1995L0069 — EN — 05.06.2003 — 004.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE95/69/EC
of22December 1995
laying down the conditions and arrangements for approving and registering certain establish-
ments and intermediaries operating in the animal feed sector and amending Directives 70/524/
EEC,74/63/EEC,79/373/EECand82/471/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
►M2Council Directive 1999/20/EC of 22 March1999 L 80 20 25.3.1999
►M3Council Directive 1999/29/EC of 22 April 1999 L 115 32 4.5.1999
►M4Council Regulation (EC) No 806/2003 of 14 April 2003 L 122 1 16.5.2003
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COUNCILDIRECTIVE95/69/EC
of22December 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/EECand82/471/EEC
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, andin particular Article 43 thereof,
Having regard to the proposal from the Commission (
1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social
Committee (3),
1.Whereas Council Directive 70/524/EEC of 23 November 1970
concerning additives in feedingstuffs(4), lays down the minimum
conditions to be met by manufacturers of certain additives,premixtures and compound feedingstuffs containing suchaddi-tives;
2.Whereas these rules restrict the manufacture or use of certaincategories of additives, premixtures and compound feedingstuffscontaining suchadditives and premixtures to th ose manufac-turers who are included on a national list;
3.Whereas individuals holding goods 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 to dero-gate from the Community provisions applying to the sector inquestion should be abolished and the criteria for approving orregistering manufacturers or intermediaries should be specified
so as to avoid distortions of competition caused by the Member-
States' different ways of applying and interpreting pre-existingapproval conditions and to forestall any potentially adverseeffects on animals, humans or the environment, given the risksinherent in using certain additives;
5.Whereas, to forestall certain particularly undesirable substancesoccurring in feedingstuffs, Council Directive 74/63/EEC of 17December 1973 on undesirable substances and products inanimal nutrition (
5), aims to limit their presence in raw materials
to an acceptable level; whereas these rules also restrict the use of
those raw materials to those persons who have the necessaryqualifications, facilities and equipment for the dilution opera-tions which ensure that the maximum levels laid down in theDirective as regards the various types of compound feedingstuffsare complied with;
6.Whereas establishments producing certain 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;1995L0069 — EN — 05.06.2003 — 004.001 — 2
(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 Commission
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 Commission
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 Commission
Directive 95/33/EC (OJ No L 167, 18. 7. 1995, p. 17).
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7.Whereas, with a view to ensuring the quality of the product and
preventing the occurrence of residues of certain additives in
animal 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, andintermediaries should be approved or registered on the basis of
standard, specific criteria;
8.Whereas the level of requirements for the exercise of activities
laid down in this Directive must be in proportion to the risksinvolved in the manufacture or use by establishments of addi-tives and premixtures listed in Directive 70/524/EEC, productscovered by Directive 82/471/EEC or raw materials containingundesirable substances or products listed in Directive 74/63/
EEC;
9.Whereas establishments which intend to manufacture or use
products 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 do
not hinder the free movement of agricultural products in the
territory of the Member States; whereas, conversely, for estab-lishments using less sensitive products, mere registration basedon an undertaking by the establishment to comply with a numberof conditions will suffice; whereas this distinction must also
apply to intermediaries which wrap, package, store or put into
circulation 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 of
their own farms, without any distinction; whereas, nonetheless,
some relief should be allowed the latter on account of the parti-cular circumstances in which they exercise their activity;
11.Whereas provision should be made for amending or withdrawingapproval if an establishment changes or ceases its activities or ifit no longer fulfils one of the essential conditions applicable toits activity; whereas the same rules should apply, mutatis
mutandis, to registration;
12.Whereas Member States may be entitled to levy fees for granting
approval; whereas the levels of such fees should subsequently beharmonized in order to obviate distortion of competition;whereas such harmonization will fall within the general frame-work of future Community rules on fees or charges to be leviedin the animal feed sector;
13.Whereas it is necessary to give the Commission the task of
adopting detailed rules for the application of this Directive,
including the conditions for approval and registration of estab-lishments in third countries;
14.Whereas, should the Council confer on the Commission respon-sibility for implementing the rules laid down on the conditionsand arrangements for approving and registering the establish-ments in question, provision should be made for close
cooperation between the Member States and the Commission
within the Standing Committee for Feedingstuffs established byDecision 70/372/EEC (
1);
15.Whereas to ensure greater transparency the conditions andarrangements relating to the approval and registration of estab-lishments in the animal feed sector should be brought togetherin a single text; whereas this entails adapting existing legislation;1995L0069 — EN — 05.06.2003 — 004.001 — 3
(1) OJ No L 170, 3. 8. 1970, p. 1.
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16.Whereas the requirement for manufacturers to be approved or
registered will make it possible for Member States to check on
manufacturers and intervene, if necessary, where substances arebeing used illegally, in particular where prohibited substancessuch as hormones or beta-agonists are in use; whereas MemberStates have a duty to check beforehand that establishmentsrequiring approval actually meet the minimum conditions which
the 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 orregistered establishments and intermediaries are indeedcomplying with the conditions imposed upon them; whereas
these provisions must apply without prejudice to Community
rules governing the organization of official checks on animalfeed;
17.Whereas it is necessary to adopt these measures at Communitylevel in order better to achieve the objectives of guaranteeingthe quality and safety of feedingstuffs,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
SCOPEANDDEFINITIONS
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 in
Articles 2 and 7 and Articles 3 and 8 respectively.
2. This Directive shall apply without prejudice to the Community
provisions concerning the organization of official checks on animalfeed.
