1. INTRODUCTION TO HANDBOOK 5

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1 CONTENTS 1. INTRODUCTION TO HANDBOOK Background of the handbook Target group of the handbook How to use the handbook? Authors team 5 2. INTRODUCTION TO REACH Meaning of REACH What is REACH and which regulation defines REACH? What is the objective of REACH? Scope of REACH Main elements of REACH What means Registration? What means Evaluation? What means Authorisation? What means Restrictions? What means Information Flow in the Supply Chain? What are the timelines of REACH implementation? Where you can find relevant information? 9 3. ACTORS AND ROLES 3.1 Actors under REACH Who are the main actors under REACH? How industrial actors are defined? 3.2. Roles under REACH How to identify your role? What are main obligations of actors? Where you can find relevant information? 4 4. REGISTRATION Aim, scope and timelines What is Registration? What is the aim of registration? What is the scope of registration? What are timelines for registration? Where you can find relevant information? Pre-registration What is pre-registration? When pre-registration takes place? What information will be required for pre-registration dossier? What happens, if you don t pre-register a substance? Where you can find relevant information? Registration dossier What is a registration dossier and how does it look like? What is the content (which information needs to be presented) of the technical dossier? Where to submit registration dossier and who checks it? Where you can find relevant information? Chemical safety assessment and chemicals safety report What is a chemical safety assessment (CSA)? What is a chemical safety report (CSR)? What is the scope of the chemical safety assessment and the chemical safety report? What are companies tasks? What are the general steps of the chemical safety assessment? What means hazard assessment, exposure assessment and risk characterisation? What is the content of the chemical safety report? Where does chemical safety report go to? Where you can find relevant information? 22

2 4.5. Data collection What and why data needs to be collected? How data can be collected? What sources can be used to obtain information? How the appropriateness of available data can be evaluated? Which tests are suitable for the registration purposes? What is the benefit of avoiding testing? How the non-test methods can be used? Where you can find relevant information? Data sharing What is Substance Information Exchange Fora (SIEF) and how will it work? What is the procedure of data sharing within SIEF? How data sharing works for the already registered substances? How joint submission of data by multiple registrants ( consortia ) will be performed? Downstream users and registration What registration means for downstream user? What means chemical safety assessment and chemical safety report for downstream user? Where you can find relevant information? AUTHORISATION Introduction to authorisation What is the aim of authorisation? What is the process of authorisation? What is the scope of authorisation? What is the relationship between authorisation and restrictions? Where can you find relevant information? Tasks to companies in authorisation process What are companies tasks under authorisation? What company needs to do to get a substance authorised? What happens after submission of authorisation application? Where can you find relevant information? Authorisation application What is the content of the authorisation dossier? What is the socio-economic analysis? Under which circumstances will the authorisation be granted? What does a company need to do after receiving the authorisation? How to review the authorisation? How to assess PBT and vpvb properties? Where can you find relevant information? RESTRICTIONS Introduction what means restrictions What substances fall under restrictions? How can restrictions be applied to substances? What do restrictions mean for a company? What you need to do if you are a manufacturer or an importer of a chemical substance? What you need to do if you are a downstream user? What you need to do if you are a producer of a preparation? Where you can find relevant information? INFORMATION FLOW IN THE SUPPLY CHAIN Safety Data Sheets What are main changes of SDS under REACH? What information should be communicated if SDS is not required? What information should be communicated up to the supply chain? What are obligations to keep and make available SDSs? What are the responsibilities of companies for information communication? Where you can find relevant information? Classification and labelling 49 2

3 What will change in classification and labelling of chemicals under REACH? What are the objectives and elements of GHS? How are the hazards classified under GHS? How does a chemicals label look like under GHS? What happens with Safety Data Sheet under GHS? How and when does the GHS come into force in the EU? What is the relationship between REACH and GHS? What does a Classification and labelling inventory mean? Where you can find relevant information? HOW TO GET STARTED WITH THE PREPARATION FOR REACH? Introduction What should companies do to prepare for REACH? STEP 1 to 3 - with what you can start to prepare for REACH? STEP 4 to 7 how to continue? What should companies do to apply with REACH? What shall manufacturer/ importer of a substance do to apply with REACH? What shall downstream user of a substance do to apply with REACH? INFORMATION SOURCES Information sources about REACH elements Where you can find relevant information on REGISTRATION? Where you can find relevant information on AUTHORISATION? Where you can find relevant information on RESTRICTIONS? Where you can find relevant information on INFORMATION FLOW? Information sources on relevant institutions EU institutions who are responsible for REACH implementation Help desks and national authorities Other information sources on relevant institutions DEFINITIONS ABBREVIATIONS 69 3

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5 1. INTRODUCTION TO HANDBOOK 1.1. Background of the handbook This handbook has been developed in the frame of the project Development of Knowledge on REACH. The project started in November 2006 and ended in March 2008 and was funded by the EU Leonardo da Vinci fund. The project was also co-financed by the Estonian Ministry of Social Affairs as well as the in-kind contributions of the project partners. The project was carried out by the Institute of Environmental Engineering of Kaunas University of Technology (Lithuania), Baltic Environmental Forum Estonia, Latvia, Lithuania, and Ircon Ltd (Czech Republic). The idea for this project was triggered by the shaping of the new chemicals policy the REACH regulation, which entered into force on 1 June The new regulation replaces several existing Community Directives and Regulations on chemicals and defines new tasks and responsibilities for actors mentioned under REACH with the aim to strengthen protection of health and the environment. A lot of trainings need to be carried out to raise the knowledge on REACH since all the actors who are concerned by REACH need to know their responsibilities, duties, deadlines and biggest upcoming changes. It is also necessary to have experts and trainers who are able to answer different questions and help industries or other interested parties. Therefore the project aimed to develop training materials on the principles of REACH and continuous training of experts on environmental, health and chemical safety issues at both consultancy and company level. More information about the project, descriptions about partner organisations, project progress and results can be found in English on the official project website Target group of the handbook The main target group for this handbook are industrial stakeholders (manufacturers, importers, downstream users of chemicals), though it can be used by the trainers, teachers and other interested parties. It is a thorough step-by-step guide for understanding REACH and its elements. Side by side with text it presents illustrative diagrams and tables to emphasise most important information and help you (manufacturers, importers, downstream users of chemicals) better understand your responsibilities and clarify your role under REACH How to use the handbook? The handbook has 11 chapters. First it gives a short overview about REACH and introduces the roles and responsibilities of industry. In the case of each substance You should identify whether the substance You produce, import or use falls into the scope of REACH registration and whether you are a manufacturer, importer or a downstream user of the substance. When you have identified your roles in the system in case of each substance, it explains the elements of REACH according to your roles. It explains what and when you have to do and where you can find the necessary information. In addition to the theoretical information you will also find useful practical information you can test whether you have understood certain aspects of REACH what needs to be done and when Authors team This handbook has been written and edited by: Kitty Kislenko, Baltic Environmental Forum Estonia Romanas Cesnaitis, Kaunas University of Technology (Lithuania) Guna Krumina, Baltic Environmental Forum Latvia Goda Kuliešytė, Baltic Environmental Forum Lithuania Miroslav Krcma, Ircon Ltd. (Czech Republic) Jolita Kruopiene, Kaunas University of Technology (Lithuania) Jolanta Dvarionienė, Kaunas University of Technology (Lithuania) Katrin Juhanson, Baltic Environmental Forum Estonia Ideas for this brochure have come from very different sources: regulation, studies, other publications, presentations and comments of experts from state authorities etc. Therefore editorial team would like to thank Ms. Heli Laarmann from Ministry of Social Affairs of Estonia and Mr. Arnis Ludboržs from the Latvian Environment, Geology and Meteorology Agency who has directly contributed to the preparation of this handbook. This project has been funded by the European Commission. This publication reflects the views of the authors, and the Commission and co-financers cannot be held responsible for any use, which may be made of the information contained therein. reflects the views of the authors, and the Commission and co-financers cannot be held responsible for any use, which may be made of the information contained therein. 5

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7 2. INTRODUCTION TO REACH 2.1. Meaning of REACH What is REACH and which regulation defines REACH? REACH is an abbreviation, which means: Registration, Evaluation and Authorisation of Chemicals. Registration, evaluation and authorisation of chemicals are procedures, which have been elaborated with the aim to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.. The processes are established by the Regulation (EC) No 1907/2006 of the European Parliament and Council of 18th December 2006, concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC What is the objective of REACH? On 13th February 2001, the European Commission adopted a White Paper setting out the strategy for a future Community Policy for Chemicals. Following extensive discussions with major stakeholders resulted in the release of the Commission s proposal (REACH Regulation) on 29 October During the next three years the proposal was preceded parallel in the European Parliament and in the Council of Ministers. The REACH Regulation was formally adopted on 18 December 2006 by the Council of Ministers following the vote in second reading of the European Parliament on 13 December REACH entered into force on 1 June The aims of REACH are to: Improve the protection of human health and the environment from the risks that can be posed by chemicals Enhance the competitiveness of the EU chemicals industry, one of the key sectors of the EU economy Promote alternative methods for assessment of hazards of substances Ensure the free circulation of substances on the internal market of the European Union REACH replaces about 40 pieces of legislation with a streamlined and improved single Regulation. Other legislation on chemicals (e.g. cosmetics, detergents) or related legislation (e.g. on health and safety of workers handling chemicals, product safety, construction products) not replaced by REACH will continue to apply. REACH has been designed not to overlap or conflict with other chemicals legislation. The REACH regulation lays down provisions regarding production, placing on the market and use of substances on their own, in preparations or in articles. The Regulation is binding in its entirety and directly applicable in all Member States Scope of REACH There are some certain substances and/or their usages, which are exempted from the registration and/or authorisation. Generally these substances are already sufficiently regulated under other existing legal acts. REACH Regulation does not apply to: radioactive substances substances, on their own, in a preparation or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit non-isolated intermediates the carriage of dangerous substances and dangerous substances in dangerous preparations by rail, road, inland waterway, sea or air waste as defined by Directive 2006/12/EC NOTE: Member States may allow for exemptions in specific cases for certain substances, on their own, in a preparation or in an article, where necessary in the interests of defence In case of some substances, groups of substances or some specific uses of substances not all REACH requirements of regulation apply: if substance is used in medicinal products (for human or veterinary use) registration, evaluation, authorisation requirements and the duty of downstream users to pass on the information on usage up the supply chain shall not apply (Attention! If the same substance is used for different purpose, then all provisions of REACH Regulation should be followed!) if substance is used in food or feeding stuffs registration, evaluation, authorisation requirements and requirements for information 7

