/or vitamin D
or
High level(s) of selenium and/or zinc and/or a minimum content of vitamin E of 44 mg/kg complete feed with a moisture content of 12 %.
The complementary feed may contain selenium, zinc, vitamin A and D in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
| Birds | Names and total amounts of each added trace element and vitamin. |
For females: during oestrus
For males: during periods of reproductive activity
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The following row is inserted between the row of the particular nutritional purpose ‘Compensation of electrolyte loss in the cases of heavy sweating’ and the row of the particular nutritional purpose ‘Nutritional restoration, convalescence’, species or category of animals: ‘equidae’:
| Support the preparation for and recovery from sport effort |
High level of selenium and a minimum content of 50 mg vitamin E per kg complete feed with moisture content of 12 %.
The complementary feed may contain compounds of selenium in a concentration higher than 100 times the relevant fixed maximum content in complete feed.
| Equidae |
Total amount of
vitamin E
selenium.
| Up to 8 weeks before sport effort – Up to 4 weeks after sport effort | The instructions for use for the feed shall ensure that the legal maximum contents of selenium for complete feed are respected. |