3. For the purposes of this Directive:(a) ‘putting into circulation’ means holding products for the purposes
of sale, including offering for 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 producing or manufacturing addi-
tives, premixtures prepared from additives, compoundfeedingstuffs or products covered by Directive 82/471/EEC and
referred to in Chapter I.1 (a) of the Annex to this Directive;
(c) ‘intermediary’ means any person other than the manufacturer or
the person producing for 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 this Direc-tive 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
APPROVALOFESTABLISHMENTSANDINTERMEDIARIES
Article 2
Approvalofestablishments
1. An establishment wishing to exercise one or more of the activities
referred to in paragraph2 must receive approval for eachof its activ-ities. A Member State may decide not to approve establishmentsreferred to in paragraph2 (f).1995L0069 — EN — 05.06.2003 — 004.001 — 4
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2. To be approved by the competent authorities an establishment:
(a) manufacturing additives or products covered by Directive 82/471/
EEC and referred to in Chapter I.1 (a) of the Annex to this Direc-tive with a view to putting them into circulation, must meet theminimum conditions laid down in Chapter I.1 (b) of the said Annex
1;
(b) manufacturing premixtures prepared from additives referred to in
Chapter I.2 (a) of the Annex, with a view to putting them intocirculation, must meet the minimum conditions laid down inChapter I.2 (b) of the said Annex;
(c) manufacturing compound feedingstuffs containing premixtures
prepared from additives referred to in Chapter I.3 (a) of the Annex,
with a view to putting them into circulation, must meet theminimum conditions laid down in Chapter I.3 (b) of the Annex;
(d) manufacturing compound feedingstuffs, witha view to putting
them into circulation, from raw materials referred to in Article 3a
(2) of Directive 74/63/EEC which contain high levels of undesir-
able substances or products, must meet the minimum conditionslaid down 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 minimum
conditions laid down in Chapter I.3 (b) of the Annex, with the
exception 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 containing high levels of undesirablesubstances or products, must meet the minimum conditions laid
down in Chapter 1.4 of the Annex to this Directive, with the excep-
tion 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 its activ-ities and does not comply with that requirement within a reasonabletime,
— 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
Approvalofintermediaries
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
the Annex respectively are put into circulation, intermediaries must be
approved.
The provisions laid down in point 7 of Chapter I.1 8 (b) or Chapter I.2
(b) of the 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 its activ-ities and does not comply with that requirement within a reasonable
time;
— amended if the intermediary has demonstrated its ability to engage
in activities which are additional to those for which it was firstapproved or which replace them.1995L0069 — EN — 05.06.2003 — 004.001 — 5
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Article 4
Approvalprocedureforestablishmentsandintermediaries
1. To obtain approval, establishments referred to in Article 2 and
intermediaries referred to in Article 3 which intend to exercise for the
first 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 their
submission.
2. Establishments and intermediaries which, on 1 April 1998, were
exercising one 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 submit
the 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
Registerofapprovedestablishmentsandintermediaries
1. For each activity, the competent authority shall enter the estab-
lishments and intermediaries it has approved in accordance with
Articles 2 and 3 in a register under an individual approval number
which identifies them, once it has established by means of on-the-spotverification that they satisfy the conditions laid down by this Directive.
In respect of intermediaries who act solely as dealers without ever
holding the product in their facilities, Member States need not carry
out on-the-sport verification of compliance with the conditions under
point 7 of Chapters I.1 (b) or I.2 (b) of the Annex, providing that thoseintermediaries lodge with the competent authority a declaration to theeffect that they meet the requirements laid down under point 6.2 inthe Annex 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 referred
to in Article 2 (3) and Article 3 (2) to withdraw or amend approval.
Article 6
Publication and communication of the list of approved establish-
mentsandintermediaries
1. Each Member State shall publish a list of the establishments and
intermediaries approved in accordance withArticles 2 and 3 for th e
first time in November 2001, and then each year, by 30 November at
the latest, the list of amendments made during the year; every fiveyears, it shall 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 to 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 Article3(1) and a list of corresponding establishments and intermediariesreferred to in Article 4(2) which have submitted applications for
approval on which the Member States have not yet taken a decision.
On request, the 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)and all or part of the list of corresponding establishments referred to inArticle 4(2) which have submitted applications for approval on whichthe Member States have not yet taken a decision.1995L0069 — EN — 05.06.2003 — 004.001 — 6
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CHAPTER III
REGISTRATION OF ESTABLISHMENTS ANDINTERMED I-
ARIES
Article 7
Registrationofestablishments
1. An establishment wishing to exercise one or more of the activities
referred to in paragraph2 must be registered by a Member State foreachactivity in accordance withth is Directive.
2. In order to be registered by the competent authorities an estab-
lishment:
(a) manufacturing additives for which a prescribed maximum level is
set and which are not included in Chapter I.1 (a) of the Annex,with a view to putting them into circulation, must meet theminimum conditions laid down in Chapter II (c) of the Annex;
(b) manufacturing premixtures containing additives referred to in
Chapter II (a) of the Annex, with a view to putting them into circu-lation, must meet the minimum conditions laid down in Chapter II(c) of the Annex;
(c) manufacturing compound feedingstuffs containing premixtures of
additives referred to in Chapter II (b) of the Annex or additives
referred to in Chapter II (a) of the Annex with a view to putting
them into circulation, must met the minimum conditions laiddown in Chapter II (c) of the Annex;
(d) manufacturing, for the exclusive requirements of its holding,
compound feedingstuffs containing premixtures of additives
referred to in Chapter II (b) of the Annex or containing additives
referred to in Chapter II (a) of the Annex, must met the minimumconditions laid down in Chapter II (c) of the Annex.
