EXPORTING PET FOOD TO THE EU

An Expert's View about Animal Food in France

Posted on: 15 Aug 2012

In the EU, pet food is not regulated by one specific piece of legislation. Exports of U.S. pet food are subject to both the EU's feed marketing legislation and veterinary legislation.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Voluntary Public - Date: 8/7/2012 GAIN Report Number: E70032 EU-27 Post: Brussels USEU EXPORTING PET FOOD TO THE EU Report Categories: FAIRS Subject Report Approved By: Cynthia Guven Prepared By: Hilde Brans and Gerda Vandercammen Report Highlights: In the EU, pet food is not regulated by one specific piece of legislation. Exports of U.S. pet food are subject to both the EU's feed marketing legislation and veterinary legislation. U.S. pet food exporters must verify the full set of import requirements with their EU customers. This report provides an overview of EU legislation relating to imports of pet food. General Information: EXPORTING PET FOOD TO THE EU EU PET FOOD LEGISLATION In the EU, pet food is not regulated by one specific piece of legislation. The EU’s feed marketing legislation covers food for companion animals as well as food for all other animals. Pet food is often also subject to the EU’s veterinary legislation which has different product coverage than the feed marketing legislation. The veterinary legislation covers products of animal origin and hay/straw as these present a risk for spreading animal diseases. The EU’s approach to deal with these risks consists of a system of mandatory consignment notification and inspection at import as well as product establishment approval and import certification in the country of origin. Specific certification rules have been developed for various product groups including for “animal by-products”. The EU’s Animal by-product legislation contains several certificates required for successfully shipping pet foods with animal origin ingredients. All exports of U.S. pet food to the European Union must comply with EU requirements including rules on labeling, hygiene, animal health, certification and the use of additives. U.S. pet food exporters must verify the full set of import requirements with their EU customers. Final import approval is subject to the importing country’s rules as interpreted by border officials at the time of product entry. Annex I of this report provides links to the relevant pieces of EU legislation relating to imports of pet food. This EU legislation is not specific to pet food. The EU production and marketing rules also cover feed for production animals and the veterinary legislation also includes other products of animal origin. Therefore, it is important to determine which category and definition in the EU legislation applies to the specific product that is intended for export to the EU. MARKETING & LABELING LEGISLATION FRAMEWORK LEGISLATION European Parliament and Council Regulation 767/2009 sets out rules for the labeling (on-pack and off-pack) and marketing of feed and pet food. Feed and pet food not complying with Regulation 767/2009 and with the provisions on feed additives laid down in Regulation 1831/2003 and Directive 90/167 will not be allowed on the EU market. Annex II to this report specifies the provisions of Regulation 767/2009 by article. DEFINITIONS (Reg. 767/2009 - ARTICLE 3) “Feed materials:” Products of vegetable or animal origin whose principal purpose is to meet animals’ nutritional needs, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing feed additives, which are intended for use in oral animal-feeding either directly as such, or after processing, or in the preparation of compound feed, or as carrier or pre-mixtures. “Compound feed:” A mixture of at least two feed materials, whether or not containing feed additives, for oral animal-feeding in the form of complete or complementary feed. “Complete feed:” Compound feed which, by reason of its composition, is sufficient for a daily ration. “Complementary feed:” Compound feed which has a high content of certain substances but which, by reason of its composition, is sufficient for a daily ration only if used in combination with other feed. “Feed intended for particular nutritional purposes (including dietetic pet food):” Feed which can satisfy a particular nutritional purpose by virtue of its particular composition or method of manufacture, which clearly distinguishes it from ordinary feed. Feed intended for particular nutritional purposes does not include medicated feedingstuffs within the meaning of Directive 90/167. GENERAL MANDATORY LABELING REQUIREMENTS (REG. 767/2009 - ARTICLE 15) Mandatory labeling information must be given in a clearly legible and indelible way, in the official language(s) of the Member State where the product is marketed, in a prominent place on the packaging. Labels must include: - Type of feed: “feed material”, “complete feed” or “complementary feed” (for pets other than cats and dogs “complete feed” or “complementary feed” may be replaced by “compound feed” - Name or business name and address of the feed business operator responsible for the labeling - Establishment approval number if available - Batch or reference number - Net quantity: expressed in units of mass for solid products, units of mass or volume for liquid products or number of units - List of feed additives preceded by the heading “additives” in accordance with Chapter 1 of Annex VI or VII to Regulation 767/2009 - Analytical constituents in accordance with Annex VII – Chapter II and moisture content in accordance with point 6 of Annex I to Regulation 767/2009 SPECIFIC MANDATORY LABELING REQUIREMENTS In addition to the general labeling requirements, Regulation 767/2009 also establishes specific labeling requirements for feed materials, compound feed, dietetic feed, pet food and contaminated feed. Pet food composed of only one feed material (Reg. 676/2009 – Article 16) - Specific name of the feed material - Analytical constituents in accordance with Annex V and Annex VII (Chapter II) to Regulation 767/2009 Where additives are added, it is recommended to follow the labeling rules applicable to compound feed. Compound Feed (Reg. 767/2009 - Article 17) - Species or categories of animals for which the compound feed is intended - Instructions for proper use - In cases where the producer is not the person responsible for the labeling: name and address or identification number of the producer - Minimum storage life: for highly perishable feed, “use before…” followed by the date DD/MM/YY; for other feed, “best before…” followed by the date DD/MM/YY - List of feed materials preceded by the heading “composition.” The name of each feed material must be indicated in descending order of weight based on the moisture content in the compound feed. - Compulsory declarations listed in Annex VII (labeling information for feed materials and compound feed for non-food producing animals. Labels on compound feed for pet animals (pet food) must list the feed materials by their specific name or category, in descending order by weight. Specific amounts may be indicated as a percentage in the feed materials list. However, if the presence of a certain feed material is emphasized on the label in words, pictures or graphics, the exact percentage by weight must be indicated. For “non- food producing animals”, the specific name of a feed material may be replaced by the category to which it belongs, e.g. “oils and fats”, in accordance with the Annex to Directive 82/475. Dietetic Feed (Reg. 767/2009 – Article 18) The label on dietetic feed must include: - The qualifying expression “dietetic” next to the type of feed - Intended use - Indication that the opinion of a nutrition expert or veterinarian must be sought before use Dietetic feed may only be marketed as such if its intended use is included in the list of acceptable intended uses set out in Directive 2008/38. Pet food may not be marketed as “dietetic” unless the nutritional purpose is included in the list of intended uses established by Directive 200/38. Claims (Reg. 767/2009 – Article 13) Labels on feed materials and compound feed may highlight the presence of a certain substance, a specific nutritional characteristic, process or function provided the claim is objective and verifiable by the competent authorities. Scientific substantiation must be available at the time the feed is placed on the EU market. Claims that feed materials and compound feed will prevent, treat or cure a disease are not allowed. Additional Labeling Requirements for Pet Food (Reg. 767/2009 – Article 19) A free telephone number or other appropriate means of communication must be provided on pet food labels for purchasers wishing to obtain additional information on feed additives or feed categories. ANALYTICAL CONSTITUENTS (ANNEX VII to Reg. 767/2009) Annex VII - Chapter II sets out rules for the indication of the analytical constituents on pet food labels. Under the heading “Analytical Constituents” the following constituents must be indicated: - Crude protein - Crude fibers - Crude oils and fats - Crude ash - Calcium, sodium and phosphorus (in mineral complementary feed) The moisture content must be indicated if it exceeds the levels established in Annex I to Regulation 767/2009. PACKAGING (Reg. 767/2009 – Article 23) As a general rule, feed materials and compound feed may be marketed only in sealed packages or containers. By way of derogation, feed materials, compound feed obtained exclusively by mixing grain or whole fruit and deliveries from producers of compound feed to packaging firms may also be marketed in bulk if the mandatory labeling requirements are provided in the accompanying documents. COMMUNITY CATALOGUE OF FEED MATERIALS The most recent Catalogue of feed materials established by Commission Regulation 575/2011 provides a list of processes, descriptions and definitions. The Catalogue enables operators to use more precise names and expressions for the feed they place on the market. Even though its use is voluntary, when used, it must comply with all relevant provisions of the Catalogue. The EU feed industry, in consultation with the Member States, the European Food Safety Authority (EFSA) and feed users, is responsible for drafting amendments to the Catalogue. In addition, the feed industry is required to