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RS 916.307 Order of 26 October 2011 on the production and release of feed (Animal Food Ordinance OSALA)

Original Language Title: RS 916.307 Ordonnance du 26 octobre 2011 sur la production et la mise en circulation des aliments pour animaux (Ordonnance sur les aliments pour animaux, OSALA)

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916.307

Guidelines for the Production and Release of Animal Food

(Animal Food Order, OSALA)

On 26 October 2011 (State 1 Er February 2016)

The Swiss Federal Council,

Having regard to art. 27 A , para. 2, 148 A , para. 3, 158, para. 2, 159 A , 160, para. 1-5, 161, 164, 177 and 181, para. 1 Bis , of the Act of 29 April 1998 on Agriculture (LAgr) 1 , given art. 29 of the Act of 7 October 1983 on the Protection of the Environment (LPE) 2 , given art. 16, para. 2, and 17 of the Law of 21 March 2003 on Genetic Engineering (LGG) 3 , given art. 9, para. 2, let. C, of the Federal Law of 24 January 1991 on the Protection of Waters (LEaux) 4 , having regard to the Federal Act of 6 October 1995 on Technical Barriers to Trade (LETC) 5 ,

Stops:

Chapter 1 General provisions

Art. 1 Object, scope

1 This order regulates the importation, production, processing, release and use of food for livestock and companion animals.

2 Primary production of feed is regulated by the order of 23 November 2005 on primary production 1 , except as provided for in that order.

3 This order does not apply to:

A.
Food for animals intended solely for export to countries with which there is no reciprocal recognition of the requirements for animal feed or the assessment of their conformity;
B.
The importation of feedingstuffs intended for re-export to countries with which there is no reciprocal recognition of the requirements for animal feed or the assessment of their conformity;
C.
The importation of pet food for private use.

4 Legislation on epizootic diseases is reserved.


Art. 2 Application Fields

Are governed:

A.
In Chapter 2:
1.
Import, release and use of raw materials, compound feedingstuffs and dietetic feedingstuffs,
2.
Labelling, packaging and presentation requirements;
B.
In Chapter 3:
1.
The procedure for the approval, release and use of additives and premixes for animal feed,
2.
The rules applicable to the control and labelling of additives and premixes for animal feed;
C.
In Chapter 4: maximum values and specific provisions for undesirable substances in feedingstuffs;
D.
In Chapter 5:
1.
Animal feed hygiene requirements,
2.
The requirements and procedures governing the traceability of feed,
3.
The conditions and procedure applicable to the registration and authorisation of establishments;
E.
In Chapter 6:
1.
The authorisation and control regime for genetically modified feedingstuffs,
2.
Provisions on the labelling and traceability of genetically modified animal feed.
Art. 3 Definitions

1 The term Animal feed : All substances or products, including additives, processed, partially processed or unprocessed, intended for the feeding of animals by the oral route.

2 In the case of feed, the following refers to:

A.
Feed materials (raw materials) ) : Products of plant or animal origin whose main objective is to satisfy the nutritional requirements of animals, in the natural state, fresh or preserved, and the by-products of their industrial processing, as well as the organic substances or Inorganic, including or not including feed additives, which are intended for use in the feeding of animals orally, either directly in the state, or after processing, or for the preparation of compound feedingstuffs For animals or as media for premixes;
B.
Complete animal feed: A food composed for animals which, because of its composition, is sufficient to ensure a daily ration;
C.
Compound feedingstuff: A mixture of at least two raw materials, including or not including feed additives, which is intended for use by the oral animal feed, in the form of a complete animal feed or a supplementary feed for Animals;
D.
Complementary animal feed: A food consisting of animals which has a high content of certain substances but which, by reason of its composition, ensures the daily ration only if it is associated with other feed;
E.
Breastfeeding food: A food consisting of animals administered in a dry state or after dilution in a given quantity of liquid, intended for the feeding of young animals to supplement or replace postcolostral breast milk or the feeding of young animals Animals such as calves, lambs or butchers;
F.
Mineral food: A supplementary food containing at least 40 % of the raw ash in relation to a food containing 88 % dry matter;
G.
Animal feed for specific nutritional purposes (dietary food): A raw material or a compound food capable of meeting a particular nutritional purpose as a result of its particular composition or manufacturing process, which clearly distinguishes it from raw materials or food Common animal compounds. Animal feed intended for particular nutritional purposes does not include medicated feeds as defined in the Ordinance of 17 October 2001 on authorisations in the field of medicinal products 1 ;
H.
Feed additives: Substances, microorganisms or preparations, other than raw materials and premixes, that are intentionally added to feed or water for the purpose of carrying out one or more of the functions referred to in s. 24, para. 3;
I.
Technological auxiliary: Any substance that is not consumed as a feed as such, used deliberately in the processing of feed or feed materials to meet a certain objective Technology during processing or processing and may result in the unintentional but technically unavoidable presence of residues of that substance or its derivatives in the final product, provided that these residues are not No adverse effects on animal health, human health or the environment, and have no effect Finished product technology;
J.
Coccidiostats and histomonostats: Substances intended to destroy or inhibit protozoa;
K.
Specific nutritional objective : An objective of satisfying the specific nutritional needs of animals whose assimilation process, absorption process or metabolism is or is likely to be temporarily or irreversibly disrupted and which May derive benefits from the ingestion of animal feeds appropriate to their condition;
L.
Premixes : Mixtures of feed additives or mixtures of one or more feed additives with raw materials or water used as media, which are not intended for direct feeding of animals;
M.
Support : A substance used to dissolve, dilute, disperse or otherwise physically alter an animal feed additive in order to facilitate its handling, application or use without changing its technological function and Without itself having a technological role.

3 With regard to labelling, the following means:

A.
Minimum durability: The period during which the establishment responsible for the labelling ensures that, under appropriate conservation conditions, the animal feed retains its declared properties;
B.
Labelling: The attribution of indications, indications, trade marks, images or signs to food for animals by affixing such information to any medium, such as a packaging, a receptacle, a delivery bulletin, a Accompanying document, a sign, a label, a leaflet, a ring, a snack or the Internet, including for advertising purposes;
C.
Label: A mark, sign, image or other descriptive, written, printed, sanded, affixed, engraved or applied to the package or container containing or attached to a food for animals;
D.
Batch: An identifiable amount of feed for which it is established that it has common characteristics, such as the origin, variety, type of packaging, packager, consignor or labelling, and, in the case of a process of Production, a quantity of product manufactured in a single plant using uniform production parameters or several of these quantities when produced in continuous order and stored together;
E.
Responsible labelling establishment: The establishment or undertaking of the feed sector which places a food for animals in circulation for the first time or, where appropriate, the establishment or undertaking of the animal feed sector under whose name or Which feed is put into circulation;
F.
Overview: The shape, appearance or packaging of the food for animals and the packaging materials used for it, as well as the manner in which it is presented and the framework in which it is disposed.

4 With regard to animals, the following means:

A.
Non-food animal (pet): An animal belonging to a species that is fed, raised or held, but which is normally not used in human consumption in Europe;
B. 2
Food animal (animal of rent) : an animal which is fed, raised or held, directly or indirectly, for the production of foodstuffs intended for human consumption, including animals which are not intended for human consumption but belong to Species that can normally be used for human consumption in Europe;
C.
Fur animal: Any animal that is fed, raised or held for the production of fur and is not used for human consumption;
D.
Daily ration: The total amount of food reported at a moisture content of 12 %, an average of which is required per day for an animal of a species, an age category, and a return determined to meet all of its needs;
E.
Oral feeding of animals: The absorption of food into the digestive tract of animals by the snout or bill, in order to cover the food needs of the animal or to maintain the productivity of healthy animals.