3. Approved establishments exercising the corresponding activities
referred to in Article 2 (2) (a), (b), (c) and (e) shall be regarded assatisfyingde facto the 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 its activ-ities and does not comply with that requirement within a reasonable
time,
— amended if the establishment declares that it is engaged in activities
which are additional to those for which it was first registered orwhich replace them.
Article 8
Registrationofintermediaries
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 or put into circulation additives or premixtures of additives.
2. Intermediaries approved in accordance withArticle 3 sh all be
regarded as meeting defactothe 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 its activ-ities and does not comply with that requirement within a reasonabletime,1995L0069 — EN — 05.06.2003 — 004.001 — 7
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— amended if the intermediary has declared that it is engaged in activ-
ities which are additional to those for which it was first registeredor which replace them.
Article 9
Registrationprocedureforestablishmentsandintermediaries
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 1
April 1998, submit a declaration to the competent authority of the
Member State in which they intend to exercise their activities.
2. Establishments and intermediaries which, on 1 April 1998, were
exercising one 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
Listofregistered establishmentsandintermediaries
1. For each activity, the competent authority shall enter the estab-
lishments and intermediaries which it has registered in accordance
withArticles 7 and 8 on a list under an individual registration number
which identifies them.
2. Member States shall update the entries of establishments and
intermediaries on the list in accordance with the decisions referred toin Articles 7 (4) and 8 (3) to withdraw or amend registration.
Article 11
Communication of the list of registered establishments and inter-
mediaries
1. Before 31 December each year, Member States shall send the
Commission the list of establishments and intermediaries registeredduring the year in accordance with Articles 7 and 8 and, every five
years, 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
COMMONPROVISIONS
Article 12
Simplifiedprocedure
Where an establishment manufacturing an additive is already author-
ized to manufacture the same active substance as a veterinarymedicinal product within the meaning of Article 24 of Directive 81/851/EEC (
1), Member States shall not be obliged to verify that the
conditions laid down in Article 2 (2) (a) and contained in Chapter I.1(b) of the Annex to this Directive have been fulfilled, with the excep-
tion of the requirements 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
approved or registered, that the requirements imposed by this Directiveare met.1995L0069 — EN — 05.06.2003 — 004.001 — 8
(1) OJ No L 317, 6. 11. 1981, p. 16. Directive as last amended by Commission
Directive 93/40/EEC (OJ No L 214, 24. 8. 1993, p. 31).
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Article 14
The Council, acting by a qualified majority on a proposal from the
Commission, shall, before 1 April 1999, adopt rules for calculatingthe level of the fee to be charged for the approval of establishments
and their intermediaries.
Article 15
Detailedarrangements,amendmentoftheAnnexandimportsfrom
non-membercountries
The following shall 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 of estab-lishments located in a non-member country and putting additives,
premixtures, products covered by Directive 82/471/EEC as referred
to in Chapter 1.1 (a) of the Annex to this Directive or feedingstuffsinto circulation within the Community, so that safeguards areprovided equivalent to those supplied by establishments located inthe Community.
These arrangements shall comprise:
— establishment and updating of a list of non-member countries
able to provide safeguards equivalent to those offered by theMember States in respect of their own establishments and able
to perform the checks referred to in Article 13,
— establishment and updating of a list of establishments which
have been found by the non-member countries on the list
referred to in the first indent to fulfil the conditions laid downin this 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 implementing this Directive, in particular the form of
the register and approval numbers;
(c) the amendments to be made to the Annexes.
Article 16
StandingCommitteeontheFoodChainandAnimalHealth
1. The Commission shall be assisted by the Standing Committee on
the Food Chain and Animal Health set up pursuant to Article 58 of
Regulation (EC) No 178/2002 (
1).
2. Where reference is made to this Article, Articles 5 and 7 of Deci-
sion 1999/468/EC (2) shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.
3. The Committee shall adopt its Rules of Procedure.1995L0069 — EN — 05.06.2003 — 004.001 — 9
(1) OJ L 31, 1.2.2002, p. 1.
(2) OJ L 184, 17.7.1999, p. 23.▼B
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CHAPTER V
ADAPTATIONOFLEGISLATION
Article 17
AmendmentofDirective 70/524/EEC
Article 13 (1) of Directive 70/524/EEC shall be replaced by the
following:
‘Article 13
1. Member States shall require that additives covered by this
Directive, premixtures prepared from these additives with a view
to their being incorporated in compound feedingstuffs andcompound feedingstuffs containing these premixtures may be putinto circulation or used only by the establishments or intermediarieswhich meet the conditions laid down, as appropriate, in CouncilDirective 95/69/EC of 22 December 1995 laying down the condi-
tions and arrangements for approving and registering certain
establishments and intermediaries operating in the animal feedsector (*).
(*) OJ No L 332, 30. 12. 1995, p. 15.’
Article 19
AmendmentofDirective 79/373/EEC
In Council Directive 79/373/EEC of 2 April 1979 on the marketing of
compound feedingstuffs (1), the following subparagraph shall be added
to Article 5 (1):
‘(k) the approval number allocated to the establishment in accor-
dance withArticle 5 of Council Directive 95/69/EC of 22
December 1995 laying down the conditions and arrangementsfor approving and registering certain establishments and inter-mediaries operating in the animal feed sector (*).
(*) OJ No L 332, 30. 12. 1995, p. 15.’
Article 20
AmendmentofDirective 82/471/EEC
Directive 82/471/EEC is hereby amended as follows:1. The following paragraph 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 laying down the conditions and arrangements 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 laid
down 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 details to be given
on the packaging of the product, on the container or on a labelaffixed thereto.1995L0069 — EN — 05.06.2003 — 004.001 — 10
(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).▼M3
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CHAPTER VI
FINALPROVISIONS
Article 21
1. Member States shall adopt, not later than 1 April 1998 the laws,
regulations and administrative provisions necessary to comply withth isDirective. 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 refer-
ence to this Directive or shall be accompanied by such reference on theoccasion of their official publication. The methods of making suchreference 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 field
governed by this Directive.