publish and maintain an online register listing feed materials not yet included in the Catalogue. The use of a feed material placed on the market for the first time must be notified to the EU feed industry representatives in order to have it listed in the Register. The Register, available at www.feedmaterialsregister.eu, is updated on a regular basis. DISTINCTION BETWEEN FEED MATERIALS Commission Recommendation 2011/25 establishes guidelines for the distinction between feed materials, feed additives, biocidal products and veterinary medicinal products. These non-binding guidelines were developed to assist feed and pet food manufacturers with the classification of their products. FEED ADDITIVES European Parliament and Council Regulation 1831/2003 sets out rules for the authorization, marketing and labeling of feed additives. This regulation covers the following feed additive categories: - Technological additives (e.g. preservatives, antioxidants, emulsifiers, stabilizing agents, acidity regulators, silage additives) - Sensory additives (e.g. flavors, colorants) - Nutritional additives (e.g. vitamins, minerals, amino acids, trace elements) - Zootechnical additives (e.g. digestibility enhancers, gut flora stabilizers) - Coccidiostats and histomonostats Additives within these specific categories and functional groups may be used only if they are included in the EU Register of authorized feed additives. The Register is updated whenever authorizations are modified and can be consulted online at http://ec.europa.eu/food/food/animalnutrition/feedadditives/registeradditives_en. htm. Additives listed in Annex VII to European Parliament and Council Regulation 767/2009 need to be declared on pet food labels. Under the heading “Additives,” feed additives must be listed by their specific name, functional group or category and the added amount of the compound must be indicated. Any additive with a maximum limit for any species must declare it even if it is cat food and the maximum limit relates to another animal. By way of derogation, for additives of the functional groups “preservatives,” “antioxidants,” and “colorants” only the functional group may be indicated on pet food labels. ORGANIC PET FOOD To date, pet food is not covered by the EU regulations on organic production (Regulations 834/2007 and 889/2008). In the absence of EU harmonized rules, organic pet food is subject to the Member States’ national rules. Information on national rules can be obtained from FAS offices in the different EU Member States. GENETICALLY MODIFIED ORGANISMS (GMOs) European Parliament and Council Regulation 1829/2003 on genetically modified food and feed sets out rules for GMOs for feed use, feed containing or consisting of GMOs and feed produced from GMOs. Article 25 stipulates that for feed containing or consisting of GMOs, the words “genetically modified (name of the organism)” must appear in parentheses immediately following the specific name of the feed. For feed produced from GMOs, the words “produced from genetically modified (name of the organism)” must appear in parentheses immediately following the specific name of the feed. The information on GMOs must be given either in the list of feed materials or as a footnote to the list of feed materials printed in a font of at least the same size as the composition list. Article 4 of European Parliament and Council Regulation 1830/2003 on traceability and labeling of GMOs and food and feed produced from GMOs stipulates that pre- packaged products containing GMOs must be labeled as “This product contains genetically modified organisms” or “This product contains genetically modified (name of organism). Article 24 of Regulation 1829/2003 establishes a tolerance level of 0.9 percent. The mandatory GMO labeling requirements do not apply to products containing GM feed materials in a proportion, for each single feed material, up to and including 0.9 percent. This tolerance level applies only to GMOs authorized in the EU whose adventitious or technically unavoidable presence can be proven. COMMUNITY CODES OF GOOD LABELING PRACTICE Article 25 of Regulation 767/2009 provides for the establishment of “Community Codes of Good Labeling Practice,” one for pet food and one for compound feed for food-producing animals. The “Code of Good Labeling Practice for Pet Food,” drafted by the European Pet Food Industry (FEDIAF), was published on the European Commission’s website in October 2011. This Code which serves as a guide for pet food labeling in the EU will be updated at least once a year and should be read in combination with the relevant EU and Member State legislation. HOW TO AVOID PROBLEMS – CHECK LISTS Border inspection officials will verify the labels on imported pet food for compliance with EU requirements. Annex 4 to the “Code of Good Labeling Practice for Pet Food” establishes a “check-list” that pet food manufacturers can use to verify compliance with EU labeling rules. VETERINARY LEGISLATION GENERAL EU REQUIREMENTS EU legislation mandates that pet food products containing an animal origin ingredient or hay/straw are subject to veterinary inspection upon entry into the EU. Pet food