COMMISSION REGULATION (EU) …/…

of XXX

amending Annex I to Regulation (EC) No 2073/2005 as regards Campylobacter in broiler carcases

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs 1 , and in particular Article 4(4) thereof,

Whereas:

(1)Commission Regulation (EC) No 2073/2005 2  lays down the microbiological criteria for certain micro-organisms and the implementing rules to be complied with by food business operators in respect of the general and specific hygiene requirements referred to in Article 4 of Regulation (EC) No 852/2004.

(2)In particular, Regulation (EC) No 2073/2005 lays down process hygiene criteria which set indicative contamination values above which corrective actions are required in order to maintain the hygiene of the process in compliance with food law.

(3)The "European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2015" 3  published by the European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control (ECDC) states that human campylobacteriosis is the most reported human food-borne illness in the Union with around 230 000 cases reported annually .

(4)In 2010 the EFSA published the analysis of the baseline survey on the prevalence of Campylobacter in broiler batches and carcases 4 . The baseline survey was carried out at slaughterhouse level in 2008 to obtain comparable figures on the prevalence and the level of contamination of broilers in the Union. EFSA concluded that broiler carcases were contaminated at an average of 75.8% with significant variations between Member States and slaughterhouses.

(5)According to the EFSA Scientific Opinion on the risk of human campylobacteriosis linked to broiler meat 5 , published in 2010, handling, preparation and consumption of broiler meat may account for 20% to 30% of human cases of campylobacteriosis, while 50% to 80% may be attributed to the chicken reservoir as a whole.

(6)The EFSA Scientific Opinion on control options for Campylobacter along the poultry meat production chain, published in 2011 6 , suggests a number of control options both at farm and at slaughterhouse level and estimates their impacts on the reduction of the number of human cases, including the introduction of a process hygiene criteria for Campylobacter. The EFSA estimates that a public health risk reduction from the consumption of broiler meat of more than 50% could be achieved if carcases complied with a limit of 1000 cfu/g and highlighted that significant different contamination levels exist between neck skin and breast skin samples.

(7)The EFSA also published in 2012 a Scientific Opinion on the public health hazards to be covered by inspection of poultry meat, which identifies Campylobacter as of high public health relevance 7 , and recommends the adaptation of the current inspection methods of poultry carcases to address Campylobacter. In particular the EFSA suggests introducing a process hygiene criterion for Campylobacter on broiler carcases..

(8)Based on the EFSA opinions of 2010 and 2011, the Commission commissioned an analysis of the costs and benefits of setting certain control measures for reduction of Campylobacter in broiler meat at different stages of the food chain 8 . The main conclusion of this cost-benefit analysis is that setting a process hygiene criterion to Campylobacter in broiler carcases would provide one of the best balances between reducing human campylobacteriosis attributed to the consumption of poultry meat and economic consequences from the application of the criterion.

(9)The process hygiene criterion for Campylobacter in broiler carcases aims at controlling contamination of carcases during the slaughtering process. In addition in order to ensure a whole chain approach as recommended by the EFSA opinion on control options for Campylobacter, control measures should also be considered at farm level.

(10)Control of Campylobacter continues to prove challenging, as vertical transmission does not appear to be an important risk factor and all depends on how effective the biosecurity measures are at excluding Campylobacter from the broilers. A step by step approach should therefore be considered, making the process hygiene criteria gradually stricter in time. Nevertheless to maintain the same level of protection in Member States where such level of protection has been already achieved, Article 5(5) of Regulation (EC) No 2073/2005 provides sufficient flexibility to apply a stricter process hygiene criterion as such alternative criterion provides for at least equivalent guarantees as the reference criterion set in Regulation (EC) No 2073/2005.

(11)In order to reduce the administrative burden for food business operators, the sampling plan for the criterion on Campylobacter should follow the same testing approach as for the process hygiene criterion set for Salmonella in poultry carcases. The same neck skin samples used for testing compliance with the process hygiene criterion set for Salmonella in poultry carcases may therefore be used for the Campylobacter analyses.

