Avis juridique important

Commission Directive 98/88/EC of 13 November 1998 establishing guidelines for the microscopic identification and estimation of constituents of animal origin for the official control of feedingstuffs (Text with EEA relevance) Official Journal L 318 , 27/11/1998 P. 0045 - 0050

COMMISSION DIRECTIVE 98/88/EC of 13 November 1998 establishing guidelines for the microscopic identification and estimation of constituents of animal origin for the official control of feedingstuffs (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to the Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 2 thereof, Whereas Directive 70/373/EEC stipulates that official controls of feedingstuffs for the purpose of checking compliance with the requirements arising under the laws, regulations and administrative provisions governing their quality and composition must be carried out using Community sampling and analysis methods; Whereas Commission Decision 94/381/EC of 27 June 1994 concerning certain protection measures with regard to bovine spongiform encephalopathy and the feeding of mammalian derived protein (2), as amended by Decision 95/60/EC (3) prohibits the feeding of protein derived from all mammalian tissues to ruminants, with the exception of certain animal products and by-products; Whereas Commission Decision 91/516/EEC of 9 September 1991 establishing a list of ingredients whose use is prohibited in compound feedingstuffs (4), as last amended by Decision 97/582/EC (5), prohibits the use of protein derived from mammalian tissue in compound feedingstuffs for ruminants; Whereas Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs (6), as last amended by Commission Directive 97/47/EC (7), provides in Article 5c that all ingredients must be mentioned where a declaration of the ingredients is provided and that the listing of ingredients is subject to several rules, inter alia, the listing of ingredients in descending order by weight for compound feedingstuffs intended for animals other than pets; Whereas Directive 97/47/EC amending the Annexes to Council Directives 77/101/EEC (8), 79/373/EEC and 91/357/EEC (9) introduces appropriate labelling provisions with regard to the prohibition of these products on their use in ruminant feed; Whereas Member States may have adopted more stringent provisions, in accordance with Article 1(2) of Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedstuffs of animal or fish origin and amending Directive 90/425/EEC (10), as last amended by the Act of Accession of Austria, Finland and Sweden; Whereas by microscopic examination the presence of constituents of animal origin can be established; whereas bones of terrestrial animals and bones of fish can be distinguished by microscopic examination; whereas the possibility of distinguishing, by microscopic examination, the bones of mammalian origin from bones of poultry origin depends on the experience of the analyst; whereas the possibility of estimation of the quantity of constituents of animal origin depends also largely on the experience of the analyst; whereas it may be appropriate according to the progress of scientific and technological knowledge, to combine microscopic examination with other methods of analysis; whereas the fixing of these guidelines for the microscopic examination do not exclude the use, instead or in addition, of methods of analysis, other than microscopic examination, which have been proved to be scientifically valid; Whereas it is therefore advisable to lay down the provisions concerning microscopic examination as guidelines; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, HAS ADOPTED THIS DIRECTIVE: Article 1 The Member States shall provide that where, with a view to officially controlling the identification and/or estimation of the amount of constituents of animal origin in feedingstuffs, microscopic examination is carried out, it shall be carried out using the guidelines set out in the Annex hereto. In accordance with the requirements posed by the competent authorities to the analysis, point 7 'Calculation and evaluation` of these guidelines are to be considered as optional, provided that in the case where the estimation of the quantity is carried out, the provisions laid down in point 7 have to be followed. The fixing of these guidelines, in respect of the procedure for microscopic examination does not exclude the use, instead or in addition, of methods of analysis, other than microscopic examination, which have been scientifically proved to be valid for the identification and/or estimation of the amount of constituents of animal origin. Article 2 The Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with the provisions of this Directive, not later than 1 September 1999. They shall forthwith notify the Commission thereof. When Member States adopt these provisions, the provisions shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. This Directive is addressed to the Member States. Done at Brussels, 13 November 1998. For the Commission Franz FISCHLER Member of the Commission (1) OJ L 170, 3. 8. 1970, p. 2. (2) OJ L 172, 7. 7. 1994, p. 23. (3) OJ L 55, 11. 3. 1995, p. 43. (4) OJ L 281, 9. 10. 1991, p. 23. (5) OJ L 237, 28. 8. 1997, p. 39. (6) OJ L 86, 6. 4. 1979, p. 30. (7) OJ L 211, 5. 8. 1997, p. 45. (8) OJ L 32, 3. 2. 1977, p. 1. (9) OJ L 193, 17. 7. 1991, p. 34. (10) OJ L 363, 27. 12. 1990, p. 51. ANNEX Guidelines for the microscopic identification and estimation of constituents of animal origin in feedstuffs 1. Objective and field of application These guidelines should be used where detection of constituents of animal origin (defined as products from processing bodies and body-parts of mammals, poultry and fish) in feedingstuffs is carried out by means of microscopic examination. In the case where the estimation of the quantity of animal constituents is carried out, the provisions under point 7 of these guidelines have to be followed. 