products containing an animal origin ingredient have to be sourced from approved establishments and have to be accompanied by a veterinary certificate. Details of the veterinary certification requirements for animal-origin products are included in EU legislation that is commonly referred to as the “EU ANIMAL BY-PRODUCTS LEGISLATION”. Exporters need to address establishment approval and certification requirements PRIOR to exporting the goods to the European Union. CONTACT APHIS Exporters need to work with the USDA Animal and Plant Health Inspection Service to obtain the required establishment approval and certification. The section Animal Products to European Union - Materials NOT for human consumption on the APHIS website is a comprehensive source of information on this topic. Information in this section covers the export requirements of products within the scope of the EU animal by-products legislation, including pet food products. Please contact your APHIS-Veterinary Services Area Office for details on how to request required approvals and certificates. FACILITY APPROVAL Prior to obtaining APHIS certificates, pet food facilities must be approved by APHIS in compliance with Regulations (EC) No 1069/2011 and (EU) 142/2011. If a facility is approved by APHIS under these regulations, the information is generally automatically submitted to the EU TRACES system. The TRACES system is an EU management tool for tracking the movement of animals and products of animal origin within the EU. It created a single central web-based database for this purpose. TRACES lists of authorized establishments are available at the following website: https://webgate.ec.europa.eu/sanco/traces/output/US/ABP- PET_US_en.pdf CERTIFICATION For the most part, certificates required by the EU for importation of pet food are standardized documents based upon the model certificates published in European Union Regulation (EU) No 142/2011. The EU requires certificates to be in an official language of the port of entry into the EU, as well as sometimes the official language of the specific EU country of destination. Many EU countries recognize several official languages. In these cases, if English is one of these languages, the certificate may be in English-only. In cases where APHIS has confirmed the acceptable “official” languages, the information is available on the IREGS website under the individual countries. CERTIFICATES HAVE TO BE ISSUED BEFORE THE SHIPMENT LEAVES FOR THE EU. Below is an overview of the various APHIS certificates needed for pet food products exported to the EU. Please note that these certificates are also required for transiting pet food products through the European Union. Furthermore, a specific certificate has been developed for shipping trade samples. PRODU CT LINK CERTIFICATE Canned Pet Health Certificate for canned petfood intended for pet food Food dispatch or transit to the European Community (Canned ) - Chapter 3(A) Process Pet Health Certificate for processed pet food other than ed pet Food canned pet food, intended for dispatch to or transit food (Process through the European Community other ed Pet than Food canned Other pet food than Canned) - Chapter 3(B) Dog Pet Health Certificate for dogchews intended for dispatch chews Food or transit to the European Community/ (Chews) - Chapter 3(C) Flavorin Pet Health Certificate for flavoring innards for use in the g Food manufacture of petfood, intended for dispatch or innards Ingredie transit to the European Community for use nt: in the Flavorin manufa g cture of innards pet food (include (digests s ) digests) - Chapter 3(E) Raw Pet Health Certificate for animal by-products for the material Food manufacture of petfood, intended for dispatch or for pet Ingredie transit to the European Community/ food nt: manufa Unproce cture ssed Animal By- Product s - Chapter 3(F) Trade Chapter CHAPTER 8 Sample 8 Health Health certificate for animal by-products to be used for s Certifica purposes outside the feed chain or for trade samples, te for intended for dispatch to or for transit through the Trade European Union Sample s Dispatc hed to the EU Chapter Please check APHIS website for guidance on when this 8 Health certificate is required: Trade Certifica http://www.aphis.usda.gov/regulations/vs/iregs/produ Sample te for cts/downloads/ee_tr_sa.pdf s Trade Sample s Transiti ng the EU HAY AND STRAW BASED PET FOODS Hay and straw are listed as products that require veterinary inspection. Per COMMISSION REGULATION (EC) No 136/2004, the U.S. is listed as an eligible country to ship these products. In absence of further detailed harmonized EU specifications, these products become subject to bilateral arrangements between the U.S. (APHIS) and the importing Member State. ANNEX I – EU LEGISLATION MARKETING & LABELING European Parliament and Council Regulation 178/2002 laying down the general principles and requirements of food law (includes definition of “feed”) European Parliament and Council Regulation 767/2009 on the placing on the market and use of feed Commission Regulation 575/2011 on the Catalogue of feed materials Commission Regulation 939/2010 on permitted tolerances