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HIGHLIGHTS ON REGULATION 1935/2004

From 22 December 2006, the regulation CE 2023/2006 establishes good manufacturing practice for materials and articles intended to come into contact with food.This fixes that from 1 August 2008, manufacturers of product designed to contact food substances (FCM, Food Contact Materials) must deem that in the production of all FCM listed in Annex 1 of Regulation 1935/2004, “good manufacturing practices” are applied.

This was the first step toward the armonization of legislation about FCM and general good manufacturing practice, lacking in some Country of the European Community.

The importance of the GMP was particulary evident after some cases of contamination of products due to inks present in packaging (i.e. Milk).The way of production following GMP was just introduced by Regulation 1935/2004 stating in the art.16 (Declaration of compliance):

The specific measures referred to in Article 5 shall require that materials and articles covered by those measures be accompanied by a written declaration stating that they comply with the rules applicable to them.

So, it just required appropriate documentation stating the compliance of materials and articles, available to the competent authorities on demand and that is not limited to general data but it deems specifically the quality of products and production.

The Regulation (EC) 1935/2004 was applied on date of its publication and, from 27 October 2006, for the section related to Traceability (Art.17). It was created for all materials and articles designed to contact directly or indirectly food substances (not just packaging but also production machines, storage facilities,valves, conveyor belts...), it introduces the following:

  • Safety Standard for the Health of consumer

  • Traceability

  • Report of compliance of all FCM

In the European Community, only ceramic, plastic and regenerated cellulose have specific legislation. The Regulation 1935/2004 was created for all other materials, for which a specific national or european legislation does not exist.

In Italy the requirements reflect substantially the european legislation. The reference legislation is the Ministerial Decree 21/03/1973 Discipline hygienic of packaging, containers, and articles, intended to come into contact with foodstuffs or with substances for personal use.

For all other objects an material not regulated by D.M. 21 March 1973 (wood, cork, fiber artificial and natural materials) there is a communication of Minister Of Health suggesting the following steps:
• examination of the composition of the material;
• contact with real food (with the evidence simulants do not apply);
• Analytical research of possible migrants in the and comparison with a sample not in place contact with the material under consideration;
• comparing the amount of the compounds migrated from material with the toxicological data in the legislation or contact with food, in the Synoptic Document

According to Regulation 1935/2004, therefore, all FCM must be sufficiently inhert to ensure an high level of protection of human health; this point is clearly explained in the Article 3:

Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could endanger human health or bring about an unacceptable change in the composition of the food or bring about a deterioration in the organoleptic characteristics thereof.

Article 17 defines instead, the traceability of materials and objects designed to contact food, which must be ensured in all stages, to facilitate monitoring, the possible withdrawal of defective products, consumer information and the attribution of responsibility.

Finally, the Declaration of compliance fixed in the Article 16,issued by the producer to the user, must ensure the information necessary to evaluate several factors including migration,the dual-use additives possibly used, the test conditions and traceability to be complete, must include alll references to European and national legislation, the description, process and plans sampling.

The regulation (EC) No 2023/2006 GMP bring on uniformity in a field that was not required to prove to operate second "good practice".

The Annex to Regulation ( "Specific rules on good manufacturing practice "processes that providethe application of printing inks) was modified by the recent Regulation (EC) No 282/2008 of27 March 2008 relating to materials and articles made of plastic recycled for contact with food, which has therefore introduced an additional reference.

Preceded by important considerations about the need harmonization between Member States (Article 2), a "proportion" of the rules governing GMP(art. 6) and, as anticipated, the definitionof specific rules for processes with inks printing, for which the GMP will ensure that "The substances are not transferred in the food because of set-off or by transfer through the substrate "(art. 7), the Regulation can be reassumed by 3 fundamental elements:

QUALITY SISTEM (Article 5): all stakeholders should establish an effective, non-formal systemquality management, taking it to apply the training of personnel, the exercise of its and knowledge and the size of operation, so as not to constitute an unreasonable burden on factory;

QUALITY CONTROL SYSTEM (art. 6): must include monitoring the implementation andtotal compliance with the GMP and must identify measures to correct any lack of conformityGMP themselves;

DOCUMENTATION (art. 7): It is neede to elaborate and mantain an adequate documentation about specific and production process.

 

How meet the requirements of Regulation 1935/2004?

To meet the requirements of Regulation (EC) No 1935/2004 may refer to certain rules andrecognized standards or applying the law, where provided.The fundamental principles of this regulation may therefore be more easily met:

danger to health: evaluating compliance with laws in force concerning the composition and migration;

no unacceptable change in the composition the food or the organoleptic characteristics: the reference is to UNI 10192, which allows assess the changes induced in the organoleptic;

Traceability: applying the international standard ISO 22005:07, combining in a single standard the two previously used, the UNI 10939, under chain, and the UNI 11020, company.