8 flow in the supply chain shall not apply (Attention! If the same substance is used for different purpose, then all provisions of REACH Regulation should be followed!) if substance is used in medical devices the duty of downstream users to pass on the information on usage up the supply chain shall not apply if substances is included in Annex IV registration and evaluation requirements shall not apply if substance is included in Annex V registration and evaluation requirements shall not apply if substance is on-site isolated intermediate or transported isolated intermediate registration (exception of Articles 8 and 9) and authorisation requirements shall not apply if substance is polymer registration and evaluation requirements shall not apply (Attention! The Commission may present legislative proposals as soon as a practicable and cost-efficient way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established, and after publishing a report on the following: (a) the risks posed by polymers in comparison with other substances; (b) the need, if any, to register certain types of polymer, taking account of competitiveness and innovation on the one hand and the protection of human health and the environment on the other) if substance is re-imported to EC (i.e. it has been already registered before and exported) registration and evaluation requirements shall not apply if substance is used in cosmetic products the requirements for information flow in the supply chain shall not apply if substance resulting from the recovery process has been registered before registration and evaluation requirements shall not apply if substance is subject of product and process orientated research and development (PPORD) excluded from registration for 5 (max. extension possible +5 or +10, if substances to be used exclusively in the development of medicinal products for human or veterinary use, or for substances that are not placed on the market) years (Attention! Still these substances shall be notified to European Chemicals Agency (ECHA, Agency) if substance is used as active substance or co-formulant in plant protection products (PPP) considered as registered; authorisation shall not apply if substance is used as active substances in biocides considered as registered; authorisation shall not apply already notified new substances (according 67/548/EEC) considered as registered (Attention! If substances is manufactured or imported in higher tonnages, some additional information may be required to meet requirements for registration under REACH!) 2.3. Main elements of REACH What means Registration? Registration is a basic condition for manufacture or import of substances. It is an administrative process under which manufacturers and importers of chemicals will gather relevant information on their substances and apply for registration to the European Chemicals Agency. You can find detailed information in the Chapter 4 of this handbook What means Evaluation? Evaluation procedure under REACH Regulation can be targeted to dossier or substance. Dossier evaluation is performed by Agency and consists of two parts: examining any testing proposal set out in a registration to avoid unnecessary testing; verifying that the information in the technical dossier is in compliance with the requirements; Substance evaluation Substance may undergo evaluation, if there is a concern over potential risks of substance to human health or the environment. Prioritisation of substances with a view to evaluation will be made on a risk-based approach (i.e. considering information on hazard, exposure, i.e. use, and tonnage). The evaluation will be carried out by Member States Competent Authorities based on the Community-wide rolling action plan. If Competent Authority considers that further information is required, registrant shall submit the information required to the Agency by the deadline set. The Competent Authority shall examine any information submitted, and shall draft any appropriate decisions within 12 months of the information being submitted. Once the substance evaluation has been completed, the conclusions may lead to restriction or Authorisation procedures What means Authorisation? Use of substances with properties of very high concern will be made subject to Authorisation; manufacturers and importers of such substances will need to apply for a special permission (Authorisation) and demonstrate that risks associated with the use of these substances are adequately controlled or that the socio-economic benefits of their use outweigh the risks and there are no suitable alternative substitute substances or technologies. You can find detailed information in the Chapter 5 of this handbook What means Restrictions? Restriction means any condition or prohibition of the manufacture, use or placing on the market of chemical substances on their own, in preparations or in articles. You can find detailed information in the Chapter 6 of this handbook. 8

9 What means Information Flow in the Supply Chain? Information about substances and preparations in the supply chain has to be passed in both directions: down (towards downstream users) and up (towards producer or importer). It improves knowledge and management of chemicals hazards and risks. The most important tool for passing information about chemicals is safety data sheets and exposure scenarios (at later stage). You can find detailed information in the Chapter 7 of this handbook What are the timelines of REACH implementation? Table 2.1: Timelines of REACH actions implementation Activity Date Entry into force of REACH 1 June 2007 European Chemicals Agency becomes operational 1 June 2008 Pre-registration of phase-in substances 1 June 2008 to 30 November 2008 Registration deadline for substances 30 November 2010 in quantities of 1000 tonnes/year and above carcinogens, mutagens and substances toxic to reproduction (CMR category 1 and 2) above 1 tonne/year substances classified as very toxic to aquatic organisms (R50/53) above 100 tonnes/year Registration deadline for substances in quantities of 100 to 1000 tonnes/year 31 May 2013 Registration deadline for substances in quantities of 1 to 100 tonne/year 31 May 2018 New Safety Data Sheets according to Title IV Information in the supply chain and according 1 June 2007 to Annex II Guide to the compilation of safety data sheets ECHA will publish on its website a list of the pre-registered substances (the names of the 1 January 2009 substances, including their EINECS and CAS number if available and other identity codes, and the first envisaged registration deadline) Member State may maintain any existing and more stringent restrictions in relation to Annex 1 June 2013 XVII on the manufacture, placing on the market or use of a substance 2.4. Where you can find relevant information? REACH regulation: REACH regulation text (Corrigenda text of the REACH Regulation published in the Official Journal of the European Union on ): en pdf Guidance materials: European Chemicals Agency: REACH Guidance: Official European Union law: 9

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11 3. ACTORS AND ROLES 3.1 Actors under REACH Who are the main actors under REACH? The REACH Regulation focuses on three basic groups of actors: Manufacturers and Importers of chemical substances, Downstream users of chemicals, Authorities (this group of actors is not subject of this chapter). Industrial actors mostly fall under first two groups. Except the industrial actors and authorities (European Chemicals Agency, competent authorities at national level) there are also other actors or interested parties, like professional users or consumers. Figure 3.1: Scheme of actors under REACH European Economic Area The responsibilities following from REACH depends on the type of actor, the object and activity How industrial actors are defined? Table 3.1: Definitions of industrial actors under REACH Manufacturer Importer Downstream user Supplier of a substance or a preparation Distributor Any natural or legal person established in the EU, who manufactures a substance within the EU (for placing on the market or for own use) Any natural or legal person established in the EU, who is responsible for import (for placing on the market or for own use) of chemicals Any natural or legal person established in the EU, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities. (Attention! A distributor or a consumer is not a downstream user) Actor using substances for production of preparations for placing on the market Producer of preparations and/or for own use Industrial user Actor using substances or preparations in industrial processes Professional user Actor using substances or preparations in processes to provide services Producer of articles Actor who produces articles within the EU Actor who re-imports originally exported registered substances on their own or in preparations; substance being re-imported is the same as the exported Re-importer substance and has been provided with required information relating to the exported substance Manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a preparation, or a preparation, (somebody who makes chemicals available on the EU market) Any natural or legal person established in the EU, including a retailer, who only stores and places on the market a substance, on its own or in a preparation, for third parties 11

12 3.2. Roles under REACH How to identify your role? REACH is based on the principle that it is up to manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use substances in a safe way, i.e. that no risk for adverse effect to human health or the environment occur or the risks are adequately controlled. Each of the mentioned actors has different tasks, responsibilities and obligations to follow in order to reach this goal. Therefore it is very important, firstly, to define where you stand in the supply chain - the identification of roles will serve you to clarify your overall obligations under REACH. Companies dealing with chemicals may have more than one role. This can be in relation to a single substance or different substances they handle. Example: If a company uses a substance supplied by an EU manufacturer, it is a downstream user. If the same company also imports the same or any other substance, it is an importer at the same time. Following questions and scheme is one of possible options, which will help you to identify what is your role. Follow the scheme below for each of the substance / preparation / article you produce, import and/or handle. NOTE: You have to define your role for each substance and for each position in supply chain! Figure 3.2: Flow chart for identifying role under REACH When you know your role you can start to identify your obligations, which, of course, depend on the kind of chemical substances and quantities produced or imported annually. NOTE: It is very important to identify and know your role already now to manage to keep pre-registration time (1 June 30 November 2008); if you miss to pre-register the substance you have no possibility for longer registering time period! 12

13 What are main obligations of actors? Table 3.2: Actors roles and main obligations under REACH Role in REACH Manufacturer and importer of substances Tasks under REACH Collect information on properties of substance (no testing) Perform testing if info is not available Classify & label Prepare SDS (also with exposure scenarios) Prepare registration dossier for all substances in amount of >1t/a CSA/CSR for substances in amounts >10t/a Collect info on uses of substance Exposure scenarios for dangerous substance in >10t/a Propose risk reduction measures Communicate info on substances downstream (SDS, label) Follow bans and restrictions Aim to agree with others on harmonised classification Share information on tests with vertebrate animals Apply for authorisation, if necessary Search for alternatives for substances of very high concern or substances with high expected regulatory outcome (HERO) Importer of preparations Identify ingredients of more >1t/a Collect information on properties of all substances in preparations (including testing if info not available) Classify & label Prepare SDS (including exposure scenarios) Communicate info on substances downstream (SDS, label) Follow bans and restrictions Prepare registration dossier for all ingredients in amount of >1t/a the same further info as for importer/manufacturer of substance to combine info on dangerous substances in case of dangerous preparations Apply for authorisation, if necessary Search for alternatives for substances of very high concern or substances with high expected regulatory outcome (HERO) Producers and importers of articles Collect info on the content of dangerous substances in articles Estimate release of dangerous substances during all life cycle Assess risk of released substance to human health and environment Follow bans and restrictions Register or notify dangerous substances in articles when they are intentionally or unintentionally released from the article (tonnage trigger > 1 t/a/importer/article type) Apply for authorisation, if necessary Search for alternatives for substances of very high concern or substances with high expected regulatory outcome (HERO) Producer of preparations Communicate uses upstream Compare information and advice of supplier with own conditions If not in compliance, communicate with supplier or notify deviance and prepare CSR Classify & label Combine info on dangerous substances in case of dangerous preparations Prepare SDS Communicate info on substances downstream (SDS, label) Follow bans and restrictions Apply for authorisation, if necessary Search for alternatives for substances of very high concern or substances with high expected regulatory outcome (HERO) Industrial/professional user Communicate uses upstream Compare information and advice of supplier with own conditions If not in compliance, communicate with supplier or notify deviance and prepare CSR Follow bans and restrictions Apply for authorisation, if necessary Search for alternatives for substances of very high concern or substances with high expected regulatory outcome (HERO) 13

14 3.3. Where you can find relevant information? Relevant parts in REACH regulation: Title I. General issues Chapter 2: Definitions and general provision Art. 3 Definitions Title V. Downstream users Guidance materials: RIP 1. REACH process description RIP 1. Flowcharts on the new EU chemicals legislation 14

15 4. REGISTRATION 4.1. Aim, scope and timelines What is Registration? Registration is a process, which provisions require manufacturers and importers to collect or generate data on the substances they manufacture or import, to use these data to assess the risks related to these substances and to develop and recommend appropriate risk management measures. There is a general obligation for manufacturers or importers of substances, individually or as part of a consortium, to submit a registration dossier to the Agency for substances manufactured or imported in quantities of 1 tonne or above per year. The registration dossier comprises: a technical dossier (variable information requirements largely depending on quantity), and a chemical safety report (at 10 tonnes and over per M/I) setting out how identified uses can be adequately controlled. Each manufacturer, importer or only representative (of a company outside EU) is individually obliged to submit a registration dossier for each his substance. However, in cases where a substance is manufactured or imported by more than one company, they are required to submit certain information together. There is still left an opt-out possibility for a manufacturer or importer to submit common parts of the registration dossier separately (article 11(3) and article 19 (2)). A substance may not be manufactured or imported if the M/I in question fail to register it. A steps of registration process please find from a scheme in the document Guidance on registration (ECHA, June 2007), Figure 1. Steps within the registration process What is the aim of registration? The aim of the registration requirement is to establish a transparent, predictable and balanced framework within which industry takes responsibility for the safety of their products. Industry is required to collect sufficient information and to use this information to determine appropriate risk management measures to be implemented by manufacturers and importers and recommend the appropriate measures to downstream users What is the scope of registration? Which substances are subject to registration? (Art. 6, 7) Each substance, either on its own or in a preparation, shall be registered when a manufacturer or importer manufactures or imports it in quantities of 1 tonne or more per year (see Art. 6). In certain circumstances also substances contained in articles shall be registered (see Art. 7). The registration needs to be done when both following conditions are met: The substance is present in produced or imported articles in quantities totalling over 1 tonne per producer or importer per year, The substance is intended to be released under normal or reasonably foreseeable conditions of use. However, it is important to remember that only substances have to be registered, preparations and articles not. What is exempted from registration? (Art. 2, 6.2, 9, 15) Registration does not apply in the following cases: If substance is exempted from REACH regulation (radioactive substance; is subject to customs supervision; non-isolated intermediate; waste; Member States may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a preparation or in an article, where necessary in the interests of defence); If substance is used: in medicinal products for human and veterinary use, in food and feeding stuffs; If substance is listed in: Annex IV (mainly these substances were exempted also from the Regulation (EC) No 793/93), or NOTE: substances listed in Annex IV and belonging to the categories are exempted from the registration provision but not necessarily from authorisation or restriction Annex V (the Annex consists of nine broad categories of substances for which registration is deemed inappropriate or unnecessary); If substance, which is re-imported, being registered before export; If substance, which is recovered, being registered before recovery; If substance is used for the product and process oriented research and development (PPORD) then these substances are exempte from the general obligation to register for five years (with possible extension for five more years); 15

