Decree No. 548 of 2012 of the Ministry of Agriculture and Forestry on the pursuit of activities in the animal feed sector

Ministry of Agriculture and Forestry, Finland NB: Unofficial translation; legally binding texts are those in Finnish and Swedish. Decree of the Ministry of Agriculture and Forestry on the pursuit of activities in the animal feed sector (548/2012) Chapter 1 – General provisions Section 1 – Scope (1) This Decree lays down the provisions on the notification, information, quality control and accounting obligations of feed business operators, as well as their approval. This Decree also lays down provisions on the obligations of an approved laboratory and a quality control laboratory used by feed business operators, as well as the labelling of animal feed. Section 2 – Relationship with certain statutes (1) In addition to this Decree, provisions on the pursuit of activities in the animal feed sector are also laid down by Regulation (EC) No 183/2005 of the European Parliament and of the Council laying down requirements for feed hygiene (hereinafter the Feed Hygiene Regulation). (2) In addition to this Decree, provisions on the pursuit of activities relating to feeds of animal origin are also laid down by Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (hereinafter the Animal By-Products Regulation), Decree of the Ministry of Agriculture and Forestry 1002/2010 on animal disease requirements for certain live animals, animal by-products and certain goods within the internal market of the European Union and Decree of the Ministry of Agriculture and Forestry 1193/2011 on the control of operators handling animal by-products and derived products and the use of certain by-products. (3) Provisions on the pursuit of activities relating to feeds of animal origin are also laid down by Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (hereinafter the TSE Regulation) and Decree of the Ministry of Agriculture and Forestry 977/2006 on inspections to be performed to combat animal diseases within the internal market of the European Community. (4) Owing to changes in the animal health situation, restrictions on trade within the internal market, transit through the territory of the internal market, and imports and exports are provided for by safeguard measures of the European Commission. (5) In addition to this Decree, provisions on the mandatory labelling of feed materials and compound feeds are laid down by Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (hereinafter the Placing on the Market and Use Regulation), and provisions on the labelling of feed of animal origin are also laid down by the Animal By-Products Regulation and the TSE Regulation. (6) Provisions on the method for calculating the energy value of compound feeds intended for poultry are laid down by Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed. (7) Provisions on the maximum levels of undesirable substances in feed and action thresholds for investigations to be carried out by Member States are laid down by Commission Regulations amending Annexes I and II to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed (hereinafter the Undesirable Substances Regulations) and their annexes. In addition to this, provisions on the maximum levels of pesticides are laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC and its annexes. Section 3 – Definitions (1) The definitions of the Feed Act (86/2008) apply in this Decree. In addition, in this Decree: 1) complementary feed, complete feed and feed batch or lot means complementary feed, complete feed and batch or lot as defined in the Placing on the Market and Use Regulation; 2) daily ration means the average total quantity of feed, calculated on a moisture content of 12 %, required daily by an animal of a given species, age category and yield, to satisfy all its needs; 3) business operator in the primary production of feed means a business operator pursuing the activities listed in Article 5(1)(a)-(c) of the Feed Hygiene Regulation, and a business operator who uses feed for feeding food-producing animals that he owns or keeps; 4) feed business means any undertaking whether for profit or not and whether public or private, as defined in Article 3(5) of Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety; 5) establishment means any unit of a feed business that carries out any feed production, preparation or distribution phase; 6) approved laboratory means a laboratory approved for testing official samples referred to in section 27 of the Feed Act; 7) official sampling guidelines means guidelines by the Finnish Food Safety Authority on the sampling of feed; 8) type of production means financially the most significant type of primary production; 9) mobile mixer means a feed business operator that produces compound feed on farms using mobile milling and mixing equipment; 10) storage company means a feed business operator providing storage services which stores feed, including separate warehouses or storage facilities; 11) transportation company means a feed business operator providing transportation services; 12) feed additive means a feed additive as defined in Article 2(2)(a) of Regulation (EC) No 1831/2003 on additives for use in animal nutrition; 13) high-risk feed means feed which on the basis of the notifications under the rapid alert system for foods and feeds in Article 50 of Regulation of the European parliament and of the Council No 178/2002 or scientific risk assessment involve a greater risk of salmonella than other feeds; 14) country of origin means the country from which a feed batch or lot is imported to Finland; 15) sample means an entity composed of one or several incremental samples taken from a feed batch or lot or part thereof; 16) incremental sample means the quantity of the sample taken from one place in the feed batch or lot or part thereof; 17) sample from the production environment means a swab or dust sample which may also contain feed, to be taken from the production premises and equipment, mixer vehicle, transportation