5 In the case of undertakings, the following means:

A.
Animal feed business: Any public or private undertaking providing for the production, manufacturing, processing, storage, transport or distribution of feedingstuffs for profit or non-profit;
B.
Institution: Any unit of production, processing or marketing of an animal feed business;
C.
The stages of production, processing and distribution: All stages, including the import, from and including the primary production of a feed, to and including its storage, transportation, sale and delivery to the user;
D.
Put into circulation: The holding of feedingstuffs for sale, including the offer for sale or any other form of sale, for free or for consideration;
E.
Traceability : The ability to trace, through all stages of production, processing and distribution, the movement of a food for animals, an animal of an annuity or a substance intended to be incorporated or likely to be Incorporated into a feed;
F.
Retail sale: The handling, processing or processing of feedingstuffs and their storage at the place of sale or delivery to the end user; they are part of the loading stations, shops, supermarkets, centres Distribution and retail outlets for wholesale trade.

6 With regard to the safety of feedingstuffs, the following means:

A.
Danger: A biological, chemical or physical agent in a food or animal feed, or a condition in which a food or feed is found, which may cause harm to health;
B.
Risk: A function of the likelihood and severity of an adverse health effect due to the presence of a hazard;
C.
Risk analysis: A process with three interrelated components: risk assessment, risk management, and risk communication;
D.
Risk assessment: A science-based, four-step process: hazard identification, characterization, exposure assessment and risk characterization;
E.
Risk management: The process, distinct from the risk assessment, to balance possible policies, in consultation with stakeholders, to take into account risk assessment and other legitimate factors, and Need to choose appropriate prevention and control measures.

7 In addition, the following means:

A.
Undesirable substance: Any substance or product, with the exception of pathogens, which is present in and/or on the product intended for animal feed and which poses a potential risk to animal health or human health or the environment or which Be likely to interfere with animal production;
B.
End user : The person who purchases a feed for the purpose of feeding it to animals, with no intention of recirculating it;
C.
Response threshold: Limit value for the content of an undesirable substance, beyond which examinations must be undertaken to determine the causes of the presence of the substance for the purpose of taking action for its reduction or elimination;
D.
Produced from genetically modified organisms (GMOs): Produced, in whole or in part, from GMOs, but not consisting of or containing GMOs;
E.
Remote communication medium: Any means of communication, such as the catalogue, the Internet, the electronic mail, which can be used to conclude a contract between a user and a delivery agent without the simultaneous physical presence of the contracting parties;
F. 3
Mixture of oils or fats: Mixing of crude oils, refined oils, animal fats, oils recovered from the food industry or derived products; if identical lots are stored successively in a container, this is not considered to be Manufacturing a mixture of fats.

1 RS 812.212.1
2 New content according to the c. I of the O of 20 May 2015, in force since 1 Er Jul. 2015 ( RO 2015 1791 ).
3 Introduced by c. I of the O of 15 May 2013, in force since 1 Er Jul. 2013 ( RO 2013 1737 ).

Art. 4 General measures for the safety of feed

1 Where a feed does not meet the requirements for its release, the Federal Office of Agriculture (OFAG) shall order the appropriate measures to remedy the situation. It may include:

A.
Impose restrictions on the release of the food for the animals concerned;
B.
Require its withdrawal from the market;
C.
Order its destruction.

2 The OFAG may charge the release of a food for animals, prohibit it, or require its removal from the market if the conditions set out in s. 148 A LAgr are completed.

3 Where a feed, identified as not meeting the safety requirements of animal feed, is part of a lot or feed of feed of the same category or corresponding to the same Description, it is assumed that the whole animal feed of this lot or shipment does not meet the requirements. This presumption may be reversed if the feed business provides evidence that the rest of the lot or shipment complies with the requirements.

4 The conformity of a feed with specific provisions shall not prohibit the OFAG from taking appropriate measures to impose restrictions on its release or to require its withdrawal from the market if there are Reason to suspect that, despite this compliance, this animal feed is dangerous.

Art. 5 OFAG requirements when there is a need to act quickly

1 In situations requiring prompt action, the OFAG may, in agreement with the services concerned, prohibit the import, release and use of food for animals that endanger human health and human health. Animals or pose a risk to the environment.

2 It may set maximum values for these feedingstuffs which must not be exceeded. Maximum values are based on international standard values or maximum values in the exporting country, or are scientifically based.

3 It may fix which feedingstuffs may be imported or put into circulation only accompanied by a declaration by the competent authorities of the exporting country or of an accredited service.

4 It sets out what indications the declaration should contain and whether documents should be attached to the statement.

5 Batches for which the documents referred to in para. 4 cannot be presented at the time of importation are turned back or destroyed if they present a risk.

Chapter 2 Raw Materials, Compound Foods and Dietetic Foods for Animals

Section 1 Purpose

Art. 6

1 This chapter does not apply to water, whether ingested directly by animals or intentionally incorporated into animal feed.

2 It is applicable subject to the order of 25 May 2011 concerning the disposal of animal by-products 1 . 2


1 RS 916.441.22
2 New content according to the c. I of the O of 31 Oct. 2012, effective from 1 Er Jan 2013 ( RO 2012 6399 ).

Section 2 General requirements

Art. 7 Import, Release and Use Requirements

1 Raw materials, compound foods and dietetic foods cannot be imported, put into circulation and used only:

A.
If they are safe;
B.
They have no direct adverse effects on the environment or animal welfare;
C.
They have no adverse effects on human or animal health;
D.
They do not pose a risk to human consumption of food derived from animals fed such food;
E.
If they are healthy, unaltered, loyal, suitable for their use and of merchantable quality.

1bis For the release of raw materials, compound foods and dietetic foods whose development is based on the use of genetic resources or traditional knowledge associated with them, the provisions of The Nagoya Order of December 11, 2015 1 Are reserved. 2

2 The Federal Department of Economics, Training and Research (DEFR) 3 Establishes technical provisions for impurities and other chemical determinants that the raw materials, compound feedingstuffs and dietetic foods must comply with.


1 RS 451.61
2 Introduced by ch. 9 of the annex to the O de Nagoya of 11 Dec. 2015, in force since 1 Er Feb 2016 ( RO 2016 277 ).
3 The designation of the administrative unit has been adapted to 1 Er Jan 2013 under Art. 16 al. 3 of the O of 17 Nov 2004 on official publications ( RO 2004 4937 ). This mod has been taken into account. Throughout the text.

Art. 8 Restrictions and prohibitions

1 DEFR lists substances for which the import, release or use as animal feed is prohibited or restricted. These prohibitions and restrictions are also valid for primary production.

2 The OFAG may amend the list referred to in para. 1, taking into account in particular the available scientific data, technological progress, attested information of the international market or the results of official controls.

3 DEFR sets the maximum content of feed additives in feedstocks and complementary foods.

Art. Catalogue of raw materials and obligation to advertise

1 Any person who imports or puts into circulation a raw material, pure or mixed in a compound or dietetic food, that is not exempt from the obligation to advertise in para. 2, nor is it on the OFAG list according to para. 3, shall communicate to the OFAG within three months after the first importation or release the following particulars: 1

A.
The name and address of the person or business who puts into circulation or imports the raw material;
B.
The name and, where appropriate, the specific labelling of the raw material;
C.
The description of the raw material and the process data for obtaining the raw material, if any, on the manufacturing process;
D.
The main nutrients in the raw material.

2 DEFR sets out the raw materials that are not to be announced. It is based on the law of the European Union. 2

3 OFAG publishes a list of announcements made.

4 The name of a raw material listed in the catalogue of raw materials, as the case may be in a compound food or a dietetic food, may be used only if all the applicable provisions of the said catalogue are Respected.

5 A raw material appearing in the catalogue of raw materials which, according to the legislation on medicinal products would be considered to be a medicinal product, cannot be imported, put into circulation or used as a raw material for the Animal feed. The OFAG may provide for exceptions.


1 New content according to the c. I of the O of 15 May 2013, in force since 1 Er Jul. 2013 ( RO 2013 1737 ).
2 New content according to the c. I of the O of 15 May 2013, in force since 1 Er Jul. 2013 ( RO 2013 1737 ).

Art. 10 Responsibilities and obligations of companies in the feed sector

The establishment responsible for the labelling of feed shall provide to the OFAG upon request all information on the composition and properties of a product put into circulation by that establishment.

