Food-Contact Materials

	Pursuant to Act no. 258/2000 Coll.			Client Handbook (conformity assessment manual)

TESTING AREA

• foodstuffs packaging (all materials)
• dishes and functional household food-contact articles (all materials)
• electrical appliences comming into contact with food
• gastrotechnology

MATERIAL EVALUATION IN FOODSTUFF CONTACT

• The laboratory performs sampling and examination of the health products safety intended for foodstuffs contact pursuant to:
• Act No. 258/2000 Coll., on Public Health Protection, and the Ministry of Health implementing Decree No. 38/2001 Coll., on Hygienic Requirements to Products Intended for Direct Contact with Foodstuffs and Meals. The results of these tests can be fully used as supporting documents to issue the declaration of compliance;
• The harmonized European Legislative (Commission Regulation /EU/ No. 10/2011, Council Directive (EU) 84/500/EEC, Regulation /EU/ No. 1935/2004) in harmonized sphere
• Requirements given in Potravinářský kodex (Food Code) of the Slovak Republic
• Requirements of the U.S. regulation CFR 21 FDA (Code of Federal Regulations, Food and   Drugs) - only plastics
• Requirements of German regulations (BfR recommendations)
• 
  

  In the scope of the assessment of FCM safety the laboratory provides the following testing service:

• Overall migrations according to the series of EN 1186-x standards
• Specific migrations of substances according to EN 13130-x standards and the series of methods developed in ITC laboratories
• Specific migrations of metals including nickel and aluminium according to requirements of the Commission Regulation (EU) No. 10/2011
• Determination of specific migrations of primary aromatic amines photometrically as screening using LC/MS method individually
• Sensory analysis of FCM
• Qualitative determination of low-molecular substances in plastics and rubbers (additives, monomers, products of degradation, softeners….)
• NIAS evaluation (Non Intentionally Added Substances)
• Testing of products from silicates (ceramic, glass, enamels and enamel surface) – migration of Pb, Cd and alternatively migration of other elements based on the client demand
• Migration tests of rubbers and products made from elastomers according to the requirements of Health Ministry Decree No. 38/2001 Coll.
• Determination of the composition of the products made from metals and alloys in terms of the assessment of conformity with the requirements of Health Ministry Decree No. 38/2001 Coll.
• Migration tests of products of metals according to Council of Europe Resolution CM/Res (2013)9
• Migration tests of non-metallic surface coatings (varnishes, anti-sticks surface coatings of pans, casseroles etc.)
• Testing of paper and paper products according to the requirements of Health Ministry Decree No. 38/2001 Coll.
• Determination of coloured and fluorescence whitened papers fastness according EU standards
• Determination of glyoxal content in paper according to DIN 54603 (requirement of BfR XXXVI)
• Determination of transfer of antimicrobial constituents in the paper product according to ČSN EN 1104 (requirement of BfR XXXVI)
• Determination of MOSH saturated hydrocarbons and MOAH aromatic mineral oils in packaging materials
• Determination of volatile substances and peroxide residues in silicone elastomers according to the requirements of BfR XV
• Colour migration according to Resolution (EU) AP (89)1 and Italian regulation D.M.
• and many other tests regarding individual requirements of the clients or material properties
•  

• ADDITIONAL TESTING OF QUALITATIVE INDICATORS

• corrosion resistance
• dishwasher resistance
• microwave resistance
• high oven temperatures resistance
• strength of handles
• flaking, peeling of surface coatings
• impact resistance
• 
  

  OVERALL MIGRATIONS

• ITC laboratory provides overall migrations into all food simulants defined in Commission Regulation (EU) 10/2011 using the methods as described in the standards group EN 1186 under the conditions (temperature and period) corresponding with real use of the products or specified by the clients. ITC laboratory experts can suggest appropriate testing conditions for overall and specific migrations. In addition we can specify relevant range testing for purpose of the FCM safety assessment and issuing of compliance declaration in relation to materials and intended conditions of use.
  
  ITC laboratory provides the overall migrations not only on the products and materials made from plastics but also on other materials and products according to the requirements given by EU, Czech Republic and other member countries regulations and alternatively according to the clients requirements.

• Food simulants (migration media) for overall migrations tests:

• simulant A – 10% ethanol, distilled water
• simulant B – 3% acetic acid
• simulant C – 20 % ethanol (or x% ethanol relating to alcohol content in the food in contact with the product)
• simulant D1 – 50% ethanol
• simulant D2 – olive oil or alternative fatty food simulants: 95% ethanol a isooctane
• simulant E – MPPO (modified polyphenylenoxide)

• Contact conditions (common design):

• total immersion
• one-side contact in migration cells
• by the product filling
• 
  

  SPECIFIC MIGRATIONS

  Only the substances set out in Annex I to Commission Regulation (EU) 10/2011 (the Union list of authorised substances) may be intentionally used in the manufacture of plastic articles and materials intended to come into contact with foodstuffs. Many of them are restricted by their specific migration limits (SML), the other ones are restricted by the overall migration limit 60mg/kg of food. ITC offers verification of migration of more than 200 substances (monomers, stabilizers, plasticizers, solvents, photoinitiators) into food simulants. ITC laboratory can also develop new analytical methods in case the method has not been available yet.
  
  ITC laboratory experts can suggest appropriate testing conditions for overall and specific migrations and in addition specify relevant range testing for purpose of the FCM safety assessment and issuing of compliance declaration in relation to materials and intended conditions of use.
  
  ITC laboratory provides the specific migrations not only on the products and materials made from plastics but also on other materials and products according to the requirements given by EU, Czech Republic and other member countries regulations and alternatively according to the clients requirements

• List of the analysed substances restricted by SML – selected substances:

• caprolactam, laurolactam
• acrylonitrile
• 1,3-butadiene
• Hexamethylentetramine
• 1-Hexene, 1-octene
• Terephthalic, isophthalic, maleic and other acids
• Methacrylates, acrylates
• Esters of phthalic acid
• Bisphenol A
• Glycols (MEG, DEG)
• Metals
• Primary aromatic amines
• Melamine
• Formaldehyde and other aldehydes
• Ultranox 626, Irganox 126
• Irganox 1076, 1010, 168, 3114, 245, 1098 and other ones
• BHT
• AOX
• Chimassorb 944, 81 and other ones
• Tinuvin 327, 622, 326 and other ones
• 9,9-bis(methoxymethyl)fluorene
• N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amines
• and other stabilisers and monomers
   

RELATED ITC SERVICES

• Conformity assessment  by Authorized  Body 224 and  Notified Body  1023
• Product certification by Accredited certification Body 3002
• Granting licences for voluntary certification mark „ITC certified quality“ – above-standard voluntary products evaluation
• Standardization service and technical information
• Certification of management systems (ISO 9001, ISO 14001, OHSAS 18001, HACCP, ISO 22000, ISO 13485)
• Technical inspection

CONTACTS

Person	Phone	fax	e-mail
Dipl.Ing. Sarka Kopeckova	+420 577 601 705	+420 577 601 389	skopeckovaitczlin.cz
Dipl.Ing. Vera Vilimkova	+420 577 601 634	+420 577 601 389	analytitczlin.cz
MUDr. Beata Frydrychova	+420 577 601 276	+420 577 601 389	mikrobiologieitczlin.cz

Post address:
Institute for Testing and Certification, Inc.
Laboratory of Analytical Chemistry and Microbiology
trida Tomase Bati 299, Louky, 763 02 Zlin
Czech Republic

The person responsible for accuracy of data: Ing. Vera Vilimkova