The Official Controls Regulation (2017/625) Import and export of animals and goods. Dr Gudrun Gallhoff, Deputy Head of Unit, SANTE.

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The Official Controls Regulation (2017/625) Import and export of animals and goods Dr Gudrun Gallhoff, Deputy Head of Unit, SANTE.G3 Seafood Global Expo 2017 27 April 2017

Replacing Regulation 882/2004 15 June 2016: Political agreement 19 December 2016: Council common position 15 March 2017: European Parliament adoption 7 April 2017:

Entry into force and application Entry into force: 27 April 2017 Main date of application: 14 December 2019 (In some cases: 27 April 2018, 27 April 2022 or 14 December 2022)

Key principles Simplification Harmonisation Efficiency Transparency The risk based approach is maintained

Scope of the OCR (Art. 1.2) Food and food safety Feed and feed safety GMOs Animal health Animal welfare Animal byproducts Plant health Plant protection products Organic production PDOs, PGIs, TSGs

Structure of the Regulation General Principles Articles 1 15 Subject matter, scope & definitions, Competent Authorities general requirements Sector Specific Requirements Articles 16 27 e.g. products of animal origin, residues, animal welfare, plant health, GMOs, plant protection products, organic production, PDO/PGI/TSGs, new risks Art. 28 33 Delegation of tasks Art. 34 42 Sampling, analyses, tests & Diagnoses Art. 43 76 IMPORT CONTROLS Art. 77-91 financing OC & official certification Article 92 101 EURLs & EURCs Art. 102 108 Administrative Assistance & Cooperation Art. 109-115 Planning + Reporting Art. 116 124 Commission Controls Art. 125 129 Conditions for entry into the EU Art. 130 Training (BTSF) Art. 131 136 IMSOC Art. 137 141 Enforcement Common Provisions - Articles 142 167

Official Controls - General rules identified risks associated with risk basis all operators regularly appropriate frequency past record (results of official controls reliability and results of own controls) o any information indicating non-compliance o food: likelihood that consumers misled on nature identity properties composition quantity durability country of origin/place of provenance method of manufacture/production animals and goods activities under the control of operators location activities/operations of operators use of products/processes/ materials/substances influence food safety integrity + wholesomeness feed safety animal health animal welfare plant health environment GMOs/PPPs

Fraud SCOPE RISK-BASED CONTROL PENALTIES if Competent Authorities detect fraud => control rules = applicable on marketing standards of agricultural products Competent Authorities to consider if consumers misled on: properties quality composition origin indications reflect operator's economic advantage turnover protect whistleblowers REFERENCE CENTRE FOR AUTHENTICITY AND INTEGRITY specialised knowledge detection methods vulnerability identification ADMINISTRATIVE ASSISTANCE + COOPERATION Member States to facilitate exchange of information between Competent Authorities + judicial authorities IT system

authorities official controls + activities (Art. 5) Effectiveness impartiality quality documented procedures for official controls written records of every control (Art. 13) Obligations operators (Art.15) Provide information name legal form activities access to computers + premises Assist + cooperate with competent authorities

Modernised system for border controls A common, risk based framework for border controls on all animals and goods entering the EU Border Control Posts (BCPs) will replace the different Border Inspection Posts (BIPs) and Designated Points of Entry (DPEs) A single standard document (CHED) will be used by operators for the prior notification of consignments Minimum requirements for facilities, equipment and staff qualifications will apply throughout all BCPs. Transmitted to the BCP through IMSOC which will allow for the integration of existing computerised systems (including Europhyt)

Entry in Union MS MS controls determine: place (options provided) frequency based on risk likelihood Compliance records QS + auto control measures importer Categories subject to border controls animals products (animal origin, germinal products, animal byproducts) plants, plant products + TCs requiring temporary increase (non-compliance) emergency measure Art. 53 178/2002 special import conditions BCP initiate operator complete competent authority in IMSOC checks documents identity physical animal welfare CHED or Common Health Entry Document single standard document

