Advanced Search

Rules On Authorised Additives In Feedingstuffs And Bioproteīn, As Well As Their Life Agenda

Original Language Title: Noteikumi par atļautajām dzīvnieku barības piedevām un bioproteīniem, kā arī to aprites kārtību

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.
Cabinet of Ministers Regulations No. 902 in Riga, 11 august 2009 (pr. No 52 40. §) rules on authorised additives in feedingstuffs and bioproteīn, as well as their life order Issued in accordance with the animal feed chain of article 8 of the law 1. determines the permitted additives in animal nutrition (additives) and bioproteīn and their life. 2. the requirements of this Regulation shall not apply to feed intended for export to a country which is not a Member State of the European Union. 3. the implementation of these provisions is monitored and controlled by the food and veterinary service (hereinafter service). 4. Additives and bioproteīn presence in animal feed service control laboratory, analyzing the additives and compound animal feed samples. 5. Animal feed additives in accordance with European Parliament and Council of 22 September 2003 on the application of Regulation (EC) no 1831/2003 on animal nutrition additives used in article 17 of the European communities published a feed additive in the register (hereinafter register), in electronic form is available on the Ministry of Agriculture website. 6. additives not listed in the registry or the intended conditions of use different from that mentioned in the register, allowed only for scientific research. 7. Authorized to manufacture, distribute, and use the bioproteīn referred to in annex 1 to these regulations and which is labelled according to 7.1: the provision in annex 1 and the regulations on animal feed labelling requirements set out in the order;
7.2. ensure the animal's diet with protein;
7.3. does not adversely affect human or animal health or the environment, nor harm the consumer and lowers the quality of foodstuffs of animal origin. 8. The rules referred to in annex 1 of the bioproteīn allowed to use as animal feed or as a feed ingredient. 9. to register the bioproteīn, derived from the provisions of annex 1 section 1.1 and 1.2 in the groups of micro-organisms in animal feed business person shall prepare a registration dossier containing information pursuant to annex 2 of these regulations and shall submit it to the European Commission. 10. Bioproteīn, which are mentioned in annex 1 of these rules or for conditions of use different from these rules referred to in annex 1, allowed only scientific research, if the service is carried out by the previous test. Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the Council of 30 June 1982 of Directive 82/471/EEC concerning certain products used in animal nutrition;
2) Council on 18 April 1983 Directive 83/228/EEC for assessing basic guidelines, some animal nutrition products used;
3) Commission of 26 July 1984 by Directive 84/443/EEC, amending the annex to Council Directive 82/471/EEC concerning certain products used in animal nutrition;
4) second Commission of 6 November 1985 Directive 85/509/EEC, amending the annex to Council Directive 82/471/EEC concerning certain products used in animal nutrition;
5) Commission of 28 October 1986 Directive 86/530/EEC, amending the annex to Council Directive 82/471/EEC concerning certain products used in animal nutrition;
6) Commission of 24 July 1990 directive 90/439/EEC, amending the annex to Council Directive 82/471/EEC concerning certain products used in animal nutrition;
7) Commission 29 June 1993 of Directive 93/56/EEC amending Council Directive 82/471/EEC concerning certain products used in animal nutrition;
8) Commission 10 July 1995 directive 95/33/EC amending Council Directive 82/471/EEC concerning certain products used in animal nutrition;
9) Council of 22 March 1999, Directive 1999/20/EC amending Directives 70/524/EEC concerning additives in feedingstuffs, 82/471/EEC concerning certain products used in animal nutrition, 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition and 95/69/EC laying down some in the animal feed sector establishments and intermediaries in the approval and registration conditions and procedures;
