THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission （1）,
Having regard to the opinion of the Europaen 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 agricultural 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 agricultural policy, this type of production may contribute towards the attainment of a better balance between supply of, and demand for, agricultural products, the protection of the environment and the conservation of the countryside;
Whereas, in response to the rising demand, agricultural products and foodstuffs are being placed on the market with indications stating or implying to purchasers that they have been produced organically or without the use of synthetic chemicals;
Whereas some Member States have already adopted rules and inspection 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 will ensure conditions of fair eompetition between the producers of products bearing such indications and give the market for organic products a more distinctive profile by ensuring transparency at all stages of production and processing, thereby improving the credibility of such products in the eyes of consumers;
Whereas organic production methods constitute a specific form of production at farm level; whereas, consequently, it should be provided that, on the labelling of processed products, indications referring to organic production methods should relate to the ingredients obtained by such methods;
Whereas, for the implementation of the arrangements concerned, provision should be made for flexible procedures whereby certain technical details or measures may be amended, amplified or further defined in order to take account of experience gained; whereas, within a suitable period, this Regulation will be supplemented by equivalent rules covering livestock production;
Whereas, in the interests of the producers and purchasers of products bearing indications referring to organic production methods, the minimum principles which must be complied with in order for products to 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 effects on the environment or result in the presence of residues in agricultural produce; whereas, in this context, practices accepted in the Community when this Regulation is adopted must be complied with in accordance with codes of practice followed in the Community when this Regulation is adopted; whereas, moreover, in the future, the principles governing the authorization of products which may be used in this type of farming must be established;
Whereas, moreover, organic farming involves varied cultivation practices and limited use of non-synthetic fertilizers and conditioners of low solubility; whereas these practices should be specified and conditions for the use of certain non-synthetic products laid down;
Whereas the procedures laid down make possible, if this appears necessary, the addition to Annex I of more specific provisions aimed at avoiding the presence of certain residues of synthetic chemicals from sources other than agriculture （environmental contamination） in the products 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 methods must be subject to a regular inspection system, meeting minimum Community requirements and carried out by designated inspection authorities and/or by approved and supervised bodies; whereas provision should be made for a Community indication of inspection to appear on 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 organic production methods:
（a） unprocessed agricultural crop products; also animals and unprocessed animal products, to the extent that principles of production and specific inspection rules for them are introduced into Annexes I and III;
（b） products intended for human consumption composed essentially of one or more ingredients of plant origin; in addition, upon adoption of the provisions concerning livestock production referred to in （a）, products intended for human consumption containing ingredients of animal origin.
2. A proposal concerning the principles and specific measures of control governing organic animal production, non-processed animal products and products intended for human consumption containing ingredients of animal origin shall be submitted by the Commission as soon as possible and before 1 July 1992.
Article 2
For the purposes of this Regulation a product shall be regarded as bearing indications referring to organic production methods where, in the labelling, advertising material or commercial documents, such a product or its ingredients is described by the indications in use in each Member State suggesting to the purchaser that the product or its ingredients have been obtained in accordance with the rules of production laid down in Articles 6 and 7 and in particular the following terms, unless such terms are not applied to agricultural products in foodstuffs or clearly have no connection with the method of production:
Article 3
This Regulation shall apply without prejudice to other Community provisions governing the production, preparation, marketing, labelling and 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 product specified in Article 1;
2. 'production' shall mean the operations involved in producing agricultural products in the state in which they are normally produced on the farm;
3. 'preparation' shall mean the operations of processing, preserving and packaging of agricultural products;
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 the subsequent marketing thereof, products as referred to in Article 1, or who markets such products;
6. 'ingredients' shall mean the substances, including additives, used in the preparation of the products specified in Article 1 （1） （b） that are still present, albeit in modified form, in the final product;
7. 'plant protection products' shall mean products as defined in Article 2 （1） of Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances （1）, as last amended 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 1973 on the approximation of the laws of the Member States relating to detergents （3）, as last amended by Directive 86/94/EEC （4）, which are intended to be used for cleaning certain products as referred to in Article 1 （1） （a）.
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 agricultural production;
（b） the product was produced in accordance with the rules laid down in Articles 6 and 7 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.
