This document is meant purely as 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
"M1 Council Directive 98/92/EC of 14 December 1998 L 346 49 22.12.1998
"M2 Council Directive 1999/20/EC of 22 March 1999 L 80 20 25.3.19991995L0069 — EN — 25.03.1999 — 002.001 — 1
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 theanimal feed sector and amending Directives 70/524/EEC, 74/63/EEC,
79/373/EEC and 82/471/EEC
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in
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 such additives;
2. Whereas these rules restrict the manufacture or use of certain
categories of additives, premixtures and compound feedingstuffscontaining such additives and premixtures to those manufacturers
who are included on a national list;
3. Whereas individuals holding goods covered by this Directive for the
sole purposes of their trade promotion or their transport are notregarded as being intermediaries as defined in this Directive;
4. Whereas with the operation of the internal market in mind, some
optional provisions which still allow the Member States to derogatefrom the Community provisions applying to the sector in question
should be abolished and the criteria for approving or registering
manufacturers or intermediaries should be specified so as to avoiddistortions of competition caused by the MemberStates’ different ways
of applying and interpreting pre-existing approval conditions and to
forestall any potentially adverse effects on animals, humans or theenvironment, given the risks inherent in using certain additives;
5. Whereas, to forestall certain particularly undesirable substances
occurring in feedingstuffs, Council Directive 74/63/EEC of 17
December 1973 on undesirable substances and products in animal
nutrition (
5), aims to limit their presence in raw materials to an
acceptable level; whereas these rules also restrict the use of those rawmaterials to those persons who have the necessary qualifications,
facilities and equipment for the dilution operations which ensure that
the maximum levels laid down in the Directive as regards the varioustypes of compound feedingstuffs are complied with;
6. Whereas establishments producing certain substances listed in Council
Directive 82/471/EEC of 30 June 1982 concerning certain products
used in animal nutrition (
6), should also be subject to approval, as
should intermediaries;
7. Whereas, with a view to ensuring the quality of the product and
preventing the occurrence of residues of certain additives in animalproducts or of high levels of certain undesirable substances which
might result from defective manufacture, all manufacturers of
additives, premixtures, compound feedingstuffs and certain productscovered by Directive 82/471/EEC, and intermediaries should beapproved or registered on the basis of standard, specific criteria;!B
(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).1995L0069 — EN — 25.03.1999 — 002.001 — 2
8. Whereas the level of requirements for the exercise of activities laid
down in this Directive must be in proportion to the risks involved in themanufacture or use by establishments of additives and premixtureslisted in Directive 70/524/EEC, products covered by Directive
82/471/EEC or raw materials containing undesirable 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 prior approval onthe basis of very strict conditions that should safeguard animals,
humans and the environment, whereas, however, in exceptional cases
Member States may decide not to approve a specific category ofestablishment, provided such measures do not hinder the freemovement of agricultural products in the territory of the Member
States; whereas, conversely, for establishments using less sensitive
products, mere registration based on an undertaking by the establish-ment to comply with a number of conditions will suffice; whereas this
distinction must also apply to intermediaries which wrap, package,
store or put into circulation additives, premixtures of additives orproducts covered by Directive 82/471/EEC;
10. Whereas, on grounds of equal treatment, the fundamental principles of
these new rules must apply both to establishments which put products
into circulation and to manufacturers/stock farmers who manufacture
feedingstuffs solely for the requirements of their own farms, withoutany distinction; whereas, nonetheless, some relief should be allowedthe latter on account of the particular circumstances in which they
exercise their activity;
11. Whereas provision should be made for amending or withdrawing
approval if an establishment changes or ceases its activities or if it nolonger fulfils one of the essential conditions applicable to its 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 be
harmonized in order to obviate distortion of competition; whereas suchharmonization will fall within the general framework of futureCommunity rules on fees or charges to be levied in 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 theconditions for approval and registration of establishments in thirdcountries;
14. Whereas, should the Council confer on the Commission responsibility
