1991R2092 — EN — 15.03.1996 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL REGULATION (EEC)No 2092/91
of 24 June 1991
on organic production of agricultural products and indications referring thereto on agricultural
products and foodstuffs
(OJ L 198, 22.7.1991, p. 1)
Amended by:
Official Journal
No page date
►M1 Commission Regulation (EEC) No 1535/92 of 15 June 1992 L 162 15 16.6.1992
►M2 Council Regulation (EEC) No 2083/92 of 14 July 1992 L 208 15 24.7.1992
►M3 Commission Regulation (EEC) No 207/93 of 29 January 1993 L 25 5 2.2.1993
►M4 Commission Regulation (EEC) No 2608/93 of 23 September 1993 L 239 10 24.9.1993
►M5 Commission Regulation (EC) No 468/94 of 2 March 1994 L 59 1 3.3.1994
►M6 Council Regulation (EC) No 1468/94 of 20 June 1994 L 159 11 28.6.1994
►M7 Commission Regulation (EC) No 2381/94 of 30 September 1994 L 255 84 1.10.1994
►M8 Commission Regulation (EC) No 1201/95 of 29 May 1995 L 119 9 30.5.1995
►M9 Commission Regulation (EC) No 1202/95 of 29 May 1995 L 119 11 30.5.1995
►M10 Council Regulation (EC) No 1935/95 of 22 June 1995 L 186 1 5.8.1995
►M11 Commission Regulation (EC) No 418/96 of 7 March 1996 L 59 10 8.3.1996
Amended by:
►A1 Actof Accession of Aust ria, Sweden and Finland C 241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
Corrected by:
►C1 Corrigendum, OJ L 21, 28.1.1995, p. 21 (2381/94)
1991R2092 — EN — 15.03.1996 — 001.001 — 2
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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
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European EconomicCommunity, 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),
Whereas demand from consumers for organically produced agricultural
products and foodstuffs is increasing; whereas a new market for agricul-tural products is thus being created by this phenomenon;
Whereas the market price for such products is higher, while the way in
which they are produced involves less intensive use of land; whereas,therefore, in the context of the reorientation of the common agriculturalpolicy, this type of production may contribute towards the attainment ofa better balance between supply of, and demand for, agricultural prod-ucts, the protection of the environment and the conservation of thecountryside;
Whereas, in response to the rising demand, agricultural products and
foodstuffs are being placed on the market with indications stating orimplying to purchasers that they have been produced organically orwithout the use of synthetic chemicals;
Whereas some Member States have already adopted rules and inspec-
tion arrangements for the use of such indications;
Whereas a framework of Community rules on production, labelling and
inspection will enable organic farming to be protected in so far as it willensure conditions of fair competition between the producers of productsbearing such indications and give the market for organic products amore distinctive profile by ensuring transparency at all stages ofproduction and processing, thereby improving the credibility of suchproducts in the eyes of consumers;
Whereas organic production methods constitute a specific form of
production at farm level; whereas, consequently, it should be providedthat, on the labelling of processed products, indications referring toorganic production methods should relate to the ingredients obtained bysuch methods;
Whereas, for the implementation of the arrangements concerned, provi-
sion should be made for flexible procedures whereby certain technicaldetails or measures may be amended, amplified or further defined inorder to take account of experience gained; whereas, within a suitableperiod, this Regulation will be supplemented by equivalent rulescovering livestock production;
Whereas, in the interests of the producers and purchasers of products
bearing indications referring to organic production methods, theminimum principles which must be complied with in order for productsto be presented with such indications should be laid down;
Whereas organic production methods entail significant restrictions on
the use of fertilizers and pesticides which may have detrimental effectson the environment or result in the presence of residues in agriculturalproduce; whereas, in this context, practices accepted in the Community
(1) OJ No C 4, 9. 1. 1990, p. 4; and
OJ No C 101, 18. 4. 1991, p. 13.
(2) OJ No C 106, 22. 4. 1991, p. 27.
(3) OJ No C 182, 23. 7. 1990, p. 12.
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when this Regulation is adopted must be complied with in accordancewith codes of practice followed in the Community when this Regulationis adopted; whereas, moreover, in the future, the principles governingthe authorization of products which may be used in this type of farmingmustbe est ablished;
Whereas, moreover, organic farming involves varied cultivation prac-
tices and limited use of non-synthetic fertilizers and conditioners of lowsolubility; whereas these practices should be specified and conditionsfor the use of certain non-synthetic products laid down;
Whereas the procedures laid down make possible, if this appears neces-
sary, the addition to Annex I of more specific provisions aimed atavoiding the presence of certain residues of synthetic chemicals fromsources other than agriculture (environmental contamination) in theproducts obtained by such production methods;
Whereas, to ensure compliance with the rules on production, all stages
of production and marketing should normally be subject to inspection;
Whereas all operators producing, preparing, importing or marketing
products bearing indications referring to organic production methodsmust be subject to a regular inspection system, meeting minimumCommunity requirements and carried out by designated inspectionauthorities and/or by approved and supervised bodies; whereas provi-sion should be made for a Community indication of inspection to appearon the labelling of the products concerned,
HAS ADOPTED THIS REGULATION:
Scope
Article 1
1. This Regulation shall apply to the following products, where such
products bear, or are intended to bear, indications referring to organicproduction methods:
(a) unprocessed agricultural crop products; also animals and unpro-
cessed animal products, to the extent that principles of productionand specific inspection rules for them are introduced into Annexes Iand III;
(b) products intended for human consumption composed essentially of
one or more ingredients of plant origin; in addition, upon adoptionof the provisions concerning livestock production referred to in (a),products intended for human consumption containing ingredients ofanimal origin.
2. A proposal concerning the principles and specific measures of
control governing organic animal production, non-processed animalproducts and products intended for human consumption containingingredients of animal origin shall be submitted by the Commission assoon as possible and before ►
M10 30 June 1995. ◄
Article 2
For the purposes of this Regulation a product shall be regarded as
bearing indications referring to organic production methods where, inthe labelling, advertising material or commercial documents, such aproduct or its ingredients is described by the indications in use in eachMember State suggesting to the purchaser that the product or its ingre-dients have been obtained in accordance with the rules of productionlaid down in ►
M10 Article 6 ◄and in particular the following terms,
unless such terms are not applied to agricultural products in foodstuffsor clearly have no connection with the method of production:
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— in Spanish: ecológico,
— in Danish: økologisk,— in German: ökologisch,— in Greek: βιολογικό ,
— in English: organic,— in French: biologique,— in Italian: biologico,— in Dutch: biologisch,— in Portuguese: biológico,
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— in Finnish: luonnonmukainen,— in Swedish: ekologisk.
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Article 3
This Regulation shall apply without prejudice to other Community
provisions governing the production, preparation, marketing, labellingand inspection of the products specified in Article 1.
Definitions
Article 4
For the purpose of this Regulation:
1. ‘labelling' shall mean any words, particulars, trade marks, brand
names, pictorial matter or symbols on any packaging, document,notice, label, board or collar accompanying or referring to a productspecified in Article 1;
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2. ‘production' shall mean the operations on the agricultural holding
involved in producing, packaging and initially labelling as productsof organic production agricultural products produced on thatholding;
3. ‘preparation' shall mean the operations of preserving and/or
processing of agricultural products, and also packaging and/oralterations made to the labelling concerning the presentation of theorganic production method of the fresh, preserved and/or processedproducts;
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4. ‘marketing' shall mean holding or displaying for sale, offering for
sale, selling, delivering or placing on the market in any other form;
5. ‘operator' shall mean any natural or legal person who produces,
prepares or imports from a third country, with a view to thesubsequent marketing thereof, products as referred to in Article 1,or who markets such products;
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6. ‘ingredients' shall mean the substances, including additives, used in
the preparation of the products specified in Article 1 (1) (b), asdefined in Article 6 (4) of Directive 79/112/EEC on the approx-imation of the laws of the Member States relating to the labelling,presentation and advertising of foodstuffs for sale to the ultimateconsumer;
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7. ‘plant protection products' shall mean products as defined in Article
2 (1) of Council Directive 79/117/EEC of 21 December 1978prohibiting the placing on the market and use of plant protection
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products containing certain active substances (1), as lastamended
by Directive 89/365/EEC (2);
8. ‘detergents' shall mean substances and preparations, within the
meaning of Council Directive 73/404/EEC of 22 November 1973on the approximation of the laws of the Member States relating todetergents (
3), as lastamended by Direct ive 86/94/EEC (4), which
are intended to be used for cleaning certain products as referred toin Article 1 (1) (a).
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9. ‘prepackaged foodstuff' shall mean any single item as defined in
Article 1 (3) (b) of Directive 79/112/EEC;
10. ‘list of ingredients' shall mean the list of ingredients referred to in
Article 6 of Directive 79/112/EEC.