2. Sensitivity Dependent on the nature of the constituents of animal origin, very small amounts (0,5 mm (or a representative part of the fraction) is applied as a thin layer to a suitable support and screened systematically under the stereomicroscope (5.4) at various magnifications for constituents of animal origin. Slides made with the sieve fraction(s) TABLE POSITION> 7. Calculation and evaluation In the case where the estimation of the quantity of animal constituents is carried out the provisions under this point have to be followed. The calculation can only be made if the constituents of animal origin contain bone fragments. Bone fragments of terrestrial warm-blooded species (i.e. mammals and birds) can be distinguished from the different types of fish bone in the microscopic slide by means of the typical lacunae. The proportion of constituents of animal origin in the sample material is estimated taking into consideration: - the estimated proportion (weight %) of bone fragments in the concentrated sediment, and - the proportion (weight %) of bone in the constituents of animal origin. The estimate has to be based on at least three (if possible) slides and at least five fields per slide. In compound feedingstuffs, the concentrated sediment as a rule contains not only terrestrial animal bone and fish bone fragments, but also other particles of high specific weight, e.g. minerals, sand, lignified plant fragments and the like. 7.1. Estimated value of the percentage of bone fragments % terrestrial bone fragments = >NUM>S×c >DEN>W % fish bone and scale fragments = >NUM>S×d >DEN>W (S= sediment weight (mg), c=correction factor (%) for the estimated portion of terrestrial animal bones in the sediment, d= correction factor (%) for the estimated portion of fish bones and scale fragments in the sediment, W=weight of the sample material for the sedimentation (mg)). 7.2. Estimated value of constituents of animal origin The proportion of bone in animal products can vary greatly. (The percentage of bone in the case of bone meals is of the order of 50 to 60 % and in the case of meat meals of the order of 20 to 30 %; in the case of fish meals bone and scale contents vary according the category and origin of fish meal, normally in the order of 10 to 20 %). If the type of animal meal present in the sample is known, it is possible to estimate the content: Estimated content of constituents of terrestrial animal products (%) = >NUM>S×c >DEN>W×f × 100 Estimated content of constituents of fish products (%) = >NUM>S×d >DEN>W×f × 100 (S=sediment weight (mg), c= correction factor (%) for the estimated portion of terrestrial animal bone constituents in the sediment, d= correction factor (%) for the estimated portion of fish bones and scale fragments in the sediment, f= correction factor for the proportion of bone in the constituents of animal origin in the sample examined, W= weight of the sample material for the sedimentation (mg)). 8. Expression of the result of the examination The different cases could be reported in the following way: 8.1. As far as was discernible under the microscope, no constituents of animal origin (as defined in point 1) were found in the submitted sample. 8.2. As far as was discernible under the microscope constituents of animal origin (3) were found in the submitted sample. In this case, the reporting of the result of the examination, if required, can be further specified as: 8.2.1. As far as was discernible under the microscope, small amounts of constituents of animal origin (4) were found in the submitted sample. 8.2.2. Dependent on the experience of the analyst: - either, as far as was discernible under the microscope, constituents of animal origin (5) were found in the submitted sample. The content of bone fragments (fish/terrestrial animals - in the case of bone fragments of terrestrial animals, eventually specified as bone fragments from poultry or mammalians, see remark 9.3) is estimated in an order of magnitude of . . .%, equal to . . .% of animal constituents when calculated on the basis of . . .% bone in the animal constituents' product (= correction factor f used), - or, as far as was discernible under the microscope, constituents of animal origin (6) were found in the submitted sample in measurable quantities. For the cases under point 8.2, 8.2.1 and 8.2.2, when bone constituents from terrestrial animals are identified, the report shall contain the additional clause: 'The possibility that the above constituents are derived from mammals cannot be excluded.` This clause is not necessary in cases where the bone fragments from terrestrial animals have been specified as bone fragments from poultry or mammalians (see remark 9.3). 9. Remarks 9.1. It is recommended in the case of many and big constituents in the concentrated sediment to sieve the sediment into two fractions (i.e. use of a 320 ìm sieve). The fraction with the big constituents can be examined as a paraffin oil preparation under a stereomicroscope with transmitted light. The fraction with the fine constituents must be examined under the compound microscope. 9.2. The concentrated sediment obtained (6.2), can, if necessary, be divided further using a concentrating agent with a greater density. 9.3. Dependent on the experience of the analyst, the distinction between constituents of mammalian or poultry origin can be made, making use of specific histological features, by which this distinction can be made. (1) OJ L 102, 15. 4. 1976, p. 1. (2) The reagents listed are commercially available, if no other indication is given. (3) The type of constituents found, for example bones (fish or terrestrial animals), meat constituents, etc. should be indicated here.