fleet, warehouse or other similar object; 18) wet feed means feed material and compound feed with a dry matter content of less than 50 per cent; 19) method for calculation means the formulae and constants of the Agrifood Research Finland, the digestibility coefficients given in the feed tables and, for ruminant feed, also the proportion of degradable protein. Chapter 2 – Registration and approval of feed business operators Section 4 – Notification for registration (1) A feed business operator shall submit a registration notification under section 18 of the Feed Act. In the registration notification, the feed business operator shall notify the following information, in addition to the information provided for in section 18 of the Feed Act: 1) a business operator in primary production shall state the type of production and operations in accordance with Chapter I of Annex 1 to this Decree; 2) a business operator other than one in primary production shall state the functions in accordance with Chapter II of Annex 1 to this Decree, and the product types in accordance with Chapter III of Annex 1 to this Decree. (2) A feed business operator shall notify the Finnish Food Safety Authority of any permanent changes to the information supplied in the registration notification, or of any other significant changes no later than the entry into force of such changes using the form published for this purpose. Section 5 – Exemptions for certain business operators in primary production (1) A reindeer herding cooperative under section 6 of the Reindeer Husbandry Act (848/1990) may submit a registration notification on behalf of a feed business operator that pursues reindeer husbandry. The information set out in section 4 of this Decree shall be annexed to the notification. (2) The notification obligation does not apply to a feed business operator who exclusively supplies primary products annually produced by the operator on a surface area of no more than three hectares directly to a local farm or similar operator to be used there. Section 6 – Application for approval (1) A feed business operator shall, before commencing or making fundamental changes to the activity, apply to the Finnish Food Safety Authority for approval of such activity, where the intention is to pursue an activity for which approval under Article 10 of the Feed Hygiene Regulation, paragraph 10 of Annex II to the Feed Hygiene Regulation or Annex IV to the TSE Regulation is required. (2) The information under section 20 of the Feed Act shall be annexed to the application. Applications for approval shall be submitted to the Finnish Food Safety Authority on the form published for this purpose. A feed business operator applying for approval shall also make the registration notification referred to in section 4 of this Decree. (3) Provisions on revoking an approval under the Feed Hygiene Regulation are laid down in Article 14 and 15 of the Regulation. (4) Provisions on the approval of operators that produce and place on the market medicated feed are laid down by Decree of the Ministry of Agriculture and Forestry 10/EEO/2008 on medicated feeds. Section 7 – Approval and identification numbers of feed business establishments (1) The Finnish Food Safety Authority shall provide an establishment approved for the pursuit of activities under Article 10 or paragraph 10 of Annex II of the Feed Hygiene Regulation with an approval number in the form given in Part A of Annex 2 to this Decree as well as, upon request, a feed business establishment referred to in Article 17(1)(c) of the Placing on the Market and Use Regulation with an identification number in the form given in Part B of Annex 2 to this Decree. Section 8 – List of registered feed business operators (1) The Finnish Food Safety Authority shall publish the list referred to in section 37 of the Feed Act on its website at www.evira.fi/portal/en/animals/feed/). The list shall be kept up to date. (2) The Finnish Food Safety Authority shall enter to the list the establishments that have been registered following the procedure laid down in section 4 or 5 of this Decree, specified by activity, product type or type of production. (3) In addition to the provisions of subsection (2), the approval number under section 7 shall be entered to the list in respect of each business operator approved under the Feed Hygiene Regulation. Chapter 3 – Notification, information and cooperation obligation of a feed business operator Section 9 – Imports (1) The obligation of a feed business operator to submit advance notification under section 32 of the Feed Act applies to high-risk feeds of plant origin and feeds mentioned in Annex I to Commission Regulation (EC) No 669/2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC (hereinafter the Third-Country Imports Regulation). (2) The advance notification shall state the following information: 1) the name and address of the importer; 2) the importer’s business or company identification number or, if none exists, personal identification number or farm identification number; 3) the name and type of the feed; 4) the quantity of the feed batch or lot; 5) the country of origin; 6) the date and place of arrival on the Finnish territory; 7) the import method used. (3) A feed business operator shall submit the notification relating to imports of feed referred to in subsection (1) no later than 24 hours before the arrival on the Finnish territory of the feed batch or lot in question by notifying the Finnish Food Safety Agency thereof for the risk-based sampling under section 13 of this Decree or the Third-Country Imports Regulation. If the day preceding the import is not a weekday, the advance notification shall be submitted by no later than the previous weekday. (4) Feed additives, premixtures and compound feeds produced from them that are mentioned in Annex 4 may only be imported from production establishments that have a representative based in Finland. The representative shall submit a notification to the Finnish Food Safety Authority