trunk new eu regulations
TRANSCRIPT
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The new marketing rules for pet food in the European Union: Safe – transparent – modern
Dr. Wolfgang TRUNKEuropean Commission
DG SANCO
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Part 1
The European Union (EU)
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27 Member States (MS)
3 Candidate Countries
Part 1 - The European Union
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500 Mio inhabitants~ 62 Mio households in EU with pets~ 60 Mio cats, ~ 56 Mio dogs, ~ 9 Mio aquaria~ 450 pet food companies Petfood Sales: ~ 6 Mio t,
~ 10 Bio € (1€=1,3$), growth rate 3% p.a.
Pet food market in the EU
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European Commission
Council of the EU
European Parliament
Economic & Social Committee
Committee of the Regions
European Council
European Court of Justice
European Court of Auditors
Institutional Triangle: Decision Makers
Advisory Committees
European Institutions
Part 1 - The European Union
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Part 2
The European Commission (COM)
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The Role of the Commission
Part 2 - The European Commission
Initiate & negotiate draft legislationEnsure implementation of EU policiesApply EU lawsRepresent the EU on the world stage
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Our Commissioners: Meglena KUNEVA and Androulla VASSILIOU
Responsible for DG SANCO,Priorities:
Protecting and improving Public healthPromoting EU food safetyProtecting the health of animals & plantsAssuring animal welfareStandards worldwide
Part 3 – DG SANCO
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Part 3
Pet food legislation as part of SANCO's Food Safety System
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Food Safety
“A World Class Food Safety System from the Farm to the Fork”
Part 3 – SANCO’s Core Activities
EU laws cover:How farmers produce feed and foodHow plants are grown, and how pesticides are usedHow ALL animals are fed, looked after, and transportedHow feed and food is processed, packaged, and soldHow feed and food is labelled for consumers
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European Food Safety Authority
EFSA provides independent scientific advice
on food safety issues
Petfood covered via assessment on adverse effects on animal health, - welfare and
environment
“Excellence in risk assessment”
EU Agencies
http://www.efsa.europa.eu
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Part 4
Legislative framework for Pet food
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Evolution of EU law (I)Provisions on pet food introduced in EU-legislation already since 1970s, e.g. labelling rules, additivesNevertheless, feed legislation dominated by rules for food producing animals End 1990s, series of crises concerning human food and animal feed (BSE, dioxin, etc.) => weaknesses in the food legislation within the EU. Response: “White Paper on Food Safety” => EU established a system for ensuring a high level of protection of public health, taking into account the protection of animal health and welfare and the environment (General Food Law, Regulation 178/2002). In line with the new "farm to fork" approach, feed legislation has been crucial as feed is a sensitive element at the very beginning of the food chain.
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Evolution of EU law (II)
Crucial points of the General Food Law (GFL):- Precautionary principle- Traceability throughout the food chain (ex pets)- Responsibility of feed and food operators for the safety of their products (ex pets)- Rapid Alert System for Food and Feed (ex pets)- Emergency measures (imports!)