16 If substance is used as active substance or co-formulant in plant protection products it is regarded as being registered; If substance is used as active substances in biocides it is regarded as being registered; If substance is used as active substances in biocides it is regarded as being registered NOTE: the same active substance may be used for other uses than plant protection and biocidal products those quantities are not exempted Substances notified in accordance with Directive 67/548/EEC will be regarded as a registration and the Agency will assign a registration number for such substance by 1 December Data for the substance already notified in accordance with Directive 67/548/ EEC should be upgraded when the next tonnage quantity threshold is reached. If substance is a polymer. NOTE: M/I of a polymer shall register a monomer, if the polymer consists of not less than 2% w/w of such monomer, and the total quantity of monomer is 1 tonne per year What are timelines for registration? (Art. 23, 24) Substances falling under the scope of the REACH Regulation and not exempted from the registration obligation must be registered before they can be manufactured or placed on the market (including import) in the EU. The substances, which have long been on the EU market (phase-in substances), and the non-phase-in substances have different timelines for registration. Pre-registration of substances starts from 1st of June This is 1 year after the entry into force of the regulation and after the establishment of European Chemicals Agency. For phase-in substances, which are manufactured or imported in a quantity of 1 tonne or more per year and which have been pre-registered between 1 June 2008 and 1 December 2008 (inclusive), the registration provisions are applied in a stepwise way to facilitate the transition to REACH (see figure 4.1). The deadlines for the registration of phase in substances have been set based on the substance volume manufactured or imported per manufacturer or importer or producer of articles within a year. A greater priority has also been given to substances of higher concern like carcinogenic, mutagenic and toxic substances (CMR) and substances, which are very toxic to the aquatic environment and may cause long-term effects in the aquatic environment. NOTE: if manufacturer forgets to pre-register the substance within the given time, a phase-in-substance becomes treated as a non-phase-in substance. NOTE: Phase-in substances are substances, which were already being manufactured or placed on the market before the entry into force of the REACH Regulation: listed in EINECS manufactured in Community but not placed on the market at least once in the 15 years before entry into force of this regulation placed on the market in the Community before entry into force of this regulation and considered as having been notified in accordance with current legislation but does not meet the definition of a polymer The phase-in deadlines after entry into force of the Regulation are presented in the following Figure 4.1. The chemicals substances, which have transitional provisions, will be registered accordingly time line presented below. Figure 4.1: Timelines for registration All substances that are not fulfilling criteria for phase-in substances, are considered as non phase-in substances. Non phase-in substances do not benefit from the transitional regime provided for phase-in substances and need to be registered before they can be manufactured, imported or placed on the market in the EU, unless they have already been notified under Directive 67/548/EEC. It is important to stress that registration of non phase-in substances will first require the submission of an inquiry dossier to determine whether a registration or another inquiry has already been submitted for the same substance so that data sharing mechanisms can apply. NOTE: A notification in accordance with Directive 67/548/EEC is regarded as a registration. It will need to be updated when a higher tonnage range is reached. 16

17 Where you can find relevant information? Relevant parts in REACH regulation: Title I. General Issues Chapter 1: Aim, scope and application Art. 1 Aim and scope Art. 2 Application Guidance materials: Guidance on registration. ECHA ( Title II. Registration of Substances Chapter 1: General obligation to register and information requirements Art. 9 Exemption from the general obligation to register for product and process orientated research and development (PPORD) Chapter 2: Substances regarded as being registered Art. 15 Substances in plant protection and biocidal products Chapter 5: Transitional provisions applicable to phase-in substances and notified substances Art. 23 Specific provisions for phase-in substances Art. 24 Notified substances 4.2. Pre-registration What is pre-registration? (Art. 28) Pre-registration is a process during which within a certain time frame all potential registrants of a substance shall submit some certain data regarding the substance and himself to the Agency. This process was developed in order to allow the potential registrants of phase-in substances to benefit from the transitional registration regime When pre-registration takes place? (Art. 28(2)) In order to be able to maintain manufacture, import and marketing of a phase-in substance during the transitional period, pre-registration is a one time process that has to take place in the period from 1 June 2008 to 1 December All manufacturers and importers of phase-in substances, who wish to take advantage of the transitional registration deadlines, will need to submit their pre-registration dossier during this period. This will allow companies to continue manufacturing and importing their phase-in substances for several years until the registration deadline is reached without interruption of placing on the market chain. Moreover, at the same time it will allow manufacturers and importers of the same substance(s) to initiate data sharing processes What information will be required for pre-registration dossier? (Art. 28(1)) The information needed for pre-registration will include the following: the name of the substance, including its EINECS and CAS number or any other identity codes; name and address of the registrant; the envisaged deadline for the registration and the tonnage band; the name(s) of substance(s), including their identity codes, for which the available information is relevant for the application of sections 1.3 ((Q)SAR) and 1.5 (grouping of substances and read-across approach) of Annex XI. All potential registrants, downstream users and third parties who have submitted information to the Agency will be participants in a substance information exchange fora (SIEF) (please see more on SIEF under chapter 4.6.1) What happens if you don t pre-register a substance? Thus, failing to pre-register a phase-in substance within the pre-registration period means that the manufacturer/importer cannot benefit from the delayed deadlines under the transitional regime of registration. Subsequently, rules of non-phase-in substances will apply to those non-pre-registered phase-in-substances. 17

18 Where you can find relevant information? Relevant parts in REACH regulation: Title II. Registration of Substances Chapter 5: Transitional provisions applicable to phase-in substances and notified substances Art. 23 Specific provisions for phase-in substances Title III. Data sharing and avoidance of unnecessary testing Chapter 3: Rules for phase-in substances Art. 28 Duty to pre-register for phase-in substances Guidance materials: RIP 1. REACH process description Guidance on pre-registration. ECHA. Guidance on registration. ECHA ( Registration dossier What is a registration dossier and how does it look like? A registration dossier is a documentation to be provided by a manufacturer or importer of substances to the Agency to get a registration. It consists of: a technical dossier (it is information obtained about substances and their uses (see table 4.1, 4.2); a chemical safety report if substances are manufactured or imported in quantities 10 tonnes per year (based on information in the technical dossier. For dangerous substances and PBT/vPvB substances the analysis needs to demonstrate that risks arising from identified use(s) of the substance can be adequately controlled).see chapter about a chemical safety report What is the content (which information needs to be presented) of the technical dossier? (Art. 10, 12, 17, 18, Annexes VI -XI) Manufacturers and importers have to collect all available existing information on the intrinsic properties of a substance regardless of tonnage manufactured or imported as well as on its manufacture and uses. This information has in turn to be compared with the standard information requirements, which depend on the quantity of the given substance for each manufacturer or importer. The information required in the technical dossier for registration depends on the volume and type of the chemical substance. Table 4.1: Annexes requirements depending on tonnage bands Tonnage band Annex VI Annex VII Annex VIII Annex IX Annex X Annex XI 1 10 t/a x (considering Annex III) x x t/a x x x x t/a x x x x x 1000 t/a x x x x x x RIP 3.1: Guidance on registration Annexes VII to X specifies the standard information requirements according to four tonnage bands from 1 tonne per year to 1000 tonnes per year. For the lowest tonnage level, the standard requirements are in Annex VII, and when a new tonnage level is reached, the requirements of the corresponding Annex have to be added. The Annexes thus need to be considered as a whole and in conjunction with the overall requirements of registration, evaluation and the duty of care as detailed in Table 1. These standard requirements may, however, be adapted (waived or increased) when appropriately justified (Annexes III and VI to XI). Accordingly, for each substance the precise information requirements may differ, according to the available information on inherent properties as well as to tonnage, use and exposure. Table 4.2: Annexes data requirements Annex VI General registrant information Identification of the substance Manufacture and use of the substance Classification and labelling Guidance on safe use Information on exposure (1-10 t/yr) Annex VII Physicochemical properties Basic human health data (skin and eye irritation, skin sensitisation, mutagenicity, acute toxicity by oral route) in vitro Ecotoxicological information (short-term toxicity to Daphnia, aquatic plants growth inhibition, biotic degradation) Other available information 18

19 Annex VIII Human health data (skin and eye irritation (in vivo), mutagenicity (in vitro), acute toxicity by inhalation and dermal route, repeated dose toxicity, reproductive toxicity, assessment of toxicokinetics behaviour from existing data) Ecotoxicological data (short-term toxicity on fish, abiotic degradation, fate in environment adsorption/ desorption) Annex IX Physicochemical properties (stability in organic solvents, dissociation constant, viscosity) Human health data (repeated dose toxicity, reproductive toxicity (pre-natal development, two generation) Ecotoxicological information (long-term toxicity on invertebrates, fish, identification of degradation products, fate and behaviour in environment. bioaccumulation in aquatic species, effects on terrestrial organisms) Annex X Human health data (long-term repeated toxicity, two-generation reproductive toxicity, carcinogenicity) Ecotoxicological information (deeper on degradation and fate and behaviour in environment, long-term toxicity for terrestrial organisms, long-term toxicity to sediment organisms and longterm reproductive toxicity to birds) Annex XI In addition to the specific rules set out in Annexes VII to X, a registrant may adapt the standard testing regime if: Testing does not appear scientifically necessary Use of existing data Weight of evidence Qualitative or Quantitative structure-activity relationship ((Q)SAR) In vitro methods Grouping of substances and read-across approach Testing is not technically possible Substance-tailored exposure-driven testing Where to submit registration dossier and who checks it? The registration dossiers need to be submitted to the Agency electronically through IUCLID 5 to facilitate the management of the expected amount of registrations. The Agency assigns a registration number and a registration date to each registration dossier received and immediately communicates this information to the registrant. IUCLID 5 is an IT system designed to prepare REACH-compliant registration dossiers, which should be submitted to the European Chemicals Agency. IUCLID 5 software is downloadable from the IUCLID website [ for free by all parties, if used for noncommercial purposes. IUCLID 5 was developed for entering, storing and disseminating information on the properties and uses of substances. In particular, for each endpoint, harmonised data templates have been developed in cooperation with the OECD so that IUCLID 5 can be used in different chemical assessment programmes. More information, such as information on exposure can also be stored in less structured but specific fields. IUCLID 5 can also be used for preparing parts of the assessment reports. In particular, there are endpoint summary sections which allow the user to report the justification and summary of the assessment at each endpoint level that could be used for the equivalent section in the Chemical Safety Report (CSR). Some of these endpoint summary sections also exist at (eco)toxicological properties level, to report DNELS and PNECs. Within 3 weeks of the registration date, the Agency performs an automated completeness check of the dossier to ascertain that all elements required for the registration are included. If the registration is incomplete, the Agency will inform the registrant within these 3 weeks from the registration date about which further information is needed and will set a deadline for completion of the dossier. For phase-in substances, a considerable number of registrations are expected to arrive just before the deadlines for the registrations. Therefore, the Agency is given 3 months from each registration deadline to check the completeness of those registrations that have been submitted within 2 months of the deadlines. However, the Agency will have to check the completeness of registrations submitted more than 2 months before the deadlines, within 3 weeks of receipt. The registrant needs to submit the requested missing information in an updated dossier to the Agency within deadline appointed by the Agency. The Agency then confirms the submission date of this information and makes a further completeness check within 3 weeks of receipt of the updated dossier. If the registrant fails to complete his registration within the set deadline, the registration will be rejected by the Agency and the manufacturer or importer is not allowed to start or continue to manufacture or import of the substance Where you can find relevant information? Relevant parts in REACH regulation: Title II. Registration of Substances Art. 10 Information to be submitted for general registration purposes Art. 12 Information to be submitted depending on tonnage Art. 17 Registration of on-site isolated intermediates Art. 18 Registration of transported isolated intermediates Annexes VI-XI Guidance materials: RIP 3.1: Guidance document on preparing the Registration dossier Guidance on registration. ECHA ( 19

