Preface. May 26 th 2006

Transcription

1 T1T Disclaimer: RIP 3.8 FINAL REPORT DRAFT Draft Technical Guidance Document on requirements for substances in articlest1t Reach Implementation Project 3.8 Final Report Service Contract Number: CCR.IHCP.C XO DHI Water & Environment, Denmark Danish Toxicology Centre, Denmark Ökopol GmbH, Germany Umweltbundesamt, Austria Federal Environmental Agency, Germany National Chemicals Inspectorate, Sweden Danish Environmental Protection Agency, Denmark Norwegian Pollution Control Authority, Norway The content of this report expresses the views of the contractors and may not reflect the position of the Commission. The Commission will at a later stage update the guidance in line with the final political agreement on the REACH regulation

2 T2T The RIP 3.8 FINAL REPORT DRAFT Preface Within the context of the proposed EU Chemicals policy, REACHT2T, the European Commission has initiated REACH Implementation Projects (RIPs) with the intention of developing tools and guidance for the new legislation. REACH Implementation Project No. 3 covers a suite of individual projects all aimed at developing guidance for industry on various aspects of REACH. Under the RIP 3.8, a Draft Technical Guidance Document on requirements for substances in articles shall be developed. This report is part of the deliverables from the Technical Guidance Document in support of the New EU Chemicals Legislation (REACH)-III: Technical Guidance Document on fulfilling the requirements for articles under REACH (REACH Implementation Project 3.8; 2005/ of 21/01/2005) The study was co-ordinated by DHI Water & Environment (the contractor) and carried out by experts from DHI Water & Environment; Danish Toxicology Centre; Ökopol GmbH; Umweltbundesamt, Austria; Federal Environmental Agency, Germany; Swedish Chemicals Inspectorate; Danish Environmental Protection Agency and the Norwegian Pollution Control Authority within the time frame of May 2005 to May During the preparation of this report, the Consortium received valuable input from members of the Stakeholder Experts Group nominated by the European Commission to discuss the progress and outcome of the project. Presidency Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC. The TGD is based on the draft text as agreed by the Competitiveness Council at its meeting on 13 December 2005 and as amended in Document No /05 of 19 December May 26 th 2006

3 RIP 3.8 FINAL REPORT DRAFT CONTENT 1 GENERAL INTRODUCTION Who is addressed by this guidance? What is an article? Legislative background for substances in articles General introduction to REACH requirements for substances in articles The phase-in scheme Time scheme for substances to be notified Other relevant legislation Why this guidance is needed and how to use it General approach to documentation INFORMATION VIA THE SUPPLY CHAIN Obtaining standardised information from suppliers Requesting non-standardised information up the supply chain WHEN IS REGISTRATION OR NOTIFICATION REQUIRED? First checking whether any of the requirements under Articles 6 and 30(4) might apply to the (substances in the) article Checking content of SVHC according to Articles 6(2) or 30(4) Screening for substances intended to be released from the article according to Article 6(1) CHECKING IF REGISTRATION IS REQUIRED ACCORDING TO ARTICLE 6(1) Obligation according to Article 6(1) Workflow 2 - Checking whether registration is required (Article 6(1)) Checking whether the total volume of articles > 1 t/a First screening if the total amount of a substance > 1 t/a Identification of substances intended to be released Checking whether the substances are exempted from registration Checking for existing registration for that specific use Determination of the total amount of each substance intended to be released Registration of substances intended to be released from articles CHECKING WHETHER COMMUNICATION OF INFORMATION UNDER ARTICLE 30(4) AND NOTIFICATION UNDER ARTICLE 6(2) ARE REQUIRED Obligation according to Article 30(4) Obligation according to Article 6(2) Overall approach to obtaining information about SVHC...28 May 26 th

4 RIP 3.8 FINAL REPORT DRAFT 5.4 Determining whether the article contains substances of very high concern (WF 1) Identification of SVHC and their amounts through supply chain communication and branch knowledge Identification of substances through chemical analysis Workflow for checking whether forwarding information and notification are required Determination of the concentration of identified SVHC Check for an intended release of the SVHC Check for existing registration for that specific use Determining whether the total amount of SVHC is > 1 t/a for the produced and imported articles with SVHC concentration > 0.1% (w/w) Check if exposure can be excluded during normal or reasonably foreseeable conditions of use Use and function of the substance and the article Potential for release Exposure of humans and the environment Appropriate instructions for use and disposal (Article 30(4)) Instructions for use and disposal Transferring the information Notification of a substance in articles CHECKING WHETHER A SUBSTANCE IN AN ARTICLE HAS BEEN REGISTERED FOR THAT SPECIFIC USE Checking registration of substances falling under Art. 6(1) and Art. 6(2) Special conditions during phase-in for substances falling under Art. 6(1) How to decide if a use has been registered for SVHC?...39 ANNEX ANNEX 1 Abbreviations, Definitions and Explanations...40 ANNEX 2 Article 6 and Article 30(4) on REACH...60 ANNEX 3 Article 54 and Article 56 of REACH...63 ANNEX 4 General information requirements for registration of substances with regard to substance identity...65 ANNEX 5 Information to be used in relation to check if notification is required...68 ANNEX 6 Illustrative cases for cheking if requirements under Article 6 and article 30(4) may apply...73 ANNEX 7 Information sources on substances in articles...98 ANNEX 8 Information sources on restrictions and methods for determination of substances released from articles101 TABLES Table 1 Requirements on standard information further to Article 9 and Annex IV information to be submitted for registration according to Article 11 of REACH are based to the substance to-tal quantity May 26 th 2006

