ANIMAL NUTRITION (ORGANISATION OF OFFICIAL INSPECTIONS) RULES

SUBSIDIARY LEGISLATION 437.72

ANIMAL NUTRITION (ORGANISATION OF

OFFICIAL INSPECTIONS) RULES

27th May, 2005

LEGAL NOTICE 147 of 2005, as amended by Legal Notice 426 of 2007.

CHAPTER I

INTRODUCTORY PROVISIONS

(1) The title of these rules is the Animal Nutrition

(Organisation of Official Inspections).

(2) These rules set out the principles governing the

organisation of official inspections in the field of animal nutrition.

(3) These rules shall apply without prejudice to more specific

European Community legislative rules, in particular European

Community customs and veterinary rules.

(4) The scope of these rules is the implementation of European

Union Council Directive 95/53/EC fixing the principles governing

the organization of official inspections in the field of animal

nutrition.

(1) For the purposes of these rules the following

definitions shall apply

"the Commission" means the European Commission;

"the Community" means the European Community;

"documentary check" means verification of the documents

accompanying a product or of any other information provided on

the product;

"establishment" means any undertaking which produces or

manufactures a product or which holds the product at an

intermediate stage before marketing or which markets the products;

"identity check" means verification, by visual inspection only,

for consistency between the documents, the labelling and the

products;

"Member State" means a State which is a Member within the

European Community;

"official inspection in the field of animal nutrition", hereinafter

called "inspection", means an insp ection by the competent

authorities to check compliance with the legislative provisions laid

down in -

(i)

any other rules in the field of animal nutrition in

which provision is made for official inspections

to be carried out in accordance with the

provisions of these rules,

(ii) European Union Council Directive 2002/32/EC

on undesirable substances and products in

animal nutrition,

(iii) European Union Council Directive 70/524/EEC

concerning additives in feedingstuffs,

(iv) European Union Council Directive 79/373/EEC

on the marketing of compound feedingstuffs,

(v) European Union Council Directive 82/471/EEC

concerning certain products used in animal

nutrition,

(vi) European Union Council Directive 93/74/EEC

on feedingstuffs intended for particular

nutritional purposes, and

(vii)

European Union Council Directive 96/25/EC on

the circulation of feed materials rules;

"physical check" means a check of the product itself, including,

where appropriate, sampling and laboratory testing;

"product intended for animal nutrition" or "product" means

animal feed or any substance used in animal nutrition;

"putting into circulation" or "circulation" means the holding of

any product intended for animal nutrition 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 and other forms of transfer

themselves;

"Third Country" means a State which is not a Member within the

European Community;

"Veterinary Services" is the competent authority as established

under article 2 of the Veterinary Services Act and for the purposes

of these rules is responsible for carrying out official checks in the

field of animal nutrition.

(2) The definitions given in European Community legislation

relating to the field of animal nutrition shall apply where

appropriate.

(1) Inspections in the field of animal nutrition are carried

out in accordance with these rules.

(2) A product shall not be excluded from appropriate

inspection on the grounds that it is intended for export.

(1)

Inspections shall be carried out -

(a) at regular intervals;

(b) where non-compliance is suspected;

(c) using means proportionate to the desired objective and

particularly in the light of the risks and of experience

gained.

(2) Inspections shall cover all stages of production and

manufacture, the intermediate stages prior to marketing, including

importation, and the use of products. The Veterinary Services shall

select the stage or stages most appropriate for the intended purpose

of the inspection.

(3) As a general rule, inspections shall be carried out without

prior warning.

(4) Inspections shall also cover uses prohibited in relation to

animal nutrition.

(1) The Veterinary Services shall draw up contingency

operational plans setting out measures to be implemented without

delay where a product for animal nutrition has been found to pose a

serious risk to human health, animal health or to the environment

and specifying powers and responsibilities as well as channels for

transmitting information. The Veterinary Services shall review

these plans as appropriate, particularly in the light of changes in the

organisation of the inspection services and of the experience

gained, including that gained in any simulation exercises.

(2) The Veterinary Services shall forward to the European

Commission the contingency operational plans drawn up by them

and also any amendments thereto.

(3) The Veterinary Services shall take due account of any

suggestion of amendment issued by the European Commission

which would help to ensure that Maltese contingency operation

plans offer equivalent guarantees of efficiency as those of Member

States.

