Food System

Italy, national plan of official controls on materials and objects intended to come into contact with foodstuffs

September 12, 2023

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The Ministry of Health has published the five-year plan (2023-2027) of official controls in Italy on materials and objects intended to come into contact with food (MOCA or FCM, Food Contact Materials).

The control plan was defined by Office 6 of DGISAN together with the Istituto Superiore di Sanità (national reference laboratory for MOCAs) and shared with regional and provincial authorities.

Table of Contents

1) Food Contact Materials, premise.

Food Contact Materials – FCM, in Italian MOCA (materials and objects intended to come into contact with food) – subject to the official controls established in the national plan include:

– Kitchen and tableware, containers, tableware, cutlery,
– Food processing machinery, including coffee machines,
– packaging materials.

Excluded, however, are antiques, covering or coating materials that are part of foodstuffs and can therefore be consumed with them (e.g., cheese rinds), and fixed public or private water supply facilities.

2) National plan of official controls on materials and objects intended to come into contact with food

Food Contact Materials Regulation (EC) No 1935/04 requires that official controls on materials and articles intended to come into contact with food be conducted:

– by the member states, in accordance with the criteria set out today in the Official Controls Regulation (EU) No 2017/625 on official feed controls (FCMR, Article 24),

– systematically, with appropriate intensity and frequency, based on identified food safety risks, the outcomes of previous controls and the reliability of self-control (FCMR, Article 9). (1)

2.1) Italy, competent authorities

Ministry of Health. It is in charge of planning and coordinating control activities by annually processing the findings of official controls at the national level, with the help of the Istituto Superiore di Sanità (ISS).

National Institute of Health. As the National Reference Laboratory-MOCA, it supports the Ministry of Health in coordination, processing of official control findings and risk reassessment, and performs activities related to litigation.

Autonomous Region and Province. The national plan calls for each Autonomous Region and Province to develop in turn a Regional/Provincial Plan (PR/PP) for official control of MOCAs in the state of finished and ready-to-food-contact products (excluding semi-finished products) made in:

 plastic
 stainless steel
 glass
 ceramics
 plastic containing bamboo.

On the basis of the risk assessment and taking into account the precipitous realities of
each territory, the Regional Authorities and Autonomous Provinces allocate the samples taken at the stages of production and distribution (understood as: storage, wholesale and retail).

Each Autonomous Region and Province identifies a contact person to be entrusted, in the
territory of jurisdiction, the coordination of the Plan itself. PR/PPs and names.
of the relevant contact persons must be forwarded to the Ministry of Health – DGISAN – Office 6 “Food Technology Hygiene” within 90 days from the date of adoption of the National Plan. PR/PPs may be updated as a result of changes made to the National Plan.

They ensure that all personnel assigned to official controls under the Plan are trained and keep up-to-date for their areas of responsibility.

Regional Authorities and Autonomous Provinces must validate by March 31 of the year following the year to which the data refer the data transmitted by the relevant laboratories in the NSIS-Food system.

ASL. They plan, coordinate and carry out official control activities in their area of responsibility.

Official controls consist of a range of activities carried out by the authorities
competent, or by the delegated bodies or individuals to whom certain tasks regarding official controls have been delegated under Regulation (EU) 2017/625.

Territorially competent ASLs transfer samples to laboratories in charge of official control; included among the controls are:

 identity, through visual inspection to verify that the content and
The labeling of a batch, including marks, seals and means of transport, in order to
Of correspondence to official accompanying documents (art.3,
Paragraph 42, of Regulation (EU) 2017/625)

 documentation, through verification of official certificates, attestations
officers, statements, and other documents (e.g., those of the nature
commercial), which accompany the match, as required by the regulations
(e.g. from Article 1(2) to Article 56(1) of the
Regulation (EU) 2017/625).

The competent authorities conducting the sampling shall report in the report of
draw all consistent and necessary information for the correct and complete
Compilation of mandatory fields in the RADISAN single computer flow of the
NSIS-Food system.

Border Control Posts (PCFs). They plan, coordinate and carry out official control activities on consignments of MOCA destined for import into the European Union, which are carried out, according to the provisions in force with specific Plan (“Plan for monitoring laboratory controls on food of non-animal origin, food supplements and MOCA imported from third countries”) drawn up by Office 8 from the General Directorate
of Animal Health and Veterinary Drugs (DGSAF) of the Ministry of Health.

