1995L0069 — EN — 22.12.1998 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE 95/69/EC
of 22 December 1995
laying down the conditions and arrangements for approving and registering certain establishments
and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC,
74/63/EEC, 79/373/EEC and 82/471/EEC
(OJ L 332, 30.12.1995, p. 15)
Amended by:
Official Journal
No page date
►M1Council Directive 98/92/EC of 14 December 1998 L 346 49 22.12.1998
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COUNCIL DIRECTIVE 95/69/EC
of 22 December 1995
laying down the conditions and arrangements for approving and
registering certain establishments and intermediaries operating inthe animal feed sector and amending Directives 70/524/EEC, 74/
63/EEC, 79/373/EEC and 82/471/EEC
THE COUNCIL OF THE EUROPEAN UNION,
Havingreg ard to the Treaty establishingthe European Community, andin particular Article 43 thereof,
Havingreg ard to the proposal from the Commission(
1),
Havingreg ard to the opinion of the European Parliament(2),
Havingreg ard to the opinion of the Economic and Social Committee(3),
1.Whereas Council Directive 70/524/EEC of 23 November 1970
concerningadditives in feeding stuffs(4), lays down the minimum
conditions to be met by manufacturers of certain additives,premixtures and compound feedingstuffs containing such addi-tives;
2.Whereas these rules restrict the manufacture or use of certaincategories of additives, premixtures and compound feedingstuffscontainingsuch additives and premixtures to those manufacturerswho are included on a national list;
3.Whereas individuals holdingg oods covered by this Directive forthe sole purposes of their trade promotion or their transport arenot regarded as being intermediaries as defined in this Directive;
4.Whereas with the operation of the internal market in mind, someoptional provisions which still allow the Member States toderogate from the Community provisions applying to the sectorin question should be abolished and the criteria for approvingorregistering manufacturers or intermediaries should be specified soas to avoid distortions of competition caused by the MemberSta-tes’ different ways of applyingand interpretingpre-existingapproval conditions and to forestall any potentially adverseeffects on animals, humans or the environment, given the risksinherent in usingcertain additives;
5.Whereas, to forestall certain particularly undesirable substancesoccurringin feeding stuffs, Council Directive 74/63/EEC of 17December 1973 on undesirable substances and products in animalnutrition (
5), aims to limit their presence in raw materials to an
acceptable level; whereas these rules also restrict the use of thoseraw materials to those persons who have the necessary qualifica-tions, facilities and equipment for the dilution operations whichensure that the maximum levels laid down in the Directive asregards the various types of compound feedingstuffs arecomplied with;
6.Whereas establishments producingcertain substances listed inCouncil Directive 82/471/EEC of 30 June 1982 concerningcertain products used in animal nutrition (
6), should also be
subject to approval, as should intermediaries;
(1) OJ No C 348, 28. 12. 1983, p. 18.
(2) OJ No C 91, 28. 3. 1994, p. 296.
(3) OJ No C 148, 30. 5. 1994, p. 21.
(4) OJ No L 270, 14. 12. 1970, p. 1. Directive as last amended by Commis-
sion Directive 95/37/EC (OJ No L 172 an 22. 7. 1995, p. 21).
(5) OJ No L 38, 11. 2. 1974, p. 31. Directive as last amended by Commis-
sion Directive 94/16/EC (OJ No L 104, 23. 4. 1994, p. 32).
(6) OJ No L 213, 21. 7. 1982, p. 8. Directive as last amended by Commis-
sion Directive 95/33/EC (OJ No L 167, 18. 7. 1995, p. 17).
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7.Whereas, with a view to ensuringthe quality of the product and
preventingthe occurrence of residues of certain additives inanimal products or of high levels of certain undesirablesubstances which might result from defective manufacture, allmanufacturers of additives, premixtures, compound feedingstuffsand certain products covered by Directive 82/471/EEC, and inter-mediaries should be approved or registered on the basis ofstandard, specific criteria;
8.Whereas the level of requirements for the exercise of activitieslaid down in this Directive must be in proportion to the risksinvolved in the manufacture or use by establishments of additivesand premixtures listed in Directive 70/524/EEC, products coveredby Directive 82/471/EEC or raw materials containingundesirablesubstances or products listed in Directive 74/63/EEC;
9.Whereas establishments which intend to manufacture or useproducts deemed sensitive under the Directive must receive priorapproval on the basis of very strict conditions that should safe-guard animals, humans and the environment, whereas, however,in exceptional cases Member States may decide not to approve aspecific category of establishment, provided such measures donot hinder the free movement of agricultural products in theterritory of the Member States; whereas, conversely, for estab-lishments usingless sensitive products, mere reg istration basedon an undertakingby the establishment to comply with a numberof conditions will suffice; whereas this distinction must alsoapply to intermediaries which wrap, package, store or put intocirculation additives, premixtures of additives or productscovered by Directive 82/471/EEC;
10.Whereas, on grounds of equal treatment, the fundamental princi-ples of these new rules must apply both to establishments whichput products into circulation and to manufacturers/stock farmerswho manufacture feedingstuffs solely for the requirements oftheir own farms, without any distinction; whereas, nonetheless,some relief should be allowed the latter on account of the partic-ular circumstances in which they exercise their activity;
11.Whereas provision should be made for amendingor withdrawingapproval if an establishment changes or ceases its activities or ifit no longer fulfils one of the essential conditions applicable to itsactivity; whereas the same rules should apply, mutatis mutandis ,
to registration;
12.Whereas Member States may be entitled to levy fees for grantingapproval; whereas the levels of such fees should subsequently beharmonized in order to obviate distortion of competition; whereassuch harmonization will fall within the general framework offuture Community rules on fees or charges to be levied in theanimal feed sector;
13.Whereas it is necessary to give the Commission the task ofadoptingdetailed rules for the application of this Directive,includingthe conditions for approval and reg istration of estab-lishments in third countries;
14.Whereas, should the Council confer on the Commission responsi-bility for implementingthe rules laid down on the conditions andarrangements for approving and registering the establishments inquestion, provision should be made for close cooperationbetween the Member States and the Commission within theStandingCommittee for Feeding stuffs established by Decision70/372/EEC (
1);
15.Whereas to ensure greater transparency the conditions andarrangements relating to the approval and registration of estab-
(1) OJ No L 170, 3. 8. 1970, p. 1.
