State registration of feed additives for animals
Order of the Ministry of Agriculture of the Russian Federation of April 1, 2005 N 48 "On approval of the Rules for state registration medicines for animals and feed additives» (as amended on December 27, 2005, August 8, 2006)
In order to implement the requirements of the Law of the Russian Federation of May 14, 1993 N 4979-1 "On Veterinary Medicine" (Bulletin of the Congress of People's Deputies Russian Federation and the Supreme Council of the Russian Federation, 1993, N 24, Art. 857; Collection of Legislation of the Russian Federation, 2002, N 1 (part I), art. 2; 2004, N 27, art. 2711; 2004, N 35, art. 3607) and federal law of June 22, 1998 N 86-FZ "On Medicines" (Collected Legislation of the Russian Federation, 1998, N 26, Art. 3006; 2000, N 2, Art. 126; 2002, N 1 (Part I), Art. 2; 2003, N 2, item 167; 2003, N 27 (part I), item 2700; 2004, N 35, item 3607) I order:
1. Approve the Rules for State Registration of Medicines for Animals and Feed Additives (attached).
2. Rosselkhoznadzor to carry out the state registration of medicines for animals and feed additives in accordance with the specified Rules.
3. To impose control over the execution of the order on the Deputy Minister S.G. Mitina, Minister A.V. Gordeev Registered with the Ministry of Justice of the Russian Federation on April 14, 2005 Registration N 6510 By order of the Ministry of Agriculture of the Russian Federation of August 8, 2006 N 222, changes were made to this Appendix See the text of the application in the previous edition Appendix to the order of the Ministry of Agriculture of the Russian Federation of April 1, 2005 N 48
Rules for State Registration of Medicinal Products for Animals and Feed Additives (as amended on December 27, 2005, August 8, 2006)
1. Rules state registration medicines for animals and feed additives (hereinafter - the Rules) are developed in accordance with the Law of the Russian Federation of May 14, 1993 N 4979-1 "On Veterinary Medicine", Federal Law of June 22, 1998 N 86-FZ "On Medicines ”, Regulations on the Ministry Agriculture of the Russian Federation, approved by Decree of the Government of the Russian Federation of March 24, 2006 N 164 and the Regulations on the Federal Service for Veterinary and Phytosanitary Surveillance, approved by Decree of the Government of the Russian Federation of June 30, 2004 N 327.
2. The Rules establish a unified procedure for the state registration of domestic and foreign medicines for animals (hereinafter referred to as medicinal products) and feed additives (hereinafter referred to as additives), with the exception of feed additives obtained from genetically modified organisms.
3. The procedure for state registration of medicinal products and additives established by the Rules is mandatory for legal entities and individuals engaged in the production, sale, use, as well as importation into the territory of the Russian Federation of medicinal products and additives.
4. The following are subject to state registration: new medicines; new additives; new combinations of previously registered medicinal products; new combinations of previously registered additives; Medicinal products previously registered but manufactured in other dosage forms, or with a new dosage, or with a different composition of excipients; additives previously registered but produced in different forms, or with a new dosage, or with a different composition of excipients; generic drugs; reproduced additives.
5. State registration of medicines and additives is carried out by Rosselkhoznadzor on the basis of the conclusion of the Federal State Institution "All-Russian State Center for Quality Control and Standardization of Medicines for Animals and Feed" (hereinafter - FGU "VGNKI") within six months from the date of submission of registration documents and data provided for in these Rules.
6. For state registration of a medicinal product or additive, the Applicant shall submit the following registration documents and data to Rosselkhoznadzor: an application for state registration of a medicinal product or additive (Appendix to the Rules); legal address of the organization - manufacturer of the medicinal product or additive; drug or supplement name, including international non-proprietary name, scientific name in Latin, main synonyms; the original name of the medicinal product or additive, if it is registered as a trademark in accordance with the legislation of the Russian Federation on trademarks, service marks and appellations of origin; a list of components that make up the medicinal product or additive, their quantity; instructions for the use of a medicinal product or additive, drawn up in accordance with the requirements of the Federal Law of June 22, 1998 N 86-FZ "On Medicines"; certificate of quality of the medicinal product or supplement; data on the production of a medicinal product or supplement; quality control methods for the medicinal product or additive; results of preclinical studies of the medicinal product or supplement; results of pharmacological and toxicological studies of the medicinal product or supplement; results of veterinary research; samples of a medicinal product or additive for examination of its quality; proposals for the price of a medicinal product or supplement; documents confirming the registration of a medicinal product or additive, if it is registered outside the Russian Federation.
7. Examination of medicines and additives is carried out by FGU "VGNKI" * by agreement of the parties. Examination of medicines and supplements includes: a) a specialized assessment of registration documents in order to draw up a reasoned conclusion about the efficacy, safety and quality of the medicine or supplement; b) study of samples of the medicinal product or additive for compliance with the requirements of regulatory and technical documentation for quality control of the medicinal product or additive and the reproducibility of the proposed research methods.
8. Based on the results of the examination, FGU “VGNKI” sends a reasoned conclusion to the Rosselkhoznadzor on the possibility or impossibility of registering a medicinal product or additive.
9. Based on the results of consideration of the documents and on the basis of the expert opinion of the Federal State Institution "VGNKI", Rosselkhoznadzor makes a decision on registration or on a reasoned refusal to register a medicinal product or additive. In case of submission of an incomplete set of registration documents and data, as well as in case of doubts about the quality and reliability of the submitted materials, the state registration procedure is suspended for a period not exceeding 3 months. If the Applicant fails to submit the missing materials about the medicinal product or additive within the established time limits, as well as if the submitted materials are found to be unreliable, the state registration of the medicinal product or additive is refused. Based on the decision on registration, the Rosselkhoznadzor issues to the Applicant a document of the established form on state registration for each form of (medicinal) drug or additive for a period of 5 years, an approved instruction for the use of the drug or additive, and agreed regulatory and technical documentation.
10. Registration of a medicinal product or additive may be suspended if a side effect of the medicinal product or additive is detected or if information about it is received that was not known at the time of registration.
