CELEX: 52008PC0553
Language: en
Date: 2008-09-18
Title: Proposal for a Council Regulation on the protection of animals at the time of killing {SEC(2008) 2424} {SEC(2008) 2425}

Important legal notice

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52008PC0553

Proposal for a Council Regulation on the protection of animals at the time of killing {SEC(2008) 2424} {SEC(2008) 2425}  /* COM/2008/0533 final - CNS 2008/0180 */  

	[pic] | COMMISSION OF THE EUROPEAN COMMUNITIES |Brussels, 18.9.2008COM(2008) 553 final2008/0180 (CNS)Proposal for aCOUNCIL REGULATIONon the protection of animals at the time of killing(presented by the Commission){SEC(2008) 2424}{SEC(2008) 2425}EXPLANATORY MEMORANDUMCONTEXT OF THE PROPOSALGrounds for and objectives of the proposalThe technical requirements of Directive 93/119/EC[1] on the protection of animals at the time of slaughter or killing have never been amended although the context has changed.New technologies have been introduced making some standards obsolete. In 2004 and 2006 two scientific opinions from the European Food Safety Authority suggested revising the Directive. In parallel the World Organisation for Animal Health adopted in 2005 two guidelines on the welfare of animals at slaughter and killing leading to similar conclusions.Animal welfare concerns have grown in our society. The legal environment has changed for slaughterhouses with the adoption of a series of EU legislative acts on food safety which emphasises the responsibilities of business operators. Mass killing during animal epidemics has raised questions about the methods used to carry them out. In 2006 the Commission adopted the first Community Action Plan on the Protection and Welfare of Animals, introducing new concepts such as the welfare indicators and centres of reference on animal welfare.Specific problems have been identified with the EU legislation such as the lack of harmonised methodology for new stunning methods, the lack of clear responsibilities for operators, the insufficient competence of personnel or insufficient conditions for the welfare of animals during killing for disease control purposes.In light of this the proposal provides substantial added value compared to the status quo.In particular by changing the legal instrument from a directive to a regulation, the proposal provides for uniform and simultaneous application, avoiding the burden and inequalities due to national transpositions. The form of a regulation is also suitable for faster implementation of changes due to technical and scientific progress. It also provides for a single set of rules making them more visible and easier to apply both for EU operators and trading partners.The proposal also contains greater flexibility for operators through the adoption of guidelines on detailed technical matters. At the same time it requires operators to take real ownership of animal welfare (self-checks on stunning procedure, standard operating procedures), and therefore contributes to a better enforcement of animal welfare at slaughter.The proposal also aims to develop learning mechanisms based on sound science (certificate of competence, centre of reference), to make animal welfare better understood and integrated in the daily tasks of animals handlers, slaughtermen and official inspectors.The main objectives of the proposal are aimed at:(1) Improving the protection of animals at the time of slaughter or killing.(2) Encouraging innovation in relation to stunning and killing techniques.(3) Providing a level playing field within the internal market for the operators concerned.In addition, this proposal will aim to achieve the following specific objectives:(1) Develop a common methodological approach to encourage new stunning methods.(2) Ensure better integration of animal welfare concerns into the production process through the requirement of Standard Operating Procedures and the appointment of Animal Welfare Officers in slaughterhouses.(3) Upgrade the standards governing slaughterhouse construction and equipment.(4) Increase the level of competence of the operators and officials concerned.(5) Improve the protection of animals during mass killing operations.General contextThis proposal will replace Directive 93/119/EC on the protection of animals at the time of slaughter or killing, which covers the killing of farmed animals.Every year nearly 360 million pigs, sheep, goats and cattle as well as more than four billion poultry are killed in EU slaughterhouses. In addition, the European fur industry kills 25 million animals, while hatcheries kill 330 million day-old-chicks. The control of contagious diseases may also require the killing of millions of animals.The present situation is not satisfactory in relation to the objectives pursued. The level of animal protection is unequally enforced in the Member States, with sometimes very unsatisfactory results. Discrepancies in requirements in the Member States for slaughterhouses and manufacturers of stunning equipment do not ensure a level playing field for them, although they compete on a global market. This situation does not encourage innovation either.Existing provisions in the area of the proposalDirective 93/119/EC will be repealed but the scope of the proposal will remain unchanged.Consistency with the other policies and objectives of the UnionNot applicable.CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENTConsultation of interested partiesConsultation methods, main sectors targeted and general profile of respondentsIn 2006 the Commission ordered an external study on the stunning practices in slaughterhouses and their economic, social and environmental consequences. In the course of the study, major stakeholders such as meat industry associations, competent authorities and animal welfare organisations were consulted.The Commission also had direct contacts with the stakeholders and with scientific, technical and legal experts concerning different aspects of the proposal. Consultations started from July 2006. The initiative was publicised through presentations at industry forums and within relevant advisory committees or groups of the Commission during the period 2006–2007.Specific webpages were created and regularly updated to inform the public about the initiative. From December 2007 to February 2008 a mailbox was opened and stakeholders invited to provide their views. The initiative was presented to the Member States via a working group in January 2008.Summary of responses and how they have been taken into accountStakeholders and Member States agreed on the principle that operators should be made more responsible for animal welfare. Stakeholders welcomed the proposal for a Regulation rather than a Directive, while Member States were divided.There was large support for introducing requirements governing Standard Operating Procedures (SOPs), and the idea of an Animal Welfare Officer (AWO) was also well received. However, animal welfare organisations and some Member States stressed the need for keeping prescriptive requirements. Other participants expressed concerns about the requirements regarding SOPs and an Animal Welfare Officer for small slaughterhouses.In light of the studies and consultations carried out, the Commission concluded that while most large scale slaughterhouses in the EU already employ a person in charge of meat quality control (who can combine the roles of supervising SOPs and of AWO at limited extra cost), this is not the case today for small slaughterhouses. As a consequence, a derogation to the AWO requirement for very small slaughterhouses has been foreseen, due to the lack of proportionality of the measure in comparison with the small number of animals slaughtered, and to avoid possible distortions of competition.All parties consulted accepted that stunning methods should be better defined.They also agreed on the need for a better knowledge policy since both official inspectors and operators sometimes lacked technical assistance. They all supported the idea of a certificate of competence. The principle of a national centre of reference received more mixed support. The Member States were worried about establishing a new administrative structure and the possible budgetary implications.Better preparedness and reporting on animal welfare in case of killing for disease-control purposes received a positive response from the Member States. Some Member States would prefer to strictly adhere to international guidelines while others would advocate a certain amount of flexibility.The above comments were taken into account as follows:(a) Concerns about the lack of prescriptive requirements were addressed through the requirement for there to be a national centre of reference. In addition the proposal contains the obligation for manufacturers of stunning equipment to provide guidance on use of their equipment. Member States should also develop codes of good practices.(b) Concerns regarding the costs related to the implementation of new standards governing infrastructures of slaughterhouses were addressed through the establishment of a transitional period for this requirement.(c) Concerns concerning administrative costs related to the establishment of national centres of reference were addressed by amending the requirements through a more flexible structure.(d) In reply to the concerns regarding the administrative burden related to the AWO, the proposal envisages the possibility of a derogation for small slaughterhouses.