MOCA sanctions: an opportunity for improvement

Sanction Decree no. 29 of February 2017 can be considered a turning point for an entire industrial sector (film manufacturers, converters and producers of food contact packaging). The perspective of a sector veteran (not without some bones to pick) opens an interesting discussion. Responses and further contributions welcome. Armando Vaccaro

As of April, sanction Decree no. 29 of 2017 of the Italian Republic is in effect. What’s that mean? It means that legislators have definitively implemented the general dispositions of EU regulation 1935/2004, aka PIM EU/2023/2006, aka GMP, imposing sanctions for non-compliance.
The new legislation also incorporates sanctions against anyone who does not enact the provisions of the following regulations, which constitute specific requirements: EU/1895/2005 (epoxy derivatives), EU/450/2009 (active and intelligent materials), EU/282/2008 (recycled plastic) and finally EU/10/2011 (materials intended to come into contact with food).
This is a great leap forward for a legislature that has always been aloof, waiting for other governments to express their views before taking action.
Truly a breakthrough, then, a turning point for an Italy where it’s often still difficult to distinguish between optional certifications (ISO 9001, BRC/IoP, ISO 22000, etc.) and the provisions of the law.
This is an Italy where “the customer asked for it” justifies accommodating even the most absurd requests, even if it’s not even one’s area of expertise... a place where even the recommendations issued by the European Union are seen as a disciplinary measure (see the latest on mineral oils, for example).
Let’s consider this sanction decree for the moment not as an imposition, but as a valuable opportunity for reflection for the whole community of Italian operators.

General criteria
Like every decree, Legislative Decree no. 29 provides for administrative sanctions that, in this case, are manifold and commensurate with the type of violation.
They reach a maximum threshold of 80,000.
The authority in charge of issuing the sanctions depends on the specific region (non-uniform application on the Italian territory). Now let’s move right to the details by interpreting a number of key articles that make up the decree.

In order to facilitate inspections, it is compulsory to register, but...
For example, let’s start with the contents of Article 6, paragraphs 1 to 4, Legislative Decree No. 29/2017, on the violation of regulations on good manufacturing practices for materials and objects in contact with food products listed under (EC) no. 2023/2006.

Paragraph 1 - In order to facilitate official inspections in accordance with the provisions of (EC) no. 882/2004, economic operators of materials and objects in contact with food products must report to the local health authority any facilities used to perform activities referred to in (EC) 2023/2006, excepting facilities exclusively dedicated to distribution to the end consumer.
Paragraph 2 - If the activity performed by the economic operator is subject to registration or validation in accordance wtih (EC) no. 852/2004 and no. 853/2004, the report required by paragraph 1 must be included in the same filing.

Paragraph 3 - Economic operators already active must take action to fulfill the requirements of paragraphs 1 and 2 within 120 days of the decree going into effect.

Paragraph 4 - Economic operators that do not fulfill the requirements of paragraphs 1, 2 and 3 are subject to financial administrative sanction.

Registration required, then! ... for even if an operator doesn’t make any filing, they are still subject to a punitive fine. Basically, converters, film manufacturers, and packaging producers generally, have 120 days to report their activities to the local competent health authority.
The problem is that the jurisdictionally competent local health authorities are still unaware of what the law requires.
Many of us have, through committees (such as Giflex), contacted the key health ministry and local health authority offices to know the specifics of this registration process. A registration form will be issued soon, and in the meantime we are all awaiting the possibility of fulfilling the provisions of the decree.