20 4.4. Chemical safety assessment and chemicals safety report What is a chemical safety assessment? A chemical safety assessment (CSA) is a structured assessment of hazards and, if the substance is hazardous, of exposure considering all life-cycle stages of the substance resulting in a characterization of risks. The aim of a CSA is to identify safe conditions for all identified uses of a substance What is a chemical safety report? A chemical safety report (CSR) documents the chemical safety assessment and it is a part of registration dossier What is the scope of the chemical safety assessment and the chemical safety report? Which substances are subject to the chemical safety assessment and the chemical safety report (Art. 14(1))? The CSA shall be performed and the CSR completed for all substances subject to registration in quantities 10 tonnes per year per registrant. Figure 4.2. Steps when to prepare a chemicals safety report NOTE: a CSA shall be conducted and documented in a CSR either for a substance on its own or in a preparation or in an article. What is exempted from the chemical safety assessment (Art. 14(2))? The CSA is not needed for a substance, which is present in a preparation, if the concentration of the substance in the preparation is less than the lowest of any of the following: concentration limits used for classification of preparations by a conventional method, given in: the table of Art. 3(3) of Directive 1999/45/EC, Annex I to Directive 67/548/EEC, Part B of Annex II to Directive 1999/45/EC, Part B of Annex III to Directive 1999/45/EC, the classification and labelling inventory established under REACH regulation, 0,1% w/w if the substance meets the PBT/ vpvb criteria (Annex XIII of REACH regulation). When the chemical safety report is not needed (Art. 14(5))? The CSR does not need to include consideration of the risks to human health from the following end uses: in food contact materials (within the scope of Regulation (EC) 1935/2004), in cosmetic products (within the scope of Directive 76/768/EEC) What are companies tasks? A requirement to perform the CSA and prepare the CSR applies to manufacturers and importers, and in certain cases may also apply to downstream users (for this case see chapter ). The requirement to implement the appropriate risk management measures identified during the CSA applies to all actors in the supply chain, starting from the registrant himself. 20

21 Table 4.3: Companies tasks regarding the chemical safety assessment and the chemical safety report Actor Manufacturers and importers of substances in quantities 10 tonnes per year Distributors Task Conduct the CSA Prepare the CSR Submit the CSR to the Agency as a part of registration documentation Prepare a SDS, and ensure that information in the SDS is consistent with the information in the CSA and the CSR In case when exposure scenarios are generated (substances classified as dangerous or being PBT/ vpvb), the relevant exposure scenarios shall be added as annex to SDS Implement the relevant risk management measures for own use Pass on SDS (with relevant exposure scenario) down the supply chain Pass on information relevant for preparation of exposure scenarios up the supply chain What are the general steps of the chemical safety assessment? The standard general elements (steps) of the CSA are: Human health hazard assessment; Physicochemical hazard assessment; Environmental hazard assessment; PBT and vpvb assessment. If it is concluded, when carrying out the first four steps of the CSA, that the substance is classified as dangerous or it is a PBT/vPvB substance, the CSA shall include some additional steps: Exposure assessment: Generation of exposure scenario(s), Exposure estimation; NOTE: The CSA shall address all identified uses! Risk characterization. The methodology for the CSA is presented in ANNEX I to REACH regulation, under the following points: Point 1 Human health hazard assessment; Point 2 Physicochemical hazard assessment; Point 3 Environmental hazard assessment; Point 4 PBT and vpvb assessment; Point 5 Exposure assessment; Point 6 Risk characterisation. More precise guidelines, how to follow the methodology, are presented in RIP 3.2. Several tools are available or will be developed to perform the CSA and generate CSR. Some of them are listed in RIP What means hazard assessment, exposure assessment and risk characterisation? The objective of hazard assessment is: To classify and label the substance with regard to human health and to determine a derived no-effect level(s) (DNEL) for workers and general population; NOTE: DNEL is regarded as level of exposure to the substance above which humans should not be exposed. To determine the classification and labelling of the substance and to assess the potential effects to human health for explosivity, flammability and oxidising potential; To classify and label the substance with regard to the environment, and to determine a predicted no effect concentration (PNEC); NOTE: PNEC is concentration below which adverse environmental effects in the environmental compartments are not expected to occur. To determine if the substance fulfils the criteria for being PBT/ vpvb (given in Annex XIII). The exposure assessment consists of determining quantitatively or qualitatively the dose/ concentration of the substance to which humans and the environment are or may be exposed. The exposure assessment consists of two steps generation of exposure scenarios and exposure estimation. Exposure scenario (ES) is a set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream user to control, exposures of humans and the environment. 21

22 NOTE: ES may describe the appropriate risk management measures for several individual processes or uses of a substance. An ES may thereby cover a range of processes or uses. ES covering a wide range of processes or uses are called Exposure Categories. An exposure estimation of human and environmental compartments to the substance (i.e. estimation of exposure level, to which human are exposed or are likely to be exposed, and estimation of predicted environmental concentrations PECs) is performed from the conditions defined in the exposure scenarios. The risk characterisation is the final step in the CSR where it should be determined whether risks arising from manufacture/import and use of the substance are adequately controlled. The registrant shall compare DNELs and PNECs with calculated exposure concentrations to humans and the environment respectively. The risk characterisation consists also of the assessment of the likelihood and severity of an event occurring due to physico-chemical properties of the substance. Risk characterisation shall be carried out for each ES. As the purpose is to prove that the risks are adequately controlled it is expected that the results of the risk characterisation should not indicate a risk in the CSR What is the content of the chemical safety report? A format for the CSR is presented under the point 7 in ANNEX I to REACH regulation. There shall be the following main headings in the CSR: Part A 1. Summary of risk management measures 2. Declaration that risk management measures are implemented 3. Declaration that risk management measures are communicated Part B 1. Identity of the substance and physical and chemical properties 2. Manufacture and uses 3. Classification and labelling 4. Environmental fate properties 5. Human health hazard assessment 6. Human health hazard assessment of physicochemical properties 7. Environmental hazard assessment 8. PBT and vpvb assessment 9. Exposure assessment 10. Risk characterisation Where does chemical safety report go to? The CSR needs to be submitted to the Agency together with the rest of registration documentation, following the same rules for timelines as for the technical dossier. IUCLID 5 is used for supplying the CSR to the Agency. The part of the CSR exposure scenarios, when they are required have to be added as an annex to safety data sheet, and provided further to downstream users Where you can find relevant information? Relevant parts in REACH regulation: TitleII. Registration of Substances Chapter 1: General obligation to register and information requirements Art. 14: CSA and duty to apply and recommend risk reduction measures Guidance materials: RIP 3.2: Guidance document on preparing the Chemical Safety Report and Guidance document on preparing the Chemical safety assessment TitleIV. Information in the supply chain Art. 31(2) and 31(7): Requirements for Safety Data Sheets TitleV. Downstream users Art. 37: Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures Art. 38: Obligation for downstream users to report information Art. 39: Application of downstream user obligations Annex I: General provisions for assessing substances and preparing chemical safety reports 22

23 4.5. Data collection What and why data needs to be collected? The technical dossier contains information on the properties, uses and classification of a substance as well as guidance on safe use. The information requirements in the REACH annexes dealing with testing vary according to the tonnage in which the substance is manufactured or imported, and to the needs of the CSA. There is certain information that is required for all registrations (Annex VI) with hazard data required being set out in Annexes VII X depending on the tonnage band. Tonnage thresholds are used, in many cases, as a simple indication of the potential for exposure. Information is needed under REACH for specific purposes: Classification and Labelling Determination of CMR substances Determination of PBT status Determination of vpvb status Risk assessment (via the Chemical Safety Assessment) Determination of any need for risk management measures How data can be collected? In many cases the information collected may consist of actual test data. New tests for registration purposes are only required, when it is not possible to provide the information in any other allowed way. For substances in quantities of 100 tonnes or more (i.e. cases where more expensive tests may be necessary) the manufacturer or importer who does not already possess the required information, only needs to submit proposals for testing necessary to meet the requirements in Annexes IX and X (for more information when testing or proposal for testing is needed please see in a Table under chapter 4.3.2). The evaluation process will verify whether the tests proposed are necessary. This is to save animals lives and avoid unnecessary costs. Other types of information might be also sufficient (especially when used in a weight-of-evidence approach) when test information meeting modern standards is not available. Such information could be: Human data Data that have not been generated in accordance with Good Laboratory Practice guidelines, or to the latest test guideline method QSAR model outputs SAR model outputs, read-across and category approaches in vitro data. General rules are set out for the use of existing information, techniques such as (Q)SARs ((Quantitative) Structure Activity Relationships) and read-across (analogues), and for waiving of data in Annex XI What sources can be used to obtain information? In compilation of registration dossier many different sources of information on substance properties, which is relevant and reliable, can be used for registration purposes. The registrant should try to optimise the value of the tests needed to be carried out. As is the case for many specialised activities, possibly the most efficient mechanism is to employ the services of those who have expertise in searching the data sources. Table 4.4: Examples of types of information sources Company files Published literature Databases and databanks QSAR, SAR models Could include studies generated in-house, commissioned studies carried out by contract houses, information on experience in use, reports from downstream companies and customers, purchased reports from other companies, collections of published papers and reviews of published data. Likely to cover the product range of the company. Requires expertise to interpret information. Could include papers reporting original findings (primary papers), review papers, books, monographs, and reports of proceedings, meetings and conferences. Covers many more chemicals than the product range of any company. The using of such kind of information it requires expertise in both identifying and interpreting information. Content depends upon the objectives of the hosts/providers (which may change with time). Databases generally direct searchers to the original sources. Databanks generally contain limited information from original sources, but usually give little insight into test information quality. Databases and databanks should be seen only as routes to the cited original sources. Cover many more chemicals than the product range of any company. Requires expertise in searching numerous systems and in interpreting information. Some of these models are freely available and some commercially. In theory they may be applied to any untested chemical, but domain applicability is an issue. Requires specialised expertise to run models and interpret results. 23