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Labelling
Article 5
1. The labelling and advertising of a product specified in Article 1
(1) (a) may refer to organic production methods only where:
(a) such indications show clearly that they relate to a method of agri-
cultural production;
(b) the product was produced in accordance with the rules laid down in
►M10 Article 6 ◄or imported from a third country under the
arrangements laid down in Article 11;
(c) the product was produced or imported by an operator who is subject
to the inspection measures laid down in Articles 8 and 9;
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(d) in the case of products prepared after 1 January 1997, the labelling
refers to the name and/or the code number of the inspectionauthority or body to which the operator is subject. Member Statesshall decide whether to require a reference to the name and/or to thecode number and shall notify the Commission accordingly.
3. The labelling and advertising of a product specified in Article 1(1) (b) may bear indications referring to organic production methods inthe sales description of the product only where:
(a) at least 95 % of the ingredients of agricultural origin of the product
are, or are derived from, products obtained in accordance with therules laid down in Article 6 or imported from third countries underthe arrangements laid down in Article 11;
(b) all the other ingredients of agricultural origin of the product are
included in Annex VI, Section C or have been provisionally author-ized by a Member State in accordance with any implementingmeasures adopted where appropriate pursuant to paragraph 7;
(c) the product contains only substances listed in Annex VI, Section A,
as ingredients of non-agriculural origin;
(d) the products or its ingredients of agricultural origin, referred to in
subparagraph (a), have not been subjected to treatments involvingthe use of substances not listed in Annex VI, Section B;
(e) the product or its ingredients have not been subjected to treatments
involving the use of ionizing radiation;
(1) OJ No L 33, 8. 2. 1979, p. 36.
(2) OJ No L 159, 10. 6. 1989, p. 58.
(3) OJ No L 347, 17. 12. 1973, p. 51.
(4) OJ No L 80, 25. 3. 1986, p. 51.
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(f) the product has been prepared or imported by an operator who is
subject to the inspection measures laid down in Articles 8 and 9;
(g) in the case of products prepared after 1 January 1997, the labelling
refers to the name and/or the code number of the inspectionauthority or body to which the operator who has carried out themost recent preparation operation is subject. Member States shalldecide whether to require a reference to the name and/or to the codenumber and shall notify the Commission accordingly.
The indications referring to organic production methods must make
it clear that they relate to a method of agricultural production andmust be accompanied by a reference to the ingredients of agricul-tural origin concerned, unless such reference is clearly given in thelistof ingredient s.
4. Ingredients of agricultural origin may be included in Annex VI,
Section C only where it has been shown that such ingredients are ofagricultural origin and are not produced in sufficient quantity in theCommunity in accordance with the rules laid down in Article 6, orcannot be imported from third countries in accordance with the ruleslaid down in Article 11.
5. Products labelled or advertised in accordance with paragraphs 1 or
3 may bear indications referring to conversion to organic productionmethods, provided that:
(a) the requirements referred to in paragraph 1 or paragraph 3 respec-
tively are fully satisfied, with the exception of that concerning thelength of the conversion period referred to in paragraph 1 of AnnexI;
(b) a conversion period of atleast12 mont hs before t he harvesthas
been complied with;
(c) such indications do not mislead the purchaser of the product
regarding its difference from products which satisfy all the require-ments of paragraphs 1 or 3. After 1 January 1996, such indicationsmust take the form of the words ‘product under conversion toorganic farming', and mustappear in a colour, size and st yle oflettering which is not more prominent than the sales description ofthe product; in this indication the words ‘organic farming' shall notbe more prominent than the words ‘product under conversion to';
(d) the product contains only one ingredient of agricultural origin;
(e) for products prepared after 1 January 1997, the labelling refers to
the name and/or the code number of the inspection authority orbody to which the operator who has carried out the most recentproduction or preparation operation is subject. Member States shalldecide whether to require a reference to the name and/or to the codenumber and shall notify the Commission accordingly.
5a. Without prejudice to the provisions of paragraph 3, the labelling
and advertising of a product as referred to in Article 1 (1) (b) may onlybear indications referring to organic production methods where:
(a) at least 70 % of the ingredients of agricultural origin are, or are
derived from, products obtained in accordance with the rules laiddown in Article 6 or imported from third countries under thearrangements laid down in Article 11;
(b) all the other ingredients of agricultural origin of the product are
included in Annex VI, Section C or have been provisionally author-ized by a Member State in accordance with any implementationmeasures adopted where appropriate, pursuant to paragraph 7;
(c) the indications referring to organic production methods appear in
the list of ingredients and only in clear relation to those ingredientsobtained according to the rules laid down in Article 6 or importedfrom third countries under the arrangements laid down in Article11; they appear in the same colour and with an identical size andstyle of lettering as the other indications in the list of ingredients.Such indications must also appear in a separate statement set in the
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same visual field as the sales description and indicating the
percentage of the ingredients of agricultural origin or derived there-from which were obtained in accordance with the rules laid down inArticle 6 or were imported from third countries under the arrange-ments laid down in Article 11. The statement may not appear in acolour, size and style of lettering which is more prominent than thesales description of the product. The statement shall be in thefollowing form: ‘X % of the agricultural ingredients were producedin accordance with the rules of organic production';
(d) the product contains only substances listed in Annex VI, Section A
as ingredients of non-agricultural origin;
(e) the product or its ingredients of agricultural origin referred to in
subparagraph (a) have not been subjected to treatments involvingthe use of substances not listed in Annex VI, Section B;
(f) the product or its ingredients have not been subjected to treatments
involving the use of ionizing radiation;
(g) the product has been prepared or imported by an operator who is
subject to the inspection measures laid down in Articles 8 and 9;
(h) for products prepared after 1 January 1997, the labelling refers to
the name and/or the code number of the inspection authority orinspecting body to which the operator who has carried out the mostrecent production or preparation operation is subject. MemberStates shall decide whether to require a reference to the nameand/or to the code number and/or shall notify the Commissionaccordingly.
6. During a transitional period expiring on 31 December 1997, the
labelling and advertising of a product as referred to in Article 1 (1) (b)prepared partly from ingredients not satisfying the requirements inparagraph 3 (a) may refer to organic production methods provided that:
(a) at least 50 % of the ingredients of agricultural origin satisfy the
requirements referred to in paragraph 3 (a);
(b) the product satisfies the requirements referred to in paragraph 3 (c),
(d), (e) and (f);
(c) the indications referring to organic production methods:
— appear only in the list of ingredients as provided for in Directive
79/112/EEC, as lastamended by Direct ive 89/395/EEC,
— clearly refer to only those ingredients obtained according to the
rules referred to in Article 6 or imported under the arrangementslaid down in Article 11;
(d) the ingredients and their relative levels appear in descending order
by weight in the list of ingredients;
(e) indications in the list of ingredients appear in the same colour and
with an identical size and style of lettering.
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7. Detailed rules concerning the implementation of this Article maybe established according to the procedure laid down in Article 14.
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8. Limitative lists of the substances and products referred to inparagraph 3 (b), (c) and (d) and paragraph 5a (b), (d) and (e) shall beestablished in Annex VI, Sections A, B and C, according to the proce-dure laid down in Article 14.
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Conditions of use and compositional requirements of these ingredientsand substances may be specified.
Where a Member State considers that a product should be added to the
abovementioned lists or that amendments should be made thereto, itshall ensure that a dossier giving the reasons for the inclusion or theamendments is sent officially to the other Member States and theCommission, which shall present it to the Committee referred to inArticle 14.
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9. For the calculation of the percentages referred to in paragraphs 3and 6, the rules provided for in Articles 6 and 7 of Directive 79/112/EEC shall be applied.
10. In a product as referred to in Article 1 (1), an ingredient obtained
according to the rules laid down in Article 6 shall not be presenttogether with the same ingredient not obtained according to those rules.
11. Before 1 January 1999, the Commission shall review the provi-
sions of this Article and of Article 10 and submit any appropriateproposals for their revision.
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Rules of production
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Article 6
1. The organic production method implies that for the production of
products referred to in Article 1 (1) (a) other than seeds and vegetativepropagating material:
(a) at least the requirements of Annex I and, where appropriate, the
detailed rules relating thereto, must be satisfied;
(b) only products composed of substances listed in Annexes I and II
may be used as plant-protection products, detergents, fertilizers, soilconditioners or for another purpose where such purpose is specifiedin Annex II in regard to certain substances. They may be used onlyunder the specific conditions laid down in Annexes I and II in so faras the corresponding use is authorized in general agriculture in theMember States concerned in accordance with the relevantCommunity provisions or national provisions in conformity withCommunity law;
(c) only seed or vegetative propagating material produced by the
organic production method referred to in paragraph 2 is used.
2. The organic production method implies that for seeds and vegeta-
tive reproductive material, the mother plant in the case of seeds and theparent plant(s) in the case of vegetative propagating material have beenproduced in accordance with the provisions of subparagraphs (a) and (b)of the previous paragraph for at least one generation or, in the case ofperennial crops, two growing seasons.