to the effect that the representative undertakes to guarantee that the production establishment located in the third country meets the requirements laid down in the Feed Hygiene Regulation. (5) The Finnish Food Safety Authority keeps a list of third-country production establishments and enters in it the name and address of both the production establishment and the representative, as well as products that require approval under Annex 4 that have been placed on the market in Finland. Section 10 – Customs declarations (1) If feed for export to another Member State of the European Union is not placed on the market in the territory of Finland, the importer shall complete Part A of the document under Annex 6 to this Decree, together with the identification information relating to the goods in a manner referred to in Annex 7 and present it at the customs point. (2) The commercial documents shall contain a reference to the document mentioned in subsection (1). If the batch or lot to be inspected is divided into parts, each part shall be accompanied by the document referred to in subsection (1). The document shall remain with the batch or lot until it is put into free circulation in the Community. (3) Provisions on the obligations of the customs authority concerning completing the information in Parts B and C of the document referred to in subsection (1) are laid down by Decree of the Ministry of Agriculture and Forestry 11/09 on the organisation of feed control. (4) When feed mentioned in Annex I to the Third-Country Imports Regulation is imported, the importer shall submit to the customs the common entry document referred to in Annex II to the Regulation, Part II of the document having been completed by the Finnish Food Safety Authority. Section 11 – Other notifications relating to feed business operators (1) A business operator shall notify the Finnish Food Safety Authority immediately of any cases where the maximum levels of undesirable substances have been exceeded observed during the receipt, production, storage or loading of feed or during any other similar activities. (2) In order to prevent the risks caused by feed that has been placed on the market, a business operator shall immediately notify the operator to whom the feed has been supplied of any findings of salmonella in the feed. Section 12 – Cooperation with the Finnish Food Safety Authority (1) A business operator shall undertake appropriate measures and engage in cooperation with the Finnish Food Safety Authority in order to prevent risks caused by feed in situations where there is cause to suspect that the feed or its production, preparation or distribution phase does not fulfil the requirements concerning feed safety. (2) A business operator shall cooperate with the Finnish Food Safety Authority to find out the sources of undesirable substances, products and organisms when their maximum levels laid down in Annex I to the Undesirable Substances Regulations are exceeded in the feed, when increased levels are detected as laid down in Annex II to the Regulations, or when salmonella bacterium is found in the feed. (3) A business operator shall report to the Finnish Food Safety Authority of the storage, identification, reprocessing and disposal of a feed batch or lot which does not fulfil the feed safety requirements, as well as of the action taken in case of contamination. (4) A business operator shall ensure that, where necessary, the feeds are rendered harmless using methods approved by the Finnish Food Safety Authority, no salmonella bacterium is present in the feeds that have been rendered harmless, and they comply with Annex I to the Undesirable Substances Regulations. Chapter 4 – Salmonella sampling in connection with imports Section 13 – Sampling and testing of samples (1) For the official salmonella control of feed, samples shall be taken from high-risk feed of plant origin in accordance with the risk-based control plan of the Finnish Food Safety Authority. The control plan to be drawn up annually shall show the name and type of feed, country of origin, and the number of feed batches or lots concerned in the sampling. (2) The sample shall be taken in connection with import using a suitable mechanical sampler or other appropriate sampling method. (3) In the official control of high-risk feed intended for feeding food-production animals, pets and fur animals one sample per every 50 000 kilograms of the feed batch or lot shall be tested. (4) In addition to the provisions of subsection (3), of feed intended directly for a mobile mixer or farm for feeding food-producing animals without heat treatment of the feed batch or lot in Finland one sample per every 25 000 kilograms of the feed batch or lot shall be tested. (5) An inspector authorised by the Finnish Food Safety Authority takes the samples referred to in subsections (3) and (4) in accordance with the official sampling guidelines. Chapter 5 – Quality control by feed business operators Section 14 – Maximum levels of undesirable substances, products and organisms (1) No undesirable substances and products at levels exceeding those in Annex I to the Undesirable Substances Regulations or salmonella bacterium may be present in feeds. (2) Complementary feed may not contain, taking account of the share established for their use in the daily ration, undesirable substances or products referred to in subsection 1 at levels exceeding the level for their content established for complete feeds. Section 15 – Sampling for salmonella testing by feed material producers (1) A feed business operator that produces feed materials for placing on the market from high-risk feed falling under the feed material categories listed in Annex 3 shall take at least one sample from the production environment per week, or one sample per every 50 000 kilograms, but at least three samples each year. (2) If the production process of the feed material includes heat treatment, samples from the production environment shall be taken, as applicable, from the cooling system. (3) In