10) Commission of 23 December 2004, Directive 2004/116/EC amending the annex to Council Directive 82/471/EEC relating to Candida guilliermondii. Prime Minister v. dombrovsky Minister of Agriculture j. Dūklav of annex 1 of the Cabinet of Ministers of 11 august 2009. Regulations no authorized bioproteīn no 902 p.k. product group the product name or product identification of the micro-organism culture substrate (specifications, if required) product of animal species particular instructions 1. Proteins obtained from micro-organisms to such groups, 2. Bacteria 3.1.1 1.1.1. Bacteria cultivated on methanol protein product obtained by the fermentation of methylotrop in methanol of Methylophilus Methylophilus-methylotrop NCIB strain of 10515 methanol, crude protein not less than 68%. Index of reflection, at least 50 pigs calves poultry fish Products on the label or on the packaging indicates: 1) the product name; 2) crude protein; 3) total ash; 4) fats; 5) moisture content; 6) "did not inhale"; 7) approval number; 8) operating instructions. The labelling of compound feedingstuffs or on the packaging indicates the product quantity in feedingstuffs 4.1.1.2. Bacteria cultured in natural protein products obtained by the fermentation of the bacterium Methylococc capsulatus (Bath), Alcaligenes acidovoran, of Bacillus brevis and Bacillus for the natural gas company. Bacterial cells are not in the product life of the Methylococc capsulatus (Bath) strain NCIMB 11132 acidovoran of the Alcaligenes strain NCIMB 12387 Bacillus brevis strain NCIMB 13288 Bacillus strain NCIMB 13280 of firm natural gas (approximately 91% 5% methane, ethane, propane, 2%, 0.5% 0.5% Isobutane, n-butane, 1% other ingredients), ammonia, and mineral salts, crude protein not less than 65% of fattening pigs from 25 up to 60 kg. Calves from 80 kg. Salmon product label or on the packaging indicates: 1) "protein product obtained by the fermentation of the bacterium Methylococc capsulatus (Bath), Alcaligenes acidovoran, Bacillus brevis of the firm in the natural gas and Bacillus"; 2) crude protein; 3) total ash; 4) fats; 5) moisture content; 6) instructions; 7) maximum levels in feed: 8% of the fattening pigs; * 8% calves; * 19% salmon (fresh water); * 33% salmon (sea water); 8) "did not inhale"; 9) approval number. The labelling of compound feedingstuffs or on the packaging indicates: 1) "protein product obtained by the fermentation of bacteria in natural gas"; 2) the quantity of product in the feed Yeast 6 5 1.2 1.2.1 Yeast that cultivated on animal or plant substrates All yeast obtained from column 3 and 4 mentioned microorganisms and substrates. In yeast cells is not the product of live Saccharomyces cerevisiae Saccharomyces carlsbergiens by kluyveromyces lactis kluyveromyces fragile the molasses, alcohol industry by-products, corn and starch containing products, fruit juices, whey, lactic acid and hydrolyzed plant fiber all animal species Candida guilliermondii 7 molasses, a by-product of the alcohol industry, the cereals and starch containing products, fruit juices, whey, lactic acid and hydrolyzed vegetable fibre, at least 16% of the dry matter production pigs 8.1.2.2. Yeasts who cultivated on substrates other than those referred to in point 1.2.1 of this annex 9.1.3. Algae 10.1.4. Lower mushrooms 11. Products obtained by the fermentation of antibiotics production method – wet penicillin Mycelium production by-product that inactive with Lactobacillus plantarum, brevis, sake, Collenoid and Streptococcus lactis to inactivate penicillin and heat-treated nitrogen mixtures of Penicillium chysogen ATCC 48271 different carbohydrate sources and their hydrolysates nitrogen expressed as crude protein not less than 7% in ruminants. Pigs on the labelling or packaging of the product indicates: 1) "spawn silage obtained in the production of penicillin"; 2) nitrogen expressed as crude protein; 3) total ash; 4) moisture content; 5) the animal species or categories; 6) approval number. The labelling of compound feedingstuffs or on the packaging indicates: "Mycelium silage was obtained in the production of penicillin". 2.12, non-protein nitrogenous compounds 13. Ammonium salts 2.1 2.1.1. ammonium lactate produced by fermentation with Lactobacillus bulgaricus CH3CHOHCOONH4 whey nitrogen expressed as crude protein not less than 44%, ruminants, from the start of rumination processes, product label or on the packaging indicates: 1) "Ammonium lactate derived from fermentation"; 2) nitrogen expressed as crude protein; 3) total ash; 4) moisture content; 5) animal species or category. The labelling of compound feedingstuffs or on the packaging indicates: 1) "Ammonium lactate derived from fermentation"; 2) the quantity of product in feedingstuffs; 3) the percentage of crude protein provided by non protein nitrogen. Indicate in the instructions for use for each animal species or category of total non-protein nitrogen which should not exceed the daily feed ration 14.
