Royal Decree 418/1987 of 20 February on the substances and products involved in the feeding of animals, partially affected by judgment 67/96 of 18 April, of the Constitutional Court, sets out the minimum conditions to be met by manufacturers of certain additives, premixtures and compound feed containing such additives, as well as intermediaries.

The level of the requirements required for the exercise of the activities provided for in this Royal Decree must be related to the risks related to the manufacture or use by the establishments of additives and premixtures collected in the Order of 23 March 1988 for the provision of rules concerning additives in feedingstuffs, products covered by the Order of 31 October 1988 and raw materials containing such additives the harmful substances or products covered by the Order of 11 October 1988. However, in exceptional cases, the competent authorities may decide not to authorise specific categories of establishments, provided that such measures do not impede the free movement of agricultural products in trade. intra-Community It is therefore appropriate that establishments which intend to manufacture or use products which, according to this Royal Decree, may pose a risk must obtain prior authorisation on the basis of very strict conditions which ensure the protection of the health of animals and people and the protection of the environment. On the other hand, for establishments using innocuous products, simple registration in a register based on a commitment by the establishments to respect certain conditions will be sufficient. This distinction should also apply to intermediaries who pack, package, store or put into circulation additives and premixtures or products referred to in the Order of 31 October 1988.

This new legislation, in the field of fundamental principles, must be applied without distinction, for reasons of equal treatment, both to the establishments which put their products in circulation and to the producers-farmers which manufacture feedingstuffs exclusively for the purposes of their livestock farming, but for the latter, certain benefits are to be provided in accordance with the particular conditions in which they operate.

It is also appropriate to provide for the possibility of amending or withdrawing authorisation if the establishment changes or ceases in its activities or if it fails to fulfil an essential condition for its business. These same rules should apply "mutatis mutandis" to registration in the register.

On the other hand, the granting of authorizations may give the right to the perception of public taxes or revenues. This perception, with regard to its size, will be fixed by the European Commission.

In order to achieve a greater degree of transparency, the conditions and modalities applicable to the authorisation and registration of establishments in the animal feed sector should be grouped together in a single text, which requires an adaptation of the existing rules.

Therefore, this Royal Decree incorporates into our legal order Directive 95 /69/EC of the Council of 22 December laying down the requirements and rules applicable to the authorisation and registration of the of certain establishments and intermediaries in the animal feed sector and amending Directives 70 /524/EEC, 74 /63/EEC, 79 /373/EEC and 82 /471/EEC. In addition, for reasons of legal certainty, the wording of Articles 3, 4, 9 and 14 is adapted to the judgment of judgment 67/96 of the Constitutional Court.

This Royal Decree is dictated in the exercise of the normative competence that Rule 16.a of article 149.1 of the Constitution reserves to the State in the field of bases and general coordination of the health.

In the elaboration of this Royal Decree the Autonomous Communities and the entities and organizations representing the interests of the sector have been consulted. It has also been favourably informed by the Inter-Ministerial Committee on Food Management.

In its virtue, on the proposal of the Ministers of Agriculture, Fisheries and Food and of Health and Consumption, with the prior approval of the Minister of Public Administrations, in agreement with the State Council and prior deliberation of the Council of Ministers at its meeting on 12 June 1998,

D I S P O N G O:

CHAPTER I

General provisions

Article 1. Object.

This Royal Decree lays down the requirements and rules applicable to establishments and intermediaries in the animal feed sector which intend to manufacture or market certain products and compound feed.

Article 2. Definitions.

1. For the purposes of this Royal Decree,

following definitions shall apply:

(a) In circulation: the holding of products for sale, including the offer, or any other form of transfer, free of charge or not, to third parties, as well as the sale and other forms of transfer themselves.

(b) Establishment: any unit dedicated to the production or manufacture of additives, prepared premixtures based on additives, compound feedingstuffs or products contained in Chapter I of Annex 1 to this Royal Decree.

(c) Intermediary: any person, other than the manufacturer or the farmer engaged in the manufacture of compound feedingstuffs only for the purposes of his or her animal husbandry, which he possesses, in a stage between production and use, additives, premixtures prepared on the basis of additives or any of the products contained in Chapter I of Annex 1 to this Royal Decree.

2. The definitions laid down in national legislation on the animal feed sector shall apply to the extent necessary.

Article 3. Scope of application.

The provisions of this Royal Decree shall apply to all establishments and intermediaries in the field of animal nutrition which proceed to the manufacture or placing on the market of products, additives, premixtures or compound feed referred to in Annexes 1 and 2.

These provisions shall apply without prejudice to the rules on the organisation of official controls in the field of animal nutrition.

Article 4. Competent authorities.

1. The competence to grant authorizations and to manage the records referred to in this Royal Decree is for the Autonomous Communities.

2. The Ministry of Agriculture, Fisheries and Food shall, for information purposes, draw up a list of establishments and intermediaries registered in the register in accordance with the provisions of this Royal Decree.

CHAPTER II

Authorization of establishments and brokers

Article 5. Approval of establishments.

1. Each establishment shall specify an administrative authorization to manufacture, for the purposes of putting into circulation, each of the following product groups:

(a) Additives or products listed in Chapter I of Annex 1.

(b) Prepared additives based on additives referred to in Chapter II of Annex 1.

(c) Compounds containing premixtures obtained from additives referred to in Chapter III of Annex 1.

