Animal Feed Sector Rules, 2005

L.N. 100 of 2005

VETERINARY SERVICES ACT

(CAP. 437)

Conditions for the Registering of Establishments operating in the

Animal Feed Sector Rules, 2005

IN exercise of the powers conferred by article 23(b) of the

Veterinary Services Act, the Minister for Rural Affairs and the

Environment, after consultation with the Veterinary Services has made

the following rules>-

(1) The title of these rules is the Conditions for the Title and scope

Registering of Establishments operating in the Animal Feed Sector

Rules, 2005.

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

under European Union Council Directive 95#69#EEC laying down the

conditions and arrangements for approving and registering certain

establishments and intermediaries operating in the animal feed sector

to allow them to exercise the activities described in rules 3 and 8 and in

rules 4 and 9 respectively, and in accordance with article 23(b) of the

Veterinary Services Act.

(3) These rules shall apply without prejudice to the legislative

provisions concerning the organization of official checks on animal feed.

CHAPTER 1

Minimum conditions which must be fulfilled by establishments and intermediaries

referred to in rules 3 and 4 (subject to approval)

CHAPTER I.1. (a)

Additives and products covered by Directive 82/471/EEC (‘products’) and referred

to in sub-rule 3 (2) (a) and sub-rule 4 (1) of these rules

Additives

— Antibiotics

all additives in the group

— Coccidiostats and other medicinal

substances

all additives in the group

— Growthpromoters

all additives in the group

— Vitamins, provitamins and chemically

well-defined substances having a

similar effect

all additives in the group

— Trace elements

all additives in the group

— Enzymes

all additives in the group

— Micro-organisms

all additives in the group

— Carotenoids and xanthophylls

all additives in the group

— Substances with antioxidant

effects

only those with a fixed maximum content

Products covered by Directive 82/471/EEC

— Proteins obtained from microorganisms

belonging to the group of

bacteria, yeasts, algae, lower fungi

all products in the group (except for

sub-group 1.2.1)

— Co-products of the manufacture of

amino acids by fermentation

all products in the group

— Amino acids and their salts

all products in the group

— Hydroxy analogues of amino acids

all products in the group

CHAPTER I.1. (b)

Minimum conditions which must be fulfilled by establishments referred to in sub-

rule 3 (2) (a) and intermediaries referred to in sub-rule 4 (1) (‘products’ referred to

in Chapter I.1(a))

1. Facilities and equipment

Facilities and manufacturing equipment must be located, designed, constructed and

maintained to suit the manufacture of the ‘products’ concerned. The lay-out, design and

operation of the facilities and equipment must be such as to minimize the risk of error and

permit effective cleaning and maintenance in order to avoid contamination, cross-

contamination and any adverse effects generally on the quality of the products. Facilities

and equipment to be used for manufacturing operations which are essential for the quality

of the products must undergo appropriate and regular checks, in accordance with written

procedures pre-established by the manufacturer for production of the products.

2. Personnel

The manufacturer must have sufficient staff possessing the skills and qualifications

necessary for the manufacture of the ‘products’ concerned. An organizational chart

setting out the qualifications (diplomas, professional experience) and responsibilities of

the supervisory staff must be drawn up and made available to the competent authorities of

the supervisory staff must be drawn up and made available to the competent authorities

responsible for inspection. All the staff must be informed clearly in writing of their

duties, responsibilities and powers, especially when any change is made, in such a way as

to obtain the desired quality of the ‘products’ concerned.

3. Production

A qualified person responsible for production must be designated. The manufacturer must

ensure that the different stages of production are carried out according to pre-established

written procedures and instructions aimed at defining, checking and mastering the critical

points in the manufacturing process.

Technical or organizational measures must be taken to avoid cross-contamination and

errors. There must be sufficient and appropriate means of carrying out checks in the

course of manufacture.

4. Quality control

A qualified person responsible for quality control must be designated.

The manufacturer must have access to a quality control laboratory having adequate staff

and equipment to guarantee and check, before the release of the ‘products’ concerned

with a view to putting them into circulation, that they comply with the specifications

defined by the manufacturer and are in conformity with the provisions laid down in

Directive 70/524/EEC or Directive 82/741/EEC. The use of an outside laboratory is

permitted.

A quality control plan must be drawn up in writing and implemented, to include, in

particular, checks on the critical points in the manufacturing process, sampling

procedures and frequencies, methods of analysis and their frequency, compliance with

the specifications — and the destination in the event of non-compliance — of raw

materials, active substances, carrier substances and ‘products’.

Samples of the active substance and of each batch of ‘product’ put into circulation or of

each specific portion of production in the case of continuous production must be taken in

sufficient quantity by a procedure pre-established by the manufacturer and be retained in

order to ensure traceability. The samples must be sealed and labelled for ease of

identification; they must be stored under conditions which prevent any abnormal change

in the composition of the sample or any abnormal adulteration. They must be kept at the

disposal of the competent authorities at least until the guarantee date of the finished

product.

5. Storage

Raw materials, active substances, carrier substances, ‘products’ which meet the

specifications — and those which do not — must be stored in suitable containers in

places designed, adapted and maintained in order to ensure good storage conditions, to

which only persons authorized by the manufacturer have access.