  
2.1.2. Ammonium acetate aqueous Ammonium acetate CH3COONH4, in not less than 55% in ruminants, the start of rumination processes, product label or on the packaging indicates: 1) "ammonium acetate "; 2) nitrogen and moisture content; 3) the animal species or category. The labelling of compound feedingstuffs or on the packaging indicates: 1) "Ammonium acetate"; 2) the quantity of product in feedingstuffs; 3) the percentage of crude protein provided by non protein nitrogen. Indicate in the instructions for use for each animal species or category of total non-protein nitrogen which should not exceed the daily feed ration in 15.
  
2.1.3. Ammonium sulphate solution (NH4) 2SO4 ammonium sulphate, not less than 35% came from non-rumination processes on the label or packaging of the product indicates: 1) "ammonium sulfate"; 2) nitrogen and moisture content; 3) animal species. New product feed for ruminants should not mix the mixture more than 0.5%. The labelling of compound feedingstuffs or on the packaging indicates: 1) "ammonium sulfate"; 2) the quantity of product in feedingstuffs; 3) the percentage of crude protein provided by non protein nitrogen. Indicate in the instructions for use for each animal species or category of total non-protein nitrogen which should not exceed the daily feed ration. New product feed for ruminants should not mix the mixture more than 0.5% 16.2.2 the products obtained in the manufacture of amino acids by fermentation method 2.2.1. Concentrated liquid by-product of the production of L-glutamic acid by fermentation with Corynebacterium melassecol ammonium salts and other nitrogen compounds sucrose, molasses, starch products and their hydrolysates nitrogen expressed as crude protein not less than 48%,. Moisture not more than 28% in ruminants when rumination processes the product label or on the packaging indicates: 1) ' by-products from the production of L-glutamic acid "; 2) nitrogen expressed as crude protein; 3) total ash; 4) moisture content; 5) animal species or categories; 6) approval number. The labelling of compound feedingstuffs or on the packaging indicates the percentage of crude protein provided by non protein nitrogen. Indicate in the instructions for use for each animal species or category of total non-protein nitrogen which should not exceed the daily feed ration in 17.

2.2.2. the concentrated liquid L-lysine-monohlorīd by-products of fermentation with Brevibacterium lactofermentum ammonium salts and other nitrogen compounds sucrose, molasses, starch products and their hydrolysates nitrogen expressed as crude protein not less than 45% in ruminants, from the start of rumination on the labelling of Products or processes on the package shall state: 1) "L-lysine production by-products"; 2) nitrogen expressed as crude protein; 3) total ash; 4) moisture content; 5) animal species or categories; 6) approval number. The labelling of compound feedingstuffs or on the packaging indicates the percentage of crude protein provided by non protein nitrogen. Indicate in the instructions for use for each animal species or category of total non-protein nitrogen which should not exceed the daily feed ration in agricultural Minister j. Dūklav in annex 2 of the Cabinet of Ministers of 11 august 2009. Regulations No 902 arrangements for providing information about individual feed materials 1. General questions 1. Determining the order in which information about individual feed materials (hereinafter referred to as the conditions), are also set out the procedures for conducting research and preparing documentation on protein-containing feed material (hereinafter referred to as the product) obtained by cultivation of microorganisms, and that can be the source of protein in animal feed. Studies are conducted and the documentation shall be prepared according to the following general conditions: 1.1. terms these studies and, if necessary, use additional information; 1.2. the information on the record indicates: the identification of the micro-organism 1.2.1; 1.2.2. the composition of the culture medium; 1.2.3. the production process; 1.2.4. the characteristics of the product, design, conditions of use, teaching practices, the characteristics of the animal nutrition; 1.2.5. the species of individual sensitivity to the product in question; 1.2.6. the risks for man and the environment where the product is used for animal nutrition or diet of foodstuffs of animal origin; 1.3. the documentation includes detailed reports on research. The number of messages in the order as specified in the guidelines; 1.4. the documentation for the study; 1.5. If not done any conditions mentioned in the study, justify the reasons why it is not done; 1.6. the studies carried out on animals in accordance with fully determine a detailed research protocol by writing fills before the study started. 1.7. the studies involved respect animal welfare requirements. The food and veterinary service will monitor the trials involved in animal welfare; 1.8. before the start of the study in the study received the owner of animals used and the consent document. The owner of the animal shall be informed in writing of the effects after taking part in the study for the liquidation of the animals or food products from these animals. A copy of this notice, dated and signed by the owner of the animal, including documentation of the study; 1.9. the publications to which reference is made in the work. 2. After approval of the product by the manufacturer of the product indicates any change in the production process of the product, or in the conditions of use and, if necessary, prepare the documentation for a new study. 