(e) In reply to the concerns about the lack of flexibility in a disease-control situation, the proposal provides for derogation when the killing involves serious human or animal health risks.An open consultation was conducted over the Internet from 20.12.2007 to 20.02.2008. The Commission received 10 responses. The results are available on http://ec.europa.eu/food/animal/welfare/slaughter/slaughter_stakeholders_en.htm.Collection and use of expertiseScientific/expertise domains concernedAnimal welfare, food safety, animal health.Methodology usedA number of references were consulted and in particular the opinions of the European Food Safety Authority from 2004 and 2006, international guidelines (OIE guidelines on slaughter and killing), national legislations within and outside the Community (USA, UK, France, New Zealand, etc.). All the relevant Food and Veterinary Office reports were also taken into account as was the external study conducted for the purpose of the Impact Assessment.Several experts were consulted (scientists, consultants or governmental experts) as well as stakeholders: slaughterhouses (red meat and poultry), farmers’ organisation, veterinarians, religious groups, animal protection organisations, manufacturers of stunning equipment.Main organisations/experts consultedAnglia-Autoflow — equipment manufacturerAnimals’ Angels — animal welfare organisationAVEC — poultry meat industryAEH — Association of European HatcheriesButina — equipment manufacturerCIWF — animal welfare organisationCOPA-COGECA — farmersEUROGROUP FOR ANIMALS — animal welfare organisationEPEXA — Association of European Hatching Egg, One-Day-Olds and Pullet ExportersEuropean Fur Breeders’ AssociationFederation of Veterinarians of EuropeFinnish Fur Breeders’ AssociationAFSSA — French Agency for Food SafetyFNICGV — red meat industryHumane Slaughter Association — animal welfare organisationIBC — International Butchers’ ConfederationOABA — animal welfare organisationPVE (Product Boards for Livestock, Meat and Eggs) — meat industryStork Food Systems — equipment manufacturerUECBV — red meat industrySummary of advice received and usedThe existence of potentially serious risks with irreversible consequences was not mentioned. In their 2004 opinion the EFSA scientists put forward over twenty technical recommendations. The following EFSA recommendations were integrated into the proposal:-  proper training for operators stunning animals;-  constant-current equipment for electrical stunning-  recording system for electrical parameters;-  recording system for gas parameters;-  limiting the use of non-penetrative captive bolt to young lambs;-  several technical improvements on the shackle line for poultry;-  severing both carotid arteries for bleeding;-  requesting gas killing for poultry (non-reversible stun).Some recommendations were not included in the proposal because the impact assessment revealed that they were not economically viable at present in the EU. This was the case in particular for the following recommendations:-  phasing out the use of carbon dioxide for pigs and poultry;-  phasing out the use of waterbath stunners for poultry.Other recommendations are not in the proposal because they refer to parameters that should be part of implementing measures.Recommendations on farm fish were not included in the proposal either because there was a need for further scientific opinion and economic evaluation in this field.Means used to make the expert advice publicly availableEFSA opinions and OIE guidelines are publicly available on the Internet:http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_home.htmhttp://www.oie.int/eng/normes/mcode/en_titre_3.7.htm.Impact assessmentThe main policy options envisaged ranged from the status quo, deregulation, technical amendments to the Directive or reorganisation of the legislation.Slaughtering costs constitute a limited portion of the total costs of slaughterhouse activities (20%) but could affect their competitiveness. Slaughterhouses are subjected to permanent official inspection through food safety legislation. The proposal does not introduce additional requirements for official inspections. Animal welfare has a positive impact on meat quality and occupational safety. It also represents positive market values. No significant environmental impacts have been identified.From comparison of the main policy options envisaged it appears that reorganising the legislation would appear to be the most advantageous choice.More specifically, the impact assessment investigates the following aspects of the reorganisation of legislation.As regards authorisation of new stunning methods, a centralised system would be a valid alternative, while a partially decentralised system would have some benefits especially in terms of flexibility and costs.Better integration of animal welfare into the process of production brings clear positive outcomes for the welfare of animals, occupational safety and meat quality. This could be done through requiring Standard Operating Procedures (SOPs) and/or the appointment of an Animal Welfare Officer. Economic costs are limited for both options, and slaughterhouses which have already implemented such measures appreciate the economic benefits.The impact assessment also indicates that there is a need for updating the standards of slaughterhouse infrastructures. It will bring social benefits, and investment costs can be reduced if a reasonable transitional period is considered.Better competence of personnel killing animals as well as setting up a specific national structure for providing technical back-up on animal welfare for officials appear to be two complementary approaches. Knowledge policy is highly efficient in terms of animal welfare, flexible for the industry and socially positive for personnel.Finally, on the issue of mass killing of animals it also indicates that a flexible option is more likely to deliver results than a traditional prescriptive approach.LEGAL ELEMENTS OF THE PROPOSALSummary of the proposed actionThe proposal will increase operators' responsibility for animal welfare. This is in line with the “hygiene package”, a raft of food safety legislation adopted in 2004 obliging operators to integrate food safety into their operations and to demonstrate that they are implementing procedures for that purpose. This approach is also consistent with the Community Action Plan on the Protection and Welfare of Animals that introduced the concept of animal welfare indicators measured on animals.The proposal will make it compulsory for personnel handling and/or slaughtering animals to possess a certificate of competence. The requirement will apply to slaughterhouses and to killing in the context of fur farming.The proposal will require each Member State to establish a national centre of reference that will provide technical assistance to officials on animal welfare at killing. The centre will provide scientific assessment for new stunning methods/equipment and newly built slaughterhouses, and will accredit bodies delivering certificates of competence concerning animal welfare.The proposal will provide precise definitions for stunning methods. It will also set up a common system for authorising new methods of stunning.The proposal will ensure that animal welfare is considered at all stages of the killing process for disease-control purposes. This will imply better preparedness but also specific animal welfare supervision and reporting to the public.In line with the hygiene regulation the proposal allows slaughter for private consumption (e.g. on farms and in backyards) provided that the general requirements of this regulation are met and in particular prior stunning.Legal basisArticle 37 of the Treaty of the European Community.Subsidiarity principleThe subsidiarity principle applies insofar as the proposal does not fall under the exclusive competence of the Community.The objectives of the proposal cannot be sufficiently achieved by the Member States for the following reason.Meat, fur and other products related to the killing of farmed animals are traded internationally. Stunning and restraining equipment is also commercialised beyond national borders. Discrepancies in welfare standards governing the killing of animals between the Member States affect the competitiveness of slaughterhouses, farmers, hatcheries and manufacturers of stunning equipment.Community action will better achieve the objectives of the proposal for the following reason.Products derived from those activities are freely traded within the EU. Therefore, the EU action is likely to have a more coherent effect and better achieve the objectives proposed.It is difficult to find indicators that would reflect the situation as regards the objectives of the proposal in a non-ambiguous way. The level of use of some irreversible methods of stunning would appear to reflect a certain level of improvement in animal welfare for poultry or pigs. However, the use of stunning methods is also influenced by economical factors.The scope of the proposal is limited to the killing of farmed animals. Those activities are largely harmonised through other Community legislations.The killing of companion animals, or performed as part of hunting or sporting activities, is not part of the proposal and remains under national competence.The proposal also allows for national measures so as to reflect the provisions of the Protocol on Protection and Welfare of Animals which refers to the need to respect national provisions relating to religious rites, cultural traditions and regional heritage.The proposal therefore complies with the subsidiarity principle.Proportionality principleThe proposal complies with the proportionality principle for the following reason(s).A Regulation offers the following advantages:-  it provides a uniform and simultaneous application in all the Member States and avoids the burden, both for the Member States and the Commission, of transposition;-  the updating of a Regulation can be more rapidly implemented; this is welcomed in this area which is subject to technical and scientific progress.-  it provides a single set of rules making them more visible and easier to apply for operators and the EU's main trading partners.The proposal has no financial implications for the Community. The impact assessment indicated that the financial implications will mainly affect operators who have poorly implemented the current EU rules. In addition, transitional periods have been laid down for measures related to the infrastructures of slaughterhouses as well as for taking into account employees already working in slaughterhouses. Derogation is also considered for small slaughterhouses as regards the requirement for an Animal Welfare Officer.The economic study also indicated that among the slaughterhouse operators that have implemented the measures mentioned in the proposal, the majority of them consider the costs to be relatively acceptable and the changes globally beneficial to their economic activity.Choice of instrumentsProposed instruments: Regulation.Other means would not be adequate for the following reason(s).Non-binding instruments were unanimously rejected by all consulted parties as a sole means to reach the objectives. Killing animals is an activity where all stakeholders consider that a minimum level playing field should be established for all operators and which needs to be checked by governments.The current EU legislation is a Directive and did not bring about a sufficient level of harmonisation.BUDGETARY IMPLICATIONThe proposal has no implication for the Community budget.ADDITIONAL INFORMATIONSimulation, pilot phase and transitory periodThere was or there will be a transitory period for the proposal.SimplificationThe proposal provides for simplification of legislation.The proposal repealing the current Directive will make national transpositions obsolete. In addition, the better integration into food safety legislation will facilitate implementation.Repeal of existing legislationThe adoption of the proposal will lead to the repeal of existing legislation.European Economic AreaThe proposed act concerns an EEA matter and should therefore extend to the European Economic Area.2008/0180 (CNS)Proposal for aCOUNCIL REGULATIONon the protection of animals at the time of killing(Text with EEA relevance)THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,Having regard to the proposal from the Commission[2],Having regard to the opinion of the European Parliament[3],Having regard to the opinion of the European Economic and Social Committee[4],Following consultation of the Committee of the Regions[5],Whereas:(1) Council Directive 93/119/EC of 22 December 1993 on the protection of animals at the time of slaughter or killing[6] establishes common minimum rules for the protection of animals at the time of slaughter or killing in the Community. That Directive has not been substantially amended since its adoption.