M.O.C.A.

The Machinery Directive implemented by L.D. n. 17 of 27/01/2010 introduces the obligation for machinery manufacturers to carry out a risk assessment and to use materials in contact which have to comply with the applicable directive.

IN APPLICATION TO REGULATION (CE) 1935/2004
Regulation (EC) 2023/2006 introduces the obligation to apply the GOOD PRACTICES OF MANUFACTURING OF MATERIALS consisting in using a particular risk assessment methodology of the entire company in order not to constitute a danger to human health during the use of materials in contact with any kind of food. Substantially, the regulation defines the common rules for the application of good manufacturing practices (GMP) to which all producers, processors and distributors of materials or objects are subjected in order to constantly guarantee the conformity and safety of finished products.

The materials and objects in contact with food are governed by both national and European provisions.
The Regulation (EC) n. 1935/2004 establishes the general requirements which all materials and objects must meet.

From 10/02/2017, all producers have the obligation to notify the competent health authority that they are producers of materials or objects in contact with food.

Traceability (Article 17 Reg. (EC) 1935/2004)
a) The traceability of materials and objects must be guaranteed at all stages to facilitate the control, the withdrawal of defective products, and provide information to consumers and finally to achieve the attribution of responsibilities;
b) The raw materials, as well as the materials used for processing must be traceable. For this purpose it is necessary to have a procedure that allows the identification of the companies from which and to which the materials and objects produced, transformed or distributed were supplied.

The materials to be tested must be contained in the list in question. Other materials in contact with food are governed by specific measures: ceramic, aluminum, etc.

Migration is the transfer (passage, transfer) of substances from the material or from the packaging or from the container to the food that must always be evaluated.

The manufacturer of substances in contact with food is obliged to accompany the material supplied with a declaration of conformity which must be kept for checks by the competent authority for investigations and in case of recall of the production batch.

SANCTIONS REGIME
In the event of non-compliance with the various regulations governing the matter, there are many sanctions that companies can face Legislative Decree 29 of 10 February 2017 . Below is the list of applicable sanctions for violations of the laws in question:
Main sanctions Art.2 paragraph 1: Production, marketing and use of MOCA which constitute a danger to human health. Sanctions from 10,000 to 80,000 euros. Art.2 paragraph 2: Production, marketing and use of MOCA in violation of global migration limits or failure to comply with good manufacturing practices. Sanctions from 7,500 to 60,000 euros.