Article 22
Thise Directive shall enter into force on the 20th day following that of
its publication in the Official JournaloftheEuropeanCommunities .
Article 23
This Directive is addressed to the Member States.1995L0069 — EN — 05.06.2003 — 004.001 — 11
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ANNEX
CHAPTER1
Minimumconditionswhichmustbefulfilledbyestablishmentsandinterme-
diariesreferred toinArticles2and3(subjecttoapproval)
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
— Growthpromoters: all additives in th e group
— Vitamins, provitamins and chemi-
cally well-defined substances having a
similar effect: all additives in the group
— Trace elements: all additives in the group— Enzymes: all additives in the group
— Micro-organisms: all additives in the group
— Carotenoids and xanthophylls: all additives in the group— Substances withantioxidant
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 manufacturing equipment must be located, designed,
constructed and maintained to suit the manufacture of the ‘products’
concerned. The lay-out, design and operation of the facilities and equip-
ment must be suchas to minimize th e risk of error and permit effective
cleaning and 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 manufacturing operations which
are essential for the quality of the products must undergo appropriate and
regular checks, in accordance with written procedures pre-established by
the manufacturer for production of the products.
2.Personnel
The manufacturer must have sufficient staff possessing the skills and quali-
fications necessary for the manufacture of the ‘products’ concerned. An
organizational chart setting out the qualifications (diplomas, professional
experience) and responsibilities of the supervisory staff must be drawn up
and made available to the competent authorities of the supervisory staff
must be drawn up and madeavailable to the competent authorities respon-
sible for inspection. All the staff must be informed clearly in writing of
their duties, responsibilities and powers, especially when any change is1995L0069 — EN — 05.06.2003 — 004.001 — 12
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made, in such a way as to obtain the desired quality of the ‘products’
concerned.
3.Production
A qualified person responsible for production must be designated.
The manufacturer must ensure that the different stages of production are
carried out according to pre-established written procedures and instructions
aimed at defining, checking and mastering the critical points in the manu-
facturing process.
Technical or organizational measures must be taken to avoid cross-contam-
ination and errors. There must be sufficient and appropriate means of
carrying out checks in the course of manufacture.
4.Quality control
A qualified person responsible for quality control must be designated.
The manufacturer must have access to a quality control laboratory having
adequate staff and equipment to guarantee and check, before the release of
the ‘products’ concerned with a view to putting them into circulation, that
they comply with the specifications defined by the manufacturer and are in
conformity withth e provisions laid down in Directive 70/524/EEC or
Directive 82/741/EEC. The use of an outside laboratory is permitted.
A quality control plan must be drawn up in writing and implemented, to
include, in particular, checks on the critical points in the manufacturing
process, sampling procedures and frequencies, methods of analysis and
their frequency, compliance with the specifications — and the destination
in the event of non-compliance — of raw materials, active substances,
carrier substances and ‘products’.
Samples of the active substance and of each batch of ‘product’ put into
circulation or of eachspecific portion of production in th e case of contin-
uous production must be taken in sufficient quantity by a procedure pre-
established by the manufacturer and be retained in order to ensure trace-
ability. The samples must be sealed and labelled for ease of identification;
they must be stored under conditions which prevent any abnormal change
in the composition of the sample or any abnormal adulteration. They must
be kept at the disposal of the competent authorities at least until the guar-
antee date of the finished product.
5.Storage
Raw materials, active substances, carrier substances, ‘products’ which meet
the specifications — and those which do not — must be stored in suitable
containers in places designed, adapted and maintained in order to ensure
good storage conditions, to which only persons authorized by the manufac-
turer have access.
They must be stored in such a way as to be easily identifiable and to avoid
any confusion or cross-contamination between the different products
mentioned above and withmedicinal substances. Additives must be pack-
aged and labelled in particular in compliance withth e provisions laid
down in Directive 70/524/EEC. Products covered by Directive 82/471/
EEC must be labelled in compliance with the provisions of that Directive.
6.Documentation
6.1. Documentation relating to the manufacturing process and
controls
The manufacturer must have a system of documentation designed to define
and ensure mastery of the critical points in the manufacturing process and
to establishand implement a quality control plan. Th e manufacturer must
keep the results of the relevant controls. This set of documents must be
kept so that it is possible to trace the manufacturing history of each batch
of ‘product’ put into circulation and to establishresponsibility if complaints
arise.
6.2. Register
The manufacturer must record the following information in order to ensure
traceability:
(a)registerofadditives:
— the nature and quantity of the additives produced, the respective
dates of manufacture and, where appropriate, the number of the
batch or of the specific portion of production in the case of contin-
uous manufacture, and the names and addresses of the1995L0069 — EN — 05.06.2003 — 004.001 — 13
▼B
intermediaries or manufacturers to whom the additives have been
delivered,
— indication of the nature and quantity of the additives delivered and,
where appropriate, the number of the batch or of the specific
portion of production in the case of continuous manufacture;
(b)registerofproductscoveredbyDirective 82/471/EEC:
— the nature of the products and the quantity produced, the respective
dates of manufacture and, where appropriate, the number of the
batch or of the specific portion of production in the case of contin-
uous manufacture,
— the names and addresses of the intermediaries or users (manufac-
turers or stock breeders) to whom these products have been
delivered, together with an indication of the nature and quantity of
the products delivered and, where appropriate, the number of the
batch or of the specific portion of production in the case of contin-
uous manufacture.