(2) Killing animals may induce pain, distress, fear or other forms of suffering to the animals even under the best available technical conditions. Certain operations related to the killing may be stressful and any stunning technique presents certain drawbacks. Operators should take the necessary measures to avoid pain and minimise the distress and suffering of animals during the slaughtering or killing process, taking into account the best practices in the field and the methods permitted under this Regulation. Therefore, pain, distress or suffering should be considered as avoidable when operators breach one of the requirements of this Regulation or use permitted practices without reflecting the state of the art, thereby inducing by negligence or intention, pain, distress or suffering to the animals.(3) The protection of animals at the time of slaughter or killing, has been covered by Community legislation since 1974, and was substantively reinforced by Directive 93/119/EC. However, large discrepancies have been observed between the Member States in implementing that Directive and major welfare concerns and differences susceptible to affect competitiveness between operators have been pointed out.(4) Animal welfare is a Community value that is enshrined in the Protocol on Protection and Welfare of Animals annexed to the Treaty establishing the European Community[7]. The protection of animals at the time of slaughter or killing is a matter of public concern that affects consumer attitudes towards agricultural products. In addition, improving the protection of animals at the time of slaughter contributes to higher meat quality and indirectly has a positive impact on occupational safety in slaughterhouses.(5) National law concerning the protection of animals at the time of slaughter or killing has an impact on competition and accordingly on the operation of the internal market in agricultural products. It is necessary to establish common rules in order to ensure the rational development of the internal market in those products.(6) The European Food Safety Authority (EFSA) has adopted two opinions on the welfare aspects of the main systems of stunning and killing of certain species of animals, namely on the Welfare aspects of the main systems of stunning and killing the main commercial species of animals[8], in 2004 and on the welfare aspects of the main systems of stunning and killing applied to commercially farmed deer, goats, rabbits, ostriches, ducks, geese and quail[9], in 2006. Community legislation in this area should be updated to take into account those scientific opinions. Recommendations to phase out the use of carbon dioxide for pigs and poultry, as well as to phase out the use of waterbath stunners for poultry were not included in the proposal because the impact assessment revealed that they were not economically viable at present in the EU. Furthermore other recommendations should not be part of this Regulation because they refer to technical parameters that should be part of implementing measures or codes of good practices. Recommendations on farm fish were not included in the proposal because there was a need for further scientific opinion and economic evaluation in this field.(7) In 2007, the World Organisation for Animal Health (OIE) adopted the Terrestrial Animal Health Code which includes guidelines for the slaughter of animals and for the killing of animals for disease control purposes. Those international guidelines contain recommendations concerning the handling, restraining, stunning and bleeding of animals in slaughterhouses and the killing of animals in cases of outbreak of contagious diseases. Those international standards should also be taken into account in this Regulation.(8) Since the adoption of Directive 93/119/EC, Community food safety legislation applicable to slaughterhouses has been profoundly amended by the adoption of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on hygiene of foodstuffs[10] and Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin[11]. Those Regulations emphasise the responsibility of food business operators to ensure food safety. Slaughterhouses are also subject to a pre-approval procedure whereby the construction, layout and equipment are examined by the competent authority to ensure that they comply with the corresponding technical rules on food safety. Animal welfare concerns should be better integrated into slaughterhouse and into their construction and layout and the equipment used therein.(9) Official controls in the food chain have also been reorganised by the adoption of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules[12] and Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption[13].(10) Conditions under which animals kept for farming purposes are killed have a direct or an indirect impact on the market for food, feed or other products and on the competitiveness of the operators concerned. Therefore, such killing operations are covered by the Community legislation. However, traditionally farmed species such as horses, donkeys, cattle, sheep, goats or pigs can also be kept for other reasons, such as, for example, pet animals, animals for shows, work purposes, or sports. Where the killing of animals of such species produces food or other products, those operations should fall within the scope of this Regulation. Consequently, the killing of wild or stray animals for population control purposes should not fall within the scope of this Regulation.(11) Fish present substantial physiological differences from terrestrial animals and farmed fish are slaughtered and killed in a very different context, in particular as regards the inspection process. Furthermore, research on the stunning of fish is far less developed than for other farmed species. Separate standards should be established on the protection of fish at killing. Therefore, provisions applicable to fish should at present be limited to the key principle. Further initiatives should consider legislative or non legislative options and may be taken by the Community based on a scientific risk assessment for the slaughter and killing of fish performed by the European Food Safety Authority and taking into account the social, economic and administrative implications.(12) It is an ethical duty to kill productive animals in severe pain, where there is no economically viable way to alleviate such pain. In most cases, animals can be killed respecting proper welfare conditions. However, under exceptional circumstances, such as accidents in remote locations, where competent personnel and equipment cannot reach the animals, complying with optimal welfare rules could prolong their suffering. In the interest of the animals it is, therefore, appropriate to exclude emergency killing from certain provisions of this Regulation.(13) Occasionally animals can be dangerous for human beings, possibly putting human life at risk, inflicting serious injuries or transmitting deadly diseases. Preventing those risks is usually performed through the proper restraining of animals but it may also be necessary to kill dangerous animals to end such risks in certain circumstances. Under those circumstances, the killing can not always be performed under the best welfare conditions due to the emergency. Therefore it is necessary to derogate from the obligation to stun or immediately kill the animals in those cases.(14) Hunting activities take place in a context where conditions of killing are very different from the ones used for farmed animals and hunting is subject to specific legislations. It is therefore appropriate to exclude killings taking place during hunting from the scope of this Regulation.(15) The Protocol on protection and welfare of animals also underlines the need to respect the legislative or administrative provisions and customs of the Member States relating, in particular, to religious rites, cultural traditions and regional heritage when formulating and implementing the Community’s policies on inter alia agriculture and the internal market. It is therefore appropriate to exclude from the scope of this Regulation cultural events, where compliance with animal welfare requirements would adversely affect the very nature of the event concerned.(16) In addition, cultural traditions refer to an inherited, established, or customary pattern of thought, action or behaviour which includes in fact the concept of something transmitted by or acquired from a predecessor. They contribute to foster long-standing social links between generations. Provided that those activities do not affect the market of animal products and are not motivated by production purposes, it is appropriate to exclude killings of animals taking place during those events from the scope of this Regulation.(17) The slaughter of poultry and lagomorphs for private consumption is not performed on a scale likely to affect the competitiveness of commercial slaughterhouses. Similarly, the necessary efforts required from public authorities to detect and control such operations would not be proportionate to the potential problems to be solved. It is, therefore, appropriate to exclude those operations from the scope of this Regulation.(18) Derogation from stunning in case of religious slaughter taking place in slaughterhouses was granted by Directive 93/119/EC. Since Community provisions applicable to religious slaughter have been transposed differently depending on national contexts and considering that national rules take into account dimensions that go beyond the purpose of this Regulation, it is important that derogation from stunning animals prior slaughter should be maintained, leaving, however, a certain level of subsidiarity to each Member State. As a consequence the present Regulation respects the freedom of religion and the right to manifest religion or belief in worship, teaching, practice and observance, as enshrined in Article 10 of the Charter of Fundamental Rights of the European Union.(19) There is sufficient scientific evidence to demonstrate that vertebrate animals are sentient beings which should therefore fall within the scope of this Regulation. Reptiles and amphibians, however, are not animals commonly farmed in the Community and it would not therefore be appropriate or proportionate to include them within the scope.(20) Many killing methods are painful for animals. Stunning is therefore necessary to induce a lack of consciousness and sensibility before, or at the same time, the animals are killed. Measuring the lack of consciousness and sensibility of an animal is complex and needs to be performed under scientifically approved methodology. Monitoring through indicators, however, should be carried out to evaluate the efficiency of the procedure under practical conditions.