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Europaudvalget 2001-02 (1. samling)
EUU Alm.del Bilag 53
Offentligt

Modtaget via elektronisk post. Der tages forbehold for evt. fejl

Europaudvalget

(Alm. del - bilag 53)

landbrugsministerråd

(Offentligt)

Medlemmerne af Folketingets Europaudvalg

og deres stedfortrædere

Bilag

Journalnummer

400.C.2-0

Kontor

EU-sekr.

11. oktober 2001

KOMITÉSAG

Til underretning for Folketingets Europaudvalg vedlægges Fødevareministeriets notat om forslag til

Kommissionens forordning om ændring af bilag III i Rådets forordning (EØF) Nr. 2092/91 af 24. juni 1991

om økologisk produktionsmetode for landbrugsprodukter og om anvendelse heraf på landbrugsprodukter og

levnedsmidler, AGRI/01/52004/_en1.

Forslaget forventes at ville blive sat til afstemning ved et møde i Den Stående Komité for Økologisk Landbrug

den 18.-19. oktober 2001.

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Notat til Folketingets Europaudvalg

om forslag til Kommissionens forordning om ændring af bilag III i Rådets forordning (EØF) Nr. 2092/91 af 24.

juni 1991 om økologisk produktionsmetode for landbrugsprodukter og om anvendelse heraf på landbrugsprodukter

og levnedsmidler.

Dokument AGRI/01/52004/_en1

Forslaget forventes at ville blive sat til afstemning ved et møde i Den Stående Komité for Økologisk Landbrug den 18. -

19. oktober 2001.

Forslaget behandles i en III a-procedure. Hvis der er kvalificeret flertal, udsteder Kommissionen forordningen. Opnås

der ikke kvalificeret flertal, forelægger Kommissionen sagen for Rådet, der kan vedtage forslaget uændret med

kvalificeret flertal eller ændre det med enstemmighed. Handler Rådet ikke inden en frist på højst tre måneder, kan

Kommissionen udstede forordningen.

Der er med det foreliggende forslag tale om mange fortrinsvis små ændringer af forordningens bilag III. Det er hensigten

at foretage en større ændring af bilag III, når denne ændring er færdigforhandlet.

Det foreslås, at kravet ved transport af produkter direkte mellem to økologiske bedrifter/virksomheder skal skærpes,

således at produkterne enten skal transporteres i lukke containere eller lignende, eller alternativt skal

bedrifterne /virksomhederne orientere kontrolorganet, inden varen transporteres.

Forslaget om, at kontrolorganer eller myndigheder skal foretage uanmeldt inspektion, især på virksomheder, hvor der

forekommer forøget risiko for svindel eller udveksling med ikke-økologiske produkter kan betyde, at de danske

myndigheder skal gennemføre yderligere økologikontrolbesøg, end dem der i dag udføres integreret med

kontrolbesøgene i henhold til den almindelige fødevarelovgivning. De statsfinansielle konsekvenser af denne del af

forslaget kan ikke vurderes på det foreliggende grundlag. Forslaget i øvrigt skønnes ikke at have statsfinansielle

konsekvenser.

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Forslaget indeholder flere krav, som allerede er indført på fødevareområdet i Danmark og det vil forbedre kontrollen, at

disse krav udvides til at gælde for hele EU. Det gælder f.eks. kravet om balanceopgørelser af regnskabet og kontrol af

virksomheder, der udfører lønarbejde ("subcontractors").

Forslaget berører ikke beskyttelsesniveauet.

Regeringen agter på denne baggrund at tilslutte sig forslaget, idet man vil arbejde for

• at betingelserne for transport direkte mellem to økologiske bedrifter/virksomheder lempes og

• at kravet om fuld sporbarhed præciseres.

Aktuelt notat til Folketingets Europaudvalg

om forslag til Kommissionens forordning om ændring af bilag III i Rådets forordning (EØF) Nr. 2092/91 af 24.

juni 1991 om økologisk produktionsmetode for landbrugsprodukter og om anvendelse heraf på landbrugsprodukter

og levnedsmidler.

Dokument AGRI/01/52004/_en1

Resumé

Kommissionen foreslår en række skærpede kontrolforanstaltninger i relation til dels den økologiske

jordbrugsproduktion, dels den videre forarbejdning og forhandling af økologiske fødevarer. Der foreslås bl.a.

skærpede krav til

dokumentation af regnskabsdata og balance mellem input/output af økologiske varer,

•

transport mellem økologiske bedrifter/virksomheder,

parallelavl af økologiske og ikke-økologiske afgrøder,

lønarbejde, samt

forholdsregler ved mistanke om overtrædelser af økologireglerne

Forslaget berører ikke beskyttelsesniveauet.

Baggrund

Kommissionen har den 3. oktober 2001 fremsendt forslag til Kommissionens forordning om ændring af bilag III i Rådets

forordning (EØF) Nr. 2092/91 af 24. juni 1991 om økologisk produktionsmetode for landbrugsprodukter og om anvendelse

heraf på landbrugsprodukter og levnedsmidler. Der er tale om en revideret udgave af et tidligere forslag med samme

dokumentnavn.