for implementing the rules laid down on the conditions and
arrangements for approving and registering the establishments inquestion, provision should be made for close cooperation between theMember States and the Commission within the Standing Committee
for Feedingstuffs established by Decision 70/372/EEC (
1);
15. Whereas to ensure greater transparency the conditions and arrange-
ments relating to the approval and registration of establishments in theanimal feed sector should be brought together in a single text; whereasthis entails adapting existing legislation;
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 are beingused illegally, in particular where prohibited substances such ashormones or beta-agonists are in use; whereas Member States have a
duty to check beforehand that establishments requiring approval
actually meet the minimum conditions which the Directive lays downfor exercise of the relevant activity; whereas national supervisory
authorities must also ensure subsequently, by means of appropriate
checks, that approved or registered establishments and intermediariesare indeed complying with the conditions imposed upon them;whereas these provisions must apply without prejudice to Community
rules governing the organization of official checks on animal feed;!B
(1) OJ No L 170, 3. 8. 1970, p. 1.1995L0069 — EN — 25.03.1999 — 002.001 — 3
17. Whereas it is necessary to adopt these measures at Community level in
order better to achieve the objectives of guaranteeing the quality andsafety of feedingstuffs,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
SCOPE AND DEFINITIONS
Article 1
1. This Directive lays down the conditions and arrangements applicable to
certain categories of establishments and intermediaries in the animal
feedsector to allow them to exercise the activities described in Articles 2and 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 animal feed.
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 other form
of transfer, whether or not free of charge, to third parties, and the sale
and other forms of transfer themselves;
(b) ‘establishment’ means any unit producing or manufacturing additives,
premixtures prepared from additives, compound feedingstuffs or
products covered by Directive 82/471/EEC and referred to in ChapterI.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
Directive 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
APPROV AL OF ESTABLISHMENTS AND INTERMEDIARIES
Article 2
Approval of establishments
1. An establishment wishing to exercise one or more of the activities
referred to in paragraph 2 must receive approval for each of its activities. A
Member State may decide not to approve establishments referred to in
paragraph 2 (f).
2. To be approved by the competent authorities an establishment:
(a) manufacturing additives or products covered by Directive 82/471/EEC
and referred to in Chapter I.1 (a) of the Annex to this Directive with aview to putting them into circulation, must meet the minimum 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 into circulation, must
meet the minimum conditions laid down in Chapter 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 the minimum conditions laiddown in Chapter I.3 (b) of the Annex;
(d) manufacturing compound feedingstuffs, with a view to putting them into
circulation, from raw materials referred to in Article 3a (2) of Directive!B1995L0069 — EN — 25.03.1999 — 002.001 — 4
74/63/EEC which contain high levels of undesirable substances or
products, must meet the minimum conditions laid down in Chapter I.4 ofthe Annex to this Directive;
(e) producing, for the exclusive requirements of its holding, compound
feedingstuffs containing premixtures which include additives referred toin 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) ofDirective 74/63/EEC containing high levels of undesirable substances or
products, must meet the minimum conditions laid down in Chapter 1.4 of
the Annex to this Directive, with the exception of the requirements set outin 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 activities and doesnot comply with that requirement within a reasonable time,
— amended if the establishment has demonstrated its ability to engage in
activities which are additional to those for which it was first approved or
which replace them.
Article 3
Approval of intermediaries
1. Where additives, products covered by Directive 82/471/EEC or pre-
mixtures of additives referred to in Chapters I.1 (a) and I.2 (a) of the 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 which wrap, package,store or put into circulation additives, premixtures of additives or productscovered by Directive 82/471/EEC.
2. Approval shall be:— withdrawn if an intermediary ceases its activities or if it is shown that it
no longer fulfils an essential condition applicable to its activities and does
not comply with that requirement within a reasonable time;
— amended if the intermediary has demonstrated its ability to engage in
activities which are additional to those for which it was first approved or
which replace them.