(d) Compound feedingstuffs containing raw materials as referred to in Article 4.2 of the Order of the Ministry of Agriculture, Fisheries and Food of 11 October 1988 concerning undesirable substances and products in feedingstuffs animal.

2. In order to obtain this authorisation, establishments shall comply with the minimum conditions laid down in Chapters I, II, III or IV of Annex 3, as they are intended to produce products of paragraphs (a), (b), (c) or (d) of the preceding paragraph, respectively.

3. The manufacture of compound feedingstuffs as referred to in paragraphs (c) and (d) of paragraph 1 shall also require authorization where they are intended solely for the purposes of the production of the manufacturer. Such authorisation is subject to compliance with the minimum requirements laid down in Chapters III and IV of Annex 3, respectively, with the exception of the content in the seventh point of both chapters.

Article 6. Authorization of intermediaries.

1. Any intermediary shall require administrative authorization to put into circulation the additives, products and premixtures described in paragraphs (a) and (b) of Article 5 (1) of this Royal Decree.

2. In order to obtain this authorisation, intermediaries shall comply with the conditions referred to in paragraph 7 of Chapters I and II of Annex 3, in the case of the putting into circulation of products in subparagraph (a) or (b), respectively.

Article 7. Granting of authorizations.

1. In order to obtain the authorization, the establishments and intermediaries that intend to proceed to the manufacture or marketing of the products described in Articles 5 and 6 of this Royal Decree will present, in any of the places provided for in Article 38.4 of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure, a request addressed to the competent body of the respective Autonomous Community.

2. The procedures for granting authorisations shall be settled within the maximum period of six months, from the time the application has entered into one of the records of the competent body.

3. If an establishment which manufactures an additive already has a manufacturing authorisation for the same active substance as a veterinary medicinal product within the meaning prescribed by Royal Decree 109/1995 of 27 January 1995 on medicinal products The competent authorities shall not be required to verify compliance with the conditions referred to in Chapter I of Annex 3 to this Royal Decree, with the exception, however, of the requirements laid down in paragraphs 1 and 2. 4, 5, 6.2, and 7.

Article 8. Extinction and modification of the authorisation.

1. Authorisation shall be extinguished in the event of a cessation of activity or if it is observed that the establishment, or intermediary, has ceased to fulfil an essential condition for its activity and does not comply with this requirement within the time limit which it regulates is determined.

2. The authorisation shall be amended if the establishment or intermediary has demonstrated its ability to engage in activities that are added to those for which it was first authorised or replaced.

CHAPTER III

Enrollment of establishments and brokers that do not require authorization

Article 9. Establishments which do not require authorisation and which must be registered.

They shall be the subject of registration, provided that they satisfy the minimum conditions set out in Chapter V of Annex 3, the establishments which are engaged in the manufacture of the following products:

(a) Additives for which a maximum content has been fixed, which are not covered by Chapter I of Annex 1 and which are intended for entry into circulation.

(b) Premixes containing additives as referred to in Chapter I of Annex 2 and intended for putting into circulation.

(c) compound feedingstuffs containing additives as referred to in Chapter I or premixtures of additives referred to in Chapter II of Annex 2, irrespective of whether they are intended for putting into circulation or to the satisfaction of the the needs of the producer's livestock.

Article 10. Intermediaries who do not require authorisation and who must be registered.

1. Any intermediary shall be entered in the relevant records to carry out the putting into circulation of the additives and premixtures described in paragraphs (a) and (b) of Article 9 of this Royal Decree.

2. In order to be registered, intermediaries shall comply with the conditions referred to in Chapter V (7) of Annex 3.

Article 11. Registration of establishments and intermediaries which do not require authorisation.

1. In order to obtain their registration, the establishments and intermediaries intending to manufacture or market the products described in Articles 9 and 10 of this Royal Decree shall submit a request to the body. The competent authority of the Autonomous Community.

2. Each registration must be carried out in the corresponding register and with an individual number to enable it to be identified.

CHAPTER IV

Register of establishments and brokers

Article 12. Registration of establishments and intermediaries.

1. The Autonomous Communities shall have one register for each activity, in which the establishments and intermediaries which have been authorised in accordance with Chapter II shall be entered, subject to verification on the ground that fulfil the conditions set out in this Royal Decree, as well as those other than those laid down in Articles 9 and 10 of this Royal Decree.

2. This registration will be an essential requirement for the exercise of the activities concerned.

3. Each authorisation shall be entered in the corresponding register with an individual number permitting its identification

Article 13. Cancellation and modification of the registration.

1. The registration shall be cancelled in the event of cessation of the activity or of the termination of the authorization, either for failure to fulfil an essential condition required for registration, for lack of compliance with it within the time limit which it regulates. determine, or for any other cause causing this effect.

2. Registration shall be amended in the event of an amendment to the authorisation or where the establishment or the intermediary declares that it is engaged in activities which require registration and which are added or replaced for those for which it was registered by first time.

CHAPTER V

Communication from establishments and brokers

Article 14. List of registered establishments and intermediaries.

1. The Autonomous Communities shall regularly send to the Ministry of Agriculture, Fisheries and Food listed in the establishments and intermediaries registered in them during each financial year.

2. On the basis of the information provided by the Autonomous Communities, the Ministry of Agriculture, Fisheries and Food shall annually draw up the following documents:

(a) List of approved establishments and intermediaries, during the corresponding financial year, throughout the national territory.

b) List of establishments and intermediaries which, without specifying authorization, were registered, during the corresponding financial year, throughout the national territory.

