COMMISSION OF THE EUROPEAN COMVLUNITIES 
C0M(91) 112 final 
Brussels, 27 March 1991 
Amendment to the proposal for a 
COUNCIL REGULATION (EEC) 
on organio production of agricultural products and indications 
referring thereto on agricultural products and foodstuffs 
(presented by the Commission pursuant to Article 149(3) 
of the EEC-Treaty) 
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EXPLANATORY MBCRAHDOM 
At its session of 12 March 1991, the European Parliament delivered its 
opinion on the Commission proposal contained in document G0M(89) 552, 
concerning the Amended proposal for a Council Regulation on organic 
production of agricultural products and indications referring thereto on 
agricultural products and foodstuffs. 
The present amended proposal takes into account these amendments suggested by 
the European Parliament on which the Commission has taken a favourable 
position. 
Also the proposal precises in more detail the examination of requests from 
third countries for recognition of equivalency (Article 11). 
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Amended proposal for a 
COUNCIL REGULATION 
on organic production of agricultural products and indications 
referring thereto on agricultural products and foodstuffs 
In response to the opinion delivered by the European Parliament^1) on the 
proposal for a Regualtion sent by the Commission to the Council on 
6 December 1989 and concerning organic production of agricultural products 
and indications referring thereto on agricultural products and foodstuffs, 
and in accordance with the third paragraph of Article 149 of the Treaty 
establishing the European Economic Community, the Commission has decided to 
amend the aforementioned proposal as follows. 
1. Throughout the regulation the term in German "biologisch" and in Spanish 
"biologico" are replaced by the terms "dkologisch" and "ecologico" 
respectively. 
2. In the 4th recital the word "recently is replaced by the word "already". 
3. The 5th recital is amended as follows: 
"Whereas a framework of Community rules on production, labelling and 
inspection are required to protect organic farming in so far as they 
ensure conditions of fair competition 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 
consumers' eyes;". 
4. In the 7th recital the words "whereas the rules covering livestock 
production should however be introduced by means of an amendment to this 
Regulation" are replaced by the words "whereas, within a suitable period, 
this regulation will be supplemented by equivalent rules covering 
livestock production". 
(1) 
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5. The 13th recital is amended as follows: 
"Whereas all operators producing or preparing products bearing 
indications referring to organic production methods must be subject to a 
regular inspection system, meeting miJxLmum Community requirements and 
carried out by designated inspection authorities and/or by approved and 
supervised private bodies; whereas this requirement should be rewarded by 
entitlement to use a Community indication of inspection on the labelling 
of the products concerned;". 
6. The 14th and 15th recitals are deleted. 
7. In Article 1 a second paragraph is introduced reading as follows: 
"2. A proposal concerning the principles and specific measures of 
control governing organio animal production, non-processed animal 
products and products intended for human consumption containing 
ingredients of animal origin will be submitted by the Commission as 
soon as possible and not later than 1 July 1992. ". 
8. In Article 2 the text of the 3 hyphens is replaced by the following: 
"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. 
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in Spanish: ecologico 
in Danish: okologisk 
in German: biologisch 
in Greek: PIOAOYIKI'I 
in English: organic 
in French: biologique 
in Italian: biologico 
in Dutch: biologisch 
in Portuguese: biologico." 
9. Article 5(1 )(c) is amended as follows: 
"(c) The product was produced or imported by an operator who has agreed 
to be subject, to the inspection measures laid down in Articles 8 
and 9.". 
10. Paragraphs 2 and 3 of Article 5 are replaced by the following text: 
"2. The labelling and advertising of a product specified in Article 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(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 Article 6 and 7 or imported from third countries 
under the arrangement laid down in Article 11; 
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b) the product contains only ingredients of non-agricultural origin 
listed in Annex VI, part A; 
c) the product or its ingredients have not been subjected, during 
preparation, to treatments involving the use of ionizing 
radiation or products not listed in Annex VI, section B; 
d) the product was prepared by an operator who has agreed to be 
subject to the inspection measures laid down in Articles 8 and 9. 
4. Notwithstanding paragraph 3, ingredients not satisfying the 
requirement in paragraph 3(a) may be used in the preparation of 
certain products as referred to in Article Kb) where 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; and 
- do not exceed 5 % of the content of the final product. 