3. (a) By way of derogation from paragraph 1 (c), seeds and vegetative
propagating material not obtained by the organic productionmethod may, during a transitional period expiring on 31December 2000 and with the approval of the competent authorityof the Member State, be used in so far as users of such propa-gating material can show to the satisfaction of the inspectionbody or authority of the Member State that they were unable toobtain on the market propagating material for an appropriatevariety of the species in question and satisfying the requirementsof paragraph 2. In that case, propagating material which is nottreated with products not listed in Annex II, Section B must beused, if available on the Community market. Member Statesshall inform the other Member States and the Commission ofany authorization granted under this paragraph.
(b) The procedure laid down in Article 14 may be applied to decide
on:
— the introduction, before 31 December 2000, of restrictions
concerning the transitional measure referred to in subpara-graph (a) with regard to certain species and/or types ofpropagating material and/or the absence of chemical treat-ment,
— the maintenance, after 31 December 2000, of the derogation
provided for in subparagraph (a) with regard to certainspecies and/or types of propagating material and with regardto the whole Community or certain parts thereof,
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— the introduction of procedural rules and criteria concerning
the derogation referred to in subparagraph (a) and the infor-mation thereon communicated to the professional organ-izations concerned, to other Member States and the Commis-sion.
4. Before 31 December 1999, the Commission shall review the
provisions of this Article, in particular paragraph 1 (c) and paragraph 2and submit any appropriate proposals with a view to their revision.
Article 6a
1. For the purposes of this Article, ‘seedlings' shall mean whole
seedlings intended for planting for plant production.
2. The organic production method implies that when producers use
seedlings, they have been produced in accordance with Article 6.
3. By way of derogation from paragraph 2, seedlings not obtained by
organic production methods may be used during a transitional periodexpiring on 31 December 1997 in so far as the following conditions aremet:
(a) the competent authority of the Member State has authorized the use
after the user or users of such material have demonstrated to thesatisfaction of the inspection body or authority of the Member Statethat they were not able to obtain an appropriate variety of thespecies in question on the Community market;
(b) the seedlings have not been treated, since sowing, with any products
other than those listed in Annex II, Sections A and B;
(c) the seedlings come from a producer who has accepted an inspection
system equivalent to the arrangements laid down in Article 9 andhas agreed to apply the restriction in subparagraph (b); this provi-sion shall enter into force on 1 January 1996;
(d) after planting, the seedlings must have been cultivated in accord-
ance with the provisions of Article 6 (1) (a) and (b) for a period ofatleastsix weeks before harvest ing;
(e) the labelling of any product containing ingredients derived from
such seedlings may not include the indication referred to in Article10;
(f) without prejudice to any restriction resulting from the procedure
referred to in paragraph 4, any authorization granted under thisparagraph shall be withdrawn as soon as the shortage comes to anend, and shall expire on 31 December 1997 at the latest.
4. (a) Where an authorization as referred to in paragraph 3 has been
granted, the Member State shall immediately notify to the otherMember State and to the Commission the following information:
— the date of the authorization,
— the name of the variety and species concerned,— the quantities that are required and the justification for those
quantities,
— the expected period of the storage,— any other information requested by the Commission or the
Member States.
(b) If the information submitted by any Member State of the
Commission and to the Member State which granted the authori-zation shows that an appropriate variety is available during theperiod of the storage, the Member State shall consider with-drawing the authorization or reducing its period of validity, andshall inform the Commission and the other Member States of themeasures it has taken, within 10 days of the date of receipt of theinformation.
(c) At the request of a Member State or at the Commission’s initia-
tive, the matter shall be submitted for examination to theCommittee referred to in Article 14. It may be decided, inaccordance with the procedure laid down in Article 14, that the
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authorization shall be withdrawn or its period of valdityamended.
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Article 7
1. Products not authorized at the date of adoption of this Regulation
for a purpose indicated in Article 6 (1) (b) may be included in Annex II,provided that the following conditions are satisfied:
(a) if they are used for the purpose of plant pest or disase control:
— they are essential for the control of a harmful organism or a
particular disease for which other biological, cultural, physicalor plant breeding alternatives are not available, and
— the conditions for their use preclude any direct contact with the
seed, the crop or crop products; however, in the case of peren-nial crops, direct contact may take place, but only outside thegrowing season of the edible parts (fruits) provided that suchapplication does not indirectly result in the presence of residuesof the product in the edible parts, and
— their use does not result in, or contribute to, unacceptable effects
on, or contamination of, the environment;
(b) if they are used for fertilization or soil-conditioning purposes:
— they are essential for specific nutrition requirements of crops or
specific soil-conditioning purposes which cannot be satisfied bythe practices mentioned in Annex I, and
— their use does not result in unacceptable effects on the environ-
ment or contribute to the contamination thereof.
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1a. The conditions provided for in paragraph 1 shall not apply toproducts which were in common use before the adoption of this Regula-tion according to the codes of practice on organic farming followed inthe Community.
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2. If need be, the following may be specified for any productincluded in Annex II:
— the detailed description of the product,
— the conditions of its use and compositional and/or solubility require-
ments, with regard in particular to the need to insure for theseproducts a minimal presence of residues on edible parts of the cropand on edible crop products as well as a minimum effect on theenvironment,
— particular labelling requirements for products referred to in Article 1
where such products are obtained with the aid of certain productsreferred to in Annex II.
3. Amendments to Annex II, concerning either inclusion or cancel-
ling of products as referred to in paragraph 1 or inclusion or amend-ments of specifications as referred to in paragraph 2, shall be adoptedby the Commission in accordance with the procedure laid down inArticle 14.
4. Where a Member State considers that a product should be added
to Annex II or that amendments should be made thereto, it shall ensurethat a dossier giving the reasons for the inclusion or the amendments issent officially to the other Member States and the Commission, whichshall introduce it to the committee referred to in Article 14.
Inspection system
Article 8
1. Any operator who produces, prepares or imports from a third
country products as specified in Article 1 for the purpose of marketingthem shall:
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(a) notify this activity to the competent authority of the Member State
in which the activity is carried out; such notification shall includethe information specified in Annex IV;
(b) submit his undertaking to the inspection system referred to in
Article 9.
2. Member States shall designate an authority or body for the recep-
tion of notifications.
Member States may provide for the communication of any additional
information which they consider to be necessary for effective supervi-sion of the operators concerned.
3. The competent authority shall ensure that an updated list
containing the names and addresses of operators subject to the inspec-tion system is made available to interested parties.
Article 9
1. Member States shall set up an inspection system operated by one
or more designated inspection authorities and/or by approved privatebodies to which the ►
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importing from third countries products as referred to in Article 1 ◄
shall be subject.
2. Member States shall adopt the measures necessary to ensure that
an operator who complies with the provisions of this Regulation andpays his contribution to inspection expenses has access to the inspectionsystem.
3. The inspection system shall comprise at least the application of the
precautionary and inspection measures specified in Annex III.
4. For the application of the inspection system operated by private
bodies, Member States shall designate an authority responsible for theapproval and supervision of such bodies.
5. For the approval of a private inspection body, the following shall
be taken into account:
(a) the standard inspection procedure to be followed, containing a
detailed description of the inspection measures and precautionswhich the body undertakes to impose on operators subject to itsinspection;
(b) the penalties which the body intends to apply where
►
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(c) the availability of appropriate resources in the form of qualified
staff, administrative and technical facilities, inspection experienceand reliability;
(d) the objectivity of the inspection body vis-à-vis the operators subject
to its inspection.
6. After an inspection body has been approved, the competent
authority shall:
(a) ensure that the inspections carried out by the inspection body are
objective;
(b) verify the effectiveness of its inspections;
(c) take cognizance of any ►
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ments◄found and penalties applied;
(d) withdraw approval of the inspection body where it fails to satisfy
the requirements referred to in (a) and (b) or no longer fulfils thecriteria indicated in paragraph 5 or fails to satisfy the requirements►
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6a. Before 1 January 1996, Member States shall issue a code numberto each inspection body or authority approved or designated in accord-ance with the provisions of this Article. They shall inform the otherMember States and the Commission thereof; the Commission shall
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publish the code numbers in the list referred to in the last subparagraphof Article 15.
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7. The inspection authority and the approved inspection bodiesreferred to in paragraph 1 shall:
(a) ensure that at least the inspection measures and precautions speci-
fied in Annex III are applied to undertakings subject to their inspec-tion;
(b) not disclose information and data they obtain in their inspection
activity to persons other than the person responsible for the under-taking concerned and the competent public authorities.
8. Approved inspection bodies shall:
(a) give the competent authority, for inspection purposes, access to
their offices and facilities, together with any information and assis-tance deemed necessary by the competent authority for the fulfil-ment of its obligations pursuant to this Regulation;
(b) send to the competent authority of the Member State by 31 January
each year a list of operators subject to their inspection on 31December of the previous year and present to the said authority aconcise annual report.