5 RIP 3.8 FINAL REPORT DRAFT Table 2 Categories of products based on main function of the product and release of chemicals during use. (The objects market with a in the table = Current DG ENT/DG ENV conclusion on borderline cases brought up by the consortium of RIP 3.8)...50 Table 3 Examples illustrating the borderline between preparations and metallic semi-finished products (from Eurofer Stainless Steel Producers Group)...54 Table 4 Information to be delivered and requested for substances used by an article producer and identified as a SVHC on the candidate list of eventually inclusion in Annex XIII or on Annex XIII of REACH (Agency website).69 Table 5 Information to be delivered and requested for preparation used by an article producer when the preparation has a potential content of SVHC...70 Table 6 Information to be delivered and requested for articles used by an article producer (for further processing) or imported...72 Table 7 Substances with intended release in NN polishing cloth and Polishing cloth for silver...74 Table 8 Substances with intended release in NN polishing cloth and Polishing cloth for silver...78 Table 9 Quantification of substances intended to be released...79 Table 10 Substances with intended release from a permanent marker...82 Table 11 Some important properties of some of the PAHs in HA oil...91 Table 12 Calculation of the amount of PAHs in an average passenger car tyre for the EU market...92 FIGURES Figure 1 EU producer and EU importer of articles...6 Figure 2 The phase-in scheme for registration and notification of substances in articles...11 Figure 3 Explanation of the symbols used in the workflows (WF 1, WF 2 and WF 3)...14 Figure 4 Information to be obtained from actors in the supply chain...17 Figure 5 Workflow for checking if requirements under Articles 6 and 30(4) may apply...19 Figure 6 Workflow for checking if registration is required...21 Figure 7 Workflow for checking if Art. 30(4) applies and if notification is required (Art. 6(2))...31 EXAMPLES Example 1 Preparation intended to be released - felt tip pen...22 Example 2 Substance intended to be released - cleaning sponge...23 Example 3 Identification of substances intended to be released - felt tip pen...24 Example 4 Reduction of substance volume to be registered...25 Example 5 Registration of same substance in more articles...25 Example 6 Registration of substance intended to be released...26 Example 7 Calculation of a concentration...33 Example 8 Calculation of the amount of a SVHC...34 May 26 th

6 T4T I.e., RIP 3.8 FINAL REPORT DRAFT 1 GENERAL INTRODUCTION 1.1 Who is addressed by this guidance? This draft Technical Guidance Document (TGD) applies to all European article producers and importers of articles into the EUT3T. It describes ways to check whether an article producer or importer has to fulfil any requirements under Article 6 and 30(4) of the European chemicals regulation REACH related to substances contained in articles. Other REACH requirements of article producers under REACH are not considered in this guidance but will be addressed in other TGDs of REACH. The European Commission will develop an overall guidance with links to the series of TGDs developed for the implementation of REACH and how to use them. Figure 1 EU producer and EU importer of articles It is only the first EU producert4t or EU importer of an article who potentially has the obligation to register or notify. However, the obligation to deliver information when required according to Article 30(4) applies to the entire article supply chain. When determining whether an article is subject to REACH requirements or not, the first step is to check whether the produced or imported objects are considered articles under REACH. T3T See Annex 1 for abbreviations and definitions. the manufacturer first transforming the substances/preparations into an article or incorporating additional substances/preparations in an existing article 6 May 26 th 2006

