EUROPA

SUMMARY

This Regulation establishes “good manufacturing practice *” for materials and articles intended to come into contact with food.

“Good practice” harmonises manufacturing procedures in the European Union for the aforementioned materials at all stages of production, from manufacture to distribution.

Manufacturers must establish a quality assurance system and a quality control system (see below) following the detailed manufacturing regulations, for example the processes involving printing inks.

Materials in contact with food include objects such as containers and packaging, but also all materials in contact with foodstuffs, such as paper and cardboard or those which could possibly transfer their constituents to food, for example inks and adhesives.

Annex 1 to Regulation (EC) No 1935/2004 includes a list of the materials covered by this Regulation: active and intelligent objects, adhesives, ceramics, cork, rubbers, glass, ion-exchange resins, metals and alloys, paper and cardboard, plastics, printing inks, regenerated cellulose, silicones, textiles, varnishes and coatings, waxes and wood.

Quality assurance system and quality control system

This Regulation includes an obligation for manufacturers to implement a quality assurance system (taking account of the personnel required to put the system in place and the size of the business), as well as a quality control system. The latter provides for measures to be taken should a business fail to comply with good manufacturing practice.

In addition, manufacturers shall create and maintain documentation regarding the specifications, manufacturing formulae and product processing which are important for the compliance and safety of the finished article, as well as those related to the various manufacturing operations. They are required to make the documentation available to the competent authorities at their request.