2. the information in the product documentation 2.1 micro-organism culture medium and manufacturing process, characteristics of product, presentation and conditions of use, methods of determination 1. Micro-organism: 1.1. classification, origin, morphology, biological characteristics, genetic manipulation carried out by micro-organisms; 1.2. safety, possible survival outside the fermenter and the effects of the environment, if the micro-organism in the environment; 1.3. stability of the micro-organism strain cultivated and pollution by other micro-organisms. The criteria of the test methods. 2. Culture medium and manufacturing process description: 2.1 structure of the substrate, added; 2.2. production, drying and purification process. Micro-devitalizācij (viability reduction) process. Product culture construction of the persistence test methods and any chemical, physical and biological damage detection in the production process; 2.3. technical processes in preparation for the use of the product. 3. The characteristics of the product: 3.1 physical and physico-chemical properties of makromorfoloģij and micro-morphology, part size, density, specific weight, higroskopism, solubility, electrostatic properties; 3.2. chemical composition and characteristics: 3.2.1. moisture content, crude protein, fats, kopceluloz, crude ash, carbohydrates. This diversity of composition; 3.2.2. total ammonium, amide, nitrate and nitrite nitrogen, nucleic acid, protein composition. Total and free amino acids, and piramidīn purine bases its qualitative and quantitative composition; 3.2.3. the total lipid (fatty acids, unsaponifiable matter, lipīdo soluble pigments, phospholipids) qualitative and quantitative composition; 3.2.4. the carbohydrate fraction; 3.2.5. inorganic component of the qualitative and quantitative composition; 3.2.6. qualitative and quantitative vitamin structure; 3.2.7. other components of the qualitative and quantitative structure-additives, residues of substrateand solvents, other potentially harmful residues of the metabolism of the substrate, feeds, production process; 3.3. microbiological contamination of the product; 3.4. the strength and stability of the product and tīrviel, both mixed with feed by using their feeding or during storage. 4. Product design and use: 4.1. proposed name for placing on the market; 4.2. proposed form for placing on the market; 4.3. intended uses in feedingstuffs. The estimated concentration of combined fodder and the quantity of the target species (animal species, provided the product) in the daily ration. 5. Detection methods-qualitative and quantitative methods for the determination of the full product feed and stuffs. Description of the methods to add information about a specific characteristics, sensitivity, detection limit, the limit of permissible errors, possible effects of other substances. Are available in a variety of product forms. 2.2. Research on the nutritional value of the product, the protein value of 1:1.1. chemical, biological and microbiological research; 1.2. studies on laboratory animals, compared to the protein reference value (the total amount of nitrogen daily intake of ruminants). 2. Studies are conducted with each of the target species, compared to the control group, which under the same conditions of feed balances receive dietary food with equivalent amounts of protein nitrogen as a total daily dose of nitrogen in ruminant. The study States: 2.1 product protein and energy value of the product under the proposed conditions of use and quantity of the various animal physiological periods (such as growth, pregnancy, the period of oviposition time); 2.2. the product's impact on the animal's growth rate, feed conversion (digestibility) speed, morbidity and mortality under the proposed conditions of use of the feed; 2.3. optimum nutritional levels of incorporation of the product in the animal's daily dose; 2.4. effect of the product under the proposed conditions of use on the technological, organoleptic or other quality indicators for food of animal origin. 3. Be informed of the experimental conditions of the target species, provide a detailed description of the studies conducted and information on: 3.1. animal species, breed, age, sex, identification procedure; 3.2. research group and the control group, the number of the number of animals in each group (the number down in order to allow for statistical analysis using suitable statistical parameters); 3.3. inclusion in product (recasting, soak) level, qualitative and quantitative ration composition and analysis; 3.4. each experimental venue, the animal's physiological condition and health, growing conditions, which comply with the legislation on animal welfare requirements; 3.5. exact duration of studies and analysis; 3.6. during the study known side effects and detection time. 2.3. Studies on the biological consequences of the use of the product in animal nutrition research objective is to assess the safety of the product, use it for target species, to determine the risks for man and the environment, which may directly or indirectly arise when the product is used for animal nutrition or food of animal origin. The toxicological studies required will depend on the nature of the product, the target species and the metabolism of the product in laboratory animals. 