9. The inspection authority and inspection bodies referred to in para-
graph 1 shall:
(a) ensure that, where an irregularity is found regarding the imple-
mentation of Articles 5 and ►
M10 6◄or of the measures
referred to in Annex III, the indications provided for in Article 2referring to the organic production method are removed from theentire lot or production run affected by the irregularity concerned;
(b) where a manifestinfringement , or an infringementwit h prolonged
effects is found, prohibit the operator concerned from marketingproducts with indications referring to the organic productionmethod for a period to be agreed with the competent authority ofthe Member State.
10. The following may be adopted in accordance with the procedure
laid down in Article 14:
(a) detailed rules concerning the requirements indicated in paragraph 5
and the measures listed in paragraph 6;
(b) implementation measures concerning the provisions of paragraph 9.
▼
M10
11. As from 1 January 1998 and without prejudice to the provisionsof paragraphs 5 and 6, approved inspection bodies must satisfy therequirements laid down in the conditions of standard EN 45011 of 26June 1989.
▼
B
Indication that products are covered by the inspection scheme
Article 10
▼M10
1. The indication and/or the logo shown in Annex V indicating thatproducts are covered by the specific inspection scheme, may appear onthe labeling of products as referred to in Article 1 only where suchproducts:
(a) satisfy the requirements of Article 5 (1) or (3);
(b) have been subject to the inspection arrangements referred to in
Article 9 throughout the production and preparation process;
(c) are sold directly by the producer or preparer to the ultimate
consumer in sealed packaging, or placed on the market as prepack-aged foodstuffs; in the case of direct sales by the producer orpreparer to the ultimate consumer, the sealed packaging is not
1991R2092 — EN — 15.03.1996 — 001.001 — 13
▼M10
required when the labelling enabled the product requiring this indi-cation to be identified clearly and unambiguously;
(d) show on the labelling the name and/or business name of the
producer, preparer or vendor together with the name or codenumber of the inspection authority or body, and any indicationrequired in accordance with the provisions of the regulations on thelabelling of foodstuffs, in accordance with Community legislation.
▼
B
2. No claim may be made on the label or advertising material thatsuggests to the purchaser that the indication shown in Annex V consti-tutes a guarantee of superior organoleptic, nutritional or salubriousquality.
3. The inspection authority and inspection bodies referred to in
Article 9 (1) must:
(a) ensure that, where an irregularity is found under ►
M10 Articles 5
and 6◄or the measures referred to in Annex III, the indication
shown in Annex V is removed from the entire lot or production runaffected by the irregularity concerned;
(b) where a manifestinfringement , or an infringementwit h prolonged
effects, is found, withdraw from the operator concerned the right touse the indication shown in Annex V for a period to be agreed withthe competent authority of the Member State.
4. Rules on withdrawal of the indication shown in Annex V where
certain infringements of Articles 5, 6 and 7 or of the requirements andmeasures in Annex III are detected may be adopted in accordance withthe procedure laid down in Article 14.
▼
M10
General enforcement measures
Article 10 a
1. Where a Member State finds irregularities or infringements
relating to the application of this Regulation in a product coming fromanother Member State and bearing indications as referred to in Article 2and/or Annex V, it shall inform the Member State which designated theinspection authority or approved the inspection body and the Commis-sion thereby.
2. Member States shall take whatever measures and action are
required to prevent fraudulent use of the indications referred to inArticle 2 and/or Annex V.
▼
B
Imports from third countries
Article 11
1. Without prejudice to Article 5, products as specified in Article 1
which are imported from a third country may be marketed only where:
(a) they originate in a third country appearing in a list to be drawn up
by a Commission decision in accordance with the procedure laiddown in Article 14 and were produced in a region or a productionunit and under the inspection of an inspection body specified, whereappropriate, in the decision concerning the third country in ques-tion;
(b) the competent authority or body in the third country has issued a
certificate of inspection stating that the lot designated in the certifi-cate:
— was obtained within a system of production applying rules
equivalent to those laid down in ►
M10 Article 6 ◄, and
— was subject to a system of inspection recognized as equivalent
in accordance with paragraph 2 (b).
1991R2092 — EN — 15.03.1996 — 001.001 — 14
▼B
2. For the purpose of deciding whether, for certain products as
specified in Article 1, a third country may at its request be included inthe list referred to in paragraph 1 (a), the following shall be taken intoaccountin part icular:
(a) the guarantees which the third country can offer, at least in respect
of production for export to the Community, as regards the applica-tion of rules equivalent to those laid down in ►
M10 Article 6 ◄;
(b) the effectiveness of the inspection measures applied, which, at least
in respect of production for export to the Community, must beequivalent to the inspection measures referred to in Articles 8 and 9to ensure compliance with the rules referred to in (a).
On the basis of this information, the regions or production units of
origin, or the bodies whose inspections are deemed to be equivalent,may be specified in the Commission decision.
3. The certificate referred to in paragraph 1 (b) must:
(a) accompany the goods, in the original copy, to the premises of the
first consignee; thereafter the importer must keep the certificate atthe disposal of the ►
M10 inspection body and/or inspection
authority ◄for not less than two years;
(b) be drawn up in accordance with procedures and a model to be
adopted in accordance with the procedure laid down in Article 14.
4. Detailed rules for the implementation of this Article may be
determined according to the procedure referred to in Article 14.
5. When examining a request from a third country, the Commission
shall require it to supply all the necessary information; it may alsoentrust experts with the task of carrying out, under its authority, anon-the-spot examination of the rules of production and inspection meas-ures actually applied in the third country in question.
▼
M2
6. (a) By way of derogation from paragraph 1, the importer(s) in a
Member State shall be authorized by the competent authority ofthe Member State to market until ►
M10 31 December
2002◄, products imported from a third country not included in
the list referred to in paragraph 1 (a) provided the importer(s)furnish(es) the competent authority of the importing MemberState with sufficient evidence that the imported products weremanufactured according to production rules equivalent to thoselaid down in ►
M10 Article 6 ◄and were subject to inspection
measures of equivalent effectiveness to those referred to inArticles 8 and 9, and that such inspection measures will bepermanently and effectively applied.
Such authorization shall be valid only as long as the abovemen-
tioned conditions are shown to be satisfied. ►
M10 Itshall
expire from the time of the decision to include a third country inthe list referred to in paragraph 1 (a), unless it concerns aproductwhich was produced in a region notspecified in t hedecision referred to in paragraph 1 (a), and which was notexamined in the framework of the request submitted by the thirdcountry, and only where that third country has agreed to thecontinuation of the authorization arrangements provided for inthis paragraph. ◄
(b) Where a Member State has received sufficient evidence from an
importer, it shall forthwith notify to the Commission and theother Member States the third country from which products areimported and supply detailed information on the production andinspection arrangements and the guarantees that they will bepermanently and effectively applied.
(c) At the request of a Member State or at the Commission’s initia-
tive, the matter shall be submitted to the Committee referred toin Article 14 for examination. Should it emerge from this exam-ination that the imported products were not manufacturedaccording to equivalent production rules and/or inspection meas-ures of equivalent effectiveness, the Commission shall requestthe Member State which granted the authorization to withdraw
1991R2092 — EN — 15.03.1996 — 001.001 — 15
▼M2
it. It may be decided, in accordance with the procedure laiddown in Article 14, that the imports in question shall be prohib-ited or that their continuation shall be subject to certain of theimport conditions being amended within a given period.
(d) The notification referred to in (b) shall not be required where it
concerns production and inspection arrangements already noti-fied by another Member State, pursuant to (b), unless significantnew evidence is submitted justifying a review of the examinationand decision referred to in (c).
Before 31 July 1994, the Commission shall re-examine the
provisions of paragraph 1 and submitany appropriat e proposalfor its review.
▼
M10
7. The Commission may, in accordance with the procedure laiddown in Article 14 at the request of a Member State, approve a thirdcountry’s inspection body which has previously been assessed by theMember State concerned and add it to the list referred to in paragraph 1(a). The Commission shall forward the request to the third countryconcerned.
▼
B
Free movement within the Community
Article 12
Member States may not, on grounds relating to the method of produc-
tion, to labelling or to the presentation of that method, prohibit orrestrict the marketing of products as specified in Article 1 that meet therequirements of this Regulation.
Administrative provisions and implementation
Article 13
The following may be adopted in accordance with the procedure laid
down in Article 14:
▼
M10
— detailed rules for applying this Regulation;
▼B
— amendments to Annexes I, II, III, IV and VI,
▼M10
— amendments to Annex V in order to define a Community logo to
accompany or replace the indication that products are covered bythe inspection scheme.
▼
B
Article 14
The Commission shall be assisted by a committee composed of repre-
sentatives of the Member States and chaired by the representative of theCommission.
Where the procedure laid down in this Article is to be followed, the
representative of the Commission shall submit to the committee a draftof 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 the urgency of thematter. The opinion shall be delivered by the majority laid down inArticle 148 (2) of the Treaty. The votes of the representatives of theMember States within the committee shall be weighed in the manner setoutin t hatArt icle. The chairman shall notvot e.