7 RIP 3.8 FINAL REPORT DRAFT 1.2 What is an article? "Article means an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition;" (REACH, Article 3(3)). An article is composed of one or more substances or preparations, and it may contain one or more materials. The materials may be of natural origin, such as wood or wool, or they may be processed such as polyvinyl chloride (PVC) or steel. Specific substances or preparations may be added to give the article special properties. A well known example is the addition of dyes to textiles. Most of the commonly used products in private households and industries are articles, e.g. furniture, clothes, vehicles, books, toys, kitchen equipment, and electronic equipment. The elements of the article definition under REACH are interpreted in the following: The function of an object is determined by the purpose of its use ("Why is the object used?") For example, the function of a pen is to write and the function of a battery is to provide energy. The shape of an object is its two- or three-dimensional form (depth, width and height). Surface means the outmost layer of the object. Design means the arrangement of the elements of design in such a way as to best accomplish a particular purpose. The design of a textile may be determined by the twist of fibres in the yarn, the weave of threads in a fabric and the treatment of the surface of the textile. An object is an article when the shape, surface and design are more important for the normal use than its chemical composition. The type of user of an article, e.g. private consumers or industrial enterprises, does not have any influence on its status as article. The Commission had no intention to change the current interpretation of substances and preparations vis-à-vis articles. What has been currently regarded as an article under the chemicals legislation should continue to be regarded as an article under REACH. In some cases, it may, however, be difficult to decide if the chemical composition or the physical appearance of an article is more important for achieving the desired end use function. Some borderline cases are objects, which consist of a containert5t containing substances or preparations. Other cases of doubt occur when substances/preparations are solids, with a specific shape such as metal bars, plates of alloys and plastics pellets, which may be further processed to an article or a part of an article. As an example a sheet of a metal will sometimes be used directly as it is for roofing and sometimes the same type of metal sheet will be processed further into another shape. For these cases of doubt, no simple decision criteria can be given. In Annexes 1b and 1c, examples of such cases are listed and it is explained if they are articles or not. If the object is an article according to the REACH definition and/or the cases in Annexes 1b and 1c, the requirements of Article 6 and 30(4) apply to the article producer or importer. If the object is a substance or a preparation, the substances have to be registered under Article 5 of REACHT6T by the manufacturer/importer of these substances. T5T The container is in itself an article. T6T Guidance for registering substances on their own, in preparations or in articles is developed in RIP 3.1. May 26 th

8 RIP 3.8 FINAL REPORT DRAFT 1.3 Legislative background for substances in articles The new regulation REACH aims to maintain and enhance the competitiveness of the EU chemicals industry as well as at the protection of human health and the environment. It contains rules of chemical substances on their own, in preparation and articles. Under REACH, it is up to the manufacturers, importers and downstream users of substances to ensure safe use of the chemical substances that they produce, import and use. It must be noted that a producer of articles is a downstream user when he incorporates a substance in an article and has to fulfil the obligations of downstream userst7t. When a substance is manufactured/imported at a volume of 1 tonne per year or more, manufacturers/importers of that substance have an obligation to gather information on the properties of the chemical substance, list the identified uses of the substance and give guidance on safe use. The information has to be submitted to the European Chemicals Agency in order to register the substance. Also producers and importers of articles have under certain circumstances an obligation to submit information about certain substances in their articles to the Agency with the aim to register or notify these substances. When receiving a registration, the Chemicals Agency will check its completeness and EU Member States experts may evaluate the information. As stated in the preface this Technical Guidance Document is based on the draft text as agreed by the Competitiveness Council at its meeting on 13 December The REACH Articles of particular importance for article producers and importers are as follows: Article 3(3): Article definition. Article 5: General obligation to register substances on their own or in preparation. Article producers may import substances on their own or in preparations for the production of their articles. In that case the article producer is also a substance importer and will have to make a normal REACH registration for substances imported in volumes above 1 tonne/a (substances on their own or as part of preparations). (Guidance on REACH Article 5 is not part of the current document6). Article 6: Defines under which circumstances article producers and importers are to register or notify substances in articles under REACH and details the notification requirements. Article 21, 26-28: Deadlines for pre-registration and registration of phase-in substances and participation in Substance Information Exchange Fora (SIEF). Article 30(4): Duty of actors in the supply chain for articles containing substances of very high concern (SVHC) to communicate information down the supply chain. Article 54 and 56: Criteria for identifying substances of very high concern that will be placed on a candidate list. Article containing substances on this list are subject to Article 30(4) (and may be subject to authorisation if included in REACH Annex XIII). The authorisation (Title VII) may apply to European article producers and importers but is explained in the Technical Guidance Document for Downstream UsersT8T and the Technical Guidance T7T See RIP 3.5: Technical Guidance Document on requirements for Down Stream Users. Preliminary study. T8T RIP 3.5 is expected to start in June May 26 th 2006

9 T9T How RIP 3.8 FINAL REPORT DRAFT Document for preparing an Application Dossier for Authorisation. Restrictions on substances (Title VIII) may apply to article producers and importers and is not further explained heret9t General introduction to REACH requirements for substances in articles Article 6 of REACH sets a conditioned obligation for article producers and importers to register or notify substances in articles: The registration is obligatory only for substances in articles and for which the following conditions are met: The substance is intended to be released during normal and reasonable foreseeable conditions of use The total amount of the substance present in the articles exceeds 1 t/a per producer or importer (Article 6(1)) The substance has not yet been registered for that use (Article 6(5)) Notification is required for substances of very high concern (SVHC) T10T present in articles and for which the following conditions are met: The substances are present in those articles in a concentration above 0.1% (w/w); and The total amount in those articles exceeds 1 t/a per producer or importer (Article 6(2)). It is not obligatory, however, to notify if the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use and disposal of the article (Article 6(2bis)) or if the substance has already been registered for that specific use (Article 6(5)). When an article contain a substance of very high concern in a concentrations above 0.1% (w/w) it is obligatory to inform the recipients of the article as a minimum about the chemical names of these substances and how the article can be safely used (Article 30(4)). Finally, it should be noticed that the Agency may decide that an article producer or importer must submit a registration for any substance in the article if all the conditions stated in Article 6(4) are met (cf. Annex 2). This may apply to SVHCs as well as other substances (not already required to be registered according to Article 6(1)). to comply with restrictions as an article producer is discussed in the RIP 3.5 on guidance for downstream users. Restrictions for importers are already part of current legislation and no further guidance is thus provided. T10T CMRs category 1 or 2, PBTs, vpvbs or substances of equivalent concern (Art. 54) included in the candidate list for Annex XIII (Art. 56) May 26 th