3. Every five years the Ministry of Agriculture, Fisheries and Food shall draw up consolidated lists.

Article 15. Communication to the European Union and the Member States.

1. The Ministry of Agriculture, Fisheries and Food shall, before 31 December of each year, communicate to the Commission of the European Union, through the appropriate course, the lists referred to in the previous Article.

2. Also, before 31 December of each year, the Ministry of Agriculture, Fisheries and Food, through the appropriate channel, shall communicate:

(a) To all Member States, the list of approved establishments or intermediaries. Those establishments which manufacture the products described in paragraphs (c) and (d) of paragraph 1 and in Article 5 (3) may be excluded from this list.

However, the information relating to these establishments shall be transmitted, in whole or in part, to all Member States requesting it.

(b) To the Member States which so request, all or part of the list of establishments and intermediaries registered in accordance with Articles 9 and 10 of this Royal Decree.

Additional disposition first. List of establishments and intermediaries.

Before 30 November 2001, the Ministry of Agriculture, Fisheries and Food shall draw up the first complete list of approved establishments and intermediaries referred to in paragraph 2 (a) of the Article 14 of this Royal Decree.

Additional provision second. Competence title.

This Royal Decree is of a basic regulation and is dictated by Article 149.1.16.a of the Constitution, which reserves the State competence in the field of bases and general coordination of health.

Additional provision third. Fee for registration.

Persons applying for the registration of an establishment or intermediary in the registers referred to in this Royal Decree shall bear a fee the amount of which shall be determined in accordance with the provisions of the Union European.

Single transient arrangement. Transitional arrangements for authorisations.

1. The establishments and intermediaries which, at the time of entry into force of this Royal Decree, exercise one or more of the activities described in Articles 5 and 6, may continue to carry out these activities until their application for authorisation which, in any event, must be submitted by 1 September 1998.

2. Similarly, the establishments and intermediaries which, at the time of the entry into force of this Royal Decree, exercise one or more of the activities described in Articles 9 and 10 may continue to carry out these activities until they are The application for registration in the register which must be submitted by 1 September 1998 shall be settled.

Single repeal provision. Regulatory repeal.

All provisions of the same or lower rank which are contrary to the provisions of this Royal Decree and, in particular, Articles 7, 10 and 11 of Royal Decree 418/1987 on substances and products shall be repealed. are involved in the feeding of animals.

Final disposition first. Right of amendment of the Annexes.

The Ministers of Agriculture, Fisheries and Food and Health and Consumer Affairs, within the scope of their respective powers, are empowered to adopt the measures necessary for the implementation of this Royal Decree, and in particular, to adapt the content of the Annexes to the amendments introduced by Community legislation.

Final disposition second. Amendment of Article 3 of Royal Decree 418/1987.

Article 3 of Royal Decree 418/1987 of 20 February on substances and products involved in the feeding of animals is worded as follows:

" Manufacturers shall communicate to the competent bodies of the Autonomous Communities the composition of compound feedingstuffs and premixtures which they intend to draw up in each of their factories, as well as the class of animals to which are intended. "

Final disposition third. Amendment of Article 4 of Royal Decree 418/1987.

The following paragraph of Article 4 is deleted:

"From this registration you will notice the person concerned within one month, for the purposes of the provisions of the previous article."

Final disposition fourth. Amendment of Article 9 of Royal Decree 418/1987.

Article 9 (1) of Royal Decree 418/1987 of 20 February 1987 on the substances and products involved in the feeding of animals is worded as follows:

"The use of new feed additives in scientific tests must be authorised by the competent bodies of the Autonomous Communities, following a favourable report by the Ministry of Health and Consumer Affairs."

Final disposition fifth. Amendment of Article 14 of Royal Decree 418/1987.

Article 14 of Royal Decree 418/1987 of 20 February on the substances and products involved in the feeding of animals is worded as follows:

" All feed, additives and premixtures shall be sent to the competent bodies of the Autonomous Communities before 31 January of each year, the quantities of each of the products manufactured for the purposes of the various animal species, as well as the quantity of cereals and protein materials used in each one, all referred to in the preceding year. '

Final disposition sixth. Entry into force.

The requirements and rules concerning the authorisation and registration of certain establishments and intermediaries in the animal feed sector as set out in this Royal Decree shall apply from the day on. following that of its publication in the "Official State Gazette".

Madrid, June 12, 1998.

JOHN CARLOS R.

The First Vice President of the Government

and Minister of the Presidency,

FRANCISCO ALVEZ-HELMETS FERNANDEZ

ANNEX 1

List of products and additives whose manufacture, use in premixtures and feed or placing on the market requires the prior administrative authorisation of establishments or intermediaries

CHAPTER I

Additives or products whose manufacture or marketing requires authorization

A) Additives:

(a) Antibiotics: all additives for the group.

(b) Coccidiostats and other medicinal substances: all additives for the group.

c) Growth factors: all additives for the group.

(d) Vitamines, provitamins and chemically well-defined substances of similar effect: all additives for the group.

e) Oligoelements: all additives for the group.

f) Enzymes: all additives for the group.

g) Microorganisms: all additives for the group.

h) Carotenoids and xanthophylls: all additives corresponding to the group.

i) Substances of antioxidant effects: only additives which have a maximum content set out in column 6 of the Annex to the Order of 23 March 1988.