2. The labelling and advertising of a product specified in Article 1 （1） （b） may refer to organic production methods only where such indications show clearly that they relate to a method of agricultural production and are accompanied by a reference to the agricultural product in question, as obtained on the farm.
3. The labelling and advertising of a product specified in Article 1 （1） （b） may refer, in the sales description of the product, to organic production methods only where:
（a） all the ingredients of agricultural origin of the product are, or are derived from, products obtained in accordance with the rules laid down in Articles 6 and 7 or imported from third countries under the agreements laid down in Article 11;
（b） the product contains only substances listed in Annex VI, Section A, as ingredients of non-agricultural origin;
（c） the product or its ingredients have not been subjected, during preparation, to treatments involving the use of ionizing radiation or substances not listed in Annex VI, Section B;
（d） the product was prepared by an operator who is subject to the inspection measures laid down in Articles 8 and 9.
4. By way of derogation from paragraph 3 （a）, certain ingredients of agricultural origin not satisfying the requirement in that paragraph may be used, within the limit of a maximum level of 5 % of the ingredients of agricultural origin in the final product, in the preparation of products as referred to in Article 1 （1） （b）, providing that such ingredients: - are of agricultural origin and are not produced in the Community in accordance with the rules laid down in Articles 6 and 7, or - are of agricultural origin and are not produced in sufficient quantity in the Community in accordance with the rules laid down in Articles 6 and 7.
5. During a transitional period expiring on 1 July 1994, indications referring to conversion to organic production methods may be given on the labelling and in the advertising of a product referred to in Article 1 （1） （a） or （b） where it is composed of a single ingredient of agricultural origin, provided that:
（a） the requirements referred to in paragraph 1 or paragraph 3 respectively are fully complied with, with the exception of that concerning the length of the conversion period referred to in paragraph 1 of Annex I;
（b） a conversion period of at least 12 months before the harvest has been complied with;
（c） the indications concerned do not mislead the purchaser of the product regarding its difference from products which satisfy all the requirements of this Regulation;
（d） compliance with the condition laid down in （a） and （b） has been duly checked by the inspection body.
6. The labelling and advertising of a product as referred to in Article 1 （1） （b） prepared partly from ingredients not satisfying the requirements in paragraph 3 （a） may refer to organic production methods provided that:
（a） at least 50 % of the ingredients of agricultural origin satisfy the requirements in paragraph 3 （a）;
（b） the product satisfies the requirements in paragraph 3 （b）, （c） and （d）;
（c） the indications referring to organic production methods:
- appear only in the list of ingredients as provided for in Directive 79/112/EEC （1）, as last amended by Directive 89/395/EEC （2）,
- clearly refer to only those ingredients obtained according to the rules as referred to in Articles 6 and 7;
（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 idendical size and style of lettering.
7. Detailed rules concerning the implementation of this Article may be established according to the procedure laid down in Article 14.
8. Limitative lists of the substances and products referred to in paragraph 3 （b） and （c） and in the first and second indents of paragraph 4 shall be established in Annex VI according to the procedure laid down in Article 14.
Conditions of use and compositional requirements of these ingredients and 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, it shall ensure that a dossier giving the reasons for the inclusion or the amendments is sent officially to the other Member States and the Commission, which shall present it to the Committee referred to in Article 14.
9. Before 1 July 1993, the Commission shall review the provisions of this Article, in particular paragraphs 5 and 6, and submit any appropriate proposal with a view to revision, if any.
Rules of production
Article 6
1. The organic production method implies that for the production of products referred to in Article 1 （1） （a）:
（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, or soil conditioners; they may be used only under the specific conditions laid down in Annexes I and II and in so far as the corresponding use is authorized in general agriculture in the Member States concerned in accordance with the relevant Community provisions or national provisions in conformity with Community law.
2. By way of derogation from paragraph 1 （b）, seeds treated with products not included in Annex II and authorized in general agriculture in the Member State concerned may be used in so far as users of such seed can show to the satisfaction of the inspection body, that they were unable to obtain on the market non-treated seed of an appropriate variety of the species in question.