Article 11:Food and feed imported into the Community for placing on the market within the Community shall comply with the relevant requirements of food law or conditions recognised by the Community to be at least equivalent thereto …
- European food Safety Authority (EFSA): separation riskassessment and - management
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Evolution of EU law (III)
On top of this horizontal new legislation, many specific laws have been successively come into force based on the spirit of the “White Paper” which tackle as well pet food:- Directive 2002/32 on undesirable substances in feed;- Regulation 1774/2002 with health rules for animal by-products;- Regulation 1829/2003 on genetically modified food and feed;- Regulation 1831/2003 on feed additives;- Regulation 882/2004 on official controls on feed and food.- Regulation 183/2005 on feed hygiene
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Evolution of EU law (IV)
Messages re pet food to be taken fromDirective 2002/32 on undesirable substances in feed:
1. List of maximum residue levels for different contaminants such as heavy metals, dioxins, mycotoxins in various feed matrices including raw materials for pet food or compound feed for pets)
2. Directive is regularly updated by the Commission based on risk assessment by EFSA
3. Implementation/control of MRLs by EU-MS
Ex: “dioxins in copper sulphate premixture” or “aflatoxins in white sunflower kernels”
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Evolution of EU law (V)Messages re pet food to be taken fromRegulation 1774/2002 with health rules for animal by-products:=>Pet food is the only feed use of meat and bone meal (by-products from animals fit for human consumption) allowed in the EU
=>Import of pet food still acc Dir 97/78/EC (EU-list with TC-establishm not yet existing): entry via BIPs after pre-notification (MS-competence) + TC of origin must be listed on the applicable Community list (TH on the list for pet food and dog chews) + Plant of production in TC of origin must be approved by the competent authority of that country + Imported product has to be accompanied by a certificate signed by
the official TC-veterinarian, which confirms that the materials used for the pet food does not pose a health risk and the respective processing standards are met to mitigate potential risks.
=> Sets microbiological criteria for certain products (Annex VIII, ch II)
Ex: “Salmonella (present /25g) in dog chews or chicken meal for pet food”
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Revision of Reg 1774/2002 on animal by-products
New Commission proposal adopted on 10 June 2008 The proposal contains the basic rules applicable to animal by-products
and is supposed to be complemented in a second step by implementing rules, to be adopted by the Commission
In accordance with the proposal, imported pet food would still have to comply with requirements which ensure that no risks to public and animal health are being introduced into the Community.
The Commission would have wide legal powers to determine the precise requirements which are applicable to such imports on the basis of the experience gained with the application of the current rules
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Evolution of EU law (VI)
Messages re pet food to be taken fromRegulation 1829/2003 on genetically modified food and feed:
1. Feed including pet food may only contain genetically modified organisms (GMOs) authorised for feed use
2. 0-tolerance for non-authorised GMOs => rejection at EU Border.
Ex: “LL601 rice or MIR604 maize in dried pet food”
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Evolution of EU law (VII)
Messages re pet food to be taken fromRegulation 1831/2003 on feed additives:
1. Authorisation of feed additives in EU differentiating for pets already since decades
2. Additives incorporated in pet food must be authorised for the respective species
3. Register of authorised feed additives regularly updated: http://ec.europa.eu/food/food/animalnutrition/feedadditives/comm_register_feed_additives_1831-03.pdf
Ex: “unauthorised feed additive Ethylenediamine Dihydroiodide (EDDI) in pet food”
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Evolution of EU law (VIII)
Messages re pet food to be taken fromRegulation 882/2004 on official controls on feed and food:
1. Controls of EU requirements undertaken by competent authority of the MS
2. MS notify their multi-annual national control plans that are elaborated based on risk
3. Import controls for pet food containing animal products have to follow veterinary rules (Dir 97/78/EC)
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Evolution of EU law (IX)
Messages re pet food to be taken fromRegulation 183/2005 on feed hygiene
1. Registration and approval of EU-establishments2. HACCP in feed businesses3. Industry guides for good hygiene practice4. General import rules still “transitional” (Art. 23+24 and 6
of 98/51 in comments)Member States may only authorise the import from third countries … from establishments which have a representative established within the Community
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Part 5: Creation of new marketing rules
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Need for revision
Circulation of feed materials and compound feed is regulated by 4 main Directives and some 50 amending or implementing acts. Some of the relevant legislative requirements date back more than 25 years. Evolution of feed legislation focussing on safety has been intense less attention on the conditions for the circulation of feed, e.g. concerning marketing conditions, labelling or advertising. The developments both in the feed business and in the legislative environment around the feed sector revealed the need to modernise and simplify the current law.