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Forslaget er fremsat med hjemmel i Rådets forordning nr. 2092/91 af 24. juni 1991 om økologisk produktionsmetode for

landbrugsprodukter og om angivelse heraf på landbrugsprodukter og levnedsmidler (herefter "økologiforordningen"), særligt

artikel 13, anden tankestreg.

Forslaget behandles i en III a-procedure i Den Stående Komité for Økologisk Landbrug. Hvis der er kvalificeret flertal,

udsteder Kommissionen forordningen. Opnås der ikke kvalificeret flertal, forelægger Kommissionen sagen for Rådet, der kan

vedtage forslaget uændret med kvalificeret flertal eller ændre det med enstemmighed. Handler Rådet ikke inden en frist på

højst tre måneder, kan Kommissionen udstede forordning en.

Nærheds- og proportionalitetsprincippet

Der redegøres ikke for nærheds- og proportionalitetsprincippet, da der er tale om gennemførelsesbestemmelser til en allerede

vedtaget retsakt.

Formål og indhold

Der er med det foreliggende forslag tale om mange fortrinsvis små ændringer af forordningens bilag III. Det er hensigten at

foretage en større ændring af bilag III, når denne ændring er færdigforhandlet.

I den foreslåede forordning, der fastlægger indholdet af økologiforordningens bilag III, er der i den indledende artikel 2 anført, at bilag III fastlægger minimumkrav, som kontrolinstanserne, når

nødvendigt, skal udbygge med henblik på at sikre fuld sporbarhed gennem hele produktionskæden.

Bilag III omhandler minimumsbetingelser for kontrolforanstaltninger.

Bilaget er i forslaget delt op i "del I. Generelle bestemmelser" og "del II. Specifikke bestemmelser". Del II er

delt op i del A for primærproducenter, del B for virksomheder, der tilbereder fødevarer, og del C for

importører af produkter og fødevarer fra tredjelande.

I det gældende bilag er der blot en opdeling i del A, B og C. Den nye opdeling i del I og II, betyder, at de

fælles bestemmelser, der tidligere var gentaget under del A, B og C, er samlet i del I.

I del I, punkt 5, er der foreslået krav om, at regnskabsdata skal dokumenteres med relevante bilag, og at regnskabet skal demonstrere balancen mellem indgående og udgående økologiske produkter.

Dette krav har ikke tidligere været præciseret.

I del I, punkt 6 foreslås det, at kravet ved transport af produkter direkte mellem to økologiske

bedrifter/virksomheder skal skærpes, således at produkterne enten skal transporteres i lukkede containere

eller lignende, eller alternativt skal bedrifterne/virksomhederne orientere kontrolorganet, inden varen

transporteres.

Herudover er under punkt 6 om transport foreslået, at produkter, der forlader virksomheden, udover de

allerede nævnt oplysninger når det er relevant skal være mærket med lotidentifikationsmærke, som kan

henføres til regnskabet. Lotidentikationsmærkningen skal være aftalt med kontrolorganet/myndigheden.

I del I, punkt 8, om kontrolbesøg foreslås tilføjet, at kontrolorganer eller myndigheder skal foretage uanmeldt

inspektion især på virksomheder, hvor der forekommer forøget risiko for svindel eller udveksling med ikke-

økologiske produkter.

I del A, B og C, under del II, foreslås mindre ændringer til de fleste punkter samt enkelte ændringer omtalt

nedennævnt, som skønnes at kunne have større betydning.

I punkt A foreslås, at reglerne for parallelavl skærpes, således at der kun kan dyrkes samme afgrøde på en

økologisk og en ikke-økologisk mark, hvis der anvendes forskellige sorter, der let kan kendes fra hinanden.

For økologisk mælk, æg og ægprodukter forslås det, at en samtidig indsamling må foregå, når der er truffet

de nødvendige foranstaltninger til sikring mod sammenblanding.

I del C fastsættes krav om, at første modtager af et importparti skal have udarbejdet en økologirapport. Hvis

importøren og første modtager er den samme, skal der kun udarbejdes en rapport. Der foreslås også her, at

regnskabet skal demonstrere balancen mellem indgående og udgående mængder.

Der foreslås en ny del D:

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Del D skal omhandle enheder involveret i produktion, tilberedning eller import af økologiske produkter, som

via kontrakt får en tredjepart til at foretage dele eller alle aktuelle operationer. Det slås herved fast, at disse

tredjeparter også skal være underlagt økologikontrol.

Udtalelser

Europa-Parlamentet skal ikke udtale sig.

Gældende dansk ret

Området er reguleret ved økologiforordningen samt suppleret i bekendtgørelse nr. 761 af 14. august 2000 om økologiske

fødevarer m.v. og bekendtgørelse nr. nr. 697 af 16. juli 2000 om økologisk jordbrugsproduktion.

Konsekvenser

Forslaget har ikke lovgivningsmæssige konsekvenser.

