REACH, an American expat’s experience Sean Mahar Euro Safety and Health sean@eurosh.com

REACH REACH Registration, Evaluation and Authorisation of CHemicals

REACH Objectives Protection of human health and the environment Maintenance and enhancement of the competitiveness of the EU chemical industry Prevention of fragmentation of the internal market

REACH Objectives Increased transparency Integration with international efforts Promotion of non-animal testing Conformity with EU international obligations under the WTO On 31 December 2008 the EU Regulation on classification, labelling and packaging of chemical substances and mixtures was officially published, and it entered into force on 20 January 2009. EU Globally Harmonised System (GHS, also known as CLP) will gradually replace the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC). As from 1 December 2010, substances need to be classified, labelled and packaged according to EU-GHS. For mixtures, the transitional phase is until 1 June 2015. The Regulation as published is available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:EN:PDF

REACH In October 2003, the European Commission adopted a proposal for a new EU regulatory framework for chemicals – REACH The REACH regulation entered into force June 1, 2007. Registration Fees The following basic registration fees are taken from Regulation (EC) No 340/2008. There are also reduced submission fees for micro, small and medium enterprises. Tonnage Category Individual Submission (€) Joint Submission (€) 1 - 10 t 1,600 1,200 > 10 t - 100 t 4,300 3,225 >100 t - 1000 t 11,500 8,625 >1000 t 31,000 23,250 The REACH fees Regulation also details fees for updating registration dossiers, requesting confidentiality, PPORD notifications, authorisation applications and appeals.

REACH deadlines 1 June 2007: REACH entry into force 1 Dec. 2008: pre-registration ends 1 Dec. 2010: registration > 1,000 t/y, or CMR 1 or 2 > 1 t/y, or R50-53 (PBT/vPvB) > 100 t/y 1 June 2013: registration > 100 t/y 1 June 2018: registration > 1 t/y year

Registration of basic information all existing and new substances exceeding a production volume of 1 tonne submitted by companies and entered in a central database Article An object which during production is given a special shape, surface or design, which determines its function to a greater degree that does its chemical composition. Examples of articles are a car, a battery and a telephone.

Evaluation of the registered information for all substances exceeding a production volume of 100 tonnes includes development of substance tailored testing programs focus on the effects of long-term exposure

Authorisation for Substances of very high concern (SVHC): Carcinogenic, Mutagenic or toxic to Reproduction (CMR) classified in category 1 or 2, Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) included in Annex XIV of REACH. Once included, they cannot be placed on the market or used after date set “sunset date” unless the company is granted an authorisation.

REACH actions Manufacturers/Importers Registration for all substances >1 tonne Chemical Safety Report (CSR) for all substances >10 tonne Participation in Substance Information Exchange Fora (SIEFs)

REACH actions Downstream Users (Customers) Apply the risk management measures identified in the SDS Exposure Scenario Make their uses known to manufacturers/importers or carry out their own CSA (confidentiality reasons) Contribute to SIEFs

Substance Information Exchange Forum (SIEF) Mandatory forum created during pre- registration to assist the sharing and data collection of REACH compliance information and studies with other registrants of the same substance.

SIEF Members Potential Registrants Third Party Representatives Data Holders Others

CEFIC SIEF Codes Leading Involved Passive Dormant European Chemical Industry Council Brussels-based organization representing the European chemical industry. Leading Involved Passive Dormant European Chemical Industry Council Brussels-based organization representing the European chemical industry. Since its creation in 1972, Cefic has grown to become one of the largest and most efficient advocacy network amongst the industry trade organizations in Europe and in the world. ► representing 29 000 companies that produce 30% of the world chemicals and employ about 1.3 million people. ► 22 national chemical federations and 6 associated federations across Europe. ► Over 170 multicultural staff. ► About 100 Sector Groups adressing issues relative to more than 120 product families. ► Over 50 Strategy Implementation Groups and Issue Teams dealing with the industry's strategic concerns such as REACH, energy, environment, international trade, research & innovation and many others. ► More than 4000 industry experts from companies and federations participate in the Cefic groups. ► Close cooperation with the US, Japan and other major chemical countries through ICCA and many federations and trade unions.