They must be stored in such a way as to be easily identifiable and to avoid any confusion

or cross-contamination between the different products mentioned above and with

medicinal substances. Additives must be packaged and labelled in particular in

compliance with the provisions laid down in Directive 70/524/EEC. Products covered by

Directive 82/471/EEC must be labelled in compliance with the provisions of those rules.

6. Documentation

6.1. Documentation relating to the manufacturing process and controls

The manufacturer must have a system of documentation designed to define and ensure

mastery of the critical points in the manufacturing process and to establish and implement

a quality control plan. The manufacturer must keep the results of the relevant controls.

This set of documents must be kept so that it is possible to trace the manufacturing

history of each batch of ‘product’ put into circulation and to establish responsibility if

complaints arise.

6.2. Register

The manufacturer must record the following information in order to ensure traceability

(a) register of additives

— the nature and quantity of the additives produced, the respective dates of manufacture

and, where appropriate, the number of the batch or of the specific portion of production

in the case of continuous manufacture, and the names and addresses of the intermediaries

or manufacturers to whom the additives have been delivered,

— indication of the nature and quantity of the additives delivered and, where appropriate,

the number of the batch or of the specific portion of production in the case of continuous

manufacture;

(b) register of products covered by Directive 82/471/EEC

— the nature of the products and the quantity produced, the respective dates of

manufacture and, where appropriate, the number of the batch or of the specific portion of

production in the case of continuous manufacture,

— the names and addresses of the intermediaries or users (manufacturers or stock

breeders) to whom these products have been delivered, together with an indication of the

nature and quantity of the products delivered and, where appropriate, the number of the

batch or of the specific portion of production in the case of continuous manufacture.

7. Intermediaries referred to in Article 4 (1)

Where the manufacturer delivers additives to a person other than a manufacturer or

products referred to in Directive 82/471/EEC to a person other than a user (manufacturer

or stock breeder), that person and any subsequent intermediary by whom they are

wrapped, packaged, stored or put into circulation shall be equally bound, as appropriate,

by the obligations laid down in points 4, 5, 6.2 and 8 and, in the case of wrapping, by

those referred to in point 3.

8. Complaints and product recall

The manufacturer or any intermediary putting a product into circulation under his own

name must implement a system for registering and processing complaints. Likewise, he

must be in a position to introduce, where this proves necessary, a system for prompt

recall of products in the distribution network. The manufacturer must define by means of

written procedures the destination of any recalled products, and before such products are

put back into circulation they must undergo a quality-control reassessment.

CHAPTER I.2. (a)

Additives referred to in sub-rule 3 (2) (b) and sub-rule 4 (1)

— Antibiotics

all additives in the group

— Coccidiostats and other medicinal

substances

all additives in the group

— Growth promoters

all additives in the group

— Vitamins, provitamins and chemically

well-defined substances having a

similar effect

A and D

— Trace elements

Cu and Se

CHAPTER I.2. (b)

Minimum conditions which must be fulfilled by establishments referred to in sub-

rule 3 (2) (b) and intermediaries referred to in sub-rule 4 (1) (pre-mixtures of

additives referred to in Chapter I.2 (a))

1. Facilities and equipment

Facilities and manufacturing equipment must be located, designed, constructed and

maintained to suit the manufacture of the pre-mixtures concerned. The layout, design and

operation of the facilities and equipment must be such as to minimize the risk of error and

permit effective cleaning and maintenance in order to avoid contamination, cross-

contamination and any adverse effects generally on the quality of the products. Facilities

and equipment to be used for operations which are essential for the quality of the

products must undergo appropriate and regular checks in accordance with the written

procedures pre-established by the manufacturer.

Preventive measures must be taken to avoid, as far as possible, the presence of harmful

organisms, with the introduction of a control plan if necessary.

2. Personnel

The manufacturer must have sufficient staff possessing the skills and qualifications

necessary for the manufacture of the pre-mixtures concerned. An organizational chart

setting out the qualifications (diplomas, professional experience) and responsibilities of

the supervisory staff must be drawn up and made available to the competent authorities

responsible for inspection. All the staff must be informed clearly in writing of their

duties, responsibilities and powers, especially when any change is made, in such a way as

to obtain the desired quality of the pre-mixtures concerned.

3. Production

A qualified person responsible for production must be designated.

The manufacturer must ensure that the different stages in production are carried out

according to pre-established written procedures and instructions aimed at defining,

checking and mastering the critical points in the manufacturing process, such as in

corporation of the additive in the pre-mixture, chronological order of production, meters

and weighing apparatus, mixer and returns, in such a way as to obtain the desired quality

of the pre-mixtures concerned in accordance with the provisions of Directive

70/524/EEC.

Technical or organizational measures must be taken to avoid cross-contamination and

errors.

4. Quality control

A qualified person responsible for quality control must be designated.

The manufacturer must have access to a quality control laboratory having adequate staff

and equipment to guarantee and check that the pre-mixtures concerned comply with the

specifications defined by the manufacturer and which will guarantee and check, in

particular, the nature, content, homogeneity and stability of the additives in the pre-

mixture, and as low a level of cross-contamination as possible. The use of an outside

laboratory is permitted.

A quality control plan must be drawn up in writing and implemented, to include, in

particular, checks on the critical points in the manufacturing process, sampling

procedures and frequencies, methods of analysis and their frequency, compliance with

the specifications — and destination in the event of non-compliance — for carrier

substances, additives and pre- mixtures (‘products’).