11. During the period of validity of the state registration document, the Applicant is obliged to report any changes that are supposed to be made to the registration documents and provide comprehensive information about the reasons for these changes and their impact on the efficacy, safety and quality of the registered medicinal product or additive, including on changes in technology and place of production.
12. Six months before the expiration of the document on state registration, the Applicant has the right to apply for registration of a medicinal product or additive for a new period.
13. A registered medicinal product or additive is entered in the state register of medicinal products for animals and feed additives.
14. Rosselkhoznadzor, within 10 days after the state registration of a medicinal product or additive, sends the following information to the Ministry of Agriculture of Russia for entering into the state register of medicinal products for animals and feed additives: a) the name of the medicinal product or additive; b) the form of the medicinal product or supplement; c) indications (field) of use of the medicinal product or additive; d) the Applicant (indicating the country or subject of the Russian Federation in which the Applicant is registered); e) manufacturing organization (indicating the country or subject of the Russian Federation in which the manufacturing organization is registered); f) registration number of the medicinal product or supplement; g) registration series of the Applicant (organization-manufacturer); h) date of registration of the medicinal product or additive; i) the period of validity of the registration of the medicinal product or additive.
15. If it is necessary to make changes to the state register of medicines for animals and feed additives, Rosselkhoznadzor sends the relevant information to the Ministry of Agriculture of Russia in the manner prescribed by paragraph 14 of the Rules.
16. The Ministry of Agriculture of Russia enters the information received into the state register of medicines for animals and feed additives no later than 5 days from the date of their receipt. Not later than 5 days after entering the information received in the state register of medicines for animals and feed additives, the Ministry of Agriculture of Russia sends an extract from the state register of medicines for animals and feed additives to Rosselkhoznadzor for issuing it to the Applicant.
17. The information contained in the state register of medicines for animals and feed additives is open to the public on the website of the Ministry of Agriculture of Russia on the Internet, and is also subject to publication by the Ministry of Agriculture of Russia.______________________________ * Article 16 of the Law of the Russian Federation of May 14, 1993 N 4979-1 "On Veterinary Medicine". By Order of the Ministry of Agriculture of the Russian Federation of December 27, 2005 N 236, these Rules are supplemented by the Appendix Appendix to the Rules for the State Registration of Medicines for Animals and Feed Additives (SAMPLE) trade name of the product - medicinal product for animals / feed additive) 1. Applicant ________________________________________________________________________ (full name legal entity in accordance with the constituent documents) 2. Location of the Applicant ________________________________________________________ ___________________________________________________________________________________________ (location address, telephone/fax, TIN of a legal entity) date/N) 4. Product information (medicine for animals/feed additive): 4.1. Product name _____________________________________________________________ (trade name/original name in Russian, scientific name in Latin _________________________________________________________________________________, including the international non-proprietary name of the animal medicinal product/feed additive) 4.2. Release form __________________________________________________________________ 4.3. Composition _________________________________________________________________________ (component composition of products according to the pharmaceutical group, active ingredient) _________________________________________________________________________________________ (presence of components of plant / animal origin that do not contain GMOs) 4.4. Purpose ________________________________________________________________________ 5. Availability of a patent, its number, owner _____________________________________________ 6. Product developer ____________________________________________________________ (name of legal entity, location address, telephone number) ___________________________________________________________________________________________ 7. Product manufacturer ________________________________________________________________ (location address, telephone number) ____________________________________________________________________________________________________ (name of manufacturer/name of foreign manufacturer) 8. Information on registration of products 005 ___________________________________________ (Signature of the Applicant/representative of the Applicant) ___________________________________________ (Full name, position held) Stamp
1. filed
The application has been submitted to the Department for Supervision of the Circulation of Medicinal Products for Veterinary Use
2. Sent to FGBU VGNKI
The registration dossier and samples were sent to the Federal State Budgetary Institution for registration tests
3. Agreement for registration tests
The applicant and FGBU VGNKI concluded an agreement for registration tests
4. Payment made
Payment for registration tests at FGBU VGNKI
5. Registration tests
FGBU VGNKI conducts registration tests of samples
6. Preparation of an expert opinion
Based on the registration tests, the FGBU VGNKI prepares an expert opinion
7.
The applicant is recommended to provide additional information/make changes to the documentation
8. Conclusion FGBU VGNKI
Based on the test results, the Federal State Budgetary Institution gives a conclusion on the possibility of registering a medicinal product / feed additive
9. Documents submitted to Rosselkhoznadzor
After the registration tests were carried out at the Federal State Budgetary Institution VGNKI, the documents were submitted for consideration to the Department for Supervision of the Circulation of Medicinal Products for Veterinary Use of the Rosselkhoznadzor
10. Harmonization of regulatory documents
The head of the department of veterinary supervision of the Rosselkhoznadzor is coordinating the regulatory and technical documentation and instructions for use
11. Documents sent for revision
The applicant is recommended to make changes to the regulatory and technical documentation / instructions for use
12. Documentation approval
Deputy Head of the Rosselkhoznadzor approves the regulatory and technical documentation for the medicinal product / feed additive
13. Registered / Registered
Date of state registration of the medicinal product/feed additive
14. Removed from registration
The application was withdrawn from registration at the request of the applicant or by decision of the Rosselkhoznadzor
15. Registration suspended
State registration procedure suspended
16. Application suspended
Application suspended
17. State registration denied
According to the conclusion of the commission of experts, state registration was denied
18. Registration canceled
Registration canceled
19. State registration confirmation
An application for confirmation of state registration has been submitted
20. Alteration
Change request submitted
Russian Federation of May 14, 1993 N 4979-1 "On Veterinary Medicine", Federal Law of June 22, 1998 N 86-FZ "On Medicines", as well as in accordance with the Regulations on the Federal Service for Veterinary and Phytosanitary Surveillance, approved by Decree of the Government of the Russian Federation of June 30, 2004 N 327, and by Order of the Ministry of Agriculture of the Russian Federation of April 1, 2005 N 48 "On Approval of the Rules for the State Registration of Medicines for Animals and Feed Additives" I order:
CONSIDERATION OF APPLICATIONS FOR THE STATE
REGISTRATION OF MEDICINAL PRODUCTS FOR ANIMALS
APPLICATION I ask you to register in the Russian Federation a medicinal product for animals / feed additive of domestic (foreign) production __________________________________________________________________ (trade name of the product - medicinal product for animals / feed additive) 1. Applicant ________________________________________________________________________________ (full name of the legal entity in accordance with the constituent documents) 2. Location Applicant ___________________________________________ (address of location, __________________________________________________________________ phone/fax, TIN of a legal entity) animals/feed additive): 4.1. Product name ________________________________________________ (trade name/original name __________________________________________________________________ in Russian, scientific name in Latin, including the international non-proprietary name of the animal medicinal product/feed additive) 4.2. Release form _______________________________________________ 4.3. Composition ______________________________________________________ (component composition of products according to the pharmaceutical group, active substance) __________________________________________________________________ (presence of components of plant/animal origin that do not contain GMOs) 4.4. Purpose __________________________________________________ 5. Availability of a patent, its number, owner __________________________ 6. Product developer _____________________________________________ (name of legal entity, __________________________________________________________________ location address, telephone number) 7. Product manufacturer _______________________________________ (location address, telephone number) __________________________________________________________________ manufacturer on English language) 8. Product registration information ______________________________ __________________________________________________________________ (registration number and date in the Russian Federation, registration expiration date, registration abroad) .O., position held) Seal
