Statutory Regulations

The primary objective all national and European legislation is to protect the health of consumers. In addition to Regulations, and Directives issued by the European Union, national legislation in each individual country must also be heeded. Furthermore, Resolutions drafted and adopted by the CoE (Council of Europe) also incorporate recommendations.

EU Regulation (EC) 1935/2004

EU Regulation 1935/2004 forms the basis of the European rules and regulations on materials and articles intended for food packaging.

Article 1 defines the purpose of this Regulation.

The Regulation applies to materials and articles which in their finished state:

are intended to come into contact with food,
are already in contact with food,
can reasonably be expected to be brought into contact with food under their normal or foreseeable conditions of use.

Pursuant to Article 3, 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,
bring about an unacceptable change in the composition of the food
or bring about a deterioration in the organoleptic characteristics thereof.

The principle underlying this Regulation is to rule out endangerment to human health and/or the change of composition and characteristics of food.

Article 16 stipulates that all materials and articles that come into contact with food are to be accompanied by a written declaration stating that they comply with the rules applicable to them.
This means that the manufacturer of printed folding boxes must draw up an declaration of compliance.

Article 17 specifies that the traceability of materials and articles be ensured at all stages of production. (This Article will come into force in October 2006).

According to both the German Food, Consumer Goods and Animal Feed Act (LFGB) and EU Regulation 1935/2004, it is the manufacturer of the food packaging and the marketer of the food who are responsible for compliance with the law.

EU Regulation (EC) 2023/2006

on good manufacturing practice for materials and articles intended to come into contact with food.

The regulation 2023/2006 lays down the principles of good manufacturing practices. The scope is the same as for the Regulation 1935/2004. It applies to all food contact materials not only for plastics.

It shall apply from 1 August 2008.

The most important articles are:

Article 5 Quality assurance system

The business operator shall establish an effective and documented quality assurance system
The starting materials shall be selected and comply with pre-established specifications
The different operations shall be carried out in accordance with pre-established instructions and procedures

Article 6 Quality control system

The quality control system shall include monitoring of the achievement of GMP

ANNEX

Printing inks shall be formulated and applied in such a manner that substances from the printed surface are not transferred to the food-contact side in concentrations in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation (EC) No 1935/2004.
Printed materials and articles shall be handled and stored in such a manner that substances from the printed surface are not transferred to the food-contact side in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation (EC) No 1935/2004.
The printed surfaces shall not come into direct contact with food.

No laws specific to printing inks and coating/varnishes exist presently, neither at national nor at European level. This applies not only to printing on the outside but also printing on the inside of packaging, that is, on the side that comes into direct contact with the food packaged.

Legislation is already in force that regulates the use of plastic materials and articles intended to come into contact with foodstuffs (the "Plastics Directive" 2002/72/EC). This Directive, however, only applies to materials and articles made exclusively of plastic.

Recommendations of the Council of Europe

Since 1969, the Council of Europe (CoE) has adopted the following Resolutions:

Resolution AP (2004) 1 on coatings intended to come into contact with foodstuffs
Resolution AP (89) 1 on the use of colorants in plastic materials coming into contact with food
Resolution AP (2002) 1 on paper and board materials and articles intended to come into contact with foodstuffs
Resolution AP (92) 2 on control of aids to polymerisation (technological coadjuvants) for plastics materials and articles intended to come into contact with foodstuffs
Resolution ResAP(2005)2 on packaging inks applied to the non-food contact surface of food packaging materials and articles intended to come into contact with foodstuffs (the "Ink Resolution").

Resolutions adopted by the Council of Europe are merely recommendations with no legally binding character.

Ink Resolution

On 14 September 2005, the Committee of Ministers of the Council of Europe adopted Resolution ResAP(2005)2:
Resolution on packaging inks applied to the non-food contact surface of food packaging materials and articles intended to come into contact with foodstuffs.

The most important points in this "Ink Resolution" are:

Printing inks, coatings and varnishes may only contain constituents that are contained in an inventory list. This document (Technical Document 1) has, however, not yet been completed.
Existing specific migration limits (SMLs) of evaluated substances are to be complied with. Regulations on the measurement of migration are in preparation (Technical Document 3).
Non-evaluated substances are not permitted to migrate to the package contents. (Migration should be less than 0.01 mg/kg.)
Printing inks and prints are to be produced in accordance with good manufacturing practice. Appropriate documents (Technical Document 2) are in preparation

Conventional, low-odour offset inks contain solvents (mineral oil, fatty acid esters) that have not been evaluated toxicologically. For a large number of package contents, the quantities that migrate to them are considerably higher than 0.01 mg/kg.

National German Statutory Regulations

At the statutory level, the German Food, Consumer Goods and Animal Feed Code (LFGB) and the German Consumer Goods Ordinance (BGVO), as skeleton law, regulate the problem area of food packaging.
The Federal Institute for Risk Analysis (BfR) has drawn up recommendations for a range of materials for food packaging.The most important paragraphs of the LFGB are § 2 that contains the definition of consumer goods and § 30 and § 31.

§ 30 forbids, along the same lines at Article 3 of EU Regulation 1935/2004, the manufacture and sale of consumer goods that can damage human health. According to § 31 LFGB, no constituent substances of consumer goods may be transferred to foodstuffs, with the exception of components that are harmless with respect to health, odour and taste.

By now, Switzerland is the only European country that issued regulations for printing inks for food packaging.
Please find more detailed information under Statutory Regulations Switzerland

All regulations, both national and European, are founded on a globally recognised principle:
No transfer of substances from packaging to foodstuffs shall be permitted unless the substances are approved or harmless, or the concentration of migrants is below the specified limit.

Even if there are currently no regulations that relate specifically to packaging made of paper and board and composites thereof, EU experts are of the opinion that the only matter of interest is which substances migrate in which concentration from a package to a foodstuff.

The following conclusions must be drawn from this:

TDI/SML values for toxicologically evaluated substances are to be complied with (TDI = tolerable daily intake)
the limit for global migration of 60 ppm (mg/kg) must not be exceeded
a limit of no concern of 10 ppb applies for toxicologically non-evaluated substances
no cmr (carcinogenic, mutagenic, reprotoxic) substances may be used.

Statutory Regulations