Undesirable Substances in Animal Feeds Rules, 2005

L.N. 81 of 2005

VETERINARY SERVICES ACT

(CAP. 437)

Undesirable Substances in Animal Feeds Rules, 2005

IN exercise of the powers conferred by article 10 of the Veterinary

Services Act, the Minister for Rural Affairs and the Environment has,

after consultation with the Minister of Health, the Elderly and

Community Care, made the following rules >

(1) The title of these rules is the Undesirable Substances in Title, scope and

applicability.

Animal Feeds Rules, 2005.

(2) These rules deal with undesirable substances in products

intended for animal feed.

(3) The scope of these rules is to implement the provisions

found under Directive 2002#32 EC of the European Parliament and of

the Council of the 7th May 2002 on undesirable substances in animal

(4) These rules shall apply without prejudice to the

provisions in>

(a)

Order (70#524) concerning additives in feedingstuffs<

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

compound feedingstuffs<

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

pesticide residues, where these residues are not listed in Schedule

I 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 feedingstuffs intended for particular

nutritional purposes.

For the purposes of these rules>

Maximum content in mg/kg

Undesirable substances

Products intended for animal (ppm) relative to a feedingstuff

feed

with a moisture content of 12

%

(1)

(2)

(3)

1. Arsenic

Feed materials with the 2

exception of

- meal made from grass, from 4

dried lucerne and from dried

clover, and dried sugar beet

pulp and dried molasses sugar 10

beet pulp

- phosphates and feedingstuffs

obtained from the processing 2

of fish or other marine animals

Complete feedingstuffs with 4

the exception of

- complete feedingstuffs for

fish

Complementary feedingstuffs

with the exception of

- mineral feedingstuffs

2. Lead

Feed materials with the 10

exception of

- green fodder

- phosphates

- yeasts

Complete feedingstuffs

Complementary feedingstuffs

with the exception of

- mineral feedingstuffs

3. Fluorine

Feed materials with the

exception of

- feedingstuffs of animal origin

2 000

- phosphates

Complete feedingstuffs with

the exception of

- complete feedingstuffs for

cattle, sheep and goats

- in milk

- other

- complete feedingstuffs for

pigs

- complete feedingstuffs for

2 000 (1)

poultry

- complete feedingstuffs for

125 (2)

chicks

Mineral mixtures for cattle,

sheep and goats

Other

complementary

feedingstuffs

4. Mercury

Feed materials with the

0,1

exception of

0,5

- feedingstuffs produced by the

processing of fish or other

marine animals

0,1

Complete feedingstuffs with

the exception of

0,4

- complete feedingstuffs for

dogs and cats

0,2

Complementary feedingstuffs

except

- complementary feedingstuffs

for dogs and cats

5. Nitrites

Fish meal

Complete

feedingstuffs

(expressed as sodium nitrite)

excluding

- feedingstuffs intended for

(expressed as sodiumnitrite)

pets except birds and aquarium

fish

6. Cadmium

Feed materials of vegetable

origin

Feed materials of animal origin

except

- feedingstuffs for pets

10 (3)

Phosphates

Complete feedingstuffs for

cattle, sheep and goats except

- complete feedingstuffs for

calves, lambs and kids

0,5

Other complete feedingstuffs

except

5 (4)

- feedingstuffs for pets

0,5

Mineral feedingstuffs

Other

complementary

feedingstuffs for cattle, sheep

and goats

7. Aflatoxin B 1

Feed materials with the

0,05

exception of

0,02

- groundnut, copra, palm-

kernel, cotton seed, babassu,

maize and products derived

from the processing thereof

0,05

Complete feedingstuffs for

cattle, sheep and goats with the

exception of

0,005

- dairy cattle

0,01

- calves and lambs

0,02

Complete feedingstuffs for

pigs and poultry (except young

0,01

animals)

0,05

Other complete feedingstuffs

Complementary feedingstuffs

for cattle, sheep and goats

(except

complementary

0,03

feedingstuffs for dairy animals,

calves and lambs)

Complementary feedingstuffs

0,005

for pigs and poultry (except

young animals)

Other

complementary

feedingstuffs

8. Hydrocyanic acid

Feed materials with the

exception of

- linseed

- linseed cakes

- manioc products and almond

cakes

Complete feedingstuffs with

the exception of

- complete feedingstuffs for

chicks

9. Free gossypol

Feed materials with the

exception of

- cotton-seed cakes

Complete feedingstuffs with

the exception of

- complete feedingstuffs for

cattle, sheep and goats

- complete feedingstuffs for

poultry (except laying hens)

and calves

- complete feedingstuffs for

rabbits and pigs (except

piglets)

