Animal Nutrition (Organisation of Official Inspections), 2005

L.N. 147 of 2005

VETERINARY SERVICES ACT

(CAP. 437)

Animal Nutrition (Organisation of Official Inspections), 2005

IN exercise of the powers conferred by article 23 of the Veterinary

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

made the following rules>-

CHAPTER I

INTRODUCTORY PROVISIONS

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

(Organisation of Official Inspections) Rules, 2005.

(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 inspection 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 Documentary and

products are introduced into the customs territory of Malta they are random

checks.

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 Designation of entry

points in Malta.

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.

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

from third countries.

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,

Veterinary Services.

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 Emergency

measures adopted

or animal health or the environment appears or spreads on the territory regarding imports

of a third country, the European Union Commission, on its own initiative originating

third country.

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.

(1) Where necessary, on-the-spot inspections may be On-the-spot

inspections in third

carried out by European Union Commission and Member States’ experts countries.

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 Inspection of

products intended

inspected with the same care as those intended to be marketed in Malta. for dispatch to a

Member State.

(1) The Veterinary Services shall carry out checks on Checks at source.

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 provisions of rule 2 (1) (a) 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 provisions of rule 2 (1) (a),

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, Co-operation

event of

re-dispatch to the country of origin or rendering harmless of the products, infringements.

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 Member State

of destination fears that such measures are 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 Co-operation with

the European

its own initiative, taking into account the nature of the infringements Commission in case

established, the European Commission may -

of infringements.

(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), it shall immediately

inform the Member States and the European 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 rule 2 (1) (a) to these rules 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 Measures to be

taken on the basis of

information indicating, on the basis of the risk assessment factors risk assessment in

available, that a consignment of products for animal nutrition poses a the event of

hazards.

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 have harmful

effects on human or animal health or on the 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 rule 2 (1) (a) to these rules 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, the Veterinary

Services shall forthwith alert the European Commission by way

of notification.

(2) The Veterinary Services 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 to 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 Considerations

when carrying out

that delays in the delivery of products are minimised and that inspections 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- On-the-spot

the-spot inspections in co-operation with the Veterinary Services of inspections

European

establishments situated in Malta.

Commission

experts.

(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 -

official sampling for

(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 Service 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 one thousand Malta Liri and not exceeding five thousand

Malta liri.

(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

Veterinary Services as a result of the said offence, the 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 Rights of appeal in

the event of

against decisions by the Veterinary Services shall not be affected by infringement.

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 Monitoring

Programmes in the

setting out the measures to be taken to achieve the aim of these rules. Field of Animal

These programmes must take into account the specific situation of Malta Nutrition.

and specify the type and frequency of the inspections, which must be

performed regularly.

(2) Before 1 st 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.

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