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Objectives: general and operational
• achieve legal clarity and a harmonised implementation, • facilitate smooth functioning of the internal market,• simplify technical requirements and remove unnecessary administrative burden,• increase competitiveness of the EU feed and farming sector, • enable users of feed to make an informed choice without being misled.
concerning authorisation procedures: ensuring procedures are proportionate to risk;for listing feed materials: the smooth functioning of the internal market by clear designations and proper information of the customer;for compound feed labelling for food producing animals: Increase innovation and competitiveness by reducing unnecessary labelling requirements;for pet food labelling: Improve the appropriateness of the pet food labels to prevent the purchaser of pet food from being confused or misled..
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Scope and definitions
Scope: Feed for ALL animals‘Food producing animal’: any animal that is fed for the production of food for human consumption including animals that are not consumed but that belong to species that can be normally consumed in the Community.
‘Non-food producing animals’: animals kept or bred but not used for human consumption such as fur animals, pets and animals kept in laboratories, zoos or circus.
‘Pet’ or ‘pet animal’: non-food producing animal belonging to species fed , bred or kept, but normally not consumed by humans in the Community;
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Definitions feed categories (I)
‘Compound feed’: mixture of feed materials, whether or not containing feed additives, for oral animal feeding in the form of complete or complementary feed => pet food‘Feed intended for particular nutritional purposes’: feed which can satisfy a particular nutritional purpose* by virtue of its particular composition or method of manufacture, which clearly distinguish it from ordinary feed. Feed intended for particular nutritional purposes does not include medicated feedingstuffs in the meaning of Directive 90/167/EEC (on “dietetic” feed no big change)
* = specific nutritional needs of certain pets or productive livestock whose assimilation, absorption or metabolism could be temporily impaired or is temporily or irreversibly impaired and therefore able to derive benefit from ingestion of feedstuffs appropriate to their condition
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Safety and marketing requirements
1. For the purposes of this Regulation, Articles 15 and 16 of Regulation 178/2002 and Article 4 of Regulation (EC) No 183/2005 shall apply, mutatis mutandis, to feed for non-food producing animals.
=> Safety requirements as well for pet food
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Proposal – Responsibilities of the feed businesses
1. For the purposes of this Regulation, Articles 17, 18 and 20 of Regulation (EC) No 178/2002 shall apply, mutatis mutandis, to feed for non-food producing animals.
=> Requirements concerning responsibility of the operator as well for pet food businesses
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Broad definition of Labelling
(p) ‘Labelling’: attribution of any words, particulars, trade marks, brand name, pictorial matter or symbol to a feed by placing this information on any medium like packaging, container, notice, label, document, ring, collar or the internet referring to or accompanying such feed, including for advertising purposes.
=> Clarification that all type of product information is covered
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General labelling rules
1. The labelling and the presentation of feed shall not mislead the user.
…
3. Where feed is offered for sale by means of distance communicationas defined in Article 2 of Directive 97/7/CE, the mandatory labellingparticulars required by this Regulation shall appear on the materialsupporting the distance selling…
Labelling particulars…given…in at least the language or one of the official languages of the Member State or Region in which it is placed on the market.
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Claims1. The labelling and the presentation of feed may draw particular attention …
provided that the following conditions are met:(a) the claim is objective, verifiable by the competent authorities and
understandable by the user of the feed, and (b) a scientific substantiation of the truthfulness of the claim (publicly
available scientific evidence or documented company research), … shall be available with the responsible operator at the time the feed is placed on the market. The MS-authority … may submit the issue of doubtful claims to the Commission who may adopt a decision.
2. Without prejudice to paragraph 1, claims concerning optimisation of the nutrition and support or protection of the physiological conditions are permitted, unless they contain a claim mentioned in paragraph (3)(a).
3. The labelling … shall not claim that(a) It will prevent, treat or cure a disease; this subparagraph, however shall
not apply to claims concerning nutritional imbalances provided that there is no pathological sign associated;
(b) it has a registered particular nutritional purpose unless it satisfies the respective registered requirements.