addition to the provisions of subsection (1), at least one sample of the end product shall be taken for every 100 000 kilograms. The requirement for sampling the end product does not apply to wet feed. (4) The obligation to take samples from the production environment or the end product does not apply to a business operator who only produces feed materials intended for feed for fur animals or pets or a business operator who only handles mechanically feed materials falling under the feed material categories "cereal grains", "seeds and fruits of oil plants" or "legume seeds" in Annex 3 without changing their state. Section 16 – Sampling for salmonella testing by compound feed producers (1) A feed business operator that produces compound feeds for food-producing animals for placing on the market shall take a sample from the production environment at least once a week from each of the receipt and production lines separately where feed materials are received or compound feeds are produced from high-risk feed materials falling under the feed material categories listed in Annex 3. (2) Business operators that use steam to heat feed shall take a sample from each of the following points: 1) the lines or pits for receiving bulk raw materials; 2) the central dust remover or dust-removal system of the receiving line; 3) the cooler; 4) the dust-removal system of the cooler; 5) the space where the cooler is located or where cooling air is taken; 6) the bulk loading line. (3) Business operators other than those referred to in subsection (2) above shall take a sample at least once a week from each of the following points: 1) the lines for receiving bulk raw materials; 2) the mixing line; 3) the dust-removal system; 4) the loading line. (4) The sampling points may be changed for each establishment on the basis of a risk assessment carried out by the business operator. Any changes and the grounds for them shall be notified to the Finnish Food Safety Authority. (5) In addition to the above provisions on the taking of samples from the production environment in subsections (1)–(3), the business operator shall take samples from the end product in connection with loading. (6) The provisions of subsections (1)–(4) shall not, however, apply to a business operator that produces compound feed for food-producing animals for placing on the market on a farm using high-risk feed falling under the feed material categories listed in Annex 3 produced only on the farm in question. Such a business operator shall take at least one sample from the production environment per every 50 000 kilograms, but at least three samples each year. Section 17 – Sampling for salmonella testing by mobile mixers (1) A mobile mixer that produces compound feed for food-producing animals for placing on the market using high-risk feed falling under the feed material categories listed in Annex 3 shall take at least one sample per month from the production environment in each mixer vehicle as part of its quality control. The samples shall be taken after the feed has been produced before the mixer vehicle is cleaned. Section 18 – Sampling for salmonella testing by transportation companies (1) A transportation company that transports high-risk feed materials falling under the feed material categories listed in Annex 3 and compound feeds containing these intended for feeding food-producing animals shall take at least one sample from the production environment in the cargo hold of each vehicle every other month. The samples shall be taken before the vehicle is cleaned. (2) The sampling obligation referred to in subsection 1 above does not apply to business operators that transport packaged feed or feed materials falling under the feed material category “cereal grains” in Annex 3. Section 19 – Sampling for salmonella testing by storage companies (1) Storage companies that store bulk feed for food-producing animals shall take at least one sample from the production environment at an empty warehouse prior to the next receipt of a batch or lot of high-risk feed material falling under the feed material categories listed in Annex 3. (2) The sampling obligation also applies to feed factories that store high-risk feed materials falling under the feed material categories listed in Annex 3 before the testing and approval of the feed batches or lots for import or placing on the market. (3) The sampling obligation does not apply to storage companies that store feed materials falling under the feed material category of “cereal grains” in Annex 3. Section 20 – Sampling for salmonella testing by business operators engaged in internal market trade (1) A feed business operator that imports high-risk feeds of plant origin from the internal market for feeding food-producing animals, fur animals or pets shall take samples of the arriving feed batches or lots in accordance with the operator's risk-based sampling plan. (2) In a feed batch or lot to be tested one sample shall be taken per every 50 000 kilograms or, if the feed is intended directly to a mobile mixer or farm, one sample per every 25 000 kilograms. (3) The sample shall be taken upon the arrival of the feed batch or lot using a suitable mechanical sampler or other appropriate sampling method. The sample shall be representative and composed of several incremental samples taken from different parts of the feed batch or lot. The sampler shall possess sufficient expertise for the task. (4) The sampling obligation does not apply to the import of small quantities of feed for the feeding of animals owned or kept by the feed business operator. Section 21 – Storage and testing of samples from the production environment and feed (1) A feed business operator shall send all samples from the production environment and feed referred to in sections 15–20 of this Decree without delay to the quality control laboratory to be tested for salmonella. (2) Notwithstanding the provisions of subsection (1), the loading samples referred to in section 16 shall only be sent to the quality control laboratory