COMMISSION DIRECTIVE 98/88/EC of 13 November 1998 establishing guidelines for the microscopic identification and estimation of constituents of animal origin for the official control of feedingstuffs (Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to the Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 2 thereof,

Whereas Directive 70/373/EEC stipulates that official controls of feedingstuffs for the purpose of checking compliance with the requirements arising under the laws, regulations and administrative provisions governing their quality and composition must be carried out using Community sampling and analysis methods;

Whereas Commission Decision 94/381/EC of 27 June 1994 concerning certain protection measures with regard to bovine spongiform encephalopathy and the feeding of mammalian derived protein (2), as amended by Decision 95/60/EC (3) prohibits the feeding of protein derived from all mammalian tissues to ruminants, with the exception of certain animal products and by-products;

Whereas Commission Decision 91/516/EEC of 9 September 1991 establishing a list of ingredients whose use is prohibited in compound feedingstuffs (4), as last amended by Decision 97/582/EC (5), prohibits the use of protein derived from mammalian tissue in compound feedingstuffs for ruminants;

Whereas Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs (6), as last amended by Commission Directive 97/47/EC (7), provides in Article 5c that all ingredients must be mentioned where a declaration of the ingredients is provided and that the listing of ingredients is subject to several rules, inter alia, the listing of ingredients in descending order by weight for compound feedingstuffs intended for animals other than pets;

Whereas Directive 97/47/EC amending the Annexes to Council Directives 77/101/EEC (8), 79/373/EEC and 91/357/EEC (9) introduces appropriate labelling provisions with regard to the prohibition of these products on their use in ruminant feed;

Whereas Member States may have adopted more stringent provisions, in accordance with Article 1(2) of Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedstuffs of animal or fish origin and amending Directive 90/425/EEC (10), as last amended by the Act of Accession of Austria, Finland and Sweden;

Whereas by microscopic examination the presence of constituents of animal origin can be established; whereas bones of terrestrial animals and bones of fish can be distinguished by microscopic examination; whereas the possibility of distinguishing, by microscopic examination, the bones of mammalian origin from bones of poultry origin depends on the experience of the analyst; whereas the possibility of estimation of the quantity of constituents of animal origin depends also largely on the experience of the analyst; whereas it may be appropriate according to the progress of scientific and technological knowledge, to combine microscopic examination with other methods of analysis; whereas the fixing of these guidelines for the microscopic examination do not exclude the use, instead or in addition, of methods of analysis, other than microscopic examination, which have been proved to be scientifically valid;

Whereas it is therefore advisable to lay down the provisions concerning microscopic examination as guidelines;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs,

HAS ADOPTED THIS DIRECTIVE:

The Member States shall provide that where, with a view to officially controlling the identification and/or estimation of the amount of constituents of animal origin in feedingstuffs, microscopic examination is carried out, it shall be carried out using the guidelines set out in the Annex hereto.

In accordance with the requirements posed by the competent authorities to the analysis, point 7 'Calculation and evaluation` of these guidelines are to be considered as optional, provided that in the case where the estimation of the quantity is carried out, the provisions laid down in point 7 have to be followed.

The fixing of these guidelines, in respect of the procedure for microscopic examination does not exclude the use, instead or in addition, of methods of analysis, other than microscopic examination, which have been scientifically proved to be valid for the identification and/or estimation of the amount of constituents of animal origin.

Article 2

The Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with the provisions of this Directive, not later than 1 September 1999. They shall forthwith notify the Commission thereof.

When Member States adopt these provisions, the provisions shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States.

Article 3

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.

This Directive is addressed to the Member States.

Done at Brussels, 13 November 1998.

For the Commission

Franz FISCHLER

Member of the Commission

(1) OJ L 170, 3. 8. 1970, p. 2.

(2) OJ L 172, 7. 7. 1994, p. 23.

(3) OJ L 55, 11. 3. 1995, p. 43.

(4) OJ L 281, 9. 10. 1991, p. 23.

(5) OJ L 237, 28. 8. 1997, p. 39.

(6) OJ L 86, 6. 4. 1979, p. 30.

(7) OJ L 211, 5. 8. 1997, p. 45.

(8) OJ L 32, 3. 2. 1977, p. 1.

(9) OJ L 193, 17. 7. 1991, p. 34.

(10) OJ L 363, 27. 12. 1990, p. 51.

ANNEX

Guidelines for the microscopic identification and estimation of constituents of animal origin in feedstuffs

1. Objective and field of application

These guidelines should be used where detection of constituents of animal origin (defined as products from processing bodies and body-parts of mammals, poultry and fish) in feedingstuffs is carried out by means of microscopic examination.

In the case where the estimation of the quantity of animal constituents is carried out, the provisions under point 7 of these guidelines have to be followed.

