From Inks to Safety Data Sheets: How Printing Plants Are Adapting to EU REACH

REACH stands for the EU regulation on Registration, Evaluation, Authorization and Restriction of Chemicals. Enacted through EU legislation, this chemical regulatory framework has been in force since June 1, 2007.

The regulation addresses safety across chemical production, trade and use. Its aims include protecting human health and the environment, strengthening the competitiveness of the EU chemical industry, supporting innovation in non-toxic and harmless compounds, preventing market fragmentation, improving transparency in chemical use, encouraging non-animal testing, and advancing sustainable economic and social development.

Under REACH, any chemical produced in Europe or imported into Europe in volumes above 1 ton per year must go through comprehensive procedures covering registration, evaluation, authorization and restriction. This helps identify chemical composition more accurately and simply, with the goal of ensuring environmental and human safety. The regulation includes major sections on registration, evaluation, authorization and restriction. Imported or produced chemicals must have a registration dossier that lists chemical composition, explains how manufacturers use the components, and provides toxicity assessment.

This information feeds into a database currently under construction. It is managed by a new EU agency based in Helsinki, Finland: the European Chemicals Agency. The agency reviews each dossier. If a chemical is found to affect human health or the environment, stricter measures may follow. Depending on several evaluation factors, a chemical may be banned or allowed only after approval.

Because building all registration data takes time, the regulation is rolled out in stages. By December 1, 2008, all materials used in the EU had to be pre-registered with the European Chemicals Agency (ECHA). The number of pre-registered materials was 145,000.

Full registration follows a staged timetable: hazardous substances, or substances used in volumes above 1,000 tons per year, had to be registered by December 1, 2010, while all other substances must complete registration by June 1, 2018.

REACH and printing inks

Substances that are mixed or formulated from different materials do not need registration, but each individual component in the mixture must be registered separately. As a result, printing inks, varnishes, adhesives and other mixed materials can only be produced from materials that have been pre-registered and registered within the prescribed period, or authorized for the prescribed use. Raw material suppliers therefore must be approved.

Will printing inks become more expensive?

Detecting toxic substances in a chemical can lead to a registration payment of EUR 300,000 or more for that substance. Ink manufacturers worry that if these registration costs are passed on to raw material sales prices, costs will increase. The impact would be especially clear for special raw materials produced in small volumes.

Ink manufacturers also worry that specialty chemical producers may withdraw certain chemicals from the market shortly before the registration deadline for cost reasons. That would require reformulation and replacement of raw materials used to compound inks. The risk is unlikely for standard printing inks made in large quantities. For years, under the prohibited list established by the European Printing Ink Association, manufacturers have already banned hazardous raw materials in inks. There is therefore little need to fear that REACH application restrictions will significantly affect the composition of standard printing inks.

The registration obligation has another effect: if a printing plant imports inks from outside Europe on its own, it must register with the European Chemicals Agency the various substances contained in those imported inks when annual consumption exceeds 1 ton.

Another core principle of REACH is to encourage communication among all supply chain participants—material manufacturers, importers and downstream users. Downstream users include formulators, meaning ink manufacturers, and end users, meaning printing plants.

It is important for printing plants, or the associations representing them, to give input on potential hazards in ink use. Based on that input, ink manufacturers develop explanatory schemes for assessing possible risks. Downstream users then receive information in the safety data sheet on substance risks, handling measures and prescribed uses. In the coming years, safety data sheets will visibly grow longer. Eventually, this process ends when the registration phase expires.

In the future, printing inks may only use prescribed substances as raw materials. Printing plants, as downstream users, are obliged to use only inks intended for prescribed applications and to follow the safe handling measures in the safety data sheet.

To make realistic rules for safe ink handling in printing plants, the European Printing Ink Manufacturers Association should stay in close contact with printing industry associations. If a printing plant fails to implement the safety measures in the safety data sheet, or uses an ink different from the prescribed one, the supplier can receive this information. The safety data sheet provided by the ink supplier is an important source of information.

The limits of the REACH regulation

Industrial and commercial applications fall within the scope of REACH. Private use of varnishes, inks and adhesives does not. Chemicals and chemical mixtures also remain restricted. This means finished printed matter is not covered by the new REACH restrictions. In other words, printed matter brought in from outside Europe is not subject to REACH restrictions even if inks were used.

Problematic substances

REACH imposes restrictions through special authorizations for problematic substances. The candidate list, which will later form Annex XIV of the regulation and is updated by ECHA on schedule, identifies substances with particularly concerning properties: substances of very high concern (SVHC). If a mixture contains such a substance, it must be shown in the safety data sheet. If an SVHC is present in printed products above 0.1%, consumers need to know this information and report it to ECHA (European Chemicals Agency). Fortunately, substances used in inks have not entered the new candidate list.

Under REACH, printing plants are considered downstream users. For all consumable materials made by mixing substances—printing inks, varnishes, fountain solution additives, cleaning agents, adhesives and others—extensive safety data sheets will be added during 2010. Printing plants will be inspected to see whether they use these materials as prescribed and whether they have implemented the required safety and labor protection measures.

Printing plants do not need to ask suppliers whether they comply with every obligation in the rulebook: REACH is current law, monitored by competent authorities. As a result, the work of printing plants has so far not changed in any major way.

The REACH regulation (EG) 1907/2006 takes up 851 pages in the Official Journal of the European Union. Today, implementation rules, explanations and interpretations issued by competent authorities, associations and research institutes run to tens of thousands of pages. This article can only offer a rough overview of its complex content.

—This article is reprinted from China Packaging Network (pack.cn), original link: http://news.pack.cn/show-362190.html