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FCM – Basis for enforcement

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The collection of basic enforcement information on generic frameworks on FCMs – Food Contact Materials

Note: in the analysis of enforcement information, a broader meaning of the term has been taken. Thus, material researched encompassed not only provisions on the setting/management of enforcement bodies or enforcement campaigns but also considered available information on the mean to perform the enforcement (e.g. availability of testing methods).

Overview of national measures or information in the EU MSs on information/requirements related to basis for enforcement:

MS Legislation Descriptions of enforcement requirements
AT BGBl. I Nr. 13/2006

BGBl. I Nr. 63/2002

Accreditation Act 2012

BGBl. II Nr. 161/1997

BGBl. II Nr. 275/2008

BGBl. I Nr. 13/2006:

– institutions and bodies entrusted or that may carry out compliance assessment of food and FCM samples taken during official controls and inspections (§ 65 (1), § 72, § 73)

– accreditation for such institutions and bodies (all tasks of the Austrian Agency for Health and Food Safety are specified in the BGBl. I Nr. 63/2002 and all the information on the accreditation requirements are set in the Accreditation Act 2012) (§ 68 (2), § 72 (4), § 73 (4))

– methods to be used for compliance testing must be suitable (§ 68 (1))

– general requirements for the professional qualification of personnel carrying out compliance assessment (§ 70, § 72 (4), § 73 (2))

BGBl. II Nr. 161/1997

– requirements for the professional qualification (e.g. training, education, etc.) of personnel involved in compliance assessment ( § 1-4)

BGBl. II Nr. 275/2008

– specific details on initial training, practical and theoretical training and demonstration of proficiency, final examination and eventual further training (with specific training plans for the different types of officials and inspectors)

BE Loi du 24 janvier 1977 – role of controls and relative actors (staff of the Federal Public Service for Public Health, Food Chain Safety and Environment appointed for this purpose by the King) (Art. 11, 12)

– swearing of an oath before the Minister or his representative for staff

CZ Zákon 258/2000 Sb.

Vyhláška 38/2001 Sb

– very general basis for actors and duties for generic enforcement, without any specific detail on FCMs in particular (Hlava V, díl 1, oddíl 1, § 80, § 84, oddíl 4, § 88 – 90)

– information on the use and on the characteristics of different products and materials. It also states that in case no official validated analytical methods exists, a method with adequate characteristics, may be used. (část první, § 2-7)

EE Toiduseadus (Food Act) of 25 February 1999

Veterinaar- ja Toiduameti põhimäärus RTL 2007, 49, 898

Veterinaar- ja Toiduameti Peadirektor Käskkiri No. 86 of 01 April 2011

Veterinaar- ja Toiduameti Peadirektor Käskkiri No. 65 of 26 March 2013

Veterinaar- ja Toiduameti Peadirektor Käskkiri No. 205 of 18 December 2014

Toiduseadus

– appoints the Veterinary and Food Board (VFB) as a competent authority for FCM

– establishes enforcement conditions and tasks, specifying all what has to be assessed (e.g. state and use of food business and its premises, processing materials, produced articles, equipment, handling, labelling, documentation, hygiene requirements, etc.) (Ch. 8)

– modalities of controls (e.g. sampling, visiting premises, collecting documentation) (Ch. 8)

– introduces and regulates a Food supervision fee to be paid by the businesses for the controls that have to be performed in their premises (Ch. 8)

– allows the supervising official to take measure in cases on non-compliances and specifies measures (Ch. 8)

– Veterinary and Food Board is the authority coordinating the preparation of the contingency and of the multi-annual control plan (Ch. 8)

– tasks and duties of the laboratories that analyse the samples (that are authorised by the Veterinary and Food Board upon written application and payment of a fee by the laboratory) and the reference laboratory (that are appointed by a directive of the Minister of Agriculture upon written application). (Ch. 9, § 52-53)

Veterinaar- ja Toiduameti põhimäärus

– organisational structure of the Veterinary and Food Board

– defines its tasks which include the supervision of the manufacturing, processing and marketing of FCM (§ 6 No. 3, § 11 and § 14 No. 1) ), the authorisation of a laboratory for analysing samples taken during official controls (§ 14 No. 4) and the organisation of trainings for official control personnel (see § 16 No. 6)

Veterinaar- ja Toiduameti Peadirektor Käskkiri No. 86 of 01 April 2011

– guidance document addressed to officials of county veterinary centres who exercise supervision in the field of FCMs and describes how to determine the “risk level” of a FCM plant, based on which the frequency of official inspections is set

– states that the beginning of each calendar year the county supervisory officials shall prepare a plan of official controls