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 disease control:
- they are essential for the control of a harmful organism or a particular disease for which other biological, cultural, physical or 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 perennial crops, direct contact may take place, but only outside the growing season of the edible parts （fruits） provided that such application does not indirectly result in the presence of residues of 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 by the practices mentioned in Annex I, and - their use does not result in unacceptable effects on the environment or contribute to the contamination thereof.
2. If need be, the following may be specified for any product included in Annex II:
- the detailed description of the product,
- the conditions of its use and compositional and/or solubility requirements, with regard in particular to the need to insure for these products a minimal presence of residues on edible parts of the crop and on edible crop products as well as a minimum effect on the environment,
- particular labelling requirments for products referred to in Article 1 where such products are obtained with the aid of certain products referred to in Annex II.
3. Amendments to Annex II, concerning either inclusion or cancelling of products as referred to in paragraph 1 or inclusion or amendments of specifications as referred to in paragraph 2, shall be adopted by the Commission in accordance with the procedure laid down in Article 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 ensure that a dossier giving the reasons for the inclusion or the amendments is sent officially to the other Member States and the Commission, which shall 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 marketing them shall:
（a） notify this activity to the competent authority of the Member State in which the activity is carried out; such notification shall include the 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 reception of notifications.
Member States may provide for the communication of any additional information which they consider to be necessary for effective supervision of the operators concerned.
3. The competent authority shall ensure that an updated list containing the names and addresses of operators subject to the inspection 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 private bodies to which the operators producing or preparing 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 and pays his contribution to inspection expenses has access to the inspection system.
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 the approval 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 precautions which the body undertakes to impose on operators subject to its inspection;
（b） the penalties which the body intends to apply where irregularities are found;
（c） the availability of appropriate resources in the form of qualified staff, administrative and technical facilities, inspection experience and 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 infringements 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 the criteria indicated in paragraph 5 or fails to satisfy the requirements laid down in paragraphs 7, 8 and 9.
7. The inspection authority and the approved inspection bodies referred to in paragraph 1 shall:
（a） ensure that at least the inspection measures and precautions specified in Annex III are applied to undertakings subject to their inspection;
（b） not disclose information and data they obtain in their inspection activity to persons other than the person responsible for the undertaking 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 assistance deemed necessary by the competent authority for the fulfilment 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 31 December of the previous year and present to the said authority a concise annual report.
9. The inspection authority and inspection bodies referred to in paragraph 1 shall:
（a） ensure that, where an irregularity is found regarding the implementation of Articles 5, 6 and 7 or of the measures referred to in Annex III, the indications provided for in Article 2 referring to the organic production method are removed from the entire lot or production run affected by the irregularity concerned;
（b） where a manifest infringement, or an infringement with prolonged effects is found, prohibit the operator concerned from marketing products with indications referring to the organic production method for a period to be agreed with the competent authority of the 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.
Indication that products are covered by the inspection scheme
Article 10
1. The indication that products are covered by the specific inspection scheme, shown in Annex V, may appear on the labelling of products as referred to in Article 1 only where such products:
（a） satisfy the requirements of Article 5 （1）, （2）, （3） and （4） and Articles 6 and 7, as well as any provisions adopted pursuant to those Articles;
（b） have been subject to the inspection arrangements referred to in Article 9 （3） throughout the production and preparation stages;
（c） have been produced or prepared by operators whose undertakings are subject to inspection by the inspection authority or an inspection body as referred to in Article 9 （1） and have been awarded the right by that authority or body to use the indication shown in Annex V;
（d） are packed and transported to the point of retail sale in closed packaging;
（e） show on the labelling the name and any registered mark of the inspection body, the name and address of the producer or processor and, where Directive 79/112/EEC applies, the indications required thereby.
2. N° claim may be made on the label or advertising material that suggests to the purchaser that the indication shown in Annex V constitutes a guarantee of superior organoleptic, nutritional or salubrious quality.
3. The inspection authority and inspection bodies referred to in Article 9 （1） must:
（a） ensure that, where an irregularity is found under Articles 5, 6 and 7 or the measures referred to in Annex III, the indication shown in Annex V is removed from the entire lot or production run affected by the irregularity concerned;
（b） where a manifest infringement, or an infringement with prolonged effects, is found, withdraw from the operator concerned the right to use the indication shown in Annex V for a period to be agreed with the 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 and measures in Annex III are detected may be adopted in accordance with the procedure laid down in Article 14.