CEFIC SIEF Codes Leading “This is a substance of high strategic importance for my company and I have available resource to (co) lead and drive registration to completion.” Involved “My company is registering and may be actively involved. My company will receive a SIEF progress report, an invoice and an invitation to comment.” dimethyl terephthalate (EC 204-411-8 CAS 120-61-6) 56 Passive 8 Involved 1411 Dormant (47, by indication, the rest by presumption)

CEFIC SIEF Codes Passive “My company has the intention to register this substance. My company will receive a SIEF progress report and an invoice.” Dormant “My company has no intention to register nor to spend money. My company will receive no communications and no invoice (besides mandatory data sharing).”

Registration Dossier Contents: a technical dossier, for substances in quantities of 1 tonne or more per year, and, in addition, a chemical safety report, for substances in quantities of 10 tonnes or more per year.

The Chemical Safety Report The main goal of the chemical safety report (CSR) is to document the chemical safety assessment (CSA), including its conclusions and results. Required for all substances >10 tonne

Chemical Safety Assessment (CSA) Human Health Hazard Assessment Human Health Hazard Assessment of Physicochemical Properties Environmental Hazard Assessment PBT and vPvB Assessment Exposure Assessment Risk Characterization

Chemical Safety Assessment The goal of the CSA is to identify and describe the conditions under which the risks are controlled. Risks are regarded as controlled when the estimated exposure levels do not exceed the derived/predicted no effect levels (DNEL or PNEC).

Chemical Safety Assessment Exposure Assessment Generation of exposure scenario(s) or the generation of relevant use and exposure categories Exposure estimation

Chemical Safety Assessment Exposure Estimation emission estimation assessment of chemical fate and pathways estimation of exposure levels.

Chemical Safety Assessment Risk Characterization human exposure comparison with DNEL environmental exposure comparison with PNEC assessment of the likelihood and severity of an event from physicochemical properties

Risk Characterisation Ratio (RCR) PEC – predicted environmental concentration

DNEL Derived no effect level “the level of exposure above which humans should not be exposed”

DNEL factors Exposure pattern: population likely to be exposed, frequency and duration of exposure, route of exposure

PNEC Predicted no effect concentration “the concentration of the substance below which adverse effects in the environmental sphere of concern are not expected to occur”

PNEC Spheres aquatic (including sediment) terrestrial atmospheric food-chain accumulation microbiological activity of sewage treatment systems

Exposure Scenarios (ES) a set of information describing the conditions under which the risks associated with the identified use(s) of a substance can be controlled. in CSR in Extended Safety Data Sheet ECHA modifies planned exposure scenario format, Agency says changes will not delay development of CSA tool 15-Apr-2009 ECHA is working on a number of modifications to the format of exposure scenarios, which will be an essential element of the Chemical Safety Report (CSR) required for many substances’ REACH registration dossiers. The agency notes that during the REACH Implementation Projects (RIP) 3.2 on information requirements and 3.3 on chemical safety assessment (CSA), two formats were developed for exposure scenarios (ES). These covered: Communication of the ES to downstream users (part D of the Guidance) Information for inclusion in the CSR (part F of the Guidance) These formats were published in the spring and summer of 2008. However, ECHA says since then industry has started to develop a process to communicate on uses and conditions of use within various supply chains, and to test out in which form to communicate the required information to customers. It adds that this work has seen a variety of approaches taken on how to present the ES information to downstream users. Most of these proposals make, in one way or another, reference to the generic sections of an ES—as suggested in part D of the guidance. The agency notes that as yet not many examples exist of the exposure scenario sections of the CSR, which need to contain more assessment-related information than the ES for communication to downstream users. Within the ECHA project for the development of a CSA tool, it became clear that the agency needed to structure the information within the ES in order to enable IT processing. It says this is a pre-requisite to facilitate mass-production and maintenance of safety assessments and the processing of exposure scenario information in supply chains. In particular, ECHA adds, formulators will need to process a high amount of incoming ES information into outgoing information for their customers. Furthermore, the agency says, setting up and using libraries of generic ESs, as organized by the European Chemical Industry Council (CEFIC), requires a defined information exchange standard in order to become useful for the wider market. User requirements have been articulated in the industry consultation group ECHA runs for the CSA tool project. Structuring the information in each generic section of the ES format also led to a discussion on the titles themselves and the expected content of information, so that the information can be appropriately reported under each title. The agency says that during the discussion in the consultation group it became clear that: The CSA tool, and hence the ES, should cover all assessment cases, not only those that can be concluded based on the initial Tier 1 exposure estimates. Therefore, the ES format should be flexible enough to present ES information derived by different methodologies. The format of the ES in the CSR and the ES in the extended safety data sheet (eSDS) should be as similar as possible, and the information in the eSDS-ES should be an extract of the information contained in the CSR. Operational conditions and risk management measures, controlling environmental risks on the one hand and worker and consumer risks on the other, should be kept in different sections of the exposure scenario in order to facilitate targeted reading. ECHA says it decided to modify the ES formats to take into account these additional requirements, from the practical perspective. It believes that the changes will be slight and will not change the required contents of the ES or delay the timing of the development of the CSA tool. The changes envisage: Three different generic formats to fit the specific needs for the different target groups: workers, consumers and the environment A number of sub-headings introduced into the ES format to reflect different types of risk management measures covering all assessment situations under REACH. The latter include reporting appropriate information on strictly controlled conditions in the ES. This was necessary to adapt to the revised Annex XI of the legislation on exposure scenarios to support exposure-based waiving, and to allow ES building for non-threshold endpoints, ECHA says. The modified formats will lead to a draft update of the guidance, and will be fed into ECHA’s consultation procedure for guidance update, a process which should start in May 2009.

