DG SANTE update: 1. New R 2017/625_ EURLs/NRLs 2. New Campylobacter PHC

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1 DG SANTE update: 1. New R 2017/625_ EURLs/NRLs 2. New Campylobacter PHC 1 2 th w o r k sh op o f t h e EU R L C a m p y lo b a ct e r S e p t e m b e r Nantes Pamina M. Suzuki Unit G4 - Food hygiene Directorate G - Crisis management in food, animals and plants DG Health and Food Safety (DG SANTE) 1

2 The new Official Control Regulation (EU) 2017/625 (OCR) Published in the Official Journal on 7 April 2017 Replaces Regulation (EC) No 882/2004 (and R 854/2004) Framework legislation on all controls by competent authorities including official sampling and analyses and requirements for official laboratories, NRLS and EURL To be completed by 34 delegated acts and 51 implementing acts 2

3 Structure of the OCR

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

5 Provisions on EURLs and NRLs Title III (Art ) - Reference laboratories Key principles: Broader scope (Plant Health) Transparency and efficiency - Decision and designation of EURLs - More specific and more precise requirements, responsibilities and tasks Accountability - Distribution of responsibilities among COM, MS, EURLs and NRLs 5

6 Building-up the legislative framework Step 1- Decision to establish a EURL official controls depend on the quality, uniformity and reliability of methods and results need to promote uniform practices in relation to the development or use of the methods Step 2- Designation of EURL Public selection process Limited in time, with minimum period of 5 years or reviewed regularly Accredited according to ISO/IEC (operating, methods of laboratory analysis and others and in a flexible manner) 6

7 EURLs Requirements Staff: Impartial, confidentiality - Suitably, training + support - International Standards - Updated Infrastructure, equipment + products - According to needs - Emergency situations OCR Equipped to comply with relevant biosecurity standards 7

8 Responsibilities and tasks of EURLs 882 Improvement + harmonization of tests develop annual/multiannual WP Scientific + technical assistance COM + NRLs (incl. training courses) assist during outbreaks OCR publish list of NRLs provide reference materials (if in WP) more specific: proficiency tests, followup & inform COM + MS cooperate to develop new methods collaborate with Third Countries, with EFSA, EMA and ECDC 8

9 Designation of NRLs 882 MSs to designate > 1 NRLs for each EURL MS may designate lab in another MS/ 3 rd Country NRL may be designated > 1 MS OCR MS may designate a NRL even if no EURL Official communication to COM, EURL + MS and public information of the name and address 9

10 882 NRLs Requirements OCR Staff: - Impartial, confidentiality - Suitably and training + support - International Standards Infrastructure, equipment and products - According to needs - Emergency situations Scope of accreditation Equipped with relevant biosecurity standards CA shall organise audits Withdraw the designation if doesn't comply with: - ISO Obligations - Expected results in proficiency tests 10

11 Responsibilities and tasks of NRLs 882 Methods of analysis + tests to official labs (OL) ensure dissemination to CA + OLs of info provided by EURL Scientific + technical assistance to CA for Multi Annual National Control Plan (MANCP) OCR Inform CA proficiency tests results and follow-up Conduct training courses for OLs Reference materials* Validate establish + maintain updated lists reference materials + manufacturers Assist CA in outbreaks 11

12 Obligations of Official Laboratories (OL) Title II, Chapter IV, Article 38 - Inform immediately CA if results indicate risk to human, animal or plant health, or as regards GMOs and plant protection products, also to the environment or point to the likelihood of non-compliance - Upon request by: EURL or NRL OL shall take part in proficiency tests. Competent Authorities: OL shall make available to the public methods used for analyses performed official controls OL shall indicate the results together with the method used for each 12 analysis

13 Obligations of the MS 882 designate NRLs OCR ensure coordination between NRLs work closely together communicate details of NRLs to COM, EURLs and other MS Update and make available to public details NRLs (name and address) 13

14 2017 J F March April M J J A S O N D April ADOPTION Timeline for EURLs 1 year ENTRY INTO FORCE APPLICATION DATE 14

15 2. The new Campylobacter Process Hygiene Criterion (PHC) on broiler meat 15

16 Content Background Campylobacter process hygiene criterion Sampling rules for Salmonella & Campylobacter Testing in the SAME lab Testing in DIFFERENT labs Campylobacter PHC - Sampling frequencies 16

17 Background high public health relevance of Campylobacter: most frequently reported foodborne pathogen in the EU broiler meat identified as the main cause of campylobacteriosis cases (2010 EFSA opinion) 2012 EFSA opinion suggests the introduction of a PHC for Campylobacter on broiler carcases: o if broiler meat <1000 cfu/g 50% public health risk reduction Setting PHC at slaughterhouse: best cost-effective control option (Cost-benefit analysis) 17