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 the firsttime one or more of the activities referred to in Article 2 and 3 shall, as from 1April 1998 submit an application to the competent authority 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
exercising one or more of the activities referred to in Articles 2 and 3respectively, may continue their activities until a decision has been taken 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 establishments
and intermediaries referred to in the first paragraph before 1 April 2001.!B1995L0069 — EN — 25.03.1999 — 002.001 — 5
Article 5
Register of approved establishments and intermediaries
1. For each activity, the competent authority shall enter the establishments
and intermediaries it has approved in accordance with Articles 2 and 3 in aregister under an individual approval number which identifies them, once it
has established by means of on-the-spot verification that they satisfy the
conditions laid down by 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-sportverification of compliance with the conditions under point 7 of Chapters I.1(b) or I.2 (b) of the Annex, providing that those intermediaries lodge with the
competent authority a declaration to the effect that they meet the requirements
laid down under point 6.2 in the Annex for the exercise of their activity.
2. Member States shall update the entries of establishments and intermedi-
aries 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 establishments
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 first time
in November 2001, and then each year, by 30 November at the latest, the list
of amendments made during the year; every five years, it shall publish aconsolidated 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 Article 3(1) and a
list of corresponding establishments and intermediaries referred to in Article4(2) which have submitted applications for approval on which the MemberStates 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 in Article 4(2) which
have submitted applications for approval on which the Member States havenot yet taken a decision.
CHAPTER III
REGISTRATION OF ESTABLISHMENTS AND INTERMEDIARIES
Article 7
Registration of establishments
1. An establishment wishing to exercise one or more of the activities
referred to in paragraph 2 must be registered by a Member State for eachactivity in accordance with this Directive.
2. In order to be registered by the competent authorities an establishment:(a) manufacturing additives for which a prescribed maximum level is set and
which are not included in Chapter I.1 (a) of the Annex, with a view toputting them into circulation, must meet the minimum 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 circulation, 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 referredto in Chapter II (a) of the Annex with a view to putting them into!B
!M2
!B1995L0069 — EN — 25.03.1999 — 002.001 — 6
circulation, must met the minimum conditions laid down 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) ofthe Annex, must met the minimum conditions 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 as satisfying de 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 activities and doesnot comply with that requirement within a reasonable time,
— amended if the establishment declares that it is engaged in activities
which are additional to those for which it was first registered or which
replace them.
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 premixtures of additives
referred to in Chapter II (a) of the Annex are put into circulation,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 with Article 3 shall be regarded as
meeting de facto the 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 activities and does
not comply with that requirement within a reasonable time,
— amended if the intermediary has declared that it is engaged in activities
which are additional to those for which it was first registered or whichreplace 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 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 they submitted thedeclaration referred to in paragraph 1 by 1 September 1998.
Article 10
List of registered establishments and intermediaries
1. For each activity, the competent authority shall enter the establishments
and intermediaries which it has registered in accordance with Articles 7 and 8
on a list under an individual registration number which identifies them.
2. Member States shall update the entries of establishments and intermedi-
aries on the list in accordance with the decisions referred to in Articles 7 (4)
and 8 (3) to withdraw or amend registration.!B1995L0069 — EN — 25.03.1999 — 002.001 — 7
Article 11
Communication of the list of registered establishments and intermedi-
aries
1. Before 31 December each year, Member States shall send the
Commission the list of establishments and intermediaries registered during
the year in accordance with Articles 7 and 8 and, every five years, they shallsend 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 manufacturing an additive is already authorized to
manufacture the same active substance as a veterinary medicinal 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 beenfulfilled, with the exception 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 haveapproved or registered, that the requirements imposed by this Directive are
met.
Article 14
The Council, acting by a qualified majority on a proposal from the
Commission, shall, before 1 April 1999, adopt rules for calculating the level
of the fee to be charged for the approval of establishments and theirintermediaries.
Article 15
Detailed arrangements, amendment of the Annex and imports from
non-member countries
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 establishments 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 theAnnex to this Directive or feedingstuffs into circulation within theCommunity, so that safeguards are provided equivalent to those supplied
by establishments located in the Community.