1. Studies carried out on each target species in comparison with a controlgroup receiving, under the same conditions of feed balances receive dietary food with equivalent amounts of protein nitrogen from common nitrogen for ruminants. Specify the following information: 1.1. maximum daily dose of the product, which does not cause adverse effects; 1.2. the possible effect of the product on the reproductive capacity and reproduction, if necessary; 1.3. effects of ingestion of the product (the natural intestinal microflora could be recycled products) under the proposed conditions of use, and the possible pathogenic micro-organisms or accumulation of substances in the gastrointestinal tract; 1.4. possible residues of the product (substrate, culture medium, solvents, toxic substances) foodstuffs of animal origin, under the proposed conditions of use; 1.5. the possible residues of the product (substrate, culture medium, solvents, toxic substances) animal excrement product under the proposed conditions of use. 2. studies on laboratory animals (trial): 2.1.-products spreading the metabolism in the body (absorption, high inflation of Akuma, biotransformation, excretion); 2.2. mutaģenēz. Contaminants (specifically mycotoxins and bacteria) or the balance of the product (substrate, culture medium, solvents) due to possible exposure to mutaģenēz's research, including vitroscreening tests using metabolic activation system; 2.3. toxicological studies carried out in comparison with the control groups that feed the same conditions receive a dietary balance food with equivalent amounts of protein nitrogen. Toxicological studies to explain the causes and mechanisms of exposure and make sure that it does not arise from unbalanced feed or product in dietary food overdose. Studies are conducted to determine the: 2.3.1. subchronic toxicity. The survey is carried out not less than 90 days, with two species, one of which is a rodent. Daily dose of the product for non-animal feed intake in at least two ways. Types are chosen in order to determine the level of safety of the product and the level of that show adverse effects. Animal groups being investigated include the appropriate number of representatives of each sex. Looking at you always provide for the control group. Scores recorded at regular intervals, in particular indicators on growth rate, feed intake, Hema toloģij, urine analysis, biochemical parameters, mortality, organ weights, heavy pathology and the main organs and vascular histopathology. The results reflect the detail and, as far as possible, also include the statistical evaluation; 2.3.2. chronic toxicity. The survey is carried out on two animal species, one of which is a rodent. The product is given in the daily ration in at least two ways of accommodating horse feed. Research carried out for at least two years in rats and at least 80 weeks in mice. The animal groups include representatives of both sexes. Provides for the control group. The subdivision referred to in point 2.3.1 examination to determine chronic toxicity is recommended with a small group of animals, which is separated from and dependent upon the main group, after the appropriate intervals throughout the experiment and the end of the surviving animals; 2.3.3. karcinoģenēz. Special attention to the appearance of tumors, any observed during the tumor type and histological tumor incidence. Effects on tumor incidence and frequency of the progress of the disease should be assessed relative to the control groups, as indicated in paragraph 2.3 of this subdivision. The results reflect the detail and, as far as possible, include statistical evaluation; 2.4. other studies. Breeding studies are conducted at least two son or daughter generations and can be combined with embryotoxicity including teratogenicity studies. Special emphasis on fertility, fertility and litter observations of postnatal development. You can use any other method which is scientifically justified and can bring measurable results (e.g. variable toxicity); 2.5. conditions for experimental studies with laboratory animals. The documentation provides detailed descriptions of the experiments carried out and information about: 2.5.1. animal species, breed, and sex; 2.5.2. the experiment and control groups, number of animals in each group (the number should be large enough for statistical analysis, using appropriate statistical parameters); 2.5.3. levels of incorporation of the product, qualitative and quantitative ration composition and analysis; 2.5.4. General rearing conditions throughout the study period; 2.5.5. exact experiment and analysis; 2.5.6. the death time and frequency in different inspection teams; 2.5.7. clinical symptoms and patoloģiskaj changes that occurred during the study, and their appearance. 3. Environmental studies. Depending on the product potential of residues (substrate, culture medium, balance, contaminants) in the target species of animal excrement of nature provides news about the spread of residue kūtsmēslo, land and water, as well as on exposure levels to the Earth's biodiversity indicators, plant growth and aquatic life. 2.4. Other relevant studies depending on product characteristics and conditions of use may request information on allergic effects on skin and eye irritation of mucous membrane, respiratory or digestive tract, to assess the potential risks associated with the products and eliminate this risk.
Minister of agriculture j. Dūklav in