5. The labelling and advertising of a product as referred to in Article 
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 organio production methods 
- only appear in the list of ingredients as provided for in 
Directive 79/112/EEC; 
- clearly refer to only those ingredients obtained according to 
the rules as referred to in Articles 6 and 7; 
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d) the ingredients and their content 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. 
6. Detailed rules concerning the implementation of this Article may be 
established according to the procedure of Article 14. 
7. Limitative lists of the ingredients provided for in paragraph 4 and 
of the products in Annex VI, parts A and B, shall be established 
according to the procedure of Article 14. 
Conditions of use and compositional requirements' of these 
ingredients and products 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 introduce it to the Committee referred to in 
Article 14. 
8. Before 1 July 1992, the Commission shall review the provisions of 
this Article, in particular paragraph 5 and submit any appropriate 
proposal with a view to revision, if any. ". 
11. Article 6 is amended as follows: 
"1. The organic production method implies that for the production of 
produots referred to in Article 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 or incorporating products 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 insofar 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 Kb), seeds treated with 
products not included in Annex II and authorized in general 
agriculture in the Member State concerned may be used insofar 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 appropriated variety of the species in question. ". 
12. Paragraphs 1 to 3 of Article 7 are amended as follows: 
"1. Products not authorized at the date of adoption of this Regulation 
for a purpose indicated in Article 6(b) may be incited 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 particular pest or 
disease of crop, 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 
treatment of perennial crops, direct contact may take place 
beyond 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-oonditioning 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 or contribute to unacceptable 
effects on or contamination of the environment. 
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 ensure 
absence of residues in edible parts of the crop and in edible 
crop products as well as a minimum effect on the environment; 
- particular labelling requirements for products referred to in 
Article 1 where such products were obtained with the aid of 
certain products in Annex II. 
3. Amendments to Annex II, concerning either inclusion or cancelling or 
products as referred to in paragraph 1 or inclusion or amendments of 
spécifications as referred to in paragraph 2 shall be decided by the 
Commission in accordance with the procedure laid down in Article 14. 
13. Article 7(4) is deleted. 
14. In Article 7(5) the word "substance" is replaced by the word "product". 
15. In Article 8(5) (a) the words "vis à vis all the operators subject to its 
inspection" are deleted. 
16. In Article 8(5)(d) the words "or fails to satisfy the requirements laid 
down in paragraphs 6, 7 and 8" are introduced after the words "in 
paragraph 4". 
17. Paragraphs 6, 7 and 8 of Atiole 8 are replaced by the following: 
"6. The inspection authority and 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 and firms 
subject to their inspection; 
b) not disclose information and data they obtain in their inspection 
activity to persons other than the persons responsible for the 
undertaking concerned and the competent public authorities. 
7. 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 as well as a brief annual 
inspection report. 
8. The inspection authority and inspection bodies referred to in 
Article 8(1) shall: 
a) ensure that, where an irregularity is found under Articles 5, 6 
and 7 or 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; 
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b) where a manifest infringement, or an infringement with prolonged 
effects is found, prohibit the operator conoerned from marketing 
products with Indications referring to the organio production 
method for a period to be agreed with the competent authority of 
the Member State. 
9. The following may be adopted in accordance with the procedure laid 
down in Article 14: 
a) detailed rules concerning the requirements Indicated in paragrpah 
4 and the measures listed in paragraph 5; 
b) implementation measures concerning the provisions of paragraph 
7.". 
18. The text of Article 9(1) is amended as follows: 
"1. Any operator who produces, prepares or imports from a third country 
products as specified in Article 1 for the purpose of marketing them 
snai i. 
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 regular inspection system referred 
to in Article 9.". 
19. Article 9(3) is deleted. 
20. Article 9(4) is amended as follows: 
"4. 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. ". 
21. Article 10(6) is amended as follows: 
"Member States shall take whatever action is required to prevent 
fraudulent use of the indication provided for in Annex V or the labelling 
as referred to in Article 2. ". 
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22. In Article 12 the words "production or the presentation" are replaced by 
the words "production, labelling or the presentation". 
23. The text of Article 15 is completed with the following indent: 
"The Commission shall each year publish in the C-series of the Official 
Journal the lists of approved bodies notified to it within the deadlines 
laid down in the previous paragraph. 