7.Intermediaries referred to in Article 3 (1)
Where the manufacturer delivers additives to a person other than a manu-
facturer or products referred to in Directive 82/471/EEC to a person other
than a user (manufacturer or stock breeder), that person and any subsequent
intermediary by whom they are wrapped, packaged, stored or put into
circulation shall be equally bound, as appropriate, by the obligations laid
down in points 4, 5, 6.2 and 8 and, in the case of wrapping, by those
referred to in point 3.
8.Complaints and product recall
The manufacturer or any intermediary putting a product into circulation
under his own name must implement a system for registering and proces-
sing complaints.
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 destina-
tion of any recalled products, and before suchproducts are put back into
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
— Growthpromoters: all additives in th e group
— Vitamins, provitamins and chemi-
cally well-defined substances having a
similar effect: A and D
— Trace elements: Cu and Se
CHAPTER I.2. (b)
Minimum conditions which must be fulfilled by establishments referred to in
Article 2 (2) (b) and intermediaries referred to in Article 3 (1) (premixtures of
additives referred to in Chapter I.2 (a))
1.Facilities and equipment
Facilities and manufacturing equipment must be located, designed,
constructed and maintained to suit the manufacture of the premixtures
concerned. The layout, design and operation of the facilities and equipment
must be suchas to minimize th e risk of error and permit effective cleaningand maintenance in order to avoid contamination, cross-contamination and
any adverse effects generally on the quality of the products. Facilities and
equipment to be used for operations which are essential for the quality of
the products must undergo appropriate and regular checks in accordance
with the written procedures pre-established by the manufacturer.
Preventive measures must be taken to avoid. as far as possible, the presence
of harmful organisms, with the introduction of a control plan if necessary.1995L0069 — EN — 05.06.2003 — 004.001 — 14
▼B
2.Personnel
The manufacturer must have sufficient staff possessing the skills and quali-
fications necessary for the manufacture of the premixtures concerned. An
organizational chart setting out the qualifications (diplomas, professional
experience) and responsibilities of the supervisory staff must be drawn up
and made available to the competent authorities responsible for inspection.
All the staff must be informed clearly in writing of their duties, responsibil-
ities and powers, especially when any change is made, in such a way as to
obtain the desired quality of the premixtures concerned.
3.Production
A qualified person responsible for production must be designated.The manufacturer must ensure that the different stages in production are
carried out according to pre-established written procedures and instructions
aimed at defining, checking and mastering the critical points in the manu-
facturing process, such as in corporation of the additive in the premixture,
chronological order of production, meters and weighing apparatus, mixer
and returns, in such a way as to obtain the desired quality of the premix-
tures concerned in accordance withth e provisions of Directive 70/524/
EEC.
Technical or organizational measures must be taken to avoid cross-contam-
ination 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 premixtures
concerned comply with the specifications defined by the manufacturer and
which will guarantee and check, in particular, the nature, content, homoge-
neity and stability of the additives in the premixture, and as low a level of
cross-contamination as possible. The use of an outside laboratory is
permitted.
A quality control plan must be drawn up in writing and implemented, to
include, in particular, checks on the critical points in the manufacturing
process, sampling procedures and frequencies, methods of analysis and
their frequency, compliance with the specifications — and destination in
the event of non-compliance — for carrier substances, additives and
premixtures (‘products’).
Samples of eachbatchof premixture put into circulation must be taken in
sufficient quantity by a procedure pre-established by the manufacturer and
be retained in order to ensure traceability. these samples must be sealed and
labelled for ease of identification; they must be stored under conditions
which prevent any abnormal change in the composition of the sample or
any abnormal adulteration. They must be kept at the disposal of the compe-
tent authorities at least until the guarantee date of the premixture.
5.Storage
‘Products’ which meet the specifications — and those which do not —
must be stored in suitable containers or in places designed, adapted and
maintained in order to ensure good storage conditions, to which only
persons authorized by the manufacturer have access.
Preventive measures must be taken to avoid, as far as possible, the presence
of harmful organisms, with the introduction of a control plan if necessary.
The ‘products’ must be stored in such a way as to be easily identifiable and
to avoid any confusion or cross-contamination between the different
products and withmedicinal substances. Premixtures must be wrapped and
labelled in accordance withth e provisions of Directive 70/524/EEC.
6.Documentation
6.1. Documentation relating to the manufacturing process and
controls
The manufacturer must have a system of documentation designed to define
and ensure the mastery of the critical points in the manufacturing process,
and to establishand implement a quality control plan. Th e manufacturer
must keep the results of the relevant controls. This sets of documents
must be kept in sucha way as to make it possible to trace th e manufac-
turing history of each premixture batch put into circulation and to
establishresponsibility if complaints arise.1995L0069 — EN — 05.06.2003 — 004.001 — 15
▼B
6.2. Register of premixtures
The manufacturer must record the following information in order to ensure
traceability:
— the names and addresses of manufacturers of additives or of intermedi-
aries, the nature and quantity of the additives used and, where
appropriate, the number of the batch or of the specific portion of
production in the case of continuous manufacture,
— the date of manufacture of the premixture, the batch number where
appropriate,
— the names and addresses of the intermediaries or manufacturers of
compound feedingstuffs to whom the premixture is delivered, the
delivery 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 subsequent
intermediary by whom they are wrapped, packaged, stored our put into
circulation shall be equally bound, as appropriate, by the obligations laid
down in points 4, 5, 6.2 and 8 and, in the case of wrapping, by those
referred to in point 3.