10 RIP 3.8 FINAL REPORT DRAFT The phase-in scheme The obligation to register substances in articles meeting the Article 6(1) criteria described above applies already 12 months after REACH enters into force (Article 137(2)), unless the article producer/importers take benefit of the phase-in scheme by making a pre-registration. An existing substance can be pre-registeredt11t at the Agency starting 12 months and ending 18 months after entry into force of REACH (Article 26(2)). If a substance has been pre-registered it is a so-called phase-in substance (see Annex 1A) and the deadline for the actual registration depends on the total volume contained in the article produced or imported and on the classification of the substance: Registration within 3 years from entry into force (EIF) of REACH: Substances in quantities of 1,000 t/a or more per manufacturer or importer Substances in quantities of 100 t/a or more per manufacturer or importer, which are classified as very toxic to aquatic organisms and may cause long-term effects in the aquatic environment (R50-53). Substances in quantities of 1 t/a or more per manufacturer or importer, which are classified as carcinogenic, mutagenic or toxic to reproduction (CMR), categories 1 and 2. Registration within 6 years from EIF of REACH: All substances in quantities of 100 t/a or more per manufacturer or importer Registration within 11 years from EIF of REACH: All substances in quantities of 1 t/a or more per manufacturer or importer Missing the deadline for registration means that the articles cannot longer be manufactured in the Community or imported - until the registration obligations have been fulfilled. T11T Guidance on how to pre-register is provided in the TGD of preparing the Registration Dossier (RIP 3.1) and the guidance on SIEFs is covered by RIP 3.4 (TGD of Data sharing) and RIP May 26 th 2006

11 RIP 3.8 FINAL REPORT DRAFT Figure 2 The phase-in scheme for registration and notification of substances in articles Substances intended to be released from articles are to be registered according to the same deadlines as the general substance registration according to Article 5. The pre-registration allows article producers and importers to benefit from the phase-in scheme described above and to participate in SIEFs. According to Article 27(1), importers shall be participants in a SIEF whereas it is optional for article producers to join. The aim of the SIEFs is to facilitate the exchange of information with the purpose of avoiding the duplication of studies Time scheme for substances to be notified The notification of substances in articles (Article 6(2-3)) shall not apply until 6 months after a substance has been identified and included in the specific candidate lists of substances of very high concern (same substances which may be subject to authorisation under REACH (Title VII)). The first deadline however for notification of substances in articles will be 3½ years (as a minimum) after entry into force of REACH (Article 6(6)). Information on substances of very high concern (SVHC) included in the candidate list (article 56(1)) for inclusion in Annex XIII and contained in articles is to be forwarded to the professional users of the article (Article 30(4)) directly after a substance is included in that list. May 26 th

12 of RIP 3.8 FINAL REPORT DRAFT The candidate list will be updated continuously when substances have been identified as meeting the SVHC criteria of Article 54. Criteria for identifying substances as CMR, PBT, vpvb or of equivalent concern is developed in the RIP Other relevant legislation The restriction on the marketing and use of certain dangerous substances and preparations (consolidated text: CONCLEG: 1976L /2004) in the existing Annex I of Directive 76/769/EEC will be repealed by HTUAnnex XVI (in Volume VI)UTH the REACH Regulation: Restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles. This means that these existing restrictions such as the ban of certain azo colorants in textiles will be included in the Annex XVI and apply instantly after EIF of REACH. However, one should be aware that other of the existing directives concerning restriction or reduction of the use or risk of certain hazardous substances in articles will still apply separately after EIF of REACH. Examples are the General Products Safety Directive 2001/95/EEC and product specific legislation such as: Directive aiming to restrict the use of certain hazardous substances in articles: Directive 2002/95/EC on the Restriction of the Use of certain Hazardous Substances in Electrical and Electronic Equipment (RoHS). Directive aiming to reduce the amount of hazardous substances in waste from articles: Directive 2000/53/EC on End of Life Vehicles (ELVs) Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE) 1.5 Why this guidance is needed and how to use it The aim of this guidance is to assist producers and importers of articles in assessing which requirements have to be complied with related to the production and import of articles. It guides article producers and importers to answers to the following questions: Do I need to pre-register and register substances under REACH? Do I need to notify substances under REACH? Do I need to forward information on substances in the articles to my customers? The approach of the guidance is based on workflows supplemented by explanations and practical advice, which are illustrated by examples. The workflows give the overview of the steps to take and questions to ask. Explanations give further details to understanding and make references to other documents or helpful tool. The examples are given in order to illustrate the work process. The procedure of the assessment is as follows: 1. Start always by deciding whether the objects in question are considered to be articles under REACH or not (c.f. Chapter 1.1 of this guidance). Only producers and importers of articles have to proceed to the workflows in the subsequently chapters of the guidance. 12 May 26 th 2006