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lishments in the animal feed sector should be brought together in
a sing le text; whereas this entails adaptingexistingleg islation;
16.Whereas the requirement for manufacturers to be approved orregistered will make it possible for Member States to check onmanufacturers and intervene, if necessary, where substances arebeingused illeg ally, in particular where prohibited substancessuch as hormones or beta-agonists are in use; whereas MemberStates have a duty to check beforehand that establishmentsrequiringapproval actually meet the minimum conditions whichthe Directive lays down for exercise of the relevant activity;whereas national supervisory authorities must also ensure subse-quently, by means of appropriate checks, that approved or regis-tered establishments and intermediaries are indeed complyingwith the conditions imposed upon them; whereas these provisionsmust apply without prejudice to Community rules governing theorganization of official checks on animal feed;
17.Whereas it is necessary to adopt these measures at Communitylevel in order better to achieve the objectives of guaranteeing thequality and safety of feedingstuffs,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
SCOPE AND DEFINITIONS
Article 1
1. This Directive lays down the conditions and arrangements applic-
able to certain categories of establishments and intermediaries in theanimal feedsector to allow them to exercise the activities described inArticles 2 and 7 and Articles 3 and 8 respectively.
2. This Directive shall apply without prejudice to the Community
provisions concerningthe org anization of official checks on animalfeed.
3. For the purposes of this Directive:
(a) ‘puttinginto circulation' means holdingproducts for the purposes
of sale, includingofferingfor sale, or for the purposes of any otherform of transfer, whether or not free of charge, to third parties, andthe sale and other forms of transfer themselves;
(b) ‘establishment' means any unit producingor manufacturingaddi-
tives, premixtures prepared from additives, compound feedingstuffsor products covered by Directive 82/471/EEC and referred to inChapter I.1 (a) of the Annex to this Directive;
(c) ‘intermediary' means any person other than the manufacturer or the
person producingfor the exclusive requirements of his holding ,compound feedingstuffs, who holds additives, premixtures preparedfrom additives, or one of the products covered by Directive 82/471/EEC and referred to in Chapter I.1 (a) of the Annex to thisDirective at an intermediate stage between production and use.
4. The definitions laid down in Community legislation on animal
feed shall apply where necessary.
CHAPTER II
APPROVAL OF ESTABLISHMENTS AND INTERMEDIARIES
Article 2
Approval of establishments
1. An establishment wishingto exercise one or more of the activities
referred to in paragraph 2 must receive approval for each of its activi-ties. A Member State may decide not to approve establishments referredto in paragraph 2 (f).
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2. To be approved by the competent authorities an establishment:
(a) manufacturingadditives or products covered by Directive 82/
471/EEC and referred to in Chapter I.1 (a) of the Annex to thisDirective with a view to puttingthem into circulation, must meetthe minimum conditions laid down in Chapter I.1 (b) of the saidAnnex 1;
(b) manufacturingpremixtures prepared from additives referred to in
Chapter I.2 (a) of the Annex, with a view to puttingthem intocirculation, must meet the minimum conditions laid down inChapter I.2 (b) of the said Annex;
(c) manufacturingcompound feeding stuffs containingpremixtures
prepared from additives referred to in Chapter I.3 (a) of the Annex,with a view to puttingthem into circulation, must meet theminimum conditions laid down in Chapter I.3 (b) of the Annex;
(d) manufacturingcompound feeding stuffs, with a view to puttingthem
into circulation, from raw materials referred to in Article 3a (2) ofDirective 74/63/EEC which contain high levels of undesirablesubstances or products, must meet the minimum conditions laiddown in Chapter I.4 of the Annex to this Directive;
(e) producing, for the exclusive requirements of its holding, compound
feedingstuffs containing premixtures which include additivesreferred to in Chapter I.3 (a) of the Annex must meet the minimumconditions laid down in Chapter I.3 (b) of the Annex, with theexception of the requirements set out in point 7;
(f) producing, for the exclusive requirements of its holding, compound
feedingstuffs which contain raw materials referred to in Article 3a(2) of Directive 74/63/EEC containinghig h levels of undesirablesubstances or products, must meet the minimum conditions laiddown in Chapter 1.4 of the Annex to this Directive, with theexception of the requirements set out in point 7.
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 itsactivities and does not comply with that requirement within areasonable time,
— amended if the establishment has demonstrated its ability to engage
in activities which are additional to those for which it was firstapproved or which replace them.
Article 3
Approval of intermediaries
1. Where additives, products covered by Directive 82/471/EEC or
premixtures of additives referred to in Chapters I.1 (a) and I.2 (a) of theAnnex respectively are put into circulation, intermediaries must beapproved.
The provisions laid down in point 7 of Chapter I.1 8 (b) or Chapter I.2
(b) of the Annex shall apply, as appropriate, to intermediaries whichwrap, package, store or put into circulation additives, premixtures ofadditives 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 itsactivities and does not comply with that requirement within areasonable time;
— amended if the intermediary has demonstrated its ability to engage
in activities which are additional to those for which it was firstapproved or which replace them.
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Article 4
Approval procedure for establishments and intermediaries
1. To obtain approval, establishments referred to in Article 2 and
intermediaries referred to in Article 3 which intend to exercise for thefirst time one or more of the activities referred to in Article 2 and 3shall, as from 1 April 1998 submit an application to the competentauthority of the Member State in which their facilities are located.
Member States shall ensure that a decision is taken on applications for
approval mentioned in the first subparagraph within six months of theirsubmission.
2. Establishments and intermediaries which, on 1 April 1998, were
exercisingone or more of the activities referred to in Articles 2 and 3respectively, may continue their activities until a decision has beentaken on their application for approval, on condition that they submitthe application before 1 September 1998.
Member States shall act on applications for approval from he establish-
ments and intermediaries referred to in the first paragraph before 1April 2001.
Article 5
Register of approved establishments and intermediaries
1. For each activity, the competent authority shall enter the establish-
ments and intermediaries it has approved in accordance with Articles 2and 3 in a register under an individual approval number which identifiesthem, once it has established by means of on-the-spot verification thatthey satisfy the conditions laid down by this Directive.
