Полиграфические предприятия активно реагируют на регламент ЕС REACH

REACH is the abbreviation of the EU regulation "Registration, Evaluation, Authorization and Restriction of Chemicals" (REGULATION co

ncerning the Registration, e

valuation, Authorization and Restriction of Chemicals), is a chemical regulatory framework enacted by EU legislation and officially implemented from June 1, 2007.

This is a regulatory proposal concerning the safety of chemical production, trade and use. The regulation aims to protect human health and environmental safety, maintain and enhance the competitiveness of the EU chemical industry and its capacity for innovation in researching and developing non-toxic and harmless compounds, prevent market fragmentation, increase the transparency of chemical use, promote non-animal testing, and pursue sustainable economic and social development.

The REACH regulation requires that any chemical imported or produced within Europe in quantities exceeding 1 ton per year must go through a set of comprehensive procedures such as registration, evaluation, authorization and restriction, so as to identify the composition of chemicals more accurately and more simply and thereby achieve the purpose of ensuring environmental and human safety. The regulation contains several major sections including registration, evaluation, authorization and restriction, requiring that chemicals (imported or produced) must have a registration dossier listing their chemical composition and explaining how manufacturers use these chemical components and the assessment of their toxicity.

This information will be entered into a database under construction, which is managed by a new EU agency located in Helsinki, Finland - the European Chemicals Agency. The agency will evaluate each dossier, and if it finds that a chemical has an impact on human health or the environment, it may take stricter measures. Based on the evaluation results of several factors, a chemical may be banned from use or may be used only after approval.

Because it takes some time to build all the data for the registration process, the new chemical regulation is implemented in stages. As of December 1, 2008, all materials used in the EU had to be pre-registered with the European Chemicals Agency (ECHA): the number of registered materials was 145,000.

Formal registration is carried out in stages: hazardous substances or substances used in quantities exceeding 1,000 tons per year must be registered before December 1, 2010, and all other substances must complete registration before June 1, 2018.

REACH and printing inks

Substances mixed or formulated from different materials do not need to be registered, but each individual component material constituting the mixed material must be registered separately. This means that printing inks, varnishes, adhesives and other mixed materials can only be made from materials that have been pre-registered and registered within the prescribed period or authorized for the prescribed use. For this purpose, raw material suppliers must be approved.

Will printing inks go up in price?

Because the data from detecting toxic substances in a substance will lead to a registration payment of 300,000 euros or more for that substance, ink manufacturers worry that if these registration costs are apportioned to raw material sales prices, costs will increase, and the increase will be particularly obvious for the costs of special raw materials manufactured in small quantities.

On the other hand, ink manufacturers also worry that manufacturers of special chemicals may, for cost reasons, withdraw these special chemicals from the market just before the registration deadline expires. This result will require reformulation and replacement of the raw materials for compounding inks. However, this situation is unlikely to occur with standard printing inks manufactured in large quantities. For a long time, because manufacturers had already banned hazardous raw materials in inks under the prohibited list drawn up by the European Printing Ink Association, there is no need to worry that the application restrictions stipulated in the REACH regulation will have a major impact on the composition of standard printing inks.

The registration obligation has the following effect: if a printing house is itself responsible for importing inks from countries outside Europe, then it is obliged to register with the European Chemicals Agency the various substances contained in the imported inks whose annual consumption exceeds 1 ton.

Another basic principle of the REACH regulation is to promote communication among all participants throughout the supply chain, that is, to promote communication among material manufacturers, importers and downstream users. Downstream users are the so-called formulators (ink manufacturers) and end users (printing houses).

It is important that printing houses, or the associations acting on their behalf, express opinions on the potential hazards in the work of using inks, on the basis of which ink manufacturers formulate explanatory schemes for assessing possible risks. Then downstream users receive these explanations concerning substance risks, handling measures and prescribed uses in the safety data sheet. Therefore, in the coming years the safety data sheet will visibly increase in length. Eventually this process comes to an end as the registration phase expires.

In the future, only these prescribed substances may be used as raw materials in printing inks. Printing houses, as downstream users, are obliged to use only inks for prescribed applications and to implement safe handling measures in accordance with the instructions in the safety data sheet.

In order to draw up realistic provisions for the safe handling of inks by printing houses, the European Printing Ink Manufacturers Association should maintain close contact with printing industry associations. If a printing house fails to implement the safety measures in the safety data sheet, or uses an ink different from the prescribed one, then the supplier can obtain 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 limits of the REACH regulation. Private use of varnishes, inks and adhesives, however, is not covered. In addition, chemicals or chemical mixtures remain restricted. This means that finished printed matter is not within the restrictions of the new REACH regulation - that is, printed matter introduced from countries outside Europe is not within the restrictions of the REACH regulation even if inks have been used.

Problematic substances

The REACH regulation sets restrictions on special authorizations for problematic substances. In the so-called candidate list (in the future in Annex XIV of the regulation, which is updated by ECHA on time), substances with particularly worrying properties [substances of very high concern (SVHC)] are listed. If a mixture contains such a substance, it must be shown in the safety data sheet. If in printed products this substance of very high concern (SVHC)

content exceeds 0.1%, then consumers need to know this information and report it to ECHA (European Chemicals Agency). Fortunately, the substances used in inks have not entered the new candidate list.

Under the REACH regulation, printing houses are regarded as downstream users. For all consumable materials mixed from substances (printing inks, varnishes, fountain solution additives, cleaning agents, adhesives, etc.), extensive safety data sheets will be added during 2010. Printing houses will be inspected as to whether they use these materials as prescribed and whether they have implemented the prescribed safety and labor protection measures.

Printing houses have no need to ask suppliers whether they comply with all the obligations of the rulebook: REACH is current law, supervised and inspected by the competent authorities. Therefore, the work of printing houses has so far not undergone important changes.

The REACH regulation (EG) 1907/2006 occupies 851 pages in the Official Journal of the European Union. At present, the implementation rules, explanations and interpretations of the REACH regulation drawn up by competent authorities, associations and research institutes amount to tens of thousands of pages. This article can only be 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