The Commission shall adopt the measure envisaged if they are in
accordance with the opinion of the committee.
1991R2092 — EN — 15.03.1996 — 001.001 — 16
▼B
If the measures envisaged are not in accordance with the opinion of thecommittee, or if no opinion is delivered, the Commission shall, withoutdelay, submit to the Council a proposal relating to the measures to betaken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral to
it the Council has not acted, the proposed measures shall be adopted bythe Commission.
Article 15
Before 1 July each year, Member States shall inform the Commission of
measures taken in the preceding year for the implementation of thisRegulation and shall communicate in particular:
— a list of the operators who, on 31 December of the previous year,
had given notification under Article 8 (1) (a) and are subject to theinspection system referred to in Article 9,
— a report on supervision pursuant to Article 9 (6).
In addition, by 31 March each year, Member States shall inform the
Commission of the list of inspection bodies approved on 31 Decemberof the previous year, their legal and operational structure, their standardinspection procedure, their penalty arrangements and, where appro-priate, their mark.
The Commission shall each year publish, in the ‘C' series of the Official
Journal of the European Communities , the lists of approved bodies
notified to it within the deadlines laid down in the foregoing subpara-graph.
Article 16
1. This Regulation shall enter into force on the day of its publication
in theOfficial Journal of the European Communities .
2. Within nine months of the entry into force of this Regulation,
Member States shall implement Articles 8 and 9.
▼
M2
3. Article 5, Article 8 (1) and Article 11 (1) shall apply from 1January 1993.
▼
B
In accordance with the procedure laid down in Article 14, the date ofapplication of Article 11 (1) may be deferred for a specified period forimports from a third country where, following a request by the thirdcountry, the stage reached in examining the matter does not permit adecision regarding the inclusion of the country concerned in the listprovided for in Article 11 (1) (a) before expiry of the period referred toin the first subparagraph.
For the purposes of complying with the conversion period referred to in
paragraph 1 of Annex I, the period which has elapsed before the entryinto force of this Regulation shall be taken into account where theoperator can demonstrate to the satisfaction of the inspection body thatduring that period he was producing in accordance with the nationalprovisions in force or, failing that, with the recognized internationalstandards for organic production.
4. For 12 months following the entry into force of this Regulation,
Member States may, by way of derogation from Article 6 (1), authorizethe use in their territory of products containing substances not listed inAnnex II, where they consider that the requirements of Article 7 (1) aresatisfied.
1991R2092 — EN — 15.03.1996 — 001.001 — 17
▼B
5. For a period expiring 12 months after the establishment of AnnexVI in accordance with Article 5 (7), Member States may continue toauthorize, in accordance with their national provisions, the use ofsubstances not listed in the said Annex VI.
6. Each Member State shall inform the other Member States and the
Commission of substances authorized pursuant to paragraphs 4 and 5.
This Regulation shall be binding in its entirety and directly applicable in
all Member States.
1991R2092 — EN — 15.03.1996 — 001.001 — 18
▼B
ANNEX I
PRINCIPLES OF ORGANIC PRODUCTION AT FARM LEVEL
Plants and plant products
1. The principles setoutin t his Annex mustnormally have been applied on t he
parcels during a conversion period of atleastt wo years before sowing or, inthe case of perennial crops other than grassland, at least three years before thefirst harvest of products as referred to in Article 1 (1) (a). The inspection bodymay, with the approval of the competent authority, decide, in certain cases, toextend or reduce that period, having regard to previous parcel use.
▼
M9
In particular, the conversion period may be reduced to the strict minimum bya Member State in situations where the parcels have been treated with aproductnotincluded in Annex II, partB as partof a pestor disease cont rolscheme made mandatory by the competent authority of the Member State onits territory or on certain parts of its territory in respect of a specific crop.
The reduction in the conversion period must take account of all the following
points:
— the parcels were already converted or were undergoing conversion to
organic farming,
— the degradation of the plant protection product concerned must result in
an insignificant level of residue in the soil and, where the latter is aperennial crop, in the crop,
— the Member State concerned must notify the other Member States of its
decision concerning the obligation of treatment and also the level of thereduction decided for the conversion period,
— products of the harvest following treatment may not be sold bearing an
indication referring to organic production.
▼
B
2. The fertility and the biological activity of the soil must be maintained or
increased, where appropriate, by:
(a) cultivation of legumes, green manures or deep-rooting plants in an appro-
priate multiannual rotation programme;
(b) incorporation in the soil of organic material, composted or not, from
holdings producing according to the rules of this Regulation. Pending theadoption of common technical rules concerning organic livestock produc-tion, by-products from livestock farming, such as farmyard manure, maybe used if they come from livestock holdings respecting existing nationalrules or, in the absence thereof, internationally recognized practicesconcerning organic livestock production.
Other organic or mineral fertilizers, mentioned in Annex II, may be applied
only to the extent that adequate nutrition of the crop being rotated or soilconditioning are not possible by the methods set out under (a) and (b) of thepreceding subparagraph.
For compost activation, appropriate micro-organism or plant-based prepara-
tions►
M4 ◄may be used.
▼M4
So-called ‘biodynamic preparations' from stone meal, farmyard manure or plantsmay also be used for the purposes covered by this paragraph.
▼
B
3. Pests, diseases and weeds shall be controlled by a combination of the
following measures:
— choice of appropriate species and varieties,
— appropriate rotation programme,— mechanical cultivation procedures,— protection of natural enemies of pests through provisions favourable to
them (e.g. hedges, nesting sites, release of predators),
— flame weeding.
Only in cases of immediate threat to the crop may recourse be had to products
referred to in Annex II.
▼
M4
4. The collection of edible plants and parts thereof, growing naturally in natural
areas, forests and agricultural areas, is considered an organic productionmethod provided that:
— those areas have received no treatments with products other than those
referred to in Annex II for a period of three years before the collection;
1991R2092 — EN — 15.03.1996 — 001.001 — 19
▼M4
— the collection does not affect the stability of the natural habitat or the
maintenance of the species in the collection area.
▼M1
Animals and animal productsPending the adoption of the proposal referred to in Article 1 (2), and for the
purpose of preparation of ingredients referred to in Article 5 (3) (a), animals shallbe raised in accordance with the existing national rules, or in the absence thereof,internationally recognized practices concerning organic livestock production.
1991R2092 — EN — 15.03.1996 — 001.001 — 20
NameDescription, compositional requirements, conditions for
use▼M7
ANNEX II
Part A
Products authorized exceptionally for use in soil conditioning and fertilization, in accordance
with the dispositions of Annex I (2)
Compound products or products containing only
materials listed hereunder:
— Farmyard manure Productcomprising a mixt ure of animal excre-
ments and vegetable matter (animal bedding)
Need recognized by the inspection body or
inspection authority
Indication of animal speciesComing from extensive husbandry and only in
the sense of ►
C1Article 6 (5) ◄of Council
Regulation (EEC) No 2328/91 (1), as last
amended by Regulation (EC) No 3669/93 (2)
— Dried farmyard manure and dehydrated
poultry manureNeed recognized by the inspection body or
inspection authority
Indication of animal speciesComing from extensive husbandry and only in
the sense of ►
C1Article 6 (5) ◄of Regulation
(EEC) No 2328/91
— Composted animal excrements, including
poultry manure and composted farmyardmanure includedNeed recognized by the inspection body or
inspection authority
Indication of the animal speciesFactory farming origin forbidden
— Liquid animal excrements (slurry, urine, etc.) Use after controlled fermentation and/or appro-
priate dilution
Need recognized by the inspection body or
inspection authority
Indication of animal speciesFactory farming origin forbidden
— Peat Use limited to horticulture (market gardening,
floriculture, arboriculture, nursery)
— Mushroom culture wastes The initial composition of the substrate must be
limited to products of the present list
— Dejecta of worms (vermicompost) and insects
— Guano Need recognized by the inspection body or
inspection authority
— Composted mixture of vegetable matter Need recognized by the inspection body or
inspection authority
— Products or by-products of animal origin as
below:
— blood meal
— hoof meal— horn meal— bone meal or degelatinized bone meal— animal charcoal— fish meal— meatmeal— feather, hair and ‘chiquette' meal— wool— fur— hair— dairy productsNeed recognized by the inspection body or
inspection authority
1991R2092 — EN — 15.03.1996 — 001.001 — 21
▼M7
NameDescription, compositional requirements, conditions for
use
— Products and by-products of plant origin for
fertilizers
(for instance, oilseed cake meal, cocoa husks,
maltculms, et c.)
