Undesirable Substances in Animal Feeds Rules, 2009

L.N. 105 of 2009

VETERINARY SERVICES ACT

(CAP. 437)

Undesirable Substances in Animal Feeds Rules, 2009

IN exercise of the powers conferred by article 10 of the

Veterinary Services Act, the Minister for Resources and Rural

Affairs has made the following rules:-

(1) The title of these rules is Undesirable Substances in

Animal Feeds Rules, 2009.

(2) The scope of these rules is to transpose and

implement Directive 2008/76/EC of the European Commission

which amends the First Schedule to Directive 2002/32/EC of the

European Parliament and Council regarding undesirable substances

in animal feeds, and to prohibit the use of such substances in products

intended for animal feeds, when the levels of such substances exceed

the maximum levels set in the Schedule I hereof.

(3) These rules shall be deemed to have come into force

on 1st April, 2009.

Regulations 1(2), 3(2), 4(2), 5(1), 6, 7, 8(1) and 9

Undesirable substances

Products intended for

Maximum content in

animal feed

mg/kg(ppm) relative to a

feeding stuff with a

moisture content of 12%

1. Arsenic

Feed materials with the

exception of

-

meal made from

grass, from dried

Lucerne and from

dried clover, and

dried sugar beet

pulp and dried

molasses sugar beet

pulp

-

phosphates and

feeding stuffs

obtained from the

processing of fish or

other marine

animals

Complete feeding stuffs

with the exception of

-

complete feeding

stuffs for fish

Complementary feeding

stuffs with the exception of

-

mineral feeding

stuffs

2. Lead

Feed materials with the

exception of

-

green fodder

-

phosphates

feeding stuff with a

moisture content of 12%

-

yeasts

Complete feeding stuffs

Complementary feeding

stuffs with the exception of

-

mineral feeding

stuffs

3. Fluorine (*)

Feed materials with the

exception of

-

feeding stuffs of

animal origin with

the exception of

marine crustaceans

such as marine krill

-

marine crustaceans

3 000

such as marine krill

-

phosphates

2 000

-

calcium carbonate

-

magnesium oxide

-

calcareous marine

1 000

algae

Vermiculite (E 561)

3 000 (**)

Complementary feeding

stuffs

-

containing 4% or

less phosphorous

-

containing more

125 per 1% phosphorous

than 4%

phosphorous

feeding stuff with a

moisture content of 12%

Complete feeding stuffs

with the exception of

-

complete feeding

stuffs for cattle

sheep and goats

-

in lactation

-

other

-

complete feeding

stuffs for pigs

-

complete feeding

stuffs for poultry

-

complete feeding

stuffs for chicks

-

complete feeding

stuffs for fish

(*) Maximum levels refer to an analytical determination of fluorine, whereby extraction

is performed with hydrochloric acid 1 N for 20 minutes at ambient temperature.

Equivalent extraction procedures can be applied for which it can be demonstrated that the

used extraction procedure has an equal extraction efficiency.

(**) Levels being reviewed by 31 st December 2008 with the aim of reducing the

maximum levels.

4. Mercury

Feed materials with the

0.1

exception of

-

feeding stuffs

0.5

produced by the

processing of fish or

other marine

animals

Complete feeding stuffs

0.1

with the exception of

-

complete feeding

0.4

stuffs for dogs and

cats

feeding stuff with a

moisture content of 12%

Complementary feeding

0.2

stuffs except

-

complementary

feeding stuffs for

dogs and cats

5. Nitrites

Fish meal

(expressed as sodium

nitrate)

Complete feeding stuffs

excluding

(expressed as sodium

nitrate)

-

feeding stuffs

intended for pets

except birds and

aquarium fish

6. Cadmium

Feed materials of vegetable

origin

Feed materials of animal

origin except

-

feeding stuffs for pets

10( 1 )

Phosphates

Complete feeding stuffs for

cattle, sheep and goats

except

-

complete feeding

stuffs for calves,

lambs and kids

Other complete feeding

0.5

stuffs except

feeding stuff with a

moisture content of 12%

-

feeding stuffs for

pets

5( 2 )

Mineral feeding stuffs

7. Aflatoxin B 1

Feed materials with the

0.05

exception of

-

ground nut, copra,

0.02

palm-kernel, cotton

seed, babassu, maize

and products derived

from the processing

thereof

Complete feeding stuffs for

0.05

cattle, sheep and goats with

the exception of

-

dairy cattle

0.005

-

calves and lambs

0.01

Complete feeding stuffs for

0.02

pigs and poultry (except

young animals)

Other complete feeding

0.01

stuffs

Complementary feeding

0.05

stuffs for cattle, sheep and

goats (except

complementary feeding

stuffs for dairy animals,

calves and lambs)