(21) Monitoring stunning efficiency is mainly based on the evaluation of consciousness and sensibility of the animals. The consciousness of an animal is essentially its ability to feel emotions and control its voluntary mobility. Despite some exceptions, such as electro-immobilisations or other provoked paralysis, an animal can be presumed to be unconscious when it loses its natural standing position, is not awake and does not show signs of positive or negative emotions such as fear or excitement. Sensibility of an animal is essentially its ability to feel pain. In general, an animal can be presumed to be insensitive when it does not show any reflexes or reactions to stimulus such as sound, odour, light or physical contact.(22) New stunning methods are regularly developed and proposed on the market in order to face the new challenges of the farming and meat industry. It is, therefore, important that the Community authorises the Commission to approve new stunning methods while keeping a uniform and high level of protection for animals.(23) Codes of good practices are necessary to provide operators and competent authorities with specific information on the parameters to be used in order to ensure a high level of protection for animals while keeping a level playing field for operators. It is, therefore, necessary that the Community authorises the Commission to adopt codes of good practices.(24) Depending on how they are used during the slaughtering or killing process, some stunning methods can lead to death while avoiding pain and minimising distress or suffering for the animals. Consequently, it is not necessary to make a distinction between reversible and non-reversible methods of stunning.(25) The conditions under which animals are stunned and the results of such stunning vary in practice due to many factors. Regular assessment of the outcome of stunning should therefore be made. For that purpose, operators should establish a representative sample for checking the efficiency of their stunning practices, taking into account the homogeneity of the group of animals, and other critical factors, such as the equipment used and the personnel involved.(26) The welfare of animals is largely influenced by the daily management of the operations, and reliable results can only be obtained if operators develop monitoring tools to evaluate their effects. Standard operating procedures should therefore be developed at all stages of the production cycle and should be risk-based. They should include clear objectives, responsible persons, modus operandi, measurable criteria of acceptability, as well as monitoring and recording procedures.(27) Well trained and skilled personnel improve the conditions under which animals are treated. Competence with regards to animal welfare implies knowledge of the basic behavioural patterns and the needs of the species concerned as well as signs of consciousness and sensibility. It also includes technical expertise with regard to the stunning equipment used. Personnel killing animals for human consumption and people supervising the seasonal killing of fur animals should therefore be required to have a certificate of competence relevant to the operations they perform. Requiring a certificate of competence for other personnel killing animals would, however, be disproportionate to the aims pursued.(28) Personnel with several years of experience may be presumed to have a certain level of expertise. A transitional period regarding the certificate of competence requirements should therefore be provided for in this Regulation with regards to such personnel.(29) Stunning equipment is developed and designed to be efficient in a specific context. Manufacturers should therefore provide detailed instructions to users concerning the conditions under which equipment should be used and maintained to ensure optimal welfare for the animals.(30) To ensure efficiency, stunning and restraining equipment should be properly maintained. Equipment that is used intensively may require the replacement of certain parts and even equipment occasionally used may decrease in efficiency due to corrosion or other environmental factors. Similarly, some equipments also need to be accurately calibrated. Operators should therefore implement maintenance procedures for that equipment.(31) Animals may suffer when stunning procedures fail. This Regulation should therefore provide for appropriate back-up stunning equipment to be available to minimise pain, distress or suffering to the animals.(32) Regulation (EC) No 854/2004 provides for a list of establishments from which imports into the Community of specified products of animal origin are permitted. The general requirements and the additional requirements applicable to slaughterhouses laid down in this Regulation should be taken into account for the purposes of that list.(33) Slaughterhouses and the equipment used therein are designed for particular categories of animals and capacities. Where those capacities are exceeded or the equipment is used for purposes for which it was not designed, it has a negative impact on the welfare of animals. Information on these aspects should therefore be communicated to the competent authorities and should be part of the approval procedure for slaughterhouses.(34) Mobile slaughterhouses reduce the need for animals to be transported over long distances and therefore may contribute to safeguarding animal welfare.. However, technical constraints for mobile slaughterhouses differ from fixed slaughterhouses and technical rules may need to be consequently adapted. Therefore, this Regulation should provide for the possibility to establish derogations exempting mobile slaughterhouses from the requirements on construction, layout and equipment of slaughterhouses.(35) Science and technical progress are regularly made with regard to the construction, layout and equipment of slaughterhouses. It is therefore important that the Community authorises the Commission for amending the requirements applicable to the construction, layout and equipment of slaughterhouses while keeping a uniform and high level of protection for animals.(36) Guidelines are necessary to provide operators and the competent authorities with specific information on the construction, layout and equipment of slaughterhouses in order to ensure a high level of protection for animals, while maintaining a level playing field for operators. It is therefore necessary that the Community authorises the Commission for adopting such guidelines.(37) Killing without stunning requires an accurate cut of the throat to minimise suffering. In addition, animals that are not mechanically restrained after the cut are likely to slow down the bleeding process, thereby prolonging unnecessarily the suffering of the animals. Animals slaughtered without stunning should therefore be individually restrained.(38) Science and technical progress are regularly made with regard to the handling and restraining of animals at slaughterhouses. It is therefore important that the Community authorises the Commission for amending the requirements applicable to the handling and restraining of animals before slaughter while keeping a uniform and high level of protection for animals.(39) Guidelines are necessary to provide operators and competent authorities with specific information on the handling and restraining of animals before slaughter in order to ensure a high level of protection for the animals, while maintaining a level playing field for operators. It is therefore necessary that the Community authorises the Commission for adopting such guidelines.(40) The experience gained in some Member States has shown that the appointment of a specifically qualified person as an animal welfare officer to coordinate and follow up the implementation of animal welfare operating procedures in slaughterhouses has provided positive welfare benefits. This measure should therefore be applied throughout the Community. The animal welfare officer should have sufficient authority and technical competence to provide relevant guidance to line personnel.(41) Small slaughterhouses predominantly involved in the direct sale of food to the final consumer do not require a complex system of management to implement the general principles of this Regulation. The requirement to have an animal welfare officer in place would therefore be disproportionate to the objectives pursued in those cases and this Regulation should provide for a derogation from that requirement for such slaughterhouses.(42) Depopulation often involves crisis management with parallel priorities, such as animal health, public health, environment, or animal welfare. Whilst it is important that animal welfare rules are complied with at all stages in the process of depopulation, it may occur that under exceptional circumstances compliance with those rules may put human health at risk or may significantly slow down the process of eradication of a disease, thereby exposing more animals to sickness and death.(43) Accordingly, the competent authorities should be permitted to derogate from certain provisions of this Regulation on a case-by-case basis where the animal health situation requires the emergency killing of animals and/or when no suitable alternatives are available to provide optimum welfare for them. Such derogations should not, however, be a substitute for proper planning. To this end, the level of planning should be increased and animal welfare properly integrated into contingency plans for contagious diseases.(44) Modern stunning and restraining equipment is increasingly complex and sophisticated, requiring specific expertise and analysis. Member States should therefore establish or appoint where already existing a specific centre of scientific and technical excellence as a reference centre, to which officials could refer when equipment or methods for stunning animals need to be assessed.(45) The efficiency of each stunning method is based on the control of key parameters and its regular evaluation. Developing national codes of good practices on animal welfare for key parameters, indicators and monitoring procedures when killing animals is therefore critical in providing proper guidance on animal welfare for operators and competent authorities.(46) The development of such codes requires scientific knowledge, practical experience and compromise among stakeholders. A reference centre or network in each Member State should therefore perform this task in cooperation with the relevant interested parties.(47) The delivery of certificates of competence should be provided in a uniform manner. Bodies or entities issuing certificates of competence should therefore be accredited according to consistent standards and by a single national authority. This role should accordingly be attributed to the reference centre.(48) Regulations (EC) No 882/2004 provide for certain action to be taken by the competent authority in case of non-compliance, in particular with regard to welfare rules. Accordingly, it is only necessary to provide for the additional actions to be taken that are specific to this Regulation.