Section 3 Dietetic Foods

Art. 11

1 The DEFR establishes the list of intended destinations and related nutritional characteristics, which give the right to the designation "dietary food for animals".

2 A dietetic feed for animals cannot be put into circulation as such only if its destination is on the list of permitted destinations and if it meets the essential nutritional characteristics of the destination Specific.

3 The DEFR includes in the list, on its own initiative or on the basis of an application for approval, new nutritional destinations and related characteristics. The application may be submitted by a natural or legal person established in Switzerland; it must be transmitted to the OFAG and demonstrate that:

A.
The specific composition of the feedstock or animal feed responds to the intended nutritional destination;
B.
Raw materials or compound feedingstuffs meet the requirements of the specific nutritional destination;
C.
Raw materials and compound feedingstuffs do not adversely affect animal health, human health, the environment or animal welfare.

4 When amending the list of nutritional destinations of dietary foods, DEFR takes into account the corresponding list of the European Union (EU).

Section 4 Labelling, presentation and packaging

Art. 12 Labelling and presentation principles

1 The labelling and presentation of raw materials, compound foods and dietetic foods should not mislead the user, in particular as regards:

A.
The destination or characteristics of the feed, in particular its nature, method of manufacture or production, its properties, composition, quantity, durability and animal species or categories of animals to which it Is intended;
B.
The allocation to the food for animals of effects or characteristics that it does not possess or the declaration that it has special characteristics, whereas all comparable food for animals has the same;
C.
The conformity of the labelling with the catalogue of feed materials for animals referred to in Art. 9.

2 Raw materials, compound and dietetic feedingstuffs sold in bulk or in non-enclosed packagings or containers shall be accompanied by a document containing all the prescribed labelling particulars.

3 Where raw materials, compound or dietetic feedingstuffs are offered for sale by means of distance communication, the labelling particulars required by this Chapter, with the exception of Indications of durability and those referred to in s. 15, para. 1, let. B, d and e, must be on the support of the distance selling or be provided by other appropriate means before the conclusion of a contract. The indications of durability and those referred to in Art. 15, para. 1, let. B, d and e, shall be made no later than at the time of delivery of the feed.

4 Only one date of minimum durability may be indicated for the raw material, the compound or dietetic feed, considered as a whole. It is determined on the basis of the shortest minimum durability of each component.

Art. 13 Liability

1 The establishment responsible for labelling guarantees the presence and material accuracy of the labelling particulars.

2 Companies in the feed sector shall ensure that all information provided by the establishments under their control meets the labelling requirements.

3 Companies in the animal feed sector shall ensure that the labelling particulars referred to in Art. 15 are transmitted from one end of the food chain to the other in all establishments under their control.

4 Animal feed companies responsible for a retail or distribution activity that do not have an impact on the labelling act diligently to help ensure compliance with the labelling requirements. Of labelling, in particular by not providing raw materials, compound or dietetic feedingstuffs for which they know or should have assumed, on the basis of information in their possession and as professionals, that they do not Do not meet these requirements.

Art. 14 Presentation of labelling particulars

1 The labelling particulars referred to in Art. 15 are in their entirety in a prominent place on the packaging, in the container, on a label affixed to them or on the accompanying document provided for in Art. 12, para. 2, in a conspicuous, clearly legible and indelible manner, at least in one of the official languages.

2 The labelling particulars must be readily identifiable and cannot be concealed by other information. They are displayed in a color, font and size such that no part of the information is hidden or highlighted, unless such variation is intended to draw attention to warnings.

Art. 15 General Labelling Requirements

1 A raw material, a compound or dietetic feed, can only be put into circulation if the following indications are provided in the context of labelling:

A.
The type of feedingstuffs: 'feedstuff for feedingstuffs', 'whole animal feed' or 'animal feed'. Depending on the case, the following expressions can also be used:
1.
Instead of "complete feed", the designation "full breastfeeding",
2.
Instead of "supplementary animal feed", the names "mineral food" or "feed of complementary breastfeeding",
3.
Instead of "whole animal feed" or "animal feed", the name "compound feed" for pet food other than cats and dogs;
B.
The name or name and address of the establishment responsible for the labelling;
C.
If required for its activity, the registration number of the establishment responsible for the labelling assigned in accordance with s. 48, para. 1 and 2 and 54, para. 1;
D.
The lot reference number;
E.
The net quantity, expressed in units of mass for solid and mass or volume units for liquid products;
F.
The list of feed additives, the declaration of which is mandatory on labelling, preceded by the heading 'additives';
G.
If intended, the moisture content.

2 The DEFR sets out the additional labelling requirements for the different types of feed.

Art. 16 Derogations and optional data

1 The DEFR sets out the derogations for labelling.

2 It prescribes the data and optional additional labelling that may accompany raw materials, compound and dietetic feedingstuffs.

Art. 17 Packaging

1 Raw materials, compound and dietetic feedingstuffs can only be put into circulation in closed containers or containers. Packages and containers shall be closed in such a way that the closure is impaired at the opening and cannot be reused.

2 Raw materials, compound feedingstuffs and the following dietetic feedingstuffs may be put into circulation in bulk or in non-enclosed packages or containers:

A.
Raw materials with no specific nutritional objectives;
B.
Compound feedingstuffs obtained exclusively by the mixing of whole grain or fruit;
C.
Shipments between producers of compound feedingstuffs;
D.
Compound foods, including dietary foods, as well as raw materials with a specific nutritional destination, delivered directly from the production company to the end user;
E.
Deliveries of producers of compound or dietetic feedingstuffs to packers;
F.
Compound or dietetic feedingstuffs intended for the end user whose weight does not exceed 50 kilograms in so far as they come directly from a closed container or container;
G.
Blocks and stones to lick.

Chapter 3 Additives and premixes for animal feed

Section 1 Purpose

Art. 18

This Chapter does not apply to:

A.
Technological auxiliaries;
B.
Veterinary medicinal products, excluding coccidiostats and histomonostats used as feed additives.

Section 2 Release conditions

Art. 19 Approval principle

1 Feed additives (additives) may be imported, put into circulation, used or processed only if they are registered.

1bis For the placing in circulation of feed additives and premixtures whose development is based on the use of genetic resources or traditional knowledge associated with them, the provisions of the Nagoya, December 11, 2015 1 Are reserved. 2

2 Mixtures of additives may be sold to the end user if all the conditions of use provided for in the approval of each additive are met.

3 The DEFR sets out the general conditions for the use of additives and premixes for animal feed.


1 RS 451.61
2 Introduced by ch. 9 of the annex to the O de Nagoya of 11 Dec. 2015, in force since 1 Er Feb 2016 ( RO 2016 277 ).

Art. List of approved additives

1 Additives in accordance with Art. 25, para. 1, let. A to c, are registered if they are on the list of additives established by the DEFR. The DEFR takes into account the decisions of the EU in drawing up this list.

2 The DEFR is included in the list of new additives on its own initiative or following a licence application.

3 It may lay down conditions for the import, release and use of additives.

4 If the conditions set out in Art. 148 A LAgr is completed, the DEFR can:

A.
Not add an additive to the list of approved additives;
B.
Delete an addendum from the list;
C.
Link the use of an additive to conditions.

5 By decision of a general nature, the OFAG may, for a maximum period of one year, authorize the release and use of the additives referred to in Art. 25, para. 1, let. A to c, which is not on the list of additives established by the DEFR in accordance with para. 1, provided that they are authorised within the EU and that the requirements of s. 28 are completed. 1


1 Introduced by ch. I of the O of 20 May 2015, in force since 1 Er Jul. 2015 ( RO 2015 1791 ).

Art. Authorisation of additives for scientific research

1 The OFAG may authorise, for scientific research purposes, the use, as additives, of unauthorised substances, with the exception of antibiotics.

2 The DEFR determines the requirements for the application file.

3 Animals that have consumed additives authorized by para. 1 may only be used for the production of foodstuffs if the OFAG confirms that it will not result in adverse effects on human health.