Exposure Scenarios (ES) Two facets Operational conditions Risk management measures (RMM)

Exposure Scenarios (ES) Operational conditions processes involved activities of workers and consumers and environment duration and frequency of exposure

Exposure Scenarios (ES) Risk management measures (RMM) to reduce or avoid direct and indirect exposure of humans and the environment during use and disposal

ES contributing scenarios industrial spray painting conditions for mixing and filling of equipment (manually) conditions for mixing and filling of equipment (automated) conditions of cleaning the equipment (manually) conditions of cleaning the equipment (automated) manual spraying with LEV and no respiratory/skin protection manual spraying without LEV, but respiratory/skin protection applied robot-spraying (closed-automated) conditions during drying of coated article (closed-automated) conditions during drying of coated article (open-ventilated)

Occupational Exposure Assessments Three elements emission estimation assessment of chemical fate and pathways; estimation of exposure levels.

Occupational Exposure Assessments

Exposure Modeling Tools ECETOC TRA Stoffenmanager EMKG/ BauA-COSHH ART “Advanced Tool” for inhalation exposure assessment RISKOFDERM BEAT (Bayesian Exposure Assessment Tool) ECHA’s CSA-Tool Chesar

ECETOC TRA Tool

Stoffenmanager www.stoffenmanager.nl 3 different versions: control banding of chemical risks; quantitative exposure assessment, and REACH worker exposure assessment.

Stoffenmanager The “Stoffenmanager” (Dutch for “substance manager”) tool originally is a web-based risk prioritizing tool for small and medium sized enterprises (www.stoffenmanager.nl). The exposure model included in the newest version (version 3.5), which is not yet (early 2008) published on the web, is a quantitative model for estimating inhalation exposure to vapours, aerosols of low volatility liquids and dusts, as well as dermal exposures. The current web-based version of the Stoffenmanager (November 2007) is version 3.0. This version does contain quantitative inhalation exposure estimates for dust, but not yet for vapours and liquid aerosols. It is also available in an English version. In the Netherlands, various branches have developed their own version of the Stoffenmanager tailored to specific needs of their branch. A web-based exposure database containing all relevant Stoffenmanager parameters is developed (STEAMbase) to further underpin and validate the underlying model. The Stoffenmanager exposure model is currently a tool, somewhere in between first Tier models and higher Tier models. The rationale of the underlying exposure algorithm is based on work of Cherrie and Schneider13 but is adapted in several ways. The model uses process information, physicochemical characteristics, and mass balance to assess exposure situations. It needs more information than e.g. the ECETOC TRA. Its use is recommended if the ECETOC TRA tool is not appropriate to use and a slightly more detailed assessment is needed. The model is incorporated in a user friendly spreadsheet format.

EMKG/ BauA-COSHH Tool http://www.reach-clp- helpdesk.de/reach/en/Exposure/Exposure.html part of the “Easy-to-use workplace control scheme for hazardous substances” (EMKG “Einfaches Maßnahmenkonzept für Gefahrstoffe”) of the Federal Institute for Occupational Safety and Health (BAuA).