In respect of intermediaries who act solely as dealers without ever
holdingthe product in their facilities, Member States need not carry outon-the-sport verification of compliance with the conditions under point7 of Chapters I.1 (b) or I.2 (b) of the Annex, providingthat thoseintermediaries lodge with the competent authority a declaration to theeffect that they meet the requirements laid down under point 6.2 in theAnnex for the exercise of their activity.
2. Member States shall update the entries of establishments and
intermediaries in the register in accordance with the decisions referredto in Article 2 (3) and Article 3 (2) to withdraw or amend approval.
Article 6
Publication and communication of the list of approved establish-
ments and intermediaries
1. Each Member State shall publish a list of the establishments and
intermediaries approved in accordance with Articles 2 and 3 for the firsttime in November 2001, and then each year, by 30 November at thelatest, the list of amendments made duringthe year; every five years, itshall publish a consolidated list.
2. Before 31 December each year, Member States shall send the
Commission the list referred to in paragraph 1.
Before 31 December each year, Member States shall send the other
Member States a list of the establishments referred to in Article 2 (2) (a)and (b) and of the intermediaries approved in accordance with Article 3(1).
Upon request, Member States shall send the other Member States all or
part of the list of establishments referred to in Article 2 (2) (c) to (f).
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CHAPTER III
REGISTRATION OF ESTABLISHMENTS AND INTERMEDIARIES
Article 7
Registration of establishments
1. An establishment wishingto exercise one or more of the activities
referred to in paragraph 2 must be registered by a Member State foreach activity in accordance with this Directive.
2. In order to be registered by the competent authorities an establish-
ment:
(a) manufacturingadditives for which a prescribed maximum level is
set and which are not included in Chapter I.1 (a) of the Annex, witha view to puttingthem into circulation, must meet the minimumconditions laid down in Chapter II (c) of the Annex;
(b) manufacturingpremixtures containingadditives referred to in
Chapter II (a) of the Annex, with a view to puttingthem intocirculation, must meet the minimum conditions laid down inChapter II (c) of the Annex;
(c) manufacturingcompound feeding stuffs containingpremixtures of
additives referred to in Chapter II (b) of the Annex or additivesreferred to in Chapter II (a) of the Annex with a view to puttingthem into circulation, must met the minimum conditions laid downin Chapter II (c) of the Annex;
(d) manufacturing, for the exclusive requirements of its holding,
compound feedingstuffs containing premixtures of additivesreferred to in Chapter II (b) of the Annex or containingadditivesreferred to in Chapter II (a) of the Annex, must met the minimumconditions laid down in Chapter II (c) of the Annex.
3. Approved establishments exercisingthe correspondingactivities
referred to in Article 2 (2) (a), (b), (c) and (e) shall be regarded assatisfyingde factothe conditions laid down in paragraph 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 itsactivities and does not comply with that requirement within areasonable time,
— amended if the establishment declares that it is engaged in activities
which are additional to those for which it was first registered orwhich replace them.
Article 8
Registration of intermediaries
1. Where additives for which a prescribed maximum level is set
other than those referred to in Chapter I.1 (a) of the Annex or premix-tures of additives referred to in Chapter II (a) of the Annex are put intocirculation, intermediaries must be registered.
The provisions laid down in point 7 of Chapter II (c) of the Annex shall
apply, as appropriate, to intermediaries which wrap, package, store orput into circulation additives or premixtures of additives.
2. Intermediaries approved in accordance with Article 3 shall be
regarded as meeting de factothe conditions laid down in paragraph 1.
3. Registration shall be:
— withdrawn if an intermediary ceases its activities or if it is shown
that it no longer fulfils an essential condition applicable to itsactivities and does not comply with that requirement within areasonable time,
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— amended if the intermediary has declared that it is engaged in
activities which are additional to those for which it was first regis-tered or which replace them.
Article 9
Registration procedure for establishments and intermediaries
1. In order to be registered, the establishments referred to in Article 7
(2) and the intermediaries referred to in Article 8 (1) shall, as from 1April 1998, submit a declaration to the competent authority of theMember State in which they intend to exercise their activities.
2. Establishments and intermediaries which, on 1 April 1998, were
exercisingone or more of the activities referred to in Articles 7 and 8respectively, may continue their activities on condition that theysubmitted the declaration referred to in paragraph 1 by 1 September1998.
Article 10
List of registered establishments and intermediaries
1. For each activity, the competent authority shall enter the establish-
ments and intermediaries which it has registered in accordance withArticles 7 and 8 on a list under an individual registration number whichidentifies them.
2. Member States shall update the entries of establishments and
intermediaries on the list in accordance with the decisions referred to inArticles 7 (4) and 8 (3) to withdraw or amend registration.
Article 11
Communication of the list of registered establishments and interme-
diaries
1. Before 31 December each year, Member States shall send the
Commission the list of establishments and intermediaries registeredduringthe year in accordance with Articles 7 and 8 and, every fiveyears, they shall send a consolidated list.
2. Upon request, Member States shall send to the other Member
States all or part of the lists referred to in paragraph 1.
CHAPTER IV
COMMON PROVISIONS
Article 12
Simplified procedure
Where an establishment manufacturingan additive is already authorized
to manufacture the same active substance as a veterinary medicinalproduct within the meaningof Article 24 of Directive 81/851/EEC (
1),
Member States shall not be obliged to verify that the conditions laiddown in Article 2 (2) (a) and contained in Chapter I.1 (b) of the Annexto this Directive have been fulfilled, with the exception of the require-ments set out in points 4, 5, 6.2 and 7.
Article 13
Checks
Member States shall ensure, by means of appropriate checks carried out
in establishments and at the premises of intermediaries which they have
(1) OJ No L 317, 6. 11. 1981, p. 16. Directive as last amended by Commis-
sion Directive 93/40/EEC (OJ No L 214, 24. 8. 1993, p. 31).
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approved or registered, that the requirements imposed by this Directiveare met.
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Article 14
The Council, actingby a qualified majority on a proposal from the
Commission, shall, before 1 April 1999, adopt rules for calculatingthelevel of the fee to be charged for the approval of establishments andtheir intermediaries.
