Implementation and control by Authorities in one country Zagreb, 17 – 18 June 2013

1. Implementation and control by Authorities in one countryZagreb, 17 – 18 June 2013 Workshop on European Food Contact legislation Milada Syčová pp.sycova@uvzsr.sk Regional Public Health Authority in Poprad, Zdravotnícka 3, 058 97, Poprad

2. Ministry of Health of Slovak republic Public Health Authority of Slovak republic Chief hygienist of Slovak republic Regional Public Health Authorities (regional hygienist) Total number : 36

3. Department of living enviromental hygiene Regional Public Health Authority Department of hygiene, food safety and cosmetic products Department of children and youth hygiene Department of preventive occupation hygiene Department of epidemiology

4. Regional Public Health Authority in Poprad • drafting legislation of FCM • preparattion of MANCP - FCM • preparation of instructions • and guidance for MANCP • and the yearly plan • preparation annual report • - results of control activities • training of staff in the field • of FCM • consultation activities for industry • expertises • first point of introduction of • consingnents – import controls • chemical analysis of FCM • microbiological analysis of FCM • organoleptic analysis of FCM National Reference Laboratory for food contact materials

5. Aims of my presentation

6. Framework regulation 1935/2004 Inspection and control measures • MS have the responsibility to enforce and control EU and national legislation (Regulation 882/2004 applies to FCM) • Commission ensures implementation of legislation by Member States • Establishment of EuRL and use of RASFF

7. Part of MANCP Requirements of Regulation (EC) No. 882/2004 Yearly plan • General aims : • to ensure compliane with certain rules or to contain certain risk • has to contain minimum level of mandatory controls • in specific areas

8. Perfect plan = 100% safety of FCM

9. Perfect plan = 100% safety of FCM

10. Perfect plan = 100% safety of FCM

11. Mission impossible....Why ? insufficient number of inspectors and ….money lacks in the legislation – no all FCM are covered by legislation (EU/national) lacks in analytical methods lacks in risk assessment …..…..

12. How to set up priorities ? Where to control ? What to control ? (articles/ materials) What to control ? (substances, DoC, GMP...) How to control ? Must be flexible

13. How to set up priorities ?

14. What are taken into account ? requirements of EU legislation specific limits for some substances DoC supporting documentations labelling traceability GMP requirements of national legislaton specific limits for some substances RASFF information information from food inspection, industry and trade FVO recomendations research studies information from EURL and DG SANCO – FCM meetings

15. What are taken into account ? inputs from consumers media information results from previous inspection number of inspectors and their knowleges number of staff in NRL laboratory capacity in NRL

16. How to control ? Which tools for control can be used? Art. 2 Regulation (EC) 882/2004 audit inspection monitoring sampling analysis documentary check

17. How to control ? Documentary check declaration of compliance supporting documentation Physical check analysis of individual or group of substances for which SMLs are set up

18. Where to control ? border FCM producers FCM importers FCM users – food industry wholesale retail distribution chain internet shops ? doorstep selling ?

19. What to control ? group of materials and articles in 1935/2004 according EU legislation only : ceramics plastics regenerated cellulose active and intelligent recycled plastics for other – national requirements applied

20. What to control ? DoC + supporting documentation Risk : Chemical analysis of individual or group of substances for which SMLs are set up : formaldehyde melamine Bisphenol A BADGE, BFDGE, NOGE... Labelling Traceability GMP

21. The control plan in Slovakia in 2013 proposal of the yearly plan is prepared by NRL for food contact materials on the regional level in cooperation with central level – Public Health Authority proposal is presented on annual meeting regarding official controls to which inspectors from the 36 regional offices are invited all inspectors can comment the proposal after adoption is sent to all health offices

22. The yearly control plan in Slovak republic Officialcontrolswithsampling • Officialcontrolswithoutsampling: • - DoC • supporting • documentation • - labelling Specialcampaign: - ceramicssell in toysshops - PS catering dishes