13 RIP 3.8 FINAL REPORT DRAFT 2. Workflow 1 (WF 1) Checking if requirements under Article 6 or 30(4) may apply in Chapter 3. From this workflow, you may be directed further to 3. Workflow 2 (WF 2) Checking if registration is required (Art. 6(1)) in Chapter 4, and 4. Workflow 3 (WF 3) Checking if Art. 30(4) applies and if notification is required (Art. 6(2)) in Chapter 5. The symbols used in the workflows are explained in Figure 3. Guidance of more general nature in relation to the work with checking the requirement for substances in articles are presented in the following sections of the guidance: General approach to documentation in relation to enforcement of requirements to article producer or importer is given in Section 1.6. The information to be expected from the suppliers in general and communication within the supply chain are explained in Chapter 2. Identification via chemical analysis, which may be an option in some cases, is presented in Section (substances intentionally released) and Section (SVHC). Chapter 6 explains how to check for existing registration of a substance for that specific use in an article. Annex 1 to this document lists the common abbreviations and definitions of REACH applied in the document. The annex includes further explanation of some of the definitions and terms related to articles in the REACH proposal. The legal text of relevance for this guidance document are copied into Annexes 2 and 3. Annex 4 explains substance identification and presents an extract of the ongoing work in RIP 3.10 on substance identity within pre-registration and inquiry prior to registration. Information to be used when checking if notification is required is included in Annex 5. The use of the workflows (WF1, WF2 and WF3) is illustrated by different cases in Annex 6. May 26 th

14 RIP 3.8 FINAL REPORT DRAFT Key to workflows NO Decision point YES Process or action Information source Links to other workflows or guidance Name of the procedure Company etc. in the process End point Figure 3 Explanation of the symbols used in the workflows (WF 1, WF 2 and WF 3) 1.6 General approach to documentation There are no specific record-keeping requirements within the Article 6 of the REACH proposal for producers/importers of articles besides registration and notification. However, the producer/importer of articles should consider documenting the results obtained completing the workflows of this guidance even if no duties under REACH have been identified. Documentation may facilitate demonstrating REACH compliance towards customers and (inspecting/enforcing) authorities. It is recommended that each producer/importer establishes routines to ensure high quality of documentation. Possible approaches could be: 14 May 26 th 2006

15 RIP 3.8 FINAL REPORT DRAFT Producers/importers of articles with implemented management systems could incorporate REACH conformity as a quality criterion accepted by the authorities with clear indications of how conformity will be secured and documented. Importers (e.g. SMEs) without a management system may follow a kind of good importing practice for articles, which could be developed by the respective industrial associations in cooperation with the responsible authorities. This might include: Following the workflows of this guidance Describing whether registration/notification is required Supporting documents including letters from suppliers, certificates, results of analysis etc. Short considerations on how the above could be done are given in relation to the cases in Annex 6. 2 INFORMATION VIA THE SUPPLY CHAIN During the assessment process of requirements for substances in articles it may be necessary to gather specific information about substances contained in articles as explained for the different steps of the assessment process in Sections 4.2.2, 5.3 and 5.4. Supply chain communication is the most important way of gathering information on the identity, property and quantity of substances contained in an article. The manufacturer or importer of a substance on its own or in a preparation, which is part of an article is the actor who in the first place has to know its identity and properties. Hence, he should be the first choice in identification of the substances in the articles. 2.1 Obtaining standardised information from suppliers Manufacturers, importers and suppliers of substances on their own or in preparation have obligation to communicate information according to Article 30 or a SDS/eSDS (extended SDS). Article suppliers (producers/importers/distributors) are, however, not legally required to communicate information on substances contained in the articles apart from the obligation in Article 30(4) under REACH. Therefore, in order to obtain information about substances in articles, it may be necessary to identify the manufacturer/importer of the substance. A SDS or an esds from an EU supplier will generally contain information on: The registration numbers of the substances, if registered (when substance volume 1t/a per manufacturer/importer) The identity of the manufacturer/importer/distributor responsible for placing the substance/preparation on the EU market The chemical names and ID numbers of the substances The concentration ranges of dangerous substances contained in the preparation May 26 th

