Commission Regulation (EC) No 429/2008Show full title

1. TECHNOLOGICAL ADDITIVES

1.1. Section I: summary of the dossier

The whole of the Section I of Annex II applies.

1.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis

The Section II of Annex II applies as following:

• for additives not subject to a specific holder of the authorisation the paragraphs 2.1.2, 2.1.3, 2.1.4, 2.1.4.2, 2.2, 2.3.1, 2.3.2, 2.4.1, 2.4.2, 2.4.4, 2.5, 2.6 apply;

• for other additives subject to a specific holder of the authorisation, the whole of Section II applies.

1.3. Section III: studies concerning the safety of the additive

Subsections 3.1, 3.2 and 3.4 of Annex II do not apply to silage additives where it can be demonstrated that:

• no detectable amounts of the active substance(s) or relevant metabolites or the active agent(s) survive in the final feed; or

• the active substance(s) and agent(s) occur as normal constituents of silage and use of the additive does not substantially increase their concentration compared to silage prepared without use of the additive (i.e. where there is no substantial change in exposure).

In the other cases the whole of Section 3 of Annex II applies.

1.3.1. Studies concerning the safety of use of the additive to the target animals

For xenobiotic(1) substances: the full subsection 3.1 of Annex II applies.

1.3.1.1. Tolerance studies for the target species

For silage additives:

• the product shall be added to a basal diet and results compared to a negative control with the same diet. The basal diet may contain a single source of silage prepared without the use of an additive.

• the dose selected for the tolerance studies shall be a multiple of the concentration present in the ensiled material at the time of normal use where this can be conclusively established. Particular consideration shall be given to product containing viable micro-organisms and their capacity for survival and multiplication during ensiling.

Tolerance studies can usually be limited to a ruminant species, normally the dairy cows. Studies involving other species are required only when the nature of the ensiled material makes it more appropriate for use with non-ruminants.

Other substances:

for the other substances requesting authorisation as technological additives not already authorised for feed use the absence of harm to animals at the highest proposed level shall be demonstrated. This demonstration may be limited to one experiment in one of the most sensitive target species or in one laboratory animal species.

1.3.1.2. Microbial studies

The whole of subsection 3.1.2 of Annex II applies.

1.3.2. Studies concerning the safety of use of the additive for consumers

1.3.2.1. Metabolic and residue studies

Metabolic and residue studies are not required if:

(1)

the substance or its metabolites are not present in the feedingstuff at time of feeding; or

(2)

the substance excreted unchanged, or its metabolites can be demonstrated to be essentially not absorbed; or

(3)

the substance is absorbed in the form of physiological compounds; or

(4)

the active component(s) of the additive consists only of micro-organisms or enzymes).

Metabolic studies also are not required if the substance is naturally present in significant amounts in food or feedingstuffs or the substance is a normal constituent of body fluids or tissues. However, in these cases, there is a requirement for residue studies which can be limited to the comparison of the tissues/products levels in an untreated group and in the group supplemented with the highest recommended dose.

1.3.2.2. Toxicological studies

Toxicological studies are not required if:

(1)

the substance or its metabolites are not present in the feedingstuff at time of feeding; or

(2)

the substance is absorbed in the form of physiological compound(s); or

(3)

the product consists of micro-organisms commonly encountered in ensiled materials or those already used in food; or

(4)

the product consists of enzymes with a high degree of purity arising from micro-organisms with a history of documented safe use.

For micro-organisms and enzymes not excluded above, genotoxicity studies (including mutagenicity) and a subchronic oral toxicity study are required. Genotoxicity studies shall not be made in the presence of living cells.

For xenobiotic substances, not exempted above, the whole of subsection 3.2.2 Annex II applies.

For other substances a case by case approach shall be taken, taking into account the level and means of exposure.

1.3.2.3. Assessment of consumer safety

The whole of subsection 3.2.3 of Annex II applies for additives requested for food producing animals.

1.3.3. Studies concerning the safety of use of the additive for users/workers

The whole of subsection 3.3 of Annex II applies. Additives containing enzymes and micro-organisms are assumed to be respiratory sensitisers unless convincing evidence to the contrary is provided.

1.3.4. Studies concerning the safety of use of the additive for the environment

The whole of subsection 3.4 of Annex II applies. For silage additives, the effects of the additive on the production of effluent from clamp or silo during ensiling shall be considered.