8.Complaints and product recall
The manufacturer or any intermediary putting a product into circulation
under his own name must implement a system for registering and proces-
sing complaints. Likewise, he must be in a position to introduce, where this
proves necessary, a system for prompt recall of products in the distribution
network. The manufacturer must define by means of written procedures the
destination of any recalled products, and before suchproducts 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
— Growthpromoters: all additives in th e 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 of
additives referred to in Chapter I.3 (a))
1.Facilities and equipment
Facilities and manufacturing equipment must be located, designed,
constructed and maintained to suit the manufacture of compound feeding-
stuffs containing premixtures. The layout, design and operation of the
facilities and equipment must be suchas to minimize th e risk of error and
permit effective cleaning and maintenance in order to avoid, as far as
possible, contamination, cross-contamination and any adverse effects gener-
ally on the quality of the products.
Facilities and equipment to be used for manufacturing operations which are
essential for the quality of the products must undergo appropriate and
regular checks, in accordance with the written procedures pre-established
by the manufacturer, or possibly, in the case of manufacture solely for the
manufacturer's own needs, pre-established by a qualified outside person
acting at the request and under the responsibility of the manufacturer.
Preventive measures must be taken to avoid, as far as possible, the presence
of harmful organisms, with the introduction of a control plan if necessary.
2.Personnel
The manufacturer must have sufficient staff possessing the skills and quali-
fications necessary for the manufacture of compound feedingstuffs
containing premixtures. An organizational chart setting out the qualifica-
tions (diplomas, professional experience) and responsibilities of the
supervisory staff must be drawn up — if appropriate in the case of manu-1995L0069 — EN — 05.06.2003 — 004.001 — 16
▼B
facture solely for the manufacturer's own needs — and made available to
the competent authorities responsible for inspection. All the staff must be
informed clearly in writing of their duties, responsibilities and powers,
especially when any change is made, in such a way as to obtain the desired
quality of the compound 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 if
necessary be from outside, but shall act at the request and under the respon-
sibility of the manufacturer.
The manufacturer must ensure that the different stages in production are
carried out according to pre-established written procedures and instructions
aimed at defining, checking and mastering the critical points in the manu-
facturing process, such as incorporation of the premixture in the
feedingstuff, chronological order of production, meters and weighing appa-
ratus, mixer and returns, in sucha way as to obtain th e desired quality of
the compound feedingstuffs in accordance with the provisions of Directive
79/373/EEC.
Technical or organizational measures shall be taken to avoid cross-contam-
ination and errors as far as possible.
4.Quality control
A qualified person responsible for quality control must be designated who,
in the case of manufacture solely for the manufacturer's own needs, may if
necessary be from outside, but shall act at the request and under the respon-
sibility of the manufacturer.
The manufacturer must have at his disposal a quality control laboratory
having adequate staff and equipment to guarantee and check that the
compound feedingstuffs containing premixtures comply withth e specifica-
tions defined by the manufacturer and which will guarantee and check, in
particular, the nature, content and homogeneity of the additives concerned
in the compound feedingstuffs, and as low a level as possible of cross-
contamination, as well as, in the case of feedingstuffs to be put into circu-
lation, the contents as regards analytical constituents (Directive 79/373/
EEC). The use of an outside laboratory is permitted.
A quality control plan must be drawn up in writing and implemented, to
include, in particular, checks on the critical points in the manufacturing
process, sampling procedures and frequencies, methods of analysis and
their frequency, compliance with the specifications — and destination in
the event of non-compliance — for raw materials, premixtures and
compound feedingstuffs ‘products’.
Samples must be taken in sufficient quantity by a procedure pre-established
by the manufacturer on the basis of each batch of compound feedingstuffs
or eachspecific portion of production in th e case of continuous manufac-
ture, and be retained in order to ensure traceability where it is put into
circulation, or on a regular basis in the case of manufacture solely for the
manufacturer's own needs. These samples must be sealed and labelled for
ease of identification; they must be stored under conditions which prevent
any abnormal change in the composition of the sample or any abnormal
adulteration. They must be kept at the disposal of the competent authorities
for an appropriate period.
5.Storage
‘Products’ which meet the specifications — and those which do not —
must be stored in suitable containers in places designed, adapted and main-
tained in order to ensure good storage conditions, to which only persons
authorized by the manufacturer have access.
Preventive measures must be taken to avoid, as far as possible, the presence
of harmful organisms, with the introduction of a control plan if necessary.
The ‘products’ must be stored in such a way as to be easily identifiable and
to avoid any confusion or cross-contamination between the different
products and withmedicinal substances or medicinal feedingstuffs, or with
raw materials containing high levels of undesirable substances and
products, or withadditives. Compound feedingstuffs intended to be put
into circulation must comply withth e provisions of Directive 79/373/EEC.1995L0069 — EN — 05.06.2003 — 004.001 — 17
▼B
6.Documentation
6.1. Documentation relating to the manufacturing process and
controls
The manufacturer must have a system of documentation designed to define
and ensure the mastery of the critical points in the manufacturing process,
and to establishand implement a quality control plan. Th e manufacturer
must keep the results of the relevant controls. This set of documents must
be kept in sucha way as to make it possible to trace th e manufacturing
history of each batch produced and, where it is put into circulation, to
establishresponsibility if complaints arise.
6.2. Register of compound feedingstuffs
The manufacturer must record the following information in order to ensure
traceability:
— the names and addresses of premixture manufacturers or intermediaries,
with the batch number if appropriate, the nature and quantity of the
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 processing
complaints.
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 destina-
tion of any recalled products, and before suchproducts are put back into
circulation they must undergo a quality-control reassessment.