(12)The international standard EN ISO 10272-2 is the horizontal method for the enumeration of Campylobacter in food and feed stuffs. It should therefore be laid down as a reference method verifying compliance with the criterion for Campylobacter in poultry carcases.

(13)It is appropriate to defer the date of application of this Regulation in order to give sufficient time for food business operators to adapt their current practices to the new requirements and to allow laboratories performing Campylobacter analyses to implement the new test methods laid down in this Regulation.

(14)Regulation (EC) No 2073/2005 should therefore be amended accordingly.

(15)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed Committee.

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EC) No 2073/2005 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 January 2018.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

(1) OJ L 139, 30.4.2004, p. 1.

(2) OJ L 338, 22.12.2005, p. 1.

(3) EFSA Journal 2016;14(12): 4634.

(4) EFSA Journal 2010; 8(03): 1503.

(5) EFSA Journal 2010: 8(1): 1437.

(6) EFSA Journal 2011;9(4): 2105.

(7) EFSA Journal 2012;10(6): 2741.

(8) https://ec.europa.eu/food/sites/food/files/safety/docs/biosafety_food-borne-disease_campy_cost-bene-analy.pdf

ANNEX

Annex I to Regulation (EC) No 2073/2005 is amended as follows:

(1)in Chapter 2, Section 2.1 is amended as follows:

(a)the table is amended as follows:

(ii)the following row 2.1.9 is added:

(ii)footnote 2 is replaced by the following:

_______________________

"(2)For points 2.1.3-2.1.5 and 2.1.9 m = M."

(b)under the heading “Interpretation of the test results”, the following text is added:

"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."

(4)In Chapter 3, Section 3.2 is replaced by the following:

"3.2Bacteriological sampling in slaughterhouses and at premises producing minced meat, meat preparations, mechanically separated meat and fresh meat.

Sampling rules for carcases of cattle, pigs, sheep, goats and horses

The destructive and non-destructive sampling methods, the selection of the sampling sites and the rules for storage and transport of samples to be used are set out in standard ISO 17604.

Five carcases shall be sampled at random during each sampling session. Sample sites must be selected taking into account the slaughter technology used in each plant.

When sampling for analyses of Enterobacteriaceae and aerobic colony counts, four sites of each carcase shall be sampled. Four tissue samples representing a total of 20 cm2 shall be obtained by the destructive method. When using the non- destructive method for this purpose, the sampling area shall cover a minimum of 100 cm2 (50 cm2 for small ruminant carcases) per sampling site.

When sampling for Salmonella analyses, an abrasive sponge sampling method shall be used. Areas most likely to be contaminated shall be selected. The total sampling area shall cover a minimum of 400 cm2.

When samples are taken from the different sampling sites on the carcase, they shall be pooled before examination.

Sampling rules for poultry carcases and fresh poultry meat

Slaughterhouses shall sample whole poultry carcases with neck skin for Salmonella and Campylobacter analyses. Cutting and processing establishments other than those adjacent to a slaughterhouse cutting and processing meat received only from this slaughterhouse, shall also take samples for Salmonella analysis. When doing so, they shall give priority to whole poultry carcases with neck skin, if available, but ensuring that also poultry portions with skin and/or poultry portions without skin or with only a small amount of skin are covered, and that choice shall be risk-based.

Slaughterhouses shall include in their sampling plans poultry carcases from flocks with an unknown Salmonella status or with a status known to be positive for Salmonella Enteritidis or Salmonella Typhimurium.

When testing against the process hygiene criteria set out in Row 2.1.5 and Row 2.1.9 of Chapter 2 for Salmonella and Campylobacter in poultry carcases in slaughterhouses and the tests for Salmonella and Campylobacter are carried out in the same laboratory, neck skins from a minimum of 15 poultry carcases shall be sampled at random after chilling during each sampling session. 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 x 26 g final samples (26 g are needed to perform analyses for Salmonella and Campylobacter from one sample in parallel). The samples shall be kept after sampling and transported to the laboratory at a temperature not lower than 1ºC and not higher than 8ºC 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 ºC shall not be used to verify compliance with the Campylobacter criterion. The 5 x 26 g samples shall be used to verify the compliance with process hygiene criteria set out in Row 2.1.5 and Row 2.1.9 of Chapter 2 and the food safety criterion set out in Row 1.28 of Chapter 1. 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 (~1g) 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 ~ 25g) shall be used for the detection of Salmonella.