Appendix No. 2
to the procedure for consideration of applications
on state registration
medicines for animals
and feed additives
REQUIREMENTS
FOR APPLICATION INSTRUCTIONS
MEDICINE OR FEED ADDITIVE
1. The name of the medicinal product or additive is Russian and Latin. Synonyms.
2. Composition. The content and chemical name of the active (their) and auxiliary (s) substances of the medicinal product or additive.
3. Form (medicinal). Appearance. Physical and Chemical properties (state of aggregation, color, transparency, solubility in water and other solvents).
4. Release form. Packing, packaging, labeling, storage conditions, transportation and shelf life of the medicinal product or supplement.
II. Pharmacological (biological) properties
5. The mechanism of action of the drug or additive.
6. Basic pharmacological, biological and other properties of a medicinal product or additive (bioavailability, toxicity, pharmacokinetics, excretion from the body, immunogenicity, reactogenicity, nutritional value, etc.).
III. Application procedure
7. Indications for use (list).
8. The procedure and conditions for the use of the medicinal product or supplement, indicating the type of animal, method, doses (single, daily, multiplicity, course), before or after feeding, diet when using the medicinal product or supplement, etc.
9. Possible side effects and complications. Prevention and treatment measures (antidotes, decontamination, neutralization).
10. Compatibility with other drugs and supplements.
11. Contraindications for use.
12. Terms of possible use of animal products after the use of a medicinal product or additive and in case of forced slaughter.
IV. Measures of personal prevention
26.06.2018
- Dear Tatyana Nikolaevna, good afternoon. As you know, as of July 1, 2018 instead of issuing paid paper veterinary accompanying documents in the state veterinary service a complete transition to electronic certification products. Although this transition has been planned for a long time, specialists still have many questions and concerns. In particular, representatives of the feed industry are interested in what kind of specialist will be able to carry it out?
Good afternoon, Vera Pavlovna. So what about fears? As in the well-known joke: “Don’t sit, but you have to start!”. In addition, not everything is so scary: so, according to by order of the Ministry of Agriculture RF No. 646, certification of feed products can be carried out by employees of enterprises that do not have a veterinary education.
For the transition, it is necessary to adjust the system of warehouse accounting for goods and integrate the system accounting with the Mercury system. Of course, the difficulties of the transition period will have to be overcome, but in the end this will allow manufacturers of products, after one-time investments, to significantly reduce time and money costs. In addition, this is easily feasible for compound feeders, and there are already enterprises that have switched to electronic registration of VSD (veterinary and sanitary documentation). The introduction of automatic blanking and registration of VSD at the weighing enterprise facilitates the work.
On the Rosselkhoznadzor website, you can get information about the educational version of the Mercury system. Before switching to a productive version, it is proposed to practice on a pilot project.
- How is VSD issued when exporting goods?
In order to enforce veterinary requirements importing countries at veterinary certification goods exported (to the CIS and EAEU countries) issued an instruction from the Rosselkhoznadzor, according to which it is necessary to conduct laboratory tests of goods for their compliance with the requirements contained in the regulatory documents of the CIS and the EAEU, in interstate standards, as well as the requirements of third countries.
Enterprises must submit product samples for analysis in laboratories that have the appropriate accreditation, implemented methods for compliance with the requirements of importing countries and use FGIS "Vesta" for the collection, transmission and analysis of information on laboratory studies of feed quality. In veterinary accompanying documents it is enough to indicate the numbers of examinations when certifying products. The use of the Vesta system is available to any laboratory in the Russian Federation, regardless of the form of ownership. But there is no registry of laboratories that use VESTA and have implemented the necessary methods. This is an obvious oversight of the regulator. However, according to the Rosselkhoznadzor, all RSHN laboratories work in this system.
- Is there any news regarding the cancellation of the state registration of premixes and BVMK?
Feed additives are registered in accordance with the order of the Ministry of Agriculture No. 48 of April 1, 2005 "On approval of the rules for state registration of medicines for animals and feed additives." In 2010, Federal Law No. 61 “On the Circulation of Medicines” came into force, and Order No. 48 has since become invalid. But with regard to the registration of feed additives, no other document was adopted, and Rosselkhoznadzor still continues to require registration of premixes on the basis of this document, considering the premix a feed additive. For several years, the Ministry of Agriculture has been developing a draft resolution of the Government of the Russian Federation on the registration of feed additives, but it is repeatedly rejected by the Ministry of Justice. This draft provides that all feed additives are subject to registration, with the exception of: intended for export and for scientific research; registered in other states of the Eurasian Economic Union; premixes, BVMK, containing additives registered in the EAEU. This document is currently in again is being approved by the Ministry of Justice.