B) Products referred to in the Order of 31 October 1988:

(a) Protein products obtained from micro-organisms belonging to the group of the bacteria, yeasts, algae and lower fungi: all products corresponding to the group (except subgroup 1.2.1. "Yeast grown on substrates of animal or plant origin").

b) Coproducts of the manufacture of amino acids by fermentation: all products corresponding to the group.

c) Amino acids and their salts: all products corresponding to the group.

D) Hydroxylated amino acids of amino acids: all products corresponding to the group.

CHAPTER II

Prohibited use additives in processing

premixtures, except authorization

(a) Antibiotics: all additives for the group.

(b) Coccidiostats and other medicinal substances: all additives for the group.

c) Growth factors: all additives for the group.

d) Vitamines, provitamins and chemically well-defined substances of similar effect: A and D.

e) Oligoelements: Cu and Se.

CHAPTER III

Prohibited use additives in manufacturing

compound feed, except authorisation

(a) Antibiotics: all additives for the group.

(b) Coccidiostats and other medicinal substances: all additives for the group.

c) Growth factors: all additives for the group.

ANNEX 2

List of products and additives whose manufacture, use in premixtures and feed or marketing requires prior registration of the establishment or intermediary in an administrative register

CHAPTER I

Additives whose presence in premixtures, intended or not to be used in the manufacture of compound feed, requires prior registration

(a) Vitamins, provitamins and chemically well-defined substances of similar effect: all additives corresponding to the group, except vitamins A and D.

(b) Oligoelements: all additives corresponding to the group, except Cu and Se.

c) Carotenoids and xanthophylls: all additives corresponding to the group.

d) Enzymes: all additives for the group.

e) Microorganisms: all additives for the group.

f) Substances of antioxidant effect: only with a fixed maximum content.

CHAPTER II

Additives whose presence in compound feed requires prior registration

(a) Vitamins, provitamins and chemically well-defined substances of similar effect: all additives for the group.

(b) Oligoelements: all additives for the group.

c) Carotenoids and xanthophylls: all additives corresponding to the group.

d) Enzymes: all additives for the group.

e) Microorganisms: all additives for the group.

f) Substances of antioxidant effect: only with a fixed maximum content.

ANNEX 3

Minimum requirements to be met by stable foundations and brokers subject to mandatory registration or authorization

CHAPTER I

Manufacture and placing on the market of products and additives contained in Chapter I of Annex 1

1. Installations and equipment

The manufacturing facilities and equipment must be located, designed, constructed and maintained in the light of the manufacturing operations of the "products" concerned. The layout, design and operation of the installations and the material shall be such as to reduce the risk of error and that effective cleaning and maintenance can be carried out in order to avoid contamination, including cross-contamination and, in general, any negative effects on the quality of the product. Installations and equipment intended for the performance of operations essential for the quality of 'products' shall be subject to appropriate and periodic validation in accordance with the written procedures which the manufacturer has previously established for the manufacture of the "products".

2. Staff

The manufacturer must have sufficient staff and possess the necessary skills and qualifications for the manufacture of the "products" in question. An establishment plan setting out the qualifications (qualifications and professional experience) and responsibilities of the management staff, which shall be made available to the competent authorities responsible for control, shall be established. All staff of their duties, responsibilities and responsibilities shall be informed in writing and in writing, in particular whenever a modification is made, so that the "products" have the intended quality.

3. Production

A qualified person who is responsible for the production shall be appointed.

The manufacturer must ensure that the various stages of production are carried out in accordance with previously established written procedures and instructions intended to define, confirm and ensure the domain of the critical points of the manufacturing process.

Technical or organizational measures will be taken to avoid errors and cross-contamination. Sufficient and adequate means must be provided for carrying out checks during manufacture.

4. Quality control

A qualified person who is responsible for quality control shall be appointed.

The manufacturer must have a control laboratory with sufficient means, both in personnel and in material, to check and guarantee, before the "products" are given out for putting into circulation, their conformity with the specifications defined by the manufacturer and with the provisions of the orders of 23 March 1988 or 31 October 1988. An external laboratory may be used.

A quality control plan shall be drawn up and implemented including, in particular, the control of the critical points of the manufacturing process, the procedures and periodicity of the sampling, the methods of analysis and the frequency, compliance with the specifications-and the destination, if they do not conform to them-of raw materials, active substances, supports and 'products'.

Samples of the active substance and of each batch of "product" put into circulation or of each defined fraction of the active substance shall be collected in sufficient quantity and in accordance with the procedure laid down by the manufacturer. production, in the case of continuous manufacture, and shall be kept so that the manufacturing process can be reconstructed. Such samples shall be sealed and labelled so that the manufacturing process can be reconstituted so as to be easily identified and kept under storage conditions which prevent any possibility of modification of its composition or abnormal alteration. They shall remain at the disposal of the competent authorities at least until the final date of guarantee of the finished product.

5. Storage

Raw materials, active substances, supports and compliant, non-compliant "products" shall be stored in appropriate containers, in places designed, adapted and maintained in such a way as to be guaranteed good storage conditions and to which only the staff authorised by the manufacturer will have access.

They shall be kept so that they can be easily identified and cannot be confused, or cross-contamination, with the various products mentioned above or with medicinal substances. The additives shall be packaged and labelled in accordance, in particular, with the provisions of the Order of 23 March 1988. The products referred to in the Order of 31 October 1988 shall be labelled in accordance with the provisions of that Order.