Forslaget om, at kontrolorganer eller myndigheder skal foretage uanmeldt inspektion, især på virksomheder, hvor der

forekommer forøget risiko for svindel eller udveksling med ikke-økologiske produkter kan betyde, at de danske

myndigheder skal gennemføre yderligere økologikontrolbesøg, end dem der i dag udføres integreret med

kontrolbesøgene i henhold til den almindelige fødevarelovgivning. De statsfinansielle konsekvenser af denne del af

forslaget kan ikke vurderes på det foreliggende grundlag. Forslaget i øvrigt skønnes ikke at have statsfinansielle

konsekvenser.

Forslaget indeholder flere krav, som allerede er indført på fødevareområdet i Danmark og det vil forbedre kontrollen, at

disse krav udvides til at gælde for hele EU. Det gælder f.eks. kravet om balanceopgørelser af regnskabet og kontrol af

virksomheder, der udfører lønarbejde ("subcontractors").

Forslaget berører ikke beskyttelsesniveauet.

Høring

Fødevaredirektoratet sendte et tidligere arbejdsdokument i høring til en række organisationer.

Landbrugsrådet, Mejeriforeningen, Landboforeningerne, Økologisk Landscenter, Landsforeningen

Økologisk Jordbrug, Danske Slagterier, Dansk Familie Landbrug og Det Danske Fjerkræråd bemærker i en

fælles skrivelse, at organisationerne generelt støtter sporbarhed i produktionen fra jord til bord. De fælles EU

bestemmelser vedrørende kontrol bør i højere grad baseres på dokumentation og oplysninger med henblik på

mæ ;ngde (im- og eksport fra en enhed) og ikke sporbarhed ned i de mindste detaljer. Der opfordres til, at der

arbejdes med egenkontrolprogrammer, og der henvises til de drøftelser, der har været med Plantedirektoratet

omkring elitekontrolordinger. Total sporbarhed for produkter, der handles i løs vægt som korn og mælk

findes urealistisk. Foreningerne finder, det bør være muligt at transportere økologiske og ikke-økologiske æg

på samme last bil, under den forudsætning, at der ikke sker sammenblanding.

Organisationerne finder videre, at de krav der stilles ved transport i ikke-lukkede containere er urealistiske.

FDB finder, at regler, der vedrører registrering af sporbarhed, bør afvente et horisontalt regelsæt i EU. FDB

finder, at for en virksomhed som FDB, der har mange centrale funktioner i forhold til detailbutikker og

særligt producerende enheder i butikken, så som bogholderi, visse kontrolfunktioner (godkendelse af

råvarer, udarbejdelse af deklarationer osv.) er det væsentligt, at det bliver muligt for enhederne at udarbejde

procedurer, som gør, at en del a f dokumentationen kan opbevares centralt og elektronisk, men tilgængeligt

for kontrolmyndigheden. FDB finder, at det skal medtages, at detailbagerier og detailslagtere i

supermarkedskæder, der sælger direkte til den endelige forbruger, ikke kan registrere modtager af varen.

Mejeriforeningen foreslår, at der indbygges en dispensationsmulighed således at der kan afhentes mælk og

æg af samme lastbil, hvis der er tale om særlige omstændigheder f.eks. særlig lang afstand mellem de enkelte

primærproducenter. Foreningen finder, at sporbarhedsafsnittet hører hjemme i den generelle lovgivning og

ikke i økologilovgivningen specifikt.

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FødevareIndustrien bemærker, at formuleringerne vedrørende forurening med ikke-økologiske ingredienser

er overflødige, da fødevareindustrien altid tager de nødvendige forholdsregler for at undgå sammenblanding

af forskellige produkter, uanset om disse er økologiske eller ej. Fuldstændig sporbarhed anses for meget

vanskeligt at efterleve for især producenter af sammensatte varer. Der bør i stedet fokuseres på en trov&ael

ig;rdig massebalance hos den enkelte producent. Endelig findes forbudet mod samtidig afhentning af

økologisk og ikke-økologiske mælk og æg hæmmende for økologiens udvikling. Efter FødevareIndustriens

opfattelse kan indsamlingen fuldt forsvarligt finde sted, som det sker i dag, hvor råvarerne er fysisk separeret

i samme transportkøretøj, eller klart mærket.

Kaffe- og Teimportørforeningen fandt et tidligere krav om desinficering uhensigtsmæssig.

SID har ingen bemærkninger til forslaget.

Den Danske Dyrlægeforeningen bemærker, at når reglerne skal implementeres i Danmark, skal det sikres, at

producenterne kun skal indberette til én myndighed.

Den tidligere udgave af forslaget har været i høring i § 2-udvalget (landbrug) og Det Rådgivende

Fødevareudvalg. I forbindelse hermed er modtaget følgende høringssvar:

Landbrugsraadet, Landboforeningerne og Dansk Familielandbrug (organisationerne) bemærker i en fælles

skrivelse, at forslaget om skærpede regler for parallelavl om, at der kun kan dyrkes samme afgrøde på

tilstødende økologiske og ikke-økologiske marker, såfremt der anvendes sorter, som let kan skelnes fra

hinanden, i princippet er udmærket. Organisationerne finder, at spørgsmålet er, hvad der let kan skelnes fra

hinanden, og orga nisationerne finder det nødvendig med en uddybning af, hvad der menes.