How can one ascertain whether infractions have occurred without reference materials on applicable evaluation criteria?
Another major cause for uncertainty is found in Article 2 (regarding violations of EC Regulation 1935/2004, Art. 3.). Quite a read! Let’s look carefully at the wording of EC/1935/2004, Art. 3, paragraph 1: “Materials and objects, including active and intelligent materials and objects, must be produced in accordance with good manufacturing practices, so that, under ordinary or foreseeable conditions of use, they do not transfer to food products substances in such quantities as to
- constitute a risk to human health;
- cause an unacceptable alteration of the food products;
- cause their organoleptic properties to deteriorate.”
In this case, the “very lenient” sanctions are imposed on infractions of Article 2, paragraph 1 of Legislative Decree no. 29/2017, which provides for fines of between 10,000 and 80,000 euro. Infractions of Legislative Decree no. 29/2017, Art. 2, paragraph 2 carry fines of between 7,500 and 60,000 euro. Infractions of Art. 2, paragraph 3 carry fines of between 5,000 and 25,000 euro.
Article 2, paragraph 1 is just for us Italian operators, and it’s fertile ground for good discussion: there is plenty of awareness on the issue but no foundation for taking resolute action in response.
Touching on the issue of NIAS, many are dangerously at risk for this type of sanction. In fact, the law does not provide for reference documents on the methodologies to apply (either nationally or at the European level).
Various work groups (and here we should thank Giflex for its excellent initiative) are working to harmonize sampling and analysis criteria.
At the European level there is also a lack of toxicological studies to identify the health effects of some NIAS, which in spite of our best efforts can develop during melting, printing, lamination, through collateral interactions etc.
The long and the short of it is that the possibility of “strange” NIAS being found in a packaging remains quite high.
In this matter, synergy with suppliers is bringing important results.
As announced during the event Manucor NIAS Infoday, held in Milan, a lot of work is being done with major suppliers of raw materials in order to reduce the risk of NIAS from stabilizer additives of various types. It is thus a mission shared by many.
But with no authoritative reference on evaluation criteria, some are right to ask: what will the health authorities check for, and with what methodologies or instruments?

Enhancing and documenting internal product inspection
Another crucial matter is documentation of the material, which must be increasingly detailed and not superficial, describing the nature of the products used down to the smallest detail. Traceability of chemicals used must thus be absolute. The opportunity for improvement lies here as well. In fact, as well-organized as a concern may be, traceability systems, all of them, still get it wrong. It is necessary that we take advantage of this chance to optimize our quality control and traceability systems, from raw materials to finished product and vice-versa.
A good policy is to have traceability procedures that function in both directions.
This takes us to Article 5 of decree no. 29, concerning “Violation of obligation to traceability and failed recall of materials and objects intended to come into contact with food products”.
Here the concepts laid out in Art. 17 of EC no. 1935/2004 and Art. 7 of Reg. EC/2023/2006 are taken up.
As for the former, paragraph 2 reads: “With due deference to technological feasibility, economic operators maintain systems and procedures to enable the identification of enterprises from which and to which materials and objects and, as the case may be, substances and products, governed by the present regulation and corresponding implementation measures, have been supplied. Said information is available to the competent authorities requiring it.”
Article 7 of Reg. EC/2023/2006, for its part, reads:
1. Operators in the sector must produce and maintain adequate paper or electronic documentation regarding specifications, formulas and manufacturing procedures relevant to compliance and safety of materials and finished products.
2. Sector operators must produce and maintain adequate paper or electronic documentation regarding registration of any manufacturing processes performed, if they are relevant to compliance and safety of materials and finished objects, as well as results of the quality control system used.
3. Said documentation must be made available to competent authorities, should they request it, by operators in the sector.”

Article 5 also has very “prickly” sanctions, wtih fines running up to 50,000 euro. It is therefore necessary to be consciencious and proactive in implementing a robust traceability system and complete, thorough documentation in accordance with those general provisions.

Violations of composition requirements
Lastly, there is Article 8 of decree no. 29 on “Violation of specific measures regarding plastic objects and materials in contact with food products as per EU regulation no. 10/2011”, it’s important to remember Art. 4 and its requirements, which we can sum up as “composition requirements”: only substances listed by the EU as authorized in appendix I can be intentionally used in the manufacture of plastic layers of a material or plastic objects:
Substances not included on the EU list or the provisional list provided by paragraph 2, letter b), must not belong to the following categories: a) substances classified as “mutagenic”, “carcinogenic” or “reprotoxic” (CMR);
b) nano-substances.

Benefits and reconsiderations
In brief, careful reading of every article of the new decree opens up a world of possibility: a packaging industry in which, finally, there is more requiring inspections and sanctions than optional certifications that in the long run end up a matter of habit or simply forgotten.
It is likely that the inspections will be carried out based on CAST guidelines or a more detailed version of the same with additional instructions. Experts are currently working on this, so it would be well to keep one’s ear to the ground through networking.
It is essential that we look at this decree as an opportunity for improvement. It is even possible to completely revamp the state of the art at one’s own concern with the assistance of consultants or employees qualified in this area in order to give the firm a head start in reaching higher quality standards, thereby protecting one’s own interests and those of the consumer.                
Armando Vaccaro
R&D Manager, Manucor SpA