Finland

The recommendation states as its basis

The audit team further noted that physical checks on goods of animal origin were performed in line with Article 4 of Implementing Regulation (EU) 2019/2130 and, based on its evaluation of selected CHEDs and data in TRACES-NT, the frequency of physical checks was generally in line with the baseline frequency rate set out in Article 5 and Annex I to Commission Implementing Regulation (EU) 2019/2129, except in the case of fishery products referred to in risk categories II and III of Annex I above, which were below the minimum frequency rate. 5.2.4.3 Checks on consignments of goods of non-animal origin and food contact materials

However, some shortcomings were noted in the frequency of physical checks on certain consignments of goods of animal origin, and in the performance of official controls on consignments of goods of non-animal origin, including follow-up in cases where such consignments are transferred to control points. The competent authorities took immediate corrective actions to address the shortcomings related to the performance and follow-up of official controls on consignments of goods of non-animal origin, thereby minimising the risk of non-compliant goods entering the EU through BCPs in Finland.

The recommendation states as its basis

The audit team visited four control points designated by Customs for the performance of identity and physical checks on consignments of goods of non-animal origin intended for human consumption, food contact materials and plants. None of the control points visited were compliant with the minimum requirements for BCPs, which is not in line with Article 53(1)(a) of the OCR and Articles 3(1)(b) and (c) and 3(2) of Implementing Regulation (EU) 2019/1014 (12). In particular, the audit team noted that: · Control point 1 had an inspection area, but without a supply of hot and cold running water and facilities for washing and drying hands, which is not in line with Article 3(1)(b) of Implementing Regulation (EU) 2019/1014. This control point had no storage facilities to keep goods chilled or frozen, which is not in line with Article 64(3)(b) of the OCR and Article 3(1)(c) of Implementing Regulation (EU) 2019/1014; · Control point 2 had three different inspection areas, but only one inspection area had a supply of hot and cold running water and facilities for washing and drying hands. Consequently, two out of the three inspection areas were not compliant with the requirements laid down in Article 3(1)(b) of Implementing Regulation (EU) 2019/1014. This control point had not storage facilities to keep goods frozen, which is not in line with Article 64(3)(b) of the OCR and Article 3(1)(b) of Implementing Regulation (EU) 2019/1014; · The inspection room in control point 3 was not maintained in good order and kept clean, which is not in line with Article 64(3)(h) of the OCR and Article 3(2) of Implementing Regulation (EU) 2019/1014; and · Control point 4 had an inspection area, but without a supply of hot and cold running water and facilities for washing and drying hands, which is not in line with Article 3(1)(b) of Implementing Regulation (EU) 2019/1014. This control point had no storage facilities to keep goods frozen, which is not in line with Article 64(3)(b) of the OCR and Article 3(1)(c) of Implementing Regulation (EU) 2019/1014. (12) In their response to the draft report, the competent authorities stated that the deficiencies in the refrigerated and frozen product facilities were due to incomplete markings in the listing of control points. Not all inspected warehouses are approved for chilled and frozen products. Customs are working to correct these errors in the list of control points. 14

The FFA and Customs informed the audit team that goods of non-animal origin entering through BCPs in Finland which are selected for identity and physical checks, including sampling, are generally forwarded to control points for the performance of these checks. However, the audit team noted that in two of these four control points visited, Customs were not using the inspection facilities for controls on consignments of goods of non- animal origin intended for human consumption and food contact materials, which is not in line with Article 53(1)(a) of the OCR. Conclusions on the compliance of border control posts with minimum requirements

The BCPs, including inspection centres thereof, were compliant with the minimum requirements for BCPs for the categories of animals and goods for which they had been designated, except for goods of non-animal origin intended for human consumption and food contact materials. In addition, all the four control points visited were not compliant with the minimum requirements for BCPs.

The recommendation states as its basis

Overall, the NAP III is generally comprehensive with 32 measures addressing all aspects of the SUD, some of which are new and others are updated measures from the previous NAP. These aim at reducing 1) the risk to human and animal health and the environment arising from the use of PPPs and 2) the dependency on the use of chemical PPPs. However, the audit team noted that the NAP does not contain quantitative objectives and targets to reduce risks and impacts of pesticide use on human health and the environment, which are required by Article 4(1) of the SUD. This is acknowledged by the CAs who also stated that, due to the limited availability of alternatives to the current PPPs placed on the market, during the discussions with the various stakeholders, it was decided to follow the implementation of the NAP through qualitative descriptions of the state of play of the ongoing measures, instead of monitoring the achievements of quantitative objectives and targets.

Five active substances of particular concern have been identified and the quantities sold are monitored (albeit somewhat imprecisely). The issue is closely followed up by the NAP steering group, as noted in a meeting held in May 2025, where it was agreed to work on identifying new active substances of particular concern7 (see also paragraph 72). However, the audit team noted that the NAP lacks timetables and reduction targets for these active substances. This is not in line with Article 4(1), second and third subparagraphs of the SUD. 6 https://tukes.fi/en/safe-use-of-plant-protection-products/national-action-plan-for-the-sustainable-use-of-plant- protection-products/national-action-plan-on-sustainable-plant-protection-iii-2023-2027 7 In its response to the draft report, the competent authority stated that: `Since the audit visit in June 2025, the list of substances of particular concern has been amended. The development of appropriate indicators for substances of particular concern is further considered in the NAP steering group.' 9 Conclusions on the NAP

The current NAP, in its third version, is generally well-structured, with 32 measures addressing all aspects of the SUD and takes into account a comprehensive review, carried out between 2022 and 2023, of the achievements obtained by its second version. It represents a solid basis for the implementation of a general strategy to reduce the risk to human, animal health and the environment arising from the use of PPPs and the dependency on the use of chemical PPPs. However, it does not contain quantitative objectives and reduction targets, including timetables and reduction targets for active substances of particular concern. This reduces the capacity of the CAs to monitor the effectiveness of the general strategy of the NAP.

The recommendation states as its basis

The audit team noted that the afore-mentioned risk mitigation measures and restrictions are priority areas for attention in the 2025 official controls programme (see paragraph 8) and this is reflected in the revised general guidance and checklist provided to inspectors. Risk-mitigation measures and restrictions in relation to water were generally verified during the official controls observed. However, with regard to buffer zones to protect surface water, inspectors generally only verify/measure compliance with the 3 m buffer zone. In general, no controls are carried out to verify compliance when wider buffer zones are applicable, as required by the relevant PPP authorisation (as was the case for certain pesticides used by the farmers visited). It is particularly noteworthy that larger buffer zones have not been enforced during a year (2025) when the focus is water protection. As a result, the CAs are unable to ensure that all the necessary risk mitigation measures to protect water are implemented by the professional users of PPPs, as required by Article 11(2)(c) of the SUD and by Article 55 of Regulation (EC) No 1107/2009.

Risk mitigation measures for protecting water bodies are specified as conditions for use in all PPP authorisations. These are specified on the PPP labels and are generally enforced during official controls. However, enforcement of required buffer zones to protect water bodies is limited to the general minimum measure of 3m. This enforcement is inadequate when larger buffer zones are necessary, which does not ensure the overall level of water protection.

The recommendation states as its basis

BACKGROUND

Compared with CAP conditionality controls, the PPP/SUD specific official controls also include the verification of compliance with the use of PPPs as laid down by Article 55 of Regulation (EC) No 1107/2009, and with the general principles of IPM, set out by Annex III to the SUD. Given the scope and objectives of the audit, the audit team paid more attention to these official controls. On an annual basis, the FFA defines a risk- based theme and allocates the number of controls to each ELY centre. Overall, between 80 to 100 of professional users of PPPs are subject to these controls annually. Each ELY centre selects the various operators to inspect taking into account the annual theme and the instructions included in a general control guidance, which is reviewed every year by the FFA. Furthermore, a checklist to be used during the inspections is also attached to the control guidance. These documents offer a solid foundation for local inspectors at ELY centres to conduct official controls. However, they do not adequately focus on the preparation of PPPs before use and the cleaning of PAE after use (see paragraph 54).

During the inspections at professional users, the audit team noted that the storage conditions are generally verified. However, operations such as the preparation of PPPs 17 before use and cleaning of PAE after use are generally not verified, or are only superficially checked, and are not included in the inspection checklist. This does not allow the CA to ensure that these operations are carried out without endangering human health and the environment, as laid down by Article 13(1) of the SUD. Conclusions on handling and storage of pesticides

Clear instructions for safe storing and disposal are given on the label of all PPPs and on the Tukes website. The collection of PPP packaging and remnants is well organised and verified by the municipalities. Nonetheless, during official controls, certain aspects like the safe preparation of PPPs and the cleaning of PAE after use are generally not checked. This reduces the ability of the CA to ensure the necessary protection of the health of professional users of PPPs and the environment.

The recommendation states as its basis

During the observed controls, the audit team noted that the verification of the implementation of IPM general principles, was superficial. The interviews tended to be more advisory rather than compliance-focused, which is corroborated by the limited and general indications outlined in the control guidance. For instance, when asked if preventive methods and control measures are used to manage pests by monitoring pest presence, a simple 'yes' response, such as 'yes, there are preventive measures and we monitor pest presence', would typically be recorded as 'YES' without further probing. Additionally, the audit team observed inconsistencies among inspectors from different ELY centres. As an example, one inspector may place more emphasis on recording pest monitoring results, while another may prioritise documenting the success of plant protection measures. This approach, which is linked to the lack of practical and measurable criteria to assess and enforce the implementation of the general principles of IPM, does not ensure that the general principles of IPM are implemented by professional users of PPPs as required by Article 55 of Regulation (EC) No 1107/2009. Moreover, the audit team noted that the NAP does not include a description of how the CAs ensure that the general principles of IPM are implemented by professional users of PPPs. This is not in line with Article14(4) of the SUD

The application of IPM general principles as laid down by Annex III to the SUD is obligatory for all professional users and a wide and comprehensive range of measures to promote IPM and organic agriculture, including IPM crop specific guidelines and pest monitoring and forecasting tools for professional users, are described in the current NAP. Nonetheless, the absence of a description of how the CAs ensure that the general principles of IPM are implemented by professional users of PPPs in the NAP and, in particular, the lack of any practical criteria establishing the minimum requirements that professional users of PPPs should meet in order to fulfil their obligations as regard the general principles of IPM, does not facilitate effective implementation by all professional users and does not provide a clear basis for effective enforcement. 19 https://www.ruokavirasto.fi/elintarvikkeet/elintarvikeala/tuote--ja-toimialakohtaiset- vaatimukset/luomuelintarvikkeet/valvonta/luomusertifikaatti/ 21

The recommendation states as its basis

The FFA has not yet drawn up the required contingency plans for any of the priority pests, contrary to the requirements of Article 25(1), (4) and (5) of Regulation (EU) 2016/2031.

The CA has not carried out any simulation exercises concerning the implementation of the contingency plans as required by Article 26(1) of Regulation (EU) 2016/2031. Nevertheless, the FFA stated that it has some experience concerning the management of outbreaks of priority pests after the successful eradication of an outbreak of Anoplophora glabripennis. 10 Conclusions on contingency plans

There is a risk of delays in applying effective and efficient measures in the case of priority pest outbreaks in Finland as none of the ten required contingency plans have been completed and no simulation exercises have been carried out.

The recommendation states as its basis

Tukes has a rule of thumb that emergency authorisations should not be given for more than five years, but exceptions have been made and the audit team noted cases of repeated emergency authorisations for many years (e.g. in one case, 8 years, so far). The audit team considered that these applications would be more correctly accommodated within the conventional authorisation framework maintaining the system's integrity as referred to in Commission Staff Working Document on emergency situations according to Article 53 of Regulation (EC) No 1107/2009. This is especially so because Tukes only grants emergency authorisations for PPPs that contain approved active substances, as mentioned above, and those PPPs are generally authorised already in one or more other MS.

Furthermore, the audit team noted that the CA had considered as a single emergency authorisation in 2023 a use granted for two non-consecutive periods of two months (April to May and September to October), which is not in line with Article 53 of Regulation (EC) 1107/2009. In addition, there are cases of single emergency authorisations granted for multiple crops or targets, which is also not in line with the said Article.

Emergency authorisations may each include multiple crops and/or targets or extend to a total period beyond 120 days. This is not in line with Article 53 of Regulation No (EC) 1107/2009. Furthermore, emergency authorisations generally involve approved active substances and PPPs authorised elsewhere. The dangers these authorisations are addressing could therefore, at least in the medium term, be contained by the regular authorisation procedures laid down in Articles 33, 40, or 51 of Regulation (EC) No 1107/2009. Using emergency authorisations repeatedly instead, waters down the integrity of the authorisation system.

Member state response

- Tukes has already started to streamline where possible its 2024 onwards icle guidance for applicants on emergency authorizations with ces recommended by the Auditors and according to the draft EU guidance currently under preparation. Following actions are ongoing and planned: · Information event for the stakeholders to be organized by the end of the year 2024. · Finalization of the national guidance for applicants on emergency authorizations. · More emphasis will be required from the applicant to demonstrate the urgency of need in more detail. · Commenting and follow-up of the EU activities regarding the rules of emergency authorizations, including the implementation of the updated guidance, when endorsed in the Standing Committee. · Each application is considered case by case. When possible, limiting the crops, pests and areas for which emergency authorizations are applied, as much as possible, to the utmost urgent situations. However, in certain cases it causes less administrative burden to grant one emergency authorization for a group of closely similar crops (e.g. apples and pears or oilseed rape and turnip rape) for the same purpose. · In cases where the PPP is intended to b

The recommendation states as its basis

As a general rule, samples are taken from distributors' warehouses and retailers. Finland aims to control about 20 PPPs annually, which is around 5% of PPPs authorised in Finland. In order to collect the samples, the only two inspectors doing controls on marketing of PPPs select the operators to be visited randomly, as they do not have operators classified based on risk. Furthermore, retailers selling only PPPs for non- professional use are usually not included. This system is not fully in line with Article 9(1) and (2) of Regulation (EU) 2017/625. Inadequate risk assessment for prioritisation of inspections was also noted in the 2014 audit.

According to information provided by Tukes inspectors, three large companies, which have approximately 130 outlets (based on the information available from open sources) supply the majority of the Finnish market of PPPs for professional use. In addition, there is an unknown number of retailers (also mainly outlets of larger chains) selling only PPPs for non-professional use. Retailers do not need to register with Tukes, so precise numbers cannot be given, and Tukes does not keep the up-to-date list of operators required by Article 10(2) of Regulation (EU) 2017/625. 10

Each centre selects the operators to be controlled for PPP use. However, the ELY centres have not been provided with risk criteria from the FFA for this. The audit team interviewed staff from three ELY centres. They stated that they select operators based on their own criteria and while they have knowledge of the farmers that receive subsidies under the Common Agricultural Policy or under other national schemes, they do not have a full overview of the universe to be controlled. In particular, the number of non- agricultural users is not known. In one ELY centre, the operators are randomly selected, in the second, the potential contamination of ground water was mentioned as a potential criterion for selection of farmers and in the third, a main crop (potatoes) cultivated in the region was a criterion for selection. This is not fully in line with Article 9(1) and (2) and Article 10(2) of Regulation (EU) 2017/625. Inadequate risk assessment for prioritisation of inspections was also noted in the 2014 audit.

Moreover, the results of the PPP residue and water status monitoring programmes are not taken into consideration for the programming of controls which is not in line with Article 24(2)(a) of Regulation (EU) 2017/625.

The CAs plan controls to define broad areas of controls at national level, based to an extent on risk. However, the lack of a clear and complete universe for control, the lack of risk assessment to target the relatively few inspections at regional level and the prior notifications of inspections may reduce the general effectiveness of controls. Delegation of certain tasks Findings

Member state response

The competent enforcement authority of market control (Tukes) 2025 onwards e all will improve its enforcement procedures by targeting controls on of a risk-based approach and · on operators selling PPP products for professional use, by · on operators selling PPP products for non-professional of use, · and by improving the risk assessment of operators in the ist chain of marketing. Ar- EU) The competent enforcement authority of market control (Tukes) will start the discussions with the Ministry of Agriculture and Forestry in order to examine financial and legislative and prerequisites and possible measures for keeping an up-to-date list of operators and retailers placing PPP products on the Finnish market. FFA is already directing controls of PPP use to areas were risks for non-compliances are expected to be high. As Ely-centers are selecting individual operators to be checked, FFA will improve sample selection instructions in control guidance. Furthermore, the results of the PPP residue and water status monitoring Page: 3 ort's recommendations received 17 September 2024 Finland to the recommendations of report ref. DG(SANTE) 2024-7976 of the audit carried out from 27 May 2024 to ho

The recommendation states as its basis

The official controls for the use of PPPs are always announced in advance. The instructions stipulate that notice should be `as short as possible' The FFA stated that controls cannot be carried out without the presence of the farmer, as they also need to check the farmer's records on the use of PPPs. In addition, given the long distances between inspection sites, the advance notice helps to prevent wasted resources by ensuring the farmer is present at the agreed time. The audit team considered that such general use of prior notifications is not in line with Article 9(4) of Regulation (EU) 2017/625. This issue was also noted in the 2014 audit.

The CAs plan controls to define broad areas of controls at national level, based to an extent on risk. However, the lack of a clear and complete universe for control, the lack of risk assessment to target the relatively few inspections at regional level and the prior notifications of inspections may reduce the general effectiveness of controls. Delegation of certain tasks Findings

Member state response

f agri- Due to the large geographical area of Finland, it is not possible in 2024 onwards out practice to organize the official control visits on farms without h no- prior notice. The aim of the prior notice is to ensure, that ed for responsible persons are available during the control. The notice out as time is kept as short as possible to ensure a proper conduct of ation controls. The same policy is followed in the majority of official of agricultural farms in Finland in order to utilize the limited resources for conducting controls as effectively as .

The recommendation states as its basis

The analyses focus on identifying the content of active substances and certain physical and chemical properties of PPPs. They do not cover co-formulants and impurities. Consequently, the CAs are unable to verify the absence of unacceptable co-formulants in PPPs, as outlined in Article 27 of Regulation (EC) No 1107/2009 and listed in its Annex IIII. They are also unable to determine whether certain impurities exceed the maximum content permitted in the approval of the relevant active substances, as referred to in Article 6(b) of the same Regulation. This is not in line with Article 24(1) of Regulation (EU) 2017/625.

The CA stated that the technical capabilities for detecting impurities, co-formulants and auxiliary substances do exist, since the laboratory is equipped with suitable analytical tools. However due to a lack of validated methods, the results cannot be reported in compliance with general standards of good laboratory practices or used for enforcement. 12

The FFA laboratory is the designated laboratory for PPP formulation analyses, and it is accredited to ISO 17025. This provides the basis for ensuring reliable results of tests and analyses. However, not including analyses for unacceptable co-formulants and regulated impurities in the sampling programme reduces the overall capability of the control system to ensure the safety of the PPPs placed on the market.

Member state response

an- The annual budget for content analysis of PPPs is negotiated late 2024 onwards f un- between the authorities within the limits of the state budget. ed to Therefore, a balance is sought between the total number of o samples and different analyses to be performed with the funding ities available. Page: 4 ort's recommendations received 17 September 2024 Finland to the recommendations of report ref. DG(SANTE) 2024-7976 of the audit carried out from 27 May 2024 to horisation and controls of marketing and use of Plant Protection Products Action Proposed by the competent authority Proposed action plan deadline ed The competent enforcement authority of market control (Tukes) sub- has started to examine the possible solutions for the expansion of 6(b) of analytical capacity to cover analysis of impurities and non- are allowed co-formulants and the work is on-going. ation Tukes would also like to advocate a more uniform coordination from the European commission in the sourcing of capability for analysis of plant protection products in EU. Page: 5

The recommendation states as its basis

Senior Meat Inspection Unit officers carry out approximately six `assessment and guidance' visits to slaughterhouses annually, where meat inspection arrangements and controls by OVs are checked and assessed. Normally, two of these visits take place in large establishments, the rest in low-capacity ones. The Animal Welfare and Identification Unit also carries out control visits to slaughterhouses. Regional managers' visits focus on staff support and HR-style aspects but also on mentoring and advising staff on meat inspection and official controls matters.

Taking into account the number of approved establishments and the frequency of visits, large slaughterhouses should receive an `assessment and guidance' visit every seven or eight years, and a low-capacity establishment once every ten or eleven years.(2)

The system to prioritise slaughterhouses to be visited by senior officers considers aspects like issues identified by OVs and enforcement taken. Establishments where OVs identify no or very few non-compliances are given low priority.

There are no regular checks at central level in order to establish if the OVs in approved slaughterhouses have a system in place to ensure that all the required controls are carried out within the agreed three-year cycle. In all establishments reviewed by the audit team, there were some controls that had not been completed at all during the last three years. Examples included `compliance with requirements of approval' or `vermin control'.

Although the CA provided some good examples of suitable and timely enforcement that had achieved positive outcomes, the audit team observed several examples where non- compliances were not identified or inadequate rating was given to those non- compliances that had actually been found. As lower rating non-compliance do not require the FBO to produce an action plan to resolve them or the OV to follow them up, an inadequately rated non-compliance has an impact on the likelihood of it being satisfactorily resolved.

Equally, there was also evidence of lack of follow up actions by OVs in some instances that the rating of a non-compliance required it, to ensure the FBO remedied the identified problems and/ or prevented the recurrence of the problem. (3) In their response to the draft report the Competent Authority noted that Regional Directors or Senior inspectors of the Meat Inspection Unit contact official veterinarians if no reports have been submitted. (4) In their response to the draft report the Competent Authority noted that the Animal Welfare and Identification Unit monitors the annual inspections and request missing reports. It also uses the annual reports to identify any deviations and provides feedback on the findings and guidance on actions to be taken to the relevant OVs. There are instructions in relation to the content of the annual animal welfare inspection 9

The design and implementation of the official control system does not provide assurance that controls over EU requirements and their enforcement are carried out correctly and uniformly across the 15 large and 44 low-capacity slaughterhouses. The system does not ensure that controls in respect of general hygiene requirements and welfare during slaughter actually take place with an appropriate frequency, or at all.

There are shortcomings in the identification, rating, action taken and follow-up of enforcement of non-compliances by the establishment OVs and in the CA supervision of those OVs that weaken the effectiveness of the enforcement that takes place.

In low-capacity slaughterhouses, FFA guides OVs to carry out hygiene monitoring activities 6-20 hours a year. If the low-capacity slaughterhouse operates less than once a month, the monitoring activities can be reduced by 50%. In reality, and as explained by the OVs dealing with low-capacity establishments, due to time constraints and clashes with their other professional activities, they do not spend any substantial amount of time to observe and assess FBOs' compliance with hygiene requirements during slaughter operations. The OVs in the low-capacity slaughterhouses visited did not routinely spend time observing the slaughter operations. As OVs, their time is usually dedicated exclusively to AMI and PMI. Only during the OIVA inspection, they might spend some time observing the slaughter operations, but not in all cases.

The time dedicated to official controls by OVs in low-capacity slaughterhouses, other than to carry out AMI and PMI, is very limited and affects the OVs' capacity to observe and assess the slaughterhouse hygiene practices and take necessary enforcement action where and when required.

Member state response

Ruokavirasto ohjaa, neuvoo ja kouluttaa teurastamoiden virkaeläinlääkäreitä jatkuvasti. Lihantarkastusyksikön järjestämä ohjaus ja neuvonta pitää sisällään mm. seuraavaa: 1) jatkuva yhteydenpito johtavan virkaeläinlääkärin ja aluejohtajan välillä 2) jatkuva ja tarvittaessa tapahtuva kohdennettu ohjaus ja neuvonta virkaeläinlääkäreiden ja Ruokaviraston lihantarkastusyksikön erityisasiantuntijoiden välillä 3) tarvittaessa tapahtuva ohjaus ja neuvonta muiden Ruokaviraston yksiköiden kanssa, esim. eläinten hyvinvointi, kuljetukset, jäljitettävyys, merkintä- ja rekisteröinti - Virkaeläinlääkäreiden ohjauksessa, neuvonnassa ja koulutuksessa painotetaan vuonna 2023 erityisesti laitosvalvontaa, lihantuotannon hygienian valvontaa, eläinten hyvinvointia sekä hallinnollisia pakkokeinoja kavirasto varmistaa, että kaikilla pienteurastamoilla on laitosvalvonnasta vastaava virkaeläinlääkäri käymällä läpi pienteurastamoiden virkaeläinlääkäreiden nimitykset vuosittain ja tarvittaessa - Pienteurastamoiden virkaeläinlääkäreiden kuukausikokouksessa koulutusaiheena maalis- ja huhtikuussa 2023 ovat eläinsuojelutarkastuksen tekeminen teurastamolla sekä hallinnolliset pakkokeinot. Lihantarkastusyksikön al

The recommendation states as its basis

Different MFCAs indicated that they are, or have been, understaffed, which influenced negatively the number of controls carried out. Therefore, control visits were not carried out as per the set frequencies (see also paragraph 17 below).