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Article 15
Detailed arrangements, amendment of the Annex and imports from
non-member countries
The followingshall be adopted in accordance with the procedure laid
down in Article 16:
(a) before 1 April 1998, practical arrangements for the approval
pursuant to Article 2 and registration pursuant to Article 7 ofestablishments located in a non-member country and puttingaddi-tives, premixtures, products covered by Directive 82/471/EEC asreferred to in Chapter 1.1 (a) of the Annex to this Directive orfeedingstuffs into circulation within the Community, so that safe-guards are provided equivalent to those supplied by establishmentslocated in the Community.
These arrangements shall comprise:— establishment and updatingof a list of non-member countries
able to provide safeguards equivalent to those offered by theMember States in respect of their own establishments and ableto perform the checks referred to in Article 13,
— establishment and updatingof a list of establishments which
have been found by the non-member countries on the listreferred to in the first indent to fulfil the conditions laid down inthis Directive,
— the possibility that experts from the Commission and the
Member States may carry out on-the-spot checks if necessary.Such checks shall be performed on behalf of the Community,which will bear the relevant expenses;
(b) measures for implementingthis Directive, in particular the form of
the register and approval numbers;
(c) the amendments to be made to the Annexes.
Article 16
Standing Committee for Feedingstuffs
The Commission shall be assisted by the StandingCommittee for
Feedingstuffs established by Decision 70/372/EEC, hereinafter referredto as ‘the Committee'.
The representative of the Commission shall submit to the Committee a
draft of the measures to be taken. The Committee shall deliver itsopinion on the draft within a time limit which the Chairman may laydown accordingto the urg ency of the matter. The opinion shall bedelivered by the majority laid down in Article 148 (2) of the Treaty inthe case of Decisions which the Council is required to adopt on aproposal from the Commission. The votes of the representatives of theMember States within the Committee shall be weighted in the mannerset out in that Article. The Chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in
accordance with the opinion of the Committee. If the measures envis-aged are not in accordance with the opinion of the Committee, or if noopinion is delivered, the Commission shall, without delay, submit to theCouncil a proposal relatingto the measures to be taken. The Councilshall act by a qualified majority.
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If, on the expiry of a period of three months from the date of referral to
the Council, the Council has not acted, the proposed measures shall beadopted by the Commission, save where the Council has decidedagainst the said measures by a simple majority.
CHAPTER V
ADAPTATION OF LEGISLATION
Article 17
Amendment of Directive 70/524/EEC
Article 13 (1) of Directive 70/524/EEC shall be replaced by the
following:
‘Article 131. Member States shall require that additives covered by this
Directive, premixtures prepared from these additives with a view totheir beingincorporated in compound feeding stuffs and compoundfeedingstuffs containing these premixtures may be put into circula-tion or used only by the establishments or intermediaries which meetthe conditions laid down, as appropriate, in Council Directive 95/69/EC of 22 December 1995 layingdown the conditions and arrang e-ments for approvingand reg isteringcertain establishments and inter-mediaries operatingin the animal feed sector(*).
(*) OJ No L 332, 30. 12. 1995, p. 15.'
Article 18
Amendment of Directive 74/63/EEC
Point (a) of Article 3a (2) of Directive 74/63/EEC shall be replaces
by the following:
‘(a) it is intended for use by establishments which meet the
conditions of Council Directive 95/69/EC of 22 December1995 layingdown the conditions and arrang ements forapprovingand reg isteringcertain establishments and interme-diaries operatingin the animal feed sector(*).
(*) OJ No L 332, 30. 12. 1995, p. 15.'
Article 19
Amendment of Directive 79/373/EEC
In Council Directive 79/373/EEC of 2 April 1979 on the marketing
of compound feedingstuffs(1), the followingsubparag raph shall be
added to Article 5 (1):
‘(k) the approval number allocated to the establishment in accord-
ance with Article 5 of Council Directive 95/69/EC of 22December 1995 layingdown the conditions and arrang ementsfor approvingand reg isteringcertain establishments and inter-mediaries operatingin the animal feed sector(*).
(*) OJ No L 332, 30. 12. 1995, p. 15.'
(1) OJ No L 86, 6. 4. 1979, p. 30. Directive as last amended by Directive
93/74/EEC (OJ No L 237, 22. 9. 1993, p. 23).
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Article 20
Amendment of Directive 82/471/EEC
Directive 82/471/EEC is hereby amended as follows:
1. The followingparag raph shall be added to Article 3:
‘3. Member States shall require that products referred to in
Chapter I.1 (a) of Council Directive 95/69/EC of 22 December1995 layingdown the conditions and arrang ements for approvingand registering certain establishments and intermediaries operatingin the animal feed sector(*) may be put into circulation only byestablishments or intermediaries which meet the conditions laiddown in Article 2 or Article 3 of that Directive, as appropriate.
(*) OJ No L 332, 30. 12. 1995, p. 15.'
2. In the Annex, for the products referred to in Chapter I.1 (a) of
this Directive, in column 7 (‘special provisions'), the terms‘approval number' shall be added as a final indent to the detailsto be given on the packaging of the product, on the container oron a label affixed thereto.
CHAPTER VI
FINAL PROVISIONS
Article 21
1. Member States shall adopt, not later than 1 April 1998 the laws,
regulations and administrative provisions necessary to comply withthis Directive. They shall forthwith inform the Commission thereof.The measures adopted shall be applicable as from 1 April 1998.
When Member States adopt these measures, they shall contain a
reference to this Directive or shall be accompanied by such referenceon the occasion of their official publication. The methods of makingsuch reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text
of the main provisions of domestic law which they adopt in the fieldgoverned by this Directive.
Article 22
Thise Directive shall enter into force on the 20th day followingthat
of its publication in the Official Journal of the European Communi-
ties.
Article 23
This Directive is addressed to the Member States.
(*) OJ No L 332, 30. 12. 1995, p. 15.