Samples of each batch of pre-mixture put into circulation must be taken in sufficient

quantity by a procedure pre-established by the manufacturer and be retained in order to

ensure traceability. These samples must be sealed and labelled for ease of identification;

they must be stored under conditions which prevent any abnormal change in the

composition of the sample or any abnormal adulteration. They must be kept at the

disposal of the competent authorities at least until the guarantee date of the pre-mixture.

5. Storage

‘Products’ which meet the specifications — and those which do not — must be stored in

suitable containers or in places designed, adapted and maintained in order to ensure good

storage conditions, to which only persons authorized by the manufacturer have access.

Preventive measures must be taken to avoid, as far as possible, the presence of harmful

organisms, with the introduction of a control plan if necessary. The ‘products’ must be

stored in such a way as to be easily identifiable and to avoid any confusion or cross-

contamination between the different products and with medicinal substances. Pre-

mixtures must be wrapped and labelled in accordance with the provisions of Directive

70/524/EEC.

6. Documentation

6.1. Documentation relating to the manufacturing process and controls

The manufacturer must have a system of documentation designed to define and ensure

the mastery of the critical points in the manufacturing process, and to establish and

implement a quality control plan. The manufacturer must keep the results of the relevant

controls. This set of documents must be kept in such a way as to make it possible to trace

the manufacturing history of each pre-mixture batch put into circulation and to establish

responsibility if complaints arise.

6.2. Register of pre-mixtures

The manufacturer must record the following information in order to ensure traceability

— the names and addresses of manufacturers of additives or of intermediaries, the nature

and quantity of the additives used and, where appropriate, the number of the batch or of

the specific portion of production in the case of continuous manufacture,

— the date of manufacture of the pre-mixture, the batch number where appropriate,

— the names and addresses of the intermediaries or manufacturers of compound feeding

stuffs to whom the pre-mixture is delivered, the delivery date, the nature and quantity of

the pre-mixture is delivered, and the batch number where appropriate.

7. Intermediaries referred to in sub-rule 4 (1)

Where the manufacturer delivers pre-mixtures to a person other than a manufacturer of

compound feeding stuffs, that person and any subsequent intermediary by whom they are

wrapped, packaged, stored our put into circulation shall be equally bound, as appropriate,

by the obligations laid down in points 4, 5, 6.2 and 8 and, in the case of wrapping, by

those referred to in point 3.

8. Complaints and product recall

The manufacturer or any intermediary putting a product into circulation under his own

name must implement a system for registering and processing complaints. Likewise, he

must be in a position to introduce, where this proves necessary, a system for prompt

recall of products in the distribution network. The manufacturer must define by means of

written procedures the destination of any recalled products, and before such products are

put back into circulation they must undergo a quality-control reassessment.

CHAPTER I.3. (a)

Additives referred to in sub-rules 3 (2) (c) and (e)

— Antibiotics

all additives in the group

— Coccidiostats and other medicinal

substances

all additives in the group

— Growthpromoters

all additives in the group

CHAPTER I.3. (b)

Minimum conditions which must be fulfilled by establishments referred to in sub-

rule 3 (2) (c) and (e) (compound feeding stuffs containing pre-mixtures of additives

referred to in Chapter I.3 (a))

1. Facilities and equipment

Facilities and manufacturing equipment must be located, designed, constructed and

maintained to suit the manufacture of compound feeding stuffs containing pre-mixtures.

The layout, design and operation of the facilities and equipment must be such as to

minimize the risk of error and permit effective cleaning and maintenance in order to

avoid, as far as possible, contamination, cross-contamination and any adverse effects

generally on the quality of the products.

Facilities and equipment to be used for manufacturing operations which are essential for

the quality of the products must undergo appropriate and regular checks, in accordance

with the written procedures pre-established by the manufacturer, or possibly, in the case

of manufacture solely for the manufacturer's own needs, pre-established by a qualified

outside person acting at the request and under the responsibility of the manufacturer.

Preventive measures must be taken to avoid, as far as possible, the presence of harmful

organisms, with the introduction of a control plan if necessary.

2. Personnel

The manufacturer must have sufficient staff possessing the skills and qualifications

necessary for the manufacture of compound feeding stuffs containing pre-mixtures. An

organizational chart setting out the qualifications (diplomas, professional experience) and

responsibilities of the supervisory staff must be drawn up — if appropriate in the case of

manufacture solely for the manufacturer's own needs — and made available to the

competent authorities responsible for inspection. All the staff must be informed clearly in

writing of their duties, responsibilities and powers, especially when any change is made,

in such a way as to obtain the desired quality of the compound feeding stuffs containing

pre-mixtures.

3. Production

A qualified person responsible for production must be designated who, in the case of

manufacture solely for the manufacturer's own needs, may if necessary be from outside,

but shall act at the request and under the responsibility of the manufacturer.

The manufacturer must ensure that the different stages in production are carried out

according to pre-established written procedures and instructions aimed at defining,

checking and mastering the critical points in the manufacturing process, such as

incorporation of the pre-mixture in the feeding stuff, chronological order of production,

meters and weighing apparatus, mixer and returns, in such a way as to obtain the desired

quality of the compound feeding stuffs in accordance with the provisions of Directive

79/373/EEC.

Technical or organizational measures shall be taken to avoid cross-contamination and

errors as far as possible.