16 PTP P RIP 3.8 FINAL REPORT DRAFT The classification of the dangerous substance(s) and information on authorisation and restriction where applicable Important and common use(s) of the substances Exposure Scenarios if the substance volume > 10 t/a per M/I including identified use(s) (see Annex 1) Information on registered, non-classified substances might not be supplied. Information according to Article 30 will be forwarded if a registered substance is subject to authorisation or restrictions. So will any other information, which is needed to enable safe use (e.g. appropriate risk management measures). In these cases, also the registration number is to be given and in addition substance identity when authorisation or restrictions apply. 2.2 Requesting non-standardised information up the supply chain In case no standard information is supplied and neither registration numbers nor substance identities are known, the manufacturer/importert12t of the substance has to be identified through communication up the supply chain. The same procedure could apply for an EU producer and an EU importer of articles. Contact the actors in the supply chain in the following order: If known, the substance manufacturer or importer (placer on the market) should be contacted directly, requesting information on the substance name, registration number etc. for establishing 13 its identitytp If known, the producer of a preparation or an article should be contacted, requesting information on substances contained herein or on the identity of their suppliers The nearest suppliers up the supply chain should be contacted, requesting information on substances in their own or in preparations or article components used in the production of the article. T12T This could be the original registrant under REACH if it is an EU manufacturer/importer. T13T For determining whether or not a registration / notification is required, it may still be necessary to identify the actor producing the preparation contained in the article and the article producer in order to find out the total amount of a substance contained in the article. 16 May 26 th 2006

17 RIP 3.8 FINAL REPORT DRAFT Figure 4 Information to be obtained from actors in the supply chain For pre-registration and/or participation in a SIEF, it is enough to have some knowledge on the substance identity (see Annex 4). For checking if registration/notification is required, more information needs to be collected. The manufacturer/importer can be identified and asked about information on the substance identity, its properties and for which uses, it was registered. If a preparation is incorporated in the article, the formulator of that preparation can be asked for the substance concentration or concentration ranget14t. The article producer himself knows the amount of the preparation contained in the article and the total amount of the article produced. If the substance manufacturer or importer cannot be identified or is not willing to co-operate, the article producer/importer has to use other means to identify the substance e.g. a combination of publicly available information in data bases, branch knowledge and conclusions from chemical analysis. 3 WHEN IS REGISTRATION OR NOTIFICATION REQUIRED? 3.1 First checking whether any of the requirements under Articles 6 and 30(4) might apply to the (substances in the) article Workflow 1 (WF1): Checking whether requirements under Articles 6 or 30(4) may apply guides the user through the first basic questions to be answered and leads him to more specific workflows on: T14T This is possible when the formulator is making the preparation from substances. If the formulator is mixing preparations or mixing substances and preparations, he might have to request information further up in the supply chain. May 26 th

18 RIP 3.8 FINAL REPORT DRAFT Checking whether registration might be required for substances in the article (Workflow 2) Checking whether notification might be required for substances in the article and if information has to be communicated (Workflow 3) Explanation for decision-making is provided in the supplementary text to the workflow. To illustrate the work processes, examples are presented in Annex 6. Both routes of WF1 have to be checked, i.e. both the content of SVHC and the intended release. Note that it is possible that an article produced/imported: May have an intended release of a SVHC (Article 6(1) applies) or May have an intended release of one substance (not a SVHC) and, at the same time a content of a SVHC not intended to be release (both Article 6(1) and Article 6(2) apply) WF 1 Checking if requirements under Article 6 or 30(4) may apply Check if Article 6 or Article 30(4) may apply Producer or importer of articles Definition of intended release Annex 1 Is there an intended release from the article? NO Does the article contain SVHC? SVHC definition Annex 1 Identify in article Chapter 5.4 YES No further action needed YES Check if registration is required Check if Art. 30(4) applies and if notification is required WF 2 WF 3 18 May 26 th 2006

19 RIP 3.8 FINAL REPORT DRAFT Figure 5 Workflow for checking if requirements under Articles 6 and 30(4) may apply Checking content of SVHC according to Articles 6(2) or 30(4) In order to check if the requirements of Articles 6(2) or 30(4) apply, it must be examined whether the article contains any substance of very high concern (SVHC), which is identified and included in the candidate list for inclusion in Annex XIII. Respective guidance is given in Chapter Screening for substances intended to be released from the article according to Article 6(1) Intended release of substances is closely related to the function or the quality of an article. If one of the following questions can be answered with yes, the release of substances from the article is intended: Does the article function by releasing substances or preparations (e.g. felt tip pens releasing ink for writing)? Does the function of the article depend on substances or preparations that are emitted or lost during use (e.g. impregnated textile cloths for cleaning)? Does the article have a secondary function or quality, which is achieved through the release of substances or preparations during use (e.g. a scented eraser)? A working definition of intended release from articles is given in Annex 1. Producers or importers of articles, from which substances are intended to be released, may have to register these substances. Respective guidance is given in Chapter 4. 4 CHECKING IF REGISTRATION IS REQUIRED ACCORDING TO ARTICLE 6(1) 4.1 Obligation according to Article 6(1) Registration of substances in articles is required when all conditions listed under Article 6(1) are fulfilled: The substance is intended to be released under normal or reasonably foreseeable conditions of use The total amount of the substance present in all articles with intended release produced or imported by one actor exceeds 1 t/a The substance has not been registered for that use (cf. Chapter 6) May 26 th

