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Certification systems on generic frameworks of FCMs

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A much greater emphasis can be found placed in the certification systems in the context of GMP than in the context for controls. The information collected on certification systems with mentions pertinent to accreditation and official controls is summarised. It refers to the certification systems responding to the need for authorisation of laboratories to perform compliance testing and details on requirements for compliance testing laboratories. The most complete (and relatively recent – 2014) at national level were those of Switzerland and Austria.

Overview of national measures in the EU MSs with mentions on certification systems for official control:

MSs Document Description
AT Food Safety and Consumer Protection Act BGBl I Nr 13-2006 (last amended by BGBl. I Nr. 67/2014) – appoints the Austrian Agency for Health and Food Safety for the official control duties (§65 (1)).

– states which institutions for compliance assessment of food and FCM samples taken during official controls and inspections (§65 (1), §72, §73).

– sets general requirements for the methods to be used for compliance testing (§68 (1)) and for the professional qualification of personnel carrying out the compliance assessment (§70, §72 (4), §73 (2)).

– requires the accreditation of all laboratories which carry out the compliance assessment for samples taken during official controls and inspections (§68 (2), §72 (4), §73 (4)).

– Agency’s laboratories must possess an accreditation in accordance with the Federal Act on the accreditation of conformity assessment bodies (Accreditation Act 2012) that supplements Regulation (EC) No 765/2008210

– It provides directions on the accreditation procedure, on the obligations of accredited conformity assessment bodies, on the terms for the termination, withdrawal, suspension and reduction of accreditation, on measures for non-compliance and on enforcement.

CH Ordinanza sul sistema svizzero di accreditamento e la designazione di laboratori di prova e di organismi di valutazione della conformità, di registrazione e d’omologazione (Ordinanza sull’accreditamento e sulla designazione, OAccD) del 17 giugno 1996 (RS 946.512), as of 1 July 2014

Ordinanza sulle derrate alimentari e gli oggetti d’uso (ODerr) del 23 novembre 2005 (RS 817.02), as of 15 July 2014

– sets rules for accreditation of bodies that perform product testing, assess product compliance

– sets conditions for designation registration and approval bodies with liability and fees.

– provides a list of international criteria applicable to the Swiss Accreditation Service and to the conformity assessment bodies (ISO standards)

– Specifies details of the accreditation process for laboratories and other institutions which are entrusted with compliance assessment

– States that official control laboratories and national bodies performing inspections need to be accredited (according to ISO 17025 and ISO 17020, respectively) (see Art. 62).

CZ Zákon 258/2000 Sb. (with its amendments) – mentions the need for certification system, without any specific detail (Hlava V,díl 1, oddíl , §84 (2), §108 (1)).
DE (AVV Rahmen-Überwachung – AVV RÜb) vom 3. Juni 2008, last amended by Verwaltungsvorschrift vom 14. August 2013 (BAnz AT 20.08.2013 B2) – states that official control laboratories are nominated by the federal states and that they need to have a QM system (§ 4(3), 5(1) AVV RÜb).
SE SE Normpack General guide on food packaging safety – mentions the need of a quality system and reports the certificate Normpack can release to attest compliance of the producer. (p6, bilaga 6)
SI Uradni list RS, št. 52/00 z dne 13. 6. 2000, last amended by Zakon o spremembah in dopolnitvah določenih zakonov na področju zdravja – ZdZPZ (Uradni list RS, št. 47/04 z dne 30. 4. 2004) Act on health suitability of foodstuffs

– states that official testing laboratories have to be certified. (22. člen, 38. Člen)

– document was repealed by the end of 2015.

Ind Industrial guidelines on traceability of materials and articles for food contact* – states that converters can carry out audits to ensure that the supplier’s process is in control, basis on ISO 9000 procedures (Section VI, VI.2).

In the context of GMP the information was very detailed and therefore is fully summarised and analysed in the article of the availability of documentation on Good Manufacturing Practice – GMP from MS and industry, including on certification systems. The analysis refers to the coverage of the checklist for GMP (from EU Regulation (EC) 2023/2006).



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