EMKG/ BauA-COSHH Tool The exposure predictive model of the German “Easy-to-use workplace control scheme for hazardous substances” is a generic tool that can be used to derive a Tier 1 inhalation exposure value for the workplace. The Easy-to-use control scheme of BAuA (the abbreviation EMKG reads “Einfaches Maßnahmenkonzept Gefahrstoffe”) [3] should be seen as an approach for filtering the rather non-risky workplace situations from those requiring detailed attention. It may be used as a first step in the exposure assessment. The exposure assessment part of this tool is based on the banding approach of the COSHH Essentials that was originally developed by HSE (UK) [4]. The tool functions only for inhalation exposure. The tool predicts a lower and an upper value for the exposure range (in mg/m3 for solids and ppm for vapours). The upper value of the exposure range should be used for the risk characterisation, i.e. the comparison with the DNEL-value. Strengths • Very clear and user friendly structure • The output has been shown basically sound for a number of ES • Provides control strategies for a range of common tasks, e.g. mixing, filling etc. • Control guidance sheets are available on the Internet Limitations • The estimates are generic in nature and therefore uncertain to some extent. • It is not possible to use the assessed exposure ranges as a basis for further iterations e.g. considering the duration of exposure (only the influence of short term exposure, i.e. < 15 min/day, is considered) • Validation of the concept is limited • Not suited for gases (handled or released) • Should not be used for tasks where fumes are generated or where dusts are formed through abrasive techniques • Not suited for CMR substances

Advanced Reach Tool (ART) www.advancedreachtool.com Incorporates a mechanistic model of inhalation exposure and a statistical facility to update the estimates with the user’s own data. “This combination of model estimates and data produces more refined estimates of exposure and reduced uncertainty.“

Advanced Reach Tool (ART)

RISKOFDERM http://product- testing.eurofins.com/media/18263/toolkit_setup.zip Eurofins was responsible for a Working Group that developed a toolkit providing employers with means of ranking dermal exposure risks in workplaces and with guidance on control measures for improved protection

RISKOFDERM

Bayesian Exposure Assessment Tool (BEAT) http://xnet.hsl.gov.uk/download/ an advanced probabilistic model for predicting dermal exposure. TNO is developing BEAT together with the UK Health &Safety Executive.

CHEmical Safety Assessment and Reporting tool (CHESAR) Tool http://chesar.echa.europa.eu/ developed by the European Chemicals Agency (ECHA) to support industry in preparing a Chemical Safety Assessment (CSA) and Chemical Safety Report (CSR)

CHEmical Safety Assessment and Reporting tool (CHESAR) Tool

Tool Test Cleaning with MEK Full shift (300 min), daily Wipe applied to large surfaces No ventilation or PPE Large room

Tool Test ART 10,000 mg/m³ ART Bayesian 17,000 mg/m³ 4 measurements (11, 4.1, 9.3, 2.6) 5.7 mg/m³ GM ART Bayesian 17,000 mg/m³ Stoffenmanager 3,693 mg/m³

Risk Management Measures (RMM) Purpose To mitigate hazards identified for occupational users, consumers and to the environment

CLP Regulation on Classification, Labelling and Packaging of Substances and Mixtures Implements GHS in Europe Applies to substances from 1 Dec 2010 Applies to mixtures from 1 June 2015

Extended Safety Data Sheet (SDS) Where ESs developed as a result of conducting a CSA, they must be annexed to the SDS and passed down the supply chain. Supplier informs his customer about the RMM recommended for safe uses of the substance.

http://guidance.echa.europa.eu/guidance_en.htm Part D provides also links to more in-depth guidance on exposure assessment, in particular how to describe uses, how to collect information on operational conditions and risk management measures, and how to carry out exposure estimates. This includes: Brief general description of identified uses and how to give exposure scenarios a short title (Chapter R.12) Risk management measures and operational conditions for building of exposure scenarios, including guidance on how to determine the effectiveness of risk management measures and how to make use of the risk management library initially set up during the development of the current guidance (Chapter R.13). Occupational exposure estimation (Chapter R.14) Exposure estimation related to consumers (Chapter R.15) Exposure estimation related to the environment (Chapter R.16) Chapter R.17 and Chapter R.18 provide guidance on exposure estimates related to life cycle stages subsequent to identified uses (releases from articles and releases from waste life stage). Chapter R.20 explains the terms that are essential for the understanding of the Guidance.