6. Documentation

1. Documentation relating to the manufacturing process and controls:

The manufacturer must have a documentation system in place to define the critical points of the manufacturing process and to guarantee its control, as well as to establish and implement a quality control plan. The manufacturer shall keep the results of the checks. The set of such documents must be kept in such a way as to enable the process of manufacturing of each batch of 'product' to be rebuilt and the corresponding responsibilities to be established in the event of a complaint.

2. Record:

In order to allow the manufacturing process to be rebuilt, the manufacturer must record the following information:

a) Registration of the additives:

1 Nature and quantity of the additives produced, dates of manufacture and, where applicable, batch number or defined fraction of the production, in case of continuous manufacture.

2 Name and address of the manufacturers or intermediaries to whom such additives have been delivered, indicating the nature and quantity of the additives delivered and, where appropriate, the batch or fraction number production, in the case of continuous production.

(b) Registration of the products referred to in the Order of 31 October 1988:

1 Nature and quantity of the "products", respective dates of manufacture and, where applicable, lot number or defined fraction of the production, in case of continuous manufacture.

2 Name and address of intermediaries or users (manufacturers or cattlemen) to whom such products have been delivered, indicating the nature and quantity of the products delivered and, where appropriate, the batch number or of the defined fraction of the production, in the case of continuous manufacture.

7. Intermediaries referred to in Article 6

When the manufacturer supplies additives to a person who is not a manufacturer, or products referred to in the Order of 31 October 1988 to a person other than a user (manufacturer or farmer), that person and any person Subsequent intermediary which packaging, packaging, storage or putting into circulation shall be subject, as the case may be, to the obligations laid down in paragraphs 4, 5, 6.2. and 8, and, in the case of packaging, to those referred to in paragraph 3.

8. Product reclamation and withdrawal

The manufacturer or any intermediary putting a product into circulation on its own behalf shall establish a system for the registration and processing of claims.

In addition, it will have to be in a position to implement, if necessary, a system of rapid withdrawal of the products present in the distribution circuit. The manufacturer must specify, by written procedure, the destination of the products withdrawn and, before any new entry into circulation, these products must be evaluated again for quality control.

CHAPTER II

Manufacture and marketing of premixtures

elaborated with additives contained in Chapter II

in Annex 1

1. Installations and equipment

The facilities and the manufacturing material shall be located, designed, constructed and maintained in the light of the manufacturing operations of the premixtures concerned. The layout, design and use of the premises and the material must be such as to minimise the risk of error and that effective cleaning and maintenance can be carried out in order to avoid contamination, including the cross-contamination and, in general, any negative effects on the quality of the product. The premises and equipment intended for the performance of operations essential for the quality of the products shall be the subject of an appropriate and periodic validation, in accordance with the procedures previously laid down by the Commission. manufacturer.

Preventive measures should be taken to avoid as far as possible the presence of harmful organisms, together with a plan of struggle, where necessary.

2. Staff

The manufacturer must have sufficient staff who have the necessary skills and qualifications for the manufacture of the premixtures concerned. An establishment plan setting out the qualifications (qualifications and professional experience) and responsibilities of the management staff, which shall be made available to the competent authorities responsible for control, shall be established. All staff of their duties, responsibilities and responsibilities shall be clearly informed in writing, in particular whenever a modification is made, in order to ensure that the premixtures have the desired quality.

3. Production

The manufacturer must ensure that the various stages of production are carried out in accordance with previously established written procedures and instructions intended to define, confirm and ensure the domain of the critical points in the manufacturing process, such as the incorporation of the additive or premixture, the chronological order of production, the measuring and weight devices, the mixer and the return flows, in order to obtain the desired quality of the premixtures concerned, in accordance with the provisions of the Order of 23 March 1988.

Technical or organizational measures will be taken to avoid errors and cross-contamination.

4. Quality control

A qualified person who is responsible for quality control shall be appointed.

The manufacturer must have a control laboratory with sufficient means, both in personnel and in material, to verify and ensure that the premixtures concerned comply with the specifications laid down by the manufacturer. in order to verify and ensure, in particular, the nature, the percentage, the homogeneity and the stability of the additives in the premixture, and the lowest possible level of cross-contamination. An external laboratory may be used.

A quality control plan shall be drawn up and implemented, including, in particular, the control of the critical points of the manufacturing process, the procedures and the periodicity of sampling, the methods of analysis and its frequency, compliance with the specifications-and the destination, if they do not conform to these-of the supports, additives and premixtures ('products ').

The samples of each batch of premixture put into circulation shall be collected in sufficient quantity and in accordance with the procedure laid down beforehand by the manufacturer, and shall be kept in order to enable the process to be reconstructed. manufacture. Such samples shall be sealed and labelled in such a way as to be easily identifiable, and shall be kept under storage conditions which exclude any possibility of modification of their composition or abnormal alteration. They shall remain at the disposal of the competent authorities at least until the deadline for the guarantee of the premixture.

5. Storage

compliant-and non-compliant-products shall be stored in appropriate containers or in places designed, adapted and maintained in such a way as to ensure good storage conditions and Those who only have access to the staff authorised by the manufacturer.

preventive measures should be taken in order to avoid as far as possible the presence of harmful organisms, by implementing, if appropriate, a plan to combat them.

Products shall be kept so that they can be easily identified and cannot be confused or cross-contamination with the various products or medicinal substances. Premixtures must be packaged and labelled in accordance with the provisions of the Order of 23 March 1988.