These arrangements shall comprise:— establishment and updating of a list of non-member countries able to
provide safeguards equivalent to those offered by the Member States
in respect of their own establishments and able to perform the checksreferred to in Article 13,!B
(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).!M1
!B1995L0069 — EN — 25.03.1999 — 002.001 — 8
— establishment and updating of a list of establishments which have
been found by the non-member countries on the list referred to in thefirst indent to fulfil the conditions laid down in 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 therelevant 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
Standing Committee for Feedingstuffs
The Commission shall be assisted by the Standing Committee for Feed-
ingstuffs established by Decision 70/372/EEC, hereinafter referred to 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 its opinion on the
draft within a time limit which the Chairman may lay down according to theurgency of the matter. The opinion shall be delivered by the majority laiddown in Article 148 (2) of the Treaty in the case of Decisions which the
Council is required to adopt on a proposal from the Commission. The votes of
the representatives of the Member States within the Committee shall beweighted in the manner set 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 envisaged are not inaccordance with the opinion of the Committee, or if no opinion is delivered,the Commission shall, without delay, submit to the Council a proposal relating
to the measures to be taken. The Council shall act by a qualified majority.
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 be adopted by
the Commission, save where the Council has decided against 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 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 and compound feedingstuffs
containing these premixtures may be put into circulation or used only bythe establishments or intermediaries which meet the conditions laiddown, as appropriate, in 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 theanimal 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 December 1995 laying down the!B1995L0069 — EN — 25.03.1999 — 002.001 — 9
conditions 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
Amendment of Directive 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 accordance
with Article 5 of 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 theanimal feed sector (
*).
(*) OJ No L 332, 30. 12. 1995, p. 15.’
Article 20
Amendment of Directive 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 December 1995 laying down the
conditions and arrangements for approving and registering certain
establishments and intermediaries operating in the animal feed sector (*)
may be put into circulation only by establishments or intermediarieswhich 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 packagingof the product, on the container or on 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 with this
Directive. They shall forthwith inform the Commission thereof. The measuresadopted 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 reference on the occasion oftheir official publication. The methods of making such 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 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 Journal of the European Communities .!B
(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).1995L0069 — EN — 25.03.1999 — 002.001 — 10
Article 23
This Directive is addressed to the Member States.!B1995L0069 — EN — 25.03.1999 — 002.001 — 11
ANNEX
CHAPTER 1
Minimum conditions which must be fulfilled by establishments and intermediaries
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 sub-
stances: all additives in the group
— Growth promoters: all additives in the group— Vitamins, provitamins and chemically
well-defined substances having a similareffect: 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 ChapterI.1(a))
1. Facilities and equipment
Facilities and manufacturing equipment must be located, designed, constructed
and maintained to suit the manufacture of the ‘products’ concerned. The
lay-out, design and operation of the facilities and equipment must be such as to
minimize the risk of error and permit effective cleaning and maintenance inorder to avoid contamination, cross-contamination and any adverse effectsgenerally on the quality of the products. Facilities and equipment to be used formanufacturing operations which are essential for the quality of the productsmust undergo appropriate and regular checks, in accordance with written
procedures pre-established by the manufacturer for production of the products.
2. Personnel
The manufacturer must have sufficient staff possessing the skills and
qualifications necessary for the manufacture of the ‘products’ concerned. Anorganizational chart setting out the qualifications (diplomas, professionalexperience) and responsibilities of the supervisory staff must be drawn up andmade available to the competent authorities of the supervisory staff must be
drawn up and madeavailable 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 wayas to obtain the desired quality of the ‘products’ concerned.!
B1995L0069 — EN — 25.03.1999 — 002.001 — 12
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 atdefining, checking and mastering the critical points in the manufacturingprocess.
Technical or organizational measures must be taken to avoid cross-con-
tamination and errors. There must be sufficient and appropriate means ofcarrying 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 theycomply with the specifications defined by the manufacturer and are inconformity with the provisions laid down in Directive 70/524/EEC or Directive82/741/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 ofnon-compliance — of raw materials, active substances, carrier substances and‘products’.