The draft report of the 2021 internal audit was provided to the audit team and highlights the following issues: a. Lack of resources of MFCAs to implement the control plans. b. Non-adherence to the FFA guidance ­ incorrect grading of deficiencies (overly positive). c. Inadequate assessment of HACCP plans.

FFA provided another example of a supervision mechanism triggered by an inspection for export approval in November 2020 showing discrepancies between the situation observed and that which was recorded for the control in the VATI system. A thorough evaluation was carried out which arrived at the following conclusions: not following the FFA guidance documents; non-adherence to the set frequencies; deficiencies incorrectly classified (overly positive); not restricting to Finland the placing on the market of certain fishery products (dioxins); and, lack of control on the issuance of export certificates. In response to these findings the MFCAs reaction indicated that the lack of resources was a justification for some of them, and that some of the controls had not been recorded in the VATI system. On the basis of their assessment and the reply from the MFCA, FFA (5) VATI ­ the information system in use in Finland since January 2019, to collect and store relevant information related to the food control systems and other tasks within the remit of FFA/MFCAs. 5 requested RSAA to re-evaluate the situation in November 2021. RSAA reply to FFA indicates that: (1) the situation regarding the frequencies improved, but still there are cases of non-adherence to them; (2) the coverage of the priority OIVA items needs to be improved (not following the FFA guidance documents); and, (3) lack of evidence of follow-up of deficiencies detected during the controls. As in the case of the internal audit draft report, many of the shortcomings detected by FFA and RSAA were also noted by the audit team, and are described in the audit report (see paragraphs 36, 66, 69 and 70 below).

Adequate internal audit and supervision mechanisms are in place, and which have identified several shortcomings that have a negative impact on the effectiveness and reliability of the controls carried out. The audit team also identified such shortcomings.

The MFCAs visited clearly indicated issues related to understaffing that have a negative impact on the implementation of the control plans.

With regard the control of approved facilities handling fishery products, the audit team noted that in half of the establishments visited , the set frequencies were not followed. MFCAs indicated that, mainly due to the lack of human resources, control frequencies were dramatically reduced to at least once a year for operators classified with a higher risk and less frequently for operators classified as low risk. Moreover, it was indicated that in principle the focus of controls would be the priority items suggested by FFA.

There is a clear trend of grading the deficiencies observed during the controls in an overly positive way. This, together with the observation of significant deficiencies not having been identified in previous control visits, call into question both the reliability and efficiency of the controls as well as the confidence that may be had in the `smiley' (10) Report available at: https://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3992. 16 scores assigned to the operators. 5.3.2 Official controls of fishery products Legal requirements Regulation (EC) No 2406/96. Article 1 and Annex I to Regulation (EC) No 2073/2005. Regulation (EC) No 1333/2008. Commission Regulation (EC) No 1881/2006. Article 18 and 35 of Regulation (EU) 2017/625. Articles 70, 71 and Chapter I and II of Annex VI to Regulation (EU) 2019/627. Findings

Currently Regulation (EC) No 1881/2006 allows Finland to avail of the following derogations concerning the official controls of fishery products: a. Article 7 (4) and (5) ­ in relation to the placing on the market of wild caught salmon, herring (larger than 17 cm), char, river lamprey, and trout, and products from those species, and products derived from those wild caught species, originated in the Baltic sea, and intended to be consumed in its territory, with levels of dioxins, and/or dioxin-like polychlorinated biphenyls (PCBs), and/or non-dioxin-like PCB, above the EU regulatory levels. Finland must apply measures to ensure that the products mentioned above are not marketed in other EU Member States and also that relevant information is passed onto the consumers regarding to any restriction of consumption due to health reasons. b. Article 7 (7) ­ in relation to the placing on the market of traditionally smoked small fish and smoked fishery products therefrom, smoked in their territory and intended for consumption in their territory, with levels of PAHs above the EU regulatory limits, but compliant with the limits applicable before 1 September 2014.

Member state response

Ruokavirasto on laatimassa yhteistyössä aluehallintovirastojen kanssa uutta ohjetta k aluehallintovirastojen toteuttamasta arvioinnista ja ohjauksesta. Ohjeessa tullaan kuvaamaan aiempaa tarkemmin, minkälaisiin toimenpiteisiin AVI:jen tulisi ryhtyä ongelmatapauksissa, esimerkiksi kun hyväksyttyjen elintarvikehuoneistojen riskiperusteinen tarkastustiheys ei toteudu. Myös toimenpiteisiin ryhtymisen kriteerit tullaan määrittämään tarkemmin. Ruokavirasto tulee ohjeistamaan, että AVI:jen toteuttamassa kunnallisten valvontayksiköiden arvioinnissa ja ohjauksessa panostetaan jatkossa erityisesti siihen, että valvontayksiköissä valvotaan rusteisesti asioita oikein, oikeissa paikoissa ja oikealla resursoinnilla. AVI:jen toteuttamaa arviointia ja ohjausta muutetaan enemmän jatkuvaan arviointiin ja sen ylläpitoon. Työkaluina ovat valvontatietojen tarkastelu, valvontayksiköiden valvontasuunnitelmien tarkastelu, AJO-käynnit, hyvien käytäntöjen jakaminen sekä puutteiden korjauksen seuranta. AVI:jen tulee jatkossa seurata myös korjaavien toimenpiteiden toteutumista, jos valvontayksikön valvontasuunnitelma ei toteudu. Uusi arvioinnin ja ohjeuksen ohje valmistuu vuoden 2022 aikana ja otetaan käyttöö

se of 29/08/2022 - Ruokavirasto vahvistaa, että toimintasuunnitelmassa esitettyjen toimenpiteiden Ares(2022)5960512 tarkoitus on vastata tarpeeseen varmistaa, että kunnalliset valvontayksiköt suorittavat valvontaa riskiluokitusohjeen mukaisin tiheyksin sekä tarpeeseen The Finnish Food Authority, in varmistaa, että käytettävissä on riittävä määrä pätevää tarkastushenkilöstöä. cooperation with the Regional State Ks liite: Guideline on Assessment and Guidance for RSAAs (Relevant parts Administrative Agencies, is preparing aimed at addressing the recommendation highlighted). new guidelines for the assessment and guidance carried out by those agencies. Tarkennus aiempaan vastaukseen: The guidelines will describe in more Kunnallisten valvontayksiköiden velvollisuus on sisäisesti varmistaa, että niiden valvontasuunnitelmat on laadittu Ruokaviraston ohjeistuksen mukaisesti. detail the measures to be taken by the Toimenpiteet poikkeamatilanteissa tulee olla määritetty kunnan Regional State Administrative Agencies laatujärjestelmässä ja valvontayksiköiden johdon tulee seurata, että in case of problems, e.g. when the risk- valvontasuunnitelmaa sekä ennalta määritettyjä korjaavia toimenpiteitä

The recommendation states as its basis

The procedures covering the approval/registration of facilities/operators are largely in line with the EU rules and, in the cases observed, was adequately implemented ­ be it with some exceptions, which impact on the full correctness of the list of approved establishments (i.e. lack of information of FFA originating the maintenance of entries for withdrawn approvals).

Member state response

Vuoden 2022 aikana tullaan lähettämään kaikille aluehallintovirastoille pyyntö elvittää alueillaan niiden hyväksyttyjen elintarvikehuoneistojen tilanne, jotka ovat hyväksyttyjen listalla, mutta joissa ei ole käyty tarkastuksella viimeisen vuoden ikana. Aluehallintovirastoja pyydetään ohjeistamaan kunnallisille valvontayksiköille toiminnan lopettaneiden hyväksyttyjen elintarvikehuoneistojen ilmoittaminen Ruokavirastoon viivytyksettä sekä muistuttamaan kunnallisia valvontayksiköitä velvoitteesta ilmoittaa hyväksytyn elintarvikehuoneiston toiminnan loppumisesta jatkossakin viivytyksettä Ruokavirastoon. Lisäksi valvontatietojärjestelmä Vatiin tullaan lisäämään ominaisuus, jonka avulla järjestelmästä lähetetään automaattinen ilmoitus Ruokavirastolle, kun kunnallinen valvontayksikkö merkitsee hyväksytyn elintarvikehuoneiston toiminnan lopetetuksi. Tavoiteaikataulu tekniselle muutokselle on vuoden 2023 loppuun mennessä. Kansallisten hyväksyttyjen elintarvikehuoneistojen listojen muutokset viedään manuaalisesti TRACES-järjestelmään viivytyksettä.

se of 29/08/2022 - Ruokaviraston elintarvikehygieniajaoston kaksi nimettyä asiantuntijaa vastaavat s(2022)5960512 hyväksyttyjen elintarvikehuoneistojen listojen ylläpidosta. Vastuuhenkilöt vastaanottavat ja käsittelevät kunnallisista valvontayksiköistä lähetetyt course of 2022, a request will be ilmoitukset ja siirtävät tiedot viivytyksettä kansallisiin hyväksyttyjen t to all Regional State Administrative elintarvikehuoneistojen listoihin sekä edelleen välittömästi TRACES- ncies asking them to clarify the järjestelmään. Sekä kansallisen että TRACES-listan ylläpito on priorisoitu uation of approved food premises in vastuuhenkilöiden työtehtävissä. Henkilöt sijaistavat toisiaan tarvittaessa. ir regions that are on the approved list Listojen ajantasaisuus varmistetaan viikoittain. Ruokaviraston toimintatapa perustuu pitkäaikaiseen kokemukseen, eikä Ruokaviraston menettelyissä tietojen that have not been inspected in the siirrossa TRACES-järjestelmään ole todettu merkittäviä viiveitä tai muita . The Regional State ongelmia. inistrative Agencies are requested Kirjallinen kuvaus Ruokaviraston prosessista on talletettu instruct the municipal control units to toiminnanohjausjärjestelmään,

The recommendation states as its basis

Provisions in the FFA guidance which are contrary to the relevant EU requirements has lead to a situation where certain establishments/operators carry out activities bleeding of fish and the in-shore storage of chilled fishery products) which would require their approval under EU law.

Member state response

Ruokaviraston ohjeet päivitetään vuoden 2022 loppuun mennessä kalastustuotteiden kutuotannon määritelmien osalta. Alkutuotannon määritelmät päivitetään EU- setusten määritelmien mukaisiksi vesiviljelyn sekä kalastuksen osalta. iden muutoksista ja niiden perusteista tullaan tiedottamaan kunnallisia valvojia onna 2023 järjestettävien kala-alan koulutusten yhteydessä. Page: 2 endations of report ref. DG(SANTE) 2022-7451 of the audit carried out from 14 March 2022 systems in place governing the production and placing on the market of fishery products Action Proposed by the competent authority

esponse of 29/08/2022 - Ares(2022)5960512 he Finnish Food Authority's guidelines will be updated by the end of 2022 with respect to the definitions of the primary d production of fishery products. As n Page: 4 30.1.2023 esponses to Recommendations 1, 2, 4, 5, 7, 9, 10, 11 and 12 and additional information on other Recommendations. e audit carried out from 14 March 2022 to 25 March 2022 in order to evaluate the food safety control systems in place governing the of fishery products Action Proposed by the competent Finnish Food Authority's additional response and further actions proposed authority regards aquaculture and fisheries, the definitions of primary production will be updated to correspond to the definitions in EU Regulations. Municipal inspectors will be informed of the changes to the guidelines and the reasons for them in connection with the fishery sector training to be organised in 23.

The recommendation states as its basis

In one case, the approval (and the HACCP based procedures) covered one activity (freezing) that in practice was not being carried out at that establishment. The freezing activity was in fact taking place at a neighbouring establishment (also approved) but the activity was covered in the approval the first establishment. This is not in line with the requirements of Article 148(3) of Regulation (EU) 2017/625.

In another case, the audit team noted that the MFCA had approved a collective facility despite the absence of: a) documented procedures indicating the activities carried out, including procedures to ensure traceability, b) a suitable HACCP plan; and, c) production records (see paragraph 72.d below). Since its first approval, MFCA did not control regularly this establishment (the control frequency was not followed). This is contrary to both the FFA and the EU rules concerning the approval of establishments of food business operators ­ Article 148(3) of Regulation (EU) 2019/625 (6).

Additionally, MFCAs did not correctly follow either the guidance provided by FFA or the applicable EU rules, resulting in the (continued) approval of establishments for activities not carried out and of non-compliant facilities/operators. The latter may apply to up to 40 establishments.

Member state response

ions related to finding No 36: Ruokavirasto tulee huomioimaan asian vuonna 2023 järjestettävissä kala-alan s valvonnan koulutuksissa, joissa tullaan muistuttamaan kunnallisia valvontayksiköitä ies elintarvikehuoneistojen hyväksymistä koskevista vaatimuksista (mm. HACCP- menettelyt) ja ohjeista. lintarvikehuoneiston hyväksymistä koskeva Ruokaviraston ohje on päivitetty .2.2022. Ohjeen päivityksestä on pidetty koulutus elintarvikevalvonnan valtakunnallisilla koulutuspäivillä 2.-3.2.2022. Ruokavirasto laatii uuden ohjeen koskien kalastajien yhteiskäyttötilojen (eng: collective establishments) vaatimuksia, hyväksymistä ja valvontaa. Tavoiteaikataulu uudelle ohjeelle on vuoden 2023 aikana. Finnish Food Authority has a differing view on the interpretation of the finding No 35: see comment in Annex 1, point 12.

esponse of 29/08/2022 - Ruokavirasto lähettää vuoden 2023 aikana aluehallintovirastoihin kirjeen, jossa Ares(2022)5960512 pyydetään alueiden kunnallisia valvontayksiköitä toimittamaan Ruokavirastoon selvitykset alueella toimivien, kalastajien hyväksyttyjen yhteiskäyttötilojen Actions related to finding No 36: tilanteesta. The Finnish Food Authority will take Havainto 35: Kyseessä olevan pakastuslaitoksen ja sen pakastustunneleita the matter into account in the training on käyttävien muiden hyväksyttyjen elintarvikehuoneistojen hyväksymispäätökset fishery sector controls in 2023, where tullaan uusimaan huomioiden asetuksen 2017/625 artiklan 148 vaatimukset. municipal control units will be reminded Ruokavirasto on ohjeistanut kyseessä olevalle kunnalliselle valvontayksikölle, r of the requirements and guidelines että pakastustoiminta tulee hyväksyä sille laitokselle, jonka tiloissa pakastaminen concerning the approval of food tapahtuu ja vastuu toiminnan vaatimustenmukaisuudesta on kyseisellä laitoksella. premises (e.g. HACCP procedures). The Finnish Food Authority's guideline w on approving food premises was updated on 4 February 2022. Training on the le update was provided at the n

The recommendation states as its basis

According to the information provided by FFA and MFCAs, fishing vessels are not controlled within the set frequencies. Despite being included at national level in the Finnish MANCP, the audit team did not find evidence in the relevant MFCAs that their control plans follow the MANCP and include controls of fishing vessels (food safety requirements). From the 56 vessels (see section 4.2 above), in 2019, 11 fishing vessels (over 12 metres) were controlled, 14 in 2020, and 6 in 2021. Moreover, the current approach for vessels under 12 metres is not in accordance with the requirements set out in Article 67 (b) of Regulation (EU) No 2019/627.

The audit team visited a primary production fishing vessel (cooled sea water) and found it broadly compliant with the applicable rules, except for the temperature requirements set in the operational (self-control) manual for the vessel which stated that fish loaded on board and maintained in cooled sea water, should be kept at not more than 5°C. This is not in line with the requirements set in Point I(B)(3) of Chapter I of Section VIII of Annex III to Regulation (EC) No 853/2004 (not more than 3°C 6 hours after loading and not more than 0°C 16 hours after loading). According to the operator, the last control of the vessel was in 2018, however no records of that visit were available.

Another operator/owner of a primary production fishing vessel above 12 meters, interviewed by the audit team, indicated that the vessel was never controlled by MFCAs with respect to food safety requirements. Aquaculture farms

The controls over approved establishments are carried out using the OIVA guidance and are recorded in the VATI system. However, in half of the establishments visited, the control frequency determined for these establishments on the basis of the risk categorisation, was not followed.

Member state response

Ruokavirasto tulee järjestämään vuonna 2023 kuntien elintarvikevalvojille koulutusta kalastustuotteiden alkutuotannon valvonnasta. Koulutuksessa tullaan istuttamaan valvojia EU-lainsäädännön vaatimuksista sekä olemassa olevien alkutuotannon valvontaohjeiden sisällöstä ja riskiluokitusohjeen mukaisista tarkastustiheyksistä. Ruokaviraston näkemyksen mukaan on riskiperusteisesti perusteltua kohdentaa kalastuksen alkutuotannon valvonta pääasiassa > 12 m pituisiin aluksiin (n= 56), sillä n. 90 % (vuonna 2021: 88 %) Suomeen puretusta vuosittaisesta saaliista on peräisin > 12 m kalastusaluksista. Myös pienempiin aluksiin kohdistetaan tarkastuksia, mikäli niiden toiminnassa on syytä epäillä tai havaitaan puutteita. Pienten alusten lukumäärä on kuitenkin hyvin suuri (2021 n = 3087) suhteessa niiden saalismäärään (n. 10 % kokonaissaaliista), minkä takia valvonnan vaikuttavuus ja tehokkuus kärsisi merkittävästi, mikäli säännöllistä valvontaa kohdistettaisiin kaikkiin Suomen < 12 m kalastusaluksiin sen sijaan, että priorisoidaan suurten alusten riittävää valvontatiheyttä. Page: 3 endations of report ref. DG(SANTE) 2022-7451 of the audit carried out from 14 March 2022 systems in place governing

se of 29/08/2022 - Kalastus: es(2022)5960512 Mekanismit, joilla toimivaltaisten elintarvikeviranomaisten tietoon voi tulla epäkohtia tai epäilyjä epäkohdista liittyen alkutuottajina toimivien kalastajien 023, the Finnish Food Authority will toimintaan: organise training for municipal food 1. ELY-keskusten suorittama kalastuksenvalvonta. Elintarvikelain (Finnish inspectors on controls on the primary Food Act 297/2021) mukaisesti kalastuksenvalvontaviranomaisella on production of fishery products. During velvollisuus ilmoittaa elintarvikevalvontaviranomaiselle sellaisista the training, inspectors will be reminded valvonnassa esille tulleista seikoista, joilla voi olla vaikutusta elintarvikkeiden turvallisuuteen tai jäljitettävyyteen tai niistä annettaviin he requirements of EU legislation as tietoihin. as of the content of existing 2. Kala-alan hyväksytyt elintarvikehuoneistot, jotka vastaanottavat kalaa primary production control guidance and kalastajilta. Esimerkiksi rekisteröitymisvelvoitteisiin, jäljitettävyyteen, of the control frequencies laid down in merkintöihin, kalojen laatuun ja kuljetuksen hygieniaan liittyviä epäkohtia the risk classification guidelines. voidaan havaita

The recommendation states as its basis

The audit team visited a primary production fishing vessel (cooled sea water) and found it broadly compliant with the applicable rules, except for the temperature requirements set in the operational (self-control) manual for the vessel which stated that fish loaded on board and maintained in cooled sea water, should be kept at not more than 5°C. This is not in line with the requirements set in Point I(B)(3) of Chapter I of Section VIII of Annex III to Regulation (EC) No 853/2004 (not more than 3°C 6 hours after loading and not more than 0°C 16 hours after loading). According to the operator, the last control of the vessel was in 2018, however no records of that visit were available.

The audit team found the same situation regarding the temperature indicated above, in the operational manual of a sister vessel owned by the same operator.

Moreover, the audit team noted that the guidance document issued by FFA is not aligned with the applicable EU rules and allows the same temperature regime as indicated in the operator's manual: a. "A" grade if "As a general rule, the operations as a whole are in accordance with the requirements." b. This grading can be given if "The activity fulfils its requirements. There may be minor shortcomings. The water temperature is not more than 5°C higher than the requirement.". 13

The controls over approved establishments are carried out using the OIVA guidance and are recorded in the VATI system. However, in half of the establishments visited, the control frequency determined for these establishments on the basis of the risk categorisation, was not followed.

Member state response

SW (Refrigerated seawater) -alusten lämpötilavaatimukset (point I(B)(3) of apter I of Section VIII of Annex III to Regulation (EC) No 853/2004) on mainittu okaviraston ohjeissa. Alkutuotannon valvontaohjeen arviointikriteereitä muutetaan vuoden 2022 loppuun mennessä niin, ettei niiden sisältö ole ristiriidassa äännösten kanssa. uokavirasto tulee järjestämään vuonna 2023 kuntien elintarvikevalvojille oulutusta kalastustuotteiden alkutuotannon valvonnasta. Koulutuksessa tullaan äsittelemään olemassa olevien alkutuotannon valvontaohjeiden sisältöä sekä EU- ainsäädännön vaatimuksia, mukaan lukien RSW-alusten lämpötilavaatimukset.

esponse of 29/08/2022 - Ares(2022)5960512 he temperature requirements for RSW (refrigerated seawater) vessels (point I(B)(3) of Chapter I of Section VIII of I Annex III to Regulation (EC) No 853/2004) are mentioned in the Finnish Food Authority's guidelines. The ssment criteria in the control guidance for primary production will be Page: 7 30.1.2023 esponses to Recommendations 1, 2, 4, 5, 7, 9, 10, 11 and 12 and additional information on other Recommendations. e audit carried out from 14 March 2022 to 25 March 2022 in order to evaluate the food safety control systems in place governing the of fishery products ction Proposed by the competent Finnish Food Authority's additional response and further actions proposed uthority ed by the end of 2022 so that their ontent no longer conflicts with the rovisions. n 2023, the Finnish Food Authority will rganise training for municipal food nspectors on controls on the primary roduction of fishery products. The raining will cover the content of xisting control guidance for primary roduction and the requirements of EU egislation, including temperature equirements for RSW vessels.

The recommendation states as its basis

In summary: a. FFA is responsible for planning, steering and developing food controls at national level. To this end, FFA developed extensive guidance documents, addressed to both MFCAs and operators. FFA also directly assists the MFCAs when required. In addition, FFA is responsible for interpreting the legislation, which serve as a basis for developing the guidance documents. In certain cases FFA can perform official control activities. b. At regional level, RSAAs oversee the implementation of the control plans and the execution of controls carried out by MFCAs. c. At local level, 62 MFCAs perform relevant official control activities, in accordance with their adopted control plans (see paragraph 41 below). In addition, as stated by FFA and MFCA staff, on many occasions during the controls the role of MCFA is closer to an advisory and counselling role, other than that of a controller. This may lead to a conflict of interest, when (a) a judgement is required on a deficiency identified during a control for which guidance has been provided and (b) on determining its seriousness and subsequent classification (e.g. see paragraphs 13, 17, 69 and 70 below).