— Seaweeds and seaweed products Only as far as obtained by:
(i) physical processes including dehydratation,
freezing and grinding;
(ii) extraction with water or aqueous acid and/or
alkaline solution
(iii) fermentation
— Sawdust and wood chips Wood not chemically treated after felling
— Composted bark Wood not chemically treated after felling
— Wood ash From wood not chemically treated after felling
— Soft ground rock phosphate Product as specified by Council Directive 76/
116/EEC (3), as lastamended by Direct ive 89/
284/EEC (4)
Cadmium content less than or equal to 90 mg/kg
of P205
— Aluminium calcium phosphate Product as specified by Directive 76/116/EEC, as
lastamended by Direct ive►
C189/284/EEC ◄;
Cadmium content less than or equal to 90 mg/kg
of P205
Use limited to basic soils (pH >7,5)
— Basic slag Need recognized by the inspection body or
inspection authority
— Crude potassium salt
(for instance: kainit, sylvinite, etc.)Need recognized by the inspection body or
inspection authority
— Potassium sulphate containing magnesium
saltNeed recognized by the inspection body or
inspection authority
Derived from crude potassium salt
— Stillage and stillage extract Ammonium stillage excluded
— Calcium carbonate of natural origin
(for instance: chalk, marl, ground limestone,
Breton ameliorant, (maërl), phosphate chalk)
— Magnesium and calcium carbonate of natural
origin
(for instance: magnesian chalk, ground mage-
sium limestone, etc.)Only of natural origin
Need recognized by the inspection body or
inspection authority
— Magnesium sulfate (for instance: kieserite)
— Calcium chloride solution Foliar treatment of apple trees, after identification
of deficitof calcium
Need recognized by the inspection body or
inspection authority
— Calcium sulphate (gypsum) Product as specified by Directive 76/116/EEC,
as amended by Directive 89/284/EEC
Only of natural origin
— Elemental sulphur Product as specified by Directive 76/446/EEC, as
amended by Directive 89/284/EEC
Need recognized by the inspection body or
inspection authority
— Trace elements Trace elements included in Directive 89/
530/EEC (5)
Need recognized by the inspection body or
inspection authority
— Sodium chloride Only mined salt
Need recognized by the inspection body or
inspection authority
1991R2092 — EN — 15.03.1996 — 001.001 — 22
▼M7
NameDescription, compositional requirements, conditions for
use
NameDescription; compositional requirements; conditions for
use— Stone meal
(1) OJ No L 218, 6. 8. 1991, p. 1.
(2) OJ No L 338, 31. 12. 1993, p. 26.
(3) OJ No L 24, 30. 1. 1976, p. 21.
(4) OJ No L 111, 22. 4. 1989, p. 34.
(5) OJ No L 281, 30. 9. 1989, p. 116.
▼B
B.PRODUCTS FOR PLANT PEST AND DISEASE CONTROL
Preparations on basis of pyrethrins extracted from
Chrysanthemum cinerariaefolium, containingpossibly a synergist
Preparations from Derris elliptica,
Preparations from Quassia amara
Preparations from Ryania speciosa
Propolis
Diatomaceous earth
Stone meal
Preparations on basis of metaldehyde containing a
repellentt o higher animal species and as far asapplied within traps
Sulphur
Bordeaux mixture
Burgundy mixture
Sodium silicate
Sodium bicarbonate
Potassium soap (soft soap)
Pheromone preparations
Bacillus thuringiensis preparations
Granulose virus preparations
Plantand animal oils
Paraffin oil
C.OTHER PRODUCTS
1991R2092 — EN — 15.03.1996 — 001.001 — 23
▼B
ANNEX III
MINIMUM INSPECTION REQUIREMENTS AND PRECAUTIONARY
MEASURES UNDER THE INSPECTION SCHEME REFERRED TO IN
ARTICLE 8 AND 9
▼M4
A.Plants and plant products from farm production or collection
▼B
1. Production must take place in a unit the land parcels and production and
storage locations of which are clearly separate from those of any other unitnot producing in accordance with the rules laid down in this Regulation;processing and/or packaging workshops may form part of the unit, where itsactivity is limited to processing and packaging of its own agriculturalproduce.
▼
M4
2. When the inspection arrangements are first implemented, the producer, even
where his activity is limited to the collection of wild plants, and theinspection body must draw up:
— a full description of the unit, showing the storage and production prem-
ises and land parcels and/or collection areas and, where applicable,premises where certain processing and/or packaging operations takeplace,
— all the practical measures to be taken by the producer at unit-level to
ensure compliance with the provisions of this Regulation,
— and, in case of collection of wild plants, the guarantees given by third
parties, if appropriate where relevant which the producer can provide toensure that the provisions of Annex I, point 4 are satisfied.
The description and the measures concerned must be contained in an inspec-
tion report countersigned by the producer concerned.
In addition, the report must 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),
— an undertaking by the producer to carry out operations in accordance
with Articles 5 and 6 and to accept, in the event of infringement,enforcement of the measures referred to in Article 9 (9) and, whererelevant, in Article 10 (3).
▼
B
3. Each year, before the date indicated by the inspection body, the producer
must notify the body of its schedule of production of crop products, giving abreakdown by parcel.
4. Written and/or documentary accounts must be kept which enable the inspec-
tion body to trace the origin, nature and quantities of all raw materialsbought, and the use of such materials; in addition, written or documentaryaccounts must be kept of the nature, quantities and consignees of allagricultural products sold. Quantities sold directly to the final consumershall be accounted on a daily basis.
▼
M1
Where the unit itself processes its own agricultural produce, the accountsmust contain the information as referred to in point B, 2, third hyphen ofthis Annex.
▼
B
5. Storage, in the unit, of input products other than those the use of which is
compatible with Articles 6 (1) (b) and 7 is prohibited.
6. Apart from unannounced inspection visits, the inspection body must make a
full physical inspection, at least once a year, of the unit. Samples for testingof products not authorized under this Regulation may be taken. However,such samples must be taken where the use of unauthorized products issuspected. An inspection report must be drawn up after each visit, counter-signed by the responsible person of the unit.
7. The producer must give the inspection body, for inspection purposes, access
to the storage and production premises and to the parcels of land, as well asto the accounts and relevant supporting documents. He must provide theinspection body with any information deemed necessary for the purposes ofthe inspection.
1991R2092 — EN — 15.03.1996 — 001.001 — 24
▼M4
8.1. Products as referred to in Article 1 may be transported to other units,
including wholesalers and retailers, only in appropriate packaging orcontainers closed in a manner preventing substitution of the content andprovided with a label stating, without prejudice to any other indicationsrequired by law:
(a) the name and address of the person responsible for the production or
preparation of the product, or, where another seller is mentioned, astatement which enables the receiving unit and the inspection body toidentify unequivocally the person responsible for the production of theproduct;
(b) the name of the product, including a reference to the organic production
method, in accordance with Article 5.
8.2. However, the closing of packaging or containers is not required where:
(a) transportation is between a producer and another operator who are both
subject to the inspection system referred to in Article 9, and
(b) the products are accompanied by a document giving the information
required under the previous subparagraph.
▼
M9
9. Where an operator runs several production units in the same area, producing
crops or crop products not covered by Article 1, together with storagepremises for input products (such as fertilizers, plant protection products,seed) must also be subject to the inspection arrangements as regards the firstsubparagraph of point 2 and points 3 and 4. Crops of the same variety asthose produced at the unit referred to in point 1 may not be produced atthese units.
However, producers may derogate from the rule referred to in the last
sentence of the preceding subparagraph:
(a) in the case of the production of perennial crop products (fruit growing,
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 providesfor the beginning of the conversion of the last part of the areaconcerned to organic production in the shortest possible periodwhich may notin any eventexceed a maximum of five years,
2. appropriate measures have been taken to ensure the permanent sepa-
ration of the products obtained from each unit concerned,
3. the inspection body or authority is notified of the harvest of each of
the products concerned at least 48 hours in advance,
4. immediately upon completion of the harvest, the producer informs
the inspection body or authority of the exact quantities harvested onthe units concerned together with any particular distinguishingfeatures (such as quality, colour, average weight, etc.) and confirmsthat the measures taken to separate the products have been applied,
5. the conversion plan and the measures referred to in points 1 and 2
have been approved by the inspection body or authority. Thisapproval must be confirmed each year after the start of the conver-sion plan;
(b) in the case of areas intended for agricultural research agreed by the
Member States’ competent authorities, provided that conditions 2, 3 and4 and the relevant part of condition 5 referred to in (a) are met;
(c) in the case of production of seed, vegetative propagating material and
transplants, provided that conditions 2, 3 and 4 and the relevant part ofcondition 5 referred to in (a) are met.
▼
B
B.Processing and packaging units for plant products and foodstuffs
composed essentially of plant products
1. When the inspection arrangements are first implemented, the producer and
inspection body must draw up:
— a full description of the unit, showing the facilities used for the
processing, packaging and storage of agricultural products before andafter the operations concerning them,
— all the practical measures to be taken at the level of the unit to ensure
compliance with this Regulation.
This description and the measures concerned must be contained in an
inspection report, countersigned by the responsible person of the unit.