2. Sensitivity

Dependent on the nature of the constituents of animal origin, very small amounts (0,5 mm (or a representative part of the fraction) is applied as a thin layer to a suitable support and screened systematically under the stereomicroscope (5.4) at various magnifications for constituents of animal origin.

Slides made with the sieve fraction(s) TABLE POSITION>

7. Calculation and evaluation

In the case where the estimation of the quantity of animal constituents is carried out the provisions under this point have to be followed.

The calculation can only be made if the constituents of animal origin contain bone fragments.

Bone fragments of terrestrial warm-blooded species (i.e. mammals and birds) can be distinguished from the different types of fish bone in the microscopic slide by means of the typical lacunae. The proportion of constituents of animal origin in the sample material is estimated taking into consideration:

- the estimated proportion (weight %) of bone fragments in the concentrated sediment, and

- the proportion (weight %) of bone in the constituents of animal origin.

The estimate has to be based on at least three (if possible) slides and at least five fields per slide. In compound feedingstuffs, the concentrated sediment as a rule contains not only terrestrial animal bone and fish bone fragments, but also other particles of high specific weight, e.g. minerals, sand, lignified plant fragments and the like.

7.1. Estimated value of the percentage of bone fragments

% terrestrial bone fragments = >NUM>S×c >DEN>W

% fish bone and scale fragments = >NUM>S×d >DEN>W

(S= sediment weight (mg), c=correction factor (%) for the estimated portion of terrestrial animal bones in the sediment, d= correction factor (%) for the estimated portion of fish bones and scale fragments in the sediment, W=weight of the sample material for the sedimentation (mg)).

7.2. Estimated value of constituents of animal origin

The proportion of bone in animal products can vary greatly. (The percentage of bone in the case of bone meals is of the order of 50 to 60 % and in the case of meat meals of the order of 20 to 30 %; in the case of fish meals bone and scale contents vary according the category and origin of fish meal, normally in the order of 10 to 20 %).

If the type of animal meal present in the sample is known, it is possible to estimate the content:

Estimated content of constituents of terrestrial animal products (%) = >NUM>S×c >DEN>W×f × 100

Estimated content of constituents of fish products (%) = >NUM>S×d >DEN>W×f × 100

(S=sediment weight (mg), c= correction factor (%) for the estimated portion of terrestrial animal bone constituents in the sediment, d= correction factor (%) for the estimated portion of fish bones and scale fragments in the sediment, f= correction factor for the proportion of bone in the constituents of animal origin in the sample examined, W= weight of the sample material for the sedimentation (mg)).

8. Expression of the result of the examination

The different cases could be reported in the following way:

8.1. As far as was discernible under the microscope, no constituents of animal origin (as defined in point 1) were found in the submitted sample.

8.2. As far as was discernible under the microscope constituents of animal origin (3) were found in the submitted sample.

In this case, the reporting of the result of the examination, if required, can be further specified as:

8.2.1. As far as was discernible under the microscope, small amounts of constituents of animal origin (4) were found in the submitted sample.

8.2.2. Dependent on the experience of the analyst:

- either, as far as was discernible under the microscope, constituents of animal origin (5) were found in the submitted sample. The content of bone fragments (fish/terrestrial animals - in the case of bone fragments of terrestrial animals, eventually specified as bone fragments from poultry or mammalians, see remark 9.3) is estimated in an order of magnitude of . . .%, equal to . . .% of animal constituents when calculated on the basis of . . .% bone in the animal constituents' product (= correction factor f used),

- or, as far as was discernible under the microscope, constituents of animal origin (6) were found in the submitted sample in measurable quantities.

For the cases under point 8.2, 8.2.1 and 8.2.2, when bone constituents from terrestrial animals are identified, the report shall contain the additional clause:

'The possibility that the above constituents are derived from mammals cannot be excluded.`

This clause is not necessary in cases where the bone fragments from terrestrial animals have been specified as bone fragments from poultry or mammalians (see remark 9.3).

9. Remarks

9.1. It is recommended in the case of many and big constituents in the concentrated sediment to sieve the sediment into two fractions (i.e. use of a 320 ìm sieve). The fraction with the big constituents can be examined as a paraffin oil preparation under a stereomicroscope with transmitted light. The fraction with the fine constituents must be examined under the compound microscope.

9.2. The concentrated sediment obtained (6.2), can, if necessary, be divided further using a concentrating agent with a greater density.

9.3. Dependent on the experience of the analyst, the distinction between constituents of mammalian or poultry origin can be made, making use of specific histological features, by which this distinction can be made.

(1) OJ L 102, 15. 4. 1976, p. 1.

(2) The reagents listed are commercially available, if no other indication is given.

(3) The type of constituents found, for example bones (fish or terrestrial animals), meat constituents, etc. should be indicated here.