There is a clear trend of grading the deficiencies observed during the controls in an overly positive way. This, together with the observation of significant deficiencies not having been identified in previous control visits, call into question both the reliability and efficiency of the controls as well as the confidence that may be had in the `smiley' (10) Report available at: https://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3992. 16 scores assigned to the operators. 5.3.2 Official controls of fishery products Legal requirements Regulation (EC) No 2406/96. Article 1 and Annex I to Regulation (EC) No 2073/2005. Regulation (EC) No 1333/2008. Commission Regulation (EC) No 1881/2006. Article 18 and 35 of Regulation (EU) 2017/625. Articles 70, 71 and Chapter I and II of Annex VI to Regulation (EU) 2019/627. Findings

Member state response

uonna 2023 järjestetään Ruokaviraston toimesta koulutusta kala-alan valvojille. t Koulutuksen aihealueita tulevat olemaan mm. HACCP, alkutuotannon valvonta sekä komission täytäntöönpanoasetuksen (EU) 2019/627 mukainen kalastustuotteiden lvonta. ACCP-arviointia esitetään seuraavaksi valvonnan valtakunnalliseksi painopisteeksi euraavalle painopistejaksolle. uokavirasto tulee ohjeistamaan aluehallintovirastoja aiempaa ksityiskohtaisemmin niille kuuluvasta kunnallisten valvontayksiköiden jatkuvasta rvioinnista. Ohjeistusta tarkennetaan muun muassa sen osalta, että luehallintovirastojen tulee seurata ja analysoida omalla alueellaan sijaitsevien alvontayksiköiden valvontatietoja ja ohjeistaa tarvittaessa, jos valvonnassa avaitaan epäkohtia. Analysointiin sisältyy mm. kala-alan hyväksyttyjen lintarvikehuoneistojen epäkohtien korjaamisen seuranta ja Oiva-arvosanojen akauman seuranta. Aluehallintovirastot raportoivat jatkossa näistä valvontatulosten akaumista Ruokavirastoon, joka tarvittaessa ohjeistaa kuntia. Ruokavirasto laatii hteistyössä aluehallintovirastojen kanssa uuden ohjeen aluehallintovirastojen oteuttamasta arvioinnista ja ohjauksesta. Ohje valmistuu vuonna 2022. Page: 4 endatio

se of 29/08/2022 - Tarkentavaa ja taustatietoa suunnitelluista toimenpiteistä: res(2022)5960512 Suomen elintarvikelain mukaan kunta vastaa elintarvikevalvonnasta omalla alueellaan. Kunnallisten elintarvikevalvontayksiköiden tulee sisäisesti varmistaa, he Finnish Food Authority will että elintarvikevalvonnan arvioinnit noudattavat valtakunnallisia ohjeistuksia, rganise training for fishery inspectors ovat johdonmukaisia ja että valvonnassa todettujen puutteiden korjaamista n 2023. Topics will include HACCP, seurataan. Kunnallisten valvontayksiköiden keinoja sisäiseen varmistamiseen rimary production controls and controls ovat esimerkiksi paritarkastukset, kuntien väliset yhteistarkastukset ja n fishery products pursuant to ristiinauditoinnit. ission Implementing Regulation Ruokavirasto on muistuttanut terveysvalvonnan johdon päivillä 2022 EU) 2019/627. valvontayksiköiden sisäisestä vastuusta ja kertonut kunnallisille valvontayksiköille auditoinnilla havaituista epäkohdista. t is proposed that HACCP assessments Ruokavirasto tulee korostamaan myös tulevissa koulutuksissa, että tarkastuksilla he national control priority for the havaittujen puutteiden arviointi tulee tehdä johdonmukais

The recommendation states as its basis

The audit team also observed significant deficiencies which would require immediate correction, not detected in previous MCFA visits, in four of the establishments visited: a. Production of smoked small fishery products without adequate control of polycyclic aromatic hydrocarbons (PAHs), as well as the absence of any indication on the product, or in the accompanying documents, that it was only intended for placing on the Finnish market, as required by the FFA guidance. The same establishment presented a poor state of cleanliness and hygiene. b. Presence of water condensation potentially dripping into unprotected products (marinated product packed in jars for ready-to-eat) and spraying of detergent solution potentially contaminating exposed products present in trays in transport trolleys. c. Existence of a band saw to cut frozen products and the absence of identification of this step in the HACCP manual, with consequent lack of consideration of the hazard "foreign bodies due to metal pieces" and of preventive and/or control measures for this hazard. d. Absence of production records, operational instructions and HACCP plan in a facility handling fishery products originating from different fishermen (cooperative establishment) and dispatching fresh/chilled products, eviscerated chilled products and chilled fillets. This establishment was unable to demonstrate the existence of 15 traceability documents for the products produced and was applying for an extension of the approval to freezing roe.

There is a clear trend of grading the deficiencies observed during the controls in an overly positive way. This, together with the observation of significant deficiencies not having been identified in previous control visits, call into question both the reliability and efficiency of the controls as well as the confidence that may be had in the `smiley' (10) Report available at: https://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3992. 16 scores assigned to the operators. 5.3.2 Official controls of fishery products Legal requirements Regulation (EC) No 2406/96. Article 1 and Annex I to Regulation (EC) No 2073/2005. Regulation (EC) No 1333/2008. Commission Regulation (EC) No 1881/2006. Article 18 and 35 of Regulation (EU) 2017/625. Articles 70, 71 and Chapter I and II of Annex VI to Regulation (EU) 2019/627. Findings

Member state response

iseen elintarvikehygienia-asetukseen (MMMa elintarvikehygieniasta 1) on valmisteilla muutos, jolla hyväksytyille elintarvikehuoneistoille äädettyä velvoitetta ilmoittaa markkinoille saattamiseen liittyvästä erityisehdosta etaan seuraavasti: vastaanottavalle toimijalle tulee ilmoittaa elintarvikkeen al toimittamiseen liittyvistä erityisehdoista kirjallisesti. Jatkossa muulla tavalla kuin isesti annettu ilmoitus ei ole riittävä. Ehdotetulla muutoksella varmistetaan ista poikkeusta koskevan tiedon kulkeminen elintarvikeketjussa. Muutos aa elintarvikevalvontaviranomaisten suorittamaa elintarvikkeiden oille saattamiseen liittyvien erityisehtojen valvontaa. Page: 5 endations of report ref. DG(SANTE) 2022-7451 of the audit carried out from 14 March 2022 systems in place governing the production and placing on the market of fishery products ction Proposed by the competent authority iva-arviointiohjeisiin (8.8 Kalastustuotteiden loistarkastukset ja jäädytyskäsittely, 7.15 Prosessissa syntyvät vierasaineet, 16.4 Dioksiinipoikkeuksen alaisen kalan ja alastustuotteiden jäljitettävyys) tarkennetaan vuoden 2022 aikana, että kansallisten oikkeusten alaisten elintarvikkeiden markkinoille saattamis

se of 29/08/2022 - Additional information: es(2022)5960512 MMMa 318/2021 muutos asetuksella MMMa 880/2022 on tullut voimaan 15.11.2022. amendment is being drafted to the nnish Food Hygiene Decree (Decree the Ministry of Agriculture and restry on food hygiene 318/2021) to ecify as follows food premises' Page: 11 30.1.2023 esponses to Recommendations 1, 2, 4, 5, 7, 9, 10, 11 and 12 and additional information on other Recommendations. e audit carried out from 14 March 2022 to 25 March 2022 in order to evaluate the food safety control systems in place governing the of fishery products Action Proposed by the competent Finnish Food Authority's additional response and further actions proposed authority obligation to notify the specific the condition for placing on the market: "The receiving operator must be informed in writing of the specific conditions relating to the supply of food. In future, a declaration will not be sufficient unless it is made in writing". The proposed amendment ensures that information on the national derogation will reach the entire food supply chain. The amendment makes it easier for food control authorities to monitor the specific conditions for placing food on

The recommendation states as its basis

With regard to organoleptic examinations, the audit team noted that the MCFAs visited do not perform them, despite it being clearly requested in the FFA guidance that such examinations be carried out. FFA indicated that staff from ELY carries out some organoleptic examinations during the landing controls, however incidental records of those controls are not made available to the food control authorities. The audit team also noted that the FFA guidance document provides for generic descriptions of organoleptic characteristics as standards and not Regulation (EC) 2406/96 as indicated in Chapter I(A) of Annex VI to Regulation (EU) 2019/627.

Specifically for histamine, the FFA guidance indicates that "sampling for histamine shall be included in official controls, unless the activity is very small and the operator can demonstrate that self-monitoring is adequate". Additionally, for imported products tested at the EU border, it indicates that official sampling is not required.

The official controls carried out by the MCFAs do not include all the relevant provisions set out in Chapter I of Annex VI to Regulation (EU) 2019/627. Organoleptic examinations, random testing for histamine and risk-based parasite testing are not carried out as required. The latter is due to an incorrect translation of the Finnish version of Regulation (EU) 2019/627.

Member state response

w of the Finnish Food Authority is that the recommendation No 9 is s incorrectly justified. he view of the Finnish Food Authority is that the recommendation No 9 is not onnected to the conclusion No 80. innish Food Authority has a differing view on the interpretation of the finding No 4 and 35. ee detailed comments in Annex 1: points 12, 23 and 24.

se of 29/08/2022 - Aistinvaraiset tutkimukset: es(2022)5960512 Aistinvaraiset arvioinnit on sisällytetty Oiva-valvontajärjestelmään 2.1.2023 alkaen. Kalastustuotteiden aistinvaraiselle arvioinnille on oma Oiva- anoleptic evaluation of fishery arviointikohta, joka tulee tarkastaa vähintään kerran kolmessa vuodessa kaikissa oducts will be included in the Oiva elintarvikehuoneistoissa, joissa käsitellään tai pidetään kaupan tuoretta aluation guidelines. The target date set kokonaista tai perattua kalaa tai eläviä tai tuoreita äyriäisiä. Uudesta Oiva- r the change is the beginning of 2023. arviointikohdasta koulutetaan valvojia vuoden 2023 aikana. Vati-järjestelmästä e Oiva evaluation guideline on tullaan keräämään vuoden 2023 lopulla raportointitiedot arviointikohdan stamine control will be updated and tarkastuksien kattavuudesta. ore detailed in 2022. Histamiini: e guideline on fishery product Ruokavirasto laatii ja toimittaa tarkemman suunnitelman histamiinin viranomaisnäytteenotosta vuoden 2023 aikana, kun analyysimenetelmään is being updated. The guideline liittyvät kysymykset (suositus 11) on ratkaistu. ll be supplemented with a reference to lation (EC) No 2406/96 and it will spe

The recommendation states as its basis

In addition, the possibility of using laboratories not designated by the authority(ies) does not comply with the above requirements above.

Member state response

alastustuotteiden aistinvarainen arviointi lisätään Oiva-tarkastusohjeisiin rkastettavaksi asiaksi. Tavoiteaikataulu muutokselle on vuoden 2023 alku. istamiinivalvontaa koskeva Oiva-arviointiohje päivitetään yksityiskohtaisemmaksi vuonna 2022. alastustuotteiden valvontaohje on päivityksessä. Ohjeeseen lisätään viittaus kseen (EY) 2406/96 ja maininta, että viranomaisvalvontaan tulee sisältyä istinvaraista arviointia ko. asetuksen tuoreuskriteerien mukaisesti, ja että arkastuksien tulokset tulee kirjata. Page: 6 endations of report ref. DG(SANTE) 2022-7451 of the audit carried out from 14 March 2022 systems in place governing the production and placing on the market of fishery products d by the competent authority iden valvontaohjeeseen lisätään maininta viranomaisten ta toteuttaa riskiperusteisesti loistestausta. Loisten varalta tehtävistä laaditaan uutta ohjeistusta. iden valvontaohjeeseen tarkennetaan lisäksi vaatimuksia liittyen imuksiin osana viranomaisvalvontaa sekä toimijoiden kimuksien vaatimustenmukaisuuden arviointia. astustuotteiden valvontaohje on tavoitteena julkaista vuoden 2023 rjestettävissä kala-alan valvojien koulutuksissa tullaan kouluttamaan äntöönpanoasetuksen (E

se of 29/08/2022 - Ruokavirasto muistuttaa tiedotteella kunnallisia valvontayksiköitä ja Ares(2022)5960512 laboratoriota alkuvuonna 2023, että kaikki viralliseen valvontaan liittyvät laboratoriotutkimukset tulee tehdä nimetyissä virallisissa laboratorioissa, myös According to the Finnish Food alihankintana teetetyt tutkimukset. Lisäksi muistutetaan, että kunnallisten Authority, official samples are not sent valvontayksiköiden tulee edellyttää tätä myös laboratorioiden kanssa directly to laboratories outside Finland's tekemissään sopimuksissa. Laboratorioita pyydetään hakemaan nimeämistä borders. However, official designated kaikille käyttämilleen alihankintalaboratorioille, joihin lähetetään tutkittavaksi laboratories in Finland subcontract virallisen valvonnan yhteydessä otettuja näytteitä. official examinations from foreign, Ruokavirasto keskustelee alihankintalaboratorioiden käytöstä myös kansallisen mainly private, commercial laboratories. akkreditointielimen, FINASin, kanssa toukokuussa 2023 pidettävässä Finnish official designated laboratories yhteistyöpalaverissa, jotta FINAS voi huomioida asiaa have been informed of the requirement akkreditointitarkastuksilla. under Control

The recommendation states as its basis

Nonetheless, the findings in respect of the analytical method used for histamine testing and the performance criteria of the analytical method used for heavy metals by one of the official laboratories, can affect those guarantees.

Member state response

okaviraston tietojen mukaan virallisia näytteitä ei suoraan lähetetä tutkittavaksi d Suomen rajojen ulkopuolisiin laboratorioihin. Suomalaiset nimetyt viralliset , as laboratoriot kuitenkin alihankkivat virallisia tutkimuksia ulkomaalaisista pääosin ityisistä kaupallisista laboratorioista. Suomalaisia virallisia laboratorioita on the tiedotettu valvonta-asetuksen (EU) 2017/625 vaatimuksista nimetä toisissa a ja ETA-maissa sijaitsevat viralliseen valvontaan käytettävät oratoriot (mm. koulutuspäivät 2019 ja 2020 sekä vertailulaboratorion 1). Osa laboratorioista on kysynyt neuvoja ja ohjeita asiaan myös ja puhelimitse. käsityksen mukaan useat suomalaisten laboratorioiden käyttämät valtioissa sijaitsevat alihankintalaboratoriot eivät ole vielä saaneet 2017/625 mukaista paikallisen viranomaisen nimeämistä viralliseksi Page: 7 endations of report ref. DG(SANTE) 2022-7451 of the audit carried out from 14 March 2022 systems in place governing the production and placing on the market of fishery products Action Proposed by the competent authority laboratorioksi eivätkä suomalaiset laboratoriot siksi ole voineet hakea niille nimeämistä Ruokavirastosta. Kesän 2022 aikana Ruokavirasto on kuiten

se of 30/09/2022 Menetelmää NMKL 196 tullaan Ruokaviraston laboratoriossa jatkossa es(2022)6757946) käyttämään kalojen ja kalatuotteiden virallisen valvonnan yhteydessä otettujen histamiini -näytteiden seulontaan. Kalojen ja kalatuotteiden valvontaan liittyvät interpretation is however that there näytteet, joiden tulos mittausepävarmuus huomioiden saavuttaa tai ylittää ot an explicit requirement to use only asetuksessa EY 2073/2005 asetetun raja-arvon, lähetetään varmistustutkimuksiin reference methods in Annex I for toiseen viralliseen laboratorioon, jolla on asetuksen EY 2073/2005 cial control samples. Validated and referenssimenetelmä käytössään. Ruokavirasto etsii ja nimeää sopivan able alternative methods should be alihankintalaboratorion histamiinitutkimuksille vuonna 2023. wed to test official control samples Metropolilab Oy tutkii tällä hetkellä pääasiassa ruokamyrkytystapauksiin verifying compliance with the liittyviä histamiininäytteitä. Jos laboratoriolla on tarvetta tutkia kalojen ja s and criteria laid down in the kalatuotteiden viralliseen histamiinivalvontaan liittyviä näytteitä, sen lation EC No 2073/2005. edellytetään jatkossa toimivan vastaavalla tavalla kuin Ruok

The recommendation states as its basis

Nonetheless, the findings in respect of the analytical method used for histamine testing and the performance criteria of the analytical method used for heavy metals by one of the official laboratories, can affect those guarantees.

Member state response

oth laboratories in Finland testing histamine will take actions to change the method reference in their accredited scopes from in-house method to NMKL 196.

se of 29/08/2022 - Ruokaviraston ohjetta laboratorioiden nimeämisestä (970/04.02.00.01/2022) on 2022)5960512 muutettu. Ohjeeseen on nyt kirjattu, että Ruokavirasto arvioi sellaisten menetelmien, joille on lainsäädännössä asetettu suorituskykykriteereitä (esim. he Finnish Food Authority has internal EC No 333/2007), vaatimustenmukaisuuden joka toinen vuosi tai kun asetuksen uideline 11011 for the designation of suorituskykykriteerit muuttuvat. Arvioinnit aloitetaan vuonna 2023. Arvioinnin aboratories. The guideline describes the piirissä ovat nimetyt viralliset laboratoriot, joilla on kyseisiä menetelmiä pproval by the Finnish Food Authority nimeämisen piirissä. f methods for which performance riteria have been set ( e.g. Commission lation (EC) No 333/2007). Prior to pproving such methods, an opinion is lways requested from the reference aboratory (Finnish Food Authority's aboratory) on compliance with the equirements set for their performance riteria. The application for approval of aboratories also states that when pplying for the inclusion of such Page: 18 30.1.2023 esponses to Recommendations 1, 2, 4, 5, 7, 9, 10, 11 and 12 and additional information on other Recommendations. e

The recommendation states as its basis

The staff interviewed by the audit team were largely familiar with the sampling instructions. However, the audit team noted three cases (all in slaughterhouses) where either only random sampling was carried out or the decision on the carcasses to sample was solely made on the basis of a documentary check without seeing/checking the animals/carcasses. This approach is not fully in line with pertinent legal requirements (11).

Whilst the residue monitoring plan is generally implemented promptly and in full in accordance with planned arrangements and in line with EU rules, some shortcomings in sample targeting in slaughterhouses allied with a failure to ensure the integrity of the chain of custody of the samples taken in slaughterhouses (pending their dispatch to the laboratory), have the potential to compromise the effectiveness of the plan.

Member state response

d Teurastamoiden virkaeläinlääkäreille toimitettavat teurastamonäytteiden ottamista varten tarkoitetut näytteenotto-ohjeet on päivitetty vuoden 2023 valvontaohjelmaa varten. Ohjeissa on tarkennettu yleisiä näytteenottoon liittyviä kohdennuskriteereitä. Ohjeissa on painotettu lisäksi eläimen tai ruhon silmämääräisen tarkastuksen välttämättömyyttä näytteenottokohteen valinnan yhteydessä. Ruokavirasto tulee antamaan teurastamoiden virkaeläinlääkäreille ja virallisille avustajille aiheeseen liittyvää koulutusta. Ruokaviraston lihatarkastusyksikön tekemiä viralliseen teurastamovalvontaan kohdistuvien sisäisten arviointi- ja ohjauskäyntien yhteydessä tarkastellaan eläinlääkkeiden jäämävalvontaohjelman näytteenotto-ohjeiden noudattamista. Käyntejä on suunniteltu tehtäväksi noin kuuteen teurastamoon vuosittain. Liite 1. Näytteenotto-ohje / liha 2023 (erityisesti keltaisella merkityt kohdat)

CA response received on 12 January 2023 The guidelines for official veterinarians of slaughterhouses, instructing them on how to take slaughterhouse samples, have been updated for the 2023 control programme. The guidelines specify in greater detail the general criteria for targeted sampling. The guidelines also stress that a visual inspection of the animal or carcass is necessary when selecting the sampling target. The FFA will provide training on this topic for official veterinarians and official auxiliaries working at slaughterhouses. During internal assessment and control visits by the FFA's Meat Inspection Unit to assess official slaughterhouse control, compliance is checked with the sampling guidelines for the control programme for veterinary medicinal product residues. The plan is to visit about six slaughterhouses every year. Page: 1 July 2023 e competent authorities of Finland in response to Report ref. DG(SANTE) 2022-7492 of the audit carried out from 06 in order to evaluate the control of residues and contaminants in live animals and animal products Action Proposed by the competent CA response July 2023 authority Annex 1. Sampling guideline / meat 2023 (in particular sect

The recommendation states as its basis

Interviewed officials indicated that, pending dispatch to the laboratory, the samples could be stored in refrigerators, freezers or at ambient temperature (e.g. honey), depending on the matrix and the analyte concerned. The audit team noted that, in the slaughterhouses, the samples were normally stored unsealed in the operator's equipment (refrigerator or freezer) during up to one week with unrestricted access to the equipment by the operator's staff. Such a practice does not ensure that the chain of custody is sufficiently maintained, and is not fully in line with pertinent legal requirements (15).

Whilst the residue monitoring plan is generally implemented promptly and in full in accordance with planned arrangements and in line with EU rules, some shortcomings in sample targeting in slaughterhouses allied with a failure to ensure the integrity of the chain of custody of the samples taken in slaughterhouses (pending their dispatch to the laboratory), have the potential to compromise the effectiveness of the plan.

Member state response

Teurastamoiden virkaeläinlääkäreille toimitettavat teurastamonäytteiden ottamista varten tarkoitetut näytteenotto-ohjeet on päivitetty vuoden 2023 al valvontaohjelmaa varten. Ohjeissa on tarkennettu näytteiden käsittelyyn, säilyttämiseen ja lähettämiseen liittyviä kohtia. Näytteet on säilytettävä sinetöityinä tai lukitussa tilassa, jonne vain virkaeläinlääkärillä on pääsy. Ruokavirasto tulee antamaan teurastamoiden virkaeläinlääkäreille ja virallisille avustajille aiheeseen liittyvää koulutusta. Ruokaviraston lihatarkastusyksikön tekemiä viralliseen teurastamovalvontaan kohdistuvien sisäisten arviointi- ja ohjauskäyntien yhteydessä tarkastellaan näytteenotto-ohjeiden noudattamista. Käyntejä on suunniteltu tehtäväksi noin kuuteen teurastamoon vuosittain. Liite 1. Näytteenotto-ohje / liha 2023 (erityisesti keltaisella merkityt kohdat) Page: 1 mendations of draft report of the audit in Finland DG(SANTE) 2022-7492 Action Proposed by the competent authority

CA response received on 12 January 2023 The guidelines for official veterinarians of slaughterhouses, instructing them on how . to take slaughterhouse samples, have been updated for the 2023 control programme. The guidelines clarify points relating to the handling, storage and dispatch of samples. The samples must remain sealed or be kept in a locked place accessible only to official veterinarians. The FFA will provide training on this topic for official veterinarians and official auxiliaries working at slaughterhouses. During internal assessment and control visits by the FFA's Meat Inspection Unit to assess official slaughterhouse control, compliance is checked with the sampling guidelines. Plans are to visit about six slaughterhouses every year. Page: 2 July 2023 e competent authorities of Finland in response to Report ref. DG(SANTE) 2022-7492 of the audit carried out from 06 in order to evaluate the control of residues and contaminants in live animals and animal products Action Proposed by the competent CA response July 2023 authority Annex 1. Sampling guideline / meat 2023 (in particular sections highlighted in yellow)

The recommendation states as its basis

In the regions visited, the audit team scrutinised 11 non-compliant results, including the follow-up actions, identified in 2019-2021 and observed the following: a. sample submission to the laboratory, completion of analyses and reporting of test results were generally timely; b. follow-up investigations were carried out in all but one case (due to resource constraints by the municipal authority concerned) within two weeks; c. contrary to EU requirements (22), in six cases where MRL violations had been identified, only a description of the events had been presented in the follow-up file but there was no record of the origin of the non-compliance having been identified and the operator's responsibilities having been established. The audit team did acknowledge that the determination of the origin of the non- compliances had not always been possible ­ but this should nevertheless have resulted in an appropriate conclusion being documented. Furthermore, the municipal authorities did not ensure that the farms visited took adequate measures to prevent further occurrences of such non-compliances (although in a number of cases general advice was given to the pertinent sector). Conclusions on follow-up of non-compliant results

Prompt investigations of non-compliant residue results contribute to identifying and reducing the causes of residues in food of animal origin. Nevertheless, the effectiveness of the system is weakened by incomplete investigations of the origin of non-compliances and an absence of verification that adequate actions had been taken by the operators to prevent further occurrences of such non-compliances.

Member state response

t Aluehallintoviranomaiset vastaavat eläinlääkejäämien tai kiellettyjen aineiden osalta määräystenvastaisiin näytteisiin liittyvien tapausten selvityksistä. Ruokavirasto laatii näiden jäämälöytöjen selvitysten yhdenmukaista tekemistä varten ohjeistuksen, jolla täydennetään kansallista lainsäädäntöä (Vierasaineasetus 1/EEO/2007). Ohjeessa huomioidaan mm. kirjallisesti laadittavia tarkastuskertomuksia koskevat vaatimukset erityisesti tapausta koskevien johtopäätösten ja toimijan vastuun osalta (mm. EU 625/2007 artikla 138). Ohjeessa painotetaan lisäksi alueellisen tiedonkulun lisäämisen merkitystä ja siihen liittyen mm. jatkoseurannan tarpeellisuutta toistuvien tapausten estämiseksi. Ruokavirasto tekee AVIen toimintaan kohdistuvia arviointi- ja ohjauskäyntejä ja niiden yhteydessä tullaan tarkastelemaan myös määräystenvastaisuuksiin liittyvien selvitysten tekoa. Ruokavirasto kouluttaa sekä Aluehallintoviranomaisia että muita selvityksiin osallistuvia viranomaisia aiheesta. Ohjeistus tulee myös kaikkien viranomaisten saataville Ruokaviraston ylläpitämässä viranomaisille tarkoitetussa intranetissä.