It is planned to introduce a state duty in the amount of 160 thousand rubles. for conducting an examination of feed additives and issuing a certificate of their registration from January 1, 2019. In order to legalize the introduction of state duty, it is necessary to amend the Tax Code and the law “On Veterinary Medicine”.
- Industry experts are already seven years waiting for the long-suffering technical regulations "On the safety of feed and feed additives". Is there any progress on this issue?
In 2016, a coordinated Russian position, harmonized with the EU directives, was sent to the EEC. But in May 2017, the Rosselkhoznadzor announced the need to revise the Russian position regarding the definition of objects technical regulation, since the inclusion of feed additives in the definition of “feed” does not comply with the legal framework of the EAEU member states, and will also require significant changes in the system of existing industry documents, GOST, etc. economic commission. In the EU, feed includes all products that are to be fed to animals, which is quite logical, but it is also logical that feeds carry a nutritional load, and feed additives perform various functions: zootechnical, technological, sensory, and also regulate the metabolism in the animal body . Feed is subject to declaration, and feed additives are subject to registration. In order to accelerate the adoption of technical regulations, it is necessary to find a solution that meets the interests of all market participants. At the same time, adaptation remains an important task. international experience to Russian realities. We consider it acceptable to divide the objects of technical regulation into feed and feed additives both in a conceptual sense and in a legislative manner. Premixes cannot be classified as feed additives, as they are a pre-mixture of registered additives, which is produced in feed mills and premix plants, where mixing uniformity is achieved. More dramatic is the fact that in our work on product safety issues, we are forced to be guided by temporary MRLs developed and approved in the 1970s and 1980s, as well as certain paragraphs of the technical regulation of the Republic of Kazakhstan “Requirements for the safety of feed and feed additives”. Veterinary regulations and the norms developed in 2003 were never approved. There are no documents containing definitions of the basic concepts and terms "feed" and "feed additives".
-FROM Now production workers and businesses are concerned about changes in the part of scheduled inspections. Can you shed more light on this issue?
- Indeed, in In the coming year, we will be affected by amendments regarding the conduct of scheduled inspections. In these amendments, the government will apply a risk-based approach, according to which enterprises in the feed industry are classified as moderate-risk enterprises and are subject to inspection once every five years. But there is one “but”: if the control body received a consumer appeal about a minor violation of mandatory requirements, and the culprit was not previously held accountable, then the control body will have the right not to conduct an inspection, but to announce a warning. The consumer's appeal regarding the violation of his rights will entail an unscheduled inspection only if the consumer filed a claim with the organization, but his appeal was not considered or the requirements were not satisfied.
If it is impossible to carry out the verification due to the absence of the head of the organization on site, a special act is drawn up about this. In this case, the supervisory authority will have another three months to decide whether to conduct a scheduled or unscheduled on-site inspection without prior notice.
When conducting inspections, an innovation will be introduced - the use of checklists by type of activity, where it will be clearly stated what exactly is to be checked, as well as at what point, at what normative act this requirement is included. When inspecting compound feed producers, inspectors refer to separate paragraphs of the TR “Requirements for the safety of feed and feed additives”. Knowing the content of the checklists will help entrepreneurs to prepare for the check in a timely manner.
- Tatyana Nikolaevna, the Ministry of Agriculture is developing methodological guidelines for the assessment biosecurity use of genetically modified (GM) organisms for the production of feed and feed additives and guidelines on conducting molecular genetic studies of genetically modified organisms for the production of feed and feed additives . How will this affect the procedure for state registration of this type of feed and what risks do feed producers with GM products have?
- Yes, such a process is underway. The absence of these guidelines is the main reason for the Rosselkhoznadzor to stop the state registration of GM feed. At the beginning of 2018, changes were made to Decree No. 839, according to which the Sodruzhestvo Group of Companies registered GM soybean meal for 5 years.
Compound feed products containing registered GM components are not subject to registration. The content of GM components of more than 0.9% is subject to declaration and labeling in accordance with the law on the protection of consumer rights (valid for sales of packaged feed through stores for the population and farmers), as well as with the 22nd technical regulation on labeling food products. There is no such regulatory document for feed, but this does not prevent supervisory authorities from applying food regulations.
There are disputable cases when soybean meal is not introduced into compound feeds and these products, accordingly, are not declared, but control studies in the laboratory reveal a GMO content of more than 0.9%. It is possible for GM soybean meal to enter as an accidental impurity in negligible quantities from the occurrence zones technological equipment. But the methodology used determines the percentage of GM soybeans as the ratio of the amount of DNA of a genetically modified soybean of a certain line to total The DNA of all soy contained in the feed, i.e. in relation to itself.
This leads to an unreliable result: the test reports indicate that more than 0.9% GMOs were found, although the manufacturer did not introduce GM components and, accordingly, did not declare (label) its products as containing GMOs. As a result, penalties are applied to it, up to the destruction of products, although the content of GM soybean meal permitted for use in the feed is not dangerous. While work is underway on laboratory methods, feed mills remain at risk of sanctions.
- IN March, the Ministry of Justice registered an order Federal Service on Veterinary and Phytosanitary Surveillance dated January 30, 2018 No. 53 “On Approval of the Guidelines for Ensuring the Functioning of the Federal State information system(FSIS) in the field of veterinary medicine. Tell our readers about this system.
- Yes, such a request accepted. It determines the operation of the veterinary information system (VetIS), which includes the Cyrano, Argus, Mercury, Vesta, Cerberus and Irena systems. The document prescribes the functions of the systems, user access and identification, establishes the types of users, the composition of the information entered, etc. VetIS must ensure the traceability of regulated goods. It will be used to issue permits for import, export and transit to the Russian Federation. This system is also designed to record the results of laboratory tests and take samples for them. VetIS will be used to collect, process and store information on the subjects of veterinary supervision (subjects, objects, processes) and state control over the circulation of medicines for veterinary use. Another area of application - monitoring of key industry indicators and notification of their excess and other tasks in the field of veterinary medicine.
- It is known that there are cases when feed mills become hostages in relations with unscrupulous grain suppliers. And they are often fined. Is it possible to change this situation?
Yes, we hope so, and The initiative to change the rules of the game in the grain market comes from the Federal Tax Service.