CHAPTER II

IMPORTS FROM THIRD COUNTRIES

(1) Notwithstanding the provisions of rule 4(1), when

products are introduced into the customs territory of Malta they are

subjected by the Veterinary Services to a documentary check of

each batch and to random identity checks in order to verify -

(a) their nature,

(b) their origin,

(c) their geographical destination,

so as determine the customs procedure applicable to them.

(2) Where appropriate, detailed rules for the application of this

rule shall be adopted in accordance with the procedure laid down in

Article 23 of European Union Council Directive 95/53/EEC.

For the purpose of the checks provided for in rule 6, the

Veterinary Services may designate particular entry points in Malta

for the various types of products. To the same end it may require

notice to be given to it of arrival of products at a particular entry

point.

(1) Conformity of products will be ensured by means of

random physical checks before they are marketed.

(2) Where appropriate, detailed rules for the application of this

rule shall be adopted in accordance with the procedure laid down in

Article 23 of European Union Council Directive 95/53/EEC.

(1) Where the checks show that products do not meet the

requirements of these rules, their entry or marketing shall be

prohibited and order their re-dispatch out of European Community

territory shall be ordered by the Veterinary Services; it shall

immediately inform the European Union Commission and Member

States that it has rejected the products, indicating the infringements

found.

(2) Notwithstanding sub-rule (1), Malta may authorise the

carrying out, under the conditions laid down by the Veterinary

Services, of one of the following operations

(a) bringing the products into line with the requirements

within a deadline to be determined, or

(b) decontamination where appropriate, or

(c) processing in any other suitable manner, or

(d) use for other purposes, or

(e) destruction of the products.

(3) The Veterinary Services shall ensure that the operations

listed in sub-rule (2) do not give rise to any adverse effects on

human and animal health or on the environment.

(4) The costs incurred in the measures taken in accordance with

sub-rules (1) and (2) shall be borne by the authorisation holder or

his representative.

(1) Where products are not marketed in Malta of which

the Veterinary Services carries out the checks referred to in rule 6

and, where appropriate, a physical check, the Veterinary Services

shall provide the person concerned with a document indicating the

type of check carried out and its outcome. Commercial documents

shall contain a reference to this document.

(2) The right of the Member State of destination to carry out

random checks on products shall not be affected.

(3) A standard document and, where appropriate, detailed rules

for the application of sub-rule (1) shall be adopted in accordance

with the procedure laid down in Article 23 of European Union

Council Directive 95/53/EC.

(1) Where a problem likely to pose a serious risk to human

or animal health or the environment appears or spreads on the

territory of a third country, the European Union Commission, on its

own initiative or at the request of a Member State, shall

immediately depending on the gravity of the situation take the

following measures, in accordance with the procedure laid down in

Article 23a of European Union Council Directive 95/53/EC

(a) suspend imports of products from all or part of the

third country concerned or from one or more specific

production establishments and, where appropriate, any

third country of transit; and, or

(b) lay down special conditions for products intended for

import from all or part of the third country concerned.

Where the Veterinary Services adopts such temporary

protective measures, it shall immediately inform the Member States

and the European Commission.

(2) However, where, the measures referred to in sub-rule (1)

are provisionally adopted by the European Commission after

informing the Veterinary Services of Malta, these measures shall be

applied by Malta and, until they have not been replaced by another

legal act, they shall continue to apply.

Where necessary, on-the-spot inspections may be carried

out by European Union Commission and Member States’ experts in

third countries to verify whether guarantees, offered by those

countries, regarding the conditions for the production and putting

into circulation of products can be considered as at least equivalent

to those required by the European Community.

CHAPTER III

TRADE WITHIN THE EUROPEAN COMMUNITY

Products intended for dispatch to a Member State are

inspected with the same care as those intended to be marketed in

Malta.

(1) The Veterinary Services shall carry out checks on

establishments in order to satisfy itself that they meet their

obligations under European Community legal rules and that

products intended to be marketed comply with European

Community requirements.

(2) Where there are grounds for suspecting that requirements

are not being met, the Veterinary Services shall carry out the

necessary checks and, if the suspicion is confirmed, take the

appropriate measures.

(1) The competent authority of the Member State of

destination may, at places of destination, check the compliance of

products with the requirements of an official inspection in the field

of animal nutrition by means of non-discriminatory random checks.

In particular, and only to the extent necessary for carrying out these

random checks, the Veterinary Services may ask operators to report

the arrival of the products to it. The Veterinary Services shall

inform the European Commission when they avail themselves of

this action.

(2) Without prejudice to sub-rule (1), where the Veterinary

Services in case of transit trough Malta or at destination has

information leading it to suspect an infringement, checks may also

be carried out during the transport of products in the territory.