20 RIP 3.8 FINAL REPORT DRAFT 4.2 Workflow 2 - Checking whether registration is required (Article 6(1)) WF 2 suggests a tiered checking, which sorts out the cases, in which registration is not required, with as little information as possible. However, it may be more efficient to perform the steps in a different sequence, e.g. if certain information is available already. Sections and describe an initial assessment, which is solely based on: The total volume of the articles produced or imported The total or the maximum volume of the preparation incorporated in the article If the need to register cannot be excluded, each unidentified substance intended to be release from the article as described in Section must be identified. Having identified the substances, it is possible: To check if any of the substances are exempted from registration in Annexes II and III of REACH To check whether the substances have already been registered for that specific use (Chapter 6) To pre-register, join a SIEF and participate in joint registrations To determine the total amount of each identified substance Guidance on determination of the total amount of a substance intended to be released is given in Section Checking whether the total volume of articles > 1 t/a If the total volume of articles per importer or producer is 1 t per year the substances intended to be released will definitely also be 1 t per year and the obligation to register substances in the articles will clearly not apply even if the articles were composed solely of dangerous substances. If, however, the total volume is > 1 t/a, the answer to the question at the Article level in Figure 6 is yes and checking must continue. 20 May 26 th 2006

21 RIP 3.8 FINAL REPORT DRAFT WF 2 Checking if registration is required (Art. 6(1)) Check if registration is required Article level Is the total volume of articles > 1t/a? NO No further action needed YES Preparation level First screening: Total amount > 1 t/a? NO No further action needed Substance level YES Determination of substance ID Section Identify each substance intended to be released from the article Substances exempted from registration? YES No further action needed NO Guide on how to check if specific use is registered Chapter 6 Check for existing registration for the specific use Registered? YES No further action needed NO Determination of substance content Section Determine the amount of each substance intended to be released Total amount of substance > 1t/a? NO No further action needed YES Workflow registration Figure 6 RIP 3.1 Workflow for checking if registration is required May 26 th

22 RIP 3.8 FINAL REPORT DRAFT First screening if the total amount of a substance > 1 t/a A first screening can be performed if either the volumes of substances/preparations incorporated in the articles or the volumes of articles placed on the market are available. If the volume of the preparation incorporated in the article is known, the critical market volume of the articles can be estimated as follows: Taking the maximum content in an article of a preparation intended to be released, the maximum amount of articles that can be placed on the market without triggering registration obligations can be determined by a simple backwards calculation: VolBarticleB [t/a] < max Conc 1[t / a] in article[%] 0.01 preparation or NumberBarticleB [number/a] < max Conc preparation 1[t / a] in article[t / article] Example 1 Preparation intended to be released - felt tip pen Example: A felt tip pen contains ink to be intentionally released. Assumption: The maximum content of ink, which consists of several substances, in the pen is 20% by weight of the pen (1) or given as 2 g ink per pen (2). The producer/importer of the pen does not produce or import other articles. The maximum amount of the article not triggering the registration obligations is estimated: (1) VolBarticleB [t/a] < 1[t / a] 20 % 0.01 = 5 t/a (2) NumberBarticleB [number of pens/a] < 1[t / a] 2g / pen = 500,000 pens/a Conclusion: The estimation shows that as long as the article is produced or imported below 5 tonnes per year or the number of pens is below 500,000 per year, the amount of ink contained in the pen is below 1 t/a and thus none of the substances contained in the ink will exceed the threshold of 1 t/a. This is a minimum estimate based on the content of a preparation in one article as it was assumed that other articles were not produced or imported. However, care has to be taken if more articles, from which the same substance is intended to be released, are produced or imported. In that case, the amounts from all these articles must be summed up. If the market volume of the articles is known, the critical concentrations of substances in the preparations intended to be released can be derived as follows: Knowing the total market volume of the article and the maximum amount of the preparation included in the article (assuming that only one preparation with the specific substance is used and in one article only), the concentration limit, below which registration is not necessary, can be calculated for the substances: 22 May 26 th 2006

23 RIP 3.8 FINAL REPORT DRAFT 1[t / a] Max. conc. of substance in preparation [%] < x100 Vol article[t / a]x Conc [%]/100 preparation Information requests up the supply chain can then be focussed on substances exceeding the concentration calculated to be critical. Example 2 Substance intended to be released - cleaning sponge Example: A cleaning sponge contains cleaning agents that are released during use. Assumption: The sponge consists of maximum 15% cleaning agent. An importer sells 30 tonnes of these sponges on the European market every year: The importer of the sponge does not import or produce other articles. He imports 4.5 t/a cleaning agent (30 t/a sponges x 15/100) Maximum concentration of substance in the cleaning agent [%] < 1[t / a] 4.5[t / a] = 22% Conclusion: This means that registration is not necessary for substances contained in the cleaning agent below 22% by weight. As this may not apply to all substances in the cleaning agent, further information has to be sought. The supplier of the sponge can be asked by the importer whether the concentration of 22% is exceeded for any (or if known a specific) of the substances used in the cleaning agent. If the first screening shows that the threshold volume for registration is exceeded, the identification process as described below should be followed Identification of substances intended to be released The substance identity can be obtained from the article producer (relevant for article importer), from the manufacturers of the preparation intended to be released or the substance manufacturer as explained in Chapter 2. If is it not possible to obtain the substance identity via supply chain communication, it may be possible to identify the substance via a combination of knowledge of the article (databases, sector publications etc.) and chemical analysis. Taking substance samples for chemical analysis should be fairly easy as they are intended to be released from the article. If substances cannot be easily separated, e.g. the substance is absorbed into a matrix, extraction from the article can be made, followed by an analysis on the extract. Another possibility is to identify substances in the evaporated air from the article (e.g. perfumed/scented articles). In general, chemical analyses have to be planned carefully taking into account which information can be obtained with which methods. A strategy for testing should be developed in collaboration with testing laboratories and based on available methods and information collected from e.g. branch organisations, research institutions and/or accredited chemical analysis laboratories. In order to obtain information on substance identities and quantities intended to be released from articles through chemical analysis, the following approach is proposed: May 26 th