CHAPTER I.4
Minimum conditions which must be fulfilled by establishments referred to in
Article 2 (2) (d) and (e) (compound feedingstuffs from raw materials which
contain high levels of undesirable substances and products (‘raw materials
concerned’))
1.Facilities and equipment
Facilities and manufacturing equipment must be located, designed,
constructed and maintained to suit the manufacture of compound feeeding-
stuffs from the ‘raw materials concerned’. The layout, design and operation
of the facilities and equipment must be such as to minimize the risk of
error and permit effective cleaning and maintenance in order to avoid
contamination, as far as possible, contamination, cross-contamination and
any adverse effects generally on the quality of the products. Facilities and
equipment to be used for manufacturing operations which are essential forthe quality of the products must undergo appropriate and regular checks, in
accordance with written procedures pre-established by the manufacturer, or
possibly, in the case of manufacture solely for the manufacturer's own
needs, pre-established by a qualified outside person acting at the request
and under the responsibility of the manufacturer.
Preventive measures must be taken to avoid, as far as possible, the presence
of harmful organisms, with the introduction of a control plan if necessary.
2.Personnel
The manufacturer must have sufficient staff possessing the skills and quali-
fications necessary for the manufacture of compound feedingstuffs from the
‘raw materials concerned’. An organizational chart setting out the qualifica-
tions (diplomas, professional experience) and responsibilities of the
supervisory staff must — if appropriate in the case of manufacture solely
for the manufacturer's own needs — be drawn up and made available to
the competent authorities responsible for inspection. All the staff must be
informed clearly in writing of their duties, responsibilities and powers,
especially when any change is made, in such a way as to obtain the desired
quality of compound feedingstuffs from the ‘raw materials concerned’.
3.Production
A qualified person responsible for production must be designated who, in
the case of manufacture solely for the manufacturer's own needs, may if
necessary be from outside, but shall act at the request and under the respon-
sibility of the manufacturer.
The manufacture must ensure that the different stages in production are
carried out according to pre-established written procedures and instructions1995L0069 — EN — 05.06.2003 — 004.001 — 18
▼B
aimed at defining, checking and mastering the critical points in the manu-
facturing process, such as incorporation in the feedingstuff of the ‘raw
material concerned’, chronological order of production, meters and
weighing apparatus, mixer and returns, in such a way as to obtain the
desired quality of the compound feedingstuffs in accordance with the provi-
sions of Directive 79/373/EEC.
Technical or organizational measures shall be taken to avoid cross-contam-
ination and errors as far as possible.
4.Quality control
A qualified person responsible for quality control must be designated who,
in the case of manufacture solely for the manufacturer's own needs, may if
necessary be from outside, but shall act at the request and under the respon-
sibility of the manufacturer.
The manufacturer must have at his disposal a quality control laboratory
having adequate staff and equipment to guarantee and check that the
compound feedingstuffs concerned comply withth e specifications defined
by the manufacturer and which will guarantee and check, in particular, the
nature, content and homogeneity of the undesirable substances and products
concerned in the compound feedingstuff, and as low a level as possible of
cross-contamination as well as compliance withth e maximum levels of
undesirable substances and products as laid down in Directive 74/63/EEC
and, in the case of feedingstuffs to be put into circulation, contents as
regards analytical constituents (Directive 79/373/EEC). The use of an
outside laboratory is permitted.
A quality control plan shall be drawn up in writing and implemented, to
include, in particular, checks on the critical points in the manufacturing
process, sampling procedures and frequencies, methods of analysis and
their frequency, compliance with the specifications — and destination in
the event of non-compliance — for raw materials, including those with
high levels of undesirable substances and products, and compound feeding-
stuffs.
Samples must be taken sufficient quantity by a procedure pre-established
by the manufacturer on the basis of each of compound feedingstuffs or
eachspecific portion of production in th e case of continuous manufacture,
and be retained in order to ensure traceability where it is put into circula-
tion, or on a regular basis in the case of manufacture solely for the
manufacturer's own needs. These samples must be sealed and labelled for
ease of identification; they must be stored under conditions which prevent
any abnormal change in the composition of the sample or any abnormal
adulteration. They must be kept at the disposal of the competent authorities
for a period appropriate to the use to which the feedingstuffs are put.
5.Storage
Raw materials, notably those containing high levels of undesirable
substances and products and compound feedingstuffs which meet the speci-
fications — and those which do not — must be stored in suitable
containers or in places designed, adapted and maintained in order to ensure
good storage conditions.
Preventive measures must be taken to avoid, as far as possible, the presence
of harmful organisms, with the introduction of a control plan if necessary.
The products must be stored in such a way as to be easily identifiable and
to avoid any confusion or cross-contamination between the different
products mentioned above and withmedicinal substances or medicinal
feedingstuffs, or withadditives or premixtures of additives. Compound
feedingstuffs intended to be put into circulation must comply withth e
provisions of Directive 79/373/EEC.
6.Documentation
6.1. Documentation relating to the manufacturing process and
controls
The manufacturer must have a system of documentation designed to define
and ensure the mastery of the critical points in the manufacturing process,and to establishand implement a quality control plan. Th e manufacturer
must in particular keep the results of the relevant controls. This set of
documents must be kept in sucha way as to make it possible to trace th e
manufacturing history of each batch produced and, where it is put into
circulation, to establishresponsibility if complaints arise.1995L0069 — EN — 05.06.2003 — 004.001 — 19
▼B
6.2. Register of compound feedingstuffs
The manufacturer must record the following information in order to ensure
traceability:
— the names and addresses of suppliers of raw materials containing high
level of undesirable substances and products, and
— the nature and level of undesirable substances and products, the
delivery date and the nature and quantity of the products manufactured,
plus the date of manufacture.
7.Complaints and product recall
The manufacturer must implement a system for registering and processing
complaints.
