Environmental packaging waste regulations

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Pharmaceutical Technology Europe

Pharmaceutical Technology Europe, Pharmaceutical Technology Europe-10-01-2006, Volume 18, Issue 10

It will remain to be seen whether pharmaceutical companies will commit lock, stock and barrel to being green.

One metre of self-adhesive labels produces one metre of label backing waste. This roughly translates into 104200 tons of waste generated from the self-adhesive label industry. From this, the importance of reducing waste is clearly evident.

The Big 5 pharmaceutical companies are taking notice of the need to become more "green" (and, of course, comply with the legislation) — a statement on one of the company's websites claims that "internally, efforts have been made to ... use more environmentally friendly packaging options". But is reducing the amount of packaging included in a crate sufficient? The answer is no!

Recent developments in labels — especially in the form of "disruptive techniques" such as label replacement — appear to be rendering the label obsolete and have the potential to aid compliance with the legislation.


In 1994, the European Union (EU) issued the Packaging and Packaging Waste Directive 94/62/EC, covering all packaging placed on the market within the EU and all packaging waste — whether disposed of at industrial/commercial sites or from private homes — regardless of the material used. The directive seeks to harmonize national measures concerning the management of packaging and packaging waste to provide a high level of environmental protection and ensure the function of the internal market.


In 2004, the EU introduced amendment 2004/12/EC, which further clarifies the definition of the term "packaging" laid down in Directive 94/62/EC. According to this amendment, all materials used for containing, protecting, handling, delivering and presenting any type of goods are considered packaging. As a result, apart from conventional packaging, labels hung directly on or attached to a product as well as sticky labels attached to a packaging item are themselves deemed "forms of packaging".

The amendment also increases the targets regarding recycling of packaging waste, therefore making the directive even more environmentally friendly. While these EU targets apply across all member states, implementation is the responsibility of the individual countries.

The packaging directive has been transposed into UK domestic law by two sets of regulations: the Packaging (Essential Requirements) Regulations 2003, which set out the requirements all items of packaging must meet before being placed on the UK market, and the Producer Responsibility Obligations (Packaging Waste) Regulations 2005, which set specific recycling and recovery targets.1

These regulations place the onus on the packaging and labelling industry to reduce the amount of waste it creates, however it is increasingly evident that traditional labelling methods are falling short when it comes to compliance.

Traditional labelling methods

Thermal transfer and inkjet printers have traditionally been the preferred choice for the production of variable print-and-apply data labels. Many significant downfalls have emerged that now have the potential to render these labelling technologies obsolete. First of all, these processes do not adhere to the above legislations as they generate considerable waste, from laminate manufacturing and label printing through to label application on packaging.

Additionally, these technologies involve the use of paints, inks, acids or solvents, which have a negative impact on the environment since they are associated with harmful toxic emissions. Costs are increased since the 280000 tons of silicone paper used in labels equates to approximately €530 million/year in manufacturing costs and €210 million/year for its disposal.2 Envirowise, the UK government programme that helps businesses improve their profits through waste reduction, estimates that businesses could save on average as much as €1500/employee by reducing waste.3

Since pharmaceutical regulations require an ever-increasing amount of readable information to appear on packaging, print and apply labels fall short because of the restricted printable area that is available.

Label replacement

The label replacement vision for the packaging (and pharmaceutical packaging) industries is radical. It aids the sector to move towards green manufacturing processes, but also provides additional benefits such as anti-counterfeiting properties.

So what exactly is label replacement? Label replacement consists of a process that features a laser-reactive coating that is applied onto the specific data marking area of the outer case while the packaging is being produced. The coating is applied by using the conventional printing process of the packaging manufacturer. On the final production line, a low energy CO2 laser 'writes' the required variable data onto the mark area causing a colour change reaction of the coating from white to black.

The most significant benefit of this solution is that it provides tangible results in the prevention of environmental pollution. This is particularly obvious when considering that there is no longer label backing or ribbons to dispose of, meaning that reduced environmental waste is created. In addition, packaging departments no longer suffer the associated disposal cost burden. Label replacement technology is totally non-toxic and since it does not require any paints, inks, acids or solvents on the production line, it does not generate any harmful toxic emissions.

An additional benefit of label replacement — especially relevant to pharmaceutical companies — is that as there is no actual label (the data is integral to the pack), so the label cannot be peeled off. According to the World Health Organization (WHO), a counterfeit medicine is "one which is deliberately and fraudulently mislabelled with respect to identity or source. Counterfeiting can apply to both branded and generic products, and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient ingredients or with fake packaging."4 By using label replacement technology, counterfeiters are presented with an additional barrier, making it harder for the pharmaceutical product to be faked.


It will remain to be seen whether pharmaceutical companies will commit lock, stock and barrel to being green, but by employing more environmentally friendly products and processes, such as label replacement, companies are taking another step toward this commitment. Of course, by employing a technique that adds extra benefits such as cost-effectiveness and counterfeit prevention, companies face a win-win situation.

Chris Wyres is technical manager at Datalase, UK.


1. www.dti.gov.uk/innovation/sustainability/packaging/page29072.html

2. www.ec.europa.eu

3. www.envirowise.gov.uk

4. www.pharmj.com/Editorial/20031004/bpc/counterfeiting.html