4. Quality control

A qualified person responsible for quality control must be designated who, in the case of

manufacture solely for the manufacturer's own needs, may if necessary be from outside,

but shall act at the request and under the responsibility of the manufacturer.

The manufacturer must have at his disposal a quality control laboratory having adequate

staff and equipment to guarantee and check that the compound feeding stuffs containing

pre-mixtures comply with the specifications defined by the manufacturer and which will

guarantee and check, in particular, the nature, content and homogeneity of the additives

concerned in the compound feeding stuffs, and as low a level as possible of cross-

contamination, as well as, in the case of feeding stuffs to be put into circulation, the

contents as regards analytical constituents (Directive 79/373/EEC). The use of an outside

laboratory is permitted.

A quality control plan must be drawn up in writing and implemented, to include, in

particular, checks on the critical points in the manufacturing process, sampling

procedures and frequencies, methods of analysis and their frequency, compliance with

the specifications — and destination in the event of non-compliance — for raw materials,

pre-mixtures and compound feeding-stuffs ‘products’.

Samples must be taken in sufficient quantity by a procedure pre-established by the

manufacturer on the basis of each batch of compound feeding stuffs or each specific

portion of production in the case of continuous manufacture, and be retained in order to

ensure traceability where it is put into circulation, or on a regular basis in the case of

manufacture solely for the manufacturer's own needs. These samples must be sealed and

labelled for ease of identification; they must be stored under conditions which prevent

any abnormal change in the composition of the sample or any abnormal adulteration.

They must be kept at the disposal of the competent authorities for an appropriate period.

5. Storage

‘Products’ which meet the specifications — and those which do not — must be stored in

suitable containers in places designed, adapted and maintained in order to ensure good

storage conditions, to which only persons authorized by the manufacturer have access.

Preventive measures must be taken to avoid, as far as possible, the presence of harmful

organisms, with the introduction of a control plan if necessary.

The ‘products’ must be stored in such a way as to be easily identifiable and to avoid any

confusion or cross-contamination between the different products and with medicinal

substances or medicinal feeding stuffs, or with raw materials containing high levels of

undesirable substances and products, or with additives. Compound feeding stuffs

intended to be put into circulation must comply with the provisions of Directive

79/373/EEC.

6. Documentation

6.1. Documentation relating to the manufacturing process and controls

The manufacturer must have a system of documentation designed to define and ensure

the mastery of the critical points in the manufacturing process, and to establish and

implement a quality control plan. The manufacturer must keep the results of the relevant

controls. This set of documents must be kept in such a way as to make it possible to trace

the manufacturing history of each batch produced and, where it is put into circulation, to

establish responsibility if complaints arise.

6.2. Register of compound feeding stuffs

The manufacturer must record the following information in order to ensure traceability

— the names and addresses of pre-mixture manufacturers or intermediaries, with the

batch number if appropriate, the nature and quantity of the pre-mixture used,

— the nature and quantity of feeding stuffs manufactured, together with the date of

manufacture.

7. Complaints and product recall

The manufacturer must implement a system for registering and processing complaints.

Likewise, he must be in a position to introduce, where this proves necessary, a system for

prompt recall of products in the distribution network. The manufacturer must define by

means of written procedures the destination of any recalled products, and before such

products are put back into circulation they must undergo a quality-control reassessment.

CHAPTER I.4

Minimum conditions which must be fulfilled by establishments referred to in sub-

rule 3 (2) (d) and (e) (compound feeding stuffs from raw materials which contain

high levels of undesirable substances and products (‘raw materials concerned’))

1. Facilities and equipment

Facilities and manufacturing equipment must be located, designed, constructed and

maintained to suit the manufacture of compound feeding stuffs from the ‘raw materials

concerned’. The layout, design and operation of the facilities and equipment must be such

as to minimize the risk of error and permit effective cleaning and maintenance in order to

avoid contamination, as far as possible, contamination, cross-contamination and any

adverse effects generally on the quality of the products. Facilities and equipment to be

used for manufacturing operations which are essential for the quality of the products must

undergo appropriate and regular checks, in accordance with written procedures pre-

established by the manufacturer, or possibly, in the case of manufacture solely for the

manufacturer's own needs, pre-established by a qualified outside person acting at the

request and under the responsibility of the manufacturer.

Preventive measures must be taken to avoid, as far as possible, the presence of harmful

organisms, with the introduction of a control plan if necessary.

2. Personnel

The manufacturer must have sufficient staff possessing the skills and qualifications

necessary for the manufacture of compound feeding stuffs from the ‘raw materials

concerned’. An organizational chart setting out the qualifications (diplomas, professional

experience) and responsibilities of the supervisory staff must — if appropriate in the case

of manufacture solely for the manufacturer's own needs — be drawn up and made

available to the competent authorities responsible for inspection. All the staff must be

informed clearly in writing of their duties, responsibilities and powers, especially when

any change is made, in such a way as to obtain the desired quality of compound feeding

stuffs from the ‘raw materials concerned’.

3. Production

A qualified person responsible for production must be designated who, in the case of

manufacture solely for the manufacturer's own needs, may if necessary be from outside,

but shall act at the request and under the responsibility of the manufacturer.