24 RIP 3.8 FINAL REPORT DRAFT Consult branch experts or sector information sources to narrow down which substances to look for (both with regard to the tonnage threshold and groups of substances). Specific requirements to substances in articles are often linked with standard methods for analytical control of compliance (see Annex 7). Identify from which part of the article to sample: Separated liquid (e.g. ink in a printer cartridge), extract from article matrix (e.g. felt material as matrix/carrier for ink in felt tip pens) or evaporation sample from the article (e.g. scent in an eraser) Develop a test strategy as a tiered process, i.e. broad screenings, narrow screenings and identification by e.g. semi-quantitative methods 15 Perform the chemical analysis for the identification of substancestp PT Example 3 Example: Felt tip pen Identification of substances intended to be released - felt tip pen A screening for organic compounds could be performed using e.g. GC-MS. The screening procedure would cover a scan of a broad range of organic compounds in order to get an overview of the number and amount of different compounds Checking whether the substances are exempted from registration The substance identities are compared with the exemptions from registration given in Annex II and Annex III of REACH. If the substance is listed in Annex II or fulfils any of the criteria of Annex III, no further obligations under Article 6(1) apply Checking for existing registration for that specific use When the substance intended to be released has been identified, it can either be pre-register or a check is made of whether the substance has already been registered for that specific use. Respective guidance is given in Chapter Determination of the total amount of each substance intended to be released If the former steps cannot exclude that registration is necessary, more information on the amount of the substances in the articles is needed. To check whether the threshold of 1 t/a is exceeded, the amount of each substance intended to be released in all articles with intended releases produced/imported within one calendar year must be summed up. Different methods or starting points may be chosen depending on the type of information available: T15T It is questionable whether chemical analysis is applicable to determine the substance identities for pre-registration and/or registration according to REACH. According to the preliminary results of RIP 3.10, the identities of the main substance component(s) have to be submitted for pre-registration but not information on e.g. impurities (Annex 4). The work of RIP 3.10 is not finished but it appears difficult to determine substance identities by analytical methods to the extent needed for a registration. 24 May 26 th 2006

25 RIP 3.8 FINAL REPORT DRAFT The total volume of the articles placed on the market is known and the concentration ranges of substances in the preparations intended to be released have been obtained from e.g. supply chain, product specifications (on specific content in specific articles) or classification thresholds. The exact concentration of the substance in the article can be obtained from e.g. mass balance (article producers), information through the supply chain, branches etc. or quantitative chemical analysis. Substance quantification by analytical methods Quantification of identified substances in an article by analytical methods is possible but may encounter difficulties when the substance/preparation is integrated in the article matrixt16t. For analytical quantification of the content of substances in article matrices, it is relevant to know how those substances are included in the article. Extraction, sampling and measurement methods have to be appropriate for the article material and for the substance to be quantified. The same general approach may be used for quantification as for identification of substances intentionally released from articles (cf. Section 4.2.2). It should be noticed that it is the total amount incorporated in the article that has to be determined and not only the amount released from the article. Calculation of the total amount of a substance intended to be released If the maximum content of a preparation in an article and the maximum concentration of a specific substance in the preparation (e.g. from a SDS delivered together with the preparation) are known, the maximum amount of the substance in the produced/imported article can be calculated. The maximum amount or volume of the substance intended to be released is: VolBsubstanceB [t/a] = WeightBarticleB [t] (max.conc.bpreparation B[%] 0.01) (max.concbsubstanceb [%] 0.01) (number of article/a) If, however, the loss of preparation during production (e.g. loss through evaporation, wash out or surplus substances) can be quantified, the substance volume to be registered may be reduced by the respective percentage. Example 4 Reduction of substance volume to be registered Example: If the producer can document that 10% of the solvent contained in the dye for a felt tip pen evaporates before the pen is finished and sealed, he may reduce the volume of the solvent to be registered by 10%. If the same substance is intended to be released from different articles of one producer or importer, the volumes of this substance in all those articles have to be summed up: Total VolBsubstanceB [t/a] = Vol BsubstanceB [t/a] per article Example 5 Registration of same substance in more articles Example: The same solvent is used in pens and in cleaning tissues T16T In the cases, in which the article is a container with a substance/preparation, the amount of substance intended to be released can easily be sampled. May 26 th