Implementation and control by Authorities in one country

Zagreb, 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

Ministry of Health of Slovak republic

Public Health Authority of Slovak republicChief hygienist of Slovak republic

Regional Public Health Authorities (regional hygienist)Total number : 36

Regional Public Health

Authority

Department of living enviromental hygiene

Department of hygiene, food safety and

cosmetic products

Department of children and youth hygiene

Department of preventive occupation hygiene

Department of epidemiology

Regional Public Health Authority in Poprad

National Reference

Laboratory for food contact

materials

- - 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

Aims of my presentation

to provide general view on preparation of the yearly control plan in the field of FCM

• +

to provide details of the yearly control plan in Slovak republic

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

Yearly plan

Part of MANCPRequirements of

Regulation (EC) No. 882/2004

General aims : • to ensure compliane with certain rules or to contain certain risk• has to contain minimum level of mandatory controls in specific areas

Perfect plan = 100% safety of FCM

all scope of materials and articles

all FCM producers in EU

all importers to EU

all FCM users - food industry

Perfect plan = 100% safety of FCM

declaration of compliance

supporting documentation

GMP

Perfect plan = 100% safety of FCM

declaration of Compliance

supporting documentation

GMP

all scope of materials and articles

all FCM producers in EU

all importers to EU

all FCM users - food industry

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- …..…..

How to set up priorities ?

Where to control ?

How to control ?

What to control ?

(substances, DoC, GMP...)

What to control ?(articles/

materials)

Must be flexible

How to set up priorities ?

Laboratory capacity

Inspectors

Legislation

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

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

How to control ?

Which tools for control can be used? Art. 2 Regulation (EC) 882/2004

audit inspectionmonitoringsamplinganalysisdocumentary check

How to control ?

Documentary check declaration of compliancesupporting documentation

Physical checkanalysis of individual or group of

substances for which SMLs are set up

Where to control ?

border FCM producers FCM importers FCM users – food industry wholesale retail distribution chain internet shops ? doorstep selling ?

What to control ?

group of materials and articles in 1935/2004

according EU legislation only : ceramicsplastics

regenerated celluloseactive and intelligent

recycled plastics

for other – national requirements applied

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

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

The yearly control plan in Slovak republic

Official controls with sampling

Official controls without sampling:

- DoC- supporting documentation- labelling

Special campaign:

- ceramics sell in toys shops- PS catering dishes

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 articles

5. New - Performance GMP audits manufacturers of materials and articles intended to come into

contact with food

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

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

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 manufacturersOther priority : it is necessary to carry out in subjects who had deficient in 2012.

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

2. Official controls without sampling

Aim : control the safety of packaging materials in food industry focused on control the required documentation

Timetable: control can be exercised during whole year 2013

Place of performance: the food industry

Performance:• 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

3. Sampling of FCM that are used as promotional 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 materials

Timetable : during the performance of official controls in 2013

Performance:• 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

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 2012Performance:

• in case of detection using these products immediately inform the NRL for materials in contact with food

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

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

Additional documents

Database of producersCategory system

Database of importers Database of wholesalers

Trainings of all operators

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

Roles of the inspectors

Provide sufficient information from official control

Improve content of official control

Sufficient control plan

Thank you for attention