The manufacture must ensure that the different stages in production are carried out

according to pre-established written procedures and instructions aimed at defining,

checking and mastering the critical points in the manufacturing process, such as

incorporation in the feeding stuff of the ‘raw material concerned’, chronological order of

production, meters and weighing apparatus, mixer and returns, in such a way as to obtain

the desired quality of the compound feeding stuffs in accordance with the provisions of

Directive 79/373/EEC.

Technical or organizational measures shall be taken to avoid cross-contamination and

errors as far as possible.

4. Quality control

A qualified person responsible for quality control must be designated who, in the case of

manufacture solely for the manufacturer's own needs, may if necessary be from outside,

but shall act at the request and under the responsibility of the manufacturer.

The manufacturer must have at his disposal a quality control laboratory having adequate

staff and equipment to guarantee and check that the compound feeding stuffs concerned

comply with the specifications defined by the manufacturer and which will guarantee and

check, in particular, the nature, content and homogeneity of the undesirable substances

and products concerned in the compound feeding stuff, and as low a level as possible of

cross-contamination as well as compliance with the maximum levels of undesirable

substances and products as laid down in Directive 1999/29/EEC and, in the case of

feeding stuffs to be put into circulation, contents as regards analytical constituents

(Directive 79/373/EEC). The use of an outside laboratory is permitted.

A quality control plan shall be drawn up in writing and implemented, to include, in

particular, checks on the critical points in the manufacturing process, sampling

procedures and frequencies, methods of analysis and their frequency, compliance with

the specifications — and destination in the event of non-compliance — for raw materials,

including those with high levels of undesirable substances and products, and compound

feeding stuffs.

Samples must be taken sufficient quantity by a procedure pre-established by the

manufacturer on the basis of each of compound feeding stuffs or each specific portion of

production in the case of continuous manufacture, and be retained in order to ensure

traceability where it is put into circulation, or on a regular basis in the case of

manufacture solely for the manufacturer's own needs. These samples must be sealed and

labelled for ease of identification; they must be stored under conditions which prevent

any abnormal change in the composition of the sample or any abnormal adulteration.

They must be kept at the disposal of the competent authorities for a period appropriate to

the use to which the feeding stuffs are put.

5. Storage

Raw materials, notably those containing high levels of undesirable substances and

products and compound feeding stuffs which meet the specifications — and those which

do not — must be stored in suitable containers or in places designed, adapted and

maintained in order to ensure good storage conditions.

Preventive measures must be taken to avoid, as far as possible, the presence of harmful

organisms, with the introduction of a control plan if necessary.

The products must be stored in such a way as to be easily identifiable and to avoid any

confusion or cross-contamination between the different products mentioned above and

with medicinal substances or medicinal feeding stuffs, or with additives or pre-mixtures

of additives. Compound feeding stuffs intended to be put into circulation must comply

with the provisions of Directive 79/373/EEC.

6. Documentation

6.1. Documentation relating to the manufacturing process and controls

The manufacturer must have a system of documentation designed to define and ensure

the mastery of the critical points in the manufacturing process, and to establish and

implement a quality control plan. The manufacturer must in particular keep the results of

the relevant controls. This set of documents must be kept in such a way as to make it

possible to trace the manufacturing history of each batch produced and, where it is put

into circulation, to establish responsibility if complaints arise.

6.2. Register of compound feeding stuffs

The manufacturer must record the following information in order to ensure traceability

— the names and addresses of suppliers of raw materials containing high level of

undesirable substances and products, and

— the nature and level of undesirable substances and products, the delivery date and the

nature and quantity of the products manufactured, plus the date of manufacture.

7. Complaints and product recall

The manufacturer must implement a system for registering and processing complaints.

Likewise, he must be in a position to introduce, where this proves necessary, a system for

prompt recall of products in the distribution network. The manufacturer must define by

means of written procedures the destination of any recalled products, and before such

products are put back into circulation they must undergo a quality-control reassessment.

CHAPTER II

Minimum conditions which must be fulfilled by establishments and intermediaries

referred to in rules 8 and 9 (subject to registration)

CHAPTER II (a)

Additives referred to in sub-rule 8 (2) (b), (c) and (d) and in sub-rule 9 (1)

— Vitamins, provitamins and chemically

well-defined substances having a

similar action

all additives in the group except for

vitamins A and D

— Trace elements

all additives in the group except for

Cu and Se

— Carotenoids and xanthophylls

all additives in the group

— Enzymes

all additives in the group

— Micro-organisms

all additives in the group

— Substances with antioxidant

effects

only those with a fixed maximum

content

CHAPTER II (b)

Additives referred to in sub-rule 8 (2) (c) and (d)

— Vitamins, provitamins and chemically

well-defined substances having a

similar action

all additives in the group

— Trace elements

all additives in the group

— Carotenoids and xanthophylls

all additives in the group

— Enzymes

all additives in the group

— Micro-organisms

all additives in the group

— Substances withantioxidant effect

only those with a fixed maximum

content

CHAPTER II (c)

Minimum conditions which must be fulfilled by establishments and intermediaries

referred to in sub-rule 8 (2) (a) and (b) and sub-rule 9 (1), (additives for which a

prescribed maximum level is set and which are not referred to in Chapter I.1 (a), pre-

mixtures of additives referred to in Chapter II (a)) and establishments referred to in sub-

rule 8 (2) (c) and (d), (compound feeding stuffs containing pre-mixtures of additives

referred to in Chapter II (b) or additives referred to in Chapter II (a)).