Art. Authorized additives

1 The additives defined in Art. 25, para. 1, let d and e, are authorized on the basis of an application for authorisation.

2 The OFAG takes into account EU decisions on the granting of authorisation. It can limit the duration of authorization. It takes into account the duration of the authorisation set by the EU.

3 The authorization is personal and non-transferable.

4 Downstream merchants do not need a new authorization if an additive has been imported or released with an authorization.

5 The OFAG may attach requirements to the authorization and set out requirements for a post-release monitoring plan.

6 It may refuse to authorise an additive, cancel an existing authorisation or attach conditions or charges if the conditions laid down in Art. 148 A LAgr are completed.

7 It publishes a list of authorised additives. 1 2


1 The list of permitted feed additives can be consulted under www.agroscope.admin.ch > Practice > Animal Nutrition > Feed Control > Legal basis > Annex 2.4a, Annex 2.4b and Annex 2.4d (for category 4) and Annex 2.5 (for category 5).
2 New content according to the c. I of the O of 20 May 2015, in force since 1 Er Jul. 2015 ( RO 2015 1791 ).

Art. Emergency Authorization

1 The OFAG may provisionally authorize the use of an additive for a period of up to five years if the conditions laid down in Art. 24, para. 2, are fulfilled and it is proved that the additive is essential for the protection of animals; the OFAG bases its assessment on the data and generally known facts.

2 The importation, release and use of limited quantities of compound feedingstuffs intended for pets containing additives designated in s. 25, para. 1, let. A to e, not registered in Switzerland, but authorised within the EU, may be authorised on a case-by-case basis by the OFAG. 1


1 Introduced by ch. I of the O of 20 May 2015, in force since 1 Er Jul. 2015 ( RO 2015 1791 ).

Art. 24 Conditions of approval

1 Approval shall be granted if the applicant proves by means of the indications required under Art. 27, that the additive complies with any use of the requirements set out in para. 2 and has at least one of the characteristics referred to in para. 3.

2 The additive should not:

A. 1
Have an adverse effect on human or animal health or the environment;
B.
Be presented in such a way that it could mislead the user;
C.
Harm the consumer by altering the specific characteristics of products of animal origin or mislead the consumer as to the specific characteristics of products of animal origin.

3 The additive shall:

A.
Have a positive effect on the characteristics of feed;
B.
Have a positive effect on the characteristics of products of animal origin;
C.
Have a positive effect on the colour of fish or ornamental birds;
D.
To meet the nutritional needs of animals;
E.
Have a positive effect on the environmental consequences of animal production;
F.
Have a positive effect on the production, performance or welfare of animals, in particular by influencing the gastrointestinal flora or digestibility of feed; or
G.
Have a coccidiostat or histomonostatic effect.

1 New content according to the c. I of the O of 31 Oct. 2012, effective from 1 Er Jan 2013 ( RO 2012 6399 ).

Art. 25 Categories of Additives

1 Depending on their functions and properties, additives are classified in one or more of the following categories:

A.
Category 1: Technological additives: all substances added to feed for technological purposes;
B.
Category 2: Sensory additives: all substances which, added to animal feed, improve or modify the organoleptic properties of animal feed or the visual characteristics of food derived from animals;
C.
Category 3: Nutritional additives: substances which have important nutritional properties, such as vitamins, trace elements, amino acids and derivatives of the ure;
D.
Category 4: Zootechnical additives: all additives used to positively influence the performance of healthy animals or the environment;
E.
Category 5: Coccidiostats and histomonostats.

2 Within the categories referred to in para. 1, the additives are distributed in one or more functional groups according to the nomenclature established by the DEFR.

3 Where appropriate, in the light of developments in scientific knowledge or technological developments, categories of additives and additional functional groups may be established by the DEFR.

Art. 26 Applications for approval or authorization

1 Applications for approval or authorization are addressed to the OFAG.

2 Applications for the approval of an additive by incorporation into the list according to Art. 20 may be made by a person or company whose domicile or head office, or a branch, is located in Switzerland.

3 Applications for authorization under s. 22 may be made by persons or undertakings whose domicile or head office, or a branch, is in Switzerland except an agreement that excludes this requirement.

4 If the application does not meet the requirements, the OFAG will provide the applicant with a period of time to complete it. If the required indications are not provided within that period, the application shall not be considered.

Art. 27 Request Folder

1 The following documents and indications are to be submitted to the OFAG:

A.
The name and address of the applicant;
B.
The designation of the additive, a proposal for its classification by category and functional group under Art. 25 and its characteristics, including, where appropriate, purity criteria;
C.
A description of the method of obtaining and manufacturing, the intended uses of the additive, the method of analysis of the additive in feedingstuffs, taking into account the intended use and, where appropriate, the method of analysis intended for Determine the level of residues of the additive or their metabolites in foodstuffs;
D.
A description of the studies carried out and any other material available which shows that the additive meets the conditions of approval;
E.
The proposed conditions for the release of the additive, including labelling requirements and, where appropriate, specific conditions for the use and handling (including known incompatibilities), the contents In the supplementary feed of the animals and the animal species and categories to which the additive is intended;
F.
In respect of additives which, in accordance with the proposal referred to in paragraph (b), do not belong to the categories referred to in Art. 25, para. 1, let. A and b: a proposal for a post-release monitoring plan;
G.
A summary of the documents cited in the letter. A to f;
H.
If available, the complete dossier of the authorisation granted by the EU, the assessments already made by the EU, or any information exchanged in the framework of the EU authorisation procedure.

2 The DEFR sets additional requirements for the establishment and submission of applications.

Art. 28 Review of applications for approval or authorization

1 The OFAG reviews applications to assess whether the conditions set out in s. 24 are completed.

2 Where an additive is already registered in a country whose requirements are recognised as equivalent to those laid down in Switzerland, the results of the examinations carried out shall be taken into account as far as the case is concerned. Accompanying the application under s. 27, the certificate of approval of that country and a copy of the documents of the approval file.

3 The OFAG reviews the application according to the principles of risk analysis.

Art. Liability

1 Once an additive has been authorised, any person or party concerned who uses or puts into circulation this substance or a feed to which it has been incorporated, guarantees that any conditions or restrictions imposed on the The use and handling of the feed additive or feed is applied.

2 Where post-release monitoring requirements have been imposed on the authorization holder, the authorization holder guarantees the performance of the monitoring and submits reports to the OFAG in accordance with the authorization. The holder of the authorisation shall immediately communicate to the OFAG any new information which may affect the assessment of the safety of use of the additive, in particular as regards the health sensitivities of categories Consumer specific. The holder of the authorisation shall immediately inform the OFAG of any prohibition or restriction imposed by the competent authority of any third country in which the additive is put into circulation.

Art. Control of Licensed Additives

1 OFAG can control an approved additive at any time. It decides on the need for a review taking into account new scientific and technical discoveries and data from controls. The OFAG takes into account EU decisions in this field.

2 The OFAG requests the authorization holder for all documents necessary for the control of the approval and provides a period of six months for the submission of documents.

3 If it comes to the conclusion that the conditions of approval laid down in Art. 24 are no longer satisfied, or if the information required under para. 2 are not provided, the OFAG revos the authorisation, withdraws the additive from the list of approved additives or adapts the list on the basis of the new information available. The OFAG takes into account EU decisions in this field. 1

4 If the holder of the authorisation proposes an amendment of the conditions of approval by filing a request with the relevant information from the OFAG, the latter shall take into account the new elements and amend the existing authorisation On the basis of his examination.

5 If the OFAG revos an authorization or does not renew it, and if the grounds for revocation or non-renewal do not relate to an effect considered to be inadmissible and potentially dangerous, a time limit may be granted for disposal, Storage and release of inventory.

6 ... 2


1 New content according to the c. I of the O of 31 Oct. 2012, effective from 1 Er Jan 2013 ( RO 2012 6399 ).
2 Repealed by c. I of the O of 31 Oct. 2012, with effect from 1 Er Jan 2013 ( RO 2012 6399 ).