Indeed, the market for domestic grain processing has not yet been rebuilt. In order to intensify the processes of “whitewashing” the market, the Federal Tax Service plans to carry out field tax audits with the involvement of law enforcement agencies. Feed mills work directly with farmers or traders in non-grain regions. Unscrupulous suppliers who do not have assets buy from agricultural producers without VAT, but more expensive than processors would buy, and sell to feed mills with VAT, thereby stealing from the state. The processor puts the VAT to be reimbursed, and the Federal Tax Service does not accept documents, as it sees a gap in the payment of VAT. Litigation begins. Feed mills are under threat because they really exist, they have assets, their leaders are real people. When carrying out tax control measures, the tax authorities are looking for the beneficiary, that is, the real company, from which, in the event of additional charges, it will be possible to recover the accrued tax payments. The “Charter of the conscientious taxpayer” is currently being developed. Companies that sign this document undertake not to participate in illegal VAT refund schemes and not to receive competitive advantage due to non-payment of taxes. Members of the Charter, when choosing a supplier, will require him to comply with the rules of the taxation system, such as: no gaps in the payment of VAT in the supply chain, the balance sheet value of the supplier's fixed assets of at least 50 million rubles, documentary confirmation of the supplier that the founder is individual. A website for Charter members is currently being created, where some members will inform others that certain suppliers are using tax schemes. Then such a supplier either wants to work correctly so as not to be at risk, or they will not buy products from him. Companies that have chosen these counterparties will not be able to prove due diligence to the tax office, which will serve as the basis for audits. This will help remove dishonest intermediaries in the chain.
- Tatyana Nikolaevna, thank you very much for taking the time for us. We hope for the best for our feed industry and for new meetings with you!
Number of impressions: 2230
Author: Interviewed by V. Dubinskaya
According to the statistics of the organizers of the exhibition "Cereals-Mixed Feed-Veterinary", the main purpose of the visit was to get acquainted with new products and technologies. On the eve of the exhibition, we publish an ordered list of feed additives presented in the official state register.
As you know, the use and launch of new feed additives on the market is impossible without registration with the Rosselkhoznadzor. The rules for state registration of medicines for animals and feed additives were approved by order of the Ministry of Agriculture dated April 1, 2005 No. 48.
They obligated manufacturers and distributors to register original medicines and feed additives; new combinations of previously registered medicines and feed additives; produced in new forms, with a new dosage, with a different composition, as well as generic drugs and feed additives. Rosselkhoznadzor registers a new product based on the expertise of the All-Russian state center quality control and standardization of medicines for animals and feed (VGNKI).
On August 8, 2006, these rules were amended (Order of the Ministry of Agriculture No. 222), placing on the Rosselkhoznadzor the obligation to maintain an open register of registered feed additives. The registration process for a new product takes about six months and includes preclinical and clinical studies, preparation of a registration dossier for submission to the Rosselkhoznadzor, its submission, examination by VGNKI and the issuance of registration documents. The volume of documents required for registration is quite impressive, which has led to the emergence of intermediaries on the market who take all the red tape.
The registration dossier includes the following documents and information:
.application for state registration of the additive;
legal address of the organization - the manufacturer of the additive;
additive names, including international non-proprietary name, scientific name in Latin, main synonyms;
the original name of the additive, if it is registered as a trademark;
a list of components that make up the additive, their quantity;
instructions for the use of the additive;
additive quality certificate;
data on the production of the additive;
additive quality control methods;
results of preclinical studies of the supplement;
results of toxicological studies of the additive;
results of veterinary research;
additive samples for examination of its quality;
proposals for the price of the additive;
documents confirming the registration of the additive, if it is registered abroad;
power of attorney (from the developer of the feed additive to the manufacturer, from the manufacturer to the applicant, from the applicant to the representative of the applicant).
Initially, the registration period for feed additives and veterinary products was five years. On April 26, 2010, the next changes in the rules made the registration of feed additives indefinite (Order of the Ministry of Agriculture No. 83). Market participants perceived the innovation as a long-awaited reduction in administrative pressure on business.
On July 14, 2006, the government adopted a regulation on the state registration of feed obtained from genetically modified organisms (Decree No. 422). So since 2007, the Rosselkhoznadzor began to maintain the third register - feed products containing GMOs. Today he reads 128 titles. Excluding expired products current list feed additives with GMOs is 97 positions. This is down from 112 such supplements in 2014. Behind last year The list was replenished with only 15 lines. In half of the cases, this was the re-registration of products already included in the register.
Today, the registration service for feed additives (both with and without GMOs) is available on the public services portal. In both cases, it is provided by Rosselkhoznadzor free of charge, but you will have to pay for the registration tests of VGNKI. Prices for the services of the institution vary significantly depending on the product category and the list of necessary tests. According to industry representatives, the average cost of registering a feed additive is 200-300 thousand rubles.
Since the concept of “feed additive” is not disclosed in Order No. 48, an answer on the need to register a new category of additive can only be obtained from the Rosselkhoznadzor. The official request is considered within 30 days. Another option is to try to find analogues of this tool in the state register on your own. Let's hope that our review will make this task easier for readers.
Issues of registration of feed additives became even more acute after the launch of the Customs Union. In 2010, unified veterinary and sanitary measures were approved on the territory of the Customs Union (Decision of the Customs Union of June 18, 2010 No. 317). In particular, this large-scale document concerns the circulation of feed additives and veterinary drugs on the territory of the union. According to paragraph 3.13 of the Regulations on the unified procedure for the implementation of veterinary control at the customs border of the Customs Union and on the customs territory of the Customs Union, the participating countries mutually recognize the results of registration of veterinary drugs and feed additives. Over the past five years, the normative integration of Russia, Belarus and Kazakhstan has not progressed much. At least from the point of view of the market of feed additives and veterinary preparations. Each side remains with its technical requirements(they will not accept the general technical regulations in any way) and their own state register. For this reason, the Russian register of registered feed additives cannot be considered exhaustive: additives from the Belarusian or Kazakh registers may well be sold on the domestic market. According to the press secretary of Rosselkhoznadzor Alexey Alekseenko, the register of feed additives in the Customs Union should be general. But when such a list will appear is unknown.