Samples of the active substance and of each batch of ‘product’ put into
circulation or of each specific portion of production in the case of continuousproduction must be taken in sufficient quantity by a procedure pre-establishedby the manufacturer and be retained in order to ensure traceability. The samplesmust 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 thecompetent authorities at least until the guarantee date of the finished product.
5. Storage
Raw materials, active substances, carrier substances, ‘products’ which meet the
specifications — and those which do not — must be stored in suitablecontainers in places designed, adapted and maintained in order to ensure goodstorage conditions, to which only persons authorized by the manufacturer have
access.
They must be stored in such a way as to be easily identifiable and to avoid any
confusion or cross-contamination between the different products mentionedabove and with medicinal substances. Additives must be packaged and labelled
in particular in compliance with the provisions laid down in Directive
70/524/EEC. Products covered by Directive 82/471/EEC must be labelled incompliance with the provisions of that Directive.
6. Documentation
6.1. D o c u m e n t a t i o n r e l a t i n g t o t h e m a n u f a c t u r i n g p r o c e s s a n d
controls
The manufacturer must have a system of documentation designed to define and
ensure mastery of the critical points in the manufacturing process and toestablish and implement a quality control plan. The manufacturer must keep theresults of the relevant controls. This set of documents must be kept so that it ispossible to trace the manufacturing history of each batch of ‘product’ put into
circulation and to establish responsibility if complaints arise.
6.2. R e g i s t e r
The manufacturer must record the following information in order to ensure
traceability:
(a) register of additives:
— the nature and quantity of the additives produced, the respective dates
of manufacture and, where appropriate, the number of the batch or ofthe specific portion of production in the case of continuous
manufacture, and the names and addresses of the intermediaries or
manufacturers to whom the additives have been delivered,
— indication of the nature and quantity of the additives delivered and,
where appropriate, the number of the batch or of the specific portionof production in the case of continuous manufacture;!
B1995L0069 — EN — 25.03.1999 — 002.001 — 13
(b) register of products covered by Directive 82/471/EEC:
— the nature of the products and the quantity produced, the respective
dates of manufacture and, where appropriate, the number of the batchor of the specific portion of production in the case of continuousmanufacture,
— the names and addresses of the intermediaries or users (manufacturers
or stock breeders) to whom these products have been delivered,
together with an indication of the nature and quantity of the products
delivered and, where appropriate, the number of the batch or of thespecific portion of production in the case of continuous 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 person other than a user
(manufacturer or stock breeder), that person and any subsequent intermediaryby whom they are wrapped, packaged, stored or put into circulation shall beequally bound, as appropriate, by the obligations laid down in points 4, 5, 6.2and 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 processingcomplaints.
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 ofany recalled products, and before such products are put back into circulationthey 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 sub-
stances: all additives in the group
— Growth promoters: all additives in the group— Vitamins, provitamins and chemically
well-defined substances having a similareffect: 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 referredto 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. Thelayout, design and operation of the facilities and equipment must be such as tominimize the risk of error and permit effective cleaning and maintenance inorder to avoid contamination, cross-contamination and any adverse effectsgenerally on the quality of the products. Facilities and equipment to be used foroperations which are essential for the quality of the products must undergo
appropriate and regular checks in accordance with the written procedures
pre-established by the manufacturer.
Preventive measures must be taken to avoid. as far as possible, the presence of
harmful organisms, with the introduction of a control plan if necessary.
2. Personnel
The manufacturer must have sufficient staff possessing the skills and
qualifications necessary for the manufacture of the premixtures concerned.An organizational chart setting out the qualifications (diplomas, professionalexperience) and responsibilities of the supervisory staff must be drawn up and
made available to the competent authorities responsible for inspection. All the
staff must be informed clearly in writing of their duties, responsibilities andpowers, especially when any change is made, in such a way as to obtain thedesired quality of the premixtures concerned.!
B1995L0069 — EN — 25.03.1999 — 002.001 — 14
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 atdefining, checking and mastering the critical points in the manufacturingprocess, 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 premixtures concerned inaccordance with the provisions of Directive 70/524/EEC.