24 The internet Search engines allow identification of electronic versions of a diverse range of data sources. In addition, websites of various expert organizations and regulatory bodies contain useful information. Much grey literature is available via this route. RIP 3.3: Technical Guidance Document (TGD) on Information Requirements on Intrinsic Properties of substances How the appropriateness of available data can be evaluated? The EU Technical Guidance Document considers data quality evaluation in two parts: Completeness of data Adequacy of data Completeness of data deals essentially with how well the existing information matches with the information required by the legislation i.e. in the case of REACH, the requirements triggered by tonnage. There is recognition of read-across possibilities from existing non-required data to the information required by the legislation. Adequacy of data is considered to be defined by two basic elements: Reliability Relevance For many existing substances, at least some of the available test data could have been generated prior to the requirements of GLP and the standardisation of testing methods. While such information may still be usable for REACH purposes, both the data and the methodology used must be evaluated in order to determine their reliability. This evaluation needs expert judgement and must be transparent, to clearly justify such use of a particular data set. The OECD process for determining the quality of existing data considers three aspects - adequacy, reliability and relevance. Table 4.5: Definitions of adequacy, reliability and relevance according to the Klimisch et al. (Klimisch HJ, Andreae E and Tillmann U (1997). A systematic approach for evaluating the quality of experimental and ecotoxicological data. Regulatory Toxicology and Pharmacology 25, 1-5) Reliability Relevance Adequacy Evaluating the inherent quality of a test report or publication relating to preferably standardised methodology and the way the experimental procedure and results are described to give evidence of the clarity and plausibility of the findings Covering the extent to which data and tests are appropriate for a particular hazard identification or risk characterisation Defining the usefulness of data for hazard/risk assessment purposes. When there is more than one study for each element, the greatest weight is attached to the study that is the most reliable and relevant RIP 3.3: Technical Guidance Document (TGD) on Information Requirements on Intrinsic Properties of substances Which tests are suitable for the registration purposes? Figure 4.3. Tests suitable for the registration purposes 24

25 Due to either their acceptance in the EU or their mutual international acceptance, the most reliable data are retrieved from studies performed according to the EU adopted test methods or to the OECD test guidelines (where tests on substances are required to generate information on) What is the benefit of avoiding testing? Annex XI of REACH describes further possibilities for waiving of testing data, including exposure considerations, the use of existing data, including human, animal, in vitro data and non-test data (e.g. (Q)SAR, SAR and read across), which might be used in order to reduce the need for further testing. The benefits of using such non-test methods (read across, grouping or chemical categorisation and (Q)SARs) have included: Avoiding the need for (further) testing. This may imply both saving of costs and in reduction of the need for tests with laboratory animals (animal welfare) Filling information gaps, also where no test would be required according to current legislation Improving the evaluation of existing test data as regards data quality and for choosing valid and representative test data for regulatory use. Furthermore use of non-test data in addition to test data employing weight of evidence has increased the confidence in the assessments. Non-test data have in addition occasionally had implications for the choice of assessment factor in environmental risk assessments, because such non-test information in comparison with available test data suggested a certain mode of action (i.e. nonpolar narcosis, i.e. minimum toxicity towards aquatic organisms) How the non-test methods can be used? Interpretation and translation of non-test information almost always require an element of expert judgement in a similar way as use of test data often does, which however is more frequently directly referred to and put into legislative rules and related evaluation procedures. As regards the conditions for using (Q)SARs, it is said that the methods should be scientifically valid (elements concerning validation of QSARs are listed in the OECD QSAR validation principles, amongst which are also requirement for definition of the applicability domain of the models) and adequate for the purpose of classification and labelling and risk assessment. For using grouping the REACH proposal states that such methods should be considered for use, when the intrinsic properties of a group of chemicals are likely to be similar or follow a similar pattern as a result of structural similarity Where you can find relevant information? Relevant parts in REACH regulation: Title II. Registration of Substances Chapter 1: General obligation to register and information requirements Art. 10 Information to be submitted for general registration purposes Art. 12 Information to be submitted depending on tonnage Art. 13 General requirements for generation of information on intrinsic properties of substances Art. 14: CSA and duty to apply and recommend risk reduction measures Guidance materials: RIP 3.1: Guidance document on preparing the Registration dossier RIP 3.3: Technical Guidance Document (TGD) on Information Requirements on Intrinsic Properties of substances ANNEX VI: Information requirements referred to in article 10 ANNEX VII: Standard information requirements for substances manufactured or imported in quantities of 1 tonne or more ANNEX VIII: Standard information requirements for substances manufactured or imported in quantities of 10 tonne or more ANNEX IX: Standard information requirements for substances manufactured or imported in quantities of 100 tonne or more ANNEX X: Standard information requirements for substances manufactured or imported in quantities of 1000 tonne or more ANNEX XI: General rules for adaption of the standard testing regime set out in annexes VII to X 25

26 4.6. Data sharing What is Substance Information Exchange Fora and how will it work? All potential registrants who have submitted information to the Agency with a purpose of pre-registration will be participants in substance information exchange fora (SIEF). Figure 4.4. Aims of SIEF Data sharing principles: is aimed at avoiding the duplication of studies (especially test with vertebrate animals); data sharing and joint submission of information in accordance with REACH shall concern technical data and in particular information related to the intrinsic properties of substances; registrants shall refrain from exchanging information concerning their market behaviour, in particular as regards production capacities, production or sales volumes, import volumes or market shares What is the procedure of data sharing within SIEF? Figure 4.5. Procedure of data sharing within SIEF 26

27 How data sharing works for the already registered substances? Any study summaries or robust study summaries of studies submitted in the framework of a registration under REACH will be made available for another manufacturers or importers after 12 years. Figure 4.6. Data sharing procedure for the already registered substances 27

28 How joint submission of data by multiple registrants ( consortia ) will be performed? When a substance is intended to be manufactured/imported in the Community by one or more manufacturers and/or by one or more importers, and/or is subject to registration under Article 7 (substances in articles), the following shall apply: Figure 4.7. Procedure of joint submission of data by multiple registrants 4.7. Downstream users and registration What registration means for downstream user? (Art. 34) A downstream user will usually be interested that his supplier registers the substance and that his use is included in the dossier as identified use. Thus, the first task of DU is to make his use known to the supplier (make an identified use). Further on downstream user should communicate the following information up the supply chain: new information on hazardous properties; any other information that might call into question the appropriateness of the risk management measures identified in a SDS supplied to him, which shall be communicated only for identified uses What means chemical safety assessment and chemical safety report for downstream user? 1. Downstream user can inform his application to supplier to make a new identified use (Art. 37(2)) NOTE: In making a use known, a downstream user shall provide sufficient information to allow the manufacturer, importer or downstream user who has supplied the substance, to prepare an exposure scenario for the CSA. 28

29 2. Downstream user must prepare the CSR for any use outside the exposure scenario communicated to him in an SDS or for any use his supplier advises against (Art. 37(4), 39(1)). Figure 4.8. Steps when to prepare a chemicals safety report NOTE: the DU need not prepare a CSR if: a SDS is not required; a CSR is not required for his supplier (i.e. manufacture/ use is less than 10 tonnes per year); the DU uses the substance or preparation in quantities of less than 1 tonne per year; the DU implements or recommends a relevant exposure scenario as communicated to him in the SDS. the DU is using the substance for the purposes of product and process oriented research and development, provided that the risks to human health and the environment are adequately controlled. 3. Downstream user has to implement the appropriate risk management measures identified in any of the following: The SDS supplied to him; His own CSA/CSR; Any information on risk management measures supplied to him in cases, when SDS is not required. 29

30 4. Downstream user must report information to the Agency (Art.38, 39(2)) Before commencing or continuing with a use of a substance that has been registered by a supplier, the downstream users shall report to the Agency in the following cases: The DU has to prepare his own CSR; The DU need not prepare the CSR due to exemptions: The DU uses the substance or preparation in total quantity of < 1 tonne per year; The DU is using the substance for the purposes of product and process oriented research and development. NOTE: The information reported by the downstream user to the Agency includes: DU identity and contacts; registration number; identity of the substance; identity of the supplier; brief description of the use(s); proposal for additional testing on vertebrate animals, where this is necessary by the DU to complete his CSA Where you can find relevant information? Relevant parts in REACH regulation: Relevant parts in REACH regulation: Title V. Downstream users Guidance materials: RIP 3.2: Guidance document on preparing the Chemical Safety Report and Guidance document on preparing the Chemical safety assessment RIP 3.5: Downstream users requirements 30

31 5. AUTHORISATION 5.1. Introduction to the authorisation What is the aim of authorisation? The aim of authorisation is to ensure that the risks from substances of very high concern are properly controlled, replaced by suitable alternatives or technologies, or justified by socio-economic grounds, having taken into account the available information on alternative substances or processes. Authorisation of substances applies to manufacturers, importers and downstream users who place a substance on the market or (who) use the substance themselves. Certain uses may be exempted (article 56) from the authorisation requirements (e.g. for use in medicinal products) generally because sufficient control mechanisms have already been established by other legal acts What is the process of authorisation? The authorisation process consists of four steps (please see written below). Industry has obligations in the third step. However, all interested parties have the opportunity to provide input in steps 1 and 2. Step 1: Compilation candidate list of substances for authorisation (by authorities) Substances of very high concern will be taken on board on the basis of the criteria described in chapter This will be done by Member State Competent Authorities or the Agency by preparing a dossier in accordance with Annex XV for every suspicious substance. Interested parties can comment on substances for which a dossier has been prepared. The outcome of this process is a list of substances, which are candidates for authorisation (the candidate list ). The list will be published and periodically updated by the Agency. If a substance is included to the candidate list then soon this substance will be moved to the list of substance which use shall be authorised. Step 2: Compilation of list of substances which use shall be authorised (by authorities) The substances included to the candidate list will be prioritised to determine which ones should be subject to authorisation as soon as possible. Interested parties are invited to submit comments during this process. At the end of the prioritization process, the following decisions are taken: which uses of the included substances will not need authorisation (e.g. because sufficient controls established by other legislation are already in place); the sunset date by when a substance can no more be used without authorisation; the date when application for authorisation shall be received to continue the use of substance after the sunset date until the decision on authorisation application will be taken. Step 3: Applications for authorisation (by industry) Applications for authorisation need to be made within the set deadlines for each use. Authorisation application procedure is described in chapter 5.2. A fee has to be paid for each application. Step 4: Granting of authorisations (by the European Commission) Authorisations will be granted if the applicant can demonstrate that the risk from the use of the substance is adequately controlled. The adequate control route does not apply for substances for which it is not possible to determine thresholds and substances with PBT or vpvb properties. If the risk is not adequately controlled, an authorisation may still be granted if it is proven that the socio-economic benefits outweigh the risks and there are no suitable alternative substances or technologies. Reviews All authorisations will be reviewed after a certain time-limit which will be set on a case-by-case basis. 31