6. Documentation

1. Documentation relating to the manufacturing process and controls:

The manufacturer must have a documentation system in place to define the critical points of the manufacturing process and to guarantee its control, as well as to establish and implement a quality control plan. The manufacturer shall keep the results of the checks. The set of such documents shall be kept in such a way as to enable the process of manufacture of each batch of premix to be reconstructed and the corresponding responsibilities to be established in the event of a complaint.

2. Premixtures record:

In order to allow the manufacturing process to be rebuilt, the manufacturer must record the following information:

1. The name and address of the manufacturer of additives or of the intermediaries; the nature and quantity of the additives used and, if appropriate.

2.o The batch number or the defined fraction of the production, in case of continuous manufacture.

3.o The date of manufacture of the premixture; the batch number, if applicable, the name and address of the manufacturers of compound feed or of the intermediaries to whom the premixture is delivered, the date of delivery and the nature of the premix and quantity of the premix delivered, as well as, if applicable, the batch number.

7. Intermediaries referred to in Article 6

When the manufacturer delivers premixtures to a person who is not an authorised manufacturer of compound feed, that person and any subsequent intermediary which packaging, packaging, storing or putting into circulation shall be linked also, as the case may be, by the obligations laid down in paragraphs 4, 5, 6.2. and 8, and, in the case of packaging, to those referred to in paragraph 3.

8. Product reclamation and withdrawal

The manufacturer or any intermediary putting into circulation a product on its own behalf shall practice a system of registration and handling of claims.

In addition, it will have to be in a position to implement, if necessary, a system of rapid withdrawal of the products present in the distribution circuit. The manufacturer must specify by written procedure the destination of the products withdrawn and, before any new entry into circulation, these products must be evaluated again for quality control.

CHAPTER III

Manufacture and marketing of compound feed made from additive-based premixtures

contained in Chapter III of Annex 1

1. Installations and equipment

The facilities and the manufacturing material shall be located, designed, constructed and maintained in the light of the manufacturing operations of compound feed containing premixtures. The layout, design and use of the premises and the material must be such as to minimise the risk of error and make it possible to carry out effective cleaning and maintenance in order to avoid, as far as possible, the pollution, including cross-contamination, and, in general, any negative effects on the quality of the product.

The premises and equipment intended for the performance of operations essential for the quality of the products shall be subject to appropriate and periodic validation, in accordance with the procedures laid down in advance established by the manufacturer or, where appropriate, in the case of manufacture for the sole use of the manufacturer, previously established by a qualified external person, who intervenes at the request of the manufacturer and under the responsibility of the manufacturer. Preventive measures should be taken to avoid as far as possible the presence of harmful organisms, by applying, if appropriate, a plan to combat them.

2. Staff

The manufacturer must have sufficient staff who have the necessary skills and qualifications for the manufacture of compound feed containing premixtures. An establishment plan setting out the qualifications (titles and professional experience) and responsibilities of the management staff-if appropriate and in the case of manufacture for the sole use of the manufacturer-shall be made available. of the competent authorities responsible for monitoring. All staff of their duties, responsibilities and responsibilities shall be clearly informed in writing, in particular whenever a modification is made, in order to ensure that compound feed has the desired quality.

3. Production

A qualified person shall be appointed who is responsible for production and who, in the case of manufacture for exclusive use, may be external, but shall intervene at the request of the manufacturer and under the responsibility of the manufacturer.

The manufacturer must ensure that the various stages of production are carried out in accordance with previously established written procedures and instructions intended to define, confirm and ensure the domain of the critical points of the manufacturing process, such as the incorporation of the premix into the feed, the chronological order of production, the measuring and weight devices, the mixer and the return flows, in order to obtain the quality of the products compound feedingstuffs in accordance with the provisions of the Order of 8 October 1992.

Technical or organizational measures shall be taken to avoid, as far as possible, errors and cross-contamination.

4. Quality control

A qualified person who is responsible for quality control shall be appointed and, in the case of manufacture for the sole use of the manufacturer, may be external, but shall intervene at the request of the manufacturer and under the responsibility for this.

The manufacturer must have a control laboratory with sufficient means, both in personnel and in material, to check and ensure that compound feed containing premixtures is in accordance with the specifications. fixed by the manufacturer as well as to verify and ensure, in particular, the nature, the percentage, the homogeneity and the stability of the additives concerned in the compound feedingstuff and the lowest possible level of cross-contamination, as, in the case of feedingstuffs intended for entry into circulation, the percentages of Analytical components (Order of 8 October 1992). An external laboratory may be used.

A quality control plan shall be drawn up and implemented, including, in particular, the control of the critical points of the manufacturing process, the procedures and the periodicity of sampling, the methods of analysis and its frequency, compliance with the specifications-and the destination, if not in compliance with these-of the raw materials, premixtures and compound feed ('products ').

The samples of each batch of compound feed or of each defined fraction of the production in case of continuous manufacture shall be collected in sufficient quantity and in accordance with the procedure laid down by the manufacturer. and shall be kept so that the manufacturing process can be reconstructed in the case of entry into circulation, or on a regular basis in the case of manufacture for the sole use of the manufacturer. Such samples shall be sealed and labelled in such a way as to be easily identifiable, and shall be kept under storage conditions which exclude any possibility of modification of their composition or abnormal alteration. They shall remain at the disposal of the competent authorities for an appropriate period.

5. Storage

compliant-and non-compliant-products shall be stored in appropriate containers or in places designed, adapted and maintained in such a way as to ensure good storage conditions and Those who only have access to the staff authorised by the manufacturer.

preventive measures should be taken in order to avoid as far as possible the presence of harmful organisms, by implementing, if appropriate, a plan to combat them.