Organisationerne mener, at man i høj grad bør tilgodese de landbrugsfaglige hensyn, der ligger i et bredt

sortsvalg; landmanden bør således kun være forpligtiget til at vælge forskellige sorter. Det vil i praksis stort

set altid være muligt at tilgodese kontrollen af sorter ved tekniske analyser.

Organisationerne er i princippet enige i forslaget om uafhængig indsamlling af produkter, men finder dog, at

der er et behov for, at praktiske forhold vedrørende indsamling af mælk og æg belyses nærmere.

Organisationerne finder, at formuleringen bør efterlade mulighed for blandet transport, hvor der ud fra et

kontrolsynspunkt ikke er nævneværdig risiko for svindel med sammenblanding af konventionelle og

økologiske produkter. Indsamling af f.eks. m& aelig;lk kan foregå uden risiko for sammenblanding, hvis der

er adskilte rum i tankbilerne eller hvis der benyttes flere vogne. Der er dokumentation for leverede og

indvejede mængder, og det forekommer således unødvendigt at skærpe kravet til indsamling.

Organisationerne finder, at en skærpelse af kravet vil betyde flere lastbiler på vejene, mælkeproduktionen

samles på stadig færre bedrifter og den øgede transport vil give større for urening, hvilket er i strid med de

økologiske principper. De samme miljøforhold og logistiske forhold gælder indsamling af æg.

Organisationerne anfører, at man kan forestille sig, at de økologiske produkter f.eks. æg bliver mærket hos

primærproducenten, således at forveksling ikke er mulig.

FødevareIndustrien finder de konkrete forslag til ændringer generelt fornuftige, og det er glædeligt at

konstatere, at der fokuseres på massebalancer, risikovurderinger og sporbarhed fremfor tekniske detaljer, der

reelt ikke styrker kontrolkonceptet. FødevareIndustrien finder imidlertid forslaget vedrørende krav om

uafhængig indsamling af økologisk mælk, æg og ægprodukter meget uheldigt, og det forudses at ville give

betydelige logisti ske problemer. Efter FødevareIndustriens opfattelse kan indsamlingen fuldt forsvarligt

finde sted, som det sker i dag, hvor råvarerne er fysisk separeret i samme transportkøretøj eller klart mærket.

Mejeriforeningen finder, at forslaget, om at økologisk mælk skal indsamles uafhængigt af ikke-økologisk

mælk, vil medføre store logistiske problemer i forbindelse med indsamlingen af mælken. Hvis der ikke er

mulighed for indsamling af økologisk mælk og ikke-økologisk mælk i samme lastbil, kan det få den

konsekvens, at økologisk mælk i ydredistrikterne eventuelt ikke kan indsamles på grund af, at det bliver for

omkostningstungt. Endvidere kan det betyde, at der skal bruges flere lastbiler til indsamlingen, hvilket

udover øget omkostninger vil betyde øget forurening og trafik af lastbiler.

De samvirkende Købmænd (DSK) er interesserede i, at kontrollen med økologiske varer, både danske og

importerede, er så effektiv, at man kan stole på, at de produkter, der sælges som økologiske, også er det. DSK

vil dog afstå fra at kommentere de foreslåede ændringer i de detaljerede regler for kontrol.

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Økonomaforeningen kan tilslutte sig forslaget, idet foreningen finder det væsentligt med både skærpelse af

sporbarheden og kontrollen i forbindelse med salg af økologiske fødevarer, og foreningen finder det

væsentligt, at der arbejdes med at opbygge et system, der er med til at sikre troværdigheden omkring de

økologiske fødevarer.

Specialarbejderforbundet i Danmark kan støtte ændringerne i forordningen.

Nærings- og Nydelsesmiddelarbejder Forbundet finder, at ændringerne i forordningen er acceptable.

HORESTA har ikke umiddelbart bemærkninger til forslaget.

Tidligere forelæggelse for Folketingets Europaudvalg

Forslaget har ikke tidligere været forelagt Folketingets Europaudvalg

Grundnotat er oversendt den 5. juli 2001.

Draft

COMMISSION REGULATION (EC) No …/..

elagt Folketingets Europaudvalg

[…]

;/..

elagt Folketingets Europaudvalg

amending Annex III of Council Regulation (EEC) No 2092/91 on organic production of agricultural products and

indications referring thereto on agricultural products and foodstuffs

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 2092/91 of 24 June 1991 on organic production of agricultural products and

indications referring thereto on agricultural products and foodstuffs, as last amended by Commission Regulation (EC) No

436/2001, and in particular Article 13, first and second indent thereof,

Whereas:

Annex III of Regulation (EEC) No 2092/91 lays down minimum inspection requirements and precautionary measures

under the inspection scheme referred to in Articles 8 and 9 of that Regulation.

Organic production of agricultural products has developed significantly in recent years. In many cases the organic

production is not anymore limited to single local productions and local trade. Currently, on the contrary, production of

organic agricultural products and foodstuffs involves very often several operators and operations, such as import,

transport, storage and packaging.

Annex III already comprises provisions for the main operators and different stages involved in the organic production of

agricultural products. However, in order to ensure the traceability of organic agricultural products throughout the

different stages of the trade chain, and finally the compliance of these products with the provisions laid down in

Regulation (EEC) No 2092/91 in the light of these recent developments, it is necessary to adapt the provisions in Annex

III.

