EUROPEAN COMMISSION Brussels, 15.1.2018 SWD(2018) 38 final PART 1/2 COMMISSION STAFF WORKING DOCUMENT THE REFIT EVALUATION of the General Food Law (Regulation (EC) No 178/2002) {SWD(2018) 37 final} EN EN Contents 1 Introduction ............................................................................................................................. 6 1.1 Purpose of the evaluation ........................................................................................................ 6 1.2 Scope of the evaluation ........................................................................................................... 7 2 Background to the GFL Regulation .......................................................................................... 8 2.1 Baseline (before 2002) ............................................................................................................. 8 2.2 Adoption of the GFL Regulation ............................................................................................. 12 2.3 Intervention logic ................................................................................................................... 20 3 Methodology of the Fitness Check ........................................................................................ 21 3.1 Method .................................................................................................................................. 21 3.1.1 Primary data collection .................................................................................................. 22 3.1.2 Secondary data analysis ................................................................................................. 23 3.1.3 Public consultation ......................................................................................................... 23 3.2 Limitations ............................................................................................................................. 23 4 State of play ........................................................................................................................... 27 4.1 Economic dimension of the food chain (2002-present) ........................................................ 27 4.2 Implementation of the GFL Regulation .................................................................................. 28 4.2.1 Common definitions in other EU secondary food legislation ........................................ 28 4.2.2 Implementation of the risk analysis principle ................................................................ 29 4.2.2.1 Risk assessment ......................................................................................................... 29 4.2.2.1.1 Risk assessment at EU level: EFSA ....................................................................... 29 4.2.2.1.2 Risk assessment at Member State level .............................................................. 36 4.2.2.2 Risk management ...................................................................................................... 36 4.2.2.2.1 Risk management at EU level .............................................................................. 36 4.2.2.2.2 Risk management at Member State level ........................................................... 39 4.2.2.3 Risk communication .................................................................................................. 40 4.2.2.4 Analysis of the overall implementation of the risk analysis principle ....................... 43 4.2.3 Allocation of responsibilities .......................................................................................... 49 4.2.3.1 Primary responsibility of FBOs – general safety requirements – withdrawals ......... 49 4.2.3.2 Official controls by MS............................................................................................... 50 4.2.3.3 Analysis of the distribution of responsibilities between FBOs and competent authorities ................................................................................................................................. 52 4.2.4 Traceability of feed and food ......................................................................................... 54 1 4.2.4.1 Implementation of traceability by FBOs .................................................................... 54 4.2.4.2 Analysis of traceability implementation .................................................................... 56 4.2.5 Principles of transparency: Public consultation and public information ....................... 57 4.2.5.1 Public consultation at EU level .................................................................................. 57 4.2.5.2 Public consultation and public information at MS level............................................ 58 4.2.5.3 Analysis of public consultation and public information principles ............................ 59 4.2.6 Protection of consumers' health beyond food safety at EU level .................................. 60 4.2.6.1 Implementation of the protection of consumers' health beyond food safety ......... 60 4.2.6.2 Analysis of the protection of consumers' health beyond food safety ...................... 61 4.2.7 Protection of consumers' interests ................................................................................ 62 4.2.7.1 Protection of consumers' interests at EU level ......................................................... 62 4.2.7.2 Protection of consumers' interests at MS level ........................................................ 62 4.2.7.3 Analysis of protection of consumers' interests ......................................................... 63 4.2.8 Trade and international aspects .................................................................................... 64 4.2.8.1 Trade and international aspects of GFL at EU level................................................... 64 4.2.8.2 National restrictions on imports/exports of feed and food ...................................... 65 4.2.8.3 Analysis of trade and international aspects .............................................................. 65 4.2.9 Strengthening of RASFF .................................................................................................. 66 4.2.9.1 Strengthening of RASFF at EU level ........................................................................... 66 4.2.9.2 Involvement of MS in RASFF ...................................................................................... 68 4.2.9.3 Analysis of RASFF ....................................................................................................... 68 4.2.10 Emergency measures and crisis management ............................................................... 70 4.2.10.1 Emergency measures and crisis management at EU level .................................... 70 4.2.10.2 Implementation of national crisis management plans .......................................... 71 4.2.10.3 Analysis of emergency measures and crisis management .................................... 71 5 Answers to the evaluation questions .................................................................................... 73 5.1 Relevance ............................................................................................................................... 74 5.1.1 To what extent is the legislative framework introduced by the GFL Regulation still relevant to address current needs and trends? To what extent are the objectives of the GFL Regulation still relevant and valid? Are there any other objectives that should be considered? .................................................................................................................... 74 5.2 Effectiveness .......................................................................................................................... 79 5.2.1 What progress has been made over time towards achieving the objectives of the legislative framework introduced by the GFL Regulation? Is this progress in line with the initial expectations? ................................................................................................. 79 2 5.2.2 Which main factors have contributed to or stood in the way of achieving these objectives? ..................................................................................................................... 88 5.2.3 Beyond these objectives, has the legislative framework introduced by the GFL Regulation led to any other significant changes both positive and negative? .............. 92 5.3 Efficiency ................................................................................................................................ 93 5.3.1 What are the costs and benefits (monetary and non-monetary) associated with the application of the legislative framework introduced by the GFL Regulation in the Member States and in the Union? ................................................................................. 93 5.3.2 What are the specific challenges to SMEs with respect to the implementation of the legislative framework introduced by the GFL Regulation? .......................................... 101 5.3.3 What good practices in terms of cost-effective implementation of the legislative framework introduced by the GFL Regulation can be identified? ............................... 105 5.3.4 What, if any, specific provisions in the legislative framework introduced by Regulation (EC) No 178/2002 can be identified that make a cost-effective