Veterinaar- ja Toiduameti Peadirektor Käskkiri No. 65 of 26 March 2013

– the risk level of a storage company can be lowered and consequently the frequency for inspections decreased, if during two consecutive inspections no non-compliances are found

Veterinaar- ja Toiduameti Peadirektor Käskkiri No. 205 of 18 December 2014

– description of annual plan for official controls in food and FCM plants (recalling Käskkiri No. 86). Provides instructions for the documentation and reporting of inspection outcomes

F I Elintarvikelaki

Sections that apply to FCM: §2; §29-41, 44-53, 54b-54e

– all actors and responsibilities in enforcement, including custom and border authorities and bodies

– competences of control authorities/bodies, national reference laboratories (NRLs) and approved laboratories for testing of official samples (and specific requirements on competence, reliability of results, trained personnel)

– written quality system for control authorities/bodies and NRLs and approved laboratories

– requirement for national control programme, control plans and municipal food control plan to include description of control measures and information (specifies information and measures)

– describes modalities of controls

– introduces administrative coercive measures

– states the right to carry out inspections, obtaining information, performing sampling, obligations of control authorities (notification, information, and guidance), and official registers

F Code de la Code de la consommation
R consommation (as amended up to 01/01/2015)

Note d’information n°2014-108

– fixes sanctions in conjunction with Art. 131-38, 131-39 and 131-21 of the Code Pénal (L212-1, L 213-1, L 213-2 I, L 213-2-1, L213-3, L213-4, L213-5, L213-6, L214-1, Ll214-2, L214-3)

– reports a Chapter with provisions on prevention (L.221-5)

Note d’information n°2014-108

– general guidance on compliance work

– general principles for compliance testing and the DoC work (see section 2.1)

– responsibilities of operators with respect to compliance work along the supply chain (3.3)

DE AVV RÜb of 3rd June 2008

LFGB of 3rd June 2013 (BGBl. I S. 1426)

AVV RÜb of 3rd June 2008

– states that EC 882/2004 Art. 6, 10 , 11 apply to the official controls of FCMs (§2, 3, 4, 7, 8)

– criteria for control personnel (qualification, characteristics of inspections teams, conduct and duties during inspections) (§2, 3, 4, 7, 8)

– criteria for controls bodies (capacity and performance assessed by proficiency testing schemes issued by the Federal Office and monitored by the competent authorities) (§2, 3, 4, 7, 8)

– criteria for sampling (decided in close collaboration between the competent authorities and the official testing laboratories and analysis of samples, for the cooperation and exchange of information between interested party in the controls chain (§2, 3, 4, 7, 8)

– states that competent authorities shall establish quality management systems (§ 5)

– states necessity to classify establishments in risk categories, based on which the control frequency will be determined (from once every three years to a maximum of once a day) (§ 6)

– stipulates the number of samples per year (e.g. 0.5 samples of tobacco products/cosmetics/ consumer product (incl. FCM) per 1000 inhabitants) (§ 9)

– defines the multi-annual national control plan (MANCP) as individual integrated control plans of federal states and a national section, specifying timeframe and actors, and the national monitoring plan meant for the performance of official controls of compliance, with detailed information on all data that have to be collected (§ 10, 11)

LFGB of 3rd June 2013 (BGBl. I S. 1426)

– delegates responsibility for official controls to the level of the federal states and defines the duties for periodic official controls and sampling of the competent authorities (including measure for encountered non-compliances) (§ 38, 39)

– detailed requirement for controls/compliance tests to be performed by specially trained personnel and defines rights of authorised personnel (§ 42)

– permits sampling by authorised personnel, requiring a portion of the sample to remain with the producer for cross-check, and it obliges the business operators to cooperate and provide all the necessary information (§ 43)

IT Circolare XIII del 27/03/2001 del Ministero della Sanità

Decreto legislativo 25 gennaio 1992, n. 108

Circolare XIII del 27/03/2001 del Ministero della Sanità

– legal background and general guidance to official controls on how to perform controls, especially for recycled/reused FCM,

– importance of supervision of producer businesses ( collection of samples, compliance of batches produced, corresponding documentation for checks)

Decreto legislativo 25 gennaio 1992, n. 108

– necessity of controls and applicable sanctions

NL Regeling van de Minister van Volksgezondheid, Welzijn of 14th March 2014 – rules for assessing compliance with migration limits (including details on migration conditions, simulants /substitute simulants, methods, alternative methods, needed equipment, detection, calculation of results, application of correction factors) (Ch.s 0.7, 0.8, 4.1, 4.2, 5, 6, annex I-IV; Ch. II, 1, annex I)