24. Article 16(4) is amended as follows: 
"4. For twelve months following the entry into foroe of this Regulation, 
the Member States may, by derogation from Article 6(l)(b), authorize 
the use in their territory of products containing substances not 
listed in Annex II, where they deem that the requirements of Article 
7(1) are satisfied. 
25. The final phrase of point 2 in Annex I is replaced by the following: 
"Pending the adoption of common technical rules <X)nœrning organio 
livestock production, by-products from livestock farming, such as 
farmyard manure, shall be introduced 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 the first 
and second hyphen above. ". 
26. The text of Annex II is replaced by the text in the annex of this 
proposal. 
27. Points 2 and 10(a) of Annex III, part A and point 2 of Annex III, part B 
are deleted. 
28. The 2nd and 3rd paragraphs of point 3 of Annex III, part A are replaced 
by the following: 
"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 œnoerned of 
products whose use is not compatible with Articles 6(1 )(b) and 7, 
an undertaking by the producer to carry out operations in aooordance 
with Articles 5, 6 and 7 and to accept, in event of infringements, 
implementation of the measures referred to in Article 8(8). ". 
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29. Point 5 of Annex III, part A is completed by the following phrase: 
"Quantities sold directly to the final consumer shall be accounted on a 
daily basis.". 
30. The last two sentences of point 7 of Annex III, part A are replaced by 
the following: 
"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. ". 
31. In point 10 of Annex III, part A the words "(b) Units producing crops or 
crop products" are replaced by "Units in the area producing crop or crop 
products". 
32. The first, second and third hyphen of point 4 of Annex III, part B are 
replaced by the following: 
"- 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 concerning them; 
operations must be carried out continuously until the complete run 
has been dealt with, separated by time and place 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 with the inspection 
body.". 
33. Point 5 of Annex III, part B is amended as follows: 
"5. Apart from unannounced inspection visits, the inspection body must 
make a full physical inspection, at least once a year, of the unit. 
Samples to check for products not authorized under this Regulation 
may be taken. However, they must be taken where the use of 
unauthorized products is suspected in order to test for traces of 
such products. An inspection report must be drawn up after each 
visit countersigned by the responsible person of the unit. ". 
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54. Annex IV is completed by the following point: 
"(f) the name of the approved body to which the operator entrusted 
inspection of this undertaking, where the Member State has 
implemented the regular inspection system by approving such 
bodies.". 
35. The following Annex is introduced after Annex V: 
"Annex VI 
A. Products permitted as ingredients of non-agrioulgtural origin 
(Article 5(3)(b)). 
B. Products permitted to be used during preparation (Article 5(3)(c))." 
ANNEX 
"ANNEX II 
A. PRODDCTS FOR FERTILIZATICN AND SOlIi-OONDITICNING 
Name Description; oompositional 
requirements; conditions for 
use 
Farmyard and poultry manure 
Slurry or urine 
Straw 
Spent mushroom composts 
Peat 
Processed animal products from slaughter­
houses and fish industries 
Organio by-products of foodstuffs and 
textile industries 
Seaweeds and seaweed products 
Sawdust, bark and wood waste 
Voodash 
Natural phosphate rock 
Calcinated alimunium phosphate rock 
Ground rock potash 
Limestone 
Chalk 
Magnesium rock 
Calcareous magnesium rock 
Epsom salt (magnesium sulphate) 
Gypsum (calcium sulphate) 
Plant based preparations 
Microbial preparations Compost activation 
Compost activation 
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B. PROPPCTS FOR PLANT PEST AMD DISEASE OOWTRX 
Name Description; oompositional 
requirements; conditions for 
use 
Bacillus thuringiensis preparations 
Pyrethrum extracted from Chrysanthemum 
cinerariaefolium 
Rotenone extracted from Derris elliptica 
Quassia amara 
Ryania speciosa 
Propolis 
Diatomaceous earth 
Stone meal 
Metaldehyde 
Sulphur 
Bordeaux mixture 
Burgundy mixture 
Sodium silicate 
Sodium bicarbonate 
Potassium soap (soft soap) 
Pheromones 
Plant and animal oils 
Paraffin oil" 

ISSN 0254-1475 
COM(91) 112 final 
DOCUMENTS 
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