(49) Regulation (EC) No 178/2002 of the European Parliament and the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[14] provides that the EFSA shall promote the networking of the national centres of reference so as to facilitate scientific cooperation, exchange of information, development and implementation of joint projects, exchange of expertise and best practices in the field of food law. As animal welfare falls within the scope of Regulation (EC) No 178/2002, the networking of the references centres provided for in this Regulation is therefore an important role for the EFSA to play and to develop.(50) The delivery of certificates of competence and training courses should be provided in a uniform manner. This Regulation should therefore set out the obligations of the Member States in this respect and the modalities under which certificates of competence are to be granted, suspended or withdrawn.(51) The construction, layout and equipment of slaughterhouses require long-term planning and investment. Accordingly, this Regulation should provide for an appropriate transitional period to take into account the necessary time to allow the industry to adapt to the corresponding requirements set out in this Regulation . During that period, the requirements of Directive 93/119/EC that are applicable to the construction, layout and equipment of slaughterhouses should continue to apply.(52) The Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive.(53) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of protecting animals at the time of killing to lay down rules for the killing of animals for the production of food, wool, skin, fur or other products, and for related operations. This Regulation does not go beyond what is necessary in order to achieve the objectives pursued, in accordance with the third paragraph of Article 5 of the Treaty.(54) The measures necessary for implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission[15],HAS ADOPTED THIS REGULATION:CHAPTER IS ubject matter, scope and definitionsArticle 1Subject matter and scope1. This Regulation lays down rules for the killing of animals kept for the production of food, wool, skin, fur or other products, and for related operations.However, as regards fish, only Article 3(1) shall apply.Chapter II, except for Article 3(1) and (2) thereof, Chapter III and Chapter IV except for Article 16 thereof, shall not apply in case of emergency killing and where compliance with those provisions would result in an immediate and serious risk for human health or safety.2. This Regulation shall not apply:(a) where animals are killed:(i) during technical or scientific experiments carried out under the supervision of the competent authority;(ii) during hunting activities;(iii) during cultural or sporting events;(iv) by a veterinarian in the framework of his/her medical practice.(b) to poultry and lagomorphs slaughtered outside of a slaughterhouse by their owner for his/her personal consumption.Article 2DefinitionsFor the purposes of this Regulation, the following definitions shall apply:(a) “killing” means any intentionally induced process which causes the death of an animal;(b) “related operations” means operations such as handling, lairaging, restraining, stunning and bleeding of animals taking place in the context and at the location where they are to be killed;(c) “animal” means any vertebrate animal, excluding reptiles and amphibians;(d) “emergency killing” means the killing of animals which are injured or have a disease associated with severe pain or suffering and where there is no other practical possibility to alleviate this pain or suffering;(e) “lairaging” means keeping animals in stalls, pens, covered areas or fields associated with or part of slaughterhouse operations;(f) “stunning” means any intentionally induced process which causes loss of consciousness and sensibility without pain, including any process resulting in instantaneous death;(g) “religious rite” means a series of acts related to the slaughter of animals and prescribed by a religion such as Islam or Judaism;(h) “cultural or sporting events” means events which are essentially and predominantly related to long established cultural traditions or sporting activities including racing or other forms of competitions, where there is no production of meat or other animal products or where that production is marginal compared to the event as such and not economically significant;(i) “standard operating procedures” means a set of written instructions aimed at achieving uniformity of the performance of a specific function or standard;(j) “slaughter” means the killing of animals for human consumption;(k) “slaughterhouse” means any establishment used for slaughtering terrestrial animals;(l) “operator” means any natural or legal person responsible for an undertaking which carries out activities covered by this Regulation;(m) “fur animals” means animals of the mammal species primarily reared for the production of fur such as minks, polecats, foxes, raccoons, coypu and chinchillas;(n) “depopulation” means the process of killing animals for public health, animal health, animal welfare or environmental reasons under the supervision of the competent authority;(o) “poultry” means farmed birds, including birds that are not considered to be domestic birds but which are farmed as domestic animals, with the exception of ratites;(p) “lagomorphs” means rabbits and hares.CHAPTER IIGeneral requirementsArticle 3General requirements for killing and related operations1. Animals shall be spared any avoidable pain, distress or suffering during their killing and related operations.2. For the purposes of paragraph 1, operators shall, in particular, take the necessary measures to ensure that animals:(a) are provided with physical comfort and protection, in particular by being kept clean, under thermal comfort and prevented from falling or slipping;(b) are protected from injury and disease;(c) are handled and housed taking into consideration their natural behaviour;(d) do not show signs of pain, fear, aggression or other abnormal behaviour;(e) do not suffer from prolonged withdrawal of feed or water;(f) are prevented from adverse interaction.3. Facilities used for killing and related operations shall be designed, constructed, maintained and operated so as to comply with the obligations set out in paragraphs 1 and 2 under the expected conditions of activity of the facility throughout the year.Article 4Methods for killing1. Animals shall only be killed using a method which ensures instantaneous death or after stunning.2. By way of derogation from paragraph 1, where such methods are prescribed by religious rites, animals may be killed without prior stunning, provided that the killing takes place in a slaughterhouse.However, Member States may decide not to apply that derogation.Article 5Stunning1. Stunning shall be carried out in accordance with the methods set out in Annex I.2. The personnel responsible for stunning shall carry out regular checks to ensure that the animals do not present any signs of consciousness or sensibility in the period between the end of the stunning process and the confirmation of death.Those checks shall be carried out on a sufficiently representative sample of animals and their frequency shall be established taking into account the outcome of previous checks and any factors which may affect the efficiency of the stunning process.3. Annex I may be amended in accordance with the procedure referred to in Article 22(2) to take account of scientific and technical progress.However, any such amendments must ensure a level of animal welfare at least equivalent to that of the existing methods as demonstrated by scientific evidence published in appropriate, internationally recognised, peer reviewed journals.4. Community Codes of good practices concerning the methods set out in Annex I may be adopted in accordance with the procedure referred to in Article 22(2).Article 6Standard operating procedures1. Killing of animals and related operations shall be planned in advance and carried out in accordance with standard operating procedures.2. Operators shall draw up and implement such standard operating procedures to ensure that killing and related operations are carried out in accordance with Article 3(1).As regards stunning, the standard operating procedures shall:(a) take into account the manufacturers' recommendations;(b) define for each stunning method used the key parameters referred to in Chapter I of Annex I.3. The standard operating procedures shall be made available to the competent authority upon request.Article 7Level and certificate of competence1. Killing and related operations shall only be carried out by persons with the appropriate level of competence to do so in accordance with the rules laid down in this Regulation.2. The following slaughter operations shall only be carried out by persons holding a certificate of competence for such operations, as provided for in Article 18:(a) the handling and care of animals before they are restrained;(b) the restraint of animals for the purpose of stunning or killing;(c) the stunning of animals;(d) the assessment of effective stunning;(e) the shackling or hoisting of live animals;(f) the bleeding of live animals.3. The killing of fur animals shall be supervised by a person holding a certificate of competence as referred to in Article 18 which corresponds to all the operations carried out under his supervision.Article 8Instructions for the use of restraining and stunning equipmentProducts marketed or advertised as restraining or stunning equipment shall not be placed on the market without appropriate instructions concerning their use and maintenance, in a manner which ensures optimal conditions for the welfare of animals.Those instructions shall in particular specify:(a) the categories or weights of animals for which the equipment is intended to be used;(b) the recommended parameters corresponding to the different circumstances of use, including the key parameters set out in Annex I;(c) for stunning equipment, a method for monitoring the efficiency of the equipment as regards compliance with the rules laid down in this Regulation.This Article shall apply where restraining or stunning is one or more of the functions of such equipment.Article 9Use of restraining and stunning equipment1. All equipment used for restraining or stunning animals shall be operated, maintained and checked by appropriately trained personnel and in accordance with the manufacturers' instructions.2. During slaughter operations, appropriate back-up stunning equipment shall be immediately available on-the-spot and used in the case of failure of the stunning equipment initially used.Article 10Imports from third countriesThe requirements laid down in Chapters II and III of this Regulation shall be relevant for the purposes of Article 12(2)(a) of Regulation (EC) No 854/2004.CHAPTER IIIAdditional requirements applicable to slaughterhousesArticle 11Construction, layout and equipment of slaughterhouses1. The construction and layout of slaughterhouses and the equipment used therein shall