(1) If, during a check carried out at the place of

destination of a consignment or during transport, the Veterinary

Services establishes the non-compliance of the products with the

with the requirements of an official inspection in the field of animal

nutrition, it shall take the appropriate measures and formally

require the consignor, the consignee or any other person entitled to

carry out, under the conditions laid down by the Veterinary

Services, one of the following operations

(a) bringing of the products into compliance within a

deadline to be determined, or

(b) rendering the products harmless where appropriate, or

(c) processing in any other suitable manner, or

(d) use for other purposes, or

(e) re-dispatch to the country of origin, after informing the

Veterinary Services of the country of the establishment

of origin, or

(f)

destruction of the products.

(2) The costs incurred in the measures taken in accordance with

sub-rule (1) shall be borne by the consignor or any other person

entitled, including where appropriate the consignee.

(1) In the event of the destruction, use for other purposes,

re-dispatch to the country of origin or rendering harmless of the

products, as provided for in rule 16(1), Malta as the Member State

of destination shall contact the Member State of dispatch without

delay. If the Member State of destination fears that such measures

are inadequate, it shall together with the Member State of dispatch

seek ways and means of remedying the situation; if appropriate this

may involve a joint on-the-spot inspection.

(2) Where the checks carried out in accordance with rule 15

show repeated irregularities, the Veterinary Services as the

competent authority of the Member State of destination shall

inform the European Commission and the other Member States.

(3) In the event of the destruction, use for other purposes, re-

dispatch to Malta or rendering harmless of products originating

from Malta, as provided for in rule 16(1), the Veterinary Services

of Malta shall take all necessary measures and notify the Member

State of destination of the nature and outcome of the checks carried

out, the decisions taken and the reasons for such decisions. If the

M e m b e r St a t e o f d e s t i n a t i o n f e a r s t h a t s u c h m e a s u r e s a r e

inadequate, the Veterinary Services and the Member State of

destination shall seek ways and means of remedying the situation;

if appropriate this may involve a joint on-the-spot inspection.

(1) At the request of the Member State of destination or on

its own initiative, taking into account the nature of the

infringements established, the European Commission may -

(a) send representatives, in co-operation with the

Veterinary Services and the Member State concerned,

to the establishment in question,

(b) request the Member State of dispatch to intensify its

checks on the products of the establishment concerned.

(2) The Member State of destination may, for its part, intensify

checks at destination on products coming from the same

establishment.

(3)

In case of products where Malta is the Member State of

dispatch, where at the request of the Member State of destination or

on its own initiative, taking into account the nature of the

infringements established, the European Commission sends

representatives to the establishment of origin, the Veterinary

Services shall afford them all the assistance necessary for carrying

out their duty. Pending the representatives’ findings, the Veterinary

Services must, if so requested by the European Commission,

intensify checks on products coming from the establishment in

question.

(1) Where a problem due to a product to be used in animal

nutrition, likely to pose a serious risk to human health, animal

health or to the environment, appears in one or more Member States

and cannot be contained satisfactorily by means of the measures

taken by any Member State concerned, the Veterinary Services,

acting in accordance with the procedure provided for in Article 23a

of European Union Council Directive 95/53/EC, shall immediately,

depending on the seriousness of the situation adopt the following

measures

(a) suspend the putting into circulation within Malta, the

use in animal nutrition or exports to third countries of

products from all or part of any Member State

concerned or from one or more establishments situated

in the territory of any Member State, or

(b) lay down special conditions for the putting into

circulation in Malta, the use in animal nutrition or

exports to third countries of products from all or part

of any Member State concerned or from one or more

establishments situated in territory of Member States.

(2) Where the Veterinary Services adopts such temporary

protective measures referred to in sub-rule (1), they shall

i m m e d i a t e l y i n f o r m t h e M e m b e r St a t e s a n d t h e E u r o p e a n

Commission.

(3) However, where the measures referred to in sub-rule (1) are

adopted by the European Commission after informing the

Veterinary Services of Malta these measures shall be applied by

Malta.

The Veterinary Services shall have access to places where

agricultural production is carried on and where the products are

manufactured or used in order to carry out the prescribed checks.