10. Theobromine

Complete feedingstuffs with

the exception of

- complete feedingstuffs for

adult cattle

“additives” means additives 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 as well as animals living freely in

the wild in cases where they are fed with feedingstuffs<

“the competent authority” means the competent authority as

mentioned in Article 2 (f) of Order (95#53) fixing the principles

governing the organisation of official inspections in the field of

animal nutrition<

“the Commission” means the Commission of the European

Union<

“complementary feedingstuffs” means mixtures of

feedingstuffs which have a high content of certain substances and

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

ration only if used in combination with other feedingstuffs<

“complete feedingstuffs” means mixtures of feedingstuffs

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

ration<

“compound feedingstuffs” means mixtures of feed materials,

whether or not containing additives, which are intended for oral

animal feeding as complete or complementary feedingstuffs<

“the Council” means the Council of the European Union<

“daily ration” means the average total quantity of

feedingstuffs, 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<

“feedingstuffs” 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 feedingstuffs

or as substrates for premixtures<

“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 feedingstuffs<

“products intended for animal feed” means feed materials,

premixtures, additives, feedingstuffs 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.

Action threshold in mg/kg

Comments

and

additionl

Undesirable

Products

(ppm) relative to a product

information (e.g. the nature of

substances

intended for intended for animal feed with a

the

investigation

to

be

animal feed

moisture content of 12 %

performed)

Mitbug] fl-Istamperija tal-Gvern - Printed at the Government Printing Press

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

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

only if they are sound, genuine and of merchantable quality. When

correctly used such products do not represent any danger to human

health, animal health or to the environment or could adversely affect

livestock production.

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

deemed not to be in conformity with sub-rule (1) if the level of

undesirable substances they contain does not comply with the maximum

levels laid down in Schedule I.

(1) Undesirable substances listed in Schedule I may be Tolerance of

undesirable

tolerated in products intended for animal feed only subject to the substances.

conditions laid down therein.

(2) In order to reduce or eliminate sources of undesirable

substances of products intended for animal feed, the competent authority,

in co-operation with economic operators, shall 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.

For a uniform approach in cases of increased levels it may be necessary

to set action thresholds to trigger such investigations. These may be

laid down in Schedule II.

(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 the level or elimination of the

undesirable substances. This information shall be transmitted in the

frame of the 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 an

undesirable substance that exceed the maximum level fixed in Schedule

I may 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

feedingstuffs, complementary feedingstuffs may not, taking into account

the proportion prescribed for their use in a daily ration, contain levels

of the undesirable substances listed in Schedule I that exceed those

fixed for complete feedingstuffs.

(1) Where the competent authority has grounds, based on

new information or a reassessment of existing information made since

the provisions in question were adopted, demonstrating that a maximum

level fixed in Schedule I, or an undesirable substance not listed therein,

present a danger to animal or human health or to the environment, it

may provisionally reduce the existing maximum level, fix a maximum

level or prohibit the presence of that undesirable substance in products

intended for animal feed. It shall immediately inform the other Member

States and the Commission and to the relevant international organisation

thereof, stating the grounds for its decision.

(2) An immediate decision shall be taken, whether to amend

Schedules I and II.

(3) Insofar as neither the Council nor the Commission and

the relevant international organisation has taken a decision, the

competent authority may maintain the measures it has implemented.

The competent authority must ensure that the decision taken is made

public.

(1) In consideration of developments in scientific and Adaptation of

Schedules.

technical knowledge, Schedules I and II shall be adapted in agreement

with decisions adopted by the relevant international organisation.

(2) Furthermore, in accordance with the procedure laid down

in Article 24, the competent authority>

(a) shall periodically adopt consolidated versions of

Annexes I and II incorporating any adaptations made pursuant to

sub-rule (1)<

(b) may define acceptability criteria for detoxification

processes as a complement to the criteria provided for products

intended for animal feed which have undergone such processes

may be defined.

(3) Measures shall be taken to guarantee the correct

application of any acceptable processes pursuant to sub-rule (2) and the

conformity of the detoxified products intended for animal feed with the

provisions of Schedule I.

Products intended for animal feed which comply with these No other restrictions

applicable.

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 Directive (95#53)#EC.

Provisions that may have an effect upon public or animal Provisions that may

be adopted.

health or on the environment shall be adopted after consultation with

the relevant international organisation.