Technical or organizational measures must be taken to avoid cross-con-
tamination 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, homogeneityand stability of the additives in the premixture, and as low a level ofcross-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 ofnon-compliance — for carrier substances, additives and premixtures (‘prod-ucts’).
Samples of each batch of premixture put into circulation must be taken in
sufficient quantity by a procedure pre-established by the manufacturer and beretained in order to ensure traceability. these samples must be sealed andlabelled for ease of identification; they must be stored under conditions whichprevent any abnormal change in the composition of the sample or any abnormal
adulteration. They must be kept at the disposal of the competent authorities at
least until the guarantee date of the 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 inorder to ensure good storage conditions, to which only persons authorized by themanufacturer 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 andwith medicinal substances. Premixtures must be wrapped and labelled inaccordance with the provisions of Directive 70/524/EEC.
6. Documentation
6.1. D o c u m e n t a t i o n r e l a t i n g t o t h e m a n u f a c t u r i n g p r o c e s s a n d
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 toestablish and implement a quality control plan. The manufacturer must keep the
results of the relevant controls. This sets of documents must be kept in such a
way as to make it possible to trace the manufacturing history of each premixturebatch put into circulation and to establish responsibility if complaints arise.
6.2. R e g i s t e r o f p r e m i x t u r e s
The manufacturer must record the following information in order to ensure
traceability:
— the names and addresses of manufacturers of additives or of intermediaries,
the nature and quantity of the additives used and, where appropriate, thenumber of the batch or of the specific portion of production in the case ofcontinuous 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 batchnumber where appropriate.!
B1995L0069 — EN — 25.03.1999 — 002.001 — 15
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 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 inpoint 3.
8. Complaints and product recall
The manufacturer or any intermediary putting a product into circulation under
his own name must implement a system for registering and processing
complaints. Likewise, he must be in a position to introduce, where this provesnecessary, a system for prompt recall of products in the distribution network.The manufacturer must define by means of written procedures the destination ofany recalled products, and before such products are put back into circulationthey 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 sub-
stances: 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 of additives referred toin 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 feedingstuffs containingpremixtures. The layout, design and operation of the facilities and equipmentmust be such as to minimize the risk of error and permit effective cleaning and
maintenance in order to avoid, as far as possible, contamination, cross-
contamination and any adverse effects generally on the quality of the products.
Facilities and equipment to be used for manufacturing operations which are
essential for the quality of the products must undergo appropriate and regularchecks, in accordance with the written procedures pre-established by themanufacturer, 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. Preventivemeasures must be taken to avoid, as far as possible, the presence of harmfulorganisms, with the introduction of a control plan if necessary.
2. Personnel
The manufacturer must have sufficient staff possessing the skills and
qualifications necessary for the manufacture of compound feedingstuffscontaining premixtures. An organizational chart setting out the qualifications(diplomas, professional experience) and responsibilities of the supervisory staffmust be drawn up — if appropriate in the case of manufacture solely for themanufacturer’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, insuch a way as to obtain the desired quality of the compound feedingstuffscontaining 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 necessarybe from outside, but shall act at the request and under the responsibility of themanufacturer.
The manufacturer must ensure that the different stages in production are carried
out according to pre-established written procedures and instructions aimed atdefining, checking and mastering the critical points in the manufacturing
process, such as incorporation of the premixture in the feedingstuff,
chronological order of production, meters and weighing apparatus, mixer andreturns, in such a way as to obtain the desired quality of the compoundfeedingstuffs in accordance with the provisions of Directive 79/373/EEC.!
B1995L0069 — EN — 25.03.1999 — 002.001 — 16
Technical or organizational measures shall be taken to avoid cross-con-
tamination 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 theresponsibility 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 compoundfeedingstuffs containing premixtures comply with the specifications defined bythe 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 wellas, in the case of feedingstuffs to be put into circulation, the contents as regardsanalytical constituents (Directive 79/373/EEC). The use of an outside laboratoryis 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 ofnon-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 each
specific portion of production in the case of continuous manufacture, and be
retained in order to ensure traceability where it is put into circulation, or on aregular basis in the case of manufacture solely for the manufacturer’s ownneeds. These samples must be sealed and labelled for ease of identification;they must be stored under conditions which prevent any abnormal change in thecomposition of the sample or any abnormal adulteration. They must be kept atthe disposal of the competent authorities for an appropriate period.