CA response received on 13 April 2023 The Finnish Food Authority has prepared a guideline on the measures to be taken by the Regional State Administrative Agency in response to non-compliant research findings (a draft guideline is attached). The guidance will be finalised and operational o in May 2023. Annex 3.1. Draft guidance on the measures to be taken by the Regional State Administrative Agency in response to non- compliant research findings. CA response received on 12 January 2023 Regional administrative authorities are responsible for investigating cases of non- compliant samples as regards residues of veterinary medicinal products or prohibited substances. The FFA will Page: 3 July 2023 e competent authorities of Finland in response to Report ref. DG(SANTE) 2022-7492 of the audit carried out from 06 in order to evaluate the control of residues and contaminants in live animals and animal products the competent CA response July 2023 for the harmonised ch residue discoveries, nt national legislation in Foodstuffs of /2007). The o account, among other ments for written audit lar as regards the operator's e.g. Article 138 of EU elines also underline ncreasing the regional tion, i

The recommendation states as its basis

The audit team noted that, at the time of the audit, the designation of the FFA laboratory as an official control laboratory was ongoing and not yet finalised. Absence of such formal designation is not in line with the requirements of EU legislation (23). The FFA advised that the designation of the laboratory would be finalised by end of September 2022.

Notwithstanding the fact that the FFA laboratory is accredited, operates methods included in its scope of accreditation and performs well in proficiency tests, the absence of official designation of the laboratory, deficiencies in the validation of analytical methods and in the operation of internal quality controls undermine the reliability of analytical results and the subsequent enforcement decisions taken.

Member state response

Ruokaviraston laboratorio- ja tutkimuslinja on nimetty asetuksen 2017/625 37 artiklan mukaiseksi viralliseksi laboratorioksi 12.9.2022. Tutkimukset, joita laboratorio voi suorittaa virallisena laboratoriona, on lueteltu päätöksen liitteenä olevassa rekisteriotteessa ja niihin kuuluvat delegoidun asetuksen 1022/1644 liitteen I mukaisten aineryhmien tutkimukset (aiemmin direktiivin 96/23 mukaiset ryhmät). Liite 2: Hyväksymispäätös (Dnro 4210/04.02.02.00/2022). Liite 3: Viimeisin päivitys rekisteriotteeseen hyväksytyistä menetelmistä on tehty 23.12.2022 lainsäädäntömuutosten vuoksi. Page: 2 mendations of draft report of the audit in Finland DG(SANTE) 2022-7492 Action Proposed by the competent authority

response received on 12 January 2023 FFA's Laboratory and Research ision was designated as an official oratory on 12 September 2022 in ordance with Article 37 of Regulation 7/625. The analyses that the laboratory carry out as an official laboratory are ted in the extract from the register ached to the decision and they include lyses of the substance groups listed in ex I to Delegated Regulation 2/1644 (previously groups listed in ective 96/23/EC). ex 2: Approval decision (No 0/04.02.02.00/2022). ex 3: The latest update to the register ract listing the approved methods was e on 23 December 2022 following islative amendments. Page: 5 July 2023 e competent authorities of Finland in response to Report ref. DG(SANTE) 2022-7492 of the audit carried out from 06 in order to evaluate the control of residues and contaminants in live animals and animal products Action Proposed by the competent CA response July 2023 authority

The recommendation states as its basis

In the validation files for thyrostats, nitrofurans and non-steroidal anti-inflammatory drugs, where testing of urine and muscle was involved, no information was available on the species from which urine and muscle included in the validations had originated. The absence of this basic data undermines claims that the methods in question were appropriately validated for certain species/matrix combinations.

In all but one (beta-lactams) of the validation files scrutinised, stability was not addressed either in solution or in matrix. This is not in line with the EU legislation (28). The audit team pointed out that, if stability data are available from scientific literature or from another laboratory, these data do not need to be determined again by the concerned laboratory, provided that identical conditions apply (28).

In all, but one, of the validation files scrutinised, ruggedness was not formally addressed/assessed while the data collected allowed this to be done. This is not in line with pertinent EU requirements (28). (25) Article 39 of Regulation (EU) 2017/625. (26) Article 6 and Point 7 of Annex II to Regulation (EU) 2021/808 and Article 34(5) of Regulation (EU) 2017/625. (27) Part 2 of Annex II to Regulation (EU) 2021/808. (28) Part 2.1. of Chapter 2 of Annex I to Regulation (EU) 2021/808. 7

In all of the validation files scrutinised, the audit team noted that the acceptability ranges for the parameters of the calibration curves had not been described, which contradicts EU requirements (29) (see also finding 47(c)).

The audit team observed a number of cases where (within day) repeatability and (between day) reproducibility values were similar. While single values can indeed be comparable, it cannot be a systemic phenomenon due to the very nature of the repeatability and reproducibility conditions, which is reflected in EU requirements (30). The possible impact of these observations on the conclusion, that the said methods were fit for their intended use, was not commented on, or discussed in any of the validation reports seen by the audit team.

In four of the validation reports for confirmatory methods scrutinised, a number of the trueness and precision (repeatability and reproducibility) values were outside the performance criteria set by EU legislation (34). The impact of such a deviation on the intended use of the methods was neither discussed nor evaluated in the validation reports.

The audit team noted that during routine use of the method for thyrostats, there was no consideration of the instability of the analytes during freezing/thawing cycles and during storage in a freezer (35) which may undermine the validity of the results (i.e. truly non-compliant samples may not be detected).

During the validation of the steroids' method, two fortification levels were used; pertinent EU legislation requires three fortification levels (36). This omission weakens the laboratory's conclusion that the method was fit for its intended use.

Notwithstanding the fact that the FFA laboratory is accredited, operates methods included in its scope of accreditation and performs well in proficiency tests, the absence of official designation of the laboratory, deficiencies in the validation of analytical methods and in the operation of internal quality controls undermine the reliability of analytical results and the subsequent enforcement decisions taken.

Member state response

Suurin osa laboratoriossa käytössä olevista analyysimenetelmistä on validoitu päätöksen (EU) 2002/657 mukaisesti. Kaikki tällaiset analyysimenetelmät l tullaan validoimaan uudelleen siten, että ne vastaavat täytäntöönpanoasetusta (EU) 2021/808 asetuksen artiklassa 7 asetettuun määräaikaan mennessä. Validoinnit toteutetaan laskemalla ja arvioimalla suorituskykyarvoja I uudelleen ja tarvittaessa täydentämällä validointia lisänäytteillä. Täysin uudet idoinnit toteutetaan täytäntöönpanoasetuksen (EU) 2021/808 mukaisesti ja hyödyntäen EURL:ien ohjeistuksia. Validointien yhdenmukaistamiseksi laboratoriossa on sisäistä ohjeistusta ja koulutusta validointien toteuttamiseen täytäntöönpanoasetuksen (EU) 2021/808 ja EURL:n ohjeistusten lisäksi. Validoinneissa tullaan erityisesti kiinnittämään huomiota siihen, että muun muassa seuraavat asiat on huomioitu validointiraporteissa riittävällä tasolla; validoinnin sisältämien lajien ja matriisien kuvaaminen kattavasti, stabiilisuustietojen esittäminen (erityisesti koskien tyreostaatteja), häiriönkestävyyden arviointi, toistettavuuden, uusittavuuden ja oikeellisuuden arvojen tarkasteluun suhteessa EU:n vaatimuksiin, riittävä väkevöintitasojen umäärä

CA response received on 13 April 2023 Laboratorio on tarkastanut validointien aikataulun tyreostaattien ja nitrofuraanien menetelmien osalta. Aikataulu kyseessä olevien In addition to the measures previously menetelmien validoinnille täytäntöönpanoasetuksen (EU) 2021/808 presented, the laboratory will take the mukaisesti on seuraava: following actions on the basis of the (i) tyreostaatit 31.12.2023 mennessä findings and recommendations of the (ii) nitrofuraanit lihaksen osalta 31.12.2023 mennessä, audit: nitrofuraanit muiden matriisien, kuten hunajan ja maidon osalta 31.3.2024 mennessä 1. A plan for the implementation and timing of validations and revalidations will be sent in a separate annex (Annex 5.1) 2. The laboratory has planned to carry out the validation of the methods by the deadline set for the methods listed under Implementing Regulation (EU) 2021/808. Validation reports for these methods will be provided as soon as validation is finalised. a. tyrostats; By 31/12/2024 b. steroids; validation ongoing, by 31.12.2023 c. nitrofurans; By 31/12/2024 Page: 6 July 2023 e competent authorities of Finland in response to Report ref. DG(SANTE) 2022-7492 of the audit carried out from

The recommendation states as its basis

The audit team scrutinised the implementation of internal quality controls for analytical runs of five non-compliant results generated in 2019-2021 by the FFA laboratory and observed the following: a. In two cases, the difference between two parallel runs considerably exceeded the methods' within-laboratory reproducibility ­ no evaluation of the possible impact of that phenomenon on the analytical and legal validity of results was made. b. In two cases, the results obtained and reported were outside the calibration ranges without any evaluation of the possible impact on the analytical and legal validity of the results. Furthermore, this may raise a question of deviation from relevant requirements of the ISO/IEC 17025:2017 accreditation (39). c. In one case, the coefficient of determination R2 of the calibration curve was below 0.35 which normally indicates unacceptably low quality of the calibration curve (though the laboratory had no acceptability criteria for the parameters of the curve, see finding 39). However, the result was calculated on the basis of that calibration curve which may put in question the validity of the decision made on the basis of that result. d. For the screening method for antibacterial substances in milk, the audit team noted that once a suspect non-compliant result was identified, the same sample was screened again before a decision was made to confirm the screened positive result with a chemical confirmatory method. This practice may lead to the situation where non-compliant results would not be identified due to false- compliant outcome of screening testing (which could for example occur due to analyte instability in matrix), is not in line with legal requirements (40) and contradicts the bioassay manual. e. For majority of the analytical runs scrutinised, the audit team noted that no quality control charts were created and maintained at the time of the testing, although relevant and sufficient quality control samples were included. The laboratory representative clarified that, for the methods scrutinised, pertinent quality control charts were in operation since 2021, while for other methods quality control charts had been in use for a longer time. The audit team saw a number of current control charts and found that they were largely in line with EU requirements (41), although not all of the values outside the established acceptance criteria had been properly spotted and analysed in a documented traceable manner.

Notwithstanding the fact that the FFA laboratory is accredited, operates methods included in its scope of accreditation and performs well in proficiency tests, the absence of official designation of the laboratory, deficiencies in the validation of analytical methods and in the operation of internal quality controls undermine the reliability of analytical results and the subsequent enforcement decisions taken.

Member state response

Kaikkien käytössä olevien menetelmien sisäisen laadunvarmistuksen ohjeistusta niin laadunvalvontanäytteiden kuin hyväksymisperusteiden osalta tullaan täsmentämään siten, että laadunvalvontamenettelyt vastaavat täytäntöönpanoasetusta (EU) 2021/808 kaikkien menetelmien osalta. Sisäisestä laadunvalvonnasta ohjeistetaan laboratorion omissa menetelmäohjeissa. Laboratorion analyysimenetelmissä sisäisenä laadunvarmistuksena analyysisarjoihin sisältyy nykyisellään lähes kaikissa tapauksissa liuotinstandardi laitteen toiminnan varmistamiseksi (instrument control sample), nollanäyte (compliant control sample) joko sisäisellä Page: 3 mendations of draft report of the audit in Finland DG(SANTE) 2022-7492 competent authority ä standardilla vahvennettuna ja/tai ilman, sekä lisäysnäyte soveltuvalla siitä, onko kyseessä seulonta- vai varmistusanalyysi. n Lisäksi sarjassa voi olla mukana reagenssinollanäyte (reagent blank). n lisäksi kalibrointinäytteitä. Niiden menetelmien lta, joissa on mahdollisesti puutteita laadunvarmistusnäytteissä, ohjeistusta aan myös laadunvalvontanäytteiden eltuvien suorituskykyarvojen osalta, tujien hyväksymisperusteet, kalibrointialue, sekä muut elliset hyväksymisperust

CA response received on 13 April 2023 e In addition to the measures previously presented, the laboratory will take the following actions on the basis of the findings and recommendations of the audit: 1. The updated internal quality control instructions of the laboratory are to be provided as separate annexes (Annexes 6.1 and 6.2) 2. Quality control cards for the methods listed below will be provided as separate annexes as of October 2022 a. tyrostats (Annex 6.3) b. steroids (Annex 6.4) C. nitrofurans (Annex 6.5) D. non-sterodial anti-inflammatory drugs (Annex 6.6) Annex 6.1: Internal quality control guidance, Laboratory guideline Page: 9 July 2023 e competent authorities of Finland in response to Report ref. DG(SANTE) 2022-7492 of the audit carried out from 06 in order to evaluate the control of residues and contaminants in live animals and animal products the competent CA response July 2023 quality control y residue analytics card, thyrostats card, steroids card for nitrofurans card for non-sterile edicines d on 12 January 2023 y assurance guidelines d, both for quality acceptability criteria, urther so that the quality are in line with tion (EU) 2021/808 ernal quality control are

The recommendation states as its basis

The Finnish constitution enables the local CAs, which are the main implementing authorities with regard to food safety, to operate with very substantial autonomy. According to Article 32 of the Food Act they must carry out food controls within their territory as provided for in the Act and submit notifications and reports to the regional CAs and CCA in accordance with the food regulations. Furthermore, they are to advise FBOs and consumers and provide information on matters covered by the Food Act.

Although evidence of flows of information from top-down and vice versa between the central, regional and local CAs was provided to the audit team, the change of IT tools has resulted in gaps of information flows (see paragraph 32). At the time of the audit the FA had crude data available on the official controls carried out at national level and the percentage of performance (Oivahymy) scores given during dairy inspections. However, they had no real-time information readily available on the planned official controls and sampling of the local CAs that could be used for national planning of the official controls.

The CAs involved in food safety and veterinary controls use several IT tools for data input and to support planning and analysis of different activities and new information systems have been developed in recent years. At the time of the audit the new IT system VATI (keskitetty valvontatietojärjestelmä) had been introduced. The central, regional and local CAs have, dependent on the IT tool, different access rights: KUTI (kunnallinen tietojärjestelmä) was used in 2013-2018 to enable the regional and central CAs to collect and browse information on controls of establishments and holdings (on holdings only since 2016) from three different IT tools used by different municipalities. The CAs do still have viewing access to it. The audit team could verify that the local CAs interviewed had used their own IT tools. VATI replaced KUTI in January 2019. The local CAs feed data of their planned and implemented annual controls on FBOs into VATI. VATI contains basic information on types of controls carried out (documentary check or inspection), types of inspections carried out (e.g. pre-approval, planned, or follow-up inspections), their duration and costs (chargeable or free of charge), action(s) in case of non- compliance(s) (guidance, request for action or administrative/coercive measures, reason for non-compliance). The audit team noted the following: i. The CCA stated that all local CAs have started to use VATI and that the system will be developed further. ii. The local CAs are supposed to upload the planned official controls, sampling and analyses, diagnostic tests on dairy holding and establishments and the results thereof into VATI. This information should be accessible to all levels of CAs. However, this was not yet the case at the time of the audit as the CCA and regional CAs have no access to the planned controls and official sampling of the local CAs in VATI and if they want to check this, they need to consult the local CAs. The CCA stated that was because all reporting bases were not yet available during the audit. 9 iii. Upcoming inspections of FBOs, based on the inspection frequency that VATI calculates automatically depending on risk criteria, are flagged in VATI. However, if the CA wants to know if it is time to check certain topics (for example, HACCP-based procedures, that need to be checked once in a three year period) this has to be checked case by case going through the previous reports. iv. The local CA can change the inspection frequency given by VATI, but has to put in a justification into the IT tool. v. The central and regional CAs were not able to filter data according to certain parameters, unlike what they could do in KUTI (for example. holdings with direct sale of raw milk could be filtered)2. vi. The CAs met from one region stated that they would not be able to extract individual reports from VATI3. vii. The national guidance for officials on notification of incidences where residues of antibiotics are detected and reported by the FBO lacks details about how these incidents should be recorded in VATI. Some of the OVs met stated they would do this and some said they would not. In one region, the regional CA stated this information is available only in local CAs. viii. Some of the local CAs interviewed stated that they had not received sufficient training on the use of VATI. ix. During the migration of dairy holding data from KUTI to VATI, some data was duplicated and not all data have been checked for correctness4. VYHA (ympäristöterveydenhuollon valvontayksikkötietojen hallintajärjestelmä) is an IT tool used for registering data on resources and controls (which are part of the multiannual national control plan, VASU,) of the regional and local CAs. VYHA is run under the MHSA. The CAs have to input results of the previous year's control activities, including controls of tobacco, food safety, veterinary activities, consumer protections and health protection. The results have to be in by 31 March. The FA extract

The constitutional structure of Finland allows the local CAs to operate with very substantial autonomy. The central and regional CAs have no enforcement powers over the local CAs in relation to controls on dairy hygiene and the CCA have very limited oversight to verify the effectiveness, consistency and uniformity of the official controls.

At the time of the audit, the central and regional CAs had restricted access to the main control database VATI intended to support the controls system. Limited training has been organised for the local CAs on its use. The official controls are further hampered by the complexity, and difficulties in use, of IT applications and databases and problems related to transfer of dairy holding control data from old databases, which impairs the reliability of the data5.

The recommendation states as its basis

Although FA and its predecessor have organised some general training on HACCP- based programmes, the last training events on dairy-specific HACCP and its assessment and dairy-specific technical requirements were organised over 10 year ago. The training organised by the central and regional CAs and veterinary and dairy umbrella organisations in recent years has been mostly focussing on controls of milk production holdings and raw milk, and its possible microbiological contamination in relation to Shigatoxin producing Escherichia coli (STEC) and Campylobacter and antibiotic residues in raw milk. The CCA organised a training day on official sampling in 2015 and another training event in 2019 on management of Listeria in the food industry. The two events were targeted at the CAs and FBOs.

Three of the six OVs interviewed, working in municipal food control units and responsible for controls of dairy establishments stated that they had not had any specific training on milk. They did not have, for example, a thorough knowledge on how to check the heat-treatment efficacy of different types of heat treatment equipment.

At the time of the audit, the central and regional CAs had restricted access to the main control database VATI intended to support the controls system. Limited training has been organised for the local CAs on its use. The official controls are further hampered by the complexity, and difficulties in use, of IT applications and databases and problems related to transfer of dairy holding control data from old databases, which impairs the reliability of the data5.

No training on dairy-specific HACCP and technical requirements have been organised for the local CAs in the last 10 years. There were clear instances of limited knowledge on the part of control staff, and indications for inadequate resources for controls of dairy holdings.

The recommendation states as its basis

Three of the six OVs interviewed, working in municipal food control units and responsible for controls of dairy establishments stated that they had not had any specific training on milk. They did not have, for example, a thorough knowledge on how to check the heat-treatment efficacy of different types of heat treatment equipment.

The CAs involved in food safety and veterinary controls use several IT tools for data input and to support planning and analysis of different activities and new information systems have been developed in recent years. At the time of the audit the new IT system VATI (keskitetty valvontatietojärjestelmä) had been introduced. The central, regional and local CAs have, dependent on the IT tool, different access rights: KUTI (kunnallinen tietojärjestelmä) was used in 2013-2018 to enable the regional and central CAs to collect and browse information on controls of establishments and holdings (on holdings only since 2016) from three different IT tools used by different municipalities. The CAs do still have viewing access to it. The audit team could verify that the local CAs interviewed had used their own IT tools. VATI replaced KUTI in January 2019. The local CAs feed data of their planned and implemented annual controls on FBOs into VATI. VATI contains basic information on types of controls carried out (documentary check or inspection), types of inspections carried out (e.g. pre-approval, planned, or follow-up inspections), their duration and costs (chargeable or free of charge), action(s) in case of non- compliance(s) (guidance, request for action or administrative/coercive measures, reason for non-compliance). The audit team noted the following: i. The CCA stated that all local CAs have started to use VATI and that the system will be developed further. ii. The local CAs are supposed to upload the planned official controls, sampling and analyses, diagnostic tests on dairy holding and establishments and the results thereof into VATI. This information should be accessible to all levels of CAs. However, this was not yet the case at the time of the audit as the CCA and regional CAs have no access to the planned controls and official sampling of the local CAs in VATI and if they want to check this, they need to consult the local CAs. The CCA stated that was because all reporting bases were not yet available during the audit. 9 iii. Upcoming inspections of FBOs, based on the inspection frequency that VATI calculates automatically depending on risk criteria, are flagged in VATI. However, if the CA wants to know if it is time to check certain topics (for example, HACCP-based procedures, that need to be checked once in a three year period) this has to be checked case by case going through the previous reports. iv. The local CA can change the inspection frequency given by VATI, but has to put in a justification into the IT tool. v. The central and regional CAs were not able to filter data according to certain parameters, unlike what they could do in KUTI (for example. holdings with direct sale of raw milk could be filtered)2. vi. The CAs met from one region stated that they would not be able to extract individual reports from VATI3. vii. The national guidance for officials on notification of incidences where residues of antibiotics are detected and reported by the FBO lacks details about how these incidents should be recorded in VATI. Some of the OVs met stated they would do this and some said they would not. In one region, the regional CA stated this information is available only in local CAs. viii. Some of the local CAs interviewed stated that they had not received sufficient training on the use of VATI. ix. During the migration of dairy holding data from KUTI to VATI, some data was duplicated and not all data have been checked for correctness4. VYHA (ympäristöterveydenhuollon valvontayksikkötietojen hallintajärjestelmä) is an IT tool used for registering data on resources and controls (which are part of the multiannual national control plan, VASU,) of the regional and local CAs. VYHA is run under the MHSA. The CAs have to input results of the previous year's control activities, including controls of tobacco, food safety, veterinary activities, consumer protections and health protection. The results have to be in by 31 March. The FA extract

At the time of the audit, the central and regional CAs had restricted access to the main control database VATI intended to support the controls system. Limited training has been organised for the local CAs on its use. The official controls are further hampered by the complexity, and difficulties in use, of IT applications and databases and problems related to transfer of dairy holding control data from old databases, which impairs the reliability of the data5.

The recommendation states as its basis

The FA was not able to provide an overview of the situation regarding the controls planned on dairy holdings in 2018-2020, even if the local CAs had entered the information into VATI. They could only provide the total number of inspections carried out: 2018 2019 2020 No of dairy Inspections No of dairy Inspections No of dairy Inspections holdings carried out holdings carried out holdings carried out 6,532 Cattle 5,975 5,566 holdings 143 140 133 Sheep/ 2 goat 6,677 658 6,115 716 5,699 716 holdings Other In total

At national level, the annual target of inspecting 20 % of dairy holdings was not reached in 2018-2020. For example, one of the regional CAs interviewed reported that 10% of the dairy holdings were inspected in 2019.

In the regions examined by the audit team, some local CAs had not reached their annual inspection targets for dairy holdings and some local CAs had not carried out any inspections within a year. For example, one local CA that had 67 dairy holdings in the control area had set the annual target to 13 inspections annually. The authorities had carried out 13 inspections in 2019, none in 2020 and so far 6 in 2021. Another local CA that had 61 dairy holdings in their control plan had checked 2 holdings in 2018, 4 14 holdings in 2019, 7 in 2020 and so far 3 in 2021 (9 more holdings planned for 2021 which were last inspected in 2013).

The official controls on dairy hygiene cover the topics listed in the CCA's guidelines. Based on the reports seen and discussions with the inspectors the grading of shortcomings and the use of emoticons is not strictly in line with the guidelines - a more lenient approach is followed. The system is further weakened by not reaching the annual inspection targets and by the fact that the results in VATI are not necessarily reliable.

The number of inspections planned and carried out in dairy establishments 2018-2020 is given below. Based on this data, not all dairy establishments were inspected annually although the targeted annual frequency varies from at least two inspections to 10 inspections/year. However, the six establishments chosen as examples for more detailed scrutiny by the audit team were inspected with their planned inspection frequency except for 2020 when some inspections were replaced by documentary checks due to COVID restrictions. 2018 Number of Number of dairy Number of Number of Number of inspections planned inspections/ leading to request for dairy establishments inspections re-inspections corrective action or carried out coercive measures establishments inspected 121 95(79%) 221 233/6 22 requests 2019 Number of Number of dairy Number of Number of Number of inspections planned inspections/ leading to request for dairy establishments inspections re-inspections corrective actions or carried out coercive measures establishments inspected 14 requests and 1 126 90 (71%) 215 238/1 coercive measure 2020 Number of Number of dairy Number of Number of Number of inspections leading to request for dairy establishments planned inspections corrective actions or coercive measures establishments inspected inspections carried out Data not yet available Data not yet Data not available 101 yet 220 available 22

Another local CA interviewed had not checked the HACCP-based programme of one dairy establishment within the 3-year period (it was last checked in 2016).

Based on the interviews of the CAs and documentary review, evidence was available that the dairy inspectors do not apply the scoring system as rigorously and in line with the guidance document and are hesitating to use enforcement measures. The operation in practice of the emoticon and scoring system intended to provide public information about the level of compliance of establishments resulted, at least in a number of the files reviewed, in an inaccurate reflection of that level of compliance. Furthermore, the annual inspection targets are not reached for all dairy establishments.