When testing against the process hygiene criteria set out in Row 2.1.5 and Row 2.1.9 of Chapter 2 for Salmonella and Campylobacter in poultry carcases in slaughterhouses and the tests for Salmonella and Campylobacter are carried out in two different laboratories, neck skins from a minimum of 20 poultry carcases shall be sampled at random after chilling during each sampling session. Before examination, the neck skin samples from at least four poultry carcases from the same flock of origin shall be pooled into a sample of 35g. Thus, the neck skin samples form 5 x 35 g samples, which in turn shall be split in order to obtain 5 x 25 g final samples (to be tested for Salmonella) and 5 x 10 g final samples (to be tested for Campylobacter). The samples shall be kept after sampling and transported to the laboratory at a temperature not lower than 1ºC and not higher than 8ºC 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 ºC shall not be used to verify compliance with the Campylobacter criterion. The 5 x 25 g samples shall be used to verify the compliance with process hygiene criteria set out in Row 2.1.5 of Chapter 2 and the food safety criterion set out in Row 1.28 of Chapter 1. The 5 x 10 g final samples shall be used to verify the compliance with the process hygiene criterion set out in Row 2.1.9 of Chapter 2. 

For the Salmonella analyses for fresh poultry meat other than poultry carcases, five samples of at least 25 g of the same batch shall be collected. The sample taken from poultry portions with skin shall contain skin and a thin surface muscle slice in case the amount of skin is not sufficient to form a sample unit. The sample taken from poultry portions without skin or with only a small amount of skin shall contain a thin surface muscle slice or slices added to any skin present to make a sufficient sample unit. The slices of meat shall be taken in a way that includes as much as possible of the surface of the meat. '

Guidelines for sampling

More detailed guidelines on the sampling of carcases, in particular concerning the sampling sites, may be included in the guides to good practice referred to in Article 7 of Regulation (EC) No 852/2004.

Sampling frequencies for carcases, minced meat, meat preparations, mechanically separated meat and fresh poultry meat

The food business operators of slaughterhouses or establishments producing minced meat, meat preparations, mechanically separated meat or fresh poultry meat shall take samples for microbiological analysis at least once a week. The day of sampling shall be changed each week to ensure that each day of the week is covered.

As regards the sampling of minced meat and meat preparations for E. coli and aerobic colony count analyses and the sampling of carcases for Enterobacteriaceae and aerobic colony count analyses, the frequency may be reduced to fortnightly testing if satisfactory results are obtained for six consecutive weeks.

In the case of sampling for Salmonella analyses of minced meat, meat preparations, carcases and fresh poultry meat, the frequency may be reduced to fortnightly if satisfactory results have been obtained for 30 consecutive weeks. The Salmonella sampling frequency may also be reduced if there is a national or regional Salmonella control programme in place and if this programme includes testing that replaces the sampling laid down in this paragraph. The sampling frequency may be further reduced if the national or regional Salmonella control programme demonstrates that the Salmonella prevalence is low in animals purchased by the slaughterhouse.

In the case of sampling for Campylobacter analysis of poultry carcases, the frequency may be reduced to fortnightly if satisfactory results have been obtained for 52 consecutive weeks. The Campylobacter sampling frequency may be reduced, after authorisation by the competent authority, if there is an official or officially recognised national or regional Campylobacter control programme in place and if this programme includes sampling and testing equivalent to the sampling and testing required for verifying compliance with the process hygiene criterion set out in Row 2.1.9 of Chapter 2. If low contamination level of flocks is set for Campylobacter in the control programme, the sampling frequency may be further reduced if this low contamination level of Campylobacter is reached over a 52 weeks 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.

However, when justified on the basis of a risk analysis and consequently authorised by the competent authority, small slaughterhouses and establishments producing minced meat, meat preparations and fresh poultry meat in small quantities may be exempted from these sampling frequencies.".