Article 9(12)(c) of the above Regulation, provides that in any event the measures taken under Article 9 shall ensure that

consumers are given guarantees that the products have been produced in accordance with Regulation (EEC) No 2092/91.

In addition, Article 9(3), states that the inspection system shall comprise at least the application of the precautionary and

inspection measures defined in Annex III. It is therefore necessary to provide that Member States and inspection bodies

shall com plete the measures of Annex III to ensure that the requirement of Article 9(12)(c), is satisfied.

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The measures provided for in this Regulation are in accordance with the opinion of the Committee referred to in Article

14 of Regulation (EEC) No 2092/91.

HAS ADOPTED THIS REGULATION:

Article 1

Annex III to Regulation (EEC) No 2092/91 is replaced by the Annex to this Regulation.

Article 2

Annex III lays down minimum requirements, which the Member States' competent authority and/or the inspection body or

authority shall, where necessary, complete by any measures to ensure complete traceability of the products during the entire

production chain and to ensure that the provisions of this Regulation, and in particular Article 9(12)(c) thereof are satisfied.

Article 3

This Regulation shall enter into force on the seventh day following that of its publication in the

Official Journal of the European

Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

[…]

and directly applicable in all Member States.

For the Commission

[…]

mission

Member of the Commission

ANNEX

ANNEX III

MINIMUM INSPECTION REQUIREMENTS AND PRECAUTIONARY MEASURES UNDER THE

INSPECTION SCHEME REFERRED TO IN ARTICLE 8 AND 9

PART I. GENERAL PROVISIONS

1. Minimum inspection requirements

The inspection requirements of this Annex apply without prejudice to Article 2 of the present Regulation.

2. Initial inspection

When the inspection arrangements are first implemented, the operator responsible must draw up:

• a full description of the unit and/or premises and/or activity;

• all the practical measures to be taken at the level of the unit and/or premises and/or activity to ensure compliance

with this Regulation, and in particular with the requirements in this Annex.

The description and practical measures concerned must be contained in a declaration, signed by the responsible operator.

In addition, this declaration must include an undertaking by the operator to perform the operations in accordance with

Articles 5, 6 and 6a and to accept, in the event of infringement or irregularities, the enforcement of the measures referred

to in Article 9 (9) and, where relevant, in Article 10 (3) and to accept to inform in writing the buyers of the product in

order to ensure that the indications referring to the organic production method are removed from this production.

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This declaration must be verified by the inspection body or authority that issues a report identifying the possible

deficiencies and non-compliances with the provisions of this Regulation. The operator must countersign this report and

take the necessary corrective measures.

3. Communications

The operator responsible must notify any change in the description or of the practical measures referred to in point 2 to

the inspection body or authority in due time.

4. Inspection visits

The inspection body or authority must make a full physical inspection, at least once a year, of the production/preparation

units or other premises. The inspection body or authority may take samples for testing of products not authorised under

this Regulation or for checking production techniques not in conformity with this Regulation. Samples may also be taken

and analysed for detecting possible contamination by unauthorised products. However, such analysis must be carried out

where the use of unauthorised products is suspected. An inspection report must be drawn up after each visit,

countersigned by the responsible person of the unit or his representative.

Moreover, the inspection body or authority shall carry out inspection visits, announced or not, covering in particular

those holdings or situations where fraudulent practices or exchange of products from organic production with other

products may exist.

5. Documentary accounts

The unit or premises must keep stock and financial records enabling the operator and the inspection body or authority to

trace:

• The supplier and, where different, the seller, or the exporter of the products;

• The nature and the quantities of agricultural products as referred to in Article 1 delivered to the unit and, where

relevant, of all materials bought and the use of such materials;

• In the case of import, the nature and the quantities of the consignment concerned;

• The nature, the quantities and the consignees and, where different, the buyers of any products as referred to in

Article 1, which have left the unit or the first consignee’s premises or storage facilities.

The data in the accounts must be documented with appropriate justification documents.

The accounts must demonstrate the balance between the input and the output.

6. Packaging and transport of products to other production/preparation units or premises

The units shall ensure that products as referred to in Article 1 may be transported to other units, including wholesalers

and retailers, only in appropriate packaging, containers or vehicles closed in such a manner that substitution of the

content cannot be achieved without manipulation or damage of the seal and provided with a label stating, without

prejudice to any other indications required by law:

a. the name and address of the operator and, where different, of the owner or seller of the product;

b. the name of the product, including a reference to the organic production method, in accordance with Article 5;

c. the name and/or the code number of the inspection body or authority to which the producer is subject and,

d. where relevant, the lot identification mark according to a marking system either approved at national level or agreed

with the inspection body or authority and which permits to link the lot with the accounts referred to in point 5.

The information under (a), (b), (c) and (d) can also be presented on an accompanying document, if such document can be

undeniably linked with the packaging, container or vehicle of the product.

However, the closing of packaging, containers or vehicles is not required where:

a) transportation is direct between a producer and another operator who are both subject to the inspection system referred to

in Article 9, and

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b) the products are accompanied by a document giving the information required under the previous subparagraph, and

c) the inspection body or authority of both the expediting and the receiving operators have been informed of such transport

operations and have agreed thereto.