Examples of legislation to be replaced by the DA Several articles of Dir. 97/78 and Dir. 91/496 (transit, transhipment, reimport etc.) Parts of Reg. 1069/2009 and 142/2011 (samples etc.) Reg. 576/2013 (pet animals) Dec. 2000/208, 2000/571 and 2011/215 (transit, transhipment, storage of non-conforming consignments, ship supply) Article 8 of Reg. 669/2009 (onward transportation) Parts of Reg. 136/2004 and Reg. 282/2004 (use of the CVED) Parts of Reg. 853/2004 and Reg. 854/2004 (derogations for fresh fish) Dir. 2000/29 (organisms harmful to plants) Reg. 206/2009 (personal luggage and postal consignments) Dec. 94/641 (Greek islands) Reg. 2012/44 (French DOM BIPs) Annex V of Croatia's Accession Treaty, Reg. 1069/2009 and 142/2011

Border control procedures (IA) Provide stakeholders with a coherent set of rules in a single document, following the different procedural steps of entry into the Union Prior notification, exchange of information, model of the CHED Presentation of consign ments to the BCP Operations to be carried out in BCP during and after controls Risk based frequencies for identity and physical checks Structural require -ments for BCPs Cooperati on and exchan ge of informa tion Format, abbreviations etc. for listing BCPs

Specific control rules (Article 77.1) Fresh fishery products, directly landed Unskinned, furred wild game Vessels leaving the EU (ship supply) Wood packaging material Feed accompanying animals Distance sales Plant products, on account of subsequent destination Goods entering in bulk (plants) "Neum Corridor" Refusal of entry by 3rd country (reimport) (HR-B&H- HR) Animals and goods exempted in accordance with Art 48

Animals and goods that may be exempted from controls at BCPs (Article 48) Trade samples and display items Scientific purposes Consumed by crew and passengers Personal luggage and for personal use Small consignments sent to natural persons Pet animals (noncommercial movement) Specific treatment, not exceed quantities Low risk or no specific risk (e.g. remote Greek islands)

Process + stakeholder involvement (2) Implementing Act Delegated Act MS working group roadmap Impact assessment concept paper draft 1 draft 2 Standing Committee on Plants, Animals, Food and Feed S t a k e h o l d e r s roadmap Impact assessment concept paper draft 1 draft 2 adoption MS Expert group adoption

Official controls and export Reg. 882/2004: "Official controls shall be applied, with the same care, to exports outside the Community " (Art. 3.4) Reg. 2017/625 (14/12/2019-): " apply to official controls performed for ( ) animals and goods ( ) to be exported from the Union" (Art. 9.6) Official controls carried out regularly, on a risk basis and with appropriate frequency In case of non-compliance: Restrict or prohibit the export of animals and food/goods

Clarity on official certification The rules on official certification apply to "official certificates which are necessary for the purposes of exporting consignments of animals and goods to third countries" (Article 86) Certifying officers shall be impartial and free from any conflict of interest and have received appropriate training Signed by certifying officer + issued on grounds of direct knowledge and facts and data relevant for the certification Commission is empowered to establish e.g. technical arrangements to ensure the issuance of accurate and reliable official certificates, and prevent risk of fraud The competent authorities shall take all appropriate measures to prevent the issuance of false or misleading official certificates or the abuse of official certificates Appropriate measures to be taken in the case of false or misleading official certificates or in the case of abuse of official certificates, e.g. the temporary suspension of the certifying officer from its duties

Financing Adequate resources for all types of controls! Mandatory fees: Slaughterhouses Cutting plants Milk products Fishery products BCPs Animals Products of animal origin, germ. prod, ABP Plant + plant protection prod. Request of operators Follow-up noncompliance safeguard measures Fees in Annex Flat rate Actual costs Optional fees: to cover costs (No fees = covered by states' general expenses/budget/tax Cost elements: Staff salary Facilities + equipment Consumables Services of delegated bodies Continuous training Travel Sampling + testing TRANSPARENCY: Make public e.g. the method and data used to establish fees, and the amount charged to each category of operators; stakeholders to be consulted on the general methods of calculation

Further information DG SANTE website: http://ec.europa.eu/food/safety/official_controls/review/index_en.htm