Impact assessment accompanying proposals for the Regulations amending the Hygiene Package

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1 Impact assessment accompanying proposals for the Regulations amending the Hygiene Package 1

2 Regulation (EC) No 178/2002 Food law Competent authorities Regulation (EC) No 882/2004 General rules for official controls Regulation (EC) No 854/2004 Specific rules for official controls on products of animal origin Food business operators Regulation (EC) No 852/2004 General rules on hygiene Regulation (EC) No 853/2004 Specific hygiene rules for products of animal origin Regulation (EC) No 2075/2005 Trichinella Regulation (EC) No 2074/2005 Other implementing rules Regulation (EC) No 2073/2005 Microbiological criteria 2

3 The context of the Hygiene Package Creation of internal market, reducing trade barriers High level of public health protection Flexibility when appropiate Simplification of legal provisions 3

4 Hygiene package applicable since 1/1/2006 Horizontal approach for all food Taking into account specific risks linked to certain foods Consolidation and elimination of certain detailed requirements (repeal of 152 legal acts) Separate texts for hygiene, official controls and animal health aspects Request of the European Parliament and Council to submit a report after 3 years of implementation 4

5 Report on the experience gained from the application of the hygiene Regulations (Com(2009) 403 final) Factual experience (both positive and negative) gained during the implementation in Identify difficulties Based on information from: Competent authorities Representatives of the food business operators and consumers organisations Commission s Food and Veterinary Office 5

6 Main conclusions and identified challenges of the Report No need for a fundamental overhaul Too early to give a balanced and detailed evaluation Problems identified were more important in small establishments Priorisation for a review of meat inspection Positive feed back from establisment of guidance documents 6

7 Amendments already made by comitology to address certain problems Provisions in certain annexes: R. 852/2004: 1 amendment R. 853/2004: 7 amendments R. 854/2004: 5 amendments Implementing acts R 2073/2005: 2 amend. (3 ongoing) R 2074/2005: 4 amendments R 2075/2005: 2 amend. (3 ongoing) Prolongation transitional measures 7

8 Amendments only possible by codecision (ordinary procedure) Articles of R. 852/2004, R. 853/2004 and R. 854/2004 Annex I of R. 853/2004 Alignment with Lisbon Treaty 8

9 Impact assessment: Why? Only possible issues subject to ordinary procedure that may have a substantial impact Risk-based task distribution in inspection? Different application of certain definitions Administrative burden by notification procedure By-products re-intended for human consumption after high refinement End of transitional measures 9

10 Approach in the IA Holistic umbrella document Specific chapters per issue 10

11 Umbrella document Procedural issues General problem definition and background General policy objectives Overview of different impacts Discarded issues e.g. editorial, alignment Lisbon Treaty, certain possible new definitions e.g. snails etc. 11

12 I: Possible delegation of inspection tasks to slaughterhouse staff Objectives Optimisation of tasks taking into account actual risks Maintaining same level of food safety including import Not jeopardizing export Options Do nothing Allow further delegations in slaughterhouses for pigs and ruminants in the articles Allow delegated act allowing future further delegations in slaughterhouses for pigs and ruminants in the articles 12

13 II: Import of composite products (end of transitional measure) Objectives Ensure that they are of no public health concern Risk-based and balanced approach Avoid disproportionate administrative burden Options Do nothing: Application on all composite products Define composite products to be covered in the articles Allow delegated act to define derogations and composite products to be covered 13

14 III: Definitions of meat preparations and meat products Objectives Ensure harmonised application Ensure correct perception of the consumer Options Do nothing Guidance document Amend definitions by ordinary procedure Allow delegated act to review definitions 14

15 IV: Definition of MSM Objectives Ensure harmonised application Ensure correct perception of the consumer Options Do nothing Guidance document Amend definition by ordinary procedure Allow delegated act to review definition 15

16 V: Management of notification procedures Objectives Reduce administrative burden Facilitate flexibility provisions Maintain transparency Options Do nothing Allow adoption of national measures by endorsement at standing committee Allow adoption of national measures by approval of Commission 16

17 VI: Raw materials for highly refined products Objectives Allow the continuation of certain existing practices Possible reduction of red tapes by applying a risk based approach Identical requirements in the EU as in TCs Options Do nothing Softening the requirement for whole chain compliance in the hygiene Regulations Create a new Regulation for certain highly refined food products 17

18 VII: Specific provisions fishery products Objectives Evaluate the practicability of provisions for Tiny factory vessels EU listing of third country s freezer vessels and reefer vessels Delegation of responsibility for vessels between countries Legal framework and procedures for import of fishery products to the EU Options Do nothing Improve the legislative provisions regarding 18 some or all of the above issues.

19 Consultations/requests for information so far Consultations carried out in preparation of: 2009 Report on experience gained from hygiene package 2010 MSM Communication Two round table conferences on review meat inspection Questionnaire on the meat inspection EFSA mandate on meat inspection 19

20 Further timing Before Summer break: request for information from stakeholders and competent authorities Second half of 2011 and first half of 2012: further consultations Second half of 2012: Commission proposals to Parliament and Council including IA Before end of 2013: adoption by 20 Council and Parliament

21 Questions? 21

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