*Including feed additives for unproductive animals.
Source: SoyaNews calculations
As of December 30, 2014, the Belarusian state register contains 699 feed additives, including 1 premix for dogs. The annual list of feed additives is approved by the Ministry of Agriculture and Food of Belarus. Products outside this list can be imported into the country under a permit valid for one year. Additives are registered for 5 years. The procedure is carried out in accordance with the Regulations on the procedure for state registration of feed additives, approved by the Resolution of the Council of Ministers of the Republic of Belarus dated 07.06.2012 No. 529.
As of December 31, 2014, the Kazakh state register contains 498 feed additives, including pet food. The registration procedure is prescribed in the Rules for State Registration of feed additives for the first time produced (manufactured) and imported (imported) into the territory of the Republic of Kazakhstan for the first time, approved by the Decree of the Government of the Republic of Kazakhstan dated February 20, 2008 No. 175. Unlike other members of the CU, feed additives are registered in Kazakhstan for a 6-year period.
It is impossible today to calculate the feed additives registered in Armenia, which became a full member of the Customs Union on October 10, 2014 due to the lack of a Russian-language version of the website of the Armenian Ministry of Agriculture. According to the Rosselkhoznadzor, the use of feed in the country is regulated by the Armenian law “On Feed” and by-laws. On the website of the Ministry of Agriculture of Kyrgyzstan, which will enter the Customs Union on May 1, 2015, there is no open register of registered feed additives. The only thing we managed to find out is that the registration of such products is carried out in accordance with the technical regulations “On the safety of feed and feed additives” (approved by the Decree of the Government of Kyrgyzstan dated May 22, 2014 No. 268) and is valid for 5 years.
However, back to Russian legislation. Market participants have repeatedly suggested that officials refuse to register mixtures and combinations of registered feed additives with a variable composition. For example, the seventh edition of the administrative regulation on the provision by the Rosselkhoznadzor of the service for the state registration of feed additives (not yet adopted) exempted vitamin mixtures, mineral mixtures, vitamin-mineral mixtures, premixes, protein-vitamin-mineral concentrates and protein-vitamin-mineral supplements from registration. manufactured in the territory of the Customs Union. The recipes of such products are constantly being adjusted to the needs of a particular client, and he will not wait half a year. Judging by the official list of mixtures, premixes and BVMK, manufacturers have gone the middle way, registering only basic recipes.
The lobbyists also failed to exclude from order No. 48 the provisions on the registration of reproduced additives already added to the register, and their modified variations. In case of re-registration or change of manufacturer, VGNKI gives a discount: secondary registration costs 30% of the price of the primary one.
Permanent re-registration leads to constant movement official registries. Products disappear from there, only to reappear six months later. There is confusion, it becomes more difficult to track new items. Even a targeted search is significantly difficult due to the many mistakes made by officials when maintaining the register in the Irena automated system. For example, some products of Premier Nutrition, AFB International, Lohmann Animal Health, Adisseo and other foreign manufacturers are listed as domestic.
And genetically modified soybeans of the SYHT0H2 (Syngenta) line, completely new for Russia, became legal in our country for just one day - April 11, 2014, when its registration began and ended.
For daily practical application livestock breeders and feeders, the register lacks a clearer classification of items. The column "Type of feed additive" is filled with data on the method of production (plant / animal origin, chemical / microbiological synthesis). It is quite difficult to find information in the register about what is new, for example, on the market for silage starter cultures or feed pigments. In addition, many positions are filled backdating, so the additions to the lists are not visual. Having pet food additives on the registry is very distracting. By the way, representatives of the pet industry have long been talking about the need for separate technical regulation in their field.
As of January 12, 2015, it contains 1,796 feed products. After subtracting expired and non-food additives, and after including registered GMO feed products (they are recorded by officials in a separate register), there were 1,612 feed additives on our list. It was they who became the object of our assortment analysis, which does not pretend to be final.
We have divided this array into 19 main categories. This will allow us to consider in detail the level of competition in each of the feed market niches and weigh the prospects for the promised import substitution. So, our unofficial registry contains 267 premix brands, 180 acidifiers to reduce pathogenic microflora and improve digestion, 163 vitamin and mineral blends, 145 enzymes and enzyme complexes, 142 feed vitamins, 76 mycotoxin adsorbents, 76 protein-vitamin-mineral concentrates, 68 feed preservatives, 65 micronutrients for the production of premixes and animal feed, 64 energy feed additives, 62 feed amino acids, 48 flavors, 39 probiotics, 30 protein supplements, 29 feed antioxidants, 21 milk replacers, 21 carotenoids , 21 names of GMO prestarters and finished feeds and 95 other additives that do not fit into these categories.
Source: SoyaNews calculations
308 of them are made in Russia (against 345 domestic products of the official list), which is slightly more than 19%. Thus, Russian manufacturers own the largest share of the assortment offered by the market. And this is without taking into account domestic compound feeds, which are not reflected in the list, since only compound feeds containing GMOs are subject to registration.
Source: SoyaNews calculations
And yet, the vast majority of feed additives circulating on the Russian market are produced abroad. These are 1304 additives, or 81% of the market assortment. Germany supplies 264 feed additives to Russia, the Netherlands - 183 additives, China - 126 additives, France - 103 additives, Belgium - 101 additives, Spain - 94 additives, Great Britain - 58 additives, USA - 53 additives, Austria - 44 additives, Poland - 35 additives, Denmark - 27 additives, Bulgaria - 25 additives, Finland - 22 additives, Italy and Switzerland - 20 additives each, Hungary - 19 additives, India, Czech Republic and Malaysia - 17 additives each, Ireland and Lithuania - 11 additives each, Canada - 10 additives, Serbia - 9 additives, Brazil, Indonesia and Ukraine - 8 additives each, South Korea- 5 additives, Slovenia - 4 additives, Greece and Australia - 3 additives each, Slovakia, Norway, Israel and Peru - 2 additives each, Latvia, Argentina, Croatia and Uruguay import one additive each.
