Graphic Arts REACH. Registration, Evaluation and Authorization of Chemicals.

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1 Graphic Arts REACH Registration, Evaluation and Authorization of Chemicals.

2 REACH background information, implications for the coating and plastics industries, and how ACTEGA Terra is getting ready for it. Commitment of ACTEGA Terra GmbH The Executive Board of ACTEGA Terra fully agrees with the overall objectives of REACH and has expressed its explicit commitment. They have also expressed their firm commitment to sustain the entire sales products portfolio under the obligations of REACH, in an effort to continue to serve ACTEGA Terra s current and future customers. Because of the complexity of REACH, however, no formal guarantees can be made that indeed all individual products will be sustained under all circumstances. Activities of ACTEGA Terra in anticipation to REACH ACTEGA Terra has been very active in preparation for REACH. We have actively informed ourselves about the discussions, both on the political level and at the level of the practical implementation. Within ACTEGA Terra, a working group has been formed to enable us to prepare ourselves for REACH. We are in the process of identifying the critical raw materials in our formulations. So we are in direct contact and dialog with our suppliers to get all necessary information. We will provide our customers with all relevant information about our activities related to the implementation of REACH. Subject of REACH REACH is the acronym for Registration, Evaluation and Authorization of CHemicals. It is a new EU (European Union) legislation for chemical substances and the most complex piece of legislation the EU has ever embarked on. It is the result of a long process that started in the nineties of the last century and that resulted in a proposal from the European Commission in 2003 that has been subject to review by both the European Parliament and the European Council of Ministers since then, and will come into effect o the 1st of June REACH will apply to the manufacture and marketing (including import from outside the EU) of substances (see below), on their own or in preparations or articles.

3 The main consequences of REACH will be: replacement of most existing EU legislation on chemical substances, including the EINECS inventory the creation of a European Chemicals Agency that will be located in Helsinki a so-called paradigm change ; this means that the responsibility will be on the industry (with help from the Agency), not on the authorities risk communication throughout the entire supply chain (manufacturer / importer > formulator > downstream user) all substances subject to REACH will have to be registered (see below for substances that are exempt) all substances subject to REACH will have to be evaluated based on predescribed physical / chemical, toxicological and ecotoxicological data for their identified uses high-risk substances will be subject to authorization, which will result in restrictions and bans for these identified uses where the risks cannot be adequately managed Which chemicals are subject to REACH? REACH applies directly to substances only. Substances are essentially chemical compounds that are obtained by any manufacturing process, including any additive to preserve its stability and any impurity derived from the manufacturing process, but excluding solvents. Substances can be marketed as such or mixed together in a formulation to form a preparation (such as coatings). REACH only applies to substances that are marketed / imported in quantities exceeding 1 metric ton per annum. Non-isolated intermediates (and hence not marketed as such) are outside the scope of REACH. Isolated intermediates and transported intermediates are subject to REACH, but reduced registration requirements apply to these.

4 Some categories of substances are also exempted from REACH, the most important being polymers (according to a strict definition). Other categories that are also excluded from the scope of REACH (as they are already subject to other strict legal obligations) are biocides, medical products, food and feedstuffs, and cosmetic products. As stated above, REACH applies directly to substances only. Indirectly, though, REACH will have a major impact on preparations (on articles only if they intentionally release substances, e.g. car tires, etc.). Registration Directly after the entry into force of REACH (1st of June 2007), substances will have to be pre-registered. The pre-registration comprises essentially the name of the manufacturer, the identity of the substance and the tonnage band. There are four different tonnage bands which correspond to the annual sales per manufacturer / importer: 1-10 tons per annum tons per annum 100-1,000 tons per annum above 1,000 tons per annum These tonnage bands correspond to the data that have to be used for the evaluation and are also used to prioritize substances. A second criterion in addition to sales volumes is used: whether the substance belongs to high-risk categories. These comprise: CMR substances class 1 and 2 (carcinogenic, mutagenic and reprotoxic) vpvb and PBT substances (very persistent and very bio-accumulating and persistent, bio-accumulating and toxic respectively) After pre-registration, registrants that have registered the same substance have to share data to save on animal testing (especially vertebrates). Registration will have to take place in three priorities, corresponding to: 1. above 1,000 tons per annum + CMR and PBT substances 2. substances in the tonnage band above 100 tons per annum 3. all others