A19:17393EU002.XX5. Where a Member State finds, in a product coming from another Member State and bearing the indication shown in Article 2 and/or Annex V, irregularities in the application of this Regulation, it shall inform the Member State which approved the inspection body and the Commission thereof.
6. Member States shall take whatever action is required to prevent fraudulent use of the indication shown in Article 2 and/or Annex V.
7. The Commission shall, before 1 July 1993, review Article 10, in particular as regards the possibility of making the indication referred to in Annex V mandatory and shall submit appropriate proposals for a revision thereof, if any.
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 Commission decision in accordance with the procedure laid down in Article 14 and were produced in a region or a production unit and under the inspection of an inspection body specified, where appropriate, in the decision concerning the third country in question;
（b） the competent authority or body in the third country has issued a certificate of inspection stating that the lot designated in the certificate:
- was obtained within a system of production applying rules equivalent to those laid down in Articles 6 and 7, and - was subject to a system of inspection recognized as equivalent in accordance with paragraph 2 （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 in the list referred to in paragraph 1 （a）, the following shall be taken into account in particular:
（a） the guarantees which the third country can offer, at least in respect of production for export to the Community, as regards the application of rules equivalent to those laid down in Articles 6 and 7;
（b） the effectiveness of the inspection measures applied, which, at least in respect of production for export to the Community, must be equivalent to the inspection measures referred to in Articles 8 and 9 to 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 at the disposal of the inspection authorities 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 also entrust experts with the task of carrying out, under its authority, an on-the-spot examination of the rules of production and inspection measures actually applied in the third country in question.
Free movement within the Community
Article 12
Member States may not, on grounds relating to the method of production, to labelling or to the presentation of that method, prohibit or restrict the marketing of products as specified in Article 1 that meet the requirements of this Regulation.
Administrative provisions and implementation
Article 13
The following may be adopted in accordance with the procedure laid down in Article 14:
- amendments to Annexes I, II, III, IV and VI,
- detailed rules for the implementation of Annexes I and III.
Article 14
The Commission shall be assisted by a committee composed of representatives of the Member States and chaired by the representative of the Commission.
Where the procedure laid down in this Article is to be followed, the representative of the Commission shall submit to the committee a draft of the measures to be taken.
The committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 （2） of the Treaty. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
The Commission shall adopt the measure envisaged if they are in accordance with the opinion of the committee.
If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral to it the Council has not acted, the proposed measures shall be adopted by the 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 this Regulation 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 the inspection 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 December of the previous year, their legal and operational structure, their standard inspection procedure, their penalty arrangements and, where appropriate, 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 subparagraph.
Article 16
1. This Regulation shall enter into force on the day of its publication in the Official 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.
3. Articles 5, 8 （1） and 11 （1） shall apply with effect from 12 months after the entry into force of this Regulation.
In accordance with the procedure laid down in Article 14, the date of application of Article 11 （1） may be deferred for a specified period for imports from a third country where, following a request by the third country, the stage reached in examining the matter does not permit a decision regarding the inclusion of the country concerned in the list provided for in Article 11 （1） （a） before expiry of the period referred to in 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 entry into force of this Regulation shall be taken into account where the operator can demonstrate to the satisfaction of the inspection body that during that period he was producing in accordance with the national provisions in force or, failing that, with the recognized international standards 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）, authorize the use in their territory of products containing substances not listed in Annex II, where they consider that the requirements of Article 7 （1） are satisfied.
5. For a period expiring 12 months after the establishment of Annex VI in accordance with Article 5 （7）, Member States may continue to authorize, in accordance with their national provisions, the use of substances 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 paragraph 4 and 5.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done an Luxembourg, 24 June 1991.
For the Council The President J.-C. JUNCKER
ANNEX I
PRINCIPLES OF ORGANIC PRODUCTION AT FARM LEVEL
Plants and plant products
1.The principles set out in this Annex must normally have been applied on the parcels during a conversion period of at least two years before sowing or, in the case of perennial crops other than grassland, at least three years before the first harvest of products as referred to in Article 1 （1） （a）. The inspection body may, with the approval of the competent authority, decide, in certain cases, to extend or reduce that period, having regard to previous parcel use.