Art. Licence renewals and authorizations

1 When a licence is renewed under s. 20, the DEFR takes account of the new EU decisions.

2 The holder of a temporary authorization under s. 22 may submit an application for renewal of the authorization to OFAG. This application must be addressed to the OFAG no later than one year before the expiry date of the current authorization.

3 The applicant sends the following information and documents to the OFAG:

A.
A copy of the authorization to release the additif;
B.
A report on the results of post-release monitoring, if provided for in the authorization;
C.
Any other new information available concerning the assessment of the safety of use of the additive and the risks to animals, human beings or the environment related to the additive in question;
D.
Where appropriate, a proposal to amend or supplement the conditions of the initial authorisation, in particular the conditions for future control operations;
E.
Where appropriate, the dossier for the renewal of the authorisation filed in the EU.

4 Art. 26 and 28 apply to the renewal of authorizations.

5 Where, for reasons beyond the control of the applicant, no decision is taken on the renewal of an authorisation before the date of expiry of the authorisation, the period of authorisation of the product shall be automatically extended to What the OFAG makes a decision. Information on the extension of the authorisation shall be published.

6 Where the OFAG does not renew an authorization and the reasons for this decision do not affect any potential effects that are considered unacceptable, the OFAG may grant a time limit for the disposal, storage and release of the Stock in stock.

Section 3 Labelling and packaging of additives and premixes

Art. 32

1 No additives or premix of additives may be put into circulation without the labelling of the packaging or container. The producer, packer, importer, vendor and distributor are responsible for the labelling of the following information in a visible, clearly legible and indelible manner, at least in one of the official languages, for each Add-on contained in the product:

A.
The specific name of the addenda in accordance with the authorisations, preceded by the name of the functional group as mentioned in the authorisations;
B.
The name or social name and address or head office of the establishment responsible for the indications referred to in this Article;
C.
Net weight or, for liquid additives and premixes, either the net volume or the net weight;
D.
Where applicable, the approval number assigned to the establishment which manufactures or puts into circulation the additive or premix;
E.
The instructions for use and any safety recommendations concerning the use and, where appropriate, the specific requirements mentioned in the authorisation, including species and categories of animals to which the additive or the premix of additives Is intended;
F.
The identification number;
G.
The lot number and date of manufacture.

1bis If the concentration of certain substances incorporated in an additive or premix poses a danger to the user within the meaning of the order of 5 June 2015 on chemicals 1 , the safety recommendations arising from the said order must be made available to the purchaser. 2

2 In the case of premixes, the paragraphs b, d, e and g do not apply to the incorporated additives.

3 As regards aromatic substances, the list of additives may be replaced by the words'mixture of aromatic substances'. This provision is not applicable to aromatics subject to quantitative limitation for use in animal feed and drinking water.

4 For premixtures, the term "premix" must appear on the label. The materials shall be indicated, in respect of the raw materials for animals, in accordance with Art. 15, and in cases where water is used as a medium, the moisture content of the premix shall be indicated. Only one minimum durability date may be specified for each premix considered as a whole; this date is determined on the basis of the durability date of the component that occurs most rapidly.

5 Additives and premixes may only be marketed in closed packagings or containers where the closure system is necessarily damaged at the opening and cannot be used again.

6 The DEFR sets the specific labelling requirements for premixtures and certain additives.


1 RS 813.11
2 Introduced by ch. I of the O of 20 May 2015, in force since 1 Er Jul. 2015 ( RO 2015 1791 ).

Section 4 Confidentiality of trade secrets

Art. 33 Confidentiality

1 The applicant may indicate which information it wishes to treat in a confidential manner because disclosure could significantly affect its competitive position. In such cases, verifiable justification must be provided.

2 The OFAG determines, after consultation with the applicant, what information other than those referred to in para. 3 which should remain confidential and inform the applicant of its decision.

3 In no case shall they be regarded as confidential:

A.
The name and composition of the additive and, where appropriate, the indication of the production strain;
B.
The physico-chemical and biological properties of the feed additive;
C.
Conclusions on the results of the study on the effects of the additive on human or animal health and on the environment;
D.
Conclusions on the results of the study on the effects of the additive on the characteristics of products of animal origin and their nutritional properties;
E.
Methods for the detection and identification of the additive and, where appropriate, monitoring requirements and a summary of monitoring results;
F.
The information to be provided in order to protect human health, animal health or the environment.

4 If an applicant withdraws or has withdrawn its application, the OFAG respects the confidentiality of all commercial and industrial information, including research and development.

Art. 34 Protecting folder information

1 Scientific data and other information contained in the application file required under s. 27 may not be used for the benefit of another applicant during the period of the authorisation, unless the latter has agreed with the previous applicant that such data and information may be used.

2 The two applicants according to para. 1 shall make every provision to agree on a shared use of information, in order not to have to carry out toxicological tests on vertebrates again. If they fail to reach agreement in this area, the OFAG may decide on the use of the information; in so doing, it ensures a reasonable balance between the interests of the parties concerned.

3 At the end of the authorisation period, the results of the evaluation carried out on the basis of the scientific data and the information contained in the application dossier may be used wholly or in part by the OFAG for the benefit of another Applicant.

Chapter 4 Undesirable Substances in Animal Food

Art. 35 Purpose

This Chapter applies to feed, including additives and premixes. It also applies to feedingstuffs from primary production.

Art. 36 Undesirable substances in animal feed

1 DEFR lists substances that can only be contained in feed to a specified value (undesirable substances). It lays down the maximum permissible values for these substances or the action thresholds from which specific measures are to be implemented.

1bis It does so in the light of applications under s. 11 A , para. 1, of the order of 18 May 2005 on biocidal products 1 . 2

2 When it adapts the list of undesirable substances according to para. 1, the DEFR takes into account the list of maximum values and intervention thresholds applicable in the EU.

3 Animal feed that has levels of undesirable substances higher than the maximum values defined in s. 1 cannot be used as animal feed or put into circulation for this use.


1 RS 813.12
2 Introduced by ch. 4 of Annex 11 to the O of 20 June 2014, in force since 15 July. 2014 ( RO 2014 2073 ).

Art. Prohibition of dilution and detoxification

Feed for which the undesirable substance content exceeds the maximum content set by the DEFR:

A.
May not be mixed for dilution with the same product or with other products intended for animal feed;
B.
Can be put into circulation only after being detoxified by a licensed producer, using a process validated by the OFAG.
Art. 38 Undesirable Substances in Complementary Foods

To the extent that the list under s. 36, para. 1 does not provide for other provisions, supplementary foods may not, taking into account the proportion prescribed for a daily ration, present levels of undesirable substances higher than those laid down as values Maximum foods.

Art. 39 Revision of maximum value

1 The OFAG may provisionally reduce the existing maximum content, set a maximum content or prohibit the presence of an undesirable substance in animal feed if new data or a new assessment of existing data Show that a maximum level set by the DEFR or an unlisted undesirable substance poses a danger to human or animal health or to the environment.

2 If the conditions set out in Art. 148 A The OFAG may take measures identical to those referred to in para. 1.

Chapter 5 Animal Food Hygiene, Registration and Establishment Licensing Requirements

Section 1 Purpose

Art. 40

This Chapter does not apply to the retail sale of pet food.

Section 2 Obligations

Art. General obligations

Companies in the feed sector shall ensure that all stages of production, processing and distribution under their control are implemented in accordance with the legislation in force and the good Practices. In particular, they shall ensure that they comply with the applicable hygiene requirements.

Art. Special obligations

1 Animal feed companies and farmers may only use feed from establishments registered in accordance with Art. 47 or approved in accordance with Art. 48.

2 Any person who produces, imports or puts into circulation animal feed shall take appropriate measures in the course of his activity so that the animal feed complies with the legal requirements, be of irreproachable quality and They are not tampered with due to improper hygiene conditions or inadequate packaging. Official controls do not release the duty of self-control.

3 Feed companies may use the guides provided for in Section 4 of this chapter to assist them in complying with their obligations under this chapter.