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ANNEX
CHAPTER 1
Minimum conditions which must be fulfilled by establishments and inter-
mediaries referred to in Articles 2 and 3 (subject to approval)
CHAPTER I.1. (a)
Additives and products covered by Directive 82/471/EEC (‘products') and
referred to in Article 2 (2) (a) and Article 3 (1) of this Directive Additives
Additives
— 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 havinga 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 bacteria, yeasts, algae,lower fungi:all products in the group (except for sub-group
1.2.1)
— Co-products of the manufacture of amino
acids by fermentation:all products in the group
— Amino acids and their salts: all products in the group
— Hydroxy analogues of amino acids: all products in the group
CHAPTER I.1. (b)
Minimum conditions which must be fulfilled by establishments referred to in
Article 2 (2) (a) and intermediaries referred to in Article 3 (1) (‘products'referred to in Chapter I.1(a))
1.Facilities and equipment
Facilities and manufacturingequipment must be located, desig ned,
constructed and maintained to suit the manufacture of the ‘products'concerned. The lay-out, design and operation of the facilities and equip-ment must be such as to minimize the risk of error and permit effectivecleaningand maintenance in order to avoid contamination, cross-contami-nation and any adverse effects generally on the quality of the products.Facilities and equipment to be used for manufacturingoperations whichare essential for the quality of the products must undergo appropriate andregular checks, in accordance with written procedures pre-established bythe manufacturer for production of the products.
2.Personnel
The manufacturer must have sufficient staff possessingthe skills and
qualifications necessary for the manufacture of the ‘products' concerned.An organizational chart setting out the qualifications (diplomas, profes-sional experience) and responsibilities of the supervisory staff must bedrawn up and made available to the competent authorities of the super-visory staff must be drawn up and madeavailable to the competentauthorities responsible for inspection. All the staff must be informedclearly in writingof their duties, responsibilities and powers, especiallywhen any change is made, in such a way as to obtain the desired qualityof the ‘products' concerned.
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3.Production
A qualified person responsible for production must be designated.The manufacturer must ensure that the different stages of production are
carried out accordingto pre-established written procedures and instruc-tions aimed at defining , checkingand masteringthe critical points in themanufacturingprocess.
Technical or organizational measures must be taken to avoid cross-
contamination and errors. There must be sufficient and appropriate meansof carryingout 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 releaseof the ‘products' concerned with a view to puttingthem into circulation,that they comply with the specifications defined by the manufacturer andare in conformity with the provisions laid down in Directive 70/524/EECor Directive 82/741/EEC. The use of an outside laboratory is permitted.
A quality control plan must be drawn up in writingand implemented, to
include, in particular, checks on the critical points in the manufacturingprocess, samplingprocedures and frequencies, methods of analysis andtheir frequency, compliance with the specifications — and the destinationin 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 ofcontinuous production must be taken in sufficient quantity by a proce-dure pre-established by the manufacturer and be retained in order toensure traceability. The samples must be sealed and labelled for ease ofidentification; they must be stored under conditions which prevent anyabnormal change in the composition of the sample or any abnormal adul-teration. They must be kept at the disposal of the competent authoritiesat 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 insuitable containers in places designed, adapted and maintained in order toensure good storage conditions, to which only persons authorized by themanufacturer 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 prod-ucts mentioned above and with medicinal substances. Additives must bepackaged and labelled in particular in compliance with the provisionslaid down in Directive 70/524/EEC. Products covered by Directive 82/471/EEC must be labelled in compliance with the provisions of thatDirective.
6.Documentation
6.1. Documentation relatingto the manufacturingprocess and
controls
The manufacturer must have a system of documentation designed to
define and ensure mastery of the critical points in the manufacturingprocess and to establish and implement a quality control plan. Themanufacturer must keep the results of the relevant controls. This set ofdocuments must be kept so that it is possible to trace the manufacturinghistory of each batch of ‘product' put into circulation and to establishresponsibility if complaints arise.
6.2. Register
The manufacturer must record the followinginformation in order to
ensure traceability:
(a)register of additives:
— the nature and quantity of the additives produced, the respective
dates of manufacture and, where appropriate, the number of thebatch or of the specific portion of production in the case ofcontinuous manufacture, and the names and addresses of the
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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 thespecific portion of production in the case of continuous manufac-ture;
(b)register of products covered by Directive 82/471/EEC:
— the nature of the products and the quantity produced, the respec-
tive dates of manufacture and, where appropriate, the number ofthe batch or of the specific portion of production in the case ofcontinuous manufacture,
— the names and addresses of the intermediaries or users (manufac-
turers or stock breeders) to whom these products have beendelivered, together with an indication of the nature and quantityof the products delivered and, where appropriate, the number ofthe batch or of the specific portion of production in the case ofcontinuous manufacture.
7.Intermediaries referred to in Article 3 (1)
Where the manufacturer delivers additives to a person other than a
manufacturer or products referred to in Directive 82/471/EEC to a personother than a user (manufacturer or stock breeder), that person and anysubsequent intermediary by whom they are wrapped, packaged, stored orput into circulation shall be equally bound, as appropriate, by the obliga-tions 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 puttinga product into circulation
under his own name must implement a system for registering andprocessingcomplaints.
Likewise, he must be in a position to introduce, where this proves neces-
sary, a system for prompt recall of products in the distribution network.The manufacturer must define by means of written procedures the desti-nation of any recalled products, and before such products are put backinto circulation they must undergo a quality-control reassessment.
CHAPTER I.2. (a)
Additives referred to in Article 2 (2) (b) and Article 3 (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 havinga 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
Article 2 (2) (b) and intermediaries referred to in Article 3 (1) (premixturesof additives referred to in Chapter I.2 (a))
1.Facilities and equipment
Facilities and manufacturingequipment must be located, desig ned,
constructed and maintained to suit the manufacture of the premixturesconcerned. The layout, design and operation of the facilities and equip-ment must be such as to minimize the risk of error and permit effectivecleaningand maintenance in order to avoid contamination, cross-contami-nation and any adverse effects generally on the quality of the products.Facilities and equipment to be used for operations which are essential forthe quality of the products must undergo appropriate and regular checksin accordance with the written procedures pre-established by the manu-facturer.
Preventive measures must be taken to avoid. as far as possible, the pres-
ence of harmful organisms, with the introduction of a control plan ifnecessary.
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2.Personnel
The manufacturer must have sufficient staff possessingthe skills and
qualifications necessary for the manufacture of the premixturesconcerned. An organizational chart setting out the qualifications(diplomas, professional experience) and responsibilities of the supervisorystaff must be drawn up and made available to the competent authoritiesresponsible for inspection. All the staff must be informed clearly inwritingof their duties, responsibilities and powers, especially when anychange is made, in such a way as to obtain the desired quality of thepremixtures 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 accordingto pre-established written procedures and instruc-tions aimed at defining , checkingand masteringthe critical points in themanufacturingprocess, such as in corporation of the additive in thepremixture, chronological order of production, meters and weighing appa-ratus, mixer and returns, in such a way as to obtain the desired qualityof the premixtures concerned in accordance with the provisions ofDirective 70/524/EEC.