for testing if salmonella bacterium is found in the sample from the production environment. Loading samples of bulk feed shall be stored for at least four months and samples of wet feed shall be stored until the date of minimum durability of the feed. (3) Each sample from the production environment and feed shall be tested separately at the laboratory. Section 22 – Measures to be taken if salmonella is found in a sample from the production environment (1) If salmonella bacteria are found in a sample from the production environment taken in connection with the receipt, production, storage or loading of feed, or other similar activity, the feed business operator shall ensure, in addition to the provisions of section 12 of this Decree, that the following measures are taken, as applicable: 1) tracing the source of the salmonella bacteria in the feed raw materials; 2) tracing the source of the salmonella bacteria in the establishment; 3) enhanced sampling from the production environment to establish the extent of salmonella infection; 4) enhanced sampling from feed; 5) enhanced cleaning and disinfection; 6) enhanced sampling from the production environment to assess the success of the cleaning and disinfection; 7) suspending feed production and distribution. Section 23 – Heat treatment of compound feed (1) A feed business operator that produces compound feed for chickens for fattening, laying hens and turkeys as well as for pigs and bovines shall ensure that the temperature of the compound feed in question during granulation or other heat treatment is no less than 81°C, or that the compound feed is heated at a temperature of no less than 75°C for 10 minutes. (2) The heat treatment obligation does not apply to a business operator with annual production of no more than six million kilograms, or to a mobile mixer. The heat treatment obligation does also not apply to vitamin and mineral complementary feed, or to liquid or wet feed. (3) In addition to the provisions of subsection (2), the Finnish Food Safety Authority may, upon application, grant a derogation from the heat treatment referred to in subsection (1) if the feed concerned is a special feed for which heat treatment is not suitable owing to its structure or properties. Chapter 6 – Feed labelling Section 24 – Pet foods (1) When providing information on feed materials of compound feeds for pets, the name of the group to which the feed material belongs may be indicated in the labelling instead of the name of the individual feed material. (2) The feed material groups referred to in subsection (1) shall be indicated in accordance with Annex 5 to this Decree. Section 25 – Indication of energy and protein value (1) The Agrifood Research Finland publishes the calculation methods and feed tables for energy and protein values on its website at www.mtt.fi/rehutaulukot1. (2) The figures given in the feed tables or values calculated on the basis of the nutritional composition specified for a feed material may be indicated as the energy and protein value of the feed material. The digestibility coefficients given in the feed table and, for the protein value of ruminant feed (amino acids absorbed through the small intestine), the proportion of degradable protein given in the feed table shall be used in the calculation. The energy value of roughage for ruminants and equines may also be calculated on the basis of the concentration of digestible organic matter (the D value). (3) The energy value of compound feed shall be determined and indicated as follows: 1) the energy values of compound feeds intended for ruminants and equines are calculatory, based on the total energy values of the individual feed materials contained in the compound feed, and they may be indicated as metabolisable energy; 2) the energy values of compound feeds intended for pigs are calculatory, based on the total energy values of the individual feed materials contained in the compound feed, and they may be indicated as net energy; 3) the energy values of compound feeds intended for poultry and fur animals are determined based on the results of an analysis of certain nutrients in the compound feed, and they may be indicated as metabolisable energy. 1 English version: https://portal.mtt.fi/portal/page/portal/Rehutaulukot/feed tables english (4) The protein values of compound feeds intended for pigs, ruminants, equines and fur animals are calculatory, based on the sum of the protein values of the feed materials contained in the compound feeds. (5) A feed business operator shall keep records of data on the nutritional composition determined for the feed materials and notify the Finnish Food Safety Authority of them upon request if the determined nutritional compositions are used in the calculation instead of the values in the feed table. (6) Indication of the energy and protein value in feed is voluntary. Chapter 7 – Requirements relating to the recording of data Section 26 – Keeping and storing records (1) A feed business operator shall keep a file containing information relating to the operator's activities in accordance with section 19 of the Feed Act. The file shall be kept in writing, using an automatic data processing system or in another similar manner. (2) A business operator in the primary production of feed shall keep records, as applicable, of any factors regulated by Annex 8 to this Decree. (3) In addition to this Decree, provisions on the record keeping obligation of a business operator using milk products for feeding food-producing animals are also laid down in the Decree of the Ministry of Agriculture and Forestry 665/2010 on the use of milk, milk-based products and by products from milk processing for feeding food-producing animals (hereinafter the Milk Decree). (4) Provisions on the record keeping obligation of a business operator other than one in the primary production of feed are laid down by Annex II to the Feed Hygiene Regulation. Provisions on records to be kept by business operators that send, transport or receive animal by-products