7. Products not satisfying the requirements of the Regulation

Where an operator considers or suspects that a product which he has produced, prepared, imported or been delivered

from another operator, is not in compliance with this Regulation, he shall initiate procedures either to withdraw from this

product any reference to the organic production method or to separate and identify the product. He only may put it into

processing or packaging or on the market after elimination of that doubt, unless it is placed on the market without ind

ication referring to the organic production method. In case of such doubt, the operator shall immediately inform the

inspection body or authority. The inspection body or authority may decide that the product cannot be placed on the

market with indications referring to the organic production method until it is satisfied, by the information received from

the operator, that the doubt has been eliminated.

Where an inspection body or authority has a substantiated suspicion that an operator has placed on the market a product

not in compliance with the Regulation, it can decide that the operator must withdraw from this product any reference to

the organic production method until the operator can demonstrate to the inspection body’s authority’s satisfaction that

the product is in compliance with the this Regulation.

8. Access to facilities

The operator must give the inspection body or authority, for inspection purposes, access to all parts of the unit and all

premises, as well as to the accounts and relevant supporting documents. He must provide the inspection body or authority

with any information deemed necessary for the purposes of the inspection.

When requested by the inspection body or authority, the operator shall submit the results of its own voluntary inspection and

sampling programmes.

In addition, importers and first consignees must submit any import authorisations under Article 11(6) and certificates of

inspection for import from third countries.

PART II. SPECIFIC PROVISIONS

A. Production of plants, plant products, livestock and/or livestock products at farm level.

This section applies to any unit involved in production as defined in Article 4(2) of products referred to in Article 1(1)

for its own account or for account of a third party.

Production must take place in a unit of which the production area, land parcels, pasturage, open-air exercise areas, open

air runs, livestock buildings, and, where applicable, the premises for the storage of crops, crop products, livestock

products, raw materials and inputs, are clearly separate from those of any other unit not producing in accordance with the

rules laid down in this Regulation.

Processing, packaging and/or marketing may take place at the production unit, where these activities are limited to its

own agricultural produce.

Quantities sold directly to the final consumer shall be accounted on a daily basis.

Storage, in the unit, of input products other than those permitted by Articles 6(1) (b) and 7, is prohibited.

A.1

Plants and plant products from farm production or collection

1. Initial inspection

The full description of the unit referred to under point 2 of Part I of this Annex must

• be drawn up even where the producer limits his activity to the collection of wild plants,

• show the storage and production premises and land parcels and/or collection areas and, where applicable, premises

where certain processing and/or packaging operations take place and

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• specify the date of the last application on the parcels and/or collection areas concerned of products, the use of which

is not compatible with Article 6 (1) (b).

In case of collection of wild plants, the practical measures referred to under point 2 of Part I of this Annex must include

the guarantees given by third parties which the producer can provide to ensure that the provisions of Annex I, section A,

point 4, are complied with.

2. Communications

Each year, before the date indicated by the inspection body or authority, the producer must notify the body or authority

of its schedule of production of crop products, giving a breakdown by parcel.

3. Several production units run by the same operator

Where an operator runs several production units in the same area, the units producing crops or crop products not covered

by Article 1, together with storage premises for input products (such as fertilisers, plant protection products, seed) must

also be subject to the general inspection arrangements laid down in Part I of this Annex as well as to the specific

inspections provisions as regards points 1, 2, 3 and 5.

The same variety as, or a variety that cannot be easily differentiated from those produced at the unit referred to in the

second paragraph of section A, may not be produced at these units.

However, producers may derogate from the rule referred to in the last sentence of the preceding subparagraph:

1. in the case of the production of perennial crop products (edible fruit bearing trees, vines and hops) provided the

following conditions are met:

1. the production in question forms part of a conversion plan in respect of which the producer gives a firm

undertaking and which provides for the beginning of the conversion of the last part of the area concerned to

organic production in the shortest possible period which may not in any event exceed a maximum of five years,

1. appropriate measures have been taken to ensure the permanent separation of the products obtained from each

unit concerned,

1. the inspection body or authority is notified of the harvest of each of the products concerned at least 48 hours in

advance,

1. immediately upon completion of the harvest, the producer informs the inspection body or authority of the exact

quantities harvested on the units concerned together with any particular distinguishing features (such as quality,

colour, average weight, etc. ) and confirms that the measures taken to separate the products have been applied,

1. the conversion plan and the measures referred to in point 1 and in point 2 of Part I have been approved by the

inspection body or authority. This approval must be confirmed each year after the start of the conversion plan.

1. in the case of areas intended for agricultural research agreed by the Member States' competent authorities, provided

that conditions 2, 3 and 4 and the relevant part of condition 5 referred to in (a) are met;

1. in the case of production of seed, vegetative propagating material and transplants, provided that conditions 2, 3 and 4

and the relevant part of condition 5 referred to in (a) are met;

1. in the case of grassland exclusively used for grazing.