1991R2092 — EN — 15.03.1996 — 001.001 — 25
▼M4
In addition, the report must include an undertaking by the operator toperform the operations in such a way as to comply with Article 5 and toaccept, in the event of infringement, the enforcement of the measuresreferred to in Article 9 (9) and, where relevant, in Article 10 (3).
▼
B
2. Written accounts must be kept enabling the inspection body to trace:
— the origin, nature and quantities of agricultural products as referred to in
Artricle 1 which have been delivered to the unit,
— the nature, quantities and consignees of products as referred to in Article
1 which have left the unit,
— any other information, such as the origin, nature and quantities of
ingredients, additives and manufacturing aids delivered to the unit andthe composition of processed products, that is required by the inspectionbody for the purposes of proper inspection of the operations.
3. Where products not referred to in Article 1 are also processed, packaged or
stored in the unit concerned:
— the unit must have separate areas within the premises for the storage of
products as referred to in Article 1, before and after the operations,
— operations must be carried out continuously until the complete run has
been dealt with, separated by place or time from similar operationsperformed on products not covered by Article 1,
— if such operations are not carried out frequently, they must be
announced in advance, with a deadline agreed on with the inspectionbody,
— every measure must be taken to ensure identification of lots and to avoid
mixtures with products not obtained in accordance with the rules laiddown in this Regulation.
4. Apart from unannounced inspection visits, the inspection body must make a
full physcal inspection, at least once a year, of the unit. Samples for testingof products not authorized under this Regulation may be taken. However,they must be taken where the use of unauthorized products is suspected. Aninspection report must be drawn up after each visit countersigned by theperson responsible for the unit inspected.
5. The operator must give the inspection body, for inspection purposes, access
to the unit and to the written accounts and relevant supporting documents.He must provide the inspection body with any information necessary for thepurposes of the inspection.
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6. Products as referred to in Article 1 may be transported to other units,
including wholesalers and retailers, only in appropriate packaging orcontainers closed in a manner preventing substitution of the content andprovided with a label stating, without prejudice to any other indicationsrequired by law:
(a) the name and address of the person responsible for the production or
preparation of the product, or, where another seller is mentioned, astatement which enables the receiving unit and the inspection body toidentify unequivocally the person responsible for the preparation of theproduct;
(b) the name of the product, including a reference to the organic production
method according to the relevant provisions of Article 5.
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 thepresence of the indications referred to in the previous paragraph, in point A.8. 1 or in point C. 8. The result of this verification shall be explicitlymentioned in the accounts referred to in point B. 2. Where the check leavesany doubt that the product concerned came from an operator subject to theinspection system provided for in Article 9, it may only be put intoprocessing or packaging after elimination of that doubt, unless it is placedon the market without indication referring to the organic production method.
C.Importers of plant products and foodstuffs composed essentially of
plant products from third countries
1. When the inspection arrangements are first implemented, the importer and
inspection body must draw up:
— a full description of the importer’s premises and of his import activities,
indicating as far as possible the points of entry of the products into theCommunity and any other facilities the importer intends to use for thestorage of the imported products;
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— all the practical measures to be taken by the importer to ensure compli-
ance with this Regulation.
This description and the measures concerned must be contained in an inspection
report, countersigned by the importer.
In addition, the report must include an undertaking by the importer:
— to perform the import operations in such a way as to comply with the
provisions of Article 11 and to accept, in the event of infringement, theenforcement of the measures referred to in Article 9 (9);
— to ensure that any storage facilities that the importer will use are open to
inspection, to be carried out either by the inspection body or, when thesestorage facilities are situated in another Member State or region, by aninspection body approved for inspection in that Member State or region.
2. Written accounts must be kept enabling the inspection body to trace for
each lot of products referred to in Article 1, imported from a third country:
— the origin, nature and quantity of the lot concerned, and on request by
the inspection body, any details on the transport arrangements from theexporter in the third country to the importer’s premises or storagefacilities;
— the nature, quantities and consignees of the lot concerned, and on
request by the inspection body, and details on the transport arrange-ments from the importer’s premises or storage facilities to theconsignees.
3. The importer shall inform the inspection body of each imported consign-
ment into the Community, giving any details this body or authority mayrequire, such as a copy of the inspection certificate for the importation oforganic products. When the products concerned are circulating in a MemberState or region other than the one where the inspection body is approved forinspection, that body may pass the information to a body, approved forinspection in that Member State or region, for on-the-spot inspection of theimported consignment.
4. Where imported products referred to in Article 1 are stored in storage
facilities where also other agricultural products or foodstuffs are processed,packaged or stored:
— 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 lots and to avoid
mixtures with products not obtained in accordance with the rules laiddown in this Regulation.
5. Apart from unannounced inspection visits, the inspection body must make a
full physical inspection, at least once a year, of the importer’s premises and,where relevant, of a selection of the other storage facilities which theimporter uses.
The inspection body shall inspect the written accounts mentioned in point C.
2 and the certificates referred to in Article 11 (1) (b) and (3). Samples fortesting of substances not authorized under this Regulation may be taken.However, they must be taken where the use of unauthorized substances issuspected. An inspection report must be drawn up after each visit, counter-signed by the person responsible for the unit inspected.
6. The importer must, for inspection purposes, give the inspection body access
to his premises and to the written accounts and relevant supporting docu-ments, in particular any import certificates. He must provide the inspectionbody with any information necessary for the purposes of the inspection.
7. Products as referred to in Article 1 shall be imported from a third country in
appropriate packaging or containers, closed in a manner preventing substitu-tion of the content and provided with identification of the exporter and withany other marks and numbers serving to identify the lot with the inspectioncertificate.
On receipt of a product as referred to in Article 1, imported from a third
country, the operator shall check the closing of the packaging or containerand the correspondance of the identification of the lot with the certificatereferred to in Article 11 (1) (b) or a similar certificate where required by theauthorities under any arrangements adopted under Article 11 (6). The resultof this verification shall be explicitly mentioned in the accounts referred toin point C. 2. Where the check leaves any doubt as to the origin of theproduct from a third country or from an exporter in a third country notaccepted under Article 11, the product may be put on the market, or
1991R2092 — EN — 15.03.1996 — 001.001 — 27
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processed or packaged, only after such doubt has been dispelled, unless it is
placed on the market without indication of the organic production method.
8. Products referred to in Article 1 may be transported to other units, including
wholesalers and retailers, only in appropriate packaging or containers closedin a manner preventing substitution of the content and provided with a labelstating, without prejudice to any other indications required by law:
(a) the name and address of the importer of the product, or a statement
which enables the receiving unit and the inspection body to identifyunequivocally the importer of the product;
(b) the name of the product, including a reference to the organic production
method under Article 5.
1991R2092 — EN — 15.03.1996 — 001.001 — 28
▼B
ANNEX IV
INFORMATION TO BE NOTIFIED AS PROVIDED IN ARTICLE 8 (1)
(a)
(a) Name and address of operator;
(b) Location of premises and, where appropriate, parcels (land register data)
where operations are carried out;
(c) Nature of operations and products;
(d) Undertaking by the operator to carry out the operations in accordance with
Articles 5, 6, 7 and/or 11;
(e) In the case of an agricultural holding, the date on which the producer ceased
to apply products the use of which is not compatible with Articles 6 (1) (6)and 7 on the parcels concerned;
(f) The name of the approved body to which the operator entrusted inspection of
his undertaking, where the Member State has implemented the inspectionsystem by approving such bodies.
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▼B
ANNEX V
INDICATION THAT PRODUCTS ARE COVERED BY THE INSPEC-
TION SCHEME
The indication that a product is covered by the inspection scheme must be shown
in the same language or languages as used for the labelling.