are laid down by the Animal By-Products Regulation. Provisions on the record keeping obligation of feed business operators that supply processed and unprocessed milk products for feeding food-producing animals are laid down by the Milk Decree. Provisions on the record keeping obligation relating to the production and supply of medicated feeds are laid down by Decree of the Ministry of Agriculture and Forestry 10/EEO/2008 on medicated feeds. (5) A feed business operator shall store the records under Annex 8 to this Decree and Annex II to the Feed Hygiene Regulation for at least five years. Provisions on storing the records on the use of plant protection products are laid down separately in Regulation (EC) of the European Parliament and of the Council concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. Chapter 8 – Laboratory summaries and sending microbial strains Section 27 – Summary of tests conducted (1) An approved laboratory referred to in section 27 of the Feed Act shall send to the Finnish Food Safety Authority, upon its request, a summary of the tests referred to in section 25 of the Feed Act and of their results. The summary shall contain the following information: 1) the different types of samples and their numbers; 2) the tests and their numbers; 3) the test results; 4) any results that contravene the feed regulations; 5) any results suggesting a health risk to humans or animals. Section 28 – Sending microbial strains to the national reference laboratory (1) A quality control laboratory used by a feed business operator referred to in section 28 of the Feed Act and an approved laboratory shall send, without delay, to the national reference laboratory any strains of salmonella isolated from feed raw materials, products, production lines, other production premises and warehouses or transportation fleets for serotyping. (2) The strains shall be accompanied by the following information: 1) the name and address and other contact details of the person commissioning the test; 2) the name and address and other contact details of the sending laboratory; 3) information on the feed and feed sample; 4) information on the strain isolated from the feed sample; 5) the test results and the test method used. Chapter 9 – Miscellaneous provisions Section 29 – Entry into force (1) This Decree enters into force on 24 October 2012. (2) This Decree repeals the Decision of the Ministry of Agriculture and Forestry on feed materials (40/1999), Decision of the Ministry of Agriculture and Forestry on compound feeds (41/1999), Decree of the Ministry of Agriculture and Forestry 712/2008 on the pursuit of activities in the animal feed sector, and Decree of the Ministry of Agriculture and Forestry 11/2010 on undesirable substances, products and organisms. (3) This Decree has been notified in accordance with Directive of the European Parliament and of the Council 98/34/EC, as amended by 98/48/EC. Section 30 – Transitional provisions (1) The sampling obligation in sections 13 and 15-20 enters into force as from 1 January 2013. (2) The heat treatment obligation in section 23 enters into force six months after the date of entry into force of this Decree in respect of compound feeds for poultry and two years after the date of entry into force of this Decree in respect of compound feeds for pigs and bovines. Commission Directive (EC) No 98/51 (31998L0051); OJ L 208, 24.7.1998, p. 43. Regulation (EC) No 999/2001 of the European Parliament and of the Council (32001R0999); OJ L 147, 31.5.2001, p. 1. Directive No 2002/32/EC of the European Parliament and of the Council (32001R0999); OJ L 140, 30.5.2002, p.10. Regulation (EC) No 178/2002 of the European Parliament and of the Council (32002R0178); OJ L 31, 1.2.2002, p. 1. Commission Directive No 2003/57/EC (32003L0057); OJ No 151, 19.6.2003, p. 38. Regulation (EC) No 882/2004 of the European Parliament and of the Council (32004R0882); OJ L 191, 28.5.2004, p. 1. Regulation (EC) No 183/2005 of the European Parliament and of the Council (32005R0183); OJ L 35, 8.2.2005, p. 1. Regulation (EC) No 396/2005 of the European Parliament and of the Council (32005R0396); OJ L 70, 16.3.2005, p. 1. Commission Regulation (EC) No 152/2009 (32009R0152); OJ No L 54, 26.2.2009, p. 1. Regulation (EC) No 767/2009 of the European Parliament and of the Council (32009R0767); OJ L 229, 1.9.2010, p. 1. Commission Regulation (EU) No 225/2012 (32012R0225); OJ No L 77, 16.3.2012, p. 1. ANNEX 1 FUNCTIONS RELATING TO THE REGISTRATION NOTIFICATION Chapter I: Functions referred to in section 4(1)(1) of this Decree concerning a business operator in primary production: a) production of feed; b) mixing of feed; and c) use of feed2. Chapter II: Functions referred to in section 4(1)(2) of this Decree concerning a business operator other than one in primary production: 1) producer of additives3; 2) producer of premixtures; 3) producer of feed materials; 4) producer of compound feeds; 5) mobile mixer; 6) retail trade4; 7) wholesale trade; 8) storage company, bulk feed; 9) storage company, packaged feed; 10) transportation company, bulk feed; 11) transportation company, packaged feed; 12) importer within the internal market; 13) importer, third-country representatives5; 14) other placer on the market; 15) exporter. Chapter III: Types of products referred to in section 4(1)(2) of this Decree concerning a business operator other than one in primary production: 1) pet foods (including food for wild birds); 2) by-products and derived products; Category 2; classification according to the Animal 2 If unweaned food-producing ruminants are fed milk replacer feed containing fishmeal, this shall be reported separately to the Finnish Food Safety Authority in accordance with Commission Regulation (EC) No 956/2008 amending Annex IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies. 3 Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition. 4 The registration obligation does not apply to business operators that exclusively pursue the retail trade of pet foods. 