18 The 50 samples shall be derived from 10 consecutive sampling sessions in accordance with the sampling rules and frequencies laid down in this Regulation Interpretation of the test results - Campylobacter spp. in poultry carcases of broilers: satisfactory, if a maximum of c/n values are > m, unsatisfactory, if more than c/n values are > m. ; 18

19 Sampling rules for Campylobacter & Salmonella testing in the SAME LAB 1. Neck skins from a minimum of 15 poultry carcases shall be sampled at random after chilling during each sampling session. 2. Before examination, the neck skin samples from at least three poultry carcases from the same flock of origin shall be pooled into one sample of 26 g. Thus, the neck skin samples form 5 26 g final samples (26 g are needed to perform analyses for Salmonella and Campylobacter from one sample in parallel). 3. The samples shall be kept after sampling and transported to the laboratory at a temperature not lower than 1 C and not higher than 8 C and the time between the sampling and the testing for Campylobacter shall be of less than 48 hours in order to ensure maintenance of sample integrity. Samples that have reached a temperature of 0 C shall not be used to verify compliance with the Campylobacter criterion. 19

20 Sampling rules for Campylobacter & Salmonella testing in the SAME LAB 3. The 5 26 g samples shall be used to verify the compliance with process hygiene criteria set out in Row and Row of Chapter 2 and the food safety criterion set out in Row 1.28 of Chapter In order to prepare the initial suspension at the laboratory, the 26 g test portion shall be transferred to nine volumes (234 ml) buffered peptone water (BPW). The BPW shall be brought to room temperature before adding. The mixture shall be treated in a stomacher or pulsifier for approximately one minute. Foaming shall be avoided by removing the air from the stomacher bag as much as possible. 10 ml (~ 1 g) of this initial suspension shall be transferred to an empty sterile tube and 1 ml of the 10 ml shall be used for the enumeration of Campylobacter on selective plates. The rest of the initial suspension (250 ml ~ 25 g) shall be used for the detection of Salmonella. 20

21 Campy & Salmonella Testing in SAME LAB e.g. 15 carcases after chilling (26 g) (26 g) (26 g) (26 g) (26 g) 5 final samples of 26 g Salmonella & Campylobacter 21

22 Sampling rules for Campylobacter & Salmonella testing in LABS 1. Neck skins from a minimum of 20 poultry carcases shall be sampled at random after chilling during each sampling session. 2. Before examination, the neck skin samples from at least four poultry carcases from the same flock of origin shall be pooled into one sample of 35 g. 3. Thus, the neck skin samples form 5 35 g samples, which in turn shall be split in order to obtain 5 25 g final samples (to be tested for Salmonella) and 5 10 g final samples (to be tested for Campylobacter). 22

23 Sampling rules for Campylobacter & Salmonella testing in the SAME LAB 4. The samples shall be kept after sampling and transported to the laboratory at a temperature not lower than 1 C and not higher than 8 C and the time between the sampling and the testing for Campylobacter shall be of less than 48 hours in order to ensure maintenance of sample integrity. Samples that have reached a temperature of 0 C shall not be used to verify compliance with the Campylobacter criterion. 5. The 5 25 g samples shall be used to verify the compliance with process hygiene criteria set out in Row of Chapter 2 and the food safety criterion set out in Row 1.28 of Chapter 1. The 5 10 g samples shall be used to verify the compliance with the process hygiene criterion set out in Row of Chapter 2. 23

24 25 g Campy & Salmonella Testing in LABS 10 g 25 g 10 g 25 g 10 g 25 g 10 g 25 g 10 g e.g. 20 carcases after chilling (35 g) (35 g) (35 g) (35 g) (35 g) 24

25 25 g Campy & Salmonella Testing in LABS 10 g 25 g 10 g 25 g 10 g 25 g 10 g 25 g 10 g e.g. 20 carcases after chilling (10g neck skin each) (35 g) (35 g) (35 g) (35 g) (35 g) 5 final samples of 25 g Salmonella testing 5 final samples of 10 g 25 Campylobacter testing

26 Campy PHC - Sampling frequencies Weekly The frequency may be reduced: to fortnightly IF satisfactory results have been obtained for 52 consecutive weeks IF national/regional control programmes for Campylobacter in place The sampling frequency may be further reduced IF low contamination level of Campylobacter is reached over a 52-week period in the farms of origin of the broilers purchased by the slaughterhouse. In case the control programme shows satisfactory results during a specific period of the year, frequency of analysis of Campylobacter may also be adjusted to seasonal variations after authorisation by the competent authority. 26

27 Thank you! Questions?! 27