Complementary feeding

0.03

stuffs for pigs and poultry

(except young animals)

feeding stuff with a

moisture content of 12%

Other complementary

0.005

feeding stuffs

8. Hydrocyanic acid

Feed materials with the

exception of

-

linseed

-

linseed cakes

-

manioc products and

almond cakes

Complete feeding stuffs

with the exception of

-

complete feeding

stuffs for chicks

9. Free gossypol

Feed materials with the

exception of

-

cotton-seed cakes

1 200

Complete feeding stuffs

with the exception of

-

complete feeding

stuffs for cattle,

sheep and goats

-

complete feeding

stuffs for poultry

(except laying hens)

and calves

-

complete feeding

stuffs for rabbits and

pigs (except piglets)

feeding stuff with a

moisture content of 12%

10. Theobromine

Complete feeding stuffs

with the exception of

-

complete feeding

stuffs for adult cattle

11. Volatile mustard oil

Feed materials with the

exception of

-

rapseed cakes

4 000

(expressed as ally1

isothiocyanate)

Complete feeding stuffs

with the exception of

(expressed as ally1

isothiocyanate)

-

complete feeding

1 000

stuffs for cattle,

(expressed as ally1

sheep and goats

isothiocyanate)

(except young

animals)

-

complete feeding

stuffs for pigs

(expressed as ally1

(except piglets) and

isothiocyanate)

poultry

12. Vinal

Complete feeding stuffs for

1 000

thiooxazolidone

poultry with the exception

(Vinyloxazolidine

of

thione)

-

complete feeding

stuffs for laying

hens

feeding stuff with a

moisture content of 12%

(1) Unless otherwise stated in these rules, the definitions

prescribed in the Act shall apply.

(2) For the purpose of these rules and unless the context

otherwise requires

“the Act” means the Veterinary Services Act;

“additives” shall have the same meaning as defined in

Article 2(a) of Council Directive Order 70/524/EEC;

“animals” means animals belonging to species normally

fed and kept or consumed by man and also animals living freely

in the wild in cases where they are fed with feeding stuffs;

“authorised provider” means a person authorised by the

authority to import and, or wholesale or retail substances or

products for animal feed according to the establishment of

these rules;

“background level” means a standard level taken

into consideration to minimise or eliminate the sources of

undesirable substances according to such level, as long as

the maximum levels of such substances are exceeded and, or

where added levels of the same substance are found in products

intended for animal feed;

“the Commission” means the Commission of the

European Union;

“the competent authority” means the Veterinary Services

Authority as established by the Act;

“complementary feeding stuffs” means mixtures of

feeding stuffs which have a high content of certain substances

and which, by reason of their composition, are sufficient for a

daily portion only if used in combination with other feeding

stuffs;

“complete feeding stuffs” means mixtures of feeding

stuffs which, by reason of their composition, are sufficient for

a daily portion;

“compound feeding stuffs” means mixtures of feed

materials, whether or not containing additives, which are

intended for oral animal feeding as complete or complementary

feeding stuffs;

“the Council” means the Council of the European

Union;

“daily portion” means the average total quantity of feeding

stuffs, calculated on a moisture content of 12%, required daily

by an animal of a given species, age class and yield, to satisfy

all its needs;

“feeding stuffs” means products of vegetable or animal

origin, in their natural state, fresh or preserved, and products

derived from the industrial processing thereof, and organic or

inorganic substances, used singly or in mixtures, whether or

not containing additives, for oral animal feeding;

“feed materials” means various products of vegetable

or animal origin, in their natural state, fresh or preserved, and

products derived from the industrial processing thereof, and

organic or inorganic substances, whether or not containing

additives, which are intended for use in oral animal feeding

either directly as such or, after processing, in the preparation of

compound feeding stuffs or as substrates for premixtures;

“final consumer” means a person who buys particular

nutritive products produced by animals for own personal use;

“Member State” means a member state of the European

Union;

“premixtures” means mixtures of additives or mixtures

of one or more additives with substances used as carriers,

intended for the manufacture of feeding stuffs;

“products intended for animal feed” means feed materials,

premixtures, additives, feeding stuffs and all other products

intended for use or used in animal feed;

“putting into circulation” or “circulation” means the

holding of products intended for animal feed for the purposes

of sale, including offering for sale, or any other form of transfer,

whether free or not, to third parties, and the sale or other forms

of transfer themselves;

“undesirable substance” means any substance or product,

with the exception of pathogenic agents, which is present in

and, or on the product intended for animal feed and which

presents a potential danger to animal or human health or to the

environment or could adversely affect livestock production.