32 What is the scope of authorisation? The substances selected for the authorisation system have hazardous properties of very high concern. What substances are subject to authorisation (article 57)? Substances of very high concern which may be included in the Annex XIV, and for which thereby the authorisation requirement will be established, are substances with the following properties: CMR substances, cat 1 and 2 - Carcinogenic, mutagenic and toxic for reproduction substances meeting the criteria for classification in category 1 and 2 in accordance with Directive 67/548/EEC Annex VI; NOTE: There is no volume threshold for the application of authorisation, and substances subject to authorisation do not necessarily have to have been registered. PBT and vpvb substances - Persistent, bioaccumulative and toxic substances and very persistent and very bioaccumulative substances in accordance with criteria in Annex XIII; Substances of equivalent concern with scientific evidence of probable serious effects (all substances of very high concern will be prioritised by the Agency and may be included in Annex XIV to the proposal by the Commission): such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria in Annex XIII but which are identified as causing serious and irreversible effects to humans or the environment which are equivalent to those of other substances listed in previous points. The Agency will publish a list of substances meeting the criteria above, taking into consideration comments from interested parties. NOTE: Persistent organic pollutants (POPs) are vpvb-substances and are therefore substances that would be subject to authorisation. However, the Stockholm Convention and the United Nations Economic Committee for Europe (UNECE) Protocol have made a list and banned the manufacture, use and placing on the market of these substances (with only a few exemptions). These banned substances will not be made subject to the authorisation system as an authorisation would never be granted for the use of these substances and exemptions allowed under the Convention/Protocol are only for a limited time. The international rules are therefore implemented under the restrictions in Annex XVII. Entries in Annex XIV Identification of the substance Identified property which makes a substance subject to authorisation: why included in the Annex (PBT, vpvb, C cat 1, or ) Sunset date(s), i.e. from this date the placing on the market and the uses of the substance are prohibited without an authorisation Application date(s) at least 18 months before the sunset date: use of the substances applied for until this date will be allowed to be continued until a authorisation decision will be taken Review periods for certain uses, if appropriate Uses or categories of uses and conditions exempted. It should be taken into account: Community legislation already ensures proper control of risks What chemicals are exempted from the authorisation (article 56/2-6)? Authorisation does not apply in the following cases: The use of substances in preparations, if they are present in the preparation: NOTE: Polymers are exempted from registration but they may still be subject to authorisation and restriction for PBT, vpvb (according criteria in Annex XIII) and substances of equivalent concern with scientific evidence of probable serious effects, below a concentration limit of 0,1 % weight by weight (w/w); for all other substances, below the lowest concentration limits specified in Directive 1999/45/EC or in Annex I to Directive 67/548/EEC, so that the preparation would not have to be classified as dangerous. Specific uses of the substances, which are exempted from the authorisation requirement in Annex XIV itself. Annex XIV (list of substances subject to authorisation) shall specify if the authorisation requirement shall apply to PPORD, as well as the maximum quantity exempted (Article 56(3)). The use of substances in scientific research and development or in product and process-orientated research and development in quantities up to 1 tonne per year. The use of a substance by a downstream user if an authorisation for that exact use has already been granted for his supplier. Uses of substances which are generally exempted from the authorisation requirement: uses in plant protection products (within the scope of Directive 91/414/EEC) uses in biocidal products (within the scope of Directive 98/8/EC) uses as medicinal products for human or veterinary use uses as food additives uses as additives in animal feeding stuffs uses as flavourings in foodstuffs uses as an on site isolated intermediate or as a transported isolated intermediate use as motor fuels (covered by Directive 98/70/EC) uses as fuel in mobile or fixed combustion plants of mineral oil products and use as fuels in closed systems. 32

33 uses of CMR in cosmetic products (within the scope of Directive 76/768/EEC) and in food contact materials (within the scope of Regulation (EC) No 1935/2004), as the risks to human health are already regulated under sector specific Community legislation. Note: If a PBT, vpvb substance or a substance of equivalent concern is included in Annex XIV, its use in cosmetic products or in food contact material, needs to be authorised as risks to the environment are not regulated in the specific legislation What is the relationship between authorisation and restrictions? Any substance subject to authorisation (Annex XIV) may be subject to the restrictions process (Annex XVII) as there may be risks that need to be addressed. Once a substance is included in Annex XIV (authorisation), it may not be restricted by inclusion in Annex XVII covering the risks to human health and the environment from the use of the substance arising from the PBT and vpvb properties. However, restrictions of uses because of risks to human health and the environment from other properties can be included in the restriction Annex XVII Where can you find relevant information? Relevant parts in REACH regulation: Title VII. Authorisation Chapter 1: Authorisation duty Article 55: aim Article 56: general (no marketing of substances in Annex XIV) Article 57: criteria for inclusion in Annex XIV Article 58: inclusion in Annex XIV (limited number each series) Article 59: determining substances that meet criteria Annex XIV: List of substances subject to authorisation Annex XVII: Restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles 5.2. Tasks to companies in authorisation process What are companies tasks under authorisation? Authorisation of substances applies to manufacturers, importers and downstream users who place a substance on the market or use the substance themselves. Table 5.1: Companies tasks under authorisation ACTOR TASK Manufacturers and importers of substances Apply for authorisation for use(s) of substances listed in Annex XIV. The application for authorisation shall be received before a certain date before the sunset date! Producers of articles 1. Use substances authorised for incorporation into the articles as set out in the authorisation. or 2. Apply for authorisation for use(s) of substances listed in Annex XIV. The application for authorisation shall be received before a certain date before the sunset date! Importers of articles Apply for authorisation for use(s) of substances listed in Annex XIV. The application for authorisation shall be received before a certain date before the sunset date! Downstream Users 1. Use authorised substances as set out in the authorisation (this info should be found in the suppliers SDS, point 15). Notify the Agency within three months of the first supply of the substance on usage of authorised substance. or 2. Or apply for authorisation for own use(s) of substances listed in Annex XIV. The application for authorisation shall be received before a certain date before the sunset date! 33

34 What a company needs to do for getting substance authorised? The authorisation procedure for industrial companies consists of several steps: 1. The Annex XIV (substances subject to authorisation) is drawn up. This list will be published and periodically updated by the Agency. A sunset date will be set for each substance in list. However, a clear date for delivering the application for authorisation to continue the use of the substance after the sunset date until the decision on application is stated as well. 2. Companies using or making available substances mentioned in Annex XIV need to apply for an authorisation for each use of the substance, regardless of the quantity, within the set deadlines. It is the duty of the applicant to demonstrate that the risk from the use is adequately controlled or that the socio-economic benefits outweigh the risks. Applicants need to submit an analysis of possible substitutes: a. If this analysis shows that suitable alternatives are available then the application must also include a substitution plan. b. If this analysis shows no suitable alternatives, information on relevant research and development activities must be provided. An authorisation will be granted if the applicant can demonstrate that the risk from the use of the substance is adequately controlled. c. If this analysis shows no suitable alternatives, then the authorisation may also be granted if the socio-economic benefits outweigh the risks. NOTE: Sunset date last day on which a substance subject to authorisation can be used without a granted authorisation or an authorisation application has been submitted before the application date also specified in Annex XIV. NOTE: PBTs, vpvbs and those CMR substances for which a safe level cannot be defined, authorisation cannot be granted based on adequate control of risk. Six years after the entry into force of the regulation, the Commission will review whether endocrine disrupters should also be excluded from the adequate control route. According to figure 5.1 companies could follow next steps in the authorisation process. Firstly companies need continuously follow and check the Annex XIV what lists the substances need to be authorised. If they find any of substance mentioned in that list they should consider the granting of authorisation. If they need to apply for the authorisation for the substance it would mean the need to compile an authorisation application, considering the joint application or one application for many substances and possible uses of substances or if they are subsequent applicants they have less obligations. Authorisation dossiers need to be submitted to agency who may ask further questions with regard of the application. 34

35 Figure 5.1: Steps to consider and questions to answer under authorisation process 35

36 What happens after submission of authorisation application? Figure 5.2: Steps between submission of authorisation application to Agency and granting the authorisation Where can you find relevant information? Relevant parts in REACH regulation: Title VII. Authorisation Chapter 2: Application of authorisation Article 60: considering for granting authorisation Article 61: re-evaluation (all granted authorisations will be reviewed) Article 62: (demands for) the application Article 63: later application Article 64: decision procedure 36

37 5.3. Authorisation application What is the content of the authorisation dossier? (Art. 62 (4), 62 (5)) Authorisation dossier shall be prepared and submitted to the Agency. Authorisation application should include the following information: (a) Identity of the substance(s) in accordance with Annex VI, point 2 a. Name or other identification of each substance b. Information related to molecular and structural formula of each substance c. Composition of each substance (b) Name and contact details of the person or persons making the application. (c) Request for authorisation, specifying for which use(s) the authorisation is sought and covering the use of the substance in preparations and/or the incorporation of the substance in articles, where this is relevant. (d) Unless already submitted as part of the registration, a chemical safety report in accordance with Annex I. Chemical safety assessment for an authorisation only needs to address the properties that led to an authorisation being required as specified in Annex XIV: CMR, PBT, vpvb or other and the risks arising from the use of the substance due to these properties. (e) Analysis of possible alternatives (substances or technologies) considering their risks and the technical and economic feasibility of substitution and including, if appropriate information about any relevant research and development foreseen or already in progress to develop such alternatives. (f) If the analysis of alternatives shows that there is a suitable alternative, the applicant must submit a substitution plan, explaining how he intends to replace the substance by the alternative (including a timetable for proposed actions). The suitability of available alternatives is assessed taking into account all relevant aspects, including whether the alternative results in reduction of overall risks and is technically and economically feasible. The application should include: (a) Socio-economic analysis conducted in cases where it cannot demonstrate adequate control of risks and where no suitable alternative exists. (b) Justification for not considering risks to human health and the environment arising either from: a. emissions of the substance from an installation for which a permit was granted in accordance with the IPPC Directive or b. from a point source governed by requirement for prior regulation under the Water Framework Directive or c. arising from the use in a medical device What is the socio-economic analysis? The purpose of a socio-economic analysis (SEA) is to evaluate what costs and benefits an action will create for society by comparing what will happen if this action is implemented as compared to the situation where the action is not implemented. The analysis typically attempts to include also the effects that are indirect or incompletely reflected by market transactions. The analysis can be used to better understand how the various costs and benefits are distributed over the various affected parties in society and whether a certain action is desirable from a societal point of view. A SEA shall ideally cover all relevant effects related to the introduction of such an action such as impacts on health and the environment and on the economy, (e.g. the costs to different actors in the supply chain and changes in consumer satisfaction), and social effects (e.g. on employment and labour quality). FOR EXAMPLE: SEAs are for example often conducted to support the decision-making process for new infrastructure projects such as bridges. In that situation possible effects could include the socio-economic effects (e.g. the investment costs of building a bridge; time saved by those using the bridge and the resulting impacts on traffic and economic activity; the effect on employment in the short and in the long run; effects on human health and the environment such as changes in air pollution and the consequent health effects, impact on how the water flows, disruption of nature areas, etc.). Under REACH, SEA arguments can be made in relation to the decision of whether or not to grant an authorisation for the use(s) of a substance and in relation to the decision whether or not to introduce a restriction Under which circumstances will the authorisation granted? The Commission will be responsible for granting or denying authorisations. Authorisations will be granted under following circumstances: 1. If the applicant demonstrates that the risk to human health or the environment from the use of the substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with exposure scenario (written in chemicals safety report risk characterization - section 6.4 of Annex I). The risk to humans and the environment can be considered to be adequately controlled, throughout the lifecycle of the substance that results from manufacture or identified uses, if: Estimated exposure levels do not exceed the appropriate DNEL (Derived No-effect levels) for humans or Estimated exposure levels do not exceed the PNEC (Predicted No-Effect Concentrations), determined from human health hazard assessment and environmental hazard assessment, and, Likelihood and severity of an event occurring due to the physicochemical properties of the substance as determined in physicochemical hazard assessment is negligible. 37