4 Companies in the feed sector who consider or have reason to believe that a feed imported, produced or put into circulation does not meet the requirements for the safety of feed Immediately withdraw the food in question from the market and inform the competent authorities. They shall inform the users of the food for animals of the reasons for the withdrawal and, if necessary, recall the feed produced already delivered where the other measures are insufficient to achieve a high level of protection of the Health.

5 The DEFR sets out the special obligations of undertakings in the animal feed sector concerning the various operations.

6 It may make provisions for the production of feed in an agricultural operation for use in the farm.

Art. 43 Obligation to maintain register for livestock

1 Every person who produces, imports or puts into circulation food for livestock shall maintain a register in which the relevant indications for the traceability of feed are recorded.

2 The DEFR may lay down requirements for the register.

3 The indications referred to in para. 1 must be kept for at least three years and submitted to the OFAG upon request.

Art. 44 Hazard Analysis Critical Control Point System (HACCP)

1 Animal feed companies that produce, import, transport, store or circulate feed must apply and maintain standard written procedures based on principles HACCP. This requirement also applies to holdings of primary production which must be registered or approved, in accordance with Art. 47, para. 2. 1

2 The procedures referred to in para. 1 is based on the following principles:

A.
Identify any danger that should be prevented, eliminated or reduced to an acceptable level;
B.
Identify critical points at which control is required to prevent or eliminate a hazard or to reduce it to an acceptable level;
C.
To establish, at critical points, the critical limitations that differentiate the acceptability of unacceptability for the prevention, elimination or reduction of identified risks;
D.
Establishing and implementing effective monitoring procedures for critical points;
E.
Establish corrective actions to be taken when monitoring reveals that a critical point is not under control;
F.
Establish procedures to verify the completeness and effectiveness of the measures described in the sub-section. A to e. Audit procedures are conducted periodically;
G.
Establish documents and records based on the nature and size of the animal feed business to demonstrate the effective application of the measures defined in the sub-section. A to f.

3 Companies in the feed sector are making the necessary changes according to para. 2 in the case of a modification in a product, in a process, or in any stage of production, processing, storage and distribution.

4 They may use, instead of guides on the application of HACCP principles, the guides of good practice developed in accordance with Art. 55.

5 The OFAG may provide relief in some cases.


1 New content according to the c. I of the O of 20 May 2015, in force since 1 Er Jul. 2015 ( RO 2015 1791 ).

Art. 45 HACCP-related documents

1 Companies in the animal feed sector must:

A.
Provide to the OFAG, in the form required, evidence that the procedures in place are in accordance with the principles set out in s. 44;
B.
Ensure that all documents describing procedures developed in accordance with s. 44 are constantly up to date.

2 The OFAG shall take into account the nature of the animal feed business when establishing the requirements for the form of the evidence referred to in para. 1, let. A.

3 It may publish guides for the preparation of HACCP documents.

Section 3 Registration and approval

Art. Principle

1 In order to carry out its activities, any undertaking in the animal feed sector must be:

A.
Registered in accordance with s. 47; or
B.
Approved, where approval is required in accordance with s. 48.

2 In the case of persons active in the primary production of feed, compulsory registration and the notification procedure shall be governed by the provisions of Art. 3 of the order of 23 November 2005 on primary production 1 .


1 RS 916.020

Art. Obligation to advertise

1 Companies in the animal feed sector:

A.
Announce to the OFAG, for the purposes of registration or approval, in the form requested, all establishments under their control who are involved in any stage of production, processing, storage, transport or Distribution of feed;
B.
Provide the OFAG with up-to-date information on all establishments under their control, including by communicating any significant changes to the activities and any closure of an existing establishment.

2 Farmers who produce on the farm of animal feed using additives for which a maximum value is applicable according to the type-approval or container premixes, shall advertise this activity to the OFAG for the purposes of Registration or registration.

Art. 48 Accreditation of institutions

1 Every person who manufactures or puts into circulation one of the following feedingstuffs shall be approved by the OFAG:

A.
Additives:
1.
Nutritional additives,
2.
Zootechnical additives,
3.
Technological additives of the group of antioxygens for which a maximum content or other limitation of employment is fixed,
4.
Carotenoids and xanthophylls,
5. 1
Coccidiostats and histomonostats;
B.
Premixes containing the following additives:
1.
Coccidiostats and histomonostats,
2.
Other zootechnical additives,
3.
Vitamin A and vitamin D,
4.
The trace elements of copper and selenium.

2 Every person who manufactures, for circulation or for the exclusive needs of its operation, compound or dietetic food using additives or premixes containing the following additives shall be approved by the OFAG:

A.
Coccidiostats and histomonostats;
B.
Other zootechnical additives.

2bis Every person who performs at least one of the following activities using oils and fats intended for entry into the feed composition shall be approved by the OFAG:

A.
Processing of raw vegetable oils, provided that the processing does not take place in an establishment which is under the legislation on foodstuffs;
B.
Manufacturing of fatty acids by oleochemical transformation;
C.
Biodiesel manufacturing;
D.
Mixture of oils or fats. 2

3 The OFAG will conduct the establishments if an on-site visit has shown that they meet the requirements set out in this order.


1 Introduced by ch. I of the O of 31 Oct. 2012, effective from 1 Er Jan 2013 ( RO 2012 6399 ).
2 Introduced by ch. I of the O of 15 May 2013, in force since 1 Er Jul. 2013 ( RO 2013 1737 ).

Art. Recognition of foreign registrations and approvals

The registrations and approvals of establishments obtained in the countries with which Switzerland has concluded an agreement for the mutual recognition of animal feed legislation are deemed to be equivalent to the registrations and Approvals granted in Switzerland.

Art. 50 Suspension of registration or approval

The OFAG temporarily suspends the registration or registration of an establishment for one, several or all of its activities when the establishment no longer meets the requirements. The suspension shall remain in effect until such time as the establishment complies with the prescribed conditions. If not completed within one year, s. 51 is applicable.

Art. Revocation of registration or approval

The OFAG revoked the registration or approval of an establishment for one or more of its activities:

A.
When the establishment ceases one or more of its activities;
B.
Where the establishment has not fulfilled the terms and conditions applicable to its activities for a period of one year;
C.
Where it detects serious irregularities or has been forced to halt production on several occasions in an establishment and the animal feed business is still unable to provide adequate guarantees in that regard Which concerns future production.
Art. Amendments to registration or approval

The OFAG shall amend on request the registration or approval of an establishment where it is shown that the establishment is in a position to carry out the additional activities desired.

Art. Exemption from site visits

1 The OFAG does not normally conduct on-site visits under s. 48, para. 3, in the case of undertakings in the animal feed sector which act solely as traders, without holding the products in their installations.

2 Such undertakings shall submit to the OFAG a declaration, in the form required, that the feed they put into circulation is in accordance with the conditions laid down in this order.

Art. Register of registered and registered establishments

1 The OFAG shall record in a national register the establishments registered under Art. 47 or approved under s. 48. Institutions shall obtain an individual identification number drawn up in accordance with the model set out in Annex V, Chapters 1 and 2 of Regulation (EC) No 183/2005 1 .

2 It shall update the data relating to establishments registered in the national register referred to in para. 1 based on decisions to suspend, revoke or amend the registration or registration under s. 50 to 52.

3 It shall publish the national register of establishments referred to in para. 1.


1 R (CE) n O 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for animal feed hygiene, OJ No O L 35, 8.2.2005, p. 1, as last amended by R (EC) n O 219/2009 of the European Parliament and of the Council of 11 March 2009, OJ L 87, 31.3.2009, p. 109.

Section 4 Good practice guides

Art. Development, dissemination and use of guides

1 The OFAG encourages the development, dissemination and use of national guides on good practice in the animal feed sector and in the application of HACCP principles, in accordance with Art. 56.

2 Compliance with national guides on good practice is optional.

Art. 56 National guides

1 Animal feed sector representatives develop and disseminate national guides on good practice:

A.
After agreement with representatives of interested user groups;
B.
Taking into account the relevant use codes of the Codex Alimentarius .