comply with the rules set out in Annex II.2. For the purposes of this Regulation the competent authority, referred to in Article 4 of Regulation (EC) No 853/2004, shall approve for each slaughterhouse:(a) the maximum throughput for each slaughter line;(b) the categories of animals and weights for which the restraining or stunning equipment available may be used;(c) the maximum capacity for each lairage area intended for equidae and animals of the bovine, ovine, caprine and porcine species and poultry and lagomorphs.3. The following may be adopted in accordance with the procedure referred to in Article 22(2):(a) derogations from the rules set out in Annex II for mobile slaughterhouses;(b) amendments necessary to adapt Annex II to take account of scientific and technical progress.4. Guidelines for the implementation of paragraph 2 of this Article and Annex II may be adopted in accordance with the procedure referred to in Article 22(2).Article 12Handling and restraining operations before slaughter1. Operators shall ensure that the operational rules for slaughterhouses set out in Annex III are complied with.2. Operators shall ensure that animals that are killed without stunning are mechanically restrained.3. Notwithstanding Article 3(1), the following methods of restraint shall be prohibited:(a) suspending or hoisting animals by their feet or legs;(b) mechanical clamping of the legs or feet of animals;(c) breaking legs, cutting leg tendons or blinding animals;(d) severing the spinal cord, such as by the use of a puntilla or dagger;(e) the use of electric currents that do not stun or kill the animals under controlled circumstances, in particular, any electric current application that does not span the brain.However, points (a) and (b) shall not apply to the shackles used for poultry.4. Annex III may be amended in accordance with the procedure referred to in Article 22(2) to take account of scientific and technical progress.5. Guidelines for the implementation of the rules set out in Annex III may be adopted in accordance with the procedure referred to in Article 22(2).Article 1 3Monitoring at slaughter1. Operators shall put in place and implement appropriate monitoring procedures to verify and confirm that animals for slaughter are effectively stunned in the period between the end of the stunning process and the confirmation of death.2. The monitoring procedures referred to in paragraph 1 shall include at least the following:(a) the name of the persons responsible for the monitoring procedure;(b) indicators designed to detect signs of unconsciousness and consciousness or sensibility in the animals subjected to killing operations in accordance with Article 4(1); or signs of life in animals subjected to slaughter operations in accordance with the first subparagraph of Article 4(2);(c) criteria of acceptability for determining whether or not the results of the indicators referred to in point (b) are satisfactory or not;(d) the circumstances and/or the time when the monitoring must take place;(e) the number of animals in each sample to be checked during the monitoring;(f) appropriate procedures to ensure that in the event that the criteria of acceptability referred to in point (c) are not met, the stunning or killing operations are reviewed in order to identify the causes of any shortcomings and the necessary changes to be made to those operations.3. A monitoring procedure shall be put in place for each slaughterline where different stunning equipment is used.4. The frequency of the monitoring checks shall take into account the main risk factors, such as changes regarding the types of animals slaughtered or personnel working patterns and shall be established so as to ensure results with a high level of confidence.5. Community codes of good practices concerning monitoring procedures in slaughterhouses may be adopted in accordance with the procedure referred to in Article 22(2).Article 14Animal welfare officer1. Operators shall designate an animal welfare officer for each slaughterhouse, to be responsible for ensuring compliance with the rules laid down in this Regulation in that slaughterhouse. He or she shall report directly to the operator on matters relating to the welfare of the animals.2. The animal welfare officer shall be under the direct authority of the operator and in a position to require that the slaughterhouse personnel carry out any remedial actions necessary to ensure compliance with the rules laid down in this Regulation.3. The responsibilities of the animal welfare officer shall be set out in the standard operating procedures of the slaughterhouse and effectively brought to the attention of the personnel concerned.4. The animal welfare officer shall hold a certificate of competence as referred to in Article 18, which covers all the operations taking place in the slaughterhouses for which he or she is responsible.5. Paragraphs 1 and 4 shall not apply to slaughterhouses slaughtering less than 1 000 livestock units of mammals or 150 000 units of poultry per year.CHAPTER IVD epopulation and emergency killingArticle 15Depopulation1. The competent authority and the operators involved in a depopulation operation shall establish an action plan to ensure compliance with the rules laid down in this Regulation, before the commencement of the operation.In particular, the killing methods planned and the corresponding standard operating procedures for ensuring compliance with the rules laid down in this Regulation, shall be included in the contingency plans required under Community legislation on animal health, on the basis of the hypothesis established in the contingency plan concerning the size and the location of suspected outbreaks.2. The competent authority and the operators involved in depopulation operations shall:(a) ensure that such operations are carried out in accordance with the action plan referred to in paragraph 1;(b) take any appropriate action to safeguard the welfare of the animals in the best available conditions.3. For the purposes of this Article and in exceptional circumstances, the competent authority may grant derogations from one or more of the provisions of this Regulation where it considers that compliance is likely to affect human health or significantly slow down the process of eradication of a disease.4. Within one year from the date of the end of depopulation operation, the competent authority referred to in paragraph 1 shall transmit to the Commission and make publicly available, in particular through the internet, an evaluation report on the results thereof.That report shall include, in particular:(a) the reasons for the depopulation;(b) the number and the species of animals killed;(c) the stunning and killing methods used;(d) a description of the difficulties encountered and, where appropriate, solutions found to alleviate or minimise the suffering of the animals concerned;(e) any derogation granted in accordance with paragraph 3.5. Guidelines for the drawing up and implementation of depopulation action plans may be adopted in accordance with the procedure referred to in Article 22(2).Article 16Emergency killingIn the case of emergency killing, the person in charge of the animals concerned shall take all the necessary measures to kill the animal as soon as possible.CHAPTER VCompetent AuthorityArticle 17Reference centres1. Each Member State shall appoint a national reference centre (hereinafter referred to as the “reference centre”) to perform the following tasks:(a) provide scientific and technical expertise relating to the approval of slaughterhouses;(b) carry out assessments of new stunning methods;(c) actively encourage the development by operators and other interested parties of codes of good practice for the implementation of this Regulation and publish and disseminate such codes, and monitor their application;(d) develop guidelines for the competent authority for the purposes of this Regulation;(e) accredit bodies and entities for the issuance of certificates of competence, as provided for in Article 18;(f) correspond and cooperate with the Commission and other reference centres, in order to share technical and scientific information and best practices as regards the implementation of this Regulation.2. Within one year from the date of the entry into force of this Regulation, Member States shall submit details of their reference centre to the Commission and the other Member States, and shall make such information publicly available on the internet.3. Reference centres may be established as a network, made up of separate entities, provided that all the tasks listed in paragraph 1 are allocated for all the relevant activities taking place in the Member States concerned.Member States may appoint for an entity located outside their own territory to carry out one or more of those tasks.Article 1 8Certificate of Competence1. For the purposes of Article 7, Member States shall designate the competent authority responsible for:(a) ensuring that training courses are available for personnel involved in killing and related operations;(b) delivering certificates of competence attesting the passing of an independent final examination; the subjects of this examination shall be relevant for the categories of animals concerned and correspond to the operations listed in Article 7(2), and the subjects set out in Annex IV;(c) approving training programmes of the courses referred to in point (a) and the content and modalities of the examination referred in point (b);2. The competent authority may delegate the organisation of the courses, the final examination and the issuance of the certificate of competence to a separate body or entity which:(a) has the expertise, staff and equipment necessary to do so;(b) is independent and free from any conflict of interest as regards the issuance of the certificates of competence;(c) is accredited by the reference centre.The details of such bodies and entities shall be made publicly available, in particular via the internet.3. Certificates of competence shall indicate for which categories of animals and for which of the operations listed in Article 7(2) or (3) the certificate is valid.Certificates of competences shall not be valid for a period exceeding five years.4. Member States shall recognise certificates of competence issued in another Member State.5. Member States may recognise diplomas delivered for other purposes as certificates of competence provided that they have been issued under conditions equivalent to those laid down in this Article.CHAPTER V INon-compliance, penalties and implementing powersArticle 19Non-complianceFor the purpose of Article 54 of Regulation (EC) No 882/2004, the competent authority may in particular:(a) request operators to amend their standard operating procedures and in particular slow down or stop production;(b) increase the frequency of the monitoring procedures referred to in Article 13;(c) withdraw certificates of competence from personnel showing insufficient knowledge or awareness of their tasks;(d) suspend or withdraw the accreditation of bodies and entities which have