5. Storage
‘Products’ which meet the specifications — and those which do not — must be
stored in suitable containers in places designed, adapted and maintained in orderto ensure good storage conditions, to which only persons authorized by themanufacturer 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 andwith medicinal substances or medicinal feedingstuffs, or with raw materialscontaining high levels of undesirable substances and 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. D o c u m e n t a t i o n r e l a t i n g t o t h e m a n u f a c t u r i n g p r o c e s s a n d
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 toestablish and implement a quality control plan. The manufacturer must keep theresults of the relevant controls. This set of documents must be kept in such away as to make it possible to trace the manufacturing history of each batchproduced and, where it is put into circulation, to establish responsibility if
complaints arise.
6.2. R e g i s t e r o f c o m pound 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.!
B1995L0069 — EN — 25.03.1999 — 002.001 — 17
Likewise, he must be in a position to introduce, where this proves necessary, a
system for prompt recall of products in the distribution network. Themanufacturer must define by means of written procedures the destination ofany recalled products, and before such products are put back into circulationthey 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 feeedingstuffs 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 effectivecleaning and maintenance in order to avoid contamination, as far as possible,contamination, cross-contamination and any adverse effects generally on thequality of the products. Facilities and equipment to be used for manufacturingoperations which are essential for the quality of the products must undergoappropriate 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 outsideperson acting at the request and under the responsibility of the manufacturer.
Preventive measures must be taken to avoid, as far as possible, the presence of
harmful organisms, with the introduction of a control plan if necessary.
2. Personnel
The manufacturer must have sufficient staff possessing the skills and
qualifications necessary for the manufacture of compound feedingstuffs fromthe ‘raw materials concerned’. An organizational chart setting out thequalifications (diplomas, professional experience) and responsibilities of thesupervisory 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 inwriting of their duties, responsibilities and powers, especially when any changeis made, in such a way as to obtain the desired quality of compoundfeedingstuffs 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 necessarybe from outside, but shall act at the request and under the responsibility of themanufacturer.
The manufacture must ensure that the different stages in production are carried
out according to pre-established written procedures and instructions aimed at
defining, checking and mastering the critical points in the manufacturingprocess, such as incorporation in the feedingstuff of the ‘raw materialconcerned’, chronological order of production, meters and weighing apparatus,mixer and returns, in such a way as to obtain the desired quality of thecompound feedingstuffs in accordance with the provisions of Directive79/373/EEC.
Technical or organizational measures shall be taken to avoid cross-con-
tamination 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 theresponsibility 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 compoundfeedingstuffs concerned comply with the specifications defined by themanufacturer 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 with the maximum levels of undesirablesubstances and products as laid down in Directive 74/63/EEC and, in the case offeedingstuffs to be put into circulation, contents as regards analyticalconstituents (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,!
B1995L0069 — EN — 25.03.1999 — 002.001 — 18
compliance with the specifications — and destination in the event of
non-compliance — for raw materials, including those with high levels ofundesirable substances and products, and compound feedingstuffs.
Samples must be taken sufficient quantity by a procedure pre-established by the
manufacturer on the basis of each of compound feedingstuffs or each specificportion of production in the case of continuous manufacture, and be retained in
order to ensure traceability where it is put into circulation, or on a regular basis
in the case of manufacture solely for the manufacturer’ s own needs. Thesesamples must be sealed and labelled for ease of identification; they must bestored under conditions which prevent any abnormal change in the compositionof the sample or any abnormal adulteration. They must be kept at the disposal ofthe 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 specifications — andthose 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 productsmentioned above and with medicinal substances or medicinal feedingstuffs, or
with additives or premixtures of additives. Compound feedingstuffs intended to
be put into circulation must comply with the provisions of Directive79/373/EEC.