Technical or organizational measures must be taken to avoid cross-
contamination and errors.
4.Quality control
A qualified person responsible for quality control must be designated.The manufacturer must have access to a quality control laboratory having
adequate staff and equipment to guarantee and check that the premixturesconcerned comply with the specifications defined by the manufacturerand which will guarantee and check, in particular, the nature, content,homogeneity and stability of the additives in the premixture, and as lowa level of cross-contamination as possible. The use of an outside labora-tory is permitted.
A quality control plan must be drawn up in writingand implemented, to
include, in particular, checks on the critical points in the manufacturingprocess, samplingprocedures and frequencies, methods of analysis andtheir frequency, compliance with the specifications — and destination inthe event of non-compliance — for carrier substances, additives andpremixtures (‘products').
Samples of each batch of premixture put into circulation must be taken
in sufficient quantity by a procedure pre-established by the manufacturerand be retained in order to ensure traceability. these samples must besealed and labelled for ease of identification; they must be stored underconditions which prevent any abnormal change in the composition of thesample or any abnormal adulteration. They must be kept at the disposalof the competent authorities at least until the guarantee date of thepremixture.
5.Storage
‘Products' which meet the specifications — and those which do not —
must be stored in suitable containers or in places designed, adapted andmaintained in order to ensure good storage conditions, to which onlypersons authorized by the manufacturer have access.
Preventive measures must be taken to avoid, as far as possible, the pres-
ence of harmful organisms, with the introduction of a control plan ifnecessary.
The ‘products' must be stored in such a way as to be easily identifiable
and to avoid any confusion or cross-contamination between the differentproducts and with medicinal substances. Premixtures must be wrappedand labelled in accordance with the provisions of Directive 70/524/EEC.
6.Documentation
6.1. Documentation relatingto the manufacturingprocess and
controls
The manufacturer must have a system of documentation designed to
define and ensure the mastery of the critical points in the manufacturingprocess, and to establish and implement a quality control plan. Themanufacturer must keep the results of the relevant controls. This sets of
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documents must be kept in such a way as to make it possible to trace
the manufacturinghistory of each premixture batch put into circulationand to establish responsibility if complaints arise.
6.2. Register of premixtures
The manufacturer must record the followinginformation in order to
ensure traceability:
— the names and addresses of manufacturers of additives or of interme-
diaries, the nature and quantity of the additives used and, whereappropriate, the number of the batch or of the specific portion ofproduction in the case of continuous manufacture,
— the date of manufacture of the premixture, the batch number where
appropriate,
— the names and addresses of the intermediaries or manufacturers of
compound feedingstuffs to whom the premixture is delivered, thedelivery date, the nature and quantity of the premixture is delivered,and the batch number where appropriate.
7.Intermediaries referred to in Article 3 (1)
Where the manufacturer delivers premixtures to a person other than a
manufacturer of compound feedingstuffs, that person and any subsequentintermediary by whom they are wrapped, packaged, stored our put intocirculation shall be equally bound, as appropriate, by the obligations laiddown in points 4, 5, 6.2 and 8 and, in the case of wrapping, by thosereferred to in point 3.
8.Complaints and product recall
The manufacturer or any intermediary puttinga product into circulation
under his own name must implement a system for registering andprocessingcomplaints. Likewise, he must be in a position to introduce,where this proves necessary, a system for prompt recall of products inthe distribution network. The manufacturer must define by means ofwritten procedures the destination of any recalled products, and beforesuch products are put back into circulation they must undergo a quality-control reassessment.
CHAPTER I.3. (a)
Additives referred to in Article 2 (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
Article 2 (2) (c) and (e) (compound feedingstuffs containing premixtures ofadditives referred to in Chapter I.3 (a))
1.Facilities and equipment
Facilities and manufacturingequipment must be located, desig ned,
constructed and maintained to suit the manufacture of compound feeding-stuffs containingpremixtures. The layout, desig n and operation of thefacilities and equipment must be such as to minimize the risk of errorand permit effective cleaningand maintenance in order to avoid, as faras possible, contamination, cross-contamination and any adverse effectsgenerally on the quality of the products.
Facilities and equipment to be used for manufacturingoperations which
are essential for the quality of the products must undergo appropriate andregular checks, in accordance with the written procedures pre-establishedby the manufacturer, or possibly, in the case of manufacture solely forthe manufacturer’s own needs, pre-established by a qualified outsideperson actingat the request and under the responsibility of the manufac-turer. Preventive measures must be taken to avoid, as far as possible, thepresence of harmful organisms, with the introduction of a control plan ifnecessary.
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2.Personnel
The manufacturer must have sufficient staff possessingthe skills and
qualifications necessary for the manufacture of compound feedingstuffscontainingpremixtures. An org anizational chart settingout the qualifica-tions (diplomas, professional experience) and responsibilities of thesupervisory staff must be drawn up — if appropriate in the case ofmanufacture solely for the manufacturer’s own needs — and made avail-able to the competent authorities responsible for inspection. All the staffmust be informed clearly in writingof their duties, responsibilities andpowers, especially when any change is made, in such a way as to obtainthe desired quality of the compound feedingstuffs containing premixtures.
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 ifnecessary be from outside, but shall act at the request and under theresponsibility of the manufacturer.
The manufacturer must ensure that the different stages in production are
carried out accordingto pre-established written procedures and instruc-tions aimed at defining , checkingand masteringthe critical points in themanufacturingprocess, such as incorporation of the premixture in thefeedingstuff, chronological order of production, meters and weighingapparatus, mixer and returns, in such a way as to obtain the desiredquality of the compound feedingstuffs in accordance with the provisionsof 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 ownneeds, may if necessary be from outside, but shall act at the request andunder the responsibility of the manufacturer.