2 The OFAG evaluates national guides to ensure that:

A.
They have been developed in accordance with para. 1;
B.
Their content can be put into practice in the sectors concerned; and
C.
That their implementation be carried out in accordance with the s. 41, 42 and 44 and requirements for animal feed. .

3 It may, on request, validate the use of Community guides approved by the EU authorities provided that these guides have been submitted to it for approval in their full, non-abbreviated version.

4 It can approve codes of good practice in the area of labelling. The codes recognised by the EU are taken into account.

Section 5 Importation of feed

Art. 57 Importing feed for animals

1 As long as the EU has laid down a list of countries from which the import of feed is permitted, DEFR may publish an equivalent list of countries from which animal feed satisfactory to art. 7 or 19 can be imported.

2 The OFAG may issue special requirements for the control of imported feed.

Art. Strengthened controls

1 DEFR may draw up a list of feedingstuffs which must be subject to enhanced controls and higher monitoring frequencies.

2 It may determine that these feeds can only be imported from specified border crossings and that they must be announced in advance.

3 The OFAG may amend the list established by the DEFR in accordance with para. 1 provided that the corresponding EU list is also amended.

4 Lots of feed are released only when the results of the control are available and do not cause any dispute.

5 Lots of feed for which the required documents cannot be submitted or that do not meet the prescribed requirements are returned or destroyed.

Art. Early Warning System

Where an animal feed, even if it is intended for pets, poses a serious risk to human or animal health or to the environment, the OFAG may transmit this information to the authorities of the Member States of the EU Where an agreement provides for the mutual exchange of such information.

Chapter 6 Genetically modified feed

Art. 60 Scope of application

This Chapter applies to:

A.
GMOs intended for the feeding of animals;
B.
Food for animals containing or consisting of GMOs, including additives;
C.
Food for animals produced from GMOs.
Art. 61 General Requirements

1 Raw materials and feed additives referred to in s. 60 (genetically modified feed) must meet the requirements set out in ss. 7, para. 1 and 24, para. 2, and should not, because of the genetic modification to which they have been subjected:

A.
Have adverse effects on human health, animal health or the environment;
B.
Mislead the user
C.
Harm the consumer or mislead the consumer by altering the specific characteristics of products of animal origin;
D.
To defer to such animal feed as they are intended to replace that their normal consumption would be nutritionally disadvantaged for human beings or animals.

2 Genetically modified feedingstuffs cannot be put into circulation, used or transformed if they are not approved under Art. 62.

3 Additives produced from genetically modified substances on the list of GMO feedingstuffs referred to in Art. 61, para. 2, may be put into circulation, used or transformed, provided that they are certified according to Art. 20 to 22.

4 For the release of genetically modified feed, the development of which is based on the use of genetic resources or traditional knowledge associated with them, the provisions of the Nagoya Ordinance of 11 December 2015 1 Are reserved. 2


1 RS 451.61
2 Introduced by ch. 9 of the annex to the O de Nagoya of 11 Dec. 2015, in force since 1 Er Feb 2016 ( RO 2016 277 ).

S. 62 Approval of raw materials and genetically modified additives

1 Genetically modified feedingstuffs are registered when they are listed in the GMO feed list.

2 The OFAG lists genetically modified foods on the GMO feed list when they:

A.
Comply with the conditions laid down in Art. 61, para. 1;
B.
Meet the conditions laid down in the order of 10 September 2008 on the release into the environment 1 .

3 Raw materials and additives for genetically modified feed may be introduced for up to 10 years in the list of GM feed. The approval shall be extended every time every 10 years without interruption, upon request, if:

A.
Is filed twelve months before the expiry date; and
B.
Contains the latest scientific knowledge, on the basis of which no further evaluation of the approval is necessary. 2

4 The OFAG may certify raw materials already approved abroad, including or consisting of GMOs that cannot multiply, where the authorization procedure applied abroad is equivalent to that of Switzerland. 3

5 It may require additional data after registration and at any time limit or cancel the approval, where the food has significant adverse effects, where it is likely to present risks or is In fact, for humans, animals or the environment.


1 RS 814.911
2 New content according to the c. I of the O of 31 Oct. 2012, effective from 1 Er Jan 2013 ( RO 2012 6399 ).
3 New content according to the c. I of the O of 15 May 2013, in force since 1 Er Jul. 2013 ( RO 2013 1737 ).

S. 63 Application for approval

1 Applications for approval of a genetically modified feed should be directed to the OFAG.

2 The application package must contain the data set out in Annex 1 of the Ordinance of the DFI of 23 November 2005 on genetically modified foodstuffs 1 .

3 In addition, the application package must demonstrate in an appropriate and sufficient manner that the conditions laid down in Art. 61 and in the order of 10 September 2008 on the release into the environment 2 Are completed.

4 In the case of an additive, the documents and particulars provided for in Art. 27 must also be provided.


Art. 64 Separation of the flow of goods

1 Any person who imports, produces or puts into circulation genetically modified feedingstuffs is required to lay down guidelines and take measures to separate the flow of goods and to prevent mixtures with non-GM organisms. Genetically modified.

2 To this end, it must establish a system of quality assurance to ensure, in particular:

A.
Identification of critical points in the animal feed industry, likely to be the subject of undesirable mixtures;
B.
The establishment of measures to prevent undesirable mixtures at the critical point level referred to in the let. A;
C.
The implementation of planned measures;
D.
Regular monitoring of the adequacy of the system in place;
E.
Specific training certificates or the appropriate experience of those responsible for enforcement;
F.
The recording of the directives and measures referred to in the Guidelines. A to e.

3 The OFAG has a right of scrutiny over all measures taken in the field of quality assurance.

Art. Obligations to inform and keep a register

1 Any person subject to the compulsory registration referred to in Art. 47 or the type-approval referred to in Art. 48 which imports or puts into circulation genetically modified feedingstuffs must at the time of release:

A.
Inform the purchaser, in writing, that the product contains or has been manufactured from such organisms;
B.
Indicate to the recipient, in writing, the unique identifiers recognized at the international level or, in the absence of such a code, the names of the organizations and their principal properties and characteristics.

2 At each stage of the release, the particulars referred to in para. 1 must be transmitted to the recipient in writing.

3 Every establishment or person subject to the compulsory registration which imports or puts into circulation genetically modified animal feed shall have the obligation to keep a register.

4 The indications referred to in paras. 1 to 3 shall be kept for at least five years and, upon request, submitted to the OFAG.

Art. 66 Labelling Requirements

1 In addition to the general labelling requirements for feed, genetically modified feed is subject to the following labelling requirements:

A.
With respect to the animal feed referred to in s. 60, let. A and b, the statement "produced from [name of organism] genetically modified" appears in brackets immediately after the specific name of the food. This statement may also be included in a note at the bottom of the food list. It is printed in a font of at least the same size as the food list;
B.
With respect to the animal feed referred to in s. 60, let. C, the statement "produced from [name of organism] genetically modified" appears in brackets immediately after the specific name of the food. This statement may also be included in a note at the bottom of the food list. It is printed in a font of at least the same size as the food list;
C.
All characteristics of a genetically modified animal feed cited in the authorization must be indicated.

2 These labelling requirements do not apply to feed containing material containing GMOs, consisting of such organisms or produced from such organisms in a proportion not exceeding 0.9 % of the food and each Of its components, provided that such presence is adventitious or technically unavoidable.

Art. 67 Adventitious or technically unavoidable contamination

Companies in the feed sector must demonstrate to the OFAG that they have taken all appropriate measures to avoid contamination.

Art. 68 Animal feed containing traces of genetically modified organisms

1 Foods which, incidentally, contain traces of unapproved GMOs or are produced from raw materials containing such traces may be put into circulation:

A.
If the percentage of these unapproved traces of GMOs does not exceed 0.5 % by mass;
B.
If the producer can attest that appropriate measures have been taken to prevent the presence of unwanted impurities; and
C.
If these GMOs may be put into circulation in accordance with Art. 19 to 23 of Regulation (EC) 1829/2003 1 , if traces of these GMOs are tolerated in the EU, or if these organisms are tolerated in accordance with Art. 23 of the Ordinance of 23 November 2005 on foodstuffs and common objects 2 .

