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Reach for the rulebook

New EU regulations will force packaging manufacturers and importers to monitor any chemical elements of their materials and final packs. Keith Nuthall reports

June 1 was a historic date for the packaging industry, because in a sense, nothing from that day will be the same again. That was when REACH – the European Union’s (EU) Registration, Evaluation, and Authorisation of Chemicals system – came into force, sparking a long series of deadlines, tests, assessments and registrations that will last from now until 2022.

While packaging companies do not generally make chemicals, but they certainly use them. Inks, coatings, adhesives are all widely employed, and, as a downstream consumer of chemicals, the packaging sector has to comply with a range of REACH rules, designed to protect the environment and human health.

According to EUROPEN – The European Organisation for Packaging and the Environment – in a new briefing note: “All operators should begin to prepare for REACH now and EUROPEN is examining its implications for the packaging chain and how it should be implemented.”

Unfortunately, the extent to which the packaging sector will have to register chemicals used in its products is still unclear, with a European Commission working party trying to decide on some key interpretations regarding the REACH regulation, which was approved last December.

A key issue for the packaging sector could be REACH’s rules as regards “articles”. The EUROPEN note said it “understands that packaging falls under the definition of an article in the Regulation which states: ‘article’ means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.” This is all well and good. But what is an article? Is it a tin of beans, or the tin and the beans individually. Is it a box of cornflakes, or a box and its cornflakes apart? For packaging, this conundrum could have a series of important implications.

This is because it affects the formulae under which companies decide whether they have to register a chemical that they are using in their products with the European Chemicals Agency – ECHA – (This body also came into being on June 1 and is now being established in Helsinki).

Manufacturers have to know what chemicals are in their packaging, and in what quantity. But they only have to register them themselves, or ensure they are registered by a supplier, under the following two sets of circumstances,

First registration is required:

*If a chemical substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year;

*And “is intended to be released under normal or reasonably foreseeable conditions of use”. So, if a packaging, for example, emits a scratch-and-sniff smell, a manufacturer and importer will have to find out what chemical had been used, and may have to register it. The same could apply if a chemical interacts with air or food to change the colour of packaging and alert a consumer that a packaged foodstuff is past its “sell-by” date, or not fit for consumption.

But of course packaging is disposed of and so it could well be deemed to be “intentionally released”. And here is the rub. A tin of beans is supposed to be eaten, if it is considered one product. It could then be argued that the disposal of the packaging is neither here nor there. But if the tin is considered a separate article, its disposal and release into the environment could be deemed part of its design, and so all kinds of packaging then come into play.

The discussion over what denotes an article also affects a second formula regarding mandatory registration of chemicals. Here, a registration is required if an article is deemed by the agency to be potentially of concern to health or the environment; and makes up 0.1% of more by weight of an article, as well as weighing more than 1 tonne given the amount of a particular article imported or made annually by a company, regardless of its release. This is important because, given the possible toxicity of some inks, some of these chemicals could be deemed substances of concern.

So, what if the “article” is deemed to be a tub of ice cream using intelligent packaging and then viewed as one single item? The chances of any chemicals in the packaging making up more than 0.1% of the overall weight would then be slight, and so they would be exempt from REACH under this formula. But what if the ice cream, the tub and the label were all considered separate articles? In such a case the chemical might just make up 0.1% of the weight – say of the label – and then it would be caught.

In all these cases, if the substance and its use by a packaging company has already been registered by a supplier, then no further action is required. But if it has not been, then a manufacturer or importer must register the substance,

EUROPEN is advising caution: “Pulp and paper, plastics, metals, glass, coatings, printing inks and adhesives are among materials used in packaging that are affected by REACH. Packaging material suppliers, converters and importers of raw materials and finished goods should ensure that they are aware of their obligations under the provisions dealing with substances in articles.”

Furthermore, it rightly points out that the key initial concern for packaging companies is the so-called pre-registration process. This needs to be completed in most cases by December 1, 2008. This involves the chemicals agency being given basic information about the chemical product which will later be registered in more detail by a packaging company or its supplier. Data to be handed over here includes a definition of the substance, how much is produced or imported (approximately), and some contact details. So calculations about what chemicals are in play REACH-wise must be done by that date.

The EUROPEN briefing note says: “Companies should begin to audit their product portfolios now and initiate dialogue with customers and suppliers. Packaging converters and packer-fillers/brand owners should encourage suppliers to pre-register all substances during the mandatory June to December 2008 timeframe.”

And while, as EUROPEN points out, there is no penalty for missing this deadline, there is a risk that without it, a chemical may not get registered, which for potentially hazardous chemicals will be compulsory for use within the EU. EUROPEN warns: “There is no guarantee substances that have not been preregistered can be registered according to the timeline laid down in the Regulation and unregistered substances will eventually have to be taken off the market.”

Here the association is referring to the REACH registration schedule, which is a series of deadlines for chemicals to be registered, which involves providing information about their classification, identity and use, in a format as laid down in Annex VI of the regulation.

As regards registration, the speed with which this work must be carried out varies according to their importance or toxicity. For existing substances deemed by the agency to be carcinogenic, mutagenic or toxic to reproduction, as well as substances produced or imported by an applicant in volumes exceeding 1,000 tonnes a year, the deadline is December 1, 2010. For those produced or imported in volumes exceeding 100 tonnes annually, it is June 1, 2013. And for smaller volume substances exceeding one tonne annually, it is June 1, 2018.

Also, for new substances, the rule is simple: if registration is required from now on, and there is no registration, sales or use in the EU of products containing them are banned.

Other issues worth considering are that by June 1, 2008 the European Commission must have specified the REACH fees and charges that will apply. It must also ensure practical access to REACH assessment documents are made available, something of key importance to environmental watchdogs. By this day, also, Member States are supposed to have forwarded to the ECHA existing risk information about chemicals and related substances that already have market approval. And by August 1, the agency is supposed to have received notification from manufacturers and importers of new chemical substances that have been officially declared to regulators, but have yet to hit the market. These substances will be allotted an identity number so that they can be assessed and registered later. Packaging manufacturers need to make sure their suppliers keep abreast of these demands.

The next key date is June 1, 2009, when the second pillar of REACH, its special authorisation procedure saying how chemical substances deemed particularly hazardous can or cannot be used, comes into force. This is when the ECHA makes its recommendation for substances which must be subject to a rigorous screening process detailed in the REACH regulation’s Title VII. The agency is charged with refreshing this list at least every two years from this date, and it supposed to include chemicals it is really worried about in its 2009 announcement.

These are far from being the only steps that must be taken by regulators and chemical producers or importers under REACH, but they are probably the key ones, at least in its earlier days.

*The European Commission has – to give it credit -released a lot of explanatory notes online, and they are free. For example visit: http://ec.europa.eu/environment/chemicals/reach/reach_in_brief04_09_15.pdf and http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm. To really check the letter of the law and read the articles and annexes mentioned above, there is the voluminous REACH regulation itself – see http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML.


“ALL OPERATORS SHOULD BEGIN TO PREPARE FOR REACH NOW AND EUROPEN IS EXAMINING ITS IMPLICATIONS FOR THE PACKAGING CHAIN AND HOW IT SHOULD BE IMPLEMENTED.” If packs are deemed as separate “articles” from their contents, their disposal could be interpreted as an “intentional release”