The products shall be kept so that they can be easily identified and cannot be confused or cross-contamination with the different products or with medicinal substances or medicated feed, or with raw materials having a high content of harmful substances or products or containing additives. Compound feedingstuffs intended for entry into circulation must be in accordance with the provisions of the Order of 8 October 1992.

6. Documentation

1. Documentation relating to the manufacturing process and controls:

The manufacturer must have a documentation system in place to define and ensure the control of the critical points of the manufacturing process, the control of which must be maintained, as well as the establishment and implementation of a quality control plan, the results of which must be maintained. This set of documents shall be kept in such a way as to enable the process of manufacture of each batch to be reconstructed and, in the case of entry into service, to establish the corresponding responsibilities in the event of a complaint.

2. Record of compound feed:

In order to allow the manufacturing process to be rebuilt, the manufacturer must record the following information:

1.o The name and address of the premix manufacturers or the intermediaries with the batch number, if applicable, the nature and quantity of the premix.

2.o The nature and quantity of the feed manufactured, with the date of manufacture.

7. Product reclamation and withdrawal

The manufacturer must practice a system of registration and handling of complaints.

In addition, it will have to be in a position to implement, if necessary, a system of rapid withdrawal of the products present in the distribution circuit. The manufacturer must define by written procedure the destination of the products withdrawn and, before any new entry into circulation, these products must be evaluated again for quality control.

CHAPTER IV

Manufacture and placing on the market of compound feed containing raw materials as referred to in Article 4.2 of the Order of 11 October 1988 with a high content of undesirable substances or products

1. Installations and equipment

Facilities and technical equipment shall be located, designed, constructed and maintained in the light of the manufacturing operations of compound feed on the basis of the "raw materials concerned". The layout, design and use of the installations and the material must be such as to reduce the risk of errors to the maximum and that effective cleaning and maintenance can be carried out in order to avoid the risk of contamination, including cross-contamination, and, in general, any negative effects on the quality of the product. The installations and equipment intended for the performance of operations essential for the quality of the products shall be subject to appropriate and periodic validation in accordance with the procedures laid down in advance by the manufacturer or, where applicable, manufacture for the exclusive use of the manufacturer, previously established by a qualified external person, who intervenes at the request of the manufacturer and under the responsibility of the manufacturer.

preventive measures should be taken in order to avoid as far as possible the presence of harmful organisms, by implementing, if appropriate, a plan to combat them.

2. Staff

The manufacturer must have sufficient staff who have the necessary skills and qualifications for the manufacture of compound feed from the "raw materials concerned". An establishment plan setting out the qualifications (titles and professional experience) and responsibilities of the management staff-if appropriate and in the case of manufacture for the sole use of the manufacturer-shall be made available. of the competent authorities responsible for monitoring. All staff of their duties, responsibilities and responsibilities shall be informed in writing and in writing, in particular whenever a change is made, in order to ensure that compound feedingstuffs based on "raw materials" have the desired quality.

3. Production

A qualified person who is responsible for production shall be appointed and, in the case of manufacture for the sole use of the manufacturer, may be external, but shall intervene at the request of the manufacturer and under the responsibility for this.

The manufacturer shall ensure that the various stages of production are performed in accordance with previously established written procedures and instructions intended to define, validate and ensure the control of the points. critical of the manufacturing process, such as the incorporation of the "raw material concerned" into the feed, the chronological order of production, the measuring and weight devices, the mixer and the return flows, so that the feed (i) the quality of the products and the quality of the products in question, and the quality of the products;

Technical or organizational measures shall be taken to avoid, as far as possible, errors and cross-contamination.

4. Quality control

A qualified person who is responsible for quality control shall be appointed and, in the case of manufacture for the sole use of the manufacturer, may be external, but shall intervene at the request of the manufacturer and under the responsibility for this.

The manufacturer must have a control laboratory with sufficient means, both in personnel and in material, to verify and ensure that the compound feed concerned complies with the specifications laid down by the manufacturer. the manufacturer, as well as to verify and ensure, in particular, the nature, the percentage and the homogeneity of the harmful substances and products concerned in the compound feed and a level of cross-contamination as low as possible, as well as respect for the maximum percentages of harmful substances and products set out in the Order of 11 October 1988 and, in the case of feedingstuffs intended for entry into service, the percentages of analytical components (Order of 8 October 1992). An external laboratory may be used.

A quality control plan shall be drawn up and implemented, including, in particular, the control of the critical points of the manufacturing process, the procedures and the periodicity of sampling, the methods of analysis and its frequency, compliance with the specifications-and the destination, if they do not conform to these-of the raw materials, in particular those containing high percentages of substances and harmful products and compound feed.

A sample of each batch of compound feed or of each defined fraction of the production in case of continuous manufacture shall be collected in sufficient quantity and in accordance with the procedure laid down by the manufacturer. shall be kept in order to enable the manufacturing process to be reconstructed in the case of entry into circulation, or on a regular basis in the case of manufacture for the sole use of the manufacturer. Such samples shall be sealed and labelled in such a way as to be easily identifiable, and shall be kept under storage conditions which exclude any possibility of modification of their composition or abnormal alteration. They shall remain at the disposal of the competent authorities for an appropriate period depending on the use of such feed.