1. Facilities and equipment

Facilities and technical equipment must be located, designed, constructed and maintained

to suit the manufacture of the additives, pre-mixtures of additives and compound feeding

stuffs containing additives or pre-mixtures of additives concerned (‘products concerned’).

2. Personnel

The manufacturer must have sufficient staff possessing the skills and qualifications

necessary for the manufacture of the ‘products concerned’.

3. Production

A qualified person responsible for production must be designated who, in the case of

manufacture solely for the manufacturer's own needs, may if necessary be from outside,

but shall act at the request and under the responsibility of the manufacturer.

The manufacturer must ensure that the different stages of production are carried out in

such a way as to obtain the desired quality of the ‘products concerned’ in accordance

with the provisions of Directive 70/524/EEC or Directive 79/373/EEC.

4. Quality control

A qualified person responsible for quality control must be designated who, in the case of

manufacture solely for the manufacturer's own needs, may if necessary be from outside,

but shall act at the request and under the responsibility of the manufacturer.

The manufacturer must draw up and implement a quality control plan to guarantee and

check that the ‘products in question’ comply with the specifications defined by the

manufacturer and that they comply, as appropriate, with the provisions of Directive

70/524/EEC or Directive 79/373/EEC.

In order to ensure traceability, samples must be taken and kept, where appropriate, from

each batch of the product or from each specific portion of production in the case of

continuous or regular manufacture. They must be kept at the disposal of the competent

authorities for a period appropriate to the use to which the feeding stuffs are put.

5. Storage

Raw materials, active substances, carrier substances, pre-mixtures and compound feeding

stuffs must be stored in places designed, adapted and maintained in order to ensure good

storage conditions.

The products must be stored in such a way as to be easily identifiable and to avoid any

confusion or cross-contamination between the different products mentioned above and

with medicinal substances or medicinal feeding stuffs. Products to be put into circulation

must be wrapped, where appropriate, and labelled in accordance with the provisions of

Directive 70/524/EEC or Directive 79/373/EEC, as appropriate.

6. Register

The manufacturer must record the following information in order to ensure traceability

(a) for additives

— the nature and quantity of the additives produced, the respective dates of manufacture

and, where appropriate, the number of the batch or of the specific portion of production

in the case of continuous manufacture,

— the names and addresses of the intermediaries or users (manufacturers or stock

breeders) to whom the additives have been delivered, with an indication of the nature and

quantity of the additives delivered and, where appropriate, the number of the batch or

of the specific portion of production in the case of continuous manufacture.

(b) for pre-mixtures

— the names and addresses of the additive manufacturers or intermediaries, the nature

and quantity of the additives used and, where appropriate, the number of the batch or of

the specific portion of production in the case of continuous manufacture,

— the date of manufacture of the pre-mixture, the number of the batch where appropriate,

— the names and addresses of the intermediaries or manufacturers to whom the pre-

mixtures have been delivered and the nature and quantity of the pre-mixture delivered,

and the number of the batch, where appropriate;

(c) for compound feeding stuffs containing pre-mixtures or additives

— the names and addresses of the pre-mixture manufacturers or intermediaries, with the

batch number where appropriate, the nature and quantity of the pre-mixture used,

— the names and addresses of the additive manufacturers or intermediaries, the nature

and quantity of the additive used and the number of the batch or of the specific portion of

production in the event of continuous manufacture,

— the nature and quantity of the feeding stuffs manufactured, with the date of

manufacture.

7. Intermediaries referred to in sub-rule 8 (1)

Where the manufacturer delivers additives to a person other than a manufacturer or stock

breeder, or pre-mixtures to a person other than a manufacturer, that person and any

subsequent intermediary by whom they are wrapped, packaged, stored or put into

circulation shall be equally bound, as appropriate, by the obligations laid down in points

4, 5 and 6.2 and, in the case of wrapping, by those laid down in point 3.

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

(1) For the purposes of these rules>

Definitions

“establishment” means any unit producing or manufacturing

additives, pre-mixtures prepared from additives, compound feeding

stuffs or products covered by Directive 82#471#EEC and referred

to in Chapter I.1 (a) of the Schedule to these rules<

“intermediary” means any person other than the manufacturer

or the person producing for the exclusive requirements of his

holding, compound feeding stuffs, who holds additives, pre-

mixtures prepared from additives, or one of the products covered

by Directive 82#471# EEC and referred to in Chapter I.1 (a) of the

Schedule to these rules at an intermediate stage between production

and use<

“putting into circulation” means holding products for the

purposes of sale, including offering for sale, or for the purposes of

any other form of transfer, whether or not free of charge, to third

parties, and the sale and other forms of transfer themselves<

“trading partner” shall have the same meaning as provided

under article 2 of the Veterinary Services Act, and shall include

trading partners of the European Union.

(2) The definitions laid down in legislation on animal feed

shall apply where necessary.

CHAPTER I

APPROVAL OF ESTABLISHMENTS AND

INTERMEDIARIES

(1) An establishment wishing to exercise one or more of the

activities referred to in sub-rule (2) must receive approval for each of

its activities. It may be decided not to approve establishments referred

to in sub-rule (2)(f).