CHAPTER III

INFORMATION SYSTEM FOR HAZARDS

FROM FEEDING STUFFS

(1) The persons responsible for the establishments must

immediately inform the Veterinary Services if they have evidence

that a consignment of products for animal nutrition which they

have brought into the territory from a third country or put into

circulation, and which they are holding or own -

(a) exceeds the maximum levels laid down in Section A of

Annex II to European Union Council Directive 2002/

32/EC beyond which the product must not be fed as

such to animals or mixed with other products for

animal nutrition, or

(b) does not comply with one of the other provisions

referred to in the definition of "official inspection in

the field of animal nutrition" in rule 2(1) and, owing to

that non-compliance and, in view of the purpose for

which it is intended, poses a serious risk to human

health, animal health or to the environment.

(2) The persons responsible for the establishments shall

provide all details enabling precise identification of the relevant

product or consignment of products and as full as possible a

description of the risk posed by the product or products concerned,

as well as all available information useful in tracing the product or

products.

(3) The persons responsible for the establishments the

Veterinary Services of action taken to prevent risks to human

health, animal health or to the environment, describing that action.

(4) The Veterinary Services shall lay down the same

information requirements concerning the risks posed by products

for animal nutrition for persons carrying out health monitoring of

holdings such as those referred to in Article 10 of Council

Directive 96/23/EC on measures to monitor certain substances and

residues thereof in live animals and animal products, and for

persons responsible for laboratories carrying out analyses.

(5) Where appropriate, the Veterinary Services shall apply the

provisions of rules 9, 14 or 16.

(1) Where the Veterinary Services of Malta have

information indicating, on the basis of the risk assessment factors

available, that a consignment of products for animal nutrition poses

a serious risk to human health, animal health or to the environment

they shall verify the information received and, where appropriate,

ensure that the necessary measures are taken so that the

consignment is not used in animal nutrition, put the consignment

under restriction and investigate immediately -

(a) the nature of the hazard and where appropriate the

level of undesirable substances,

(b) the possible origin of the undesirable substances or of

the hazard, in order to assess the risk more closely.

(2) Where appropriate, the risk assessment shall be extended to

other consignments of the same product or to other products in the

feed or food chain which might contain undesirable substances or

in respect of which such a hazard might exist, taking into account

any admixture of the undesirable substances in other products for

animal nutrition and possible recycling of dangerous products into

the feed chain.

(3) Where the existence of a serious risk is confirmed in

accordance with sub-rule (1), the Veterinary Services shall ensure

that the final destination of the consignment containing undesirable

substances, including possible decontamination, further action to

render the products harmless, reprocessing or destruction, cannot

h a v e h a r m f u l e ff e c t s o n h u m a n o r a n i m a l h e a l t h o r o n t h e

environment and where it is possible that the undesirable

substances or the risk of such substances being present has

extended to other consignments or to the feed or food chain.

(4) Subject to sub-rule (3) the Veterinary Services shall

immediately identify and put under control other consignments of

the products deemed hazardous and also, where appropriate,

identify live animals fed with hazardous products and implement

the measures provided for in European Union Council Directive 96/

23/EC or in other relevant veterinary provisions relating to animal

health or to the food safety of products of animal origin ensuring

co-ordination between the relevant control services, in order to

avoid the hazardous products being put into circulation and to

ensure the enforcement of recall procedures for the products

already in circulation.

(1) Where the Veterinary Services finds that a product for

animal nutrition which has been put into circulation in Malta and in

that of Member States, or a product originating in a third country

which has been brought into the territory in order to be put into

circulation in Malta or in the Member States -

(a) exceeds the maximum levels laid down in Section A of

Annex II to Council Directive 2002/32/EC beyond

which the product must not be fed as such to animals

or mixed with other products for animal nutrition, or

(b) does not comply with one of the other provisions

referred to in the definition of "official inspection in

the field of animal nutrition" in rule 2(1) and, owing to

that non-compliance and the purpose for which it is

intended, poses a serious risk to human health, animal

health or to the environment,

t h e Ve t e r i n a r y S e r v i ce s s h a l l f o r t h w i t h a l e r t t h e E u r o p e a n

Commission by way of notification.

(2) The Veterinary Services shall provide sufficient

information to identify the products concerned, trace and put them

under control and, where appropriate, the live animals fed with

them, and shall specify safeguard measures envisaged or already

taken, in order to enable the European Commission properly to

inform the Member States.

(3) The Veterinary Services shall immediately alert the

European Commission of any follow up measure taken in respect of

the notified hazards, including information concerning the end of

the risk situation.

(4) The Veterinary Services shall participate in the setting up

and operational phases of a system for rapid exchange of

information under conditions set in accordance with the procedure

provided for in Article 23 of European Union Council Directive 95/

53/EC, with a view to expediting transmission and dissemination of

the alerts referred to in sub-rule (1) and the information referred to

in rule 9(1).