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Feed additive labelling pet food
The following additives shall be listed with their specific name and/or their identification number, added amount and the respective name of the functional group or the category:(a) additives where a maximum content is set for any kind of target species ,(b) additives belonging to the categories ‘zootechnical additives’ and ‘coccidiostats and histomonostats’,(c) additives belonging to the functional group of ‘urea and its derivatives’ of the category ‘nutritional additives’.By way of derogation from this paragraph, for additives of the functional groups ‘preservatives’, antioxidants’ and ‘colourants’ only the respective functional group may be the indicated. In this case the information pursuant to paragraph 1 shall be disclosed by the person responsible for the labelling to the purchaser on his request.
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Specific mandatory labelling requirements for compound feed (I)
1. … the labelling of compound feed shall also include the following:
(d) the indication of the minimum storage life …(e) the list of the feed materials of which the feed is composed, bearing the
heading “composition” and indicating the name of each feed material and listing those feed materials in descending order by weight; that list may include the percentage of weight.
Mandatory nutrient labelling petfood: - Protein- Dietary fibres- Crude oils and fats- Crude ash
.
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Specific mandatory labelling requirements for compound feed (II)
2. As regards the list provided for in paragraph 1(e), the following requirements shall apply:
…(c) in the case of compound feed intended for non-food producing animals,
the indication of the specific name of the feed material may be replaced by the name of the category to which the feed material belongs to.
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Additional labelling requirements for pet food
On the label of pet food a free telephone number or other appropriate means of communication shall be indicated in order to allow the purchaser to obtain information in addition to the mandatory particulars on:(a) the feed additives incorporated into the pet food, (b) the feed materials incorporated that are designated by category.
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Pet food in “multipacks”
For quantities of pet food sold in packages with several containers, certain particulars may be given only on the outer package instead of each container, provided that the combined total quantity of the package does not exceed 10 kg.
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Market transparency on feed materials
1. The Community Catalogue of feed materials shall be created as a tool to improve the labelling of feed materials and compound feed. The Catalogue shall facilitate the exchange of information on the product properties and list the feed materials in a non-exhaustive manner.
2. The first entries in the Catalogue shall be those listed in Part B of the Annex to Directive 96/25/EC and the Annex to Directive 82/471/EEC.
3. The placing on the market of a feed material that is not listed in the Catalogue shall immediately be notified to the representatives of the European feed business sectors who shall publish a register of these notifications on the Internet.
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Community Codes of good labelling practice
1. The Commission shall encourage the development of two Community Codes of good labelling practice, one for pet food and one for compound feed for food producing animals.
2. The Codes shall aim at improving the appropriateness of the labelling. They shall, in particular, include provisions on the presentation of the mandatory labelling particulars, on the voluntary labelling and on the use of claims.
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Establishment of the Catalogue and Codes
1. Catalogue and Codes shall be developed by all appropriate representatives of European feed business sectors:
(a) in consultation with other concerned parties, such as feed users;(b) in collaboration with the competent authorities of the Member States and, where
appropriate, the Authority…2. Generally, Catalogue and Codes are to be approved by the Commission with
the advisory procedure. 3. If in the Catalogue maximum contents of chemical impurities, levels of botanical
purity or mandatory constituent labelling particulars are set, the regulatory procedure with scrutiny has to be applied.
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State of play
EP-plenary voted overwhelmingly in favour on 5 Feb 2009
Formal approval by AG-Council probably in April 2009
Publication late spring 2009
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Part 7: Résumé Pet food since long fully integrated into EU-legislation Legislation considers special status of pets New proposal for marketing Regulation closes gaps re
responsibility of the feed business operator Better focus on difference between marketing of pet food
and feed for food producing animals Wide definition of labelling includes advertisement
(brochures, flyers …) in all media including the internet. Provisions on claims will improve control possibilities for
Member states authorities
Thank you for your attention