been accredited in accordance with Article 17(1)(e).Article 20PenaltiesThe Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by [1 January 2011] at the latest and shall notify it without delay of any subsequent amendment affecting them.Article 21Implementing RulesAny detailed rules necessary for the implementation of this Regulation, including for the slaughter or the killing of fish, may be adopted in accordance with the procedure referred to in Article 22(2).Article 22Committee Procedure1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, established by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council.2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its Rules of Procedure.CHAPTER VIIFinal ProvisionsArticle 23Repeal1. Directive 93/119/EEC is repealed.However, for the purpose of Article 24(1) of this Regulation, the following provisions of Directive 93/119/EEC shall continue to apply:(a) Annex A:(i) Paragraph 1 of Section I;(ii) Paragraph 1 and the second sentence of paragraph 3 and paragraphs 6, 7 and 8 of Section II;(b) Annex B, paragraph 1;(c) Annex C, paragraphs 3.A.2, 3.B.4 and paragraphs 4.2 and 4.3 of Section II;(d) Annex F, paragraphs 4(a) and 6(a) of Section II.2. References to the repealed Directive shall be construed as references to this Regulation.Article 24Transitional provisions1. Until 31 December 2018, Article 11(1) shall only apply to new slaughterhouses or for any new construction, layout or equipment covered by the rules set out in Annex II, which have not entered into operation before the date of [application/entry into force] of this Regulation.2. Until 31 December 2014, Member States may provide for certificates of competence, as referred to in Article 18, to be issued without examination to persons demonstrating relevant uninterrupted professional experience of at least [ten] years.Article 25Entry into ForceThis 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 [1st January 2011].This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels,For the CouncilThe PresidentANNEX ILIST OF METHODS OF STUNNING AND KILLING AND RELATED SPECIFICATIONS(as referred to in Article 5(1))Chapter I — MethodsTable 1 — Mechanical methodsNo | Name | Description | Category of animals | Key parameters | Specific requirements for certain methods - Chapter II of this Annex |1 | Penetrative captive bolt pistol | Severe and irreversible damage of the brain provoked by the shock and the penetration of a captive bolt. | All species. | Position and direction of the shot. Appropriate velocity and diameter of bolt according to animal size and species. | Not applicable. |2 | Non-penetrative captive bolt pistol | Severe damage of the brain by the shock of a captive bolt without penetration. | Ruminants up to 10 kg, poultry and lagomorphs. | Position and direction of the shot. Appropriate velocity and diameter of bolt according to animal size and species. | Not applicable. |3 | Firearm with free projectile | Severe and irreversible damage of the brain provoked by the shock and the penetration of one or more projectiles. | All species. | Position of the shot. Power of the cartridge. | Not applicable. |4 | Maceration | Immediate crushing of the entire animal. | Chicks up to 72 hours and egg embryos. | Maximum size of the batch to be introduced. Measure to prevent overloading. | Point 1. |5 | Cervical dislocation | Manual stretching and twist of the neck provoking cerebral ischemia. | Birds up to 3 kg. | Not applicable. | Point 2. |Table 2 — Electrical methodsNo | Name | Description | Category of animals | Key parameters | Specific requirements of Chapter II of this Annex |1 | Head-only electrical stunning | Exposure of the brain to a current generating a generalised epileptic form on the Electro-Encephalogram (EEG). | All species. | Minimum current (A or mA). Minimum voltage (V). Maximum frequency (Hz). Minimum time of exposure. Maximum stun-to-stick interval (s). Frequency of calibration of the equipment. Optimisation of the current flow. Prevention of electrical shocks before stunning. | Point 3. |2 | Head-to-Back electrical killing | Exposure of the body to a current generating at the same time a generalised epileptic form on the EEG (stunning) and the fibrillation or the stopping of the heart (killing). | All species except lambs or piglets of less than 5 kg live weight and cattle. | Minimum current (A or mA). Minimum voltage (V). Maximum frequency (Hz). Minimum time of exposure. Frequency of calibration of the equipment. Optimisation of the current flow. Prevention of electrical shocks before stunning. | Point 3. Point 4 for foxes and chinchillas. |3 | Electrical waterbath | Exposure of the entire body through a waterbath to a current generating a generalised epileptic form on the EEG (stunning) and possibly the fibrillation or the stopping of the heart (killing). | Poultry. | Minimising pain at shackling. Optimisation of current flow. Maximum shackle duration before the waterbath. Immersion of the birds up to the base of the wings. Maximum stun-to-stick interval for frequency over 60 Hz. | Point 5. |Table 3 — Gas methodsNo | Name | Description | Category of animals | Key parameters | Specific requirements of Chapter II of this Annex |1 | Carbon dioxide at high concentration | Exposure of conscious animals to a gas mixture containing more than 30% carbon dioxide. | Pigs, poultry and fur animals. | Carbon dioxide concentration. Duration of exposure. Maximum stun-to-stick interval (pigs). | Point 6. Point 7 for poultry. |2 | Carbon dioxide at low concentration | Exposure of conscious animals to a gas mixture containing less than 30% of carbon dioxide. | Pigs and poultry. | Carbon dioxide concentration. Duration of exposure. Maximum stun-to-stick interval in case of stunning (pigs). | Point 7 for poultry. |3 | Inert gases | Exposure of conscious animals to a inert gas mixture such Argon or Nitrogen containing less than 2% of oxygen. | Pigs and poultry. | Oxygen concentration. Duration of exposure. Maximum stun-to-stick interval in case of stunning (pigs). | Point 7 for poultry. |4 | Carbon monoxide (pure source) | Exposure of conscious animals to a gas mixture containing more than 4 % of carbon monoxide. | Fur animals and piglets. | Quality of the source of the gas. Carbon monoxide concentration. Duration of exposure. Temperature of the gas. | Point 8. |5 | Carbon monoxide associated with other gases | Exposure of conscious animals to a gas mixture containing more than 1 % of carbon monoxide associated with other toxic gases. | Fur animals. | Carbon monoxide concentration. Duration of exposure. Temperature of the gas. Filtration of the gas produced from engine. | Point 8. Point 9. |Table 4 — Other methodsNo | Name | Description | Category of animals | Key parameters | Specific requirements of Chapter II of this Annex |1 | Lethal injection under veterinary supervision | Loss of consciousness and sensibility followed by irreversible death induced by the injection of veterinary medicines. | All species. | Not applicable. | Not applicable. |Chapter II — Specific Requirements for Certain Methods1. MacerationThis method shall provide instantaneous maceration and death of the animals.2. Cervical dislocationThe methods of cervical dislocation shall not be used on more than fifty animals per day.3. Head-only electrical stunning3.1 When using head-only electrical stunning, electrodes shall span the brain of the animal.3.2 Head-only electrical stunning shall be carried out in accordance with the minimum currents set out in Table 1.Table 1 — Minimum currents for head-only electrical stunningCategory of animals | Bovine animals of 6 months or older | Bovine animals less than 6 months | Animals of ovine and caprine species | Animals of porcine species | Chicken | Turkeys |Minimum current | 1,28 A | 1,25 A | 1,00 A | 1,30 A | 240 mA | 400 mA |4. Head-to-back electrical killing4.1 Animals of the ovine, caprine and porcine species.The minimum currents for head-to-back electrical killing shall be 1 ampere for sheep and 1,30 amperes for pigs.4.2 FoxesElectrodes must be applied to the mouth and rectum with a current of a minimum value of 0,3 amperes and a minimum voltage of 110 volts for at least three seconds.4.3 ChinchillasElectrodes must be applied ear to tail with a current of a minimum value of 0,57 amperes for at least 60 seconds.5. Electrical waterbath stunning of poultry5.1 Animals shall not be shackled if they are too small for the waterbath stunner or if shackling is likely to induce or increase the pain suffered (such as injured animals). In these cases, they shall be killed by an alternative method.5.2 Shackles shall be wet, prior to hanging live birds, which shall be hung by both legs.5.3 Waterbath stunning shall be carried out in accordance with the minimum currents laid down in Table 2, and animals shall be exposed to that current for a minimum duration of at least four seconds.Table 2 — Electrical requirements for waterbath stunning equipmentFrequency (Hz) | Chickens | Turkeys | Ducks and geese |< 200 Hz | 100 mA | 250 mA | 130 mA |From 200 to 400 Hz | 150 mA | 400 mA | Not permitted |From 400 to 1500 Hz | 200 mA | 400 mA | Not permitted |6. Carbon dioxide at high concentration (over 30%)No animals shall show signs of consciousness or sensibility after 30 seconds of exposure.7. Carbon dioxide at high and low concentration, use of inert gases or a combination of those gas mixtures for poultryUnder no circumstances shall gases enter into the chamber or the location where poultry are to be stunned and killed in a way that it could create burns or excitement by freezing or lack of humidity.8. Carbon monoxide (pure source or associated with other gases) for fur animals8.1 Animals shall be kept under visual supervision at all times.8.2 They shall be introduced one by one, and it shall be ensured that before the next animal is introduced the previous one is unconscious or dead.8.3 Animals must remain in the chamber until they are dead.9. Carbon monoxide associated with other gases for fur animals9.1 Gas produced by an engine specially adapted for that purpose may be used provided that tests have shown that the gas used:(a) has been suitably cooled;(b) has been sufficiently filtered;(c) is free from any irritant component or gas.9.2 Animals shall not be placed in the chamber until the minimum concentration of carbon monoxide has been reached.ANNEX IICONSTRUCTION, LAYOUT AND EQUIPMENT OF SLAUGHTERHOUSES(as referred to in Article 11)1. All lairage facilities1.1 Ventilation systems shall be designed, constructed and maintained so that the welfare of the animals is constantly ensured, taking into account the expected range of weather conditions.1.2 Where mechanical means of ventilation are required, provision shall be made for emergency back-up facilities in the event of breakdown.2. Lairage facilities for animals not delivered in containers2.1 Pens, passageways and races shall be designed and constructed to allow:(a) the animals to move freely in the required direction using their behavioural characteristics and without distraction;(b) pigs or sheep to walk