– mention that assessment of substances not included in the EU list has to take place on the basis of internationally recognised scientific risk assessment principles or based on the TTC principle (Ch.s 0.7, 0.8, 4.1, 4.2, 5, 6, annex I-IV; Ch. II, 1, annex I)

NO LOV-2003-12-19-124

(Ch. II, § 5-11, 13, 14, Ch. VI, § 33)

FOR-1993-12-21-1381

LOV-2003-12-19-124

– sets actions the enforcing authorities can do and obligation for producers to provide the requested material

– sets the obligation for companies to take any necessary measure and to inform the authorities if problems are encountered, to ensure that the location, design and operation of activities meet appropriate hygienic standards, to ensure that the personnel is properly trained, to ensure the traceability of materials and its availability to authorities, to provide access to premises, assistance, and allow sampling

FOR-1993-12-21-1381

– supervision and implementation of the legislation on FCMs is responsibility of the Norwegian Food Safety Authority (Mattilsynet) (Kapittel VII, § 27, § 28)

PL Ustawa z dnia 25 sierpnia 2006 (Dz. U. 2010 nr 136 poz. 914) – description on how official controls are performed and competences of each body (Art. 88-94)

– appointment of the bodies of the State Sanitary Inspection as competent for official controls of FCMs, their rights when performing controls (e.g. to enter the food business at any time, to analyse technological processes and recipes to the extent necessary for controls, to have access to all documentation pertinent to the purposes of the control, to collect samples of FCM for laboratory testing) (DZIAŁ V, Art. 73, 76, 78)

– accreditation for bodies of the State Sanitary Inspection (DZIAŁ V, Art. 73, 76, 78)

– duties regarding the controls to be performed at the border by border sanitary inspectors (based on compulsory notification of the importer 48 hours before the arrival of the shipment), that will issue a compliance certificate, and according to regulations by the health minister (Art. 79-84)

SK VÝNOS z 9. júna 2003 č. 1799/2003 – 100

Regionálne úrady verejného zdravotníctva v sr – Metodický návod EXTERNÉ AUDITY

VÝNOS z 9. júna 2003 č. 1799/2003 – 100

– requirements of validated analytical methods verification of compliance (§ 8)

Regionálne úrady verejného zdravotníctva v sr – Metodický návod EXTERNÉ AUDITY

– internal requirements for the implementation of GMP external audit systems for manufacturers

– basic processes and responsibilities of persons involved in the process of auditing and evaluation systems for GMP manufacturers (with check list for GMP audits )

SI Uradni list RS, št. 47/04 z dne 30. 4. 2004

(16-20. člen, 22. člen, 27. člen, 32,33. člen, 37,38. člen) repealed at the end of 2015

– actions and actors of official controls

– instructions on inspections, sampling, testing, etc.

CH Legge federale sulle derrate alimentari e gli oggetti d’uso of 9th October 1992

Ordinanza sulle derrate alimentari e gli oggetti d’uso of 23rd November 2005

Legge federale

– sets the obligation of self-monitoring for the manufacturers (Art. 23)

– general rights and duties for official control authorities (incl. regular controls, sampling) (Art. 24)

– delegates responsibility for official controls to cantons and their specially trained personnel and specialised laboratories (Art. 40)

– delegates responsibility for training of authorised personnel to the cantons (authorised personal has to fulfil the requirements set by the Swiss Federal Council) (Art. 41)

– third-party institutions can be authorised to take over tasks related to official controls (Art. 43a)

Ordinanza

– states the duty of self-monitoring for manufacturers (Art. 49)

– states the duty to perform regular official controls for FCM (incl. sampling) and defines basic requirements for sampling and requirements for personnel authorised to perform official controls (Art. 56-58, 63)

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

CH Bewertung von „Konformitätserklärungen“ für FCM im Vollzug auf Basis der SVI-JIG Checkliste vom 19.02.2012 Issued by the Association of Chemists ‘Verband der Kantons-chemiker der Schweizhe’

– GMP guidance document

– checklist to assess the completeness and quality of a Declaration of Compliance and it provides further explanations on the required information. The document is addressed to inspectors for use during official controls

UK 2010 No. 2225

FOOD, ENGLAND

The Materials and Articles in Contact with Food (England)

Regulations 2010

PART 5: defined offences

Defines execution and enforcement power to each food authority port health authority and food agency. (for Reg. 1935/2004 and 2023/2006)

– defines offences by third party

– gives a three year time limit for enforcement.

Illustrate rights for general defences

– defines when samples needs to be analyses (section 19), secondary,

-defines application of samplings

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