The recommendation states as its basis

Besides the official controls, milk co-operatives belonging to the dairy plants provide guidance and services to dairy holdings. This includes holding visits to check the hygiene conditions of the holdings, to check and service milking equipment and milk cooling tanks. The milk co-operative's inspectors write reports of their visits. The audit team was provided with a copy of one such report. The report was very detailed and included recommendations and actions to take, including deadlines. However, no follow- up inspection took place although there were serious shortcomings (including animal welfare ones to be corrected immediately) and the FBO had not informed the local CA of the situation (see paragraph 79) although Article 14 of the Animal Welfare Law 4.4.1996/247 requires to either help an animal that is injured, sick or helpless or to notify the CAs.

The CCA responsible for the official controls over the dairy sector stated that the co- operation between the milk co-operatives and CAs varies, depending on the individuals and stated that these entities should be included in the official controls (these entities are also responsible for the collection and transport of raw milk, see paragraph 79). 5.4.1 Health requirements for raw milk and colostrum

The dairy co-operatives responsible for the collection and transport of raw milk are not included in official controls and their co-operation with the CAs is not always adequate.

The collection and transport of raw milk from the dairy holdings to the dairy establishments is organised by milk co-operatives belonging to the dairy plants. The FBOs buy the milk from the farmers, organise the milk collections (usually every second day) and provide them with milk collection tanks. These organisations are not covered by the official controls (see paragraphs 58 and 59). The audit team examined one dairy holding report of a consultant a milk collection co-operative. The report contained several shortcomings related to milking hygiene. The audit team requested to see the raw 19 milk data for this holding. This data was not provided to the audit team despite having been requested several times.

The recommendation states as its basis

The audit team followed up two cases related to dairy holdings were enforcement measures had been taken. These were linked to two cases of long-standing animal welfare issues. The reports seen had significant shortcomings that had a negative impact on milk hygiene. In both cases the cows were extremely dirty as well as their stables, the feed was contaminated with dung. In one case the animal welfare inspector (municipal OV) had informed the local CA responsible for the dairy hygiene controls about the shortcomings. However, in spite of this notification, no dairy hygiene inspection was carried out. In addition to the animal welfare report, the report of the dairy co-operation on milking hygiene had identified several serious shortcomings related to animal welfare. The consultant had not passed this information to the local CAs. In the second case there had been long-standing problems with dairy hygiene, but no points had been judged as D.

The audit team checked a follow-up inspection carried out by a local CA to verify the actions taken on previous shortcomings regarding maintenance. Coincidentally, on this holding antibiotic residues in raw milk had been detected in the dairy at milk reception. The reason for this was a human error that had allowed the automatic milking robot to milk a cow that had been treated. The smiley follow-up report of the local CA had the points in relation to medication and treatment records of animals, identification of treated animals and adherence to withdrawal periods judged as excellent. The local CAs and CCA considered this as a correct judgement as the incident was because of human error and not because of negligence, although this is not a criterion mentioned in the inspection guideline.

The official controls on dairy hygiene cover the topics listed in the CCA's guidelines. Based on the reports seen and discussions with the inspectors the grading of shortcomings and the use of emoticons is not strictly in line with the guidelines - a more lenient approach is followed. The system is further weakened by not reaching the annual inspection targets and by the fact that the results in VATI are not necessarily reliable.

The control system has, since some years, a strategic goal that on average 85% of FBOs should be in category A (excellent) and B (good) and this target has been reached the last three years. The number the number of dairy inspections in 2018 and 2019 that resulted in requests for corrective actions or coercive administrative measures was 14 and 1, respectively, and one re-inspection was carried out in 2019.

The audit team noted that some reports had these points scored as B, although the local CA had asked for an action plan with deadlines. This is not in line with the guidance on the scoring scheme, which provides for a C score in these cases. 5.6.2.2 Hazard Analysis and Critical Control Points based systems Legal requirements Article 5 of Regulation (EC) No 852/2004. Findings

Based on the interviews of the CAs and documentary review, evidence was available that the dairy inspectors do not apply the scoring system as rigorously and in line with the guidance document and are hesitating to use enforcement measures. The operation in practice of the emoticon and scoring system intended to provide public information about the level of compliance of establishments resulted, at least in a number of the files reviewed, in an inaccurate reflection of that level of compliance. Furthermore, the annual inspection targets are not reached for all dairy establishments.

The recommendation states as its basis

The FA and MAF establish annual contracts for the FAs planned work, including parameters to evaluate the outcome. The control system has, since some years, a strategic goal that on average 85% of CA's inspections of the FBOs should have an excellent or good outcome. This target has been reached in the last three years (see paragraphs 93 and 94.

The audit team followed up two cases related to dairy holdings were enforcement measures had been taken. These were linked to two cases of long-standing animal welfare issues. The reports seen had significant shortcomings that had a negative impact on milk hygiene. In both cases the cows were extremely dirty as well as their stables, the feed was contaminated with dung. In one case the animal welfare inspector (municipal OV) had informed the local CA responsible for the dairy hygiene controls about the shortcomings. However, in spite of this notification, no dairy hygiene inspection was carried out. In addition to the animal welfare report, the report of the dairy co-operation on milking hygiene had identified several serious shortcomings related to animal welfare. The consultant had not passed this information to the local CAs. In the second case there had been long-standing problems with dairy hygiene, but no points had been judged as D.

The audit team checked a follow-up inspection carried out by a local CA to verify the actions taken on previous shortcomings regarding maintenance. Coincidentally, on this holding antibiotic residues in raw milk had been detected in the dairy at milk reception. The reason for this was a human error that had allowed the automatic milking robot to milk a cow that had been treated. The smiley follow-up report of the local CA had the points in relation to medication and treatment records of animals, identification of treated animals and adherence to withdrawal periods judged as excellent. The local CAs and CCA considered this as a correct judgement as the incident was because of human error and not because of negligence, although this is not a criterion mentioned in the inspection guideline.

The official controls on dairy hygiene cover the topics listed in the CCA's guidelines. Based on the reports seen and discussions with the inspectors the grading of shortcomings and the use of emoticons is not strictly in line with the guidelines - a more lenient approach is followed. The system is further weakened by not reaching the annual inspection targets and by the fact that the results in VATI are not necessarily reliable.

The review carried out by the audit team of several inspection reports suggests that the scores given for dairy establishments are often too lenient. The regional CAs had also noted this in some of their supervisory reports on the local CAs. The CAs cited staff shortage (avoidance of re-inspections obligatory for C and D scores), prioritisation of other tasks, lack of experience in the control sector and lack of training as main reasons for this. The audit team noted the following: many reports with A and B scores included shortcomings with deadlines for corrective actions (which should have resulted in a C grade and a re-inspection), shortcomings were described in additional notes (and thus did not lead to a poorer score), some shortcomings were repeated in consecutive inspection reports without leading to a poorer score, and some reports had inspection points that had been evaluated superficially, resulting in a good score, not all relevant points were inspected in the required 3-year period, the local CA use the OIVA guidelines as checklists. However, the guidelines are not detailed enough to support in-depth checking of, for example, the HACCP and effectiveness of heat treatment, although VATI informs the inspector when the next inspection is due, it does not flag up what control topics need to be checked to ensure full coverage in 3 years. 5.6.2 Official controls at establishment level

The audit team noted that some reports had these points scored as B, although the local CA had asked for an action plan with deadlines. This is not in line with the guidance on the scoring scheme, which provides for a C score in these cases. 5.6.2.2 Hazard Analysis and Critical Control Points based systems Legal requirements Article 5 of Regulation (EC) No 852/2004. Findings

According to the OIVA inspection reports, the FBOs had taken samples of final products and equipment in order to check compliance with the microbiological criteria in Regulation (EC) No 2073/2005. The results were generally in line with the limits set in the EU legislation. The audit team noted the following shortcomings: One FBO had taken pooled product samples as part of the own control programme to be tested for L. monocytogenes instead of five separate samples. This is not in line with Annex I to Regulation (EC) No 2073/2005. The local CA had not identified this shortcoming. Two FBOs were taking environmental samples to be tested for L. monocytogenes after, but not during, processing. This is not in line with the EURL Guidelines on sampling the food processing area and equipment for the detection of L. monocytogenes. The local CA had not identified the shortcoming. Another FBO had detected L. monocytogenes twice in drain samples, including a drain in a production area during a visit in October 2020. The FBO had not taken a sample of the dairy product produced after the last positive test. Despite this shortcoming, and asking the FBO to provide an action plan with a deadline of 2 weeks, the Listeria own controls were judged as A (excellent). The next two inspection reports did not mention if the action plan had been provided. 25 5.6.2.4 Traceability, labelling and identification marking Legal requirements Article 18 of Regulation (EC) No 178/2002. Article 5 of, and Chapter IV, Section IX, Annex III to Regulation (EC) No 853/2004. Article 5 of Regulation (EU) 2019/627. Findings

Based on the interviews of the CAs and documentary review, evidence was available that the dairy inspectors do not apply the scoring system as rigorously and in line with the guidance document and are hesitating to use enforcement measures. The operation in practice of the emoticon and scoring system intended to provide public information about the level of compliance of establishments resulted, at least in a number of the files reviewed, in an inaccurate reflection of that level of compliance. Furthermore, the annual inspection targets are not reached for all dairy establishments.

The recommendation states as its basis

Domestic legislation defines the areas that have been categorised as `remote' under Article 19(1)(b) of Regulation (EC) No 1069/2009. For ABP derived from some species, the entire territory of Finland is considered a remote area. In particular, ABP from slaughtering of horses and from aquatic animals can be disposed of by burial or landfilling throughout Finland, when authorised under environmental rules. However, according to the FFA, operators do not routinely avail of these possibilities.

This was confirmed during interviews held in a region where fish processing is an important economic activity. The audit team noted that, while this area was categorised as `remote' for ABP from aquatic animals, there were arrangements in place for collection and use of such ABP, in particular for feeding to fur animals or for other purposes outside the feed chain. Some of the inspection reports of food operators processing fish in other parts of Finland indicated similar collection arrangements for ABP.

The audit team noted that slaughtering of horses usually takes place in multi-species slaughterhouses, the majority of which are located in areas where ABP of the other species slaughtered are collected. ABP from horses can therefore be collected from such slaughterhouses. This was confirmed during the interview of an official veterinarian, who was substituting for other official veterinarians in several slaughterhouses, some of which were slaughtering horses.

Based on the above-mentioned, the audit team noted that there are viable collection and transport arrangements in areas that have been categorised as `remote' and consequently such areas do not meet the definition of a `remote area', as laid down in Article 3(23) of Regulation (EC) No 1069/2009.

FFA representatives stated that for those species for which the entire territory of Finland is categorised as a `remote area', the risk assessments referred to in point (d) of Section 2 of Chapter III of Annex VI to Regulation (EU) No 142/2011 were not carried out. 5 Conclusion on the system in place for collection, use and disposal on ABP and DP

The system in place for collection, use and disposal of ABP and DP is largely adequate. For ABP derived from some species (fish, horses), the entire territory of Finland has been defined as a `remote area'. However, such designation is not justified since operational means of collection, disposal and use of ABP are available throughout the entire country. In practice, despite the absence of a risk assessment carried out by the competent authority, the impact of this shortcoming is probably limited and the quantities of ABP that might be disposed of by burial or landfilling are likely to be small, as most operators seem to make use of the existing collection arrangements.

Member state response

lfil Maa- ja metsätalousministeriö on laatimassa hallituksen esitystä, essment. jolla on tarkoitus muuttaa eläimistä saatavista sivutuotteista annettua lakia 2015/517 poistamalla artiklan 19.1(b) mukainen syrjäinen alue hevosten teurastuksesta saatavien sivutuotteiden osalta. Kalasta saatavien sivutuotteiden osalta tarkoitus on rajata artiklan 19.1(b) mukainen syrjäinen alue Pohjois-Suomeen, jossa etäisyydet käsittelylaitoksiin ovat pitkiä. Tarkoituksena on, että esityksen eduskuntakäsittely olisi vuoden 2021 lopussa/vuoden 2022 alussa ja uusi laki tulisi voimaan ensi vuonna.

The recommendation states as its basis

The FFA has implemented a system for registration of fur animal farms where the feeding of fur animals (foxes and racoon dogs) with proteins derived from animal of the same species can take place (such feeding is hereafter referred to as `intra-species recycling'). An accurate and complete registration of farm is important for the purpose of official controls, as operators must comply with specific requirements (Chapter I of Annex II to Regulation (EU) No 142/2011). Farms where intra-species recycling take place are registered in the animal keepers' register with an indication of the concerned species (for other farms there is a statement that intra-species recycling is not carried out). 6

The FFA, despite efforts to spread the information to fur animal farmers, noted that around 50% of all fur animal farms are currently registered for intra-species recycling, which is believed to be far below the percentage of farms actually involved in intra- species recycling. This incomplete registration was confirmed during the interview of RVO of a region where most of the fur animals are located.

The audit team noted that inspections of fur animal farms must verify that these are correctly registered for intra-species recycling, if applicable. However, some MVO interviewed stated that they usually rely on the farmers statement that they are registered (or not) rather than checking the register. This led to situations where, when comparing register information and the corresponding inspection reports, the audit team noted contradictory information.

The audit team also noted that the information contained in the register was not fully reliable. The FFA explained that the migration of data between the previous and current IT system supporting the animal keepers' register resulted in inconsistencies in the information recorded. The FFA stated that the data contained in the register would be corrected.

RVO carry out checks on animal welfare, including at fur farms, during which is it required that the information contained in the animal keepers' register is checked (in general and not only for intra-species recycling). Some RVO interviewed stated that during such checks, in case of incorrect registration, the farmer is asked to update the register and that this is usually done orally. As a consequence, the FFA could not provide evidence of such checks or that follow-up had taken place in case of incorrect registration (which, in any case, would prove difficult in the absence of official records).

Based on the above-mentioned gaps, the ability of the current system to ensure that the register of fur animal farms (where intra-species recycling occurs) is updated over time is rather limited and this register is likely to remain incomplete. This does not ensure that the requirements of point 3(a)(i) of Chapter I of Annex II to Regulation (EU) No 142/2011 are fulfilled. Conclusion on registration, approval and listing

Arrangements in place for registration, approval and listing provide assurance that the vast majority of operators active along the chain of ABP and DP are known, which facilitates the implementation of official controls. However, an incomplete and, currently, not reliable registration of fur farms concerned with intra-species recycling prevents the system from being fully in line with Union rules. 5.3.2 Planning of official controls

Member state response

lace in Ruokavirasto laatii vuoden 2021 aikana erillisen lomakkeen lajinsisäisen kierrätyksen valvontaa varten. Lomake voidaan (EU) täyttää mm. hyvinvointitarkastuksen yhteydessä ja koska lomake on erillinen hyvinvointilomakkeesta, niin tiedonkeruu tarkastuksilta on helpompaa. Lajinsisäisen kierrätyksen valvonnan toteuttamisesta laaditaan oma sivu Pikanttiin. Pikantin avulla valvontoja suorittavat valvojat voivat lähettää kysymyksiä Ruokavirastolle ja Ruokavirasto voi vastata niihin kyseisellä sivulla. Kysymykset ja vastaukset ovat nähtävillä kaikille valvojille, joten tiedon levittäminen Pikantin avulla on tehokasta. Eläintenpitäjä- ja pitopaikkarekisterissä havaittua tiedon siirtämiseen liittynyttä ongelmaa ollaan korjaamassa.

The recommendation states as its basis

The audit team noted that official controls carried out by MVO cover burial of ABP in remote areas. FFA has issued guidance on burial, which encompasses all relevant requirements of Union legislation. However, such guidance does not specify how municipal veterinarians can verify that burial of ABP does not result in risks to underground water, as required by point 3(b) of Section 1 of Chapter III of Annex VI to 9 Regulation (EU) No 142/2011. In addition, MVO involved in inspections on disposal of bovine animals in a remote area, confirmed to the audit team that burial conditions were not checked during official controls, in particular whether burial locations were chosen to minimise risks to underground water. This does not fulfil the requirements of Section 3 of Chapter III of Annex XVI to Regulation (EU) No 142/2011.

Official controls are mostly implemented as planned and are largely suitable to assess the applicable Union requirements on ABP and DP. There are, however, exceptions such as verification of burial conditions in remote areas, where such controls do not cover all applicable requirements. This might result in potential risks to water from burial of ABP in these areas.

Member state response

sks to Maa- ja metsätalousministeriö, Ruokavirasto ja ympäristöministeriö ovat yhdessä selvittäneet käytäntöjä, jolla of syrjäisellä alueella toimiva kunnaneläinlääkäri saa kätevimmin tiedon tietyn hautauspaikan mahdollisesta sijainnista pohjavesialueella. Ruokavirasto ohjeistaa Pikantin kautta kyseisten alueiden AVEja ja kunnaneläinlääkäreitä tiedon hankinnasta. Lisäksi koulutuspäivillä tullaan korostamaan hautaamisen aiheuttamaa vaaraa pohjavesille ja siten valvonnan tärkeyttä. Page: 1 s of report ref. DG(SANTE) 2021-7204 of the audit carried out from 22 March 2021 ontrols on animal by-products (ABP) and derived products (DP) authority liittyvän oman a huomioidaan myös aneläinlääkäri täyttää lomakkeen ksien myös muiden sektoreiden ut MMM:lle sivutuotteiden vaatimusten lisäämistä nlääkärin valvontaoikeus myös amien riskien osalta ja ö olisi selkeää.

The recommendation states as its basis

The audit team noted that operational instruction 12729/8 requires that "inspections must be carried out unannounced unless a notification is necessary and justified shortly before the inspections to ensure the presence of the staff and documents required for the inspection". However, the FFA informed the audit team that, in case of inspections of feed manufacturers (i.e. manufacturers of feed materials, feed additives/premixtures and compound feed), 5 between two and four weeks notice is normally given to the operators. The FFA stated that such a notice period is necessary for inspectors to be adequately prepared and allows for the request and analysis of relevant documents in advance. The audit team scrutinised three cases selected at random. In all, the time between the original notification of the operator and the date when the requested documentation was supposed to be provided by the operator was substantial ­ from one and a half to five weeks. The information provided by the FFA did not demonstrate that there had been any audit-related preparatory work in this period. The audit team pointed out that while prior notice can be justified in rare cases (remote locations, irregular working hours, etc.), systematic provision of prior notice is not in line with the requirements laid down by Article 9(4) of Regulation (EU) 2017/625. The FFA further specified that the control activities carried out on the only group of FeBOs systematically announced in advance (i.e. feed manufacturers) comprised 15% of all types of the control activities.

The inspection planning system is based on appropriate risk-related factors and thus ensures that the official controls are carried out on all operators regularly, on a risk basis and with appropriate frequency. However, the effectiveness of the system is weakened by providing unjustified prior notice of inspections to feed manufacturers, shortcomings in the assessment of operators' HACCP plans, and incomplete verification of the appropriateness of operators' retained samples. (9) (1) https://www.ruokavirasto.fi/yritykset/rehu--ja-lannoiteala/rehut-ja-rehualan-toimijat/rehujen-merkinnat2/, (2) https://www.ruokavirasto.fi/globalassets/tietoa-meista/asiointi/oppaat-ja- lomakkeet/yritykset/rehuala/ohjeet/rehujen_merkintaopas.pdf, (3) https://www.ruokavirasto.fi/globalassets/tietoa- meista/asiointi/oppaat-ja-lomakkeet/yritykset/rehuala/ohjeet/lue-pakkausmerkintoja-ja-tee-oikeita-valintoja- lemmikkisi-parhaaksi.pdf 7 5.2.2 Sampling 5.2.2.1 Planning of official sampling

Member state response

Ruokavirasto tekee seuraavat muutokset rehujen alvontajärjestelmään, jotta tarkastusten ennakkoilmoitustarve saadaan minimoitua ja varmistettua, että valvonta-asetuksen (EU) 2017/625 vaatimukset täyttyvät. Rehujen valvontajärjestelmään lisätään uusia ennakolta ilmoittamattomia tarkastuksia. Tietojen saanti etukäteen parantaa valvonnan vaikuttavuutta Ruokavirasto muuttaa tarkastusten ennakkomateriaalin pyyntömenettelyä. Jatkossa Ruokavirasto lähettää rehujen valmistajille yhtenäisen etukäteiskyselyn (esim. valvontavuoden alussa). Näin tiedonsaantitarve juuri ennen tarkastusta vähenee, mikä puolestaan lyhentää yksittäisen tarkastuksen ennakkoilmoitustarvetta, koska auditointia varten tarpeellinen materiaali on jo viranomaisen saatavilla. Etukäteisinformaation avulla Ruokavirasto arvioi toimijoiden laadunvarmistusta, varmistaa riskiperusteisen valvonnan sekä suunnittelee tarkastukset räätälöidysti. Valvonta toteutetaan siten, että toimija ei voi ennakolta ilmoittamattoman tarkastuksen jälkeen päätellä, että seuraava hänen tiloissaan tehtävä tarkastus olisi ennakolta ilmoitettu auditointityyppinen tarkastus. Kahden tyyppisiä tarkastuksia Ruokavirasto tulee jatkossa tekemään kahden tyyp

The recommendation states as its basis

For the establishments listed in section 2 of this report, the audit team scrutinised the inspectors' assessments of operators' HACCP plans, analysed the most recent reports of the official controls performed and interviewed the inspectors involved. The audit team noted that the assessment of the operators' hazard identification part of the HACCP-plan was not always comprehensive and, in several cases there was an absence of hazard identification and analysis particularly with regard to minor ingredients, like feed additives/premixtures, and processing aids. The failure of the operators to identify relevant hazards, as required by Article 6(2)(a) of Regulation (EC) No 183/2005, was in general spotted by most of the inspectors during the interviews but was not however, systematically reflected in the reports seen. Consequently, the operators were not notified about those deficiencies and were thus not incentivised to rectify those.

The inspection planning system is based on appropriate risk-related factors and thus ensures that the official controls are carried out on all operators regularly, on a risk basis and with appropriate frequency. However, the effectiveness of the system is weakened by providing unjustified prior notice of inspections to feed manufacturers, shortcomings in the assessment of operators' HACCP plans, and incomplete verification of the appropriateness of operators' retained samples. (9) (1) https://www.ruokavirasto.fi/yritykset/rehu--ja-lannoiteala/rehut-ja-rehualan-toimijat/rehujen-merkinnat2/, (2) https://www.ruokavirasto.fi/globalassets/tietoa-meista/asiointi/oppaat-ja- lomakkeet/yritykset/rehuala/ohjeet/rehujen_merkintaopas.pdf, (3) https://www.ruokavirasto.fi/globalassets/tietoa- meista/asiointi/oppaat-ja-lomakkeet/yritykset/rehuala/ohjeet/lue-pakkausmerkintoja-ja-tee-oikeita-valintoja- lemmikkisi-parhaaksi.pdf 7 5.2.2 Sampling 5.2.2.1 Planning of official sampling

Member state response

Ruokavirasto laatii toimijoille tiedotteen, jossa ohjeistetaan toimijoita siitä, että kaikki raaka-aineet; lisäaineet, esiseokset, ml. apuaineet tulee arvioida erikseen ja yksityiskohtaisesti n vaarojen arvioinnissa. Samalla muistutetaan Ruokaviraston HACCP -ohjeesta, joka löytyy Ruokaviraston nettisivuilla. Ruokavirasto laatii twiitin julkaisemastaan tiedotteesta, jolla lisätään asian näkyvyyttä. HACCP -dokumentteja ja etenkin vaarojen arviointeja käydään läpi toimijoiden kanssa seuraavalla tarkastuskäynnillä ja samalla varmistetaan, että toimijat ovat Page: 3 ry 2021 eport ref. DG(SANTE) 2020-7012 of the audit carried out from 02 September controls on general feed hygiene Action Proposed by the competent authority asian huomioineet. Varmistetaan, että valvonnan raportointi toteutuu havaittujen puutteiden osalta. Suunniteltu aikataulu: Ehdotetut toimenpiteet toimeenpannaan vuoden 2021 aikana.

The recommendation states as its basis

As for the operators' obligation to take samples of ingredients and of each batch of products manufactured and placed on the market, or of each specific portion of production (in the case (8) https://www.ruokavirasto.fi/yritykset/rehu--ja-lannoiteala/rehut-ja-rehualan-toimijat/rehualan-toiminta/rehujen- jaljitettavyys/ 6 of continuous production) in sufficient quantities using a procedure pre-established by the manufacturer (hereinafter: retained samples), the audit team noted that adequate verification was carried out on the presence of the written procedure and the samples, and labelling of those. However, the sealing of said samples was not verified during the controls scrutinised by the audit team. This is not in line with the requirements laid down by part 4 of section "Quality control" of Annex II to Regulation (EC) No 183/2005.