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 appropriate 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 the adoption of common technical rules concerning organic livestock production, by-products from livestock farming, such as farmyard manure, may be used if they come from livestock holdings respecting existing national rules or, in the absence thereof, internationally recognized practices concerning 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 soil conditioning are not possible by the methods set out under （a） and （b） of the preceding subparagraph.
For compost activation, appropriate micro-organism or plant-based preparations （biodynamic preparations） may be used.
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.
ANNEX II
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ANNEX III
MINIMUM INSPECTION REQUIREMENTS AND PRECAUTIonARY MEASURES UNDER THE INSPECTION SCHEME REFERRED TO IN ARTICLE 8 AND 9
A.Farms producing plants and plant products
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 unit not producing in accordance with the rules laid down in this Regulation; processing and/or packaging workshops may form part of the unit, where its activity is limited to processing and packaging of its own agricultural produce.
2.When the inspection arrangements are first implemented, the producer and inspection body must draw up:
-a full description of the unit, showing the storage and production premises and land parcels and, where applicable, premises where certain processing and/or packaging operations take place,
-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.
In addition, the report must specify:
-the date of the last application on the parcels concerned of products the use of which is not compatible with Articles 6 （1） （b） and 7,
-an undertaking by the producer to carry out operations in accordance with Articles 5, 6 and 7 and to accept, in event of infringements, implementation of the measures as referred to in Article 9 （9）.
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 a breakdown by parcel.
4.Written and/or documentary accounts must be kept which enable the inspection body to trace the origin, nature and quantities of all raw materials bought, and the use of such materials; in addition, written or documentary accounts must be kept of the nature, quantities and consignees of all agricultural products sold. Quantities sold directly to the final consumer shall be accounted on a daily basis.
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 testing of products not authorized under this Regulation may be taken. However, such samples must be taken where the use of unauthorized products is suspected. An inspection report must be drawn up after each visit, countersigned 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 as to the accounts and relevant supporting documents. He must provide the inspection body with any information deemed necessary for the purposes of the inspection.
8.Products as referred to in Article 1 which are not in their packaging for the end consumer may be transported to other units only in appropriate packaging or containers closed in a manner which would prevent substitution of the content and provided with a label stating, without prejudice to any other indications required by law:
-the name and address of the person responsible for the production or preparation of the product,
-the name of the product,
-that the product is covered by the inspection arrangements laid down in this Regulation.
9.Where an operator runs several production units in the same area, units in the area producing crop or crop products not covered by Article 1 must also be subject to the inspection arrangements as regards the first subparagraph of point 2 and points 3, 4 and 5. Plants of the same variety as those produced at the unit referred to in point 1 may not be produced at these units.
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 and after 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.
In addition, the report must include an undertaking by the operator to perform the operations in such a way as to comply with Article 5 and to accept, in the event of infringements, the implementation of measures as referred to in Article 9 （9）.
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 and the composition of processed products, that is required by the inspection body 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 operations performed 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 inspection body,
-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.
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 testing of products not authorized under this Regulation may be taken. However, they must be taken where the use of unauthorized products is suspected. An inspection report must be drawn up after each visit countersigned by the person 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 the purposes of the inspection.
6.The requirements in respect of transport laid down in point 8 of Part A are applicable .
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 inspection system by approving such bodies
ANNEX V
INDICATION THAT PRODUCTS ARE COVERED BY THE INSPECTION 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:OEkologisk Landbrug - EF Kontrolordning D:Biologische Agrarwirtschaft - EWG-Kontrollsystem GRÂéïëïãéêÞ Ãaaùñãssá - Óýóôçìá AAëÝã÷ïõ EOK EN:Organic Farming - EEC Control System F:Agriculture biologique - Système de contrôle CEE I:Agricoltura Biologica - Regime di controllo CEE NL:Biologische landbouw - EEG-controlesysteem P:Agricultura Biológica - Systema de Controlo CEE
ANNEX VI
A.Substances permitted as ingredients of non-agricultural origin （Article 5 （3） （b））:
B.Substances permitted to be used during preparation （Article 5 （3） （c））:
C.Ingredients of agricultural origin （Article 5 （4））:
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