Skills laboratories. They perform the analysis. Laboratories in charge of official control are in Lombardy: ATS Milan and ATS Insubria; in Liguria: to ARPAL; in Piedmont: to ARPA and IZS Piedmont Liguria and Valle d’Aosta Section of Cuneo; in Friuli Venezia Giulia: to ARPA; in Emilia Romagna: to IZSLER; in Tuscany: to Azienda USL of Florence; in Marche: to ARPA; in Umbria: to ARPA; in Lazio: to ARPA; and in Puglia: to ARPA).
They enter sampling data and analysis results into the system
“NSIS-Food” information as soon as possible and no later than February 15 of the year
subsequent to the one to which they refer.
In order to ensure the accuracy of analytical data and the correct interpretation of the
data, participate in specific training activities and comparative tests organized by the
National Reference Laboratory or by the Union Reference Laboratory
European; the schedule is communicated in the PR/PP.

2.2) Official sampling

Official sampling must be performed by taking matrices suitable for:

– Verify the compliance of food contact materials with current regulations, viz.

– Collect elements for risk assessment. (2)

Based on the official control plan and risk assessment, sampling can be:

– Selective, for the verification of compliance of food-contact materials and objects with current regulations, or

– targeted, to ascertain compliance with current regulations in the case of an alert notification and/or its follow-up.

The declaration of conformity of the food contact materials-and, if applicable, the documents necessary for the proper performance of the analysis (e.g., composition, intended use, time and temperature of use), to be forwarded to the designated competent laboratory-are verified and acquired at the sampling stage.

2.3) Official sampling, rate composition.

The composition of aliquots (number of pieces/objects/materials) of food contact materials (FCM, in Italian MOCA) samples varies according to their type and depending on the proper performance of analysis by the assigned laboratory of competence.

The minimum quantity of each aliquot is that necessary to achieve the lowest limits of quantification of the analytes sought by taking into account both legislative and analytical requirements (e.g., requirements for repeatability of analysis).

The image below summarizes the planned samples for a total of 1,000 samples each year over the five-year period 2023/2027 in relation to:

– combination and type of FCM/MOCA,

– percentage of samples,

– analyte-group of analytes to be searched for the purpose of official control.

2.4) Breakdown of official controls in individual regions and autonomous provinces

The distribution of official controls for each Region/Autonomous Province (PA) is defined on the basis of the resident population indicated by ISTAT as of Dec. 31, 2020, and still guarantees a (unfortunately small) minimum number of 10 samples to be taken by each Region/Autonomous Province.

The diagram below represents the breakdown of samples for each Region and Autonomous Province in Italy.

3) Interim Conclusions.

The European regulation of materials and articles intended to come into contact with food (MOCA, or FCM) is to date outdated, fragmented and extremely deficient, as has been repeatedly reported. (3)

The safety of contact materials is closely linked to food safety in the face of the real risks of migration of toxic chemicals-often unknown and undisciplined-in food for every segment of the population, including the vulnerable.

However, the official controls established in this national plan, like those likely in other member states, are infinitesimal compared to the millions of food contact materials everywhere produced that are released into the European Union each year. (4)

Paolo Rebolini and Dario Dongo

Notes

(1) Dario Dongo. Contact materials, safety issue. GIFT(Great Italian Food Trade). 27.9.18

(2) Legislative Decree Feb. 2, 2021, no. 27. Provisions for the adaptation of national legislation to the provisions of Regulation (EU) 2017/625. Consolidated text as of 2/28/22 on Normattiva https://tinyurl.com/ctcnahuy. Official controls on food contact materials cover the areas under Art. 2(1), while the risk assessment must be carried out in accordance with Annex I, Section 1, item 1

(3) Dario Dongo, Paolo Rebolini. Kitchenware and food contact materials, test conditions in EU. GIFT(Great Italian Food Trade). 22.8.22

(4) The paucity of notifications to the RASFF of food safety risks related to food contact materials – 231 cases in the whole of 2022 in 27 member states – is in turn emblematic of the utter inadequacy of official controls in this area. See Dario Dongo, Marta Strinati. RASFF 2022, EU food security report. GIFT(Great Italian Food Trade). 1.8.23

Paolo Rebolini

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Food technologist expert in production and distribution of food and packaging, with a focus on quality management and food safety. Third party auditor for the international standard BRCGS packaging and trainer Approved Trainer Partner of BRCGS.