The inspection planning system is based on appropriate risk-related factors and thus ensures that the official controls are carried out on all operators regularly, on a risk basis and with appropriate frequency. However, the effectiveness of the system is weakened by providing unjustified prior notice of inspections to feed manufacturers, shortcomings in the assessment of operators' HACCP plans, and incomplete verification of the appropriateness of operators' retained samples. (9) (1) https://www.ruokavirasto.fi/yritykset/rehu--ja-lannoiteala/rehut-ja-rehualan-toimijat/rehujen-merkinnat2/, (2) https://www.ruokavirasto.fi/globalassets/tietoa-meista/asiointi/oppaat-ja- lomakkeet/yritykset/rehuala/ohjeet/rehujen_merkintaopas.pdf, (3) https://www.ruokavirasto.fi/globalassets/tietoa- meista/asiointi/oppaat-ja-lomakkeet/yritykset/rehuala/ohjeet/lue-pakkausmerkintoja-ja-tee-oikeita-valintoja- lemmikkisi-parhaaksi.pdf 7 5.2.2 Sampling 5.2.2.1 Planning of official sampling

Member state response

Ruokavirasto laatii toimijoille tiedotteen, jossa heitä edellytetään huomioimaan, että rehuhygienia-asetuksen edellyttämät raaka-aine ja tuotannon vastanäytteet tulee sinetöidä asianmukaisesti ja ne tulee olla viranomaisen saatavilla asianmukaisen ajan. Rehun valmistajien tarkastuskäynneillä valvotaan, että viranomaista varten otetut vastanäytteet on sinetöity asianmukaisesti. Tarvittaessa asiassa ohjeistetaan toimijoita ja puututaan mahdollisiin epäkohtiin, jos niitä havaitaan. Ruokavirasto laatii twiitin julkaisemastaan tiedotteesta, jolla lisätään asian näkyvyyttä. Suunniteltu aikataulu: Ehdotetut toimenpiteet toimeenpannaan vuoden 2021 aikana. Page: 4

The recommendation states as its basis

The documentary checks of food of non-animal origin subject to special import conditions are carried out at the Customs Electronic Centre (at central level) and not in the listed DPEs. The listed DPEs are "virtual" with neither physical facilities nor personnel available on-the-spot to perform the documentary checks. This procedure is not in line with the requirements laid down in Article 8(1)(a) of Regulation (EC) No 669/2009, Article 9(1) of Regulation (EC) No 884/2014, Article 8(1) of Regulation (EU) No 2015/175 and Article 10(1) of Regulation (EU) No 2016/6.

The operators comply with the obligation to pre-notify the arrival of their consignments: those that use TRACES e-mail scanned copies of the Common Entry Documents (CEDs) to Customs, and where required, scans of the certificates, declarations, laboratory test results and other required documentation, e.g. invoices, prior to the physical arrival of the goods. Customs verify the scanned documents but never request originals of the certificates or laboratory result reports. This hinders the verification of the authenticity of the health certificates, declarations and the laboratory results due to the reliance on scanned documents, which is contrary to the requirements of Article 5 and 9(2) of Commission Implementing Regulation (EU) No 884/2014, Article 5 and 8 of Regulation (EU) 2015/175 and Article 5 and 10 of Regulation (EU) No 2016/6.

The listed DPEs have no facilities for carrying out identity and physical checks. The identity and physical checks are performed upon request of the Customs Electronic Centre at the Customs' authorised warehouses by trained Customs staff.

The way in which the system for documentary checks of the consignments of food of non-animal origin subject to special import conditions has been set up (checks are being carried out centrally instead of at the entry points at the border) is contrary to EU requirements. Furthermore, Customs do not check the originals of certificates or other relevant documents and therefore are not in a position to ascertain their authenticity.

The seven listed DPEs have no dedicated facilities for carrying out the import checks (documentary, identity and physical checks, including sampling). The identity and physical checks are performed upon request of the Customs Electronic Centre at the Customs' authorised warehouses (for details, see section 5.2.4.3) and no list is available of DPIs and control points. Contrary to the requirement of Article 8 of Regulation (EU) No 884/2014 and Article 19(2) of Regulation (EC) 669/2009, Customs has not published a list of DPIs and control points as the goods must be inspected in Customs authorised warehouses. Information on the warehouses can be obtained through the warehouse search at the following website: https://tulli.fi/en/e-services/search-and-query- services/warehouse-ids. 5.4.2 BIP Vaalimaa

The authorities have not put in place appropriate physical facilities within the listed DPEs, and there is no list of DPIs and control points available. The system in place does not satisfy the EU requirement that documentary checks should be performed at the border and cannot ensure that checks on consignments of products of non-animal origin subject to special import controls are carried out under the suitable and hygienic conditions expected of DPEs and DPIs.

Member state response

Competent authority response received on 12 September 2019 Finnish Customs has commenced corrective measures. Along with the entry into force of the new control Regulation, as from 14 December 2019, DPEs will be replaced by BCPs, through which products subject to intensive checks enter the country. In future Customs will inspect the original documents in connection with the import of the products into the country. The BCP and CP data will be available online as from 14 December 2019. Amendment November 26, 2019 The documentary checks will be performed at each Border Control Post designated for imports of food of non-animal origin by Finnish Customs, starting from December 14, 2019. Page: 1

The recommendation states as its basis

There is a system in place for the official controls of FIAs, including import, marketing and their use that is overall fit for purpose, and includes appropriate action in case of non-compliance. However, not all requirements of the EU legislation on FIAs are presently included in the controls and therefore not subject to verification and enforcement, as appropriate.

Member state response

in the Evira has now included the requirements by Annex II of tiveness as Regulation (EC) No 1333/2008 on colours in the form of aluminium lakes in the training programme for inspectors. The topic was discussed in online training provided for the inspectors in the end of October 2018 (see separate presentation). The material of the online training is also available to all inspectors in extranet service of food control authorities. The requirements and control of aluminium lakes of colours will also be added to the control guide of FIAs in the next update in the beginning of 2019. The control guide is available on the Evira's website: https://www.evira.fi. Page: 1

The recommendation states as its basis

Evira informed the audit team that the Guidelines for inspectors, which were issued in 2006, is in the process of being updated. The audit team noted that the information in the guidelines, which provide for a risk based approach to inspections was not up-to-date. 9 https://www.evira.fi/en/about-evira/about-us/activity/laboratory-services/ 10 https://www.evira.fi/en/plants/import-and-export/ 7

Evira also informed the audit team that additional, specific guidance is issued, as required. This may be issued by email or as a specific guidance document. Examples of guidance provided by email in 2017 concerned the changing distribution of A. glabripennis and Agrilus planipennis (Emerald ash borer). A guidance document on the import inspection of host plant species for Xylella fastidiosa was also issued in 2017 aimed at inspectors performing such checks at Helsinki Airport. The audit team interviewed an Evira inspector responsible for performing checks of host plants and noted that the list of such plants was not up-to-date, for example, it did not include Rosemary (Rosmarinus officinalis), which is listed in the Commission database of host plants of X. fastidiosa11, and is imported into Finland. There was also no reference to the statements of pest status submitted by non-EU countries, which are published by DG Health and Food Safety12, and are necessary for the correct performance of documentary checks for host plants.

Inspectors have access to instructions and guidelines for import controls, in line with Article 1, and Item 1(a) of the Annex, to Directive 98/22/EC. However, the guidelines for inspection and the specific guidance relating to X. fastidiosa were not up-to-date, which is not in line with that same legislation. 5.1.6 Planning of official controls

The lack of up-to-date information on interceptions relevant to plants and plant products imported into Finland, and national inspection guidelines, undermines the response of the import control system to new risks to plant health.

Member state response

Evira have made a new guidance document on the import inspection of host species for Xylella fastidiosa according to COM findings (Associate findings No. 19, 22). Evira will also update the guidance documents for Evira and Customs related to inspection of wood originating from Russia. Updated document will take effect by the end of December 2018 (Related to conclusion No. 29). Evira will give a new guidance document related to import inspection for plants for planting (Associate finding No. 18). The new instructions will be given before the end of December 2018.

The recommendation states as its basis

The audit team noted that neither the Evira inspectors, nor the Customs Laboratory officers performing checks of plants for planting and plant produce at Helsinki Airport or the place of destination visited, had up-to-date information on such products that had undergone official interception, such as the EU Alert List13 or EUROPHYT notifications, which is not in line with Article 1, and Item 1(e) of the Annex, to Directive 98/22/EC.

The lack of up-to-date information on interceptions relevant to plants and plant products imported into Finland, and national inspection guidelines, undermines the response of the import control system to new risks to plant health.

Member state response

Evira has already provided the links for Europhyt notifications, alert list, EPPO news on new pests and IPPC pest report via iranet for all phytosanitary inspectors. However, to further nhance the awareness of these information the senior officer of plant health unit responsible for risk based control will send a reminder email with above mentioned links attached for inspectors in both Evira and Customs every two months. In addition, Evira has made a preliminary plan to further develop the effectiveness of the communication related to interceptions (Attached). The plan will be further modified and implemented in phases by the end of December 2018 (Associate finding No. 21). Page: 1

The recommendation states as its basis

The audit activities have consisted of one pilot project per year since 2014 and each project covers a specific area of the official controls. Plant health, the residue control programme for food of animal origin, and the Salmonella control programme are the three projects that have been carried out so far. In 2017, an audit project on the control of fertilisers will be carried out. The competent authority has prepared a multi-annual audit programme for the period 2015-2018 that includes areas based on the choices made by the Directors of Evira in the context of the pilot phase of the audit function. The purpose was to have audits in sectors that could be used for modelling and further developing the audit system. The topics mostly cover horizontal issues and are selected in such a way that 50 % are audit projects on food safety, 25 % on plant health and 25 % on animal health and welfare. 12

The audit programme is planned based on the resources available (capability of two audit projects per year) and it is considered that in five years there will be five projects on food safety and two or three projects on plant health and production and an equal number on animal health and welfare.

The audit system has not defined the audit universe and as regards the audit programme development, the process is not well-documented and transparent, and it does not include risk-based prioritisation.

The audit team noted that the extended scope and time-consuming nature of the audit programme and its execution combined with the limitations in the availability of human resources, makes it unfeasible to cover all relevant areas of official controls in a five- year period. Conclusions on the development of the programme of audits

The process for the audit programme development is not well-documented or transparent and it does not follow risk-based prioritisation, which means that it does not result in programmes that could achieve an appropriate risk-based coverage of relevant official control activities. The development of the audit programme is further constrained by the lack of stable and sufficient resources without which the continuity in the provision of audit services cannot be ensured. 5.2.5 Implementation of the audit process 5.2.5.1 Legal requirements Article 2(6) of Regulation (EC) No 882/2004 states that "Audit" "means a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives." In section 5.1 of the Annex of Decision 2006/677/EC further guidance is provided to Member States on the `Systematic Approach', including: "A systematic approach should be applied to the planning, conduct, follow-up and management of audits. To that end, the audit process should: ....... -- be supported by documented audit procedures and records to ensure consistency between auditors and to demonstrate that a systematic approach is followed, -- include procedures for generating audit findings, including the identification of evidence of compliance and noncompliance, as appropriate, and for preparing, approving and distributing audit reports, -- include procedures to review audit conclusions, in order to identify system-wide strengths and weaknesses in the control system, disseminate best practice and ensure the monitoring of corrective and preventive actions, 13 -- be monitored and reviewed to ensure the audit programme's objectives have been met and to identify opportunities for improvement." Section 6.1 of the Annex of Commission Decision 2006/677 provides guidance on implementation of the Audit Process: "To comply with the requirements of Article 4(6) of Regulation (EC) No 882/2004, the audit system should cover the following three points set out in Article 2(6): (a) Verification of compliance with planned arrangements in order to provide assurances that official controls are carried out as intended and that any instructions or guidelines given to staff carrying out the controls are followed. This may largely be addressed by document review, but will also require on-site verification. The audit team will require good generic audit knowledge and skills to address this audit objective. (b) Verification of the effective implementation of planned arrangements. In order to assess effectiveness, that is the extent to which planned results are achieved, on-site operational implementation must be included. This should include an assessment of the quality and consistency of the controls and should involve on-site audit activities. The audit team will require the relevant technical expertise in order to address this audit objective. (c) The audit system should also seek to assess whether the planned arrangements are suitable to achieve the objectives of Regulation (EC) No 882/2004, and in particular the single integrated multi-annual national control plan. This should include assessing the suitability of official controls, with regard, for example, to their frequency and the methods applied, having regard to the structure of the production chain(s) and to production practices and volume. The audit team should have substantial knowledge and understanding of system auditing, together with relevant technical input to address this audit objective. In order to determine whether the planned arrangements are suitable to achieve the objectives set out in (c) above, the following should be considered: Audit criteria should include strategic objectives stemming from Regulations (EC) No 178/2002 and (EC) No 882/2004 (including the single integrated multi-annual national control plan) and national legislation. The primary

Member state response

- Suomi on yhdessä muiden Pohjoismaiden kanssa käynnistänyt työn riskiperusteisen au- ditointijärjestelmämallin rakentamiseksi. Tähän liittyen Belgia jakaa Pohjoismaiselle työryhmälle parhaita käytäntöjä omasta järjestelmästään elokuussa 2017. - Lisäksi Suomi on huomioinut yhteensovittamisen tarpeen Suomen elintarvikeketjun monivuotiseen kansalliseen valvontasuunnitelmaan (VASU) sisältyvän valvonnan riskiperusteisuu- den kehittämisen kanssa. VASTUUHENKILÖ: Anna Huttunen AIKATAULU: elokuu 2017 alkaen

The recommendation states as its basis

The audit team noted that for the two audit projects that were carried out in in 2014 and 2015, the audited services have provided neither comments on the content of the draft 19 reports nor action plans to address the identified deficiencies (some of which were significant). The competent authority stated in the closing meeting that actions have been taken to address the recommendations of the audit reports but could not provide evidence at that time. By request of the DG SANTE audit team after the audit, the competent authority confirmed that no documented evidence related to the addressing of audit recommendations was available. Thus the competent authorities could not demonstrate that they take appropriate measures in the light of the results of the audits carried out, contrary to the requirement of Article 4(6) of Regulation (EC) No 882/2004.

The audit team noted the lack of arrangements in place to ensure that issues are raised to the attention of the senior management so that the organisation takes responsibility and top management supports the audit function. This is in reference to longstanding deficiencies related to the results of the audits (delay in the finalisation of the reports because audited authorities do not provide comments on the draft reports in a timely manner (or at all), lack of corrective action plans etc.). Conclusions on follow-up of audit recommendations

The competent authority does not ensure that audit results are acted upon therefore the impact of the audit function on the quality and the effectiveness of official controls is limited. The need to implement corrective actions in response to audit results is not brought to the attention and ownership of senior management and thereby deficiencies in the performance of the official controls can remain outstanding/reoccur for a long period of time. 5.2.7 Transparency 5.2.7.1 Legal requirements Article 4(6) of Regulation (EC) No 882/2004 requires, inter alia, that "audits ........shall be carried out in a transparent manner". Section 5.2 of the Annex of Commission decision 2006/677 provides guidance on transparency, including the following: "In order to demonstrate the audit process is transparent, documented procedures should, in particular, include a clearly defined audit planning process, audit criteria and audit report approval and distribution mechanisms. Management and implementation of the audit process should be transparent to all relevant stakeholders. In particular, there should be full transparency between the audit body and the auditee. Ensuring the audit process is transparent in the eyes of other stakeholders will assist in the dissemination of information, and in particular in the sharing of best practice within and between competent authorities. 20 The Member States should adopt the appropriate measures to ensure their audit systems are transparent, taking national legal and other requirements into account. To that end, the Member States should consider encouraging practices that improve the transparency of the process." 5.2.7.2 Findings

Member state response

he - Suomen tarkoituksena on luoda yhteneväinen käytäntö Article korjaavien ja ehkäisevien toimenpiteiden toteuttamiseksi ja niiden toteutumisen seuraamiseksi muiden auditointi- ja arviointi- järjestelmien kanssa (esim. sisäiset tarkastukset, sisäiset auditoinnit, komission auditoinnit, ketjuauditoinnit). - Auditoinnin tulosten käsittelyä korjaavien ja ehkäisevien toimenpiteiden määrittelyä ja niiden toteuttamisen seurantaa koskevat pääperiaatteet: · 1. Auditoitava käy läpi ja vastaa auditointi- ryhmän toimittamaan raporttiluonnok- seen. Vastauksessa kommentoidaan ra- porttiluonnoksen sisältöä, havaintoja ja suosituksia ja esitetään toimintasuunnitelma suositusten johdosta tehtäviksi tarpeellisiksi korjaaviksi ja ehkäiseviksi toimenpiteiksi. 2. Auditoitava toimittaa laatimansa vastauksen toimintasuunnitelmineen auditointi- ryhmälle, joka arvioi toimintasuunnitelman soveltuvuutta suositusten toteuttamiseksi. 3. Auditointiryhmä toimittaa Eviran johdolle auditoitavan Page: 1 13 July 2017 ort ref. DG(SANTE)/2017-6017-MR of the audit carried out from 03 April t article 4(6) of Regulation (EC) No 882/2004 (national audit system) ditoitavan esittä- sekä sen stelmän Page: 2

The recommendation states as its basis

Evira informed the audit team that it does not consider surveillance of national production through sampling and testing necessary, because the Customs' checks on incoming food ingredients (used by domestic producers) is considered to provide sufficient safeguards since GMOs are not commercially grown in Finland. According to Evira no food items containing GMOs are produced in Finland and consequently as the customs already checks the imported potential GM ingredients, there is little need to check potential cross contamination again at the national production level. Annual tests carried out up to 2013 did not, according to Evira, give any non-compliant test results. However, due to the subsequent absence of any level of sampling and testing, coupled with the limited knowledge of the total population of operators that handle ingredients relevant to GMOs by Evira (see paragraph 44), the latter is not in a position to demonstrate that documentary checks are effective.

Evira classifies feed business operators into risk categories. The classification determines the frequency of inspection. Production of medicated feed, use of animal proteins and production volume are the main factors determining the risk category. As regards GMOs, Evira has chosen to almost exclusively sample and test (for authorised and non-EU-authorised GMOs) feed that is not labelled as containing GMOs (not supposed to contain authorised GMOs above a 0.9% level). However, there is no evidence that feed containing authorised GMO above 0.9% (and labelled as such) is less 7 likely to contain non-EU-authorised GMOs supporting its exclusion from sampling and testing.

Concerning paragraphs 24 and 25, Article 9.1 of Regulation (EC) No 1830/2003 requires Member States to ensure that inspections and other control measures including sample checks and testing (qualitative and quantitative), as appropriate, are carried out to ensure compliance with the Regulation while Article 4.2(a) of Regulation (EU) No 882/2004 requires CAs to ensure the effectiveness and appropriateness of official controls.

However, the effectiveness of documentary checks at Finnish food business operators is not underpinned with surveillance through sampling and testing of nationally produced food.

With regard to feed, excluding GMO containing feed from testing for non-EU- authorised GM events has the potential to reduce the effectiveness of the official controls.

Member state response

ive), as There is no commercial cultivation of GM crops in Finland. All GMO potential GM raw material and products are imported to Finland either from third countries or originating from internal EU trade. Finnish Customs is responsible for border control of foodstuffs of plant origin whether originating from third countries or EU Member States. The Customs has a detailed risk-based sampling plan targeted to commodities relevant for GM material. Thereby the Finnish producers' and manufacturers' goods are controlled for potential GM ingredients already at the point of import for their raw materials. Finland considers the present control system for GM food effective and appropriate. The control of GM food is part of the national Oiva food business operator control system applied for food production and guidelines to carry out Oiva checks which also take into account GM foods are in use. Continuous monitoring/surveillance of GM food by sampling and analysis at the manufacturing stage is currently not regarded necessary as the raw-material of interest is already subject for controls at an earlier stage. Control at the national level is primarily based on document checks. However, testi

The recommendation states as its basis

Evira has a framework contract with its laboratory for the GMO analysis of feed samples. The contract is flexible with regard to the GM events covered. It is stipulated that methods must be accredited or the validity of the method must be demonstrated otherwise. The contractual turnaround time of samples is two weeks for obtaining quantitative results for EU ­ authorised GM events.

The Customs Laboratory and the Evira Laboratory have been accredited to standard ISO 17025:2005. Both laboratories operate analytical methods for an adequate range of GM events. All methods of the Evira Laboratory for GM events in feed and 64 out of 68 methods of the Customs laboratory for GM events in food were included in the scope of 14 accreditation. The methods of the Customs laboratory have not been specifically accredited for seed. Since some of the accredited methods for feed apply to seed as a feedingstuff, the practical implications could be minor. However, the use of methods not included in the scope of accreditation, for testing of official samples, is not in line with the requirements of Article 12 of Regulation (EC) No 882/2004.

The CAs have access to a broad scope of accredited analytical capability for GM events, which underpins the effectiveness of the control system. However, current contractual arrangements, or the absence of those, leave room for the use of non-accredited methods and this has the potential to undermine the reliability of analytical test results. 5.3.7 Enforcement measures Legal requirements Articles 4(5) and 33 of Directive 2001/18/EC. Articles 45 of Regulation (EC) No 1829/2003. Article 11 of Regulation (EC) No 1830/2003. Findings

Member state response

official Seed testing has been added to scope of accreditation of Finnish he Customs Laboratory in May 2017. Finnish accreditation body ired by FINAS approved the adding and the final decision will be made in the autumn. Please find more information in Annex II. Page: 3

The recommendation states as its basis

In Finland, three laboratories are designated to perform pesticide residue analysis in organic products. In order to be designated, laboratories have to be accredited for pesticide residue analysis under ISO/IEC 17025, as required by Article 12 (2) of Regulation (EC) No 882/2004. Another criterion, taken into account by EVIRA for designation of laboratories, is the number of analytes sought. However, the scope of accreditation is not a criterion for designation. In addition, there are no clear instructions for designated laboratories with regard to methodology and implementation of laboratory analysis in order to detect and quantify substances not authorised for organic production, as required by Article 65 (2) of Commission Regulation (EC) No 889/2008.

In the first laboratory, a quality management system for routine pesticide residue analyses is in place. However, the audit team observed some weaknesses, including the following: 9 for standards, standard solutions and working solutions, records were available, but inconsistent labelling of standard solutions does not allow for a proper traceability; testing and replacement of standard solutions is performed by only a single injection and application of deviation criteria for comparison of old and new standards could not be demonstrated; requirements for identification and confirmations, i.e. application of acceptable deviations in retention time and ion ratio could not be demonstrated, which can result in false positive or false negative analytical results; for the analysis of organic samples, the corresponding quality control samples (routine recovery checks) are spiked at levels four times the reporting limit and underperformance of recovery data is not taken into account in reporting of results; this can have an impact on the quantification of pesticide residues; sample homogenisation is performed at room temperature, which is known to cause inadequate homogenisation, as well as degradation of certain analytes during sample preparation.

The overall performance of the second laboratory is generally good. Some weaknesses were identified in the implementation of routine pesticide residue analyses, such as: sample homogenization performed at room temperature, in-house validation data for some of the commodity groups was incomplete and traceability for calculation of analytical results could not be demonstrated comprehensively clear.

Laboratories for pesticide residue analysis in organic products have been designated. However, the lack of clear instructions from the CA for designated laboratories with regard to the methodology and implementation of laboratory analysis results in weaknesses in the implementation of routine pesticide residues analyses and may reduce the reliability of analytical results.

Member state response

instructions Evira täydentää luomuvalvontaan nimettyjen laboratorioiden facilitate kanssa tekemiään sopimuksia erillisellä liitteellä, jossa authorised for täsmennetään luomutuotteiden analysoinnissa käytettävää 4/2007 read metodologiaa ja analyysien toteutusta. Ohje valmistuu 1.12.2016. Lisäksi Evira merkitsee vuoden 2017 alusta sopimuksiin kullekin analysoitavalle tuoteryhmälle käytettävän analyysimenetelmän. Sopimukset valmistuvat 1.3.2017. Toinen laboratorio selvittää mahdollisuutta ottaa käyttöön kylmähomogenointi vuoden 2017 aikana. Uusien laitteiden käyttöönoton yhteydessä toinen laboratorio pyrkii suorittamaan validoinnit kattavammin SANTE 2015 ­ ohjeen mukaisesti. Validoinnit saatetaan valmiiksi 31.12.2017 mennessä. Toinen laboratorio ohjeistaa menetelmäohjeeseensa tarkemmin, mihin analyysituloksiin liittyvät laskutoimitukset tulisi merkitä. Menetelmäohjeen päivitetty versio valmistuu viimeistään 31.1.2017. Kohta 37. Ensimmäisessä laboratoriossa on käytössä tavanomaisten torjunta- ainejäämien analyysejä koskeva laadunhallintajärjestelmä. Tarkastusryhmä havaitsi kuitenkin joitakin puutteita: - standardiliuokset ja käyttöliuokset oli dokumentoitu, mutta standardiliuosten epä

The recommendation states as its basis

Although PDO/PGI/TSG feature in the risk classifications, currently official controls focus on food safety which means that, in practice, official controls on PDO/PGI/TSG are not undertaken.