2 Where a lot of imported raw material presents adventitious traces of unapproved GMOs other than those referred to in para. 1, the OFAG may exceptionally permit, upon request, the release of feed containing these traces, provided that:

A.
The rate of contamination does not exceed 0.5 %;
B.
These organizations may legally be released as animal feed in Canada or the United States;
C.
Detection methods and appropriate reference materials are available;
D.
The applicant may exclude from appropriate measures any contamination of foodstuffs; and
E.
The applicant shall provide the information necessary to verify whether the conditions referred to in the let. A to d are filled.

3 The OFAG sets tolerances for traces of GMOs that have been deregistered.


1 R (CE) n O 1829/2003 of the European Parliament and of the Council of 22. 2003 on genetically modified food and feed, OJ L 268, 18.10.2003, p. 1, as last amended by R (EC) n O 298/2008 of 11.3.2008, OJ L 97, 9.4.2008, p. 64.
2 RS 817.02

Chapter 7 Enforcement

Art. 69 Competencies of DEFR

1 DEFR sets tolerances for differences between the measured value and the declared nutrient content.

2 It may lay down requirements for sample collection and analysis.

3 It sets the method for calculating the nutritional value of compound feedingstuffs.

4 It may lay down conditions for the transport of feed.

5 In so far as the safety of foodstuffs or feedingstuffs requires it, it may prescribe the analyses which undertakings must carry out. 1


1 Introduced by ch. I of the O of 15 May 2013, in force since 1 Er Jul. 2013 ( RO 2013 1737 ).

Art. Competencies of the OFAG

1 Unless otherwise provided, the execution of this order shall be the responsibility of the OFAG. It authorites in particular the additives and nutritional destinations of dietary food for animals and controls feed and undertakings at all stages of production, processing and distribution Animal feed.

2 The OFAG may issue guidelines for the delimitation of raw materials, additives and other products such as veterinary drugs. It takes into account the relevant decisions of the EU on this occasion.

3 It may collect or request samples and analyse or analyse them.

4 It may analyse or cause to be analysed each year a sample by product, or several samples where the conduct of a company or a person justifies it; the costs of the analysis shall be borne by the undertaking or the person who Produced, manufactured, imported, repackaged, processed or packaged animal feed.

5 Samples that are not ex gratia are paid at the market price. No compensation shall be paid to the enterprises or persons who produce, manufacture, import, repack, process or condition the food for animals subject to control.

6 The OFAG can adapt the annexes to the order of 26 October 2011 on the Animal Feed Book 1 Amended European law, where the amendments are of limited scope.

7 ... 2

8 In the event of an emergency affecting human health, animal health or the environment, and subject to intellectual property provisions, the OFAG may provide the buyer with information according to para. 1 if, after weighing the respective legitimate interests of the manufacturers and purchasers, it concludes that the provision of the information is justified. Where appropriate, the OFAG shall provide such information subject to the purchaser's signature of a confidentiality clause.


1 RS 916.307.1
2 Repealed by c. I of the O of 31 Oct. 2012, with effect from 1 Er Jan 2013 ( RO 2012 6399 ).

Art. Requirements for Testing

1 Subject to other provisions, controls shall be carried out in accordance with the technical provisions of Chapters I to V of Regulation (EC) N O 882/2004 1 .

2 The OFAG includes:

A.
Checks are carried out on a regular and proportionate basis according to documented procedures ensuring uniform quality controls;
B.
To ensure effective coordination with the competent authorities where compliance checks with this order can be carried out in conjunction with the checks on compliance with other provisions;
C.
Ensure that the laboratories responsible for the official animal feed analysis work according to internationally agreed procedures and use validated methods of analysis;
D.
To order adequate measures if the provisions of this order are not complied with;
E.
Have control plans and a crisis management plan;
F.
Ensure that controls are carried out as a general rule without prior notice;
G.
To ensure that appropriate and properly maintained facilities and equipment are available to carry out official feed controls in an efficient and effective manner.

3 It shall carry out internal audits or conduct external audits, and shall take appropriate measures in the light of their results to ensure that the objectives set out in this order are met. These audits are subject to independent review and are carried out in a transparent manner.


1 R (CE) n O 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls carried out to ensure compliance with the legislation on food for animals and foodstuffs and with the provisions relating to Animal health and animal welfare, OJ L 165, 30.4.2004, p. 1, last amended by R (EU) n O 208/2011, OJ L 58, 3.3.2011, p. 29.

Art. 72 Requirements for Laboratories

The laboratories responsible for the official analysis of feed must be accredited and carry out their activities in accordance with the European standard EN ISO/IEC 17025 " General requirements concerning the competence of laboratories Calibration and testing ".

Art. Collaboration between authorities

1 The OFAG may associate customs officers with its control activity.

2 If an animal feed may be imported only under the conditions set out in s. 5 or 58, customs officers may take appropriate measures on the instruction of the official control of feed.

3 With regard to the application of the animal feed provisions consisting of or containing GMOs, the OFAG directs and coordinates the procedure by involving the Federal Office of the Environment (OFEV) and the Federal Office Food safety and veterinary affairs (FVO) 1 The OFAG lays down its decisions in agreement with the OFEV and the FVO.

4 With regard to the application of the provisions on feed other than those referred to in para. 3, the cooperation of the OFEV is governed by Art. 62 A And 62 B The Federal Act of 21 March 1997 on the organization of government and administration 2 .


1 The designation of the administrative unit has been adapted to 1 Er Jan 2014 pursuant to Art. 16 al. 3 of the O of 17 Nov 2004 on official publications ( RO 2004 4937 ). This mod has been taken into account. Throughout the text.
2 RS 172.010

S. 74 Consultation of the Swiss Institute for Therapeutic Products

The Swiss Institute for Therapeutic Products should be heard on an advisory basis with regard to matters concerning the delimitation of raw materials or additives and veterinary medicinal products.

Art. 75 Cooperation with oversight bodies

1 The OFAG may delegate the controls provided for in this order to supervisory bodies accredited in accordance with the European standard ISO/IEC 17020 " General criteria for the operation of different types of bodies Inspection " 1 Or any other standard that has a closer relationship to the delegated tasks in question.

2 It ensures that these organizations:

A.
Have qualified and experienced staff, infrastructure and operational procedures to ensure impartial and quality control of compliance with the provisions of this order;
B.
Adequately communicate the results of these controls.

3 It may specify in instructions the obligations and requirements for organizations and controls.

4 It organises audits or inspections of these bodies. If it is clear from an audit or inspection that they are not performing properly the tasks delegated to them, the delegation may be withdrawn. Where appropriate, the delegation shall be withdrawn without delay if the monitoring body does not take appropriate corrective measures in due time.


1 The text of this standard can be consulted or obtained from the Swiss Standards Association, Bürglistrasse 29, 8400 Winterthur: www.snv.ch.

Art. 76 Marketing Statistics

At the request of the OFAG, any company in the animal feed industry producing, putting into circulation or importing feed is required to provide information on the quantities of feed released.

Chapter 8 Final provisions

Art. 77 Repeal of the law in force

The order of 26 May 1999 on feed 1 Is repealed.


1 [ RO 1999 1780 2748 Annex 5 c. 6, 2001 3294 hp. II 14, 2002 4065, 2003 4927, 2005 973 2695 Ch. II 19, 5555, 2007 4477 ch. IV 70, 2008 3655 4377 Annex 5, c. 14, 2009 2599, 2011 2405].

S. 78 Transitional provisions

1 Approvals issued for additives before the entry into force of this Ordinance shall remain valid.

2 The registrations and approvals of establishments made before the entry into force of this Order shall remain valid.

3 Animal feed may be labelled and packaged under the old right until December 31, 2012. They can be put into circulation until stocks are exhausted.

Art. Entry into force

This order shall enter into force on 1 Er January 2012.



RO 2011 5409



State 1 Er February 2016