for compositional labeling of feed and pet food Commission Directive 82/475 laying down categories of feed materials for pet food labeling Commission Recommendation 2011/25 establishing guidelines for the distinction between feed materials, feed additives, biocidal products and veterinary medicinal products Commission Directive 2008/38 establishing a list of intended uses of animal feedingstuffs for particular nutritional uses Council Directive 90/167 on the use and marketing of medicated feedingstuffs European Parliament and Council Directive 2001/82/EC on the Community code relating to veterinary medicinal products Council Regulation 834/2007 on organic production and labeling of organic products European Parliament and Council Regulation 1829/2003 on genetically modified food and feed European Parliament and Council Regulation 1830/2003 concerning the traceability and labeling food and feed produced from genetically modified organisms FEED ADDITIVES European Parliament and Council Regulation 1831/2003 on additives for use in animal nutrition European Register for feed additives Commission Regulation 378/2005 on detailed rules for the implementation of Regulation 1831/2003 as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorizations of feed additives FEED HYGIENE AND CONTROL European Parliament and Council Regulation 183/2005 laying down requirements for feed hygiene European Parliament and Council Directive 2002/32/ on undesirable substances in animal feed Commission Decision 2004/217 adopting a list of materials whose circulation or use for animal nutrition purposes is prohibited Commission Regulation 152/2009 laying down the methods of sampling and analysis for the official control of feed TRACEABILITY & CERTIFICATION REQUIREMENTS European Parliament and Council Regulation 1069/2009 laying down health rules as regards animal by-products and derived products not intended for human consumption European Parliament and Council Regulation 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies VETERINARY REQUIREMENTS Council Directive 97/78/EC laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries Commission Decision 2007/240/EC laying down new veterinary certificates for importing live animals, semen, embryos, ova and products of animal origin into the Community pursuant to Decisions … (provides guidance on how to fill out part I of the export certificate) Commission Decision concerning lists of animals and products to be subject to controls at border inspection posts under Council Directives 91/496/EEC and 97/78/EC Commission Regulation 136/2004 laying down procedures for veterinary checks at Community border inspection posts on products imported from third countries (notification of arrival of the shipment required from the IMPORTER) European Parliament and Council Regulation 1069/2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by- products Regulation) Commission Regulation142/2011 implementing 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 implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (contains model health certificates) ANNEX II – PROVISIONS OF REGULATION 767/2009 – BY ARTICLE PROVISION SUBJECT Article 1 Objective Article 2 Scope Article 3 Definitions Article 4 General safety requirements Article 5 Responsibilities and obligations of feed businesses Article 6 Restriction and prohibition on the marketing or use of certain materials for animal nutrition purposes Article 7 Adoption of guidelines clarifying distinction between feed materials, feed additives and other products Article 8 Content of feed additives Article 9 Marketing of feed intended for particular nutritional purposes Article 10 List of intended uses Article 11 Principles for labeling and presentation Article 12 Designation of the person responsible for labeling Article 13 Claims Article 14 Presentation of labeling information Article 15 General mandatory labeling requirements Article 16 Specific labeling requirements for feed materials Article 17 Specific labeling requirements for compound feed Article 18 Specific labeling requirements for dietetic feed Article 19 Additional labeling requirements for pet food Article 20 Additional labeling requirements for non-compliant feed Article 21 Derogations Article 22 Voluntary labeling Article 23 Packaging Article 24 Community Catalogue of feed materials Article 25 Community codes of good labeling practice Annex I Technical provisions on impurities, milk replacer, feed materials for binding or denaturing, ash level and moisture content Annex II General provisions on labeling referred to in Article 11 Annex III List of restricted or prohibited materials Annex IV Permitted tolerances for compositional labeling Annex V Compulsory declaration of feed materials referred to in Article 16 Annex VI Labeling information for feed materials and compound feed for food producing animals Annex VII Labeling information for feed materials and compound feed for non-food producing animals Annex VIII Labeling of non-compliant feed
Posted: 15 August 2012

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EXPORTING PET FOOD TO THE EU   By Foreign Agricultural Service