Volatile mustard oil

Feed materials with the

exception of

- rape-seed cakes

Complete feedingstuffs with

the exception of

- complete feedingstuffs for

cattle, sheep and goats (except

young animals)

- complete feedingstuffs for

pigs (except piglets) and

poultry

Vinyl thiooxazolidone Complete feedingstuffs for

(Vinyloxazolidine thione)

poultry with the exception of

- complete feedingstuffs for

laying hens

Rye ergot (Claviceps All feedingstuffs containing

purpurea)

unground cereals

Weed seeds and unground All feedingstuffs

3 000

and uncrushed fruits containing

alkaloids, glucosides or other

toxic substances separately or

in combination including

(a) Lolium temulentum L.,

1 000

(b) Lolium remotum Schrank

1 000

(c) Datura stramonium L.

1 000

Castor oil plant - Ricinus All feedingstuffs

10 (expressed in terms of

communis L.

castor-oil plant husks)

Crotalaria spp.

All feedingstuffs

Aldrin Singly or combined

All feedingstuffs with the 0,01

exception

expressed as dieldrin

Dieldrin

of

0,2

- fats

Camphechlor (toxaphene)

All feedingstuffs

0,1

Chlordane (sum of cis- and All feedingstuffs with the 0,02

trans-isomers

and

of exception of

oxychlordane, expressed as - fats

0,05

chlordane)

DDT (sum of DDT-, TDE- All feedingstuffs with the 0,05

and DDEisomers, expressed as exception of

DDT)

- fats

0,5

Endosulfan (sum of alpha-

All feedingstuffs with the 0,1

and betaisomers and of

exception of

endosulfansulphate expressed

- maize

0,2

as endo-sulfan)

- oilseeds

0,5

- complete feedingstuffs for 0,005

fish

Endrin (sum of endrin and All feedingstuffs with the 0,01

of delta-ketoiendrin, expressed exception of

as endrin)

- fats

0,05

Heptachlor (sum of

All feedingstuffs

with

the 0,01

heptachlor and of hepta-

exception of

chlorepoxide, expressed as

- fats

0,2

heptachlor)

Hexachlorobenzene (HCB)

All feedingstuffs

with

the 0,01

exception of

- fats

0,2

Hexachlorocyclo-hexane

(HCH)

All feedingstuffs with the

0,02

26.1. alpha-isomers

exception of

- fats

0,2

Compound feedingstuffs with

0,01

20.2. beta-isomers

the exception of

- feedingstuffs for dairy cattle

0,005

Feed materials with the

0,01

exception of

0,1

- fats

0,2

26.3. gamma-isomers

All feedingstuffs with the

exception of

2,0

- fats

Dioxin (sum of PCDD and Citrus pulp

500 pg I-TEQ/kg

PCDF),

expressed

in AMENDED

BY

DIR

(upper bound detection limit)

international toxic equivalents 2003/57/EC

Apricots

-

Prunus

armeniaca L.

Bitter almond - Prunus

dulcis (Mill.) D.A.m Webb

var. amara (DC.) Focke (=

Prunus amygdalus Batsch var.

amara (DC.) Focke)

Unhusked beech mast -

Fagus silvatica L.

Camelina - Camelina

sativa (L.) Crantz

Mowrah, Bassia, Madhuca

- Madhuca longifolia

(L.)

Macbr. (= Bassia longifolia L.

Seeds and fruit of the plant

= Illipe malabrorum Engl.)

species listed in the first

Madhuca indica Gmelin (=

All feedingstuffs

column hereof, as well as their

Bassia latifolia Roxb.) = Illipe

processed derivatives may only

latifolia (Roscb.) F. Mueller)

be present in feedingstuffs in

Purghera - Jatropha curcas

trace amounts not quantitavely

L.

determinable

Croton - Croton tiglium L.

Indian mustard - Brassica

juncea (L.) Czern. and Coss.

ssp. integrifolia (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

Black mustard - Brassica

nigra (L.) Koch

Ethiopian mustard -

Brassica carinata A. Braun

(1) The competent authority may also prescribe a maximum fluorine content of 1,25 % of the

phosphate content.

(2) Fluorine content per 1 % phosphorus.

(3) The competent authority may also prescribe a maximum cadmium content of 0,5 mg per 1 %

phosphorus.

(4) Member States Competent authority may also prescribe a maximum cadmium content of 0,75

mg per 1 % phosphorus.

(5) 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.