5 During registration, not all actual test data have to be submitted only so-called robust summaries for a certain number of end points the exact end points depend upon the volume band of the substance involved. Further, for substances in volume bands exceeding 100 tons per annum, only proposals for the actual testing are required at this stage. These have to be approved by the Agency prior to the actual generating of the data. Also, the registrant has to submit general information regarding the exposure and risk management measures for the identified uses (see below). Data required for evaluation The data required for evaluation are the result of the decisions after registration, i.e. the reviewing by the Agency of the proposals for further testing. The data required, again, depend on the volume band for the substance (for the producer / importer or, when applicable, the consortium of producers / importers for the substance involved). Essentially, the costs involved comprise: technical dossier chemical safety assessment (CSA, only for substances above 10 tons per annum) chemical safety report (CSR, only for substances above 10 tons per annum) extended safety datasheet registration (plus, if applicable, authorization) costs (these depend on the volume band) The costs involved can only be estimated based on the current proposal and may vary from one substance to the other, depending on the actual testing that has to be performed: 1 10 tons per annum: approx. 75, tons per annum: approx. 300, ,000 tons per annum: approx. 650,000 above 1,000 tons per annum: more than 1,

6 Authorization Authorization may be required if a substance has data that show that the substance is or is reasonably suspect to have either PBT or vpvb (see above for explanation of the acronym) or CMR (see above for explanation of the acronym) or endocrine disrupting (= influencing hormonal interactions) properties. Based on this, a Member State may submit a dossier to have the substance in the candidate list for authorization. After prioritization, based on the following criteria: PBT or vpvb properties or wide dispersive use or high volumes, the Commission may decide to put the substance on an official list of substances subject to authorization. If authorization is required, the full body of data for the substance will be evaluated by the Agency. If concluded positively authorization, like registration, is identified use-specific the EU Commission grants authorization. This authorization, however, is probably going to be limited in time, with regular reviews and possibly with a substitution obligation within a well-defined period of time. Specifics of the authorization process are among those that are most likely to change in comparison to the actual proposal document, as it is subject to intense political debate. Identified use and exposure Identified use, a key concept of REACH, is a new concept in the EU legislation for chemical substances. Essentially it means that the registration, evaluation (and authorization, if applicable) are usespecific, as the safety assessment not only takes the hazard (intrinsic substance property), but also the exposure (of humans or the environment) into consideration. For this, the basic concepts are: exposure scenarios (or use categories in combination with exposure categories) exposure assessment risk management measures (which are, of course, use-specific)

7 How detailed these exposure scenarios will be is still subject to intense political debate. Industry stresses that REACH has to be practical and therefore strongly advocates the concept of use categories and exposure categories. The use categories in the current proposal are: industrial use professional use consumer use Specifications for industrial use in the current proposal are: used in closed system and / or use resulting in inclusion into or onto matrix and / or non-dispersive use and / or dispersive use But there is quite strong political pressure to go beyond that which could, eventually, be as specific as: coating, spray applied for organic solvent borne paints based on alkyd chemistry, air drying. Significant route(s) of exposure in the current proposal are: human exposure: oral and / or dermal and / or inhalatory environmental exposure: water and / or air and / or solid waste and / or soil pattern of exposure: accidental / infrequent and / or occasional and / or continuous / frequent Not only will the final position of REACH have a major impact on how to conduct the chemical safety assessment (exposure parameters have to be generated in order to be taken into account!), but this would also result in highly complex and lengthy extended safety datasheets.

8 Information along the supply chain REACH recognizes two distinct levels along the supply chain: manufacturer / importer formulator / downstream user (e.g. coating manufacturer) Important for both the formulator and the downstream user is to check whether their identified use is included. If it is, he has to check whether the exposure parameters are being complied with and whether the risk management measures are being affected. If the identified use is not included, the formulator / downstream user has two options: 1. to do his own chemical safety evaluation or 2. to ask his supplier to do this for him The means of communication between these levels is the extended safety datasheet in which the various data will have to be communicated.

9 Timetable 1st June 2007 REACH coming into force 2007/ 2008 pre-registration Until 2010 registration of all substances: above 1,000 tons per annum and all CMR substances and PBT and vpvb substances and all substances classified N, R50-53 above 100 tons per annum Until 2016 evaluation of all substances above 100 tons per annum Until 2018 registration of all other substances Beyond 2018 evaluation of all other substances Contacts at ACTEGA Terra for REACH Sabine Grüneberg, QC and Environment Phone: +49 (0) , Dr.-Ing. Hans-Michael Lenz, Head of QC and Environment Phone: +49 (0) , ACTEGA Terra Lehrte, March 2007 Until 2012 evaluation of all substances above 1,000 tons per annum Until 2013 registration of all substances above 100 tons per annum

10 ACTEGA Terra GmbH Industriestrasse Lehrte Tel Fax