Likewise, he must be in a position to introduce, where this proves neces-
sary, a system for prompt recall of products in the distribution network.
The manufacturer must define by means of written procedures the destina-
tion of any recalled products, and before suchproducts are put back into
circulation they must undergo a quality-control reassessment.
CHAPTERII
Minimumconditionswhichmustbefulfilledbyestablishmentsandinterme-
diariesreferred toinArticles7and8(subjecttoregistration)
CHAPTER II (a)
Additives referred to in Article 7 (2) (b), (c) and (d) and in Article 8 (1)
— Vitamins, provitamins and chemi-
cally well-defined substances having a
similar action:all additives in the group except for
vitamins A and D
— Trace elements:all additives in the group except for
Cu and Se
— Carotenoids and xanthophylls: all additives in the group
— Enzymes: all additives in the group— Micro-organisms: all additives in the group
— Substances withantioxidant
effects:only those with a fixed maximum
content
CHAPTER II (b)
Additives referred to in Article 7 (2) (c) and (d)
— Vitamins, provitamins and chemi-
cally well-defined substances having a
similar action: all additives in the group
— Trace elements: all additives in the group
— Carotenoids and xanthophylls: all additives in the group— Enzymes: all additives in the group
— Micro-organisms: all additives in the group
— Substances withantioxidant effect:only those with a fixed maximum
content
CHAPTER II (c)
Minimum conditions which must be fulfilled by establishments and intermedi-
aries referred to in Article 7 (2) (a) and (b) and Article 8 (1), (additives for
which a prescribed maximum level is set and which are not referred to in
Chapter I.1 (a), premixtures of additives referred to in Chapter II (a)) and estab-
lishments referred to in Article 7 (2) (c) and (d), (compound feedingstuffs1995L0069 — EN — 05.06.2003 — 004.001 — 20
▼B
containing premixtures of additives referred to in Chapter II (b) or additives
referred to in Chapter II (a)).
1.Facilities and equipment
Facilities and technical equipment must be located, designed, constructed
and maintained to suit the manufacture of the additives, premixtures of
additives and compound feedingstuffs containing additives or premixtures
of additives concerned (‘products concerned’).
2.Personnel
The manufacturer must have sufficient staff possessing the skills and quali-
fications necessary for the manufacture of the ‘products concerned’.
3.Production
A qualified person responsible for production must be designated who, in
the case of manufacture solely for the manufacturer's own needs, may if
necessary be from outside, but shall act at the request and under the respon-
sibility of the manufacturer.
The manufacturer must ensure that the different stages of production are
carried out in such a way as to obtain the desired quality of the ‘products
concerned’ in accordance withth e provisions of Directive 70/524/EEC or
Directive 79/373/EEC.
4.Quality control
A qualified person responsible for quality control must be designated who,
in the case of manufacture solely for the manufacturer's own needs, may if
necessary be from outside, but shall act at the request and under the respon-
sibility of the manufacturer.
The manufacturer must draw up and implement a quality control plan to
guarantee and check that the ‘products in question’ comply with the speci-
fications defined by the manufacturer and that they comply, as appropriate,
withth e 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 eachbatchof th e product or from eachspecific portion
of production in the case of continuous or regular manufacture. They must
be kept at the disposal of the competent authorities for a period appropriate
to the use to which the feedingstuffs are put.
5.Storage
Raw materials, active substances, carrier substances, premixtures and
compound feedingstuffs must be stored in places designed, adapted and
maintained in order to ensure good storage conditions.
The products must be stored in such a way as to be easily identifiable and
to avoid any confusion or cross-contamination between the different
products mentioned above and withmedicinal substances or medicinal
feedingstuffs. Products to be put into circulation must be wrapped, where
appropriate, and labelled in accordance withth e provisions of Directive
70/524/EEC or Directive 79/373/EEC, as appropriate.
6.Register
The manufacturer must record the following information in order to ensure
traceability:
(a)foradditives:
— the nature and quantity of the additives produced, the respective
dates of manufacture and, where appropriate, the number of the
batch or of the specific portion of production in the case of contin-
uous manufacture,
— the names and addresses of the intermediaries or users (manufac-
turers or stock breeders) to whom the additives have been
delivered, with an indication of the nature and quantity of the addi-
tives delivered and, where appropriate, the number of the batch or
of the specific portion of production in the case of continuous
manufacture.
(b)forpremixtures:
— the names and addresses of the additive manufacturers or interme-
diaries, the nature and quantity of the additives used and, where
appropriate, the number of the batch or of the specific portion of
production in the case of continuous manufacture,
— the date of manufacture of the premixture, the number of the batch
where appropriate,1995L0069 — EN — 05.06.2003 — 004.001 — 21
▼B
— the names and addresses of the intermediaries or manufacturers to
whom the premixtures have been delivered and the nature and
quantity of the premixture delivered, and the number of the batch,
where appropriate;
(c)forcompoundfeedingstuffs containingpremixturesoradditives:
— the names and addresses of the premixture manufacturers or inter-
mediaries, with the batch number where appropriate, the nature and
quantity of the premixture used,
— the names and addresses of the additive manufacturers or interme-
diaries, the nature and quantity of the additive used and the number
of the batch or of the specific portion of production in the event of
continuous manufacture,
— the nature and quantity of the 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 manu-
facturer or stock breeder, or premixtures to a person other than a
manufacturer, that person and any subsequent intermediary by whom they
are wrapped, packaged, stored or put into circulation shall be equally
bound, as appropriate, by the obligations laid down in points 4, 5 and 6.2
and, in the case of wrapping, by those laid down in point 3.1995L0069 — EN — 05.06.2003 — 004.001 — 22