5 Feed business operators that import products referred to in Annex 4 to this Decree to Finland. By-Products Regulation 1069/2009; 3) by-products and derived products; Category 3; classification according to the Animal By-Products Regulation 1069/2009; 4) fishmeal and feed containing fishmeal (including dicalcium phosphate and tricalcium phosphate of animal origin, blood products and blood meal); 5) feed for food-producing animals; 6) feed for fur animals; 7) medicated feed6. 6 Medicated feed may only be produced or re-sold by business operators approved separately for this purpose. ANNEX 2 PART A STRUCTURE OF THE APPROVAL NUMBER UNDER SECTION 7 1. α 2. FI 3.1 One character is used to show if a producer of additives 3.2 One character is used to show if a producer of premixtures 3.3 One character is used to show if a producer of compound feed 3.4 One character is used to show if a placer on the market 3.5 One character is used to show if a producer and placer on the market of certain oils, fats and products obtained from these. 3.6 Three digits are reserved for the serial number 1. The symbol “α” shows that the feed business establishment has been approved. 2. ISO code of the Member State, which is FI for Finland. 3. National reference number including no more than two alphanumerical characters. 3.1. The first character is 1 if the establishment is a producer of additives mentioned in point 1 of Annex 4 to this Decree, otherwise 2. 3.2. The second character is 1 if the establishment is a producer of premixtures from additives mentioned in point 2 of Annex 4 to this Decree, otherwise 2. 3.3. The third character is 1 if the establishment is a user of additives mentioned in section 3 of Annex 4 to this Decree or premixtures containing these in producing compound feed, otherwise 2. 3.4. The fourth character is 1 if the establishment is a placer on the market of additives mentioned in Annex 4 to this Decree or premixtures containing these, otherwise 2. 3.5 The fifth character is 1 if the establishment practises operations under paragraph 10 of Annex II to the Feed Hygiene Regulation, otherwise 0. 3.6–3.8 Three digits give the serial number of an individual establishment. PART B STRUCTURE OF THE IDENTIFICATION NUMBER UNDER SECTION 7 1. ISO code 2. 8 digits are reserved for the serial number 1. The ISO code of the Member State or third country where the production establishment is located. 2. National reference number including no more than two alphanumerical characters. ANNEX 3 FEED MATERIAL CATEGORIES INCLUDING HIGH-RISK FEED REFERRED TO IN SECTIONS 15–19 Feed material category Examples of feed falling under the category Cereal grains Oats, barley, rye, wheat, rice, maize Products and by-products obtained from cereal grains 1) Wheat gluten, bran, middlings, maize gluten, maize starch, distillers’ grains, brewers’ grains Seeds and fruits of oil plants Groundnut, soya bean, sunflower seeds, rapeseed, turnip rapeseed, cotton seeds, flax seeds and sesame seeds Products and by-products obtained from seeds and fruits of oil plants 2) Rapeseed, turnip rapeseed, coconut, palm and soya expeller, meal and proteins Legume seeds, and products and by products obtained from them Pea middlings Other seeds and fruits, and products and by-products obtained from them By-products and mass from pressing (e.g. citrus pulp) Fish, other aquatic animals, and products and by-products obtained from them 5) Fishmeal 1) The sampling obligation does not apply to hydrolysed by-products of cereal starch (e.g. barley molasses) or to products and by-products obtained from cereal starch saccharification (dextrose, dextrose molasses, etc.). The sampling obligation does also not apply to products and dough from the bakery industry. 2) The sampling obligation does not apply to vegetable oils. 3) The sampling obligation does not apply to fish oils. ANNEX 4 PRODUCTS REFERRED TO IN SECTION 9(5) 1. ADDITIVES 1.1 Technological additives: • additives falling under category 1(b) (“antioxidants”) of Annex I to Regulation (EC) No 1831/2003 with a confirmed maximum concentration 1.2 Sensory additives: • additives falling under category 2(a) (“colourants”) of Annex I to Regulation (EC) 1831/2003: carotenoids and xanthrophylls 1.3 Nutritional additives: • all additives falling under category 3 in Annex I to Regulation (EC) No 1831/2003 1.4 Additives affecting animal production: • all additives falling under category 4 in Annex I to Regulation (EC) No 1831/2003 1.5 Category of coccidiostats and histomonostats: • all additives 2. PREMIXTURES 2.1 Nutritional additives: • additives falling under category 3(a) (“vitamins, provitamins and chemically well-defined substances having similar effect”) in Annex I to Regulation (EC) No 1831/2003: A and D • additives falling under category 3(b) (“compounds of trace elements”) in Annex I to Regulation (EC) No 1831/2003: Cu and Se 2.2 Additives affecting animal production: • additives falling under category 4(d) (“other zootechnical additives”) in Annex I to Regulation (EC) No 1831/2003 2.3 Category of coccidiostats and histomonostats: • all additives 3. COMPOUND FEED 3.1 Additives affecting animal production: • additives falling under category 4(d) (“other zootechnical additives”) in Annex I to Regulation (EC) No 1831/2003 3.2 Category of coccidiostats and histomonostats: • all additives ANNEX 5 FEED MATERIAL GROUPS THAT MAY BE GIVEN INSTEAD OF THE NAME OF THE INDIVIDUAL FEED MATERIALS IN COMPOUND FEED FOR PETS Feed material group Definition 1. Meat products and products of animal origin Fresh or suitably preserved fleshy parts obtained from warm-blooded land animals, and preparations and products originating from the processing of the carcases, or parts of carcases, of warm-blooded land animals 2. Milk and milk preparations Fresh or suitably processed preparations, and by-products generated by their processing 3 Eggs and egg preparations Fresh or suitably processed egg preparations, and by-products generated by their processing 4 Fats and oils Animal and plant fats and oils 5. Yeasts