A.2 Livestock and livestock products produced by animal husbandry

1. Initial inspection

When the inspection system applying specifically to livestock production is first implemented, the full description of the

unit referred to under point 2 of Part I of this Annex must include:

• a full description of the livestock buildings, pasturage, open-air exercise areas, open air runs, etc., and, where

applicable, the premises for the storage, packaging and processing of livestock, livestock products, raw materials

and inputs,

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• a full description of the installations for the storage of livestock manure.

The practical measures referred to under point 2 of Part I of this Annex must include:

• plan for spreading manure agreed with the inspection body or authority, together with a full description of the

areas given over to crop production,

• where appropriate, as regards the spreading of manure, the arrangements with other holdings complying with the

provisions of this Regulation.

• management plan for the organic-production livestock unit (e.g. management for feeding, reproduction, health,

etc.).

2. Identification of livestock

The livestock must be identified permanently using techniques adapted to each species, individually in the case of large

mammals and individually or by batch in the case of poultry and small mammals.

3. Livestock records

Livestock records must be compiled in the form of a register and kept available to the inspection authorities or bodies at

all times at the address of the holding.

Such records, which are to provide a full description of the herd or flock management system, must contain the following

information:

• by species, as regards livestock arriving at the holding: origin and date of arrival, conversion period, identification

mark and veterinary record;

• as regards livestock leaving the holding: age, number of heads, weight in case of slaughter, identification mark and

destination;

• details of any animals lost and reasons;

• as regards feed: type, including feed supplements, proportions of various ingredients of rations and periods of

access to free-range areas, periods of transhumance where restrictions apply;

• as regards disease prevention and treatment and veterinary care: date of treatment, diagnosis, type of treatment

product, method of treatment and practitioner’s prescription for veterinary care with reasons and withdrawal

periods applying before livestock products can be marketed.

4. Several production units run by the same operator

Where a producer, in accordance with point 1.6. of Annex I, section B, manages several production units, the units

which produce livestock or livestock products not covered by Article 1 must also be subject to the inspection system as

regards point 1 of this subsection on livestock and livestock products and as regards the provisions on livestock

management, livestock records and the principles governing storage of animal husbandry products used.

A derogation with regard to the requirement of different involved species in point 1.6 of Annex I, part B, may be granted

to holdings carrying out agricultural research by the inspection body or authority in agreement with the competent

authority of the Member State, where the following conditions are met:

• appropriate measures, agreed with the inspection body or authority have been taken in order to guarantee the

permanent separation between livestock, livestock products, manure and feedingstuffs of each of the units;

• the producer informs the inspection body or authority in advance of any delivery or selling of the livestock or

livestock products;

• the operator informs the inspection body or authority of the exact quantities produced in the units together with all

characteristics permitting the identification of the products and confirms that the measures taken to separate the

products have been applied.

5 . O t h e r r e q u i r e me nt s

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By way of a derogation from those rules, the storage of allopathic veterinary medicinal products and antibiotics is

permitted on holdings provided that they have been prescribed by a veterinarian in connection with treatment as referred

to in Annex I, that they are stored in a supervised location and that they are entered in the farm register.

B. Units for preparation of plant and livestock products and foodstuffs composed of plant and livestock products

This section applies to any unit involved in the preparation, as defined in Article 4(3), of products referred to in Article 1(1),

for its own account or for account of a third party, and including in particular also:

• units involved in packaging and/or re-packaging of such products;

• units involved in labelling and/or re-labelling of such products.

1. Initial inspection

The full description of the unit referred to under point 2 of Part I of this Annex must show the facilities used for the

reception, the processing, packaging, labelling and storage of agricultural products before and after the operations

concerning them, as well as the procedures for the transport of the products.

1. Documentary accounts

The documentary accounts referred to in point 5 of Part I shall include the verification referred to in point 5 of this

subsection.

Preparation units handling also products not from organic production

Where products not referred to in Article 1 are also processed, packaged or stored in the production unit concerned:

• the unit must have areas separated by place or time within the premises for the storage of products as referred to in

Article 1, before and after the operations; these areas must be managed in order to ensure identification of lots and to

avoid any mixing with or contamination by products and/or substances not in compliance with this Regulation,

• operations must be carried out continuously until the complete run has been dealt with, separated by place or time

from similar operations performed on products not covered by Article 1,

• if such operations are not carried out at regular times or on a fixed day, they must be announced in advance, with a

deadline agreed on with the inspection body or authority,

• every measure must be taken to ensure identification of lots and to avoid mixtures with products not obtained in

accordance with the rules laid down in this Regulation,

• operations on products in accordance with the rules laid down in this Regulation must be carried out only after

complete cleaning of the production equipment. The effectiveness of the cleaning measures must be checked and

recorded.

4. Packaging and transport of products to other preparation units

Milk, eggs and egg-products from organic farming shall be collected independently from products not produced in

accordance with this Regulation. Simultaneous collection may occur where appropriate measures are taken to prevent any

possible contamination with products not produced in accordance with this Regulation and to ensure the identification of the

products produced in accordance with the provisions of this Regulation. The operator keeps the information relating to

collec tion days, hours, circuit and date and time of reception of the products available to the inspection body or authority.