5. Storage

Raw materials, in particular those containing high percentages of harmful substances and products, and compound feed, compliant and non-compliant, and specifications, must be stored in appropriate containers or in containers. places designed, adapted and maintained in such a way as to ensure good storage conditions.

preventive measures should be taken in order to avoid as far as possible the presence of harmful organisms, by implementing, if appropriate, a plan to combat them.

Products shall be preserved in such a way that they can be easily identified and cannot be confused, or cross-contamination, with the different products referred to above or with medicinal substances or feedingstuffs medicinal products or with additives or premixtures thereof. Compound feedingstuffs intended for entry into circulation must be in accordance with the provisions of the Order of 8 October 1992.

6. Documentation

1. Documentation relating to the manufacturing process and controls:

The manufacturer must have a documentation system in place to define and ensure the control of the critical points of the manufacturing process, the control of which must be maintained, as well as the establishment and implementation of a quality control plan. The manufacturer shall keep the results. This set of documents shall be kept in such a way as to allow the process of manufacture of each batch to be reconstituted and, in the case of entry into service, to establish the corresponding responsibilities in the event of a complaint.

2. Record of compound feed:

In order to allow the manufacturing process to be rebuilt, the manufacturer must record the following information:

1.o The name and address of suppliers of raw materials containing high percentages of harmful substances and products, with an indication of the nature and percentage of harmful substances and products, the date of delivery and,

2.o The nature and quantity of the feed manufactured, with the date of manufacture.

7. Product reclamation and withdrawal

The manufacturer shall establish a system for the registration and handling of complaints.

In addition, it will have to be in a position to implement, if necessary, a system of rapid withdrawal of the products present in the distribution circuit. The manufacturer must define by written procedure the destination of the products withdrawn and, before any new entry into circulation, these products must be evaluated again for quality control.

CHAPTER V

Manufacture and placing on the market of products and additives contained in Annex 2

1. Installations and equipment

The installations and the technical equipment must be located, designed, constructed and maintained in the light of the manufacturing operations of additives, premixtures of additives, compound feed containing additives or premixtures of additives in question ('products in question ').

2. Staff

The manufacturer must have sufficient staff and possess the necessary skills and qualifications for the manufacture of the products in question.

3. Production

A qualified person who is responsible for production shall be appointed and, in the case of manufacture for the sole use of the manufacturer, may be external, but shall intervene at the request of the manufacturer and under the responsibility for this.

The manufacturer must ensure that the various stages of production are carried out in such a way as to obtain the desired quality of the products in question, which will be adjusted, as the case may be, to the provisions of the Order. of 23 March 1988 or the Order of 8 October 1992.

4. Quality control

A qualified person shall be appointed who is responsible for quality control and who, in the case of manufacture for the sole use of the manufacturer, may be external, but shall intervene at the request of the manufacturer and under the responsibility for this.

The manufacturer shall draw up and implement a quality control plan, which ensures and ensures that the products in question are in conformity with the specifications defined by the manufacturer and, as the case may be, comply with the provisions of the in the Orders of 23 March 1988 and 8 October 1992.

Samples shall be collected and retained in order to enable the manufacturing process to be reconstructed, if appropriate, from each batch of product or from each defined fraction of the production in case of continuous or regular manufacturing. They shall remain at the disposal of the competent authorities for an appropriate period depending on the use of such feed.

5. Storage

Raw materials, additives, supports, premixtures and compound feed shall be stored in places designed, adapted and maintained in such a way as to ensure good storage conditions.

Products shall be preserved in such a way that they can be easily identified and cannot be confused, or cross-contamination, with the different products referred to above or with medicinal substances or feedingstuffs medicines. Products intended for entry into circulation shall be packaged, where appropriate, and shall be labelled in accordance with the provisions laid down, as the case may be, by the orders of 23 March 1988 or 8 October 1992.

6. Record

In order to allow the manufacturing process to be rebuilt, the manufacturer must record the following information:

a) In the case of additives:

1. The nature and quantity of the additives produced, the respective dates of manufacture and, if applicable, the batch number or the defined fraction of the production, in case of continuous manufacture.

2.o As well as the name and address of the intermediaries or users (manufacturers or cattlemen) to whom the additives have been supplied, with an indication of the nature and quantity of the additives and, if appropriate, the batch or Defined fraction of the production, if any, of continuous manufacture.

b) In the case of premixtures:

1 Name and address of manufacturers of additives or of intermediaries, the nature and quantity of the additives used and, where appropriate, the batch number or defined fraction of the production, in the case of manufacture continues.

2.o The date of manufacture of the premix, the batch number, if applicable, and

3.o The name and address of the manufacturers or intermediaries to whom the premixture has been supplied, the nature and quantity of the premix supplied and, if applicable, the batch number.

c) In the case of compound feed containing premixtures or additives:

1 Name and address of the manufacturers of the premix or intermediaries, with the batch number, if applicable, and the nature and quantity of the premix used.

2.o The name and address of the manufacturers of the additive or of the intermediaries, the nature and quantity of additive used and the batch number or defined fraction of the production, in the case of continuous manufacture, and

3.o The nature and quantity of feed manufactured, with the date of manufacture.

7. Intermediaries referred to in Article 10

When the manufacturer supplies additives to a person who is not a manufacturer or a farmer, or premixtures to a person other than a manufacturer, that person and any subsequent intermediary which packaging, packaging, store or puts in the movement shall also be subject, as the case may be, to the obligations laid down in paragraphs 4, 5 and 6.2 and, in the case of packaging, to those referred to in paragraph 3.