Killed, dried yeast cells 6. Fish and fish products Fresh or suitably preserved fish, and parts of fish, and by-products generated by their processing 7. Cereals Cereals, irrespective of the degree of grinding, or products produced from starchy endosperm 8 Vegetables Fresh or suitably preserved vegetables and legumes 9. Products of plant origin Products particularly generated by the processing of cereals, plants, legumes and oil plant seeds 10. Protein concentrates of plant origin Products of plant origin where the protein has been enriched through processing to make a concentrate with at least 50% raw protein of dry matter and where it has been possible to modify the protein structure 11. Minerals Inorganic substances suitable for animal feed 12. Sugars Various sugars 13. Fruits Fresh or suitably preserved fruits 14. Nuts Nut kernels 15. Seeds Seeds, whole or coarsely ground 16. Marine algae Fresh or suitably preserved marine algae 17. Molluscs and crustaceans Fresh or suitably preserved molluscs, crustaceans, marine animals in shell, and by-products generated by their processing 18. Insects Insects and their different development stages 19 Bakery products Breads, cakes, biscuits and pasta preparations ANNEX 6 EUROPEAN UNION A Inspection of feed imported from third countries to the EU 1 Sender/Exporter 2 Serial number 4 Customs document number 3 Recipient 5 Annexed documents 1. [ ] Yes 2. [ ] No 6 Declarant/Representative 7 Origin 7.1 Identification number (if used) 9 CN code 11 Gross weight (kg) In fo rm a ti o n o n i m p o rt e d b a tc h o r lo t 8 Description of the goods [ ] 8.1 [ ] 8.2 [ ] 8.3 [ ] 8.4 [ ] 8.5 10 Number of packages 12 Net weight (kg) B 13 Documentation and identification inspections under section 11 of the Decree of the Ministry of Agriculture and Forestry 11/09 13.1 [ ] Documentation inspection 13.2 Identification inspection 1. [ ] Yes 2. [ ] No In sp ec ti on s co n d u ct ed 14 Physical inspections under section 11 of the Decree of the Ministry of Agriculture and Forestry 11/09 14.1 Physical inspection 1. [ ] Yes 2. [ ] No 14.2 Laboratory tests conducted 1. [ ] Yes 2.[ ] No Analysis type: If tests are conducted, enclose a copy of the results 14.3 Laboratory tests underway: 1. [ ] Yes 2. [ ] No Analysis type: C C er ti fi ca ti on 15 Supplementary identification information and official stamp of the competent authority for the place of entry 16 Authorised authority .................................................................................... Place and date .................................................................................... Signature .................................................................................... Name in block letters D 17 (Optional) Reserved for the competent authority of the destination Member State ANNEX 7 INDIVIDUAL RULES FOR THE COMPLETION OF PART A OF THE DOCUMENT IN ANNEX 6 A Information on the imported batch or lot 1. Sender/Exporter State the full name and address of the relevant person or company. 2. Serial number Give the serial number on the document issued by the competent authority. 3. Recipient State the full name and address of the person or company to whom the goods are being sent. 4. Customs document Give the customs document number. 5. Annexed documents Give the reference number for documents accompanying the batch or lot. 6. Declarant/Representative State the full name and address of the relevant person or company. If the declarant and the exporter/sender are the same person, write “sender” or “exporter”. 7. Origin State the name and address of the company or place of origin. 7.1 Where possible, state the establishment identification number. 8. Description of the goods Tick the appropriate point: [ ] 8.1 ― additives/premixtures [ ] 8.2 ― feed materials [ ] 8.3 ― compound feed [ ] 8.4 ― feed intended for special nutritional purposes [ ] 8.5 ― other products, please specify 9. CN code State the CN code. 10. Number of packages State the number of packages or write “bulk goods” for unpackaged products. 11. Gross weight (kg) State the gross weight in kilograms. 12. Net weight (kg) State the net weight in kilograms. ANNEX 8 RECORD KEEPING REQUIREMENTS FOR A BUSINESS OPERATOR IN PRIMARY PRODUCTION UNDER SECTION 26 a) In the case of feeds for animals intended for food production7 for each species and group of animal, the name or type of the feed8 and quantity of the feed; the name and address of the feed seller/supplier, the date of supply of the feed and the identification number for the feed warehouse to which the feed in question was delivered9 date of cessation of use of the feed, if there is a withdrawal period. b) For feed sold/supplied from the farm: name or type of the feed and quantity of the feed; name and address of the buyer/recipient of the feed, and the date of supply. c) Results of samples taken from the feed d) For the use of plant protection products and biocides: the name and quantity of the plant protection product or biocide used; period of use. With regard to the requirement to keep feed records, retaining any receipts of purchase and/or sale, or other similar supporting documents, such as records kept for each block, is sufficient provided that they show the items required for the records, as set out above. With regard to the requirement to keep records of the results from tests on feed, retaining the test certificates from such tests is sufficient. If a farmer is committed to the environmental aid, the records kept on the use of plant protection products in accordance with the conditions for environmental aid are also sufficient with regard to the requirements relating to feed. 7 also applies to feed produced on the farm 8 e.g. rape seed, extracted 9 Guidelines have been prepared by the industry on the labelling necessary to identify feed stocks and for using them on livestopck farms farms. The guidelines can be found on the Association for Animal Disease Prevention (ETT) website: www.ett.fi (Finnish only). Compliance with the guidelines is voluntary.