In the case of multinational corporations, such as Cargill, Alltech and DSM, the geography of production becomes rather conditional information - they have factories in many countries. If the same product is supplied by global players from several countries at once, the feed additive is registered twice, thrice, in a word, as much as necessary. It happens that the same brand has three producing countries. In our review, these nuances are taken into account in the geography of deliveries. Market practice is such that whoever wants to import a new additive into Russia first registers it. Therefore, importers usually enter into exclusive contracts with foreign manufacturers, securing their monopoly.
Few today doubt that Russia will face economic difficulties in 2015. Difficult times are coming for domestic animal husbandry and the agro-industrial complex as a whole. It will be a time to optimize costs, get rid of ballasts, tighten belts. Confidence in tomorrow will be even less than usual. But business always has freedom of choice and competition. Due to the growth of the exchange rate, products for feeding farm animals will certainly become more expensive. However, there is always the opportunity to compare similar supplements and choose something else. Now it has become a little easier.
How we thought
When assigning an additive to one category or another, we based on the formulation of the product's purpose given by the manufacturer, as well as on the descriptions of a particular additive on thematic sites. The names of feed additives are given by us in random order, but grouped by country and manufacturer for ease of practical use.
Other feed additives
In our list of feed additives that are not included in the above categories, there are 98 items left. These are feed additives of the most diverse profile. They do not compete in any particular segment of the feed market, but, perhaps, simply for a progressive feeder. It makes no sense to describe the geography of their production, as we did for clearly segmented products. But for convenience, they, like all parts this review, grouped by country and manufacturer.
1. "Vetelakt" ("Agrovetzashchita", Russia) for the normalization of intestinal microflora and optimization of digestion processes in animals prebiotic
2. "Phytodoc-enterospas" ("Agrovetzashchita", Russia) for the normalization of motility of the gastrointestinal tract and digestive processes in animals
3. "Volstar" ("Agrovetzashchita", Russia) for the normalization of metabolism in poultry and pigs
4. "Ecostimulus-1" ("Ametis", Russia) to increase the productivity and safety of agricultural animals, incl. birds
5. "Ecostimulus-2" ("Ametis", Russia) to increase the productivity and safety of agricultural animals, incl. birds
6. "Solunat" (brand-1.5) ("Vilana", Russia) to increase the productivity of cattle and pigs
7. "Solunat" (brand-ZK) ("Vilana", Russia) to increase the productivity of cattle and pigs
8. "Vitabion" ("BiokhimPharm", Russia) for the normalization of metabolism in fur-bearing animals
9. "Piter-Pit" ("Piter-Pit", Russia) to increase the productivity and safety of agricultural animals, incl. birds
10. "Flarin" ("Pokrovsky plant of biological products", Russia) to improve the safety and productivity of pigs
11. Humimax (Uralekosoil, Russia) to increase productivity, normalize metabolic processes and increase the body's natural resistance in agricultural animals and poultry, normalize reproductive function in pigs and cows
12. "Guvitan" ("Russ", Russia) to increase the productivity and safety of agricultural animals, incl. birds
13. "Silvekol" ("Cluster", Russia) for young poultry in order to increase the safety and productivity of the canopy
14. Butofan Or (Nita-Pharm, Russia) to normalize metabolism, increase productivity and non-specific resistance of agricultural poultry
15. "Verva" ("NTP of the Institute of Chemistry of the KSC Ural Branch of the Russian Academy of Sciences", Russia) to increase the productivity and safety of agricultural animals
16. "Extrafit" ("Electrol-B", Russia) to improve the safety of livestock and productivity of agricultural animals, incl. birds
17. "Lecimax-Forte" ("Agrosystem", Russia) to improve the digestibility of nutrients in feed for pigs and poultry
18. "Abiopeptide" ("A-Bio", Russia) to activate protein metabolism in farm animals, incl. birds, as well as fish, fur-bearing animals, cats and dogs
19. "Ecumentol" (Vetos-Pharma, Russia) to improve the safety and productivity of agricultural animals, incl. birds
20. "Libekrin" ("Belfarmacom", Russia) to increase the natural resistance and productivity of agricultural animals, incl. birds
21. "Lipocar" ("Karaton-Lad", Russia) for the normalization of metabolism, increasing the resistance and productivity of agricultural animals, incl. birds and fish
22. Vitaminized fish oil (Vetspektrum, Russia) for the normalization of metabolism in animals, incl. birds
23. "Apistim" (NPC "Fox and Co", Russia) to stimulate the development of bee colonies
24. "Baksin-KD" ("Nikopharm", Russia) to increase the natural resistance of the body and the safety of young animals, improve the reproductive functions of animals and poultry
25. "Multisan Nectar" (Sano Moderne Tierernahrung, Germany) for enrichment of cattle rations with carbohydrates and optimization of metabolism in the rumen prebiotic
26. "Salut" (Agrochemica, Germany) to normalize the balance of electrolytes and prevent diarrhea in piglets and calves
27. "Sangrovit" (Phytobiotics, Germany) to improve the productivity of cattle, pigs and poultry by stimulating digestion processes and increasing feed intake
28. "Sangrovit WS" (Phytobiotics, Germany) to improve the productivity of cattle, pigs and poultry by stimulating digestion processes and increasing feed intake
29. "Sangrovit Extra" (Phytobiotics, Germany) to improve the palatability of feed and increase the productivity of agricultural animals, birds and fish
30. "Biopolim FZ-Granulate" (Schulze & Hermsen, Germany) to improve the digestion of cattle, pigs and the microclimate in livestock buildings
31. Globigen Pig Dozer (EW Nutrition, Germany) to normalize metabolism and increase live weight in newborn piglets
32. "Globigen Dia Stop" (EW Nutrition, Germany) to increase the intensity of growth and safety of piglets and calves