The manufacturer must have at his disposal a quality control laboratory
havingadequate staff and equipment to g uarantee and check that thecompound feedingstuffs containing premixtures comply with the specifi-cations defined by the manufacturer and which will guarantee and check,in particular, the nature, content and homogeneity of the additivesconcerned in the compound feedingstuffs, and as low a level as possibleof cross-contamination, as well as, in the case of feedingstuffs to be putinto circulation, the contents as regards analytical constituents (Directive79/373/EEC). The use of an outside laboratory is permitted.
A quality control plan must be drawn up in writingand implemented, to
include, in particular, checks on the critical points in the manufacturingprocess, samplingprocedures and frequencies, methods of analysis andtheir frequency, compliance with the specifications — and destination inthe event of non-compliance — for raw materials, premixtures andcompound feedingstuffs ‘products'.
Samples must be taken in sufficient quantity by a procedure pre-estab-
lished by the manufacturer on the basis of each batch of compoundfeedingstuffs or each specific portion of production in the case of contin-uous manufacture, and be retained in order to ensure traceability where itis put into circulation, or on a regular basis in the case of manufacturesolely for the manufacturer’s own needs. These samples must be sealedand labelled for ease of identification; they must be stored under condi-tions which prevent any abnormal change in the composition of thesample or any abnormal adulteration. They must be kept at the disposalof 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 andmaintained in order to ensure good storage conditions, to which onlypersons authorized by the manufacturer have access.
Preventive measures must be taken to avoid, as far as possible, the pres-
ence of harmful organisms, with the introduction of a control plan ifnecessary.
The ‘products' must be stored in such a way as to be easily identifiable
and to avoid any confusion or cross-contamination between the differentproducts and with medicinal substances or medicinal feedingstuffs, orwith raw materials containinghig h levels of undesirable substances and
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products, or with additives. Compound feedingstuffs intended to be put
into circulation must comply with the provisions of Directive 79/373/EEC.
6.Documentation
6.1. Documentation relatingto the manufacturingprocess and
controls
The manufacturer must have a system of documentation designed to
define and ensure the mastery of the critical points in the manufacturingprocess, and to establish and implement a quality control plan. Themanufacturer must keep the results of the relevant controls. This set ofdocuments must be kept in such a way as to make it possible to tracethe manufacturinghistory of each batch produced and, where it is putinto circulation, to establish responsibility if complaints arise.
6.2. Register of compound feedingstuffs
The manufacturer must record the followinginformation in order to
ensure traceability:
— the names and addresses of premixture manufacturers or intermedia-
ries, with the batch number if appropriate, the nature and quantity ofthe premixture used,
— the nature and quantity of feedingstuffs manufactured, together with
the date of manufacture.
7.Complaints and product recall
The manufacturer must implement a system for registering and
processingcomplaints.
Likewise, he must be in a position to introduce, where this proves neces-
sary, a system for prompt recall of products in the distribution network.The manufacturer must define by means of written procedures the desti-nation of any recalled products, and before such products are put backinto circulation they must undergo a quality-control reassessment.
CHAPTER I.4
Minimum conditions which must be fulfilled by establishments referred to in
Article 2 (2) (d) and (e) (compound feedingstuffs from raw materials whichcontain high levels of undesirable substances and products (‘raw materialsconcerned'))
1.Facilities and equipment
Facilities and manufacturingequipment must be located, desig ned,
constructed and maintained to suit the manufacture of compound feee-dingstuffs from the ‘raw materials concerned'. The layout, design andoperation of the facilities and equipment must be such as to minimizethe risk of error and permit effective cleaningand maintenance in orderto avoid contamination, as far as possible, contamination, cross-contami-nation and any adverse effects generally on the quality of the products.Facilities and equipment to be used for manufacturingoperations whichare essential for the quality of the products must undergo appropriate andregular checks, in accordance with written procedures pre-established bythe manufacturer, or possibly, in the case of manufacture solely for themanufacturer’s own needs, pre-established by a qualified outside personactingat the request and under the responsibility of the manufacturer.
Preventive measures must be taken to avoid, as far as possible, the pres-
ence of harmful organisms, with the introduction of a control plan ifnecessary.
2.Personnel
The manufacturer must have sufficient staff possessingthe skills and
qualifications necessary for the manufacture of compound feedingstuffsfrom the ‘raw materials concerned'. An organizational chart setting outthe qualifications (diplomas, professional experience) and responsibilitiesof the supervisory staff must — if appropriate in the case of manufacturesolely for the manufacturer’s own needs — be drawn up and made avail-able to the competent authorities responsible for inspection. All the staffmust be informed clearly in writingof their duties, responsibilities andpowers, especially when any change is made, in such a way as to obtainthe desired quality of compound feedingstuffs from the ‘raw materialsconcerned'.
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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 ifnecessary be from outside, but shall act at the request and under theresponsibility of the manufacturer.
The manufacture must ensure that the different stages in production are
carried out accordingto pre-established written procedures and instruc-tions aimed at defining , checkingand masteringthe critical points in themanufacturingprocess, such as incorporation in the feeding stuff of the‘raw material concerned', chronological order of production, meters andweighing apparatus, mixer and returns, in such a way as to obtain thedesired quality of the compound feedingstuffs in accordance with theprovisions 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 ownneeds, may if necessary be from outside, but shall act at the request andunder the responsibility of the manufacturer.
The manufacturer must have at his disposal a quality control laboratory
havingadequate staff and equipment to g uarantee and check that thecompound feedingstuffs concerned comply with the specifications definedby the manufacturer and which will guarantee and check, in particular,the nature, content and homogeneity of the undesirable substances andproducts concerned in the compound feedingstuff, and as low a level aspossible of cross-contamination as well as compliance with the maximumlevels of undesirable substances and products as laid down in Directive74/63/EEC and, in the case of feedingstuffs to be put into circulation,contents as regards analytical constituents (Directive 79/373/EEC). Theuse of an outside laboratory is permitted.
A quality control plan shall be drawn up in writingand implemented, to
include, in particular, checks on the critical points in the manufacturingprocess, samplingprocedures and frequencies, methods of analysis andtheir frequency, compliance with the specifications — and destination inthe event of non-compliance — for raw materials, includingthose withhigh levels of undesirable substances and products, and compoundfeedingstuffs.