23. The yearly control plan in Slovak republic In 2013, official controls are carried out as follows:1. Official controls with sampling (timetable)2. Official controls without sampling 3.Special for 2013 - Sampling of FCM that are used as promotional items to promote the sale of food products, magazines, etc.4.Special for 2013 - Monitoring the use of active and intelligent materials and articles5.New - Performance GMP audits manufacturers of materials and articles intended to come into contact with food

24. 1. Official controls with sampling Aim : Targeted sampling of products based on : Chemical risk:- PAA, formaldehyde, melamine, phenols, Cd, Pb, Cr, Ni, Sb, Hg, As- eters of phthalic acid (DBP, BBP, DEHP, DIDP, DINP)- DEHA (bis (2-ethylhexyl) adipate)- octene, acetaldehyde- volatile substances- glycols (mono-and di-ethylene glycol)- Bisphenol A, F, S- BADGE, BFDGE, NOGE- and other monomers and chem. compounds depending on the mat. composition (styrene, caprolactam, vinyl acetate, residual solvents, etc.)Microbiological risk:- Coliform bacteria, fungi, yeastsThe risk of affecting the sensory properties:- Taste, smell, appearance

25. 1. Official controls with sampling The list of samples which are control each year : melamine kitchen utensils polyamide kitchen utensils baby bottles ceramic articles plastic packaging materials The list of specific samples which are controled in 2012 or in 2011 (requiremets of market, interest of consumers....) PET bottles and PET preforms silicone kitchen utensils ceramic knives glass caps with decorated rim

26. 1. Official controls with sampling Timetable: sampling carried out according to timetable (from march to november) – each regional office know when (in which month) The sampling sites:Priority sampling is carried out in settlements of : importers wholesale and manufacturers Other priority : it is necessary to carry out in subjects whohad deficient in 2012.

27. 1. Official controls with sampling Performance: sampling carried out in accordance with special guidance the planned amount of samples are divided on all region from region - send the requested number of samples controls of labelling and documentation inspection of storage conditions

28. 2. Official controls without sampling Aim :control the safety of packaging materials in food industry focused on controlthe required documentationTimetable:control can be exercised during whole year 2013Place of performance:the food industryPerformance:• the requesting and assessment of documentation (DoC, supporting documentation) in food industry • control of min. 5 food businesses within the territorial jurisdiction of each regional office Declaration of compliance Supporting documents

29. 3. Sampling of FCM that are used aspromotional items Aim:sampling of FCM which are used as promotional gifts to promote sales of other products (food products, magazines, etc.) due to possible use of poor quality and hazardous materialsTimetable :during the performance of official controls in 2013Performance:• cereal bowls, cups, plastic bowls, ceramic mugs, glass tumblers etc. can be used as promotional items • for these products is increased risk that their production is low-quality materials used, which may endanger human health• in the event of such products should make their collection in a number of 4 units during the year 2013

30. 4. Monitoring of use of active and intelligent materilas and articles Aim :to monitor the use of active and intelligent materials and articles Timetable :during the performance of official controls in 2012 Performance:• in case of detection using these products immediately inform the NRL for materials in contact with food

31. 5. Performance GMP audit of FCM manufactures Aim :To perform an audit of GMP in manufacturer Timetable:time is defined by each regional office Performance:• follow the Guidance and Check list for performance of external audit work for the good manufacturing practices by manufacturers of materials and articles intended to come into contact with foodstuffs sent in 2010• preferably be carried out audit of manufacturers of plastics and ceramics, and then by other manufacturers

32. Supporting documents for performing of official controls Special guidance with list of all relevant legislation act and requirements: how to sampled, number of samples how to control labelling how to control DoC + supporting documentation Special guidance for control of GMP check list Special document – information about each controls

33. Additional documents Database of producers Category system Database of importers Database of wholesalers Trainings of all operators

34. Training of staff for each yearly plan – the inspectors have to be trained special workshop – evaluate the concrete DoC and supporting documentation Special workshop for import control international workshop or conference with colleagues from Czech republic

35. Roles of the inspectors

36. Thank you for attention