33. Globigen Jump Start (EW Nutrition, Germany) to increase productivity and safety in piglets, calves and sows
34. "Pig Protector" (Biochem, Germany) for the normalization of digestion processes in newborn piglets
35. "Kuprosol 50" (Animal Health Concepts, the Netherlands) to improve the productivity and safety of poultry
36. "Lianol Ferti" (Ardol, the Netherlands) to activate the metabolism and improve the reproductive function of sows
37. "Lianol Colostro" (Ardol, the Netherlands) to improve the safety of newborn piglets
38. "Lianol Solapro" (Ardol, the Netherlands) to increase the productivity and safety of agricultural animals, incl. birds
39. "Unilit" (Schils, the Netherlands) to stabilize the water-salt balance in the body of calves in order to increase their safety
40. "Lactofid 70" (DV Nutrition, the Netherlands) for enriching the diets of agricultural animals, incl. birds, lactose
41. "Laktoflo" (DV Nutrition, the Netherlands) for enrichment of diets of agricultural animals, incl. birds, lactose
42. "Asidbaf" (Celtic Sea Minerals, Ireland) for the regulation of acid-base balance in the stomach of farm animals, incl. birds, as well as enrichment of diets with calcium and magnesium
43. "Agromega" (Agritech, Ireland) for enrichment of diets of agricultural animals, incl. birds, fatty acids
44. "Aromabiotic Poul 60" (Vitamex, Belgium) for optimizing digestion processes in piglets and poultry
45. "Optigen II" (Alltech, De Ster - L.Vandenbergheenzonen, Belgium) for enrichment and balancing of cattle rations for non-protein nitrogen
46. "Lisofort dry" (Kemin, Belgium) to increase the digestibility and assimilation of nutrients in the diets of pigs, birds and aquaculture
47. "Lisofort Booster dry" (Kemin, Belgium) to increase the digestibility and assimilation of nutrients in the diets of pigs, poultry and aquaculture
48. "Nuvisol Hatch L" (Nutrex, Belgium) to increase the productivity and safety of agricultural poultry, improve the fertility of eggs and hatchability of young animals
49. "Esid-Pak 4Way 2X WS" (Alltech, Belgium, Great Britain) for optimization of digestion processes in pigs, calves and poultry
50. "Bio-Mos" (Alltech, Belgium, UK) to increase the productivity and safety of agricultural animals, incl. birds prebiotic
51. "Aktigen" (Alltech, Belgium, USA, UK) to increase the overall resistance and increase the productivity and safety of agricultural animals, incl. birds prebiotic
52. "De-Odorez" (Alltech, USA) for binding ammonia and other harmful gases in digestive tract and excrement of agricultural animals, pets and birds
53. All-G Rich (Alltech, USA) to meet the need for docosahexaenoic acid (DHA) in farm animals, incl. birds and fish
54. Rumenate Pharmpack (Alltech, UK, USA) yeast supplement for all types of ruminants
55. Economize (Alltech, USA, UK) for the normalization of metabolism in farm animals, incl. birds
56. "Salmat" (Bluegrass Dairy and Food, USA) for enrichment of diets of cattle, pigs and poultry with Omega-3 polyunsaturated fatty acids
57. "Carbovet T" (Est Callegari, France) for the normalization of the gastrointestinal tract of agricultural animals and birds
"Aviance III" (Techna, France) to increase the meat and egg productivity of poultry
65. "Nutrizan" (Neolait, France) to improve the safety of young farm animals during periods of stress and unbalanced feeding
66.HAT (Cofathim, France) to improve the productivity, safety and reproductive qualities of agricultural animals
67. Koleis (Physan La Probiolyse, France) to optimize digestion, increase productivity and safety of farm animals, incl. birds and rabbits
68. "Mets plus" (Lipidos Toledo, Spain) to improve the safety and productivity of agricultural animals, including birds
69. Liptosafe (Lipidos Toledo, Spain) to improve the safety and productivity of agricultural animals, incl. birds
70. "Viusid-Vet" (Catalysis, Spain) to improve the safety and productivity of poultry
77. "Optomega-50" (Optivite, Great Britain) for enrichment of diets of agricultural animals, incl. birds, Omega-3 polyunsaturated fatty acids
78. "Biotal SC Platinum" (Biotal, Great Britain) for improvement of cicatricial digestion, enrichment and balancing of diets of highly productive ruminants for selenium and zinc
79. "Krina" for pigs (DSM, Switzerland) control of the microflora of the gastrointestinal tract and stimulation of the secretion of digestive enzymes
80. "Krina" for birds plus (DSM, Switzerland) control of the microflora of the gastrointestinal tract and stimulation of the secretion of digestive enzymes
81. "Krina" for ruminants (DSM, Switzerland) to optimize the processes of cicatricial digestion in cattle and small cattle
82. "XOS 35P Xylo-oligosaccharides" (Shandong Longlive Bio-Technology, China) to improve digestion, increase weight gain and safety of pigs and poultry prebiotic
83. "Auto East" (Angel Yeast, China) to optimize digestion, increase productivity and safety of pigs, poultry and Far Eastern turtles
84. "Zigbir" (Natural Remedies, India) to normalize metabolism, increase productivity and safety of poultry
85. "Fitosi" (Natural Remedies, India) to improve the safety and productivity of agricultural poultry
86. "Mannazel +" (Likra, Austria) to improve the safety and productivity of agricultural animals, incl. birds prebiotic
87. "Enviro plus" (Delacon Biotechnik, Austria) to reduce the level of ammonia and improve zoohygienic conditions for keeping pigs and poultry
88. "Highlais" (Usina Santo Antonio, Brazil) to strengthen the immune system, improve the condition of the intestinal mucosa and increase the digestibility of feed in the diets of farm animals
89. "Levabon Rumen E" (Biomin, Brazil) to improve digestion and increase the productivity of cattle
90. "Imprinting plus" (Akron, Italy) to increase the natural resistance and safety of calves
91. "Fortibak" (Silo, Italy) for optimization of digestion processes in pigs and poultry
92. "Pelltech II" (Borregaard, Norway) to increase the strength of granules and the efficiency of granulation of feed for agricultural animals, poultry and fish
93. Mentovet (Biofaktor, Poland) to improve the safety of agricultural birds and pigeons
94. "Gerbapharm L" (Sidomuncul Pupuk Nusantara, Indonesia) to increase the productivity of agricultural animals, incl. birds
95. "Progut" (Hankkija, Finland) to improve the safety and productivity of agricultural animals, incl. birds
Anna Sokolova