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Regulatory
Consequences of the classification of substances and products
used in animal nutrition |
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Processing
aids are defined by Regulation No
1831/2003: |
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Processing
aids do not need to undergo a pre-marketing authorisation
to be placed on the market. No specific labelling
rules shall be applied. |
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The
handling and transport of processing aids are regulated by Directive 67/548 and Directive 1999/45 on dangerous
substances and preparations: |
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For
processing aids classified as dangerous according to these legislations,
additional labelling information is needed on the
bags. These labelling requirements are related to
safety signs, risk sentences and safety sentences. Application of these labelling requirements will also lead to specific rules
for transport (ADR) and storage of goods. |
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Veterinary substances are regulated by Directive 2001/82: |
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Veterinary substances can only be placed on the market following
a pre-marketing authorisation, given after a
through risk assessment and risk management of the substance. Veterinary substances can only be administered to the animals
after having been prescribed by a veterinarian. Veterinary substances can only be placed on the market if their
packaging is bearing the relevant labelling
information and that the package insert is appropriately filled in (Title V
of the Directive) In its Title VI, the Directive determines the rules for the
possession, distribution and dispensing of veterinary substances |
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The handling and transport of veterinary substances are
regulated by Directive 67/548 and Directive 1999/45 on dangerous
substances and preparations: |
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For veterinary substances classified as dangerous according to
these legislations, additional labelling information is needed on the
bags. These labelling requirements are related to
safety signs, risk sentences and safety sentences. Application of
these labelling requirements will also lead to
specific rules for transport (ADR) and storage of
goods. |
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A preparation of feed additive is a formulation containing the
additive active substance(s) in a form which can be used for animal nutrition
(e.g. coated vitamins, coated enzymes…). |
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Additive Active Substances/Preparations of feed additives are
regulated by Regulation No 1831/2003: |
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Before placing an additive active substance on the market, this
regulation requires them to be included in a positive list following a risk
assessment and risk management procedure (Article 4 of the Regulation). |
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- In the case of feed additives authorised
with a link to a specific holder of the authorisation,
the preparation of feed additives correspond to the authorised
products. - In the case of feed additives not authorised
with a link to a specific authorisation holder, the
additive active substance shall be authorised with
specific conditions for use. Then any preparation of the additive active
substance can be placed on the market under the conditions established in the
register entry related to the active substance. |
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Furthermore, the Article 16 of this regulation imposes labelling particulars to be used for customer information
and traceability follow up. Some additive active substances/preparations of feed additives
may be authorised under the conditions that a
post-market monitoring is being set by the European Commission after proposal
from the applicant. The applicant shall ensure proper implementation of the
post-market monitoring plan. |
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The manufacture and use of additive active
substances/preparations of feed additives are regulated by Regulation No 183/2005: |
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This regulation imposes quality requirements for the production
of the additive active substances/preparations of feed additives as well as
the implementation of HACCP principles. In addition, for most of the additive
active substances/preparations of feed additives placed on the market an
approval system (linked to the pre-operating inspection for new sites and
regular inspections for existing sites) is in place. |
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The handling and transport of additive active
substances/preparations of feed additives are regulated by Directive 67/548 and Directive 1999/45 on dangerous
substances and preparations: |
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For additive active substances/preparations of feed additives
classified as dangerous according to these legislations, additional labelling information is needed on the bags. These labelling requirements are related to safety signs, risk
sentences and safety sentences. Application of these labelling
requirements will also lead to specific rules for transport (ADR) and storage
of goods. |
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The use of other ingredients in feed additives preparations is
regulated by Regulation No 1831/2003
(for feed additives used in the preparation – e.g. antioxidants) or by Directive 2002/32 (for feed materials
used as carriers – e.g. starch) |
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Preparations of feed additives are aiming at facilitating the
use of an additive active substance in animal nutrition. Preparations of feed
additives contain other ingredients than the additive active substance. In
general, two types of ingredients are used: |
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- feed additives for preservation or anti-oxidation. These
additives should be authorised for the use
according to Regulation No 1831/2003 (see above) - carriers: these carriers should comply with the regulatory
framework of feed materials (see below) |
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Feed Materials are regulated by Directive 96/25: |
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Directive 96/25 regulates the marketing of feed materials,
including the labelling conditions. |
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Specific feed materials are regulated by Directive 82/471 |
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Directive 82/471 is applicable for products acting as direct or
indirect protein sources and are manufactured by
specific processes. This Directive defines a procedure for evaluation and
registration of these products. Furthermore, this Directive regulates the
marketing of those protein sources, including the labelling
conditions. |
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The manufacture and use of feed materials are regulated by Regulation No 183/2005: |
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The production of raw agricultural products is considered by
Regulation No 183/2005 is considered as primary production of feed and the
requirements are listed in the Annex I of that regulation. The production and
use of other feed material is linked to the implementation of the
requirements defined in Annex II of the Regulation No 183/2005. |
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The use of feed material of animal origin is regulated by Regulation No 999/2001 and Regulation No 1774/2002 |
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The use of feed material of animal origin is normally prohibited
in animal nutrition. However the Regulation No 999/2001 defines some
exemption of use of certain products of animal origin (e.g. non ruminant gelatine, milk and egg products). Furthermore, this
regulation limits the intra-species use of certain material of animal origin.