38 2. If authorisation cannot be granted under previous paragraph or applicant cannot demonstrate adequate control from substance use then authorisations may be granted if it is shown that the socio economic benefits outweigh the risks to human health or the environment and if there are no suitable alternative substances or technologies. If the use poses a high risk and a suitable alternative (taking into account cost, availability, and efficacy and risks of the alternative) is available, this will be a key consideration for the authorisation decision and unless there are other considerations, it is unlikely that an authorisation will be granted. The applicant always has to include an analysis of alternatives in his application for an authorisation, including information about any relevant research and development activities, if appropriate. If the applicant has identified a suitable substitute then he also has to submit a substitution plan. It is up to the applicant to decide whether he wants to include a socio-economic analysis (SEA) or not. NOTE: An authorisation can never be granted for a use, which is not allowed under the restrictions in Annex XVII. An example is if consumer use of a CMR substance is restricted in Annex XVII, and this substance is included in authorisation Annex XIV, an authorisation for consumer use of this substance will always be refused. Authorisation decision specifies (article 60/9): Person(s) to whom the authorisation is granted. Identification of the substance(s). Use(s) for which the authorisation is granted and its conditions. This is important for the holder of the authorisation and also for their downstream users as they all have to apply these conditions set out in the authorisation. Review period - authorisations granted for socio-economic reasons shall normally be time-limited. Thus, if such an authorisation is granted for an unlimited time, this has to be justified. Any monitoring arrangements What does a company need to do after receiving the authorisation? 1. The holder of an authorisation shall include the authorisation number on the label before he places the substance or preparation on the market. 2. The holder of an authorisation shall update chemical Safety Data Sheets and include the authorisation number on the SDS (point 15). 3. A time-limited authorisation expires without further decision by the Commission at the end of the time limit, unless the holder of the authorisation has submitted a new application 18 months before the end of the time limit. 4. Other decisions may be reviewed at any time if the circumstances under which they were granted have changed. Such a change of circumstances may be for example a change in the scientific basis for an authorisation decision or that environmental quality objectives as defined under the IPPC Directive or Water Framework Directive are not met because of diffuse emissions to water or the air How to review the authorisation? Holder of the authorisation needs to submit a review report at the latest 18 months before the expiry of the review period set in the authorisation decision. Rather than re-submitting all elements of the original application for the current authorisation, the holder of an authorisation may submit only the number of the current authorisation. A holder of an authorisation granted in accordance with socio-economic analyse or alternative plan shall submit: Update of the analysis of alternatives, including information about any relevant research and development activities by the applicant If the update of the analysis of alternatives shows that there is a suitable alternative available, he shall submit a substitution plan, including a timetable for proposed actions by the applicant. If the holder cannot demonstrate that the risk is adequately controlled, he shall also submit an update of the socio-economic analysis contained in the original application. If he can now demonstrate that the risk is adequately controlled, he shall submit an update of the chemical safety report. If any other elements of the original application have changed, he shall also submit updates of these element(s). Authorisation may be also reviewed at any time if Changes that affect the risk or the socioeconomic impact appear New information on alternatives becomes available Environmental quality standards are not met All authorisations will be reviewed after a certain time, which will be set on a case-by-case basis. In setting the length of this review period the Commission will take into account relevant information, including the risks of the substance and of alternatives, socio-economic benefits, analysis of alternatives and any substitution plan. If suitable substitutes have become available by the time of the review, the Commission may amend or withdraw the authorisation, even one given for adequate control How to assess PBT and vpvb properties? The data on the intrinsic properties of the substance has to be evaluated to identify whether it possesses one or more of PBT or vpvb properties. Criteria for evaluation are set in Annex XIII. NOTE: although the following criteria do not apply for inorganic substances, but shall apply to organo-metals. 38

39 Table 5.2: Criteria for the identification of persistent, bioaccumulative and toxic substances (PBT-substances). A substance that fulfils all three of the criteria of the sections below is a PBT substance: P Persistence Half-life in marine water > 60 days Half-life in fresh- or estuarine water > 40 days Half-life in marine sediment > 180 days Half-life in fresh- or estuarine water sediment > 120 days Half-life in soil > 120 days B Bioaccumulation Bioconcentration factor (BCF) > 2000 T Toxicity Long-term no-observed effect concentration (NOEC) for marine or freshwater organisms < 0,01 mg/l Substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2, or 3) Other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC. Table 5.3: Criteria for the identification of very persistent and very bioaccumulative substances (vpvb-substances). A substance that fulfils the criteria of the sections below is a vpvb substance: P Persistence B Bioaccumulation Half-life in marine, fresh- or estuarine water > 60 days Bioconcentration factor (BCF) > 5000 Half-life in marine, fresh- or estuarine water sediment > 180 days Half-life in soil > 180 days Where can you find relevant information? Relevant parts in REACH regulation: Title VII. Authorisation Chapter 2: Application of authorisation Article 62: (demands for) the application Article 63: later application Article 64: decision procedure Chapter 3: Authorisation in the supply chain Article 65: obligations to owner of authorisation Article 66: obligations to downstream user Guidance materials: RIP 3.7: Guidance on preparing an Application Dossier for Authorisation RIP 3.2: Methodology guidance to develop a CSR (also) for an authorisation application RIP 3.9: Methodology guidance to develop a SEA (also) for authorisation application Annex XIII: Criteria for the identification of persistent, bioaccumulative and toxic substances and very persistent and very bioaccumulative substances Annex XVI: Socio-economic analysis 39

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41 6. RESTRICTIONS 6.1. Introduction what means restrictions Restrictions are one of REACH elements, name of which are not contained in the abbreviation of regulation (REACH) but still plays an important role. Restriction means any condition for or prohibition of the manufacture, use or placing on the market of chemicals substances on their own, in preparations or in articles What substances fall under restrictions? Substances under restrictions are substances, which cause unacceptable risks to human health or the environment in all European Union countries, therefore also control measures need to be implemented in whole European Union. Restrictions can mean a total ban of the manufacture of a certain substance or just restrictions for certain uses. Restrictions procedure under REACH is similar to previous legislation on marketing and use restrictions under Directive 76/769/EEC, in fact, these restrictions are taken over by REACH regulation. Substances, which are under certain restrictions, are listed in the Annex XVII of the REACH regulation How can restrictions be applied to substances? If there is an unacceptable risk to human health and environment, which occur from manufacture, placing on the market and use of certain substance, annex XVII shall be amended by adopting a completely new restrictions or amending current restrictions. Decision shall take into account the inherent characteristics of the substance, the economic value of the substance, its effect to human health and the environment, possible alternatives for the use of the substance, socio-economic impact of the restrictions. Figure 6.1: Decision process under restrictions 41

42 6.2. What do restrictions mean for a company? Every actor in the supply chain needs to comply with restrictions for use of substances, which are listed in the Annex XVII of the REACH regulation What you need to do if you are a manufacturer or an importer of chemical substance? Figure 6.3: Actions which need to be made by manufacturer and importer What you need to do if you are a downstream user? Figure 6.4: Action which need to be made by downstream user What you need to do if you are a producer of a preparation? Figure 6.5: Actions which need to be made by producer of preparation 42

43 Where you can find relevant information? Relevant parts in REACH regulation: Title VIII. Restrictions on the manufacturing, placing on the market and use of certain dangerous substances, preparations and articles Chapter 1: General issues Art. 67 General provisions Chapter 2: Restrictions process Art.68 introducing new and amending current restrictions Art. 69 Preparation of a proposal Art. 70 Agency opinion Committee for Risk assessment Art. 71 Agency opinion: Committee for Socio- economic Analysis Art. 72 Submission of an opinion to the Commission Art. 73 Commission decision Guidance materials: RIP 4.4: Guidance for the preparation of an Annex XV dossier for restrictions Reference name: Guidance on Annex XV for restrictions This document describes how the authorities (Member States Competent Authorities or the Agency on request from the Commission) can prepare an Annex XV dossier to propose a restriction under REACH Annex XV: Dossiers Chapter 2 Content of dossiers Point 3. Dossiers for restrictions proposal 43

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45 7. INFORMATION FLOW IN THE SUPPLY CHAIN This chapter describes the information flow, which under REACH means that manufacturers, importers, downstream users and distributors will have a number of additional obligations, most noticeably a significant increase in communication up and down the supply chain, as well as requirements for reporting, updating and maintaining information. The communication requirements of REACH shall ensure that not only manufacturers and importers but also downstream users and distributors have the information they need to use chemicals safely. Information relating to health, safety and environmental properties, risks and risk management measures is required to be passed both down and up the supply chain, and between all actors in that supply chain. The main topics of this chapter are: Changes under REACH in Safety Data Sheets (SDSs), which will remain the primary communication tool. A new Classification and Labelling System called Globally Harmonised System of Classification and Labelling of Chemicals (GHS) (only mentioned in REACH, though will enter into force later) Safety Data Sheets What are main changes of SDS under REACH? REACH requires that manufacturers and importers of substances and preparations communicate how the substances can be used safely for humans and the environment. The main method of this communication down the supply chain remains the SDS. The SDS shall be prepared in accordance with similar principles, which applied before. REACH came into force with some minor changes (Article 31): Under REACH the format of the SDS will change - the order of Sections 2 and 3 will be reversed. For substances that require a chemical safety assessment (CSA), the information provided in the SDS must be consistent with the CSA and any relevant exposure scenarios (ES) should be annexed to the SDS. Supplier of a substance or a preparation shall provide safety data sheet for substance or preparation if: substance or preparation is classified as dangerous substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative (according REACH Annex XIII) substance is included in the authorisation list Supplier shall provide safety data sheet for preparation what is not dangerous, but contains: one substance hazardous to human health or environment if concentration 1 % by weight for nongaseous preparations concentration 0,2 % by volume for gaseous preparations one substance that is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative if concentration 0,1 % by weight for non-gaseous preparations concentration 0,2 % by volume for gaseous preparations a substance for which there are Community workplace exposure limit values set A safety data sheet shall be provided free of charge on paper or electronically. 45