6. Documentation
6.1. D o c u m e n t a t i o n r e l a t i n g t o t h e m a n u f a c t u r i n g p r o c e s s a n d
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 toestablish and implement a quality control plan. The manufacturer must inparticular keep the results of the relevant controls. This set of documents must
be kept in such a way as to make it possible to trace the manufacturing history
of each batch produced and, where it is put into circulation, to establishresponsibility if complaints arise.
6.2. R e g i s t e r o f c o m pound 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 thedate of manufacture.
7. Complaints and product recall
The manufacturer must implement a system for registering and processing
complaints.
Likewise, he must be in a position to introduce, where this proves necessary, a
system for prompt recall of products in the distribution network. Themanufacturer must define by means of written procedures the destination ofany recalled products, and before such products are put back into circulationthey must undergo a quality-control reassessment.
CHAPTER II
Minimum conditions which must be fulfilled by establishments and intermediaries
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 having a similaraction:all additives in the group except for
vitamins A and D!
B1995L0069 — EN — 25.03.1999 — 002.001 — 19
— 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 having a similaraction: 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)
Minimum conditions which must be fulfilled by establishments and intermediaries
referred to in Article 7 (2) (a) and (b) and Article 8 (1), (additives for which a prescribedmaximum level is set and which are not referred to in Chapter I.1 (a), premixtures ofadditives referred to in Chapter II (a)) and establishments referred to in Article 7 (2) (c)
and (d), (compound feedingstuffs 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
qualifications necessary for the manufacture of the ‘products concerned’.
3. Production
A qualified person responsible for production must be designated who, in the
case of manufacture solely for the manufacturer’ s own needs, may if necessarybe from outside, but shall act at the request and under the responsibility of themanufacturer.
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’ inaccordance with the provisions of Directive 70/524/EEC or Directive79/373/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 ifnecessary be from outside, but shall act at the request and under theresponsibility of the manufacturer.
The manufacturer must draw up and implement a quality control plan to
guarantee and check that the ‘products in question’ comply with the
specifications defined by the manufacturer and that they comply, as appropriate,
with the provisions of Directive 70/524/EEC or Directive 79/373/EEC.
In order to ensure traceability, samples must be taken and kept, where
appropriate, from each batch of the product or from each specific portion ofproduction in the case of continuous or regular manufacture. They must be keptat the disposal of the competent authorities for a period appropriate to the use to
which the feedingstuffs are put.!
B1995L0069 — EN — 25.03.1999 — 002.001 — 20
5. Storage
Raw materials, active substances, carrier substances, premixtures and com-
pound feedingstuffs must be stored in places designed, adapted and maintainedin 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 productsmentioned above and with medicinal substances or medicinal feedingstuffs.Products to be put into circulation must be wrapped, where appropriate, andlabelled in accordance with the provisions of Directive 70/524/EEC or Directive79/373/EEC, as appropriate.
6. Register
The manufacturer must record the following information in order to ensure
traceability:
(a) for additives:
— the nature and quantity of the additives produced, the respective dates
of manufacture and, where appropriate, the number of the batch or ofthe specific portion of production in the case of continuousmanufacture,
— the names and addresses of the intermediaries or users (manufacturers
or stock breeders) to whom the additives have been delivered, with anindication of the nature and quantity of the additives delivered and,where appropriate, the number of the batch or of the specific portion
of production in the case of continuous manufacture.
(b) for premixtures:
— the names and addresses of the additive manufacturers or intermedi-
aries, 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 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 the batch,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, the natureand quantity of the premixture used,
— the names and addresses of the additive manufacturers or intermedi-
aries, the nature and quantity of the additive used and the number ofthe batch or of the specific portion of production in the event ofcontinuous 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 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 theobligations laid down in points 4, 5 and 6.2 and, in the case of wrapping, bythose laid down in point 3.!
B1995L0069 — EN — 25.03.1999 — 002.001 — 21