Regulations 5 (2) and 9

Undesirable

Products intended

Action threshold in mg/kg {ppm}

Comments and additional

substances

for animal feed

relative to a product intended for animal

information (e.g. nature of

feed with a moisture content of 12%

investigations to be performed)

for the record

B

€1.86

(1) These rules shall apply without prejudice to the

provisions in

(a) Order 70/524 concerning additives in feeding

stuffs;

(b) Order 96/25and Order 79/373 on the marketing of

compound feeding stuffs;

(c) Orders relating to the fixing of maximum levels for

pesticide residues, where these residues are not listed in The

First Schedule to this Order;

(d) veterinary legislation relating to public health and

animal health;

(e) Order 82/471 concerning certain products used in

animal nutrition;

(f) Order 93/74 on feeding stuffs intended for particular

nutritional purposes.

(2) The competent authority shall establish and apply

all such administrative measures required in terms of these rules

in order to ensure that there is no breach of these rules and also

to reduce the risk to final consumers and all other additional risk

to animals and to the environment according to the establishment

of the provisions mentioned in Schedule I hereof. The measures

established in these rules shall be in conformity with and according

to the requirements of the Food Chain and Animal Health.

(3) These measures shall include the direct confiscation

of the product, the suspension of activities carried out by the service

provider when these are creating a risk to final consumers and to the

environment and also the application of administrative fines.

(1) Products intended for animal feed may enter for use

in Malta from third countries, be put into circulation and, or used

in Malta only if they are sound, genuine and of negotiable quality.

When correctly used these products do not represent any danger to

human health or animal health or to the environment and could not

adversely affect livestock production.

(2) In particular, products intended for animal feed shall

be deemed not to be in conformity with sub-rule (1) of this rule, if

the level of undesirable substances they contain does not comply

with the maximum levels laid down in Schedule I hereof.

(1) Undesirable substances listed in Schedule I hereof

may be tolerated in products intended for animal feed only if they

are subject to the conditions laid down therein.

(2) The competent authority shall, in co-operation with

economic operators, carry out investigations to identify the sources

of undesirable substances, in cases where the maximum levels are

exceeded and in cases where increased levels of such substances are

detected, taking into account background levels, in order to reduce

or eliminate sources of undesirable substances in products intended

for animal feed. Maximum levels may be established so that cases

of added levels are treated uniformally and if such maximum levels

are exceeded such investigation could be necessary. These may be

laid down in Schedule II hereof.

(3) The competent authority shall transmit to the

Commission and to the relevant international organisation and to

the other Member States all relevant information and findings of the

source and the measures taken to reduce such level or to eliminate

the undesirable substances. This information shall be transmitted in

the form of an annual report to be transmitted to the Commission and

to the relevant international organisation according to the provisions

of Article 22 of Directive 95/53/EC except in those cases where the

information is of immediate relevance for the other Member States.

In this latter case, the information shall be transmitted immediately.

Products intended for animal feed containing levels of

undesirable substances that exceed the maximum level fixed in the

Schedule I hereof shall not be mixed for dilution purposes with the

same, or other products intended for animal feed.

In so far as there are no special provisions for complementary

feeding stuffs, taking into account the portion prescribed for their

use in a daily portion, such shall not contain levels of undesirable

substances listed in Schedule I hereof that exceed those fixed for

complete feeding stuffs.

(1) The competent authority may, on grounds based on

new information or a reassessment of existing information made

after the relevant provisions were adopted, provisionally reduce

the existing maximum level and fix a maximum level or prohibit

the presence of such undesirable substance in products intended

for animal feed, when such information indicates that a maximum

level laid in Schedule I hereof, or an undesirable substance not listed

therein, may present a danger to animal or human health or to the

environment.

(2) In such case, the competent authority shall

immediately inform the other Member States, the Commission and

the relevant international organisation, and it shall state the grounds

for its decision.

(3) Insofar as neither the Council nor the Commission

or the relevant international organisation has taken a decision, the

competent authority may maintain the measures it has implemented.

The competent authority shall ensure that the decision taken is made

public.

(1) Schedules I and II hereof shall be adapted in terms of

scientific developments and technical knowledge according to the

decisions adopted by the relevant international organisation.

(2) The competent authority in accordance with the

procedure laid down in Article 24 of the Act

(a) shall periodically adopt consolidated versions

of Schedules I and II hereof inserting any adaptations made

pursuant to sub-rule (1) of this rule;

(b) may define acceptable criteria for detoxification

processes which shall complement the criteria provided for

products intended for animal feed which have undergone such

processes.

(3) The competent authority shall take all such

appropriate measures which guarantee the correct application of any

acceptable processes pursuant to sub-rule (2) of this rule and also

the conformity of the detoxified products intended for animal feed

with the provisions of the Schedule I hereof.

Products intended for animal feed which comply with

these rules shall not be subject to any other restrictions on circulation

as regards the presence of undesirable substances other than those

provided for in these rules and in Directive 95/53/EC.