46 What information should be communicated if SDS is not required? If a SDS is not required, then the supplier still has to communicate key risk information about the substance or preparation in particular stating if it is subject to authorisation or restriction, together with any other relevant information to enable appropriate risk management measures to be put in place. Suppliers shall update this information and communicate it down the supply chain without delay on the following occasions (Article 32): as soon as new data which may be necessary to enable appropriate risk management measures to be identified and applied become available; once the substance has been registered; once an authorisation has been granted or refused; once a restriction has been imposed. That new information shall be provided free of charge to all former recipients to whom they have supplied the substance or preparation within the preceding 12 months. REACH requires that suppliers of articles inform their customers about substances of very high concern contained in concentrations above 0.1% (Article 33). Consumers can also request such information What information should be communicated up to the supply chain? REACH requires an actor in the supply chain to provide the following information to the next actor or distributor up the supply chain (Article 34): new information on hazardous properties, regardless of use; any other information that may come into question the appropriateness of the risk management measures recommended by the supplier. Distributors shall then pass on that information to the next actor or distributor up the supply chain What are obligations to keep and make available SDSs? REACH requires that workers and their representatives shall be granted access by their employer to the SDS information or other relevant information if SDS is not required about substances and preparations that they use or may be exposed in their work (Article 35). General obligation to keep and make available information is for at least 10 years (Article 36). The safety data sheet shall be supplied, if a downstream user so requests, in the official languages of the Member States in which the substance or preparation is placed on the market, unless the Member State(s) concerned provide otherwise (Article 31(5))) What are the responsibilities of companies for information communication? Here you will find a short schematic overview about the information flow under REACH for four major actors manufacturers, importers, downstream users and distributors. The last table will also define the roles of producers and importers of articles. 46

47 Figure 7.1: Information flow under REACH Information through the Supply Chain RIP 1: Flowcharts on the new EU chemicals legislation REACH 47

48 Table 7.1: Tasks of different stakeholders Role Downstream information flow Upstream information flow Required actions Manufacturer + Importer 1. For dangerous substances and preparations 1 : prepare and supply information in SDS to DUs or distributors. 2. For non-dangerous substances: prepare and supply information for non-dangerous substances to DUs or distributors. For substances 10 tons per year: 3. Exposure scenarios (ES) shall be provided and annexed to the SDS. Obtain information (on uses, use conditions) from downstream users to complete CSA (Chemical Safety Assessment) Evaluate risk for each identified use through whole life cycle. Define the risk reduction measures. 1. Comply with any restrictions on manufacture, placing on the market and use of substances and preparations as set out in Annexes XVI and XVII. 2. Classify and label all substances and preparations that are placed on the market (Directive 67/548/EEC and 1999/45/ EC). 3. Conduct risk assessments and reduce risks for any chemical agent occurring at the workplace (Directive 98/24/EC). 4. Keep REACH information available for a period of at least ten years (Article 33). For substances 1 tonne per year: 5. Implement appropriate risk management measures (RMM) for own manufacture (M) and use (M and I) (Annex XVI). 6. Recommend appropriate risk management measures (RMM) in SDS (Article 29). For substances 10 tonne per year: 7. Perform a chemical safety assessment (CSA), documented in the chemical safety report (CSR) (Article 13). 1. Comply with any restrictions on manufacture, placing on the market and use of substances and preparations as set out in Annexes XVI and XVII. DU + Distributor 1. For dangerous substances and preparations 2 : supply information in SDS to DUs or distributors. 2. For non-dangerous substances: supply information for non-dangerous substances to DUs or distributors. For substances 10 tons/year: 3. For dangerous substances manufactured or imported in quantities of 10 tons per year or more, exposure scenarios (ES) shall be annexed to the SDS to DUs or distributors further downstream. 1. Inform M or I about the use and conditions of your/your client s substance. 2. New hazard information or appropriateness of risk management measures needs to be passed up the supply chain until the M or I of the substance receive the information. (Only DU): 3. If DU use of substance is not covered by the exposure scenarios (ES) in the SDS annex: inform supplier of the use scenario and await new SDS with updated ES(s) or conduct own chemical safety assessment and (if substance usage tonnage 1 tons/year) notify the Agency. 2. Use authorised substances as set out in the authorisation (or apply for authorisation) (Article 53) 3. Implement risk management measures as set out in SDS (Article 34). 4. (Only DU) If DU use is not covered by the SDS annex, conduct own chemical safety assessment and (if DU tonnage =1 tonne/year) notify the Agency (or inform supplier of the use and await new SDS with updated ES(s)) (Article 34). 5. Conduct risk assessments and reduce risks for any chemical agent occurring at the workplace (Directive 98/24/EC). 1 Dangerous in accordance with Directives 67/548EEC or 1999/45EC 2 Dangerous in accordance with Directives 67/548/EEC or 1999/45/EC 6. Keep REACH information available for a period of at least ten years (Article 33). 48

49 Producers of articles Article 33 must be taken into account 1. Inform M or I about the use and conditions of your/your client s substance. The same as above 2. New hazard information or appropriateness of risk management measures needs to be passed up the supply chain until the M or I of the substance receive the information. Importers of articles Article 33 must be taken into account Not applicable 1. Comply with any restrictions on manufacture, placing on the market and use of substances and preparations as set out in Annexes XVI and XVII. 2. Keep REACH information available for a period of at least ten years (Article 33) Where you can find relevant information? Relevant parts in REACH regulation: Title IV. Information in the supply chain Art. 31 Requirements for Safety Data Sheets Art. 32 Duty to communicate information down the supply chain for substances on their own or in preparations for which a safety data sheet is not required Art. 33 Duty to communicate information on substances in articles Art. 34 Duty to communicate information on substances and preparations up the supply chain Art. 35 Access to information for workers Art. 36 Obligation to keep information Guidance materials: RIP 3.2: Guidance on preparing the Chemical Safety Report (CSR). Annex II: Guide to the compilation of safety data sheets 7.2. Classification and labelling What will change in classification and labelling of chemicals under REACH? To implement the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) in EU a new proposal of a regulation is developed and it is currently proceeded parallel in the Council of the European Union and in the European Parliament (the system is only mentioned in REACH, though will enter into force later). GHS will mainly affect chemical substance manufacturers, chemicals importers and producers of preparations. Under the proposed regulation, these groups have the general obligation to self-classify and label their substances and mixtures. Though, professional users, industrial users and producers of articles need to know new rules and how to issue and interpret them. GHS system will also affect workers and consumers involved in hazard communication through labels and SDSs. In the previous 30 years different classification and labelling schemes developed around the world resulted in the same chemical being classified and labelled differently depending on where it was made and also for different purposes, like use and transport. This lead to a lot of confusion for the end user and an ever increasing financial burden for industry What are the objectives and elements of GHS? Main objectives of GHS: To help industry by harmonizing and simplifying the worldwide classification and labelling systems, by reducing compliance costs associated with the numerous current systems and by facilitating international trade. To help users by ensuring more consistent hazard classification and communication leading to better health, safety and environmental protection. To help regulators, manufacturers, importers and end users by supporting and improving the information flow up and down the chemical supply/use chain. 49

50 Key elements of GHS: The GHS regulation will have 2 main elements: A harmonised classification system for chemical substances and mixtures; A harmonised system for hazard communication for workers, consumers and transporters. Fundamentally, GHS is the same as our existing classification and labelling system, as both systems: are hazard based; apply to substances and preparations (referred to as mixtures in GHS); deal with physical, health and environmental hazards existing in chemicals; require suppliers to classify and label on the basis of existing available data; require chemicals to be labelled; require safety data sheets to be supplied to professional users. Still some new terms and changes are foreseen under GHS. Table 7.2: Comparison of existing EU classification and labelling system versus GHS: Existing EU system System for classification and labelling deals only with the supply and use of chemicals Supply labelling and transport labelling are different Orange hazard symbols Risk (R) phrases with the code numbers, e.g. R43 Safety (S) phrases with the code numbers, e.g. S24, S37 Term preparation GHS Applies to both the supply/use and transportation of chemicals Aligning supply with transport regulations there are a number of additional hazard classes and categories being introduced, most notably a number of additional physical hazard classes and categories. Pictograms in the shape of a square set at a point, with a white background and red border Hazard statements Precautionary statements Term mixture How are the hazards classified under GHS? Table 7.3: Classification of hazards under GHS Physical Hazards Health Hazards Environmental Hazards There are 16 GHS physical hazard classes largely based on the already existing criteria used by the UN Model Regulation on the Transport of Dangerous Goods. Each class contains one or more hazard categories: 1. Explosives; 2. Flammable Gases; 3. Flammable Aerosols, 4. Oxidising Gases, 5. Gases Under Pressure, 6. Flammable Liquids, 7. Flammable Solids, 8. Self-Reactive Substances, 9. Pyrophoric Liquids, 10. Pyrophoric Solids, 11. Self-Heating Substances, 12. Substances which, in contact with water, emit flammable gases, 13. Oxidising Liquids, 14. Oxidising Solids, 15. Organic Peroxides 16. Corrosive to Metals. There are 10 GHS health hazard classes in the GHS proposed Regulation: Each class contains one or more hazard categories. 1. Acute Toxicity; 2. Skin Corrosion/Irritation; 3. Serious Eye Damage/Eye Irritation; 4. Respiratory or Skin Sensitisation; 5. Germ Cell Mutagenicity; 6. Carcinogenictiy; 7. Reproductive Toxicity; 8. Specific Target Organ Toxicity - Single Exposure; 9. Specific Target Organ Toxicity - Repeated Exposure 10. Aspiration Hazard. There are 4 GHS Environmental hazard classes in the GHS proposed Regulation: The Proposed Regulation also adds an additional EU hazard class: Hazardous for the Ozone Layer. 1. Acute Aquatic Toxicity; 2. Potential for Actual Bioaccumulation; 3. Degradation for Organic Chemicals 4. Chronic Aquatic Toxicity. 50

51 How does a chemicals label look like under GHS? A GHS label consists of pictograms, signal words, hazard statements, product identifiers and precautionary statements. To ensure that customers can easily take notice of the hazard information on packages, general rules are set out to determine the colours, size of labels, formats, legibility and location of label elements. Supply label The label elements: hazard pictogram(s) signal word, hazard statement and precautionary statement(s) shall be located together on the label. The supplier may choose the order of the hazard and precautionary statements. This requirement is in the existing Classification, Packaging and Labelling (CPL) legislation. Table 7.4: Hazard symbol comparison used today and under GHS Hazard symbols used today Physicochemical Health Environmental Explosive Toxic Dangerous for the environment Oxidizing Harmful or Irritant Flammable Corrosive GHS pictograms Explosive Acutely toxic, cat. 1-3 Dangerous for the environment Flammable Milder health effects Oxidizing Serious health effects Gases under pressure Corrosion Transport label 51

52 Figures 7.2: Transport pictograms, which show the variation in background and colour The Exclamation mark pictogram with the signal word Warning primarily replaces the St. Andrew s cross and its indications of danger, Irritant and Harmful. The GHS hazard statement will replace risk phrases e.g. R41. It will be assigned to: Acute Toxicity (Oral, skin & inhalation), Category 4 Skin Corrosion/Irritation, Category 2 Serious Eye Damage/Eye Irritation, Category 2A Skin sensitisation, Category 1 Specific Target Organ Toxicity (single exposure), Category 3 Figure 7.3: Example of GHS hazard label EU Label GHS Label Irritant Risk of serious damage to eyes Warning Causes serious eye irritation UN 1263CAS# XXXX-xx-x PAINT (2-METHYL FLAMMALINE,LEAD CHROMOMIUM) DANGER Highly flammable liquid and vapour.keep away from heat and ignition sources.causes damage to the liver and kidneys through prolonged or repeated exposure to the skin.keep away from food and drink.wash hands thoroughly after use and before eating. First aidwash affected area of body thoroughly with soap and fresh water. Great Lake Paints Inc., Columbus, Ohio, USA. Telephone