5. Reception of products from other preparation units

On receipt of a product as referred to in Article 1, the operator shall check the closing of the packaging or container where it

is required and the presence of the indications referred to in point 6 of Part I of this Annex. The operator shall crosscheck

the information on the label referred to in point 6 of Part I with the information on the accompanying documents. The result

of this verification shall be explicitly mentioned in the documentary accounts referred to in point 5 of Part I.

C. Imports of plants, plant products, livestock, livestock products and foodstuffs composed of plant products

and/or livestock products from third countries.

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This section applies to any production unit involved, as importer and/or as first consignee, in the import and/or reception,

for its own account or for account of another operator, of products referred to in Article 1(1). For the purpose of this

section:

- the importer shall mean the natural or legal person within the European Community who presents a

consignment for release for free circulation into the European Community, either on its own, or through a

representative,

- the first consignee shall mean the natural or legal person referred to in Article 11 (3) a) to whom the

consignment is delivered and who will accept it for further preparation and/or marketing.

1. Initial inspection

1. Importers:

1. The full description of the unit referred to under point 2 of Part I of this Annex must include the importer’s

premises and of his import activities, indicating the points of entry of the products into the Community and any

other facilities the importer intends to use for the storage of the imported products pending their delivery to the

first consignee.

1. In addition, the declaration referred to under point 2 of Part I must include an undertaking by the importer to

ensure that any facilities that the importer will use for storage of products are submitted to inspection, to be

carried out either by the inspection body or authority or, when these storage facilities are situated in another

Member State or region, by an inspection body or authority approved for inspection in that Member State or

region.

1. First consignee:

2. The full description of the unit referred to under point 2 of Part I must show the facilities used for the reception and

storage, and, where relevant, the processing, packaging, labelling and storage of agricultural products before and after

the operations concerning them, as well as for the transport of the products.

When the importer and the first consignee are the same legal person and operating in one single unit, the reports

referred to in point 2 of Part I can be formalised within one single report.

1. Documentary accounts

When the importer and the first consignee are not operating in one single unit, both of them must keep stock

and financial records.

On request of the inspection body or authority, any details on the transport arrangements from the exporter in

the third country to the first consignee and, from the first consignee’s premises or storage facilities to the

consignees within the EC must be provided.

1. Information on imported consignments

The importer shall, at the latest by the time that the certificate is submitted to the relevant Member State's authority in

accordance with Article 4 point 1 of Commission Regulation (EC) N° 1788/2001 of 7 September 2001 laying down

detailed rules for implementing the provisions concerning the certificate of inspection for imports from third countries

under Article 11 of Council Regulation (EEC) No 2092/91 on organic production of agricultural product s and

indications referring thereto on agricultural products and foodstuffs, inform the inspection body or authority of each

imported consignment into the Community, giving:

◦ the name and address of the first consignee,

◦ any details this body or authority may require, such as a copy of the inspection certificate for the importation of

organic products. On the request of the inspection body or authority of the importer, the latter must pass the

information to the inspection body or authority of the first consignee.

1. Importers and first consignees handling also products not from organic production

When imported products referred to in Article 1 are stored in storage facilities where also other agricultural products

or foodstuffs are stored:

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◦ the products as referred to in Article 1 must be kept separate from the other agricultural products and/or

foodstuffs,

◦ every measure must be taken to ensure identification of consignments and to avoid mixtures with products not

obtained in accordance with the rules laid down in this Regulation.

5. Inspection visits

The inspection body or authority shall inspect the stock and financial records mentioned in section C, point 2 and the

certificates referred to in Article 11 (1) (b) and (3).

Where the importer performs the import operations by different units or premises, he must make available on request, the

reports foreseen under point 2 and 4 of Part I of this Annex for each of these facilities.

6. Reception of products from a third country

Products as referred to in Article 1 shall be imported from a third country in appropriate packaging or containers, closed in a

manner preventing substitution of the content and provided with identification of the exporter and with any other marks and

numbers serving to identify the lot with the certificate of inspection for import from third countries.

On receipt of a product as referred to in Article 1, imported from a third country, the first consignee shall check the closing

of the packaging or container and the correspondence of the identification of the consignment with the certificate referred to

in Regulation (EC) N° 1788/2001. The result of this verification shall be explicitly mentioned in the accounts referred to in

section C, point 2.

D. Units involved in the production, preparation or import of products referred to in Article 1(1) and which have

contracted out to third parties in part or in total the actual operations concerned.

Initial inspection

With regard to the operations, which are contracted out to third parties, the full description referred to in point 2 of Part I

shall include

• a list of the subcontractors with a description of their activities and the inspection bodies or authorities to which they

are subject; these subcontractors must have agreed to have their holding being subject to the inspection regime of

Article 9, in accordance with the relevant sections of Annex III;

• all the practical measures, including inter alia an appropriate system of documentary accounts, to be taken at the level

of the unit to ensure that the products the operator places on the market can be traced to their suppliers, and, where

different, their sellers, as well as to their consignees and, where different, their buyers.

Where the operator and the subcontractors are inspected by different inspection bodies or authorities, the inspection report

referred to in point 2 of Part I must include the provision that the different inspection bodies can exchange information on

the operations under their inspection and on the way this exchange of information can be implemented.