CONDITIONS FOR THE REGISTERING OF ESTABLISHMENTS OPERATING IN THE ANIMAL FEED SECTOR RULES

SUBSIDIARY LEGISLATION 437.68

CONDITIONS FOR THE REGISTERING OF

ESTABLISHMENTS OPERATING IN THE

ANIMAL FEED SECTOR RULES

8th April, 2005

LEGAL NOTICE 100 of 2005.

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

Registering of Establishments operating in the Animal Feed Sector

Rules.

(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 rule 3(2)(a) and rule 4(1)

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 micro-

organisms belonging to the group of all products in the group (except for sub-

bacteria, yeasts, algae, lower fungi

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 rule 3(2)(a) and intermediaries referred to in 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

T h e m a n u f a c t u r e r m u s t h a v e s u ff i c i e n t s t a ff p o s s e s s i n g t h e s k i l l s a n d

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 q u a l i f i e d p e r s on r e s po n s i b l e f o r p r o d u c t i o n m u s t b e d e s i gn a t e d. T h e

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.

The manufacturer must record the following information in order to ensure

(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 Rule 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 rule 3(2)(b) and 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 rule 3(2)(b) and intermediaries referred to in 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

T h e m a n u f a c t u r e r m u s t h a v e s u ff i c i e n t s t a ff p o s s e s s i n g t h e s k i l l s a n d

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.

CONDITIONS FOR THE REGISTERING OF ESTABLISH-

MENTS OPERATING IN THE ANIMAL FEED SECTOR

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 rule 4(1)

W h e r e t h e m a n u f a c t u r er d e l i v e r s p r e - m i x t u r e s t o a p er s o n o t h e r t h a n 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 rule 3(2)(c) and (e)

- Antibiotics

all additives in the group

- Coccidiostats and other medicinal

substances

all additives in the group

- Growth promoters

all additives in the group

CHAPTER I.3. (b)

Minimum conditions which must be fulfilled by establishments

referred to in 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

ch ec k s, i n a cc or d a nc e w i th t h e w r it t e n p r oc e d u r e s p r e - e s t a bl i s h e d b y th e

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.

CONDITIONS FOR THE REGISTERING OF ESTABLISH-

MENTS OPERATING IN THE ANIMAL FEED SECTOR

2. Personnel

T h e m a n u f a c t u r e r m u s t h a v e s u ff i c i e n t s t a ff p o s s e s s i n g t h e s k i l l s a n d

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 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

CONDITIONS FOR THE REGISTERING OF ESTABLISH-

MENTS OPERATING IN THE ANIMAL FEED SECTOR

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

T h e m a n u f a c t u r e r m u s t h a v e s u ff i c i e n t s t a ff p o s s e s s i n g t h e s k i l l s a n d

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

CONDITIONS FOR THE REGISTERING OF ESTABLISH-

MENTS OPERATING IN THE ANIMAL FEED SECTOR

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 rule 8(2)(b), (c) and (d) and in rule 9(1)

- Vitamins,

provitamins

and

chemically well-defined substances a l l a d d i t i v e s i n t h e g r o u p e x c e p t f o r

having a similar action

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 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

with

antioxidant

effects

only those with a fixed maximum content

CHAPTER II (c)

Minimum conditions which must be fulfilled by establishments and intermediaries

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

maximum level is set and which are not referred to in Chapter I.1 (a), premixtures of

additives referred to in Chapter II (a)) and establishments referred to in 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

T h e m a n u f a c t u r e r m u s t h a v e s u ff i c i e n t s t a ff p o s s e s s i n g t h e s k i l l s a n d

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

(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 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.

(1)

For the purposes of these rules

"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;

"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 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.

CONDITIONS FOR THE REGISTERING OF ESTABLISH-

MENTS OPERATING IN THE ANIMAL FEED SECTOR

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 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

premixtures 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;

(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, 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 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.

(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 rule 3(3) and 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 rule 3(2)(a) and (b) and of the intermediaries

approved in accordance with rule 4(1) and a list of corresponding

establishments and intermediaries referred to in 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 rule 3(2)(c) to (f) and all or part of the

list of corresponding establishments referred to in 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 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 meet the

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

Schedule.

(3) Approved establishments exercising the corresponding

activities referred to in 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).

(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

rule 8(2) and the intermediaries referred to in 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

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

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

establishments and intermediaries registered during the year in

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

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).

CHAPTER III

COMMON PROVISIONS

Where an establishment manufacturing an additive is

already 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 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 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 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 laid down in Article 16 of Directive 95/69/EEC

(a) practical arrangements for the approval pursuant to

rule 3 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 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 sub-paragraph (i) 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;

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

CONDITIONS FOR THE REGISTERING OF ESTABLISH-

MENTS OPERATING IN THE ANIMAL FEED SECTOR