CHAPTER THREE
SAFETY ISSUES IN THE EU WITH REGARD TO PACKAGING

3.1 Food safety, SuperRegulation

3.1.1 Food contact legislation and SuperRegulation

Safety is not a new concern for the EU. One of the most well known directives concerning food safety is the directive 89/109/EEC relating to materials and articles intended to come into contact with foodstuffs which has been issued on December 1988. This directive has been repealed by the recent Framework Regulation 2004/1935/EC (published in the EU Official Journal on 13 November 2004).

2. This Regulation shall apply to materials and articles, including active and intelligent food contact materials and articles, (hereinafter referred to as materials and articles) which in their finished state:
(a) are intended to be brought into contact with food; or
(b) are already in contact with food and were intended for that purpose; or
(c can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use.

3. This Regulation shall not apply to:
(a) materials and articles which are supplied as antiques;
(b) covering or coating materials, such as the materials covering cheese rinds, prepared meat products or fruits, which form part of the food and may be consumed together with this food;
(c) fixed public or private water supply equipment.

Regulation 2004/1935/EC, article 1


Another important point of this Regulation is that:
1. 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:
(a) endanger human health; or
(b) bring about an unacceptable change in the composition of the food; or
(c) bring about a deterioration in the organoleptic characteristics thereof.

Regulation 2004/1935/EC, article 3


Some definitions are also added to the new version of this framework regulation :

Traceability: the ability to trace and follow a material or article through all stages of manufacture, processing and distribution;

Placing on the market: the holding of materials and articles for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves.

Active food contact materials and articles: means materials and articles that are intended to extend the shelf-life or to maintain or improve the condition of packaged food. They are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food.

Intelligent food contact materials and articles): means materials and articles which monitor the condition of packaged food or the environment surrounding the food.

Regulation 2004/1935/EC, article 2

Traceability and intelligent packaging are more extensively treated in part 3.1.7 and 3.1.8 respectively.

According to article 15, paragraph 1 (a) of the Regulation 2004/1935/EC, “Without prejudice to the specific measures referred to in Article 5, materials and articles, which are not yet in contact with food when placed on the market, shall be accompanied by:
(a) the words ‘for food contact’, or a specific indication as to their use, such as coffee machine, wine bottle, soup spoon, or the symbol reproduced in Annex II; and
(b) if necessary, special instructions to be observed for safe and appropriate use; and
(c) the name or trade name and, in either case, the address or registered office of the manufacturer, processor, or seller responsible for placing on the market established within the Community; and
(d) adequate labelling or identification to ensure traceability of the material or article, as described in Article 17; and
(e) in the case of active materials and articles, information on the permitted use or uses and other relevant information such as the name and quantity of the substances released by the active component so as to enable food business operators who use these materials and articles to comply with any other relevant Community provisions or, in their absence, national provisions applicable to food, including the provisions on food labelling.”

A new obligation has arisen together with this new Regulation; that of is explained this in part 3.1.7.

Directive 89/109/EEC stipulates (in article 3) that specific directives would be passed for the following materials: Plastics, including varnish and coatings; Regenerated cellulose; Elastomers and rubber; Paper and board; Ceramics; Glass; Metals and alloys; Wood, including cork; Textile products; Paraffin waxes and micro-crystalline waxes.

In 2004/1935/EC this list is updated according to the latest developments in terms of European legislation. There are new categories and existing ones that have been split into two, as follows:
· Active and intelligent materials and articles
· Adhesives
· Ceramics
· Cork
· Rubbers
· Glass
· Ion-exchange resins
· Metals and alloys
· Paper and board
· Plastics
· Printing inks
· Regenerated cellulose
· Silicones
· Textiles
· Varnishes and coatings
· Waxes
· Wood

To date only 3 specific directives have been issued for: plastics (Directive 2002/72/EC); ceramics (Directive 84/500/EEC); and regenerated cellulose (93/10/EEC).

Directives on plastics

The Directive which presently governs the use of plastics materials and articles for packaging use is Directive 2002/72/EC. Published in August 2002, it is replacing the “Monomers Directive” 90/128/EC and has been amended by Directives 2004/1/EC and 2004/19/EC (January and March 2004).

Directive 2002/72/EC establishes:
· An overall migration limit of 60mg (of substances)/kg (of foodstuff or food simulants) for all substances migrating from a material into foodstuffs);
· A positive list of authorised monomers and other starting substances, with restrictions on their use (such as specific migration limits) where applicable. Some monomers remain provisionally authorised at national level pending a re-evaluation by the EFSA;
· A list of authorised additives and in some cases, restrictions on their use (such as specific migration limits). In addition there exist also national lists of authorised additives;
· The procedures for adapting, revising and/or completing the lists of authorised substances.

Directive 2002/72/EC has been amended by Directive 2004/1/EC, which suspends the use of the blowing agent azodicarbonamide as from 02 August 2005.

A further amendment Directive 2004/19/EC lays down that the list of authorised additives will become a positive list. To this end the following deadlines have been set:
· 31.12.2006 Submission of dossier to EFSA for all additives currently on national lists which have not yet been evaluated by EFSA
· At the latest 31.12.2007, the Commission will establish a provisional list of additives which may continue to be used subject to national law until EFSA has evaluated them. Only additives that were permitted in one Member State, and for which a valid petition has been received by EFSA before 31.12.2006 can be included in the provisional list.

Directive 2004/19/EC lays down that for migration of food contact material additives, which also are permitted as direct food additives, the stricter limit applies. They shall have no technological function in the final foodstuff.

Directive on ceramics

Ceramics are regulated by Council Directive 84/500/EEC. The Directive sets migration limits for cadmium and lead which might be released from decoration and/or glazing. It gives an analytical method for the determination of the migration of these substances.

Directives on regenerated cellulose film

Regenerated cellulose film is regulated by Commission Directive 93/10/EEC as amended by Directive 93/111/EC. The Directive sets a positive list of authorised substances and the conditions under which they can be used. A recent amendment Commission Directive 2004/14/EC introduces changes for plastic coated regenerated cellulose film.