Member state response

n korjaava toimenpide suosituksen perusteella ja aikataulu y toimenpiteelle suluissa: - Korjataan nimisuojatuotteita koskevaa valvontaohjetta mm. seuraavilta osin: 1) korostetaan hyväksytyn nimisuojahakemuksen olevan ensisijainen vertailussa käytettävä asiakirja valvontaa tehtäessä 2) korostetaan vaadittavan em. asiakirjan yksityiskohtaista noudattamista (1-2Q/2016) - Kaikille elintarvikevalvontaa suorittaville valvontayksiköille annetaan pyyntö suorittaa valvontatoimenpiteitä, kuten FVO:n tarkastusraportissa suositellaan (1-2Q/2016). Valvontaa koskevat tarpeet nostetaan esille myös Aluehallintovirastojen työnohjauspäivillä 2016 tai viimeistään keväällä 2017. - Oiva-tietojärjestelmästä seurataan miten tarkastusten määrä ja kattavuus muuttuu ja onko tarpeen tehostaa kehotusta vuoden 2017 ensimmäisellä neljänneksellä.

DO/PGI/TSG Valviran korjaava toimenpide suosituksen perusteella ja aikataulu opriate frequency toimenpiteelle suluissa: - Sisäinen ohje SAN-, SMM- ja APT- valvontatoimenpiteiden toteuttamiseksi (1-2Q/2016) sisältäen seuraavat pääkohdat: tuotteen rekisteröinti, alku- ja tuotantotarkastuksien suorittaminen, tuote-eritelmän tarkastus sekä hallinnolliset toimenpiteet. - Sisäisessä ohjeessa pääpaino on priorisoitu kotimaisten valmistajien valmistamille nimisuojatuotteille. Maahantuotujen nimisuojatuotteiden valvonta pyritään toteuttamaan resurssien puitteissa normaalin valvonnan ohessa. - Erillinen valvontalomake SAN-, SMM- ja APT- kohteiden tarkastukseen ( 1-2Q/2016), jossa huomioidaan valmistettavan tuotteen tuote-eritelmä. Valvira huomauttaa, ettei sillä kuitenkaan ole käytössään asetuksen (EU) N:o 1151/2012 36 artiklan 2 kohdassa edellytettäviä voimavaroja, joita tehtävien hoito saman asetuksen 36 artiklan 1 kohdan toisen kappaleen ja 37 artiklan 1 kohdan mukaisesti edellyttää. Valvira priorisoi esittämänsä SAN-, SMM- ja APT- valvontatoimenpiteensä koskemaan Suomessa valmistettuja tuotteita. Maahantuotujen SAN-, SMM- ja APT- tuotteiden valvonta toteutetaan resurssien puitteissa norm

The recommendation states as its basis

No controls relating to verification of compliance before placing the product on the market were undertaken, although procedures exist for such activities. 5.2.3 Procedures and Performance of Official Control Activities Legal Requirements Articles 12, 13(1), 23, 24(1), 36(3), 44 and 46(1) of Regulation (EU) No 1151/2012. Article 18 of Regulation (EC) No 178/2002. Articles 8(1), 9 and 10(2)(b)(vi) of Regulation (EC) No 882/2004. Regulation (EU) No 1169/2011 Official controls at producers / processors

Member state response

viran korjaava toimenpide suosituksen perusteella ja aikataulu imenpiteelle suluissa: - Kaikille elintarvikevalvontaa suorittaville valvontayksiköille lähetetään kehotuskirje suorittaa näitä valvontatoimenpiteitä kuten suosituksessa sanotaan. (1- 2Q/2016). Valvontaa koskevat tarpeet nostetaan esille myös Aluehallintovirastojen työnohjauspäivillä 2016 tai viimeistään keväällä 2017. - Oiva-tietojärjestelmästä seurataan miten valvontatoimenpiteiden määrä muuttuu ja onko tarpeen tehostaa kehotusta vuoden 2017 ensimmäisellä Page: 1 January 2016 ort ref. DG(SANTE)/2015-7412-MR of the audit carried out from 26 ted to Protected Designation of Origin (PDO), Protected Geographical al products and food stuffs' ljänneksellä. ira haluaa kuitenkin huomauttaa, että kyseisiä nakkotarkastuksia vaativia tilanteita esiintyy harvoin, koska sia nimisuojatuotteita tai niiden valmistajia tulee Suomessa rvoin markkinoille.

t verification of Valviran korjaava toimenpide suosituksen perusteella ja aikataulu g the product on toimenpiteelle suluissa: Article 37(1) of - Ohje SAN-, SMM- ja APT- tuotteiden valmistamisesta ja sesta markkinoille alkoholijuomien valmistajille ) Markkinoille tulevien kotimaassa valmistettujen atuotteiden tuotannon aloituksen tarkastus ja nimisuoja itelmän vastaavuuden tarkastus Markkinoilla olevien kotimaassa valmistettujen atuotteiden tuotannon aloituksen tarkastus ja nimisuoja itelmän vastaavuuden tarkastus a posteriori. (3-4Q/2016)

The recommendation states as its basis

There was no system of official controls in place for PDO/PGI/TSG due to: (i) no verification of compliance being undertaken prior to placing the product on the market, which is not in line with Article 37 of Regulation (EU) No 1151/2012, (ii) no systematic market controls being undertaken, which is not in line with Article 36 of Regulation (EU) No 1151/2012 and (iii) registered names not being subject to official controls covering the verification of compliance with the Product Specification, as required by Article 36 of Regulation (EU) No 1151/2012. 5.2.4 Enforcement Measures Legal Requirements Article 13(3) of Regulation (EU) No 1151/2012. Articles 54 and 55 of Regulation (EC) No 882/2004. Findings 8 Food

Member state response

Eviran korjaava toimenpide suosituksen perusteella ja aikataulu menpiteelle suluissa: Korjataan nimisuojatuotteita koskevaa valvontaohjetta säyksellä: "Suojan saanutta nimeä, kun samassa teydessä käytetään nimisuojaa osoittavaa tunnusta, ei e pakkausmerkinnöissä tai muussa rkkinointimateriaalissa sallittua taivuttaa, vaan nimi lee esittää hyväksytyssä perusmuodossa." (1-2Q/2016) Evira tulee tekemään 2-5 valvonnan tarkastusta, jossa urataan valvojan tekemää nimisuojatuotteiden rkastusta tuotantolaitoksissa. (3-4Q/2016)

l controls covering Valviran korjaava toimenpide suosituksen perusteella ja aikataulu sponding Product toimenpiteelle suluissa: gulation (EU) No - Kohdassa Suositus 1 korjaavat esitetyt toimenpiteet myös tämän kohdan toimenpiteet Lisäksi jatketaan SAN-, SMM- ja APT- tuotteita vien toimijoiden pitämistä riskinarvioinnin yhtenä , jonka perusteella muodostuu tarkastusfrekvenssi e (1Q/2016).

The recommendation states as its basis

There was no system of official controls in place for PDO/PGI/TSG due to: (i) no verification of compliance being undertaken prior to placing the product on the market, which is not in line with Article 37 of Regulation (EU) No 1151/2012, (ii) no systematic market controls being undertaken, which is not in line with Article 36 of Regulation (EU) No 1151/2012 and (iii) registered names not being subject to official controls covering the verification of compliance with the Product Specification, as required by Article 36 of Regulation (EU) No 1151/2012. 5.2.4 Enforcement Measures Legal Requirements Article 13(3) of Regulation (EU) No 1151/2012. Articles 54 and 55 of Regulation (EC) No 882/2004. Findings 8 Food

Member state response

Eviran korjaava toimenpide suosituksen perusteella ja aikataulu oimenpiteelle suluissa: Kaikille elintarvikevalvontaa suorittaville lvontayksiköille lähetetään kehotuskirje suorittaa näitä lvontatoimenpiteitä kuten suosituksessa sanotaan. (1- /2016). Valvontaa koskevat tarpeet nostetaan esille ös Aluehallintovirastojen työnohjauspäivillä 2016 tai imeistään keväällä 2017. Nimisuojaa koskevaa valvontaohjetta täydennetään iolla, jossa käsitellään markkinoille saatettujen misuojatuotteiden valvontaa. (1-2Q/2016) Evira pyytää kolmelta valvontayksiköltä rkastuspöytäkirjat nimisuojatuotteita koskevista rkkinavalvontakäynneistä ja selvittää sen perusteella, Page: 2 January 2016 ort ref. DG(SANTE)/2015-7412-MR of the audit carried out from 26 ted to Protected Designation of Origin (PDO), Protected Geographical al products and food stuffs' onko lisäkoulutukseen tarvetta. (4Q/2016) Page: 3

he use of registered Valviran korjaava toimenpide suosituksen perusteella ja aikataulu blished in Article toimenpiteelle suluissa: Kohdassa Suositus 1 esitetyt korjaavat toimenpiteet myös tämän kohdan toimenpiteet Valvira pyytää komissiolta (EU) ohjausta hyvistä istä ja toimintatavoista, kuinka suoritetaan otujen ja markkinoille saatettujen SAN-, SMM- ja APT- en valvontaa. Lisäksi Valvira pyytää komissiolta suomenkielisiä tuote- Page: 2 ations received 27 January 2016 endations of Report ref. DG(SANTE)/2015-7412-MR of the audit carried out from 26 rol systems related to Protected Designation of Origin (PDO), Protected Geographical ) for agricultural products and food stuffs' eritelmiä toteuttaakseen SAN-, SMM- ja APT- viinituotteiden (maataloustuote E-Bacchus tietokanta) valvontaa.

The recommendation states as its basis

All of the re-imported goods via Finnish BIPs are indicated as channelled from the entry BIP to establishment of origin, as required. However, LVUs responsible do not always confirm in TRACES the arrival at destination (TRACES window 41 of the CVED is not filled in for most of them). BIPs staff stated that there is a written agreement of acceptance signed by the re-importer.

A number of consignments of blood products were imported, which require channelling (Annex XIV, Chapter II, Section 2 point 3.2 of Commission Regulation (EU) No 142/2011). About 50% of consignments were channelled in TRACES by the entry BIP, as required. Each of those consignments were confirmed by the LVU at destination using TRACES. The instructions for import controls did not cover the controls required for blood products, and the different officials interpreted the requirements of the Regulation (EU) No 142/2011 in different ways. The central competent authorities amended the instructions during the FVO audit and distributed these to the BIPs immediately.

Arrival of (rejected) consignments channelled to an incinerator for destruction was not confirmed in TRACES, contrary to the requirements. The reason is that the notification on the channelled consignment does not reach the environmental authority in charge of controls at the incinerator (who is not a TRACES user). It was noted that, instead of the TRACES confirmation, the system ensures that the BIP receives a paper document confirming the arrival at destination of the consignment. 5.2.8 Animal welfare checks

Some of the CVEDAs issued by BIPs in other Member States, with destination in controlled destinations in Finland, did not include records of the controls at destination in the control part of the TRACES document. 6 5.2.9 INTRA module

The INTRA documents for some consignments sent to control bodies in a different Member State, the "control part" had never been filled in by the authority at destination. One consignment of live animals exported via another Member States had no control part filled in at the point of exit from the EU. The authorities in Finland did not follow-up such cases to verify the reason for the absence of records in that control part.

A national instruction requires the filling in of the control part for documents of consignments of animals arriving for slaughter from other Member States. For other animals, all incoming consignments of live pigs and cattle should also be controlled at destination. However, there is only some evidence in TRACES of controls on such consignments having taken place. The missing information on the required controls did not trigger any action from the competent authority. The checks for other consignments are performed on the basis of risk or suspicion. 5.2.10 DOCOM module

Consignees are instructed to do checks on all consignments arriving from other Member States. If the place of destination is under the control of an official, the veterinarian should ensure that all the checks are done and record this in TRACES. 80% of DOCOMs arriving to Finland have the control part completed in TRACES. 74% of documents going out from Finland have the controls at destination recorded in TRACES.

Daily monitoring on the certificates provided in TRACES is carried out by EVIRA and regional official veterinarians. However, officials met at the LVUs were not always aware that some DOCOM notifications received via TRACES had not been followed up. Normally such notifications are deleted after a certain time, and the system does not ensure that notifications are followed up before being deleted. 7 5.2.11 CEDs and CHED-PPs modules

Finnish competent authorities are correctly using TRACES, with some specific exceptions (controls on consignments which require confirmation of receipt at destination are not always recorded in the system). This lack of information in the system undermines the communication between competent authorities in relation to the specific controls.

Member state response

t TUONTI: Rajaeläinlääkäri (Anna-Stiina Antola) on 24.11.2014 kouluttanut eläinlääkäreitä aluehallintovirastoista liittyen erien kanavointiin ja niiden seurantaan TRACESissä. Paikalla oli edustaja aluehallintovirastosta (Jani Soini) joka on vastuussa kanavoitujen erien valvonnasta. - \\evira.local\evira\VALO\RALU\RAJA\ELÄINLÄÄKINNÄLLINEN RAJATARKASTUS\KOULUTUKSET\Anna-Stiina Luennot\Kanavointi\Kanavointi.ppt: Kanavointi.ppt Ohjeistus internetissä on päivitetty, kaikki verituotteet kaikista lajeista on kanavoitava. "Sekä Suidae ja Tayassuidae-taksoneihin kuuluvista eläimistä että niihin kuulumattomista eläimistä (naudat, lampaat jne.) saatavat verituote-erät on kanavoitava asetuksen 142/2011 liitteen XIV II luvun 2 jakson kohtien 3.2. ja 3.3.mukaisesti. Tarkemmat ohjeet vasemmassa linkissä "sivutuotteiden ja elintarvikkeiden kanavointi". http://www.evira.fi/portal/fi/tietoa+evirasta/asiakokonaisuudet/elaimista+saatavat+sivutuottee t/tuonti+ja+vienti/tuonti+eu+n+ulkopuolelta/verituotteet/verituotteet+teknisiin+tarkoituksiin/ Ohjeistus internetissä on päivitetty: http://www.evira.fi/portal/en/food/import+and+export/import+from+non- eu+countries/instructions+for+importers++customs+and+

Member state response

Uudessa tämän vuoden syksyllä eduskunnan käsittelyyn tulevassa sivutuotelaissa on tarkennettu viranomaisen rekisteröintitoimivaltaan liittyneitä puutteita. Lakiesityksessä on annettu Elintarviketurvallisuusviraston tehtäväksi rekisteröidä välittäjät, jotka toimivat yksinomaan jälleenmyyjinä eivätkä missään vaiheessa säilytä tuotteita tiloissaan. Elintarviketurvallisuusviraston tehtävänä olisi myös isteröidä kuljetusliikkeet. Kuitenkin kaatopaikolle tai polttolaitoksiin tteenä hävitettäviä sivutuotteita kuljettavat toimijat ja kompostointi tai biokaasulaitoksiin sivutuotteita kuljettavat toimijat rekisteröidään ympäristöhallinnon ylläpitämään jätehuoltorekisteriin. Eviralla olisi ekisteriin tiedonsaantioikeus. Kun viranomaiselle annetaan toimivalta edellä mainittujen toimijoiden rekisteröintiin, voidaan ne myös huomioida valvontaohjeissa ja valvontasuunnitelmassa ja sisällyttää toimijaluetteloon.

Member state response

sisältää asetuksen (EY) 1069/2009 artiklassa 48(3) mainittuja tuotteita, virkaeläinlääkärin tulee aina varmentaa lähetyksen saapuminen Suomeen täyttämällä valvontaosio TRACES-järjestelmään. Paikallisille kintäyksiköille korostetaan entisestään ilmoituksen tekemisen kitystä ja samalla ettei ilmoittamisen aikarajaa ylitetä. Toimijan ja virkaeläinlääkärin on sovittava miten erien saapuminen määräpaikkaan ilmoitetaan kyseiselle virkaeläinlääkärille niin, että eläinlääkäri voi varmistua siitä, että erät ovat todella saapuneet. Evira on lisännyt seen lähetysten saapumisesta ja niiden ilmoittamisesta Page: 1 the competent authority on 3 October 2014 s of Report ref. DG(SANCO)/2014-7067-MR of an audit carried out f animal by-products (abp) and derived products tyiskohtaisen ohjeistuksen toimijan ja virkaeläinlääkärin välisestä ttelystä. Ohje on Eviran sivustolla ://www.evira.fi/files/attachments/fi/elaimet/tuonti_ja_vienti/eujasen /traces_docom-ohje_versio_3.pdf. Toimija informoi aeläinlääkäriä sähköpostitse tai faksilla jokaisen lähetyksen umisesta. Asiakirjatodisteita voi lähettää sähköpostitse skannattuina teinä. Paikallisille eläinlääkintäyksiköille annetaan suositus suorittaa uneiden

Member state response

ut internal Elintarvikelain mukaan aluehallintovirasto suunnittelee, ohjaa ja in the light of valvoo elintarvikevalvontaa sekä valvoo elintarvikemääräysten 04) as required noudattamista toimialueellaan sekä arvioi kunnan elintarvikevalvonnan järjestämistä ja julkaisee arvioinnin tulokset ja arvioi kuntien valvontasuunnitelmat sekä tarkastaa niiden noudattamista. Eviralla ja aluehallintovirastolla ei ole suoraa käskyvaltaa kuntien elintarvikeviranomaisiin, koska kunnilla on Suomen perustuslain takaama kunnallinen itsehallinto toimivaltaansa kuuluvissa asioissa, kuten elintarvikevalvonnassa. (katso Country profile, Audit system). Kunnan elintarvikeviranomainen on toimivaltaisena viranomaisena velvollinen noudattamaan elintarvikelainsäädäntöä itsenäisesti. Valtiolla on käynnissä hankkeita, joiden yhteydessä selvitetään kuntien itsehallinnollista asemaa ja elintarvikevalvonnan organisaatiota. Aluehallinnon rooli ja tehtävät elintarvikevalvonnassa ovat parhaillaan maa- ja metsätalousministeriössä tarkastelussa myös elintarvikelain kokonaisuudistuksen yhteydessä.

Member state response

Lihantarkastus ja valvonta on ollut monessa pienteurastamossa eri tarkastuseläinlääkärin vastuulla valvonnan valtiollistamisen alkuvaiheen järjestelyiden vuoksi. Valvonnan koordinaatiota kehitetään edelleen siten, että niissä pienteurastamoissa, jotka ovat Eviran vakinaisten tarkastuseläinlääkäreiden valvonnassa, sama henkilö vastaa lihantarkastuksesta ja laitosvalvonnasta. Eviran rkastusyksikön aluejohtajan roolia valvonnan koordinaatiossa korostetaan. Elintarvikelain muutoksen myötä 1.6.2013 alkaen Evira on voinut sopia kunnan kanssa sekä lihantarkastuksen että laitosvalvonnan järjestämisestä. Kaikissa kuntasopimuksen mukaisissa valvontakohteissa toiminta järjestetään edellä mainitulla tavalla vuoden 2013 aikana. Pienteurastamoiden valvonta tullaan kuitenkin jatkossa järjestämään siten, että pienteurastamot ovat Eviran vakinaisten tarkastuseläinlääkäreiden valvonnassa. Pienteurastamoiden valvonnan koordinoinnin tueksi laaditaan parhaillaan monivuotista pienteurastamoiden valvontasuunnitelmaa. Valvontasuunnitelma sisältää myös tarkastuseläinlääkäreille jaettavan laitosvalvontaohjeen sekä koulutussuunnitelman laitosvalvojille annettavasta koulutuksesta. Lisäksi valvojien koulutukse

ntrols Owing to arrangements during the initial phase of transferring responsibility for monitoring activity to Evira (Finnish Food Safety Authority) at national level, various inspection veterinarians have been responsible for carrying out meat inspection and supervision in many low-throughput slaughterhouses. The coordination of monitoring activity will be developed further so that, at those low-throughput slaughterhouses that are under the supervision of inspection veterinarians from Evira's permanent staff the same person will be responsible for both meat inspection and establishment inspection. As part of the coordination process, the role of the regional managers of Evira's meat inspection unit will be stepped up. Following an amendment to the Food Act, since 1 June 2013 Evira has been able to agree both meat inspection and establishment inspection arrangements with the municipalities. The organisational arrangements for monitoring activities in 2013 at all inspection sites specified in municipal agreements are as described above. In future, however, the monitoring of low-throughput slaughterhouses will be organised in such a way that they will be under the supervision of ins

Member state response

lukuussa 2012 antamaa ohjetta "Laitoksen hyväksyminen, kennetaan yksityiskohtien osalta syksyllä 2013. Laitoksen tä koskevia asioita käsitellään Eviran järjestämissä laisuuksissa. Aluehallintoviranomaisia pyydetään ohjaus- ja äynneillään varmistamaan, että säädettyjä menettelyjä noudatetaan. Eviran tekemillä ohjaus- ja äynneillä teurastamoihin ja pienteurastamoihin ja niiden oleviin laitoksiin varmistetaan laitosten menettelyjen vaatimustenmukaisuus.

Evira's guidance document No 16033 'Establishment approval' issued in ) December 2012 will be fine-tuned in autumn 2013. Issues regarding the approval of establishments will be dealt with in training sessions held by Evira. The regional authorities will be asked to confirm, by means of guidance and assessment visits, compliance with the approval procedures laid down. Guidance and assessment visits by Evira to slaughterhouses, low- throughput slaughterhouses and associated establishments will include a check on whether establishments comply with the approval procedures.

Member state response

staa elintarvikevalvontaohjelmassa (EVO) olevan en valvontakohteiden riskiluokituksesta ja iheydestä. Ohje riskiluokituksesta ja tarkastustiheydestä myös teurastamoille, poroteurastamoille ja tamoille ja niiden yhteydessä oleville laitoksille. ltaiset viranomaiset ottavat uuden ohjeen käyttöön n valvontasuunnitelmiaan vuodelle 2015.

anised Evira will be updating the instructions on inspection frequency and the risk classification of inspection targets included in its food control plan. vant Guidance on risk classification and inspection frequency will also be drawn up for slaughterhouses, reindeer slaughterhouses, low-throughput slaughterhouses and associated establishments. The competent authorities will apply the new guidance when drawing up their inspection plans for 2015.

Member state response

ntarvikehygieniayksikkö tekee teurastamoihin ja tamoihin valvontaan kohdistuvia ohjaus- ja äyntejä sekä poroteurastamoihin lihantarkastuksen ja siihen valvonnan arviointikäyntejä. Näillä käynneillä tarkastellaan ranomaisten havaitsemien epäkohtien korjaamisen ja ohjataan valvontaa ryhtymään tarpeellisiin iin. tovirastojen kuntiin tekemillä ohjaus- ja arviointikäynneillä toviranomaiset ohjaavat tarvittaessa epäkohtien n parantamiseen, jos kunnan valvontaviranomaisen ranta havaitaan tässä suhteessa riittämättömäksi. etojen julkistaminen eli ns. Oiva-järjestelmä velvoittaa ranomaisen tekemään seurantakäynnin yrityksessä sen seksi, että toimija on korjannut havaitut epäkohdat. Oiva lä hetkellä vähittäismyynnin piirissä olevissa ehuoneistoissa, ja se laajenee laitoksiin 1.5.2015 alkaen. et tulokset Oivasta seurantatyökaluna ovat erittäin .