(2) To be approved by the competent authorities an

establishment>

(a) manufacturing additives or products covered by Directive

82#471#EEC and referred to in Chapter I.1 (a) of the Schedule to

these rules with a view to putting them into circulation, must meet

the minimum conditions laid down in Chapter I.1 (b) of the said

Schedule<

(b) manufacturing pre-mixtures prepared from additives

referred to in Chapter I.2 (a) of the Schedule, with a view to putting

them into circulation, must meet the minimum conditions laid down

in Chapter I.2 (b) of the said Schedule<

(c) manufacturing compound feeding stuffs containing pre-

mixtures prepared from additives referred to in Chapter I.3 (a) of

the Schedule, with a view to putting them into circulation, must

meet the minimum conditions laid down in Chapter I.3 (b) of the

Schedule<

(d) manufacturing compound feeding stuffs, with a view to

putting them into circulation, from raw materials referred to in

Article 5 of Directive 1999#29#EEC which contain high levels of

undesirable substances or products, must meet the minimum

conditions laid down in Chapter I.4 of the Schedule to these rules<

(e) producing, for the exclusive requirements of its holding,

compound feeding stuffs containing pre-mixtures which include

additives referred to in Chapter I.3 (a) of the Schedule must meet

the minimum conditions laid down in Chapter I.3 (b) of the

Schedule, with the exception of the requirements set out in point 7

thereof<

(f) producing, for the exclusive requirements of its holding,

compound feeding stuffs which contain raw materials referred to

in Article 5 of Directive 1999#29#EEC containing high levels of

undesirable substances or products, must meet the minimum

conditions laid down in Chapter 1.4 of the Schedule to these rules,

with the exception of the requirements set out in point 7 thereof.

(3) Approval shall be>

withdrawn if an establishment ceases its activities or if it is

shown that it no longer fulfils an essential condition applicable to

its activities and does not comply with that requirement within a

reasonable time, amended if the establishment has demonstrated

its ability to engage in activities which are additional to those for

which it was first approved or which replace them.

(1) Where additives, products covered by Directive 82#471#EEC Approval

intermediaries

or pre-mixtures of additives referred to in Chapters I.1 (a) and I.2 (a) of

the Schedule respectively are put into circulation, intermediaries must

be approved. The provisions laid down in point 7 of Chapter I.1 8 (b) or

Chapter I.2(b) of the Schedule shall apply, as appropriate, to

intermediaries which wrap, package, store or put into circulation

additives, pre-mixtures of additives or products covered by Directive

82#471#EEC.

(2) Approval shall be>

withdrawn if an intermediary ceases its activities or if it is

shown that it no longer fulfils an essential condition applicable to

its activities and does not comply with that requirement within a

reasonable time<

amended if the intermediary has demonstrated its ability to engage

in activities which are additional to those for which it was first approved

or which replace them.

Approval procedure

(1) To obtain approval, establishments referred to in rule 3 and

intermediaries referred to in rule 4 which intend to exercise for the first

time one or more of the activities referred to in rules 3 and 4, shall

submit an application to the competent authority in which their facilities

are located.

(2) The competent authority shall ensure that a decision is

taken on applications for approval mentioned in sub-rule (1) within six

months of their submission.

(1) (a) For each activity, the competent authority shall enter

the establishments and intermediaries it has approved in accordance

with rules 3 and 4 in a register under an individual approval number

which identifies them, once it has established by means of on-the-spot

verification that they satisfy the conditions laid down by these rules.

(b) In respect of intermediaries who act solely as dealers

without ever holding the product in their facilities, it is not needed

to carry out on-the-sport verification of compliance with the

conditions under point 7 of Chapters I.1 (b) or I.2 (b) of the

Schedule, providing that those intermediaries lodge with the

competent authority a declaration to the effect that they meet the

requirements laid down under point 6.2 in the Schedule for the

exercise of their activity.

(2) The competent authority shall update the entries of

establishments and intermediaries in the register in accordance with

the decisions referred to in sub-rule 3 (3) and sub-rule 4 (2) to withdraw

or amend approval.

(1) A list of the establishments and intermediaries approved in

accordance with rules 3 and 4 shall be published, and then each year,

by the 30th November at the latest, the list of amendments made during

the year< every five years, a consolidated list shall be published.

(2) Before the 31st December of each year, the competent

authority shall send to the Commission the list referred to in sub-rule

(1). Before the 31st December each year, the competent authority shall

send the trading partners a list of the establishments referred to in sub-

rule 3(2)(a) and (b) and of the intermediaries approved in accordance

with sub-rule 4(1) and a list of corresponding establishments and

intermediaries referred to in sub-rule 5(2) which have submitted

applications for approval on which the competent authority has not yet

taken a decision. On request, the competent authority shall send the

trading partners all, or part of the list of establishments referred to in

sub-rule 3(2)(c) to (f) and all or part of the list of corresponding

establishments referred to in sub-rule 5(2) which have submitted

applications for approval on which the competent authority has not yet

taken a decision.

CHAPTER II

REGISTRATION OF ESTABLISHMENTS AND

INTERMEDIARIES

(1) An establishment wishing to exercise one or more of the Registration

establishments

activities referred to in sub-rule (2) must be registered by the competent

authority for each activity in accordance with these rules.