Samples must be taken sufficient quantity by a procedure pre-established
by the manufacturer on the basis of each of compound feedingstuffs oreach specific portion of production in the case of continuous manufac-ture, and be retained in order to ensure traceability where it is put intocirculation, or on a regular basis in the case of manufacture solely forthe manufacturer’s own needs. These samples must be sealed andlabelled for ease of identification; they must be stored under conditionswhich prevent any abnormal change in the composition of the sample orany abnormal adulteration. They must be kept at the disposal of thecompetent authorities for a period appropriate to the use to which thefeedingstuffs are put.
5.Storage
Raw materials, notably those containinghig h levels of undesirable
substances and products and compound feedingstuffs which meet thespecifications — and those which do not — must be stored in suitablecontainers or in places designed, adapted and maintained in order toensure good storage conditions.
Preventive measures must be taken to avoid, as far as possible, the pres-
ence of harmful organisms, with the introduction of a control plan ifnecessary.
The products must be stored in such a way as to be easily identifiable
and to avoid any confusion or cross-contamination between the differentproducts mentioned above and with medicinal substances or medicinalfeedingstuffs, or with additives or premixtures of additives. Compoundfeedingstuffs intended to be put into circulation must comply with theprovisions of Directive 79/373/EEC.
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6.Documentation
6.1. Documentation relatingto the manufacturingprocess and
controls
The manufacturer must have a system of documentation designed to
define and ensure the mastery of the critical points in the manufacturingprocess, and to establish and implement a quality control plan. Themanufacturer must in particular keep the results of the relevant controls.This set of documents must be kept in such a way as to make itpossible to trace the manufacturinghistory of each batch produced and,where it is put into circulation, to establish responsibility if complaintsarise.
6.2. Register of compound feedingstuffs
The manufacturer must record the followinginformation 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 manufac-tured, plus the date of manufacture.
7.Complaints and product recall
The manufacturer must implement a system for registering and
processingcomplaints.
Likewise, he must be in a position to introduce, where this proves neces-
sary, a system for prompt recall of products in the distribution network.The manufacturer must define by means of written procedures the desti-nation of any recalled products, and before such products are put backinto circulation they must undergo a quality-control reassessment.
CHAPTER II
Minimum conditions which must be fulfilled by establishments and inter-
mediaries referred to in Articles 7 and 8 (subject to registration)
CHAPTER II (a)
Additives referred to in Article 7 (2) (b), (c) and (d) and in Article 8 (1)
— Vitamins, provitamins and chemically well-
defined substances havinga similar action:all additives in the group except for vitamins A
and D
— Trace elements: all additives in the group except for Cu and Se— Carotenoids and xanthophylls: all additives in the group— Enzymes: all additives in the group— Micro-organisms: all additives in the group— Substances with antioxidant effects: only those with a fixed maximum content
CHAPTER II (b)
Additives referred to in Article 7 (2) (c) and (d)
— Vitamins, provitamins and chemically well-
defined substances havinga 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 effect: only those with a fixed maximum content
CHAPTER II (c)
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Minimum conditions which must be fulfilled by establishments and interme-
diaries referred to in Article 7 (2) (a) and (b) and Article 8 (1), (additives forwhich a prescribed maximum level is set and which are not referred to inChapter I.1 (a), premixtures of additives referred to in Chapter II (a)) andestablishments referred to in Article 7 (2) (c) and (d), (compound feeding-stuffs containingpremixtures of additives referred to in Chapter II (b) oradditives 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, premixtures ofadditives and compound feedingstuffs containing additives or premixturesof additives concerned (‘products concerned').
2.Personnel
The manufacturer must have sufficient staff possessingthe skills and
qualifications necessary for the manufacture of the ‘products concerned'.
3.Production
A qualified person responsible for production must be designated who, in
the case of manufacture solely for the manufacturer’s own needs, may ifnecessary be from outside, but shall act at the request and under theresponsibility 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 ‘prod-ucts 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 ownneeds, may if necessary be from outside, but shall act at the request andunder 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 thespecifications defined by the manufacturer and that they comply, asappropriate, 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 portionof production in the case of continuous or regular manufacture. Theymust be kept at the disposal of the competent authorities for a periodappropriate to the use to which the feedingstuffs are put.
5.Storage
Raw materials, active substances, carrier substances, premixtures and
compound feedingstuffs must be stored in places designed, adapted andmaintained 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 differentproducts mentioned above and with medicinal substances or medicinalfeedingstuffs. Products to be put into circulation must be wrapped, whereappropriate, and labelled in accordance with the provisions of Directive70/524/EEC or Directive 79/373/EEC, as appropriate.
6.Register
The manufacturer must record the followinginformation in order to
ensure traceability:
(a)for additives:
— the nature and quantity of the additives produced, the respective
dates of manufacture and, where appropriate, the number of thebatch or of the specific portion of production in the case ofcontinuous manufacture,
— the names and addresses of the intermediaries or users (manufac-
turers or stock breeders) to whom the additives have been deliv-ered, with an indication of the nature and quantity of the addi-tives delivered and, where appropriate, the number of the batchor of the specific portion of production in the case of continuousmanufacture.
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(b)for premixtures:
— the names and addresses of the additive manufacturers or inter-
mediaries, the nature and quantity of the additives used and,where appropriate, the number of the batch or of the specificportion of production in the case of continuous manufacture,
— the date of manufacture of the premixture, the number of the
batch where appropriate,
— the names and addresses of the intermediaries or manufacturers
to whom the premixtures have been delivered and the nature andquantity of the premixture delivered, and the number of thebatch, where appropriate;
(c)for compound feedingstuffs containing premixtures or additives:
— the names and addresses of the premixture manufacturers or
intermediaries, with the batch number where appropriate, thenature and quantity of the premixture used,
— the names and addresses of the additive manufacturers or inter-
mediaries, the nature and quantity of the additive used and thenumber of the batch or of the specific portion of production inthe event of continuous manufacture,
— the nature and quantity of the feedingstuffs manufactured, with
the date of manufacture.
7.Intermediaries referred to in Article 8 (1)
Where the manufacturer delivers additives to a person other than a
manufacturer or stock breeder, or premixtures to a person other than amanufacturer, that person and any subsequent intermediary by whomthey are wrapped, packaged, stored or put into circulation shall beequally bound, as appropriate, by the obligations laid down in points 4, 5and 6.2 and, in the case of wrapping, by those laid down in point 3.