1.4. Section IV: studies concerning the efficacy of the additive

Technological additives are intended to improve or stabilise the characteristics of feed but have generally no direct biological effect on animal production. Evidence of the efficacy of the additive must be provided by means of appropriate criteria as reflected in recognised acceptable methods, under the intended practical conditions of use in comparison with appropriate control feed.

Efficacy will be assessed by in vitro studies, with the exception of substances for control of radionuclide contamination. The appropriate end-points are indicated in the following table for the various functional groups.

End-points for different technological additives

Functional group	End-points for demonstration of efficacy
(a) Preservatives	Inhibition of microbial growth, particularly that of biotic and spoilage organisms. The period for which a preserving effect is claimed shall be demonstrated.
(b) Antioxidants	Protection against oxidative damage of key nutrients/components during feedingstuff processing and/or storage. The period for which a protecting effect is claimed shall be demonstrated.
(c) Emulsifiers	Formation/maintenance of stable emulsions of otherwise immiscible or poorly miscible feed ingredients.
(d) Stabilisers	Maintenance of the physico-chemical state of feedingstuffs.
(e) Thickeners	Viscosity of the feed materials or feedingstuffs.
(f) Gelling agents	Formation of a gel resulting in a change in the texture of the feedingstuff.
(g) Binders	Pellet durability or performance of pellet formation.
(h) Substances for control of radionuclides	Evidence of reduced contamination of food of animal origin.
(i) Anti-caking agents	Flow ability. The period for which an anti-caking effect is claimed shall be demonstrated.
(j) Acidity regulators	pH and/or buffering capacity in feedingstuffs.
(k) Silage additives	Improved production of silage; Inhibition of undesirable micro-organisms; Reduction of effluents; Improved aerobic stability.
(l) Denaturants	Indelible identification of feed materials.

Silage additives

Separate tests shall be made to demonstrate the effect requested on ensiling process(2). The trials shall be performed with one example of each of the following categories (where all or unspecified forages are involved):

• easy to ensile forage: > 3 % soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp),

• moderately difficult to ensile forage: 1,5—3,0 % soluble carbohydrates in the fresh material (e.g. meadow grass, fescue or wilted alfalfa);

• difficult to ensile forage: < 1,5 % soluble carbohydrates in the fresh material (e.g., orchard grass or leguminous plants).

Where requests are restricted to sub-categories of forage described in terms of dry matter (DM), the dry matter range shall be explicitly stated. Three tests shall then be made with material representative of the range, where possible using examples of different botanical origin.

Specific tests are required for the particular feedingstuffs.

The duration of the study normally shall be 90 days or longer at a constant temperature (recommended range 15—25 ^oC). Use of a shorter duration must be justified.

As a rule measurements of the following parameters shall be provided in comparison to the negative control:

• dry matter and calculated dry matter losses (corrected for volatiles),

• pH- decrease,

• concentration of volatile fatty acids (e.g. acetic, butyric and propionic acids) and lactic acid,

• concentration of alcohols (ethanol),

• concentration of ammonia (g/kg of total nitrogen), and

• content of hydro-soluble carbohydrates.

In addition, other microbiological and chemical parameters shall be included as appropriate to substantiate the specific claim made (e.g. numbers of lactate assimilating yeasts, numbers of Clostridia, numbers of Listeria and biogenic amines).

An effect sought for effluent reduction will be judged against the total volume of effluent produced over the entire experimental period, taking into account the likely effect on the environment (e.g. ecotoxicity of the effluent or biological oxygen demand). Reduction of effluent production shall be demonstrated directly. The capacity of the silo shall be sufficient to allow effluent to be released with the application of pressure. The duration of the study shall normally be 50 days. If a different period is used, this shall be justified.

Improved aerobic stability shall be demonstrated in comparison with a negative control. Stability studies shall be of at least seven days duration after exposure to air and additive shall provide evidence of stability for at least two days longer than that shown by untreated control. It is recommended that the experiment is made at an ambient temperature of 20 ^oC and a rise in temperature of 3 ^oC or more above background taken as indicative of instability. Temperature measures may be replaced by measurement of CO₂ production.

1.5. Section V: post-market monitoring plan

This section shall apply under provision of Article 7(3)(g) of Regulation (EC) No 1831/2003. That is, a post-market monitoring plan is required only for additives that are GMOs or are produced from GMOs.

(1)

A xenobiotic is a chemical substance which is not a natural component of the organism exposed to it. It can also cover substances which are present in much higher concentrations than are usual.

(2)

For purpose of this Regulation, ‘ensiling process’ means process by which natural deterioration of organic matter is controlled by acidification in anaerobic condition resulting from natural fermentation or/and addition of silage additives.