Provisions that may have an effect on public health

or animal health or on the environment may be adopted after

consultation with the relevant international organisation.

The Undesirable Substances in Animal Feeds Rules,

2005. 2005 are hereby being revoked.

B

Rye ergot

All feeding stuffs

1 000

(Claviceps

containing ungrounded

purpurea)

cereals

Weed seeds and

All feeding stuffs

3 000

ungrounded and

uncrushed fruits

containing alkaloids,

glucosides or other

toxic substances

separately or in

combination

including

Datura stramonium

1 000

L.

Castor oil plant –

All feeding stuffs

Ricinus communis

(expressed in terms of

L.

castor-oil plants husks)

Crotalaria spp.

All feeding stuffs

Aldrin

All feeding stuffs with

0.01

||

the exception of

Singly or combined

expressed as dieldrin

- fats

0.2

||

18. Dieldrin

Dieldrin b"ala

- xa"mijiet

0.02

dieldrin

Camphechlor

All feeding stuffs

0.1

(toxaphene)

feeding stuff with a

moisture content of 12%

Chlordane (sum of

All feeding stuffs with the

0.02

cis- and

exception of

transisomers and of

oxychlordane,

-

fats

0.05

expressed as

chlordane)

DDT (sum of DDT-,

All feeding stuffs with the

0.05

DDD-, (or TDE-)

exception of

and DDE- isomers,

expressed as DDT)

-

fats and oils

0.5

Endosulfan (sum of

All feeding stuffs with the

0.1

alpha- and beta-

exception of

isomers and of

endosulfansulphate

-

maize

0.2

expressed as

endosulfan)

-

oilseeds

0.5

-

complete feeding

0.005

stuffs for fish

Endrin (sum of

All feeding stuffs with the

0.01

endrin and of delta-

exception of

ketoi-endrin,

expressed as endrin)

-

fats

0.05

Heptachlor (sum of

All feeding stuffs with the

0.01

heptachlor and of

exception of

heptachlorepoxide,

expressed as

-

fats

0.2

heptachlor)

Hexachlorobenzene

All feeding stuffs with the

0.01

(HCB)

exception of

- fats

0.2

feeding stuff with a

moisture content of 12%

Hexachlorocyclo-

hexane (HCH)

alpha-isomer

All feeding stuffs with the

0.02

exception of

-

fats

0.2

beta-isomers

Compound feeding stuffs

0.01

with the exception of

-

feeding stuffs for

0.05

daily cattle

Feed materials with the

0.01

exception of

-

fats

0.1

26.3 gamma-isomers

All feeding stuffs with the

0.2

exception of

-

fats

2.0

Dioxin (sum of

Citrus pulp

500pg I-TEQ/kg

PCDD and PCDF),

(upper bound detection

limit) ( 3 )

expressed in

international toxic

equivalent

feeding stuff with a

moisture content of 12%

Unhusked beech

mast — Fagus

silvatica L.

Mowrah,

Bassia,

Madhuca

–

Madhuca longfolia

(L.)

Macbr.

(=

Bassia longifolia L.

=

Illiped

malabrorum Engl.)

Madhuca

indica

Gmelin (= Bassia

latifolia Roxb.) =

Illipe

latifolia

(Roscb.) F. Mueller)

Seeds and fruit of

the plant species

Purgghera –

listed opposite as

Jatropha curcas L.

All feeding stuffs

well as their

processed

Croton – Croton

derivates may

tiglium L.

only be present

in feeding stuffs

Indian mustard-

in trace amounts

Brassica juncea(L.)

not quantitatively

Czern. And Coss.

determinable

ssp intergrfolia

(West.) Thell.

Sareptian mustard –

Brassica juncea (L.)

Czern. And Coss.

ssp. juncea

Chinese mustard –

Brassica juncea (L.)

Czern. And Coss.

ssp. juncea var.

lutea Batalin

Undesirable substances

Products intended for

Maximum content in

animal feed

mg/kg(ppm) relative to a

feeding stuff with a

moisture content of 12%

Black mustard –

Seeds and fruit of the

Brassica nigra (L.)

plant species listed

Koch

opposite as well as their

All feeding stuffs

processed derivates may

only be present in

Ethiopian mustard –

feeding stuffs in trace

Brassica carinata A.

amounts not

Braun

quantitatively

determinable

( 1 ) Member States may also prescribe a maximum cadmium content of 0.5 per 1%

phosphorus.

( 2 ) Member States may also prescribe a maximum cadmium content of 0.75 per 1%

phosphorus.

( ) Upper bound concentrations are calculated assuming that all values of the

different congeners less than the limit of detection are equal to the limit of

detection.

B