side by side, except in the case of races leading to the restraining equipment.2.2 The water supply system shall be designed and constructed so as to allow all animals access to clean water at all times without being injured or limited in their movements.2.3 There shall be a waiting pen, with a level floor and solid sides, between the holding pens and the race leading to the point of stunning, to ensure a steady supply of animals for stunning and killing and to avoid animal handlers having to rush animals from the holding pens. The waiting pen shall be so designed that animals cannot be trapped or trampled.2.4 Floors shall be built in such way as to minimise the risk of animals slipping, falling or injuring their feet.3. Restraining equipment and facilities3.1 Restraining equipment and facilities shall be designed and built to:(a) optimise the application of the stunning or killing method;(b) prevent injury or contusions to the animals;(c) minimise struggle and vocalisation when animals are restrained.3.2 Restraining boxes used in conjunction with a captive bolt shall be fitted with a device that restricts both the lateral and vertical movement of the head of the animal.3.3 Systems restraining bovine animals by inversion or any unnatural position shall not be used.4. Electrical stunning equipment4.1 Electrical stunning equipment shall be fitted with a device which records the details of the electrical key parameters for each animal stunned or killed.4.2 Electrical apparatus shall deliver a constant current.5. Waterbath stunning equipment5.1 Shackle lines shall be designed and positioned in such a way that birds suspended on them are clear of any obstruction and that disturbance to the animals is reduced to a minimum.5.2 The whole length of the shackle line up to the point of entry into the scald tank must be easily accessible in case animals have to be removed from the slaughterline.5.3 The size and shape of the metal shackles shall be appropriate to the size of the legs of poultry to be slaughtered so that electrical contact can be secured without causing pain.5.4 Waterbath stunning equipment shall be equipped with an electrically insulated entry ramp and designed and maintained so as to prevent overflow of water at the entrance.5.5 The electrodes in waterbath stunning equipment must extend the full length of the waterbath. The waterbath must be designed and maintained in such a way that when the shackles pass over the water they are in continuous contact with the earthed rubbing bar.5.6 A system in contact with the breast of the birds shall be built from the point of shackling until the birds enter the waterbath stunner in order to calm them down.5.7 Waterbaths shall be supplied with a constant current.5.8 Access to the waterbath stunning equipment shall be available to allow the bleeding of birds that have been stunned and remain in the waterbath as a result of a breakdown or delay in the line.6. Gas stunning equipment for pigs6.1 Gas chambers and equipment used for conveying animals through them shall be designed and built to:(a) optimise the application of the stunning by gas;(b) prevent injury or contusions to the animals;(c) minimise struggle and vocalisation when animals are restrained.6.2 The gas chamber shall be equipped to measure, display and record the gas concentration and the time of exposure, and to give a clearly visible and audible warning if the concentration of gas falls below the required level.6.3 The gas chamber and conveying mechanism shall be designed and constructed to allow visual inspection at all stages of the stunning.6.4 The gas chamber shall be designed in a manner that, even at the maximum permitted throughput, the animals are able to lie down without being stacked on each other.7. Gas stunning equipment for poultry7.1 Points 6.1 and 6.2 shall apply to gas stunning equipment for poultry.7.2 Facilities for poultry shall be designed and built so that animals are only conveyed into the gas mixtures in transport crates without being unloaded.ANNEX IIIOPERATIONAL RULES FOR SLAUGHTERHOUSES(as referred to in Article 12)1. The arrival, moving and handling of animals1.1 The welfare conditions of each consignment of animals shall be systematically assessed by the animal welfare officer or a person reporting directly to the animal welfare officer in order to identify the priorities, in particular by determining which animals have specific welfare needs and the corresponding measures to be taken.1.2 Animals must be unloaded as quickly as possible after arrival and subsequently slaughtered without undue delay.In the case of poultry or lagomorphs, the total time of transport added to the time spent between unloading and slaughter shall not exceed 12 hours.In the case of mammals, except lagomorphs, the total time of transport added to the time spent between unloading and slaughter shall not exceed:(a) 19 hours for unweaned animals;(b) 24 hours for equidae and pigs;(c) 29 hours for ruminants.After the expiry of those time limits, the animals must be lairaged, fed, and subsequently given moderate amounts of food at appropriate intervals. In such cases, the animals shall be provided an appropriate amount of bedding or equivalent material which guarantees a level of comfort appropriate to the species and the number of animals concerned. This material must ensure adequate absorption of urine and faeces.1.3 Containers in which animals are transported must be handled with care, and in particular must not be thrown or dropped.1.4 When containers are put one on top of the other, the necessary precautions shall be taken:(a) to limit urine and faeces falling on the animals placed underneath;(b) to ensure stability of the containers;(c) to ensure that ventilation is not impeded.1.5 For the purpose of slaughter, unweaned animals, lactating dairy animals, females having given birth during the journey or animals delivered in containers shall be given priority over other types of animal. If this is not possible, arrangements shall be made so as to relieve them from their suffering, in particular by:(a) milking dairy animals at intervals of not more than 12 hours;(b) providing appropriate conditions for suckling and the welfare of the newborn animal in the case of a female having given birth;(c) providing water in the case of animals delivered in containers.1.6 Mammals, except lagomorphs, which are not taken directly to the place of slaughter after being unloaded, must have drinking water available to them from appropriate facilities at all times.1.7 It shall be prohibited to:(a) strike or kick the animals;(b) apply pressure to any particularly sensitive part of the body in such a way as to cause animals avoidable pain or suffering;(c) lift or drag the animals by the head, ears, horns, legs, tail or fleece, or handle them in such a way as to cause them avoidable pain or suffering;(d) use prods or other implements with pointed ends.1.8 The use of instruments which administer electric shocks shall be avoided as far as possible. In any case, such instruments shall only be used for adult bovine animals and adult pigs which refuse to move, and only when they have room ahead of them in which to move. The shocks shall last no longer than one second, be adequately spaced and shall only be applied to the muscles of the hindquarters. Shocks shall not be used repeatedly if the animal fails to respond.1.9 Animals shall not be tied by the horns, antlers, nose rings or by legs tied together. When animals need to be tied, the ropes, tethers or other means used shall be:(a) strong enough not to break;(b) such as to allow the animals, if necessary, to lie down and to eat and drink;(c) designed in such a way as to eliminate any danger of strangulation or injury, and so as to allow animals to be quickly released.2. Additional rules for mammals in lairage (except for lagomorphs)2.1 Each animal shall have enough space to stand up, lie down and turn around.2.2 Animals shall be kept securely in the lairage and care must be taken to prevent them from escaping and from predators.2.3 Every day that the slaughterhouse operates, before any animal arrives, isolation pens for animals that require specific care shall be prepared and kept ready for immediate use.2.4 The condition and state of health of the animals in a lairage shall be regularly inspected by the animal welfare officer or a person having an appropriate competence.3. Bleeding of animals3.1 Where one person is responsible for the stunning, shackling, hoisting and bleeding of animals, that person must carry out all those operations consecutively on one animal before carrying out any of them on another animal.3.2 When the stunning method does not kill the animal, the two carotid arteries or vessels from which they arise shall be systematically severed.3.3 Birds shall not be slaughtered by means of automatic neck cutters unless it can be ascertained whether or not the neck cutters have effectively severed the blood vessels. When neck cutters have not been effective the bird shall be killed immediately.ANNEX IVCORRESPONDENCE BETWEEN ACTIVITIES AND REQUIREMENTS FOR EXAMINATION OF COMPETENCE(as referred to in Article 18)Slaughter operations listed in Article 7(2) | Subjects for examination of competence |All operations listed in Article 7 (2) (a) to (f). | Animal behaviour, animal suffering, consciousness and sensibility, stress in animals. |(a) the handling and care of animals before they are restrained; | Practical aspects of handling and restraining animals. |(b) the restraint of animals for the purpose of stunning or killing; |(c) the stunning of animals; | Practical aspects of stunning techniques. Back-up stunning and/or killing methods. Maintenance of stunning and/or killing equipments. |(d) the assessment of effective stunning; | Monitoring the effectiveness of stunning. Back-up stunning and/or killing methods. |(e) the shackling or hoisting of live animals; | Practical aspects of handling and restraining animals. |(f) the bleeding of live animals. | Monitoring the effectiveness of stunning. Back-up stunning and/or killing methods. |[1] OJ L 340, 31.12.1993, p. 21.[2] OJ C xxx, xx.xx.xxxx, p. xx.[3] OJ C xxx, xx.xx.xxxx, p. xx.[4] OJ C xxx, xx.xx.xxxx, p. xx.[5] OJ C xxx, xx.xx.xxxx, p. xx.[6] OJ L 340, 31.12.1993, p. 21. Directive as last amended by Regulation (EC) No 1/2005 (OJ L 3, 5.1.2005, p. 1).[7] OJ C 340, 10.11.1997, p. 110.[8] The EFSA Journal (2004) 45, p. 1.[9] The EFSA Journal (2006) 326, p. 1.[10] OJ L 139, 30.4.2004, p. 1; corrected version (OJ L 226, 25.6.2004, p. 3).[11] OJ L 139, 30.4.2004, p. 55; corrected version (OJ L 226, 25.6.2004, p. 22). Regulation as last amended by Commission Regulation (EC) No 1243/2007 (OJ L 281, 25.10.2007, p. 8).[12] OJ L 191, 28.5.2004, p. 1. Regulation as last amended by Commission Regulation (EC) No 737/2008 (OJ L 201, 30.7.2008, p. 29).[13] OJ L 226, 25.6.2004, p. 83. Regulation as last amended by Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).[14] OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 202/2008 (OJ L 60, 5.3.2008, p. 17).[15] OJ L 184, 17.7.1999, p. 23.