CHAPTER IV

GENERAL PROVISIONS AND INSPECTIONS

(1) In Malta, inspections shall be carried out in such a way

that delays in the delivery of products are minimised and that

inspections do not result in unjustified obstacles to the marketing

thereof.

(2) Officials responsible

for

inspection

are

subject

to

professional confidentiality

Provided that, this provision shall not affect the possibility

for the Veterinary Services of disseminating information necessary

to prevent a serious risk to human health, animal health or to the

environment.

(1) Experts from the European Commission may, make

on-the-spot inspections in co-operation with the Veterinary

Services of establishments situated in Malta.

(2) The Veterinary Services shall afford the experts referred to

in sub-rule (1) all the assistance necessary for carrying out their

duties.

(1) Where products are sampled for the purpose of

analysis, the Veterinary Services shall adopt the provisions

necessary -

(a) to ensure that those subject to checks are entitled to a

second opinion,

(b) to ensure that officially sealed reference samples are

preserved.

(2) The Veterinary Services shall draw up a list of laboratories

responsible for carrying out analyses, and shall ensure that such

laboratories are designated on account of their capabilities.

(3) Sampling and analysis are carried out in accordance with

European Community rules.

(4) In the absence of European Community rules and methods,

the Veterinary Services shall take all necessary steps to satisfy

itself that inspections are carried out -

(a) in accordance with

standards

recognised

by

international bodies;

(b) in the absence of such standards, in accordance with

scientifically recognised rules which comply with the

general principles of the agreement with Member

States.

(5) Detailed rules for the application of this rule may be

adopted in accordance with the procedure laid down in Article 23

of European Union Council Directive 95/53/EC.

(1) The provisions of these rules shall be applied in full.

(2) Subject to the provisions of these rules and of the

Veterinary Services Act, a person who infringes any of the

provisions arising from these rules, shall on conviction be liable to

a fine (multa) of not less than two thousand and three hundred and

twenty-nine euro and thirty-seven cents (2,329.37) and not

exceeding eleven thousand and six hundred and forty-six euro and

eighty-seven cents (11,646.87).

(3) Without prejudice to the provisions in sub-rule (1), the

court may also order any person who is found guilty of committing

an offence under these rules, to pay for the expenses incurred by

the Veterina ry Services a s a re su lt o f th e sai d off ence, th e

revocation of the permit issued under European Union Council

Directive 95/69/EC and any other rules in the field of animal

nutrition and the confiscation, retention and disposal of the items

not complying with these rules and other rules in the field of animal

nutrition.

(1) Rights of appeal existing under the laws in force in

Malta against decisions by the Veterinary Services shall not be

affected by these rules. Decisions taken by the Veterinary Services

where an infringement has been found and the reasons for such

decisions must be notified to the operator concerned by such

decisions or his representative.

(2) If the operator concerned or his representative so requests,

the said decisions and reasons must be communicated to him in

writing with details of the rights of appeal which are available to

him under the law in force in Malta performing the checks and of

the procedure and time limits applicable.

(1) The Veterinary Services shall drawn up programmes

setting out the measures to be taken to achieve the aim of these

rules. These programmes must take into account the specific

situation of Malta and specify the type and frequency of the

inspections, which must be performed regularly.

(2) Before 1st April of each year, the Veterinary Services shall

transmit to the European Commission all relevant information

concerning the implementation of the programmes referred to in

sub-rule (1) during the previous year, specifying -

(a) the criteria used in drawing up the programmes,

(b) the number and type of inspections carried out,

(c) the results of the inspections, in particular the number

and type of infringements found,

(d) action taken where infringements have been found.

(3) The information referred to in sub-rule (2) be presented in

the form of annual reports in accordance with the specimen drawn

up by the European Commission.

(4) The Veterinary Services shall follow the recommendation

concerning a co-ordinated inspection programme drawn up by the

European Commission.

(5) Without prejudice to sub-rules (1), (2) and (4), where the

protection of human or animal health or the environment requires

the prompt introduction of limited, specific, co-ordinated

programmes of inspections, the Veterinary Services, according to

the decisions taken by the European Commission, shall take the

necessary measures in accordance with the procedure laid down in

Article 23 of European Union Council Directive 95/53/EC.

(6) The programmes referred to in sub-rule (5) shall in

particular serve in situations provoked by any specific incident.