Regulation No 1774/2003 defines the production rules for certain products of
animal origin to be used in animal nutrition. In addition, this Regulation
sets the requirements of pre-operation approval of the manufacturing site and
the provision of an authorisation number to be
given to each production site. According to this regulation, only category 3
materials (i.e. products fit for human consumption) can be used for the
production of animal by-products to be used in animal nutrition. |
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Veterinary products are regulated by Directive 2001/82: |
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Veterinary products can only be placed on the market following a
pre-marketing authorisation, given after a through
risk assessment and risk management of the product (including active
substances and other components). |
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Veterinary products can only be placed on the market after
having been prescribed by a veterinarian. Veterinary substances can only be placed on the market if their
packaging is bearing the relevant labelling
information and that the package insert is appropriately filled in (Title V
of the Directive) In its Title VI, the Directive determines the rules for the
possession, distribution and dispensing of veterinary substances |
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The handling and transport of veterinary substances are
regulated by Directive 67/548 and Directive 1999/45 on dangerous
substances and preparations: |
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For veterinary substances classified as dangerous according to
these legislations, additional labeling information is needed on the bags.
These labelling requirements are related to safety
signs, risk sentences and safety sentences. Application of these labelling requirements will also lead to specific rules
for transport (ADR) and storage of goods. |
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Premixtures are regulated by Regulation No 1831/2003: |
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Premixtures being placed on the
market shall only contain authorised feed additives
according to Regulation No 1831/2003 for the animal species and category
concerned. The Article 16 of this regulation imposes labelling
particulars to be used for customer information and traceability follow up. |
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The manufacture and use of premixtures
are regulated by Regulation No
183/2005: |
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This regulation imposes quality requirements for the production
of the premixtures as well as the implementation of
HACCP principles. In addition, for premixtures
containing certain feed additives, the operators placing them on the market
should be approved (linked to the pre-operating inspection for new sites and
regular inspections for existing sites). |
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The handling and transport of premixtures
are regulated by Directive 67/548
and Directive 1999/45 on dangerous
substances and preparations: |
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For premixtures classified as
dangerous according to these legislations, additional labelling
information is needed on the bags. These labelling
requirements are related to safety signs, risk sentences and safety
sentences. Application of these labelling
requirements will also lead to specific rules for transport (ADR) and storage
of goods. |
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Compound feed are regulated by Directive 79/373: |
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Compound feed shall be produced and labelled
in accordance with this legislation. |
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The manufacture and use of compound feeds are regulated by Regulation No 183/2005: |
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This regulation imposes quality requirements for the production
of the compound feeds as well as the implementation of HACCP principles. In
addition, for compound feeds containing certain feed additives, the operators
placing them on the market should be approved (linked to the pre-operating
inspection for new sites and regular inspections for existing sites). |
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Complete feeds are regulated by Directive 79/373: |
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Complete feeds shall be produced and labelled
in accordance with this legislation. |
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The manufacture and use of complete feeds are regulated by Regulation No 183/2005: |
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This regulation imposes quality requirements for the production
of the complete feeds as well as the implementation of HACCP principles. In
addition, for complete feeds containing certain feed additives, the operators
placing them on the market should be approved (linked to the pre-operating inspection
for new sites and regular inspections for existing sites). |
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Complementary feeds are regulated by Directive 79/373: |
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Complementary feeds shall be produced and labelled
in accordance with this legislation. |
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The manufacture and use of complementary feeds are regulated by Regulation No 183/2005: |
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This regulation imposes quality requirements for the production
of the complementary feeds as well as the implementation of HACCP principles.
In addition, for complementary feeds containing certain feed additives, the
operators placing them on the market should be approved (linked to the
pre-operating inspection for new sites and regular inspections for existing
sites). |
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The use of feed additives in complementary feeds is regulated by
Regulation No 1831/2003: |
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The regulations authorising feed
additive may set limits for the use of certain feed additives in
complementary feed. Before such limitations are harmonised
in the context of this Regulation, limitations for certain additives (e.g. coccidiostats and histomonostats)
are set in Directive 70/524. |
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Supplementary feed are not yet defined nor regulated but they
are used largely by farmers. FEFANA is currently developing proposals for
setting a harmonised level playing field for these
products. |
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Dietetic feeds are regulated by Directive 79/373: |
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Dietetic feeds shall be produced and labelled
in accordance with this legislation. |
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The manufacture and use of dietetic feeds are regulated by Regulation No 183/2005: |
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This regulation imposes quality requirements for the production
of the dietetic feeds as well as the implementation of HACCP principles. The
same rules as for complete or complementary feed apply for dietetic feed. |
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The labelling of dietetic feed is regulated
by Directive 93/74 and Directive 94/39: |
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Dietetic feed should be labelled and
placed on the market following the requirements of Directive 93/74.
Furthermore, the Directive 94/39 sets particular nutritional purposes to be
used when labelling the dietetic feed. In order to
be used as a dietetic feed, a feed shall contain specific feed materials or
additives at specific levels. |
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Medicated feeds are regulated by Directive 79/373: |
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Medicated feeds shall be produced and labelled
in accordance with this legislation. Medicated feed can only be placed on the
market, if there are accompanied by a prescription from a veterinarian. |
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The preparation, placing on the market and use of medicated feed
are regulated by Directive 90/167: |
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This Directive requires the medicated feed to be produced from authorised medicated premixes only and defines the rules
applicable for their placing on the market, including labelling
requirements, as well as the conditions for use on farms, linked to a
veterinary prescription. |
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The manufacture and use of medicated feeds are regulated by Regulation No 183/2005: |
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This regulation imposes quality requirements for the production
of the medicated feeds as well as the implementation of HACCP principles. The
same rules as for complete feed apply for medicated feed. |
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O Restart
© FEFANA 2008 |