UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS RULES

SUBSIDIARY LEGISLATION 437.59

UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS

RULES

1st April, 2009

LEGAL NOTICE 105 of 2009, as amended by Legal Notice 358 of 2010.

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

Animal Feeds Rules.

(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.

L.N. 358 of 2010.

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

Undesirable substances

Products intended for animal feed

Maximum

content in mg/

kg (ppm)

relative to a

feedingstuff

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

- pulp kernel expeller,

4 (***)

- phosphates and calcerous marine algae

- calcium carbonate,

- magnesium oxide,

- feeding stuffs obtained from the

25 (***)

processing of fish or other marine

animals, including fish,

- seaweed meal and feed materials

40 (***)

derived from seaweed,

Iron particles used as tracer.

Additives belonging to the functional group

of compounds of trace

- copper sulphate pentahydrate and

copper carbonate,

- zinc, oxide, manganese oxide and

copper oxide,

Complete feedingstuffs with the exception of

- complete feedingstuffs for fish and

10 (***)

complete feedingstuffs for fur animals,

Complementary feedingstuffs with the

exception of

- mineral feedingstuffs,

(*)

The maximum levels refer to total arsenic.

(**) Maximum levels refer to an analytical determination of arsenic, whereby extraction is performed

in nitric acid (5% w/w) for 30 minutes at boiling temperature. Equivalent extraction procedures can be

applied for which it can be demonstrated that the used extraction procedure has equal extraction

efficiency.

(***) Upon request of the competent authorities, the responsible operator must perform an analysis to

demonstrate that the content of inorganic arsenic is lower than 2ppm. This analysis is of particular

importance for the seaweed species Hizikia fusiforme.

UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS

Undesirable substances

Products intended for animal feed

Maximum

content in mg/

kg (ppm)

relative to a

feedingstuff

with a moisture

content of 12%

2. Lead

Feed materials with the exception of

- green fodder

- phosphates

- yeasts

Complete feeding stuffs

C o m p l e m e n t a r y f e e d i n g s t u ff s w i t h t h e

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 such as marine krill

3 000

- phosphates

2 000

- calcium carbonate

- magnesium oxide

- calcareaous marine algae

1 000

Vermiculite (E 561)

3 000 (**)

Complementary feeding stuffs

- containing 4% or less phosphorus

- containing more than 4% phosphorus

125 per 1%

phosphorus

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 feedingstuffs for chicks

- complete feedingstuffs 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.

(**) The levels shall be reviewed by 31st December 2008 with the aim of reducing the maximum

levels.

UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS

Undesirable substances

Products intended for animal feed

Maximum

content in mg/

kg (ppm)

relative to a

feedingstuff

with a moisture

content of 12%

4. Mercury (*) (**)

Feed materials with the exception of

0,1

- feeding stuffs produced from fish or by

0,5

the processing of fish or other aquatic

animals,

- calcium carbonate.

0,3

Compound (complementary and complete)

0,1

feeding stuffs with the exception of

- mineral feed,

0,2

- compound feedingstuffs for fish

0,2

- compound feedingstuffs for dogs, cats

0,3

and fur animals.

(*)

The maximum levels refer to total mercury.

(**) Maximum levels refer to an analytical determination of mercury, whereby extraction is performed

in nitric acid (5% w/w) for 30 minutes at boiling temperature. Equivalent extraction procedures can be

applied for which it can be demonstrated that the used extraction procedure has equal extraction

efficiency.

5. Nitrites

Feed materials with the exception of

15 (expressed

as sodium

nitrate)

- fishmeal,

30 (expressed

as sodium

nitrate)

- silage.

Complete feedingstuffs with the exception of

15 (expressed

as sodium

nitrate)

- complete feedingstuffs for dogs and cats

with a moisture content exceeding 20%

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 stuffs except

0.5

- feeding stuffs for pets

5( 2 )

Mineral feeding stuffs

Oth er co mpl emen tar y fe edi ng stu ff s f or

0.5

cattle, sheep and goats

( 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.

UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS

Undesirable substances

Products intended for animal feed

Maximum

content in mg/

kg (ppm)

relative to a

feedingstuff

with a moisture

content of 12%

7. Aflatoxin B 1

Feed materials with the exception of

0,05

- ground nut, copra, palm-kernel, cotton

0,02

seed, babassu, maize and products

derived from the processing thereof

Complete feeding stuffs for cattle, sheep and

0,05

goats with the exception of

- dairy cattle

0,005

- calves and lambs

0,01

Complete feeding stuffs for pigs and poultry

0,02

(except young animals)

Other complete feeding stuffs

0,01

Complementary feeding stuffs for cattle,

0,05

sh eep and g oat s (ex cep t co mp lemen tar y

feeding stuffs for dairy animals, calves and

lambs)

Complementary feeding stuffs for pigs and

0,03

poultry (except young animals)

Other complementary feeding stuffs

0,005

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

- cottonseed

5 000

- cottonseed cakes and cottonseed meal

1 2000

Complete feeding stuffs with the exception

of

- complete feeding stuffs for adult cattle,

- complete feeding stuffs for sheep

(except lambs) and goats (except kids),

- complete feeding stuffs for poultry

(except laying hens) and calves

- complete feeding stuffs for rabbits,

lambs, kids and pigs (except piglets).

10. Theobromine

Complete feeding stuffs with the exception

of

- complete feedingstuffs for pigs,

- complete feedingstuffs for dogs, rabbits,

horses and for animals.

UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS

Undesirable substances

Products intended for animal feed

Maximum

content in mg/

kg (ppm)

relative to a

feedingstuff

with a moisture

content of 12%

11. Volatile mustard oil

Feed materials with the exception of

- rape-seed cakes

4 000

(expressed as

allyl

isothiocyanate)

Complete feeding stuffs with the exception

150 (expressed

of

as allyl

isothiocyanate)

- complete feeding stuffs for cattle, sheep

1 000

and goats (except young animals)

(expressed as

allyl

isothiocyanate)

- complete feeding stuffs for pigs (except

500 (expressed

piglets) and poultry

as allyl

isothiocyanate)

(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" m eans 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

t he ind ustrial pro cessing ther eo f, and organi c 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.

Undesirable substances

Products intended Action threshold Comments and additional

for animal feed

relative to a

information (e.g. the

feedingstuff with nature of the investigation

a moisture

to be performed)

content of 12%

(1) These rules shall apply without prejudice to the

provisions in

(a) Order 70/524 concerning additives in feeding stuffs;

(b) Order 96/25 and 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 Schedule I;

(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. 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), 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

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

m a x i m u m l ev e l s ar e e x c ee d e d s u ch i n v e s t i g a t i o n co u l d b e

necessary. 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 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

t o t h e r e l e v an t i n t e r n a t i on a l o rg a n i sa t i o n ac c o r d i n g t o t h e

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

Schedule I 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 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 down in Schedule I, 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 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 inserting any adaptations made

pursuant to sub-rule (1);

(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) and also the conformity of the

detoxified products intended for animal feed with the provisions of

the Schedule I.

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

an im al h e al th o r o n th e e nv i r on m e nt m ay be ad op t ed af t er

consultation with the relevant international organisation.

UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS

Substituted by

Vinyl

Complete feeding stuffs for poultry with the

1 000

thiooxazolidone

exception of

( Vi n y l o x a z o l i d i n e

- complete feedingstuffs for laying hens

thione)

Rye ergot

A l l f e e d i n g s t u ff s c o n t a i n i n g u n g r o u n d

1 000

(Claviceps purpurea)

cereals

Weed seeds and

All feedingstuffs

3 000

unground

and

uncrushed

fruits

containing alkaloids,

glucosides or other

toxic

substances

separately or in

combination including

Datura sp.

1 000

Seeds and husks

All feedingstuffs

from Ricinus communis

L., Croton tiglium L.

and Abrus precatorius

L. as well as their

processed derivates

(****), separately or in

combination.

(****) In so far determinable by analytical microscopy.

Crotalaria spp.

All feedingstuffs

Aldrin

All feeding stuffs with the exception of

0,01

Singly or combined

expressed as

- fats

0,2

18. Dieldrin

Dieldrin

- xa]mijiet

0.02

Camphechlor

All feeding stuffs

0.1

(toxaphene)

Chlordane (sum of

All feeding stuffs with the exception of

0.02

cis- and trans-isomers

- fats

0.05

and of oxychlordane,

expressed as chlordane)

UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS

Undesirable substances

Products intended for animal feed

Maximum

content in mg/

kg (ppm)

relative to a

feedingstuff

with a moisture

content of 12%

DDT (sum of DDT-,

All feeding stuffs with the exception of

0.05

DD D- , ( o r TD E- ) a n d

- fats and oils

0.5

DDE-

isomers,

expressed as DDT)

Endosulfan (sum of

All feeding stuffs with the exception of

0.1

alpha- and beta-

- maize

0.2

isomers and of

- oilseeds

0.5

endosulfansulphate

expressed as endo-

- complete feeding stuffs for fish

0.005

sulfan)

Endrin (sum of

All feeding stuffs with the exception of

0.01

endrin and of delta-

- fats

0.05

ketoiendrin, expressed

as endrin

Heptachlor (sum of

All feeding stuffs with the exception of

0.01

heptachlor and of

- fats

0.2

heptachlorepoxide,

expressed as

heptachlor)

Hexachlorobenzene

All feeding stuffs with the exception of

0.01

(HCB)

- fats

0.2

Hexachlorocyclo-

All feeding stuffs with the exception of

0.02

hexane (HCH)

26.1 alpha-isomer

- fats

0.2

26.2 beta-isomers

Compound feeding stuffs with the exception

0.01

of

- feeding stuffs for dairy cattle

0.005

Feed materials with the exception of

0.01

- fats

0.1

26.3. gamma-isomers

All feeding stuffs with the exception of

0.2

- fats

2.0

Dioxin (sum of

Citrus pulp

500pg I-TEQ/

PCDD and PCDF)

kg

(upper

expressed in

bound detection

limit)( 3 )

international toxic

equivalent

( 3 ) 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.

UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS

Undesirable substances

Products intended for animal feed

Maximum

content in mg/

kg (ppm)

relative to a

feedingstuff

with a moisture

content of 12%

Unhusked

beech

mast - Fagus silvatica

L.

Purghera - Jatropha

curcas L.

Indian mustard -

Brassica juncea (L.)

Seeds and fruit

Czern. and Coss. ssp.

of the plant

i n t e g r i f o l i a ( We s t . )

species listed

Thell.

opposite as

Sareptian mustard -

well as their

Brassica juncea (L.)

processed

Czern. and Coss. ssp.

All feedingstuffs

derivatives may

juncea

only be present

in

feeding

Chinese mustard -

stuffs in trace

Brassica juncea (L.)

amounts not

Czern. and Coss. ssp.

q u a n t i ta t i v e l y

j u n c e a v a r. l u t e a

determinable

Batalin

Black mustard -

Brassica nigra (L.)

Koch

Ethiopian mustard -

Brassica carin ata A.

Braun