(2) In order to be registered by the competent authorities an

establishment>

(a) manufacturing additives for which a prescribed maximum

level is set and which are not included in Chapter I.1 (a) of the

Schedule, with a view to putting them into circulation, must meet

the minimum conditions laid down in Chapter II (c) of the Schedule<

(b) manufacturing pre-mixtures containing additives referred

to in Chapter II (a) of the Schedule, with a view to putting them

into circulation, must meet the minimum conditions laid down in

Chapter II(c) of the Schedule<

(c) manufacturing compound feeding stuffs containing pre-

mixtures of additives referred to in Chapter II (b) of the Schedule

or additives referred to in Chapter II (a) of the Schedule with a

view to putting them into circulation, must met the minimum

conditions laid down in Chapter II (c) of the Schedule<

(d) manufacturing, for the exclusive requirements of its

holding, compound feeding stuffs containing pre-mixtures of

additives referred to in Chapter II (b) of the Schedule or containing

additives referred to in Chapter II (a) of the Schedule, must met

the minimum conditions laid down in Chapter II (c) of the Schedule.

(3) Approved establishments exercising the corresponding

activities referred to in sub-rule 3 (2) (a), (b), (c) and (e) shall be regarded

as satisfying de facto the conditions laid down in sub-rule (2)(a), (b),

(c) and (d).

(4) Registration shall be>

withdrawn if an establishment ceases its activities or if it is

shown that it no longer fulfils an essential condition applicable to

its activities and does not comply with that requirement within a

reasonable time,

amended if the establishment declares that it is engaged in activities

which are additional to those for which it was first registered or which

replace them.

(1) Where additives for which a prescribed maximum level is

set other than those referred to in Chapter I.1 (a) of the Schedule or pre-

mixtures of additives referred to in Chapter II (a) of the Schedule are

put into circulation, intermediaries must be registered. The provisions

laid down in point 7 of Chapter II (c) of the Schedule shall apply, as

appropriate, to intermediaries which wrap, package, store or put into

circulation additives or pre-mixtures of additives.

(2) Intermediaries approved in accordance with rule 4 shall

be regarded as meeting de facto the conditions laid down in sub-rule

(1) hereof.

(3) Registration shall be>

(a) withdrawn if an intermediary ceases its activities or if it is

shown that it no longer fulfils an essential condition applicable to

its activities and does not comply with that requirement within a

reasonable time,

(b) amended if the intermediary has declared that it is engaged

in activities which are additional to those for which it was first

registered or which replace them.

In order to be registered, the establishments referred to in sub-

rule 8 (2) and the intermediaries referred to in sub-rule 9 (1) shall submit

a declaration to the competent authority of the trading partner in which

they intend to exercise their activities.

(1) For each activity, the competent authority shall enter the

establishments and intermediaries which it has registered in accordance

with rules 8 and 9 on a list under an individual registration number

which identifies them.

(2) The entries of establishments and intermediaries on the

list shall be updated in accordance with the decisions referred to in sub-

rules 8 (4) and 9 (3) to withdraw or amend registration.

(1) Before the 31st December of each year, the list of Communication

the list of registered

establishments and intermediaries registered during the year in establishments and

accordance with rules 8 and 9 shall be sent to the Commission and, intermediaries

every five years, a consolidated list thereof shall be sent.

(2) Upon request, the competent authority shall send to the

trading partners all or part of the lists referred to in sub-rule (1) hereof.

CHAPTER III

COMMON PROVISIONS

Where an establishment manufacturing an additive is already Simplified

procedure

authorized to manufacture the same active substance as a veterinary

medicinal product within the meaning of article 29 of the Veterinary

Services Act, the competent authority shall not be obliged to verify that

the conditions laid down in Article 3 (2) (a) and contained in Chapter

I.1 (b) of the Schedule to these rules have been fulfilled, with the

exception of the requirements set out in points 4, 5, 6.2 and 7.

The competent authority shall ensure, by means of appropriate Checks

checks carried out in establishments and at the premises of intermediaries

which they have approved or registered, that the requirements imposed

by these rules are met.

According to the procedure laid down in article 28(b) of the Fees

Veterinary Services Act, the rules for calculating the level of the fee to

be charged for the approval of establishments and their intermediaries

shall be adopted.

The following shall be adopted in accordance with the procedure Detailed

arrangements,

laid down in Article 16 of Directive 95#69#EEC>

amendment of the

Annex and imports

from non-member

(a) practical arrangements for the approval pursuant to rule 3

countries

and registration pursuant to rule 8 of establishments located in a

third country and putting additives, pre-mixtures, products covered

by Directive 82#471#EEC as referred to in Chapter 1.1 (a) of the

Schedule to these rules or feeding stuffs into circulation within

Malta or a trading partner, so that safeguards are provided

equivalent to those supplied by establishments located in Malta or

in the territory of a trading partner.

These arrangements shall comprise>

(i) publication of the list established and updated by the

Commission, of third countries able to provide safeguards

equivalent to those offered by Malta or the territory of a trading

partner in respect of their own establishments and able to

perform the checks referred to in rule 14,

(ii) publication of the list established and updated by the

Commission of establishments which have been found by the

third countries on the list referred to in paragraph (i) above to

fulfil the conditions laid down in these rules,

(iii) the possibility that experts from the Commission,

Malta and the territory of trading partners may carry out on-

the-spot checks if necessary<

(b) measures for implementing the Schedule to these rules<

(c) the amendments to be made to the Schedule to these rules.