Evira's food hygiene unit will carry out guidance and assessment visits e focusing on supervision of slaughterhouses and low-throughput e 54 slaughterhouses and evaluation visits to reindeer slaughterhouses as regards meat inspection and associated supervision. These visits will involve an examination of the follow-up given to the correction of instances of non- compliance found by the supervisory authorities. During guidance and assessment visits to the municipalities carried out by the Regional State Administrative Agencies, the regional authorities will order that remedial measures for non-compliance be improved in cases where the follow-up carried out by the municipal supervisory authorities is 20 September 2013 found to have been lacking. The publication of monitoring data through the Oiva system obliges monitoring authorities to carry out their follow-up inspections of undertakings in such a way as to ensure that operators have actually corrected the instances of non-compliance found. At present Oiva concerns food premises in the retail sector, but it will be extended to establishments from 1 May 2015. To date, use of Oiva as a follow-up tool has produced very positive result

Member state response

en valvontayksiköiden toiminnan vaikuttavuutta ja a parannetaan ensisijaisesti tehostamalla olemassa olevien käyttöä. a valvontayksiköitä on yhdistetty suurempiin ksiin (ympäristöterveydenhuollon yhteistoiminta-alueet) ja osalta tavoitetaso saavutetaan vuoden 2014 alussa. isvaiheen jälkeen tämä parantaa johtamista ja tehostaa käyttöä, mistä on saatu jo palautetta raportoinnin Kunnallisten valvontayksiköiden VASU-raportit, oma arvio valvonnan toimivuudesta). Keskusvirasto- ja parannetaan kunnallisten valvontayksiköiden seurantaa. en strategian yhteydessä laaditaan mittaristo koko ketjun n ja vaikuttavuuden seuraamiseksi. Yksi mittariehdotus on en määrä/valvontaan käytetty aika. Tehottomimpiin kuntiin an neuvontaa ja ohjausta tilanteen parantamiseksi. elakia ja muita kuntien ympäristöterveydenhuollon lakeja ttamassa ja muutoksilla pyritään tehostamaan kuntien ksujen perimistä ja näin saamaan lisää resursseja käyttöön. ä yhteydenpitoa terveysvalvonnan johtajiin. Johtamisen eksi ja valvonnan tehokkuuden varmistamiseksi, i ympäristöterveydenhuollon alueellisille koulutuspäiville än kohdennettua koulutusta terveysvalvonnan johtajille. ii terveysvalvonnan johtajien käyttöön mittariston, j

equired The effectiveness and efficiency of the municipal supervisory units' work at will be improved primarily by stepping up use of the existing resources. ired by ular The municipal supervisory units have been merged to form larger entities ected (Environmental and Health Sectors) and the target level for this work will be achieved at the start of 2014. Once the start-up period has been completed, this will improve management and increase resource use. Feedback has already been received on this in the context of reporting requirements (monitoring plan reports from the municipal supervisory units, constituting their own assessment of the effectiveness of monitoring activity). Monitoring by the municipal supervisory units will be improved at central and regional level. Evira's new strategy will see the development of a measuring tool to track the efficiency and effectiveness of the entire control chain. One proposed indicator is the number of inspections/time spent on monitoring. The most inefficient municipalities will be issued advice and guidance on how to improve the situation. The Food Act and other legislation concerning municipal environmental health protection are being am

Member state response

a on lähettänyt ohjauskirjeen 9.7.2013 kaikille MSM:a istavien laitosten tarkastuseläinlääkäreille. Kirjeessä astuseläinlääkäreitä pyydetään kiinnittämään huomiota anisesti erotetun lihan merkintöihin laitoksissa ja vaatimaan oksia korjaamaan mahdolliset virheelliset merkinnät.

On 9 July 2013 Evira sent a guidance letter to all inspection veterinarians responsible for establishments producing MSM, asking them to pay r attention to the labelling of MSM at establishments and order establishments ents to correct any incorrect labels.

Member state response

a ohjeen ante mortem ­tarkastuksen tekemisestä keväällä ohje valmistuu, tarkastuseläinlääkäreille annetaan asiasta .

Evira will issue instructions in spring 2014 on the performance of ante- mortem examinations. Training will be provided to inspection veterinarians once the instructions are ready.

Member state response

ohjeet 10501/1 ja 10502/1 on päivitetty, järjestetään mikrobikriteeriasetuksesta, ohjeista ja HACCP - sta paikallisille elintarvikevalvontaviranomaisille. Evira uudesta ohjeesta toimijoita. Lisäksi paikallisia isia kannustetaan neuvomaan asetuksen (EY) N:o vaatimuksista toimijoita.

Once Evira Guidelines Nos 10501/1 and 10502/1 have been updated, aining on the Microbiological Criteria Regulation, the Guidelines and . HACCP auditing will be organised for the local food control authorities. Evira will inform operators of the new guidance. In addition, the local monitoring authorities will be encouraged to inform operators of the requirements of Regulation (EC) No 2073/2005.

Member state response

ektiivin 98/83/EY vaatimukset on implementoitu ssa lainsäädännössä sosiaali- ja terveysministeriön a talousveden laatuvaatimuksista ja valvontatutkimuksista edestä tutkitaan kontaminantit ja pestisidit vähintään n määrittämällä vähimmäistiheydellä STM:n asetuksen . Vettä toimittavan laitoksen tai elintarviketoimijan oman n viranomaisvalvonnasta vastaa uojeluviranomainen. etoimijan on pyydettävä harvemmin tutkittavien muuttujien lokset vettä toimittavalta laitokselta jos vettä toimittava julkaise niitä säännöllisesti kaikkien saataville. staa hyväksyttyjen elintarvikehuoneistojen veden an ohjeistuksen syksyn 2013 aikana ja ohjeistukseen ohta, jossa elintarvikealan laitosta kehotetaan huolehtimaan että vettä toimittavan laitoksen harvemmin tekemien n tulokset hankitaan ja että niitä säilytetään niin kauan kuin jat tutkitaan vedestä uudelleen.

cover All the requirements of Directive 98/93/EC were transposed into national law by Regulation No 461/2000 of the Ministry of Social Affairs and Health on the quality and monitoring requirements for potable water. In accordance with the Ministerial Regulation, water is tested for contaminants and pesticides at least at the minimum frequency laid down in the Directive. Responsibility for official monitoring of water supply plants or food operators' own water sources lies with the health protection authorities. Food operators should ask the water supply plant for the test results for the less frequently tested parameters if the plant does not regularly make them available. Evira will rework the instructions on own-checks of water by approved food premises in autumn 2013. The instructions will include a section in which establishments in the food sector will be advised to separately ensure that they obtain the results of water supply plants' less frequently carried out tests and that these results are kept until the parameters in question are tested again.

Member state response

ideline No 10501/1 deals with the requirements of Annex I, f Regulation (EC) No 2073/2005 in a manner fully in line with the ding to the Guideline and its annexes, the testing frequency may slaughter hygiene is good, if the test history is acceptable and if rity approves the reduced testing frequency. In addition, the Guideline dealing with sampling at slaughterhouses and cutting that reduced testing frequencies are 'subject to approval by the authority'. lines Nos 10501/1 and 10502/2 will be updated and further clarified by 2013. Instructions for authorities on the issue of testing frequency will be d into Guideline No 10502/1.

Member state response

n the Evira website for operators receiving foodstuffs of animal Member States and the food control authorities monitoring them ied. At training sessions, the issue of non-discriminatory checking will . During inspections carried out by Evira, account will be taken of the f own controls required by the local food control authorities. l veterinarians responsible for the two establishments mentioned in the Evira's other official veterinarians will be informed in August 2012 that ermitted to require a 100% sampling frequency during own controls.

Member state response

ted to be 63 municipal control units by 2013, as compared to 88 at 2011. After the changes, and with only a few exceptions, the ealth control units will have at least ten full-time equivalent staff, propriate specialisation and division of labour.

Member state response

l control activities is gathered directly from the local control cated system that also gathers information from microbiological of food control directly from the local laboratories. ovides the regional and central authorities with information sed by the local control units, including so as to make it possible ify the regularity of control activity, its risk-based nature and the the cases of non-compliance found. The KUTI system is being ages. premises section (KUTI 1a) allows activity information to be ntrols targeting high-risk activities may be monitored (e.g. cold rement where highly perishable foods are sold and served). KUTI ound 90% of control units. ection (KUTI 2a) covers the collection of inspection data, e.g. the known as 'ABCD forms') on which matters to be checked are basis. The following information on inspections is obtained: the spection (e.g. suspected food poisoning), the findings, the from the non-compliance and an assessment as to what probably pliance. KUTI 2a is currently being rolled out and, at the start e in around 10% of control units. Evira is planning to issue an at the KUTI system is used. In addition, together with the ion system operators, it will be

Member state response

nes Nos 10501/1 and 10502/1 have been updated, training on ical Criteria Regulation, the Guidelines and HACCP auditing will r the local food control authorities. In future, such training will be arly.

Member state response

Guideline No 10501/1 deals with this matter and also makes e EU guides. In addition, the annexes contain recommendations equency for environmental samples. ll be drawn up when the Guideline is being updated. ferred to under point 5 will also deal with this issue.

Member state response

ce laboratory has gathered information from the official ion in the proficiency test rounds and on success therein. hering will continue and the laboratories will be guided in the ciency test round.

Member state response

inted to update the CPs and the OM during 2013. revised regularly, at least every fifth year, for

Member state response

s clearly discussed that at least the analytical gical surveillance should be accredited. The scope dual methods is currently under discussion in of the Regulation of official feed and food ormance of Evira in testing of reference samples ovides evidence that analytical methods used in atisfactorily. D only suspect cases are being tested. Also no d out for AHS. Evira has agreement with the EU-RL ect samples for testing. 7025 accreditation by the Finnish Accreditation n the scope of this audit serological testing for ection using molecular methods have been prepare the files and request accreditation for used in serological surveillance for AI, CSF, 3-2014.

Member state response

ted to do the updating to meet the requirements ) No 1099/2009. Page: 1 /2012-6401-MR of an audit carried out ation to animal health, including provisions by the Competent Authority

Member state response

CPs will be updated during 2013 to meet the tion. A person has been appointed to do the

Member state response

ecially the substitutes will be trained in October detected during the audit, in particular the nd on veterinary checks, specifically the staff and substitutes will also continue ng "Better training safer food". vira each participant must take part in an exam effectiveness of the training provided.

Member state response

ness of official controls performed at Finnish BIPs checks, veterinary decisions, the use of consignments has been enhanced with the for using Traces and performing physical checks consignments have been updated in the internet a.fi/portal/fi/elintarvikkeet/tuonti_ja_vienti/tuont eita_tuonnista__kauttakulusta_ja_muonituksesta et_rajaelainlaakareille_ja_tuojille_tarkastuksen_v osta/ directions: put into TRACES after correction on hard VED, collecting double payments in case of Page: 1 012-6510-MR of an audit carried out ities with regard to the import/transit oosing the correct ransit in Traces. the table of excited nments, trolled destination and ese consignments. ification (double ignment in Part I of r or date of issue, emporary admission inary certificates for claration. l samples and co- ere is only need to 012-6510-MR of an audit carried out ities with regard to the import/transit lsinki airport BIP's ed during the audit in a ÄKINNÄLLINE onfirmation and follow- an be found in the link rtificates for horses (for or the responsible CA in all veterinarians during the e, but Helsinki port BIP e before last summer the unicipal veterinarian ki port BIP are the tificates for horses c

Member state response

Evirassa ryhdytään laatimaan kevään 2012 aikana kansallista r to sivutuotteiden valvontastrategiaa. Strategiatyössä tullaan etsimään ratkaisuja koko sivutuotealan valvontajärjestelmässä havaittujen eikkouksien poistamiseksi sekä selkeytetään eri viranomaisten tehtäväjakoa valvonnassa ja laaditaan suunnitelma valvonnan koko ketjun toiminnan tehokkuuden varmentamiseksi. Evira järjestää teurastamoiden tarkastuseläinlääkäreille ja läänineläinlääkäreille vuosittain useita koulutustilaisuuksia, ja kehottaa sivutuotteita valvovia eläinlääkäreitä osallistumaan niihin aktiivisesti. Evira järjestää vuonna 2012 kuntien virkaeläinlääkäreille koulutusohjelman, jonka kahdessa osiossa käsitellään eläinperäisiä sivutuotteita koskevaa lainsäädäntöä ja valvontaa.

tastrategia on tarkoitus saada valmiiksi

Member state response

t out Kansallisen 1.1.2012 voimaan tulleen asetuksen (MMMa 1193/2011) mukaisesti valvontaviranomaiset valvovat toimivaltaansa kuuluvia uotealan laitoksia vuosittain laatimansa riskiperusteisen valvontasuunnitelman mukaisesti. Evira laatii vuosittain valvontaohjeen valvontasuunnitelmien perustaksi. Evira on laatinut valvomilleen laitoksille teurastamoja ja niiden yhteydessä olevia keräyskeskuksia lukuun ottamatta riskipisteytysjärjestelmän (ohje toimitettu FVO:lle ennen tarkastusta), jota sovelletaan vuodesta 2012 alkaen. Riskipisteytykseen sisältyy säädösten vastaisuuksien seuranta. Teurastamojen yhteydessä olevia Page: 1 ived on 06 March 2012 of Report ref. DG(SANCO)/2011-8959-MR of an audit carried out alth rules on animal by-products (ABP) and derived products the Competent Authority vovat teurastamojen tarkastuseläinlääkärit omien ensa mukaisesti. an tekemään tarkastukset ennalta ilmoittamatta kaan, siten kuin 882/2004 on säädetty. Jos tehdä ennalta ilmoittamatta, ilmoitus tehdään ellä varoitusajalla. Tarkastuksen tavoite ei tällöin orittaa ennalta ilmoittamatta tai ennalta ilmoittaen, nön vaatimuksista ja tarkastuskohtaisesta usharkinnasta. Suomessa tarkastuksia ei ole tarkast

sätalousministeriön asetuksen 1193/2011 hje aluehallintovirastoille valmistui ja hallintovirastot laativat tämän ohjeen en ja riskiperusteisen a kattaa myös aluehallintoviraston alueella nan. Eviran ohjeessa kerrotaan kunkin suuri osuus aluehallintoviraston ja kunnan in tyyppisistä laitoksista on vähintään at laitokset määrittelee aluehallintovirasto itse aan riskinarviointiinsa perustuen. Eviran riskinarvioinnissa huomioon aiemmilla tteet, tuotantomäärä sekä muut riskitekijät. kriteerit on kirjattava niteltujen tarkastusten lisäksi tarkastuksia a. Aluehallintovirastot raportoivat Eviralle, sekä itse tekemänsä että kuntien Page: 1 -8959-MR of an audit carried out cts (ABP) and derived products by the Competent Authority tu tekemään tarkastukset ennalta sittain.

Member state response

ivutuotevalvonta on sisällytetty Eviran auditointisuunnitelmiin. f Ohjeita ja tarkastuslomakkeita päivitetään ottaen huomioon missiossa havaitut epäkohdat ja valvojia ohjataan valvomaan riittävään dokumentaatioon perustuen. Teurastamoiden valvojia ohjeistetaan varmentamaan tuotettujen eri sivutuoteluokkien määriä ristiintarkastamalla ja vertaamalla määriä teurastettujen eläinten määriin ja teurastamosta lähettyihin sivuotteisiin. Myös käsittelylaitosten sivutuotevirtoja tullaan seuraamaan tehokkaammin. Evira on määräyksessään 1.11.2011 (toimitettu FVO:lle marraskuussa 2011) määrännyt auditointikohteina olleet käsittelylaitokset jatkossa kalibroimaan lämpösähköparit ja painemittarit toimeenpanoasetuksen mukaisesti kerran vuodessa sekä järjestämään riittävät menettelyt sen varmistamiseksi, että partikkelikoko ennen painesterilointia on enintään 50 mm. Käsittelylaitokset ovat vastineessaan 28.11.2011 ilmoittaneet toimivansa jatkossa määräyksen mukaisesti. Jatkossa kalibrointitodistukset ja partikkelikoon seurannan toteutus tarkastetaan jokaisen Eviran tarkastuskäynnin yhteydessä. Myös polttolaitosten Page: 3 ceived on 06 March 2012 of Report ref. DG(SANCO)/2011-8959-MR of an audit car

le sekä turkisrehusekoittamoille (specific 1 päivätty kirje (Dnro 7388/0761/2011), jossa sioista: ja niiden kirjaamisesta, a, uljetuksenaikaisista että omavalvontaan on relatiivisena vai siteltävien erien käsittelylle kirjanpidon säilyttämisestä allisten asiakirjojen a ellaisten laitteiden uusimisesta, utuotteiden käsittelyyn. tujen asioiden toteutumista myös a on tarkastanut toukokuussa 2012 Page: 2 -8959-MR of an audit carried out cts (ABP) and derived products kset ja todennut, että skimateriaalin 10.2011 kaikille reille. FVO:n auditoinnin ssä koulutuksissa: ivillä (16.2.2011) sekä 27.4.2012) on luennoitu ttu tekemään otettujen eri luokan eurastamosta ja rinnakkais- e lähetettiin 31.10.2011 tettiin alvomiensa laitosten dennetusti huolehdittu. mukaisiin isätty laitosten

Member state response

e Keräilyalueilla tapahtuvaan raatojen hautaamiseen on kiinnitetty erityistä omiota jo vuosien ajan. Vuotuisen seurannan lisäksi vuonna 2009 ttoman hautaamisen valvonta ja siihen puuttuminen lääni- ja kansallinen erityishanke. Hautausmäärät ovatkin ävästi ja vuonna 2011 määrä on alle 6 %. Määrää tuskin , ilman tehokasta sanktiomahdollisuutta, josta tullaan sa sivutuotelaissa, jonka valmistelu on jo alkanut 1.11.2011 mukaan auditointikohteena olleen n on ryhdyttävä toimenpiteisiin lainsäädännön pitoisuuden saavuttamiseksi. Käsittelylaitos on neessaan 28.11.2011 muuttavansa GTH:n ä 30.12.2011 mennessä niin, että massan lämpötila on ä vähintään 80 °C. Menetelmän muuttamisen jälkeen n ottanut käyttöön annostelun käyttöönotto- ja , joka koostuu lisättävän GTH:n määrän kirjaamisesta Page: 4 eived on 06 March 2012 of Report ref. DG(SANCO)/2011-8959-MR of an audit carried out alth rules on animal by-products (ABP) and derived products posed by the Competent Authority ittain otettavasta näytteestä. Näytteitä otetaan sekä hosta että rasvasta niin kauan, kunnes analyysit osoittavat, että uus on vakiintunut vähintään lainsäädännön edellyttämälle äytteitä otetaan kuitenkin vähintään neljän kuuk

saattaa voimaan vuoden 2014 alusta Page: 3 -8959-MR of an audit carried out cts (ABP) and derived products t Authority

Member state response

aupalliset asiakirjat tarkastetaan jokaisen Eviran tarkastuskäynnin eydessä ja läänineläinlääkäreitä, kunnaneläinlääkäreitä ja kuntien evalvontaviranomaisia ohjataan tarkastamaan ne huolellisesti astusten yhteydessä. Toimijoita opastetaan kaupallisten en lainsäädännön mukaisessa laatimisessa. e ja valvojille tarkoitetuissa Eviran ohjeissa on liitteinä tuksen mukaiset kaupallisen asiakirjan mallit.

husekoittamoita (specific users) on (Dnro 7388/0761/2011) muistutettu, että ttava kaikilta osin asetuksen 142/2011 kirjanpitoa on säilytettävä laitoksen ää asiaan huomiota tekemiensä Asiasta ohjeistetaan myös muita itoinnin kohteena olleissa äynyt toukokuussa 2012. Kirjanpito oli sesti saatavilla. n otettu huomioon Eviran järjestämissä eläinlääkäreiden jatkokoulutuspäivillä ien koulutuspäivillä (16.3.2012 ja isista asiakirjoista ja siitä että kaikkien eiden mukana on oltava kaupallinen ikki lainsäädännön edellyttämät tiedot. lä 9.11.2011 on luennoitu uosituksista koskien kaupallisia tarkastuksia tekeville tarkastajille 2 tuotiin esille FVO:n auditoinnin Page: 4 012 -8959-MR of an audit carried out cts (ABP) and derived products nt Authority irjojen vaatimuksista ja kaupallisten korostettu tarkastustoimeksiannoissa.

Member state response

iran määräyksen 1.11.2011 mukaan auditointikohteena olleen sittelylaitoksen on järjestettävä riittävät menettelyt sen seksi, että partikkelikoko ennen painesterilointia on enintään tikkelikoon tarkkailu tulee kuvata laitoksen asuunnitelmassa ja HACCP-järjestelmässä sekä työohjeessa. aitos on vastineessaan 28.11.2011 selvittänyt, että molemmille njoille on valmistettu tarkastuslevyt, joissa on 50 mm:n aukko. tuotantolinjoilta otetaan kerran vuorokaudessa näyte, jonka ava tarkastuslevyn aukosta. Page: 5 ceived on 06 March 2012 of Report ref. DG(SANCO)/2011-8959-MR of an audit carried out alth rules on animal by-products (ABP) and derived products on Proposed by the Competent Authority an 3 käsittelylaitoksen osalta tarkastetaan, että hienomurskain on ; jos hienomurskain on ehjä, se hienontaa raaka-aineen ennen esterilointia alle 25 mm:n partikkelikokoon. an 3 käsittelylaitos määrättiin myös laatimaan työohje, jonka isesti toimitaan, jos jonkin käsittelyerän painesterilointi nnistuu. Käsittelylaitos on toimittanut työohjeen Eviraan 0.2011. ttelylaitoksissa tarkastetaan jatkossa jokaisen Eviran tarkastuksen ydessä, että partikkelikoon valvonnasta löytyy kirjanpito. Myös alvontasuunnite

To ensure that the requirements on HACCP based procedures and own checks laid down by Articles 28 and 29 of Regulation (EC) No 1069/2009 are complied with in processing plants.

Member state response

eurastuksessa syntyvien sivutuotteiden hautaus on kielletty äisten alueiden ulkopuolella maa- ja metsätalousministeriön uksella 1192/2011. Koska kotiteurastuksen sivutuotteiden keräilyn estäminen käytännössä vaatii aikaa, annetaan asetuksessa kiellolle tymäaikaa vuoden 2012 loppuun.

To ensure that ABP produced during on-farm slaughtering is disposed of in accordance with Articles 12, 13 and 14 of Regulation (EC) No 1069/2009.

Member state response

nsisäistä ruokintaa käyttävien turkistarhojen rekisteri valmistui ja tettiin käyttöön 17.1.2012. Tilat saadaan rekisteriin vuoden 2012 aikana Evira on lähettänyt ohjeen Suomen Turkiseläinten Kasvattajain Liitolle Page: 6 ived on 06 March 2012 of Report ref. DG(SANCO)/2011-8959-MR of an audit carried out alth rules on animal by-products (ABP) and derived products ction Proposed by the Competent Authority uoden 2011-2012 nahkontakauden aikana otettavista TME-näytteiden ääristä ja kohteista 23.1.2012. Kyseisten tarhojen valvonta on 1.1.2012 oimaan tulleen kansallisen MMM asetuksen No. 1193/2011 mukaan nnettu kunnaneläinlääkärien tehtäväksi, jolloin myös tarhojen oimintaedellytysten toteutumista tullaan jatkossa valvomaan entistä aremmin. ME-tauti on eläintautilain mukaan vastustettava eläintauti, jota päillessään tuottajan on välittömästi oltava yhteydessä irkaeläinlääkäriin. uottajille tullaan lähettämään kirje, jossa muistutetaan TME-taudista, en oireista, ilmoitusvelvollisuudesta tautiepäilytilanteessa sekä ajinsisäisen käytön vaatimuksista.

Ma 1123/2011 mukaan jatkossa ekistereihin. Tällä hetkellä toimivien öityä viimeistään 29.6.2012. Rekisteröinnin rkistarhojen lajinsisäinen käyttö. Tietoa ja tä, rekisteröinneistä ja TSE-taudeista rjeitse Evirasta vuoden 2012 aikana. Tästä ehden välityksellä ja turkistarhaajien in kautta.

Member state response

Maa- ja metsätalousministeriö on huomioinut annetun suosituksen ja esittänyt lausuntovaiheessa olevassa asetusmuutoksessa muutoksia isättäviin aineisiin. MMM on esittänyt sekoitettavaksi aineeksi äsiteltyä siipikarjanlantaa ja turkiseläintenlantaa 3 % pitoisuutena ja aliumsulfaatin poistamista sallittuna aineena vuoden 2012 jälkeen. setuskäsittelyn yhteydessä maa- ja metsätalousministeriö on pyytänyt lan asiantuntijoilta lausuntoa esitetyistä muutoksista. aa- ja metsätalousministeriö on esittänyt muutettavaksi oimassaolevaa asetusta siten että maatalouskäyttöön markkinoitaviin Page: 7 ived on 06 March 2012 of Report ref. DG(SANCO)/2011-8959-MR of an audit carried out alth rules on animal by-products (ABP) and derived products the Competent Authority ina tehtävä artiklan 22 mukainen lisäys. Page: 8

tuksella 12/12 määrännyt Suomessa lannoitteen ruokintakäyttöä estäväksi arjan tai turkiseläinten lannan vähintään 6 % uudesta lisättäväksi aineeksi MMM on aatalouden tutkimuskeskukselta ja saanut ngin yliopiston alan asiantuntijoilta. aatin käyttö sallittuna lisäaineena on Page: 5 -8959-MR of an audit carried out cts (ABP) and derived products siten että on aina tehtävä artiklan rkoitettujen ainesosien aste from international means of transport is nt". Tämä ei pidä paikkansa, sillä kansainvälinen