ES: Agricultura Biológica — Sistema de control CEE
DK: Økologisk Landbrug — EF Kontrolordning
▼A1
D: Ökologische Agrarwirtschaft — EWG-Kontrollsystem, or Biologische
Landwirtschaft — EWG-Kontrollsystem
▼B
GR: Βιολογική Γεωργία —Σύστηµα Ελέγχου ΕΟΚ
EN: Organic Farming — EEC Control SystemF: Agriculture biologique — Système de contrôle CEEI: Agricoltura Biologica — Regime di controllo CEENL: Biologische landbouw — EEG-controlesysteemP: Agricultura Biológica — Sistema de Controlo CEE
▼
A1
FI: Luonnonmukainen maataloustuotanto — ETY: n valvontajärjestelmä —
Ekologiskt jordbruk — EEG-kontrollsystem
S: Ekologiskt jordbruk — EEG-kontrollsystem
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ANNEX VI
INTRODUCTION
For the purposes of this Annex, the following definitions will apply:
1. ingredients: substances as defined in Article 4 of this Regulation under the
restrictions as referred to in Article 6 (4) of Council Directive 79/112/EEC of18 December 1978 on the approximation of the laws of the Member Statesrelating to the labelling, presentation and advertising of foodstuffs for sale tothe ultimate consumer (
1);
2. ingredients of agricultural origin:
(a) single agricultural products and products derived therefrom by appro-
priate washing, cleaning, thermic and/or mechanical processes and/or byphysical processes having the effect of reducing the moisture content ofthe product;
(b) also, products derived from the products mentioned under (a) by other
processes used in food processing, unless these products are consideredfood additives or flavourings as defined under points 5 or 7 hereunder;
3. ingredients of non-agricultural origin: ingredients other than ingredients of
agricultural origin and belonging to at least one of the following categories:
3.1. food additives, including carriers for food additives, as defined under
points 5 and 6 hereunder;
3.2. flavourings, as defined under point7 hereunder;3.3. water and salt;3.4. micro-organism preparations;3.5. minerals (including trace elements) and vitamins;
4. processing aids: substances as defined in Article 1 (3) (a) of Council
Directive 89/107/EEC (
2) on the approximation of the laws of the Member
States concerning food additives authorized for use in foodstuffs intended forhuman consumption;
5. food additives: substances as defined in Article 1 (1) and (2) of Directive
89/107/EEC and covered by that Directive or by a comprenhensive Directiveas referred to in Article 3 (1) of Directive 89/107/EEC;
6. carriers, including carrier solvents: food additives used to dissolve, dilute,
disperse or otherwise physically modify a food additive without altering itstechnological function in order to facilitate its handling, application or use;
7. flavouring: substances and products as defined in Article 1 (2) of Council
Directive 88/388/EEC of 22 June 1988 on the approximation of the laws ofthe Member States relating to flavourings for use in foodstuffs and to sourcematerials for their production (
3), and covered by that Directive.
GENERAL PRINCIPLES
Sections A, B and C cover the ingredients and processing aids which may be
used in the preparation of foodstuffs composed essentially of one or moreingredients of plant origin, referred to in Article 1 (1) (b) of this Regulation, withthe exception of wines.
Notwithstanding reference to any ingredient in Sections A and C or any
processing aid in Section B, any ingredient or such processing aid shall be usedonly in accordance with relevant Community legislation and/or national legisla-tion compatible with the Treaty and, in the absence thereof, in accordance withthe principles of good manufacturing practice for foodstuffs. In particular, addi-
(1) OJ No L 33, 8. 2. 1979, p. 1
(2) OJ No L 40, 11. 2. 1989, p 27.
(3) OJ No L 184, 15. 7. 1988, p 61.
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Name Specific conditions (5)tives shall be used according to the provisions of Directive 89/107/EEC and,
where relevant, those of any comprehensive Directive as referred to in Article 3(1) of Directive 89/107/EEC; flavourings shall be used according to the provi-sions of Directive 88/388/EEC and solvents according to the provisions ofCouncil Directive 88/344/EEC of 13 June 1988 on the approximation of the lawsof the Member States on extraction solvents used in the production of foodstuffsand food ingredients (
1).
SECTION A — INGREDIENTS OF NON-AGRICULTURAL ORIGIN
(REFERRED TO IN ARTICLE 5 (3) (B) OF REGULA-TION (EEC) No 2092/91):
A.1. Food additives, including carriers
E 170 Calciumcarbonates —
E 270 Lactic acid —E 290 Carbondioxyde —E 296 Malic acid —E 300 Ascorbic acid —
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E 306 Tocopherol-rich extract anti-oxydant in fats and oils
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E 322 Lecithins —
E 330 Citric acid —
▼M5
E 333 Calcium citrates —
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E 334 Tartaric acid (L (+) −) —
E 335 Sodium tartrate —E 336 Potassium tartrate —
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E 341 (i) Monocalciumphosphate raising agent for self raising flour
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E 400 Alginic acid —
E 401 Sodium alginate —E 402 Potassium alginate —E 406 Agar —
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E 407 Carrageenan —
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E 410 Locustbeam gum —
E 412 Guar gum —E 413 Tragacanth gum —E 414 Arabic gum —E 415 Xanthan gum —E 416 Karaga gum —E 440 (i) Pectin —E 500 Sodiumcarbonates —E 501 Potassiumcarbonates —E 503 Ammoniumcarbonates —E 504 Magnesiumcarbonates —E 516 Calcium sulphate CR
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E 524 Sodiumhydroxyde surface treatment of Laugengebäck
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E 938 Argon —
(1) OJ No L 157, 24. 6. 1988, p 28.
1991R2092 — EN — 15.03.1996 — 001.001 — 32
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Name Specific conditions (5)
Name Specific conditionsE 941 Nitrogen —
E 948 Oxygen —
(5) CR-carrier.
A.2. Flavourings within the meaning of Directive 88/388/EEC
Substances and products as defined in Article 1 (2) (b) (i) and 1 (2) (c) of Directive
88/388/EEC labelled as natural flavouring substances or natural flavouring prepara-tions, according to Article 9 (1) (d) and (2) of that Directive.
A.3. Water and salt
Drinking waterSalt (with sodium chloride or potassium chloride as basic components), generally used
in food processing.
A.4.
Micro-organism preparations
(i) Any preparations of micro-organisms normally used in food processing, with the
exception of micro-organisms genetically modified within the meaning of Article2 (2) of Directive 90/220/EEC;
(ii) Micro-organisms genetically modified within the meaning of Article 2 (2) of
Directive 90/220/EEC: if they have been included according to the decisionprocedure of Article 14.
A.5. Minerals (including trace elements) and vitamins
Only authorized as far as their use is legally required in the foodstuffs in which they
are incorporated.
SECTION B — PROCESSING AIDS AND OTHER PRODUCTS WHICH MAY BE USED FOR
PROCESSING OF ORGANICALLY PRODUCED INGREDIENTS OF AGRICUL-TURAL ORIGIN, REFERRED TO IN ARTICLE 5 (3) (C) OF REGULATION(EEC) No 2092/91
Water
Calcium chloride coagulation agentCalcium carbonateCalcium hydroxideCalcium sulphate coagulation agentMagnesium chloride (or nigari) coagulation agentPotassium carbonate drying of grapes
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Sodium carbonate sugar production
Sodium hydroxyde sugar protection, olive treatmentSulphuric acid sugar production
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Carbon dioxide
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Name Specific conditions
Nitrogen
Ethanol solventTannic acid filtration aidEgg white albumenCaseinGelatinIsinglassVegetable oils ►
M5greasing, releasing or antifoaming
agent◄
Silicon dioxide gel or colloidal solutionActivated carbonTalcBentoniteKaolinDiatomaceous earthPerliteHazelnutshells
▼
M5
Rice meal —
▼M3
Beeswax releasing agent
Carnauba wax releasing agent
Preparations of micro-organisms and enzymes:
(i) Any preparations of micro-organisms and enzymes normally used as processing aids in food
processing, with the exception of micro-organisms genetically modified within the meaning ofArticle 2 (2) of Directive 90/220/EEC;
(ii) Micro-organisms genetically modified within the meaning of Article 2 (2) of Directive 90/
220/EEC:
If they have been included hereunder according to the decision procedure of Article 14.
SECTION C — INGREDIENTS OF AGRICULTURAL ORIGIN WHICH HAVE NOT BEEN
PRODUCED ORGANICALLY, REFERRED TO IN ARTICLE 5 (4) OF REGU-LATION (EEC) No 2092/91
C.1. Unprocessed vegetable products, as well as products derived therefrom by processes
referred to under definition 2 (a):
C.1.1. Edible fruits, nuts and seeds
Coconuts
Brazil nutsCashew nutsDatesPineapplesMangoesPapayasSloesCocoaMaracujas (Passion fruit)ColanutsPeanutsRosehipsSallowthornsBlueberries
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Maple syrup
QuinoaAmaranthHorseradish seed
▼
M5
▼M3
Pine kernelsRadish seeds
▼
M5
AcornsFenugreekAcerolaChicory
▼
M8
Dried banana powder ( Musa L.)
Gooseberries ( Ribes crispa L.)
Dried strawberry powder ( Fragaria L.)
Dried raspberries ( Ribus idaeus L.)
Dried red currants ( Ribes rubrum L.)
C.1.2. Edible spices and herbs
—
▼M11
Lesser galanga ( Alpinia officinarum )
Allspice (Pimenta dioica )
▼M3
C.1.3. Cereals
▼M5
▼M3
Wild rice (Zizania plauspra )
C.1.4. Oil seeds and oleaginous fruits
Sesamum seeds
C.1.5. Miscellaneous
Algae, including seaweed
C.2. Vegetable products, processed by processes as referred to under definition 2 (b):
C.2.1. Fat s and oils, whet her or notrefined, butnotchemically modified, derived from plant s
other than:
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olive
sunflower
C.2.2. Sugars; starch; other products from cereals and tubers
Cane and beetsugar
Starches produced from cereals and tubers, not chemically modifiedRice paperGluten
▼
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Fructose
▼M3
C.2.3. Miscellaneous
Lemon juice
▼M8
▼M3
C.3. Animal Products
Honey
Gelatin
▼M5
Buttermilk powder
▼M3
Edible aquatic organisms, not originating from aquaculture
▼M5
Lactose